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Regulation on China New Chemical Substance Notification Has Come into Force

"Measures for the Environmental Management of New Chemical Substances (2010)"(MEP No. 7 issued by the Chinese Ministry of Environmental Protection (MEP)) has come into force since 15 October 2010 already. The old version of Regulation issued by the State Environmental Protection Administration (SEPA) on 12 September 2003 was abolished simultaneously.

China REACH not only inherits the new chemical substance notification system, fixes more refined and reasonable notification categories and notification forms and introduces risk assessment, but also sets up a new tracking control system, enhances the procedures and measures of new chemical substance management and specifies the requirements for regulatory inspection. Compared to the old Measure, the texts of China REACH are adjusted from 29 articles to 52 articles, realizing the comprehensive amendment to the old version.

China REACH introduces many new technologies and concepts, including article management, article categories, agent notification, risk assessment, repeated notification, scientific research record, control measures, data sharing, annual report, new information report, new use notification and retrospective assessment, which shorten the assessment and notification time, specify the notification details and materials required and put forward the principle of "higher tonnage, more data".

In order to provoke enforcement of this regulation, CRC-MEP had held a two days workshop in Beijing to discuss more details of this regulation and related guidance on 21st and 22nd Oct. The participants gave their feedbacks to CRC-MEP on the enforcement of this regulation during this workshop.

Furthermore, the team leader of notification unit, Mr Nie introduced that CRC hasn’t received regular notification dossier until 21th Oct, most of the dossiers they were dealing with are scientific research record, simplified notification, as well as the regular notification dossiers according with old version requirements. However, they already got many inquire call regarding to the details of regular notification dossier. Obviously, the implementation of China REACH brings huge challenges for Chinese chemical substance management system. However, opportunities come with challenges. The new regulation is very important to enhance Chinese chemical risk assessment level, stimulate public awareness of the potential risk of new chemical substances and maximize the benefit of new chemical substances under the precondition of protecting both human health and environment.

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