UNIVERSITÀ DEGLI STUDI DI MACERATA
Dipartimento di Diritto Privato e del Lavoro Italiano e Comparato
IUS/03 Diritto Agrario
CORSO DI DOTTORATO DI RICERCA
IN
Diritto Agrario, Alimentare e Ambientale, Nazionale e Comunitario
CICLO XXIV (con proroga)
TITOLO DELLA TESI
The consumer of foodstuffs in the European Union.
Origin, evolution and legislative requirements for food information to consumers
TUTOR
Chiar.mo Prof. Alberto Germanò
DOTTORANDO
Dott. Federica Zolla
COORDINATORE
Chiar.mo Prof. Francesco Adornato
ANNO 2013
A Maria Pia Ragionieri
A cui devo tutto.
Insegnante, guida, madre.
Senza la quale non sarei dove sono oggi.
Grazie.
Bruxelles, 08.01.2013
Mi sia concesso ringraziare le due persone che hanno reso possibile questo lavoro.
Il Professor Alberto Germanò, Maestro impagabile.
Grazie per l’aiuto datomi e soprattutto per la pazienza infinita. Per l’insegnamento continuo in questi
ultimi 5 anni. Uno dei pochi ed ultimi che possono ancora esser chiamati “ docenti”.
Il mio grazie più sincero va infine al mio fidanzato, Nicolò.
Per la pazienza, il supporto e l’incoraggiamento costante.
Nulla sarebbe stato possibile senza di te.
“The consumer of foodstuffs in the
European Union. Origin, evolution and
legislative requirements for food
information to consumers”.
PhD Dissertation by Federica Zolla
INDEX
INDEX .......................................................................................................................................... 1
INTRODUCTION ............................................................................................................................ 3
CHAPTER I: EU Consumer protection policy ................................................................................. 10
1.1
Background, political and economical purposes. .................................................................. 10
1.2
The development of the movement in Europe ..................................................................... 13
1.3
Non-contractual liability as protection of the food consumer: the so called "Snail in the
Ginger Beer Case"- Donoghue v Stevenson- 26th May 1932. ........................................................... 16
1.4
The consumer of foodstuffs in Community legislation. ........................................................ 20
1.5
The notion of consumer ........................................................................................................ 26
1.6
Protection of health: the right to information and labelling claims ..................................... 32
1.7
First reflections: which Labelling for foodstuffs? .................................................................. 33
1.8
The modern age of information to consumers. .................................................................... 39
1.9
Regulation (EU) 1169/2011 of 25 October 2011: refer to Chapter III. .................................. 41
CHAPTER II: European Union’s regime for regulating health claims made on food in commercial
communications ......................................................................................................................... 45
1.10
The area of food and nutrition information as a goal for the European policy- makers. ..... 45
1.11 Towards an healthy diet and harmonised EU rules on nutrition and health claims.
Regulation 1924/2006 ....................................................................................................................... 49
1.11.1
“Reduction of disease risk claims” and “functional claims” .......................................... 53
1.11.2
“Claims referring to children's development and health” ............................................ 54
1.11.3
General principles applied to both nutrition and health claims ................................... 57
1.11.4
The principle of nutrient profiles................................................................................... 60
1.11.5
Mandatory nutritional information. .............................................................................. 64
1.11.6
Community authorisation of the inclusion of health claims ......................................... 66
1.11.7 The Authorization Procedure for Nutrient-Function Claims that were submitted for
approval by January 2008.............................................................................................................. 68
1
1.11.8
National provisions ........................................................................................................ 72
1.11.9 Transitional measures for the use of health claims made on foods that do not comply
with the provisions of Regulation 1924/2006 ............................................................................... 74
1.11.10
1.12
Health claims for probiotics: why EFSA rejected them ............................................. 79
A new and recent tendency: the functional products........................................................... 81
CHAPTER III: Food labelling and food information in the new EU legislation ................................. 87
1.13
Regulation 1169/2011: a corollary of the European system of consumer protection ......... 87
1.14 The EU Commission Proposal for a regulation on the provision of food information to
consumers, Brussels, 30.1 2008, COM (2008) 40 final ...................................................................... 90
1.15
Creating the premises for an informed consumerism .......................................................... 93
1.16
Principles of Regulation 1169/2011 ...................................................................................... 97
1.17
Labelling: content and presentation ................................................................................... 101
1.18
Nutrition information .......................................................................................................... 105
1.19
Voluntary particulars: information on product qualities .................................................... 106
1.20
National measures on additional mandatory particulars.................................................... 109
CONCLUSIONS: The construction of consumer liability ...............................................................114
BIBLIOGRAPHY ..........................................................................................................................119
2
“The consumer of foodstuffs in the European Union. Origin, evolution and
legislative requirements for food information to consumers”
INTRODUCTION
In the present study on the protection of the consumer of foodstuffs in the European Union,
reference will be specifically made to Reg. 1924/2006 on nutrition information and health
claims (chapter II) and to Reg. 1169/2011 on the provision of food information to consumers
(chapter III). It is first and foremost important to underline – before chapter I, dealing with the
history and policy of consumerism – the profiles/aspects underpinning the consumer issue:
that is to say, the consumer’s role as fundamental party in the contracts governed by EU law1
the producer’s duty to inform and the consumer’s right to be informed.
Composed by sources of different nature (EU and national laws; the Constitution, ordinary
laws, provisions of independent administrative authorities, codes of conduct 2), the sector of
consumption has generated a substantial corpus of legislation, bringing the several provisions
on consumers together.
That does not concern the final consumer of foodstuffs specifically 3, but rather the
“consumer” in all the types of contracts in which the consumer is included. The parties to the
contract have clearly and adequately been classed according to the new social context, so as to
protect the interests of the addressees of goods and services 4. During the ancien régime, the
1
Regarding theItalian law, see Codice del Consumo, d.lgs 6 settembre 2005 n. 206 "Codice del consumo, a
norma dell'articolo 7 della legge 29 luglio 2003, n. 229" published in the Gazzetta Ufficiale n. 235 of 8 otober
2005 - Supplemento Ordinario n. 162. See also Alpa e Rossi Carleo (a cura di), Codice del consumo.
Commentario, Napoli, 2005; Cavazzoni, Di Nella, Mezzasoma e Rizzo (a cura di), Il diritto dei consumi: realtà
e prospettive, Napoli, 2008; Cuffaro (a cura di), Codice del consumo e norme collegate, 2a ed., Milano, 2008.
2
See Alpa, Il diritto dei consumatori, IV edizione, Roma-Bari, 2002, p. 10.
3
Refers to the introduction of a final consumer concept, see infra p. 7, p. 34 for the Directive 2000/13 which
contains provisions identifying explicit limits and ban to the goal and contents of labelling. Regarding the EU
food law, see Germanò, Corso di diritto agroalimentare, Torino, 2007. See also Costato, La Politica Agricola
Comune nel settore dell’alimentazione, in Trattato di Diritto Agrario, III, Il diritto agroalimentare, Torino,
2011,p.1 and I principi e requisiti generali della legislazione alimentare, in the same volume, p. 19. For a
compared overview between national and European legislation see Vitolo, Il diritto alimentare nell’ordinamento
interno e comunitario, Napoli, 2003.
4
Concerning the prospective for a European code for contract law see Bonell, Verso un codice europeo dei
contratti, in Europa e diritto privato, 1998, p. 171; Castronuovo, “I principi del diritto europeo dei contratti” e
l’idea di codice, in Riv. dir. com., 1995, I, p. 21; Zencovich, “Il codice civile europeo”, le tradizioni nazionali e
3
individuals subject to the law were distinguished between nobles and non-nobles, or between
merchants and non-merchants. The collection of data such as age, sex, social and economic
situation of the parties was introduced only with time. Today, even though “consumer” is a
neutral formulation5, it is first and foremost a category of contract.
In other words, setting “civil contracts” against “commercial contracts”
6
is not appropriate
anymore. Rather, it is time to counter the “civil” contracts – that any person or civis can sign –
with “market contracts” – in which the person operates as entrepreneur, consumer or user. 7.
The aforementioned approach intends to respond to the asymmetry in contractual power
between the parties, which is the major problem of modern legal systems in the framework of
the fundamental rule of competition within the market. Which is why a new conceptual
category can be inferred, which is suitable to underpin the application of the contractual
arrangements governing goods – including foodstuffs – and services. 8
Thus, if the code determines new conceptual categories as criteria to classify experience, the
jurist interpreting the Community rules on foodstuffs cannot but consider the consumer in the
light of those rules. Therefore, the consumer plays a fundamental role in the interpretation and
argumentation process9.
il neopositivismo, in Foro it., 1998, V, c. 62. And also Alpa e Buccico, La riforma dei codici in Europa e il
progetto di codice civile europeo, in Materiali dei seminari 2001, Giuffrè, 2002.
Although it was conceived since the 70s, a European contract code law did not exist at the time. It might thus be
worth seeing Kahn-Freund, Common law and civil law, Imaginary and real obstacles to assimilation, in
Cappelletti (a cura di), New prospective for a Common law of Europe, Firenze, 1978, p. 14, where he stated that
”[w]hilst political and economic unity […] may require harmonisation of special branches of the law […] to
harmonize entire legal systems is, from the point of view of the political, economic and cultural future of Europe,
a work of supererogation, and, moreover the work perhaps more of a Sysyphus than a Hercules”.
5
Alpa, Il diritto dei consumatori, already mentioned, p. 25.
6
Reference to the Italian civil code of 1865 and the Italian trade code of 1882.
7
See Oppo, Categorie contrattuali e statuti del rapporto obbligatorio, in atti del Convegno del cinquantenario
della Rivista di diritto civile, Il diritto delle obbligazioni e dei contratti: verso una riforma? Le prospettive di
una novellazione del libro IV del codice civile nel momento storico attuale, Treviso, 23-25 marzo 2006,
Bologna, 2006, p.43. Also see Lipari, Prolegomeni ad uno studio sulle categorie del diritto civile, in Riv.dir.civ.,
2009, I, p. 515. See also Gentili, I concetti nel diritto privato europeo, in Riv.dir.civ., 2010, I, p. 761.
8
Zoppini, Il contratto asimmetrico tra parte generale, contratto di impresa e disciplina della concorrenza, in
Riv. Dir. Civ., 2008, I, p. 515. See also Roppo, Contratto di diritto comune, contratto del consumatore, contratto
con asimmetria di potere contrattuale: genesi e sviluppi di un nuovo paradigma, in Riv.dir.priv., 2001 p. 769.
See also Vettori, Libertà di contratto e disparità di potere, in Riv.dir.priv., 2005 p. 743. And see also De Poli,
Asimmetrie informative e rapporti contrattuali, Padova, 2002 and Gentili, Informazione contrattuale e regole di
scambio, in Riv.dir.priv., 2004 p. 555.
9
The importance of the real conditions of both contractors has led to the definition of a “third kind of contract”,
relevant in the business to business sales. Here the weak position refers to one of the business operator. See on
the topic Zeno-Zencovich, Il diritto europeo dei contratti (verso la distinzione tra “contratti commerciali” e
“contratti dei consumatori”), in Giur.it., 1993, IV, p.69. See also Buonocore, Contratti del consumatore e
4
Consequently, while in a purchase agreement the vendor/producer’s counterparty was a
general purchaser according to the civil code, today the foodstuff’s vendor/producer’s
counterparty is the consumer, intended as “a reasonably well informed and prudent
consumer”10. That needs be kept in mind when applying the requirements concerning food
consumption11.
The issue of information about the foods needs to be analysed from both the producer’s and
the consumer’s perspectives.
The producer must inform; the consumer has the right to be informed.
Bearing these two different profiles in mind, when the producer informs, he/she not only has
the opportunity to attract clients
12
, indicating the properties and the characteristics of the
products put on the market, but also and especially the duty to give the consumer all necessary
information to make a free choice, thus respecting the principles of transparency enshrined in
article 10 of reg. 178/2002 on information for citizens. 13. Which is why the label is pivotal 14:
contratti di impresa, in Riv.dir.civ., 1995, I, p.6. See also Di Sabato, Contratti dei consumatori, contratti di
impresa, in Riv. Trim. dir.proc.civ., 1995, p. 657. On the third kind of contract see Pardolesi, Prefazione, in
Colangelo, L’abuso di dipenenza economica tra disciplina della concorrenza e diritto dei contratti. Un’analisi
economica e comparata, Torino, 2004, p. XII; Minervini, Il terzo contratto, in Contratti, 2009, p. 493. See also
Amadio, Il terzo contratto. Il problema, in Gitti, e Villa (a cura di) Il terzo contratto, Bologna, 2008, p. 15;
Scognamiglio, Principi generali e disciplina speciale nell’interpretazione dei contratti dei consumatori, in
Riv.dir.comm., 1997, I, p.950. Regarding the “status” of consumer see Borghi, Lo status di produttore e di
consumatore di alimenti, in Riv.dir.alim., n. 2/2008, p. 3.
10
See Court of Justice 16 July 1998, C-210/96, point 31.
11
See Tamponi, La tutela del consumatore di alimenti: soggetti, oggetto e relazioni, in Rook Basile – Germanò
(a cura di), Agricoltura e alimentazione tra diritto, comunicazione e mercato, Milano, 2003, p. 301. Again
Tamponi, La tutela del consumatore di alimenti nel momento contrattuale: valore delle indicazioni obbligatorie
e volontarie nella formazione del contratto, in Costato – Germanò – Rook Basile, Trattato di Diritto Agrario, III,
Il Diritto agroalimentare, Torino, 2011, p. 584.
Concerning the consumer definition and the food consumer in particular see Art. 2, dir. 20 December 1985, n.
85/577/CEE; Art. 1, D.Lgs. 27 May 2005, n. 102; Art. 2, dir. 5 April 1993, n. 93/13/CEE; Art. 1, dir. 25 May
1999, n. 1999/44/CE; art. 1469-bis c.c. e art. 3, Italian Consumer Code; art. 18, Italian Consumer Code, as
modifed by, Art. 1, D.Lgs. 2 August 2007, n. 146, which implements dir. 11 May 2005, n. 2005/29/CE . The food
consumer definition is specifically mentioned in Art. 3, point 18 of the Reg. (CE) 28 January 2002, n. 178/2002
as the ‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food
business operation or activity. See also Lucifero, La sicurezza alimentare e la tutela degli interessi del
consumatore di alimenti, in Riv.dir.agr., 2008, I, p. 77 and Sirsi, A proposito degli alimenti senza OGM, in
Riv.dir.agr, 2005, I, p. 30.
12
Concerning the mandatory labeling information, see Germanò, Corso di diritto alimentare, Torino, 2007. And
more from the same Author, Sull’etichetta degli alimenti, in Riv. dir. agr., 2010, p. 90 and Le indicazioni in
etichetta (e la loro natura) e i segni degli alimenti, in Riv.dir.agr., 2012, I, p. 207. Lucifero, Etichettatura degli
alimenti: comunicazione legale e comunicazione volontaria, in Diritto e giurisprudenza agraria, alimentare e
dell'ambiente, I, 2009, p. 14.
13
Viti, Commento all’art. 10 del Reg. 178/2002, in Idaic, La sicurezza alimentare nell’Unione europea, in
Nuove Leggi Civili Commentate , 2003, p. 223.
5
transferring a great deal of relevant information to the food market: information about the
nature and quality of goods, about price, possibly about the date and place of delivery of the
good and about the compensation, but also information on the safety requirements the food
product must meet to be put on the food market. The label is therefore expected to show
ingredients, the presence of allergens, the expiry date and the complex nutrition claims. All
these information rules allow the exchange to be considered both from the private law’s
perspective of the contract,
15
and from the public authority’s point of view. The aim is to
protect beforehand all consumers of foodstuffs in the same market16.
Reg. 178/2002 provides for the involvement of EU consumers, imposing on public authorities
in general and on EFSA in particular the duty to inform. 17. That must be taken into account.
In that connection, the communication from the Commission on the Consumer Policy Action
Plan 1999-2001 (COM(1998) 696 final) is worth mentioning18.
14
For a complete overview of food labeling legislation, see Rook Basile, L’informazione dei prodotti alimentari,
il consumatore e il contratto, in Germanò- Rook Basile, Il diritto alimentare tra comunicazione e sicurezza dei
prodotti, Torino, 2005, p. 15. Tommasini, La disciplina giuridica dell’etichettatura degli alimenti, in Costato –
Germanò – Rook Basile, Trattato di Diritto Agrario, III, Il Diritto agroali-mentare, Torino, 2011, p. 494. See
also Albisinni, Etichettatura dei prodotti alimentari, in Banca dati on line “Diritto alimentare”, in
www.leggiditaliaprofessionale.it; Germanò, Informazioni alimentari halal: quale responsabilità per un’etichetta
non veritiera?, in Riv.dir.agr., 2010, I, p. 5. See Puoti, Etichettatura di prodotti agroalimentari: aspetti
problematici, Relazione al XVII Congresso UAE held in Pescara on 19-21 June 2003. More Costato, Le etichette
alimentari nel nuovo regolamento 1169/2001, in Riv.dir.agr., 2011, p.674. See also Albisinni, Il nuovo
regolamento Ue sull’informazione ai consumatori, in http//www.georgofili.net/scheda digitale.asp?IDV=3152
15
Concerning mislading claims and producers liability see Tamponi, La tutela del consumatore di alimenti nel
momento contrattuale: valore delle indicazioni obbligatorie e volontarie nella formazione del contratto, in,
Trattato di Diritto Agrario, III, Il diritto agroalimentare, already mentioned, p. 599. See also Villa, Contratto e
violazione di norme imperative, Milano, 1993; Albanese, Violazione di norme imperative e nullità del contratto,
Napoli, 2003. Galgano, Tratt. dir. civ., II, Padova, 2009, p. 322. See also Germanò, Informazioni alimentari
halal: quale responsabilità per un’etichetta non veritiera?, in Riv.dir.agr., 2010, I, p. 5. And also Capelli, La
responsabilità del produttore (con riferimento alla Direttiva CEE n. 85/374), Parma, 1988. From the same
Author Responsabilità degli operatori del settore alimentare, in Alimenta, XIV, 2006, p. 201.
Regarding the general principle of civil liability see Carnevali, Responsabilità del produttore e prova per
presunzioni, in Responsabilità civile e previdenza, 1996, IV, p. 481. From the same Author, Prevenzione e
risarcimento nelle direttive comunitarie sulla sicurezza dei prodotti, in Responsabilità civile e previdenza, 2005,
I, p. 9
16
Germanò, Il mercato alimentare e la sicurezza dei prodotti, in Riv.dir.agr., 2008, I, p.99. See also Tamponi,
La tutela del consumatore di alimenti: soggetti, oggetto e relazioni, in Rook Basile-Germanò (a cura di),
Agricoltura e alimentazione tra diritto, comunicazione e mercato, Milano, 2003, p. 301.
17
See Sabbatini, Commento agli art. 38-42 del Reg. 178/2002, in Idaic, La sicurezza alimentare nell’Unione
europea, in Nuove Leggi Civili Commentate, 2003, p. 383.
18
See http://ec.europa.eu/consumers/cons_int/serv_gen/links/action_plan/ap01_it.pdf
The right to have access to information is contented in Cartagena Protocol on Biosafety, which is an
international agreement on biosafety, as a supplement to the Convention on Biological Diversity. The Biosafety
Protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms
resulting from modern biotechnology.
6
Furthermore, it is all the more important to consider the consumer’s right to be informed.
Consumers protection law “consists in a discipline of information, that is to say a knowledge
usable to choose goods”19. Which is why, the legal rules governing information are like the
moment when the consumer exercises the freedom to express preference for a producer
against his/her competitors. The market, instead, is where the exchange takes place. The
consumer of foodstuffs can be rightly considered as in need of social protection, since what
he/she eats becomes part of him/herself. Still, if “faulty” products are eaten or drunk the
consumer takes something potentially harmful. Nevertheless, for competing producers the
consumer is the economic entity called to make a decision and a judgement. For that role to
be played appropriately, he/she needs fair and complete information20.
The right to receive information is enshrined in the Universal Declaration of Human Rights
(New York, 1948), in the European Convention for the Protection of Human Rights and
Fundamental Freedoms (Rome, 4th November, 1950), in the Convention on access to
information, public participation in decision making and access to justice regarding
environmental matters (Aarhus, 25th June, 1998), as well as in article 255 of the Treaty of
Amsterdam (now article 15 TFEU) as far as the right of access to documents is concerned 21.
A rule establishing the right to be informed is absent from both EU and Italian national laws;
but legal writers do refer to that right
22
just like it is mentioned in the rules ensuring food
safety23.
19
Irti, La concorrenza come statuto normativo, in Scritti in onore di Emilio Romagnoli, Milano, 2000, p. 943.
20
On this point of view see Losavio, Il consumatore di alimenti nell’Unione europea e il suo diritto di essere
informato, Milano, 2007, p. 238, where the Author refers to the words of Galloni, La funzione del diritto agrario
nella dimensione del mercato dal produttore al consumatore: bisogni, valori e nuovi modelli, in Germanò e
Rook Basile (a cura di) Agricoltura e alimentazione tra diritto, comunicazione e mercato, already mentioned., p.
24: “La consapevolezza che l’informazione attribuisce alla scelta, restituisce a quest’ultima il suo potere; come
nella vita politica la scelta espressa tramite il voto permette l’esercizio della democrazia, così anche nelle
relazioni economiche, se correttamente informati, i consumatori sono portatori di una volontà politica”.
21
Regarding the right to access to the documents on 5 May 1993, the Commission adopted Communication 93/C
156/05 on public access to institutions’ documents which set out the results on a survey on public access to
documents in different Member States and concluded that there was a case for development further the access to
documents at Community level. On 2 June 1993, the Commission adopted Communication 93/C 166/04 on
openness in the Community. In it the Commission elaborated the basic principles governing access to
documents.
22
In the Italian doctrine the right to be informed has been elaborated around the Article 21 of the Italian
Constitution. Starting from the 70s two different profiles arised: one referring to the concept of “freedom of
information” and the other one around the concept of “freedom to be informed”. Two theories have been
diffused: the individualist and the functionalist one. The first one recognizes the freedom of information as
contained in the Italian Constitution, this freedom is only focused on the holders’ interest (in this sense Costanzo,
voce Informazione nel diritto costituzionale, in Dig. Disc. Pubbl., Torino, 1993, p. 332). The second one states
that the freedom of information characterizes the democratic aspect of the Constitution. See Losavio, Il
consumatore di alimenti nell’Unione europea e il suo diritto ad essere informato, already mentioned, p. 34- 38.
7
The Italian legal writers tried to connect that right to constitutional provisions, considering it a
fundamental right, as it belongs to the category of social rights, which are rather instrumental
rights, because they allow social imbalances to be eliminated and to fully and truly exercise
civil and political liberties24.
Now, information is being treated as a legal right
25
and knowledge as a common good.
“Common goods” cannot be considered commodities. “Actually, common goods only exist in
a qualitative relation. We do not ‘have’ a common good (an ecosystem, water), but somehow
we ‘are’ (taking part in) a common good (we are water, we belong to an urban or rural
ecosystem). The same distinction between being and having, just like the one between subject
and object, is questioned by a political theory that considers common goods as crucial26”.
According to such an approach, among common goods one can count “natural common goods
(i.e. the environment, water, pure air) and social common goods (i.e. the cultural heritage,
historical records, knowledge), but also material common goods (i.e. squares, public parks)
and intangible goods (i.e. the world wide web)”27. )”. In that sense, law recognises “every
common good as central, according to the full and immediate satisfaction of its fundamental
rights, to the fulfilment of social duties to express solidarity to the whole group and to
participate in the management of common goods”28.
Concerning the “passive” aspect of the right to be informed, bellowing from the article 21 of the Italian
Constitution, (right of a knowledge, then right to inform and to be informed) see Paladin, Problemi e vicende
della libertà di informazione nell’ordinamento giuridico italiano, in Paladin (a cura) La libertà di informazione,
Torino, 1979, p.1.
23
It could be possible to talk about a real right for the consumer to be informed? The consumer determines his
choices, above all concerning choices linked to food. Several legislations in the Italian panorama refer to the
right of the consumer to be informed, such as the law 10 April 1991 n. 126 “Norme per l’informazione del
consumatore”, the law 30 July 1998 n. 281 “Disciplina dei diritti dei consumatore e degli utenti”, both of them
directly recognize a personal right to be informed for consumers. Referring to the food labeling the d.lgs January
1992 n. 109 implementing the directive 89/395/CEE and the directive 89/396/CEE relating to the labelling,
presentation and advertising of foodstuffs. Do not forget also the Italian Consumer Code, d.lgs 6 th September
2005, n. 206.
24
See Martines, Diritto costituzionale, Milano, 1994, p. 691.
25
Perlingeri, L’informazione come bene giuridico, in Rass.dir.civ., II, 1990, p. 327.
26
Mattei, Beni comuni. Un manifesto, Laterza, Roma-Bari, 2011, p. 52. See also Jannarelli, Relazione generale: i
beni comuni tra vecchi e nuovi paradigmi, in Germanò- Viti (a cura di), Agricoltura e beni comuni (Atti del
Convegno Idaic Lucera- Foggia, 27- 28 October 2011), Milano, 2012, p. 10, and in the same source see also
Rook Basile, Premessa alla I sessione p. 29.
27
Mattei, already mentioned, p. 54.
28
Mattei, already mentioned, p. 60.
8
If knowledge, considered as information received, was counted among common goods – as
not exclusive goods, thus not appropriable by anyone and as non-rival goods, thus usable by
anyone – then information could be easily considered as a fundamental human right.
9
CHAPTER I: EU Consumer protection policy
1.1 Background, political and economical purposes.
Consumption is at the base of almost all economic activities and its role has been expanded by
the development of exchange economies that, in recent decades, has highlighted its
communicative and identifiable definitions. In fact, it is the very existence of adequate
consumer protection itself that allows for the better functioning of economic systems through
the marginalisation of improper enterprises, consolidation of citizens’ rights and the
promotion of economical and social development. The issue of consumer protection has
historic roots: the Old Testament, the Code of Hammurabi and the ancient Indian laws all
hold evidence of prohibition against adulterated food and false weights, even if they should be
considered simple measures to contain transaction costs, a far cry from the modern concept of
consumer-friendly policies29.
An early form of the movement to protect consumers’ rights has its origins in the United
States of America, where before any other country in the world, conditions for the emergence
and rapid development of monopolistic and oligopolistic capitalism were created30 .
Until the early years of the twentieth century, the final consumer was burdened with all the
costs related to quality control of the acquired product, as well as the weight of these costs if
this did not match the expected quality or safety requirements31. The criterion of the retailer's
fault liability came into play only when the negligence was serious and obvious.
The first event to mark the beginning of consumer-friendly policies is the "Antitrust" law
(Sherman Act) of 1890, which was neither designed nor intended to serve that purpose, but
instead aimed to protect the small trade and craft production from the overwhelming power of
monopolists and large industrial agglomerations. The Sherman Act, in fact, excluded all
29
Concerning the relation between religion, magic and diet see, also for the authors mentioned, Babuscio,
Alimenti sicuri e diritto, Analisi di problemi giuridici nei sistemi amministrativi delle Autorità per la sicurezza
alimentare europee e statunitense, Milano, 2005.
30
31
Zunz, Why the american century?, Chicago-London, the University of Chicago press, 1998.
Alpa, Il diritto dei consumatori, Roma-Bari, 2002, p. 3.
10
actions that tended to create a profit from a situation of monopoly. In the first part, the law
prohibited all practices that restricted the chances of competition, such as price controls. The
second part however, forbade companies holding a monopoly on a market segment to use this
to spread out to other sectors. Unfair competition thus became an offense, and with the
passing of time protecting consumers from unfair business practices became the main reason
for this law.
The contribution of women was fundamental to the subsequent development of consumer
protection policy. Middle-class women, who were not freed from domestic work and who had
not even achieved equality with men, became the main consumers in the mass market and
thus acquired a leading role in launching this new form of collective action.
Most American women did not perceive the world with workers’ eyes, since their main
interest was as a consumer.
They were the ones to do the food shopping; they were the ones to manage the family budget
and they were the ones who would suffer most the effects of poor quality, fraud and high
prices32.
Consumer awareness initially manifested itself as a reformist drive to alleviate the lot of the
working class, since the main objective of the National Consumer League, founded in 1898,
was to protect the workers and not the consumers. Florence Kelley, who in May of that year
represented the Consumers League of Chicago at the constituent meeting of the national
organisation, boasted of the great work carried out by her league together with the workers of
the cigar industry to combat factories that exploited workers. Kelley became the promoter of a
"consumer label" designed to reward those companies that treated employees properly and to
punish those who abused workers, especially if they were women and children. Soon,
however, middle-class women hoisted the consumer flag as their own and adapted it to their
clients’ needs: in fact, "Good Housekeeping" published a list of quality food products in 1905,
a year before Congress approved the Food and Drug Act as well as the Meat Inspection Act33.
From there on after, men and women all over the country organised a string of consumer
clubs and voluntary organisations in order to vigil over the quality of products and the
32
Mitchell, The backward art of spending money, in American economic review, June 1912, p. 269.
33
Borchers, et al., The History and Contemporary Challenges of the US Food and Drug Administration, in
Clinical Therapeutics, Vol. 29, No. 1, 2007, p.2.
11
protection of workers. Their activities were supported by the National Bureau of Standards’
test programmes and by the diffusion in American houses of an informative pamphlet “Care
and Repair of the House”.
When in 1936 the first issue of a rival publication, “Consumers Union Reports” came out,
consumer awareness had by then become a widespread reality. The movement never
abandoned its concerns about factory conditions but it concentrated primarily on the quality of
products.
It is therefore clearly evident that the fight against aggressive capitalism and food fraud
provoked the first wave of “Consumerism”.
The second wave of protests in the mid-thirties was established by similar problems:
unexplained increases in consumer prices and marketing of harmful medicines. However,
American consumers, already immersed in the era of mass production, reacted in a more
conscious and decisive manner.
Their reaction, coupled with mass strikes by housewives, led to stronger laws on the
authenticity of food and an extension of the powers of the Federal Trade Commission, to
combat the use of unfair and fraudulent trade practices. It is in this very period that we find
the beginnings of the organisational phenomenon which gave rise to the afore-mentioned
magazine “Consumers Research Bulletin”, as well as to the subsequent birth of “Consumer’s
Union”, an association which is still very active today and known for its broad range of
publications and radio-television broadcasts all over north America on analyses and tests of
services and goods34 .
At this point two problems emerged; first of all, the absolute need for information regarding
product quality and safety, without which the consumer could not make wise choices. The
second problem was related to the consumer’s need to have political representation which
could strengthen the scattered, numerous and still disunited views. The third phase, which
continues today and marks the consolidation of positions as well as consumer awareness,
began in the fifties and finally saw the entrance into the arena of European countries
The first consumer organisation on the old continent was born in Denmark in 1947, and
subsequently, in 1955 in the United Kingdom where it was the actual government who
34
AA.VV., Tendenze evolutive nella tutela del consumatore, Napoli, 1998.
12
established the “Consumer Council” to ensure that consumers were given the possibility to
express themselves on matters that traditionally were reserved to producers. This new phase
was inspired by a different interpretation of the concept of responsibility, which enabled the
transition from a regime of fault-based liability (which had to be proved every time)to the
principle of strict liability 35.
According to this latter principle, it is the manufacturer who bears the burden of proving that
the damage caused by the use of the product does not depend on his conduct, finally offering
a good margin of safety to the consumer. The reasons that led to this reversal of the burden of
proof, which are still valid today, lie in the complexities of mass production in which it is
difficult to pinpoint both the cause of the damage and the subject (amongst the many involved
in the production and distribution chain) to whom attribute the blame. Furthermore, it was
believed that the manufacturer was best placed to work on prevention 36
1.2 The development of the movement in Europe
The situation in Europe was quite different. Denmark and the U.K set an example that was
followed by both the Scandinavian countries and the Benelux area, as well as by France and
Germany. In these countries, the establishment of administrative bodies was to be followed up
in many cases by special legislation.
For its part, the EEC, after a serious declaration of intent in the Treaty of Rome to pursue
active consumer protection, let fifteen years pass before taking up a firm position on
consumerism. In the seventies, in fact, it became accepted within the EEC, that a series of
necessary and urgent measures were needed, not only to defend the health and economical
interests of European citizens but also to harmonise legislation in the member states in order
35
Elkstrom, Revisiting the family tree: historical and future consumer behavior research, in Academy of
Marketing Science Rev., 2003, p. 213.
36
Howard, Buyer behavior in marketing strategy, 4th ed., Englewood Cliffs, 1994.
13
to prevent possible conflict and promote businesses in need of streamlined legislation that
favoured commercial trade37.
Between 1972 and 1975 an intense debate took place on the subject, which underlined how
the field of competition could be extended to consumer protection since the provision
(Articles 85-86 of the Treaty of Rome) confers powers to the Community to legislate on
“limiting production, markets or technical development to the prejudice of consumers”38 .
The resolution of the EC Council of 14 April 1975 systematically reorganised all the
initiatives and priorities in the field of consumer protection and pointed out very clearly that
the objectives of the intervention are:
1) The consumer’s right to protection of health and safety;
2) The consumer’s right to protection of economic interests;
3) The consumer’s right of redress;
4) The consumer’s right to information and education;
5) The consumer’s right of representation (the right to be heard).
Within the European Community the conflicts between the interests of the consumer
protection committees and the industry committees have created a situation of uncertainty,
therefore the early eighties were characterised by sector-specific interventions related to
consumer information, advertising and after-sale guarantees.
Other amendments to the Treaty of Rome by Article 18 of the Single European Act, and more
specifically Article 100 A, seemed to pave the way for a more dynamic consumer policy at
Community level. Furthermore, various community initiatives had forced the member states,
often even those who had made the most progress in enacting legislation in the field of
consumer protection, to adopt provisions that otherwise would not have been foreseen.
37
Alpa, Il diritto dei consumatori, IV ed., Roma-Bari, 2002.
38
Alpa, Il diritto dei consumatori, IV ed, already mentioned., p. 9.
14
In the context of the construction of Europe, the free movement of goods and services cannot
be an end in itself but should only be considered a tool with which to promote the
improvement of living standards, objective referred to in Article 2 of the Treaty39
An even more complex discourse needs to be held in terms of prior recognition and
subsequent protection of the food consumer, as a specific category of “species in genus”
consumer. The food product market has always been particularly sensitive to the consumer
demands of quality and safety; not surprisingly, it is in this sector that the
Court has had to deal for the first time with the issue of direct liability of the producer towards
the consumer40 .
The arrival of mass production has created cracks in the once unified artisanal system of
production and distribution, in the sense that the industrial production of goods is now
entrusted to a number of diverse and specialised subjects other than the final vendor, with
which the buyer no longer has any direct legal relationship. In this perspective, the need to
develop a new form of protection for those harmed by faulty goods placed on the market is
accompanied by the equally important need to regulate and promote modern production
which reaches high standards of safety and quality41
This regulation, moreover, should be able to also protect so-called bystanders, that is to say,
those individuals who come into contact with the defective goods as mere users, without there
being a legal relationship with the supplier of said goods. In fact, the problem related to
manufacturers’ liability is at the core of the matter of consumption, due to the obvious links
between the phenomenon of damages involved in the production process and the society of
mass consumption. The legislation currently being examined is concerned, in general, with
ensuring adequate compensation to those affected by technical errors, defects in the
production process and the large manufacturing industry’s negligence of employees as well as
providing a solution to the problem of rational distribution of the costs associated with these
types of damage42.
39
Costato, Circolazione degli alimenti, competenza nazionale e competenza comunitaria, in Dir. Giur. Agr.,
2004, p. 159.
40
Flandrin- Montanari (a cura di), Storia dell’alimentazione, Roma – Bari, 1997.
41
Verbeke, Agriculture and the food industry in the information age, in Eur Rev Agric Econ, 2005, p. 32.
42
Martinello - Baker, Il consiglio nazionale dei consumatori e degli utenti, in AA.VV., Alpa e Levi (a cura di), I
diritti dei consumatori e degli utenti, Milano, 2001.
15
1.3
Non-contractual liability as protection of the food consumer: the so
called "Snail in the Ginger Beer Case"- Donoghue v Stevenson- 26th
May 1932.
Until 1932, the year in which the House of Lords ruled on the Donoghue case, the consumer
had no legal footing to use against the manufacturer of a defective product and source of
damage.
Up to that moment, the opposing principle of non-liability prevailed, based on the attribution
of a privileged status to certain categories of people, including manufacturers, who therefore
were absolved from the duty to act in accordance with the rights and integrity of others. The
possibility of appealing to the existence of a fault-based liability was not foreseen, in fact
claiming for damages against the tort was not allowed if there was no previous existing
contractual relationship with the latter.
Thanks to the principle enunciated in the case of Donoghue v Stevenson, the "neighbour
principle", the Lords sustained that the defendant owed the plaintiff a general duty of care,
and therefore, condemned the manufacturer to recovery.
