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FCM Regulations in the EU, Switzerland and UK
This module will look at food contact materials (FCM) regulations in the EU, Switzerland and UK (after Brexit). After defining what is meant by FCMs, the module will examine the key regulatory requirements in these markets. 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 a few big lines, several potential options will be presented with respect to the (revised or new) Framework Regulation, planned for Commission adoption in third quarter of 2022
- the most recent amendment to the Swiss Ordinance on Materials and Articles intended to come in contact with food (SR 817.023.21) – Annex 10 for printing inks used in food contact applications, 1 December 2020; additionally, the process of updating Part B of Annex 10 will be discussed; and
- the implementation of the Materials and Articles in Contact with Food (England, Wales, Northern Ireland and Scotland) Regulations 2012, following the end of the Brexit transition period on 31 December 2020; a comparison with the existing EU FCM regulations will be provided.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- the current regulations concerning FCMs in the EU, Switzerland and UK, including activities to revise the EU Framework Regulation
- which FCM substances have been already placed on 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 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.