Partial Animal testing ban in China

Animal testing for “nospecial-use cosmetics” (now called “general-use cosmetics”) made in China has been banned since 2014. Imported cosmetics without product registration, i.e. with no animal testing, are allowed to be sold on cross-border ecommerce platforms, however not at physical shops for general trading.

NMPA (National Medical Products Administration) published the “Provisions for Management of Cosmetic Registration and Notification Dossiers” on 4th March 2021. In paragraph 33, it is clearly defined under which preconditions a toxicological testing for general-use cosmetics are not demanded any more. The measures took effect from 1st May 2021.

Toxicological testing, which is always linked with animal testing in China, can be banned if the manufacturer can guarantee the product safety via: 

1. The manufacturer owns an official production qualification management certificate such as GMP or ISO issued by competent authority in the country of origin.
2. Safety assessment of cosmetic product can confirm the safety of product.

However, there are three exceptions, and they are:

1. baby and child products
2. cosmetic products contain new raw materials which are not in the IECIC list yet but are newly notified and still in the three-year monitoring period
3. according to the quantitative rating system, the applicant, the domestic responsible person, and the manufacture are classified as key supervision target.

It means, without animal testing, general-use cosmetics can enter the Chinese cosmetic market and sell not only on cross-border ecommerce platforms but also at physical shops after 1st May 2021.

New regulation: CSAR

The “Cosmetic Supervision and Administration Regulation” (CSAR) took effect on 1st January 2021 and replaced the outdated “Cosmetic Hygiene Supervision Regulation” (CHSR), which was implemented in 1990 and has been a major hurdle to progress and innovation in the cosmetic sector. CSAR is becoming the most stringent supervision regulation in the history of Chinese cosmetic industry and will also have an impact on the global cosmetic market. Now, a new era of Chinese cosmetic sector begins.

Important points for European brands

There are a lot of new provisions linked to CSAR such as notification of new cosmetic ingredients, safety assessment and efficacy claim, etc. which have been published for public consultation. Some of them have also been published officially. This move aims to ensure the quality and safety of cosmetic products, safeguard the health of consumers, and keep the cosmetic industry on a sound growth trajectory.

A registrant (for product registration) or filer (for product notification) will often be required in CSAR and denotes a company or organisation that requests registration or notification for finished cosmetic products or raw materials. They are brand owners or manufacturers who are responsible for quality, safety, and efficiency claims. The registrant or filer should have a quality management system and be able to monitor and evaluate adverse effects of cosmetic products.

The registrant or filer shall fulfil the relevant obligation of pre-market registration or notification, conduct pre-market safety assessments by themselves or entrusted institutions, and perform the related obligation of post-marketing adverse reaction monitoring.

Overseas registrants or filers of cosmetics shall designate a corporate legal entity in China to handle the registration or notification of cosmetics and assist in monitoring of adverse reaction of cosmetics and product recall. More than ten subsidiary guidelines have been published for public consultation since the CSAR was published last year and more will follow. The CSAR consists of six chapters with 80 clauses (compared with only 34 clauses of CHSR). The themes include:

1. General guidelines (10 clauses)
2. Cosmetic raw materials and finished cosmetic products (15 clauses)
3. Production and sales (20 clauses),
4. Supervision and administration (13 clauses)
5. Legal liability (18 clauses)
6. Supplementary articles (4 clauses)

New definition of cosmetic products

Cosmetic products are industrial chemicals for daily use that are applied onto the human surface of the skin, hair, nail, lips, etc. via application, spraying or other similar methods for the purpose of cleansing, protecting, beautifying, and decorating. With respect to the previous definition the terms “any” external part and function “eliminate unpleasant odour” have been removed.

Clarification of cosmetics

Cosmetics are divided into two groups, i.e., general-use cosmetic (before non-special-use) and special cosmetic (before special-use).

Special cosmetics include cosmetics of hair dye, hair perm, anti-freckle and whitening, sun protection, some anti-hair loss and other products that claim new efficiency.

The remaining cosmetic products belong to general-use cosmetics. The animal testing ban is only for general-use cosmetics. However, special cosmetics should be registered and approved as before, so it means for special cosmetics will endure a longer registration duration and higher cost and animal testing for toxicological tests.

Toothpaste doesn’t belong to cosmetics but shall be regulated as a general-use cosmetics according to the provision of CSAR and can be claimed with the functions of caries prevention, anti-dentin sensitivity and dental-plague inhibition, etc. Soap does not apply to this CSAR, but soap with special cosmetic efficiency

does apply to the regulation and should be notified or registered. Anti-hair loss products are clarified into three groups: general-use anti-hair loss product is one which only improves or strengthens the hair quality; if anti-hair loss cosmetic products can improve scalp/hair roots, it belongs to special cosmetic; antihair loss medicine product promotes hair growth through participatio

New cosmetic raw materials – notification or registration?

The registration of new cosmetic ingredient was a complex, expensive and time consuming process in China. This is the reason why many ingredients used by the cosmetic industry in the EU and America are not listed in the IECIC (Inventory of Existing Cosmetic Ingredients in China).

In China, only the ingredients on the IECIC list are allowed to be used for cosmetic products. Only four new ingredients are approved between 2011 and December 2020. The total amount of approved cosmetic ingredients in China is now about 8.787. In the meantime, the amount of “International Cosmetic Ingredient Dictionary and Handbook” has reached approx. 22.620 ingredients. Limited ingredients significantly hinder the development of China’s cosmetic industry and make it impossible for some cosmetic products with new ingredients to enter the Chinese market. According to the CSAR, the management of cosmetic raw materials will now be regulated on their risk. Raw materials considered as high risk like preservatives, sunscreen filters, whitening agents, colourants, etc. will have to register and obtain approval, while the management of raw materials with low risk such as extracts, moisturisers will be subjected to filing management, i.e. notification. There is three-year monitoring for notified raw materials before officially listing them on the IECIC list.

Safety Assessment

Safety assessment for cosmetic products is demanded for registrationand  notification. Qualifications for safety assessors with professional knowledge of cosmetics quality and safety and more than five years of relevant professional experience is demanded. 

Cosmetic vigilance

Post-market surveillance is strengthening. Adverse reaction monitoring systems of cosmetic products, safety risk monitoring and evaluation system, cosmetics quality and safety risk information exchange processes will be set up. Cosmetic registrants/filers should set up a recall system in the meantime.

Efficacy claims

The registrant/filer of the cosmetic product is obliged to publish the summary of the scientific literature, research data or product efficacy test evaluation, on which the efficacy claims are based, on the designated website by the state council’s drug supervision department for public consumption.

Labelling

Provisions of labelling are also defined, name of registrant/filer, production license number and contract manufacturer, product name. INCI list, expiry date, etc. should be printed on the label. Imported cosmetics can use a Chinese folding box or stick with a Chinese label whose content should be consistent with the original one.

Legal liabilities

There will be more severe punishments for those who flout the laws. Fines and penalties will be increased significantly for relevant responsible persons. CSAR lists description of violations and the relevant punishments, such as selling products containing prohibited or not in the IECIC listed raw materials, untrue or false claims of cosmetic products, selling products without registration or notification, etc.

The punishment varies from a small fine to lifetime disqualification from working in the cosmetics industry, depending on the severity of the violation. The relevant authority may audit manufactures aboard upon requirement.

References

¹ www.gov.cn

² www.nmpa.gov.cn, National Medicine Product Administration

³ www.stats.gov.cn, National Bureau of Statistics