The new China REACH
As of 1 January, 2021, the new China REACH, also known as China New Chemical Substance Notification (MEE Order No. 12), has been officially enforced.
The previous China REACH (MEP Order No. 7) has also been replaced by this new China REACH (MEE Order No. 12). Enterprises which manufacture or export new chemicals into China should begin complying with the new regulatory requirements laid out in this new China REACH.
Included in this new China REACH are some significant updates regarding notification scope, notification type, notification procedure, notification material requirements and post-notification requirements.
New chemicals, which are defined as those substances not listed in the IECSC (Inventory of Existing Chemical Substances in China) will be required to comply with the new China REACH. Chemical substances which are listed in the IECSC but where the use of such substances is outside the permitted scope will also need to comply.
The new China REACH also confirms that APIs of Pharmaceuticals, Pesticides and Veterinary Drugs and products with specific function, e.g., surface treating agents, chelating agents, flocculating agents, etc., are all outside the notification scope.
For crystalline hydrate and its anhydrous substance, they will both be treated the same under the New China REACH. For example, if the crystalline hydrate is an existing chemical or the notification has been completed, its anhydrous substance will also be treated as compliant in China, and vice versa.
CIRS will also give a presentation on the new China REACH at the EC Webforum Regulation: Navigating chemical legislation in Asia on April 21. In addition to China, the web event will also focus on regulations in Japan and South Korea.
Under the new China REACH, there are only three notification types: Regular registration, simplified registration and record filling. The suitable notification type for a substance depends on the registration tonnage band (< 1 ton/year, 1-10 ton/year and >10 ton/year) and the substance property (normal substance, polymer, polymer of low concern, etc.). There are also new conditions for Polymer of Low Concern according to the new China REACH.
The updates regarding the notification procedure are mainly concerning the dossier review procedure from the relevant Chinese authority (MEE-SCC, Solid Waste and Chemicals Management Center from Ministry of Ecology and Environment), especially the requirement which stipulates that the dossier shall be updated within 6 months after receiving comments from the authorities.
Notification material requirements
In general, the new China REACH mainly focuses on new substances which are Persistent (P), Bio accumulative (B) and Toxic (T). If the substance has no such properties, only the basic data is required. However, if the substance has P or B or both P and B properties, further data including Toxicokinetic, Carcinogenicity, Chronic Toxicity, etc. may be required. The necessary data used to determine P, B and T properties will also be required in the dossier.
Regarding data sources, either data from Chinese laboratories with national accreditation or foreign laboratories with GLP qualifications will be acceptable. However, several eco-toxicological tests will still be required to be processed in a Chinese lab with a Chinese species, for example, toxicity tests with fish, the bioaccumulation test, the activated sludge inhibition test, etc. For tests which cannot be processed, alternative tests methods including QSAR, READ ACROSS, Expert Evaluation Statement, etc. may be acceptable under the new China REACH.
For enterprises which plan to keep their business information confidential during Regular Registration or Simplified Registration, a confidential necessity statement including confidential items, confidentiality period, confidentiality reasons, confidentiality measures, etc. will be required. The maximum confidentiality period is five years.
For enterprises which plan to process Regular Registration where the target substance is highly hazardous, a social and economic benefit analysis report will be required. This is mainly used to prove the necessity and advantage of using this highly hazardous new chemical from the perspective of economic and social benefit rather than its risky impact on human health and the environment.
Details requirements regarding annual reporting, activity reporting, information disclosure, information transfer, dossier update, etc. are included. Inspection measures from local authorities are also regulated.