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RulesOf.EU
Regulation (EU) No 10/2011 · Annex IV ·Applies since 1 May 2011

What a plastic food-contact material declares to the business it is sold to

At every marketing stage except retail, a plastic material or article intended to come into contact with food must be accompanied by a written declaration of compliance. Article 15 of Regulation (EU) No 10/2011 requires it; Annex IV says what it contains — eleven numbered points and no form. This free tool assembles those eleven points in each of the 22 languages, in the Regulation's own wording. It does not test your material, and it does not decide whether it complies.

Which materials are covered

Annex IV binds plastics, and nothing on this page reaches any other material. Article 2 draws the line, and these are its words rather than a summary of them.

This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:

  • materials and articles and parts thereof consisting exclusively of plastics;
  • plastic multi-layer materials and articles held together by adhesives or by other means;
  • materials and articles referred to in points a) or b) that are printed and/or covered by a coating;
  • plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
  • plastic layers in multi-material multi-layer materials and articles.

This Regulation shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:

  • ion exchange resins;
  • rubber;
  • silicones.

This Regulation shall be without prejudice to Union or national provisions applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles.

Three Regulations carry a declaration under Article 16 of Regulation (EC) No 1935/2004, and they do not all work the same way. Two prescribe content — a numbered list of what the declaration must say, with no form to follow: Regulation (EU) No 10/2011 for plastics, and Regulation (EC) No 450/2009 for active and intelligent materials. The third prescribes a form — Regulation (EU) 2022/1616 for recycled plastic, whose Annex III is a template with numbered sections, boxes to tick and a signature block. This page is the first: what you produce below is a content list, and its layout is yours.

Other food-contact materials have their own specific measures and their own declaration requirements — ceramics under Directive 84/500/EEC, regenerated cellulose film under Directive 2007/42/EC, active and intelligent materials under Regulation (EC) No 450/2009. This page is not any of those. Recycled plastic is a different case and a common confusion: it is NOT outside this Regulation. Regulation (EU) 2022/1616 adds rules for it on top, and points 10 and 11 below are where recycling appears in this declaration.

What the declaration is issued for

What Annex IV requires

Annex IV fixes the content and nothing else. Everything below is the Regulation's own wording with your answer beside it, in the order the annex prints it. Items marked as applying only in a stated case are not counted.

The written declaration referred to in Article 15 shall contain the following information:

the identity and address of the business operator issuing the declaration of compliance;

the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;

the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;

the date of the declaration;

confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;

adequate information allowing the downstream business operators to ensure compliance with this Regulation relative to the substances used for which restrictions and/or specifications are set out in Annexes I and II, including adequate information on the presence of non-intentionally added substances if present in an amount that could cause non-compliance of a final material with Article 3 of Regulation (EC) No 1935/2004.

At intermediate stages, this information shall include the identification and amount of the following substances contained in the intermediate material:

substances that are subject to restrictions and/or specifications in Annex II, or

substances for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to an individual migration into food from the final plastic material or article exceeding 0,00015 mg/kg food;

adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;

specifications on the use of the material or article, such as:

type or types of food with which it is intended to be put in contact;

time and temperature of treatment and storage in contact with the food;

the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 or equivalent information;

when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation;

when the plastic material is a batch of material intended for reprocessing:

the confirmation that it complies with Articles 10(1) and 10(2) of this Regulation and that it has been collected and used in accordance with point C of the Annex to Regulation (EC) No 2023/2006; and

as appropriate, a specification of its composition and instructions for reprocessing;

when the plastic material has been manufactured with one or more substances included in the Union list of authorised substances in accordance with Article 5 of this Regulation that have been manufactured from waste, a confirmation that the substances used are compliant with point (1) of Article 8 of this Regulation.

The declaration

Annex IV prescribes content, not a form. Article 16 of Regulation (EC) No 1935/2004 requires the written declaration and says nothing about what it looks like; this Regulation's Annex IV lists eleven things it must contain. So there is no model to reproduce here: no numbered boxes, no unique identification code, no signature block, no notified body and no CE marking — the CE marking does not exist in food-contact law. What you produce below is a document carrying eleven pieces of information, and its layout is yours.

Four of the eleven are conditional, in the act's own words. Point 9 applies when a functional barrier is used in a multi-layer material or article; point 10 when the plastic material is a batch intended for reprocessing; point 11 when it was manufactured with substances made from waste. Point 8's three sub-items are introduced by “such as”. Leaving those empty when they do not apply is correct, and the counter beside the document does not count them.

Who it goes to, and when it has to be renewed. Article 15(1) makes the declaration available at the marketing stages other than at the retail stage — it is a document between businesses, not something handed to a shopper. Article 15(3) requires it to permit easy identification of what it covers, and to be RENEWED when substantial changes in composition or production bring about changes in migration, or when new scientific data becomes available. A declaration issued once and never revisited is the ordinary way this obligation is failed.

What is not here. Article 16 requires supporting documentation — the experiments, calculations and evidence behind what you declare — to be made available to the competent authority on request. That is a separate obligation from this document, and no generator can produce it: it is your test data.