ECHA's Workshop Paves the Way for Animal Testing-Free Chemicals Regulation

ECHA's Workshop Paves the Way for Animal Testing-Free Chemicals Regulation

  • Over 500 participants engage in the European Chemicals Agency (ECHA) workshop about New Approach Methodologies (NAMs) as alternatives to animal testing in chemical hazard assessment.
  • The workshop, which was held on 31 May and 1 June, focused on achieving a common understanding of NAMs' potential in reducing regulatory dependence on animal testing and expediting their regulatory acceptance.
  • This way, ECHA reaffirms its commitment to supporting the development of new methodologies, contributing to future EU chemicals regulation, and collaborating internationally for faster progress.

Currently, addressing the use and potential implementation of NAMs has been attempted several times. However, there is no consensus on how to implement these technologies in a practical way due to the diverse approaches taken under different legislations and jurisdictions.

The NAMs workshop "Towards an animal-free regulatory system for industrial chemicals" organized by (ECHA) was intended to set up guidelines that would eventually allow, for a future where animal testing plays little to no role in regulatory decision-making. By bringing together stakeholders from various fields, the workshop gathered feedback and commitments to expedite the transition towards a regulatory system that relies on alternative testing methods.

The NAMs workshop, held on 31th May and 1st June, 2023, accomplished two main objectives:

  • a) Collecting feedback and commitments from all stakeholders on how to accelerate the transition to a non-animal testing regulatory system.
  • b) To detect the critical needs within the current regulatory system bringing perspectives from different backgrounds.

With the organization of this workshop, the ECHA has made it clear that it is fully committed to actively seek for a replacement of animal testing in the hazard assessment of chemicals, even though this is a big undertaking. The main challenges NAMs are facing now and identified at the workshop are summarized below:

Non Animal Approaches state-of-the-art

NAMs have been used in hazard and risk assessments at three different levels within the context of REACH and CLP:

  • By registrants to replace animal testing in support of hazard identification and classification, aiming to provide scientifically relevant, fit-for-purpose data to enable better informed decisions.
  • By registrants to support read-across and category approaches, to limit the testing requirements for each individual substance.
  • By authorities to support screening and priority setting by identifying potential substances of concern for further data gathering and assessment.

Although NAMs have been more widely used to support the screening, prioritization and read-across approaches, there are only a limited number of endpoints studies based on non- animal testing strategies that been approved for the classification and labelling of substances. Such studies are only related to: skin sensitisation, skin and eye irritation and (partially ) genotoxicity. On the other hand, for more complex toxicological endpoints, such as reproductive toxicity or carcinogenicity, the information requirements still rely mainly on animal testing methods.

Therefore, there is an opportunity for NAMs as they constitute a tool to explore and identify what are the critical elements needed to enable hazard and risk assessment without reliance on animal testing. Thus, scientific progress and fundamental policy changes need to go hand by hand and support each other if NAMs are to become relevant in the future.

Critical elements necessary to transit to a non-animal system

To facilitate a responsible transition towards a NAMs based assessment system, the first step is to identify what are the critical elements needed to enable hazard and risk assessment without reliance on animal testing, knowing that animal-free systems will need to:

  • Allow conclusions whether a substance does or does not have hazardous properties.
  • In case a toxic property has been identified, determine the level of its severity (effect type and its potency).
  • Express predicted toxicity values in external doses used in risk assessment and risk management.

Therefore, the minimum critical needs to be addressed are:

  • NAMs for hazard identification: ability to demonstrate that NAMs can be used to allow a conclusive outcome on the (or lack of) hazardous properties for given regulatory endpoint.
  • NAMs for hazard characterization: ability to reliably identify hazard and derive reference values based on changes at the molecular/cellular level instead of observed adversity in an organism, and to inform how severe the toxic effect is for human health or environment.
  • NAMs for extrapolation: ability to reliably convert nominal concentrations measured or predicted by NAM into external doses used to set safety levels to communicate the hazard and assess the risks.

The workshop also addressed the need for international standardization of NAM. In particular, agreement among international organizations is required so benefits derived from, the Mutual Acceptance of Data (MAD) system are kept. To that end, the OECD plays a crucial role in harmonizing approaches and gaining wider acceptance for NAMs, ensuring their internationally harmonized application and acceptance among jurisdictions. Cooperation and dialogue among stakeholders are necessary for a successful transition, and platforms like the EPAA facilitate monitoring, alignment, and experience exchange. ECHA is committed to supporting policymakers in developing a consistent approach based on increased NAM usage and the eventual phasing out of animal testing.