Japan Revises Food Additive Standards in the Food Sanitation Act  

On 28 August 2024, Japan’s Consumer Affairs Agency (CAA) notified the World Trade Organization (WTO) of the revision of food additive standards in the Food Sanitation Act. These changes include the removal of certain use standards for methyl cellulose and updates to the storage guidelines for dimethyl dicarbonate. 

Some Background 

Under Article 12 of the Food Sanitation Act 1947, designated food additives may be sold as per the Prime Minister. However, Article 13 of the Act establishes the standards for food additives in accordance with the Ministry of Health and Welfare Public Notice No. 370 of 1959, which forbids the sale of such additives unless they meet the requirements. The Committee on Food Additives of the Food Safety Standards Council in response to a request from the Prime Minister of Japan, has removed the use guidelines for methylcellulose and updated the storage guidelines for dimethyl dicarbonate. 

Removed Use Standards for the Methyl Cellulose 

Revised Storage Standards for Dimethyl Dicarbonate 

Comment Period and Enforcement Dates 

The 60-day comment period ends on 26 October 2024. The revised standards will take effect 6 months after their official publication in the gazette. 

On 1 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly released a notice to designate perfluorohexane sulfonic acid (PFHxS)-related chemicals as Class I Specified Chemical Substances. In addition, the notice also specifies a ban on the import of 10 products containing PFHxS-related chemicals. Although there is no deadline for implementation, the ministry stated that more talks will take place after 2025. 

PFHxS designated as Class I Specified Chemical Substances 

The manufacture, import and use of PFHxS-related chemicals will be banned unless deemed needed. PFHxS,,characterised by a branched structure with 6 carbon atoms i.e. perfluoro (hexane-1-sulfonic acid) or perfluoro (alkanesulfonic acid) are derived from compounds with a (tridecafluoroalkyl) sulfonyl group and six carbon atoms. A license is required to manufacture or import these chemicals. 

The Notice provides specific details on the chemicals listed, identified by their CAS numbers: 

Ministry bans import of 10 products containing Class I Specified Chemical Substances 

The following products containing PFHxS-related chemicals will be banned from import: 

1. Fire extinguishers, extinguishing agents for fire extinguishers, and foam extinguishing agents 

2. Etching agents used in metal processing  

3. Surface treatment agents for plating and additives for their preparation 

4. Fabrics treated to impart water- or oil-repellent properties  

5. Clothing treated to impart water- or oil-repellent properties  

6. Floor coverings treated to impart water- or oil-repellent properties  

7. Water-repellent agents, oil-repellent agents, and textile protective agents  

8. Antireflective agents used in semiconductor manufacturing  

9. Etching agents used in semiconductor manufacturing  

10. Resist for semiconductors 

Regulations on the use of Class I Specified Chemical Substances 

According to the Chemical Substances Control Law (CSCL), the use of chemicals is prohibited except for essential use or for testing and research purposes.  

Technical Standards for Handling of Class I Specified Chemicals 

When handling the following products that use Class 1 Specified Chemical Substances, follow the separately prescribed technical handling standards: 

• Fire extinguishers,  

• Extinguishing agents for fire extinguishers 

• Foam extinguishing agents 

Manufacturing Permit 

According to the Notice, manufacturers need to obtain a permit to produce such Class I Specified Chemicals and shall seek permission from the Ministry of Economy, Trade and Industry (METI). The application must include the following details: 

• Name or trade name and address, and in the case of a corporation, the name of its representative 

• Location of business establishment 

• Name of the Class 1 Specified Chemical Substance   

• Structure and capacity of the manufacturing facility. 

After approval of the permit, the manufacturer must immediately notify the Ministry of Environment (MOE). 

Import Permit 

For importers, an import permit is required from the Ministry of Economy, Trade and Industry, with an application containing the following details:  

• Name or trade name and address, and in the case of a corporation, the name of its representative. 

• Name of the Class 1 Specified Chemical Substance. 

• Import quantity