The Donoghue v Stevenson case law has been defined not only as "revolutionary" and "single
most important decision in the history of the law of torts' but even as the "most important
decision in all the common law". Of course, one refers to the so called "Snail Case" or "Snail
in the Ginger Beer Case", i.e., to Donoghue v. Stevenson which has not only influenced
English product liability law but (above all) the English law of torts43. The case is important
for historical reasons and there is no doubt that the case matters to contemporary legal
interpretation—its ‘radiating effects’ continue to resonate into the present44.
43
Donoghue v. Stevenson has been treated in several papers; see, e.g., Donoghue v. Stevenson and the modern
law of negligence - the paisley papers (Peter Burns ed.1991); see Stevenson in Retrospect, 20 Mod. L. Rev 1
(1957); Florence O'Donoghue, A half-ce
ntury of neighborliness: Donoghue v. Stevenson reconsidered, law & justice 4, 1984; Alan Rodger, Lord
MacMillan's Speech in Donoghue v. Stevenson, 108 L.Q.R.236 (1992); Criscuoli, Introduzione allo studio del
diritto inglese, Le fonti, Milano, 1981, p. 360.
The problem was the doctrine of privity, due to the fact that Ms. Donoghue had not directly stipulated the
contract for the ginger beer. She didn’t pay the beer, her friend did. The House of Lords ion this case moved the
discipline from the contract itself to the torts. Concerning the doctrine of privity see Criscuoli , Il contratto nel
diritto inglese, Padova, 1990, p. 343. See also Serio, Introduzione a Williams - Hepple, I fondamenti del diritto
dei torts, Napoli, 1983. See also Viglione, L’interpretazione del contratto nel common law inglese. Problemi e
prospettive, in Supplemento annuale di studi e ricerche della Riv.dir.civ., 2008, p.133.
44
Warner, Judicial Reasoning and Precedent: Negligently Inflicted Psychological Injuries, (1990) 10 Legal
Studies (1) 63, 75.
16
It was ten to nine at night on 26 August 1928 when Mrs. Donoghue , a Glaswegian shop
assistant, arrived by tram at the Wellmeadow Café, to meet a friend. Soon after she arrived,
this friend ordered and paid for an ice-cream and ginger beer.
The ginger beer arrived in an opaque bottle and the proprietor of the Wellmeadow, Mr Francis
Minchella, poured some ginger beer over the ice-cream, which Mrs. Donoghue drank.
Sometime later, her friend then lifted the said ginger-beer bottle and was pouring out the
remainder of the contents … when a snail, which had been, unknown to the pursuer, her
friend, or the said Mr Minchella, in the bottle, and was in a state of decomposition, floated out
of the said bottle.
Seeing the snail caused Mrs. Donoghue immediate shock and illness, and over time her
condition became worse. On 29 August 1928 she consulted a doctor and was found to be
suffering from gastroenteritis caused by the snail-infected ginger-beer. Her condition further
worsened and on 16 September 1928 she received emergency treatment at the Glasgow Royal
Infirmary, suffering repeated vomiting, acute pain in her stomach, and mental depression. She
was rendered unfit for her employment.
She lost wages and incurred expense as a result of her injuries and sued the manufacturer of
the ginger beer, Mr. Stevenson, an Aerated-Water Manufacturer, for £500 damages for her
suffering.
Mrs. Donoghue’s legal position seemed hopeless since, as her friend had bought the drink, the
friend and not Mrs. Donoghue had contracted with the proprietor of the Wellmeadow:
therefore, she could not rely on any implied warranty concerning the safety of the drink.
The friend did, however, notice the address of the manufacturer, Mr Stevenson, on the bottle
of ginger beer. The only legal recourse open was to sue Mr Stevenson in negligence, but at
that time, no relationship between manufacturers end consumers was recognised by the law.
In this famous case law, the House of Lords found a new relationship of responsibility in
law— not between Mrs. Donoghue and the proprietor of the café, but between Mrs.
Donoghue and the manufacturer of the ginger beer.
It was held that although he had no contractual connection to her, Mr Stevenson ought to have
had someone like Mrs Donoghue ‘in contemplation’ when producing his ginger beer.
17
The decision produced a new duty of care between manufacturer and consumer, a relationship
which, despite being central to the burgeoning market society of the early twentieth century,
had not previously been the subject of tort law45.
Before this case, manufacturers could send harmful products out into the world with impunity
except towards a limited class of people, with whom they had a contract. The principle
contended was that the manufacturer, or indeed the repairer, of any article, apart entirely from
contract, owes a duty to any person by whom the article is lawfully used to see that it has been
carefully constructed. The principle of tort lies completely outside the region where such
considerations apply, and the duty, if it exists, must extend to every person who, in lawful
circumstances, uses the article made.
However, the case is important beyond the introduction of this specific consumer relationship,
since the ‘neighbour principle’ was a formulation of a general duty of care, which redefined
responsibility between individuals in civil society. This relationship of duty changed tort law,
from a legal responsibility based on specific categories to one that recognised a general
rationale of liability. The case established that tort possessed an underlying logic.
Negligence law thereby became adaptive and opened up to new categories of injury and
relationship that had previously not been imagined by the courts, thereby ‘increasing social
obligation’.
The formulation of a general duty was a creative leap in itself, but it also introduced creativity
as a practice in judicial recognition of tort claims, and meant judges in future cases need not
rely on pre-existing categories in determining claims.
The liability for negligence, is no doubt based upon a general public sentiment of moral
wrongdoing for which the offender must pay. But acts or omissions which any moral code
would censure cannot in a practical world be treated so as to give a right to every person
injured by them to demand relief.
This decision, which some authors consider as being linked to the industrial revolution,
influenced not only product liability law, but the law of torts as well. Up until the beginning
45
Warner, ‘Judicial Reasoning and Precedent: Negligently Inflicted Psychological Injuries’ (1990) 10 Legal
Studies (1) 63, 75. See also Casals, Una panoramica sui “Principles of European Tort Law”, in Responsabilità
civile e previdenza, 2005, II, p. 1277.
18
of the 20th century, English product liability law was based upon the same principles as the
law of tort, i.e., holding the manufacturer liable required not only the proof of his
carelessness, but also proof of a "breach of a particular duty of care owed ... to the victim.
And it was this specific duty of care which, up to the beginning of the 20th century, prevented
the possible application of the law of torts to the manufacturer, "since it was thought that
whereas a person who manufactured - or repaired goods of any kind - was under a duty of
care towards his purchaser or customer, he owed no such duty to any third party with whom
he had no contract."
However, since Donoghue v. Stevenson, product liability has changed: most legal systems
belonging to the common law area have substituted strict liability for fault liability46.
A few years after the famous Donoghue v Stevenson judgment, the principle was extended to
a case of harm to a child injured by the sudden fall of a tombstone; and subsequently was
extended to the liability of repairers, builders, producers of food and beverages, household
appliances, chemical and industrial products, motor vehicles, clothing, while the term
consumer came to include the ultimate consumer of the product and anyone else physically
close who could sustain injury as a result from its use.
46
See Germanò – Massart - Rook Basile, (a cura di), La responsabilità per prodotti difettosi in agricoltura, in
Prodotti agricoli e sicurezza alimentare, Atti del Congresso mondiale di diritto agrario dell’unione mondiale
degli agraristi universitari in memoria di Louis Lorvelle, Milano, 2003, p.529. From the same Author, La
responsabilità civile dell’impresa alimentare per danni da prodotti difettosi, in Banca dati on-line Diritto
alimentare. www.leggiditaliaprofessionale.it, par. 6. See also Giuffrida, La responsabilità civile per danno da
prodotto alimentare difettoso, in, Costato – Germanò – Rook Basile, Trattato di Diritto Agrario, III, Il Diritto
agroalimentare, already mentioned, p. 617. See also Giardina, La responsabilità civile del produttore di
alimenti, in Regole dell’agricoltura regole del cibo, Produzione agricola sicurezza alimentare e tutela del
consumatore, Pisa, 2005, p. 101; Cavaliere, Product Liability in the European Union: Compensation and
Deterrence Issues, in European Journal of Law and Economics, 18, 2004, p. 304, more Borghi, Art. 63 Responsabilità extracontrattuale per danno da prodotto, in AA. VV., Trattato notarile (diretto da F. Preite), Atti
notarili. Diritto comunitario e internazionale, I, Diritto internazionale privato, Torino, 2011, p. 1205. More
Nicolini, Danni da prodotti agroalimentari difettosi/responsabilità del produttore, Milano, 2006; Palmieri., La
responsabilità dell’impresa alimentare, in Paoloni (a cura di) Alimenti, danno e responsabilità, Ed. Angeli,
Milano, 2008, p. 92.See also p. 17 Chapter I and the mentioned notes.
19
1.4 The consumer of foodstuffs in Community legislation.
The analysis of consumer protection and food safety requires preliminary remarks on the
terms of the matter at hand: "food" and "consumer". In order to achieve a high level of
consumer protection and to allow the movement of safe and wholesome food, current
Community legislation takes all aspects of the food production chain into account by moving
from primary production and the production of feed, reaching all the way to the consumer.
This is why it is necessary to identify the individuals covered by protection laws, the object of
the rules of safety and the beneficiary of protection.
The problem of food safety began to emerge, at least in Europe, about sixty years ago, due to
the changing modes of food production and distribution which was now done in bulk47.
This led to the emergence of new problems in terms of health and consumer protection against
the harmful effects arising from unsafe products on the market.
The change of the production system has in fact amplified previously isolated problems: in
the artisanal production system problems with foodstuffs could be considered isolated, while
an error in mass production can determine fault in the series produced as a whole, as well as
with a single specimen.
In the wake of production, distribution has also changed: in the past craftsmen
(manufacturers) and retailers were embodied in the same person, but now the distributor is
completely unrelated to the production process, finding himself to be signatory to a contract
regarding already sealed packs, and therefore not able to perform any quality control checks
on the products. It stands to reason then, that guaranteeing food safety means establishing
independent standards, the effectiveness of which is ensured by actual checks.
The right to food safety was in fact, until a few decades ago, unknown to the law even to the
emerging branch that would later take the name of food law48. It was however, governed
sometimes by criminal law and sometimes by administrative law, from which it takes its
jargon, methods and principles.
The actual attention that was devoted to it by the various national legislatures, rather than
47
Mercurio, Osservazioni sulla sicurezza alimentare, prodotti agricoli e responsabilità civile, in Dir. giur. agr.,
II, 2007, p. 433.
48
Rizzioli, I principi generali del diritto alimentare nella legislazione e giurisprudenza comunitarie, Roma,
2008, p. 27.
20
reflect a holistic approach, was actually inspired by urgency and the need to fight contingent
predicaments49
From the second half of the nineties, however, the legislative situation began to change, and
as a result mainly of the "mad cow crisis" but not only, the Community institutions, even
though faced with more or less legitimate resistance from member states, felt it was time to
draft systematic and consistent regulations in matters of food safety50.
First of all, in terms of norms, that intention was first expressed in the Commission’s Green
Paper on the principles of food law in the European Union in 1997, and more evidently three
years
later
with
the
White
Paper
on
Food
Safety
COM(1999)719-
http://eurlex.europa.eu/LexUriServ/site/it/com/1999/com1999_0719it01.pdf).
Secondly, we must not neglect the fact that a strong impetus to the emergence of food safety
as an independent field of study is derived from the European Union’s membership to the
circuit of large international organisations, with whose trade rules European food safety ones
cannot collide. More precisely, the differences at national level threatened to jeopardise the
objectives of liberalisation implied in the establishment of the WTO, and in particular those of
the Sanitary and Phytosanitary Agreement (the so-called SPS Agreement).
Lastly, a change of consumer awareness occurred; as food and nutrition are no longer just
seen as a necessity and a pleasure but may also give cause for concern, linked to dangers and
emerging risks to human health51. From this point of view, there is a very interesting
Eurobarometer survey commissioned by EFSA (European Food Safety Authority)52, together
with the Directorate General for Health and Consumer Protection of the European
Commission, which has provided a reconstruction of the psychological attitude of the average
49
Frewer, Fischer, Scholderer &Verbeke, Food safety and consumer behavior, in Innovation of Food Production
Systems: Product Quality and Consumer Acceptance, 2003, p. 125.
50
Pennings, Wansink, Meulenberg, A note on modeling consumer reactions to a crisis: The case of the mad cow
disease, in International Journal of Research in Marketing, 2002, 19, p. 91.
51
Worsley, Nutrition knowledge and food consumption: Can nutrition knowledge change food behavior, 2002,
Asia Pac J Clin Nutr 11, p. 579.
52
Concerning the European Safety Authority, see Capelli – Klaus- Silano, Nuova disciplina del settore
alimentare e Autorità europea per la sicurezza alimentare, Milano, 2006. See also Gabbi, L’autorità europea
per la sicurezza alimentare, Genesi, aspetti problematici e prospettive di riforma, Milano, 2009. Adornato, voce
Autorità alimentare per la sicurezza alimentare, in Diritto alimentare. Mercato e sicurezza, BD on line, dir. da
Albisinni, Wolters Kluwer It., www.leggiditaliaprofessionale.it , 2008.
21
food consumer: the latter has an overall positive perception of food, and only one in five
associated it with concerns regarding possible risks or disease53 .
However, paradoxically perhaps, when some of the possible risks associated with food were
brought to the participants’ attention, more of them became fearful.
After the BSE crisis, the Commission showed that it had become aware of the seriousness of
the situation, recognising it to be the right moment to "adjust the structure of their services" (
see the § 5- Part I- Commission Green Paper on “The general principles of food law in the
European union”) and change the law, so incomplete so as not to even contemplate a
definition of food. Only a list of foods existed in the Treaty, prepared for the highly political
purpose of achieving the objectives set out by the CAP (Common Agricultural Policy), in
Article 39 of the Treaty.
These good intentions however, were not followed up by immediate concrete action, so much
so that only in 1999, when the Belgian dioxin crisis emerged, the European Community
seemingly showed not to have learned the lesson and the first regulatory paradoxes came to
light: in fact, most of the laws were related to foodstuffs for animals, rather than for human
consumption.
In spite of the lack of unanimity of viewpoints among economic and political actors as to why
the original Community system of crisis management failed, it is generally accepted that a
reason could be found in the internationalisation of trade. In particular, in the field of public
health the member states have transferred some competence to the Community, and respect of
international obligations have led to the adoption of arbitrational and inefficient decisions.
Connected to this issue is the poor application at national level of measures adopted "outside",
which is ill received by consumers and has resulted in a crisis of confidence in decisionmaking powers. It has therefore been natural for some to define the European model as
"paradoxical" because of the lack of democratic control over the decisions taken in the food
sector and the absence of an explicit precautionary principle54 .
Under these circumstances, the Community institutions could not help but notice the
53
Available online:http://www.efsa.europa.eu/en/riskcommunication/riskperception.htm.
54
On this topic sse Borghi, Il rischio alimentare e il principio di precauzione, in Trattato di diritto agrario, III,
Il diritto agroalimentare, already mentioned, p.53. Also Gradoni, commento all’art.7 Reg. 178/2002, in Idaic, La
sicurezza alimentare nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p. 204. See also
Dehousse- Lewalle, La dioxine, la Belgique et l’Europe, Une nouvelle crise du modèle agricole européen, in
Studia diplomatica, 1-2, 2000, p. 23. For a more specific profile concerning the principle of responsability to
which the European Institutions should be inspired see Jonas, Il principio di responsabilità. Un’etica per la
civiltà tecnologica, Torino, 1993.
22
inadequacy of the existing rules, which only through very broad interpretation could cover the
principle of food safety. Moreover, there was a complete lack of regulation of the food chain.
The afore-mentioned good intentions were later manifested in Regulation (EC) 178/2002 of
the European Parliament and of the Council, which lay down the general principles and
requirements of food law, established the European Food Safety Authority and set out
procedures in matters of food safety55.
This regulation is the basis of all European (and internal) food law, in relation to measures
relating to food and feed in general and in particular.
The wide scope of the regulation is demonstrated by the fact that it takes all aspects of the
food chain into account, from production to processing to consumption, and its main objective
is to ensure a high level of protection of human and animal health, as well as guarantee free
trade of food and feed.
The legal basis on which it is founded is plural: Article 37 of the Treaty (now Article 43),
which justifies the adoption of common agricultural legislation, Article 95 (now Article 114),
aimed at the establishment and functioning of the internal market, Article 133, related to the
common trade policy, and Article 152 (now Article 168),providing for an exception to the
application of the procedure in the field of agriculture when there are measures to be taken in
the veterinary and phytosanitary sectors, justified by the need to protect public health. The
food crisis and the urgent need to remedy the situation have meant that the legislation issued
takes the form of regulations, to be directly applicable and mandatory in all Member States
from the date of entry into force.
The Regulation is highlighted for giving a legal definition to "food" and for introducing a
food policy based on risk analysis and the precautionary principle56.
As far as the first point is concerned, the need to define “food” was urgent since in the
absence of a common legal notion each Member State was free to uphold its own, thus giving
way to the existence of conflicting interpretations, which in turn led to the creation of many
obstacles to the free movement of food within the Union. In particular, the Court of Justice
55
Idaic (a cura di), La sicurezza alimentare nell’Unione europea,in Nuove leggi civili commentate, 2003, n.1-2.
See also Nicolini, Il prodotto alimentare: sicurezza e tutela del consumatore, Milano, 2003.
56
La regolazione e la promozione del mercato alimentare nell'Unione Europea – Esperienze giuridiche
comunitarie e nazionali, Atti del convegno Udine 24.25 Novembre 2006, (a cura di) D’Addezio e Germanò,
Milano, 2006.
23
has been called upon several times over the years to clarify whether a product had to be
classified as food or medicine (529 Cfr. CGCE 30 November 1983, case law n. 227/82; 28
October 1992, case law n. C-219/91; 29 April 2004, case law n. C-387/99 e C-150/00; 9 June
2005, cases law n. C-211/03, C-299/03, C-316/03,and. C-318/03); before the adoption of the
Regulation, the Court had consistently maintained that the differing interpretations could not
be avoided, and accordingly different rules could be applied to the same product.
The Green Paper of 1997 had already highlighted the discontent brought about by this
unsatisfactory situation, and emphasised the need to reach a common legal notion of a
foodstuff; the 2002 regulation acknowledged these signals and in order to give legal certainty
to future food legislation, encodes a clear notion of food or foodstuff in Article 2. (“Any
substance or product, whether processed, partially processed or unprocessed, intended to be,
or reasonably expected to be ingested by humans. Food’ includes drink, chewing gum and
any substance, including water, intentionally incorporated into the food during its
manufacture, preparation or treatment. ‘Food’ shall not include: a)feed; b) live animals
unless they are prepared for placing on the market for human consumption;
c) plants prior to harvesting; d) medicinal [ . . . ], e) cosmetics [ . . . ], f) tobacco and tobacco
products [ . . . ], (g) narcotic or psychotropic substances [ . . . ], h) residues and
contaminants”).
This definition is derived from the Codex Alimentarius (art. 3.1 of the Code of Ethics for
International Trade in Food, : “[ . . . ] food means any substance, whether processed, semiprocessed or raw which is intended for human consumption and includes drink, chewing gum
and any substance which has been used in the manufacture, preparation or treatment of food
but does not include cosmetics or tobacco or substances used only as drugs”) and takes
account of the various definitions known in the Member States, even if a certain similarity
with the concept of food given by the 1990British Food Safety Act is noted. The above
definition is intentionally broad, consistent with the objective of the regulation to control all
stages of production of a food destined for consumption, hence the European legislator’s
decision to have the definition encompass all substances that can be ingested orally, inhaled or
24
taken via gastric intubation, except those expressly excluded57.
There are also some specifically mentioned products, such as drinks, water, chewing gum and
any substance intentionally incorporated into food (such as vitamins, minerals, etc.) in the
course of its manufacture, preparation or treatment: the reason for this explicit mention is
quite clear if you remember the rationale underlying the description of the concept of food:
food needed to be assured its legal status in order to prevent future conflicts58.
The Regulation identifies the recipients of the obligations of protection, the object of the
safety rules and the recipient of protection. Indeed, after having first qualified any public or
private entity engaged in any of the activities related to a stage in the production, processing
and distribution of food (referring equally to either agricultural or commercial business)as an
obligor, the notions of "food" and "consumer" are then identified.
The product put into circulation for direct human consumption becomes "food" from the
moment it is likely to be ingested. It is at this point that consumers are the beneficiaries of
protection that ensures accurate information through proper labelling of the product
characteristics. The food must also have nutritional purposes; in fact, the notion does not
include any food product that is not or not yet intended for consumption, such as plants prior
to harvesting or feed; or if in spite of being ingestible provide no nutritional function, such as
medicines; or if not fit for consumption, such as contaminants59.
57
Concerning the Codex Alimentarius see Hollo, Sobre la base agraria del derecho alimentario, in Revista de
derecho agrario y alimentario, XXV, 2009, p.115. See also Berri-Carugno- Mazzitti, (a cura di), Estratto
dall’appendice del Codice della legislazione alimentare, Che cosa è il Codex Alimentarius, in Riv. Dir. agr,
1992, II, p. 140. Bevilacqua, La Codex Alimentarius Copmmission e la influenza sulle politiche comunitarie e
nazionali, in Agricoltura-Istituzioni – Mercati, n. 1/2006, p. 35. Also Borghi, Valutazione e gestione del rischio e
standards del Codex Alimentarius, in Agricoltura-Istituzioni – Mercati, n. 3/2007, p. 57.
58
Losavio, “Alimenti non sicuri e tutela della salute: il potere residuale degli Stati membri tra libera
circolazione delle merci (artt. 28 e 30) e armonizzazione (art. 95)”, in Dir. giur. agr., 2007, p 170.
59
Costato, Circolazione degli alimenti, competenza nazionale e competenza comunitaria, in Dir. Giur. agr.,
2004, p. 159.
25
1.5 The notion of consumer
From an objective point of view, the recipient of the protection is the “consumer”.
A natural person acting “for purposes which can be regarded as outside his or her trade,
business or profession” or “for purposes that do not fall within the sphere of his commercial
or professional activity”(Council Directive 93/13/EEC of 5 April 1993 on unfair terms in
consumer contracts) or “purposes unrelated to business or profession” (Art. 1469-bis Italian
civil code and art. 3, Italian Consumer Code).
The consumer of foodstuffs is specifically defined in Article 3(18) Regulation (EC) No
178/2002 of 28 January 2002, as the "ultimate consumer of a foodstuff who will not use the
food as part of any food business operation or activity”.
While in general, the consumers identified as being distinguished from both the manufacturer
and the person who uses the product or conduct business, the consumer of foodstuffs in
particular, is identified as the ultimate and final recipient of the product, i.e. as the one who
eats the food.
The consumer is not only the one set aside from the producer, but is also diverse from the
intermediate user, meaning the one who uses food for purposes other than nutritional ones.
So, if consumers are those who use the product as a food or drink, persons who conduct food
retail operations or food business operators inserted in the production of the food, are not
considered as such.
That said, protection of food consumers is the protection of fundamental rights relating to the
person, that is, the right to food safety, the protection of life, health and well-being,
safeguarded by the Article 32 of the Constitution, as well as the right to information which is
functional in achieving the right to an informed choice. Consumer protection is also the
protection of market interests related to consumption, thus the defence of economic
interests60.
60
Gonzales Vaquè, La notion “de consommateur moyen” selon la jurisprudence de la Cour de justice des
Communautés Européennes, in Revue du droit de l’Union Européenne, 2004, 1, p. 69.
26
The main purpose of Regulation 178/2002 is in fact the protection of health, that is to say a
fundamental right of the consumer, seen as a person with essential and non-negotiable rights
to life and safety, effective in all member states and the Community.
In identifying the general objectives of a high level of protection of human life and health,
Article 5 of the Regulation establishes the right to health as a right that takes precedence over
all others. If the legal notion of food contains an intentionally broad definition thus allowing
the European legislator to control all stages of food production, the instrument designed to
ensure a high level of protection of human and animal health is the risk analysis referred to in
Article 6(1) of Regulation (EC) No 178/2002; clarification on the principles and criteria
drawn up and used by the Institutions in order to allow the adoption of appropriate measures
to eliminate or reduce a food safety risk and consequent damage, in particular with regards to
the assessment and management stages61.
The decision to establish a system of close monitoring of food safety risks in order to identify
potential hazards at each step of the food chain is the result of the impact that globalisation
has had on the safety of food and animals, which is why early on in the preamble (n°17),
Regulation 178/2002 states that “Where food law is aimed at the reduction, elimination or
avoidance of a risk to health, the three inter connected components of risk analysis — risk
assessment, risk management, and risk communication — provide a systematic methodology
for the determination of effective, proportionate and targeted measures or other actions to
protect health”.
The process of risk analysis is a reflection of the more general requirement of administrative
transparency, which should inspire scientists and politicians in the transmission of
information during "the entire period of the risk analysis process" (art. 3 Regulation n.
178/2002).
On this basis, part of the doctrine considers the principle of risk analysis to be the expression
of a general principle of Community law, encoded in food legislation. This law is referred to
in Article 253 of the Treaty, which requires the stating of the reasons for Community laws62.
61
Meyer, Risk Analysis in accordance with Article 6, Regulation (EC) No. 178/2002, in European Food and
Feed Law Review, 2006, 3, p. 144.
62
See Gradoni, Commento all’art. 6 del Reg. 178/2002, in Idaic, La sicurezza alimentare nell’Unione Europea,
in Le Nuove Leggi Civili Commentate, already mentioned, 1-2, 2003, p. 199.
27
However, others believe the particular reference to the protection of health and life of humans
prevents us from considering risk analysis as evidence of the general principle of motivation
in the food industry.
The principle is observed by entrusting the risk assessment to highly qualified scientists; this
is why scientific risk assessment in food safety matters has been entrusted to EFSA (European
Food Safety Authority, created with the same Regulation 178 of 2002) whose scientists must
be sufficiently independent in order to disallow political and economic interests from
influencing the evaluation process, which consequently influences its subsequent management
and communication, as was the case during the crisis of the "mad cow" disease. Lastly, the
experts who pronounce themselves on any risk assessment must be transparent, this is shown
by the publication of the proceedings relating to the assessment of risk as well as permitting
access to the information and opinions developed by the scientists.
Once the assessment phase finishes, the management one begins in which the protagonists are
the various European and national policy makers who choose the most appropriate measures
for the prevention and control of possible risks associated with food consumption. The
problem of this phase regards the conciliation of consumer health protection with the
economic interests of national and Community food business operators. For the adopted
measure to be legitimate, it must comply with the general principles of good management,
which means that it must be rigorously scientifically based thus taking the particular
circumstances of the specific risk into account and secondly it must comply with the known
principle of proportionality, which applied to the food sector means that the possible
restrictive trade measures must be appropriate and necessary to achieve the objectives
legitimately pursued.
In this regard it should be noted that the Court of Justice did not deem legitimate the Danish
measures prohibiting the systematic marketing of all products fortified with vitamins and
minerals if no distinction was made in relation to the different vitamins and minerals used or
the level of risk to health that the fortification entailed (Court of Justice, Case law 23rd
September 2003, n. C-192/01, Commission c. Denmark).
Continuing on the subject of vitamins and minerals, the Dutch administrative practice of
authorising the marketing of fortified foods only if the operator demonstrated (so-called
probatio diabolica) that such fortification would respond to a nutritional need of the Dutch
28
population was also considered to not be in compliance with Community law63.
The principle of proportionality also means that, where possible, it is necessary to choose the
least onerous measure amongst several theoretically appropriate ones, so that any
inconvenience caused is not disproportionate to the aims pursued, in the food sector the
Commission's position on this aspect is to consider the attempt to reach a level of zero risk
(so-called zero tolerance)disproportionate, since it is known that a risk can never be totally
cleared, that is totally eliminated.
The practical and direct application of the principle of proportionality requires the carrying
out of a cost-benefit analysis, the benefits and costs of a specific measure; this analysis
consists in comparing the positive and negative consequences most likely to be produced by
the intended measure and those expected in the absence of the adoption of the measure.
European food law (Regulation 178/2002) knows another principle connected to the principle
of risk analysis, the scope of which is undoubtedly more extensive than the first, to the point
that some speak of a European " Ètat de précaution”.
The principle referred to is undoubtedly the precautionary principle laid down in Article 7 of
Regulation (EC) No 178/2002, which should be applied when the potential for adverse effects
to health is detected(resulting from evaluation of the available scientific information).
However, the surrounding scientific uncertainty makes it unfit as such to consent
comprehensive risk analysis.
The conceptual origin of the precautionary principle goes back to the German legal tradition
and it is found for the first time in the Federal Emission Control Act of March 1974; from this
initial area the principle has shifted to other areas, such as chemistry, biotechnology, nuclear
power, all of which were characterised by strong innovation, which, however, did not
correspond to a level of complete and homogeneous techno-scientific knowledge. For these
reasons, according to the general principle (also German) of protection against hazards,
precaution is the political and legislative choice to push the threshold of activation forward
when it comes to government intervention to protect the health and safety of citizens64.
63
Court of Justice 2nd of December 2004 case law n. C-41/02, Commission v Netherlands.
64
Sollini, Il principio di precauzione nella disciplina comunitaria della sicurezza alimentare, Milano, 2006, p. 2.
29
The precautionary principle spread from Germany to beyond the territorial and applicative
boundaries, moving in international environmental law and more generally in the context of
policies aimed at protecting human health65.
Examples of the international reception of the precautionary principle is Principle n°15 of the
Rio Declaration on Environment and Development of 1992, Article 1 of the Cartagena
Protocol on Biosafety in 2000, while human health is cited in Article 5.7 of the WTO
Agreement on the Application of Sanitary and Phytosanitary Measures (the so-called SPS
Agreement) of 1994.
Let us not forget the European Commission’s Communication in 2000 on the precautionary
principle, thanks to which the latter was included in the risk analysis section of the Codex
Alimentarius. It was during the preparatory work on this part of the Codex that contrasts
emerged between the European Union and the United States, due to the non-acceptance of
precautionary Europe, in conflict with the typical pragmatic, science-based American attitude.
This is the political landscape and precautionary context in which the Community initiative to
legally establish the precautionary principle among the fundamental principles of food law,
was developed.
If the political background of the precautionary principle is clear, the legal one, that is the
legal basis referred to in the construction of the community, is less so. The reference is Article
174(2), TEC, which, in listing the four basic criteria of EU environmental policy, expressly
refers to the precautionary principle, unfortunately without defining it.
It was then that the question of whether it is possible to establish a link between said provision
and precaution within food safety matters arose; the uneasily answered issue has even given
rise to a divergence of interpretation between the Court of First Instance and the Court of
Justice.
The first in particular, believes that despite the Treaty mentioning precaution only with
reference to environmental policy it nevertheless can claim a wider scope, and be regarded as
a general principle of Community law66.
According to the Court however, it would be useless to refer to Article 174 TEC, since the
precautionary principle already possesses enough strength of its own and could impose itself
65
Borghi, Le declinazioni del principio di precauzione, in Riv. dir. Agr., 2005, I, p. 714.
66
Case law- 26th November 2002, Cases T-74/00, T-76/00, from T- 83/00 to T- 85/00, T-132/00, T-137/00 e T140/00.
30
as an unwritten general principle of both environmental and food Community law.
It is through adhering to the Court’s statement, that Article 7 of Regulation (EC) No
178/2002, which regulates the relationship between risk and scientific uncertainty, can be
drawn close.
31
1.6 Protection of health: the right to information and labelling claims
As far as the protection of the right to health is concerned, Regulation 178/2002 had to be in
accordance with the other Community provisions whose objective was product health and
safety, namely the Product Liability Directives 85/374/EEC and 1999/34/EC as well as
Directive 2001/95/EC on general product safety, to be applied when there are no specific
Community provisions. In this perspective provisions for information becomes of significant
importance, that is to say the provisions for food labelling. From the point of view of the
relationship between the producer and consumer, freedom of economic initiative is
undoubtedly coordinated with the values connected to the objectification of personality.
Moreover, business activities should not only cover the protection of the right to health, the
guarantee against unfair contract terms, protection against deceptive messages, but also
consider the values of freedom and human dignity67.
An objective criterion for the identification of potential scams and unfair contract terms is the
notion of the so-called "average consumer68"; according to the law this is a normally informed
and reasonably prudent person despite being "a cultural and abstract type" of consumer 69, who
can be identified among a small minority of consumers in a particular market sector.
The criterion of normality and reasonableness with regards to attention and information, is
applied in order to identify the "consumer" category and accompanied by more stringent
criteria aimed at assessing the impact of messages on the individual, (with below average
information and attention span), taking into account, therefore, not the consumer as an
abstract category but the consumer as an individual70.
The concept of protection of the so-called average consumer needs to be objectively balanced
with the principle of free movement of goods.
67
Information as a right to be informed see Masini Il diritto all’informazione e l’etichettatura dei prodotto
agroalimentari: utilità del metodo casistico, in Riv.dir.agr., 2003, III, p. 500 and from the same Author S., Corso
di diritto alimentare, Milano, Giuffrè, 2008, p. 89.
68
See Gonzales Vaqué - La notion “de consommateur moyen” selon la jurisprudence de la Cour de justice des
Communautés Européennes, in Revue du droit de l’Union Européenne, 2004, already mentioned, p. 69. And also
Poncibò, Il consumatore medio, in Contratto e impresa Europa, 2007, II, p. 734; from the same Author, La
nozione di consumatore medio, in Persona e danno, Cendon (a cura di), 2008, p. 23.
69
Court of Justice, 10th September 2009, Cases n. 446/07; Trib. Roma, 25 th February 1998; Trib. Napoli 26th
June 1997; Trib. of Padova, 29th November 1994.
70
Rook Basile, Prodotti agricoli, mercato di massa e comunicazione simbolica, in Dir.giur.agr., 1995, p.138.
32
The protection of consumers against deceptive messages is certainly a value to consider, but
to some extent is subject to the market laws.
Similarly, when we say that deception, if not severe, cannot justify obstacles to the free
movement of goods71 we draw up a system in which the values of the person in terms of
freedom of choice and correct information are guaranteed, but only to the extent to which they
are compatible with the business and free market interests at the basis of Community law72.
The information in fact, indifferently pertains to the consumer in the same way, regardless of
whether the latter is an economic subject, the counterpart of the producer and consumer of
goods or a person in its moral dimension, holder of the fundamental right to be informed in
view of the awareness that choice is an expression of the dignity of the individual as well as a
tool for the protection of health. In this perspective, Article 10 of Regulation 178 imposes an
obligation on national and EU authorities as well as on political and scientific bodies, to
provide information in the case of risk to human health, identifying the food, the risk that it
may present, and the measures taken or about to be taken to prevent, reduce or eliminate that
risk73.
1.7 First reflections: which Labelling for foodstuffs?
Food labels usually contain information that can broadly fall within three main categories
according to their rationale and content. Food labels information can indeed be either
mandatory, optional or prohibited. At first, national regulation aimed at allowing the
consumers appreciate the particular qualities of a given product, and possibly highlight the
health-related qualities of such food74.
However, such discipline, which proved useful for protectionist purposes, became
inapplicable once it was recognised it was not compliant with the European Community rules
71
Zolla, Utilizzo del sorbato di potassio ai fini della conservazione dei prodotti alimentari, in Ri.dir.agr. VI,
2010, p. 379.
72
Di Lauro, Comunicazione pubblicitaria e informazione nel settore agroalimentare, Milano, 2005, p.11.
73
See Germanò e Rook Basile, La sicurezza alimentare, in Il diritto alimentare tra comunicazione e sicurezza,
Milano, 2005, p.291.
74
Worsley, Nutrition knowledge and food consumption: Can nutrition knowledge change food behavior, Asia
Pac J Clin. Nutr 11, p. 579, 2002.
33
on the free movement of goods. Indeed, initially the discipline of food labelling at national
level were designed just for purposes of supervision of the sanitary quality of food75.
This changed once the European Community decided to intervene.
The European Community intervened leveraging on the Article 100 and 100(a) of the (at that
time) current Treaty establishing the European Community. These are the articles that
regulate the establishment and functioning of the common market. In the current version of
the Treaty these articles have been replaced by Articles 115 and 114.
The ratio of the intervention was about giving equal dignity to consumers and industry at the
fulcrum of protection, adding the vital aims of a proper and complete information, and
allowing for a fully informed consumer choice, to the fundamental rules on the competition at
the very basis of the European common market76.
This is also due to the fact that the original aim of such policy was substantially different, i.e.
to ensure sufficient food, essential safety requirements and reasonable prices.
After the Agricultural Policy of the European Community proved successful in guaranteeing
food autonomy and self-sufficiency in Europe, however, not only the focus of such policy
moved from quantitative aims to qualitative ones, but also the decreasing restrictions applied
to the common market and the consequent increase of food products exchanged on a crossborder basis favoured some arguments against the framework itself. Such an increase in the
movement of products within Europe did not take into consideration cultural differences at
national level, rather working on the basis of simple and straightforward rules.
