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Japan's Positive List System for Food Contact Materials Now in Effect

25 Jun 2025

Japan's Positive List System for Food Contact Materials Now in Effect

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Japan Trade
Japan's Positive List (PL) regulation for food contact materials (FCMs) officially took effect on June 1, 2025, as announced by the Consumer Affairs Agency (CAA). The new system establishes stricter safety controls for synthetic resins used in utensils, containers, and packaging (UCP).
Key Provisions of the Positive List
1. Legal Framework
- Article 16: Prohibits the use of harmful substances in UCP.
- Article 18: Authorizes the establishment of safety and manufacturing standards.
2. Regulatory Structure
- General Standards: Ban hazardous substances (e.g., lead, certain dyes).
- Material-Specific Standards: Cover glass, rubber, sterilized bags, and other items.
3. Approved Substances (Annex I)
- Table 1: 201 permitted base polymers.
- Table 2: 840 approved additives, categorized by material type with usage restrictions.
4. Scope of Application
- Applies to all synthetic resin layers in UCP.
- Excludes non-resin materials, surface coatings, and unintended byproducts.
5. New Substance Approval Process
- Requires PL revisions, safety reviews, or monomer notifications, depending on usage and risk assessment.
6. Transition Period
- A 5-year grace period (until June 1, 2025) allows previously manufactured or marketed products to remain compliant.
Industry Implications
- Compliance Requirements: Manufacturers and importers must ensure all synthetic resin components meet PL standards.
- Documentation: Companies should prepare technical dossiers demonstrating compliance with approved substances.
- Enforcement: The CAA will conduct market surveillance to verify adherence.
The PL system aims to:
- Strengthen consumer protection by preventing harmful chemical migration into food.
- Align Japan's regulations with global standards (e.g., EU and U.S. FCM frameworks).
- Provide clearer guidelines for industry innovation while ensuring safety.
Disclaimer: Blooming reserves the right of final explanation and revision for all the information.
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