Principles for Next Generation Risk Assessment of Cosmetics

In an international collaboration of regulators and industry, JRC scientists contributed to the compilation of overarching principles for the safety assessment of cosmetics without animal testing.

Animal testing for the safety assessment of cosmetic ingredients and products has been completely banned in the EU. The safety of cosmetics therefore needs to be ensured by new methods and strategies. This is in line with a general shift in toxicology from testing in whole organisms as a “black box” towards understanding the mechanisms behind adverse effects, allowing for a more informed and targeted evaluation of chemicals. The cosmetics sector has a unique opportunity to lead progress in chemical safety assessment.

An international working group of regulators and industry from the European Union, Brazil, Canada, Japan and United States has outlined nine overarching principles that underpin the integration of novel methods and data for the safety assessment of cosmetic ingredients. This working group is part of the International Cooperation on Cosmetics Regulation (ICCR) which discusses common issues on cosmetics safety.

The four main principles of the ‘next generation’ risk assessment state that the methods used for safety evaluation need to be relevant to assess the effect on human health and the overall goal should be the prevention of harm.

A hypothesis on the biological mechanisms of the effects should lead the evaluation, as well as considerations of the way, duration and frequency of the exposure to the substance. The other five principles describe how the assessments should be conducted and documented.

The ‘next generation’ risk assessment uses new approach methodologies such as in vitro testing in cell lines or 3D organoids, combined with computational modelling.

The methods are being developed in view of a higher relevance for humans, compared to tests in animals, and thus to ensure a better protection of human health. To provide additional guidance to safety assessors, the working group has issued a second report which describes examples of these novel methods with their strengths and limitations and illustrates how they can be used in the cosmetic safety evaluation process.

This report also builds on a previous ICCR activity that developed an overview of in silico methods for cosmetics safety assessment, to which the JRC also contributed.

Read more in:

• Dent M. et al., “Principles underpinning the use of new methodologies in the risk assessment of cosmetic ingredients”, Computational Toxicology, 7 (2018), pp. 20-26. doi: 10.1016/j.comtox.2018.06.001
  This is the first article in the Computational Toxicology Special Issue on “In Silico Approaches for the Safety Assessment of Cosmetic-Related Substances”, guest-edited by a JRC scientist.
• ICCR Report on Integrated Strategies for Safety Assessment of Cosmetic Ingredients: Part 2
• Report from the Commission to the European Parliament and the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2015-2017), COM/2018/531 final.

Related Content

“Principles underpinning the use of new methodologies in the risk assessment of cosmetic ingredients”

ICCR Report on Integrated Strategies for Safety Assessment of Cosmetic Ingredients: Part 2

Report from the Commission to the European Parliament and the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2015-2017)