Declaration of Compliance

What is a Declaration of Compliance?

A declaration of compliance (DoC) is a written or electronic document that is an important tool for checking if a plastic article meets the requirements of Regulation (EU) No. 10/20111 and Regulation (EC) No. 1935/20042.

The purpose of this document is to ensure that each step in the production chain takes responsibility for product compliance as far as possible and passes on any information required so the next link in the chain can continue to guarantee compliance. Within the production chain, it is important for each step to know exactly what is required from the previous step. This helps contribute to overall compliance with legislative requirements.

Declaration of compliance vs test report

A DoC can be issued only with information on the product for which it is issued. This information includes all compliance tasks carried out by the business operator issuing the DoC, as reflected in the supporting documents.

In accordance with Article 16 of Regulation (EU) No. 10/2011, supporting documents “shall include the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance”.

Supporting documents

Supporting documents are generated and updated by the business operator issuing the DoC and are not intended to be sent throughout the supply chain. They should be delivered to the competent national authorities upon request. The DoC received by the business operator from the supplier will form part of its compliance tasks, as well as other information such as product test results.

What information does a DoC include?

In order to facilitate the work of business operators when drawing up the DoC, Annex IV of Regulation (EU) No. 10/2011 provides details on the information to be included. The European Union also publishes guidelines on information in the supply chain3, which aim to address the exchange of information in the supply chain on the requirements for compliance with Regulation (EU) No. 10/2011.
Article 15, Section 1 of Regulation (EU) No. 10/2011 establishes the general obligation that “at the marketing stages other than at the retail stage, a written declaration […] shall be available”. Moreover, the supplier of intermediate materials that do not include plastic, such as inks, coatings and adhesives, are not obliged to deliver a DoC unless required by national legislation, given that there is no harmonized EU requirement. However, suppliers are recommended to provide clients with suitable information.
The latest amendment of Regulation 10/2011, Regulation (EU) 2020/12454, also includes changes in the DoC. It amends Section 6 of Annex IV of this regulation to specify that the amount of limited substances in accordance with Annex II must be included in the DoC:

“(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
At intermediate stages, this information shall include the identification and amount of substances in the intermediate material:
— that are subject to restrictions in Annex II, or
— 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 a migration from the final material exceeding 0.00015 mg/kg food or food simulant.”

It is worthy of note that the Directorate-General for Health and Food Safety (DG SANTE) provides guidelines so that this information is applied to Non-Intentionally Added Substances (NIAS).

A DoC template will be established in future amendments of the plastics regulation to ensure that everyone is working with the same digital format.

AIMPLAS provides assistance and test services for materials and plastic articles intended to come into contact with food.

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

(2) Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food.

(3) https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_es.pdf

(4) COMMISSION REGULATION (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.