Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Nel mese di ottobre 2010 la FVO ha condotto
una missione in Italia per la verifica dello stato di
attuazione delle normativa comunitaria in
materia di MOCA. La missione ha visitato le
regioni Marche e Piemonte. Sono state rilevate
alcune Non Conformità (14…).
•
1
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
1
Garantire che il personale addetto ad
effettuare i controlli ufficiali riceva la
formazione adeguata in materia di HACCP, AA,
MCA ed etichettatura conformemente
all'articolo 6 e all'allegato II del regolamento
(CE) n. 882/2004.
La DGSAN ha inviato una nota informativa alle Autorità Competenti Regionali (ACR) sulle
criticità emerse nel corso dell’audit e ha invitato ad intraprendere, ove necessario, le azioni
necessarie per superare le carenze riscontrate;in particolare è stata richiamata
l’importanza della formazione del personale che effettua i controlli per MOCA, additivi e
igiene ( all.1).
•
2
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
4
Garantire che i controlli ufficiali comprendano le attività di
ispezione degli operatori MCA e l'esame del materiale
scritto conformemente all'articolo 10, paragrafo 2, lettera
e), del regolamento (CE) n. 882/2004.
•
Per quanto riguarda le attività di vigilanza sugli operatori il MS sta
predisponendo un provvedimento normativo volto a rendere obbligatorio
per gli operatori alimentari, compresi i produttori di MOCA, l’inserimento
dello stabilimento in un’anagrafica nazionale.
Nell’immediato la DGSAN ha richiamato alle ACR (all. 1) l’importanza
dell’attività di ispezione secondo procedure documentate, comprendendo
la verifica del materiale scritto;
3
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
5
Garantire che le procedure documentate siano
costantemente seguite conformemente
all'articolo 8, paragrafo 1, del regolamento (CE) n.
882/2004.
•
Nell’ambito del Coordinamento Interregionale per la Sanità animale e
la Sicurezza Alimentare è stato istituito un gruppo di lavoro sul
Controllo ufficiale sui MOCA che ha lo scopo di individuare modalità
condivise di applicazione della normativa e prioritariamente si
occuperà di definire delle Linee guida nazionali per il controllo dei
MOCA
4
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
6
Garantire che le procedure di verifica siano applicate per
consentire la valutazione dell'efficacia dei controlli ufficiali
conformemente all'articolo 8 del regolamento (CE) n.
882/2004.
•
Si intendono sviluppare delle modalità per la verifica
dell’efficacia dei controlli ufficiali………..Inoltre nella nota
informativa…… DGSAN ha invitato le Autorità Competenti
Regionali (ACR)…….ad attivarsi affinché venga verificata
l’efficacia dei controlli ufficiali conformemente all'articolo 8
del regolamento (CE) n. 882/2004.
5
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
9
Garantire che le autorità competenti
intervengano in caso di irregolarità
conformemente all'articolo 54 del regolamento
(CE) n. 882/2004.
•
La DGSAN ha espresso delle precisazioni in merito ad alcuni rilievi formulati
durante l’ispezione sulle misure adottate dalla ACL e ha richiamato nella nota di
cui all’allegato 1, rivolta alle Regioni, oltre alla puntuale applicazione dell’articolo
54, le misure sanzionatorie esistenti in materia di MOCA e AA, al fine di una
applicazione omogenea della normativa.
6
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
12
Garantire che gli ispettori ufficiali siano a conoscenza dei
requisiti della dichiarazione di conformità di cui all'allegato
VI bis della direttiva 2002/72/CE della Commissione e ne
garantiscano la corretta applicazione.
•
L’uff. VI della DGSAN invierà, entro marzo 2011,
una nota indirizzata alle ACR e agli USMAF che
richiami le normative nazionali e comunitarie sui
MCA, comprese le plastiche, e descriva le
modalità
di
effettuazione
dei
controlli
relativamente alle dichiarazioni di conformità.
