Japan announces 2023 schedule for low volume notification

On 20 October 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MOE) have jointly published the 2023 schedule for companies to notify new chemical substances manufactured or imported in volumes of less than one tonne per annum (TPA), or to apply for small-volume permits under the Chemical Substances Control Law (CSCL).

An applicant code must be requested by 9 December 2022 from businesses submitting online applications for the first time. In order to fulfil the deadline for the initial online application, the ministry anticipates notifying the code on 11 January 2023.

For receiving the confirmation of manufacturing or importing small amount of chemicals substances from the Government of Japan, one can apply through following methods under the given dates:

• Online electronic submission on e-Gov website
• Optical disc by mail to METI
• Paper documents filed with the MOE

On the same day the three Ministries also published the deadline for companies to submit applications for low volume chemical permits under the Chemical Substances Control Law (CSCL) or to notify new chemical substances manufactured or imported in volumes of less than ten TPA in a separate notice.

Applicants can submit their applications for the permits via the e-Gov website, METI, or via mail that is addressed to the ministry. One month after the application deadline, the results of the applications will be made public. Detailed instructions for submissions are available on the METI website.

Companies must provide biodegradation studies and/or bioaccumulation studies to support their applications, as well as the projected amounts they anticipate to import or manufacture. The government must be able to evaluate the substance's potential for bioaccumulation, human toxicity, and ecotoxicity through biodegradation studies that provide information and analytical data on degradation products. Good laboratory practice (GLP) compliance is required for test data.

Companies who are making their first online application must have an applicant code. Companies must apply for the code by 10 January 2023 and may anticipate receiving it on 8 February 2023 in order to fulfil the first application deadline.

Applicants who want to manufacture or import the chemicals must include all the relevant details about company name, addresses, notifier or responsible person, volume, uses of chemicals to be exported, and the structural formula of the chemicals in the application. To guarantee that the overall national yearly volume is within the acceptable range for the given substance, the government will modify the authorised amounts for each application.

The Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE) and Ministry of Economy, Trade and Industry (METI) are jointly responsible for processing the applications.

The penalty for non-compliance is prison of up to one year or a maximum fine of 50 M Japanese yen.