The Plastic Materials and Articles in Contact with Food (Wales) (No.2) Regulations 2008

1. Introductory Text

2. PART 1 Preliminary

   1. 1. Title, application and commencement

   2. 2. Interpretation

3. PART 2 Requirements for Materials and Articles

   1. 3. Restriction on the use, sale or import of plastic materials and articles

   2. 4. Restriction on the use of monomers in the manufacture of plastic materials and articles

   3. 5. Restriction on the use of additives in the manufacture of plastic materials and articles

   4. 6. Required standard for non-migration of constituents of monomers

   5. 7. Required standard for non-migration of constituents of additives

   6. 8. Required standard for products obtained by bacterial fermentation

   7. 9. Required standards relating to overall migration limits

   8. 10. Required standard for non-migration of primary aromatic amines

   9. 11. Required standard relating to plastic multi-layer materials and articles

   10. 12. Provisions relating to the use of certain epoxy derivatives (BADGE, BDGE and NOGE)

   11. 13. Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis

   12. 14. Labelling and documentation

4. PART 3 Execution and Enforcement

   1. 15. Enforcement

   2. 16. Offences and Penalties

   3. 17. Offences by corporate bodies or Scottish partnerships

   4. 18. Time limit for prosecutions

   5. 19. Offences due to the act or default of a third party

   6. 20. Defence of exercising due diligence etc.

   7. 21. Transitional defence relating to PVC gaskets containing epoxidised soybean oil

   8. 22. Other transitional defences and savings

   9. 23. Procedure where a sample is to be analysed

   10. 24. Secondary analysis by the Government Chemist

5. PART 4 Application for Authorisation

   1. 25. Applications for inclusion of an additive in the Community list of authorised additives

6. PART 5 General and Supplementary

   1. 26. Application of provisions of the Act

   2. 27. Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

   3. 28. Amendments to the Materials and Articles in Contact with Food (Wales) Regulations 2007

   4. 29. Amendment of the Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Wales) Regulations 2008

   5. 30. Revocations

7. Signature

8. 1. SCHEDULE 1

      Supplementary provisions relating to Annexes II and III

      1. 1. In Sections A and B of Annexes II and III...

      2. 2. If a substance appearing in the Annexes as an individual...

      3. 3. (1) The items identified in Section A or B of...

      4. 4. In the case of substances listed in Section B of...

      5. 5. Where an entry in column 4 of the Annexes (restrictions...

   2. SCHEDULE 2

      Provisions Applicable when Testing Compliance with the Migration Limits

      1. 1. General Provisions

      2. 2. Where any migration test specified in this Schedule and, where...

      3. 3. (1) Subject to sub-paragraph (2), any testing of migration from...

      4. 4. (1) Any sample of plastic material or article must be...

      5. 5. Where a plastic material or article is intended to come...

      6. 6. Special provisions relating to the fat reduction factor

      7. 7. (1) Correction by the FRF may not be used —...

      8. 8. If use of the FRF under paragraph 6 or 7(2)...

      9. 9. Special provisions relating to the correction of specific migration in simulant D

      10. 10. Special provisions relating to overall migration

      11. 11. (1) Where a plastic material or article is intended to...

      12. 12. (1) Any plastic material or article which exceeds its overall...

      13. 13. Special provisions relating to caps, lids, gaskets, stoppers and similar sealing articles

   3. SCHEDULE 3

      Overall and Specific Migration Testing Using Food Simulants

      1. PART 1 Basic Rules

         1. 1. Subject to paragraphs 2, 3 and 4 of this Part,...

         2. 2. Subject to paragraphs 3 and 4 of this Part, substitute...

         3. 3. Subject to paragraph 4 of this Part, alternative tests as...

         4. 4. In migration testing it is permissible to—

      2. PART 2 Food Simulants to be used in Migration Testing

         1. 1. Subject to Parts 3, 4, 5 and 7, the simulants...

         2. 2. For the purposes of this Schedule a reference to an...

         3. 3. The characteristics of rectified olive oil referred to in the...

         4. 4. The fatty food simulants referred to in the Table are...

         5. 5. Where a fatty food simulant specified in paragraph 4 is...

      3. PART 3 Selection of Food Simulants

         1. 1. Testing, reduction factors and definition of food types

         2. 2. (1) Where a test is carried out on a plastic...

         3. 3. Food types are defined in Table 1 below as follows...

         4. 4. Selection of simulants for testing materials and articles intended for contact with all food types

         5. 5. Selection of simulants for testing materials and articles which are already in contact with a known food

         6. 6. Selection of simulants for testing materials and articles which are accompanied by a specific indication

         7. 7. The simulant or simulants to be used in testing a...

         8. 8. A specific indication referred to in paragraph 7 is expressed...

      4. PART 4 Simulants to be used in relation to a Specific Food or Group of Foods

         1. 1. For the purposes of this Schedule a simulant is specified...

         2. 2. For the purposes of this Part —

         3. 3. Where a reduction factor is specified in the Table in...

         4. 4. (1) Where the letter “a” is shown in brackets after...

         5. 5. Where a food is listed in the Table under both...

      5. PART 5 Migration Test Conditions (Times and Temperatures)

         1. 1. General criteria

         2. 2. Where the plastic material or article being tested is intended...

         3. 3. For the purposes of this Part the worst foreseeable conditions...

         4. 4. Volatile migrants

         5. 5. Special cases

         6. 6. Where the carrying out of a migration test under contact...

         7. 7. Where, in actual use, the plastic material or article being...

         8. 8. The Table to this Part must be read with the...

      6. PART 6 Substitute Fat Test for Overall and Specific Migration

         1. 1. Subject to paragraphs 2, 4 and 5, all the test...

         2. 2. Test conditions other than those specified in the Table to...

         3. 3. For each test— (a) a new test specimen must be...

         4. 4. Where carrying out a migration test causes any physical or...

         5. 5. Any test conditions in the Table to this Part which...

         6. 6. The Table to this Part must be read with the...

      7. PART 7 Alternative Fat Tests for Overall and Specific Migration

         1. 1. Subject to paragraph 2 of this Part the conditions which...

         2. 2. The condition in sub-paragraph (a) of paragraph 1 does not...

         3. 3. The migration tests referred to in paragraphs 2 and 3...

   4. SCHEDULE 4

      Information to be contained in a declaration of compliance

      1. 1. The name and address of the business operator which manufactures...

      2. 2. The identity of the materials, articles or substances intended for...

      3. 3. The date of the declaration.

      4. 4. Confirmation that the plastic materials or articles meet the relevant...

      5. 5. Adequate information relating to the substances used for which restrictions...

      6. 6. Adequate information relating to the substances which are subject to...

      7. 7. Specifications on the use of the plastic material or article,...

      8. 8. Confirmation, when a plastic functional barrier is used in a...

9. Explanatory Note