Food Contact Materials Regulation EC 1935 2004

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Food Contact Materials,Regulation EC 1935 2004,European Implementation Assessment Study. On 16 July 2015 the coordinators for the European Parliament s Committee on Environment. Public Health and Food Safety requested authorisation to draw up an implementation report on. the Food Contact Materials Regulation EC No 1935 2004. This in house supporting study has been produced by the Ex Post Impact Assessment Unit of. the Directorate for Impact Assessment and European Added Value within the European. Parliament s Directorate General for Parliamentary Research Services It looks at the. implementation of the relevant legal framework regulating food contact materials at EU level. and Regulation EC No 1935 2004 in particular The research paper builds on stakeholders. perceptions of implementation as shared within a survey conducted by the Unit between. December 2015 and February 2016 We would like to express our gratitude to all stakeholders. who participated in the survey thus helping to underpin EU evidence based policy making in. the field of food safety, Food contact materials FCMs are widely used in everyday life in the form of food packaging. kitchen utensils tableware etc When put in contact with food the different materials may. behave differently and transfer their constituents to the food Thus if ingested in large. quantities FCM chemicals might endanger human health or change the food itself Therefore. food contact materials are subject to legally binding rules at EU level currently laid down in. Regulation EC No 1935 2004 which aims at ensuring FCM safety but also the effective. functioning of the internal market in FCM goods, The regulation sets up a general safety requirement applicable to all possible food contact. materials and articles and envisages a possibility for the adoption of specific safety. requirements i e further harmonisation at EU level for seventeen FCMs listed in Annex I to. Regulation EC No 1935 2004 So far specific safety requirements have been adopted only for. four FCMs plastics including recycled plastics ceramics regenerated cellulose and so called. active and intelligent materials Where specific requirements have not been adopted at EU level. Member States could adopt such measures at national level which is the case for several widely. used FCMs such as paper board metals alloys glass coatings silicones rubbers printing. However as reported by the majority of stakeholders participating in this survey the lack of. specific measures at EU level for some food contact materials articles negatively impacts the. functioning of the internal market for the relevant material article and its food safety. Stakeholders across businesses consumers environmental and health NGOs researchers as. well as Member States competent authorities are in favour of specific measures at EU level for. the FCMs that are not yet harmonised at EU level,EPRS European Parliamentary Research Service. Ekaterina Karamfilova Ex Post Impact Assessment Unit with Martin. Sacher Ex Post Impact Assessment Unit, Giulio Sabbati Publications Management and Editorial Unit graphics.
ABOUT THE PUBLISHER, This paper has been drawn up by the Ex Post Impact Assessment Unit of. the Directorate for Impact Assessment and European Added Value within. the Directorate General for Parliamentary Research Services of the. Secretariat of the European Parliament,To contact the Unit please email. EPRS ExPostImpactAssessment ep europa eu,LINGUISTIC VERSIONS. Original EN,This document is available on the internet at. http www europarl europa eu thinktank,DISCLAIMER, The content of this document is the sole responsibility of the author and.
any opinions expressed therein do not necessarily represent the official. position of the European Parliament It is addressed to the Members and. staff of the EP for their parliamentary work Reproduction and translation. for non commercial purposes are authorised provided the source is. acknowledged and the European Parliament is given prior notice and sent. Manuscript completed in April 2016 Brussels European Union 2016. PE 581 411,ISBN 978 92 823 9173 0,DOI 10 2861 162638. CAT QA 01 16 462 EN N,PE 581 411 2,Food Contact Materials Regulation EC No 1935 2004. Table of Contents,Executive summary 8,Introduction 11. 1 The EU food contact materials FCM policy legal framework 13. 1 1 Framework Regulation EC No 1935 2004 and relevant legal acts 13. 1 1 1 Key objectives 13,1 1 2 Scope of application 13. 1 1 3 General safety requirements at EU level 14, 1 1 4 Specific safety requirements further harmonisation at EU level 15.
