GLI INQUINANTI ORGANICI PERSISTENTI IN UNA PROSPETTIVA NAZIONALE ED EUROPEA THE PERSISTENT ORGANIC POLLUTANTS FROM THE EUROPEAN AND THE NATIONAL PERSPECTIVES Monitoraggio dei POPs sul territorio alpino Copyright © 2007 - ARPA Lombardia ISBN 978-88-903167-0-8 Le Alpi e i progetti transnazionali T.Magnani, C.Belis Agenzia Regionale per la Protezione dell’Ambiente Lombardia Dip. Sondrio via Stelvio, 35- 23100 Sondrio In seguito al veloce progredire della globalizzazione, le Alpi sono state caratterizzate da profondi cambiamenti strutturali, culturali ed ecologici. Il concetto di sviluppo sostenibile e la considerazione della dimensionalità territoriale diventano sempre più importanti per la definizione di strategie politiche in grado di gestire questi cambiamenti. Oggi, le Alpi sono probabilmente la macroregione europea con i contatti interculturali più intensi in relazione allo spazio occupato ed esigono il confezionamento di una soluzione unica per lo sviluppo sostenibile di un territorio che ricopre una superficie di 190.000 Kmq in cui vive una popolazione di 13,6 milioni di abitanti. Rafforzare la cooperazione e contribuire allo sviluppo di una identità e capacità comune di agire nello spazio alpino è stato il primo obiettivo della Convenzione delle Alpi, un accordo di diritto internazionale, stipulato già nel 1991, fra Austria, Svizzera, Germania, Francia, Principato di Monaco, Liechtenstein, Italia, Slovenia e Comunità Europea. Tale Convenzione è stata un indubbio precursore dello sviluppo inclusivo e sostenibile dell’arco alpino con il suo approccio integrato includente la dimensione ecologica, economica e sociale per le aree di montagna e valutando attentamente l’interdipendenza delle differenti dimensioni dello sviluppo. Per individuare soluzioni innovative e sostenibili, data la dimensione transfrontaliera o internazionale, la Convenzione delle Alpi ha posto in primo piano il tema del ricorso alla cooperazione transnazionale come stimolo e sostegno di strategie atte allo sviluppo strutturale dello Spazio Alpino nella nascente Europa unita. In seguito, il tentativo di coinvolgere il territorio affinché esprimesse la propria vocazione ad inserirsi politicamente, economicamente e socialmente nel contesto europeo ha generato politiche volte a ridurre le criticità derivanti dalla cessazione della condizione frontaliera (e delle attività ad esse connessa) e dal perdurare di molti elementi di conflitto (linguistici, infrastrutturali, normativi, etc.). Per far si che il coinvolgimento degli attori locali non rimanesse limitato ai pochi chilometri di confine, dalla seconda metà degli anni Novanta il programma Interreg ha delineato le grandi aree di cooperazione trasnazionale grazie alle quali il territorio diventa una nuova dimensione della politica europea. Le Regioni si ritrovano in un’area che non coincide più con i confini nazionali, ma che ricerca nel rapporto con le altre istituzioni e nella integrazione territoriale il proprio punto di equilibrio. Il programma transnazionale “Spazio Alpino” interessa un’area geografica che comprende circa 70 milioni di abitanti distribuiti in un territorio caratterizzato dalla più grande catena montuosa del continente europeo e dai circostanti territori collinari e Monitoraggio dei POPs sul territorio alpino di pianura; tale spazio alterna zone di montagna, scarsamente popolate e caratterizzate da un ricco patrimonio naturale e culturale, ad insediamenti urbani e metropoli densamente popolate. Le zone ammissibili interessano sette regioni italiane: Valle d’Aosta, Piemonte, Liguria, Lombardia, Friuli-Venezia-Giulia, Veneto e Trentino-Alto Adige. Sono inoltre coinvolti la Francia (Rhône-Alpes, Provence-Alpes-Côte d’Azur, Franche-Comté, Alsace), la Germania (Oberbayern e Schwaben, Tubingen e Freiburg im Breisgau), la Slovenia e l’Austria (gli interi paesi). Partecipano inoltre al programma, come membri a pieno titolo, due paesi extra-comunitari: la Svizzera e il Liechtenstein. In sintesi, la strategia del programma si articola in quattro assi prioritari. • la priorità 1 “Promozione dello Spazio alpino quale spazio competitivo e vitale nel quadro di uno sviluppo territoriale policentrico nell’Unione europea” che comprende due misure: la conoscenza reciproca e le prospettive comuni; la competitività e lo sviluppo sostenibile; • la priorità 2 “Sviluppo di sistemi di trasporto sostenibile, con particolare riguardo all’efficienza, all’intermodalità e al miglioramento dell’accessibilità” che comprende due misure: le prospettive e l’ analisi; il miglioramento dell’esistente e la promozione di sistemi di trasporto futuri attraverso soluzioni intelligenti di grande e piccola scala come l’intermodalità; • la priorità 3 “Saggia gestione della natura, del paesaggio e del