Japan, known for its stringent global food safety standards, has continuously tightened regulations on Food Contact Materials (FCMs). To further enhance food safety, the Ministry of Health, Labour and Welfare (MHLW) introduced a Positive List system for FCMs in June 2020. After revisions and public consultations, the list will officially take effect on June 1, 2025.
On February 6, 2025, Japan’s Consumer Affairs Agency released the Positive List Q&A Guidance, providing detailed compliance instructions for businesses. This article summarizes key points to help companies navigate the new requirements efficiently.
I. Scope of the Positive List
1. Definition of Synthetic Resins
- Included: Thermoplastic resins (e.g., polyethylene, polystyrene), thermosetting resins (e.g., phenolic resin, melamine resin), and thermoplastic elastomers (e.g., polystyrene elastomers, styrene block copolymers).
- Excluded: Thermosetting elastomers (e.g., butadiene rubber, nitrile rubber).
2. Scope
The revised Positive List comprises two tables:
- Base Materials (Table 1): Synthetic resin polymers with molecular weight ≥1,000 and solid at room temperature (e.g., PET, polycarbonate). These are categorized by chemical structure (e.g., ester bonds, amide bonds) and physical properties (e.g., glass transition temperature, ball pressure temperature), covering 21 categories.
- Example: Polypropylene (classified as olefin-based backbone polymers), polyamide (classified as amide-bond backbone polymers).
- Additives (Table 2): Organic low-molecular-weight substances (molecular weight <1,000) or substances with molecular weight >1,000 but in liquid form or with specific functional groups (e.g., plasticizers, antioxidants). Additive usage limits are set based on base material type.
3. Exemptions
- Non-synthetic resin materials: Such as rubber, inorganic materials (metals, silicates, etc.), natural substances (including extracts and distillates like rosin and naphtha, but excluding substances and related substance groups obtained solely through the purification of specific components) and their chemical derivatives (excluding chemically modified cellulose).
- Functional migration substances: Substances released from packaging to exert intended effects in food.
- Surface treatment agents: Coatings for anti-static or anti-fog purposes.
- Chemical reaction byproducts: Substances formed during material processing.
- Non-intentionally Added Substances (NIAS): Substances that are not present in the final product. For example, substances removed during the production process (such as additive solvents) and impurities contained in raw materials (such as residual monomers, catalysts, polymerization aids, by-products, etc.).
II. Multi-Layer Structures and Special Scenarios
1. Compliance for Multi-Layer Materials
- Food-contact layer: Must comply with the Positive List.
- Non-contact layers: Exempt if migration ≤0.01 mg/kg (no health risk level).
Example: The resin A in the inner layer (food contact layer) of a beverage can must comply with the positive list, while the intermediate metal layer, being a non-synthetic resin material, is exempt. The outer resin B (printing layer) does not need to comply with the positive list.
2. Special Processes
- CVD-coated films: Considered as an independent layer, and their applicability to the list is determined based on the properties of synthetic resins.
- Edge contact: Non-intentional edges (e.g., multi-layer film edges) are not considered food-contact surfaces.
III. Special Rules for Colorants and Recycled Materials
1. Colorants
- Pigments (e.g., iron oxide) used solely for coloring are exempt but must meet existing safety standards.
- Multi-functional additives (e.g., fillers, lubricants) are regulated as additives.
2. Recycled Materials
- Physical recycling: Permitted if residual additives pose no migration risk.
- Chemical recycling: Treated as new raw materials, requiring full compliance.
IV. Transition Period and Compliance Deadlines
- Before June 1, 2020: Products already produced, imported, sold or used remain compliant under pre-Positive List rules even after the transition period ends,
- June 1, 2020 - May 31, 2025 (During the Transition Period): Appliances or containers/packaging that are sold, manufactured, imported, or used, and are similar to those before June 1, 2020, will be considered as included in the positive list. These products may continue to be sold or used even after the transition period ends.
Exception: Raw material forms are excluded.
- After June 1, 2025: Full compliance mandatory for all products.
V. Compliance Recommendations for Businesses
With Japan’s FCM regulations entering their final countdown, businesses must closely monitor policy developments, proactively establish compliance strategies, and prioritize addressing high-risk areas (e.g., multi-layer packaging and recycled materials) to avoid trade risks.
CIRS Group recommends a three-step strategy:
Step 1: Material Screening: Verify if existing synthetic resins and additives are listed; replace non-compliant substances.
Step 2: Process Evaluation: Validate safety of multi-layer structures and recycled materials via migration testing or simulations.
Step 3: Documentation Management: Maintain certificates of composition, test reports, and compliance records for audits.
Further Information