……
7
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
13
Garantire che i controlli ufficiali comprendano la valutazione
delle procedure basate sul sistema HACCP, sulle BPF e sulle
BPI conformemente all'articolo 10, paragrafo 2, lettera d),
del regolamento (CE) n. 882/2004.
•
……………Si intende inserire l’attività di verifica
dell’applicazione delle BPF nelle Linee guida per il
controllo dei produttori MOCA che saranno definite
nel gruppo di lavoro MOCA di cui alla Racc. n. 5.
8
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
14
Garantire che i produttori degli MCA attuino le
BPF conformemente al regolamento (CE) n.
2023/2006 della Commissione.
Le ispezioni FVO sui MOCA
•
E’ previsto, entro marzo 2011, l’invio di una nota
alle Associazioni degli operatori del settore MOCA
per richiamare gli obblighi di attuazione delle BPF,
che peraltro sono oggetto di verifica nell’ambito del
controllo ufficiale.
9
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
La strategia del controllo ufficiale segue quindi
una strada ben delineata dalle
raccomandazioni della
Missione FVO e delle relative asserzioni del
Ministero della Salute.
a) Formazione degli addetti al controllo
ufficiale (corsi ISS/MS, corsi RT, corsi Aziendali)
b) Incremento della EFFICACIA del controllo
ufficiale dove per EFFICACIA si deve intendere
capacità e rapidità della rimozione delle cause
che hanno prodotto NC.
•
c) Verifica della effettiva applicazione di manuali di buone pratiche
laddove non sia in essere un sistema di HACCP.
10
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Gli aspetti connessi alla produzione hanno il netto sopravvento su quelli
connessi alla sicurezza alimentare. In alcuni casi è addirittura assente
qualunque consapevolezza di essere parte di una filiera.
Le corrette modalità di produzione commercializzazione
e utilizzo di MOCA devono divenire patrimonio
collettivo nell’interesse primario di consumatori.
•
11
Filiere
lunghee
Materie
prime
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Produttore
O.S.A.
es. Acque
semilavorati
Scarsa
professionalit
tà
Distributore
“professional
e”
O.S.A.
es. accoppiato
Converter
Scarsa
professionalità –
Non percezione del
problema
O.S.A.
(es. vetro )
Consumat
ore
Distributore
12
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Vediamo come sono andate le cose negli altri
Paesi membri della UE…
•
13
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
France
2007-7187 Food additives and
food contact
materials
Overall, a satisfactory system is in place for both FCM and FA although
focusing on market controls. Major shortcomings identified are the
lack of validation of analytical methods for the majority of FA in the
laboratory visited and the limited scope of accreditation. Minor
shortcomings have also been identified in the scope of
audit system and the limited notifications through the RASFF.
•
14
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Denmark
2008-7832 Food Additives and
Food Contact
Materials
OVERALL CONCLUSION
Overall there is a good control system in place for FA and those FCM that are
subject to specific measures. Official controls are carried out on a risk basis with
appropriate frequency. Some shortcoming were identified in the range of FCM
subject to official controls, in the scope of official controls and audit system, in the
inspection procedures observed by the mission team in the establishments visited
and in the implementation of RASFF. However, these minor shortcomings do not
•affect the reliability of the control system in place.
15
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Germany
•
2008-7841 Specific audit on the
official control systems in
place for food additives
and for food contact
materials
(parte di general audit)
Conclusions
The implementation of GMP guides and training of all parties involved
is currently ongoing. Official controls do not yet include the
assessment of GMP in FCM establishments (Regulation
2023/2006), as required by Article 10(2)(d) of Regulation No 882/2004.
16
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Finland
2009-8149 import controls, food
additives and food
contact materials
controlli import FCM
6 OVERALL CONCLUSIONS
Overall, there is an official control system in place in relation to import controls, FAs
and FCMs in Finland which is mainly implemented in accordance with the relevant
EC legislation. However, some shortcomings, relating to import procedures, the
assessment
of FAs and procedures on HACCP principles, and limited GMP
•
implementation in FCM manufacturers, have been identified which might hamper
the effective implementation of the official control system.