patrimonio culturale, promozione dell’ambiente e prevenzione di rischi naturali” che comprende tre misure: la natura e le risorse, in particolare l’ acqua; la buona gestione e la promozione dei paesaggi e del patrimonio culturale; la cooperazione nel settore dei rischi naturali; • la priorità 4 “Assistenza tecnica” che comprende due misure: l’ attuazione del programma; l’ informazione e la valutazione. Sono moltissimi oggi i progetti realizzati e quelli in fase di realizzazione sullo Spazio Alpino, ma, al di là degli importanti risultati ottenuti, occorre ricordare che l’obiettivo generale del programma è quello di aumentare la competitività e l’attrattività dell’area di cooperazione attraverso lo sviluppo di azioni comuni in settori dove la cooperazione transnazionale è necessaria per arrivare a soluzioni sostenibili. Il Programma tende inoltre ad implementare metodologie per incubare e sviluppare strumenti che influenzino anche i comportamenti e le percezioni sulla necessità, nell’Europa unita, di delineare accordi in un processo lavorativo che promuova e massimizzi la possibilità di un apprendimento comune e condiviso tra i vari partners dei progetti e che apporti un valore aggiunto alla integrazione tra i Paesi. Il significato etimologico della Cooperazione Trasnazionale è di difficile espressione nella sua essenza ed significato . La parola rimanda sicuramente ad una attività collaborativa tra i diversi Paesi ed è atta a descrivere scambi di prassi, di attività, di prodotti, tra i diversi Paesi all’interno della Comunità Europea, ma sottende anche Le Alpi e i progetti transnazionali a scambi più preziosi quali il dialogo, i know-out, l’integrazione culturale e sociale fondamentale per lo sviluppo di una comune civiltà europea. Il progetto transnazionale “Monitoraggio degli inquinanti organici persistenti (POP’s) ed altri inquinanti nella Regione Alpina”, ad acronimo Monarpop, ha concentrato l’attenzione sulle foreste delle Alpi ritenute un importante recettore per i POP’s trasportanti anche da aree distanti, tematica sulla quale non esistevano finora studi scientifici che, in ogni modo, quantificassero l’entità del problema. Nato da una cooperazione tra Austria, Italia, Germania, Slovenia e Svizzera, il Monarpop, i cui risultati vengono presentati nel presente Convegno, ha coinvolto istituzioni locali, regionali e nazionali, a cominciare dal 2004, con l’obiettivo, tra gli altri, di affidare ai decisori politici le conclusioni tecniche al fine di operare soluzioni strategiche in ottemperanza alla Convenzione sui POP’s. Un ultimo, ma non meno importante, obiettivo del progetto è l’informazione e la comunicazione. La strategia di comunicazione ha previsto una gamma differenziata di elementi (portale Internet) e strumenti (banca dati di progetto) per uno scambio sistematico di esperienze e per promuovere non solo le reti telematiche, ma anche, e soprattutto, lo scambio interdisciplinare. Monitoraggio dei POPs sul territorio alpino 11 Copyright © 2007 - ARPA Lombardia ISBN 978-88-903167-0-8 Environmental protection and transnational cooperation in the alpine space: results and perspectives Ivan Curzolo INTERREG IIIB Alpine Space JTS Stadt Rosenheim - Postfach 1209 - D - 83013 Rosenheim - Germany Abstract The Alpine Space area represents one of the most manifold regions in the heart of the European Union. In fact, this area is a major contact zone, were different European cultures and languages (German, Latin and Slavic) meet. This diversity is also visible in respect with political and socio-economical aspects, as considerable social and economic disparities, often within small distances, are evident. The Alpine Space represents also an important transnational European co-operation area. Its co-operation characteristic has integrated the Alpine tradition for over several decades. It extends from political and administrational co-operations on national or regional level, to co-operations on smaller scale between local authorities and private institutions, some of them developing within the frame of European Community Initiatives and programmes (like INTERREG). Monarpop is one of the 58 operations co-financed by the European Development Fund (ERDF) through the INTERREG IIIB Alpine Space Programme 2000 – 2006. These projects that have developed and are developing their activities according to three thematic priorities: • spatial planning and competitiveness; • fostering the development of sustainable transport systems; • wise management of natural landscapes and cultural heritage as well as promotion of the environment and prevention of natural disasters. The aim of the project Monarpop, is to carry out a survey on persistent organic pollutants (POPs) and other pollutants in the Alpine region, as