09:00 - 12:00 GMT
FCM Regulations in USA and migration testing
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 (US FDA) – under the Code of Federal Regulations (CFR) Title 21 – defines FCM substances, known as food contact substances (FCSs).
An overview of all the regulations affecting FCMs in the US will follow. Topics discussed include the food contact notification (FCN) programme and the generally recognised as safe (Gras) notice procedure.
The session will also cover the regulatory status of substances such as: bisphenol-A (BPA) and perfluoroalkyl and polyfluoroalkyl substances (PFASs), versus their presence in FCMs and food contact articles. In this context, we will look at the US NTP’s CLARITY-BPA programme, which has been undertaken by the Department of Health and Human Services. This aims to clarify the potential health effects of long-term exposure to BPA.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- 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.