Indeed, the European Community body of rules governing the labelling of foods has swung
between the divergent stances of ensuring the freedom of movement within the common
markets and guaranteeing an appropriate information to European consumers.
75
Turner et al., Label Claims for Foods and Supplements: A Review of the Regulations, in Nutrition in Clinical
Practice, Vol.20, No.1, 2005, p.30.
76
Heckman - Sherry - Gonzales De Mejia, Energy Drinks: An Assessment of Their Market Size, Consumer
Demographics, Ingredient Profile, Functionality, and Regulations in the United States, in Comprehensive
Reviews in Food Science and Food Safety, Vol. 9, 2010, p. 303.
34
Only recently several regulation models have been developed that aim to make the quality and
identity of foodstuffs a verifiable trait of the mass product as well77.
This new regulation models take a rather innovative stance towards food labelling,
considering it part of a “negotiation mechanisms” based on elements such as features, quality,
identity. These elements are indeed considered to be essential and functional for a consumer
to make a proper and free choice, strengthening the trust relationship between the informant
(the producer and his commitment) and the informed (the consumer and his expectations). As
a consequence of such a legal commitment, an obligation arises from the purchase. Such an
obligation is in turn regulated by the contents and several information of the food label of the
given product.
As part of a proper contractual agreement, the consumers are thus attributed by the contents of
the food label the role of beneficiaries of protection, but also as agents of extensive control
and of a certain opportunity to act78.
After these first norms related to food safety and consumer information, during the 70s and
the 80s the European Community adopted further measures on food labels and safety, with an
horizontal stance, i.e. Council Directive (89/398/CEE) of 3 May 1989 "on the approximation
of the laws of Member States relating to foodstuffs for particular nutritional uses”, and
Council Directive 79/112/EEC of 18 December 1978 “on the approximation of the laws of the
Member States relating to the labelling, presentation and advertising of foodstuffs for sale to
the ultimate consumer”.
As mentioned above, Directive 79/112 has a broad scope and does not only focus on food
labelling: indeed, it clearly identifies other elements, such as presentation and advertising as
distinctive of industrially produced food. On the other hand, wholesale food it asserts that
European Member States “retain the right, depending on local practical conditions and
circumstances, to lay down rules in respect of the labelling of foodstuffs” and should use
labelling methods which guarantee “consumer information79”.
77
Becker, European Food Quality Policy: The Importance of Geographical Indications, Organic Certification
and Food Quality Assurance Schemes in European Countries, in The Estey Centre Journal of International Law
and Trade Policy, vol. 10, 1/2009, p.111.
78
Lucifero, Etichettatura degli alimenti: comunicazione legale e comunicazione volontaria, in Dir.giur.agr,
2009, p. 14.
79
See Losavio, Il consumatore di alimenti nell’Unione Europea e il suo diritto di essere informato, already
mentioned, 2007.
35
As for the broad packaged food category, the Directive introduces innovative horizontal rules.
These involve the definition of labelling, which Article 1(3)(a) of said directive defines as
“any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a
foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying
or referring to such foodstuff”; pre-packaged foodstuff, which Article 1(3)(b) defines as “any
single item for presentation as such to the ultimate consumer and to mass caterers, consisting
of a foodstuff and the packaging into which it was put before being offered for sale, whether
such packaging encloses the foodstuff completely or only partially, but in any case in such a
way that the contents cannot be altered without opening or changing the packaging”.
The Directive also contains provisions identifying explicit limits and ban to the goal and
contents of labelling.
Article 2(1)(a) clearly introduced some general definitions and provisions, applicable
horizontally to various packaged food products:
-“labelling,” means “any words, particulars, trade marks, brand name, pictorial matter or
symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or
collar accompanying or referring to such foodstuff” (Article 1(3)(a) Council Directive
79/112/EEC of 18 December 1978);
-“pre-packaged foodstuff" means “any single item for presentation as such to the ultimate
consumer and to mass caterers, consisting of a foodstuff and the packaging into which it was
put before being offered for sale, whether such packaging encloses the foodstuff completely
or only partially, but in any case in such a way that the contents cannot be altered without
opening or changing the packaging” (Article 1(3)(b) Council Directive 79/112/EEC of 18
December 1978);
-“The labelling and methods used must not”:
a) “be such as could mislead the purchaser to a material degree, particularly: (i) as to
the characteristics of the foodstuff and, in particular, as to its nature, identity,
properties, composition, quantity, durability, origin or provenance, method of
manufacture or production; (ii) by attributing to the foodstuff effects or properties
which it does not possess; (iii) by suggesting that the foodstuff possesses special
characteristics when in fact all similar foodstuffs possess such characteristics” (Article
2(1)(a) Council Directive 79/112/EEC of 18 December 1978);
36
- “the name under which a foodstuff is sold” shall be the name provided for in the applicable
Community laws, regulations and administrative provisions and in the absence of which, in
those of the Member State in which the product is sold to the final consumer in accordance
with Article 5 of Council Directive 79/112/EEC of 18 December 1978.
This Directive is thus considered as a milestone in the regulation of information for
consumers in the market, and it goes way beyond the simple provisions for what is allowed,
for what is mandatory and what is prohibited in the labelling of foods. Indeed, this piece of
legislation strikes a balance between the above-mentioned trade off between the need to
information for consumers and the excessive burden caused by “irrelevant information, which
could lead to misinformation and deceptiveness”.
As a consequence of the provisions lay down in the Directive, indeed, it clearly derives that
all the information which are of non-material nature and are required to be inserted into food
labelling, would be deemed as excessive and unlawful because of their negative effect on the
free movement of goods within the common market. The rationale behind such an effect
stems from the fact that only material elements (which are considered as linked to different
needs of consumers) differentiate a food product from another would be considered as
compliant and thus appropriate and proportionate to sugar be reported within food labels.
Directive 89/395/EEC of 14 June 1989 introduced some amendments to The Directive
79/112/EEC. These new provisions focused on some general rules, i.e. the introduction of a
special label for “products subjected to ionizing radiation”. It also introduces the rules for the
“use by” date according to the different categories of fresh and preserved food.
Later on, Directive 90/496/EEC of September 24 1990 introduced specific requirements
relating to so-called "nutrition labelling", stating that the latter is optional, but if a nutrition
information appears on labelling, in presentation or in advertising, nutrition labelling becomes
mandatory.
Community law was finally reorganized and consolidated by the Directive 2000/13/EC of 20
March 2000 on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs.
This Directive, which replaced Directive 79/112/EEC institutes a codification of the rules
already in force, and does not introduce significant changes to those already established. Of
far greater importance are the changes introduced by Regulation (EC) 178/2002 on food
safety, which as well as introducing a long and interesting series of definitions, in particular
37
what is meant by "traceability" (Article 3(15)), also adopts original provisions concerning the
presentation and labelling food and feed, in order to facilitate its traceability (see article 16
and article 18)80. It is a reform that focuses on "transparency" in communicating with
consumers, enabling labelling to become a tool for widespread control, this being a
fundamental element throughout the governing policy of the food market81.
80
Article 3, paragraph I n. 15 of the Regulation 178/2002 gives the definition of traceability as the ability to trace
and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a
food or feed, through all stages of production, processing and distribution. See on Article 3 of Reg. 178/2002,
Germanò – Rook Basile, commento all’art. 3 del Reg.178/2002, in Idaic, La sicurezza alimentare nell’Unione
europea, in Nuove Leggi Civili Commentate, already mentioned, 2003, p. 159. See also Definitions of European
food law, in Costato - Albisinni (editors), European food law, Bologna, 2012, p. 91.
Rook Basile, Il sistema della sicurezza alimentare attraverso le definizioni del regolamento 178/2002, in
Agricoltura – Istituzioni - Mercati, n.3/2007, p. 45.
On traceability see also Costato, La rintracciabilità degli alimenti, in Trattato di diritto agrario, III, Il diritto
agroalimentare, Torino, 2011, p.533; Sirsi, Commento all’art. 18 Reg.178/2002, in Idaic La sicurezza
alimentare nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p.168; and also Di Martino,
Rintracciabilità obbligatoria e rintracciabilità volontaria nel settore alimentare, in Riv.giur. agr, III-2005, p.
141. See also Di Lauro, Comunicazione pubblicitaria e informazione nel settore agro-alimentare, Milano, 2005,
p. 245.
81
Masini, Il diritto all’informazione e l’etichettatura dei prodotti agroalimentari: utilità del metodo casistico, in
Riv. dir. agr., 2003, III, p. 1, p. 500.
38
1.8 The modern age of information to consumers.
Consumers’ behaviour regarding diet is strongly influenced the information given by
producers above all through the new sophisticated communication technics. can be strongly
affected by communication and information. The uncertainty about the quality or about the
safety of the foodstuffs are not always related to more active information research.
Consumers make decisions about food several times a day, choices are determined by a series
of personal and environmental factors. Whether the act of eating is a simple snack decisions
are complex and influences many. The environment either facilitates or impedes the ability of
people to act on their biological predisposition.
Consumers seem to want more pleasure from food, they want to obtain more and more
information about the to get a better diet, to know the environmental and technological
conditions under which the food has been produced82.
Information about health and nutritional composition can be used by consumers in their
choices and in the evaluation of the quality expectations83.
Media and advertising in general play a fundamental role particularly in today’s food
environment, where consumers choices are often based on emotional feelings or follow
bordering routes of information processing. In cases where consumers face uncertainty, an
obvious solution seems to be the provision of more information. However, more information
does not necessarily mean better informed consumer84.
Information is likely to be effective only when it addresses specific information needs and can
be adequately processed and used by its target audience. This point is illustrated by the
experience from a campaign aimed at informing beef consumers about beef quality labelling
and traceability in Belgium85.
82
Grunert, Food quality and safety: consumer perception and demand. in Eur. Rev. Agric. Econ. 32, 2005, p.
369.
83
See Borghi, I requisiti di tutela dei prodotti di qualità, in Riv.dir.alim., n.2/2009, p.11. See also Grunert –
Wills, A review of European research on consumer response to nutrition information on food labels, in J Public
Health, 15, 2007, p.384.
84
Costato, L’informazione dei consumatori postrema frontiera della C.E., in Riv. dir. alim., 2008/4, p.3.
85
Verbeke – Ward & Avermaete, Evaluation of publicity measures relating to the EU beef labelling system in
Belgium, in Food Policy, 2002 27, p. 339. See also: Verbeke & Ward, Consumer interest in information cues
39
Although consumers’ food choices can be influenced by information the real effect of
communication can’t be taken for grant. In particular health and nutrition claims are evaluated
together with motives for food choice such as taste, price and convenience86.
In the 21st century consumers are somewhat more “rational” in their purchase choices; so that
the most paying off strategies in food labelling would be those focusing on “transparent”
labels, on a “near and warm” label, on plausibility and sincerity of the communication87.
Consumers in the modern age are more conscious than in past and, consequently, on the
marketplace a more descriptive labelling could, to some extent, be more appreciated
nowadays than in the past.
In The Omnivore's Dilemma, A Natural History of Four Meals book by Michael Pollan,
published in 2006, the Author asks the clear and frank question of «what we should have for
dinner». And the answer is « as omnivores, the most unselective eaters, we humans are faced
with a wide variety of food choices, resulting in a dilemma». Pollan indeed suggests that,
prior to modern food preservation and transportation technologies, this particular dilemma
was largely resolved, primarily through cultural influences.
Information processing is largely conditional on whether consumers perceive a real need for
information, as well as a clear benefit from engaging in active reasoning and using the
information provided. Such benefits may pertain to reducing consumers’ uncertainty and
improving their objective and subjective knowledge base, or to assisting consumers in making
choices that better align with their actual preferences88.
In the 21 century the labelling and the advertising techniques are complex and sometimes
contain overlapped information. Such information covers the needs and expectations of a
defined target of consumers. In the modern age indeed people spend a lot of time collecting
denoting quality, traceability and origin: An application of ordered probit models to beef labels, In Food Qual
Prefer, 2006, 17, p. 453. Bernues, Olaizola & Corcoran, Labelling information demanded by European
consumers and relationships with purchasing motives, quality and safety of meat. in Meat Sci, 2003, 65, p. 1095.
86
Alba & Hutchinson, Dimensions of consumer expertise. in J Consum Res, 1987, 13, p. 411. See also
Kinnucan, Myrland & Paudel, Relative impacts of health information and advertising on commodity markets: US
meats. in Health, Nutrition and Food Demand, 2003, p. 187.
87
Di Lauro, La comunicazione pubblicitaria comparativa nel settore agroalimentare tra verità e suggestione, in
Riv.dir.agr., I, 2000, p. 87.
88
Noah, A Review of the New York State Task Force on Life & the Law’s Report Dietary Supplements:
Balancing Consumer Choice Safety, in Journal of Law, Medicine & Ethics, Vol. 33, Fasc. 4, 2005, p. 860.
40
information, finding the right shop and selecting products thinking of high quality,
sustainability, and so on. Consumers’ decision making processes take longer than before89.
In other words, tendencies of the new age of communication are drown by selectivity and
strongly influenced by the relation between quality and price. In this view, communication to
consumers should be transparent, informative, near and warm, true and the more and sincere
possible.
1.9 Regulation (EU) 1169/2011 of 25 October 2011: refer to Chapter III.
The need for transparent communication with consumers have finally led to the proposal
submitted by the Commission on 30 January 2008, aiming for a European Parliament and
Council Regulation on the provision of food information to consumers.
This proposal for a Regulation, as stated in the report that accompanies it, was designed to
consolidate and update the two aforementioned areas of labelling legislation, namely the
general food and nutrition labelling respectively covered by Directives 2000/13/EC and
90/496/EEC. In addition to merging and amending the said directives, the Regulation (note
we have moved from the directive instrument to that of a regulation, which is not usual in
dealing with these matters) would affect a large number of other Community sources,
indicated in the same report.
It is interesting to read under which status quo the Commission Proposal was submitted (on
page 5); when evaluating the impact of the possible choices to be made, it is explained that no
intervention would maintain the "current situation, characterized by scattered legislation",
with a number of adverse effects (i.e., “piecemeal and confusing rules undermining the
effective implementation; unjustified burdens on food business because of out-dated,
redundant or unclear requirements; inconsistent consumer use of labels; ineffectiveness of
labelling as a communication tool; failure of the legislation to adapt to changing markets and
consumers' legitimate demands”).
89
Verbeke & Van Kenhove, Impact of emotional stability and attitude on consumption decisions under risk: The
Coca-Cola case in Belgium, in J Health Comm 2002, 7, p. 455. See also Worsley, Nutrition knowledge and food
consumption: Can nutrition knowledge change food behavior, in Asia Pac J Clin.Nutr, 2002, 11, p. 579.
41
November 2011 finally saw the approval of European Parliament and Council Regulation
1169/2011 of 25 October 2011, which amended Regulations (EC) 1924/2006 and (EC)
1925/2006 and the abrogation of Directives 87/250/EEC, 90/496/EEC, 1999/10/EC,
2000/13/EC, 2002/67/EC, 2008/5/EC and Regulation (EC) 608/2004.
Examining the contents of Regulation 1169, as well as other food safety regulations such as
the 178/2002 and those constituting the hygiene package in 2004, we can see that in essence,
we are not dealing with acts of approximation but with the unification of laws, or better even,
with the replacement of national legislation (dating back in time to initial CE legislation), with
Community law. Food labelling has long been regulated by scattered and sometimes confused
and unclear regulations; it was thus desirable to unite them in a single text, the reason behind
choosing the form of a regulation.
The draft, object of our discussion, replaces a very long string of directives. One of the key
challenges to be solved surely was finding the balance between the interests of consumers and
those of the processors and the difficulty of understanding labelling. Among the assertions
contained in the proposal for the regulation, the Commission’s substantially equidistant
position between consumers and producers is evident: in fact, it is stated, among other things,
that “Member States wish to balance the needs of consumers and industry, taking into
account, any issues that are specific to their country”90.
In the same Proposal for the Regulation, the Commission notes that:
– consumers find it difficult to read and understand labels;
– there are a number of foods from which information on allergens91 is missing;
90
Several foodstuffs such as for potatoes, onions, garlic, herbs and spices can be treated with ionizing radiations
in order to improve their hygienic conditions, see Ragionieri, Le regole della produzione degli alimenti e il
trattamento con radiazioni ionizzanti, in Trattato di diritto agrario, III, Il diritto agroalimentare, already
mentioned, p. 133. See also Boniglia, Onori e Sapori (a cura di), Trattamento degli alimenti con radiazioni
ionizzanti, in Rapporto Istisan 04/21, 2004, p. 6; Also Losavio e Babuscio, La normativa per il trattamento degli
alimenti con radiazioni ionizzanti nell’Unione europea e negli Usa, in Economia e dir. Agroalimentare, 2005, n.
2, p. 52. See for the hygienic controls Capelli, Prodotti agroalimentari di qualità: controlli e responsabilità, in
Riv.dir.alim., n. 4/2011, p. 28.
91
Concerning the presence in foodstuffs of allergenic substances see Ragionieri, La disciplina degli allergeni
negli alimenti, in Trattato di diritto agrario, III, Il diritto agroalimentare, Torino, 2011, p. 141; Germanò, La
normativa di riferimento sugli ingredienti allergenici e sull’obbligo della loro etichettatura, in Riv. dir. agr.,
2007, I, p. 379; Losavio, Le regole comunitarie e nazionali relative all’igiene dei prodotti, in Trattato di diritto
agrario, III, Il diritto agroalimentare, Torino, 2011, p. 183. Concerning the Hygienic package see Costato,
L’agricoltura e il nuovo regolamento sull’igiene dei prodotti alimentari, in Dir.giur.agr., 2004, p. 735. See also
Losavio, La riforma della normativa comunitaria in materia di igiene dei prodotti alimentari: il c.d. “pacchetto
igiene”, in Dir.giur.agr., 2004, p. 679. See finally Costato, Sicurezza alimentare e scienza “igienicosanitaria”,
in Agricoltura – Istituzioni - Mercati, n.2/2006, p. 207.
42
– origin labelling is a problematic area;
– there is a legal limbo concerning ingredient listing of alcoholic beverages.
It is certain that consumer interests, in application of the Treaty rules on public health, should
have preferential treatment, but the Commission’s position seems be balanced between the
two interests, even if the first one, the consumer’s, is a real and true right, linked to that of
health, while the latter is obviously and truly just an interest. The Commission appears to be
sensitive to the issue of manufacturers, which may be reflected in consumer prices, but the
balance sought must take into account the opportunity to provide consumers with clear and
certain information, especially regarding sanitation.
We cannot however, omit the fact that at present this mission appears to be almost impossible.
In fact, informing consumers is problematic since the obstacle is found in the difficulty of
reading and understanding of labels.
The new Regulation 1169/2011 (EU) of 25 October 2011, will be applicable from 13
December 2014, except for Article 9(1)(l) (on nutrition labelling), effective from 13
December 2016 and Annex VI, Part B (on “minced meat”), applicable from 1 January 2014.
As pointed out by the European Commission in its Communication of February 2011
(Brussels, 22 February 2011, COM (2011) 77 final), the proposal “consolidates and updates
two important areas of labelling legislation, the general food and nutrition labelling covered
by Directives 2000/13/EC[1] and 90/496/EEC[2] respectively”.
It “recasts also six other Directives concerning the labelling of certain categories of foods.
The objectives of this proposal are:
- To simplify the food labelling legislation by creating a single instrument for
principles and requirements for horizontal labelling requirements regarding general
and nutrition labelling;
- To include specific provisions on the responsibilities along the food chain with
respect to the presence and accuracy of food information;
- To establish measurable criteria for certain aspect of legibility of food labelling;
- To clarify the rules that apply with respect to country of origin or place of
provenance labelling;
- To introduce mandatory nutrition labelling in the principal field of vision for the
majority of processed foods;
43
- To establish a system of governance for certain aspects of voluntary food labelling
through endorsement by Member States.
The new Regulation introduces important innovations, both in terms of the institutional
procedural and expertise profiles, and with respect to the merits of the discipline. The
adoption of a regulation in substitution of the previous directives is a clear indication of a
trend that moves from harmonisation towards the unification of the rules, and places this
legislation within the more general process leading to the adoption of European Codes, which
characterises a large part of the most recent EU legislation. In general terms, the new
regulation has shifted the focus from labelling itself to the more general theme of information
and communication as a means of ensuring the consumer’s active role in making decisions
and choices to buy and consume.
The detailed analysis of the Regulation is deferred to Chapter III.
44
CHAPTER II: European Union’s regime for regulating health
claims made on food in commercial communications
1.10 The area of food and nutrition information as a goal for the
European policy- makers.
The relationship between diet and health has been well known since ancient times because
correct eating habits are at the basis of a person’s harmonious development. The proper
balance in the relationship between diet and health is influenced by environmental conditions
such as climate, disorders (genetic or acquired) and contingent factors such as, for example,
lifestyle or particular activities undertaken. Diet is also conditioned by the availability of food
or raw materials. This however, is increasingly losing importance in the era of globalisation of
markets, which makes it possible to choose from between many different fresh or processed
foods from all over the world92.
Certain foods are suitable not only in satisfying nutritional needs, but also in carrying out
primary functions in terms of health: on one hand, they are used effectively as part of a diet
intended specifically for individuals with certain diseases or with particular physiological
conditions; on the other hand, they play an important role in the maintenance / improvement
of a good state of physical and mental health and in the management of some disease risk
factors in healthy individuals who wish to remain so.
Furthermore, in Europe, particular account needs to be taken of the rapid change of lifestyle
experienced by European citizens, consequence in part of modern working life and the
phenomenon of urbanisation. All these factors have made the areas of food and nutrition
particularly important for policy-makers at European level. For several years now,
Community legislature has repeatedly intervened to regulate the complex discipline of what is
now called food law93.
92
Costato, L’informazione dei consumatori postrema frontiera della C.E., in Riv.dir.alim., 4/2008, p.3.
93
Reinert – Rohrmann - Linseisen, Lifestyle and diet in people using dietary supplements. A German color
study, in European Journal of Nutrition, Vol. 46, 2007, p. 165.
45
The relationship between diet and health has become increasingly important as it affects
various interests such as the free movement of food and consumer protection as protection of
subjective interests.
This is particularly important because what industry is allowed to say about the impact on
health of the foods it sells is an essential element in a number of areas, such as consumer
awareness, consumer education, product research and development, and research-funding
opportunities.
By providing information to consumers, nutrition labels and health claims on foods have the
potential to contribute to the achievement of public health objectives. Labelling provides
consumers with information about the nutritional properties of a food and health claims
(statements connecting a food, food component or a nutrient to a state of desired health)
provide information to consumers about the nutritional and health advantages of particular
foods or nutrients. Health claims are also a marketing technique used by food companies94.
Labels may create confusion if they are not presented in a format that consumers readily
understand.
Although some surveys suggest a high level of understanding, evidence from Europe and
North America indicates that consumers have problems understanding the information
conveyed on labels when presented in certain formats. For example, confusion may arise
about the association between sodium and salt and in interpreting the nutrient quantities on
the label.
The consumer has become more demanding in the purchasing of food; a high level of food
safety and quality is required and interest is shown in the sanitary characteristics as well as the
methods and places of food production. At this level, diverse sanitary, economic,
environmental and social aspects affect consumer choices. In order to ensure adequate
consumer protection, food labelling must be adequate and truthful, with regards to nutrients
and other characteristics of the food.
This is why Community legislation on the labelling of foodstuffs has, for decades, provided
harmonised and detailed guidelines.
Before the approval of Regulation 1169/2011 the rules for the labelling of foodstuffs were
provided by Directive 2000/13 EC (now replaced by Regulation 1169/2011), where labelling
94
Verhagen – Vos – Francl – Heinonem - Van Loveren, Status of Nutrition and Health Claims in Europe, in
Archives of Biochemistry and Biophysics, 501, 2010, p. 7.
46
and its forms of presentation were intended to provide clear and accurate information to
consumers.
In particular, they must not:
(a) be such as could mislead the purchaser as to the characteristics of the foodstuff; by
attributing to the foodstuff effects or properties which it does not possess;
(i) suggest that the foodstuff possesses special characteristics when in fact all similar
foodstuffs possess such characteristics;
(b) attribute to any foodstuff the property of preventing, treating or curing a human
disease, or refer to such properties, subject to Community provisions applicable to
natural mineral waters95 and foodstuffs for particular nutritional uses.
Such prohibitions or restrictions also applied to the presentation and advertising of foodstuffs.
The Directive applied to pre-packaged foodstuffs which were to be delivered to the final
consumer or to restaurants, hospitals, canteens and other similar mass caterers. It did not
apply to products intended for export outside the European Union (EU). The labelling,
presentation and advertising of foodstuffs must not mislead the consumer as to the foodstuff’s
characteristics or effects and attribute to a foodstuff (except for natural mineral waters and
foodstuffs intended for special diets, which are covered by specific Community provisions)
properties for the prevention, treatment or cure of a human illness.
The labelling of foodstuffs m include compulsory information. The particulars indicated on
products must be easy to understand, visible, legible and indelible. Some of them must appear
in the same field of vision. The compulsory particulars include the name under which the
product is sold and list of ingredients, which are listed in descending order of weight and
designated by their specific name, subject to the derogations provided in Annexes I, II, III and
III a). Ingredients which belong to more than one category are indicated according to their
principal function.
The date of minimum durability consists of the day, month and year, except in the case of
foodstuffs that will not keep for more than three months (the day and month are sufficient),
foodstuffs which will not keep for more than 18 months (the month and year are sufficient),
and foodstuffs which will keep for more than 18 months (year is sufficient).
95
Pavesi, L’acqua potabile per il consumo umano: elemento di preparazione ed ingredienti di alimenti e
bevande. Le acque minerali, in Dir.giur.agr., 2011, p. 595.
47
The date shall be preceded by the words: ‘Best before …’ when the date includes an
indication of the day or ‘Best before end …’ in other cases.
In the case of foodstuffs which are highly perishable, the date of minimum durability shall be
replaced by the ‘use by’ date.
The compulsory particulars also include any special storage conditions or conditions of use,
the name or business name and address of the manufacturer or packager, or of a seller
established within the EU territory, the place of origin or provenance where failure to give
such particulars might mislead the consumer, instructions for use should be included to enable
appropriate use of the foodstuff and the indication of the acquired alcoholic strength of
beverages containing more than 1.2 % by volume of alcohol.
48
1.11 Towards an healthy diet and harmonised EU rules on nutrition and
health claims. Regulation 1924/2006
The new and more accurate scientific knowledge about the potential risks related to food
consumption has confirmed the rightness of a multipurpose approach towards nutrition. It has
been indeed recognised that diet and certain foods can meet not only nutritional needs, but can
also bring important contributions to the achievement and maintenance of good health.
In the past, due to the absence of harmonised Community rules on nutrition and health claims,
several Member States have adopted legislation to regulate the use of such claims in the
labelling and advertising of food while others have allowed their use without any regulation.
Hence, the need to codify the whole matter in a Community regulation: Regulation (EC)
1924/200696.
The main purpose of this Regulation is that of ensuring consumers a high level of protection
by making it possible to make informed purchasing decisions97. It ensures the effective
functioning of the internal market, allowing fair competition between businesses and assists in
the promotion and protection of technological innovations in the food industry. The
Regulation, applicable from l July 2007, incorporates the general principles of Directive
2000/13/EC and establishes an exception to the provisions of Article 2(1)(b) of that directive
whereby it consents (as a result of compliance with specific provisions and subject to
authorisation) the use of claims that state or imply that diet and certain foods can make
important contributions to the support and maintenance of health. Regulation 1924 does not
96
For a complete overview of the Regulation, see Costato, Le indicazioni nutrizionali nel regolamento
1924/2006, in Riv. Dir. Agr., 2008, I, p. 299. And also Di Lauro, voce, Indicazioni nutrizionali e health claims,
in Diritto alimentare, Mercato e sicurezza, 3/2011, p. 47. See also Costato – Borghi – Rizzioli, Compendio di
diritto alimentare, V edizione, Padova, 2011.
97
The current legal requirement in Europe is that companies that make claims on food products must prove that
their claims are truthful and that their advertising does not mislead consumers. At this time, there is no legal
requirement to show that the average consumer understands the claim. However, Regulation 1924/2006 states
that they can only be used if there is the expectation that the average consumer will understand their claimed
beneficial effects (article 5.2). This Regulation shall apply to nutritional and health claims made in commercial
communications, whether labelling, presentation or advertising, regarding foods to be delivered as such to the
final consumer, including foods that are placed on the market unpacked or supplied in bulk. All claims have to
comply with the general principles that they are not false, ambiguous or misleading (as laid down in article 3),
and they have to be scientifically substantiated (article 6).
49
acknowledge pharmacological properties in foods, in fact these properties are typical of
medicines only98.
The Regulation 1924, has certainly been one of the most controversial pieces of legislation of
the last decade in the area of EU food law99. Its significant on the food industry, particularly
on functional foods and food supplements, as made its gradual implementation quite complex
and contentious100. The food industry have raised strong critics about some of its provisions,
such as nutrient profiles, that’s why its ongoing implementation has constantly been the
subject of extensive press coverage, with a number of tough political and technical debates,
since its adoption in December 2006101.
The Regulation requires that all such nutrition and health claims comply with the Regulation’s
requirements, in particular, nutrition claims can only be used when they are listed in the
Annex to the Regulation, while health claims must be authorized in accordance with the
Regulation and included in one of the lists of permitted claims. Only health claims that have
been assessed and authorized in accordance with the Regulation 1924 will be permitted on the
EU market.
98
Concerning the dinstiction between foodstuffs and medicinals see Petrelli, I prodotti alimentari della salute, in
Costato-Borghi-Russo e Manservisi (a cura di), Dalla Riforma del 2003 alla PAC dopo Lisbona, Napoli, 2011, p.
298. Capelli-Klauss, Le regole che consentono di distinguere i prodotti alimentari dai medicinali con riferimento
alla disciplina europea, in Alimenta, 2005, p. 153. See also the sentence15 July 2004, C-239/02 Douwe Egberts
concerning the interpretation of the Community rules concerning the labelling and advertising of foodstuffs,
especially coffee. The label “DynaSwelteKoffie” has been considered in contrast with the Eu legislation thus
referring to an health effect. See Germanò-Rook Basile, Manuale di diritto agrario comunitario, Torino, 2010, p.
203.
99
For a complete overview of the Regulation, see Masini, Prime note sulla disciplina europea delle indicazioni
nutrizionali e sulla salute, in Dir. Giur. Agr., 2007, p. 73. How a consumer goes about understanding a particular
nutritional and health claim can be viewed as an example of human information processing where individuals are
exposed to external information, pay a certain degree of attention to it, bring all or some of it into their cognitive
system, perhaps elaborate on it and form an assessment or evaluation that may or may not result in behaviour.
Hence an outline of how this information processing is presumed to work is useful for deciding how best to
assess consumer understanding. Humans are active information processors, so they usually think about and build
on information, rather than just passively respond to it. There is a constant interaction between externally
obtained information and internal knowledge representations already present in memory. This interaction can be
broken down into a series of stages of information processing that individuals may go through before they act
based on the information. In this respect Grunert & Wills, A review of European research on consumer response
to nutrition information on food labels, in J Public Health, 2007, 15, p. 384.
100
Regarding the development of functional food, see Cubadda – Marconi, Sviluppo di alimenti funzionali a base
di cereali arricchiti con beta glucani dell’orzo: una rassegna, in Ingredienti alimentari, 2008, 36, p. 6.
101
Capelli-Klaus, Il Regolamento CE n.1924/2006 in materia di indicazioni nutrizionali e sulla salute da
riportare sulle etichette dei prodotti alimentari, in Diritto Comunitario e degli Scambi Internazionali, Fasc. 4,
2007, p.803.
50
The Regulation 1924 lays down specific provisions regarding the use of all nutrition and
health claims made in commercial communication, whether in labelling, in the presentation or
in the advertising of food to the ultimate consumer or to restaurants, hospitals, schools,
canteens and similar mass caterers, and takes into account the general guidelines of the Codex
Alimentarius.
The nutrition and health claims governed by regulation 1924, ex Article 2(2)(1), have a strict
voluntary basis, that is to say any nutrition and health claim foreseen as required by EU
legislation does not fall within the scope of regulation 1924.
Regulation 1924, ex Article 1(5)(a)(b)(c)(d) applies without prejudice to EU provisions
concerning foodstuffs for particular nutritional uses, exploitation and marketing of natural
mineral waters, quality of water intended for human consumption and food supplements.
Therefore, in the absence of specific provisions on the authorisation of any non-mandatory
health and nutrition claims set out by the sources of law expressly cited in Article 1(5) of
Regulation (EC) No 1924/2006, the nutrition and health claims made on foods which fall
within the scope of the directives subject to regulation No 1924 continue to be subject to the
conditions and general and specific requirements provided for by the EU regulation.
The claims covered by the Regulation are characterised, above all, for their voluntary basis; in
fact pursuant to Article 2(2)(1), they are identified with "any message or representation which
is not mandatory under Community or national legislation, including pictorial, graphic or
symbolic representation, in any form, which states, suggests or implies that a food has
particular characteristics”.
The category of claims is divided into two types: nutrition claims on one hand, defined as any
claim that states, suggests or implies that a food has particular beneficial nutritional properties
due to energy or other nutrients (Article 2(2) (4), and health claims on the other hand,
identified as "any claim that states, suggests or implies that a relationship exists between a
food category, a food or one of its constituents and health" (Article 2(2)(5))102.
102
The new EU legislation on nutrition and health claims emphasizes that the wording of such claims should be
understandable and meaningful to the consumer and they will only be permitted if the average consumer can be
expected to understand the beneficial effects as expressed in the claims. In particular, definitions must be
specified for what constitutes adequate evidence to demonstrate understanding of the claimed beneficial effects.
Furthermore, methods for generating such evidence of understanding must be developed, taking into account the
studies discussed in the ‘conclusions and recommendations’ section, showing that understanding of nutrition and
health claims can be influenced not only by the specific claim made on the product but also by other sources of
51
The key principle laid down in the Regulation is that all nutrition or health claims
must be approved at the EU level through the applicable procedures and be included in a
positive list. Only the claims mentioned in the EU positive lists will be permitted in the EU.
The distinction between the two cases is quite clear, however, there may be threshold cases;
for example when the word "contains" is followed by a reference to a nutrient. In some cases,
this regards the introduction of a health claim. This occurs in those cases in which the name of
the substance or category of substances contains a description, indication of a feature or a link
to a health effect. For example, "contains probiotics"103 (probiotics are associated with health
benefits).
Regarding health claims, the Regulation distinguishes between the type of physiological
effect claimed and type of consumer: hence it provides with different authorisation procedures
and the inclusion in different lists.
It is also described and regulated the particular case of trade mark or brand name which can
be understood as a nutrition or health claim. It can be used in the labelling, presentation or
advertising of a food without having been approved through the authorization processes
established by the Regulation, only when “it is accompanied by a related nutrition or health
claim […] which complies with the provisions of this Regulation” (Article 1(3).) The
trademarks or brand names in existence prior to 2005 is particularly lengthy, as Article 28(2)
provides that such marks and brand names “may continue to be marketed until 19 January
2022 after which time the provisions of this Regulation shall apply”104.
information such as the packaging and advertising. Furthermore, with the introduction of the new legislation for
approval of nutrition and health claims, legislators and companies will need to agree on the appropriate levels of
evidence for adequate consumer understanding and the appropriate use of a method(s) to provide this evidence
so that it is comparable across countries and products. In this respect Verhagen – Vos – Francl – Heinonen Loveren, Status of Nutrition and Health Claims in Europe, in Archives of Biochemistry and Biophysics, 501,
2010, p. 7.
103
Regarding the already mentioned distinction between medicinals and foodstuff, see Petrelli, I probiotici:
criteri per la qualificazione dei prodotti quali alimenti o medicinali nel diritto comunitario, in Riv. Dir. Agr.,
2008, I, p. 539. See also Zolla, Per il diritto comunitario l’aglio liofilizzato in forma di capsule non è un
medicinale, in Riv. Dir. Agr., 2008, II, p. 39. And more Capelli, L’Aglio è un alimento o un farmaco?, in Dir.
Com. Scamb. Int, I, 2010, p. 42.
104
Coutrelis-Corre, The Legal regime of a Community Trade Mark “Construed as a Nutrition or Health Claim”,
European Food and Feed Law Review, 2008, p. 30.
52
1.11.1
“Reduction of disease risk claims” and “functional claims”
Article 2(2)(6) of Regulation No. 1924, states, “‘reduction of disease risk claim’ means any
health claim that states, suggests or implies that the consumption of a food category, a food or
one of its constituents significantly reduces a risk factor in the development of a human
disease”; the claim is subject to a distinct authorisation procedure governed by Articles 15,
16, 17 and 19 which provides for the inclusion in the list referred to in Article 14.
The claims referring to the reduction of disease risk (so called reduction of disease risk
claims) are distinguished from other health related ones called "functional claims"105.