POPs, which belong to the most toxic existing compounds and accumulate in the food webs and in environmental media, endanger the Alpine ecosystems and by that the sustainable development of the Alpine Space. Although the activities started already in 2003, the highly experimental features of the project phases, together with the use of very sensitive and innovative technology which was scarcely tested before, had led the need to extend the time implementation of the project. Results are therefore firstly available and shown in these three international conferences of Venice, Bormio and Salzburg. While the current programming period is fading away with the implementation of 12 Monitoraggio dei POPs sul territorio alpino the approved operations, the new programming period is already a reality on the horizon. The Alpine Space Programme 2007 – 2013 will aim at increasing competitiveness and attractiveness of the cooperation area by developing joint actions in fields where transnational cooperation is required for sustainable solutions. Five EU Countries (Austria, France, Germany, Italy and Slovenia) together with the two partner Countries (Liechtenstein and Switzerland) have joined again forces to draw up a document that aims at being a synthesis between programmes in the field of regional competitiveness and employment and programmes fostering cross-border and interregional cooperation. The Operational Programme has been formally approved by the European Commission in September 2007. Programme priorities focus on different fields of action. Beside the promotion of competitiveness and attractiveness, mentioned in the beginning, particular attention will be given to accessibility and connectivity as well as the promotion of natural resources and cultural heritage. Although rather similar in the budget dimension, the new programme will support a different approach when approving projects for co-funding. Activities will have to cover the entire alpine area, be characterised by concrete and tangible results that shall be used also after the end of the public funds support. The involvement of policy makers and political sector shall be granted as well. Monitoraggio dei POPs sul territorio alpino 13 Copyright © 2007 - ARPA Lombardia ISBN 978-88-903167-0-8 Present and future in the risk assessment of chemicals with PBT properties Ana B. Payá Pérez European Chemicals Bureau, Institute for Health and Consumer Protection, Joint Research Centre, Ispra, Italy 21024 E-mail:[email protected] Riassunto Questo articolo illustrerà lo stato attuale della valutazione di 127 sostanze prodotte in elevate quantità (HPVCs), biocidi e pesticidi che sono state condotte dal Comitato Tecnico della UE sulle sostanze nuove ed esistenti sottogruppo per la valutazione del potenziale PBTs, o vPvBs, o POPs nell’ambito della strategia temporanea per la gestione delle sostanze vPvBs e PBTs (Dir. 93/67, Reg. 1488/94, Dir. 98/8/EC e Dir. 91/414/ECC). Verranno inoltre presentati i principali elementi delle linee guida sulla valutazione delle sostanze PBT/vPvB sotto la normativa REACH. Abstract The paper will illustrate the current status of the evaluation of 127 high production volume substances (HPVCs), biocides and pesticides which has been carried out by the EU Technical Committee on New and Existing Substances subgroup for the evaluation of potential PBTs or vPvBs or POPs in the context of the EC’s Interim Strategy for Management of PBT and vPvB substances (Directive 93/67, Regulation 1488/94, Directive 98/8/EC and Directive 91/414/ECC). The main elements of the guidance developed on how to assess PBT/vPvB substances under REACH Regulation will be presented. Introduction Substances fulfilling PBT criteria are substances that are persistent, bio-accumulative and toxic, while vPvB substances are characterised by a particularly high persistency in combination with a very high tendency to bio-accumulate, but not necessarily proven toxicity. The persistence and bioaccumulation criteria for POPs and vPvB substances are identical. The identification of substances with PBT properties in the EU Risk Assessment process started on year 2003 under the existing substances Regulation 793/93. How these properties are defined by the criteria laid down in Annex XIII of the REACH Regulation (Registration, Evaluation and Authorization of Chemicals) will be described. HPVCs are substances or substance mixtures produced/imported in the EU by a particular producer/importer in amounts exceeding 1000 t/yr at least once between 1990 and 1994. OJ L 396, 30.12.2006 p.1; Directive 2006/121/EC and Regulation (EC) No 1907/2006. 