Japan has been making significant changes to its regulatory framework for food contact materials (FCMs), set to take effect on June 1, 2025. The Ministry of Health, Labour and Welfare has finalized the structure of the Positive List (PL) system for synthetic resin materials, marking a major shift in how chemicals used in food-related utensils, containers, and packaging are regulated.
Table of Contents
Overview of the Positive List System
The Positive List system, introduced through amendments to Japan’s Food Sanitation Act in 2018, focuses on controlling the types of substances permitted in synthetic resins for FCMs. This system ensures that only approved substances can be utilized, enhancing consumer safety and aligning with international standards, notably the European Union’s plastics regulation (Commission Regulation (EU) No 10/2011).
Amendments and Key Changes
On November 30, 2023, the Ministry of Health, Labour and Welfare (MHLW) published Notice No. 324, formalizing the Positive List framework. This structure consisted of two primary components:
- Table 1: Details 21 base polymer materials and their permissible monomers.
- Table 2: Lists 827 approved additives used in the production of these materials.
Further updates were introduced in 2024, aimed at refining this system. The main revisions included:
- Adjustment of use limits for substances with Serial Nos. 129, 147, and 698.
- Removal of specific requirements for “ethoxylated and/or propoxylated glycerol” (Serial No. 143).
- Addition of 13 new substances, expanding the list to include Serial Nos. 828 to 840.
Clarifications on Substance Naming
The most recent amendments also clarify rules around naming substances in the Positive List. For polymers described as primarily composed of specific monomers or starting materials, these components must make up more than 98 % of the polymer by mass. If multiple starting materials are involved, their combined mass percentage must exceed this threshold. Additionally, ingredients used in quantities below 2 % do not need to be specified in the substance name but must still comply with corresponding concentration limits.
Manufacturers are expected to fully comply with the Positive List system by June 1, 2025.
Conclusion
Japan’s shift to the Positive List system for food contact materials represents a significant advancement in regulatory oversight, aiming to safeguard public health and align with global standards. The forthcoming changes require manufacturers to adapt their processes to meet stringent compliance requirements. As the June 2025 deadline approaches, continued collaboration between regulatory bodies and industry players will be essential for a smooth transition.