17
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Greece
2009-8152 Food additives and
food contact
materials
OVERALL CONCLUSION
Overall, there is an official control system in place for FA and FCM. Certain
organisational difficulties and resource shortages have lead to
shortcomings in the application of the Community requirements. Due to
the identified significant deficiencies the official control of FA and FCM is
not carried out in accordance with the relevant Community legislation.
•
18
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Lithuania
•
2009-8159 Food hygiene, food
additives, food contact
materials
OVERALL CONCLUSIONS
Overall, there is an official control system in place in relation to food hygiene, FAs
and FCMs in Lithuania which is mainly implemented in accordance with the
relevant EC legislation. However, some deficiencies, relating to monitoring of FAs
consumption, documented procedure(s) for FCM manufacturers' inspection,
assessment of the declaration of compliance, NRL laboratory for FCM
and limited GMP implementation in FCM manufacturers, have been identified.
19
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
China
•
2009-8156 Food Contact
Materials (FCM)
OVERALL CONCLUSIONS
The control system in place on FCM destined for export to the EU has improved
since the previous mission, including the introduction of certain EU
requirements on FCM. However, deficiencies regarding laboratory
performance, the incomplete investigation of companies notified through the
RASFF and the potential risk of non-compliant FCM exported to the EU via
Hong Kong mean that equivalence with EU requirements cannot be
guaranteed.
20
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
United Kingdom
2009-8170 Food Additives and Food
Contact Materials
OVERALL CONCLUSIONS
Overall the official controls on FA and FCM in the UK largely ensure that the relevant
legislative requirements are complied with. Official controls are carried out on a risk basis
with appropriate frequency, according to documented procedures. Some shortcomings
were noted with regard to an analytical method used for testing FA, assessment of DoC
for FCM and checks on FA purity criteria. The report makes some recommendations to
the competent authorities of the UK to address the shortcomings noted.
•
21
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Slovenia
2009-8168 Food hygiene, traceability,
labelling, bottled water,
food additives and food
contact materials
OVERALL CONCLUSIONS
Overall, there is an official control system in place in relation to food
hygiene, FAs and FCMs in Slovenia which is mainly implemented in
accordance with the relevant EC legislation. However, some deficiencies,
relating to monitoring of FAs consumption, NMW recognition, controls of
Fas and FCMs is some establishments, have been identified.
•
22
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Portugal
•
2009-8173 Food hygiene, traceability,
labelling, bottled water, food
additives and food contact
materials
OVERALL CONCLUSIONS
The official control system of foodstuffs including FCM and FA are not
satisfactory as a number of shortcomings in relation to a lack of monitoring of FA
consumption, lack of official controls in FA and FCM, unknown level of HACCP
implementation and the failure to report non compliances to the RASFF have
been detected. There are procedures in place for the recognition and official
control of NMW with some deficiencies identified.
23
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Latvia
2009-8174 Food of plant origin - food
hygiene, traceability,
labelling, bottled water, food
additives and food contact
materials
OVERALL CONCLUSIONS
Overall, there is an official control system in place in relation to food hygiene,
natural mineral waters and food additives controls in Latvia which is mainly
implemented in accordance with the relevant EC legislation. However, a number
of shortcomings, related to official controls of FCM business operators,
monitoring for FA consumption, assessment of HACCP principles put in place
•and controls of FA and FCM in the establishments visited, laboratory analysis for
FCM, have been identified
24
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Romania
2010-8573 Food contact
materials and food
additives
OVERALL CONCLUSION
Overall, there is an official control system put in place by the CAs in the context of this
mission.
The system for FA is generally implemented following the relevant EC legislation.
Nonetheless, the deficiencies identified regarding coordination, training, audits and
laboratory hamper the efficiency of the system.
