HEALTH, ENVIRONMENTAL & REGULATORY SERVICES (HERS) CHINA’S NEW COSMETICS REGULATION (CSAR)

Consulting & Compliance Support

China State Council released the final version of the Cosmetics Supervision and Administration Regulation (CSAR) on 29 June 2020. This regulation came into force on 01 January 2021 and replaced the existing Cosmetics Hygiene Supervision Regulations.

Background - “General cosmetic products” are • Addition of efficacy claims CSAR aims to ensure the quality and safety classified as other cosmetics, which requirements of cosmetics through strengthening the excludes special cosmetic products. - The applicant is required to submit supervision and management of cosmetics - Toothpaste is not considered sufficient scientific evidence (literature, and controlling the production and a cosmetic product; however, a research data or product efficacy operations to protect consumer health. notification must be completed before evaluation data) on the NMPA’s website entering the market. for claim substantiation. In preparation for the CSAR, guidance documents and supporting rules are being • Management of new cosmetic • Information on the safety published gradually to help the cosmetics ingredients assessment and requirements for industry implement this new regulation. - Registration will be required for new safety assessors cosmetic ingredients with higher risk, - A safety assessment is required before Regulation Changes such as preservatives, sunscreens, placing cosmetic products on the colorants, hair dyes, spot removing and Chinese market. China’s new cosmetics regulation addresses whitening agents. compliance requirements, and many of the - Safety assessors must have key changes and updates are as follows: - Notifications are required for other new professional knowledge of cosmetics cosmetic ingredients. quality and safety and have more than • New cosmetic definitions, scope and - After new ingredients are placed 5 years of relevant work experience classifications on the Chinese market, annual in production or quality safety - The classification of “special cosmetic safety and usage reports must be management. products” (cosmetics with special submitted to NMPA for a period of 3 - General cosmetics can be exempted purpose or function) has been updated 3 consecutive years. After 3 years, from animal testing if the safety and to include hair dyeing, hair perming, the new ingredients will be included quality requirements (GMP/ISO issued spot removing and whitening, anti- in the Inventory of Existing Cosmetic by government) is met/proven. Safety hair loss and any new function (as Ingredients in China (IECIC) if no safety assessments will be accepted in determined by the National Medical concerns arise. place of animal testing, with certain Products Administration [NMPA]). restrictions. CHINA’S NEW COSMETICS REGULATION (CSAR)

Responsible Person & Implications for Intertek Solutions The Intertek Advantage Industry Intertek provides a comprehensive range Through our network of more than 1,000 Registrants or notifiers based overseas of services for beauty and personal care laboratories and offices in more than can authorize a Chinese entity as their products to ensure quality, safety, efficacy 100 countries, Intertek helps local and Chinese Responsible Person (CRP). The CRP and regulatory compliance. Partnering with international companies ensure their is responsible for the quality, safety and Intertek helps brands and producers speed products meet quality, safety, hygiene, and efficacy of cosmetic products. The CRP is up their international growth, optimize the social and environmental responsibility responsible for: quality and safety of their supply chain standards around the world. and reduce total costs. We can help you 1. Registration/Notification of the product understand your regulatory obligations to Total Quality. Assured. in the name of the overseas registrant/ achieve compliance. filer 2. Carrying out adverse reaction Our services include: monitoring, product recalls, new • Toxicological Safety Assessments cosmetic ingredients monitoring reports • Toxicological Profiles of Ingredients 3. Cooperating with supervision and • Registration & Notification of New inspection under the local regulatory Cosmetic Ingredients authorities • Registration & Notification of Domestic/ Imported Cosmetic Products Cosmetics businesses must be aware of the • Labelling Reviews new regulatory requirements because as • Literature Review & Data Collection FOR MORE INFORMATION of 01 January 2021, the penalties for non- • Regulatory Dossiers compliance will increase significantly. Failure • Microbiology & Stability Testing to comply with CSAR may result in the [email protected] • Cosmetic Packaging Analysis responsible person facing a lifetime ban for • Causality Assessment the production and operation of cosmetics • Compliance Solutions in China. • Regulatory Support intertek.com/home-personal-care/ • Sustainability Solutions