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FCM Regulations in the US and Canada
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. As part of this, the session will look at the US NTP’s CLARITY-BPA programme, which is being carried out by the Department of Health and Human Services. This aims to clarify the potential health effects of long-term exposure to BPA.
Additionally, we will look at Canadian regulations that directly impact food packaging. We will begin with a look at how under the Division 23 of the Food and Drugs Act and Regulations, Section B23.001, Canada defines food packaging materials.
Among the topics to be discussed will be categories 1 and 2 letters of no objection (LONO) applications that a convertor/formulator can voluntarily submit to Health Canada.
Category 1 and 2 templates will be presented and discussed, as well as the data requirements for LONO applications and the timelines on feedback from Health Canada.
Examples of food packaging materials that Health Canada has already approved will be given as well.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- which of the US 21 CFR regulations apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives, (can) coatings, etc
- which regulations apply to food packaging materials in Canada, 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
- which products have already been cleared in Canada, for food contact applications
- what the restrictions are for certain key-listed FCM substances with respect to their specific migration limit (SML)
- 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
- what are the steps for Canadian LONO applications (categories 1 and 2); and
- how to demonstrate compliance with food contact applications in the above mentioned markets.