Plant extract can be one of the targets which the “China Reach” might cast upon its attention. Many plant extract products consist of substances which are defined by “China Reach” as new substances, as they may usually not be included in IECSC (Inventory of Existing Chemical Substance in China http://www.crc-mep.org.cn/m006/m006_c1.aspx). As has been up in the rise over the past decade, the plant extract is as a marginal industry developing fast and appearing increasingly frequent in pharmaceutical, fine chemical and agriculture industries. Its use is expanding while scientific research is continuing not far behind the trend we’ve seen and that really triggers cases a lot more than ever in their new substance notification under “China Reach”. However the mere notification for plant extract as new substance is, unlike other new chemical substance, far from easy.

Difficulty for purification

The plant extract product is literally the mixture of active ingredients, water and organic solvent. According to “China Reach”, the active ingredient purified from the product is the sole focus by notification. Despite what the regulation dictates, the reality is, as a result of incompetence of current technology, material and equipment and other basically required elements, even if the purification of plant extract were obtained, the substance itself may be swiftly modified in its property and structure far different from that when previously containing in corresponding solvents. it is often difficult to conduct complete purification. Facing more and more cases such as this, the enforcement body—CRC-MEP therefore takes concession as to accepting data generated by mixture that contains the notifying plant extract. Meanwhile, the plant extract features complex compositions, difficulty therefore also exists in analysis of data because of the absence of structural formula, concentration and composition.

What potential notifers confront of

In response to afore-mentioned circumstances, there are questions often raised by those potential notifers as they consider notifying their plant extract under “China Reach”. Usually their confusions may end up with plight on whether they should relinquish the idea of proceeding to the notification. Because CRC-MEP allows company to notify plant extract by its mixture, solvent that contains the same plant extract, however, may differ. Thus, although company A has successfully notified its plant extract, company B, despite its using different solvent to contain the same plant extract, can be the immediate beneficiary 5 years later when, normally, the previously notified plant extract is due to be listed in IECSC in whose substances included are free from notification obligation. It is disputable that since “China Reach” regulation came into force on October 15, 2010, plant extract notification, whatever solvent its notifying mixture might carry, are concluded only by the plant extract as new substance to be notified. The blindness towards solvent can lead to reluctance in fulfilling the “China Reach” obligation many plant extract producers or importers ought to, given that the solvent itself might be exclusively designed that many notifers may consider it as commercially confidential. Indeed, early bird secures only the regulation upon its notifying plant extract with latent risk against its commercial interest looming all the time afterwards.

Our Suggestion

Information disclosure concerns notifiers during notification of plant extract. REACH24H has been frequently addressed by our clients regarding this issue. We’d suggest notifiers of plant extract, instead of using its CAS number for substance identification, there would be more agreeable option as CRC-MEP has recently approved of its viability on its latest publication of FAQ online. For example: one plant extract has butanediol as its organic solvent, the naming of it may go as: “substance extracted from XXX by water and butanediol at a ratio 1:1”, so as to replace the CAS number for substance identification.

You may also visit the following website for reference:

http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=363&T0=00000&LanguageType=CH&Sub=3

Meanwhile the latest edition of FAQ published by CRC-MEP will soon meet its English version by REACH24H, you may contact us by info@reach24h.com for any questions or needs.

About REACH24H

REACH24H is a China-based consulting firm, specializing in providing chemical regulatory consultancy, agency and technical support. Our main focus covers the major chemical regulations emerged all around the world, such as EU REACH, EU CLP, China Reach, China GHS, etc. We aim at assisting chemical manufacturers, importers and downstream users to effectively meet the chemical regulatory obligations as well as remove chemical regulatory barriers to their business. In recent years, our services have expanded to a larger extent with cutting-edge IT solution provided and partnerships with globally famous regulatory services providers established, such as WERCS, ChemAdvisor, etc. Our comprehensive cooperation with law enforcement bodies such as the ECHA in EU and CRC-MEP in China, ensure our staying at the forefront of regulatory development, helping us seizing the key to the regulatory affairs and trend.