1. Competent authority

2. Product compliance

Regulation (EC) No 1935/2004 on Materials and Articles Intended to Come into Contact with Food is a fundamental regulation for FCM enterprises to follow before placing FCM on the European market. It sets out general principles and requirements for the safety and inertness of all FCMs. Commission Regulation (EC) No 2023/2006 is another important regulation, which raises mandatory Good Manufacturing Practice (GMP) requirements for all FCMs.

For specific materials, besides following the general regulations, they shall conform with corresponding regulations as listed below.

Please note that

• In the absence of specific EU-level rules, the Member States may develop their own national rules as per Regulation No 1935/2004. Therefore, enterprises need to pay attention to the national rules of Member States in additional to EU-level rules.

• Polyamide and melamine plastic kitchenware from Chinese Mainland and Hong Kong shall additionally comply with Commission Regulation (EU) No 284/2011.

2.1 Management of materials

As disclosed in the table above, the EU only sets specific measures for 4 materials, namely, plastic, active and intelligent materials and articles, ceramic, as well as regenerated cellulose film.

However, as per the legislation framework for FCM in the EU Regulation (EC) No 1935/2004, 17 materials and articles may be covered by specific measures. For other 13 groups of materials (e.g., coatings, paper, etc.) that haven’t been covered by specific measures yet, enterprises usually refer to Member States' national legislations, Council of Europe resolutions, industry guidance, etc.

2.2 Management of substances

At present, the EU only establishes the Union List of substances that are permitted for use in the manufacturing of plastic materials (Commission Regulation (EU) No 10/2011) and regenerated cellulose film (Commission Directive 2007/42/EC). Please note that for recycled plastics, their recycling process shall also be authorized via individual decisions.

Commission Regulation (EC) No 450/2009 on Active and Intelligent Materials and Articles Intended to Come into Contact with Food indicates there will be a Union list of substances permitted for the manufacture of active and intelligent materials. However, the list has not been published yet.

For other groups of food contact materials without a Union list of allowed substances, enterprises usually refer to Member States' national legislations, Council of Europe resolutions, industry guidance, etc.

2.2.1 Authorization of new substances

In the situation where the EU has adopted a Union list of substances, enterprises that want to use substances outside the list shall submit an application as per Regulation (EC) No 1935/2004.

To be specific, the applicant shall prepare the dossier following EFSA’s Guidance and submit an application to the authority of the Member State. After receiving the dossier from the authority of the Member State, EFSA will conduct evaluation and provide an opinion. Then the European Commission will decide the authorization based on EFSA’s opinion. Once authorized, the substance will be added to the positive list of substances.

2.3 Declaration of Compliance (DoC) document

DoC, a document to state the compliance of materials, is mandatory to be provided for the following types of FCMs or situations:

• Plastic FCMs (including recycled plastics)

• Active and intelligent materials

• Ceramics

• Regenerated cellulose film

• Materials and articles containing “BADGE” (CAS No 001675-54-3) and its derivatives

• Using Bisphenol A in varnishes and coatings intended to come into contact with food

• Polyamide and melamine plastic kitchenware from Chinese Mainland and Hong Kong

Detailed requirements for DoC can be read at the links above.

3. Label

The general labeling requirements for FCM at different circulation stages are specified in Article 15 of Regulation (EC) No 1935/2004. Besides, enterprises shall conform with the labeling requirements as specified in the regulations for specific materials, if any.

* Global Food Compliance Service

We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.

Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and customized report

Please feel free to contact us via food@chemlinked.com if you need any help.