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Contents
Data Requirements
Over 30% of visits to the CRC-MEP website are related directly to this issue.
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. Through tough talks with the CRC-MEP, we finally 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 as well as a self-statement of the situation are incorporated.
Case Study 2: Read-across Data
Some cosmetic companies are committed not to use animal testing, which makes it a challenge to get the laboratory test data, which is required under China REACH.
REACH24H has worked out two solutions for such a dilemma.
REACH24H could arrange to order the animal tests required and the cosmetic company could purchas the existing animal test data from REAH24H;
Read-across approach could be adopted to avoid the animal tests.
Read-across is one of data sources for 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.
Case Study 3: Expert Committee Review
Expert committee review is quite a unique feature of China REACH. In practical compliance work, REACH24H found that there still exist some poorly defined grounds. In such cases, active communication with the CRC-MEP is very critical. There are many such cases that REACH24H’s efficient communication with the experts from CRC-MEP has helped the Non-Chinese companies to avoid the risk of notification failure.
Case Study 4: Toxicological tests: Yes or No?
A Non-Chinese company would like to the file for the regular notification, which requires the most complete data set in the dossier. The toxicologist from that company believed that there is no need to do the carcinogenic toxicity and chronic toxicity. However, through consultation with the experts from CRC-MEP, those 2 tests are compulsory according to the “Guidance on the China new chemical substances notification” and no exemption qualifications are satisfied. In this case, REACH24H helps the companies to avoid possible delays in notification procedure and potential rejection from the CRC-MEP.
Confidential Information
How to protect the company information as confidential is one of the major concerns for most foreign companies. Generally, there are two approaches to realize this goal under China REACH: either use generic name to replace the chemical substance name; or appoint a third party to submit the notification dossier to the CRC-MEP.
Case Study 1: Generic Name
REACH24H have come across several cases that the Non-Chinese companies want to keep the substances chemical name as CBI (Confidential Business Information). Under China Reach, chemical substance names can be treated as CBI by replacing the chemical substance name as the generic name according to the “Guidelines for generic name of new chemical substances” (HJ/T 420-2008). REACH24H have rich experience in the generic naming of the chemical substances. In most cases, REACH24H will have to prepare a confidential justification for companies which would like to keep several substances’ name information inaccessible to the public.
Case Study 2: Third Party Submission
Under China REACH, a third party is allowed to submit the CBI information directly to the CRC-MEP. The third party could be foreign legal entities. REACH24H as the OR will facilitate the submission of materials from the third party without having access to the materials. This approach serves as an effective strategy for protecting confidential information.
Notification Type: Joint Notification or Individual Notification?
A large foreign company A has over 40 daughter companies all over the world. They intend to submit one notification dossier to have the parent company together with all the 40 daughter companies covered by one notification dossier, which initially seems like Mission Impossible.
Through consultation with the experts from CRC-MEP, REACH24H worked out two notification strategies.
A. Joint Notification
The parent company together with its 40 daughter companies will be the notifier, appoints one daughter company in China as the OR. POA and Contracts signed between the parent company+40 daughter companies and the daughter company in China. Since tonnage accumulation applies joint notification, and higher tonnage implies higher data requirements, this notification strategy could lead to uncontrollable high costs and unexpectedly long delays (it takes long time for some tests to be done).
B. Individual Notification
The parent company and the 40 daughter companies will submit their individual notification dossier so that there will be no tonnage accumulation. The test report could be shared among all these companies. REACH24H prepared all the dossier and Risk Assessment reports. This strategy keeps the cost controllable and test duration within reasonable bounds.
Through discussion with the company, Strategy B was adopted.
Post-Notification Work
REACH24H could help the companies to prepare the annual report, 1st time manufacture/import activity report, every time transfer activity reports once the DUs are changed.
