FCM Regulation (EC) No 1935/2004 and national provisions

Food contact materials are materials and articles coming into direct or indirect contact with food during its production, processing, storage, preparation and serving before its consumption.

In the European Union, food contact materials are regulated under the EU Framework Regulation (EC) No 1935/2004 setting out general safety requirements for all food contact materials. In addition, specific measures have been introduced to plastics, recycled plastics, regenerated cellulose film, ceramics and active and intelligent materials at EU level. The safety of FCM is evaluated by the European Food Safety Authority (EFSA). 

Other types of food contact materials which are not subject to any specific EU measure (i.e. coatings, adhesives, and paper) are regulated at national level by EU Member States's provisions.

Drinking Water Directive (EU) 2020/2184 (DWD)

The Drinking Water Directive is designed to safeguard public health by setting the minimum hygiene and chemical safety standards for materials that come into contact with drinking water. Both drinking water contact materials (DWD) and FCM are governed by similar principles of ensuring chemical safety, migration control, and consumer protection. This makes it reasonable to combine the regulatory processes for both. 

In practice, borderline cases involving both FCMs and DWDs often arise. Examples include polymeric materials used in water filtration devices, kitchen appliances with integrated water tanks, or coatings and adhesives that may contact both drinking water and food. In such instances, distinguishing between FCM and DWD regulations is not always  straightforward. Consistent evaluation is required to address overlapping safety endpoints, migration testing protocols, and toxicological risk assessments. A combined service provides consistent regulatory guidance and prevents conflicting approaches when one material is subject to multiple regulatory frameworks.

Our services

We help ensure the compliance of your food contact materials by providing support in:

• Expert guidance through the FCM / DWD authorisation process
• Compliance checks of products and ingredients
• Development of registration strategy and test program to be performed (incl. coordination, management and supervision of testing)
• Compilation and submission of complete registration dossiers to competent authorities on the EU (EFSA) and national level
• Assessment of the safety of chemicals in contact with food and drinking water as well as of NIAS (non-intentionally added substances)
• Migration calculation
• Negotiations with regulatory authorities and scientific bodies on client’s behalf 
• Scientific and technical support for related regulatory fields, such as materials that come into contact with drinking water.