Japan Regulatory News

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.

The Japanese Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade, and Industry (METI), and Ministry of the Environment (MoE) held consultations on 18 February 2023, regarding a ...

The Japanese Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade, and Industry (METI), and Ministry of the Environment (MoE) held consultations on 18 February 2023, regarding a ban on the production and import of PFHxS and its salts, as well as the import of some product types containing them, through a partial revision to the Chemical Substance Control Law's (CSCL) Enforcement Ordinance. The action aims to bring the nation into compliance with a global PFHxS ban adopted by the Stockholm Convention on POPs last year.

According to the announcement, comments were given a deadline of 19 March 2023.

The three ministries designated the substance as a Class I specified chemical. According to the CSCL, Class I specified chemicals are those that Japan has determined to be persistent, extremely bioaccumulative, or which have a risk of long-term toxicity to humans.

In Japan, the Poisonous and Deleterious Substances Control Law (PDSCL) designates poisonous and deleterious substances according to their acute toxicity level. On 26 January 2023, the Ministry of Heal...

In Japan, the Poisonous and Deleterious Substances Control Law (PDSCL) designates poisonous and deleterious substances according to their acute toxicity level. On 26 January 2023, the Ministry of Health, Labour and Welfare (MHLW) issued a proposal to designate 3-Aminopropan-1-ol and its mixtures with a concentration of 1% or more as a Deleterious Substance.

The MHLW has categorized 3-Aminopropan-1-ol as Category 1 Skin corrosion/irritation as well as serious eye damage/eye irritation in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) standards established by Japan. The selection of Deleterious Substances is mostly based on these risk groups.

Manufacturers, importers, and distributors of this substance have the obligation to register this substance with the MHLW and are subject to Safety Data Sheet and labelling requirements under the PDSCL.

The MHWL took public opinions on the proposal until 24 February 2023. The changes are anticipated to be completed on 25 May 2023, and go into force on 1 June 2023.

The Ministry also plans to remove Diantimony tetraoxide from the list of Deleterious Substances and change the concentration cut-off for 2-Isobutoxyethanol from 10% to 15%.