Data Collection under China Reach

One of the crucial steps for China Reach (new chemical substance notification) stakeholders would be test data collection. In both simplified and regular notifications, the regulation requires notifiers to provide experimental reports done by MEP-approved laboratories according to the authority. The experimental reports will then be submitted for expert review which marks as barrier ahead of the completion of the notification. Experts are summoned by MEP to review the reports based on their professional expertise while the information included in the reports may not fit in with their perspectives. The technical strength and a keen follow-up on the latest CHINA REACH trend would be most necessary.

The tests for data collection in accordance with the China Reach include the physicochemical, the toxicological, and the eco-toxicological experiments among which the last one must be conducted within Chinese territory by using the Chinese test organism, by the GLP laboratory authorized by MEP to carry it out, which, there are only nine of them.The authorized laboratory will follow the GLP standards when the experiment begins and fill in the final experimental report afterwards. The reports would largely be correct in line with the CHINA REACH requirements, the mismatch, however, does exist due to a crystal clear fact in China, that is: the nine solely MEP-approved laboratories are too few in comparison with the total number of China Reach notifiers that, the only access to obtain the eco-toxicological data, which seized by these laboratories, would assure their unremitting and considerable sum of income.The lack of market competition causes much less attention to the quality of experimental report and the notifiers therefore have to bear escalated risk of failing to pass the expert review as final step on CHINA REACH notification procedure. The slightest wrong catch could immediately result in the experts’ decline and the notification procedure shall inevitably suffer an abrupt halt.

Particulars in Lab concern

Following a case that occurred just recently, let us take a more detailed view into this issue.

When a company tended to export their chemical products into Chinese market, a further precaution had been taken by directly consulting chemical regulatory expert—the Reach24H Consulting group China, who has a team of experienced professionals with solid technical background, on their experimental report done by their entrusted MEP-approved laboratory. Two units of data aroused the experts’ attention, from which later on a grave yet imperceptible mistake was spotted:

The data of CO₂ Produced, collected by the method of OECD301B—Ready Biodegradability-CO₂ Evolution Test, were completely the same both in inoculums Control-1 and Toxicity Control. A check was immediately done on the degradation, by adopting these two units of data. According the result of analysis, the suspected mistake would be laboratory mistakenly copy the whole array of data of the Inoculum Control-1 into the segment of Toxicity Control, which was later on confessed by the laboratory themselves.

The above circumstance only explains a tip of the iceberg; the practical case over the quality of experimental reports seems endless in number while the actual problems are also varied. Take another look at the case mentioned, there is one other distinct hidden danger threatening the final completion of ‘CHINA REACH’. That is the details in experimental report.A standard operation on those details would be, taking the Ready Biodegradability-Closed Bottle Test(OECO301D) for example, the experimental report ought to include the intact ‘raw data’ when describing the preparation of test medium, including the ‘culture medium’, ‘test substance’, the volume of inoculums and the final test medium; the data analysis should contain the intermediate result along with the other data. The question is when it comes to these details;some laboratories roughly describe or omit the process of preparation, only fill out final result. The indolence may put more obvious risk to the affected notifiers.

Technical Review and Support

To solve the data issue in China Reach, the following qualifications might be very much required:

——Solid technical support. The experimental report would be not at all a format that only calls for a comprehensive knowing of the regulation itself. Even equipped with a team of professional regulatory experts, the company themselves have their failing on reviewing the information included in the reports which are in total technical jargons. With slim knowledge on the technical term, the high demand of physiochemical, toxicological and eco-toxicological background while reviewing the reports could leads to an entire mess when sifting through the errors possible.

Therefore, experts with profound knowledge basis and expertise to review the experimental report, particularly those with high profile in eco-toxicology field, are very much needed.

——In-depth study on China Reach. The continuous following up of CHINA REACH since its implementation, for its key obligations and the latest updates, due to be immensely important.Deepened understanding and grip of ‘CHINA REACH’ trend plays defining roles in dealing with specific obligations under it.

——Techniques and experiences on data review. The grim part of experimental review under ‘CHINA REACH’ data collection is usually caused by the varied mistakes. The certain experiences in data reviewing and techniques for it have to be normally the only possible solution to reduce the risk of ‘CHINA REACH’ experimental report failures.

——Proper picking of laboratory. Irresponsible for any outcome due to the mistakes appear on the experimental report, the laboratory is largely dependable by more of their working attitude than the expertise they provides. Thus, how to pick a laboratory with up-to-detail attitude counts in the final ‘expert review’.

——Regular contact with MEP experts. During the China Reach notification, the ‘expert review’ as one important step poses the biggest challenge towards all notifiers particularly those with feeble knowledge of experimental report review. Maintain a steady connection with MEP would duly help you more accurately orientate your ‘CHINA REACH’ tactics.

As a whole, the robust technical background coupled with the hold of the latest regulatory trend serves two essentials that, given ample experiences in dealing with China REACH issues can company finally resolve ‘CHINA REACH’ issues, particularly the data collection.

About Reach24H Consulting Group China

Reach24H Consulting Group China is the chemical regulatory expert specializing in providing regulatory consultancy and technical support for chemical companies from around the world in facing the chemical regulatory affairs. Its core expert team has many years’ experiences in study and dealing with major chemical regulations such as EU REACH, EU CLP, China Reach, China GHS, etc. Experts in Reach24H have different backgrounds including in-depth involvement in toxicological and eco-toxicological field. It has also build broad and regular communication with many of those law enforcement authorities such as ECHA in Europe, MEP in China. As a China-based regulatory service provider, the Reach24H has established partnerships with MEP-approved GLP laboratories in China and assures timely interaction with them during the data collection under China Reach.

Should you have any further questions regarding China REACH or other regulations, you may also contact us by the following information:

Email: info@reach24h.com

Phone: 86-0571-87007500