Paul O’Brien, a regulatory analyst at Chemlinked said that he is expecting to see China change its animal testing requirements for imported cosmetics “in the short term”.
Realistically, O’Brien believes China will begin to move forward by utilising a system which will continue animal testing on high-risk products and ingredients, while those considered low-risk will be exempt.
Instead, lower-risk products or ingredients will be eligible to generate safety data through the use of alternative models or computer-based quantitative risk assessment.
Reading between the lines
O’Brien pointed out that China efforts in developing facilitated market entry pathways for imported cosmetics, such as the special filing system, and cross-border e-commerce (CBEC) which are based on post-market assessment, surveillance principle and industry self-regulation.
This new facilitated market entry principle is best exemplified in China's special filing system for first imported general cosmetics, he said. It was initially implemented as a pilot program in Pudong but was recently expanded nation-wide, which allowed for a “greatly expedited route to market”.
O’Brien added, “Sure animal testing data is still required for now but reading between the lines of administrative reform and regulatory trends, I’ve a feeling it’s not long before all of that changes.”
O’Brien further elaborated on China’s ongoing efforts to reform its policies, such as replacing the former Chinese Food and Drug Administration with State Administration for Market Regulation (SAMR), and setting up the first department specifically for administrating cosmetics in China, namely China's Cosmetic Safety Supervision Department which is under the National Medical Products Administration.
“Part of its broad mandate of the SAMR and NMPA's Cosmetic Safety Supervision Department is a shift towards post-market assessment, classified management of cosmetics and optimization of technical standards to align with global best practices.”
With new optimised oversight mechanisms being developed, such as more efficient feedback loop between market authorities and customs authorities to regulate premarket inspections based on post market violations and optimise post-market rectifications such as recalls based on testing at ports.
“Additionally we can expect digitisation of administrative processes which will further facilitate this feedback loop likely leveraging supply chain digitisation and traceability,” said O’Brien,
Not just cosmetics
O’Brien highlighted that animal testing is not just prevalent in the cosmetics sector.
“While animal testing of cosmetics gets all the attention, animal testing is also heavily utilised in other sectors,” he said. “Use of risk stratification to determine regulatory compliance obligations represents a broader regulatory trend in China which has already been rolled out in China's pesticide sector, a significant reduction in animal testing requirements.”
He added, “I expect will also be implemented in its health food sector going forward, also likely to mean reduction in animal testing.”