The new regulation will be implemented on January 1, 2021. Following the release of CSAR, China will publish a series of supporting documents and administrative rules, which will further establish China’s cosmetic regulatory framework.

To ensure a smooth transition, a five-year grace period was granted for hair growth, hair removal, breast beauty, slimming and deodorant products, which were already registered.

The new regulation brings many changes, below are some of the highlights:

• unified filing system for domestic and imported non-special use cosmetics (now referred as general cosmetics)
• new cosmetic ingredient registration and management
• new rules on efficacy testing and claim substantiation
• safety risk assessment and exemption from mandatory animal testing

Updated product categories

Toothpastes are now considered general cosmetics and are regulated under CSAR. However, soaps remain outside of scope of CSAR, with the exception of soaps with special cosmetic efficacy.

Cosmetic products are referred to as general cosmetics and special use cosmetics. The latter include hair dyes, hair perms, whitening products, sunscreen products, anti-hair loss products and products with new efficacies. These are all subject to pre-market registration. On the other hand, general cosmetics include all other cosmetic products and only require filing.

New cosmetic ingredient management

Cosmetic ingredients are classified as ‘’new’’ and ‘’used’’ ingredients. New ingredients with high risk, such as preservatives, sunscreens, whitening agents, colorants, and hair dyes require registration and approval from the National Medical Products Administration (NMPA). Other new ingredients are subject to filing with NMPA.

Cosmetic efficacy claims

Cosmetic claims must be substantiated by sufficient scientific evidence, which will be made publicly available on the NMPA’s website.

Safety assessment and animal testing

General cosmetics will no longer be subject to mandatory animal testing, whether they are produced domestically or imported into China. Safety assessments will be accepted in place of animal testing. However, there are some exceptions, which will still require animal testing:

• products intended for use by children or infants
• products with new ingredients, which have been approved but are not yet listed in the IECIC

Additional requirement for imported cosmetics

Imported cosmetic products also need to submit certifications relating to manufacturing quality control of the overseas manufacturers as well as documents, that prove those products have been placed on the market in the country of origin. For products, which are specifically produced for China, the applicant must provide research and test data for Chinese consumers.

The post China released the final version of Cosmetic Supervision and Administration Regulation (CSAR) appeared first on CE.way.

1. Check if ingredients are allowed for use in China

Firstly, it is important to check if the ingredients can be found on any of the lists published in the Chinese cosmetics regulation. In order to assure your formula contains only the ingredients allowed for use in cosmetics in China, they have to be found on the Inventory of existing cosmetic ingredients (IECIC 2015). If the ingredient cannot be found, it means you have a new cosmetic ingredient, which has not been used in China before. This means that in order to use this new ingredient, you will have to undergo the time-consuming process of new ingredient registration. If the ingredient is found to be safe by the competent authority, you will get a certificate with 4-year validity. If no adverse effects are observed during this time, the ingredient will be added to the IECIC.

If your ingredients can be found on the list of existing cosmetic ingredients, you also have to check the following lists:

• List of prohibited substances
• List of restricted substances
• List of allowed preservatives
• List of allowed UV filters
• List of allowed colorants
• List of allowed hair dyes

If your product contains a restricted ingredient, it is important to follow the restrictions provided in the Safety and Technical Standards for Cosmetics 2015.

2. Check the ingredient nomenclature

Cosmetic ingredients in the formula and on the label of the products that are sold in China have to be listed according to their Chinese INCI names. Therefore, it is important to make sure that you are using the correct nomenclature by checking the Catalogue of Standard Chinese Name of International Cosmetic Ingredients (INCI Chinese version).

It is possible that there is no INCI name for your ingredient. In this case, you can adopt its chemical name, botanical name or the name written in the Chinese Pharmacopoeia.

3. Check if the mixtures are written correctly

Like in the EU, in China, it is also important to write the whole composition of the mixture used in the formulation. If you have a raw material that is composed of different substances, you have to list all of them by their Chinese INCI name and also provide the percent of each ingredient in this mixture, as well as the percent of this raw material (mixture) in the finished cosmetic product.

4. Choose the appropriate ingredient function

According to the Chinese cosmetics regulation, there are only 69 cosmetic ingredient functions, which are allowed to be listed in the formula. It is important to choose only among those 69 functions and to choose the most appropriate one for your ingredient. The competent authority will check if the selected function corresponds to the ingredient. In case you have a mixture, the function should be applied to the mixture and not the individual substances.

The post Chinese cosmetics regulation: 4 steps to formula compliance appeared first on CE.way.