Global Food Contact Materials Regulations

This module will look at Japanese regulation on food safety as it impacts FCMs and food contact articles. Before taking a deep dive into the regulation, the session will look at how Japan defines FCMs under its new Food Safety Law.

Several key aspects affecting FCMs in the updated Japanese Food Safety Law will be addressed. Among the topics will be FCM substances already listed and allowed in the manufacturing of utensils, containers and packaging (UCPs) of foods in Japan.

Details of the newly established rules on UCPs from the Japanese Ministry of Health, Labour and Welfare (MHLW), as of 01 June 2020, will also be discussed.

Currently such rules include positive lists of base materials and additives, reorganised as of 24 December 2021 and amended as of 26 April 2022. In the latter amendment, adjacent to the positive lists on base materials and additives (ie tables 1 and 2, respectively), the MHLW has added three other tables covering ‘pending’, ‘to be deleted’ and ‘integrated’ FCM substances. The latest draft table 1 lists the synthetic polymers, and the corresponding allowed essential monomers as well as optional substances and optional chemical treatment substances, allowed in making base materials intended for use in food contact applications. Draft table 2 lists the corresponding additives allowed for use in manufacturing FCMs.

During this module, you will learn about:

• what is new in the amended Food Sanitation Act in Japan, and how it impacts FCMs;
• FCM substances placed on positive lists in Japan (as of 26 April 2022), and the transition period;
• the restrictions for listed food contact additives or FCM substances with respect to their allowed input concentration (wt.%) for certain polymer groups;
• 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 under the Japanese Food Safety Law, 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 petition steps in Japan, under its MHLW, for adding a new FCM substance to a positive list; and
• how to demonstrate compliance of materials and articles intended for use in food contact applications on the Japanese market, and the importance of place in the supply chain.

Ioan Paraschiv, PhD

Group Leader, Global Food & Food Contact Materials (FFCM) Division, Knoell, Netherlands