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China REACH requires that the ‘new’ chemical substances in China to be notified to the Chemical Registration Center -Ministry of Environmental Protection (CRC-MEP). A new substance is any chemical substance that is not included in the Inventory of Existing Chemical Substances in China. (IECSC). Categories of exemption from notification include finished products, naturally occurring substances, alloys and non-isolated intermediates.
China REACh impacts many industries including the textile, agrochemical and plastics industryies due to its broad scope and definition of a new chemical substance. Under China REACh, new substances or polymers require notification before being produced or imported. New substances contained in preparations or articles may also require notification.
Preparations: Substances present in preparations or mixtures such as surfactants, plasticizers, preservatives, dispersing agents, flame retardants etc. are also subject to notification if they are classified as new substances, are not included in the IECSC and have not been manufactured in China before 2003.
Impurities: New substances as impurities are permitted to be present in the substances up to certain limits. If the impurities exceed the limits, the substance would be considered as a multi-constituent substance.
Raw materials and Intermediates:The registration of cosmetics, pharmaceuticals, pesticides, veterinary medicine, feed additives, radioactive materials etc. are governed by other regulations and thus are not affected by China REACh. However their raw materials and intermediates, if not included in the IECSC, are subject to registration.
The scope of the regulation also extends to new chemical substances of variable composition and complex reaction products without unique structural formula. The notification requirements for an intermediate are the same as that of a substance.
Polymers: Under China REACh, polymers are considered to be a type of chemical substance. While the definition of a polymer is similar to that of EU REACh, the notification procedure is quite different. Unlike EU REACh, polymers themselves require notification if they are new substances. If the new substance monomer is present in a low concentration (<2% w/w), or the polymer is a ‘Low concern polymer’, polymers may be registered by simplified notification. Polymers are assigned special provisions in the MEP’s Guide for New Chemical Substance Notification with special requirements for the polymers registered by regular notification.
Articles: Articles with intended release of a new substance require notification, irrespective of the quantity released. The new substance released is required to be notified. Examples include scented products, ink cartridges and fire-fighting equipment.
