Japan’s Positive List for Food Contact Materials: Compliance Essentials
Introduction
Japan introduced a Positive List (PL) system for food contact materials (FCMs) under the revised Food Sanitation Act (No. 46 of 2018), which officially came into effect on June 1, 2020. This regulatory shift aims to ensure the safety of synthetic resins, additives, and coatings used in food packaging and utensils. The Positive List approach aligns Japan’s FCM regulations with global standards.
Timeline of Positive List Implementation
Initial Release and Updates
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April 28, 2020: Japan’s Ministry of Health, Labour and Welfare (MHLW) issued Notification No. 196, introducing the first version of the Positive List for synthetic resins and additives.
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June 1, 2020: The regulation became effective, establishing the requirement for synthetic resins used in food contact applications to comply with the PL.
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March 6, 2023: The latest draft version of the PL was released, reflecting industry feedback and regulatory refinements.
Transition Period (2020–2025)
A five-year transition period (June 1, 2020 – May 31, 2025) allows products already on the Japanese market before June 1, 2020, to continue being sold. However, after May 31, 2025, all synthetic resins used in food contact applications must comply with the Positive List.
Scope of the Positive List Regulation
The Positive List applies to:
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Base Polymers: Synthetic resins used in plastics and coatings, excluding non-thermoplastic rubber.
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Additives: Substances retained in the final product to alter the physical or chemical properties of synthetic resins.
The regulation does not apply to:
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Substances that do not remain in the final product (e.g., catalysts, polymerization aids).
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Impurities and residual additives in monomers of base polymers.
Structure of Japan’s Positive List
1. Base Resin List (Table 1)
|
Polymer Category |
Characteristics (Classification Criteria) |
|
1 |
Heat resistance ≥ 150°C |
|
2 |
Main monomers are olefins, such as mono-olefins and diolefins |
|
3 |
Heat resistance < 150°C; main monomers include esters, alcohols, acids, etc. |
|
4 |
Main monomers are oxygen-containing olefins, such as vinyl acetate and vinyl ethers |
|
5 |
Polymers used for coatings, where chemical reactions occur during the film-forming process |
The PL categorizes base polymers by monomer type and polymer properties into five groups (Groups 1–5). Each group consists of subcategories detailing essential monomers, optional substances (e.g., initiators, crosslinking agents), and chemical treatments.
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Groups 1–4: Cover general synthetic resins and plastics.
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Group 5: Covers coating materials that undergo chemical transformation during application.
2. Additives List (Table 2)
Table 2 lists the additives permitted for use in the base resins authorized in Table 1, which are expected to remain in the final product and function within the base resin. This list specifies approved additives for each base resin group. It includes:
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Serial Number
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Chemical name
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CAS number
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Maximum allowable usage levels
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Specific conditions for use
Staying Updated on Japan’s Positive List
MHLW continues to update the Positive List based on industry feedback and scientific evaluation. Stakeholders are encouraged to participate in public consultations and propose additional substances for inclusion.
For the latest full version of Japan’s Positive List, follow regulatory updates from MHLW or consult compliance experts specializing in food contact material regulations.
Conclusion
With the 2025 deadline approaching, businesses must ensure full compliance with Japan’s Positive List regulations. Companies dealing with food packaging, synthetic resins, and coatings should proactively assess their materials and adapt to the evolving regulatory framework.
For expert guidance on Japanese FCM compliance, including SDS preparation, regulatory approvals, and testing strategies, consult professionals who specialize in food contact material regulations.
