EU Declaration of Compliance for plastic food contact materials

Published October 27, 2022

Paula Hirsilä

Paula Hirsilä – MSc, chemistry

LinkedIn

Food contact and packaging materials, Measurlabs

paula.hirsila@measurlabs.com

The Declaration of Compliance (DoC) is a document that illustrates a food contact material’s compliance with the relevant EU regulations. The purpose of the declaration is to demonstrate that all the necessary testing has been performed with satisfactory results – and that the material has thus been found safe. With regard to plastic materials, the required testing procedure and the requirements for the DoC are described in regulation (EU) No 10/2011, also known as the Plastics Regulation. 

Measurlabs provides all the food contact material testing services that are required for writing the DoC. Our testing experts also offer consultation on the topic of compliance. The first meeting is free of charge.

When is a Declaration of Compliance required?

Article 15 of the EU Plastics Regulation states that a Declaration of Compliance should be made available at every stage of marketing, except when selling the finished product to a consumer. This means that each business entity within the production chain has to provide the declaration to its direct customers down the chain. In addition, the declaration has to be provided to relevant authorities upon request.

Here are some examples of situations where the declaration is required: 

  • A raw material manufacturer produces chemicals that are used in the production of plastic food contact materials – the DoC needs to be provided to manufacturers that use these substances to make intermediate plastic materials.

  • A manufacturer produces intermediate materials, such as plastic films, powders, or granules – the DoC needs to be provided to the producers of finished food contact articles. 

  • A manufacturer makes finished food contact products, such as plastic bottles, lunch boxes, or packaging  – the DoC needs to be provided to the users, distributors, and retailers of the product. 

In the example above, the term user refers to a business operator that puts food in contact with the material. This includes, for example, food manufacturers, restaurants, and bakeries. 

Plastic packaging supply chain
Manufacturers within the production chain have to provide the DoC to their direct customers.

Providing the Declaration of Compliance at every step of the production chain ensures that each business operator has sufficient information on the composition of the substance or material that they use in their operations. This is key to ensuring the safety and compliance of the finished food contact article.

What needs to be included in the DoC for plastic food contact materials?

Content requirements for the Declaration of Compliance are laid out in Annex IV of Regulation (EU) 10/2011. The requirements are summarized below:

  • Identity and address of the business operator issuing the declaration

  • Identity and address of the manufacturer or importer of the material

  • Description of the material

  • The date of the declaration

  • Confirmation that the plastic material or substance is compliant with all the relevant EU regulations

  • Information on the substances used in the production of the material, including their degradation products 

  • Information on the level of specific migration of restricted substances from the material to food

  • Specifications of use for the material (e.g. type of food, contact time, temperature)

  • For a multi-layer material with a functional barrier, a confirmation that the barrier prevents the migration of harmful substances into food

Supporting documents

The Declaration of Compliance needs to be backed up with evidence that proves the food contact material’s regulatory compliance. This evidence includes the results of overall and specific migration tests, as well as a description of the testing procedure. The supporting documents must be provided to the relevant authorities upon request.

How to get the Declaration of Compliance?

The Declaration of Compliance is a self-issued document. This means that the manufacturer of a plastic food contact material is responsible for writing the declaration in accordance with the rules set out in Regulation 10/2011.

If you are not sure where to start, our experts are happy to help with any concerns relating to the DoC. You can book a free 30-minute consultation with food contact material expert Paula Hirsilä through the link below: 

Book a meeting here

The meeting can be used to discuss the declaration in more detail or to plan a preliminary testing plan for your material. We offer a comprehensive range of testing services for food contact materials, including specific and overall migration testing, identification of non-intentionally added substances, and detection of heavy metals. 

References:

Regulation (EU) No 10/2011 (PDF)

Guidance on Regulation (EU) No 10/2011 (PDF)

Check out our food contact material testing services

We offer all the tests that are needed for writing the DoC