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:

Programme 1: Targeted Risk Assessment (TRA) tool

Since the introduction of the TRA in 2004, thousands of users have downloaded the tool and its supporting technical guidance from the ECETOC website. In addition to the guidance contained in the tool’s User Guide, ECETOC has described its technical basis in ECETOC Technical Reports TR93 (2004), TR107 (2009), TR114 (2012), TR124 (2014), TR131 (2018), TR 140 (2022) and TR 141 (2023) – all reports are available here.

Since 2010, the worker and consumer modules of the TRA have been used as the basis for estimating human exposures to chemicals within ECHA’s Chesar tool.

Four groups are active under this Transformational Programme:

Programme 2: 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 methologies (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

Programme 3: Next generation environmental risk assessment​

ECETOC is scoping a programme relating to Next generation environmental risk assessment: mechanistic- and exposure-based approaches.

Three pillars are being considered:

  • 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).

A stakeholder survey was launched in Q1 2024 and this results will be analysed to identify the focus and next steps.