182

Serial Lecture: Regulations for Color Materials -8J. Jpn. Soc. Colour Mater., 90〔5〕，182–190（2017）

Overview of China New Chemical Substance Notification(Regulation Framework, Key Point and Implementation Progress)
Zhang Mo＊,†＊ Technical Dept. - Asia-Pacific Chmical Registration, Technical Supervisor, REACH24H Consulting Group China,

14th floor, Building No 3, Haichuang Technology Center 1288 West Wen Yi Road, Hangzhou, 311121 China†Corresponding Author, E-mail: zhangmo@reach24h.cn(Received February 17, 2017; Accepted March 30, 2017)
Abstract
In China, new chemicals are regulated by Ministry of Environmental Protection Order No.7 and required to be notified before entering into
Chinese market. The current regulation has been implemented for seven years and new amendments are in progress. Here the framework ofthe regulation, the key point and the implementations of China new chemical notification are reviewed before the revision release. Besides,
the main possible amendments are also summarized according to the latest revision progress.
Key-words: China new chemical notification, MEP Order No.7, SCC, Framework, Guidance revision

1．Introduction
China is one of the countries in the world enforcing
registration system for new chemical substance which has
not been put into domestic market before. The regulation
called ‘Measures on the Environmental Management ofNew Chemical Substances’ was published initially on 12thSep 2003, as Order No.17 of State Environmental Protection
Agency. At that time the companies which intend to produce
new chemicals in China or import new chemicals into China
were required to summarize the data of the chemical andsubmit it to China authority to get market approval. In thelate 2000s, influenced by the ‘Risk Assessment’ concept
in chemical management field, the ‘Measures’ in China
was revised and subsequently issued by Chinese Ministryof Environmental Protection as Order No. 7 on 19th Jan
2010 (China State Environmental Protection Agency wasupgraded to Ministry of Environmental Protection in 2008).
The revised ‘Measures’ is usually called ‘the New Measures’and it’s the current valid version to regulate new chemicals inChina. According to ‘the New Measures’, companies which
produce new chemicals in China or import new chemicals
into China are still the main body obliged to notify chemicals
to Chinese authority. What differs is, in addition to the hazard〔氏名〕 張沫〔現職〕 中国 REACH24Hコンサルティング・グルー
プ アジア地域化学品登記技術マネージャー〔趣味〕 読書，旅行〔経歴〕 2012 年浙江大学生物化学科修士課程終了。
同年 REACH24Hに入社，中国新化学物質申告に従事，数多くの申請成功実績をもっている。

© 2017 Journal of the Japan Society of Colour Material

data, the companies also take responsibilities of doing risk
assessment for chemicals and submit the data set together withthe risk assessment report to Chinese authority for approval.

2．Authorities and Functions
2.1 Major Administration Department
In the complicated legislative framework of chemical
management in China, the level of ‘Measures on theEnvironmental Management of New Chemical Substances’is right lower than the ‘Regulations on the Control over
Safety of Hazardous Chemicals’, Decree No.591 of China
State Council. Since it’s a ministerial regulation, Ministryof Environmental Protection (hereafter referred to MEP) is
the primary administration department, which takes chargeof publishing regulation, issuing registration certificates,making the public announcement and giving supervision
notice to local environmental protection bureaus, etc.
2.2 Technical Supporting Department
Chemicals Registration Centre of MEP (hereafter referredto CRC-MEP ) has been in charge of all the technicalsupporting work of new chemical notification since the 2003
version of ‘Measures’ was implemented. In 2013, CRC-MEP
was combined with Solid Waste Management Centre of MEP
and a new department named Solid Waste and Chemicals
Management Center of Ministry of Environmental Protection(hereafter referred to SCC-MEP) was established. SCC issubordinated with MEP and mainly focus on the drafting andrevising of relevant technical supporting documents of new
chemical notification, the most important of which is China
New Chemical Substance Notification Guidance, the maintechnical document that guides the notifiers to complete－22－