ACCESS- FOCUS ON CHINA
Author
Mr. Zhongrui Li (Mr. Ray Li),
Toxicological Risk Assessor,
Intertek
ABSTRACT
The purpose of this chapter is to give a brief overview of the cosmetic legislation and regulatory status for importers who are interested in supplying their cosmetic products to the Chinese market. The difference and similarity between EU and Chinese regulations are summarized. Cosmetic legislation, definitions, the registration process, and new ingredient requirements are also discussed to help the reader understand how to enter the marketplace in Mainland China.
2.3.3.1 Category of cosmetics in China: special use and nonspecial use cosmetic
2.3.3.2 Oral products requirements
2.3.3.3 Document and testing requirements during product registration
2.3.3.4 Animal testing requirements in China
2.3.3.5 Safety assessment for ingredients and finish products
2.3.3.6 Comparison of EU and China regulation requirements
2.3.3.7 Existing and new cosmetic ingredients in China
2.3.3.1 CATEGORY OF COSMETICS IN CHINA: SPECIAL USE AND NONSPECIAL USE COSMETIC
Cosmetic regulation in China is based on Regulations Concerning the Hygiene Supervision over Cosmetics (1990). “Cosmetic products” are defined as those daily-used chemical products (substance and mixture) applied on the surface of any part of the human body (such as skin, hair, nails, oral, and lips) by way of smearing, spraying, or other similar methods to keep the body clean; to get rid of undesirable smell; to protect the skin; to make up the face, and to increase appearance and beauty. The definition is similar to that of the EU Cosmetic Directive 76/768/EEC and includes prohibited and restricted substances that are listed in the EU Hygienic Standard for Cosmetics (2007). The main difference between the EU and Chinese regulations is that cosmetic products are divided and managed in two categories: “special use” and “nonspecial use” products. Nonspecial-use cosmetics include hair care, nail care, skin care, perfumes, and makeup. Special-use products include hair growth, hair dye, hair perm, hair removal, breast shaping, fitness, deodorizing, spots removal, and sun block.
2.3.3.2 ORAL PRODUCTS REQUIREMENTS
Oral care products are not listed in either of the two categories, and instead are regulated according to other separate national standards (e.g., GB 8372-2008 gives specified requirements for toothpaste). Furthermore, there are guidelines, national standards, and industry standards on cosmetic products that present specific requirements. These include, but are not limited to, testing methods, labeling, and registration. Consequently, compliance with the legal requirements is made difficult to understand for importers or distributors foreign to China. The authorities have noticed that and now are discussing the matter with industry; it is very likely that oral products will be treated as “cosmetic” and regulated by China FDA.
2.3.3.3 DOCUMENT AND TESTING REQUIREMENTS DURING PRODUCT REGISTRATION
For imported cosmetic products, except oral care products, and unlike the trend in the EU and U.S., registration and animal testing are required by China’s State Food & Drug Administration (CFDA) before marketing. Such testing can take several months or more to perform before registration is possible. The nonspecial-use cosmetics do not require registration, but notice should be provided to provincial authorities if the products were manufactured by domestic companies, including internal brands that have manufactured products in mainland China. The Registration Documents are listed in the Table 1. The application form and all other documents should be written in simplified Chinese and the original language of the technical document should also be submitted to CFDA together with its translation.
Table 1: China FDA required registration documents for cosmetics
Nonspecial-use cosmetics | Special-use cosmetics |
Application form for imported cosmetics (nonspecial use) | Application form of imported cosmetics (special use) |
Product formula—INCI name in both English and Chinese | Product formula—INCI name in both English and Chinese |
Quality standard of product (specification) | For products with the function of slimming, breast care, and hair growth, documents should provide the effective ingredient based on scientific data and a brief introduction and sketch of production process. |
Testing report of inspection institute accredited by Ministry of Health (MOH) and relative documents | Brief description of manufacture technology and procedure chart |
Original package (including label) or package (including label) designed for the Chinese Market | Quality standard of product (specification) |
Certification documents of sale permission for the registered product in country of origin (region) or manufacturing country (region)-free sale certification | If products contain ingredients that endanger health, documents should provide the related safety assessment data (test report for concerned impurities). |
If products contain ingredients that endanger health, documents should provide the related safety assessment data (test report for concerned impurities) | Testing report of inspection institute accredited by Ministry of Health (MOH) and relative documents |
