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.Timeline of Positive List Implementation
Initial Release and Updates
- April 28, 2020: Japan’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.
- June 1, 2020: The regulation became effective, establishing the requirement for synthetic resins used in food contact applications to comply with the PL.
- March 6, 2023: The latest draft version of the PL was released, reflecting industry feedback and regulatory refinements.
Transition Period (2020–2025)
A five-year transition period (June 1, 2020 – May 31, 2025) allows 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.Scope of the Positive List Regulation
The Positive List applies to:- Base Polymers: Synthetic resins used in plastics and coatings, excluding non-thermoplastic rubber.
- Additives: Substances retained in the final product to alter the physical or chemical properties of synthetic resins.
- Substances that do not remain in the final product (e.g., catalysts, polymerization aids).
- Impurities and residual additives in monomers of base polymers.
Structure of Japan’s Positive List
1. Base Resin List (Table 1)
Polymer Category | Characteristics (Classification Criteria) |
1 | Heat resistance ≥ 150°C |
2 | Main monomers are olefins, such as mono-olefins and diolefins |
3 | Heat resistance < 150°C; main monomers include esters, alcohols, acids, etc. |
4 | Main monomers are oxygen-containing olefins, such as vinyl acetate and vinyl ethers |
5 | Polymers used for coatings, where chemical reactions occur during the film-forming process |
- 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. It includes:- Serial Number
- Chemical name
- CAS number
- Maximum allowable usage levels
- Specific conditions for use
