On September 4, 2026, Japan's Consumer Affairs Agency (CAA) convened the first meeting of the year of the Utensils, Containers and Packaging Panel under the Food Sanitation Standards Council, which reviewed the "Handling Method for Listing Substances with Histories of Use in the Positive List (Draft)". The draft method is intended to establish an additional procedure for substances that had histories of use before the positive list system took effect but were not included in the current positive list because they missed the opinion solicitations. After such substances are listed in the positive list, risk management will be implemented in the same manner as for currently listed substances, and no safety review will be conducted. Companies related to food utensils, containers and packaging and their raw materials for export to Japan need to pay close attention.
Background: Substances "Missed" after Full Implementation of the Positive List
Japan's positive list system for synthetic resins used in food utensils, containers and packaging has been in effect since June 1, 2020, with a five-year transitional period. The transitional period expired on May 31, 2025, and the system has been fully implemented since June 2025. Before full implementation, the competent Japanese authorities solicited opinions from companies and other stakeholders several times and sorted out the substances to be included in the positive list based on the submissions received.
However, some companies failed to make submissions because they were unaware of the opinion solicitations. Although the substances they used had already served as raw materials for food utensils, containers and packaging before the positive list system took effect (June 1, 2020), they were not included in the current positive list. Recently, a company consulted the CAA on the listing of such substances. The CAA considers that, apart from the fact of "failing to submit opinions during the solicitation stage", such substances are in the same situation as the currently listed existing substances in terms of risk, so their risk management can be implemented in the same manner as for existing substances.
Key Points of the Draft Handling Method
According to the draft method, the arrangements for listing such substances in the positive list are as follows:
- Prior consultation: confirm the substance's history of use and its risk assessment priority classification (i.e., the priority classification for risk assessment of existing substances reported at the panel's meeting on June 26, 2025) through prior consultation;
- Initiation of the listing procedure: based on a company's application, initiate the amendment procedure for Appended Table 1 of the Specifications and Standards for Foods, Food Additives, etc. (MHLW Notification No. 370 of 1959, hereinafter referred to as the "Specifications and Standards") or the amendment procedure for the monomers notification, to include the substance in the positive list; considering that such substances have been in use since before the system took effect, the summary documents for the amendments, which serve as materials for the consultation with the Food Safety Commission of Japan (FSCJ), are required to be equivalent in content to those used when the current positive list was formulated;
- No safety review: the safety review procedure (provided in Section 3A9 of the Specifications and Standards) applies only to substances for which it is not appropriate to implement risk management in the manner prescribed by Appended Table 1 (such as new substances expected to be used only in limited applications); the substances added this time will not undergo the safety review;
- Risk assessment after listing: handled in accordance with the risk assessment policy for existing substances reported at the panel's meetings on June 26, 2025 and December 15, 2025; for substances belonging to Group 6, the CAA will organize them based on hearing the opinions of the FSCJ, in line with the arrangements for advancing assessment requests for existing substances.
The CAA also stated that, as the full implementation of the positive list system has a short history, it will continue to promote the proper operation of the system and the dissemination of relevant information.
Listing Routes and Procedures
The additions will be carried out through two types of procedures, which differ in scope of application:
Appended Table 1 amendment: applicable to substances suitable for risk management in the manner prescribed by Appended Table 1, mainly revisions to the specifications of substances listed in Table 2 of Appended Table 1 (changes to use restriction limits, special remarks, etc.); substances that have no specifications in Table 2 yet and are intended for new use may also use this procedure if they are considered suitable for management through an Appended Table 1 amendment;
Monomers notification amendment: applicable to cases where monomers, etc. (essential monomers, optional substances, essential chemical treatments and optional chemical treatments) are to be added to the tables of Annexes 1 to 21 of the Notification on Monomers, etc. Constituting the Base Materials Specified in Table 1 of Appended Table 1 of the Specifications and Standards (dated November 30, 2023, Notification No. 1130-1, hereinafter referred to as the "monomers notification"), or where use beyond the prescribed scope is intended.
In terms of procedure, for an Appended Table 1 amendment, a company submits an application to the Food Sanitation Standards Review Division of the CAA; after document confirmation and other steps, the CAA prepares the draft amendment to Appended Table 1 and submits it to the Utensils, Containers and Packaging Panel of the Food Sanitation Standards Council for deliberation, and consults the FSCJ for a health effect assessment of food on the draft amendment; after the FSCJ conducts the assessment (including public comment) and replies with the assessment result, the CAA prepares the draft amendment to Appended Table 1 again and consults the Food Sanitation Standards Council (including public comment), thus finally completing the amendment of the Specifications and Standards. For a monomer notification amendment, a company submits an application to the Food Sanitation Standards Review Division of the CAA, and the amendment is completed after document confirmation and the report of the Food Sanitation Standards Council; in principle, applications received within a certain period will be processed in batches.
Risk Assessment Arrangements after Listing
According to the classification reported at the panel's meeting on June 26, 2025, the existing substances currently listed in the positive list are classified 1 to 6 by risk assessment priority:
Groups 1 to 4: comprising food components or food additives, substances with a molecular weight of 1,000 or above (polymers only), food additives approved by either or both of the United States and the European Union, and substances approved by either or both of the United States and the European Union for use as additives for synthetic resins, etc.; 565 substances in total, with "significantly low" priority;
Group 5: substances with less exposure or fewer exposure opportunities (e.g., substances with dietary concentrations not exceeding 0.05 mg/kg, substances of Cramer structural Class I not exceeding 0.9 mg/kg, adhesives, substances with limited uses, small production or import volumes, limited business operators, etc.); 233 substances in total, with "low" priority;
Group 6: the remaining substances; 42 substances in total, with "high" priority.
At present, no individual risk assessments are conducted for Groups 1 to 5; the CAA will collect information on their health effects in due course and submit assessment requests where necessary. For Group 6, the National Institute of Health Sciences (NIHS) takes the lead in collecting toxicity tests and other data, and assessment requests are to be submitted to the FSCJ in sequence at a pace of 4 to 5 substances per year around April each year, with a plan to complete the assessment of high-priority substances in 8 to 10 years. After the substances added this time are listed in the positive list, their risk assessments will be arranged under the same policy.
ChemRadar Insights
In light of this development, companies exporting food contact materials and related raw materials to Japan may pay attention to the following:
- Screen the listing status of substances: check whether the base materials, monomers, polymers, additives, etc. in use are already listed in the current positive list; for unlisted substances, verify whether they had a history of use in Japan as raw materials for food utensils, containers and packaging before June 1, 2020, and preserve supporting materials such as purchase and sales records and proof of application as early as possible;
- Assess the feasibility of addition and start early: the addition starts with prior consultation, and the data requirements of the amendment summary documents are equivalent to those used when the current positive list was formulated; as the preparation of toxicological, migration and other data takes a long time, companies with needs are advised to assess feasibility and plan data preparation as early as possible, and maintain communication with downstream customers and industry associations;
- Follow the implementation progress: the content reviewed this time is still a draft handling method submitted for the council's discussion, and the final handling method and specific application arrangements are subject to the CAA's subsequent publications; substances of Group 6 may be prioritized for risk assessment after listing, and relevant companies may continue to follow the assessment progress and its potential impact on use limits, uses, etc.
