化学品风险评价

The Introduction of New Chemical Regulation and

Environmental Risk Assessment Requirement in China

Jinglei NIE, Jing YE

(Chemical Registration Centre of MEP, Beijing 100012, China)

Abstract: In 2010, the Ministry of Environmental Protection (MEP) promulgated the amended Measures on Environmental Management of New Chemical Substances (MEP Order No 7), and came into force from October 15th, 2010. This paper will introduce this new regulation on new chemical substance management, and including the important changes, focus on the requirement of Risk assessment and risk control measures on new chemical substance management in China.

Keywords: new chemical substance, regulation, risk assessment, environment

1 BACKGROUND

Being one of the biggest producers of chemicals in the world, China takes the first place on the market in terms of the amount of its products in the world chemical industry. Although the chemical industry of China has been developed very rapidly in recent decades, its industrial structure and layout of chemicals are not appropriate, resulting many serious environmental problems.

These reasons urged the administrative authorities to build an effective environmental management system of chemicals, develop advanced technologies to prevent pollutions caused by chemicals and strengthen chemical control legislation and regulations.

2 ENVIRONMENTAL MANAGEMENT OF NEW CHEMICAL

2.1 Old Regulation of New Chemical

On 12th Sep 2003, the former State Environmental Protetion Adiministration (SEPA) issued the Measures on Environmental Management of New Chemical Substances (SEPA Order No. 17) which had been implemented since 15th Oct 2003. According to this document, the manufacturers or importers of a new chemical substance shall apply and obtain the registration certificate prior to manufacture and import such substance.

Based on the amount of chemical substances proposed to be notified, there were three levels of normal notification. The higher level notified, the more data required. A Notification-Review Procedure has been established to cover processes of notification, acceptance, review, approval and supervision.

2.2 New Regulation of New Chemical

To improve the environmental management of new chemical substances and control environmental risks posed by new chemical substances, the Measures on Environmental Management of New Chemical Substances were amended and promulgated by the Ministry of Environmental Protection on January 19th, 2010, and became effective from October 15th, 2010 (MEP Order No 7) and, at the same time, the Measures on Environmental Management of New Chemical Substances (SEPA Order No. 17) issued by the former SEPA was repealed.

There are six chapters in the Measures which are general provisions, notification procedures, registration administration, follow-up control, legal responsibilities and supplementary provisions.1

Author Biography: Jinglei NIE, male, vice professor, the chief of the new chemical notification division of the CRC-MEP. Email: niejl@.