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On 1 June 2025, Japan’s Positive List (PL) for FCMs came into force. Japan’s Consumer Affairs Agency (CAA) releases the manual for introduction to the positive list on the portal on the same day. Japan's Positive List (PL) System regulates synthetic resins used in food-contact utensils and packaging under the Food Sanitation Act. Only materials listed in the official PL can be used, unless migration into food is below 0.01 ppm or the material is in non-food-contact layers proven safe.

Key Insights from the Manual for PL

1. Legal Articles:

• Article 16: Bans harmful substances in utensils, containers, and packaging (UCP).
• Article 18: Allows setting of safety standards and manufacturing criteria.

2. Structure of Standards:

• General Standards: Ban harmful substances like lead and certain dyes.
• Material-specific and Use-specific Standards: Cover items like glass, rubber, and retort pouches.

3. Annex I (Positive List):

• Table 1: 21 categories of approved base polymers.
• Table 2: 840 approved additives with usage limits by material class.

4. Scope:

• All synthetic resin layers in UCPs are covered.
• Non-resin materials, surface coatings, and unintended by-products are excluded.

5. New Substance Procedures:

• PL amendment, safety review, or monomer notification update depending on usage and risk.

6. Transition:

• 5-year grace period until 1 June 2025.
• Products sold or made before enforcement are deemed compliant during this period.

The system aims to enhance food safety by systematically controlling materials used in food-contact applications.

Obligations for Stakeholders

• Manufacturers/importers of raw materials and UCPs must provide PL-compliance info.
• Users and distributors have duty to confirm and communicate compliance.

Not required to disclose individual substances; confirmation documents (specifications sheets, certificates) are sufficient.

On 6 June 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a list of 50 carcinogenic chemicals on the ASEAN-Japan Chemical Safety Database portal. The update was also released on the country’s National Institute of Technology and Evaluation - Chemical Risk Information Platform (NITE-CHRIP) portal.  

Background 

In Japan, carcinogenic substances are subject to strict obligations under the Industrial Safety and Health Act (ISHA), which requires records to be kept for up to 30-years. 

Previous update in December 2022 

Earlier, in December 2022, the MHLW classified 200 chemicals as carcinogenic and started enforcement in a phased manner starting from April 2023. More details can be found here.  

Obligations for Stakeholders 

From 1 April 2027, the following will be mandatory for stakeholders: 

• Mandatory GHS-compliant labelling and provision of Safety Data Sheets (SDS). 

• Risk assessment before use, implementation of exposure control measures, and health monitoring for workers.  

• Employers must conduct regular medical examinations, particularly for substances classified as Group 1 or 2A carcinogens, maintain detailed exposure and health records, and notify authorities when required.  

• Additional regulations, such as the Chemical Substances Control Law (CSCL) and PRTR Law, also apply to environmental reporting and emissions control.