An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union

Abstract

Risk assessments of various types of chemical compounds are carried out in the European Union (EU) foremost to comply with legislation and to support regulatory decision-making with respect to their safety. Historically, risk assessment has relied heavily on animal experiments. However, the EU is committed to reduce animal experimentation and has implemented several legislative changes, which have triggered a paradigm shift towards human-relevant animal-free testing in the field of toxicology, in particular for risk assessment. For some specific endpoints, such as skin corrosion and irritation, validated alternatives are available whilst for other endpoints, including repeated dose systemic toxicity, the use of animal data is still central to meet the information requirements stipulated in the different legislations. The present review aims to provide an overview of established and more recently introduced methods for hazard assessment and risk characterisation for human health, in particular in the context of the EU Cosmetics Regulation (EC No 1223/2009) as well as the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC 1907/2006).

Keywords:

• Regulatory risk assessment
• REACH
• cosmetics
• non-animal methods
• new approach methodologies

Acknowledgements

The authors would like to give thanks to Dr. Vânia Vilas Boas at the Department of In Vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Belgium (VUB) for her support throughout the project, and to Miss Manon Wery at the Department of In Vitro Toxicology and Dermato-Cosmetology, VUB, who has provided excellent administrative help. The authors gratefully acknowledge the comments provide by reviewers selected by the Editor and whose identity was not made known to the authors. Further, the authors wish to thank Prof. Mark Cronin at the School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, United Kingdom; Mr. Bertrand Desprez at The French Agency for Food, Environmental and Occupational Health & Safety, France; Dr. Anne Kienhuis at the Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), The Netherlands; and Dr. Catherine Mahony at Procter & Gamble, United Kingdom who have read and provided valuable input on the revised manuscript.

Declaration of interest

EAD and MV declare that they have no conflict of interest. The employment affiliations of the authors are shown on the cover page. EAD gathered the data and wrote the initial manuscript. MV provided expertise and participated in the preparation and editing of the manuscript. MV acted as corresponding author.

TV and VR are members of the Scientific Committee on Consumer Safety (SCCS) and TV is a former member of the European Centre for the Validation of Alternative Methods (ECVAM) Validation Management Group concerning toxicokinetics and metabolism. TV and VR read and provided their expertise, which greatly helped to improve the manuscript. In their work with the SCCS, TV and VR may participate in regulatory proceedings related to the content of this paper. Through her work with the Innovation Centre 3R Alternatives (IC-3Rs), VR advocates the use of non-animal methods which have been discussed in this paper. MV and EAD have not participated during the last five years in legal, regulatory or advocacy proceedings related to the contents of this paper.

Funding was received by Cosmetics Europe and the European Chemical Industry Council and solely used to fund EAD and MV. The funder had no influence on the manuscript’s content. None of the other authors received compensation.

Additional information

Funding

This work was supported by Cosmetics Europe as part of the Long Range Science Strategy programme and the European Chemical Industry Council.