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Here we would like to share some case studies where REACH24H helped foreign companies comply with China REACH in an efficient manner.In practice, most notifications are conducted under the general case of simplified notification or regular notification which will be reflected in this article.
Case Study 1: Invalid Test Data
The substance of the company is a plant extract not being able to be extracted out of its organic solution. Meanwhile, the concentration of the plant extract in the organic solution is too low to produce valid test data.
We carried out talks for several weeks on end with both researchers of our committed laboratory and experts in CRC. First, we made a confirmation with the company whether a pure sample could be obtained in technical ways. As we expected, the company gave us a negative result, so we requested them to issue a prudent self-statement with justification materials attached.
Now that purification seemed impossible, we tried considering if they could test on the whole products (solvents) but our communication with the laboratory concluded that the concentration of the new substance in the ethanol solvent was too small that the tested data ended up as invalid data. Again, we requested the laboratory to issue an expert statement in line with the requirement of the regulation.
In the following step, we made numerous inquiries to the CRC-MEP helpdesk for advice on this kind of issue. The CRC experts replied that they had not reached a solution for the present and they would report the question to the Ministry of Environmental Protection. In the meantime, we set about making a comprehensive evaluation on the current justification materials and potential risks of failure.
In the end, we managed to submit the notification dossier without the testing data of pure plant extract, instead, an eco-toxicological test report on the whole product (the plant extract in organic solution) in our committed laboratory, a representative agent statement as well as a self-statement of the situation by the company are incorporated.
Case Study 2: Read-across Data
One of our non-Chinese clients is committed not to take animal tests due to the company's social responsibility policy, which makes it a challenge to get the laboratory test data, which is required under China REACH. Although the EU REACH registration conditionally accepts non-animal test alternatives like QSAR, read-across or grouping, etc., China's New Chemical Substance Notification has insisted on the single approach of animal testing for certain important endpoints.
REACH24H has worked out two solutions for such a dilemma.
REACH24H could arrange to order the animal tests required and the non-Chinese client could purchase the existing animal test data from REACH24H. For the sake of business confidentiality, the client could sign an agreement with REACH24H and pay only a small portion of the testing cost for track management service.
Read-across approach could be adopted to avoid the animal tests. Read-Across is one of the data sources for the substance notification dossier. However, CRC-MEP puts very strict standard on the similarity of the substances used for read-across. In terms of read-across, CRC-MEP remains very conservative on its inclusion in the notification dossier.
For this case, our Non-Chinese client adopted the first solution. Animal testing is obliged to be done in the appointed Chinese lab, however, this is not true for non-animal testing (approved by China's Ministry of Environmental Protection). Company could decide which lab to choose, a Chinese lab or an MAD (Mutual Acceptance of Data) GLP lab. Generally Speaking, data generated by the MAD GLP lab are of high quality and could be accepted by EU REACH registration, but expensive to purchase; While data from the appointed Chinese lab is less expensive but could only be used for new substance notification in China.