The latter describe or refer to the role of a nutrient or other substance in growth, development
and the functions of the body, the psychological and behavioural functions, slimming or
weight control or reduction in the sense of hunger or an increase in the sense of satiety or to
the reduction of the available energy from the diet (Article 13(l)(a)(b)(c). "Functional claims"
are subject to an authorisation procedure that where appropriate, is cumulative, ex Article
13(3), or individual, pursuant to ex Article 13(5), which refers to Article 18.
The key distinction between the "reduction of disease risk claims" and "functional claims" is
the specification of the physiological effect announced by the health claim. In fact, with
regards to “reduction of disease risk claims”, the physiological effect is the reduction of the
risk of disease resulting from the consumption of the food.
105
Coppens-Fernandez da Silva- Pettman, European regulations on nutraceuticals, dietary supplements and
functional foods: a frame work based on safety, in Toxicology, II, 2006, p. 62.
53
1.11.2
“Claims referring to children's development and health”
Further differentiation made by Regulation 1924 on health claims relates to the recipients of
the claimed physiological effect, distinguishing claims that relate to the development and
health of children from all the others.
These claims, pursuant to Article 14(1), may be provided after being individually authorised
to be included in the list referred to in Article 14 and in fulfilment of all the conditions in
accordance with the procedure laid down in Articles 15, 16 and 19.
Pursuant to Article l0(1) of Regulation 1924, health claims are prohibited unless they comply
with the general requirements in Chapter II and the specific requirements of Chapter IV, and
are authorised by the Commission by the same Regulation and included in the claims referred
to in Articles 13 (health claims other than those referring to the reduction of disease risk and
to children's development and health) and 14 (referring to the reduction of disease risk claims
and claims referring to children's development and health)106.
Anyhow the wording of the provision is unfortunate.
The reference to Article 2(1)(b) of Directive 2000/13 does not apply where claims referring to
children’s development and health are concerned since the latter provision only mentions the
ban on advertising for food referring to diseases. The provision in Directive 2000/13 indeed
does not concern the development and health of children.
At the first reading the European Parliament made the proposal to authorize claims referring
solely to children only after a scientific examination but the proposal was not accepted.
However the aim of the provision even now is to protect the children against inaccurate
claims107.
106
Concerning the matter of obesity as a public problem see Recuerda Girela, La regulation de la publicidad de
alimientos dirigida a menores en el derecho comparado como strategia contra la obesidad, in Revista de
derecho agrario y alimentario, XXV, 2009, p. 77. Indeed in the past years, European population has experienced
an increase in several chronic diseases linked to dietary and lifestyle factors. In particular obesity is increasing at
an alarming rate all over Europe, while warnings about its diffusion have intensified. As a result nutrition-related
measures are highly ranked in the agenda of the European Union political priorities. Specifically, at the end of
2011 the EU introduced new rules on food labelling requirements by adding a nutritional declaration, see
Chapter III Paragraph 3.10 p. 106.
107
Meisterernst – Ballke - llm, Yhe provision on claims concerning the development and health of children in
regulation 1924/2006- better regulation?, in European Food and Feed Law Review, 2008, p. 178.
54
The regulation does not define what “children” means, but this term may be reasonably
understood to indicate an individual in the phase of life between birth and the end of the
period of growth.
The related recital, the one n°16, in any case do not contain any explanation of the terms
“children”, it refers to specific group of consumers such as children under the aspect of
misleading.
On
this
respect
the
UN
Convention
on
the
rights
of
the
Child
(http://www2.ohchr.org/english/law/pdf/crc.pdf) defines child in its article 1 as being “every
human being below the age of eighteen years unless under the law applicable to the child,
majority is attained”.
It is questionable whether Article 14(1) of the Regulation 1926 was intended to cover children
up to that age, because the above definition includes the age of majority as a legal constituent.
It appears more probable to base the matter on the medical distinction of certain age groups,
since the provision refers to children ‘s development and health.
It is also questionable whether an unborn child is to be considered a child. The UN
Convention on the Rights of the Child refers to children only after their completed birth.
In both medicine and law the matter depends on the time of the child’s birth.
Nor do other European legal acts contain a definition of the term “children”108. Claims has to
refer to children’s development and health in order to fall within the scope of application of
Article14(1)(b). A mere reference to growth and development is unlikely to be considered
sufficient for an assumption of this connection. The reason is that Article 23(1)(a) mentions
claims which relate to growth and development as being health claims that should be initially
be included in the list according to Article 13(3).
Hence such claims are not to be considered claims about the development and the health of
children- at least not automatically- although growth and development play a role primarily
where children are concerned.
108
Only Directive 2006/141/EC in Article 2 provides for the definition of infant and young children on infant
formulae and follow-on formulae, namely;
- "infants" means children under the age of 12 months;
- "young children" means children aged between one and three years.
55
The European Commission initially took the view that claims concerning the development
and the health of children were only involved where the term children was used; general
claims which also included children should therefore not constitute claims in the sense of
Article2(1)109 .
The example mentioned by the Commission was: “calcium is good for children’s growth”. In
view of the fact that few studies are conducted with children, the definition criterion is more
likely to be theoretical for most claims.
In addition to it, the Commission stated that all health claims used on products or in
advertisement that are intended to exclusively for children are to be considered health claims
in the sense of Article 14(1)(b).
However the conclusion reached by the Commission was that the borderline between Article
13 and Article 14 should be drawn primarily on the basis of substantiating scientific proof110.
The reason is that the statement made in the Guidance Document of the Standing Committee
on the Food Chain and Animal Health –dated December 2007- that “the classification has not
impact on the level of substantiation needed for the authorization” is not compatible with the
wording of the Regulation. In this respect reference is first made to the first sentence of
Recital 26: “Health claims other than those referring to the reduction of disease risk and to
children’s development and health, based on generally accepted scientific evidence, should
undergo a different type of type of assessment and authorization”.
Hence the legislator proceeded on the assumption of different levels of assessment and
established such different levels last but not least on those grounds. Otherwise it would have
been possible to institute a uniform procedure for all claims111
109
Nielsen, Feenstra , Recession in food”, in Functional Foods Symposium, April 2009, Amsterdam.
110
Turner. et al., Label Claims for Foods and Supplements: A Review of the Regulations, in Nutrition in Clinical
Practice, Vol.20, No.1, 2005, p.30.
111
Roberfoird, Scientific concepts of functional foods in Europe: Consensus document, in British Journal of
Nutrition, 81, Suppl. 1, p. 1.
56
1.11.3
General principles applied to both nutrition and health claims
Chapter II of the Regulation is entitled “General principles” and applies to both nutrition and
health claims that, under Article 3(I), “may be used in the labelling, presentation and
advertising of foods placed on the market in the Community only if they comply with the
provisions of this Regulation”.
Article 3, second sentence also lays down specific restrictions in addition to a general ban on
misleading claims112.
Article 3(2) provides that without prejudice to Directives 84/450/EEC and 2000/13/EC, the
use of nutrition and health claims shall not:
(a) be false, ambiguous or misleading;
(b) give rise to doubt about the safety and/or the nutritional adequacy of other foods;
(c) encourage or condone excess consumption of a food;
(d) state, suggest or imply that a balanced and varied diet cannot provide appropriate
quantities of nutrients in general;
(e) refer to changes in bodily functions which could give rise to or exploit fear in the
consumer, either textually or through pictorial, graphic or symbolic representations.
The provision in this article lists five groups of claims the use of which is prohibited. The
bans extend to “the use of nutrition and health claims”. As a matter of principle, the use of
nutrition claims has to be consistent with the positive list according to Article 8 and the
Annex of the Regulation. As a rule, claims that satisfy these requirements will not be
considered misleading. The provisions of Article 3(2) can play a role in the authorisation
procedure, i.e. in the assessment by EFSA of a health claim applied for, in accordance with
Article 16(3)(b) and in the development of a proposal for the wording of a health claim
pursuant to Article 16(4)(c). The provision in Article 3(2)(c) prohibits the use of nutrition and
health claims which encourage or condone the excessive consumption of a food. The
112
Studies of consumer understanding of nutritional communications and nutritional and health claims have
been carried out for a variety of different reasons and using a wide range of approaches. Objectives range from
improving nutrition communication and evaluation of potential regulatory strategies28 to improving marketing
communications for food products with claims and evaluation of new business opportunities. In this respect
Rhymerr, Issues Surrounding Health Claims for Barley, in The Journal of Nutrition, 2008, p. 1237.
57
significance of this provision lies in the valuation of health claims during the authorisation
procedure. The advertising for a food will condone its consumption so it could be difficult to
judge the extent to which such consumption is excessive.
According to Article 4(1), nutrition and health claims may be borne by foods or certain
categories of foods that correspond to specific nutrient profiles based on scientific knowledge
about diet and nutrition and their relation to health. These profiles were to be set by the
Commission, together with the conditions of use of the claims, by January 19, 2009 using the
regulatory procedure with scrutiny referred to in Article 25(3), after acquiring a relevant
scientific opinion from EFSA and consulted stakeholders (in particular food business
operators and consumer groups). With the same procedure, and after consulting the parties
concerned, the updates would be decided113.
Several consumer groups in the European Union and some Member States requested Article
4; it leans towards preventing foods, with scientifically unfavourable nutritional profiles
owing to an unbalanced relationship between diet, nutrition and health, from inducing
consumer choice through the use of claims. According to EFSA the “profiles will also help
ensure that consumers who utilise claims to guide healthy diet choices, and who may perceive
foods bearing claims as having a nutritional or health advantage, are not misled as to their
overall nutritional value”114.
Since the submission of the first draft of the Regulation (in the year 2003) the Regulation has
been the subject of political and technical debates.
The Regulation indeed would prohibit true statements, it was argued that misleading
statements were already banned under other EU provisions.
The EU legislator has, in fact, responded to the criticism in the course of the legislative
procedure and has integrated the interdictions of Article 11 intended in the first draft into the
provision of Article 10(3)115.
113
Costato, Le indicazioni nutrizionali del Reg. n. 1924/2006, in Riv. Dir. agr., 2008, I, p. 301.
114
European Food Safety Authority (2008) The setting of nutrient profiles for foods bearing nutrition and health
claims pursuant to Article 4 of the Regulation (EC) No. 1924 /2006 (Request No EF SA-Q-2007-058). Scientific
Opinion of the Panel on Dietetic Products, Nutrition and Allergies, adopted on 31 January 2008. The EFSA
Journal 644, p. 1–44, http://www.efsa.europa.eu/en/scdocs/doc/644.pdf.
115
The additional mandatory labelling requirements referred to in Article 10(2) must be indicated when health
claims are made, including during the transition period laid down in Article 28(5) for health claims as referred to
in Article 13(1)(a). They are not necessary when only nutrition claims are made. This information must be
displayed on-pack, except if no such pack exists, in which case it must be displayed in the presentation and
advertising for the product in question. If the information is already included on the label, it is not necessary to
58
The full ban of nutrition and health claims for foods not conforming to specific nutrient
profiles has been eased by the provision of Article 4(2) described afterwards for cases in
which a single nutrient exceeds the nutrient profile.
All measures taken by the EU legislator have to be proportional and satisfy the standards of
European Fundamental Rights116
mention it in the presentation and/or advertising for the product in question. The exact wordings of the required
statements are under the responsibility of the food business operator.
Concerning Article 10(3) general and non-specific references to the benefits of the product or substance for
overall good health are only permitted if accompanied by a specific health claim included in the Community list
or approved via the Article 14 procedure. However, this requirement can only be enforced when the Community
list of permitted health claims will be published (Article 13 claims), unless the generic statement refers to a claim
that has already been authorised (Article 13(5) claims or Article 14 claims).
Concerning the Article 11 it refers specifically to “national associations (…)”. Therefore, a strict interpretation
of the Regulation would restrict the scope of Article 11 to national associations only, excluding thereby
European and international associations of medical, nutrition or dietetic professionals and health-related
charities. However, as there are no a priori clear legal or scientific reasons to treat European or international
associations in a different way as national associations, it is expected that this provisions will also apply to these.
This interpretation has been reinforced by an informal agreement by Member State experts – reached at the 5th
of June 2008 meeting of the Commissions Claims Work Group – according to which it would be acceptable to
treat International and European health related associations and charities in the same way as national
associations. However, this remains an informal agreement with no legal status and could potentially be
challenged in court. An amendment to Article 11 to clarify its scope would be necessary to ensure legal
certainty. As long as there are no Community rules on recommendations of or endorsements by national
associations of medical, nutrition or dietetic professionals and health-related charities, any existing national rules
would be applicable. In the case where specific rules on this matter would not exist at the national level and that,
therefore, no prohibition exists at national level, it is understood that such recommendations and/or endorsement
would be permitted.
116
See on this point the ECJ Decision on the validity of the Directive on Food Supplements, Case number
C154/04 and C155/04.
59
1.11.4
The principle of nutrient profiles
Article 4 puts in place provisions that may restrict the use of claims on certain foods or
categories of foods based on their nutritional composition (nutrient profile). The Regulation
stipulates the said nutrient profiles including exemptions should have been determined under
the regulatory procedure with scrutiny until January 19, 2009117.
The main reason for establishing nutrient profiles is to prevent the use of claims misleading
consumers about the true nutritional value of the food. It should be avoided that the nutrition
and health claims cover the nutritional status of food (Recital 10 of the Regulation118).
In any case, under paragraph 3 of the same Article 4, “beverages containing more than 1.2%
by volume of alcohol shall not bear health claims”. Article 4(5), as amended by Regulation
(EC) No 107/2008, provides that “Foods or categories of foods other than those referred to in
paragraph 3, for which nutrition or health claims are to be restricted or prohibited, may be
determined in accordance with the procedure referred to in Article 24(2) and in the light of
scientific evidence”.
Originally nutrient profiles were a sort of visual or calculative system to describe the
nutritional value of an entire food or part of a food. The legislator with the Regulation 1924
leaves open, how profiles to be determined have to be designed in detail, but at the same time
lays down factors and limits to be observed in the determination.
117
Nutrition labeling is considered a relevant component of public health policies attempting to stem the obesity
epidemic in Europe. Scientific evidence to prove its actual use by consumers and the resulting impact on dietary
energy intake, body weight, and health remains largely absent. While consumers like to see nutrition information
on food and drink packages and appear able to use any labeling scheme to choose more healthful options out of a
limited choice set under experimental conditions, they pay little attention to nutrition labels in real life. This lack
of attention is partly driven by a lack of motivation, but the grander scheme suggests that price, taste,
convenience, and shopping habits are simply far more important than nutrition information when making food
purchasing decisions. Shopping under time pressure–a common phenomenon among today’s consumers–further
impedes nutrition label use for healthy food shopping. The new EU food information regulation, which makes
nutrition labeling mandatory, provides an opportunity for monitoring the impact of this policy on public health.
However, simply providing such information will not be enough to justify expectations for a (positive) change in
people’s dietary habits. Instructive educational campaigns are required that raise awareness, understanding, and
the motivation to use nutrition labels, taking into account the diverse needs of the European consumers. Refers to
Chapter III, p.100-105. See on nutrition profiles in labelling Masini, Corso di diritto alimentare, Milano, 2001,
p. 193
118
Coppens, The Impact of the Nutrition and Health Claims Regulation on the Food Industry, European Food
and Feed Law Review, 2007, p. 67.
60
Anyhow the specific nutrient profile including exemptions should be determined for food or
food categories. In the determination of the system of nutrient profiles the wide variety of the
different foods categories and their respective contribution to the diet should be considered119.
For the determination of nutrient profiles the following factors should be taken into
consideration (Article 4(1).
-
Amount of undesired nutrients or other substances
-
Role and importance of the food in the diet
-
Importance for certain risks groups
-
the overall nutritional composition of the food and the presence of nutrients that
have been scientifically recognized as having an effect on health
-
Beneficial nutrients.
The use of nutrition and health claims with regards to food ready for consumption in
accordance with the manufacturer's instructions is subject, under Article 5120, to the fulfilment
of several general conditions and needs to be substantiated by generally accepted scientific
evidence. EU legislature requires the scientifically corroborated guarantee that the substances
for which the claim is made, have been shown to have a beneficial nutritional or physiological
effect.
What a generally accepted data is? This requirement is repeated several times in essentially
the same wording both in the recitals and in the text of the Regulation. Recital 17 mentions
for instance scientific proof as the main aspect to be taken into account for the use of nutrition
and health claims121.
The term “scientific knowledge” is used in Article 4(1) and “scientific evidence” is used in
Article 13(5). It has to be stressed that in the past statements on the effects of food had to be
scientifically supported in the sense of directive 2000/13/EC. Although the differences in the
119
Petrelli, Health food and health and nutritionally claims, in Costato-Albisinni (editors), European Food Law,
already mentioned, p. 301.
120
In certain cases, the “significant quantity” of the nutrient or other substance – for which the claim is made –
which must be present in the final product is clearly defined in Community legislation. For example, in the case
of certain nutrition claims (source of fibre, high protein, etc.), the significant amount is mentioned in the
conditions applicable to these nutrition claims as laid down in the Annex to the Regulation. Also, in the case of
vitamins and minerals, the significant amounts are defined in the Annex to Directive 90/496/EEC on nutrition
labelling. In the case of health claims, the significant amounts are likely to be defined in the applicable
conditions of use for such claims.
121
Meulen, Scientific Substantiation of Health Claims- The soft core of the Claims Regulation, European Food
and Feed Law Review, 2006, p. 154.
61
Regulation is not so evident, it could be argued that the objective of the Regulation requires a
higher level of proof than was previously intended in practice with regard to nutrition and
health claims. This was obvious during the legislative procedure through a dispute on the
wording of the provision. The original draft indeed referred to the English language version of
“generally accepted scientific data”, and on the basis of that critics at that time concluded that
proof always had to be provided by means of data, by studies based on statistics. At first
reading in the European Parliament the provision was amended so that “accepted scientific
knowledge” was considered sufficient. Such a knowledge, i.e. based on experience could
constitute adequate scientific proof. However both Council and Commission have insisted on
the original wording, so that at the second reading compromise was found: “generally
accepted scientific evidence”. This amendment has to be understood in the sense that
statistical data is not always required as scientific proof. Concluding, the term “general
accepted” is not defined, and it most likely depends on what has to be considered “proven
knowledge” according to the state of art. General accepted of course doesn’t mean that
scientific knowledge has to be completely undisputed.
It is also required that the substance for which the claim is made, is present in the final
product in significant quantities or that the substance is absent or present in reduced quantities
in order to produce the nutritional or physiological effect claimed. A further condition is
compliance with the specific conditions laid down in Chapter III (nutrition claims) or Chapter
IV (health claims), according to the case. In any case, the use of nutrition and health claims is
permitted, in accordance with the principle of proportionality, only if the average consumer
can be expected to understand the beneficial effects as expressed in the claim (Article 5(2)).
The criterion of the average consumer is not statistical: the national authorities must take into
account the Court of Justice’s cases law122 which refer to a reasonably well informed and
prudent consumer, keeping the social, cultural and linguistic factors in mind. In the event that
a claim is specifically directed to a group of consumers who are particularly vulnerable,
owing to certain characteristics (e.g. age), to misleading information, it is considered desirable
to take the average member of that group into account when assessing its impact.
It can be said that this provision relies heavily on the horizon of the consumer circles
addressed. Recital N. 16 of the Regulation 1924 corresponds word for word to Recital N. 18
of Directive 2005/29 on unfair business practices, indeed in that provision the notional
122
ECJ judgement of July 1998, Case N. C-210/96: ECJ judgement 16 September 2004, Case N. C-329/02.
62
consumer is described in further detail in a normative manner, in that manner depends on the
average member of a group of consumers when a commercial practice is directed to a
particular group.
The question whether the understanding of an average consumer has to be established through
empirical research in an individual case, based on a public opinion survey, is disputed. Recital
N. 16 states that the determination of an average consumer is not a statistical test. When
judging the question “how the average consumer would react typically in a given case” the
national courts have to “rely on their own capacity for judging while taking into account the
case law of the court”. This led to consider the consumer’s viewpoint as based on a fiction
and not ascertained.
After all, Article 6 enshrines the principle of the necessary scientific substantiation of claims
by specifying that nutrition and health claims are based on generally accepted scientific
evidence that justifies the use of such claims. The food business operator or the person
placing a product on the market shall be obliged, at the request of the competent authorities of
the Member States, to present the relevant elements and data which establish compliance with
the Regulation123.
123
Food business operator making a nutrition or health claim on a particular product must be able to provide the
necessary data, upon request by national competent authorities, demonstrating that the claim made on the
product complies with all the relevant provisions of the Regulation. This would include for example, evidence
demonstrating that the nutrient/substance for which the claim is made is bio-available, data showing that the
quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the
nutrient/substance to which the claim relates, that the substance present in the final product making the claim is
indeed the same for which the health claim in question has been authorised, etc. During the transition period laid
down in Article 28.5 for health claims as referred to in Article 13(1)(a), food business operators must also be
able to provide the necessary evidence demonstrating that the claim made complies with all the applicable
provisions of the Regulation as well as any applicable national legislation.
63
1.11.5
Mandatory nutritional information.
Among the general principles we also find the obligation to provide nutritional information
when a nutritional health claim is made, with the exception of generic advertising. This is the
case of the so-called "Two-step health claim", where the claim contains a reference to the
relationship between health and diet, and a link of this claim to a claim on the nutritional
content of the product. An example could be the following: “ Contains low levels of saturated
fat”124.
Chapter IV of Regulation 1294 lays down specific requirements for health claims.
Article l0(2) foresees the need to support health claims with the following additional
information which is to be provided in labelling or, in its absence, presentation and
advertising:
(a) a statement indicating the importance of a varied and balanced diet and a healthy
lifestyle;
(b) the quantity of the food and pattern of consumption required to obtain the claimed
beneficial effect;
(c) where appropriate, a statement addressed to persons who should avoid using the
food; and
(d) an appropriate warning for products that are likely to present a health risk if
consumed to excess.
Pursuant to paragraph 3 of the same Article, the reference to general, non-specific benefits of
the nutrient or food for overall good health or health-related well-being is only permitted if
accompanied by a specific health claim included in the lists provided for in Articles 13 or 14
of Regulation No 1924.
Article 12 establishes that there are restrictions on the use of certain health claims, which are:
(a) claims which suggest that health could be affected by not consuming the food;
124
For a company to make a nutrition claim on their product, the specific claim must be listed in the Annex to
the Regulation. Examples listed in the Annex include ‘low fat’, ‘no added sugars’, ‘high fibre’ and ‘source of
calcium. In each case, conditions are specified for each claim, for example, foods claiming to be ‘low fat’ must
have no more than 3g fat per 100g. In order to make nutrition claims that comply with the conditions in the
Annex it is essential to know the amount of the nutrient in question in the food.
64
(b) claims which make reference to the rate or amount of weight loss;
(c) claims which make reference to recommendations of individual doctors or health
professionals and other associations other than national associations of medical,
nutrition or dietetic professionals and health-related charities125.
125
For a complete overview on Regulation 1924, see Meisterernst- Haber, The silent Revolution- Legal overview
on regulation 1924/2006 on Nutrition and Health Claims, European Food and Feed Law Review, 2007.
65
1.11.6
Community authorisation of the inclusion of health claims
Articles 15, 16, 17 and 19 lay down the procedure which concerns authorisation for inclusion
in the list referred to in Article 14 of “reduction of disease risk claims” and “claims referring
to children's development and health” together with all the necessary conditions for their
use126.
In the case of “reduction of disease risk claims”, labelling or, if no such labelling exists, the
presentation or advertising shall also bear a statement indicating that the disease to which the
claim is referring has multiple risk factors and that altering one of these risk factors may or
may not have a beneficial effect.
For the claims to be included in the list referred to in Article 14, authorisation should be
granted on a case-by-case basis after EFSA has evaluated the scientific dossier. The applicant
shall submit an application (Article 15), providing all the information required by Article 15
and the specific rules set out in regulation (EC) No 353/2008, to the national competent
authority of a Member State who shall promptly inform EFSA of receipt, as well as make the
application itself and any supplementary information received by the applicant available to
it127.
The Authority, in turn, informs the other Member States and the Commission of the
application, transfers a copy of the documents to them and makes a summary available to the
public128.
The health claims to be included in the list referred to in Article 14, are examined by EFSA,
which shall, pursuant to ex Article 17, prepare an opinion (within five months from the date
of receipt of a valid application, extended, at most, for another two months in the event that
the Authority requires supplementary information from the applicant) in order to verify that
the claim is substantiated by scientific evidence and that its wording meets the requirements
126
Meisterernst – Ballke, The provision on claims concerning the development and health of children in
regulation 1924/2006 – better regulation?, in European Food and Feed Law Review, 2008, p. 178.
127
Rubino, Il claim “senza zuccheri aggiunti” nel nuovo regolamento 1924/06 CE: problematiche interpretative
ed applicative, in Alimenta, 2007, p.1 .
128
Grossklaus, Nutrient Profiles- The Precondition for Health Claims, European Food and Feed Law Review,
2007, p. 210.
Concerning the protection of health Albisinni, L’informazione del consumatore e la tutela della salute, in
Costato (diretto da) Trattato breve di diritto agrario italiano e comunitario, Padova, 2003, p. 631.
66
set by Regulation 1924. The opinion shall be forwarded to the Commission, the Member
States and the applicant, and subsequently made public.
The applicant may make comments to the Commission within thirty days of publication.
Finally, within two months after the receipt of EFSA’s opinion, the Commission shall submit
to the Standing Committee on the Food Chain, a draft decision on the lists of permitted health
claims taking the opinion of the Authority and any relevant provisions into account.
If there is no accordance with EFSA’s opinion, an explanation for the differences is provided.
The draft decision amending the list of permitted health claims (thus in favour of the inclusion
of the new claim), shows the particulars laid down in Article 16(4) (46)129.
A final decision on the application, designed to amend non-essential elements of this
Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 25(3) (47). The Commission shall inform the applicant of
the decision taken and publish the details in the Official Journal of the European Union.
129
Martinez et al, The regulation on Nutrition and Health Claims Made on Food: Role of the European food
Safety Authority, European Food and Feed Law Review, 2007, p. 76.
67
1.11.7
The Authorization Procedure for Nutrient-Function Claims that
were submitted for approval by January 2008
As explained before, the Regulation established an authorization procedure for nutrientfunction claims, whereby the Member States had to send to the European Commission, before
the end of January 2008, their national lists of proposed health claims to be evaluated by
EFSA.
The Regulation clarifies that until the establishment of a EU list of permitted health claims
this list is established, claims submitted for approval through this procedure will be allowed to
remain on the market until a final decision is adopted on them.
The Commission was probably expecting a few hundred health claims to be tabled for
adoption.
However, the twenty-seven EU Member States submitted national lists of approximately
44,000 health claims. Some Member State submitted more than 10,000 claims, which had
been proposed by its national food industry, whereas another Member State submitted only
nine, which were the only ones that had officially been approved in the past by the national
authorities.
With some time and effort, the Commission was able to reduce the list of proposed claims to
around 4,600, by removing duplicates and deleting entries that were incomplete or
inappropriate.
The Commission announced the adoption of the Article 13 list in 2 steps:
1. health claims other than those for botanical substances;
2. health claims for botanical substances.
Because the number of claims to be assessed remained quite high, EFSA confirmed the
publication in several batches.
The first EFSA evaluations were mostly negative (66% for the first batch, 98% for the
second) with rejections of most claims submitted on probiotic bacteria/microorganisms,
antioxidants, plant extracts/botanicals, and claims on carbohydrate glycemic index/response.
Commission then announced the intention to restructure the process of progressive adoption
of the list of permitted health claims, dividing the process in two steps.
68
First, the list of permitted health claims for all substances other than so-called "botanicals".
EFSA was asked to finalize its evaluation of all remaining claims, other than botanicals, by
the end of June 2011.
This approach has been considered beneficial for the consumer, who, once the list is adopted
and fully operational, will be assured that all health claims on the market have been
substantiated by science.
Between October 2009 and July 2011, the European Food Safety Authority published 6
batches of scientific opinions on proposed health claims covering 2758 claims. EFSA found
that only 20% of these claims were scientifically substantiated. The reasoning behind the
rejection of these claims includes the following:

Insufficient identification of the relevant substance (e.g., “probiotics” or “dietary
fibre” without specification of the particular strain or fibre);

Lack of evidence that the claimed effect is beneficial (e.g., "antioxidant properties"
and renal "water elimination");

Imprecise health claims (e.g., "energy" and "vitality", "women's health" or "mental
energy");

Lack of human studies;

Food categories that are considered too broad to be linked to specific effects (e.g.,
"fruits and vegetables" and "dairy products").
On 25 May 2012, the EU finally published its list of 222 so-called "general function health
claims" that are permitted to be made on foods.
The European Commission and the SCFCAH, the key regulatory food committee gathering
experts from all 27 EU Member States, consolidated 222 claims that were approved by EFSA
onto a final list of permitted claims together with their conditions of use. Some of the claims
approved by EFSA that did not make it into this final list include the statement on fat
consumption and the related benefit for fat soluble vitamin absorption and the claim on the
benefits of sodium for muscle function. Although scientifically proven, these claims were
considered likely to convey a conflicting and confusing message to consumers given the
69
overall negative contribution of fat and sodium to nutrition and health. The European
Parliament and the Council both agreed with the final list as proposed by the Commission130.
A good illustration of the strict evaluation criteria being used by EFSA is provided by its
opinion on an application for a reduction-of-disease-risk claim on cranberry juice. The
proposed claim was: “[the product] helps reduce the risk of urinary tract infection in women
by inhibiting the adhesion of certain bacteria in the urinary tract. EFSA concluded that the
evidence submitted by the applicant was insufficient to establish a cause-effect relationship
between the consumption of the product in question and the claimed effect”. Although the
application dossier contained a number of human studies, they were dismissed by EFSA for
several reasons, such as the fact that six human studies were judged of limited relevance
because the claim targeted healthy women (aged 16 and above), whereas the studies were
carried out on unhealthy subjects (patients suffering from neurogenic bladder) and children. In
an additional human study the daily dose of the active substance consumed was
approximately six times higher than the use levels proposed for the claims131.
The list of authorized claims could be verified after a certain period due to the fact that
evolution of scientific progress may request a revision.
Pursuant to Article 19, the applicant / user of a claim included in one of the lists provided for
in Articles 13 and 14 may apply for a modification of the relevant list. In such a case the same
procedures that were used for the inclusion of the claim (Articles 15 to 18) are applied. The
Authority, on its own initiative or at the request of Member States can express an opinion on
whether a health claim included in the relevant list still meets the conditions required by
Regulation (EC) No 1924/2006. EFSA’s opinion is first transmitted to the Commission and
the Member States and where relevant to the original applicant, before being made public. If
appropriate, the authorisation is suspended modified or revoked in accordance with the
procedures laid down in Articles 17 and 18. Chapter V of Regulation (EC) No 1924/2006 lays
down the general and final provisions.
130
European Food Safety Authority (2009a) Scientific substantiation of a health claim related to Article 14 of
Regulation (EC) No. 1924/2006 (Question No EFSA-Q-2008-117) Scientific Opinion of the Panel on Dietetic
Products, Nutrition and Allergies, adopted on 22 January 2009. The EFSA Journal 943 1–15.
http://www.efsa.europa.eu/en/scdocs/doc/943.pdf).
131
EFSA, Draft Scientific Report of EFSA - Briefing document for stakeholders on the evaluation of Article 13.1,
13.5
and
14
health
claims
(“Briefing
Document
for
Stakeholders”),
available
at
http://www.efsa.europa.eu/en/events/event/nda100601.htm.
70
After all the authorised claims are included in a special public register in order to ensure
transparency and to avoid the repetition of applications relating to health claims that have
already been assessed (Article 20 of the Regulation). The register, which is established and
maintained by the Commission, contains approved nutrition and health claims, together with
the conditions of application and any limitations as well as a list of rejected health claims and
the reasons for their rejection132.
The Community register is public and gives transparency in the already evaluated claims to
avoid repeated applications for authorization. The register is indeed update when claims are
authorised, modified, put on hold extended or withdrawn.
Health claims authorised on the basis of proprietary data are recorded in a separate Annex to
the Register133.
For this information further details have to be given in the Register as follows:
- date of authorization
- name of the original applicant
- information on the authorization on the basis of protected data
- information on the restriction of the use of the claim.
132
European Food Safety Authority (2009b) Technical Report of EFSA: Frequently Asked Questions (FA Q)
related to the EFSA assessment of Article 14 and 13.5 health claims applications. The EFSA Journal 7(9) 1339.
http://www.efsa.europa.eu/en/scdocs/doc/1339.pdf.
133
See Thron-Meyer, Health Claims under Regulation 1924/2006: Requirements profile Analysis of the
Opinions issued by EFSA, European Food and Feed Law Review, 2009, p. 119.
71
1.11.8
National provisions
The Community, in accordance with the principles of subsidiarity and proportionality (Article
5 of the Treaty establishing the European Community), regulates nutrition and health claims,
since the aims of ensuring the effective functioning of the internal market and a high level of
consumer protection are better achieved at Community level rather than at a national one. Its
efforts do not extend beyond what is needed to achieve the objectives of the Treaty. In view
of Community legislation, pursuant to ex Article 22, Member States, without prejudice to the
provisions of the Treaty and in particular Articles 28 and 30, may not restrict or forbid trade
or advertising of foods in compliance with Regulation (EC) No 1924/2006 by applying nonharmonised national provisions134.
The ban in Article 22 extends to the application of non-harmonized national provision, e.g.
national standards. It is without relevance in this respect whether the provisions concern
certain foods or restrict or prohibit the use of nutrition and health claims for foods in general.
According to the clear-cut wording of Article 22, the harmonization covers not only trade, i.e.
placing on the market in the sense of Article 8(3) of Regulation 178/2002 and related legal
transactions, but also advertising, i.e. all statements and information provided outside the
labelling135.
Moreover, Article 23 of the same Regulation lays down the obligation for Member States to
notify the Commission of the intention to adopt new measures (capable of affecting the
Community legislation on nutrition and health claims) and the reasons justifying them. The
Commission shall give its opinion on these national measures. If the state has not received a
negative opinion, six months after the notification is sent it may adopt the measures.
Otherwise, the Commission shall, in accordance with the procedure referred to in Article
25(2), and within six months after the notification, determine whether the envisaged measures
may be implemented, possibly making appropriate amendments.
However, in cases where there are serious grounds to believe that the claim does not comply
with Regulation 1924 or that the reasons for its scientific substantiation are insufficient, the
134
Capelli-Klaus, Il Regolamento CE n.1924/2006 in materia di indicazioni nutrizionali e sulla salute da
riportare sulle etichette dei prodotti alimentari, in Diritto Comunitario e degli Scambi Internazionali, IV, 2007,
p.803.
135
Coutrelis, Regulatory Obstacles to the International Trade of Health Food, European Food and Feed Law
Review, 2006, p. 220.
72
Member States (and the Commission) may adopt special safeguard measures (Article 24)
enabling the temporary suspension of the use of a claim within their territory. Such measures
must be communicated to the Member States and the Commission, specifying the reasons for
the suspension, and are the subject of a decision taken in accordance with the procedure
referred to in Article 25(2).
73
1.11.9
Transitional measures for the use of health claims made on
foods that do not comply with the provisions of Regulation
1924/2006
Article 28 lays down transitional measures, designed to allow manufacturers to gradually
adjust to the new rules and permit the short-term marketing of foods which do not comply
with the provisions introduced by the Regulation if they were placed on the market or labelled
prior to the date of application of Regulation 1924. Diverse general and specific hypothesises
are provided for, and the movement of the product is subject to special conditions and
prerequisites.
The first hypothesis of non-compliance, provided for in Article 28(1), is general and refers to
the set of indistinct regulations introduced by Regulation 1924. In order to be marketable in
spite of its non-conformity, the food must be placed on the market or labelled prior to the July
2007 (date of application of the Regulation). Foods that do not comply may be marketed until
their expiry date and in any event no later than 31 July 2009.
It has been argued that this transitional measure has had for foods that have a limited shelf life
(such as, for example, fresh milk and yogurt). The reduced “life” of a product, in fact, has not
always and consistently permitted the marketing of a significant amount of said product in
due time or in such a way as to enable the sale of all stocks carrying labelling which is no
longer legally compliant136.
As regards the meaning of “placing on the market”, the definition in Article 3(8) of
Regulation 178/2002 applies, according to which it is “the holding of food or feed for the
purpose of sale, including offering for sale or any other form of transfer, whether free of
charge or not, and the sale, distribution, and other forms of transfer themselves”. The holding
of the purpose of sale is probably the earliest possible point in time for the criterion of placing
on the market. This presuppose possession of the food with the inherent intention of selling it,
without that intention having to be perceivable to others yet. The provision also applies where
foods have already been labelled, i.e. labelling in the sense of Article 1(3)(a) of Directive
2000/13. As a rule, belled foods are held for the purpose of sale and hence placed on the
market.
