Food Contact Materials Practical Training Series

This module will look at key 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 key regulations affecting FCMs in North America. 

Topics will include the food contact notification (FCN) programme and the generally recognised as safe (GRAS) notice procedure. In addition, the session will cover the regulatory status of certain substances in FCSs, such as bisphenol-A (BPA) and perfluoroalkyl and polyfluoroalkyl substances (PFAS), and the impact of California's Proposition 65 on food packaging. We will examine case studies on how to comply with FDA FCM regulations in the USA. 

By attending this training course, you will learn (in relation to the USA): 

• which of the US 21 CFR regulations apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives and (can) coatings, including different product categories (for example, 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), with case study examples; 

• 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; and 

• the impact of California's Proposition 65 on food packaging. 

This module will also look at key Canadian regulations that directly impact food packaging. We will begin by examining how Canada defines food packaging materials under Division 23 of the Food and Drugs Act and Regulations, section B.23.001. Among the topics will be letters of no objection (LONO) applications (categories 1 and 2), which a convertor/formulator can submit voluntarily to Health Canada. Category 1 and 2 templates will be presented and discussed, as well as the data requirements for LONO applications and timelines for feedback from Health Canada. Examples of food packaging materials that Health Canada has already approved will also be given, and we will discuss the impact of the Safe Foods for Canada Regulations on food packaging.

By attending this training course, you will learn (in relation to Canada): 

• how Canada’s regulations apply to the FCMs you are interested in; 

• key FCM regulations in Canada; 

• impact of Safe Foods for Canadians Regulations (SFCR) on FCM; 

• FCMs that have already been assessed and cleared by the Canadian Food Inspection Agency (CFIA) and thereafter by Health Canada; 

• the restrictions for certain key listed FCM substances, with respect to their specific migration limits (SMLs); 

• carrying out a worst-case calculation (WCC) in cases where experimental or theoretical (modelling) migration data is missing; 

• migration testing conditions to be applied in relation to a LONO category 2, with case study examples; 

• the analytical challenges in identifying non intentionally added substances (NIAS) that migrate into food under intended conditions of use; 

• key steps when considering the risk assessment of FCM substances migrating into food;
• the steps for Canadian LONO applications (categories 1 and 2); with case study examples; and 
• how to demonstrate the compliance of materials and articles intended for use in food contact applications on the Canadian market, and the importance of their place in the supply chain. 

Trainer: Dr Alastair Mak, PhD

Toxicologist, Environmental and Human Toxicology, Knoell USA