Saturday, 10 June 2023 13:55

European Chemicals Agency Workshop: First Kick-off for Better Understanding Featured

On May 31 and June 1, the European Chemicals Agency (ECHA) hosted a two-day workshop in Helsinki to discuss with various stakeholders how to accelerate the transition to an animal-free chemical evaluation system. The main goal of the workshop was to better understand each other, as all stakeholders took different perspectives. Meanwhile, researchers are considering how an exit strategy could succeed.


European Chemicals Agency building in Helsinki.
Photo: Wikipedia

Successful citizens' initiative
The European Citizens' Initiative (ECI) "Save Cruelty-Free Cosmetics - For a Europe without animal testing" with its 1.2 million signatures has succeeded in getting that the European Commission has to address the content of its demands. The Commission has to strengthen the protection of the ban on animal testing for cosmetics, to redesign the EU chemicals legislation and to develop a strategy for the gradual phasing out of the use of animals in research, regulatory testing and education.

EU strategy: Chemicals to be safe and sustainable by 2030
According to estimates by the European Environment Agency, robust information is said to be available for only about 0.5% of all chemicals on the market. This also leads to the revision of the Chemicals Regulation (REACH) and the Regulation for the Classification, Categorization and Packaging of Chemicals (CLP Regulation). The two are the most important regulations for the regulation of chemicals.

Revision of REACH and the work of the European Chemicals Agency
ECHA has the expertise and is ready to support policymakers in developing appropriate and robust approaches to chemicals regulation based on increased use of NAMs and, eventually, the phasing out of animal testing, as was said during the workshop. First, however, an amendment to the REACH annex is feared to lead to more animal testing for the time being, even though some testing guidelines are to be deleted, such as on skin, eye irritation or skin sensitization. In contrast, supplementary animal tests are to be added, especially endocrine disrupting tests and those for immune and developmental neurotoxicity, as confirmed by the ECHA report published at the beginning of June.(1)  

According to ECHA, two key questions would need to be addressed to move toward full replacement of animal testing: How can a new, non-animal approach cover the main adverse effects and diseases of concern to society? And how can a similar or better level of protection be provided for human health and the environment?

To strengthen the effort for animal-free methods, ECHA wants to increase cooperation within and outside Europe through platforms such as EPAA and APCRA, get more involved in scientific projects such as ASPIS or PARC, and expand internal capacities.

Parallel: New non-animal test approach
The first ideas may be provided by Elisabeth Berggren and Andrew Worth of the European Commission's Joint Research Center.(2) The scientific team has proposed a new regulatory approach to the safety assessment and management of chemicals. It is based primarily on the use of new non-animal methods, called New Approach Methodologies (NAMs). NAMs are to be used to determine the efficacy and safety (toxicodynamics) of chemicals, as well as to determine the metabolism, residence time and accumulation in the body (toxicokinetics). In this way, chemicals can be classified according to their degree of hazard.

In this way, chemicals can be classified according to hazard level. According to this concept, the legal requirements are to be adapted to the new methods and not vice versa. The new safety assessment system is to be applicable to all substances; the level of protection is to be comparable to that of the current legislation based on animal testing. Substances of particular concern can then be banned, those of moderate concern restricted and those of low concern released. During the implementation period of this concept, animal testing would be reduced step by step.

Integrate NAMs into testing strategies when worthwhile
However, not every animal-free method would be used: For example, from a battery of animal-free individual tests for developmental neurotoxicity, only those methods would be selected and added to already recognized methods if they provide clear added value to the overall assessment, rather than the entire testing strategy developed by scientists and EFSA over years of work.

(1) European Chemicals Agency (20239: The use of alternatives to testing on animals for the REACH Regulation. Fifth report under Article 117(3) of the REACH Regulation, June 2023.
(2) Berggren E, Worth AP. Towards a future regulatory framework for chemicals in the European Union - Chemicals 2.0. Regul Toxicol Pharmacol. 2023 Jun 12;142:105431. doi: 10.1016/j.yrtph.2023.105431. Epub ahead of print. PMID: 37315707.