Order No. 12 of the Chinese Ministry of Ecology and Environment (MEE), “Environmental management measures Registration of new chemicals, ”Will replace the order n ° 7 of the Ministry of Environmental Protection (MEP),“ Environmental management measures for new chemical substances ”, the January 1, 2021. To implement MEE decree no.12, the MEE has finally published its “Guide for the environmental management of the registration of new chemicals“(Guidelines) on November 17, 2020, which will replace the” Guidelines for the Notification and Registration of New Chemicals “under MEP Order No. 7 on January 1, 2021.
The final guide is generally the same as the draft guide that was reported in our memorandum of August 20, 2020, “China publishes draft guide for environmental management of registration of new chemicals.” There are, however, some important changes regarding the protection of confidential information and data requirements for the regular registration of new chemicals with potential for persistence (P) and / or bioaccumulation (B).
The main changes to the Final Guide are summarized below:
- Physicochemical properties test data generated in laboratories outside of China will be acceptable if the laboratory complies with the administrative requirements applicable in the country in which it operates; compliance with the requirements of the International Organization for Standardization (ISO) 17025 will no longer be required;
- The five-year protection period for confidential information is limited to identity information for new chemicals and can be extended for a maximum of five additional years;
- In vitro skin and eye irritation test data will be accepted if the results are conclusive, that is to say, clearly positive or clearly negative;
- The toxicological data requirements for regular registrations are classified into three categories depending on the P and / or B potential of the substance. Only substances with both P and B potential will require extensive toxicological testing;
- Chironomid sediment-water toxicity testing will only be required for the regular registration of substances that have both P and B potential; and
- Intermediates of pharmaceuticals, pesticides and / or veterinary drugs that have P and / or B potential are exempt from the additional data requirements for regular registrations of all other new chemicals that have P and / or B potential.
Overall, the Final Guide is good news. It addresses some of the main industry concerns about the status quo and reduces the data requirements for the regular registration of new chemicals with P or B potential, although the data requirements are still focused. on hazards and based on test results, not risks.
© 2020 Le Groupe Acta All rights reserved.Revue nationale de droit, volume X, number 329