December 8, 2021
By Yuko Howell, senior regulatory specialist, UL’s Supply Chain department
On Oct. 20, 2021, a partial amendment to the Ordinance for Enforcement of the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof, known as the Japan PRTR Law, was issued, updating the Class 1 Designated Chemical Substances and the Class 2 Designated Chemical Substances in the Ordinance.
Class 1 Designated Chemical Substances has increased from 462 substances to 515 substances. The number of Class 2 Designated Chemical Substances increased from 100 substances to 134 substances. The breakdown of the Class 1 and Class 2 Designated Substances below shows the new additions, deselections, and a reshuffling of the current designated substances.
Manufacturers, Importers and users of the Class 1 Designated Chemical Substances are subject to the annual reporting requirement for the system of Pollutant Release and Transfer Register (PRTR), and chemical suppliers of Class 1 and Class 2 Designated Chemical Substances and their mixture products are required to prepare and provide a Safety Data Sheet (SDS) to their customers.
The amended PRTR ordinance will come into effect on April 1, 2023, and subsequently, the substance tracking for the purpose of the PRTR reporting and SDS preparations for the newly designated substances will be required.
The requirement to prepare an SDS for the substances deselected from the designation will remain until the effective date. After April 1, 2023, the requirement will no longer apply to the deselected substances.
To facilitate a smooth transition, the Ministry of Economy, Trade and Industry (METI) is requesting business entities to prepare SDSs for newly designated chemical substances during the transition period. In practice, this means business entities are required to include the name and the concentration information of the designated chemical substance on the SDS and distinguish between two different statuses, e.g., before and after the amendment becomes effective. The component cannot be claimed as confidential business information (CBI) under this law.
The information on the designated chemical substances can appear either in Section 3 or 15 of the SDS, and the METI provides the following as examples of how businesses can implement the transitional measures on the SDS.
|Example 1: Deselected substance
Substance X PRTR Class 1 Designated Chemical Substance (effective until March 31, 2023)
|Example 2: Class 1 substance before the amendment becoming Class2 after the amendment
Substance Y PRTR Class 2 Designated Chemical Substance (PRTR Class 1, effective on April 1, 2023)
|Example 3: A substance newly selected as Class 1 Designated Chemical Substance
Substance Z (PRTR Class 1, effective on April 1, 2023)
Introduction of control numbers (管理番号)
Each designated chemical substance is assigned an ordinance number, and the ordinance number can be reassigned each time the ordinance undergoes an amendment. This can be an unnecessary burden on businesses, as a designated chemical substance can have two different ordinance numbers, and they need to be managed during the transition period. To ease this burden, the METI introduced the control number system, where the Ministry provided a separate aggregated list of current and amended version of Class 1 and Class 2 Designated Chemical Substances and assigned a unique control number to each individual designated chemical substance. Starting April 1, 2023, the control number will be identified along with the chemical name in the PRTR reporting. Giving this potential new requirement, it is strongly recommended by the METI to include the control number of the Class 1 or 2 Designated Chemical Substance on the SDS.
- Partial Amendment to the Ordinance for Enforcement of the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (Cabinet Order No. 288 of Oct. 20, 2021)
- METI website detailing the amendment
- Complete list of Class 1 and Class 2 Designated Chemical Substances with CAS numbers published by the METI
- METI notice regarding preparation of SDS following the amendment