The system for FCM cannot ensure adequate controls on FCM due to the weaknesses
•identified in terms of training, coordination, risk categorisation, enforcement, audits,
inspection and laboratory capability and performance.
25
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Malta
•
2010-8590 Food hygiene, food
contact materials
and food additives
OVERALL CONCLUSIONS
Overall, the CAs have put in place an official control system covering the
sectors evaluated during this audit. In the area of food hygiene there is a
satisfactory system of official controls, based mainly on the assessment of
prerequisites. The assessment of HACCP has not been applied correctly due
to the absence of guides and training for the inspectors. The system for FCM
and FA cannot ensure adequate controls due to weaknesses identified in
terms of training, lack of official guidelines, staffing, laboratory capacity and
accreditation.
26
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Czech Republic
2010-8576 Food additives and
food contact
materials
OVERALL CONCLUSION
Overall, there is an official control system in place for FA and FCM. The official control of
FA is undertaken as part of the official control of foodstuffs. The system for FA controls is
mainly carried out following the relevant EC legislation. The FCM chain is subject to
official controls. However, some shortcomings have been identified regarding the cooperation between the competent authorities, availability of clear guidelines and
instructions, training, inspection procedures, limited knowledge of FCM legislation,
assessment of declaration of compliance and good manufacturing practices for FCM,
•
notification
through RASFF, which might hamper the effectiveness of these official
controls.
27
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Poland
•
2010-8578 food contact
materials and food
additives
OVERALL CONCLUSIONS
It can be concluded that there are procedures established and controls
undertaken through all stages of FCM and food production and distribution.
However significant deficiencies in coordination of control activities between
CAs and lack of clear instructions on FA and FCM reduces the efficiency
of the current control system. The monitoring of consumption of FA has not
been implemented.
28
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Bulgaria
2010-8584 for food contact
materials and food
additives
OVERALL CONCLUSION
The official control of FA and FCM is undertaken as part of the broader official
control of foodstuffs. The system for FA is mainly carried out following the relevant
EC legislation. However, the shortcomings identified regarding assessment of
documentation and the limited scope of laboratory analysis might reduce the
efficiency of the system. The official control system for FCM is newly set up and
requires legal registration of FCM manufacturers and traders. However, a number of
shortcomings have been identified in relation to the very limited scope of analysis,
•accreditation status and the incomplete assessment of the DoC, which may lead to
ineffective controls.
29
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Italy
•
2010-8591 Food hygiene, traceability,
labelling, food contact
materials and food additives
OVERALL CONCLUSION
Considerable progress has been made since the last mission on food hygiene.
However, assessment of HACCP systems by inspectors was inadequate. The
specific controls of FA / FCM are at a very early stage. The laboratories,
although well equipped and well staffed are constrained by their lack of
accredited methods and non- participation in proficiency tests. These
shortcomings hamper the full implementation of relevant EU legislation.
30
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Latvia
2011-6000 Food contact
materials
OVERALL CONCLUSIONS (follow up)
Overall, adequate progress has been made since the last mission and all the
recommendations concerning FCM have been addressed. Amended legislation will be in
force from 2012 which will provide national legal powers for FCM controls, including
assessment of Good Manufacturing Practice and improved uniformity towards
enforcement measures.
A number of shortcomings remain in relation to training and practice in assessing the
DoC
• for FCM and the formal communication to the Commission of the designation
status of the NRL. Nevertheless, the NRL had co-operated well with the European Union
Reference Laboratory. Good cooperation between the central administration and the
territorial offices was also evident.
31
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Austria
2011-8997 Food additives and
for food contact
materials
OVERALL CONCLUSIONS
There is a generally good legal framework established for the official control of FA
and FCM in Austria. CAs, official laboratories and NRL are clearly designated and
sufficiently staffed to undertake their duties. However, shortcomings in the
cooperation and coordination between Cas involved in the official controls observed
in one visited region reduces the efficiency of official controls.