14 Monitoraggio dei POPs sul territorio alpino The European Commission and the Member States are committed to identify and assess further POP substances to be included under the international agreements in order to contribute to achieving the 2020 chemicals target adopted at the World Summit on Sustainable Development. The procedure of implementation of a new chemical into the POPs list is determined in the Stockholm Convention. The proposing Party shall provide a statement of the reasons for concern of including, where possible, a comparison of toxicity or ecotoxicity data with detected or predicted levels of a chemical, resulting or anticipated from its long-range environmental transport, and a short statement indicating the need for global control. A very significant argument for implementation of a substance to the POPS list is the need of the global control. For the inclusion of the chemical into the POPs group the most important is the potential risk for human and environment. One of the main sources of information that have triggered action on emerging POPs is the Technical Committee on New and Existing Subtances (TCNES) subgroup on PBTs which currently addresses all pesticides, biocides, new chemicals and high production volume chemicals (HPVCs). An update of the conclusions of finalized assessment on various PBTs will be provided. Background on EU PBT Assessment Process Directive 93/67, Regulation 1488/94 and Directive 98/8 require that an environmental risk assessment be carried out on notified new substances, on priority existing substances and active substances and substances of concern in a biocidal product, respectively. The scope of the Risk Assessment covers emissions and consequent environmental impact and human exposures at each stage of the life-cycle of a priority substance from production, through processing, formulation, use and disposal. Protection goals are established for the environmental compartments - atmosphere, aquatic organisms, sediment and soil dwelling organisms, microorganisms in WWTPs, and mammals and birds exposed via accumulation in the food chain. Exposure of humans from all relevant sources is considered including exposure from consumer products and through air, food, and drinking water and the workplace. Each exposure scenario is assessed individually, and where appropriate, an overall combined exposure is also estimated. The objective of the PBT/vPvB assessment is different from the other risk assessment approaches as it seeks not to estimate safe concentrations but to minimize releases of PBT and vPvB substances and thereby exposure of humans and the environment to substances that cannot be controlled with reasonable effort once they have been released. The PBT assessment was developed to respond to the additional concerns for the potential impact of individual substances on marine ecosystems which may not be adequately addressed by the methodologies used for the inland environmental risk assessment. Present and future in the risk assessment of chemicals with PBT properties 15 These concerns are: a.the concern that hazardous substances may accumulate in parts of the marine environment and that: (i)the effects of such accumulation are unpredictable in the long-term; (ii)that such accumulation would be practically difficult to reverse; b.the concern that remote areas of the oceans should remain untouched by hazardous substances resulting from human activity, and that the intrinsic value of pristine environments should be protected. The detailed methodology is described in the Technical Guidance Document on Risk Assessment for New and Existing Substances (TGD, 2003). The criteria of PBTs and vPvBs are defined in the TGD-2003 as given in table 1. Table 1.- PBT or vPvB criteria according to the TGD-2003 for implementing Directive 93/67, Regulation 1488/94 and Directive 98/8. Property PBT-criteria vPvB-criteria P Half-life > 60 d in marine water or > 40 d in freshwater* or half-life > 180 d in marine sediment or > 120 d in freshwater sediment* Half-life > 60 d in marine- or freshwater or >180 d in marine or freshwater sediment B BCF > 2000 BCF > 5000 T Chronic NOEC < 0.01 mg/l or CMR or endocrine disrupting effects Not applicable * For the purpose of marine environmental risk assessment half-life data in freshwater and freshwater sediment can be overruled by data obtained under marine conditions. Under REACH a PBT/vPvB assessment is required for all substances manufactured or imported in the EU in amounts of 10 or more tones per year that are not exempted from the registration requirement. An additional guidance has been developed in the REACH Implementation Project (RIP) 3.2-2 Guidance on PBT and vBvP assessment (RIP 3.2-2, 2007) following the Annex XIII of Regulation (EC) No 1907/2006. In practice, the PBT and vPvB assessment comprises of 1 or 3 steps (comparison with the criteria and, if these