Zhejiang Cosmetic Officials Disclose Research Content of CSAR and Group Standards for Alternatives

On April 3, 2019, Zhejiang Health & Beauty Industry Development Forum was held by Zhejiang Health Products Cosmetics Industry Association, attended by a number of Zhejiang government officials and dozens of cosmetic enterprises including Mary Kay, Proya, etc.

During the Forum, Wang Weidong, Director of Zhejiang MPA Cosmetics Safety Supervision Department, expounded the future trends of cosmetics supervision, including the research content of Cosmetics Supervision and Administration Regulations ^[1] (CSAR) and pending Administrative Measures for Cosmetics. Kuang rong, Director of Zhejiang Institutes for Food and Drug Control (ZIFDC), said that Zhejiang is developing 7 group standards for alternative methods for cosmetic finished products.

Research Content of CSAR:

On Mar. 30, 2019, Ministry of Justice and NMPA organized a symposium held in Hangzhou, China, on the revision of CSAR, mainly focused on the following 6 aspects:

1. Cosmetics definition modification. The original cosmetics definition is “Daily chemical products that are applied on the surface of any part of the human body by smearing, spraying and other similar ways to maintain body hygiene, to get rid of undesirable odors, to protect the skin and to enhance appearance”. The terminology “Daily chemical products” in the definition is proposed to be modified into “products” or “daily products”.

2. The implementation of classified management for cosmetic new ingredients. High risk ingredients such as new preservatives, sunscreens, colorants, hair dyes, whitening agents shall register with NMPA and obtain approval, while low risk ingredients will only require filing certificates.

3. Special use cosmetics scope modification. Special use cosmetics will be adjusted into 6 kinds of products which are hair dyes, hair perming, whitening cosmetics, sunscreens, anti-hair loss products and cosmetics that claim new efficacies.

Hair maintenance/regeneration/growth products will be newly classified as 3 types, 1. Anti-hair loss 2. Anti-hair breaking 3. Hair growth. There is the potential that these products will be subject to a new supervision mode.

4. Cosmetics efficacy claims shall have sufficient scientific evidence. The evidence can be relevant literature, research data or product efficacy evaluation data.

5. Cosmetics network trading management. The management responsibility of the online trading e-commerce platform for cosmetics operators within the platform will be clarified.

6. Adverse reaction monitoring. Cosmetics enterprises shall report adverse reactions that may be related to the use of cosmetics.

The management of soaps claiming the efficacy of special use cosmetics will be clarified in CSAR.

*Please be noted the above research contents of CSAR are still under discussion and are subject to change.

Administrative Measures for Cosmetics: Pending/Planned Measures

Good Manufacturing Practice for Cosmetic Products will be promulgated and implemented shortly after the promulgation of CSAR. It will put forward higher requirements for enterprise personnel, facilities and management, including strengthening the management of personnel qualifications, materials, semi-finished products and finished products, keeping the original records of product testing and batches, etc.

Also non-special use cosmetics filing management will be strengthened. Specific measures include:

1) Establishing dynamic glossary (including synonymous terms) of cosmetic prohibited labeling/advertisement claims

2) Upgrading filing management system,

3) Launching a pilot scheme of quantitative management of cosmetic enterprise to stratify enterprise and corresponding inspection/supervision stringency based on history of compliance. Enterprise that comply with all relevant standards will benefit and substandard enterprise will face heightened administrative demands.  

Latest Development in Alternatives to Animal Testing of Cosmetics in Zhejiang

On Mar. 22, 2019, China newly approved 4 alternatives and included them into Cosmetic Safety and Technical Standards 2015 ^[2]. As of 2019, China has a total of 6 alternatives which are developed based on OECD Test Guidelines. The testing methods in OECD Guidelines are all designed for chemicals, not for cosmetics. The connection between cosmetics and chemicals is that often many of the ingredients used in cosmetics are chemicals. The testing methods in OECD Guidelines adopted by China as alternatives are toxicological tests designed to replace toxicological tests involving animals for the registration and pre-market approval of cosmetic ingredients. However it is impossible to extrapolate the safety of finished products based on the safety of individual ingredients tested in isolation as ingredients could interact or modify the effects of other ingredients. Registration of new cosmetic ingredients in China is also extremely burdensome from a regulatory compliance aspect and requires significant time and financial investment. Combining all these factors together means that the 6 alternatives included in Cosmetic Safety and Technical Standards 2015 are meaningless for foreign enterprises looking to avoid animal testing. In other words, products made by foreign companies still require animal testing before entering China via general trade.

Realizing a total ban on animal testing of testing of cosmetics in China requires full implementation of a risk assessment system, or the adoption of alternatives for finished products. Due to relatively late implementation of risk assessment in China’s cosmetic administrative system and the comparatively weak technical capacities of domestic SMEs, a total ban is not likely to happen in the short term, but China is now on the way to the validation of alternatives for finished cosmetic products. Zhejiang is developing 7 group standards for alternative methods for cosmetic final products, 3 of them are soliciting public opinions and are expected to be released in mid-2019. The other 4 are still being drafted and are expected to be released by the end of 2019. The release of group standards will promote the development of national standards for alternative methods for cosmetic final products.