The official controls are generally carried out in accordance with documented
procedures. However these procedures are inconsistent and are not yet harmonised
between
and within Länder and leads to inconsistency in the implementation of
•
controls. A number of shortcomings were noted by the FVO team in the
performance of inspectors mainly in one of two visited regions.
32
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Belgium
2011-8998 Food additives and
food contact
materials
OVERALL CONCLUSIONS
Overall there is a centralised and consistent approach to official controls which
includes the manufacture and distribution of FA but only the distribution of FCM. All
relevant legislation is in place and the competent authorities, national reference
laboratory and control laboratories are clearly designated and sufficiently staffed to
undertake their duties. Official controls of manufacturers of FCM are at a very
preliminary stage, however, sampling of FCM at the distribution level is well
controlled.
The inspectors had not received sufficient training in FCM. The
•
laboratories visited were generally considered satisfactory except for the absence of
analytical methods for aniline and saccharin. To date audits did not focus on FA and
FCM. There was good cooperation between and within the competent authorities.
33
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Portugal
2011-8996 Food hygiene, traceability,
labelling and bottled water
and for food additives and
food contact materials
(follow up)
6 OVERALL CONCLUSION
Overall, three out of nine recommendations from mission report DG (SANCO) 20098173 have been adequately addressed. Positive action has been taken to address the
shortcomings relating to the analysis of Sudan dyes and NMWs. The issues relating to
the labelling of allergens has been clarified, these are checked as part of the monitoring
programme. The policy for reporting RASFF notifications remains non-compliant.
Recommendations related to the levels of implementation of HACCP and GMP remain
•
open. There is still an absence of any convincing policy for official controls to be carried
out regularly, on a risk basis and with appropriate frequency. This is mainly due to the
competent authorities not having access to a reliable source of information of all
registered / licensed establishments. Work is in progress to enable all CAs to have
access to each others registration / licensing data. The CCA is preparing legislation to
34
clarify the designation of each CA.
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Sweden
Le ispezioni FVO sui MOCA
2011-6001 food additives and
for food contact
materials
OVERALL CONCLUSION
The official control system for FAs is mainly carried out following the relevant EU
legislation. However, the shortcomings identified regarding assessment of
documentation and the limited knowledge and experience of the inspectors
regarding official controls of FAs use reduce the efficiency of the system. The
official control system for FCMs deals only with the use of FCMs and does not
cover the production and import of FCMs. This deficiency together with the lack
of laboratory analysis, written control procedures, specific training and the
limited knowledge and experience of the inspectors regarding official control of
• might hamper the effectiveness of the system. However, the NFA is aware
FCMs
of these shortcomings and has prepared a strategic plan for performing
FCMs official controls. Its implementation depends on the availability of the
necessary resources – staff, knowledge and laboratory capacity.
35
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Hungary
2011-8999 food additives and
for food contact
materials
OVERALL CONCLUSION
Overall, the official control system for food additives is carried out following the
relevant EU legislation. However, shortcomings were identified regarding the
assessment of documentation and use of food additives due to inadequate training of
the inspectors and a lack of written procedures and instructions provided.
The official control system for food contact materials has been established in 2011. It
does not cover all FCM manufacturers. This deficiency together with the lack of written
•
control
procedures, specific training and the limited knowledge and experience of the
inspectors regarding official control of food contact materials limits the effectiveness of
the system.
36
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Le ispezioni FVO sui MOCA
Danimarca Francia
Lituania
Grecia
Regno
Unito
Germania
Lettonia
Portogallo
Finlandia
Malta
Romania
Slovenia
Rep. Ceca
Italia
Austria
Polonia
Bulgaria
Belgio
•
Svezia
Ungheria
2
5
9
4
37
Materiali e Oggetti a Contatto con Alimenti
Cerere – 12 ottobre 2012
Grazie per la vostra attenzione
Dr. Ambrogio Pagani
UF SAN – Azienda Usl 2 Lucca
[email protected]
38