content_image/475202.jpg content_image/475201.jpg
<img src='content_image/475202.jpg'>

<img src='content_image/475201.jpg'>

requests for new in vivo studies, or for having to repeat existing studies as a result of updated test guidelines, or because the study is considered to be of insufficient quality, hence minimising the need for additional animal testing. 

• Several substances falling within EFSA’s domain of activity have received significant attention from researchers developing NAMs. A large majority of recent publications on substances with public attention such as bisphenol A, phthalates, glyphosate, etc., as well as nano and advanced materials such as titanium dioxide, include the generation of NAMs data. The pressure from researchers, stakeholders and risk assessors for a transparent assessment of “all” existing scientific information, not just guideline studies, is increasing. This situation offers EFSA and its risk assessment network, the opportunity for contributing to PARC and other initiatives, by developing clear recommendations for facilitating the use of these studies in the regulatory context. 

• The use of NAMs for complementing existing animal data and fulfilling data gaps during the risk assessment process offers new opportunities for collaboration between risk assessors and academic researchers. The co-design of NAMs-based Integrated Assessment and Testing Strategies (IATA) and also AOPs for selected case studies of EFSA interest, and the incorporation of the results in EFSA regulatory assessments, will introduce risk assessors to the use of results from new toxicological tools and promote the interest of researchers in regulatory assessments. 

• Society requires EFSA to produce more informative human health risk assessments, e.g. addressing vulnerable sub-populations. NAMs can provide mechanistic understanding which can be combined with scientific knowledge on human variability and used to identify the drivers of susceptibility within the population, so providing a more powerful and future-proof scientific assessment. 

• While at EU level JRC is leading the validation and 3Rs activities and ECHA the use of NAMs for screening and standardisation, the use of NAMs for mechanistic hazard assessments and informative risk characterisation of chemicals in the regulatory context represents a clear opportunity, and is key for the next generation testing and assessment of chemicals in food and feed. 

## Cooperation: 

• Increase cooperation with key players in Europe, in particular DG JRC, ECHA, EMA, EU Member States, and international regulatory networks such as OECD, APCRA, GCRSR 5  and ILMERAC 6 . The roadmap will be built on: 

o existing cooperation lines with the organisations mentioned above and with DG SANTE, DG RTD & Innovation, and the European Partnership for Alternative Approaches to Animal Testing (EPAA) 

o further involvements in the activities of international organisations, in particular OECD, FAO and WHO, and 

o extended bilateral collaborations with interested international partners, such as U.S. EPA, U.S. FDA and Health Canada. 

• This situation offers an opportunity for EFSA and its partners, connected to the future of chemical risk assessment, to share the work, avoid duplication and jointly prioritise activities for the evolution of the paradigm to incorporate NAMs based mechanistic understanding and 

