Food Contact Material & Recycled Plastic

Japan's Positive List for Food Contact Materials: Compliance Essentials

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Japan Food Contact Materials | Positive List Compliance

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 five-year transition period ended on May 31, 2025. Companies supplying synthetic resin-based food contact materials to Japan should now ensure that applicable base polymers and additives are listed, conditions of use are met, and supporting documentation is available for downstream customers and authorities.

Introduction    |    Timeline    |    Scope    |    PL Structure    |    Compliance Actions    |    Staying Updated    |    How REACH24H Can Help

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.

Food contact materials in Japan include utensils, containers, and packaging that come into direct contact with food or food additives during production, storage, distribution, preparation, or consumption. For companies exporting packaging, containers, coatings, films, resins, and related materials to Japan, Positive List compliance is now a key market access requirement.

Japan's FCM regulatory management is now overseen primarily by the Consumer Affairs Agency (CAA), while the Food Safety Commission of Japan (FSCJ) conducts scientific risk assessments. Industry associations such as JCII also play an important practical role through voluntary standards and substance lists.

Timeline of Positive List Implementation

Initial Release and Updates

DateRegulatory MilestoneBusiness Implication
April 28, 2020Japan’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.Companies needed to begin screening base polymers and additives against the new PL framework.
June 1, 2020The regulation became effective, establishing the requirement for synthetic resins used in food contact applications to comply with the PL.New products had to consider PL status, while pre-existing products benefited from a transition period.
March 6, 2023The latest draft version of the PL was released, reflecting industry feedback and regulatory refinements.Stakeholders were encouraged to review substance entries and follow list updates.
May 31, 2025The five-year transition period ended.Synthetic resins used in food contact applications should now comply with Japan’s Positive List requirements.

Transition Period (2020–2025)

A five-year transition period from June 1, 2020 to May 31, 2025 allowed 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.

Compliance note: Since the transition period has ended, companies should treat PL screening, conformity testing, and supporting documentation as active compliance requirements rather than future preparation tasks.

Scope of the Positive List Regulation

The Positive List applies mainly to synthetic resins used in utensils, containers, packaging, coatings, and related food contact applications. Companies should assess whether their materials fall within the scope of the PL before supplying products to the Japanese market.

Scope ItemIncluded / ExcludedCompliance Focus
Base polymersIncluded. Synthetic resins used in plastics and coatings, excluding non-thermoplastic rubber.Confirm whether the base polymer is listed and whether it falls under the appropriate polymer group.
AdditivesIncluded. Substances retained in the final product to alter the physical or chemical properties of synthetic resins.Check whether the additive is listed, and verify use levels and specific conditions.
Substances not remaining in the final productGenerally excluded, such as catalysts and polymerization aids.Confirm whether the substance remains in the final food contact material.
Impurities and residual additives in monomers of base polymersGenerally outside the direct PL scope described in the article.Still assess overall safety, migration and customer documentation requirements where relevant.

The regulation does not remove the need for broader food contact material safety assessment. For substances not regulated under the synthetic resin Positive List, businesses should still manufacture materials or articles in accordance with general safety requirements and conduct appropriate testing or risk assessment where applicable.

Structure of Japan's Positive List

1. Base Resin List (Table 1)

Polymer CategoryCharacteristics / Classification Criteria
1Heat resistance ≥ 150°C
2Main monomers are olefins, such as mono-olefins and diolefins
3Heat resistance < 150°C; main monomers include esters, alcohols, acids, etc.
4Main monomers are oxygen-containing olefins, such as vinyl acetate and vinyl ethers
5Polymers 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 such as initiators and crosslinking agents, and chemical treatments.

  • Groups 1–4: Cover general synthetic resins and plastics.

  • 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.

The Additives List includes:

  • Serial Number;

  • Chemical name;

  • CAS number;

  • Maximum allowable usage levels;

  • Specific conditions for use.

Practical note: PL compliance is not limited to checking whether a substance name appears on the list. Companies should verify the relevant base resin group, additive use level, conditions of use, final material type, and intended food contact conditions.

Compliance Actions for Businesses

Businesses manufacturing or selling synthetic resin-based utensils, containers, or packaging in Japan should follow a practical “list-based entry + testing + documentation” approach. This helps confirm that the material is built from permitted substances and that the finished product meets applicable safety requirements.

Compliance StepRecommended ActionKey Output
Material identificationIdentify whether the product is a synthetic resin-based FCM, coating, packaging or utensil within the PL scope.Regulatory applicability conclusion.
Positive List screeningScreen base polymers, monomers, additives and relevant functional substances against Japan’s PL.PL compliance screening report.
Condition-of-use reviewVerify maximum usage levels, material categories, food contact conditions and intended applications.Condition-of-use assessment.
Conformity testingConduct required testing based on material type, intended use and applicable Japanese standards.Test report and compliance evidence.
Technical documentationPrepare supplier information, formulation details, substance evidence, test reports and compliance statements.Customer-ready technical file or compliance package.

For basic monomers and additives within the scope of synthetic resins but not included in the Positive List, an application procedure will be required in accordance with future orders issued by the Japanese authority.

For substances not regulated under the synthetic resin Positive List, businesses must select and manufacture materials or articles in accordance with general safety requirements. Where applicable regulations mandate testing, companies are required to conduct the necessary assessments to verify product compliance. Additionally, a self-directed risk assessment should be performed to ensure the safety of the product under actual conditions of use.

Staying Updated on Japan's Positive List

Japanese authorities continue to update the Positive List based on industry feedback and scientific evaluation. Stakeholders are encouraged to follow official updates, participate in public consultations where applicable, and propose additional substances for inclusion where necessary.

For the latest full version of Japan's Positive List, companies should follow regulatory updates from the Consumer Affairs Agency, the Ministry of Health, Labour and Welfare, the Food Safety Commission of Japan, and relevant industry associations such as JCII.

REACH24H tip: Companies should not wait until customer audits or customs issues arise. PL status, testing evidence and technical documentation should be reviewed before shipment, especially for multi-layer materials, coatings, imported resins, recycled materials, and products with complex additive packages.

Need to confirm whether your food contact materials comply with Japan’s Positive List?

REACH24H can help you screen base polymers and additives, verify conditions of use, design testing strategies, and prepare compliance documentation for Japan’s FCM market.

   Contact Our FCM Specialists  

How REACH24H Can Help

REACH24H provides food contact material compliance support for companies supplying packaging, utensils, containers, coatings, plastics, recycled materials, and related food contact products to Japan and other global markets. For Japan, our support focuses on Positive List screening, material compliance assessment, testing strategy, Declaration of Compliance preparation, and technical documentation.

Support AreaREACH24H Services
Japan FCM Regulatory AssessmentAssess whether products fall within Japan’s FCM regulatory scope and whether the synthetic resin Positive List applies.
Positive List ScreeningScreen base polymers, additives, monomers and related substances against Japan’s PL and condition-of-use requirements.
Testing Strategy and Result ReviewDevelop testing plans and review results against applicable Japanese FCM standards and product use scenarios.
DoC and Technical File PreparationPrepare customer-ready compliance documents, supplier declarations, test report summaries and supporting technical files.
JCII and Industry Association SupportSupport communication with Japanese industry associations and assist with voluntary standard or certification-related matters where relevant.
Global FCM Market AccessProvide integrated support for EU Food Contact Materials, China Food Contact Materials, ASEAN FCM compliance, and U.S. Food Contact Materials.

Conclusion

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 Positive List screening, SDS or compliance documentation preparation, regulatory review, approvals, and testing strategies, companies should consult professionals specializing in food contact material regulations.

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Official References

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