Transformational Programmes

As part of the ECETOC Board’s decision to devote part of its resources to thought leadership, ECETOC has established a set of Transformational Programmes (TP), with 3-5 year timespans, addressing topics of longer-term scientific relevance which have the potential to transform chemicals management.

Three Transformational Programmes are underway:

Development of an Integrated Approach for Chemicals Assessment

This Transformational Programme emerged during the Human Health Scoping meeting which took place in February 2018.

Chemicals have many uses which are of great benefit to society. Over the past 50 years, the regulatory system that enables the use of chemicals without causing harm to people has significantly evolved. Yet, it does not currently allow new approach methodologies to be used in the assessment of toxicity.

ECETOC believes that much of the technology which is required to provide a 21st century regulatory system for chemicals (including pesticides and biocides) already exists, but that it requires a new framework.

The team has worked on a concept paper to present and analyse our current system for assessing hazard, exposure and the current rules for classification and risk characterisation. The paper called ‘A framework for chemical safety assessment incorporating new approach methodologies within REACH’ was published in the journal Archives of Toxicology and can be downloaded here. The team has been in dialogue with external stakeholders (such as JRC and ECHA) to seek interest and exchange thoughts. The group published a second paper on opportunities to utilise new assessment methodologies (NAMs) to provide additional data and knowledge for low-tonnage chemicals governed by the EU’s REACH Regulation, and as a way for registrants and regulators to gain experience in their application and interpretation – the paper is available here.

The following two Task Forces have been initiated under this Transformational Programme:

Staged assessment for low tonnage chemicals Task Force

Smart In vivo Studies Task Force

Next generation environmental risk assessment​

ECETOC has a group of experts active on scoping: Next generation environmental risk assessment (NG(E)RA): mechanistic- and exposure-based approaches.

A stakeholder survey was launched in Q1 2024 on the following three pillars:

  • Intelligent mechanistic ecotoxicity assessment (i.e. integration of current methodologies relating mechanistic/mode of action understanding, including modelling, cross-species extrapolation, omics etc).
  • Enhancing application of exposure in environmental risk assessment (i.e. utilization of refined screening and higher tier models).
  • Exposure-informed targeted environmental testing strategies (i.e. incorporate consideration of the relevant species, compartments, dose etc).

Based on the survey outcomes, the group identified the following focus area: Development of a NG(E)RA concept/framework using an intelligent systems-based approach integrating key knowledge on exposure as well as mechanism of toxicity.

​Elevating exposure science in chemical safety assessment

The Transformational Programme was established in October 2024 as a follow-up to the ECETOC workshop ‘Elevating exposure science in chemical safety management’ held in October 2023.

Exposure assessment plays an essential role in effective and efficient chemical risk assessment and management, and opportunities have been identified to facilitate and elevate its use.

The objectives of the Transformational Programme are as follows:

  • Facilitate greater implementation of exposure-led approaches in chemical risk assessment and management
  • Maintain and develop Targeted Risk Assessment (TRA) tool
  • Increased consideration and acceptance of exposure information, including the ECETOC TRA tool
  • Advanced readiness of exposure assessments in the context of circularity and sustainability

The Transformational Programme coordination team overseas the ECETOC activities relating to exposure science, identifies new focus areas and fosters synergies with other relevant initiatives such as ISES-Europe, PARC etc.

The relevant ECETOC activities on exposure science are as follows: