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The Regulation Concerning Hygiene Supervision over Cosmetics has significant impact on the cosmetics industry in China and has provided the foundation for regulating both cosmetics manufacturing in China and cosmetics importing into China. This law was formed in 1989, but after more than twenty years in practice, discussions around the need for amendments have recently emerged.
According to the regulation, a cosmetics production license is required for manufacturing cosmetic products in China. The license is controlled by the China Food and Drug Administration (CFDA, formally the SFDA of Ministry of Health), and issued by the health administrative department of province, autonomous region or municipal cities. This regulation also sets the rules for cosmetic materials, ingredients, packaging materials, and containers that are in direct contact with cosmetic products. For new materials that are used for cosmetic product manufacturing, an approval from the health administrative department under the State Council is required, while a hygiene license is required for special use cosmetics, such as hair perm, dyes, removal, deodorizing, etc.
According to Article 15 of the regulation, importers of first-time cosmetic products are required to submit relevant documents to the health administrative department under the State Council. These documents include such items as specifications, the quality standard, the method of testing, and a sample of the cosmetic product, along with production approval. This approval must be issued by the official department of the exporting country (or region) in order to get an approval from the authority. All imported cosmetic products need to get the inspection approval from the Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ).
According to the Administrative Measures on the Inspection, Quarantine and Supervision of Chinese Imported & Exported Cosmetics (AQSIQ No. 2011-143), all cosmetic product importers need to be registered with AQSIQ. Registration numbers are provided for import and export inspections.
Two recent developments with regard to registrations and licensing have drawn major attention from the industry:
- No pre-market registration required by CFDA for importing “Non-Special Use Cosmetics.” The first involves registrations associated with importing “Non-Special Use Cosmetics.” According to an announcement from the State Commission Office for Public Sector Reform (SCOPSR) regarding the Organization Reform on CFDA on May 15, 2013, importing “Non-Special Use Cosmetics” (i.e. regular use for hair care, nail care, skin care, make-up, and perfume, etc.) no longer requires registration with the CFDA, but only with provincial level FDA. This change is significant in that it reduces the administrative burden and may expedite the registration process for foreign companies. A registration for the same type of cosmetics, if manufactured in China, has not been required, except when obtaining a record-keeping certificate from the provincial FDA within two months after placing them into the market. Still, it remains to be seen whether China will come up with a new “registration” requirement with the provincial FDA for imported Non-Special Use Cosmetics or revoke the registration requirement at all and grant the same record-keeping certificate requirement to domestically manufactured Non-Special Use Cosmetics.
- Cosmetic Production License no longer required for domestically-manufactured cosmetics. According to CFDA Notice 2013-213, the AQSIQ will no longer govern domestically-manufactured cosmetics and its conventional Cosmetic Production License will not be required. Until this notice, all domestically-manufactured cosmetics were required to have two licenses: a Cosmetics Production License with AQSIQ and a Hygiene License for “Special Use Cosmetics” (such as hair perm, dyes, removal, deodorizing, etc.) or record-keeping certificate (for “Non-Special Use Cosmetics”) with provincial FDAs. For new licensing applications, all manufactures now only need to apply for the Cosmetics Manufacturer Hygiene License with CFDA, effective from October 11, 2013. The licenses that had been obtained previously will be honored until their expiration dates.
Sookie Hong is a regulatory expert on the Asia Pacific region. She regularly discusses hot topic regulations in China, Japan, Korea, and Taiwan. On October 17, 2013, she presented GHS Development in Asia Pacific: Compliance and Challenges at The 3rd Shanghai Summit Meeting on Chemical Regulations in China, Korea and Japan. To view her presentation, please click here.