Guidance on Regulation (EU) No 10/2011 on plastic materials MOCA

Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain

This Guidance document is part of a series of documents to provide guidance on application of Regulation (EU) No 10/2011(1) on plastic materials and articles intended to come into contact with food (the "Plastics Regulation"). The series covers general guidance, guidance on migration testing, guidance on migration modelling and the present guidance on information in the supply chain.

This Guidance document covers information to be generated and exchanged in the supply chain, as required in the context of compliance with the Plastics Regulation. Specifically, this Guidance document addresses:

- the aim of the Declaration of Compliance ("DoC");
- the DoC for plastic materials and articles, products from intermediate stage of their manufacturing and substances intended for the manufacturing of those materials and articles – set out in Article 15 and Annex IV of the Plastics Regulation;
- Adequate information on coatings, adhesives and inks ('non-plastic intermediates") which become part of plastic materials and articles (hereinafter "Adequate Information"). Recital 30 of the "Plastics Regulation" explains the reasoning behind the "Adequate Information": "…, for coatings, printing inks and adhesives to be used in plastic materials and articles, "Adequate Information" should be provided to the manufacturer of the final plastic article that would enable him to ensure compliance for substances for which migration limits have been established in this Regulation."

The Guidance document therefore contains recommendations for this information to be provided, even if it has not been harmonised at EU level.

This Guidance document also explains the link of the DoC with the Regulation (EC) No 1935/2004(2) on materials and articles intended to come into contact with food (the "Framework Regulation") and Regulation (EC) No 2023/2006(3) on good manufacturing practice for materials and articles intended to come into contact with food (the "GMP Regulation"). This Guidance document is based on the current understanding of the Commission Services on the availability of a DoC at all marketing stages, except the retail stage, as provided for in Article 15(1) of the Plastics Regulation.

The Guidance document will be updated in case the provisions of the Plastics Regulation are amended, in order to improve clarity, consistency and applicability. It should be noted that this Guidance document does not elaborate on the DoC for materials and articles already in contact with food, such as packaging. Where appropriate, this Guidance document mentions certain aspects related to supporting documents, to the labelling provisions of the Framework Regulation or to documentation requirements under the GMP. However, it does not aspire to cover these topics in depth (See box on page 6).

The competent authorities of Member States can also request documentation on the food contact material of packaged food based on Article 10 of Regulation (EC) No 882/20044 on official controls to ensure the verification of compliance with feed and food law (the "Control Regulation"). Certain Member States have set out national requirements for the DoC for other materials. These are not subject of this Guidance document, but need to be respected in cases where national law is applicable.

(1) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
(2) Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
(3) Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ L 384, 29.12.2006, p. 75).
(4) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 191, 28.5.2004, p. 1).

Version History	Version Date	Change
1.0	28.11.2013	original version
1.1*	12.01.2016	information update on this title page

* Translated versions have not been updated

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