Japan Regulatory News

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%.

Hair dyes and "quasi-drugs" are governed under the Pharmaceutical and Medical Devices Act in Japan. Before producing or promoting their products, businesses must first meet registration requirements a...

Hair dyes and "quasi-drugs" are governed under the Pharmaceutical and Medical Devices Act in Japan. Before producing or promoting their products, businesses must first meet registration requirements and receive approval from the Ministry of Health, Labour and Welfare (MHLW).

 The MHLW announced in two separate notifications on 23 December 2022, that it will remove two additives from its list of additives for quasi-drugs products and one from its positive list for hair dyes. They become operative on 1 January 2023.

Methylrosaniline chloride and Stearyl dimethyl amine are removed from the approved list for quasi-drugs. The updated list consists of total 2746 additives. Two additives i.e. Hydrogenated Lanolin and Methoxyethylene Maleicanhydride Copolymer, are also renamed to "Lanolin, Hydrogenated" and "Methoxyethylene Maleic Anhydride Copolymer" respectively. The names of further six additives such as N-Acetyl-L-Cysteine, Ethanolamine, Synthetic Zeolite, etc. are also revised.

The positive list for hair dyes was also updated to eliminate methylrosaniline chloride and also renamed the additive "3-Propanol (Reagent)" as "2-Propanol (Reagent)". There are a total of 1848 additives in the most recently updated list.

The additives are used in pharmaceuticals and health products as well as some cosmetic products like skin whiteners, deodorants, hair coloring dyes, etc.

On 26 December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a notice containing new requirements for several substances to its food contact materials (FCMs) positive list ...

On 26 December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a notice containing new requirements for several substances to its food contact materials (FCMs) positive list for polymers.

On April 2020, the ministry published its first draft positive list of substances under the amended Food Sanitation Act of Article 18(3), which became effective on 1 June 2020. Companies were granted a five-year transition period until 31 May 2025, during which they may comply with the regulation. Enforcement is set to begin on 1 June 2025.

Substances on the positive list are currently divided into two tables:

The revision of table 1 for polymers is based on industry comments on the April 2022 proposed draft tables. A revised draft of table 2 for additives is anticipated to be released in early 2023.

The ministry has revised numerous existing compounds, such as ester of methacrylic acid with ethylene glycol, aromatic hydrocarbon and ethylene glycol or oxirane with new standards, limits, and conditions for use. For several compounds like 1, 4-butanediamine, butyl acrylate, methyl methacrylate, etc. the ministry eliminated the pre-existing standards.

The MHLW has also updated the names of compounds in English and Japanese as well as the CAS and code numbers in the notice.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has classified 200 substances under Category 1 for carcinogenicity. The announcement was made on 26 December 2022, under an amendment to the Ind...

Japan’s Ministry of Health, Labour and Welfare (MHLW) has classified 200 substances under Category 1 for carcinogenicity. The announcement was made on 26 December 2022, under an amendment to the Industrial Safety and Health Act (ISHA).

Companies handling these compounds are required to adhere to ISHA regulations, which include maintaining records of the safety precautions implemented as a consequence of risk assessment and the level of worker exposure for 30 years.

The mandatory requirement will be implemented in two phases.

Phase 1:

Enforcement will begin on 1 April 2023 for 120 substances which include:

• Biphenyl
• Tetrafluoroethylene
• 1,2,3-trichloropropane

Phase 2:

Enforcement will begin on 1 April 2024 for the remaining 80 substance which include-

• Lead styphnate
• Glycidamide
• Chloramphenicol

On 15 December 2022, the Ministry of Labour, Health and Welfare (MHLW) released a document containing a plan to introduce workplace exposure limits for 860 chemical substances under the Industrial Saf...

On 15 December 2022, the Ministry of Labour, Health and Welfare (MHLW) released a document containing a plan to introduce workplace exposure limits for 860 chemical substances under the Industrial Safety and Health Act (ISHA). Companies will need to implement risk assessments and take the necessary measures to keep workers’ exposure to those substances within allowable limits.

The ministry will publish a list of 120 compounds with exposure limits that will be in effect for the current financial year, which ends on 31 March 2023, following the last expert conference on 30 January 2023. The MHLW is expected to list 170 substances in the financial year 2023, 180 substances in the year 2024 and 390 substances in the year 2025 and after. Once public comments have been received, ISHA will be amended and the exposure limits will be in force. The ministry did not provide a date for its amendment.

On 30 November 2022, Japan informed businesses that in cases where air exposure levels for organic solvents and other compounds have exceeded authorized concentration limits, occupational risk assessments must be conducted using personal sampling techniques. Enforcement begins on 1 April 2024.

The MHLW is not intending to establish workplace exposure limits for the regulated compounds included on the designated chemical substances list at this time. The Ordinance on Prevention of Hazards Due to Specified Chemical Compounds establishes precise guidelines and precautions for certain substances to avoid exposure.