Request a Demo
While the cosmetic finished products are not under the supervision of the MEP (the SFDA is in charge of cosmetics management), the manufacture and importation of cosmetic ingredients in China are under the control of the “Measures on the Environmental Management of New Chemical Substances” (dubbed as China REACH, MEP Order 7) in China, the same as industry chemicals.
Many popular cosmetic ingredients are plant extract which are advertised to bring the “natural, green and healthy effect” into the cosmetics, e.g. essential oil. Generally, plant extract could be obtained through water-steam distillation, extrusion, decoction, enfleurage (like making tea) or solvent extraction. The regulatory obligation of this kind of ingredients under China REACH is usually complicated due to their diverse processing methods. Some compliance guidance is shared as follows.
Step I. Exemption
Stipulated in the guidance of China REACH, the naturrally occuring substances are free from the obligations. The exemption clause goes
(i) Unprocessed substances or substances processed only by manual, mechanical or gravitational methods, or by water dissolution, water displacement or thermal dehydration etc.;
Although all plant extracts meet the category of “Naturally occurring substances” because they are the components from natural plants, it is the processing methods that determine whether they are eligible for exemption. Only a few processing techniques could be exempted from China REACH, i.e. manual, mechanical or gravitational methods, or by water dissolution, water displacement or thermal dehydration etc. Therefore, if a plant extract is produced through extrusion, enfleurage, it would be exempted for sure. However, regarding the other two common methods not mentioned in the Guidance, the Chemical Registration Center of Ministry of Environmental Protection (CRC-MEP) published an official updated FAQ on its website in which the two situations are specified:
Water-steam distillation---not exempted;
Solvent extraction---not exempted if any solvent other than water is applied.
Step II. IECSC Inclusion
If you determine that your ingredient could not be exempted, check if they are included in the existing chemical inventory--IECSC 2010.
Some plant ingredients are included in the IECSC and considered as existing substances under China REACH, e.g. Orange, sweet, extract, and Chrysanthemum, extract.
Since the INCI (International Nomenclature of Cosmetic Ingredients) name is not listed in the IECSC, the chemical name should be used in search instead. CAS No is recommended to improve the searching accuracy if applicable.
Besides the self-check with the online IECSC, it is strongly recommended to submit a formal inquiry to confirm the status of the ingredient since the confidential substancs are not known to the public. Only the plant extract not included in the IECSC is obliged to notify under China REACH. Moreover, the solvent in the product should not be neglected, for which a substance status inquiry is also needed.
Step III. Notification
In most cases, the annual tonnage of plant extract is lower than 1 ton per year since it is difficult to collect and the yield of the required plant is limited (Remember to calculate the “real” annual tonnage, excluding the amount of solvent). Hence, the simplified notification (general case) is most probably applicable for the company.
Besides the paper work, the notification requires 1~3 eco-toxicity test(s): (biodegradability, acute fish toxicity, acute earthworm toxicity) conducted by the MEP-approved-labs, depending on the substance properties. The test requirement does cause some confusion as to whether it is necessary to purify the plant extract in solution to perform the tests. It could be difficult to since the purification process could lead to deformation of the substance into other unwanted ones, which makes it impossible to explain the study results. We inquired the authority about the question and got the response that the notifiers could use the whole mixture/preparation containing the new substance to perform the eco-toxicity test, the authority will accept the study report and the notified substance name is requested to be “extract of xxx plant by xxx solvent” (See the FAQ recently updated on the CRC-MEP website, ChemLinked News Release).
On the other hand, we have discussed with the eco-toxicity lab experts on the possibility that this testing approach might be abused by some dishonest companies. The lab confirmed that if some companies intentionally dilute the plant ingredient with specific solvent, the testing expense could be saved due to the falsified eco-toxicity study result. For example, the acute fish & earthworm tests could be avoided if the substance is tested to be biodegradable due to dilution. This dishonest trick could expose the notifying company to the risk of being caught by the expert committee of the MEP. Therefore, it is strongly recommended to use the actual commercial product to run the test.
In case that the cosmetic ingredient company might manufacture or import a few samples for eco-toxicological testing before the commercial activity, the SRRN (Scientific Research Record Notification) could be applied if the annual tonnage is lower than 0.1 t. More complicated regular notification has to be filed for annual tonnage of over 1t.
To sum up, notification of plant extract under China REACH is no longer a vague area since the CRC-MEP has released clarification through the official FAQ. Meanwhile, profound experience has been accumulated through our successful notification for many cosmetic ingredients of plant extract following the guidance of the authority and advices from the labs.
