Q&A on SFDA Registration of New Cosmetic Ingredient SymWhite®377 (Phenylethyl Resorcinol) by Symrise in China
Original Article by CIRS
14 March 2013, Symrise get the first skin-whitening agent recently approved by SFDA in China. CIRS has summarized a few questions in order that Symrise Regulatory Affairs experts might share its experience and challenges to help other companies improve their efficiency during registration of new cosmetic ingredient.
Dr Robert Fellous (RF) (currently Director of Intertek Healthcare & Beauty and previously Symrise SVP Global Regulatory Affairs) and Mrs. Wu Lan (WL) Symrise ASPAC Regulatory Affairs Director have kindly answered our questions.
What is the main incentive for Symrise to register this new cosmetic ingredient with SFDA considering that only a few ingredients have ever got approved by SFDA?
RF: Symrise is a leading supplier for innovative active cosmetic ingredients. At the early stage of marketing of SymWhite®377, a Skin Whitening agent, it was evident that Symrise’s success would be supported by SFDA Registration.
China is one of the most important skin whitening markets In addition several Global Cosmetic customers require SFDA approval before any acceptance of new cosmetic raw material in their portfolio.
So whatever the level of difficulty, the registration to the SFDA was extremely stimulating to demonstrate Symrise Life Essential’s vision and leadership.
How long has it taken for Symrise to get this new ingredient approved since you decided to register?
WL: We have started our first submission in March 2009, followed by providing a series of additional testing reports, documents and explanations, etc. altogether it has taken about 3.5 years to get the ultimate approval by the end of 2012, which is quite significant.
What were the main issues during the process of registration?
RF:You will not be surprised if I am reporting that one of the main questions was related to the possible presence of impurities, which is still today the main focus of SFDA. SymWhite® 377 being a resorcinol derivative (INCI: Phenylethyl resorcinol), the Chinese authority was concerned by the potential presence of resorcinol residues. However we did show that it was not a concern as described below.
WL:another aspect is how to convince the product safety under all kinds of potential application conditions. This is quite challenging - there is no good practice to follow and no external expert to consult, as nobody knows better this product than we are. Thanks to the strong toxicological team within Symrise, we have handled these inquires successfully without too much delay.
How did you describe the production process not only to meet the requirements of authority but also to keep critical steps confidential?
RF: While the reaction steps of the process need to be described (including the presence of solvents and impurities), this description does not need to include all critical technical details, which is allowing to protect confidential information.
May we know if read-cross or other animal alternative methods have been used in this case or not?
RF:We did not need to use any read across method to assess the safety of the Phenylethyl resorcinol. Indeed the Symrise safety dossier was complete enough to defend our use level recommendation for the proposed product categories.
However in vitro alternative methods were a critical point in the exchange with SFDA. In order to convince SFDA that resorcinol was not released by metabolism, we provided in vitro data (using microsomal fraction and hepatocytes) supporting the evidence of no release.
These data were not considered as convincing enough by SFDA evaluation committee, which requested in vivo metabolism data. We provided these additional data which strongly confirmed our preliminary results.
We understand that Phenylethyl Resorcinol is a skin-whitening agent to be used in cosmetics. Have you provided efficacy studies to support your claim during the approval?
WL: SFDA evaluation is more focused on safety side.
SFDA proposed to request verified analytical methods for ingredient and safety risk substances in Nov last year. Have your analytical methods been verified by labs designated China SFDA? If not, has China SFDA made any comments on those methods provided?
WL:Several analytical methods developed by Symrise have been verified by accredited labs from SFDA.
What is your advice for companies to avoid possible mistakes and shorten registration process?
RF:You need a highly qualified Regulatory Affairs expert with good scientific background located in China, able to coordinate dossier submissions and to closely interact with SFDA, which is the case in Symrise.
WL:Once you get questions or inquiries from experts, it is of vital importance to understand the ultimate purpose for asking. You need to take time to make everything clear in order that your feedback could meet their expectation, by this way you could avoid being challenged back and forth, and the most important is to save your valuable time.
I also recommend providing documents as complete as possible at one time – for the first submission and also for answering the notices, this could facilitate experts to get a global view and to draw a conclusion within one commission; if one point has to be discussed in several commissions, it’s difficult to guarantee the consistency.
What is overall vision for the next coming years
RF:The acceptance of recognized and harmonized testing methods (especially validated in vitro alternative methods but also any OECD protocols) is a top priority.
Today, a Global registration strategy raises significant issues due to discrepancies of local rules. The regulatory frameworks must be more consistent to avoid test duplication, keep timeline and costs reasonable for the development of new Cosmetic raw materials.
Cosmetic Industry stakeholders and authorities should further continue sharing their experiences to develop a better mutual understanding.
WL:Cosmetic management in China will keep on a per-market registration model, however China SFDA has realized the importance for controlling the raw material in the whole system, and they are turning their attention more and more to raw material side, which is also a global trend.
As cosmetics is related to human wellbeing, SFDA and other related authorities will keep on strengthening the management and supervision at various stages, personally I am expecting a more transparent, effective and standardized management system in the coming years.
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