Food contact materials – Europe
The use of food contact materials (FCM) is regulated in many parts of the world. In Europe, Framework Regulation (EC) No 1935/2004 lays down the general rules covering all food contact materials, whilst the Good Manufacturing Practice (GMP) Regulation (EC) 2023/2006 covers the methods and procedures under which the materials are produced. TSG Consulting, in conjunction with sister company Leatherhead Food Research, supports FCM producers in meeting regulatory compliance requirements around the world.
Food contact materials are widely used in everyday life; from the devices used in food production, packaging used to preserve and protect food during transport and sale, the utensils used by consumers to prepare and eat meals, to the machine used by baristas to make our favourite morning coffee.
Foods vary widely in their type and chemical composition and different food contact materials may behave differently when they come in to contact with food. Most of these materials transfer some of their constituents to the food. Such constituents are often called migrants and it is the control of their presence in food that is the purpose of FCM legislation. Should materials transfer or migrate at a sufficient level, it could have an impact on human health or change the food itself.
Framework Regulation (EC) No 1935/2004 and GMP Regulation (EC) 2023/2006 establish general safety requirements for all food contact materials. However, they only provide general guidance. Harmonized standards exist for plastics (including recycled plastics), ceramics, active & intelligent materials, and regenerated cellulose. All other materials are governed at individual member state level. For companies manufacturing products for sale outside of the EU, individual nations, or clusters of nations, have their own specific regulations regarding acceptable migration levels and the mechanisms by which these regulations are implemented.
FCM producers are responsible for the regulatory compliance of their end products. Proof of this compliance, including adherence to regional and type-specific regulations, is required for the legal use of such products.
Bringing a new food contact material to market, to a new region, for use with a new food type, or undertaking remedial action on a pre-existing product, can be complex and time consuming.
TSG can help
TSG Consulting, in partnership with our sister company Leatherhead Food Research, can support you through these challenges.
Combining our strength in industrial chemicals, toxicology and human health, and Leatherhead Food Research’s expertise in the global food industry, we can help raw material producers, converters or food packagers in all aspects of food contact compliance, including:
- 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
Combining 100 years of food science innovation (Leatherhead Food Research) with nearly 30 years of international regulatory expertise (TSG Consulting), we support clients in all aspects of regulatory compliance for new food contact substances and materials. We aim to understand our clients’ goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. Our team of experts is deadline-focused, responsive, committed and professional. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great care to cultivate long-term partnerships with clients.
Frequently asked questions
Any material that food touches in the supply chain from farm to consumer is considered to be food contact. These materials include the following product types: plastics, ceramics, recycled materials, active and intelligent materials and articles, printing inks, varnishes and coatings, paper and board, adhesives, regenerated cellulose, rubbers, silicones, epoxy materials, metals and alloys, glass, cork and wood, colorants, and pigments. TSG can advise which regulations your company must comply with, as well as undertake a risk assessment of substances present in your products.
A declaration of compliance (DOC) is a written document, declaring that a particular product complies with the relevant EU regulation. In the EU, it is a mandatory requirement for business operators to provide a DOC for food contact plastics (including recycled plastics), active and intelligent materials, ceramics and regenerated cellulose film. For other types of FCM, such as paper and inks, a DOC is only mandatory in some European member states but does provide an excellent starting point for a compliance statement to satisfy your customer’s needs.
The EU plastics regulation (EU No 10/2011) also requires FCM manufacturers to provide customers with a written DOC for finished plastic materials and articles, products from intermediate stages of their manufacturing, as well as for the substances intended for the manufacturing of those materials and articles. Declarations of compliance do not need to be made available at the retail stage.
TSG Consulting can advise when a DOC is required, as well as assist in the preparation of the written document.
The EU has some of the highest food contact safety standards in the world, with legislation ensuring that food is safe for consumers regardless of the materials it comes into contact with in the supply chain. A key tool to ensure the flow of information to enabling swift reaction when risks to public health are detected is RASFF – the Rapid Alert System for Food and Feed.
Vital information exchanged through RASFF can lead to products being recalled from the market and actions placed upon the company supplying them.
Should this happen to one of your products, TSG Consulting can examine the evidence and recommend remedial action to get your product back on the market as quickly as possible.
Migration testing is the experimental assessment of the migration (transfer) of components from food contact materials into the food. It is conducted under controlled and standardised laboratory conditions and is used to verify that products are compliant with the applicable regulations. Food contact regulations set out the migration limits based on a toxicological risk assessment, and suppliers of FCM must demonstrate that their products comply with the relevant overall migration limits (OML), specific migration limits (SMLs) and/or maximum permitted quantities (QMs).
TSG Consulting can manage migration testing for food contact materials should testing be required. Alternatively, we can often use mathematical calculations or computer models to avoid migration testing, saving you time and money.
To notify a new FCM, you will need to submit a package of information (called a dossier or notification) to the relevant regulatory authority. Although the exact information requirements vary between authorities the general principles are similar and involve supplying:
- A description of your new FCM, its intended use and how it is manufactured
- Mathematical estimates of migration, or actual migration measurements which are used to calculate consumer exposure
- Toxicological evidence which increases in scope and complexity as consumer exposure increases
- An explanation of why the FCM is safe in the intended use; and (sometimes)
- An environmental impact assessment
The information requirements are extensive and complex, meaning that dossiers can often contain hundreds of pages. TSG Consulting can prepare dossiers for submission to EFSA, EU member state authorities, the US FDA and Health Canada.