REACH Compliance For EU Exporters In China 

At Horizon Risk Consultancy Ltd we are able to provide you with cost-effective REACH compliance and chemical registration services through our partner CIRS, a leading regulatory compliance consultancy headquartered in Hangzhou, China.

       

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 in 2010, through the enactment of the ‘Measures for the environmental management of new chemical substances’ by China’s Ministry of Environmental Protection (MEP).  The Chinese Ministry of Ecology and Environment (MEE) issued its Order 12 – The Measures for the Environmental Administration Registration of New Chemical Substances in 2020. It replaces China MEP Order 7 and comes into force on 1 Jan 2021. 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.

Your Challenges

No single Chinese regulatory authority is responsible for 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 Chinese authorities, you must proceed via a registered regulatory representative established in China. Our partner CIRS is a recommended service provider by China Inspection and Quarantine Bureau (CIQ).

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
Differences	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 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

Registration Process

Initial Assessment
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 collection
Data analysis and evaluation
Data gap assessment
Qualifying documents for translation in Chinese

Testing
Writing a testing proposal, sending the sample to certified labs
Dossier preparation and submission
Post-notification Maintenance

Translations and Notarization
Updating the notification dossier upon changes
reporting to local enforcement authorities
Fulfilment of other post-notification obligations

Please contact us to discuss your specific needs and how we can help.