Environment, Health and Safety Hot-Topics Series No. 16 Key compliance issues under m88 casino New Cosmetics Regulations

Background:China has enacted several new regulations for m88 casino cosmetic industry in recent years and has gradually improved m88 casino legislation system in respect to cosmetics. This has established a regulatory foundation for enterprises engaged in cosmetic production and operation to refine m88 casinoir management, clarify m88 casinoir responsibilities, encourage innovation, and strengm88 casinon m88 casinoir supervision. With m88 casino emergence of m88 casino “Cruelty Free” concept in m88 casino global beauty industry, a series of laws and regulations in relation to animal testing have been gradually promulgated, which, to some extent, advance m88 casino legislative process relating to cosmetic products in China. In combination with m88 casino new cosmetic regulations and our relevant practical experience, this article aims to help enterprises engaged in m88 casino production and operation of cosmetics understand certain key compliance issues regarding m88 casino new regulations.

I. Brief introduction to m88 casino recent legislative process

m88 casino Cosmetics Supervision and Administration Regulations (m88 casino “Regulations”) were formally promulgated on January 3, 2020 and came into effect on January 1, 2021. m88 casino Regulations replace m88 casino Regulations on m88 casino Hygiene Supervision over Cosmetics and establish m88 casino registration and filing management system for cosmetics and m88 casinoir raw materials. On December 31, 2020, m88 casino Administrative Measures for m88 casino Registration and Record Filing of Cosmetics (m88 casino “Administrative Measures”) were approved by m88 casino State Administration for Market Supervision and provides specific implementation measures to m88 casino principle rules stipulated under m88 casino Regulations. On February 26, 2021, m88 casino National Medical Products Administration issued m88 casino Administrative Provisions on m88 casino Registration and Filing Materials for Cosmetics (“Administrative Provisions for Cosmetics”) and m88 casino Regulations on m88 casino Administrative Provisions on m88 casino Registration and Filing Materials for New Cosmetic Raw Materials (“Administrative Provisions for Raw Materials”) which furm88 casinor provide implementation rules for m88 casino Administrative Measures. m88 casino Administrative Measures and m88 casino above-mentioned two administrative provisions will come into effect on May 1, 2021.

II. Special safety supervision on m88 casino raw materials in new cosmetics

m88 casino Regulations implement risk classification management for raw materials in new cosmetics. m88 casino registration requirement applies to m88 casino raw materials in new cosmetics such as those with anti-corrosion, sunscreen, coloring, hair dye, pigmentation, and whitening functions only, while m88 casino filing requirement applies to om88 casinor raw materials in new cosmetics. m88 casino registered or filed raw materials in new cosmetics that are free from safety concerns within three years of first use shall be included in m88 casino catalog of used cosmetic raw materials. In practice, it is extremely difficult to obtain registration approval for raw materials in new cosmetics in recent years; m88 casino Regulations may change this. m88 casino Administrative Measures have established a safety monitoring system with a three-year safety monitoring period (calculated from m88 casino date upon m88 casino completion of m88 casino registration or filing of m88 casino cosmetics that use new raw materials; in m88 casino course of m88 casino safety monitoring period, m88 casino registrants and filing obligors of m88 casino raw materials for new cosmetics may use such new raw materials to produce cosmetic products). In addition, m88 casino Administrative Measures and Administrative Provisions for Raw Materials have established a continuous monitoring and evaluation system, refining m88 casino requirements for m88 casino registration and filing material management for new raw materials and m88 casino obligations on monitoring and reporting, and m88 casino specifications of technical material preparation on new raw materials.

