ECETOC Transformational Programme develops framework to assess safety of chemicals using ‘new approach methodologies’

Scientists from the Centre for chemical safety assessment, ECETOC, have published a new framework to assess the safety of chemicals that incorporates ‘new approach methodologies’ (NAMs), such as computer modelling, or experiments carried out in test tubes or petri dishes.

The proposed framework allows a phased introduction of NAMs into the EU’s chemical safety assessments and enables science-based safety decisions that have the same level of public health protection, but use fewer animal tests and take up less time and fewer resources.

The EU’s regulatory system has evolved over the past 50 years, aiming to allow chemicals to be used to benefit society without causing harm to human health and the environment. To date, this has relied largely on animal testing which is expensive, as well as unacceptable to large parts of society. There are also doubts over the transferability of animal data to humans.

The concern around animal testing has come alongside rapid advancements in in silico and in vitro methods, built on the back of the developments in technology, computing, and molecular biology. This has led to a huge investment by government, industry, and academia to develop NAMs to assess chemicals (including pesticides and biocides), however the EU regulatory system does not currently allow them to be used.

The new framework, published in the journal Archives of Toxicology (96, 2022), is part of an ECETOC Transformational Programme that, over a three- to five-year timespan, aims to develop a new integrated approach for chemical assessment.

It incorporates in silico, in vitro and in vivo methods designed to meet the requirements of the EU chemical legislation, REACH, in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers.

The paper also puts three example chemicals through the proposed framework and the outcomes for all three were either the same, or more conservative, than assessments made using conventional studies.

The paper “A framework for chemical safety assessment incorporating new approach methodologies within REACH” can be found here.