CHEMICAL COMPLIANCE IN CHINA FOR EU EXPORTERS
The Chinese chemical regulatory framework has become increasingly influenced by international chemical regulations, in particular, the European and US framework. The previous legislation of management of new chemical substances in China was amended on October 15th, 2010, through the enactment of the ‘Measures for the environmental management of new chemical substances’ by China’s Ministry of Environmental Protection (MEP). This regulation is similar to EU REACH and adopts several principles and concepts of the European regulation, and thus has been called ‘China REACH’. However, China REACH is a general term for legislation covering hazardous, toxic and new chemical substances while the Measures specifically regulate new chemical substances.
Horizon Risk Consultancy Ltd provide you with cost-effective chemical compliance and registration services through our partner CIRS, a leading regulatory compliance consultancy headquartered in Hangzhou, China.
No single Chinese regulatory authority is responsible for with chemicals registration. A number of government authorities deal with chemical management in China. This means a simple chemical product can fall in the jurisdiction of several authorities.
EU exporters cannot submit new chemicals applications directly to China authority, you must proceed via a registered regulatory representative established in China.
Comparison of EU REACH and China REACH
|EU REACH||China REACH|
|Similarities||Only Representative/‘OR’-like agent, risk assessment report, process and product orientated research and development (PPORD)
Accumulative data requirements according to tonnage band
Enquiry for new substances
Definition of polymer
|Covers: existing and new chemicals||Covers: only new chemicals|
|Compliance types: registration, restriction, authorisation||Compliance types: notification, IECSC, supplementation|
|Polymer: register monomers||Polymer: notify itself|
|CSR: only required if >10 ton/year||Risk assessment report: required in all regular notifications (> 1 ton/year), and exempted in notifications for polymers|
|Legal entity or natural person in the EU||Legal entity with a registered capital over CNY 3 million in China|
|Data: mandatory sharing of data of vertebrate animals; tests are not required to be performed in EU||Data: voluntary sharing of all data; 3 types of tests should be performed in authorised Chinese labs using local species|
IECSC Search – Evaluation of whether a substance is within the scope of China REACH and determination of right notification type
New Chemical Substance Notification
Data Gap Analysis
Data analysis and evaluation
Data gap assessment
Qualifying documents for translation in Chinese
Writing testing proposal, sending sample to certified labs
Dossier preparation and submission
Translations and Notarization
Updating the notification dossier upon changes
reporting to local enforcement authorities
Fulfillment of other post-notification obligations