FCM Regulations in USA and Migration Testing

Content: 

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.