The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing

Abstract

The decisions we make on chemical safety, for consumers, workers and the environment, must be based on the best scientific data and knowledge available. Rapid advances in biology, in cell-based technologies and assays, and in analytical and computational approaches, have led to new types of highly relevant scientific data being generated. Such data enable us to improve the safety decisions we make, whilst also enabling us to avoid animal testing. Stimulated by the UK and EU bans on animal testing for cosmetics, Next Generation Risk Assessment (NGRA) approaches, which integrate various types of non-animal scientific data, have been established for assessing the safety of chemical ingredients used in cosmetics and other consumer products. In stark contrast, the chemicals regulations in Europe and other parts of the world have not kept pace with modern safety science and regulators are now mandating even more animal testing. Urgently closing this science–regulation gap is essential to upholding the EU’s legislative requirement that any animal testing is a last resort. The ongoing revisions of UK and EU chemicals strategy and regulations provide an opportunity to fundamentally change the design and assessment paradigm needed to underpin safe and more sustainable innovation, through applying the best science and tools available rather than continuing to be anchored in animal tests dating back many decades. A range of initiatives have recently been launched in response to this urgent need, in the UK as well as in the EU.

Brazilian National Network of Alternative Methods (RENAMA) 10th Anniversary: Meeting of the Associated Laboratories, May 2022

“…eye irritation, skin corrosion); more recently, the tools and approaches have evolved toward being more mechanisticfor instance, with the understanding of toxicity pathways/adverse outcome pathways (AOPs) and the establishment of integrated approaches to testing and assessment (IATAs) for risk assessment. [8][9][10][11][12][13][14][15][16] Such frameworks started to gain pace in the 2000s, especially after the publication of the National Research Council report, 'Toxicity testing in the 21st century: A vision and strategy', at the request of the US Environmental Protection Agency (US EPA). This report proposed a shift from the traditional animal tests to more human-relevant in vitro models that allow better understanding of the potential hazard and risks to human health induced by exposure to chemicals.…”

“…Moving from the science to the regulatory space, there are challenges to face in different geographies, such as hygiene products and disinfectants testing in China, as well as ingredients testing challenges in Europe due to the EU Chemical Strategy for Sustainability (https://environment.ec.europa.eu/strategy/chemicals-strategy_en), under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which has requested new animal testing for widely used chemicals with existent safety data. 11,26 On the other hand, there has been progress toward the uptake of non-animal approaches — such as the publication of the Scientific Committee on Consumer Safety (SCCS) guidance notes for cosmetic safety assessment, 18 as well as the Organisation for Economic Co-operation and Development (OECD) case studies showing how NAMs can be integrated and used in practice for weight-of-evidence safety decisions (https://www.oecd.org/chemicalsafety/series-testing-assessment-publications-number.htm).…”

The 3Ranker: An AI-based Algorithm for Finding Non-animal Alternative Methods

“…Dermatitis was chosen in view of the EU ban on animal testing for cosmetics, which has led to a number of successful non-animal replacement skin sensitisation and irritation tests being developed, validated and even legally accepted. [11][12][13] Parkinson's disease was chosen as an example of a neurodegenerative systemic disease, which are believed to be generally less amenable to the application of non-animal alternative approaches. 14 Using 3Ranker, we efficiently identified papers featuring potential Three Rs alternatives among the thousands of abstracts that were retrieved for these topics.…”

Editorial

“…On the 15th anniversary of Julia Fentem delivering the FRAME Annual Lecture, she returned last November, to share her insight into the scientific advances that have been made in alternatives and how these can be applied in safety assessment. A summary of her excellent lecture, Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing , is reported in this issue, 7 and the full lecture is available on Youtube (The FRAME Annual Lecture 2022; slides can be accessed at http://frame.org.uk/app/uploads/2022/12/Julia-FRAME-lecture-16Nov22-1.pdf). In her lecture, Fentem demonstrated Unilever’s application of Next Generation Risk Assessment (NGRA) using New Approach Methodologies (NAMs) to ensure product safety, and she shared her perspective on how we can gain greater acceptance of these in the regulatory arena.…”