The Consumer Affairs Agency (CAA) of Japan issued two notifications on November 6, 2025, enacting the second round of revisions to the Positive List (PL) for Synthetic Resins in Food Contact Materials. This adjustment involves the monomer composition of acrylic polymers, access rules for ink additives, and exemption pathways for functional barrier layers, marking a further step in aligning Japan's FCM regulatory system with that of the European Union.
Basis for Revisions
- Notification No. 601: Revises Appendix 16 of Table 1 in the Positive List — the list of monomers for acrylic polymers.
- Notification No. 625: Revises the general implementation policy under MHLW Notification 1130-No.4, adding a new Synthetic Resins/Additives in Printing Inks section and updating the Q&A document.
Key Changes
- Acrylic Polymers
- Prohibits the use of C18 alkyl acrylate as a comonomer.
- Adds dicyclopentenyl methacrylate as a permissible monomer for copolymer systems where acrylic acid as the principal monomer constitutes ≥50%.
- Removes previous usage restrictions on the UV absorber 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl] ethyl methacrylate.
- Inks and Additives
- The Positive List system now explicitly covers synthetic resins and additives in printing inks.
- Substances not listed in Table 1 or Table 2 must qualify for exemption via a functional barrier layer or apply for individual authorization.
- The list is not applicable to utensils, containers, or packaging used for food additives, which remain regulated under the Specifications and Standards for Food Additives.
- Identification of Functional Barrier Layers
- A new Q&A item (Q42) states that if a specified diffusion model can demonstrate migration levels ≤0.01 mg/kg, actual migration testing can be exempted.
Implementation Timeline
- Notification No. 601: Effective upon announcement, with no transition period.
- Notification No. 625: Implemented concurrently with the current Positive List (mandatory from June 1, 2025).
Key Compliance Actions
- Formula Verification
- Acrylic resins: Immediately check for the presence of C18 alkyl acrylate and replace the monomer if necessary.
- Ink systems: Verify that all resins and additives are listed in Table 1/Table 2 or qualify for an exemption.
- Barrier Assessment
- Packaging with a double-layer structure can commission laboratories to perform diffusion model calculations to obtain a BES (Barrier Efficacy Statement) document.
- When using recycled plastics as a barrier layer, complete migration test data is still required; model-based exemption alone is not permissible.
- Compliance Documentation
- Provide updated Japan Declarations of Compliance (J-DOC) to Japanese clients, attaching monomer lists and barrier model reports (if applicable).
Further Information