136
Meisterernst, A Learning Process? Three years of Regulation 1924/2006 on Nutritional and Health Claims
Made on Foods, European Food and Feed Law Review, 2010, p. 59.
74
The second hypothesis of non-compliance, again provided for in Article 28(1), is specific and
relates to the conditions for the use of nutrition and health claims established by Article 4.
As is well known the purpose of this article is to prevent foods with scientifically
“undesirable” nutrient profiles from inducing consumer choice, owing to the misleading use
of nutrition and health claims in advertising and consequentially leading consumers, who are
just trying to make healthy choices in the context of a balanced diet, astray. Foods that do not
comply with the provisions referred to Article 4(1) may be marketed until twenty-four months
following the adoption of the relevant nutrient profiles and their conditions of use.
Another hypothesis of non-compliance with respect to specific provisions of Regulation 1924
is governed by Article 28(2), according to which “products bearing trade marks or brand
names existing before 1 January 2005 which do not comply with this Regulation may
continue to be marketed until 19 January 2022 after which time the provisions of this
Regulation shall apply”. This provision, of course, refers to the non-fulfilment of the
conditions provided for in Article 1(3) of Regulation No 1924 that subordinates the use of a
trade mark or a brand name appearing in the labelling, presentation or advertising of a food
which may be interpreted as a nutrition or health claim, identified in the requirement that the
labelling, presentation or advertising must bear a related nutrition or health claim that
complies with Regulation No 1924. It is questionable whether the transitional period only
relates to protected trademarks and brand names.
The European Parliament at the beginning of the drafting text intended to exclude trade marks
in the sense of Directive 89/104 (Council Directive 89/104/EEC of 21 December 1988 to
approximate the laws of the Member States relating to trade marks ) from the scope of
Regulation 1924. This was refused by the Commission. However, in the final text, no
reference was made to Directive 89/104 , this is a clear indication that definitions in
Regulation 1924 are independent.
It thus follows that up to 19 January 2022 it is possible to use such trademarks or brand
names, as long as they existed prior to January 2005, regardless of the related nutrition or
health claims. The scope of the transitional provision, however, is not perfectly clear. If
particular problems do not seem to stem from the meaning of "trademark" in view of specific
national and Community legislation, the same can not be said for "brand names", the
definition of which is neither found in Regulation (EC) No 1924/2006 nor readily inferable
75
from Community legislation. With a certain degree of accuracy, it can be said that the trade
name is the commercial name, not normally required at EU or national level, used by
businesses in a non-private way to effectively communicate a specific type product to the
consumer. More general speaking, it is a product name; in this sense, even an invented name
could be qualified as a trade name.
Lastly, Article 28(5) of Regulation 1924 governs the transitional regime of health claims
describing or referring to the role of a nutrient or other substance in the growth, development
and functions of the body (Article 13(1)(a)). Such claims may be made from the date of entry
into force of Regulation No 1924 until the adoption of the list referred to in Article 13(3)
under the responsibility of food business operators provided that they comply with the
Regulation and with the applicable national provisions, and without prejudice to the adoption
of safeguard measures as referred to in Article 24. The unclear text makes for the uncertain
application of the transitional measure to health claims as referred to in Article 13(1)(a); they
are in compliance with the Regulation and the national provisions, used after the entry into
force of the Regulation and not included in the (national) lists provided by Member States to
the Commission pursuant to Article 13(2).
Special prevision is foreseen for health claims describing or referring to psychological and
behavioural functions, to slimming or weight-control, a reduction in the sense of hunger, an
increased sense of satiety or reduction of the available energy from the diet under Article
(13)(b) (c).
These claims fall under the category of functional claims, as well as those relating to the
development and health of children in Article 14(1)(b), as amended by Regulation (EC) No
109/2008. Presuming that they have already been used in compliance with national provisions
before the entry into force of Regulation 1924, the use of such claims is governed by Article
28(6), in two different ways depending on whether they have been subject to evaluation and
authorisation in a Member State.
Finally, it should be noted that Article 28 of Regulation No 1924 does not provide for a
transitional period for reduction of disease risk claims. Regulation (EC) No 109/2008
clarifies, in whereas no. 4, that the lack of need for transitional measures for these claims is
76
due to the fact that foods bearing such claims should not have been on the Community market
before the entry into force of Regulation 1924 because of the prohibition of claims referring to
the prevention, the treatment and the cure of a disease by Directive 2000/13/EC137.
Concluding, it could be said that Regulation 1924 uses technical presentation terminology in
preventative Community authorisation procedures. Healthy and functional foodstuffs are
presented in non-mandatory communication formulas that are considered suitable in correctly
promoting purchases in terms of quality and expected health benefits.
Thus ensuring both the consumer’s right to make informed food choices in line with a chosen
lifestyle and health conditions, as well as the elimination of all obstacles to the free movement
of goods offered on the common market (steps that ensure fair competition between
businesses).
At the same time Regulation (EC) No 1924/2006 supports the promotion of innovation in the
food sector in ways that, by allowing a limited term of protection of scientific data and other
information relevant to the application for authorisation to use new claims, manage to balance
the protection of investments in research made by innovators in gathering the information
with the need to ensure access to claims by small and medium-sized businesses138.
It should, however, be highlighted that the regulatory system introduced with Regulation
1924, also permit an albeit indirect Community coding of functional foods deemed able to
produce the physiological effect certified by the registration of the nutrition or health claim.
Therefore concretely making it difficult to create barriers to the movement of these foods in
the single market.
Furthermore, the use of that nutrition or health claim on a product reduces the risk of
divergent qualifications in several Member States (whether as food or as medicine) due to the
137
Urala, Arvola and Lahteenmaki, Strength of health related claims and their perceived advantage. in
International Journal of food Science and Technology , 2003, 38, p. 815.
138
See Petrelli, Le nuove regole comunitarie per l’utilizzo di indicazioni sulla salute fornite sui prodotti
alimentari, in Riv. Dir. agr., 2009, I, p. 50. See also Masini, Prime note sulla disciplina europea delle
indicazioni nutrizionali e sulla salute, in Dir.giur. agr., 2007, p. 73; Capelli - Klaus, Il Regolamento CE
1924/2006 in materia di indicazioni nutrizionali e sulla salute che dovranno essere ripettate a partire dal 1
luglio 2007 dagli operatori del settore alimentare e dalle Autorità di controllo, in Alimenta, 2007, 5, p. 105. See
also Banares Vilella, El Regolamento 1924/2006: alegationes o declarations alimentarias? In Revista de
derecho alimentario, 2007, p. 13. See also Masini, Prime note sulla disciplina europea delle indicazioni
nutrizionali e sulla salute, in Dir.giur.agr., 2007, I, p. 73. See also Fuentes, La publicidad y presentacion de los
alimentos. El nuevo Regolamento relativo a las propriedades nutrizionale y saludables de los alimentos, in
Dir.giur.agr., 2007, I, p. 148.
77
prevailing presumption (in light of the Court of Justice’s restrictive interpretation of the
concept of medicine) of that product belonging to a food category.
78
1.11.10
Health claims for probiotics: why EFSA rejected them
Probiotics are bacteria that are added to food products to promote health and well-being, they
should have by definition health benefits. Health claims on probiotics suggest that there is a
relationship between the specific food and maintaining good health or that the food can
reduce the risk of a disease139.
Thereby, the health claim valuation centres on defining what probiotics are, controlling the
related human intervention studies. New studies supposed to be conducted on claims for
healthy populations while most intervention studies with probiotics have been focused in
patients or subjects at risk of specific diseases. EFSA has elaborated several opinions
illustrating the need of more in deep researches for probiotics in the future.
One of the best example of products sold as probiotics are the fermented dairy drink, or
yogurts, containing bacterium Lactobacillus casei.
The European food industry is investing a lot in the production of probiotics so that the profits
margin for them is significantly higher than for ordinary products. Food marketers therefore
stress the uniqueness of their probiotic strains giving them fancy names such as Lactobacillus
immunitas or Lactobacillus defensis.
All these characteristics are often similar to common yogurt but this tendency response to a
particular need from consumers for foods that promote health and well-being140.
EFSA has been requested to provide a scientific opinion on thousands of candidate claims.
Such opinions are based on the dossier submitted with the claim and on the relevant EU
regulations141.
By July 2011, EFSA had published opinions on some 3,000 claims.
Almost 80% of them were judged “not insufficiently proved”: however, none of the approved
claims dealt with probiotics.
139
See Petrelli, I Probiotici: criteri per la qualificazione dei prodotti quali alimenti o medicinali nel diritto
comunitario, in Riv. dir.agr., 2008, I, p. 562.
140
Satine, Is my Yogurt lying? Developing and applying a framework for determining whether wellness claims
on probiotics yogurt is mislead, in Food and Drug Law Journal, 2008, p. 537.
141
Further details can be found in various EFSA documents (EFSA Panel on Dietetic Products, Nutrition and
Allergies (NDA) EFSA Journal, 2011, 9(4), p. 1984.
79
In many of its opinions on probiotics, EFSA stated that the outcomes measured did not equate
a beneficial physiological effect. Manufactures had always presented irrelevant effects of
probiotics in their claim submission to EFSA. In certain cases a product was supposed to have
a positive effects on defense mechanism in human body, even several studies demonstrated
that concentration of white cells and proteins in blood may change with the use of probiotics.
For these reasons manufacturers have often used these effects to justify advertisements for
probiotics because they refer to “defense mechanisms”. This was intended only in a general
sense. Such claims were indeed rejected by EFSA, because of a lack of the ‘beneficial
physiological effect’ demanded by EU law. Furthermore even if a probiotic can prevent a
disease it within the framework of European legislation on health claims it is illegal to state to
consumers that a food can prevent, treat or cure a disease (Directive 2000/13 as already
explained). Probiotic producers have stressed that they can’t prove probiotics efficacy against
disease because EU regulations forbid medical claims. On their opinion many claims
submitted for authorization alluded to strengthening of the immune system and the defense
against infections and there is abundant evidence that consuming probiotics causes an
increase in the number of probiotic bacteria in the intestines, but EFSA did not consider this a
beneficial effect as such.
EFSA published new guidance on the scientific requirements for health claims related to gut
and immune function142.
That guidance paper does not maintain a strict boundary between health claims and medical
claims. EFSA now explicitly accepts the frequency and severity of intestinal and respiratory
tract infections as outcomes to be considered in the evaluation of claims.
In assessing each claim, the NDA Panel makes a scientific judgement on whether the claimed
effect is considered to be a beneficial physiological effect in the context of the specific claim,
as described in the information provided and taking into account the population group for
whom the claim is intended. For function claims, a beneficial effect may relate to
maintenance or improvement of a function.
This guidance document should solve the problem of probiotic producers and allied scientists
that they do not know which outcomes are needed to get a claim approved, and that they
cannot present disease outcomes as evidence143.
142
Scientific opinion - Guidance on the scientific requirements for health claims related to gut and immune
function - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) EFSA Journal 2011, 9(4), p. 1984.
80
1.12 A new and recent tendency: the functional products
Technological advances in recent years have made it possible to produce foods which provide
a virtuous relationship between diet and promoting a state of physical and mental wellbeing,
according producers’ claims. Maintaining a high level of consumer protection has made it
necessary to regulate some aspects of the marketing of functional foods in Europe through the
establishment of harmonised rules on the conditions and requirements which legitimise the
producer’s use of communication formulas; those that have been deemed appropriate in
advertising the health benefits reasonably expected through consumption.
Consumers, in fact, must be able to rely on the truthfulness and accuracy of the nutrition and
health claims borne by labelling and used in the advertising of foodstuffs. This information is
a key factor in regards to the consumer’s choice to purchase or not. In recent years, consumer
awareness towards healthy food and a healthy relationship between diet and health has also
increased.
The technological innovations of recent decades have made the large-scale production of food
possible; these foods are characterised by a specific healthy function, acquired as a result of
an artisanal or industrial process144.
This highly technological process is able to provide the right quantity of those substances that
represent the efficient cause of the healthy function. Both in traditional foods that either do
not originally have them or if the percentage contained is not reasonable compared to the
production of the positive effect on health.
Partially harmonised EU legislation has regulated ad hoc legal types in the production and
marketing of certain foods that produce beneficial health effects due to components that are
either naturally present in them or added. Initially the regulated foods were those concerning
special dietary requirements (i.e. dietary products and foods for infants).
More recently, through Directive No 2002/46/EC, EU legislation has also harmonised
regulation on food supplements which have been defined as “foodstuffs the purpose of which
143
Zolla, Riportare sulle etichette alimentari indicazioni sulla salute false e non accertate scientificamente
costituisce una forma di pubblicità ingannevole, in Dir. giur. agr., 2009, IV, p.277.
144
Verbeke, Consumer acceptance of functional foods: socio-demographic, cognitive and attitudinal
determinants. In Food Qual Prefer, 2005, 16, p. 45.
81
is to supplement the normal diet and which are concentrated sources of nutrients or other
substances with a nutritional or physiological effect, alone or in combination”.
Finally, Regulation (EC) No 1925/2006 has regulated the addition of vitamins and minerals to
foods and the use of certain other substances which have nutritional or physiological effects
with the result of the ingestion of amounts greatly exceeding those reasonably expected to be
ingested under normal conditions of consumption of a balanced and varied diet and/or would
otherwise represent a potential risk to consumers (so-called “enriched foods”) (European
Commission, Health and Consumer Protection – Directorate General, Community Register on
the addition of vitamins and minerals and of certain other substances to foods pursuant to
Regulation (EC) No 1925/2006, Directorate and – Safety of the food chain – Unit E4: Food
and law, nutrition and labelling).
The food industry has recently shown considerable interest in healthy natural foods that are
destined for healthy individuals who wish to remain that way. In view of their role in
improving or maintaining a good state of health and welfare, playing a physiological role that
goes beyond (and is still independent of) that provided by the ingestion of nutrients.
The incredible commercial success recorded in markets around the world has stimulated a
global circulation of functional foods: however, there is no harmonised technical legislation
on an international level regarding the characteristics of the substances used in their
composition and the specific health effects caused by their consumption.
This results in a complex overlap between the different regulatory systems at state or
supranational level that attempt to regulate the production and marketing of functional
foodstuffs145.
In 1996, the Commission launched concerted action on functional foods called FUFOSE
(Functional Food Science in Europe), coordinated by the International Life Sciences Institute
(ILSI), the aim of which was to adopt a scientific approach towards foods with beneficial
effects on human health or able to reduce the risk of disease; 2001 saw the development of the
project PASSCLAIM (Process for the Assessment of Scientific Support for Claims on foods),
again coordinated by ILSI, which aimed to solve some of the current issues related to the
validation, the scientific substantiation of the claims and consumer communication146.
145
Coppens- Fernandez da Silva- Pettman, European regulations on nutraceuticals, dietary supplements and
functional foods: a frame work based on safety, in Toxicology, Vol.221, 2006, p. 62.
146
Ashwell, Conceptos sobre los alimentos funcionales, ILSI Europe, 2004, ILSI Press, Belgium.
82
The FUFOSE action in particular, was completed in 1998 with the unanimous approval of a
final document that reached a “European Consensus” on the characteristics and scientific
concepts of functional foods147.
According to this document, “A food can be regarded as functional if it is satisfactorily
demonstrated to affect beneficially one or more target functions in the body, beyond adequate
nutritional effects, in a way that is relevant to either improved stage of health and well-being
and/or reduction of risk of disease. A functional food must remain food and it must
demonstrate its effects in amounts that can normally be expected to be consumed in the diet: it
is not a pill or a capsule, but part of the normal food pattern.”
The document highlights that functional foods are not pills or capsules but food in the
traditional sense of the term that produces demonstrable and specific beneficial effects
exercised on one or more functions of the human organism (physiological effect)148.
In particular “functional” can describe a natural food, a food to which a component has been
added or a food from which a component has been removed using technology or
biotechnology. It may also be a food where the nature of one or more components has been
modified and / or the bioavailability of one or more elements. The food may be aimed at the
entire population or specific target groups; the marketing must be accompanied by clear
information in communication to consumers; safety must be guaranteed by official inspection
certificates, consumption must be assessed in the context of normal daily food intake.
The EU legal order has not yet defined an ad-hoc legal type for functional foods: using the
scientific concept of the FUFOSE final document it is evident that there are areas of overlap
of these foods with a certain legal typology of foods characterised by a specific health
function at EU level. For example, the so-called enriched foods governed by Regulation (EC)
No 1925/2006: the addition to food of vitamins, minerals and other substances with a
nutritional or physiological effect, in fact may be explained in terms of functional purposes.
147
Robeirdfoird, Scientific concepts of functional foods in Europe: Consensus document, in British Journal of
Nutrition, 81, Suppl. 1, p. 1; Agget et al., Passclaim. Process for the Assessment of Scientific Support for Claims
on Food. Consensus on Criteria, in European journal of nutrition, 2005, vol. 44, supplement 1, p. 1. See also
Serre, Question d’actualité Allegations de santé des aliments: une perspective communautaire, in Annales
pharmaceutiques française, 2006, volume 64, n. 5, p. 335. See also Bigi, Etichette chiare e veritiere per i
prodotti alimentari: approvato in via definitiva dal Parlamento europeo un nuovo regolamento comunitario, in I
contratti, 2006, p. 737.
148
Asp - Control, Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM): overall
introduction, in European Journal of Nutrition, Suppl.1, 2003, p. 1.
83
It should however, be pointed out that the addition may be required to satisfy other
requirements such as, for example, replenishing the concentration of vitamins and minerals
reduced during the production process. It should also be noted that enriched foods with
precise functional aims do not represent all the products which could be scientifically defined
as a functional food; a food is functional, in fact, when it causes a beneficial health effect due
to substances it already naturally contains (in sufficient quantity) or the elimination of a
component with technology or biotechnology.
On the other hand, there is a sharp line of demarcation between functional foods and food
supplements: the latter, in fact, cannot be confused with functional foods both because of the
form of presentation and for their intended purpose. Food supplements are sold in dosed unit
form, such as tablets and capsules while functional foods are and remain foods in the
traditional sense of the term. As for the purpose, food supplements complement the normal
diet whereas functional foods must prove their action in the amount in which they are
normally ingested149.
The lack of regulation of functional foods as a legal ad hoc type led EU legislature to
determine the general terms of use of voluntary nutrition and health claims made by the
industry on foods, through Regulation (EC) No 1924/2006. This Regulation, in fact, without
prejudice to the provisions laid down by EU directives on foodstuffs intended for particular
nutritional uses, lends itself to regulate the methods of presentation to consumers on the health
benefits of functional foods.
All foods belonging to the types mentioned above, namely products intended for special diets,
natural mineral waters, food supplements, enriched foods and functional foods have the
common goal of producing a positive physiological benefit due to a series of elements either
naturally found in products or that are reproducible by industry. The common goal of
producing a positive health benefit is a necessary and sufficient element in constituting a
specific category of foods, that of “health” foods, described as such owing to their
properties150.
149
Ashwell,. Functional foods: a simple scheme for establishing the scientific validity for all claims, in Public
Health Nutrition, 2001, 4(3), p. 859.
150
Marette, Roosen, Blanchemanche and Feinblatt-Mélèze, Functional food, uncertainty and consumers’ choice:
A lab experiment with enriched yoghurts for lowering Cholesterol, in Food Policy, 2010, 35, p. 419.
84
Since the category of health foods is not overseen by EU law, its elaboration is possible only
through interpretation; recognition of this category is very useful as it promotes the resolution
of several difficult issues related to the production and the marketing of foods with health
benefits in the European area in the respect and most suitable reconciliation of the values,
principles and fundamental and general interests such as, for example, the increased
protection of human health and the effective functioning of the internal market.
However, these products do not cover all the innovative types of products that have been
introduced in the food industry in recent years.
For a complete classification, it could be useful to recall the conceptual framework developed
by Cannella et al. (2007) Cannella C., Giusti A.M., Pinto A., Dal cibo per tutti agli alimenti
personalizzati, Pensiero Scientifico Editore, Roma, 2007, who suggested the following
categorization:
“Fortified food: foods made more nutritious without altering their energy value. Fortification
is a technological process used to add non-energy producing nutrients (minerals and/or
vitamins) to traditional foods of widespread consumption such as, for example, iodized salt or
cereals fortified with folic acid. These substances are of paramount importance to increase the
content of specific nutrients in a given population when nutritional deficiencies have been
shown to exist.
Enriched food: foods whose concentration of one or more nutrient/s, already existing in nature
but that are often lost during processing, is increased. An example is the addition of vitamins
and/or minerals to breakfast cereals or the addition of calcium to fruit juices or soy milk.
Supplemented food: in this case the addition consists in introducing a nutrient that was not
originally contained in the food, such as omega-3 fatty acids or phytosterols in milk and its
derivatives, or carotenoids and Vitamin D added to margarine in order to make its profile
more similar to that of butter”.
Putting a system of rules into place for individual food products with health benefits under the
aegis of a category (health foods,) allows for the reconstruction of synergies and meanings in
in connecting laws that are able resolve several grey areas with regards to the demarcation
line between medicines and food; it allows the identification of mechanisms to overcome
85
stalemate situations in the intra-EU movement of goods through indirect forms of EU
harmonisation that stimulate new standardisation processes of substances used in food151.
These processes can be activated at the request of private operators (e.g. using the system of
voluntary nutrition and health claims under Regulation EC No 1924/2006) or by initiative of
the Commission and the Member States (e.g. through the activation of the procedure referred
to in Article 8 of EC Regulation No 1925/2006).
The Community legislation of certain foods in ad hoc legal types (because of their recognised
ability to produce positive health benefits) makes the elaboration of the "health foods"
category possible and useful. Firstly, the creation of the category allows for the better
identification of the elements that are constitutive in the distinction between its products and
medicines152, referring them to the common health function “denominator” (albeit within safe
parameters), rather than to special regulations peculiar to this or that specific food type (which
could more easily be considered “transferable” in terms of the general food-medicine
relationship); secondly, it facilitates the highlighting of special characteristics which justify
differential regulation of products within the same food category. This allows the interpreter
to “master” the application of several useful instruments in a more general and more elastic
way153.
These instruments aid in overcoming obstacles to the movement of the product within the EU,
in some cases pushing even beyond the explicitly marked (by reference legislation) borders,
when that is deemed justifiable on the basis of guaranteeing the function of effectiveness
connected to the conscious and responsible consumption of food.
151
Frewer, Scholderer, and Lambert, Consumer acceptance of functional foods: issues for the future, in British
Food Journal, 2003, 105 (10), p. 714.
152
See Petrelli, I prodotti alimentari della salute, in, I prodotti alimentari della salute, in Costato – Borghi Russo e Manservisi (a cura di), already mentioned, Napoli, 2011, p. 291.
153
Hilliam, Functional food: how big is the market?, in World of Food Ingredients, 2000, 12, p. 50.
86
CHAPTER III: Food labelling and food information in the new
EU legislation
1.13 Regulation 1169/2011: a corollary of the European system of
consumer protection
As already demonstrated in the previous chapters, food information to consumers was
governed by Directive 2000/13/EC of 20 March 2000 on food labelling154.
Now however, it is disciplined by Regulation (EU) No 1169/2011155 of the European
Parliament and the Council of 25 October 2011 on the provision of food information to
consumers156. The key feature of this legislative choice lies in the fact that previously all
mandatory and voluntary food information was disciplined by a directive, that as such obliged
all member states to reach the same goal while being left the freedom to choose how. The aim
of the precedent legislation was in fact the approximation of the laws of the Member States
154
Concerning the Directive 2000/13 see Germanò, Corso di diritto agroalimentare, Torino, 2007, p. 127;
Costato, Compendio di diritto alimentare, Padova 2006; Ventura, Principi del diritto alimentare, Milano, 2001;
Vitolo, Il diritto alimentare nel diritto interno e comunitario, Napoli, 2003.
155
See regarding the “Proposal for a regulation of the European Parliament and of the Council on the provision
of food information to consumers” (COM(2008)0040 – C6-0052/2008 – 2008/0028(COD) Bolognini, Il ruolo
dell’etichettatura degli alimenti Nella prospettiva del Trattato di Lisbona, in Costato – Borghi – Russo Manservisi (a cura di), Dalla Riforma del 2003 alla Pac dopo Lisbona, Napoli, 2011, p. 363. See also documents
from the Workshop on Food products and information to consumers, organized by European Food law
Association, Efla, and by the Italian Food law Association, Aida, in Milan June 2011, documents published on
Riv. dir. alim., 2001, II, p. 24. For a comment on the Regulation itself see Jannarelli, La fornitura di
informazioni sugli alimenti ai consumatori nel nuovo regolamento n. 1169/2011 tra l’onnicomprensività
dell’approccio e l’articolazione delle tecniche performative, in Riv. dir. agr., 2012, I, p. 38; Russo, Deleghe
normative e atti di esecuzione nel reg. Ue n. 1169/2011, , in Riv. dir. agr., 2012, I, p. 47; Albisinni, La
comunicazione al consumatore di alimenti, le disposizioni nazionali e l’origine dei prodotti, , in Riv. dir. agr.,
2012, I, p.66; Giuffrida, Pratiche leali di informazioni e informazioni volontarie, , in Riv. dir. agr., 2012, I, p.
79; Forti, Determinazioni nutrizionali, , in Riv. dir. agr., 2012, I, p. 94; Canfora, La responsabilità degli
operatori alimentari per le informazioni sugli alimenti, in Riv. dir. agr., 2012, I, p. 114. And see also Germanò,
Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, , in Riv. dir. agr., 2012, I, p. 270.
156
Concerning the participation of the European Parliament to the agricultural legislation acts see Costato, Il
nuovo titolo dedicato all’agricoltura nel TFUE, in Costato-Borghi-Russo-Manservisi (a cura di), Dalla Riforma
del 2003 alla Pac dopo Lisbona, Napoli, 2011, p. 73. For a complete overview of the Lisbon Treaty see
Baudouin, Le Traité de Lisbonne et la Politique agricole commune, in Revue du droit rural, 2010, p. 3. And also
Goldoni, Introduzione ai lavori della «Giornata studio» in IL trattato di Lisbona: quali novità per la
regolamentazione dell’agricoltura?, Riv.dir.agr. 2010, I, p. 167. And more on the competence of Member States
on food safety in abscence of an EU harmonized legislation, see also Losavio, Alimenti non sicuri e tutela della
salute: il potere residuale degli Stati membri tra libera circolazione delle merci (art. 28 e 30) e armonizzazione
(art.95), in Dir. giur.agr., 2007, p. 369. Concerning the European Institutions competence see AlbisinniSorrentino, Il primato delle Istituzioni Nella riforma della PAC, in Agricoltura- Istituzioni-Mercati, n.1/2008.
87
relating to the labelling, presentation and advertising of foodstuffs; the current framework on
the other hand marks the transition to an immediately binding single piece of legislation with
regards to both Member States and individual citizens.
Ever since the birth of the Common Agricultural Policy (CAP), European law governing food
policies has always been of an incentivising and promotional nature. It was a series of norms
aimed at the rise and implementation of a regulated and productive agricultural economy.
Today, globalisation has increasingly led to forms of integral liberalism and will probably
lead to the end of promotional law since it is considered to be disruptive to the free market
and free competition on a global level.
The European Institutions are abandoning the idea of directly intervention when dealing with
the agricultural market157. European law is becoming more and more of a regulative nature,
one which each time precisely identifies the discipline to which all the Member States must
adhere, laying down definitions and establishing rules of comportment158. In the recent
decades a new tendency has developed; that of elaborating real “codes” in European
agriculture159.
Examples are the European code for rural development (1698/2005 now Regulation 74/2009)
and the European code on the common organisation of agricultural markets 1234/2007160.
Basically, a transition was made from the web of numerous legislative dispositions to a formal
single act that reordered, systemised and thus incorporated those laws of areas that had
originally been left out of the text. Furthermore, those sectors that had previously been
governed by national law became more and more influenced by Community legislation,
characterised by the imposition of common rules. The profile of centralised regulation has
also taken over the field of what is strictly defined as European Food Law161.
157
Le nuove misure di rafforzamento della politica di sviluppo rurale, in Casadei- Sgarbanti (a cura di), Il nuovo
diritto agrario comunitario, Milano, 2005, p. 77.
158
In particular, concerning the regulation 3/2008 on information provision and promotion measures for
agricultural products on the internal market and in Third Countries see Gencarelli, La politica comunitaria di
promozione dei prodotti agroalimentari: origine ed evoluzione, in Dir.giur.agr., 2009, p. 383.
159
See Albisinni, Il diritto agrario europeo dopo Lisbona fra intervento e regolazione: i codici europei
dell’agricoltura, in Agricoltura-Istituzioni-Mercati, n.2/2011, p. 29 . from the same Author, Verso un codice
europeo dell’agricoltura, in Atti dell’Accademia dei Georgofili, Firenze, 2005, p. 411.
160
See Costato, Il regolamento unico sull’organizzazione comune dei mercati agricoli (Reg. CE 22 ottobre 2007,
n. 1234), Commentario di Luigi Costato, in Le nuove leggi civili commentate, 2009, p. 181.
161
Concerning the European food law see Commentario “La sicurezza alimentare nell’Unione europea”, a cura
dell’IDAIC, in Le nuove leggi civ. comm., 2003, p. 114; Also Germanò-Rook Basile, Manuale di diritto agrario
comunitario, Torino, 2010; Costato, I principi del diritto alimentare, in Diritto Alimentare. Mercato e sicurezza,
dir. da Albisinni, Wolters Kluwer Italia, Milano, 2009, www.leggiditaliaprofessionale.it; Costato, Corso di
88
This has well justified the use of the regulation instrument over that of the previously used
Directive162.
Regulation 1169/2011, which lays down the rules concerning the provision of food
information to consumers, can certainly be considered to be part of the European system of
consumer protection that has been enriched over the years by several legislative measures163.
Among these measures we can cite the following examples, Directives: 84/450 concerning
misleading advertising164; 85/374 on product liability165; 85/577 on contracts negotiated away
from business premises166; 87/102 on consumer credit; 90/314 on tourist packages; 93/13 in
relation to unfair terms in consumer contracts167; 94/47 on timeshares; 97/7 on distance
contracts; 98/6 on price indications; 98/27 on injunctions; 99/44 on sales of consumer goods
and 2005/29 on unfair business to consumer commercial practices 168. These pieces of
legislation, directives to be precise, establish frameworks and ensure minimum harmonisation
in all Member States. Today however, the European legislator is trying to create a legislative
diritto agrario italiano e comunitario, III ed., Milano, 2008; Costato-Borghi-Rizzioli, Compendio di diritto
alimentare, IV ed., Padova, 2011. Costato (a cura di), Trattato breve di diritto agrario italiano e comunitario, III
ed., Padova, 2003 ; Albisinni-Costato (a cura di), European food law, Bologna, 2012.
162
Costato, Principi e requisiti generali della legislazione alimentare, in Costato – Germanò - Rook Basile
(diretto da), Trattato di diritto agrario, III, Il diritto agroalimentare, Torino, 2011, p. 19.
163
Alpa – Conte - Rossi Carleo, La costruzione del diritto dei consumatori, in Alpa (a cura di), I diritti dei
consumatori, in Ajani- Benacchio, (diretto da), Trattato di diritto privato dell’Unione europea, III, Torino, 2009.
Concerning the up growing system of the food consumer protection in Eu legislation see Albisinni, Sistema
agroalimentare, in Digesto civ., Agg., II, Torino, 2009, p. 498.
164
The Directive 84/450 has been modified by Directive 2005/29, implemented in Italy with the d.lgs. 2 August
2007 n. 145. For a comment on the Directive 2005/29, see Maione, Le pratiche commerciali sleali nella direttiva
2005/29/CE, in Alpa – Capilli (a cura di), Lezioni di diritto privato europeo, Padova, 2007, p. 1068.
165
For an overview see Germanò, La responsabilità dei prodotti difettosi in agricoltura, in Rook Basile, Massart
e Germanò (a cura di), Prodotti agricoli e sicurezza alimentare, Milano, 2003. From the same Author, La
responsabilità del produttore agricolo, in Costato (diretto da), Trattato breve di diritto agrario italiano e
comunitario, Padova, 2003, p. 743.
166
See on the topic Jannarelli (a cura di), Le vendite aggressive, Napoli, 1995.
167
Concerning the abusive clauses, Alpa e Bianca (a cura di), Le clausole abusive nei contratti stipulati con i
consumatori. L’attuazione della direttiva comunitaria del 5 aprile 1993, Padova, 1996.
168
Concerning unfair commercial practices see Cristofaro, (a cura di), Le “pratiche commerciali sleali tra
imprese e consumatori”. La direttiva 2005/29/Ce, Torino, 2006. Also Jannarelli, La concorrenza e l`agricoltura
nell`attuale esperienza europea: una relazione speciale, in Riv.dir.agr., 2009, IV, p. 515. Concerning the Italian
authority for competition and market see Astazi, Pratiche commerciali scorrette e tutela dei consumatori: I
nuovi poteri dell’AGCM, in Riv.dir.alim., 2/2008, p. 42. Concerning the competion in the food market see
Jannarelli, La concorrenza nel sistema agro-alimentare e la globalizzazione dei mercati, in Dir. giur. agr., 2000,
p. 433; From the same Author Il regime della concorrenza nel settore agricolo tra mercato unico e
globalizzazione dell’economia, in Riv. dir. agr., 1997, I, p. 416.
89
review in order to ensure that consumers of each member state receive more uniform
treatment so as to eliminate the differences between states as much as possible.
For example, this is the goal of Directive 2011/83 on consumer rights which reconfirms the
need to establish common rules in order to provide citizens with more opportunities and
guarantees with regards to the purchase of goods and services across borders. This Directive
modifies or replaces the earlier directives, No 85/577 on contracts negotiated away from
business premises, No 93/13 on unfair terms, No 97/7 on distance contracts and No 99/44 on
the sale of consumer goods. Furthermore, together with the regulations mentioned above, it
helps to compose a single legal system, one that is increasingly homogeneous for all member
States of the European Union.
1.14 The EU Commission Proposal for a regulation on the provision of
food information to consumers, Brussels, 30.1 2008, COM (2008) 40
final
Information is the essential instrument of the consumer policy and proved vital for consumer
themselves. Drawing on such a position the European Commission issued the Proposal COM
(2008) 40 on the provision of food information to consumers169. The consumer is thus
empowered by the policy of the European Commission, which is based on the assumption that
the consumers, when informed in a complete and proper way, will make the markets more
efficient by taking decisions in an economically rational way.
As a matter of fact, nutrition labelling, and other consumer information in general, aim at
providing the consumer with the essential knowledge to take proper decisions and at the same
time increase the transparency in the market. It seems important to highlight that both
nutritional science and the media often report equivocal or contradictory findings, thus
providing further benefits to the consumer lack of knowledge.
However, the irrational side of consumer behaviour needs to be take in consideration as well.
There are indeed consumers which do not strive for more information and are find with their
169
For a comment to the Proposal see Costantino, Prime considerazioni sulla recente proposta di regolamento
comunitario sulle informazioni alimentari ai consumatori, in Riv.dir.agr., 2008, I, p. 152.
90
ignorance of food characteristics, either on purpose or unconsciously. This may be for lack of
interest, or time, or awareness.
It does not appear easy to explain why consumers take irrational decisions (at detriment of
their own health and wellbeing). The purchasing decision aspect of consumers has been
studied by behavioural economics. It appears indeed that some at least three general
purchasing patterns can arise among consumers when buying products: a selective perception,
decisions based upon past experiences; and conclusions based on the way information is
presented.
Indeed, when a consumer performs a purchase decisions, he is subjected to many
environmental distractions which impact on his behaviour and attitude, such as the very
position of a given product on the shelf, which can be either comfortable and attractive or
force the consumer to bend and make efforts; packaging is another element worth mentioning.
The purchase decisions is a process which can be influenced, given the preferences which
take form in the consumer at the moment of the purchase. Moreover, some consumers take
decision in an irrational way, based on immediate impulse rather than on rational thinking or
long term perspectives self-restraint such as counselling group on healthy nutrition.
Behavioural economics also plays a major role in assessing and studying purchasing decision
from consumers. Indeed, there seems to be a strong impact of rewards and punishment ( thus
incentives and disincentives) associated with food choices. Proper incentives might indeed
prevent consumers to fall victim of bad behaviour such as the love for fried food or sweets.
However the repetitive experience of mistaken purchasing decision seems to be problematic.
The purchase decision, and the possible repetition of a mistaken purchase is also very much
linked to the self-confidence of a person. For instance, when people neglect the fat-content of
a given food they behave according to their immediate impulse rather than according their
long term benefit. The realization of this can in turn harm the self-confidence of a person, and
over multiple repetitions can turn into a self-fulfilling prophecy.
This is possibly due because consumers also resist to the information they are provided with.
Again, behavioural economics seems to provide for an analysis of this aspect: more
information does not necessarily mean better decision making and more rational behaviour. It
is the latter category the one which does reject the rational use of nutritional information and
behave instinctively.
