FCM Regulations in the US
This is the third webinar in a series of ten that will address food contact material (FCM) regulations and compliance in key markets around the globe.
Among the countries and regions we will be looking at are the EU, Switzerland, the US, China, Canada, the Mercosur countries and Japan. Each webinar will last an hour and there will be time for questions from attendees.
Your guide for all ten webinars will be Dr Ioan Paraschiv, regulatory affairs manager at knoell NL.
The third webinar 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).
This will be followed by an overview of all the regulations affecting FCMs. Topics to be discussed include the food contact notification (FCN) program 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 webinar, you will learn:
- 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 applications.
More webinars in this series:
- Mercosur Regulations on Food Contact Materials & Compliance – 29 September
- Swiss Regulations on Food Contact Materials & Compliance – 13 October
- Canadian Regulations on Food Contact Materials & Compliance – 27 October
- Chinese Regulations on Food Contact Materials & Compliance – 10 November
- How to Prepare a Declaration of Compliance for Food Contact Materials – 24 November
- Risk Assessment of IAS & NIAS Migrating from Food Contact Materials and Articles – 8 December
- Japanese Regulations on Food Contact Materials & Compliance – 15 December
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