1 1 5 Labelling 19, 1 1 6 Traceability of food contact materials and articles and relevant. compliance documentation declarations of compliance 19. 1 1 7 Inspections control measures and sanctions 20. 1 1 8 Safeguard measures 21, 1 2 Other sources of rules for food contact materials 21. 2 Methodology 23,2 1 Data collection and processing 23. 2 2 Identification and selection of relevant stakeholders 25. 2 2 1 Identification of relevant stakeholders 25,2 2 2 Selection of relevant stakeholders 25. 2 2 2 1 Selection of stakeholders with legal obligations under Regulation. EC No 1935 2004 25, 2 2 2 2 Selection of stakeholders with legitimate interest in the.
achievement of the market and safety objectives of Regulation EC. No 1935 2004 26, 2 3 Representativeness of relevant stakeholders 26. 2 3 1 Representativeness of the stakeholders with legal obligations under. Regulation EC No 1935 2004 27, 2 3 2 Representativeness of stakeholders with legitimate interest in the. achievement of the market and safety objectives laid down in. Regulation EC No 1935 2004 29, 3 Key findings stakeholders perception and assessment of food contact. materials implementation reality 30,3 1 Assessment of current EU FCM rules 30. 3 1 1 Assessment of the current EU FCM policy objectives and instruments. checking Relevance and Coherence 30, 3 1 2 Assessment of the scientific basis on which EU food contact materials.
rules are being adopted checking Effectiveness Utility 36. 3 1 3 Mapping and assessing the state of play as regards EU specific. measures under Article 5 1 of Regulation EC No 1935 2004. checking Relevance Effectiveness Utility 44, 3 1 4 Mapping and assessing current rules on good manufacturing practice. and related documents declarations of compliance checking. Effectiveness 57, 3 2 Assessment of the implementation of current EU FCM rules 60. PE 581 411 3,European Implementation Assessment, 3 2 1 Assessment of the implementation of good manufacturing practices. and related documents declarations of compliance checking. Effectiveness and Efficiency 60, 3 2 2 Assessment of compliance and enforcement costs generated by the. implementation of relevant FCM rules checking Efficiency 65. 3 2 3 Assessment of compliance and enforcement control activities and. cooperation between relevant stakeholders checking. Effectiveness Efficiency Utility 70,3 2 4 General implementation assessment 77.
4 Identification of major implementation problems and stakeholders key. recommendations Final implementation assessment 96. 4 1 Problems inherent to the current EU FCM rules Stakeholders key. recommendations 96, 4 1 1 Problems inherent to the current EU FCM rules 96. 4 1 2 Stakeholders key recommendations 98, 4 2 Problems inherent to the implementation of existing EU FCM rules. Stakeholders key recommendations 103,4 2 1 Traceability of FCMs 103. 4 2 2 Controls of food contact materials 104,4 3 Final implementation assessment 106. 4 3 1 Assessment against the set of key assessment criteria for evaluations. relevance coherence European added value effectiveness and. efficiency 106, 4 3 2 Assessment against additional assessment criteria utility and.
complementarity 107,5 Conclusions 108,6 Bibliography 111. Annex I 117,Annex II 135,PE 581 411 4,Food Contact Materials Regulation EC No 1935 2004. List of figures, Figure 1 EU legislation on food contact materials 16. Figure 2 Stakeholders final implementation assessment 107. List of graphs, Graph 1 Stakeholders participating in the survey 27. Graph 2 FCM candidates for further harmonisation at EU level 57. Graph 3 Businesses assessment of compliance costs by level of the cost source 66. PE 581 411 5,European Implementation Assessment,List of abbreviations.
bw body weight, BADGE bisphenol A diglycidyl ether also abbreviated as BPA. BFDGE bisphenol F diglycidyl ether also abbreviated as BPFNOGE novolac glycidyl. CEN European Committee for Standardization, CMR substances that are carcinogenic mutagenic or toxic for reproduction. CoE Council of Europe,COM European Commission,DA delegated act. DoC declaration of compliance under Article 16 of Regulation EC No 1935 2004. DG SANTE European Commission Directorate General for Health and Food Safety. EDCs endocrine disrupting chemicals,EFSA European Food Safety Authority EU Agency. ENVI Committee of the European Parliament on Environment Public Health and Food. EP European Parliament, ESCO Scientific Cooperation Projects EFSA s ESCO Working Group on non plastic food.
