Inviting public opinion
China’s National Institutes for Food and Drug Control (NIFDC) closed its public consultation on the proposal to introduce the direct peptide test method for ascertaining skin allergies in cosmetics products and the “method for short exposure of chemical raw rabbit corneal epithelium cell (STE) for cosmetic chemicals” to identify eye irritation on 15th February 2018.
Amid this consultation, and as we await its results, we spoke with Troy Seidle, Vice President, Humane Society International to ask whether China is avoiding adopting alternative animal testing methods, and what the barriers exist to moving this conversation on.
At present, China Food and Drug Administration (CFDA) stipulates that the basis risk assessment procedure when conducting a safety assessment report requirement must consist of a four-stage process: Hazard identification, hazard characterisation (dose–response relationship), exposure assessment, and risk characterisation.
Alternative methods in China
“I would not say that China is steering away; indeed, NIFDC and other authorities have been moving incrementally toward greater and swifter uptake of non-animal testing methods for cosmetics and other regulated products,” encouraged Seidle.
However, there are a number of “hurdles that make this a slower process in China than in the EU or US”.
Why is China slower than the US and the EU to adopt these?
A lack of training is a core barrier to the uptake of non-animal alternative methods, Seidle highlighted. These should focus on “local testing facilities and safety assessors in companies, government and independent reviewers in the conduct and interpretation of non-animal test methods”.
HSI and others have been supporting these efforts financially for the past several years to help further alternative non-animal testing developments in China.
2. Creating a centre
China is currently without its own centre for alternative methods. It only has observatory status at the International Cooperation of Alternative Test Methods. While this “brings together all national centres for validation of alternative methods”, China is yet to have its own dedicated unit.
When it comes to non-animal alternative testing methods in China, it is important to look at the country’s “history of testing finished cosmetics and regulating on this basis vs. ingredient-based safety assessment in most other parts of the world”.
While finished cosmetics are “complex mixtures”, OECD test guidelines, on the other hand, are validated using pure chemicals.
Commenting on the repercussions of this disparity, Seidle went on: “As a result, additional scientific work may be needed to verify the applicability of OECD methods/risk assessment to Chinese cosmetic formulations and whether methodological refinements are needed. This takes time and funding.”
The reliable local supply of non-animal models such as 3D human skin or corneal tissue “takes time to establish, and shipments from international suppliers can be cost-prohibitive”. In addition, these “may not be viable by the time the biological material clears customs and is delivered to a testing facility”, Seidle commented.
Multinationals operating in China
Questions may be asked as to how China’s stance on non-animal alternative testing methods impacts multinational companies that hail from other countries but which operate in the Chinese market.
While concerns and controversy exist, Seidle states that “companies manufacturing non-special-use cosmetics in mainland China have the potential as of 2014 to forego pre-market animal testing provided they can supply a robust ingredient-based product safety assessment, which is the norm in other parts of the world”.
“Anecdotal reports suggest that some companies have been successful in avoiding pre-market animal testing for domestically manufactured non-special-use cosmetics since 2014,” he added.
However, Seidle went on to say that companies “importing cosmetics of any kind into China continue to be subject to premarket animal testing requirements, which include at a minimum eye and skin irritation testing on rabbits”.
Moving forward, “it is hoped that as NIFDC acceptance of OECD non-animal methods grows, any such pre-market testing will become non-animal in nature”.
In the right direction
While China may be perceived as lagging behind its US and EU counterparts, Seidle emphasised: “Chinese authorities and stakeholders are actively working to catch up to other developed nations in terms of testing infrastructures, training and competence, and regulatory policy to maintain a high level of consumer safety and unobstructed trade.”
“As a result of years of investment and behind-the-scenes work by many stakeholders, uptake of non-animal methods is now an area of active work for NIFDC and other authorities, which I regard as a positive and hopeful development,” encouraged Seidle.