China’s first-imported non-special use cosmetics filing management

Chinese cosmetics regulation: 4 steps to formula compliance

One of the first steps in the cosmetic product registration process in any country is checking if the formula is compliant with the relevant cosmetics regulation. China has strict requirements regarding the cosmetic ingredients, which includes lists of prohibited and restricted ingredients for use in cosmetics. In addition, the regulation also provides guidance on the use of correct ingredient nomenclature. It is important to make sure that the product formula does not contain any prohibited substances and that any restricted substances fall within the required restriction limits. Any deviations found in the formula will result in rejection by the competent authority during the technical review of the Chinese cosmetics registration process.

  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.

  1. 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.

  1. 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.

  1. 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.