China Reach Regulation for Various Sectors

China's State Council published the final version of the COsmetic Supervision and Administration Regulation (CSAR) and this came into force on 1 January 2021 and replaced the Cosmetic Hygiene Supervision REgulations. CSAR regulates all cosmetics and cosmetic raw materials in China. All the manufacturers, importers and exporters must ensure that their cosmetic products and raw ingredients meet the compliance obligations under CSAR before producing, importing, and exporting business.

Substances are divided into two categories:

• cosmetic raw ingredients
• cosmetic products.

Based on different types of substances, different submission procedures (record filing and registration) apply.

Cosmetic raw material is defined as natural or synthesis ingredients which are used in making cosmetic products. According to the requirements, existing ingredients need to do record filing submission, while new ingredients must do a formal registration to produce or place in China. The distinguished point for checking the procedure for ingredients Is to check if it falls within the cosmetic inventory.

IECIC stands for Inventory of Existing Cosmetic Ingredients in China. Currently, it contains 8972 existing cosmetic ingredients. In addition to the main inventory, there are seven cosmetic inventory lists that can be used in parallel with IECIC. If ingredients are found on the inventory, then it only needs to submit record filing.

New raw ingredients are defined as cosmetic ingredients that are not listed in the IECIC inventory.

Applicants need to submit the following documents to comply with CSAR:

1. Applicant’s details which include name, address, and contact.
2. Research and Development report which addresses the sources and properties of the ingredients, basis of efficacy, data, etc.
3. Quality control standard. It needs to explain the process during the production of the cosmetic ingredient, quality specification index, testing methods, and possible risks.
4. Safety evaluation report. Toxicological safety evaluation data, evaluation, and necessary toxicological test data must be given in this report.

The application may take up to 4 months before a decision is made. The technical committee will need around 3 months to undertake the evaluation work.

The registration timeline of cosmetic products is the same as cosmetic ingredients registration. But the submission documents are different. For cosmetic products registration, applicants need to prepare:

1. The name, address, and contact information of the registration applicant filing person and manufacturer.
2. product name, formula, or full product ingredients.
3. Standards implemented by the product.
4. Product label sample.
5. Product inspection report.
6. Product safety assessment data.
7. Registrant qualification

For imported cosmetics, they must be labeled in Chinese and contain the following information:

1. Product name, special cosmetics registration certificate number
2. The name and address of the registrant, recorder, and entrusted production enterprise
3. Cosmetic production license number
4. The standard number of the product
5. All ingredients
6. Net weight
7. Use period, method of use and necessary safety warnings

CSAR also introduces the annual reporting requirements. Applicants should submit the annual report of cosmetics from January 1 to March 31 each year.

1. Basic information and production of new cosmetic ingredients.
2. Information on cosmetic registrants, filers, or entrusted manufacturers who use new raw materials to produce cosmetics.
3. Information on cosmetics using new raw materials, including product name, product registration or filing number, number of products produced or imported, sold, etc.
4. Sampling inspection, investigation, and recall of cosmetics produced with new raw materials.
5. The adverse reaction monitoring system, statistical analysis of adverse reactions, and measures of cosmetics produced with new cosmetic ingredients for cosmetics manufacturers.
6. Risk monitoring and evaluation management system and measures of cosmetics produced with new cosmetic ingredients for cosmetics manufacturers.