91
When the European Commission begun working on the legislative proposal, two different
models of information to the consumers were considered. On the one hand, the Commission
took into consideration the so called Traffic Light System170. This system has its main
advantage in the simplicity and immediate understanding by the consumer: a given product is
attributed a colour depending on the level of fat, salt and sugar that it contains. Of course, the
red light represents a high level of these nutritionals; the green light instead will identify
healthier foods, with limited amounts of the above mentioned elements.
The other system considered was the Guideline Daily Amounts (GDAs). This system is less
immediate and requires the consumer to put more attention when undertaking a purchase. The
system consists in providing for each product the level of its nutritional elements, compared to
the daily consumption amounts suggested. This amounts can be either expressed in percentage
of the suggested daily consumption. The fact that this model was also referred to as expanded
nutrition labelling.
The trade off between the two systems seems thus to be in the immediate clarity and impact
on the decision making process of the consumer. Each of them gained support from different
health care and consumer organizations. For instance, the traffic light model was quoted as
more immediate, given that for this nutrient, there is a red warning signal, so think again
about your consumption and avoid frequent consumption of this food.
It thus happened that while the proposal was still discussed within the European Commission,
different position among the stakeholders emerged.
Notably, the retailers and manufacturers expressed a preference for the “expanded nutrition
labelling”, and refused to adopted voluntarily the Traffic Light System. They believed this
system was too simplistic and subjective, because it provided for too few category of foods
(i.e. red, yellow, green), and it did not provide enough information and insights on the actual
healthiness of a food product. They thus concluded the Traffic Light System did prove
discriminatory, and counterproductive for the health of consumers. One of the main detracting
examples of the excessive simplicity was that even fruits would have been labelled yellow or
red, given their sugar levels.
170
First reflections on the traffic light system see Costato., Etichette dei prodotti alimentari: il Parlamento
europeo respinge il semaforo, in Riv.dir.alim., 1/2010, p. 1, and also Bolognini, Il ruolo dell’etichettatura degli
alimenti nella prospettiva del Trattato di Lisbona, in Costato-Borghi-Russo-Manservisi (a cura di), Dalla
riforma del 2003 alla PAC dopo Lisbona, already mentioned, p. 363.
92
This position was of course criticized by supporter of the Traffic Light System. They indeed
argued that such an objection was preposterous, since all food products would have been
“evaluated according to the same criteria”.
The detractors of the Traffic Light System went further, arguing that the system was not
neutral, independent and comprehensive in the way it provided information to consumers
about the level of nutrients. Finally, the Traffic Light System was criticized for its lack of
solid scientific foundation, while the GDA model was instead an instructional and educative
way to provide information to consumers.
After a thorough public debate, the GDA system was finally picked up by the European
Commission as the one to pursue in its policy.
1.15 Creating the premises for an informed consumerism
October 25th of 2011 finally saw the issuing of the European Parliament and Council
Regulation No 1169/2011 on the provision of food information to consumers.
Thus from this point on, the labelling, presentation and advertising of foodstuffs were no
longer governed by a directive with different possible ways of implementation in the 27 EU
member states, but were now covered by a single legislative measure which unified the rules
for all states and subjected all citizens to the same normative provisions.
Which brings us to the question “Why was it necessary to regulate food information to
consumers with a legal instrument such as the EU regulation?” The answer is surely
attributable to the growing necessity of knowing the origin, composition and nutritional
properties of what we eat. Above all however, the new legislation enacted (or tried to)
provisions that are as clear as possible, precise and transparent.
In general, all food information is always given to consumers through the use of one
instrument: the label171.
171
Germanò, Corso di diritto agroalimentare, Torino, 2007, p. 146; Germanò - Rook Basile (a cura di), Il diritto
alimentare tra comunicazione e sicurezza dei prodotti, Torino, 2005; Costato, Compendio di diritto alimentare,
already mentioned; Albisinni, Etichettatura dei prodotti alimentari, in Diritto alimentare. Mercato e sicurezza,
BD on line, dir. da F. Albisinni, Wolters Kluwer It., www.leggiditaliaprofessionale.it, 2012; from the same
Author, Le norme sull’etichettatura dei prodotti alimentari, in Tratt. Dir. agr. Nazionale e comunitario, diretto
93
Regulation 1169/2011 lists elements that must be contained in the label as “any words,
particulars, trademarks, brand name, pictorial matter or symbol”, and refers not only to the
label itself, but also to “any packaging, document, notice, label, ring or collar accompanying
or referring to such foodstuff”. It is a “horizontal” regulation to which other “vertical”
interventions on certain products are connected; for example, the Food Supplements Directive
2002/46 of 10 June 2002 (which Regulation No 1169/2011 expressly excludes from the
application of Section 3 on nutrition declaration, Article 29(1)(a)).
Another example is that of the natural mineral waters172 Directive 2009/54 of 18 June 2009
that Regulation 1169/2011 expressly excludes from the application of Section 3 (natural
mineral waters) of Chapter IV on mandatory food information, (Article 29(1)(b)). Further
examples include regulations on the designation of origin (PDO), on geographical indications
(PGI) and traditional specialities guaranteed (TSG) of agricultural products and foodstuffs:
Regulation 510/2006 on PDO and PGI, and Regulation 509/2006 on TSG to which
Regulation 1169/2011 refers making it subject without prejudice to the labelling requirements
provided for (Article 26(1))173.
Generally speaking, it can be said that Regulation 1169/2011 offers a very broad regulatory
framework that aims to simplify and rationalise the provisions of previous regulations. This
intent is already discernible in the title of the Regulation itself, which refers to the provision
of information to consumers in general (and not only to the labelling, presentation and
advertising of foodstuffs, as in the case of Directive 2000/13/CE); this already marks
da Costato, Padova, 2003, p. 631. See also Lucifero, Etichettature degli alimenti,in Digesto civ., Agg., Torino
2009, p. 210,
172
Pavesi, L’acqua potabile per il consumo umano: elemento di preparazione ed ingredienti di alimenti e
bevande. Le acque minerali, in Dir.giur.agr., 2011, p. 595.
173
See Reg. 510/2006 of 20 March 2006 concerning Pdo and Pgi, Reg. 509/2006 del 20 March 2006 concerning
Stg and Reg. 834/2007 del 28 June 2007 concerning the organic scheme. On the Proposal of a Regulation on
these three schemes see Strambi, La proposta di regolamento sugli schemi di qualità dei prodotti agricoli, in
Goldoni - Sirsi, Il ruolo del diritto nella valorizzazione e nella promozione dei prodotti agro-alimentari, Milano,
2011, p. 177. See also Lucifero, La comunicazione simbolica nel mercato alimentare: marchi e segni del
territorio, in Costato – Germanò - Basile (diretto da), Trattato di diritto agrario, III, Il diritto agroalimentare,
already mentioned., p. 321; Masini, Pdo, Pgi and Stg, in Costato-Albisinni (editors), European Food Law,
Bologna, 2012 p. 351. On the organic scheme see also Canfora, L’agricoltura biologica nel sistema
agroalimentare. Profili giuridici, Bari, 2002; from the same Author Organic food, in Costato-Albisinni (editors),
European Food Law, already mentioned, p. 369. Concerning the competitiveness linked to the geographical
indications see Trapè, Qualità e competitività nelle produzioni agroalimentari. Le indicazioni geografiche tra
esigenze di coerenza e di efficacia, in Agricoltura – Istituzioni-Mercati, n. 3/2008. See also Vedaschi, Le
indicazioni geografiche semplice e la corretta informazione del consumatore, in Dir.pubbl.comp. eur., 2001, p.
384. See finally Lucifero, Il territorio: rapporto tra regole del produrre e regole del vendere, in Germanò- Rook
Basile, Il diritto alimentare tra comunicazione e sicurezza dei prodotti, Torino, 2005, p. 105. More concerning
the Budvar sentence see Germanò, Manuale di diritto agrario, Torino, 2010, p. 157.
94
significant differences between the two texts. The Regulation aims to build more than just a
set of rules and its goal is to act as an obligatory point of reference for all matters relating to
the communication between producers and consumers. In this way, a real fabric of rules has
been created, as was already similarly done by Regulation (EC) No 178/20023 which brought
a new approach to food law, providing it with principles. However it should be noted that the
objective of clarification and simplification has not always been reached, and there are
various gaps left by the legislature.
The aim behind the provision of food information is that of achieving a high level of
protection of consumer health and interests. The information is to allow the consumer to make
informed and “safe” choices, while taking economic, environmental, health, social and ethical
factors into account. The information given must also ensure the free movement of food
within the protection of the interests of producers and the implementation of quality
production174.
The legislative intent behind Regulation 1169/2011 is to provide protection for the diverse
interests of various persons (consumers and producers), which manifest in rarely reconcilable
positions within the market. Certainly the most innovative aspect of the Regulation is that it
has expanded the sphere of interests protected by the legislator: it no longer only safeguards
protection of the health and economic interests of the various actors in the market. Today
environmental, social and ethical issues are also taken into account.
This change could thus help to build and open new dimensions in the field of communication
and food information and would confirm the idea of the concept of the so-called informed and
conscious consumer.
But what is a conscious consumer? Is there is a difference between informed choice and
conscious choice? With Regulation 1169/2011, the legislator aims (or seems to aim) to
174
See documents from the XXVII Congrès National dell’AFDR sur La politique de qualité des produits
agricoles in Revue de droit rural, 2001, p. 17. It is already known that a legislative definition of quality doesn’t
exist, because it is not possible to frame the concept and because it is deeply linked to a personal choice. The
European Commission has published in November 2008 the Green Paper on agricultural product quality:
product standards, farming requirements and quality schemes, and in April 2009 the Impact Assessment Report
(IAR) following the answers of stakeholders involved. Then on 2009 the Communication from the Commission
the European Parliament and the Council on COM(2009) 234 final on agricultural product quality policy. On
September 2012 the Parliament has adopted in first reading the text Com(2010)0733. Referring to the Green
Paper see Germanò, La qualità dei prodotti agro-alimentari secondo la Comunità europea, in AdornatoAlbisinni- Germanò (a cura di), Agricoltura e alimentazione. Principi e regole della qualità, Milano, 2010, p.
189. Strambi, La proposta di regolamento sugli schemi di qualità dei prodotti agricoli, in Goldoni-Sirsi, Il ruolo
del diritto nella valorizzazione e nella promozione dei prodotti agro-alimentari, Milano, 2011, p. 177).
95
educate and inform the modern consumer. This intention, however, leads us to the so-called
reverse side of the coin: the widening of both the area of responsibility of the manufacturer or
supplier of the information, and of commitment by the consumer, who ideally is open to
receiving information and to being educated.
96
1.16 Principles of Regulation 1169/2011
The principles governing food information are laid down in Article 4:
(a) information on the identity and composition, properties or other characteristics of the
food175;
(b) information on the protection of consumers’ health and the safe use of a food176.
(c) information on nutritional characteristics so as to enable consumers 177, including those
with special dietary requirements, to make informed choices.
Thus, the rules laid down in the regulation aim to create a system of information that is fair,
clear, precise and comprehensible; necessary in order to reach the goal of allowing the
consumer to make informed choices178.
175
The first category of mandatory particulars pursuant to Art. 4 concerns characteristics of the food. The
essential information on the identity of the food is its name. Concerning the previous statements of the Directive
79/112 see Chapter I p. 35. The most important information on the composition is the list of ingredient pursuant
to Article 9 in conjunction with Art. 18. This also includes mandatory particulars on ingredients causing
allergies or intolerances pursuant to Article 9 par. 1 lit c) as well as the quantitative indications of individual
ingredients. Information on properties or other characteristics refer especially to its state of minimum durability,
the country of origin or place or provenance pursuant Article 9 in conjunction with Art. 26 and where applicable,
the alcoholic strength. For a comparison with the previous legislation, now repealed by Regulation 1169/2001
see Chapter I p. 35 (concerning the Directive 79/112) and p. 36 (concerning the Directive 2000/13).
176
The second category of mandatory particulars tallies with the corresponding objectives of the Regulation
pursuant Art. 3. The legislator distinguishes between three different groups of information, but does not provide
an exhaustive list, which is also clear in this context from the words “in particular”. Health related mandatory
particulars indeed are first of all information on “compositional attributes that may be harmful to the health of
certain groups of consumers. These so called “vulnerable” consumers group including allergies suffers, babies,
infants and other children as well as pregnant women and possibly also other person. Regarding the presence of
allergenic substances in foodstuffs see Chapter II p. 41. See Ragionieri, La disciplina degli allergeni negli
alimenti, in Trattato di diritto agrario, III, Il diritto agroalimentare, already mentioned, p. 141; Germanò, La
normativa di riferimento sugli ingredienti allergenici e sull’obbligo della loro etichettatura, in Riv. dir. agr.,
2007, I, p. 379; Losavio, Le regole comunitarie e nazionali relative all’igiene dei prodotti, in Trattato di diritto
agrario, III, Il diritto agroalimentare, Torino, 2011, p. 183; and also Di Lauro, Il diritto alimentare: un diritto in
movimento. (il caso dell’etichettatura degli allergeni), in Riv.dir.agr., 2007, I, p. 75.
177
Concerning the nutritional information provided by Regulation 1924/2006 see Chapter II p. 57-63.
178
It should be said that although Article 4 is captioned “Principles governing mandatory food information” the
provision in fact stipulates something else. The Article indeed contains a non exhaustive list of categories into
which mandatory information within the meaning of Article 2. Par. 2 lit c) can fall. Art. 4 par. 2 establishes
criteria which have to be observed when examining the need for such mandatory information without, however,
making such an examination compulsory. Paragraph 1 shall limit the circle of mandatory information to three
different categories. However, because of the word “in particular” it leaves scope for the legislator to establish
mandatory information, which would not fall into one of the categories of Article 4 par. 1. Thus, the stipulation
is not so significant for labeling practice.
97
This means that the health protection is remitted to the consumer itself who is put in a
condition to know what he is going to eat, while the hygienic requirements are definitely
considered as pre-requirements179.
Article 5 is entitled “Consultation of the European Food Safety Authority” and entrenches the
significance of EFSA in food information law. Wherever measures in this field are “likely to
have an effect on public health”, the Authority shall be consulted. This may concern healthrelated mandatory particulars within the meaning of Art. 4 par. 1 lit b) but it also may concern
implementing acts on voluntary information pursuant Article 36.180
The legislator finally refers to the producers’ interests and to the promotion of quality
products stating that a transparent labelling should avoid unfair competition among producers.
In this respect Article 7 seems to be complete while stipulates that food information shall not
be misleading particularly:
(a) as to the characteristics of the food and, in particular, as to its nature, identity, properties,
composition, quantity, durability, country of origin or place of provenance, method of
manufacture or production;
(b) by attributing to the food effects or properties which it does not possess;
(c) by suggesting that the food possesses special characteristics when in fact all similar foods
possess such characteristics, in particular by specifically emphasizing the presence or absence
of certain ingredients and/or nutrients;
(d) by suggesting, by means of the appearance, the description or pictorial representations, the
presence of a particular food or an ingredient, while in reality a component naturally present
or an ingredient normally used in that food has been substituted with a different component or
a different ingredient.
179
In this respect Costato, Le etichette alimentari nel nuovo regolamento 1169/2001, in Riv.dir.agr., 2011, p.663.
180
Concerning the voluntary particulars see p. 108. Essentially the provision is based on the fundamental
principle of recent European food law, namely to put food law provisions on a strong scientific base within the
meaning of Article1 par. 1 Regulation 178/2002.
98
The fact that has been avoided an exhaustive lists of prohibited conducts gives to the whole
system a comprehensive character.
Finally Art. 7 par. 4 extends both provisions to advertising and presentation of food. These
stipulations supplement the general European ban on misleading practices pursuant to Article
6 of Unfair Commercial Practices Directive 2005/29181 and thereby substantiate the general
food law ban on misleading advertising and presentation pursuant Art. 16 Regulation
178/2002.
The Regulation 1169/2011 does not give a definition of what is misleading. In accordance to
the European Court of Justice jurisprudence is understandable that the information must be
suitable to deceive the average, reasonably and well informed consumer182.
The use of statutorily prescribed labelling elements, for examples a legal name, can thus not
establish a breach of the prohibition to mislead in principle.
Concerning the characteristics of the food the “nature” and the “identity” are essential
product characteristics while the “composition” is essentially determined by its ingredients.
The danger of deception regarding the composition arise particularly where ingredients are
advertised which are not contained in the product in the product or a false impression is
created regarding the ingredients used183. According to the case law of the European Court of
181
Concerning unfair commercial practices see Cristofaro, (a cura di), Le “pratiche commerciali sleali tra
imprese e consumatori”. La direttiva 2005/29/Ce, Torino, 2006; and also Jannarelli, La concorrenza nel sistema
agro-alimentare e la globalizzazione dei mercati, in Dir. giur. agr., 2000, p. 433; From the same Author Il
regime della concorrenza nel settore agricolo tra mercato unico e globalizzazione dell’economia, in Riv. dir.
agr., 1997, I, p. 416.
182
See Gonzales Vaqué - La notion “de consommateur moyen” selon la jurisprudence de la Cour de justice des
Communautés Européennes, in Revue du droit de l’Union Européenne, 2004, p. 69. See the already mentioned
judgments Court of Justice, 10th September 2009, Cases n. 446/07; Trib. Roma, 25 th February 1998; Trib. Napoli
26th June 1997; Trib. of Padova, 29th November 1994 in Chapter I p. 31.
183
The label is forbidden to include claims that are likely to mislead the consumer as to the characteristics of the
food in relation to the nature, identity, properties, composition, quantity, durability, country of origin or place of
provenance and the method of production or origin (Article 7(1)(a)). In particular, labelling must not attribute to
the food effects or properties which it does not possess (Article 7(1)(b)); must not suggest that the food possesses
special characteristics when all similar products possess them (Article 7(1)(c)); and should not attribute to the
food the property of preventing, treating or curing diseases (Article 7(3)), in other words it must not contain
health-related claims. From the existence of provisions on prohibited labelling information we can deduce the
possibility of placing voluntary information alongside mandatory information. In other words, the food producer
can “enrich” the label with a number of particulars, messages, and additional wording enabling it to attract the
consumer's attention in order to win the competition in the market. In this context, the unique relationship that
exists between labelling and advertising is highlighted. The Community provisions on labelling also apply to
presentation and those on the prohibition of health claims also apply to advertising. Concerning the measures to
defend the health of European citizens see Chapter I p. 12 for the historical evolution, and p.30 concerning the
legislation on protection of health. See Germanò, Corso di diritto agroalimentare, already mentioned, p. 147.
Concerning the advertising in food labeling, see Di Lauro, Comunicazione pubblicitaria ed informazione nel
settore agro-alimentare, Milano 2005. From the same Author, La comunicazione e la disciplina della pubblicità
99
Justice claims emphasising the absence of certain substances, which however are in fact
contained in a food, are particularly suitable to deceive, for example “without preservatives”
for as preserved product184.
Concerning the “effects or properties” refer to effects that the product does not possess,
health-related effects are categorically prohibited according to Art. 2-13 and 14 of the
Regulation 1924/2006185. On the contrary if they are authorized the special ban on misleading
claims pursuant Art. 3 lit a) of Reg. 1924/2006186.
Finally Article 8 of Regulation 1169/2011 determines the responsibilities of the food business
operators for food information. It is particularly concerned with deciding who has to furnish
information, especially in cases when the operator does not have the information to label the
food or else where the operator does not sell it to the final consumer. Art. 8 par. 4 establishes
a supply ban for distributors, the whole provision instead has to be understood as contrary to
the background of Article 17 of Regulation 178/2002
which establishes the general
responsibility of food business operators for the observance of food law requirements in
respect of their own activities. It is interesting to underline that par. 3 of Article 8 bans
distributors and marketers of food who “do not affect food information” to supply food where
the information is non-compliant187. Normally, this only applies to retailers since
manufacturers as well as packers or bottlers regularly affect food information through their
activities.
dei prodotti alimentari, in Costato - Germanò - Rook Basile (diretto da), Trattato di diritto agrario, III, Il diritto
agroalimentare, Already mentioned, p. 547; Labels, names and trade marks, in Costato - Albisinni (editors),
European food law, already mentioned, p. 285.
184
A special case of potentially misleading information of the composition of a food is also the “imitation”
regulated by Article 7 par. 1 lit. d) see infra. The durability is the minimum durability which has to be labelled
pursuant Art.9 par. 1 lit. F) , if a food is in fact not as durable as labelled, the corresponding information is
misleading. Indications on “the country of origin or place of provenance” which have to be labelled pursuant Art.
9 and Art. 26 can also be misleading, this is especially the case of if the food does not in fact originate from the
indicated country of origin or was not produced at the place of provenance, respectively.
185
See Chapter II p. 56.
186
Ban on disease-related information expressly exempts natural mineral waters and foods for particular
nutritional uses as well as disease-related indications especially authorized pursuant to European law.
187
See Costato, Le etichette alimentari nel nuovo regolamento 1169/2001, in Riv.dir.agr., 2011, already
mentioned, p.664.
100
1.17 Labelling: content and presentation
Regulation 1169/2011 defines in a very accurate way the food information expressed in the
label that shall be available and shall be easily accessible to consumers.
Article 15 calls for a language that is “easily understood” by consumers in the Member State
in which the food is marketed188. As for placement, it is stated that mandatory food
information shall be marked in a conspicuous place in such a way as to be easily visible,
clearly legible and, where appropriate, indelible. It shall not in any way be hidden, obscured,
detracted from or interrupted by any other written or pictorial matter or any other intervening
material (Article 13) and characters using a microscopic font size are forbidden. Labels must
show the components of the food product: ingredients, additives and enzymes189, flavourings,
sweeteners, colorants and preservatives. The following particulars are also mandatory: the net
quantity, the actual alcoholic strength by volume in alcoholic beverages, instructions for use
of the food and any special conditions of storage and use, the manufacturer's name and the
place of origin if failure to do so may mislead the consumer.
Article 2(2)(g) of Regulation 1169/2011, as the most of Regulations in the food law tradition,
gives a list of definitions, deferring to other definitions contained in other related legislations,
such as primarily Regulation 178/2002190.
It lastly defines the “place of provenance”. It is referred to as “any place where a food is
indicated to come from” but that is not the “country of origin” as determined in accordance
with Articles 23-26 of Regulation (EEC) No 2913/92 on the Community Customs Code,
(most recently updated by Regulation 450/2008 of 23 April 2007) 191. The same Article
188
Concerning the language on food labeling see Valletta, La lingua sull’etichetta dei prodotti alimentari, tra
tutela del consumatore e rispetto della libera circolazione delle merci, in Riv. dir. agr., 2001, II, p. 68.
189
See Trapè- Lattanzi, Food additives and contaminants, in Costato-Albisinni (editors), European Food Law,
already mentioned, p. 401.
190
Among the others Article 2 defines “food information”, “prepacked food”, “ingredient”, “label” “field of
vision””legibility”, “legal name” and so on. It refers to the Hygiene package Regulations 852/2004 and
853/2004, to the Regulation 1332/2008 and 1333/2008 concerning the use of enzyme and the food additives and
to the Directive 114/2006 concerning the misleading and comparative advertising.
191
This entails, in broad lines, the country of last, substantial, economically justified processing. For specific
details on the ‘origin’ definition, refer as mentioned to Article 23 to 26 of the Customs Code Regulation. On the
other hand, the place of provenance is any other place than the country of last substantial transformation where a
food is indicated to come from. This could for example be the place of farming, place of cultivation, fishing area,
a town/region/group of countries where the food is indicated to come from, etc. The provisions in the
Regulation refer to country of origin or place of provenance, providing flexibility for food business operators as
to which indication to use. The name, business name or address of the food business operator is not an indication
101
2(2)(g) of Regulation 1169 states that “the name, business name or address of the food
business operator on the label shall not constitute an indication of the country of origin or
place of provenance of food within the meaning of this Regulation”. Since the new regulation
no longer contains a norm that identifies products covered by the definition of “goods
originating in a country”, Article 38 was needed, with which a broad mandate was given to
the Commission to adopt specific rules for the application of Articles 26 (on the
“acquisition/proof of origin”) and 27 (on the “acquisition/proof of origin”).
Article 9 of Regulation 1169/2011, again establishes (as was already the case in the previous
legislation) the mandatory indication of food supplements, genetically modified organisms
and allergenic substances192. Mandatory particulars also include the “use by” date of a product
as well as (for some foods), information necessary for traceability and of course, the price.
The new factor is found in the obligation to indicate the nutritional values193. The aim is to
of the country of origin or place of provenance, and is therefore not subject to the rules on origin in this
Regulation. Regarding the place of origin see Albisinni, I codici europei dell’agricoltura, in Costato – Borghi –
Russo - Manservisi (a cura di), Dalla Riforma del 2003 alla PAC dopo Lisbona, Napoli, 2011, p. 42; from the
same Author L’origine dei prodotti agroalimentari e la qualità territoriale, in Riv.dir.agr., 2003, p. 23, and
L’origine dei prodotti alimentari in etichetta, in Tratt. Breve dir.agr. it e comunitario, diretto da Costato, III ed.,
Padova 2003, p. 639. More Germanò, Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, , in
Riv. dir. agr., 2012, I, p. 270.Also Masini, Dal “mistero” dell’origine al diritto all’informazione nella
presentazione dei prodotti agroalimentari, in Dir.giur.agr., 2003, p. 72.
192
Currently, all pre-packaged food products must indicate on the label the presence in their product of specific
ingredients which the EU has identified as causing allergenic reactions in certain people or to which individuals
can be intolerant to. This list of substances remains the same as that in the current rules (see Annex II of
Regulation (EU) No 1169/2011 for the list). However, under the new rules, they must now be indicated in the list
of ingredients and the name of the substance must be emphasised through a typeset that clearly distinguishes it
from the rest of the list of ingredients, e.g. by means of the font, style or background color. For pre-packaged
foods which are exempt from the requirement to provide a list of ingredients, e.g. alcohol, the indication on the
label must comprise of the word ‘contains’ followed by the name of the substance or product as listed in Annex
II to the Regulation. Under the new rules, the requirement to highlight the use of any of these substances in the
production of a foodstuff has been extended to foods sold loose such as food in restaurants, take-aways, canteens
and deli counters etc. Rules on the means by which this information must be made available to the consumer for
foods sold loose, must be introduced by each Member State. Concerning the presence in foodstuffs of allergenic
substances see Ragionieri, La disciplina degli allergeni negli alimenti, in Trattato di diritto agrario, III, Il diritto
agroalimentare, already mentioned, p. 4. See also Benozzo, Etichettatura degli allergeni, sicurezza alimentare e
responsabilità civile,in Casadei-Sgarbanti (a cura di), Il nuovo diritto agrario comunitario. Atti in onore di Luigi
Costato, Milano, 2005 p. 35; more Germanò, La normativa di riferimento sugli ingredienti allergenici e
sull'obbligo della loro etichettatura, in Riv. dir. agr., 2007, I, 379.
193
Currently, the provision of nutrition information is voluntary unless a nutrition related claim is made when the
declaration then becomes mandatory. From 13th December, 2016, nutrition information will be mandatory for
most pre-packaged foodstuffs. For food businesses who provide nutrition information on a voluntary basis
between 13th December, 2014 and 13th December, 2016, the declaration must comply with the new Regulation.
There are a number of foodstuffs which are exempt from the mandatory requirement to provide nutrition
information and these are listed in Annex V to the Regulation and include unprocessed products that comprise a
single ingredient or category of ingredients, herbs, spices, salt, chewing gums, foods in packaging or containers
the largest surface of which has an area of less than 25cm. Also included in the exemption is food, including
handcrafted food directly supplied by the manufacturer of small quantities of products to the final consumer or to
local retail establishments directly supplying the final consumer. To facilitate the comparison of products in
different package sizes, the requirement that the mandatory nutrition declaration should refer to 100g or 100ml
102
give systematic structure to food information necessary in ensuring the consumer’s right to
information. Consumers should be allowed to make informed choices and to acquire relevant
information with regards both to protecting their own health, as well as to environmental,
social, religious and ethical factors.
As is known, the identity of the product is given by its commercial name194.
Many of the “legal” names for food products are today contained in Regulation 1234/2007 of
22 October 2007 on the single CMO195 or in specific legislation. In accordance with this legal
practice, Regulation 1169/2011 specifies that the “legal name” of a food product is laid down
in the applicable Community provisions (Article 17(1)).
It adds that in the absence of such provisions, reference should be made to the laws,
regulations and administrative provisions applicable in the Member State in which the product
is sold to the final consumer (Article 2(2)(n)). If there are no specific national rules defining
the product, the name consecrated by use and custom should be used, in essence, the so-called
“customary name” defined by Article 2(2)(o) of Regulation 1169/2011.
In accordance with the principle of mutual recognition196, the use in the Member State of
marketing of the name of the food under which the product is legally manufactured and
amounts has been retained. Portion-based declarations are allowed in addition to this where food is pre-packed
and individual portions or consumption units are identified. See on the topic Jannarelli, La fornitura di
informazioni sugli alimenti ai consumatori nel nuovo regolamento n. 1169/2011 tra l’onnicomprensività
dell’approccio e l’articolazione delle tecniche performative, in Riv. dir. agr., already mentioned, p. 38;
194
Concerning the legal definitions see La denominazione merceologica legale dei prodotti agricoli e il
principio del mutuo riconoscimento in Germanò- Rook Basile, Manuale di diritto agrario comunitario, Torino,
2010, p. 239.
195
Costato, Il regolamento unico sull’organizzazione comune dei mercati agricoli (Reg. CE 22 ottobre 2007, n.
1234), Commentario di Luigi Costato, in Le nuove leggi civili commentate, 2009, p. 181. See also from the
same source Strambi-Ferrucci, - Capo II «Organizzazioni di produttori, organizzazioni interprofessionali e
organizzazioni di operatori» artt. 122-127), p 133, and also Germanò-Rook Basile, - Commento alla parte II
«Mercato interno» - Titolo I «Intervento sul mercato» - Capo I «Intervento pubblico e ammasso privato» (Art.643), p. 12.
196
On the principle of mutual recognition see Sgarbanti, Il principio del mutuo riconoscimento e la
denominazione dei prodotti alimentari, in Costato- Germanò- Rook Basile (diretto da), Trattato di diritto
agrario, III, Il diritto agroalimentare, already mentioned, p. 475. And also Jannarelli, La circolazione dei
prodotti agricoli nella Comunità europea: dal principio del mutuo riconoscimento alla tutela della qualità, in
Dir. Agricoltura, 1992, p. 33. From the same Author , Dal principio del mutuo riconoscimento (sentenza Cassis
de Dijon) alla tutela della qualità dei prodotti, in Il sistema agro-alimentare e la qualità dei prodotti, Rook
Basile (a cura di), Milano, 1992, p. 129; Germanò-, Manuale di diritto agrario comunitario, Torino, 2008, Rook
Basile p. 241; Masini, Corso di diritto alimentare, Milano, 2008, p. 27.; Costato, Compendio di diritto
alimentare, Padova, 2007, p. 132; Nicolin, Il mutuo riconoscimento tra mercato interno e sussidiarietà, Padova,
2005, I.
103
marketed in the Member State of production shall be allowed, (Article 17(2)). However, the
name of the food in the Member State of production shall not be used in the Member State of
marketing when the food which it designates in the Member State of production is so
different, as regards its composition or manufacture, from the food known under that name in
the Member State of marketing (Article 17(3))197.
As for the expiration date, it should be noted that this is the date by which the food should be
consumed, as the sale/cession of the product is not allowed after that date. It differs from the
date of minimum durability, which instead is the date until which the food retains its
properties, meaning it should “preferably” be consumed by that date.
With regards to the instructions for the safe use of the food it must be said that the omission of
such information is also noted in terms of strict liability for damage caused by defective
products (Directive 85/374 of 25 July 1985). In order to evaluate the “safety” that can be
expected from a product, the presentation, instructions and warnings provided need to be
considered. In other words, the lack of information on the correct use of the product makes it
“faulty” and makes the producer responsible for the damage that has resulted from its use. It is
true that the manufacturer could prove that the product was objectively capable of providing
the required safety and that the “faultiness” stemmed from the fact that the consumer acted in
an unreasonably foreseeable manner; however there is no doubt that the flaw makes it the
responsibility of the food manufacturer for any damage resulting from the reticent, incomplete
or ambiguous information given on the product label.
197
Germanò, Corso di diritto agroalimentare, Torino 2007, 75. As the principle of mutual recognition was
finally recognized as no sufficient for particular foodstuffs with specific qualitative characteristics the problem
was faced by the European Court of Justice in the now famous case law Smanor. In this judgment the Court has
affirmed that the protection of particular characteristics of a product shall predominate on the free movement
principle. See case 298/87 of 4 July 1988, Smanor, in Raccolta, 1988, p. 4489. For a comment see Sgarbanti,
Trattato breve di diritto agrario italiano e comunitario, II ediz. Padova, 1997, p. 563.
104
1.18 Nutrition information
Regulation 1169/2011 therefore marks the transition from voluntary to mandatory nutrition
information as the latter was previously provided on a voluntary basis in accordance with
certain regulatory requirements set out in Directive CE 496/90. The decision to make nutrition
information mandatory is motivated by variety of reasons that all aim to fulfil the same goal,
that of creating the conditions for an “informed choice”. Above all, it is the result of the
growing interest in the relationship between diet and health, due to the emerging problems
related to bad diet and in particular to obesity198.
Nutrition labels are therefore considered to be a way to inform consumers, but also to “assist”
(whereas 34) in the knowledge of the basic principles in the field of nutrition199. Nutrition
declarations should allow the consumer to identify the food “in line” with their needs, to make
conscious use of it and adopt choices which meet health and dietary requirements. The
information must be well presented and well expressed in relation to the unit or portion and
list energy values calculated on the basis of the conversion factors listed. Here the legislator
has made some significantly important choices such as requiring that the nutrition declaration
be placed in the same field of vision (whereas 41 and Article 34), and be generally expressed
in the same measurement units of 100 g or 100ml (Article 32). In some specified cases the
nutrition declaration may be indicated by portion or by consumption unit accompanied or not
by the energy value expressed per 100g and per 100ml. A list of foods that are exempted from
the requirement of the mandatory nutrition declaration is presented (Annex V). The
Regulation provides for forms of expression of the nutrition declaration and energy value
other than the table (which is the most common), as in the case of the adoption of graphical
198
Concerning children’s health and related diet problems see Chapter II p. 62 and the already mentioned
Meisterernst – Ballke, The provision on claims concerning the development and health of children in regulation
1924/2006 – better regulation?, in European Food and Feed Law Review, 2008, p. 178.
199
Nutritional labelling has received considerable attention in the literature due to increasing consumer interest
in health and diet issues. Food labels are valued as a source of information and most often the first means for
directly connecting with a consumer, however its potential is not always well exploited. Labels may be an
instrument for reinforcing generic claims and for establishing product differentiation, differentiation across food
categories and within a specific category. Moreover, labels provide a source of health related information for
comparing products and may, occasionally, be the consumer’s first exposure to a health related issue.
Specifically, nutrition labels are intended to help consumers choose more healthful foods. Relevant Literature
has pointed out that in the case of nutrition or health claims direct economic benefits emerge because truthful
and correctly understood claims increase the efficiency of final purchase decisions. In addition, providing
nutrition information increases incentives for producers to create more healthful foods and helps consumers in
choosing a healthier diet, which leads to lower costs from diet related illnesses.
105
forms or symbols) and always in accordance with specific conditions such as the ability to
certify that the consumer understands such forms of expression and that they are not
misleading. New legislation has sought to bring order among the many interests existing in
this field, in relation to both producers and consumers. The consumer, therefore, has the
possibility of reaching a better understanding and also to take part in the process of nutrition
education.
But things are not as simple as they may seem. The consumer of foodstuffs will need to
handle a growing amount of information that is increasingly technical and complex in nature.
It is suspected that in the end, the final result will be that too much information will actually
generate misinformation200. Nutrition information should perhaps also have the task of
bringing the consumer's attention to the basic elements of nutrition but could also contribute
to a race towards the mirage of health as the marketing of certain products as food. At this
point we re-encounter the old problem, raised several times by both doctrine and case law,
that of distinguishing between a food and a medicine. (Directive EC 27/2004).
1.19 Voluntary particulars: information on product qualities
The law on consumer protection also considers it to be a fundamental right to be informed of
the elements related to product quality, or the presence of those characteristics that
subjectively express a quality of the product in which the consumer is interested and for
which he makes the choice to purchase. Voluntary information is expression not only of
producers’ interest to win over customers, but also of consumers’ interest in learning more
about what the food represents.
The consumer wants and needs to be guaranteed before “use” of the product, that said
product will have the characteristics that meet the expected needs. These features and
characteristics are measured, in general, through the products conformity to the requirements
expressed in a specific technique or specific disciplines that are “formulated” and then
200
Even though labelling is a very important tool for transferring information on product characteristics to
consumers but its potential is not always well exploited. Findings emerged from the current research reveal that,
despite high consumer interest in the nutritional properties of foods, nutritional labels are not a useful source of
information. This results are consistent with earlier researches on information on food labels in Europe that
reported nutrition labeling particularly confusing for consumers, especially due to the use of technical/scientific
and numerical information, see Caswell – Mojduszka, Using Informational Labeling to Influence the Market for
Quality in Food Products, in American Journal of Agricultural Economics, 5, 1996, p. 1248.
