Global Food Contact Materials Regulations

This module will look at the US regulations that directly impact FCMs and food contact articles. The session will start by examining 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 (FCSs). 

We will follow this with an overview of all the regulations affecting FCMs in North America. Topics to be discussed include the food contact notification (FCN) programme and the generally recognised as safe (Gras) notice procedure. The session will also discuss the regulatory status in FCSs of substances such as: bisphenol-A (BPA) and perfluoroalkyl and polyfluoroalkyl substances (PFAS) and the impact of California's Proposition 65 on food packaging.

During this module, you will learn about:

• which of the US 21 CFR regulations apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives, (can) coatings, etc, including different product categories (eg, finished articles and formulated products, as well as single additives)
• which substances have already been cleared by US FDA under 21 CFR § 174-186
• how to carry out a worst-case calculation (WCC) in cases of missing experimental or theoretical (modelling) migration data
• which migration testing conditions are to be applied, with case study examples
• what the key steps are when considering the risk assessment of FCS migrating into food from an FCM or food contact article
• what the steps are for a US Food Contact Notification (FCN)
• what the steps are for a US Gras Notice
• how to demonstrate compliance with food contact applications in the US
  perfluoroalkyl and polyfluoroalkyl substances (PFAS) US state regulations
• the impact of California's Proposition 65 on food packaging

Tina Robertson

Senior Regulatory Affairs Manager, Food Contact Materials, knoell USA