Japan Regulatory News

In a notice published in the official government gazette Kanpo on 26 May 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) added 3-Aminopropan-1-ol (CAS number 156-87-6) and mixtures there...

In a notice published in the official government gazette Kanpo on 26 May 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) added 3-Aminopropan-1-ol (CAS number 156-87-6) and mixtures thereof with a concentration of 1% or more to its list of poisonous and deleterious substances. The MHLW designated the substance, used in electronics, cosmetics, textiles, synthetic resin and pharmaceuticals, as 'deleterious' and the designation came into force on 1 June 2023.

The MHLW has classified 3-Aminopropan-1-ol as Category 1 Skin corrosion/irritation as well as serious eye damage/eye irritation in line with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) standards established in Japan. These hazard classes are the primary considerations in selecting Deleterious Substances.

The amendment also includes the following changes, valid from 26 May 2023, to the list of Deleterious Substances:

• The concentration cut-off is changed from 10% to 15% for 2-Isobutoxyethanol (CAS number 4439-24-1), currently designated as a Deleterious Substance. 2-isobutoxyethanol mixtures with less than 15% are excluded from the list.
• Removal of diantimony tetraoxide (CAS number 1332-81-6) and its mixtures from the list of deleterious substances.

Manufacturers, importers, and distributors of Poisonous and Deleterious Substances have the obligation to register their substances with the MHLW and will be subject to SDS and labelling requirements. According to the government's Chemical Risk Information Platform (CHRIP), there are currently 585 substances on the poisonous and deleterious substance list.

On 1 June 2023, the Ministry of Land, Infrastructure, Transport, and Tourism (MLIT), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of the Environment (MOE) of Japan jointly anno...

On 1 June 2023, the Ministry of Land, Infrastructure, Transport, and Tourism (MLIT), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of the Environment (MOE) of Japan jointly announced the proposal to add cybutryne to the list of hazardous substances that need permission when dismantling a ship. Cybutryne is a biocide used in antifouling paints. The action comes after cybutryne was added to the standards for creating an inventory of hazardous elements in April 2023 by the International Maritime Organisation's subcommittee on pollution prevention and response.

The enforcement is anticipated to begin in the middle of July, and public comment is ongoing until 2 July 2023.

It becomes mandatory for ship owners to provide an inventory of any hazardous materials discovered in the ship's machinery and structure in accordance with the country's Proper Implementation of Ship Recycling and Dismantling Act. This act aspires to align with the Hong Kong International Convention for the Safe and Ecologically Sound Recycling of Ships (HKC). The HKC was adopted by the International Maritime Organisation (IMO) in 2009 and will enter into effect 24 months after 15 states have signed it and other prerequisites have been satisfied. The HKC is aimed at ensuring that ships, when being recycled after reaching the end of their operational lives, do not pose any unnecessary risk to human health and safety or to the environment.

On 29 March 2023, Japan’s Ministry of Economy, Trade, and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) released the classification results...

On 29 March 2023, Japan’s Ministry of Economy, Trade, and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) released the classification results for classifying substances under the UN Globally Harmonised System (GHS) of classification and labelling of chemicals.

The list includes classification outcomes for substances that have been reclassified several times in prior years, and it covers 3,281 different substances. The justifications for each substance's classification are listed separately.

The outcomes can be used by businesses as a guide for creating GHS labels or safety data sheets (SDSs). However, according to the National Institute of Technology and Evaluation (NITE), it is not mandatory to provide the classification result on a label or SDS for Japan.

In May 2019, METI, MHLW and MOE jointly released the Japanese standards on chemical classification, labelling, and safety data sheets (SDSs) that are in line with the sixth revised version of the Globally Harmonised System (GHS). The standards are:

• JIS Z 7252: Classification of chemicals based on GHS 6 classifications and labelling
• JIS Z 7253: Hazard communication of chemicals based on GHS 6 labelling and SDSs

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:

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 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.