EU Declaration of Compliance (DoC) for Food Contact Materials Guide

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Issuing a Declaration of Compliance (DoC) is mandatory when importing plastic food contact materials in the European Union. Notice that this also includes products containing plastic parts, such as stainless steel bottles, or plastic composite materials.

In this guide, we explain how importers can issue a Declaration of Compliance (DoC).

Note: The FCM Declaration of Compliance (DoC) is not the same as the Declaration of Conformity (DoC) required for products covered by one or more “CE marking directives”. You can read more about the CE Declaration of Conformity in this article.

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What is a Declaration of Compliance (DoC)?

The Declaration of Compliance is a self-issued document stating certain information about a food contact material or food contact products. This information is generally included:

  • Importer/Manufacturer
  • Product name
  • List of materials/components
  • Statement declaring that the product is compliant with certain regulations
  • Information about the substances
  • Types of food the material is made for contact with
  • Time and temperature
  • Information about the test methods

The purpose of the DoC is to demonstrate that the product is fully compliant with certain regulations and specify the testing methods applied to prove this. Ultimately it comes down to demonstrating that your food contact product is safe and doesn’t contain or transfer restricted chemicals or heavy metals.

The FCM Declaration of Compliance may be provided to retailers, customers, customs authorities, or market surveillance authorities.

Plastic FCM

Which products require a Declaration of Compliance (DoC)?

The Declaration of Compliance is mandatory for all plastic food contact materials, such as food packaging and lunch boxes. That said, many food contact products, such as stainless steel water bottles, also have plastic components. As such, a DoC is often required for any food contact product containing plastics – including composites.

Product Examples

Declaration of Compliance (DoC) Example

(1) The identity and address of the business operator issuing the declaration of compliance

(2) the identity and address of the business operator which imports the product

(3) the identity of the materials, the articles, products:

(4) the date of the declaration;

(5) Declaration of Compliance

(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;

(7) 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;

(8) Usage

a. Types of food (which the product is made to be in contact with)

b. Time and Temperature

c. Ratio of food contact surface area to the volume used to establish the compliance of
the material or article

(9) Functional Barrier

Source: 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 (Link)

Do I need a lab test report before I can issue the DoC?

Yes, you must specify the testing methods in the Declaration of Compliance. Further, you also need to provide information about material substances. Unless you have your own in-house lab, which only large companies do, you must obtain a lab test report before you can issue the DoC.

Further, you must also declare which EU FCM regulations the product is compliant with. Our recommendation is that you ask a test company to make that assessment for you.

Here are some companies offering EU FCM lab testing services:

  • QIMA
  • Intertek
  • TUV
  • SGS

Can I get a DoC from the manufacturer?

Most plastic food contact products are manufactured in Mainland China. In our experience, few (if any) Chinese FMC manufacturers can provide ready-made DoCs. This doesn’t necessarily mean that their products are non-compliant – only that they are not EU compliance experts.

As always, it’s the importer’s responsibility to issue the Declaration of Compliance when procuring food contact products.

What can happen if I don’t have a Declaration of Compliance?

In my experience, it’s often retailers that request the Declaration of Compliance from importers or manufacturers. Hence, you cannot sell your product to retail chains and stores without a Declaration of Compliance.

That said, it’s also possible that the customs authorities may check your goods, or that national market surveillance authorities may issue a forced recall – meaning that you cannot sell your product.

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
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