Last week, France’s ANSM unveiled a dedicated online platform via Demarches-simplifiees which enabled French beauty makers to apply for a Good Manufacturing Practices [Bonnes Practiques de Fabrication] certificate to prove production sites complied with China’s safety requirements. Obtaining the certificate, alongside providing compliant product safety assessments, exempted firms from previously required animal testing.
Regulatory requirements for animal testing exemptions in China were outlined in a subsidiary regulation of the country's updated Cosmetic Supervision and Administration Regulation (CSAR) - the draft document Instructions for Cosmetic Registration and Notification Dossiers, published by the country's National Institutes for Food and Drug Control (NIFDC).
Up until the issue of this draft legal text last year, China had required animal testing for all imported cosmetics on arrival, excluding those sold via cross border e-commerce channels; carried out by Chinese local health control authorities, not brands.
Good Manufacturing Practices certificate compliant with CSAR conditions
All Good Manufacturing Practices certificates obtained via the portal complied with CSAR conditions because they were issued by a French government regulatory department, rather than a third-party institution or association.
Each certificate request made via the site cost €1,400, following a decree inserted into Article R. 5131-2 of the French Public Health Code, and could be accepted or refused once the dossier with all documents was reviewed.
However, certificates could only be obtained for the manufacture of general-use or ‘ordinary’ cosmetics – most products across all categories, bar those that claimed to be designed for use in infants and children or products using new ingredients that were still under safety monitoring. Items considered ‘special use’ cosmetics such as hair dyes and sun products were also not exempt and, when exported to China, still remained subject to animal testing requirements.
Full details on how to apply for the Good Manufacturing Practices certificate were outlined by ANSM in full here.
FEBEA president ‘delighted’ with progress
“We are delighted with this progress, which rewards several years of efforts made with the Chinese authorities,” said Patrick O’Quin, president of the French Beauty Federation for Beauty Companies (FEBEA).
French cosmetics companies would now be able to export to China “under new conditions”, O’Quin said – particularly important given China was now France’s second-largest trading partner.
“…The cosmetics industry is the only industry in Europe to have completely banned animal testing, and we are happy to continue to evolve regulations in other parts of the world,” he said.
FEBEA said the mobilization of French cosmetic companies and health authorities to develop the platform providing certifications had enabled a “decisive breakthrough” that rewarded “many years of industry efforts” with Chinese authorities.
Immediate effect? China easing strict animal testing on cosmetics
Whilst France had done everything necessary to qualify for new animal testing exemptions when exporting cosmetics to China, Hedy He, senior regulatory analyst at Asia-Pacific regulatory and market intelligence specialist ChemLinked, said it was important to note that China's Instructions for Cosmetic Registration and Notification Dossiers was "still a draft and not finalised yet, which means animal testing exemption for important general cosmetics is not effective for now".
The final version of the Instructions was expected to be released before May 2021, He told CosmeticsDesign-Europe.
But China had already started to adapt its previously strict need for animal testing on cosmetics, ceasing animal testing on certain products, including shampoos, shower gels and make-up, manufactured and marketed in China since June 2014. And when the country updated its CSAR regulations in June, last year – effective since January 1, 2021 – this new option of animal testing exemptions for imported general-use cosmetics was unveiled.
Whilst experts at the time suggested that obtaining such exemptions on cosmetics animal testing would likely prove too complex for foreign companies, He said the ANSM online portal released in France would certainly enable French cosmetic companies to enter China "smoother and faster", in alignment with animal testing exemption requirements.
And once more cruelty-free French beauty products reached China, she said it would force Chinese companies to conduct more product research, development and innovation and launch more competitive products. From a regulatory perspective, He said animal testing exemptions for imported general-use cosmetics would help the Chinese government accumulate experience in the supervision and management of safety assessment.