contact materials,EC European Community,EU European Union. EU RL FCM European Union Reference Laboratory for Food Contact Materials. FCM s food contact material s, FDA Food and Drugs Authority of the United States of America. FVO DG SANTE Directorate Health and Food Audit and Analysis ex Food and. veterinary office FVO,GMP good manufacturing practice. IIA interinstitutional agreement, ISO International Organization for Standardization. JRC Joint Research Centre of the European Commission. LWP lightweight packaging,MEP Member of the European Parliament.
MMM multilayer multi materials,PE 581 411 6,Food Contact Materials Regulation EC No 1935 2004. NIASs non intentionally added substances, ORPI oligomers reaction and degradation products and impurities. PEMSAC Platform of European Market Surveillance Authorities in Cosmetics. PET PETE polyethylene terephthalate, PBTs persistent bio accumulative and toxic substance s. vPvBs very persistent and bio accumulative,PFCs perfluorinated compounds. ppm parts per million,ppb parts per billion,PVC Polyvinyl chloride.
REACH registration evaluation authorisation and restriction of chemicals under. Regulation EC No 1907 2006,R D research and development. REFIT Regulatory Fitness and Performance Program of the European Commission. SVHC substances of very high concern,SMEs small and middle size enterprises. TPE thermoplastic elastomers, TFEU Treaty on the Functioning of the European Union. PE 581 411 7,European Implementation Assessment,Executive summary. Food contact materials FCMs are widely used in everyday life in the form of food. packaging kitchen utensils tableware etc When put in contact with food and depending. on their composition and properties the different materials may behave differently and. transfer their constituents to the food Thus if ingested in large quantities FCM. chemicals might endanger human health or change the food itself Therefore since 1976. food contact materials have been subject to legally binding rules at EU level The main. objectives of EU FCM policy are to ensure the effective functioning of the internal market. of FCM goods and to secure a high level of protection of human health and the interests. of consumers, The current EU FCM legal framework lays down a general safety requirement aimed at.
ensuring that the substances migrating from the material into the food do not endanger. human health or change the food itself This general safety requirement applies to all. possible food contact materials articles The possibility for adoption of specific safety. requirements specific measures for individual food contact materials 1 i e further. harmonisation at EU level does exist However so far only a few specific measures. such as for plastics and ceramics for example have been adopted at EU level Specific. safety requirements are by nature implementing measures therefore the existence or. absence of EU specific measures for some food contact materials directly impacts the. implementation of the general safety requirement mentioned above and the achievement. of market and safety objectives In particular the lack of EU specific measures for some. FCMs leaves the possibility for EU Member States to adopt such measures at national. level which as revealed by this study creates internal market barriers without. necessarily securing FCM safety, This in house European Implementation Assessment summarises the results of a. stakeholders survey conducted by the EPRS Ex Post Impact Assessment Unit between. December 2015 and February 2016 It aims to assess the implementation of existing EU. FCM rules and in particular framework Regulation EC No 1935 2004 thus. supporting the work of the European Parliament s Committee on Environment Public. Health and Food Safety on a dedicated Implementation Report on that legislation. Based on stakeholders perceptions problems inherent to the EU FCM legal framework. itself and to the implementation of relevant rules were identified. For a large majority of stakeholders across almost all categories the current legal. framework regulating food contact materials at EU level is not complete The lack of. Food Contact Materials Regulation EC 1935 2004 European Implementation Assessment Study On 16 July 2015 the coordinators for the European Parliament s Committee on Environment Public Health and Food Safety requested authorisation to draw up an implementation report on the Food Contact Materials Regulation EC No 1935 2004 This in house supporting study has been produced by the Ex Post

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