|Find out more about the new regulations
Would you like to know more about China’s new regulatory framework for imported cosmetics?
Knudsen&CRC is participating in two free webinars on the subject, one in Europe on 25 March at 14:00 CET and one on 8 April at 13.30-14.30 Shanghai time.
Details of the European webinar here.
Details of the Asia edition via this link
Publisher’s introduction: From 1 May, animal testing is no longer required on general cosmetics imported into China if they meet the requirements set out by China’s National Medical Products Administration (NMPA).
What does this mean for the international cosmetics sector? To find out more, we approached Shanghai-based Knudsen&CRC, a Danish-owned, Shanghai-based consulting firm devoted to assisting foreign companies in product certification and regulatory compliance. It provides in-depth consumer and market research and hands-on solutions for businesses wishing to sell to the Chinese consumer.
The Moodie Davitt Chairman Martin Moodie spoke to Knudsen&CRC CEO & Partner Mette Knudsen and Senior Regulatory Advisor Cathy Zhu about the detail and implications of the new regulatory framework.
The Moodie Davitt Report: How do you assess the significance of the change in regulations pertaining to the waiving of animal testing on cosmetics under specific conditions?
Knudsen&CRC: I think this new cosmetics regulation is very much in line with China’s development into a modern, innovative market with focus on consumer health and safety – and product innovation (quality, R&D). In addition, an increased focus on sustainability.
The first priority of the China government is to protect China consumers’ health & safety – and then they are willing to approve more open and positive measures on how to waive animal testing.
It is identical to what happened in Europe. Since 2013, Europe implemented the cosmetics regulation to waive animal tests on all cosmetics ingredients, but so far based on EU REACH it still requires exposure (toxicology) test on cosmetics ingredients for professional workers. [Note: REACH is an EU regulation adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry -Ed]
There is no doubt that China’s new regulation will bring positive trends and attract more and more people paying attention to animal well-being in the future.
For, say, a ‘clean’ or otherwise socially minded brand wanting to enter China, can they do so from May without any such constraints – or are there limitations?
After 1st of May all of the registrations shall follow up with the new regulation. Below are the requirements for waiving animal test for regular cosmetics:
- The production entity shall provide the relevant certification of Quality Management System issued by the local government of the country (region). Details not yet announced
- To provide enough safety & risk assessment materials confirming the safety of the products; Details not yet announced
- The filing products are not aimed at children or infants;
- The filing products do not contain any new raw materials that are not included in the approved list;
- The applicant, the responsible person in China as well as production entity have not been listed as key supervision objects. (If the product is produced by more than one production entity, then all of the entities shall obtain the official certificate in order to waive the animal test.)
So Hainan’s offshore duty free sector would be viewed just as the China local market in this context?
Hainan province is definitely included in the regulation as it belongs to Mainland China. It is different from the offshore duty free stores in an international airport. We consulted with Hainan Provincial MPA and they confirmed that all of the cosmetics sold in duty free in Hainan will be regulated as regular cosmetics [in terms of] registration or filing.
Sum up please the difference between Hainan offshore duty free and traditional airport duty free in China?
They are totally different. ‘Hainan offshore duty free’ belongs to Mainland China. Here ‘offshore’ refers to ‘离岛’ (‘leaving Hainan Island’). The visitor can purchase the products from these duty free stores by having a ticket to leave Hainan province (but not leave Mainland China).
And for those offshore duty free stores in the international airports, the ‘offshore’ means ‘离境’ (‘leaving Mainland China’) and do not belong to Mainland China – that is why they are not specified by the regulation. Only the visitor that takes an international flight can go to these stores.
Is cross-border ecommerce affected by the new cosmetics regulations?
The new regulation will not affect the requirements of cross-border ecommerce.
What are the biggest challenges that the implementation of the new law will present?
The biggest challenge is the use of the new system and raw material declaration. In the future, all of the raw materials used in the formula shall be declared by the supplier, which is an unprecedented change. Another big challenge is that we do not yet have all the details on the national QMS/GMP certificates that will enable companies to bypass mandatory animal testing for imported cosmetics.
Your advice to brands?
Brands should begin to prepare now – but should expect that it will take time to be ready to register imported cosmetics.
Most importantly is that the national cosmetics associations and governments agree on a QMS/GMP certificate that can be approved by China. There will be a transition period before the new regulatory framework is fully implemented and the system is working. Brands can use this time to prepare all the documentation required.