What is China 'REACH'?

New Chemical Substances 2003
Guidance 2004

China's existing REACH-like regulation for chemical substances is known as PEANCS, short for Provisions on the Environmental Administration of New Chemical Substances. Issued by the State Environmental Protection Administration (SEPA) of the Ministry of Environmental Protection (MEP), it became effective on October 15, 2003. It is administered by SEPA's Chemical Registration Center (CRC).

Prior to manufacturing or importing a "new" chemical substance, the manufacturer or importer (whether domestic or foreign) must submit a Notification and receive a Registration Certificate from the CRC. The notification form includes a description of the chemical substance; uses of the substance and the type of human/environmental exposure; the substance's inherent characteristics; toxicological (human) test results; eco-toxicological test results including testing in China with Chinese testing organisms; recommendations for safe usage; and payment of a fee.

Notification and registration are at the substance level; chemical products themselves are not registered. However, new chemical substances in the following chemical products are covered: chemical fertilizers, detergents, inks, paints, stabilizers, dyes, flavoring agents, antioxidants, solvents, fillings, carriers, surface active agents, plasticizers, preservatives, defoaming agents, dispersing agents, antiprecipitants, drying agents, dehydrators, emulsifiers, anti-emulsifiers, thickeners, acid/base neutralizers, fire retardants, lubricants, coagulants, flocculants, chelating agents, agglutinates, and "other products of chemical reactions that occur to give substances (materials) particular physical or chemical properties so that they can perform their specific functions."

"Existing" chemical substances, i.e. those that have been published to the Inventory of Existing Chemical Substances manufactured or imported in China (IECSC), are not required to submit a notification. The IECSC is a dynamic list. Once the environmental and public-health impact of a "new" chemical has been assessed by the CRC-SEPA, it is published to the IECSC and is no longer managed as a new chemical substance. In 2007, the IECSC included 45,021 chemical substances:

The public list may be searched on the CRC website, currently located at http://www.crc-mep.org.cn/iecscweb/.

There is also a confidential list of 2,994 substances. A manufacturer/ importer may request an internal CRC search to confirm that his "new" chemical substance was not previously notified/registered.

The Categories of Chemical Substances listed in Guidance Attachment 2 are also not considered "new" chemical substances:

Chemicals managed by other existing laws and regulations: such as radioactive substances, military industry products, pyrotechnics, biological substances, pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods and food additives, feed and feed additives, tobacco and tobacco products

Substances existing in nature: Substances processed only by manual, mechanical, gravitational, water solubility or flotation or heat dehydration; substances extracted from the atmosphere; and natural polymers without physical or chemical processing

Special categories: glass, frit, pottery raw materials and ceramic ware, steel and steel products, high alumina and Portland cements, non-metallic alloys

Articles that maintain their overall structure and shape during final use (incidental or surface chemical reactions are allowed), such as batteries, fibers, thin film, leather, paper, yarn, pencils

Non-commercial or unintentionally produced substances: impurities, waste water/gas/solids and by-products, reactions to environmental factors, reactions during final use

In the following situations, "new" chemicals are required to submit an application for Notification Exemption (but no testing data is required):

Monomer is less than 2% of the polymer
Test sample is for required ecotoxicological testing within China
Quantity for scientific research purposes is 100 kg or less
Quantity for technological research & development is 1,000 kg or less

China's existing regulation of new chemical substances is currently under review by the MEP, with the new rules expected to become effective in October 2010.

Prohibited Chemicals 2005
Severely Restricted Chemicals 2006
Registration of Toxic Chemicals 2007

China maintains three lists of toxic chemicals:

"Prohibited" commodities that may not be imported into China
"Prohibited" commodities that may not be exported from China
Toxic chemicals whose import/export is "severely restricted"

Importing a chemical on the "severely restricted" list is a two-step process. First, the foreign business partner pays a $10,000 fee for a Registration Certificate. The certificate (if approved by SEPA) is issued with a quantity limit and is valid for two years. The domestic company then applies for an Import Clearance Notification which is required for customs clearance.

Domestic companies that wish to export chemicals on the "severely restricted" list must also apply to SEPA for an Export Clearance Notification.

This summary is intended to give you an easy-to-understand overview and does not constitute legal advice. The actual standard in the original language should be reviewed and used for all business, legal, and product compliance purposes.

Should you need assistance in assessing how China's REACH will affect your company, we stand ready to help you. Just email us or give us a call at 972-679-8996 for a timely and personalized response.

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