Global food contact material (FCM) regulations are detailed and demanding. In the EU, general rules for FCM use are laid out in Framework Regulation (EC) No 1935/2004 while Good Manufacturing Practice (GMP) Regulation (EC) 2023/2006 covers the methods and procedures under which the materials are produced. We work closely with FCM manufacturers and suppliers to clarify what’s required, streamline compliance and support access to the EU and other global markets.
The EU has some of the most stringent food contact safety standards in the world. Bringing a new FCM product to market or extending supply to a new region or food category can be complex and time-consuming from a regulatory perspective. It’s the same when remedial action needs to be taken on an existing FCM product. Sagentia Regulatory works closely with colleagues at Leatherhead Food Research to help clients understand and navigate the specific measures for different material types.
FCM regulatory scope
FCM regulations cover every stage of the food chain to ensure all materials in contact with food are safe, functional, and fit for purpose.
- FCMs include industrial food processing equipment, food packaging materials, consumer utensils and devices used in food service outlets
- Different types of food interact with materials in different ways depending on their chemical composition. This affects FCM safety and performance
- Chemical migration is the primary focus of FCM regulation. Most materials transfer traces of their chemical constituents to the food they contact
- FCM rules are designed to control the type and quantity of substances that can migrate, protecting human health and food quality
Regulatory requirements for FCMs in the EU
Regulatory responsibilities for FCM producers are complex in the EU. Some requirements are harmonised but others are regulated at the member state level.
- EU general principles are established under Framework Regulation (EC) No 1935/2004 which sets baseline FCM requirements, and GMP Regulation (EC) 2023/2006 which defines rules for safe manufacturing processes
- Harmonised measures currently exist for some specified products, such as plastics (including recycled plastics), ceramics, active and intelligent materials, and regenerated cellulose
- All other materials are governed at the member state level. Requirements and acceptable migration levels can vary across countries
- FCM producers are legally responsible for ensuring their products comply with all relevant regulations. It is essential to demonstrate and document compliance with general, regional, and material-specific requirements for markets where products are sold
Sagentia Regulatory support for FCM compliance
We can help you navigate FCM requirements with confidence, offering strategic guidance and practical support wherever you need it. Services include:
- Document preparation, including Declarations of Compliance (DOC)
- Obtaining necessary substance information from suppliers
- Preparation of QA, QC and associated documentation
- Risk assessment of substances present in end products, but not included on lists of authorised chemicals
- Notification of new FCMs to regulatory authorities
- Management of migration testing should it be required
- Support with food packaging alerts and product recalls
Why choose Sagentia Regulatory?
Our food contact regulatory experts draw on Sagentia Regulatory’s specialist expertise in toxicology, industrial chemicals, and human health, and Leatherhead Food Research’s deep knowledge of the global food industry. Our team has a strong track record helping raw material producers, converters, and food packagers across all aspects of FCM compliance.
