Caroline Rainsford, Head of Scientific Services captures key conversations from CTPA’s New Approach Methodologies (NAMs) workshop with scientists, NGOs, academia and Regulators.
As far back as the 1980s, the UK cosmetics industry was seeking out alternatives to animal testing and in 1997 it completely moved away from all animal testing of cosmetics products and ingredients through a voluntary industry initiative: well before bans were introduced in the UK and EU in 2004 and 2009 respectively. Over the last 25 years, the UK and EU cosmetics industry has invested more than €70 million in what are known as New Approach Methodologies, or “NAMs”, making it a global leader in this important field today and well positioned to advise others.
In fact, our industry takes great pride in its commitment to replacing animal testing and to sharing its knowledge and expertise, which is why last month it took its pioneering approach one step further. CTPA convened an expert workshop on NAMs, bringing together cosmetics company scientists, animal-free testing providers, NGOs, academia and UK Government regulators. A key objective of the workshop was to promote the use of NAMs as scientifically robust alternatives to animal testing for purposes beyond UK and EU Cosmetics Regulation. In particular, to comply with UK REACH.
Our latest blog captures key conversations and themes from that workshop as part of our continued commitment to share knowledge on this important issue…
The ‘regulatory dilemma’
The ‘regulatory dilemma’ posed by REACH testing requirements, and how to overcome it, was a key theme of the day. In my opening presentation I explained that, in effect, the regulatory landscape can force cosmetic ingredient manufacturers to test certain chemicals on animals to prove environmental or worker safety, when the use of NAMs has already proven their safe use within cosmetics and personal care products under UK and EU Cosmetics Regulation. While this testing does not contravene the strict cosmetics animal testing bans, CTPA and the UK cosmetics industry want to do everything possible to promote the use of NAMs as scientifically robust alternatives to animal testing for these vital safety requirements under other chemicals legislation, especially UK REACH.
It's clear that a successful world-leading UK strategy on alternatives to animal testing will need cooperation both nationally and internationally, depending as much on political will as on scientific advances. Dr Fiona Sewell, Head of Toxicology at the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and Professor Alan Boobis, Emeritus Professor of Toxicology at Imperial College London explained the current work on NAMs taking place in the UK and elsewhere in the world that will help to facilitate this. Dr Paul Russell, Science and Programme Leader at Unilever, shared how NAM leaders in the cosmetics industry have already produced and shared training materials for the wider cosmetics industry and global regulators through the Animal-Free Safety Assessment (AFSA) project. Indeed, perspectives from the cosmetics industry highlighted strategies used by ingredient suppliers, product manufacturers and testing houses to demonstrate the safety of ingredients without the need for animal data.
A pressing need for progress
This global progress is becoming increasingly important. Expansion of chemicals legislation across the world is creating an urgent need to progress the acceptance and use of NAMs around the world; a point reinforced at the workshop by Clare Liptrot, Product Safety and Regulatory Affairs Manager at Croda International, a cosmetic ingredient supplier who offered a live, global view on the issue.
Dr Catherine Mahoney, Research Fellow at P&G, took up this challenge with some encouraging outputs from the journey so far, such as a successful workflow for systemic toxicity risk assessment without any reliance on animal data. The cutting-edge science being developed to predict the impact of chemicals was further brought to life by Paul Walker, VP and Head of Toxicology and Innovation Efficiency at Cyprotex.
Participants were able to get their teeth into the challenges and questions raised during the case study discussions., where proving that a chemical is safe for workers who might be exposed to it at manufacturing sites seemed to be a key sticking point. The REACH regulation frequently mandates animal testing, but Dr Carl Westmoreland, Director of Science and Technology at Unilever, demonstrated how worker safety can be assured using NAMs.
During the discussions, it was agreed that having a chemicals legislation which is outcomes-focussed rather than being prescriptive on methods that must be used, would help to overcome this challenge. Standardisation and identification of best practice in use of NAMs will assist their acceptability by regulators and promote wider use.
Being brave and making waves
The next ‘regulatory dilemma’ to be tackled through a case study was how to demonstrate environmental safety using NAMs. James Dawick, Toxicology and Risk Assessment Manager at Innospec, explained the strategy that the company took to avoid animal testing following a request for further data from the European Chemicals Agency (ECHA) on a specific cosmetic ingredient.
Participants recognised the need for open and frank scientific dialogue between industry and regulators, as there is a fear amongst REACH Registrants of NAM approaches being rejected by regulatory authorities in favour of traditional animal data. ‘Be brave’ was the message from this case study – encouraging a change in mindset towards NAMs for both industry and regulators.
The theme of being brave and going forward with novel approaches was cemented by the third case study from Dr Carol Treasure, Managing Director of XCellR8. Carol explained how XCellR8, as a testing house, can assess the genotoxic potential of cosmetic ingredients using NAMs. The approach combines existing and new methodologies and human-relevant systems to give reliable, robust safety assurance that the cosmetic does not pose a genotoxicity risk. This case study generated a discussion around the fact that science usually progresses more rapidly than legislation. As it establishes new standalone UK chemicals regulatory frameworks, the UK has a unique opportunity to fully integrate NAMs into a framework which considers exposure along with hazard, to understand real-life human or environmental risk.
Onwards and outwards
Dr Matt Dent, Science Leader at Unilever, introduced the final session of the workshop, by considering how we can build confidence that NAMs are protective of safety. Building familiarity, having clear regulatory guidance or precedence for their use, and having standardised protocols will help build the utility of information from NAMs in making safety decisions.
This crucial workshop will build a foundation for future work and in the final discussion, participants discussed how to drive the momentum on wider use of NAMs in the UK, and over time in the EU and globally. Cross-sector collaborations with other UK chemical industries, strong UK links with other global organisations to share our vast knowledge and expertise, and a strong political will to progress NAMs in UK legislation all received strong agreement from participants.
Instead of viewing animal data as the ‘holy grail’ in risk assessment, novel, non-animal approaches, which accurately predict effects and are fully focused on the relevant endpoint, whether human health or the environment, are the real gold-standard.