Japan Regulatory News

On 16 March 2023, Japan announced the inclusion of 1,469 substances to the list of chemicals for which companies are required to maintain safety data sheets (SDSs) and labels that comply with the UN&#...

On 16 March 2023, Japan announced the inclusion of 1,469 substances to the list of chemicals for which companies are required to maintain safety data sheets (SDSs) and labels that comply with the UN's Globally Harmonised System of classification and labelling (GHS) in accordance with the country's Industrial Safety and Health Act (ISHA).

There will be two phases of enforcement. The list of substances in Appendix 1 of the notice has a proposed enforcement date of April 2025, and the list of substances in Appendix 2 has a proposed enforcement date of April 2026; however, according to the WTO notice these dates are subject to change.

There are total 651 substances included in Appendix 1 examples are-

Appendix 2 consists of total 818 substances which includes-

In Japan, the GHS is implemented under three laws, which include the Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL).

According to the MHLW, it will be necessary for companies to label containers or packages containing the chemicals with specific information, including the substance name, based on the sixth revised edition of the GHS.

In March 2023, Japan’s Ministry of Health, Labour, and Welfare (MHLW) proposed revised guidelines for measuring workplace exposure limits for hazardous substances under the country’s Industrial Sa...

In March 2023, Japan’s Ministry of Health, Labour, and Welfare (MHLW) proposed revised guidelines for measuring workplace exposure limits for hazardous substances under the country’s Industrial Safety and Health Act (ISHA).

A public consultation on the revised technical guidelines for the application of concentration standards was initiated in March 2023, by the MHLW in order to reduce health risks from chemical compounds. The consultation ended on 5 April 2023. The guidelines are expected to be enforced on 1 April 2024.

The guidelines include details on the risk reduction measures, workplace concentration standard values (exposure limits) with their application, and workplace exposure measuring methods for 73 substances including their sampling and analysis methods.

The list of substances includes:

In a notice published on March 31, 2023, the Japanese Ministry of Economy, Trade, and Industry (METI) and the ministries of Health, Labour, and Welfare (MHLW) and Environment (MOE) announced the remov...

In a notice published on March 31, 2023, the Japanese Ministry of Economy, Trade, and Industry (METI) and the ministries of Health, Labour, and Welfare (MHLW) and Environment (MOE) announced the removal of six substances from their priority assessment chemicals (PACs) list under the country's Chemical Substances Control Law (CSCL).

The six substances that have been removed are:

• Ethylamine
• Methyl dodecanoate
• Benzoic acid benzyl ester
• Camphene
• O-dichlorobenzene
• Chlorodifluoromethane (HCFC-22)

Priority assessment chemicals (PACs) are the substances that METI believes may be hazardous to the environment or human health. Companies must submit annual reports to METI for these substances when manufacturing or importing them in volumes of one tonne or more per year.

According to the National Institute of Technology and Evaluation’s (NITE) Chemical Risk Information Platform, there are a total of 218 substances listed under the PAC list. The six substances removed from the PACs list no longer require annual reporting as they are now classified as general chemicals.

In a notice published on 27 March 2023, the Japanese Ministry of Economy, Trade and Industry (METI), the ministries of Health, Labour and Welfare (MHLW) and Environment (MOE) announced that they will ...

In a notice published on 27 March 2023, the Japanese Ministry of Economy, Trade and Industry (METI), the ministries of Health, Labour and Welfare (MHLW) and Environment (MOE) announced that they will monitor the manufacturing and importation volumes of eight substances to consider their removal from the Priority Assessment Chemicals (PACs) list.

The substances are: 

• tritolyl phosphate – used in vinyl plastics, as a lubricant additive and in waterproofing materials;  
• aniline – used in dyes and intermediates, photographic chemicals, urethane foams (pictured), pharmaceuticals, explosives and petroleum refining;  
• nitrilotriacetic acid – used in cleaning products, personal care products and pesticides;  
• 2-(tert-butylamino)-4-(cyclopropylamino)-6-(methylthio)-1,3,5-triazine – used as an anti-fouling agent in paints and as a biocide;  
• trioctylamine – used in fuel production;  
• salt of N,N-diethyl-N-methyl-2-[(2-methylprop-2-enoyl)oxy]ethan-1-aminium – used in pharmaceuticals and medical articles;  
• 4,4'-diamino-3,3'-dichlorodiphenylmethane (also known as 4,4'-methylenebis(2-chloroaniline)) – used as a curing agent for polyurethanes and epoxy resins; and  
• mixture of bicyclo [2.2.1] heptane-2,5(or 2,6)-diyl dicyanide – a compound. 

In a separate notice, published in the official government gazette Kanpou on 3 April 2023, the Japanese Ministry of Economy, Trade and Industry announced the classification of six substances as PACs under the country's Chemical Substances Control Law (CSCL).

The six substances are as follows:

• sodium salt of 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid; 
• alpha,alpha'-[(alkyl(C=8-18, normal chain)azanediyl)bis(ethane-2,1-diyl(or ethylethane-2,1-diyl))]bis{omega-hydroxypoly[oxyethane-1,2-diyl/oxy(methylethane-1,2-diyl)]} (The repeating number of repeating unit is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer that is less than 1,000.);
• salt of {ester of 2-hydroxy-N-(2-hydroxyethyl)-n, n-dimethylethan-1-aminium and [saturated fatty acid(C=10-18, normal chain)(or unsaturated fatty acid(C=18, normal chain))]} or salt of {ester of 2-hydroxy-n-(2-hydroxypropyl)-n,n-dimethylpropan-1-aminium and [saturated fatty acid(C=10-18, normal chain)(or unsaturated fatty acid(C=18, normal chain))]}; 
• alpha-(alkyl(C=6-18))-omega-hydroxypoly[oxyethane-1,2-diyl/oxy(methylethane-1,2-diyl)](Limited to the number-average molecular weight of the polymer of less than 1,000.); 
• alpha-hydro-omega-[(3-methylbut-3-en-1-yl)oxy]poly(oxyethane-1,2-diyl) (The repeating number of repeating units is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer of less than 1,000.); and
• [alpha-(alkanoyl(C=8-18, normal chain))-omega-methoxypoly(oxyethane-1,2-diyl) or alpha-(alkenoyl(C=8-18, normal chain))-omega-methoxypoly(oxyethane-1,2-diyl)] (The repeating number of repeating unit is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer of less than 1,000.). 

Priority Assessment Chemicals (PACs) are substances that are believed to be hazardous to the environment or human health. Companies must submit annual reports to METI for these substances when manufacturing or importing them in volumes of one tonne or more a year.

On 6 March 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft of its latest revised positive list for food contact materials (FCMs) which includes substances for listing r...

On 6 March 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft of its latest revised positive list for food contact materials (FCMs) which includes substances for listing requested by companies, and revised use requirements for some substances under table 1 and 2. Table 1 consist of base materials like dichloromethylphenylsilane, 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane, [n-2-(aminoethyl)-3-aminopropyl]dimethoxy methylsilane, etc. and Table 2 consists of for example triallyl isocyanurate, triester of benzoic acid and 2-ethylhexanoic acid with trimethylolpropane.

The first draft of the positive list for FCMs was published in August 2019 under the amended Food Sanitation Act. Currently, the positive list consists of:

• Approximately 300 base polymer resins
• 750 additives
• 180 base polymer resin additives
• 50 trace monomers

The revision follows a consultation phase from 26 April 2022 to 15 July 2022, where businesses were asked to provide comments and list suggestions to the MHLW. Enforcement of the new revision is expected to begin on 1 June 2025.

The Japan Food Contact Material Safety Centre gave companies advice at the end of March to review the list of compounds, the Ministry's policies based on company comments, and the revised use restrictions for some substances.

On 14 February 2023, Japan’s Ministry of Environment (MOE) announced its plan of drawing up proposals to designate poly(oxyethylene) nonylphenyl ether (NPE) as class II specified chemical substance....

On 14 February 2023, Japan’s Ministry of Environment (MOE) announced its plan of drawing up proposals to designate poly(oxyethylene) nonylphenyl ether (NPE) as class II specified chemical substance.

Class II specified chemicals are those that have been discovered (or are soon anticipated to be discovered) in significant amounts in the environment and are believed to represent a risk of long-term harm to persons and/or the ecosystem. Currently, there are 23 substances in this class, including trichloroethylene, tetrachloroethylene, carbon tetrachloride, and triphenyltin N,N-dimethyldithiocarbamate. Class II specified substances are regulated under Japan’s Chemical Substances Control Law and require mandatory reporting of present and anticipated production quantities.

In Japan, NPE is widely used as:

• wetting agent, emulsifier, and dispersant in textile processing.
• detergents, dishwashing liquids, and floor cleaners in household and industrial cleaning products.
• defoaming agent in the production of paper and pulp.
• emulsifier and wetting agent in the production of pesticides and herbicides.
• emulsifier and surfactant in cosmetic products such as shampoos, body washes, facial cleansers, etc.

By the end of 2023, the MOE plans to inform the WTO and launch a public consultation on the recommendations.

On 31 January 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft notification to begin measuring workers’ exposure to 15 specified chemical substances, dust and organic ...

On 31 January 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft notification to begin measuring workers’ exposure to 15 specified chemical substances, dust and organic solvents, using personal sampling, under the Industrial Safety and Health Act (ISHA).

Owing to their high toxicity, the specified chemical compounds are subject to preventative actions under the MHLW's Ordinance on Prevention of Risks Due to Specified Chemical Substances.

The Specified Chemical Substances are listed below:

• Benzene
• Acrylonitrile
• Formaldehyde
• Ethylene oxide
• Auramine
• Ortho-toluidine
• Dimethyl sulfate
• Propylene oxide
• Magenta
• Diantimony trioxide
• Dimethyl-2,2-dichlorovinyl phosphate (DDVP)
• Refractory ceramic fiber
• Methyl bromide
• Naphthalene

The changes to ISHA were anticipated to be completed in March 2023, and go into force on 1 October 2023.

In the report “Expert Committee on Chemical Substance Management Financial Year (FY) 2022”, the MHLW also suggested workplace environment concentration standard values (exposure limits) and testing techniques for 67 compounds. Moreover, it lists substances due for assessment in the upcoming financial years. The report was released on 10 February 2023.