09:00 - 12:00 GMT
FCM Regulations in Switzerland and migration testing
This module will look at the Ordinance of the Swiss Federal Department of Home Affairs (FDHA) on materials and articles that are intended to come into contact with food, also known as the Consumer Goods Ordinance (SR 817.023.21).
The ordinance establishes the requirements for different FCMs, including plastics, cellulose films, ceramics, glass, silicone, etc. Particular emphasis will be placed on Annex 10 of the Swiss Ordinance, which covers printing inks used in food contact applications.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- the restrictions that apply to certain 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 check for migration of FCM substances used in manufacturing of printing inks for food contact applications, in accordance with the Swiss Ordinance (eg concrete case study examples will be provided and discussed, with reference to the EuPIA (European Printing Ink Association) guidance;
- 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, for a new FCM petition/authorisation to the Swiss authority; and
- how to demonstrate compliance of materials and articles intended for use in food contact applications on the Swiss market, and the importance of place in the supply chain.