It has taken 3.5 years for Symrise to successfully get Phenylethyl Resorcinol, a new cosmetic ingredient for skin-brightening, approved by China’s SFDA last December. (see Chemlinked news on 14 Dec 2012)
China’s huge potential market for skin-whitening products was the biggest motivation for Symrise to take the initiative despite time consuming and tough registration procedures. The safety of the new ingredient is the main concern of the SFDA’s evaluation committee, which required Symrise to comprehensively prove this. Another stumbling block centered around the safety concerns relating to possible hazardous impurities,especifically Resorcinol.
In vitro analysis provided strong evidence that resorcinol was not a metabolite of Phenylethyl Resorcinol. However the result was not deemed clinically significant by the SFDA who requested animal testing procedures to corroborate the in vitro analysis. As requested, Symrise performed in vivo testing which verified the safety of their product.
It is acknowledged that the EU Commission has fulfilled its commitment to ban the sales of cosmetics tested on animal from 11 March 2013. Compared with the active promotion of non-animal testing in the EU, China is still in the process of adopting its first alternative method (3T3 NRU phototoxicity test) and not likely to follow suit soon. The current situation has generated ethical issues about animal protection and created a dilemma for many cosmetic giants. For instance, Pangea Organics who is in firm support of non-animal testing chose to withdraw from the Chinese market due to its ethical concerns.
Although a hard nut to crack, the successful registration of Phenylethyl Resorcinol by Symrise is a source of inspiration for the cosmetics industry. It serves as a template for companies to follow and more clearly outlines the demands for clinical safety and efficacy required by the SFDA. The take home messages learned from this experience are;
- Have an experienced regulatory affairs expert in China for consulting and timely communication with the SFDA;
- Submit registration dossiers as complete as possible at the first time;
- Have thorough understanding of any feedback from the SFDA evaluation experts to make correct response;
In China there is no protection period for new cosmetic ingredients once approved. However the key advantage still lies with the original applicant since certain key technical steps of the production process can be kept confidential.
From a long-term prospective, one of the priority concerns of the Chinese government is to standardize in vitro testing methods for cosmetics or ingredients. Communication between the government and industries is also of critical importance and we can expect formal guidance for risk assessment of impurities and potential risk substances in cosmetics.
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