Alissa Sasso is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
China is on a steady path toward improved chemicals management, one that in many ways increasingly resembles the policies of the European Union’s REACH regulation. On July 11th, China’s State Administration of Work Safety (SAWS) finalized and published its “Measures for the Administration of the Registration of Hazardous Substances,” which became effective August 1st. The new rule applies to all existing substances in China’s Catalogue of Hazardous Chemicals and is aimed at increasing the effectiveness of the primary legislation on the management of hazardous chemicals, known as Decree 591.
The new rule, an update of the initial rule from 2002, complements earlier regulatory steps taken to address new chemicals. A description of the major changes to the registration process, compiled by the consulting group REACH24H, is available here. Below we’ve highlighted and provided a summary of the most significant requirements under the new Measures (and those most relevant to the U.S. chemical industry):
- Extension to importers
- Enhanced data requirements
- Expansion of chemicals subject to registration
Extension to importers. While registration of these toxic chemicals by domestic manufacturers has been required since 2002, for the first time importers will be required to submit registration dossiers. Foreign manufacturers do not themselves register; rather, their partner companies that import their chemicals into China or appointed representatives do. Hence, foreign manufacturers (including those in the U.S.) will need to supply data for submission as part of the registrations for their chemicals. For many companies based in countries already operating under heightened chemical regulations, this may be less of a burden; but for companies in the U.S., these data requirements will likely require more effort.
Enhanced data requirements. Taking another page out of REACH’s play book, companies are now required to submit detailed information on classification and labeling, hazard properties including environmental and toxicological data, use and safety procedures.
Expansion of chemicals subject to registration. The Catalogue of Hazardous Chemicals serves much the same purpose as ECHA’s Classification and Labeling Inventory. Although the new Measures do not themselves specify an update to the Catalogue, China is aiming for a revision of the catalogue by the end of 2012 (Chemical Watch, subscription required). The new list will at least double the scope of the current catalogue, with expected totals between 7,000 and 10,000 chemicals. This means that all companies involved in the chemical market in China will need to closely follow updates to the list, as the additions will trigger new obligations. The major reason for the increase in the size of the list is the identification of more chemicals meeting the broad definition of “hazardous” substances, including chemicals which are highly “toxic, corrosive, explosive, flammable, and do harm to human body, facilities and environment.”
Aspiring to REACH
REACH’s influence is showing up in China through more than just stricter legislative policies. SAWS intends to directly utilize the registration data being collected and disseminated by ECHA under REACH to inform further additions to its Catalogue (Chemical Watch, Subscription required). This will include consideration of chemicals that ECHA has identified as priorities.
We’ve blogged before about the important step that ECHA took to address endocrine disruptors through “equivalent concern” justifications. Now this same step is popping up in China. In a Chemical Watch webinar discussing Decree 591,Andy Burgess of Acta-PLS stated that companies doing business in China should also expect chemicals of “equivalent concern” to be regulated soon. (It’s not just China: South Korea is dealing with endocrine disruptors too).
China and other countries are clearly following REACH closely, in some cases mirroring ECHA’s movements in identifying key areas to include in their domestic programs. And while many in U.S. industry continue to argue that REACH is not a “gold standard,” REACH is leading many other countries to take similar steps to improve chemical safety.
Although China’s hazardous chemical registration largely resembles the “R” in REACH, the policies do deviate in terms of the scope of chemicals to be addressed. Registration in China is currently limited to substances listed in its Catalogue of Hazardous Chemicals. In contrast, REACH ultimately will systematically address all existing chemicals above 1 metric ton in annual production, with specific deadlines based on tonnage bands. However, as noted above, China is making serious efforts to increase the number of existing chemicals to be addressed.
Some critics of China’s new policies have called for more clarity in the “vague language” of the Measures relating to the “gradual reduction of prioritized chemicals,” pushing for an even greater adoption of REACH-like strategies (Chemical Watch, subscription required). Regardless, the rate at which China is publishing supporting amendments elaborating on the controls it is imposing on hazardous substances, including the scheduled update to the Catalogue, is impressive.
China blows past the U.S. …. again
China has had a prioritized list of “hazardous chemicals” in place for a decade. In contrast, we in the U.S. have no such formal list under the 36-year-old Toxic Substances Control Act, under which EPA has managed to require testing of only a few hundred of the tens of thousands of existing chemicals in U.S. commerce.
How does the scope of China’s regulations overlap with chemicals used in the U.S.? Let’s take a look at how many of the chemicals prioritized for registration in China are being produced or used in the U.S. An English version of the Catalogue of Hazardous Chemicals, compiled by the consultant Chemical Inspection and Regulation Services (CIRS) is available here; our analysis presented below is based on the approximately 2500 chemicals that have accompanying CAS numbers on that list.
- Almost half of the substances, 1188 chemicals, appear on the public portion of the U.S. TSCA Inventory.
- 568 of the substances were publicly reported in the 2006 Inventory Update Reporting (IUR) reporting cycle, which means these chemicals were manufactured in 2005 in amounts of 25,000 pounds or more per year per site.
For most of these overlapping chemicals, companies can manufacture or use them in the U.S. without ever notifying the EPA. The registration process in China and the incorporation of importers into it will exert additional pressure on U.S. companies that participate in the international chemicals market. These companies are already dealing with dramatically different chemical policies at home and abroad; how much longer can U.S. companies afford to operate under such different management regimes?
Stricter regulations are here to stay
The additional obligations under China’s new regulations are not to be taken lightly. Failure to comply with registration obligations could seriously hamper doing business in China. We’ve previously reported on China’s ramped-up enforcement system, with the most serious penalties being criminal. In the past year this enforcement system has shown that it is more than just bark: the Ministry of Environmental Protection has revoked several applications for the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC), and has publicized the names of violators that submitted poor quality data or forged reports, including via social media (Chemical Watch Webinar). Publicly criticizing companies that fail to comply with chemical regulations as “bad actors” is being supplemented with the government’s authority to bar a violating company from submitting new chemical notifications for up to three years. The use of social media as a means of punishment reinforces a point we’ve made before: that consumer demand for safer chemicals is becoming a powerful force (also see here and here).
China’s growing commitment to improved chemical safety may help to put an often cited excuse of U.S. industry to rest: that heavier U.S. regulations will push business overseas to China. Not only have China’s latest moves leveled the playing field for domestic and foreign chemical producers, they’ve done so by raising the bar, with more to come. It’s long past time for the U.S. to throw its hat in the ring because the momentum for safer chemicals worldwide shows no sign of slowing down.