106
“communicated” via a recognised language. Sometimes, these characteristics are then
“certified” by qualified certification bodies which, via the use of a sort of quality patent,
ensure that the process of making the products has used a particular technological method, i.e.
use of techniques to obtain the desired quality; the product has certain qualities that the
consumer expects to find because of the declaration and information on quality201.
Certified information is part of the category of voluntary information, however, this category
primarily includes the information that the manufacturer intends to communicate other than
that which is mandatory, i.e. information on quality provided on labelling that induces
customer choice. But what is meant by information on quality? There is no statutory
definition of quality because there is no absolute concept of quality. We are therefore dealing
with requirements that go beyond the fact that the product has been produced in a hygienic
manner and in accordance with the rules on food safety; these are the ones that make it a
“food” for the purposes of trade in the European Union in accordance with Regulation
178/2002 on food safety. So what is the quality that the consumer subjectively looks for in
food? With the term “quality” we refer to supplementary, (i.e. additional) features in the food
product. It is now known that agricultural production in certain specific places or in
accordance with certain procedures, is capable of adding a specific feature to the product
which the consumer takes into account when choosing. If the quality does not originally exist
then production and trade rules must be identified and set, compliance with which enables the
claim that the product has an added organoleptic, environmental or social value that
corresponds to the personal desires of consumers202.
We therefore need regulatory standards that help the manufacturer both to win the race
against competitors and to “conquer” the consumer, by controlling the communication of
these features. These additional requirements are therefore voluntarily communicated via
labelling. They may include, for example, the signs PDO, PGI203, TSG204 and “organic”205,
201
See Germanò, Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, in Riv.dir.agr., 2012, I, p.
214.
202
See Germanò, Le politiche europee della qualità alimentare, in Agricoltura e alimentazione, principi e regole
della qualità, disciplina internazionale, comunitaria, nazionale, atti del Convegno Nazionale Idaic, AdornatoAlbisinni-Germanò (a cura di), Torino, 2010, p. 189. From the same source see also Giuffrida, Introduzione alla
IV sessione, p. 235; Jannarelli, Panel discussion, p.272. for a background of quality policy see also Jannarelli,
Dal principio del mutuo riconoscimento (sentenza Cassis de Dijon) alla tutela della qualità, in Il sistema
agroalimentare e la qualità dei prodotti, Profili tecnici, economici e giuridici, Atti del Convegno di Verona: 2526 novembre 1991, p. 140.
203
Lucifero, La comunicazione simbolica nel mercato alimentare: marchi e segni del territorio, in Trattato di
Diritto Agrario, III, Il diritto agroalimentare, already mentioned, p. 252. For a complete overview, see GermanòRook Basile, Manuale di diritto agrario comunitario, Torino, 2010, p. 295.
107
which are Community signs subject to specific regulations that have led to their respective
“disciplines”.
We thus come to the problem of the origin (communicable or otherwise) of food products.
The problem is complex, due to the fact that food manufacturers and farmers do not agree
upon the meaning of “origin” because of their conflicting interests. The first group assigns to
the term “origin” the meaning of the location of the “factory”, while the latter means the
location of plants, trees or shrubs from which the transformed final product came. Besides,
there is no clear rule on the meaning of “origin”, since the word does not necessarily refer to
the geographical origin of the product and could indicate the location of processing. The latter
solution would undoubtedly raise many problems for farmers whose products are given a
reputation amongst consumers depending on territory. These farmers would in fact get
protection only and uniquely for products that could aspire to EU recognition of a PDO or
PGI206.
Nonetheless, Article 9(i) of Regulation 1169/2011 also lists among the mandatory particulars,
the country of origin or place of provenance as referred to in Article 26 according to which
the indication of the country of origin or place of provenance is mandatory where failure to do
so might mislead the consumer. The way the legislation is formulated leads us to believe that
the legitimacy of the protection of the name of origin appears to only be permitted if there is
danger of confusion between the original product and one coming from another place, and
could therefore serve to neutralise this danger; for example, the explicit specification of the
different geographical origin of the food207.
Article 39(2) of Regulation 1169/2011 gives the Member States the faculty of introducing the
mandatory particular of the country of origin or place of provenance of foods not only “where
there is a proven link between certain qualities of the food and its origin or provenance”, but
also where there is evidence that the majority of consumers attach significant value to the
provision of that information. While on one hand, industrial products are, as a rule,
204
See Canfora, Le specialità tradizionali garantite, in Trattato di Diritto Agrario, III, Il diritto agroalimentare,
already mentioned, p. 73. For the geographical indications see Germanò-Rook Basile, Manuale di diritto agrario
comunitario, Torino, 2010, p. 237.
205
Cristiani, Il metodo di produzione biologico, in Trattato di diritto agrario, III, Il diritto agroalimentare,
already mentioned, p. 74.
206
Germanò Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, in Riv.dir.agr., 2012, I, p. 279.
207
On the same topic see also Albisinni, I codici europei dell’agricoltura, dopo Lisbona, in Costato – Borghi –
Russo – Manservisi (a cura di), Dalla riforma del 2003 alla PAC dopo Lisbona. I riflessi sul diritto agrario
alimentare e ambientale, already mentioned, p. 43.
108
“qualified” by know-how that is easily “separable” from the original place of production,
agricultural products on the other, are “qualified” above all by the geographical location and
thus may be essential to the production of that particular and specific (or special) product 208.
The reference to a particular and very specific land raises the problem of the use of the
geographical name as a symbol that is capable of transmitting a message. Thus, what matters
is whether it is possible to attribute value to the name of the geographical locations of
production; in other words, if, how and by what means the holder of farms in areas that are
particularly renowned for their agriculture, could take advantage of the favourable location
and be protected in such a situation209.
1.20 National measures on additional mandatory particulars
The thorniest issue is the one that relates to the possibility of “adding” to the particulars that
are mandatory under EU law, other “national” particulars, which are also mandatory. Article
39 of Regulation 1169/2011 provides for the possibility for Member States to include on
labelling, so-called additional mandatory national particulars, raising the question of the label
as an obstacle to the movement of products in the single market. It is in fact entitled “National
measures on additional mandatory particulars”.
It states that by decision of the Member States, other particulars may become mandatory, i.e.
particulars other than those that the European Union has included in the category of
mandatory particulars to be included on labelling. More precisely, each Member State may
adopt measures requiring additional mandatory particulars when this concerns the protection
of public health, consumer protection, fraud prevention and protection of industrial and
commercial property rights, indications of provenance, registered designations of origin and
the prevention of unfair competition.
208
See Albisinni, L’aceto balsamico di Modena, il torrone di Alicante e la birra di Warstein, in, Riv.dir.agr., II,
2001, p. 101
209
Galli, La disciplina dell’origine dei prodotti industriali tra codice doganale comunitario e (illegittima)
regolamentazione protezionistica nazionale, Galli-Gambino (a cura di), Codice commentato della proprietà
industriale ed intellettuale, Torino, 2011, p. 2660.
109
As we are dealing with technical regulations, all this is of course in accordance with the
“stand still” procedure. “Stand still” in fact, is the system devised to prevent the Member
States from “building” technical regulations that could prevent the free movement of goods; it
is governed by Directive 98/34 of 22 June 1998. It lays down the procedure, to be followed by
Member States, for the provision of information in the field of technical standards 210. It
subordinates their introduction to prior notification to the Commission and requires a
“standstill period” of 6/12 months from the notification, on pain of rendering the national
technical regulation unenforceable against third parties. The standstill period is intended to
give the Commission the opportunity not only to evaluate the effects of the national technical
regulation on intra-Community trade, but also to provide for the adoption of possible uniform
technical standards.
With regards to including additional mandatory national particulars on labelling, Article 45 of
Regulation 1169/2011 introduces the tacit consent rule three months after notification to the
specific procedures for notifying the Commission. However, the right to include the so-called
additional mandatory national particulars on the labelling is given only if the Member State
shows that there is a link between certain qualities of the food and its origin or provenance,
and proves that the majority of consumers attach significant value to the provision of
information on the country of origin or place of provenance. It is clear that the “link” that
must exist between the quality of the food and its origin can not be the same link that must
exist in order for the food to be upgraded to the category of PDO or PGI. Article 39 states
“certain qualities” and it is no simple task to give a specification or an exemplification. It is
easier to consider the other condition required; that there is evidence “that the majority of
consumers attach significant value to the provision of that information”, since here we are
referring to the reputation that binds the community of local producers with the local name of
the product, a reputation which resounds with consumers’ expectations.
210
Concerning the Ssand still rule, see Germanò – Rook Basile, Manuale di diritto agrario comunitario, already
mentioned, p. 45. Lazzara, La normativa tecnica. Integrazione tra pubblico e privato nella prospettiva della
pluralità degli ordinamenti: “incorporazione”, rinvio, collegamento e riconoscimento, in Studi in onore di
Alberto Romano, Napoli 2011, p. 395. More Ancora, Normazione tecnica e certificazione di qualità. Elementi
per uno studio, in Il Consiglio di Stato, II, 1994, p. 1575, From the same Author, Normazione tecnica,
certificazione, qualità e ordinamento giuridico, Torino 2000, p. 200. F. Salmoni, Le norme tecniche, Milano
2001, p. 245, L. Mengoni, Diritto e tecnica, in Riv. trim. dir. proc. civ., 2001, p. 1; Zei, Tecnica e diritto tra
pubblico e privato, Milano 2008, p. 7. On the non respect of the stand still rule see the sentence 30 April 1996,
C-194/94 Securitel and 8 September 2005, C-303/04 Lidl Italia
110
In light of the requirements of Article 39 of Regulation 1169/2011 it could be argued that the
way is being paved for the famous labelling particular “Made in ....”, a particular which is
very dear to Italian farmers211.
A prime example of this issue is in fact the Italian “case” of extra virgin olive oil 212. At the
end of 1997, the Italian olive growers protested against the industrial practice of also
packaging oil from outside the Community as “made in Italy” oil. These protests led
Parliament to pass the law August 3, 1998 No 313, which establishes the obligation to
indicate on the label virgin oil and extra virgin olive oil as obtained with Italian olive trees
and this, it is said, in order to properly inform consumers and to protect freedom and informed
choice. However, already on 5 March 1998, the Commission had requested that Italy comply
with Directive 83/189 on the standstill period, specifically to comply with the obligation to
send notification of the planned technical measure and wait for the prescribed moratorium.
Parliament and the Italian government did not take the necessary steps and thus law 313/1998
was passed. A few months later, in front of the District Court of Milan, a question was raised
by a multinational food company (Unilever) regarding non-contractual compliance on a
modest batch of oil (barely 650 litres of oil valued at nearly 5,000,000 lire) as the debtor
questioned the goods since the label did not comply with what the new law prescribed. The
magistrate in Milan thus raised the question before the Court of Justice. The Court, by
211
In Italy, in addition to the “Made in Italy” labeling issue it should be highlighted that local authorities tend to
patent local geographical indications, see Zolla, Tutela della produzione alimentare made in Italy nella
normativa penale, in Dir. giur. agr., 2007, p. 505. On this topic see also Rubino, Le Denominazioni Comunali di
Origine (De.C.O.) e la loro protezione nel quadro della disciplina comunitaria sulle denominazioni geografiche
dei prodotti alimentari, in Dir.Un.Eur., 2007, p. 125; from the same Author, Le denominazioni locali e la
circolazione dei corrispondenti prodotti nel territorio dell’Unione europea, in Costato – Borghi – Russo –
Manservisi (a cura di), Dalla riforma del 2003 alla PAC dopo Lisbona, already mentioned, p. 337. See also
Bianchi, I marchi delle amministrazioni degli enti pubblici politico-territoriali, in Riv.Dir.Comm., 1992, I, P.
279. Creta-Sabatino, Quale made in Italy? Ancora molti dubbi da sciogliere, in Riv. dir. ind., 2001, I, p. 172
212
Germanò, Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, in Riv. dir. agr., 2012, I, p.
274. Concerning the olive oil case, see Albisinni, Azienda multifunzionale, mercato, territorio. Nuove regole in
agricoltura, Milano, 2000, p. 135. See also the sentence of Torino tribunal, 9 December 2004, commented by
Albisinni, Dall’etichetta al marchio: origine degli alimenti ed origine della materia prima in un caso di diritto
industriale, in Dir. Giur. Agr., 2005, p. 665. Regarding the famous case on the Azienda Olearia del Chianti, see
the sentence of TAR Lazio 26 June 2004, n. 6292, commented by Minelli, L’olio Chianti è solo quello del
Chianti, in Dir. Giur. Agr., 2005, p. 259. The sentece of TAR Lazio has been confirmed by the Consiglio di
Stato, Sezione VI, 17 February 2006, n. 660 (sentence published in Dir. Giur. Agr., 2007, p. 137, commented by
Rauseo, Pubblicità ingannevole ed uso illecito dell’indicazione geografica nel commercio dell’olio extravergine
d’oliva). On the same case, the Agcm (Autorità garante della concorrenza e del mercato) issued a sentence on 27
July 2006, n. 15770, commetned by Masini, Perseverare non è (sempre) diabolico: l’origine dell’olio resta
quella delle olive, in Dir. Giur. Agr., 2007, p. 418. See also Minelli, Olive oil, in Costato – Albisinni (editors),
European food law, already mentioned, p. 437. Concerning the misleading information on labeling, see Zolla,
Riportare sulle etichette alimentari indicazioni sulla salute false e non accertate scientificamente costituisce una
forma di pubblicità ingannevole, in Dir. giur. agr., already mentioned, p.277, On misleading trade practices see
Calvo, Le pratiche commerciali sleali “ingannevoli”, in Cristofaro (a cura di), Le “pratiche commerciali sleali”
tra imprese e consumatori. La direttiva 2005/29/CE e il diritto italiano, Torino, 2007, p. 171.
111
judgment of 26 September 2000, C-443/98, Unilever, declared the Italian legislation to be
unlawful as it was a technical regulation that had not respected the standstill period.
Meanwhile, the Commission adopted Regulation 2815/98 of 22 December 1998, which
concerned marketing standards for olive oil. It was determined that the origin was designated
either by a specific geographical area whose name had been registered as a protected
designation of origin or by a protected geographical indication or by the Member State or a by
third country; and made it clear that an extra virgin or virgin olive oil would be deemed to
have been obtained in a geographical area only if that oil had been extracted from olives in a
mill located within that area. Italy contested Regulation 2815/98 and brought the matter
before the Court of Justice, thus establishing another dispute that ended with a new sentence
for Italy. With judgment of 14 December 2000, C-99/99, Italy v Commission, the Court of
Justice decided that the appeal was unfounded; the Italian complaints were not to be in any
way justified given the discretionary power enjoyed by the Commission on the regulation of
EU agriculture.
Nonetheless, the story continued. In fact, the Commission set out a new regulation,
Regulation 2152/2001 of 31 October 2001, which amended Regulation 2815/98, providing
that the origin of olive oil should be determined by reference to both milling but also to the
place of harvest (the olive grove): in essence, it is now recognised that “the designation of
origin corresponds to the geographical area in which the olives are harvested and to the
location of the mill where the oil has been extracted”. The solution was confirmed by
Regulation 1019/2002 of 13 June 2002 and subsequently reaffirmed by Regulation 182/2009
of 6 March 2009, which foresaw the possibility of providing, for virgin and extra virgin olive
oils, information on both the State of origin of the olives and the State in which they were
processed into oil, as the mention of the local regional region was reserved to PGI or PDO
oils. Therefore, EU law introduced the possibility to give notice of the place of harvest of the
olives as well as that of the pressing. However, with the Decree of 9 October 2007, the Italian
Ministry of Agriculture and Forestry (MiPAAF) established the obligation to indicate the
Member State or third country corresponding to the geographical area in which the olives
were harvested and where the oil mill in which the virgin oil or extra virgin olive oil was
extracted, in order to guarantee traceability. The Ministry decree was foreseen by Article 1-ter
of the Legislative Decree June 24, 2004 No 157 as introduced by the Conversion Law 25 June
2004 No 157.
112
Coming back to Regulation 1169/2001 what it currently prescribes? With regards to labelling
on all foodstuffs Article 39 recognises the right to include additional particulars concerning
the country of origin or place of provenance whenever, for the purposes of fraud prevention,
consumer protection and prevention of unfair competition, there is evidence of the link
between certain qualities of the food and its origin or provenance.
113
CONCLUSIONS: The construction of consumer liability
In light of the emission of the last pieces of European legislation concerning food information
for consumers but not only, it could be concluded that it all culminates in the reference to the
concept of the so-called average consumer. The latter is treated as an individual who is
reasonably well informed and who, at the time of purchase will read the information on food
labels. This figure, however, does not always correspond to the real average consumer, who
often in actual fact does not only not read all the information but worse, ends up only seeing
sought-after information on the labelling in question. In short, the personal tastes and singular
needs of each person end up seeing the desired health benefits in a food even if nonexistent213.
The Community framework for consumer protection thus aims at ensuring the concreteness of
the rights of consumers, the right to protection of health and the right to protection of
economic interests and finally, even the right to information and education. On the one hand,
therefore, a developed system which seems to be based on the idea that the consumer is weak
and as such needs to be supported and protected, on the other hand however, one which seems
to show trust in the consumer’s ability to decode data and be thorough and free in making
choices. In conclusion, what emerges is an almost double consumer figure: on one side a
fragile subject to be protected and on the other, wise and prudent. Legislation is therefore
being produced that ends up multiplying the information requirements, making the provision
of more and more detailed information mandatory and in some cases, generates
misinformation rather than information.
The information provided on products is ever increasing and this can make most labels
unreadable, regardless of the efforts made in terms of clarity, readability and accuracy. It is
clear that in this scenario the possibility of a conscious or informed choice would only be the
result of “training”. However it could never really be claimed that all this leads to a
substantial lack of freedom of choice.
How is the consumer actually affected?
213
Carmignani, La tutela del consumatore nel Trattato dopo Lisbona, in Riv.dir.agr., 2010, I, p. 291. Albisinni,
Soggetti ed oggetti della sicurezza, non solo alimentare, in Europa, prima e dopo Lisbona, in Riv.dir.agr., 2010,
I, p. 607.
114
Society experienced a transition from a system where production facilities played a major role
to consumerism. Taking stock of that transition is the inevitable starting point to begin
reflecting upon the “consumer”. Consumption determines time in “modern” life. It has
increasingly moved from being a phenomenon necessary to “absorb” supply, to a reality that
cannot be considered in a relation of subordination anymore, having acquired its own role. As
it has been stated, when consumption is assumed as “final” consumption, it implies the
presence of a “consumer”.
The present study mentioned the final consumer of food, its origin, development and (ever
changing) legal protection. The origin of modern consumerism, and of the consumer
accordingly, was a consequence of the Industrial Revolution, which irrevocably determined a
global spreading of products. In such a system, producers (and distributors) must find the
right methods to have their products chosen over their competitors’.
As it has been said, no reference to consumers protection is made in the Italian Constitution
due to the very well known synthesis between social requirements and the “pressure” of the
industrial bourgeoisie. Even the Italian Civil Code has been affected, especially at the
beginning, by the laying of such foundations: before promulgating the Italian Anti-trust
Legislation (Law No 287/1990), the market was not ruled by ad hoc prescriptions. In fact,
even the entire contract law is based on the single concept of “subject of law”, without
prejudice to the mechanisms to guarantee the principle of “equality”, at least formally (see
articles 1341, 1342 and 2597 of the Italian Civil Code). To public authorities, consumers, just
like users, were subject to a “second-class” protection, as a consequence of the conflict
resolution in the relations between enterprises (to respect the “principles of sound
administration”, stated in Article 97 of the Constitution, and then of the “principles of
transparency” resulting from of Law No 241/1990).
Even taking stock of the aforementioned considerations, the consumer protection policy at
European level is still considered one of the main instruments to reach the goal of total
European integration. Its importance is recognized by the Treaty of Maastricht, which
established the EU on the 7th of February 1992 (entered into force on the 1st of November
1993) and by the introduction of a specific Title for consumer protection (Article 129 A).
In this sense, the consumer policy was “constitutionalised” at European level, becoming one
of the Community’s overall objectives, as identified by the amendment to Article 3 of the
Treaty (see letter “s”). Finally, the Amsterdam Treaty of 1997, generalized the attention given
115
to human rights, to most vulnerable positions and to the quality of life, all affecting the
consumer as the individual’s alter ego in a precise moment – the purchase – which is normal
in his/her social life. In this light, the “consumer” was included in the Italian Civil Code with
Law No 52/1996, which also introduced chapter XIVa, laying down rules for “consumer
contracts” after Article 1469, so as to implement the Directive on Unfair Terms in Contracts
(93/13/EEC). Two years later, Law No 281/1998 also extended such protection to consumers’
associations.
After recognition comes the interest to find measures to protect the consumer. First of all, it is
important to consider the producer’s safety and accountability, so that the products put on the
market are not defective, “dangerous” or not safe .
Conformity of the goods with the contract must be guaranteed, as well as an adequate level of
information on the economic transaction. This has to do with the previously examined
implications of the asymmetry in information which separated the producer/vendor from the
consumer.
The description and the demonstration of the distinctiveness of foodstuffs and its
requirements have been the centre of the present study.
These requirements, as it has been shown, outline the specific legal status of those who ingest
the good.
The particular statuses of food and its consumer’s inevitably shaped the specific legal
characteristics of the contracts regulating them, directly or indirectly.
The reasons of such a differentiation are many, but most especially the particular character of
agriculture, intended both as production of raw materials and as processing of agricultural
products. Which is why, the legal order has been providing particular contracts for decades
now. These contracts are ruled by standards which are not used in other economic sectors.
They are special, because they were intentionally established to protect the fragile “business
environment” around food production. For the same reasons, the legislator introduced later on
“special rules” to regulate the effects of contracts in the food sector, so as to protect now
businesses, now consumers – in an apparently unilateral way.
Food information and consequently labels have played an increasingly important role to
assure consumer protection.
116
A new way to contract, through the retail industry, must be acknowledged, especially for
foodstuffs. There has been a gradual reduction in sales in the traditional food stores – where
verbal dealing used to reign supreme – and an increase in trade in large shopping centres –
where products are “silently” discovered on the shelves, chosen and paid at the checkout
counter.
Therefore, a “qualified agreement” is more and more necessary, as both the Italian Consumer
Code and Regulation No 1169 of 2011 refer to the need for the producer to inform the
consumer in such a way that he/she may accept the producer’s proposal as a result of an
“informed consent”.
The issue of labelling must be considered in this context, especially as far as the relevance of
the indications given on the label is concerned, whether they are compulsory or voluntary.
Non compliance with the rules for labelling falls on the entrepreneur’s activity and on the
single act the consumer starts when buying the product. Therefore, through labelling,
communication has a widespread control function on the food market as a fundamental
element of the related management policy.
Which is why, information in the food market plays an essential role: those concluding a
contract must be in the position to know.
The informed consent is now the prerequisite to conclude contracts validly, as asymmetry in
information determines a disparity preventing to serve the interests of the weaker party. Thus,
information becomes an essential condition for the validity of the single contractual
relationship and for an equitable market; information preventively protects the consumer as a
person, i.e. as a stakeholder of both economic and existential interests.
The role of information has indeed changed in time. It used to be a precondition for the
consumer’s choice; it is now an instrument to protect the consumer as a buyer. Information
means “obligations” for the seller and as prior notification it falls outside the contractual
framework, preceding even the advertisement phase. The essential elements of food
information are now part of a standardised information. In conclusion, the content of the
contract is passed into the label: the signs and words printed on the label join the ranks of
contractual clauses, with the same requirements.
117
Which is why, information in the food sector has a particularly significant role: EU food law
can be considered a law of self-responsibility. The only form of consumer (self)protection in
the food sector consists in choosing one product instead of another. Nevertheless, the
consumer’s choice is not based on information only, but also on the principle of transparency
of the contract.
Therefore, good faith has a fundamental role to play.
The inevitable clash between the entrepreneur’s interests – trying to win the race against other
operators – and the consumer’s ones – willing to obtain safe and high quality products,
instead – continues to be an unfair competition, which can be only rebalanced through an
effective transparent disclosure and public monitoring.
The right to information – from which the balance of the terms of the contract depends – is
the expression of the duty of good faith. So, according to the principle of substantive equality,
it has to be respected in every contract, whether between entrepreneurs or between
entrepreneurs and consumers.
The information reported shows the piece of news itself, its elaboration and spreading, but
also the relation between who informs and who receives. Thus, the right to information can be
considered as the synthesis of the obligations imposed to the producer, of the legal
instruments needed for communication and most of all, of the relation between who informs
and who receives. In that sense, the link between the right to information and labelling is
created when the contract is concluded and through the instruments the legislator prepares to
ensure the creation of an informed consent.
Thus, the status of the consumer is a new status. He/she tends to be more and more informed
and aware.
To conclude, food safety does not only protect from unfair practices and promotes health
protection. It also pursues another interest: the interest to be informed.
118
BIBLIOGRAPHY
 AA.VV., Tendenze evolutive nella tutela del consumatore, Napoli, 1998
 Adornato, voce Autorità alimentare per la sicurezza alimentare, in Diritto alimentare.
Mercato e sicurezza, BD on line, dir. da F. Albisinni, Wolters Kluwer It.,
www.leggiditaliaprofessionale.it , 2008
 Agget et al., Passclaim. Process for the Assessment of Scientific Support for Claims on
Food. Consensus on Criteria, in European journal of nutrition, 2005, vol. 44,
supplement 1, p. 1
 Alan Rodger, Lord MacMillan's Speech in Donoghue v. Stevenson, 108 L.Q.R.236
(1992)
 Alba & Hutchinson, Dimensions of consumer expertis,. in J Consum Res, 1987, 13, p.
411
 Albanese, Violazione di norme imperative e nullità del contratto, Napoli, 2003
 Albisinni, Azienda multifunzionale, mercato, territorio. Nuove regole in agricoltura,
Milano, 2000, p. 135
 Albisinni, Dall’etichetta al marchio: origine degli alimenti ed origine della materia
prima in un caso di diritto industriale, in Dir. Giur. Agr., 2005, p. 665
 Albisinni,
Etichettatura dei prodotti alimentari, in Banca dati on line “Diritto
alimentare”, in www.leggiditaliaprofessionale.it; dir. da F. Albisinni, Wolters Kluwer
It., www.leggiditaliaprofessionale.it, 2012
 Albisinni, I codici europei dell’agricoltura, dopo Lisbona, in Costato – Borghi – Russo
– Manservisi (a cura di), Dalla riforma del 2003 alla PAC dopo Lisbona. I riflessi sul
diritto agrario alimentare e ambientale, Napoli, 2011, p. 43
 Albisinni, Il diritto agrario europeo dopo Lisbona fra intervento e regolazione: i codici
europei dell’agricoltura, in Agricoltura-Istituzioni-Mercati, n.2/2011, p. 29
119
 Albisinni,
Il nuovo regolamento
Ue sull’informazione ai
consumatori,
in
http//www.georgofili.net/scheda digitale.asp?IDV=3152
 Albisinni, L’aceto balsamico di Modena, il torrone di Alicante e la birra di Warstein,
in, Riv.dir.agr., II, 2001, p. 101
 Albisinni, L’informazione del consumatore e la tutela della salute, in Costato (diretto
da) Trattato breve di diritto agrario italiano e comunitario, Padova, 2003, p. 631
 Albisinni, L’origine dei prodotti agroalimentari e la qualità territoriale, in
Riv.dir.agr., 2003, p. 23
 Albisinni, La comunicazione al consumatore di alimenti, le disposizioni nazionali e
l’origine dei prodotti, , in Riv. dir. agr., 2012, I, p.66
 Albisinni, Sistema agroalimentare, in Digesto civ., Agg., II, Torino, 2009, p. 498.
 Albisinni, Soggetti ed oggetti della sicurezza, non solo alimentare, in Europa, prima e
dopo Lisbona, in Riv.dir.agr., 2010, I, p. 607
 Albisinni, Verso un codice europeo dell’agricoltura, in Atti dell’Accademia dei
Georgofili, Firenze, 2005, p. 411
 Albisinni-Costato (a cura di), European food law, Bologna, 2012
 Albisinni-Sorrentino, Il primato delle Istituzioni nella riforma della PAC, in
Agricoltura- Istituzioni-Mercati, n.1/2008
 Alpa – Conte - Rossi Carleo, La costruzione del diritto dei consumatori, in Alpa (a
cura di), I diritti dei consumatori, in Ajani- Benacchio, (diretto da), Trattato di diritto
privato dell’Unione europea, III, Torino, 2009.
 Alpa e Bianca (a cura di), Le clausole abusive nei contratti stipulati con i consumatori.
L’attuazione della direttiva comunitaria del 5 aprile 1993, Padova, 1996
 Alpa e Buccico, La riforma dei codici in Europa e il progetto di codice civile europeo,
in Materiali dei seminari 2001, Giuffrè, 2002
 Alpa e Rossi Carleo (a cura di), Codice del consumo. Commentario, Napoli, 2005;
120
 Alpa, Il diritto dei consumatori, IV ed., Roma-Bari, 2002.
 Amadio, Il terzo contratto. Il problema, in Gitti, e Villa (a cura di) Il terzo contratto,
Bologna, 2008, p. 15.
 Ancora, Normazione tecnica e certificazione di qualità. Elementi per uno studio, in Il
Consiglio di Stato, II, 1994, p. 1575.
 Ancora, Normazione tecnica, certificazione, qualità e ordinamento giuridico, Torino
2000, p. 200.
 Ashwell, Conceptos sobre los alimentos funcionales, ILSI Europe, 2004, ILSI Press,
Belgium.
 Ashwell, Functional foods: a simple scheme for establishing the scientific validity for
all claims, in Public Health Nutrition, 2001, 4(3), p. 859.
 Asp - Control, Process for the Assessment of Scientific Support for Claims on Foods
(PASSCLAIM): overall introduction, in European Journal of Nutrition, Suppl.1, 2003,
p. 1.
 Astazi, Pratiche commerciali scorrette e tutela dei consumatori: I nuovi poteri
dell’AGCM, in Riv.dir.alim., 2/2008, p. 42.
 Babuscio, Alimenti sicuri e diritto, Analisi di problemi giuridici nei sistemi
amministrativi delle Autorità per la sicurezza alimentare europee e statunitense,
Milano, 2005.
 Banares Vilella, El Regolamento 1924/2006: alegationes o declarations alimentarias?
In Revista de derecho alimentario, 2007, p. 13.
 Baudouin, Le Traité de Lisbonne et la Politique agricole commune, in Revue du droit
rural, 2010, p. 3.
 Becker, European Food Quality Policy: The Importance of Geographical Indications,
Organic Certification and Food Quality Assurance Schemes in European Countries, in
The Estey Centre Journal of International Law and Trade Policy, vol. 10, 1/2009,
p.111.
121
 Benozzo, Etichettatura degli allergeni, sicurezza alimentare e responsabilità civile,, in
Casadei - Sgarbanti (a cura di), Il nuovo diritto agrario comunitario. Atti in onore di
Luigi Costato, Milano, 2005 p. 35.
 Bernues, Olaizola & Corcoran, Labelling information demanded by European
consumers and relationships with purchasing motives, quality and safety of meat. in
Meat Sci, 2003, 65, p. 1095.
 Berri – Carugno - Mazzitti, (a cura di), Estratto dall’appendice del Codice della
legislazione alimentare, Che cosa è il Codex Alimentarius, in Riv. Dir. agr, 1992, II, p.
140.
 Bevilacqua, La Codex Alimentarius Copmmission e la influenza sulle politiche
comunitarie e nazionali, in Agricoltura-Istituzioni – Mercati, n. 1/2006, p. 35
 Bianchi, I marchi delle amministrazioni degli enti pubblici politico-territoriali, in
Riv.Dir.Comm., 1992, I, p. 279
 Bigi, Etichette chiare e veritiere per i prodotti alimentari: approvato in via definitiva
dal Parlamento europeo un nuovo regolamento comunitario, in I contratti, 2006, p.
737
 Bolognini, Il ruolo dell’etichettatura degli alimenti nella prospettiva del Trattato di
Lisbona, in Costato – Borghi – Russo - Manservisi (a cura di), Dalla Riforma del 2003
alla Pac dopo Lisbona, Napoli, 2011, p. 363
 Bonell, Verso un codice europeo dei contratti, in Europa e diritto privato, 1998, p. 171
 Boniglia, Onori e Sapori (a cura di), Trattamento degli alimenti con radiazioni
ionizzanti, in Rapporto Istisan 04/21, 2004, p. 6
 Borchers, et al., The History and Contemporary Challenges of the US Food and Drug
Administration, in Clinical Therapeutics, Vol. 29, No. 1, 2007, p.2
 Borghi, Art. 63 - Responsabilità extracontrattuale per danno da prodotto, in AA. VV.,
Trattato notarile (diretto da F. Preite), Atti notarili. Diritto comunitario e
internazionale, 1. Diritto internazionale privato, Torino, 2011, p. 1205
122
 Borghi, I requisiti di tutela dei prodotti di qualità, in Riv.dir.alim., n.2/2009, p.11.
 Borghi, Il rischio alimentare e il principio di precauzione, in Trattato di diritto
agrario, III, Il diritto agroalimentare, Torino, 2011, p.53
 Borghi, Le declinazioni del principio di precauzione, in Riv. dir. Agr., 2005, I, p. 714
 Borghi, Lo status di produttore e di consumatore di alimenti, in Riv.dir.alim., 2/2008,
p. 3
 Borghi, Valutazione e gestione del rischio e standards del Codex Alimentarius, in
Agricoltura-Istituzioni – Mercati, n. 3/2007, p. 57
 Buonocore, Contratti del consumatore e contratti di impresa, in Riv.dir.civ., 1995, I,
p.6
 Calvo, Le pratiche commerciali sleali “ingannevoli”, in Cristofaro (a cura di), Le
“pratiche commerciali sleali” tra imprese e consumatori. La direttiva 2005/29/CE e il
diritto italiano, Torino, 2007, p. 171
 Canfora, L’agricoltura biologica nel sistema agroalimentare. Profili giuridici, Bari,
2002
 Canfora, La responsabilità degli operatori alimentari per le informazioni sugli
alimenti, in Riv. dir. agr., 2012, I, p. 114
 Canfora, Le specialità tradizionali garantite, in Trattato di Diritto Agrario, III, Il
diritto agroalimentare, Napoli, 2011, p. 73
 Canfora, Organic food, in Costato-Albisinni (editors), European Food Law, Padova,
2011, p. 369
 Cannella et al., Dal cibo per tutti agli alimenti personalizzati, Pensiero Scientifico
Editore, Roma, 2007
 Capelli – Klaus - Silano, Nuova disciplina del settore alimentare e Autorità europea
per la sicurezza alimentare, Milano, 2006
123
 Capelli - Klaus, Il Regolamento CE 1924/2006 in materia di indicazioni nutrizionali e
sulla salute che dovranno essere ripettate a partire dal 1 luglio 2007 dagli operatori
del settore alimentare e dalle Autorità di controllo, in Alimenta, 2007, 5, p. 105
 Capelli-Klaus, Il Regolamento CE n.1924/2006 in materia di indicazioni nutrizionali e
sulla salute da riportare sulle etichette dei prodotti alimentari, in Diritto Comunitario
e degli Scambi Internazionali, IV, 2007, p.803
 Capelli-Klauss, Le regole che consentono di distinguere i prodotti alimentari dai
medicinali con riferimento alla disciplina europea, in Alimenta, 2005, p. 153
 Capelli, L’Aglio è un alimento o un farmaco?, in Dir. Com. Scamb. Int, I, 2010, p. 42
 Capelli, La responsabilità del produttore (con riferimento alla Direttiva CEE n.
85/374), Parma, 1988
 Capelli, Prodotti agroalimentari di qualità: controlli e responsabilità, in Riv.dir.alim.,
n. 4-2011, p. 28
 Capelli, Responsabilità degli operatori del settore alimentare, in Alimenta, XIV, 2006,
p. 201
 Carmignani, La tutela del consumatore nel Trattato dopo Lisbona, in Riv.dir.agr.,
2010, I, p. 291
 Carnevali, Prevenzione e risarcimento nelle direttive comunitarie sulla sicurezza dei
prodotti, in Responsabilità civile e previdenza, 2005, I, p. 9
 Carnevali, Responsabilità del produttore e prova per presunzioni, in Responsabilità
civile e previdenza, 1996, IV, p. 481
 Casadei, Le nuove misure di rafforzamento della politica di sviluppo rurale, in
Casadei- Sgarbanti (a cura di), Il nuovo diritto agrario comunitario, Milano, 2005, p.
