China Chemical Regulatory

China has enacted its own version of REACH. The amendment of the 2003 “Measures on the Environmental Management of New Chemical Substances,” adopted last December and entering into force this October 15, 2010, will bring China’s chemicals control legislation partially into line with the EU’s REACH regulation. Its impact will be on the manufacturing/importing of “new” chemical substances, i.e., those substances placed on the market in China that are not currently on the Inventory of Existing Chemical Substances Manufacturers or Imported in China (IECSC). The IECSC currently lists only about 45,000 of the estimated more than 100,000 substances that are on the market globally and which are likely used or produced also in China. The new law will thus have substantial impact notwithstanding it concerning only “new” substances.

Following the EU’s practice of releasing important interpretive “guidance” well after adoption of the law, the Ministry of Environmental Protection of the People’s Republic of China (MEP) released six supporting documents (drafts) on its website on June 2, 2010:

Four notification forms and instructions
One guidance on new chemical substances notification
Baseline of Supervision, Administration, and Inspection

Compliance through:

Notification and registration checks

First activity report of new chemical substances
Risk management measures (facilities, personal protection, training)
Administration requirements

Follow-up control for new chemical substances

City-county level—on-site inspections
Province level—problems collected and reported to the MEP
MEP—enforcement actions

Local authorities are entitled to establish their own directives in accordance with each specific situation. Measures may differ from place to place when local governments issue their own directives in the future.

Key provisions of the China New Chemicals Control Measures include:

Notification required on all “new” substances, hazardous and not and whether placed on the market as such, in a preparation or intentionally released from an article.
Increased data requirements relating to respective tonnage bands (same as REACH).
More detailed risk assessment, new requirements on classification and labeling and on safety data sheets.
Notification must be made by a legal entity in China—comparable to the EU’s REACH regulation. Thus only China-based companies can notify directly. Like under REACH, manufacturers outside the jurisdiction can comply only through appointment of an “Only Representative”-type entity in the country.
There are three types of notification:

Typical notification—new substances manufactured/imported annually > 1 tonne.
Simplified notification (meeting criteria):

Regular Simplified notification: Annual production or import volume <1 tonne.
Special Simplified notification: If one of the following four conditions applies:

New substances manufactured or imported for use as intermediate only or for export only, if < 1 tonne annually;
Polymers of low concern or containing a new chemical substance or monomer of < 2%;
New substances manufactured or imported for scientific research purposes between 0.1 tonne and 1 tonne annually (one year notification exemption, non-renewable); or
New substances for technical R&D purposes, where the annual production or import volume is < 10 tonnes (not exceeding two years).

A “scientific research record” is required when a new substance:

Is used for scientific study purposes and has annual quantity < 0.1 tonne; or
Is a sample to be tested in a Chinese laboratory (test sample imported for new chemical substance testing in China).

Steptoe’s China Chemical Regulation Capabilities

Steptoe advises multinational companies on interpreting and ensuring compliance with the New Chemicals Control Measures. In addition, for clients in the chemicals sector, Steptoe is working on projects relating to the emerging regulation of antimicrobials and biocides. This work is principally focused in our Beijing office, but also draws upon our regulatory experience in Brussels and Washington.

More generally, Steptoe’s Beijing office advises non-Chinese companies entering and doing business in the Chinese market. In particular, we assist non-Chinese companies with regulatory, government relations and corporate matters associated with their operations in China. We also help resolve market access and other issues before various national and provincial Chinese government agencies. Steptoe’s knowledge of the Government of China, and experience in the EU and US provide a unique platform to aid our clients’ success.

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