Japan Regulatory News

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 12 December 2022, Ministry of Economy, Trade and Industry (METI) of Japan notified the WTO of the proposal to reduce the use of fluorocarbons in air conditioners and meet global warming potential (...

On 12 December 2022, Ministry of Economy, Trade and Industry (METI) of Japan notified the WTO of the proposal to reduce the use of fluorocarbons in air conditioners and meet global warming potential (GWP) targets. Companies are required to meet GWP objectives specified for certain goods by a target fiscal year under the Act on Rational Use and Proper Management of Fluorocarbons. Global warming potential is the heat absorbed by any greenhouse gas in the atmosphere, as a multiple of the heat that would be absorbed by the same mass of carbon dioxide (CO₂).

Fluorocarbons are fluorinated carbon chain polymers, and they belong to the class of per- and polyfluorinated compounds (PFCs). PFCs are used in refrigerants and solvents and have been recognized as chemicals of concern for some time because of their persistence and ecological toxicity.

Following are the newly listed products and their targets:

The enforcement of the proposed changes is anticipated to begin in March 2023 after a 60-day comment period, with the exception of the labelling regulations, which would take effect in October 2023.

Japan establishes GWP targets for the sectors with the highest environmental effect and where non-fluorinated refrigerants or other low-GWP compounds are commercially accessible and energy efficient.

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.

On 21 November 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW) published an interim report on worker exposure measuring requirements, in order to assist businesses in getting ready t...

On 21 November 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW) published an interim report on worker exposure measuring requirements, in order to assist businesses in getting ready to comply with proposed changes to the Industrial Safety and Health Act (ISHA). The report includes mandatory personal sampling for certain substances 

The ISHA will be updated by 31 March 2023 to match the suggested measuring requirements contained in the report. The recommendations from the "Panel of Experts on Chemical Substance Management Interim Report" include information on the requirements for measuring worker exposure for the short-term (15 minutes) and long-term (8 hours), sampling location, and evaluation of data for risk assessment. They are intended to ensure that businesses comply with the ministry's allowable concentration limits under the ISHA.  

Recommendation from the 'Panel of Experts on Chemical Substance Management Interim Report'   

Japan approved the revisions to ISHA in May 2022. The revision includes the recruitment of workplace risk assessment managers and safety equipment specialists. Furthermore, modifications to the standards for safety data sheets (SDS) and labelling were included. These changes are expected to be implemented gradually over the following two years 2023-2024. 

MHLW also plans to provide more technical details on requirements for respiratory protective equipment, sample collection and risk assessment methods. 

In Japan, companies must notify new chemical substances manufactured or imported in volumes of less than one tonne a year or apply for small-volume permits. Companies are also required to submit appli...

In Japan, companies must notify new chemical substances manufactured or imported in volumes of less than one tonne a year or apply for small-volume permits. Companies are also required to submit applications for new chemical substances manufactured or imported in volumes of less than ten tonnes per year under the Chemical Substances Control Law (CSCL). The CSCL aims to reduce the risks that chemicals pose to human health and avoid environmental degradation.

The Ministry of Economy, Trade, and Industry (METI) has recently published a manual to assist companies in submitting the necessary data online when applying for authorization to manufacture or import new chemicals. The manual guides through how to set up an e-Gov account, confirm browser settings, install and setup e-applications, and gives instructions for providing information online.

According to METI, all applications should be submitted online by 2025.