On 9 September 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MoE) jointly published the Notification Schedule for Manufacture and Import of New Chemical Substances for 2023.
The three ministries announced that companies must provide the necessary information via electronic notifications on the website of the National Institute of Technology and Evaluation (NITE). It is mandatory to include following information in the Notification:
company name and address
the name of the responsible agent or notifier
the substance information such as name of substance or compound, chemical structure and formula, uses, expected volume of production or import for the next three years, relevant test results, etc.
If companies need clarifications on any of the requirements, they can submit their request via enquiry forms on the METI and the NITE websites.
The Chemical Substances Control Law (CSCL) divides chemicals into existing and new chemicals. New chemicals must also be notified to, and evaluated by, METI for their biodegradation, bioaccumulation and toxicity to humans and the environment before and after they are placed on the market.
New Chemical Notification Schedule for 2023
Deadlines for submission of preliminary examination materials
Deadlines for new chemical substances with risk assessment results released by the end of March 2018
Deadline for notification
6 October 2022
23 December 2022
5 January 2023
3 February 2023
19 December 2022
3 March 2023
10 March 2023
11 January 2023
3 April 2023
10 April 2023
7 February 2023
28 April 2023
8 May 2023
10 March 2023
26 May 2023
2 June 2023
6 April 2023
30 June 2023
7 July 2023
4 August 2023
8 June 2023
25 August 2023
1 September 2023
5 July 2023
29 September 2023
6 October 2023
4 August 2023
26 October 2023
2 November 2023
12 September 2023
24 November 2023
1 December 2023
Furthermore, the ministries said that they plan to release the 2024 schedule by September 2023.
Japanese standards on chemical classification, labelling and safety data sheets (SDSs), JIS Z 7252 and JIS Z 7253, have been aligned with the Globally Harmonized System (GHS) Rev.6.Until May, 24, 2022, chemical suppliers were given the time to arrange and update relevant SDSs and labels to adapt to new requirements. GHS labels and SDSs are mandatory for the chemicals regulated by the three main clauses for chemicals in Japan, that is, the Industrial Safety and Health Law (ISHL), the Pollutant Release and Transfer Register (PRTR) Law and the Poisonous and Deleterious Substances Control Law (PDSCL).
Whereas for other chemicals falling outside these regulatory categories, implementation of GHS classification and hazard communication elements is encouraged. Despite their different applicable scopes, these laws overall convey the same standards on the criteria for classification, labeling and SDS preparation for:
JIS Z 7252:2019 Classification of chemicals based on GHS of Classification and Labelling of Chemicals, and
JIS Z 7253:2019 Hazard Communication of Chemicals Based on GHS - Labelling and Safety Data Sheet.
The notable revision after these standards were published in May 2019, was the incorporation of an additional hazard class for desensitized explosives with new H statements, H206 to H208, into the standards. A sub-hazard category (i.e., Pyrophoric gas) was also introduced for flammable gases.
Noteworthily, the 3-year grace period expired on May 24, 2022. Therefore, individuals have to follow up with the new requirements to ensure compliance within the industry.
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