The belief that the goals of chemical safety and ending animal testing are mutually exclusive — that to achieve one requires sacrificing the other — is a fallacy not rooted in science.
It is true that we cannot robustly assess every imaginable human health or environmental concern via non-animal approaches at the present time. That said, the EU’s current ‘hazard tick-box’ approach to chemical testing, classification and assessment is stuck in the past, falling ever farther behind the state-of-the-art in safety science, and the more agile and adaptable regulatory frameworks of its closest trading partners.
Despite the best intentions of EU lawmakers, REACH has nonetheless become the largest mass animal-testing program in European history.
More than a year has passed since a nearly-unanimous European Parliament resolution called for an EU action plan to accelerate a transition to innovation without animal testing. In that time, more than 1.4 million Europeans have echoed this demand by adding their names to a citizens’ initiative calling, among other things, for transformative change to the EU’s chemicals regulation to “ensure human health and the environment are protected by managing chemicals without the addition of new animal testing requirements”.
The European Commission’s official reply to the Parliament defended the current patchwork of laws and funding initiatives, asserting that “a transition to innovation without the use of animals is best supported by focusing on and intensifying current efforts”. One might expect such transition efforts to include revisions foreseen under the Chemicals Strategy for Sustainability (CSS) to EU regulations for chemicals (REACH), classification, labelling and packaging (CLP) and cosmetics. However, a recent Commission proposal to introduce new CLP hazard classes made no discernible strides away from reliance on animal data. In fact, one Commission official has publicly stated that to achieve the ambitions of the CSS, an increase in animal testing will be “unavoidable”.
To support the swift and efficient identification of high-risk substances for regulatory action, we recommend introducing a science-based prioritization process.
Once-in-a-generation opportunity to course-correct
The best intentions of EU lawmakers notwithstanding, REACH has become the largest mass animal-testing program in European history. Considering that the legal text of REACH may not be reopened for another 15 years, the forthcoming revision under the CSS represents a once-in-a-generation opportunity to course-correct and introduce structural and policy reforms to REACH that will meet the expectations of EU citizens, civil society and corporate stakeholders in advancing the common goals of chemical safety and sustainability without animal suffering.
It is time for the EU to move away from a ‘tick-box’ mindset.
Toward this end, we recommend the following structural, process, and policy revisions to REACH:
- Risk-based prioritization. To support the swift and efficient identification of high-risk substances for regulatory action, we recommend introducing a science-based prioritization process that incorporates use and exposure information to determine relative risks and margin of safety and evaluates potential bioactivity using a battery of high-throughput in vitrotests. A ‘bioactivity-exposure ratio’ can then be calculated and used to prioritize substances of greatest concern and widest exposure for further assessment or regulatory action. This could provide a more streamlined and effective approach to the identification of substances of the highest concern for human health and the environment without animal-intensive testing.
- Protective measures first. REACH should ensure that chemical risks are efficiently managed as early in the process as possible, and that additional animal testing is considered only if essential for informing risk-management measures. If a test is unlikely to add value to regulatory decision-making (for example, if a substance is already classified for a closely-related endpoint or one that will trigger tight restrictions), it should not be performed or required. To this end, it is time for the EU to move away from a ‘tick-box’ mindset (i.e., compliance checks during the Dossier Evaluation phase, which focus only on identifying “data gaps”) to hypothesis-based or triggered testing (e.g. during the Substance Evaluation phase, where testing is carried out only if truly needed per the “last resort” requirement). Such an approach would not only reduce animal testing but would also help to speed up the review of substances — by not postponing regulatory action pending the conduct of time-consuming animal tests that may not have any impact on the outcome of a risk assessment.
- Non-animal method based assessment of new substances. A tiered, optimized testing strategy informed by data from state-of-the-art non-animal methods (NAMs) should be applied for the assessment of new substances under REACH. Such a strategy could begin with an evaluation of the properties of most concern, such as persistence, bioaccumulation and mobility. Determination of information needs for the assessment of toxicity could again leverage the battery of high-throughput in vitro bioactivity assays noted above. Such mechanistic insight could support hypothesis-driven testing in place of a rigid list of standard information requirements. We further recommend establishment of a new committee within the European Chemicals Agency (ECHA) with expertise in NAM-based testing and risk assessment for chemicals that could advise registrants on appropriate testing proposals, and support ECHA staff and member country authorities in building confidence in chemical safety assessments based on NAMs.
- Method–agnostic information requirements. A major obstacle to the use and acceptance of NAMs under REACH is the highly-prescriptive language of Annexes VII-X, which are often specific to the level of a test guideline. Even when new methods have become available, ECHA has applied an extremely narrow interpretation such that any variation from the prescribed method is rejected (such as we have observed this even when a substitute animal test for reproductive toxicity has been proposed). To overcome this, regulatory concerns need to be described as information needs in method-agnostic language, so that the same level of information is met but with discretion in the methods that may be used.
- No new or expanded animal-based information requirements. Whether by expanding existing REACH information requirements to other categories of substances (for example, lower tonnage chemicals and polymers), adding new animal-based information requirements, or labelling certain health concerns as “critical hazards” and committing to require testing to support classification, the Commission has set the stage for a number of potential scenarios that could lead to the suffering and death of millions more animals. Whether testing in addition to the wealth of existing data would have a tangible impact on regulatory, or downstream health and environmental outcomes, is dubious.
- Stipulate phase-out goal. REACH needs stronger directional language to ensure that the ultimate goal of phasing out animal testing is achieved in a more timely fashion. We can’t get there if we do not agree to a more specific timetable for phase-out commitments and execution.
A tiered, optimized testing strategy informed by data from state-of-the-art non-animal methods (NAMs) should be applied.
These recommendations are further elaborated in the following peer-reviewed article.
It appears the Commission’s legislative proposal to amend REACH will be delayed until the fourth quarter of 2023, which gives us time to come together as stakeholders, discuss and assess each other’s concrete suggestions for improving REACH, and to negotiate a path forward that meets our collective ambitions, and the noble aims of the CSS and European Green Deal.
