Practical guidance on data collection for new chemical substance notification (China REACH), according to REACH24H experts

Sep. 27th, 2012
1492

Unlike regulations in other regions such as EU REACH where the required testing information can be obtained through the LOA, the China New Substance Notification requires companies to collect the testing data through testing experiment by accredited laboratory, or by negotiating with owners of certain data to see if they are willing to share them.

For years the Reach24H Consulting Group China has been successfully assisting companies around the world to handle their testing data responsibilities. It has long been the partner of many globally recognized laboratories as well as those from inside China who are accredited to carry out the testing experiments under “China REACH”. In some grim parts of collecting testing data for all registrants, the Reach24h Consulting Group has its unique advantages in the following respects:

Mailing of sample:

The Reach24H communicate with the laboratory and confirm the mail address and the information of the recipient;

The Reach24H contact the client and mail the sample to the laboratory;

The Reach24H takes the agency assignment of custom clearance (only refer to the exporting test sample when it is inspected by the Chinese custom);

The Reach24H traces the sample after it is mailed and maintains contact with the laboratory in a regular basis to make sure the smooth arrival of the sample;

Communication with laboratory and provision of necessary product information

The Reach24H fills up and examines the sample information questionnaire;

The Reach24H compiles the POA of the testing experiment;

Follow-up to the testing experiment

The reach24H maintains follow-up of the testing experiment on a regular basis as well as communication with the laboratory to solve all kinds of technical problems emerged during the testing. Any information come out of the testing period will be duly reported to the clients.

The Reach24H also carries out the initial examination of the PROTOCOL given by the laboratory and make confirmation thereafter.

Experimental report

The Reach24H examines the draft of experimental report which will be later on decided by the clients whether the official experimental report can be based upon it.

The Reach24H manages to examine and confirm the official experimental report.

Payment for the testing experiment

The way of payment varies according to different laboratories. For all the clients of Reach24H, they will only have to pay the first half normally when the laboratory gives its PROTOCOL and the second half shortly after the examination of the initial draft.

Through the above-mentioned services, the assurance of a perfect testing data collection is certainly beyond doubt. In addition to collecting data through laboratory experiments, there are other channels to obtain the required data, such as QSAR, Read-across, literature, authoritative database or expert statement. Specifically speaking, the physic-chemical data can be obtained by QSAR while the toxicological data the publicly issued literature and database and the exemption database the expert statement. All these approaches would significantly shorten the period of data collection, yet pose potential risk of disqualification of the data due to a simple fact that the Panel Judges in CRC would normally hold suspicious attitude of these data obtained far from difficult and certainly cast keener eyes upon them, which will lower the possibility of the final approval.

Thus seems more than certain that, as has been defined by its exceptional system, the most solid and effective way of data collection would be to cooperate with the accredited laboratories. In this sense, once the company asks a Chinese laboratory to work on the data collection, the immediate obstacle would be the communication. Not only the regular follow-up which must be crucial during the testing experiment, but also the examination of the drafted report soon after the experiment, both of which contains so large chunk of technical information which would daunt both sides if there is no adequate and effective communication.

The Reach24h offers a bridge to let the whole data collection period go without a hitch. Fundamentally aware of the importance of the technical data, the Reach24h is armored with a seasoned team of technical experts who will assure the quality of each communication during the testing period and convince the clients with a cross-examined report after the testing experiments. Global giants such as BASF, DOW, MERCK, Johnson & Johnson, etc. have long been cooperating with Reach24H in facing up to China Reach. Moreover, in some certain cases where the tests are compelled to be carried out in China, the advantages of its being the local figure in regulatory affairs brings more convenience to all the potential registrants, not only in the term of language, but also the good relationship Reach24H has with the enforcement authority–the CRC-MEP.