France is leading the charge in making GMP certificates easier to obtain in a bid to reduce the number of products that require animal testing when exported to China.
Last August and November, China released the first and second draft Instructions for Cosmetic Registration and Notification Dossiers which proposed that general cosmetics can be exempted from animal testing.
General cosmetics refer to all the products complying with the definition of cosmetics within the Cosmetic Supervision and Administration Regulation (CSAR), except for the special cosmetics namely hair dyes, hair perming products, freckle-removing and whitening products, sunscreens, anti-hair loss products and cosmetics claiming new efficacy. But it should be noted that the draft ‘Instructions’ regulate two preconditions and three exceptions for the animal testing exemption:
Only by fulfilling both of the following two conditions can companies of general cosmetics apply for the exemption of animal testing:
- General cosmetic manufacturers have obtained the GMP certificates issued by the competent authority of the country (region) where they are located
- The safety assessment results can fully confirm the safety of products.
As long as one of the following 3 conditions applies, companies are still required to conduct animal testing:
- Products claim to be used by infants/children;
- Products using new cosmetic ingredient during their 3 years of required monitoring;
- The notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA.
For the first precondition-submission of GMP certificates, ChemLinked commented that “some overseas cosmetic companies may face a barrier for the animal testing exemption as they may fail to submit the GMP certificate granted by the local government cosmetic authority. In some regions, like the EU, the government cosmetic authority won’t issue an official GMP certificate due to the local cosmetic regulatory scheme. The GMP certificates that can be provided are generally issued by cosmetic associations or international standardization organizations.”
However, it now appears that the official GMP certificates may not be a barrier. Recently France ANSM (National Agency for the Safety of Medicines and Health Products), the French health authority, announced that it would issue the GMP certificates for local cosmetic manufacturers and has already launched an online platform for them to obtain the certificates.
Additionally, more countries in Europe are considering joining the league. “The U.K. government is working closely with industry to create a certification system that will satisfy new Chinese regulations on cosmetics, following the removal of the requirement for animal testing on imported cosmetics,” said a U.K. Department of International Trade spokesperson.
Nevertheless, it’s an open question whether the Chinese government will recognize the GMP certificates.
Apart from the GMP certificates, safety assessment is also a mandatory condition for the animal testing exemption, which may pose a challenge for cosmetic companies as well.
China has released the draft Technical Guidelines for Cosmetic Safety Assessment for public consultation on July 29, 2020. However, the draft Guidelines introduce very strict requirements for safety assessment, such as:
- For finished products, the safety assessment shall not only focus on the assessment of all ingredients but also on the overall stability of the product, even the interaction of the packaging material and the content.
- Safety assessors are required to have a professional background, such as pharmacy, chemistry or toxicology, and at least 5 years of relevant working experience, and need to understand the cosmetic production process, quality and safety control requirements, toxicological assessment methods, etc.
Furthermore, the draft ‘Guideline’s haven’t clearly stated whether to recognise the safety assessment report issued by foreign institutions or foreign safety assessors.
As the ‘Guidelines’ haven’t been finalized, whether the safety assessment will still be subject to such strict requirements remains to be seen.
Now the animal testing exemption for general cosmetics is still on the drawing board. Once it is implemented, international cruelty-free brands will be able to tap into the Chinese cosmetic market under new conditions. Although there are great limitations and challenges, the exemption would undeniably be a great benefit for international cosmetic companies and also a big step taken by China towards reducing animal testing.
ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence across Cosmetic, Chemical, Food and Agrochemical Industries. ChemLinked boasts a multidisciplinary team of scientists, compliance specialists and language experts backed by the vastly experienced technical teams at REACH24H, to ensure over 44,000 registered members to acquire authoritative information and dependable consultancy services. ChemLinked aims to remove any regulatory barriers that prevent you from exporting your products into China and other countries in the Asia-Pacific region
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