FCM Regulations in USA and Migration Testing

Web Seminar of 3 hours


During this module, you will learn about:

  • US 21 CFR regulations that apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives, (can) coatings, etc;

  • substances already cleared by the US FDA under 21 CFR § 174-186;

  • the restrictions on certain key listed FCM substances with respect to their specific limitations;

  • how to carry out a worst-case calculation (WCC) in cases of missing experimental or theoretical (modelling) migration data;

  • migration testing conditions to be applied according to US FDA requirements, with case study examples;

  • key steps when considering the risk assessment of FCS migrating into food from an FCM or food contact article;

  • the steps for a US food contact notification (FCN) petition to the US FDA;

  • the steps for a US Gras Notice to the US FDA;

  • the requirements for a threshold of regulation (TOR) (21 CFR § 170.39) exemption application to the US FDA; and

  • how to demonstrate compliance of materials and articles intended for use in food contact applications on the US market, and the importance of place in the supply chain.



Target audience
Regulatory Affairs Managers or Products Stewardship Specialists active in companies situated in different positions of the food contact supply chain
Language of training material