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Commission Regulation (EU) No 10/2011Show full title

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Subject matter

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Placing on the market of plastic materials and articles

  3. CHAPTER II COMPOSITIONAL REQUIREMENTS

    1. SECTION 1 Authorised substances

      1. Article 5.Union list of authorised substances

      2. Article 6.Derogations for substances not included in the Union list

      3. Article 7.Establishment and management of the provisional list

    2. SECTION 2 General requirements, restrictions and specifications

      1. Article 8.General requirement on substances

      2. Article 9.Specific requirements on substances

      3. Article 10.General restrictions on plastic materials and articles

      4. Article 11.Specific migration limits

      5. Article 12.Overall migration limit

  4. CHAPTER III SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES

    1. Article 13.Plastic multi-layer materials and articles

    2. Article 14.Multi-material multi-layer materials and articles

  5. CHAPTER IV DECLARATION OF COMPLIANCE AND DOCUMENTATION

    1. Article 15.Declaration of compliance

    2. Article 16.Supporting documents

  6. CHAPTER V COMPLIANCE

    1. Article 17.Expression of migration test results

    2. Article 18.Rules for assessing compliance with migration limits

    3. Article 19.Assessment of substances not included in the Union list

  7. CHAPTER VI FINAL PROVISIONS

    1. Article 20.Amendments of EU acts

    2. Article 21.Repeal of EU acts

    3. Article 22.Transitional provisions

    4. Article 23.Entry into force and application

  8. Signature

    1. ANNEX I

      Substances

      1. 1. Union list of authorised monomers, other starting substances, macromolecules obtained...

      2. 2. Group restriction of substances

      3. 3. Notes on verification of compliance

      4. 4. Detailed specification on substances

    2. ANNEX II

      Restrictions on materials and articles

      1. 1. Plastic materials and articles shall not release the following substances...

      2. 2. Primary aromatic amines which are not listed in Table 1...

    3. ANNEX III

      Food simulants

      1. 1. Food simulants

      2. 2. General assignment of food simulants to foods

      3. 3. Specific assignment of food simulants to foods for migration testing...

      4. 4. Food simulant assignment for testing overall migration

      5. 5. General derogation to the assignment of food simulants

    4. ANNEX IV

      Declaration of compliance

      1. The written declaration referred to in Article 15 shall contain...

      2. the identity and address of the business operator issuing the...

    5. ANNEX V

      COMPLIANCE TESTING

      1. CHAPTER 1 Testing for specific migration of materials and articles already in contact with food

        1. 1.1. Sample preparation

        2. 1.2. Conditions of testing

        3. 1.3. Analysis of migrated substances

        4. 1.4. Account of substances originating from other sources

      2. CHAPTER 2 Testing for specific migration of materials and articles not yet in contact with food

        1. 2.1. Verification method

          1. 2.1.1. Sample preparation

          2. 2.1.2. Choice of food simulant

          3. 2.1.3. Conditions of contact when using food simulants

          4. 2.1.4. Specific conditions for contact times above 30 days at room...

          5. 2.1.5. Specific conditions for combinations of contact times and temperature

          6. 2.1.6. Repeated use articles

          7. 2.1.7. Analysis of migrating substances

          8. 2.1.8. Verification of compliance by residual content per food contact surface...

        2. 2.2. Screening approaches

          1. 2.2.1. Replacing specific migration by overall migration

          2. 2.2.2. Residual content

          3. 2.2.3. Migration modelling

          4. 2.2.4. Food simulant substitutes

          5. 2.2.5. Single test for successive combinations of time and temperature

      3. CHAPTER 3 Testing for overall migration

        1. 3.1. Standardised testing conditions

        2. 3.2. Substitute overall migration tests for tests with food simulant D2...

        3. 3.3. Verification of compliance

          1. 3.3.1. Single use articles and materials

          2. 3.3.2. Repeated use articles and materials

        4. 3.4. Screening approaches

          1. 3.4.1. Residual content

          2. 3.4.2. Food simulant substitutes

      4. CHAPTER 4 Correction factors applied when comparing migration test results with migration limits

        1. 4.1. Correction of specific migration in foods containing more than 20 %...

        2. 4.2. Correction of migration into food simulant D2

        3. 4.3. Combination of correction factors 4.1 and 4.2.

    6. ANNEX VI

      Correlation tables

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