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The Plastic Materials and Articles in Contact with Food (England) Regulations 2006

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The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 STATUTORY INSTRUMENTS 2006 No. 1401 FOOD, ENGLAND The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 Made - - - - - 23rd May 2006 Laid before Parliament 2nd June 2006 Coming into force - - 30th June 2006 £12.00 STATUTORY INSTRUMENTS 2006 No. 1401 FOOD, ENGLAND The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 Made - - - - 23rd May 2006 Laid before Parliament 2nd June 2006 Coming into force - - 30th June 2006 CONTENTS PART 1 Preliminary 1. Title, application and commencement 3 2. Interpretation 3 PART 2 Requirements for Materials and Articles 3. Restriction on the use, sale or import of plastic materials and articles 5 4. Restriction on the use of monomers in the manufacture of plastic materials and articles 5 5. Restriction on the use of additives in the manufacture of plastic materials and articles 6 6. Required standard for non-migration of constituents of monomers 6 7. Required standard for non-migration of constituents of additives 7 8. Required standard for products obtained by bacterial fermentation 7 9. Required standards relating to overall migration limits 7 10. Required standard for non-migration of primary aromatic amines 8 11. Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis 8 12. Labelling 8 13. Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE) 9 PART 3 Execution and Enforcement 14. Enforcement 9 15. Offences and Penalties 10 16. General defences 10 17. Transitional defences and savings 11 18. Procedure where a sample is to be analysed 12 19. Secondary analysis by the Government Chemist 12 PART 4 Application for Authorisation 20. Applications for inclusion of an additive in the Community list of authorised additives 13 PART 5 General and Supplementary 21. Application of provisions of the Act 13 22. Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990 13 23. Amendments to the Materials and Articles in Contact with Food (England) Regulations 2005 13 24. Revocations 14 SCHEDULE 1 — Authorised Monomers 14 PART 1 — List of Monomers with Restrictions and Specifications 15 PART 2 — Supplementary 29 SCHEDULE 2 — Authorised Additives 31 PART 1 — Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (not being Additives to which Paragraph 5 of Part 3 of this Schedule Applies) 32 PART 2 — Incomplete List of Additives Used in the Manufacture of Plastic Materials and Articles (Being Additives to which Paragraph 5 of Part 3 of this Schedule Applies) 45 PART 3 — Supplementary 51 SCHEDULE 3 — Products Obtained by Bacterial Fermentation 53 SCHEDULE 4 — Specifications 54 SCHEDULE 5 — Applicable Provisions when Testing Compliance with the Migration Limits 56 SCHEDULE 6 — Overall and Specific Migration Testing Using Food Simulants 59 PART 1 — Basic Rules 60 PART 2 — Food Simulants to be used in Migration Testing 60 PART 3 — Selection of Food Simulants 62 PART 4 — Simulants to be used in relation to a Specific Food or Group of Foods 64 PART 5 — Migration Test Conditions (Times and Temperatures) 68 PART 6 — Substitute Fat Test for Overall and Specific Migration 69 PART 7 — Alternative Fat Tests for Overall and Specific Migration 70 2 The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 16(2), 17(1) and (2), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990(a), and now vested in her(b). In accordance with section 48(4A) of that Act she has had regard to relevant advice given by the Food Standards Agency. As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(c), there has been open and transparent public consultation during the preparation and evaluation of these Regulations. PART 1 Preliminary Title, application and commencement 1. These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (England) Regulations 2006, apply in relation to England only and come into force on 30th June 2006. Interpretation 2.—(1) In these Regulations — “the Act” means the Food Safety Act 1990; “authorised officer” means any person, whether or not an officer of the enforcement authority, who is authorised by it in writing to act in matters arising under these Regulations; “BADGE” has the meaning given in Article 1(1)(a) of Regulation 1895/2005; “BFDGE” has the meaning given in Article 1(1)(b) of Regulation 1895/2005; “business” is to be construed in accordance with section 1(3) of the Act; “capable” means capable as established under regulation 11; “Directive 82/711” means Council Directive 82/711/EEC(d) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 97/48/EC(e); “Directive 85/572” means Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs(f); (a) 1990 c.16. (b) Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c. 28). Those functions, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46) as read with section 40(2) of the 1999 Act. Section 17(1) was amended by paragraph 12(a), section 17(2) by paragraph 12(b) and section 48 by paragraph 21, of Schedule 5 to the 1999 Act. (c) OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4). (d) OJ No. L297, 23.10.1982, p.26. (e) OJ No. L222, 12.8.1997, p.10. (f) OJ No. L372, 31.12.1985, p.14. 3 “Directive 88/388” means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(a); “Directive 89/107” means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption(b); “the Directive” means Commission Directive 2002/72/EC(c) relating to plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 2004/19/EC(d); “EEA State” means a Member State (other than the United Kingdom), Norway, Iceland and Liechtenstein; “EFSA” means the European Food Safety Authority; “enforcement authority” means an authority having responsibility under regulation 14 for executing and enforcing these Regulations; “food” is to be construed in accordance with section 16(5) of the Act; “good technical quality” means good technical quality as regards the purity criteria; “handling of food” means use in connection with the storage, preparation, packaging, sale or serving of food; “import” means import in the course of a business; “material or article” means a material or article falling within the definition of materials and articles in Article 1(2) of Regulation 1895/2005; “monomer” means any substance that is included for the purposes of the Directive among monomers and other starting substances; “NOGE” has the meaning given in Article 1(1)(c) of Regulation 1895/2005; “the 1998 Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1998(e); “the 2005 Regulations” means the Materials and Articles in Contact with Food (England) Regulations 2005(f); “plastic material or article” means anything which for the purposes of the Directive is included among those plastic materials and articles and parts thereof to which the Directive applies; “the Purity Directives” means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(g), Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs(h) and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners(i); “Regulation 1895/2005” means Commission Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food(j); “sell” includes offer or expose for sale or have in possession for sale, and “sale” shall be construed accordingly; (a) OJ No. L184, 15.7.1988, p.61. (b) OJ No. L40, 11.2.1989, p. 27. (c) OJ No. L220, 15.8.2002, p.18. (d) OJ No. L71, 10.3.2004, p.8. (e) S.I. 1998/1376, as amended in relation to England by S.I. 2000/3162, S.I. 2002/2364, S.I. 2002/3008, S.I. 2004/3113 and S.I. 2005/325. (f) S.I.2005/898. (g) OJ No. L178, 28.7.97, p.1, as last amended by Commission Directive 2004/46, OJ No.
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