Page 74 - EXPORT MAGAZINE MULTISECTOR

REPOR T

BE READy WITH DoCuMENTATIoN which is the overarching legislation for cosmetics in China.
To AVoID ANIMAL TESTINg IN CHINA Toothpaste, while not classified as cosmetics, is managed
To avoid animal testing on cosmetics products registered for by reference to the CSAR. Just as recently as December 1,
general trade in China, companies must satisfy the following 2023, new legislation entitled Toothpaste Supervision and
requirements: Administration Regulation (TSAR) came into effect.
1. be a “general” cosmetic only Applicants who already had a history of selling toothpaste
2. the ingredients in the formula shall be already listed in the in China were allowed to submit a simplified notification
Inventory of Existing Cosmetics Ingredients in China, known of their products up to and including November 30, 2023.
as IECIC. The last version is from 2021. This pathway is now closed and companies who wish to sell and
3. a Product Safety Assessment Report must be submitted as part distribute toothpaste in China must submit a notification to the
of the submission confirming the product’s safety NMPA. See Figure 2 for a summary of the relevant categories of
4. a good Manufacturing practice (gMp) certificate or cosmetics requiring approval under CSAR and TSAR in China.
comparable certification of the quality management system
of the applicant is required. Importantly, this GMP certificate
must be issued by the local government / competent ENSuRE youR EFFICACy CLAIMS
authorities of the country (region) where the manufacturer is ARE CHINA CoMPLIANT
located. Cosmetics registered or filed in China must specify their
cosmetic efficacy claim. There is a defined list, including
The difficult requirement is the GMP Certificate, because “special” claims such as whitening, or sunscreen and “general”
many companies will have such certificates issued by claims such as moisturizing or hair-care. Efficacies claimed will
an industry association or third party such as Intertek. require proof in the form of human trials (if special efficacies)
This is NOT acceptable if you want to avoid animal tests for or lab tests or literature, unless they are basic efficacies
your China approvals. Another difficulty is that the competent which can be directly recognised by vision, smell
3
authorities of some countries, notably USA and Australia, and other senses (eg cleansing, body refreshing).
refuse to issue such certificates at this stage. Therefore, brands should be aware of their cosmetics
A possible workaround is that state or even local efficacies or ask experts who can properly analyse the product
government certificates can be used instead (eg the states packaging and formula. Making more efficacy claims will
of California and Jersey both issue GMP certificates for mean that filings or registrations will be more expensive,
companies located in those states, even though the US FDA because proof is required for each efficacy claim.
at the national level does not do so). The Italian Ministry
of Health issues GMP certificates accepted by China. KEEP uP To DATE WITH CHANgINg
REguLAToRy REQuIREMENTS
With the implementation of China’s new cosmetics framework
under the CSAR in 2021, there are frequent ongoing updates
and additional requirements for new approvals and for
products already approved. Therefore, it is important that
companies continue to stay up to date One example of an
important regulatory update was the introduction of the
Chinese good Manufacturing Practices for Cosmetics.
It came into effect on July 1, 2022, and applies to both
domestically produced and imported cosmetics. The aim
of the NMPA in introducing the GMP is to ensure that
cosmetics are safe for consumers and to make clear that the
responsibility for the quality, safety and efficacy of products on
the market lies with the manufacturer who notifies or registers
a product as well as their contract manufacturers. Since the
PRoDuCTS WITH SPECIAL CoNSIDERATIoNS: Chinese GMP is still relatively new professional support from
Children’s cosmetics are not considered a separate category, companies with experience in Chinese regulatory affairs can
however, if a product targets babies or children aged 12 or under, be crucial in carrying out a gap analysis of your current Quality
the cost and the timeframe for approval tend to be higher due Management System as well as undertaking mock-audits to
to stricter sample tests and application dossier requirements. prepare you for NMPA onsite inspections.
Soaps which have efficacy claims of “special” cosmetics are
required to register as “special” cosmetics according to the
Cosmetics Supervision and Administration Regulation (CSAR) 3 For the list of efficacy claims and required proofs, please contact the author.

72 www.exportmagazine.net