Navigating Japan’s Food Contact Material Regulations: What Businesses Should Know

Overview

As global regulatory scrutiny on food safety intensifies, Japan has taken major strides in strengthening its food contact materials (FCM) regulations. With the full enforcement of the Positive List (PL) system for synthetic resins approaching in June 2025, international manufacturers and suppliers must act now to ensure compliance.

What Are Food Contact Materials?

Food contact materials (FCMs) refer to any materials or articles intended to come into direct contact with food or whose components may migrate into food. In Japan, this includes utensils, containers, and packaging (UCP), which are clearly defined under the Food Sanitation Act. These cover tools, containers, and packaging that are in direct contact with food or food additives throughout production, storage, and consumption.

Key Regulatory Bodies in Japan

Japan’s regulatory oversight of FCMs is jointly managed by two main authorities:

Consumer Affairs Agency (CAA)

As of April 1, 2024, the CAA officially assumed responsibility for managing food contact materials, including developing safety regulations and risk management strategies.

Food Safety Commission of Japan (FSCJ)

Operating under the Cabinet Office, the FSCJ conducts scientific risk assessments of food-related materials and facilitates public communication through stakeholder engagement and updated regulatory publications.

Industry Associations

In addition to government oversight, several Japanese industry associations—such as JCII (Japan Chemical Innovation and Inspection Institute), the Paper Association, and the Printing Ink Association—play a crucial role by publishing voluntary standards and substance lists. These have gained broad acceptance and serve as key references in compliance practices.

Japan’s Evolving Regulatory Framework for FCMs

Japan’s food safety legislation is built upon two cornerstone laws:

• Food Sanitation Act
• Basic Act on Food Safety

A major regulatory milestone was the 2018 amendment to the Food Sanitation Act, which introduced the concept of a Positive List system for synthetic resins. This amendment also mandated the use of Good Manufacturing Practices (GMP) and required businesses to ensure traceability and safety information transfer throughout the supply chain.

Implementation Timeline:

• Positive List for Synthetic Resins Introduced: April 28, 2020
• Enforcement Start Date: June 1, 2020
• Transition Period: Until May 31, 2025
• Full Enforcement Date: June 1, 2025

What’s Covered in Japan’s Positive List?

The Positive List covers materials and additives used in synthetic resin-based food contact products. It is composed of:

• Table 1: Base polymers (molecular weight ≥1000 Da)
• Table 2: Additives (molecular weight <1000 Da, or specific polymers with functional groups)

Only substances listed in the PL may be used for manufacturing applicable FCMs.

Compliance Process for Businesses

Companies manufacturing or selling synthetic resin-based utensils, containers, or packaging in Japan must follow a “List-based Entry + Testing” approach:

• Material Compliance: All components must be sourced from the Positive List.
• Conformity Testing: Finished products must undergo safety testing per Japan’s standards.

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 a future order 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 must be performed to ensure the safety of the product under actual conditions of use.

How We Support Your Compliance Journey

At REACH24H Consulting Group, we offer end-to-end regulatory services designed to streamline your market entry and ensure long-term compliance in Japan:

• FCM compliance assessment and regulatory strategy
• Conformity testing supervision and result validation
• Declaration of Conformity (DoC) preparation
• JCII membership application support
• Certification assistance for JCII standards
• Liaison with Japanese authorities and industry groups
• Supplier chain audits and material verification

Why Choose Us?

With extensive global experience and a deep understanding of regional FCM regulations (including the EU, US, China, Canada, and Mercosur), REACH24H helps clients navigate complex compliance landscapes efficiently.

Our core advantages include:

• Expertise Across Major Markets: Proven success in new substance registration and recycled material approvals across Asia, Europe, and the Americas.
• Strong Laboratory Network: Access to accredited partners for reliable and timely testing.
• Direct Regulatory Access: Robust communication channels with Japanese regulators and associations.
• Custom Solutions: Tailored compliance strategies based on your product profile and target market.

Ready for Japan’s 2025 Regulatory Shift?

The countdown to Japan’s full Positive List enforcement is underway. Partner with REACH24H to ensure your food contact materials meet Japan’s rigorous standards—on time and without risk.