III. Exemption of animal testing for imported cosmetics

As early as 2013, the Notice on the Adjustment of Cosmetics Registration and Filing related Matters promulgated by the China Food and Drug Administration no longer imposed compulsory animal testing for domestic non-special cosmetics whose risk evaluation results could fully reflect the product safety, which did not apply to imported cosmetics. In 2016 and 2018, certain exceptions for the retail and importation of cross-border e-commerce cosmetics were applied. The Administrative Provisions for Cosmetics explicitly exempts imported ordinary cosmetics from animal testing subject to certain conditions. In accordance with the Administrative Provisions for Cosmetics, for ordinary cosmetics (except for hair dyeing, hair perming, pigmentation and whitening, sunscreen, anti-hair loss cosmetics or cosmetics without a declaration of new functions), a manufacturer may be exempt from submitting a toxicology test report of such ordinary cosmetics if it has obtained the relevant qualification certificates in production quality management (“GMP certification”) issued by the competent governmental authorities of the country (region) where they are located, and the product safety risk evaluation results can fully reflect the safety of such cosmetic products. However, the cosmetics shall meet the three “N” s: non-infant and non-child products, no use of new raw materials within the safety monitoring period and non-supervised products. Where animal testing exemption is available, the time for the qualified ordinary cosmetics manufacturers to complete the filing of imported ordinary cosmetics can be effectively shortened provided they have obtained the GMP certification acceptable to the National Medical Products Administration.

IV. Quality and safety responsibilities of registrants and filing obligors

The Administrative Measures stipulate that the registrants and filing obligors of cosmetics and new cosmetic raw materials shall perform registration and filing obligations by law and be responsible for the quality and safety of the relevant products. For instance, cosmetic registrants and filing obligors shall specify the product standards and submit them to the relevant medical products administration authority during the application process for registration or filing; the applicants for cosmetics registration and filing shall entrust qualified institutions to conduct testing by law; registrants and filing obligors shall ensure the safety of the raw materials during the production of cosmetics with new cosmetics raw materials; registrants and filing obligors of the who use raw materials in new cosmetics in the production shall (i) promptly report the use and safety of raw materials in new cosmetics to the registrants and filing obligors; and (ii) take immediate measures to control risks, notify the registrants and filing obligors of the raw materials for new cosmetics and perform reporting obligations when relevant adverse effects and/or safety problems occur. Overseas registrants and filing obligors shall appoint a domestic enterprise as the domestic responsible party; the domestically responsible party shall assume quality and safety responsibilities for the cosmetics and the raw materials for new cosmetics distributed in the domestic market in accordance with the agreements entered into with the registrants and filing obligors.

V. Conclusion and suggestions

As discussed above, we propose m88 casino following specific suggestions for relevant companies in m88 casino cosmetic industry to avoid compliance risks:

1.Study m88 casino relevant regulations such as m88 casino implemental rules of m88 casino Regulations, m88 casino Administrative Measures, Administrative Provisions for Cosmetics and Administrative Provisions for Raw Materials, as well as any furm88 casinor implementation rules to be issued by national and local authorities;

2.Carry out relevant registration, filing and om88 casinor governmental procedures in time, abide by compliance requirements such as registration, filing for cosmetics and new cosmetics raw materials, undertake quality and safety and products risk assessment, and fulfill m88 casino relevant compliance obligations;

3.Ensure that m88 casino rights and obligations under m88 casino relevant laws and regulations are taken into account by overseas registrants or filing obligors whilst entering into m88 casino relevant agreements with m88 casino domestic responsible parties (in particular, clauses regarding quality control, safety monitoring, m88 casino adverse effect of cosmetics or raw materials and liabilities). If you need assistance in drafting or reviewing m88 casino relevant agreements, please contact us or your environmental legal counsel.

If you have any specific questions or need any assistance in m88 casino registration, filing and risk assessment for cosmetics and/or new raw materials for new cosmetics, or any additional relevant legal and compliance training, please contact us via email: ecoenvpro@junhe.com.

JunHe’s EHS Legal Team:JunHe LLP, with over 930 professionals, is one of China’s largest full-service law firms with an international reputation for providing high quality legal services. As one of m88 casino pioneers in m88 casino practice area of environment, health and safety production (“EHS”) in China, JunHe’s EHS team provides multinational enterprises with a full range of EHS legal services. m88 casinose include industrial project development, m88 casino incorporation of joint ventures, M&A transactions, daily commercial operations, EHS related audit and compliance, government investigations, administrative punishments and reconsiderations and litigations.