Long-awaited changes are being implemented by China's new cosmetic regulation (CSAR). From cosmetics classification to ingredient application, claim substantiation, safety assessments, and more, the new regulations are clearer and more extensive.

China's New Cosmetic Regulation (CSAR): Key Changes

Finally released by the State Council of the People's Republic of China in June 2020 to replace the Cosmetics Hygiene Supervision Regulations which date back to 1989, China's CSAR brings some long-awaited changes. With updates related to the definition and classification of cosmetics, ingredient application, safety assessments and more, cosmetic manufacturers wishing to sell products there need to be in the know.
CSAR: China's New Cosmetic Regulatory Framework

China's CSAR (meaning Cosmetics Supervision and Administration Regulation), released on June 29, 2020, went into effect on January 1, 2021. Through the CSAR, China's cosmetic regulations were updated to better address claim substantiation, cosmetic classification, safety requirements and administrative obligations.

Thanks to the CSAR, China's regulations are clearer for cosmetic companies based both within the country and internationally.

China's CSAR: Toward the End of Animal Testing for Cosmetics?

Despite the many points addressed in the CSAR, China is not entirely putting an end to its animal testing requirement. With that said, the practice is not as pervasive as it once was, since general cosmetics are no longer subject to it, regardless of whether they were produced domestically or abroad.

Cosmetic Definition and Classification

According to China's CSAR, any "daily chemical products intended to be applied on human skin, hair, nails, lips, mouth, etc., by spreading, spraying or other similar ways for cleansing, protecting, beautifying, or grooming purposes" are considered cosmetics. This means that the term doesn't apply to products related strictly to basic hygiene, such as soaps and products designed to eliminate unpleasant odor.

Under the CSAR, China considers hair dyes and perms, whitening products, anti-hair-loss products, sunscreens, and products with new efficacy as special cosmetics. Those that fall outside of these categories are classified as general cosmetics.

The regulation is also phasing out certain cosmetics that were previously labeled as "special use". This includes hair growth or depilating products, breast beauty or weight loss cosmetics, as well as deodorants. After a period of five years, these will no longer be produced, imported, or sold.

Manufacturers now need to abide by the appropriate filing procedure to be able to sell general cosmetics and to register their special cosmetics with the National Medical Products Administration (NMPA). Filing certificates are a one-time requirement, whereas registration certificates are only valid for five years.

As for imported cosmetics, a manufacturing certificate is necessary, along with a certificate of free sale from the country of origin. Manufacturers who target the Chinese market exclusively must provide research and test data carried out with this specific market in mind.

Cosmetic Efficacy Claims, Safety Assessment and Requirements for Safety Assessors

Any cosmetic efficacy claims must be substantiated for distribution on the Chinese market. Companies need to provide sufficient scientific evidence and to make the information publicly available on the National Medical Products Administration's website. Any literature, evaluation data regarding the product's efficacy, or other research data that can substantiate the claims should be included.

Under China's CSAR, cosmetics as well as new cosmetic ingredients must be subject to a safety assessment without which they cannot be registered or filed. Safety assessors must be industry professionals and have over five years of relevant experience in the quality and safety assessment of cosmetic products.

New Cosmetic Ingredient Application

The CSAR China implemented states that new cosmetic ingredients must be registered (if considered high-risk) or filed (if no particular risk is associated with the ingredient) with the NMPA.

UV filters, preservatives, dying agents, whitening agents, as well as colorants represent a high risk and warrant additional yearly reports on their safety and usage. Those new ingredients with no safety concerns are to be added to the IECIC (Inventory of Existing Cosmetic Ingredients).

Administrative Obligations for Enterprises

Any cosmetic manufacturer wishing to apply for cosmetic registration or filing under China's CSAR needs to be established as a legal entity. This also implies that these companies should have a quality management system in place and be able to carry out assessments to monitor any adverse effects their products may have.

Applicants are held responsible for the quality, efficacy, and safety of the products they want to distribute.
It is worth nothing that new administrative rules and supporting documents will be added to the CSAR as China continues to refine its policies.