REACH revision could increase animal testing ‘stronger terms needed’

This article is part of our special report Animal protection – in Europe and beyond.

A revision of the EU’s REACH regulation covering the ‘Registration, Evaluation, Authorisation and Restriction of Chemicals' must clean up the chemicals risk assessment and the chemicals market, falling in line with the Clean Industrial Deal, argue animal rights advocates.

With decarbonisation and boosting competitiveness priorities for the EU, within the chemical testing industries, it should create a ‘simplified legislative framework to reduce the administrative burden for the industry, while still maintaining the safety of human health and the environment’.

While a revision of REACH is welcomed by animal advocacy groups, particularly the opportunity to introduce more non-animal testing methods, the proposals to date have not been met with glee.

CEFIC, the forum of chemical companies across Europe, has produced a 10-point action plan to simplify REACH. One pressing point for Humane World for Animals is its call for the last resort requirement to be put under a microscope and refined in greater detail.

“We really need to see a much better leveraging of the last resort requirement, which is already built within REACH, where, in theory, animal testing should only be done as a last resort. But we, along with a number of our collaborators, published a paper last year which indicated that this wasn't really happening,” says Jay Ingram, Managing Director, Chemicals, R&T, Humane World for Animals.

“This really needs to be strengthened, there needs to be a lot more specificity around what “last resort” actually means and how it is demonstrated, both by registrants (industry), who are going to be proposing tests, but also by the regulatory bodies themselves, who will be requesting additional data.”

“It needs to be much stronger in terms of how we actually determine whether this last resort threshold has been reached - we really need to see strengthening on the enforcement of that last resort requirement,” he says.

Testing in complex areas

Ingram has also expressed his concerns that the revision of REACH could lead to an increase in testing on animals in some complex areas.

“We are also insisting that this revision of REACH doesn't bring in new or expanded animal testing. There’s been a revision to the CLP regulation last year, which brought in new classification categories for endocrine disruption, amongst other things,” says Ingram.

“The issue is endocrine disruption is an extremely complex topic from a toxicological perspective, and we fear that this change to CLP will have a knock-on change to REACH, where they will be asking for a huge amount more animal testing to be done to determine the endocrine disruption potential of chemicals,” he explains.

“And not just new chemicals, but also ones that have already gone through the REACH process, and that all of this new data will be generated without a clear idea of how or whether it can be used to make safer decisions about chemicals.”

“There are non-animal methods for endocrine disruption that are available and are of good quality,” says Ingram as he explains how complex the topic of endocrine testing is and that we must better understand the use of the data from such testing before there is a call for an increase on animal testing – technology can play a role as a safe alternative here.

New approach methods

One of CEFIC’s action plans to simplify REACH includes the introduction of a new safety assessment scheme that supports an increased uptake of reliable animal-free safety assessment methods - New Approach Methodologies, or ‘NAMs’.

CEFIC’s suggestion is to ‘reduce the hazard focus of REACH, allowing more flexibility in achieving a high degree of safety’ and to remove ‘default requirements for animal testing wherever possible.’

It wants regulators to give greater justification on ‘why concerns cannot be addressed using exposure-based approaches or NAMs, such as when rejecting proposals for read-across, grouping, or NAMs to avoid animal tests.’ It also seeks to ‘adapt data requirements to utilise NAMs together with exposure considerations: a chemical can only cause harm if it can reach a target and interact with it.’

Could we see a rise in the use of NAMs in chemical testing with the correct revisions to REACH?

“On a positive side, the Commission is also working on the roadmap for phasing out animal testing, which is the result of Save Cruelty Free Cosmetics/End Animal Testing European Citizens’ Initiative (ECI),” says Antigoni Effraimidou, a senior strategist at Humane World for Animals.

She added: “We can see there's already movement, which we feel is very positive to see, because it marks a landmark opening for the advanced chemical safety assessment, and it can also bring this cultural change in the scientific world that we are looking for, and hopefully also regulatory transformation.”

“There are some complex endpoints which the Commission feels that there will be a need also to develop new non-animal methods, but we do see this attitude from the policy makers, the willingness to go through that,” she said.

[Edited By Brian Maguire | Euractiv's Advocacy Lab ]