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How does China REACH work?

If a substance is not listed in IECSC or exempt from the regulation then it is advised to file an official request to the CRC to determine if the substance is really a new substance under China REACH. This is necessary because there are substances in IECSC which cannot be searched from outside. The search cost 3000 RMB (ca. 433 USD; October 2018) per substance.

If the CRC should not find the substance in the IECSC then it is a new substance and a notification needs to be filed, independently from its yearly manufactured or imported tonnage. There are three different types of notification in the China REACH regulation, depending on the desired usage and the quantity of the chemical:

Type of Notification

Desired field of usage

Scientific Research Record Notification (SRRN)

Substances which:
- are used for scientific research and less than 0.1 t/a
- specimen for ecotoxicological tests in Chinese GLP laboratories

Simplified Notification (SN)
Basic conditions

New chemical substance with less than 1 t/a.

Simplified Notification (SN)
Particular conditions

- export out of China (<1 t/a);
- scientific reasearch (0.1 - 1 t/a)
- polymers (only monomers listed in the IECSC)
- polymers (containing <2% (w/w) of new monomers)
- polymers of low concern
- product and procedure research (<10 t/a)

Regular notification (RN)

New substance quantities (=>1 t/a)
There are 4 different tiers, depending on the quantity:
- 1-10 t/a
- 10-100 t/a
- 100-1000 t/a
- >1000 t/a

The regular notification has three different options:
- Joint notification:
o Two or more applicants apply together for the same chemical (quantities add up)
- Serial notification:
o An applicant files a notification for different substances with similar molecular structures and test data for the same or similar purposes (quantities add up)
- Repeated notification:
o Test data of other applicants is being used (quantities add up)

If the regular registration is chosen than it is mandatory to send the dossier to the CRC-MEP for processing. This dossier will be checked for completeness, assessed and finally transferred to the MEP for admission.

The information which are needed for the notification are for example physical and chemical properties, toxicological and ecotoxicological properties. The higher the yearly quantity the more tests are needed. An exchange of test data is possible but not required. The ecotoxicological tests need to be carried out in Chinese laboratories with Chinese specimen.

The Scientific Research Notification (SRRN) is the simplest type of notification. No test data is required, only basic information.

The Simplified Notification requires one to three ecotoxicological tests, depending on type and properties of the substance. No tests are necessary if special conditions apply.

One rule for the Regular Notification is that the higher the quantity the higher the required test data. The physical and chemical tests are the same for all the four different tiers and vary only by physical state (liquid, solid or gaseous). Toxicological and ecotoxicological tests vary widely with the yearly quantity. Classification and labeling in accordance with EU CLP rules might not be sufficient, because China has slightly different GHS-criteria. Also, it is possible that a risk assessment is required.

Test procedures:

In China:
- (Chinese) Guidelines for Testing of Chemicals (HF/T 153-2004), the Chinese standard is not internationally recognized.

Out of China:
- (Chinese) Guidelines for Testing of Chemicals (HF/T 153-2004), or OECD, ISO and other internationally recognized test methods.

Chinese creatures for tests

The term "Chinese creatures for test" refers to creatures which are cultivated in china and therefore meet certain requirements. These are Gobiocypris rarus, Xiphophorus helleri, Brachydanio rerio or Danio rerio and so on. Other requirements for the creatures refer to the test methods in the chemical Test Guidelines (HJ/T153-2004).

China is not an OECD member country, therefore ecotoxicological test data which is obtained through one of the official MEP laboratories is not accepted in other countries.

In addition, existing QSAR reports are only a reference and the Chinese committee can always request additional data if they think the QSAR data are not sufficient.

                                                             

 
 
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