Navigating Japan’s New Era of Food Contact Material Compliance

Consumer CompactHardgoodsOctober 08, 2026

The regulatory landscape for food contact materials (FCMs) in Japan has changed significantly. Following the end of the five-year transition period on May 31, 2025, companies placing synthetic resin FCMs on the Japanese market must now comply with the country’s Positive List (PL) requirements.

Japan’s PL system reflects a broader global shift toward more proactive, science-based regulation of FCMs. Regulators are placing greater emphasis on understanding and controlling the substances used in food contact applications, while increasing visibility across supply chains.

For manufacturers, suppliers, brand owners and importers, compliance now requires greater insight into chemical composition, stronger documentation practices and effective traceability. While these requirements create new challenges, they also provide an opportunity to strengthen governance, build customer confidence and support market access in an increasingly regulated environment.

What is a Positive List?

A PL is a regulatory framework that permits only substances that have been specifically evaluated and authorized for use in FCMs. In principle, substances not included on the list cannot be used unless a specific exemption applies.

For manufacturers, compliance is not determined solely through migration testing of the finished product. Companies must now also understand and control the constituent polymers, monomers and additives used in production and demonstrate that they are authorized under the applicable legislation. This shifts regulatory focus upstream into raw materials and product development.

Positive Lists: a global trend

Japan is not alone in adopting a PL framework. Around the world, regulators are embracing positive-list-based approaches to strengthen the oversight of substances used in FCMs and support consumer protection.

The European Union has long maintained the Union List under Regulation (EU) No. 10/2011 for plastic FCMs, while China applies a similar framework through GB 4806.6 and GB 9685. In the United States, food contact substances are regulated through pre-market authorization mechanisms and indirect food additive regulations. Although the regulatory structures differ, they share a common principle: substances intended for food contact applications should be reviewed and authorized before use.

This trend is being driven, in part, by growing concerns about chemical safety and increasing demand for visibility across complex global supply chains. PL systems help address these challenges by establishing clear inventories of authorized substances and supporting a more structured, risk-based approach to oversight.

For businesses operating across multiple markets, navigating different regulatory frameworks and managing substance data across jurisdictions can be challenging. Organizations with strong regulatory intelligence and compliance processes will be better positioned to support global market access.

What Japan’s PL system means for industry

Japan introduced its PL system through amendments to the Food Sanitation Act, creating a regulatory framework for synthetic resin FCMs. The system came into force on June 1, 2020, with a five-year transition period designed to give industry time to adapt.

That transition period ended on May 31, 2025. From June 1, 2025, FCMs within scope must fully comply with PL requirements. Only authorized substances may be used in regulated food contact applications and companies must be able to demonstrate and communicate compliance throughout the supply chain.

The framework primarily covers synthetic resin materials, including plastics and plastic coatings. Authorized substances are listed according to their function and composition, with specific conditions of use that may include restrictions relating to food type, temperature and application.

Japan has also strengthened requirements for good manufacturing practice (GMP) and information sharing, supporting a more robust compliance ecosystem for FCMs entering the Japanese market.

Challenges of PL compliance

While Japan’s PL framework enhances food safety and strengthens oversight, achieving compliance can be complex.

Key challenges include:

Limited access to formulation data – demonstrating compliance requires detailed information on polymers, additives, monomers, CAS numbers and residual concentrations. However, upstream suppliers may be reluctant to disclose proprietary formulation details, making it difficult for downstream companies to assess compliance
Complex product structures – multilayer packaging, coating, adhesives and barrier materials can complicate compliance assessments. Companies must determine which materials fall within the scope of the regulation and verify the compliance status of each applicable component
Supply chain transparency requirements – business operators are required to demonstrate to downstream customers in a supply chain that products comply with the positive list. Compliance depends on obtaining accurate and reliable information throughout the supply chain. Gaps in data or documentation can create significant challenges when demonstrating conformity with regulatory requirements
Managing documentation and regulatory assessments – unlike traditional product testing, PL compliance requires a combination of formulation reviews, supplier information gathering and regulatory evaluations. These activities can place additional demands on quality, regulatory and product stewardship teams

Despite these challenges, companies that establish robust compliance processes, strong supplier communication and effective documentation practices will be better positioned to maintain market access and support ongoing compliance in Japan.

Looking ahead

Japan’s PL system marks an important step in the global shift toward substance-based regulation of FCMs. As regulatory expectations continue to evolve, businesses will need greater visibility into material composition, stronger supplier engagement and more robust compliance processes.

For manufacturers, importers and brand owners, preparation is key. Organizations that invest in regulatory monitoring, supplier collaboration and technical compliance capabilities will be better positioned to maintain access to the Japanese market and adapt to future regulatory developments.

SGS solutions

We support the global food contact materials industry with services designed to simplify compliance and reduce regulatory risk. Our experts can review formulation data, supplier information and technical documentation to assess polymers, monomers and additives against applicable PL requirements, helping identify potential gaps before products enter the Japanese market.

To support supply chain transparency, we assist with documentation reviews, compliance declarations and supplier communication. We can also evaluate supporting information and provide guidance on the evidence needed to demonstrate compliance with Japanese regulatory expectations.

In addition, we offer a broad range of FCM services, including migration testing, chemical characterization, non-intentionally added substance (NIAS) assessments, GMP evaluations and compliance assessment programs. Together, these services help organizations build a comprehensive compliance strategy that extends beyond PL requirements.

Finally, our regulatory training, technical workshops and consultation services help businesses understand evolving requirements and strengthen their internal compliance capabilities.

Discover more about how SGS can help for food contact material compliance.