Japan Announces Draft Procedures for Adding New Substances to the Positive List

Japan publicized a draft of the procedures that companies should follow for preparing and submitting applications to amend and add new substances to the Positive List of synthetic resins for utensils, containers, and packaging (UCP). The draft was explained at the UCP subcommittee, Food Sanitation Standards Council of Consumer Affairs Agency (CAA) meeting on March 27, 2025.  

Japan’s positive list system for synthetic resins for UCP for food or food additives took effect on June 1, 2020, but a five-year grace period was allowed during which time unlisted substances used in Japan prior to June 1, 2020, could continue to be sold. The revised Positive List, which will be effective from June 1, 2025, includes a table of Base Materials (Table 1), with Annexes (the monomers list), and a table of Additives (Table 2). Any monomer, monomer combinations, or additives used therein that are not explicitly listed in Table 1 or Table 2 are not permitted to be used in UCP after June 1, 2025.

CAA has announced draft procedures for three types of applications:

1. Amending Additive Listings: This procedure would be used to request changes to clearances for substances that are already listed in Table 2, such as expanding an existing use level limit or condition of use for the additive. The Food Safety Commission of Japan (FSC-J) will complete a risk assessment for all applications that are filed with CAA to expand a listing for an additive that is already authorized in Table 2.  
2. Safety Review: This procedure would be to request approval for new additives that are not already listed in Table 2. Approval of these will be conditioned on a risk assessment review by FSC-J.  
3. Amending Annex of Table 1 (monomer list): This procedure would be used to request that a new essential monomer, optional substance, or optional chemical treatment be added to the Annexes of Table 1. The approval does not require a risk assessment review by FSC-J and, therefore, would be completed within CAA.  

For these procedures, pre-consultation with CAA is required. CAA plans to handle applications as a “batch” of multiple applications and to review them “periodically.” As a result, some applications would not be reviewed immediately after submission.  

While CAA intends to make these draft procedures official and effective by this summer, the Agency is still accepting applications under the current procedure, effective until May 31, 2025 (for the current procedures in English, please refer to the following: https://www.mhlw.go.jp/content/11130500/000660903.pdf). Importantly, changes to the application procedures are not expected to result in changes to the guidance for the risk assessment that FSC-J uses (i.e., major changes regarding the data required to be included in applications to amend the Positive List are not anticipated). If companies have been waiting to submit their applications, they may consider contacting CAA now. 

Details on the new positive list system that becomes effective after June 1, 2025, can be found here (in Japanese). 

For more information on Japan’s Positive List, see the Packaginglaw.com articles, A Move to Mandatory; Japan Finalizes its Positive List for “Synthetic Resins” and Japan Publishes Final Version of the Positive List.