JRC publishes Review on current EU regulatory requirements for chemical risk assessment and opportunities to include NAMs

Posted on: 07/10/2022

Scientists of the Joint Research Centre (JRC) of the European Commission recently published a summary review of the current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetics Products Regulation.

Besides the EU Directive 2010/63/EU on the protection of animals used for scientific purposes, other legislations to promote the use of non-animal testing methods are in place. Two major regulations in the scope of the regulatory risk assessment are the REACH Regulation No 1907/2006 and the Cosmetic Products Regulation No 1223/2009. Both encourage the implementation of the 3Rs Principle, and thus the use of different types of in vitro and in silico methodologies, wherever possible. Since 2009, the cosmetics regulation even banned animal testing for cosmetics and their ingredients in the EU.

For certain specific endpoints in local toxicity, non-animal testing methods can be used to evaluate the hazard of chemicals. This is applicable for skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, other endpoints are more complex and still rely on the use of animals. This is mainly in the fields of systemic toxicity, repeated dose toxicity and reproductive and developmental toxicity. In the coming period, it will be further investigated in which areas non-animal methods could be more integrated into a regulatory setting. It is already observed that a one-on-one replacement strategy, i.e. replace one animal test with one non-animal testing method, is not the way to proceed, but that a combination of different in silico models and in vitro testing methods would be the best way forward.

In this review article, JRC scientists examine these critical toxicological endpoints one by one, and discuss the availability and opportunities to include non-animal testing methods in each of these areas. Setting-up (new) frameworks at EU and international levels can help to facilitate the regulatory acceptance of these methods. An example of such an initiative is the ‘International Cooperation on Alternative Test Methods (ICATM)’. The main objective of ICATM is to promote international cooperation between different governmental organisations, and stimulate the development, validation and use of non-animal testing methods for regulatory purposes. Besides establishing international collaborations, strengthening knowledge sharing and increased data sharing are crucial elements in the uptake of non-animal testing methods. As new technologies are continuously being developed, and their future potential often remains limited within their own application domain, is important to broaden knowledge sharing beyond the regulatory setting and build bridges with biomedical research. In the light thereof, the EU published a report to promote cross-disciplinary research in science called “Bridging across Methods in the Biosciences (BeAMS)”.

In the recently published EU Chemicals Strategy for Sustainability there is an active call for new innovative methods in chemical safety testing to further reduce the dependency on animal testing. Therefore, dialogue with all stakeholders is needed.

Read the full article here.

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