Brussels, 5 May 2021 – A task force set up by the Centre for chemical safety assessment (ECETOC) has recommended improvements to the Exposure Based Adaptation (EBA) procedure in EU chemical legislation which ensures that substances manufactured or imported into the EU are safe for human health and the environment.
The EU’s REACH legislation requires companies to provide information on the properties of substances through testing, or by other means. But in situations where there is no human or environmental exposure to a chemical, or if it is so low that additional data will not lead to improvement of risk management, it is possible to waive some information requirements for registering the substance, so avoiding unnecessary animal testing.
The use of EBA recognises that the goal to ensure a high level of protection should not negatively impact competitiveness of the industry, or lead to an unjustified increase in new toxicological studies requiring animal testing.
However, while EBA could be an efficient tool to drive risk- and exposure-based testing strategies, while also reducing the need for excessive animal studies, the task force found that companies have not used them as much as they could have done.
The ECETOC task force identified several inconsistencies which make the use of exposure-based approaches challenging to navigate. Its report identifies pitfalls in the guidance to registrants on the use and construction of EBA rationales, as well as highlighting areas where the REACH legal text should be improved.
ECETOC’s Technical Report 137 makes recommendations to revise the legal text and guidance and to clarify vague terminology. It also details the proceedings of a virtual workshop in October 2020 where the task force’s work was presented and discussed by stakeholders from industry, NGOs, Member State Competent Authority representatives, the European Chemical Agency (ECHA) and the European Commission.
The stakeholder workshop was split into three sessions: discussion of the regulatory basis for and experience with EBA; analysis of the existing provisions for EBA; and how to modify the ‘risk-based’ EBA.
Based on the task force’s work, as well as feedback from the workshop, the report provides a series of specific recommendations on EBA.
It recommends revising the existing paradigm for data generation under REACH to a more exposure-informed system, in which information on known and/or anticipated uses, along with the associated human exposure, is well characterised. To achieve this, progress will need to be made on standardised use description, exposure assessment strategies and risk control measures. Moreover, there may be a need to devise a ‘hierarchy of uses’ concept.
For the risk-based EBA approach, the task force made several recommendations to increase confidence in the exposure estimates and the remaining uncertainty, as well as to increase efficiency in communicating the results. These recommendations cover the types of use for which EBA can be used, the management of the level of uncertainty by a more coherent allowance of lower tier data usage for EBA and the use of the Threshold of Toxicological Concern (TTC), a tiered approached to risk assessment and dedicated formats of exposure scenarios for EBA.
The report concludes that it is evident EBA can reduce animal testing while still protecting human health. But to be efficient, the underlying rationale and requirements must be coherent and transparent. In addition, while the task force focused on the use of EBA under REACH, its recommendations would also be relevant to other jurisdictions where exposure is a driver for determining the scope of the hazard and risk characterisation.
Olivier De Matos, ECETOC Secretary General said: “The task force’s report advances the development of good science-based decision-making, as well as providing a documentation framework for exposure-based adaptations of human health endpoints for chemicals. This will ensure efficient EU chemical regulation, while also valuing animal lives.”
Download the report here.