Consortium Outputs

Mapping Relevant Legislation

NETRI –  task leader  WP2

Part 1: The European Legal Foundation and Conceptual Ambiguity. The European Union is actively committing to a transition toward more ethical chemical and pharmaceutical safety assessment methods. The first section of the NAMWISE report analyzes European legislation across various sectors to evaluate its flexibility regarding the integration of NAMs. A primary observation emerges: no legislative text explicitly defines the term “NAM”. Nevertheless, Directive 2010/63/EU on the protection of animals used for scientific purposes serves as a common foundation and harmonizes all sector-specific regulations.

 Key Take-Home Message: Although the term “NAM” lacks an explicit legal definition in the texts, Directive 2010/63/EU establishes the essential common framework for reducing animal testing in Europe.

Part 2: The Advancement of Cosmetics and Opportunities within REACH and CLP. The acceptance of alternative methods varies significantly across industrial sectors. The cosmetics sector stands out as the most advanced to date. This progress is driven by the strict legal ban on testing cosmetic ingredients on animals within the EU. Other major regulatory frameworks are evolving in parallel. The REACH and CLP frameworks increasingly enable the integration of NAM-derived data through adaptation provisions, Weight of Evidence approaches, and integrated assessment strategies. Regulatory confidence increasingly depends on demonstrating that a NAM is fit-for-purpose within a defined context of use, rather than universally replacing animal studies.

 Key Take-Home Message: The strict regulatory ban propels the cosmetics sector to the forefront of innovation, while REACH and CLP open concrete pathways for NAMs through targeted adaptive approaches.

Part 3: A Still Fragmented Regulatory Acceptance. The main obstacle identified by this mapping lies in the lack of global uniformity. Despite sector-specific progress, the regulatory acceptance of NAM-derived data remains fragmented. Technical criteria and the level of confidence granted to alternative approaches vary greatly from one sector to another. To fully exploit the potential of NAMs, greater harmonization of evidentiary requirements across sectors may facilitate broader regulatory uptake of NAM-derived data

 Key Take-Home Message: The global adoption of NAMs is currently slowed down by a fragmented and heterogeneous regulatory acceptance across different industrial sectors. 

Our NAMs definition: An approach that does not rely on live non-human vertebrate animals including independently feeding larval forms, and foetal forms of mammals as from the last third of their normal development, and live cephalopods (as defined by the directive 2010/63/EU).