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

Issuing a Declaration of Compliance (DoC) is mandatory when importing and manufacturing certain food contact materials in the European Union. Notice that this also includes consumer products such as drinking bottles, cutlery, and individual components.

In this guide, we explain how you can determine if your specific food contact material or product requires a Declaration of Compliance, and what you must know before creating one.

Covered Regulations

• Plastic Materials Regulation ((EU) 10/2011)
• Use of Bisphenol A in Varnishes and Coatings Regulation ((EU) 2018/213)
• Active and Intelligent Materials Regulation ((EC) No 450/2009)
• Recycled Plastic FCM Regulation ((EC) No 282/2008)
• Ceramics Directive (84/500/EEC)
• Regenerated Cellulose Film Directive (2007/42/EC)
• Epoxy Derivatives Restriction Regulation ((EC) 1895/2005)
• FCM from China or Hong Kong Regulation ((EU) No 284/2011)

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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

What is the purpose of a Declaration of Compliance?

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.

Who may need to see our Declaration of Compliance?

The FCM Declaration of Compliance may be provided to retailers, customers, customs authorities, or market surveillance authorities. Notice that the specific contents required in the DoC differ depending on the applicable regulation.

Which products require a Declaration of Compliance (DoC)?

The Declaration of Compliance is mandatory for all plastic food contact materials that fall within Plastic Materials Regulation ((EU) 10/2011), 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

• Stainless steel water bottles
• Plastic lunch boxes
• Bamboo melamine composite plates
• Plastic food packaging

Other Food Contact Materials

Food contact materials that fall within the scope of the following regulations also require a Declaration of Compliance:

• Use of Bisphenol A in Varnishes and Coatings Regulation ((EU) 2018/213)
• Active and Intelligent Materials Regulation ((EC) No 450/2009)
• Recycled Plastic FCM Regulation ((EC) No 282/2008)
• Ceramics Directive (84/500/EEC)
• Regenerated Cellulose Film Directive (2007/42/EC)
• Epoxy Derivatives Restriction Regulation ((EC) 1895/2005)
• FCM from China or Hong Kong Regulation ((EU) No 284/2011)

Declaration of Compliance (DoC) Examples

The required information in your DoC depends on the applicable regulation or regulations. Here is an overview of DoC requirements for different EU FCM regulations. Notice that these examples may be outdated, so you need to check the latest version of the relevant FCM regulation on the EU website.

Plastic Materials Regulation ((EU) 10/2011)

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

2. 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;

3. 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;

4. the date of the declaration;

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

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. specifications on the use of the material or article, such as:
(i) type or types of food with which it is intended to be put in contact;
(ii) time and temperature of treatment and storage in contact with the food;
(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article;

9. 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.

Use of Bisphenol A in Varnishes and Coatings Regulation ((EU) 2018/213)

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

2. the identity and address of the business operator which manufactures or imports the coated material or article;

3. the identity of the varnished or coated material or article;

4. the date of the declaration;

5. confirmation that the varnish or coating applied to the material or article meets the restrictions laid down in Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;

6. specifications on the use of the coated material or article, such as:
(a) the type or types of food with which it is intended to be put into contact;
(b) the time and temperature of treatment and storage in contact with food;
(c) the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.

Active and Intelligent Materials Regulation ((EC) No 450/2009)

1. the identity and address of the business operator which issues the declaration of compliance;

2. the identity and address of the business operator which manufactures or imports the active and intelligent materials and articles, or the components intended for the manufacturing of those materials and articles, or the substances intended for the manufacturing of the components;

3. the identity of the active and intelligent materials and articles or the components intended for the manufacturing of those materials and articles, or the substances intended for the manufacturing of the components;

4. the date of the declaration;

5. the confirmation that the active or intelligent material or article complies with the relevant requirements laid down in this Regulation, Regulation (EC) No 1935/2004, and in specific Community measures applicable;

6. adequate information relative to the substances which constitute the components, for which restrictions are in place under the Community or national provisions applicable to food and this Regulation; where appropriate, specific purity criteria in accordance with the relevant Community legislation applicable to food and, the name and quantity of the substances released by the active component, to allow the downstream business operators to ensure compliance with those restrictions;

7. adequate information on the suitability and effectiveness of the active or intelligent material or article;

8. specifications on the use of the component, such as:
(i) the group or groups of materials and articles in which the component may be added to or incorporated into;
(ii) the conditions of use necessary to achieving the intended effect;

9. specifications on the use of the material or article, such as:
(i) the type or types of food intended to be put in contact with it;
(ii) the time and temperature of treatment and storage in contact with the food;
(iii) the ratio of food contact surface area to volume used to establish the compliance of the material or article;

10. when a functional barrier is used, the confirmation that the active or intelligent material or article complies with Article 10 of this Regulation.
The written declaration shall permit an easy identification of the active and intelligent materials and articles or the component or the substance for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration or when new scientific data are available.

Recycled Plastic FCM Regulation ((EC) No 282/2008)

PART A

Additional information in the declaration of compliance for recycled plastic materials and articles

The written declaration referred to in Article 12(1) shall contain the following additional information:

A declaration that only recycled plastic from an authorised recycling process has been used listing the EC Register number of the authorised recycling process.

PART B

Additional information in the declaration of compliance for recycled plastic

The written declaration referred to in Article 12(2) shall contain the following additional information:

1. The declaration that the recycling process has been authorised listing the EC Register number of the authorised recycling process;

2. The declaration that the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted;

3. The declaration that a quality assurance system according to Section B of Annex to Regulation (EC) No 2023/2006 is in place.

Ceramics Directive (84/500/EEC)

1. the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into the Community;

2. the identity of the ceramic article;

3. the date of the declaration;

4. the confirmation that the ceramic article meets relevant requirements in this Directive and Regulation (EC) No 1935/2004.
The written declaration shall permit an easy identification of the goods for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration of lead and cadmium.

Regenerated Cellulose Film Directive (2007/42/EC)

1. At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16(1) of Regulation (EC) No 1935/2004.

2. Paragraph 1 shall not apply to materials and articles made of regenerated cellulose film which by their nature are clearly intended to come into contact with foodstuffs.

Epoxy Derivatives Restriction Regulation ((EC) 1895/2005)

1. At the marketing stages other than the retail stages, materials and articles containing BADGE and its derivatives shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004.

2. Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities on demand.

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 SUD
• TUV Rheinland
• Eurofins
• SGS
• Bureau Veritas

How much does it cost to obtain a Declaration of Compliance?

It doesn’t necessarily cost anything to issue the Declaration of Compliance itself. However, as lab testing is often required when issuing a DoC, it means you need to factor in that cost.

You can also hire a consultant to draft a Declaration of Compliance for you. You should expect to pay at least 500 EUR per issued declaration.

Can I get a DoC from the manufacturer?

Most 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 FCM 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.