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.