The challenging Chinese market is famous for its regulatory difficulties especially regarding the importation of hair&beauty products. One of the most controversial topics is the testing of cosmetics on animal that is required in many cases to have the authorization to sell foreign product in the Chinese market. In this article we provide some tips that can be useful for brands who are engaged in the starting phase of importation into China.

By Miriam Bandinelli

The cosmetics market in China is the world’s second largest, and one of the fastest growing. Imported brands dominate the high-end of the market and growing cosmetics brands cannot ignore the market potential. However, preparation and investment is first required to obtain the regulatory approvals to be able to sell into the market. In recent years the China cosmetics regulatory framework has been substantially strengthened and revised, with the result that animal testing can be avoided but cosmetics claims testing and validation requirements have become stricter.

Read on for the top 5 tips cosmetics brands should know when obtaining China certification for their cosmetics whilst avoiding animal testing.

Chinese market
Miriam Bandinelli Senior Account Manager at Cisema

Tip #1 General or special? Categorise your product

According to the substantially revised Chinese cosmetic regulation known as CSAR (or Cosmetics Supervision and Administration Regulations), cosmetics are classified into “special” and “general” cosmetics for the purposes of approval for general trade in China.

  • General” cosmetics are cosmetics other than “special” cosmetics, including fragrances, make-up, nail cosmetics, hair care, skin care, etc.
  • “Special” cosmetics include sun protection, hair dyes, hair perming, anti-hair loss, and freckle removal and whitening, and cosmetics that claim new effects.

According to the latest regulations only general cosmetics for adult consumers can avoid animal testing. The approval of general cosmetics for baby/infants and special cosmetics requires necessarily animal testing in China.

Tip #2: Be ready with documentation to avoid animal testing in China

To avoid animal testing on cosmetics products registered for general trade in the China market, companies must submit following documents together with the registration dossier:

  1. a Product safety assessment report in Chinese as confirmation of the product safety
  2. a GMP (Good Manufacturing Practice) certificate or comparable certification of the quality management system of the applicant is required. Importantly, the GMP certificate must be issued by the local competent authorities of the country (region) where the manufacturers are located.

The difficult requirement in the author’s experience is the GMP Certificate, because many companies will have such certificates issued by an industry association or third party. This is fine for a “normal” filing but NOT if you want to avoid animal tests for your China approvals.

Another difficulty is that the competent authorities of some countries, such the US FDA , refuse to issue such certificates at this stage. A possible workaround is that state or even local government certificates can be used instead (eg the states of California and Jersey both issue GMP certificates for companies located in those states, even though the US FDA won’t). In Italy the Italian Ministry of Health issues a GMP certificate acceptable for the NMPA.

Tip #3: Have a clear strategy about your domestic responsible agent (DRA)

Cosmetics brands must have a local representative in China that is a Chinese entity in order to be approved for general sales. Known as the domestic responsible agent or DRA, it submits the regulatory approval and is the point-of-contact for the brand with the regulator for continuing compliance and communications.

Applicants have 3 broad options

  1. Own subsidiary
  2. Distributor
  3. Third-party agency service

Having a company’s own subsidiary is an appropriate long-term strategy, but can be expensive and time-consuming to establish until volumes are large. The subsidiary must also have compliance-related staff who are up to date with regulations and can respond to regulator requests.

Selecting a distributor as DRA is the easy option, but the author cautions companies to do so only after considering fully the available options. The DRA is the entity that submits the application dossier which must contain detailed and confidential information about the products, eg formula and production process. This has clear intellectual property risks.

The DRA also controls the online account which must be set up to submit the approvals, and so the applicant will continue to be wholly reliant on the distributor’s continued cooperation for adding/deleting ports and consignees (especially other distributors), or to change the DRA itself.

Selecting a third-party agency service is a sensible option to retain independence and better manage IP risks. This solution is neutral and preserves full control over NMPA online account, ensures independence for future decisions, including adding/deleting ports and consignees, or DRA changes.

Tip #4: Know your China efficacy claim

Cosmetics registered or filed in China now require to specify their cosmetic efficacy claim. There is a defined list, including “special” claims like whitening, or sunscreen and “general” claims like moisturizing or hair-care. Based on the categorization of the efficacy claim the animal testing can be avoided or not. Products showing “special” claims normally cannot avoid animal testing in China.

Therefore, brands should be aware of their cosmetics efficacies or ask experts who can properly analyse the product packaging and formula.

Tip #5: Keep up to date with changing regulatory requirements.

With the implementation of China’s new cosmetics framework under the CSAR, there are frequent ongoing updates and additional requirements for new filings and for products already filed. Therefore, it is important that companies continue to stay up to date with the frequently updating requirements, whether for already filed products or those new to file. A transparent and professional relationship with the DRA is crucial.

A number of service providers have regulatory news updates in English because the official updates and guidelines are only published in Chinese.

In conclusion, to get cosmetics approved whilst avoiding animal testing in China and satisfying also the increasingly strict China regulatory requirements, international manufacturers must have an updated and correct knowledge of the regulation and a transparent relationship with their China local agent (DRA). But the efforts are worth it for the growing market potential, provided the initial set-up and regulatory compliance is appropriately implemented.

About the author:

Miriam Bandinelli is Senior Account Manager at Cisema since 2015, a China-focused full service regulatory consultancy founded in Munich and Beijing in 2002. She supports international companies obtain their product certification and achieve regulatory compliance in China. She is a specialist for the Chinese NMPA, CML and CCC registrations. Regularly writing articles and speaking on China regulatory affairs and pathways for life sciences products.

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