Strict requirements: COSSMA

photo: Andrei David Stock/Shutterstock.com

Various new regulations apply in China when a cosmetic product is to be launched or imported in the market. Rongmei Hui-Drobnik explains what these are and what foreign brands should know if they want to join the Chinese market.

After the implementation of Cosmetic Supervision and Administration Regulation (CSAR) on 2021, many related measures and provisions were published last year. For foreign cosmetic brands and manufactures there is a lot to know. Let’s have a quick look at the update subsidiary cosmetic regulations in China:

Good Manufacturing Practices for Cosmetics (GMPC) was issued in January 2022. The GMPC finalises the requirements for qualification and duties of the person in charge of quality and safety, ensures the traceability of cosmetic products, clarifies the further requirements for entrusted production, etc.
Guidelines for Enforcement of Medical Aesthetic Advertising defines medical aesthetic. These ads belong to medicine advertisement. The advertiser should obtain a license for medical institution.
Supervision and Administration Provisions Children Cosmetics publishes very strict regulations for children cosmetics, including the principle of choosing ingredients, safety assessment, packaging design, registration, and notification, claims and post-market surveillance, etc. Toxicological test (animal test) for children’s cosmetics is mandatory.
Administrative Measures for Supervision and Administration of Cosmetics Production and Operation refines the responsibilities of cosmetics registrant/notifier and entrusted manufacture, such as production quality management practices, safety management system, purchase inspection and recording system, etc.
Administrative Measures for Cosmetics Labelling
Inventory of Existing Cosmetic Ingredients China 2021 (IECIC) contains nearly nine thousand ingredients.
Inventory of prohibited ingredients for cosmetics
Technical guidelines for safety assessment of cosmetics requires a mandatory safety assessment from 2022. Safety assessment which is established in the EU may be only used as reference.
Standards for cosmetic efficacy claim evaluation
Classification rules and catalogue of cosmetics introduces the classification coding system according to efficacy claim, application area and method, target user, dosage form. It came into effect on 1st May 2021.
Provisions for Management of New Cosmetic Ingredient  Registration and Notification dossiers details the requirements of registration dossiers for high-risk raw materials, notification dossiers for low-risk ones and ingredients’ safety status report. In addition, it specifies that data from animal testing alternative methods for ingredients’ registration/notification can be conditionally accepted. The date of implementation was from 1st May 2021.
Provisions for Management of Cosmetic Registration and  Notification dossiers describes the documentation requirements for the application, modification, renewal, and cancellation of cosmetic registration/notification and details the conditions for no animal test. These provisions began on 1st May 2021.
Administrative measures for cosmetics registration and  notification have taken effect from 1st May 2021. It refers to cosmetic and new cosmetic ingredients, such as the procedures and obligations of registration/notification, etc.

Labelling requirements

The Administrative Measures for Cosmetics Labelling will come into effect from 1st May 2022. For cosmetics that have been registered or notified before that date, the deadline of compliance will be 1st May 2023.

The content of the label should be legal, true, complete, accura- te and consistent with the content of the product which is submitted for the registration or notification. Imported cosmetics must have an original Chinese folding box or affixed Chinese labels. The contents of Chinese labels regarding safety and efficacy claims of products should be consistent with the original ones. It should contain the following contents:

Chinese product name and registration number for special cosmetics.
The name and address of registrant/notifier and the domestic responsible person.
The name and address of entrusted manufacturer, if the registrant/notifier is not the manufacturer.
The product executive standard number.
Complete ingredients: The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the product. Ingredients in concentrations of less than 0.1% should be separately preceded by the term “other trace ingredients”.
Net content in national legal unit of measurement
Period of use: There are two options, one is manufacture date combined with shelf life, the other is production batch no. with expiry date or period after opening (PAO).
Application: description of how to use the product.
Precaution and safety warnings, as for children cosmetics.
Logo for children’s cosmetics.
Other contents should be marked in accordance with laws.

Prohibited phrases

Some defined means or claims on cosmetics labels are strictly prohibited, such as: use of medical terminology, name of medical celebrity, words describing medical action and effect, or name of approved drug expressly or impliedly indicating that the product has medical effect; misleading consumers by using terms and mechanisms that are not widely accepted by the scientific community; misleading consumers by fabricating false information; implying functions, that the product does not actually have, or is not permitted to have, and somer more.

Children cosmetics

The NMPA (National Medical Products Administration) published the mandatory logo for children cosmetics in December 2021. All children cosmetic must take the logo from 1st May 2023. Products with claims as “suitable for every age group”, “for the whole family” or use trademarks, patterns, similar pronunciation, letters, hanyu pinyin (official romanisation system for standard), numbers, symbols, packaging forms etc. to suggest that the product is intended for use by children, are regulated in accordance with children’s cosmetics.

The warnings such as “Caution, use under adult’s supervision” should be printed on the packages. Claims with food and medicine should be avoided, and claims as “food grade, edible” or food-related patterns on packages are not allowed either.

Cosmetic claims

According to the Classification Rules and Catalogue of Cosmetics published in April 2021, there are 26 categories of cosmetic claims plus new efficacy A. These categories include hair dyeing, perm, whitening, sun protection, anti-acne, nourishing, repairing, cleansing, make up remover, moisturising, beauty and grooming, fragrance, deodorisation, anti-wrinkle, lifting, soothing, exfoliation, hair care, anti-hair breakage, anti-dandruff, hair colour treatment, depilation, and shaving aids.

