May-26-2025
On 16 May 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of compounds and mixtures that required labelling and safety data sheets (SDS). The list is available on the country’s Workplace Safety Portal, managed by the Ministry. According to the Industrial Safety and Health Act (ISHA), the Globally Harmonized System (GHS) for labelling must be followed.
List of Labelling & SDS Delivery
According to Article 57 and 57-2 of the ISHA, it is mandatory to provide a label and SDS for the listed chemicals to safeguard workers’ health and the environment. A total of 2316 chemicals are now listed, with requirements coming into effect in phases from April 2025 and April 2026.
Previous Update in March 2025
In March 2025, the MHLW released a list of 7 chemicals subject to labelling and SDS delivery.
Insights from the Amended List
From the revised list, the following must have label and SDSs:
1530 chemicals applicable from 1 April 2025
779 chemicals applicable from 1 April 2026
Obligations for Stakeholders
Manufacturers, importers, suppliers, and employers are subject to labelling and Safety Data Sheet (SDS) delivery obligations under Japan's Industrial Safety and Health Act (ISHA).
May-15-2025
Update: On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published a revised Q&A document on its portal to further clarify the provisions of a Positive List for Food Contact Materials (FCMs). The CAA has also added a comparison of the previous and newly updated Q&A provisions.
Original Text:
On 6 February 2025, Japan’s Consumer Affairs Agency (CAA) published a Q&A document on its portal to clarify the provisions of a Positive List for Food Contact Materials (FCMs). The Positive List is currently in a 5-year transition period ending on 1 June 2025. At the end of the transition period, only entries on the list will be permitted in food contact applications. New materials must undergo assessment before they can be added to the list.
Key Insights from the Q&A Document
The main focus of the Q&A document is the Positive List of FCMs, which is governed by the Food Sanitation Act and overseen by the CAA. In general, this Act provides the basis for establishing standards for FCMs.
The Q&A document covers topics which include following:
Scope and definition of the Positive List.
Exclusions from the list.
Specific product categories.
Provisions for polymeric substances.
Limits for additives.
Implementation guideline.
Guidance for Stakeholders
The Food Sanitation Act regulates FCMs in Japan, and the CAA frequently updates its portal to reflect the most recent changes to the requirements and criteria for foods and food additives. The purpose of this Q&A document is to help suppliers, importers, and manufacturers in making efficient use of the Positive List. Adhering to the list helps to prevent non-compliance in the manufacture, import and supply of FCMs.
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