Global Food Contact Materials Regulations

This module will look at food contact material (FCM) regulations in the EU. After defining what is meant by FCMs, it will examine the key regulatory requirements in this market. Topics of discussion will include:

• ongoing activities, supervised by the European Commission (DG Sante), on the revision of the Framework Regulation (EC) No 1935/2004 including the inception impact assessment (IIA); in broad strokes, several potential options will be presented on the (revised or new) Framework Regulation, planned for Commission adoption by mid 2023;
• the recently adopted version of the 21st amendment to the German Consumer Goods Ordinance (Bedarfsgegenständeverordnung, BedGgstV), which regulates the use of printing inks and varnishes in food contact materials and articles; and
• upcoming announced 16th, 17th and 18th amendments of Regulation (EU) No 10/2011 on plastic food contact materials and articles.

During this module, you will learn about:

• current regulations concerning FCMs in the EU, including activities to revise the EU Framework Regulation;
• FCM substances already placed on positive lists associated with existing FCM regulations;
• the restrictions that apply to certain key listed FCMs with respect to their specific migration limits (SMLs);
• how to carry out a worst-case calculation (WCC) when experimental or theoretical (modelling) migration data is missing;
• migration testing conditions to be applied to different types of FCMs, such as compliance testing requirements laid down in Annex V of Commission Regulation (EU) No 10/2011 on plastic materials and articles, BfR Recommendations XXXVI on paper and board, and other national member state FCM regulations, with related case study examples;
• the analytical challenges in identifying non-intentionally added substances (Nias) that migrate into food under intended conditions of use;
• key steps when considering the risk assessment of FCMs migrating into food;
• the steps, and data requirements that apply, for a new FCMs petition/ authorisation in the EU and at the national member state level; and
• how to demonstrate compliance of materials and articles intended for use in food contact applications on the EU market, and the importance of place in the supply chain.

Ioan Paraschiv, PhD

Group Leader, Global Food & Food Contact Materials (FFCM) Division, Knoell, Netherlands