How China is responsible for safety decisions
The Chinese landscape contains a variety of obstacles that need to be overcome to push the alternative non-animal cosmetics testing forward.
“One key difference in China is that the regulator, not the manufacturer, is responsible for safety decisions,” expressed Erin Hill, Co-Founder and President Institute for In Vitro Sciences (IIVS). Ultimately, “consumers rely on the government to ensure safety”.
“Given this personal liability it is understandable that regulators make change cautiously,” added Hill. “There have been cases – albeit extreme – that government officials have been imprisoned or even executed for incorrect decisions.”
IIVS purposefully ensures that its programmes are “very inclusive” – they strive to bring together scientists from the provinces and various agencies, reaching out to the esteemed dermatology community including cosmetic safety reviewers and engaging the academic community.
Commenting on how these activities fuels progression, Hill went on to say: “The more the scientific community at large embraces these new methods, the more confidence the CFDA will have to make changes.”
Government agencies in cooperation
Recently, IIVS collaborated with BASF to import a cell-based assay for skin sensitisation, LuSens. These cells are imported through one agency (AQSIQ) and will be distributed to provincial CFDA laboratories through NIFDC.
“As in many countries, different government agencies don’t always work closely together, to our knowledge this is the first time such coordination has occurred around alternatives,” Hill expressed.
Ease of Implementation
“Not all methods accepted at the OECD level are readily implemented in China,” Hill noted. “For instance, the test system, tissue or equipment may not be available.”
As a result, IIVS has worked to identify skin or eye (or other) model manufacturers in China including L’Oreal and BioCell (Formerly ReShine) Biotech, which provide 3-dimensional tissue constructs for skin and eye irritation testing. They have also helped source necessary equipment – again working originally with BASF to provide opacitometer units in order to perform the Bovine Cornea Opacity and Permeability assay (BCOP).
Ironing out technicalities
“Additionally there are many technical issues that need to be worked out,” Hill warned. IIVS has an alternatives laboratory, which offers all of these methods to industry on an everyday basis and has participated in many of their validations.
Equipped to solve these technical issues, this would include finding new assays or optimising existing ones.
“Our network with industry and the (Central/) provincial laboratories is key to get this type of technical work done,” Hill stated.
Proposed alternative tests
Sharing her views on a realistic timeframe for China and the wider cosmetics industry to bring about change in terms of increasing alternative non-animal testing methods, Hill champions the belief that “they will continue to accept alternative methods at a fairly steady basis”.
The landscape initially does appear positive: “After reviewing comments of the STE and DPRA (for which we have provided training for years) I feel fairly confident they will accept these tests.”
“However, both of these tests don’t lend themselves well to testing of final formulations which is currently required in China,” commented Hill.
Moving forward, IIVS will continue to work with industry and labs in China such as the Zhejiang IFDC to demonstrate how final formulations can be tested in vitro.
“It’s very important to work with China to find solutions that fit their needs," emphasised Hill.
Training is key in China. This stems from CFDA's statement that they need the proper infrastructure in alternatives in China through proficient laboratories and sufficient capacity to meet demand before regulations will change. Thus, IIVS isn’t just “training” but assisting the government in building its infrastructure.
IIVS networks across agencies in China to promote collaboration in alternatives. There are two main agencies that have provincial laboratories: CFDA and AQSIQ.
There are also CDC labs that have experience in alternatives. At present, ZJIFDC has applied to be a key laboratory in alternatives of the CFDA and they have capabilities in most of the in vitro methods for cosmetics. We are pleased that the head of our International Outreach programme, Dr Quanshun Zhang, has been invited to be part of the scientific advisory committee for the lab.
When it comes to China establishing its own validation centre for alternative methods, Hill commented: “In working with the head of the NIFDC we have learned of their intention to create a Validation Centre for alternative methods (VAM). They have asked IIVS’ help in learning about the styles of different VAM’s around the world and also help them identify other interested scientists in China who are working on alternatives.”