This module will look at US regulations directly impacting FCMs and food contact articles. Before taking an in-depth look at the regulations, the webinar will look at how the US Food and Drug Administration (FDA), under the Code of Federal Regulations (CFR) Title 21, defines FCM substances, known as food contact substances (FCS).
Followed by an overview of all the regulations affecting FCMs. Topics to be discussed include the food contact notification (FCN) programme and the Generally Recognised as Safe (Gras) Notice procedure, as well as the current regulatory status on FCS such as: bisphenol-A (BPA) (Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), and perfluoroalkyl and polyfluoroalkyl substances.
During this module, you will learn:
Ioan ParaschivRegulatory Affairs Manager FCM & REACh, Knoell, Netherlands
- which of the 21 CFR regulations apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives, (can) coatings, etc;
- which substances have already been cleared by US FDA under 21 CFR § 174-186;
- what are the steps for a Food Contact Notification (FCN);
- what are the steps for a Gras Notice;
- which migration testing conditions are to be applied, with case study examples;
- how to carry out a worst-case calculation (WCC) in cases of missing experimental or theoretical (modelling) migration data;
- what the specifications are for certain key-listed FCM substances with respect to their specific migration limit (SML);
- what the key steps are when considering the risk assessment of FCS migrating into food from an FCM or food contact article; and
- how to demonstrate compliance with food contact materials in applications.
- introduction of regulations concerning FCS
- FCS substances that are already approved and which have been placed on positive lists associated with existing FCM regulations.