09:00 - 12:00 GMT
FCM Regulations in Canada and migration testing
This module will look at Canadian regulations that directly impact food packaging. We will begin with examining how Canada defines food packaging materials under Division 23 of the Food and Drugs Act and Regulations, section B23.001.
Among the topics will be letters of no objection (LONO) applications (categories 1 and 2) that a convertor / formulator can submit voluntarily to Health Canada.
Category 1 and 2 templates will be presented and discussed, as well as the data requirements for LONO applications and timelines for feedback from Health Canada.
Examples of food packaging materials that Health Canada has already approved will also be given.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- how Canada’s regulations apply to the FCMs you are interested in;
- current FCM regulations in Canada;
- FCMs that have already been assessed and cleared by the Canadian Food Inspection Agency (CFIA) and thereafter by Health Canada;
- the restrictions for certain key listed FCM substances, with respect to their specific migration limits (SMLs);
- carrying out a worst-case calculation (WCC) in cases where experimental or theoretical (modelling) migration data is missing;
- migration testing conditions to be applied in relation to a LONO category 2, with 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 FCM substances migrating into food;
- the steps for Canadian LONO applications (categories 1 and 2); and
- how to demonstrate compliance of materials and articles intended for use in food contact applications on the Canadian market, and the importance of place in the supply chain.