Making Sense of China’s New CSAR
-- A Joint Presentation by Zhi Li & Wintest
What is SCC 76?
On December 12-14, SCC(Society of Cosmetic Chemists) 76, which is the 76th Annual Scientific Meeting & Showcase as well as the premier conference for cosmetic science education, was successfully held in Los Angeles, California.
Founded in 1945, the SCC is the oldest and largest membership organization focused exclusively on cosmetic science education, with the mission to share scientific information, innovation and research in the cosmetics and personal care industry through education, events and publications.
Featuring more than 40 speakers in 8 breakout sessions and 3 keynotes, SCC 76 covered the latest research and innovation. Over 1,000 people from top cosmetic/personal care brands, manufacturers, suppliers, academia, and regulatory organizations around the globe were in attendance to share the inspiration, innovation, and education to keep them at the top.
The technical education sessions offer top-notch scientific information on the latest topics and trends. This year, presentations on the following topics were shared: The Future of Beauty | Diversity in Beauty | Make Up, Fragrance, and Sensory | Innovations in Skin Care| Hair Care Innovations| Future of Skin Care | Sustainability | Modern Formulation and Sunscreen Design| Claims & Regulatory.
Wintest Engagement in Claims & Regulatory
On December 14, Dr. Zhi Li, Vice President of Chinese American Cosmetic Professional Association (CACPA) & Independent Consultant, presented Making Sense of China’s New CSAR in the session Claims & Regulatory. Wintest participated in the preparation of this presentation and co-published this with Zhi Li.
In the presentation, a new cosmetic regulation era in China was introduced to the audience, which arrived along with the Cosmetic Supervision and Administration Regulation(CSAR) that was implemented on January 1, 2021 by the State Council of P.R. China.
CSAR manages cosmetic ingredients in two groups. One is the existing ingredients in the Inventory of Existing Cosmetic Ingredients in China (IECIC); the other is the new ingredients requiring pre-market registration/notification, followed by 3-year monitoring before getting incorporated into IECIC, which is the focus of this sharing.
Zoomed in on the registration/notification of New Cosmetic Ingredients, it was analyzed that risk-based strategy was adopted by China National Medical Products Administration (NMPA). High risk new cosmetic ingredients (preservative, sunscreen, freckle/spot-removal/whitening agent, colorant, hair-dyer…) require pre-market registration for approval by National Medical Products Administration (NMPA). Medium risk and low risk new cosmetic ingredients require pre-market notification for acceptance by National Medical Products Administration (NMPA).
The NCI pre-market notification filing process includes Responsible Person Authorisation & System Account Application, Notification Dossier Preparation & Testing to Prove Safety, NMPA Format Review, and Notification Information published on the NMPA Official Website. Six different situations are categorized by NMPA, mostly based on the potency and the use history of new cosmetic ingredients. Meanwhile, twelves types of toxicity study are listed (A-L), different combination of which matching to the aforementioned six situations.
A Tricky Issue: Non-Animal Testing/Cruelty Free
With extensive and in-depth investigation on CSAR and regulations around the world, such as OECD431 (2016) and ECVAM, possibilities of non-animal alternatives were further explored and fully discussed case by case. Meanwhile, how to get around animal tests and with what substitute tests were shared.
To date, 47 new cosmetic ingredients have been completed with the pre-market notification filing process and entered the 3-year monitoring period, the ongoing technical review.
How to be prepared?
Compliance is the driving force for the prosperity and healthy development of cosmetic business.
Wintest has successfully completed the pre-market notification filing process on NMPA platform for three new cosmetic ingredients, which are β-Alanyl Hydroxyprolyldiaminobutyroyl Benzylamide, Oligopeptide-215, Nicotinamide Mononucleotide. The first two ingredients are both originally-structured ingredients developed by Winkey R&D, with the Oligopeptide-215 being the first peptide NCI accepted by NMPA.
Backed by the successful experience gained and accumulated, Wintest have built a professional team with the expertise and insights on properly handling regulatory compliance issues of new cosmetic ingredients with NMPA.
Please feel free to contact us for any further discussions or consultations at wintest@winkey-china.com (email) or www.wintestservice.com/ (website).