CFDA for Cosmetic Products

All cosmetic products require CFDA (China Food and Drug Administration) approval for export to, and sales in China. Some Cosmetics will also require a technical review by a CFDA approved institution.

According to the decision of the Central Committee of the CCP on March 17th, 2018, the CFDA was replaced by the NMPA (National Medical Products Administration). However, related regulations and personnel responsibilities are expected to remain unchanged. Until the legal and structural changes of the authorities are completed, the term CFDA is still in use.

The “Regulations Concerning the Hygiene Supervision over Cosmetics”, approved by the Chinese Ministry of Health dictates which products need CFDA approval. Some of the cosmetic products include:

• Hair growth products
• Hair coloring products
• Hair perming products
• Hair removal products
• Sun protection products
• Breast enlargement or breast reduction products
• Muscle growth products
• Weight loss or slimming products
• Deodorant
• Products for spot removal (e.g. pigmented spots)

Four steps are required for a successful CFDA approval process:

• Application

Depending on the product and product category, relevant application documents must be prepared and filed with the CFDA. All information in the documents should be 100% consistent with the actual product specifications, otherwise it may result in a rejection of the application. Typically, the application and supporting documentation must be submitted in the Chinese language.

Supporting documentation, such as test reports testifying to the hygienic safety of the product (including microbiological, chemical and toxicological tests results) issued by an accredited test laboratory, should accompany the application (s. Appendix “Toxicological investigation”). If the tests are performed by a foreign (non-Chinese) laboratory, relevant certifications and accreditations of the test laboratory (e.g., “Good Clinical Practice”) should also be submitted.

• Animal testing

Cosmetic products manufactured by foreign companies and exported to China are currently required by regulations (as of November 2014) to undergo animal testing prior to approval for the Chinese market. Cosmetics which are not used for special purposes can, under certain circumstances, receive approval without the use of animal testing.

• Preliminary examination

The CFDA will check the accuracy and completeness of the submitted application documents. If determined that the product does not require CFDA approval, it will be directly communicated to the applicant. Generally, the CFDA will conduct their preliminary examination within 5 days. If no initial problems are found with the documents, the process of approval will begin. At this point it is crucial to have close communication with the CFDA to be informed about the application progress and the preliminary examination(s).

• Technical examination

With regard to the above listed cosmetics for special purposes, a technical examination by the “Assessment Center for Health Products” will be carried out. This will usually be completed within 90 working days. For other cosmetic products, such as perfume, nail care and shampoo, this examination is not necessary.

• Registration Certificate

Once approved, the registration certificate is issued by the CFDA and the product can then legally be exported and sold on the Chinese market.

Do you want to know more about CFDA registration? Then download our CFDA-Booklet for free here!

Appendix:
Animal trials for toxicological investigation under the Hygiene Regulations for cosmetic products:

1.  Acute Oral Toxicity Test
2.  Acute Dermal Toxicity Test.
3.  Dermal Irritation / Corrosion Test
4.  Acute Eye Irritation / Corrosion Test
5.  Skin Sensitization Test (allergic contact dermatitis)
6.  Skin Phototoxocity test
7.  Salmonella Typhimurium / Reverse Mutation Assay
8.  In Vitro Mammalian Chromosome Aberration Test Cells
9.  In Vitro Mammalian Cell Gene Mutation Test
10.  In Vivo Mammalian Bone Marrow Chromosome Aberration Test Cell
11.  Mammalian Erythrocyte Micronucleus Test
12.  Testicle Cells Chromosome Aberration Test
13.  Subchronic Oral Toxicity Test
14.  Subchronic Dermal Toxicity Test
15.  Teratogenicity test
16.  Combines Chronis toxicity / carcinogenicity test
17.  In Vitro Mammalian Chromosome Aberration Test Cells

If applicable, also the following examinations (no animal testing):

1. Safety and Efficacy Evaluation in Human: Human Skin Patch Test, Safety Evaluation of Using tests of Cosmetics on Human Body.
2. Tests in vivo of UV Protection Efficacy of Cosmetic Sunscreens on SPF, PFA or PA values.
3. Other additional studies such as the investigation of asbestos in the cosmetic products.

If you interested in the CFDA approval for cosmetic products, please do not hesitate to contact us.

• We will check if your product needs CFDA approval
• We will provide you with a transparent, non-binding quote for CFDA approval of your product
• We accompany you through the complete registration process, including all communications with the Chinese authorities and support with the assessment process in China.
• We pay all application and evaluation fees to the Chinese authorities.
• We will ensure that your CFDA approval process runs smoothly and that the effort on your part is minimized.

If you have any questions or concerns, please do not hesitate to Email or call us: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673