Global Food Contact Materials Regulations

This module will look at food contact material (FCM) regulations in the EU. After defining what is meant by FCMs, it will examine the key regulatory requirements in this market. Topics of discussion will include:

• ongoing activities, supervised by the European Commission (DG Sante), on the revision of the Framework Regulation (EC) No 1935/2004 including the inception impact assessment (IIA); in broad strokes, several potential options will be presented on the (revised or new) Framework Regulation, planned for Commission adoption by mid 2023;
• the recently adopted version of the 21st amendment to the German Consumer Goods Ordinance (Bedarfsgegenständeverordnung, BedGgstV), which regulates the use of printing inks and varnishes in food contact materials and articles; and
• upcoming announced 16th, 17th and 18th amendments of Regulation (EU) No 10/2011 on plastic food contact materials and articles.

During this module, you will learn about:

• current regulations concerning FCMs in the EU, including activities to revise the EU Framework Regulation;
• FCM substances already placed on positive lists associated with existing FCM regulations;
• the restrictions that apply to certain key listed FCMs with respect to their specific migration limits (SMLs);
• how to carry out a worst-case calculation (WCC) when experimental or theoretical (modelling) migration data is missing;
• migration testing conditions to be applied to different types of FCMs, such as compliance testing requirements laid down in Annex V of Commission Regulation (EU) No 10/2011 on plastic materials and articles, BfR Recommendations XXXVI on paper and board, and other national member state FCM regulations, with related 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 FCMs migrating into food;
• the steps, and data requirements that apply, for a new FCMs petition/ authorisation in the EU and at the national member state level; and
• how to demonstrate compliance of materials and articles intended for use in food contact applications on the EU market, and the importance of place in the supply chain.

Hélène Bernazeau

Regulatory Affairs Manager, Food & Food Contact Materials (FFCM) Division, knoell, France

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 (PFAS) and the impact of California's Proposition 65 on food packaging.

During this module, you will learn about:

• which of the US 21 CFR regulations apply to the FCMs you are interested in, including plastics, paper, paperboard, adhesives, (can) coatings, etc, 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
• 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
• how to demonstrate compliance with food contact applications in the US
  perfluoroalkyl and polyfluoroalkyl substances (PFAS) US state regulations
• the impact of California's Proposition 65 on food packaging

Tina Robertson

Senior Regulatory Affairs Manager, Food Contact Materials, knoell USA