The Standard for Cosmetic Efficacy Claim Evaluation defines 20 efficacy claims with relevant efficacy evaluation methods. These should be based on adequate scientific evidence which include scientific literature, research data or the evaluation tests of cosmetic efficacy claims. These include human efficacy evaluation test, customer using test and tests in a lab.

Acceptable evaluation standards are:

China’s mandatory national standards, methods specified in the technical specifications for cosmetics.
Methods contained in other relevant regulations, national standards, and industry standards.
Methods specified in relevant foreign regulations or technical standards.
Methods published by domestic and foreign authoritative organisations, technical institutions and industry associations, published in professional academic journals/magazines, or developed and established by cosmetic companies.

The cosmetic registrant/notifier is responsible for scientific, authenticity and reliability of submitted abstracts of efficacy claims evidence. They should upload evidence abstracts of product efficacy to the website which is designated by the NMPA in accordance with this Standard for Cosmetic Efficacy Claim Evaluation while the process of registration/notification since 2022.

For products that can be directly identified by sight, smell, and other senses, or whose effects occur by simple physical covering, adhesion, friction and which are clearly identified on the label as having only physical effects for efficacy claims no efficacy test will be required.

There is a transition period for submission of evidence of efficacy claims: registered/notified cosmetics before May 2021 should submit efficacy claim reports before May 2023, registered/notified cosmetics between May 2021 and 31st Dec. 2021 should submit efficacy claim reports before May 2022. All cosmetics (exeptions mentioned before) must submit evidence of efficacy claim while registration/notification if registration/notification happens since 2022.

What type of testing is required for efficacy claims?

√ means mandatory tests which should be performed in accordance with the mandatory national standards and must be completed by the NMPA accredited labs in China.
* means selectable and one must be selected.
△ means “scientific literature or research data” which must be combined with one of the following tests: Human Efficacy Evaluation Test, Customer Using Test, or tests in lab.
Scientific literature or research data may be the only evidence for efficacy claims of moisturising, hair care and effective of raw materials efficacy claims. It is very difficult to meet this requirement.
Claims of products for pregnant or lactating women are among the new efficacy claims. The requirements for documents and tests will be very high.

In October 2021, NMPA officially launched a year-long special rectification campaign to overhaul the online cosmetic market. It alerts not to use claims as stem cells, “Shua Suan” (acid peeling), pharmaceuticals or medical cosmetics, dishonest or misleading claims and expressed or implied medicinal effects.

An article regarding “Stem cell is a false concept” published on the official website of NMPA states that “so-called plant stem cells are essentially a type of plant cell that can only stimulate and increase other types of plant cells, but not human cells.” “Some products’ claim that cosmetic products contain plant stem cells, which can lead consumers to misunderstand that plant stem cells have a stimulating effect on human cells.” Stem cells are not included in the Inventory of Existing Cosmetics Ingredients China (IECIC) 2021. NMPA has not approved registration/notification of cosmetic ingredients related to stem cells, so it is not allowed to use claims with stem cells for cosmetics in China.

The NMPA clarified that acid peeling, or chemical peeling can only be applied by a medically qualified professional in a hospital or clinic institute. Other claims such as eyelash growth promotion, “edible” or “food grade” cosmetics, cannabis cosmetics, cosmeceuticals, etc. are also banned in China.

Strict market requirements

The Chinese cosmetic industry has now entered a new era of strict regula- tions. Last year several prestige international cosmetic brands had to pay penalties because of violating them. Some Chinese manufacturers had to close because they couldn’t meet the strict requirements and lost their production license. Results of random checks on cosmetics are published on the official website of NMPA if the cosmetic products have problems with quality, packaging without Chinese labels or faulty claims, etc.

China has strengthened its supervision on the cosmetic sector. International cosmetic giants are now key target of supervision. According to incomplete statistics from May to August in 2021, there were nine administrative penalty cases related to cosmetic giants. The reasons are dishonest or misleading claims or claims without test evidence or scientific literature, claimed SPF value doesn’t match the tested result, etc.

There are 52 shipments of imported cosmetics which are found unqualified from January to August in 2021 according to the statistics from the General Administration of Customs China. These cosmetics have been returned or destroyed at the port on site.

Sustainable packaging

State Administration for Market Regulation (SAMR) China launched Requirements of Restrictions Excessive Package – Food and Cosmetics last year which will come into effect from September 2023 with a two-year transition period. Excessive packaging or over-packaging is defined as a product whose packaging interspace ratio, packaging layers, and packaging costs exceed the necessary function requirements.

The main issues of packaging for cosmetics in China are use of too many packaging layers, an excessive amount of empty space inside the package and high cost as a result of packaging which are far beyond the basic requirements of the packaging’s own function. An extreme example is a folding box of a 20ml eye cream that is as big as a box for shoes.

The restrictions regulate the packaging requirements for 31 categories of food and 16 categories of cosmetics. They specify in detail the requirements for the volume of empty interspace allowed in a pack, packaging layers, the value of costs to be spent.

It is easy for customers to calculate if product packaging is excessive. The packaging interspace ratio must not exceed 30% of total volume. The cost of all packaging does not exceed 20% of the sales price of the product, except for packaging that comes into direct contact with the contents.

Conclusion

A European brand that wants to enter the Chinese market should take into consideration the following aspects:

How to protect the confidential information such as formulation, manufacture process, supplier information of raw materials, etc. while registration/notification?
Who will be the domestic responsible person who will have access to the confidential information?
Which claims are allowed? Which efficacy claims will be printed on the package? Can the claim be proved by the required test or scientific literature or research data?
Is the registration/notification agent reliable and competent?

General speaking, the European cosmetic brands are advised to learn the new Chinese cosmetic regulations before they enter the Chinese market.