are met, emission characterization and risk characterization) that are outlined in a guidance document developed as part of the REACH Implementation Projects (RIPs). This guidance for PBT/vPvB assessment shall ensure that all existing information as well as information that can be developed with alternative methods (in vitro, QSAR and read-across) is taken into account in the most appropriate way in order to save costs and reduce the need for conducting new animal experiments. Results and Discussion A screening-study among the 2682 high production volume chemicals (HPVC) in the IUCLID database (ECB 4/14/02) was performed to identify potential persistent, 16 Monitoraggio dei POPs sul territorio alpino bioaccumulating and toxic substances (PBTs) and very persistent and very bioaccumulating substances (vPvBs). A total of 127 substances were selected for evaluation. At present 5 substances (Table 2) have been identified as POPs, 21 substances are fulfilling PBT criteria and 64 have been de-listed, 8 substances have been deferred and 25 are undergoing evaluation. The PBT list and Summary Assessment Reports are published on the European Commission’s European Chemicals Bureau (ECB) Website: http://ecb.jrc.it/esis/index.php?PGM=pbt Table 2. Substances identified as POPs by the TC NES subgroup for PBT assessment Substance Name CAS Number EC Number Molecular formula Conclusions Hexachlorobuta1,3-diene 87-68-3 201-765-5 C4Cl6 Lindane 58-89-9 200-401-2 C6H6Cl6 POP Hexachlorobenzene 118-74-1 204-273-9 C6Cl6 POP Endosulfan 115-29-7 204-079-4 Clofenotane 50-29-3 200-024-3 P/vP; vB and T very high potential for longrange atmospheric transport. C9H6Cl6O3S Fulfilling BPT criteria & POP C14H9Cl5 POP Conclusions The PBT list and Summary Assessment Reports are published on the European Commission’s European Chemicals Bureau (ECB) Website: http://ecb.jrc.it/esis/index. php?PGM=pbt Under REACH the identification of a substance as being PBT/vPvB according to the criteria in Annex XIII or one that other data suggest an equivalent level of concern does not automatically lead to a proposal for inclusion in Annex XIV and the subsequent requirement for authorisation. Detailed guidance is provided in RIP 3.2-2 Guidance. In future new POPs will be added to the list reported by The Council of the EU (SEC (2007/341) which contains a total of 12 substances that have been so far proposed to be added in the Stockholm Convention and/or the UNECE Protocol on POPs. These substances have been divided in two groups. First group are substances that are or have been widely used in EU: Commercial pentabromodiphenyl ether (c-pentaBDE; CAS N. 32534-81-9); commercial octabromodiphenyl ether (c-octaBDE; CAS n. 32536-52-0); perfluorooctane sulfonate (PFOS), short-chain chlorinated parafins (SCCPs; CAS N. 85535-84-8) and α-lindane (CAS N. 319-84-6) and β-lindane (CAS N. 319-85-7). The second group are substances chlordecone (CAS N. 143-50-0), hexabromodiphenyl ether (hexaBDE; CAS N. 36483-60-0); pentachlorobenzene (CAS N. 608-93-5); Present and future in the risk assessment of chemicals with PBT properties 17 hexachlorobutadiene (CAS N. 87-68-3) and polychlorinated naphtalenes. Additional substances i.e. endosulfan (CAS N. 115-29-7), dicofol (CAS N. 115-32-2), trifluralin (CAS N. 1582-09-8), pentachlorophenol (CAS N. 87-86-5) that may exhibit POP characteristics are currently under discussion in the EU TCNES subgroup on PBTs. Bibliography ECB 4/14/02. Identification of potential PBTs or vPvBs among the IUCLID high production volume chemicals. ECB internal report, 2002. RIP 3.2-2 Guidance for PBT and vPvB Assessment (In prep. 2007). ECB report http://ecb. jrc.it/REACH SEC (2007) 341. Commission Staff Working Document. Community Implementation Plan for the Stockholm Convention on Persistent Organic Pollutants. Brussels, 14 March 2007. TGD (2003). De Bruijn, J., Hansen, B.G., Johansson, S., Luotamo, M., Munn, S.J., Musset, C., Olsen, S.I., Olsson, H., Paya-Perez, A.B., Pedersen, F., Rasmussen, K., Sokull-Kluttgen, B. - Technical Guidance Document in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Part 1 and Part 2 - EUR 20418/EN/1+2 (2003). Munn S., Allanou R., Aschberger K., Cosgrove O., Pakalin S., Paya Perez A., B. SchwarzSchulz, G. Pellegrini, S. Vegro - European Union Risk Assessment Report - 2,2’6,6tetrabromo-4,4’-isopropylidene diphenol (tetrabromobisphenol-A) - EUR 22161 EN, PB/2006/IHCP/3067 Hansen, BG, A van Haelst, K van Leeuwen, P van der Zandt: Priority setting for existing chemicals: The European Union risk ranking method (EURAM). Document ECB 4/02/98 Tyle, H, HS Larsen, EB Wedebye, D Sijm, T Pedersen Krog, J Niemelä: Identification of potential PBTs and vPvBs by use of QSARs. Document SHC/TS 2-3/029, Copenhagen 2002-06-27, DK EPA