Since the “Regulations on Safe Management of Hazardous Chemicals in China” (Decree 591) have been published in 2011 many companies are trying to understand how to register chemicals in the country. The new regulations are certainly one of the most complex legislative measures in China.

The Workshop “New Legislative Regulations for Chemicals in China” took place on October 21, 2013, at the DECHEMA House, Frankfurt am Main, Germany. It was organized by DECHEMA (Society for Chemical Engineering and Biotechnology) and AICM (Association of International Chemical Manufacturers), and was supported by VCI (Verband der Chemischen Industrie e.V.) and CEFIC (The European Chemical Industry Council).

 

Regulations on Safe Management of Hazardous Chemicals in China

The State Council of China published a revised version of the “Regulations on Safe Management of Hazardous Chemicals in China” in 2011 (Decree 591; see Fig. 1).

 

Figure 1. Decree 591 – Regulations on Safe Management of Hazardous Chemicals in China (Graphic from CRC of MEP).

 

There are 102 articles and 8 chapters, which include general provisions, safety management of manufacture and storage, safety management of use, safety management of operation and marketing, safety management of transportation, registration of hazardous chemicals and emergency response, and legal liabilities and supplementary provision [1]. Dozens of supporting measures and numerous national standards have also been issued for this law.

More than seven government bodies (see Fig. 2) are involved in the implementation of this law. It is the main law regulating hazardous chemicals in China.

 

Figure 2. Map of authorities for chemical management in China (Graphic from AICM).

 

Interpretation of Administration Measures for Hazardous Chemicals Registration

To help in the understanding of the administration measures required for the registration of hazardous chemicals the State Administration of Work Safety (SAWS) has issued the “Interpretation of Administration Measures for Hazardous Chemicals Registration”, Order 53 of the SAWS. It was implemented as of August 1, 2012. In total there are 7 chapters and 34 articles.

To allow a better understanding of this complex matter the legislative authority experts from CRC of MEP (Chemical Registration Center of Ministry of Environmental Protection of the People’s Republic of China) and SAWS–NRCC (State Administration of Work Safety – National Registration Center for Chemicals) were invited to Frankfurt to give detailed explanations on:

• How to register chemicals in the People’s Republic of China.
• How to achieve the material safety data sheet (MSDS) & Safety Label.
• How to implement a physical hazards & classification management.
• The difference between EU REACH and China REACH.

 

The Chemical Regulation Framework in China

The chemical regulation framework in China is the key point for foreigners to understand how laws, regulations, or standards are determined (see Fig. 3). A map of authorities for chemical management in China gives an overview on whom to contact to register chemicals in China (see Fig. 2).

 

Figure 3. Chemical Regulation Framework in China (Graphic from AICM).

 

Definitions of hazardous chemicals are based on the Globally Harmonized System (GHS). Hazardous chemicals refer to highly toxic substances and other chemicals that are toxic, corrosive, explosive, flammable, or are combustion supporting and can do harm to people, facilities, or the environment. [1]

The catalogue of hazardous chemicals should be determined, promulgated, and properly adjusted in accordance with the hazard identification and classification by the SAWS, as well as the Ministry of Industry and Information Technology, the public security authorities, the Ministry of Environmental Protection, the Ministry of Health, the quality supervision, inspection and quarantine department, the transport department, the railway department, the civil aviation department, and the agricultural department under the state council [1].

Obligations under the regulation Decree 591 are imposed on manufacturers of hazardous chemicals in China, importers of chemicals into China, and the storage, use, sales, and transportation of chemicals in China. The previous versions of clauses from 2002 for the production, storage, import, use, sales, and transporting of hazardous chemicals will be replaced by new ones by end of this year.

All chemicals classified as hazardous chemicals should be registered at SAWS–NRCC.

For an effective registration process, experts recommend improving the communication with local officials, by using associations as a platform to approach authorities with general problems and to share best practice methods within the industry.

 

Reference

[1] Decree 591: Regulations on Safe Management of Hazardous Chemicals in China, translation by Dr. Michael Chang, Chemical Insprection & Regulation Service (CIRs), China and Ireland, 2012.

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• Workshop documentation is available through DECHEMA Ausstellungs-GmbH at a price of € 150 from Ms. Sinian Huang at [email protected]