Oct-23-2024
On 18 October 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of Environment (MOE) jointly released a notice seeking toxicity information for ethyl hydrogen sulphate and 26 related chemicals.
Based on the data submitted by the companies, these 27 chemicals will be designated as either Priority Assessment Chemicals (PACs) or General Chemical Substances under the Chemical Substances Control Law (CSCL). The designation will be enforced from the beginning of FY 2025.
Council Negotiation in January 2024
In January 2024, METI, MHLW and MoE jointly held a council negotiation for the delisting of ethyl hydrogen sulphate (Serial Number: 244) from the PAC list and the revision of the assessment unit. The Council concluded that delisting will occur at the end of FY 2024 and will depend on the results of the assessment units which involve toxicity data along with other information. Once delisted from the PACs list, the CAS number will be revised in the notification.
Priority Assessment Chemicals
The possible negative effects of Priority Assessment Chemicals (PACs) have led to heightened monitoring of these substances. According to the Chemical Risk Information Platform of the National Institute of Technology and Evaluation (NITE), 225 chemicals are now classified as PACs.
Companies that manufacture or import these compounds in quantities of more than one tonne per year are required to submit annual reports to ensure compliance with METI laws and to promote overall safety and accountability in the handling of chemicals.
Company Obligations
Companies are required to submit the following information for ethyl hydrogen sulfate:
CAS Registry Number
Toxicity information (algae growth inhibition test, daphnia acute immobilization test and fish acute toxicity test)
Hazard assessment information
Physical and chemical properties
Submission Procedure and Deadline
Companies can submit the relevant information to METI by 22 November 2024, either mail or in-person. According to the results of the screening evaluation conducted by new assessment units, ethyl hydrogen sulphate will either be designated as a PAC at the start of FY 2025 or treated as a general chemical substance.
Oct-18-2024
On 27 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved amendments to the Standards and Criteria for Foods, Food Additives. This amendment revises the positive list of food contact materials (FCMs) under the Food Sanitation Act.
This amendment will revise the usage provisions of 4 polymers in Table 1 and add 13 new additives to Table 2 of the FCM positive list. There are now 840 entries on the list.
Public Consultation in May 2024
Before approving the amendment, the MHLW held a public consultation from 24 May 2024 to 22 June 2024 to gather feedback on the proposed changes to the FCM positive list. This consultation specifically addressed revisions to the polymer use provisions and the addition of new additives, which were included in the final amendment.
Standards and Criteria for Foods, Food Additives
The Standards and Criteria for Foods, Food Additives contain requirements and guidelines for foods, milk and milk products, food additives, apparatus, and containers and packaging regulated by the Food Sanitation Act and other laws. The MHLW regularly revises these standards to keep them up to date and to protect human health and the environment.
Japan’s Positive List of FCMs
For synthetic resins used as primary materials in food utensils, containers, and packaging, the amended Food Sanitation Act introduced a positive list system on 1 June 2020. Only materials deemed safe and specifically included in the Positive List are permitted for use, which by default forbids the use of synthetic resin materials.
The MHLW released the Japanese version of FCM Positive List (containing 827 entries) on 30 November 2023, followed by the English version on 25 December 2023. Details can be found here.
Enforcement Date
The amendment came into effect on promulgation. The revised FCM positive list will be enforceable from 1 June 2025, although existing materials may continue to be used until the end of the five-year transition period, which is 31 May 2025.
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