77
 Casals, Una panoramica sui “Principles of European Tort Law”, in Responsabilità
civile e previdenza, 2005, II, p. 1277
124
 Castronuovo, “I principi del diritto europeo dei contratti” e l’idea di codice, in Riv.
dir. com., 1995, I, p. 21
 Caswell – Mojduszka, Using Informational Labeling to Influence the Market for
Quality in Food Products, in American Journal of Agricultural Economics, 5, 1996, p.
1248
 Cavaliere, Product Liability in the European Union: Compensation and Deterrence
Issues, in European Journal of Law and Economics, 18, 2004, p. 304
 Cavazzoni - Di Nella - Mezzasoma e Rizzo (a cura di), Il diritto dei consumi: realtà e
prospettive, Napoli, 2008
 Coppens - Fernandez da Silva - Pettman, European regulations on nutraceuticals,
dietary supplements and functional foods: a frame work based on safety, in Toxicology,
II, 2006, p. 62
 Coppens, The Impact of the Nutrition and Health Claims Regulation on the Food
Industry, European Food and Feed Law Review, 2007, p. 67
 Costantino, Prime considerazioni sulla recente proposta di regolamento comunitario
sulle informazioni alimentari ai consumatori, in Riv.dir.agr., 2008, I, p. 152
 Costanzo, voce Informazione nel diritto costituzionale, in Dig. Disc. Pubbl., Torino,
1993, p. 332.
 Costato – Borghi - Rizzioli, Compendio di diritto alimentare, IV ed., Padova, 2011
 Costato (a cura di), Trattato breve di diritto agrario italiano e comunitario, III ed.,
Padova, 2003
 Costato – Borghi – Rizzioli, Compendio di diritto alimentare, V edizione, Padova,
2011
 Costato, Circolazione degli alimenti, competenza nazionale e competenza comunitaria,
in Dir. giur. agr., 2004, p. 159
 Costato, Compendio di diritto alimentare, Padova, 2007
125
 Costato, Corso di diritto agrario italiano e comunitario, III ed., Milano, 2008
 Costato, I principi del diritto alimentare, in Diritto Alimentare. Mercato e sicurezza,
dir.
da
F.
Albisinni,
Wolters
Kluwer
Italia,
Milano,
2009,
www.leggiditaliaprofessionale.it.
 Costato, I principi e requisiti generali della legislazione alimentare, in Trattato di
Diritto Agrario, III, Il diritto agroalimentare, Torino, 2011, p. 19
 Costato, Il nuovo titolo dedicato all’agricoltura nel TFUE, in Costato – Borghi –
Russo - Manservisi (a cura di), Dalla Riforma del 2003 alla Pac dopo Lisbona, Napoli,
2011, p. 73.
 Costato, Il regolamento unico sull’organizzazione comune dei mercati agricoli (Reg.
CE 22 ottobre 2007, n. 1234), Commentario di Luigi Costato, in Le nuove leggi civili
commentate, 2009, p. 181.
 Costato, L’agricoltura e il nuovo regolamento sull’igiene dei prodotti alimentari, in
Dir.giur.agr., 2004, p. 735
 Costato, L’informazione dei consumatori postrema frontiera della C.E., in Riv. dir.
alim., 4/2008, p.3
 Costato, La rintracciabilità degli alimenti, in Trattato di diritto agrario, III, Il diritto
agroalimentare, Torino, 2011, p.533
 Costato, Le etichette alimentari nel nuovo regolamento 1169/2001, in Riv.dir.agr.,
2011, p.674
 Costato, Le etichette alimentari nel nuovo regolamento 1169/2001, in Riv.dir.agr.,
2011, p.663
 Costato, Le indicazioni nutrizionali del Reg. n. 1924/2006, in Riv.dir. agr., 2008, I, p.
301
 Costato, Le norme sull’etichettatura dei prodotti alimentari, in Tratt. Dir. agr.
Nazionale e comunitario, diretto da Costato, Padova, 2003
126
 Costato, Sicurezza alimentare e scienza “igienicosanitaria”, in Agricoltura –
Istituzioni - Mercati, n.2/2006, p. 207
 Costato., Etichette dei prodotti alimentari: il Parlamento europeo respinge il semaforo,
in Riv.dir.alim., 1/2010, p. 1
 Coutrelis,
Regulatory Obstacles to the International Trade of Health Food, in
European Food and Feed Law Review, 2006, p. 220
 Coutrelis-Corre, The Legal regime of a Community Trade Mark “Construed as a
Nutrition or Health Claim”, in European Food and Feed Law Review, 2008, p. 30
 Creta - Sabatino, Quale made in Italy? Ancora molti dubbi da sciogliere, in Riv. dir.
ind., 2001, I, p. 172
 Criscuoli , Il contratto nel diritto inglese, Padova, 1990, p. 343
 Criscuoli, Introduzione allo studio del diritto inglese, Le fonti, Milano, 1981, p. 360
 Cristiani, Il metodo di produzione biologico, in Trattato di diritto agrario, III, Il diritto
agroalimentare, Torino, 2011, p. 74
 Cristofaro, (a cura di), Le “pratiche commerciali sleali tra imprese e consumatori”. La
direttiva 2005/29/Ce, Torino, 2006
 Cubadda – Marconi, Sviluppo di alimenti funzionali a base di cereali arricchiti con
beta glucani dell’orzo: una rassegna, in Ingredienti alimentari, 2008, 36, p. 6
 Cuffaro (a cura di), Codice del consumo e norme collegate, 2a ed., Milano, 2008
 D’Addezio, La regolazione e la promozione del mercato alimentare nell'Unione
Europea – Esperienze giuridiche comunitarie e nazionali, Atti del convegno Udine
24.25 Novembre 2006, (a cura di) D’Addezio e Germanò, Milano, 2006
 De Poli, Asimmetrie informative e rapporti contrattuali, Padova, 2002
 Di Lauro, Comunicazione pubblicitaria e informazione nel settore agroalimentare,
Milano, 2005, p.11
127
 Di Lauro, Il diritto alimentare: un diritto in movimento. (il caso dell’etichettatura degli
allergeni), in Riv.dir.agr., 2007, I, p. 75
 Di Lauro, La comunicazione e la disciplina della pubblicità dei prodotti alimentari, in
Costato - Germanò - Rook Basile (diretto da), Trattato di diritto agrario, III, Il diritto
agroalimentare,Torino, 2011, p. 547
 Di Lauro, La comunicazione pubblicitaria comparativa nel settore agroalimentare tra
verità e suggestione, in Riv.dir.agr., I, 2000, p. 87
 Di Lauro, voce, Indicazioni nutrizionali e health claims, in Diritto alimentare, Mercato
e sicurezza, 3/2011, p. 4
 Di Martino, Rintracciabilità obbligatoria e rintracciabilità volontaria nel settore
alimentare, in Riv.giur. agr, III, 2005, p. 141
 Di Sabato, Contratti dei consumatori, contratti di impresa, in Riv. Trim. dir.proc.civ.,
1995, p. 657
 Dehousse- Lewalle, La dioxine, la Belgique et l’Europe, Une nouvelle crise du modèle
agricole européen, in Studia diplomatica, 1-2, 2000, p. 23
 Elkstrom, Revisiting the family tree: historical and future consumer behavior research,
in Academy of Marketing Science Rev., 2003, p. 213
 Flandrin- Montanari (a cura di), Storia dell’alimentazione, Roma – Bari, 1997
 Forti, Determinazioni nutrizionali, , in Riv. dir. agr., 2012, I, p. 94
 Frewer, Fischer, Scholderer &Verbeke, Food safety and consumer behavior, in
Innovation of Food Production Systems: Product Quality and Consumer Acceptance,
2003, p. 125
 Frewer, Scholderer, and Lambert, Consumer acceptance of functional foods: issues for
the future, in British Food Journal, 2003, 105 (10), p. 714
128
 Fuentes,
La publicidad y presentacion de los alimentos. El nuevo Regolamento
relativo a las propriedades nutrizionale y saludables de los alimentos, in Dir.giur.agr.,
2007, I, p. 148
 Gabbi, L’autorità europea per la sicurezza alimentare, Genesi, aspetti problematici e
prospettive di riforma, Milano, 2009
 Galgano, Tratt. dir. civ., II, Padova, 2009, p. 322.
 Galli, La disciplina dell’origine dei prodotti industriali tra codice doganale
comunitario e (illegittima) regolamentazione protezionistica nazionale, in GalliGambino (a cura di), Codice commentato della proprietà industriale ed intellettuale,
Torino, 2011, p. 2660
 Galloni, La funzione del diritto agrario nella dimensione del mercato dal produttore al
consumatore: bisogni, valori e nuovi modelli, in Germanò e Rook Basile (a cura di)
Agricoltura e alimentazione tra diritto, comunicazione e mercato, Milano, 2003, p. 24
 Gencarelli, La politica comunitaria di promozione dei prodotti agroalimentari: origine
ed evoluzione, in Dir.giur.agr., 2009, p. 383
 Gentili, I concetti nel diritto privato europeo, in Riv.dir.civ., 2010, I, p. 761
 Gentili, Informazione contrattuale e regole di scambio, in Riv.dir.priv., 2004 p. 555
 Germanò – Massart - Rook Basile, (a cura di), La responsabilità civile dell’impresa
alimentare per danni da prodotti difettosi, in Banca dati on-line Diritto alimentare.
www.leggiditaliaprofessionale.it,
 Germanò – Massart - Rook Basile, (a cura di), La responsabilità per prodotti difettosi
in agricoltura, in Prodotti agricoli e sicurezza alimentare, Atti del Congresso mondiale
di diritto agrario dell’unione mondiale degli agraristi universitari in memoria di Louis
Lorvelle, Milano, 2003, p.529.
 Germanò - Rook Basile (a cura di), Il diritto alimentare tra comunicazione e sicurezza
dei prodotti, Torino, 2005
129
 Germanò – Rook Basile, commento all’art. 3 del Reg.178/2002, in Idaic, La sicurezza
alimentare nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p. 159
 Germanò - Rook Basile, Manuale di diritto agrario comunitario, Torino, 2010
 Germanò Le indicazioni in etichetta (e la loro natura) e i segni degli alimenti, in
Riv.dir.agr., 2012, I, p. 279
 Germanò, Corso di diritto agroalimentare, Torino, 2007
 Germanò, Il mercato alimentare e la sicurezza dei prodotti, in Riv.dir.agr., 2008, I,
p.99
 Germanò, Informazioni alimentari halal: quale responsabilità per un’etichetta non
veritiera?, in Riv.dir.alim., 2010, p. 8
 Germanò, La normativa di riferimento sugli ingredienti allergenici e sull’obbligo della
loro etichettatura, in Riv. dir. agr., 2007, I, p. 379.
 Germanò, La qualità dei prodotti agro-alimentari secondo la Comunità europea, in
Adornato- Albisinni- Germanò (a cura di), Agricoltura e alimentazione. Principi e
regole della qualità, Milano, 2010, p. 189
 Germanò, La responsabilità dei prodotti difettosi in agricoltura, in Rook Basile,
Massart e Germanò (a cura di), Prodotti agricoli e sicurezza alimentare, Milano, 2003
 Germanò, La responsabilità del produttore agricolo, in Costato (diretto da), Trattato
breve di diritto agrario italiano e comunitario, Padova, 2003, p. 743
 Germanò, Sull’etichetta degli alimenti, in Riv. dir. agr., 2010, p. 90
 Germanò, Le politiche europee della qualità alimentare, in Agricoltura e
alimentazione, principi e regole della qualità, disciplina internazionale, comunitaria,
nazionale, atti del Convegno Nazionale Idaic, Adornato-Albisinni-Germanò (a cura di),
Torino, 2010, p. 189
 Germanò-, Manuale di diritto agrario comunitario, Torino, 2008
 Germanò, Manuale di diritto agrario, Torino, 2010
130
 Giardina, La responsabilità civile del produttore di alimenti, in Regole dell’agricoltura
regole del cibo, Produzione agricola sicurezza alimentare e tutela del consumatore,
Pisa, 2005, p. 101
 Giuffrida, La responsabilità civile per danno da prodotto alimentare difettoso, in,
Costato – Germanò – Rook Basile, Trattato di Diritto Agrario, III, Il Diritto
agroalimentare, Torino, 2011, p. 617
 Giuffrida, Pratiche leali di informazioni e informazioni volontarie, , in Riv. dir. agr.,
2012, I, p. 79
 Goldoni, Introduzione ai lavori della «Giornata studio» in Il trattato di Lisbona: quali
novità per la regolamentazione dell’agricoltura?, Riv.dir.agr. 2010, I, p. 167
 Gonzales Vaqué - La notion “de consommateur moyen” selon la jurisprudence de la
Cour de justice des Communautés Européennes, in Revue du droit de l’Union
Européenne, 2004, p. 69
 Gradoni, Commento all’art. 6 del Reg. 178/2002, in Idaic, La sicurezza alimentare
nell’Unione Europea, in Le Nuove Leggi Civili Commentate, 1-2, 2003, p. 199
 Gradoni, commento all’art.7 Reg. 178/2002, in Idaic, La sicurezza alimentare
nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p. 204
 Grossklaus, Nutrient Profiles- The Precondition for Health Claims, in European Food
and Feed Law Review, 2007, p. 210
 Grunert & Wills, A review of European research on consumer response to nutrition
information on food labels, in J Public Health, 2007, 15, p. 384
 Grunert, Food quality and safety: consumer perception and demand. in Eur. Rev.
Agric. Econ. 32, 2005, p. 369
 Heckman - Sherry - Gonzales De Mejia, Energy Drinks: An Assessment of Their
Market Size, Consumer Demographics, Ingredient Profile, Functionality, and
Regulations in the United States, in Comprehensive Reviews in Food Science and Food
Safety, Vol. 9, 2010, p. 303
131
 Hilliam, Functional food: how big is the market?, in World of Food Ingredients, 2000,
12, p. 50
 Hollo, Sobre la base agraria del derecho alimentario, in Revista de derecho agrario y
alimentario, XXV, 2009, p.115
 Howard, Buyer behavior in marketing strategy, 4th ed., Englewood Cliffs, 1994
 Irti, La concorrenza come statuto normativo, in Scritti in onore di Emilio Romagnoli,
Milano, 2000, p. 943
 Jannarelli (a cura di), Le vendite aggressive, Napoli, 1995
 Jannarelli, Dal principio del mutuo riconoscimento (sentenza Cassis de Dijon) alla
tutela della qualità dei prodotti, in Il sistema agro-alimentare e la qualità dei prodotti,
Rook Basile (a cura di), Milano, 1992, p. 129
 Jannarelli, Il regime della concorrenza nel settore agricolo tra mercato unico e
globalizzazione dell’economia, in Riv. dir. agr., 1997, I, p. 416
 Jannarelli, La circolazione dei prodotti agricoli nella Comunità europea: dal principio
del mutuo riconoscimento alla tutela della qualità, in Dir. Agricoltura, 1992, p. 33
 Jannarelli, La concorrenza e l`agricoltura nell`attuale esperienza europea: una
relazione speciale, in Riv.dir.agr., 2009, IV, p. 515
 Jannarelli, La concorrenza nel sistema agro-alimentare e la globalizzazione dei
mercati, in Dir. giur. agr., 2000, p. 433
 Jannarelli, La dissciplina dell’atto e dell’attività: I contratti tra imprese e tra imprese e
consumatori, in Lipari (a cura di), Diritto privato europeao, II, Milano, 2008, p. 498
 Jannarelli, La fornitura di informazioni sugli alimenti ai consumatori nel nuovo
regolamento n. 1169/2011 tra l’onnicomprensività dell’approccio e l’articolazione
delle tecniche performative, in Riv. dir. agr., 2012, I, p. 38
132
 Jannarelli, Relazione generale: i beni comuni tra vecchi e nuovi paradigmi, in
Germanò - Viti (a cura di), Agricoltura e beni comuni (Atti del Convegno Idaic LuceraFoggia, 27- 28 October 2011), Milano, 2012, p. 10
 Jonas, Il principio di responsabilità. Un’etica per la civiltà tecnologica, Torino, 1993
 Kahn-Freund, Common law and civil law, Imaginary and real obstacles to
assimilation, in Cappelletti (a cura di), New prospective for a Common law of Europe,
Firenze, 1978, p. 14
 Kinnucan, Myrland & Paudel, Relative impacts of health information and advertising
on commodity markets: US meats. in Health, Nutrition and Food Demand, 2003, p. 187
 Lazzara, La normativa tecnica. Integrazione tra pubblico e privato nella prospettiva
della pluralità degli ordinamenti: “incorporazione”, rinvio, collegamento e
riconoscimento, in Studi in onore di Alberto Romano, Napoli 2011, p. 395.
 Lipari, Prolegomeni ad uno studio sulle categorie del diritto civile, in Riv.dir.civ.,
2009, I, p. 515
 Losavio e Babuscio, La normativa per il trattamento degli alimenti con radiazioni
ionizzanti nell’Unione europea e negli Usa, in Economia e dir. Agroalimentare, 2005,
n. 2, p. 52
 Losavio, Alimenti non sicuri e tutela della salute: il potere residuale degli Stati membri
tra libera circolazione delle merci (art. 28 e 30) e armonizzazione (art..95), in Dir.
giur.agr., 2007, p. 369
 Losavio, Il consumatore di alimenti nell’Unione europea e il suo diritto di essere
informato, Milano, 2007
 Losavio, La riforma della normativa comunitaria in materia di igiene dei prodotti
alimentari: il c.d. “pacchetto igiene”, in Dir.giur.agr., 2004, p. 679
 Losavio, Le regole comunitarie e nazionali relative all’igiene dei prodotti, in Trattato
di diritto agrario, III, Il diritto agroalimentare, Torino, 2011, p. 183.
133
 Lucifero, Etichettatura degli alimenti: comunicazione legale e comunicazione
volontaria, in Dir. giur. agr, I, 2009, p. 14.
 Lucifero, Etichettature degli alimenti,in Digesto civ., Agg., Torino 2009, p. 210
 Lucifero, Il territorio: rapporto tra regole del produrre e regole del vendere, in
Germanò- Rook Basile, Il diritto alimentare tra comunicazione e sicurezza dei
prodotti, Torino, 2005, p. 105
 Lucifero, La comunicazione simbolica nel mercato alimentare: marchi e segni del
territorio, in Costato – Germanò - Basile (diretto da), Trattato di diritto agrario, III, Il
diritto agroalimentare, Torino, 2011, p. 321
 Lucifero, La sicurezza alimentare e la tutela degli interessi del consumatore di
alimenti, in Riv.dir.agr., 2008, I, p. 77 and Sirsi, A proposito degli alimenti senza
OGM, in Riv.dir.agr, 2005, I, p. 30
 Maione, Le pratiche commerciali sleali nella direttiva 2005/29/CE, in Alpa – Capilli (a
cura di), Lezioni di diritto privato europeo, Padova, 2007, p. 1068
 Marette, Roosen, Blanchemanche and Feinblatt-Mélèze, Functional food, uncertainty
and consumers’ choice: A lab experiment with enriched yoghurts for lowering
Cholesterol, in Food Policy, 2010, 35, p. 419
 Martinello - Baker, Il consiglio nazionale dei consumatori e degli utenti, in AA.VV.,
Alpa e Levi (a cura di), I diritti dei consumatori e degli utenti, Milano, 2001
 Martines, Diritto costituzionale, Milano, 1994
 Martinez et al, The regulation on Nutrition and Health Claims Made on Food: Role of
the European food Safety Authority, European Food and Feed Law Review, 2007, p. 76
 Masini Il diritto all’informazione e l’etichettatura dei prodotto agroalimentari: utilità
del metodo casistico, in Riv.dir.agr., 2003, III, p. 500
 Masini, Corso di diritto alimentare, Milano, 2008
 Masini, Corso di diritto alimentare, Milano, 2011
134
 Masini, Dal “mistero” dell’origine al diritto all’informazione nella presentazione dei
prodotti agroalimentari, in Dir.giur.agr., 2003, p. 72
 Masini, Il diritto all’informazione e l’etichettatura dei prodotti agroalimentari: utilità
del metodo casistico, in Riv. dir. agr., 2003, III, p. 1, p. 500
 Masini, Pdo, Pgi and Stg, in Costato - Albisinni (editors), European Food Law,
Bologna, 2012 p. 351.
 Masini, Perseverare non è (sempre) diabolico: l’origine dell’olio resta quella delle
olive, in Dir. Giur. Agr., 2007, p. 418.
 Masini, Prime note sulla disciplina europea delle indicazioni nutrizionali e sulla
salute, in Dir.giur. agr., 2007, p. 73.
 Masini, Promessa e responsabilità delle dichiarazioni in etichetta, in Dir. giur. agr.,
2011, p. 743
 Mattei, Beni comuni. Un manifesto, Roma-Bari, 2011
 Meisterernst – Ballke, The provision on claims concerning the development and health
of children in regulation 1924/2006 – better regulation?, in European food and feed
law review, 2008, p. 178
 Meisterernst- Haber, The silent Revolution- Legal overview on regulation 1924/2006
on Nutrition and Health Claims, in European Food and Feed Law Review, 2007
 Meisterernst, A Learning Process? Three years of Regulation 1924/2006 on Nutritional
and Health Claims Made on Foods, in European Food and Feed Law Review, 2010, p.
59
 Mengoni, Diritto e tecnica, in Riv. trim. dir. proc. civ., 2001, p. 1.
 Mercurio, Osservazioni sulla sicurezza alimentare, prodotti agricoli e responsabilità
civile, in Dir. giur. agr., II, 2007, p. 433
 Meulen, Scientific Substantiation of Health Claims- The soft core of the Claims
Regulation, in European Food and Feed Law Review, 2006, p. 154
135
 Meyer, Risk Analysis in accordance with Article 6, Regulation (EC) No. 178/2002, in
European Food and Feed Law Review, 2006, 3, p. 144
 Minelli, L’olio Chianti è solo quello del Chianti, in Dir. giur. agr., 2005, p. 259
 Minelli, Olive oil, in Costato – Albisinni (editors), European food law, Padova 2001, p.
437
 Minervini, Il terzo contratto, in Contratti, 2009, p. 493
 Mitchell, The backward art of spending money, in American economic review, June
1912, p. 269
 Nicolini, Il mutuo riconoscimento tra mercato interno e sussidiarietà, Padova, 2005
 Nicolini, Danni da prodotti agroalimentari difettosi/responsabilità del produttore,
Milano, 2006
 Nicolini, Il prodotto alimentare: sicurezza e tutela del consumatore, Milano, 2003
 Nielsen, Feenstra , Recession in food”, in Functional Foods Symposium, Amsterdam,
2009.
 Noah, A Review of the New York State Task Force on Life & the Law’s Report Dietary
Supplements: Balancing Consumer Choice Safety, in Journal of Law, Medicine &
Ethics, Vol. 33, Fasc. 4, 2005, p. 860
 Oppo, Categorie contrattuali e statuti del rapporto obbligatorio, in atti del Convegno
del cinquantenario della Rivista di diritto civile, Il diritto delle obbligazioni e dei
contratti: verso una riforma? Le prospettive di una novellazione del libro IV del codice
civile nel momento storico attuale, Treviso, 23-25 marzo 2006, Bologna, 2006, p.43
 Ostrom, La conoscenza come bene comune. Dalla teoria alla pratica, Hess – Ostrom(a cura di), Torino, 2009
 Paladin, Problemi e vicende della libertà di informazione nell’ordinamento giuridico
italiano, in Paladin (a cura) La libertà di informazione, Torino, 1979, p.1
136
 Palmieri., La responsabilità dell’impresa alimentare, in Paoloni (a cura di) Alimenti,
danno e responsabilità, Ed. Angeli, Milano, 2008, p. 92
 Pardolesi, Prefazione, in Colangelo, L’abuso di dipenenza economica tra disciplina
della concorrenza e diritto dei contratti. Un’analisi economica e comparata, Torino,
2004, p. 12
 Pavesi, L’acqua potabile per il consumo umano: elemento di preparazione ed
ingredienti di alimenti e bevande. Le acque minerali, in Dir.giur.agr., 2011, p. 595
 Pennings, Wansink, Meulenberg, A note on modeling consumer reactions to a crisis:
The case of the mad cow disease, in International Journal of Research in Marketing,
2002, 19, p. 91
 Perlingeri, L’informazione come bene giuridico, in Rass.dir.civ., II, 1990, p. 327
 Peter Burns, Donoghue v. Stevenson and the modern law of negligence - the paisley
papers, Peter Burns ed.,1991
 Petrelli, Health food and health and nutritionally claims, in Costato-Albisinni (editors),
European Food Law, already mentioned, p. 301.
 Petrelli, I probiotici: criteri per la qualificazione dei prodotti quali alimenti o
medicinali nel diritto comunitario, in Riv.dir.agr., 2008, I, p. 539
 Petrelli, I prodotti alimentari della salute, in Costato – Borghi - Russo e Manservisi (a
cura di), Dalla Riforma del 2003 alla PAC dopo Lisbona, Napoli, 2011, p. 291
 Petrelli, Le nuove regole comunitarie per l’utilizzo di indicazioni sulla salute fornite
sui prodotti alimentari, in Riv.dir.agr., 2009, I, p. 50
 Pollan, The Omnivore's Dilemma, A Natural History of Four Meals, Penguin Books,
2006
 Poncibò, Il consumatore medio, in Contratto e impresa Europa, 2007, II, p. 734;
 Poncibò, La nozione di consumatore medio, in Persona e danno, Cendon (a cura di),
2008, p. 23
137
 Puoti, Etichettatura di prodotti agroalimentari: aspetti problematici, Relazione al XVII
Congresso UAE held in Pescara on 19-21 June 2003
 Ragionieri, La disciplina degli allergeni negli alimenti, in Trattato di diritto agrario,
III, Il diritto agroalimentare, Torino, 2011, p. 4
 Ragionieri, Le regole della produzione degli alimenti e il trattamento con radiazioni
ionizzanti, in Trattato di diritto agrario, III, Il diritto agroalimentare, Torino, 2011, p.
133
 Rauseo, Pubblicità ingannevole ed uso illecito dell’indicazione geografica nel
commercio dell’olio extravergine d’oliva, in Dir. giur. agr., 2007, p. 13
 Recuerda Girela, La regulation de la publicidad de alimientos dirigida a menores en el
derecho comparado como strategia contra la obesidad, in Revista de derecho agrario
y alimentario, XXV, 2009, p. 77
 Reinert – Rohrmann - Linseisen, Lifestyle and diet in people using dietary supplements.
A German color study, in European Journal of Nutrition, Vol. 46, 2007, p. 165
 Retrospect, 20 Mod. L. Rev 1 (1957); Florence O'Donoghue, A half-century of
neighborliness: Donoghue v. Stevenson reconsidered, law & justice 4, 1984
 Rhymerr , Issues Surrounding Health Claims for Barley, in The Journal of Nutrition,
2008, p. 1237
 Rizzioli, I principi generali del diritto alimentare nella legislazione e giurisprudenza
comunitarie, Roma, 2008, p. 27
 Roberfoird, Scientific concepts of functional foods in Europe: Consensus document, in
British Journal of Nutrition, 81, Suppl. 1, p. 1
 Rook Basile, Il sistema della sicurezza alimentare attraverso le definizioni del
regolamento 178/2002, in Agricoltura – Istituzioni - Mercati, n.3/2007, p. 45
 Rook Basile, L’informazione dei prodotti alimentari, il consumatore e il contratto, in
Germanò - Rook Basile, Il diritto alimentare tra comunicazione e sicurezza dei
prodotti, Torino, 2005, p. 15
138
 Rook Basile, Premessa alla I sessione, in Germanò - Viti (a cura di), Agricoltura e beni
comuni (Atti del Convegno Idaic Lucera- Foggia, 27- 28 October 2011), Milano, 2012,
p. 29
 Rook Basile, Prodotti agricoli, mercato di massa e comunicazione simbolica, in
Dir.giur.agr., 1995, p.138
 Roppo, Contratto di diritto comune, contratto del consumatore, contratto con
asimmetria di potere contrattuale: genesi e sviluppi di un nuovo paradigma, in
Riv.dir.priv., 2001 p. 769
 Rubino, Il claim “senza zuccheri aggiunti” nel nuovo regolamento 1924/06 CE:
problematiche interpretative ed applicative, in Alimenta, 2007, p. 1.
 Rubino, Le Denominazioni Comunali di Origine (De.C.O.) e la loro protezione nel
quadro della disciplina comunitaria sulle denominazioni geografiche dei prodotti
alimentari, in Dir.Un.Eur., 2007, p. 125
 Rubino, Le denominazioni locali e la circolazione dei corrispondenti prodotti nel
territorio dell’Unione europea, in Costato – Borghi – Russo – Manservisi (a cura di),
Dalla riforma del 2003 alla PAC dopo Lisbona, already mentioned, p. 337
 Russo, Deleghe normative e atti di esecuzione nel reg. Ue n. 1169/2011, , in Riv. dir.
agr., 2012, I, p. 47
 Sabbatini, Commento agli art. 38-42 del Reg. 178/2002, in Idaic, La sicurezza
alimentare nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p. 383
 Salmoni, Le norme tecniche, Milano 2001, p. 245
 Satine, Is my Yogurt lying? Developing and applying a framework for determining
whether wellness claims on probiotics yogurt is mislead, in Food and Drug Law
Journal, 2008, p. 537
 Scognamiglio, Principi generali e disciplina speciale nell’interpretazione dei contratti
dei consumatori, in Riv.dir.comm., 1997, I, p.950
 Serio, Introduzione a Williams - Hepple, I fondamenti del diritto dei torts, Napoli, 1983
139
 Serre, Question d’actualité Allegations de santé des aliments: une perspective
communautaire, in Annales pharmaceutiques française, 2006, volume 64, n. 5, p. 335
 Sgarbanti, Il principio del mutuo riconoscimento e la denominazione dei prodotti
alimentari, in Costato- Germanò - Rook Basile (diretto da), Trattato di diritto agrario,
III, Il diritto agroalimentare, Torino, 2011, p. 475
 Sgarbanti, in Trattato breve di diritto agrario italiano e comunitario, II ediz. Padova,
1997, p. 563
 Sirsi, Commento all’art. 18 Reg.178/2002, in Idaic La sicurezza alimentare
nell’Unione europea, in Nuove Leggi Civili Commentate, 2003, p.168
 Sollini, Il principio di precauzione nella disciplina comunitaria della sicurezza
alimentare, Milano, 2006, p. 2
 Strambi, La proposta di regolamento sugli schemi di qualità dei prodotti agricoli, in
Goldoni - Sirsi, Il ruolo del diritto nella valorizzazione e nella promozione dei prodotti
agro-alimentari, Milano, 2011, p. 177
 Strambi-Ferrucci,
-
Capo
II
«Organizzazioni
di
produttori,
organizzazioni
interprofessionali e organizzazioni di operatori» artt. 122-127), Commentario di Luigi
Costato, in Le nuove leggi civili commentate, 2009, p 133
 Tamponi, La tutela del consumatore di alimenti nel momento contrattuale: valore delle
indicazioni obbligatorie e volontarie nella formazione del contratto, in Costato –
Germanò – Rook Basile, Trattato di Diritto Agrario, III, Il Diritto agroalimentare,
Torino, 2011, p. 584
 Tamponi, La tutela del consumatore di alimenti: soggetti, oggetto e relazioni, in Rook
Basile – Germanò (a cura di), Agricoltura e alimentazione tra diritto, comunicazione e
mercato, Milano, 2003, p. 301.
 Thron-Meyer, Health Claims under Regulation 1924/2006: Requirements profile
Analysis of the Opinions issued by EFSA, European Food and Feed Law Review, 2009,
p. 119
140
 Tommasini, La disciplina giuridica dell’etichettatura degli alimenti, in Costato –
Germanò – Rook Basile, Trattato di Diritto Agrario, III, Il Diritto agroalimentare,
Torino, 2011, p. 494
 Trapè- Lattanzi, Food additives and contaminants, in Costato-Albisinni (editors),
European Food Law, already mentioned, p. 40
 Trapè, Qualità e competitività nelle produzioni agroalimentari. Le indicazioni
geografiche tra esigenze di coerenza e di efficacia, in Agricoltura – Istituzioni-Mercati,
n. 3/2008
 Turner et al., Label Claims for Foods and Supplements: A Review of the Regulations,
in Nutrition in Clinical Practice, Vol.20, No.1, 2005, p.30
 Urala, Arvola and Lahteenmaki, Strength of health related claims and their perceived
advantage. in International Journal of food Science and Technology , 2003, 38, p. 815.
 Valletta, La lingua sull’etichetta dei prodotti alimentari, tra tutela del consumatore e
rispetto della libera circolazione delle merci, in Riv. dir. agr., 2001, II, p. 68
 Vedaschi, Le indicazioni geografiche semplice e la corretta informazione del
consumatore, in Dir.pubbl.comp. eur., 2001, p. 384
 Ventura, Principi del diritto alimentare, Milano, 2001
 Verbeke – Ward & Avermaete, Evaluation of publicity measures relating to the EU
beef labelling system in Belgium, in Food Policy, 2002 27, p. 339
 Verbeke & Van Kenhove, Impact of emotional stability and attitude on consumption
decisions under risk: The Coca-Cola case in Belgium, in J Health Comm 2002, 7, p.
455
 Verbeke & Ward, Consumer interest in information cues denoting quality, traceability
and origin: An application of ordered probit models to beef labels, In Food Qual
Prefer, 2006, 17, p. 453
 Verbeke, Agriculture and the food industry in the information age, in Eur Rev Agric
Econ, 2005, p. 32
141
 Verbeke, Consumer acceptance of functional foods: socio-demographic, cognitive and
attitudinal determinants. In Food Qual Prefer, 2005, 16, p. 45
 Verhagen – Vos – Francl – Heinonem - Van Loveren, Status of Nutrition and Health
Claims in Europe, in Archives of Biochemistry and Biophysics, 501, 2010, p. 7
 Vettori, Libertà di contratto e disparità di potere, in Riv.dir.priv., 2005 p. 743
 Viglione, L’interpretazione del contratto nel common law inglese. Problemi e
prospettive, in Supplemento annuale di studi e ricerche della Riv.dir.civ., 2008, p.133
 Villa, Contratto e violazione di norme imperative, Milano, 1993
 Viti, Commento all’art. 10 del Reg. 178/2002, in Idaic, La sicurezza alimentare
nell’Unione europea, in Nuove Leggi Civili Commentate , 2003, p. 223
 Vitolo, Il diritto alimentare nell’ordinamento interno e comunitario, Napoli, 2003
 Warner, Judicial Reasoning and Precedent: Negligently Inflicted Psychological
Injuries, (1990) 10 Legal Studies (1) 63, 75
 Worsley, Nutrition knowledge and food consumption: Can nutrition knowledge change
food behavior, 2002, Asia Pac J Clin Nutr 11, p. 579
 Zei, Tecnica e diritto tra pubblico e privato, Milano 2008
 Zencovich, “Il codice civile europeo”, le tradizioni nazionali e il neopositivismo, in
Foro it., 1998, V, c. 62
 Zencovich, Il diritto europeo dei contratti (verso la distinzione tra “contratti
commerciali” e “contratti dei consumatori”), in Giur.it., 1993, IV, p.69
 Zolla, Per il diritto comunitario l’aglio liofilizzato in forma di capsule non è un
medicinale, in Riv. Dir. Agr., 2008, II, p. 39
 Zolla, Riportare sulle etichette alimentari indicazioni sulla salute false e non accertate
scientificamente costituisce una forma di pubblicità ingannevole, in Dir. giur. agr.,
2009, IV, p.277
142
 Zolla, Tutela della produzione alimentare made in Italy nella normativa penale, in Dir.
giur. agr., 2007, p. 505
 Zolla, Utilizzo del sorbato di potassio ai fini della conservazione dei prodotti
alimentari, in Ri.dir.agr. VI, 2010, p. 379
 Zoppini, Il contratto asimmetrico tra parte generale, contratto di impresa e disciplina
della concorrenza, in Riv. Dir. Civ., 2008, I, p. 515
 Zunz, Why the american century?, Chicago-London, the University of Chicago press,
1998
Jurisprudence
 Court of Justice 8th September 2005, C-303/04
 Court of Justice of 4th July 1988 C-298/87
 Court of Justice 15th July 2004, C-239/02
 Court of Justice 16th July 1998, C-210/96
 Court of Justice 2nd of December 2004, C-41/02
 Court of Justice 30th April 1996, C-194/94
 Court of Justice, 10th September 2009, C- 446/07
 Court of Justice, 10th September 2009, C- 446/07
 Court of Justice, 12th July 2005 C-154/04 and C-155/04.
 Court of Justice, 7th July 1998 C-210/96
 Court of Justice, 16th September 2004 C-329/02.
 Tribunal 26th November 2002, Cases T-74/00, T-76/00, from T- 83/00 to T- 85/00, T132/00, T-137/00 e T-140/00.
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 Tribunal of Roma, 25th February 1998;
 Tribunal of Napoli 26th June 1997.
 Tribunal of Padova, 29th November 1994.
144