Global Food Contact Materials Regulations

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

• EU FCM Regulations: definitions, current landscape and new developments with a focus on plastic FCM;
• Declaration of Compliance (Conformity) (DoC) and Supply chain: information that should be disclosed in connection with the roles and obligations of the different business operators;
• Compliance testing of FCM – identification of NIAS/ IAS 

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;
• 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.

Hélène Bernazeau

Regulatory Affairs Manager, Food & Food Contact Materials (FFCM) Division, knoell, France

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

• the amended (draft) Swiss Ordinance on Materials and Articles intended to come in contact with food (SR 817.023.21) – Annexes 2, 9 and 10;
• the process of removing Part B of Annex 10 on printing inks for food contact applications;
• the current regulations concerning all different types of FCMs in Switzerland;
• which FCM substances have been already placed on Swiss positive lists associated with existing FCM regulations;
• what restrictions apply to certain key-listed FCMs with respect to their specific migration limits (SMLs);
• how to carry out a worst-case calculation (WCC) where there is experimental or theoretical (modelling) migration data is missing;
• which migration testing conditions are to be applied, with case studies;
• what the analytical challenges are during the identification of non-intentionally added substances (Nias) that migrate into food under intended conditions of use;
• what the key steps are when considering the risk assessment of FCMs migrating into food;
• the steps, and the data requirements, for a new FCM petition/ authorisation in these markets; and,
• how to demonstrate compliance with food contact applications in the above-mentioned markets, and the importance of position in the supply chain. 

Ms Friederike Danneberg, PhD

Regulatory Affairs Manager, REACH & Food Contact Materials, knoell, Germany