Continued increases in the general population and a growing middle class has put China on track to become the largest global market for cosmetic and personal care products in the next decade. But for international brands, taking advantage of China’s lucrative cosmetics market requires overcoming significant compliance hurdles that are markedly different from those imposed in the U.S. the European Union and other major markets, including in some cases animal testing requirements intended to verify human safety. This article will provide a brief summary of the registration and testing requirements applicable to cosmetic products in China, and discuss how TÜV SÜD can help ease the path to regulatory approval.
The market for cosmetic products in China
The U.S. International Trade Administration (ITA) estimates that the sale of cosmetic products in China reached $50 billion (USD) in 2015. This represents approximately 18 percent of the global market for cosmetics, and places China with the U.S. and Japan among the top three leading countries for cosmetic products. However, the ITA estimates that only about 10 percent of China’s population uses cosmetic products on a regular basis, spending an average of just $24 (USD) per person in 2014, compared with $223 per year in South Korea and $174 per year in Japan. These market characteristics portend above average annual growth increases of 7-10 percent in China’s cosmetic market over the next several years, outpacing market growth in other, more developed economies.
Even more encouraging is the apparent growing interest among Chinese consumers in premium cosmetic brands. A survey conducted by investment firm Morgan Stanley found that 84 percent of Chinese respondents indicated their intention to purchase more expensive or similarly priced skincare and makeup brands in the coming year. This interest in high-end products is also being driven in part by more widespread online access to premium cosmetic brands, as well as increased international travel by Chinese consumers to global shopping destinations, such as Paris, London and New York.
China’s registration and testing requirements for imported cosmetic products
Originally implemented in 1990, China’s Regulation concerning the hygiene supervision over cosmetics organises cosmetic products into one of two categories. “Non-special purpose cosmetics” include products with no medicinal effect, such as skin care products, makeup and lipstick, nail care products, perfumes and colognes, and hair care products like shampoos and conditioners. The term “special purpose cosmetics” covers products that promote specific beauty or health benefits, such as products for hair growth or hair removal, hair colours and dyes, deodourants, products for body shaping or fitness, and anti-spot or UV-blocking creams and lotions.
Under Chinese law, all imported cosmetic products, regardless of their classification, are subject to pre-market review and approval under regulations promulgated by the China Food and Drug Administration (CFDA, formerly the State Food and Drug Administration, SFDA). The CFDA is responsible for the administration and oversight of the pre-market review programme, and for the authorisation of designated testing bodies that conduct pre-market product testing. The CFDA is also responsible for post-market surveillance regarding the quality and safety of cosmetic products already on the market.
In brief, the regulatory approval process for imported cosmetic products involves the following steps:
- Appointment of a “Responsible Agent”: Non-Chinese manufacturers, exporters and distributors of both categories of cosmetic products must first appoint an authorised agent based in China to act of their behalf in all matters related to regulatory approval. The authorised agent can be a China-based subsidiary, an importer, or an independent third party.
- Establish an account on the CFDA’s online registration system: Before registering a new cosmetic product, the appointed responsible agent must apply for a user name and password to access the CFDAs online registration system. The authorised agent must be able to provide evidence of a valid business license and a notarised letter of appointment when the online account is established.
- Document product ingredients: Product ingredients in cosmetic products must conform with the list of approved and restricted ingredients as detailed in CFDA’s Technical Safety Standards for Cosmetics (TSSC). Published in 2015 and in effect as of late 2016, the TSSC updates the approved and restricted ingredients list originally provided in 2007’s Hygienic Standards for Cosmetics. Product ingredients not included in the TSSC must be separately reviewed for their safety and approved by the CFDA prior to use in a cosmetic product.
- Evaluate product labelling: Product labelling for cosmetic products imported into China must include the product name, the address of the producer, the country of origin, ingredients, production and product expiration dates, and use instructions, precautions or warnings. This information must be provide in Chinese, either through the use of a special label applied over the original label, or a label designed exclusively for use on products to be sold in China.
- Conduct product sample testing: All imported cosmetic products must be tested in a CFDA-authorised testing laboratory based in China, even those products that have been previously tested and approved for sale in another country. All cosmetic products are subject to hygiene testing, specifically physio-chemical, microbiological and toxicological testing (which may involve animal testing). Special purpose cosmetic products must also be evaluated for human safety, which typically evaluates the risk of dermal and ocular irritancy and dermal sensitisation.
- Prepare and submit product dossier for review by CFDA: Once testing is complete, applicants prepare a product dossier which incorporates all product and testing documentation and submits the dossier to the CFDA for its review and further technical assessment.
The entire application, testing, dossier preparation and CFDA review process can take as long as nine months to a year, depending on the type and ingredient complexity of the cosmetic product.
Other considerations for importers of cosmetic products
Imports of CFDA-approved cosmetic products are also subject to inspection and testing at ports of entry by agents of China’s Inspection and Quarantine Bureau (CIQ). As part of the inspection, CIQ agents will review the CFDA licensed issued in connection with the product being imported, as well as other product-related documentation. Product labelling will be evaluate for conformity with the applicable Chinese regulations and standards, and agents will also conduct physiochemical and microbiological testing on random product samples. Products that pass this inspection will be issued a certificate of inspection, and allowed to complete the review by Customs officials.
It is important to note that non-special purpose cosmetic products produced in China are subject to far less rigorous review. In some cases, manufacturers can reduce time to market by partnering with a China-based company that can assemble finished cosmetic products from ingredients shipped to them by the manufacturer. Of course, another alternative is to utilise e-commerce platforms to ship cosmetic products directly to consumers, bypassing the regulatory process altogether.
How we can help
TÜV SÜD state-of-the-art testing facility in Shanghai, China is fully equipped to conduct all testing consistent with the requirements of Safety and Technical Standards for Cosmetics 2015, including physio-chemical, microbiological and toxicology testing. For more information about TÜV SÜD testing services for cosmetic and personal care products for China, speak to us today.