REACH: the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation

In 2006, the European Union introduced new legislation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), with the aim of ensuring a high protection of human health and the environment and the promotion of alternative test methods. The regulation requires companies to provide information about the health effects and environmental hazards of almost every chemical used in Europe. As a result, REACH demands the results of tests on animals, and if companies don’t already have that data, they are required to perform new tests.

Key players:

European Commission, European Chemicals Agency (ECHA) and national authorities

Here we describe three key issues and how you can take action.

The Regulation and the Tests

PETA estimates from official reports that by 2016, more than 1 million animals have already been used in tests to meet REACH data requirements and it is expected that many more animals will be used in the coming years. Those tests included painful skin and eye tests leading to terrible suffering and death even though reliable non-animal methods exist.

Companies that manufacture or import substances in low volumes (between 1-100 tonnes per year) are required to register their substances by 31 May 2018. ECHA estimates that up to 25,000 substances will be registered – this is three times more than for either of the previous deadlines in 2010 and 2013, meaning that millions of animals are expected to suffer and die.

To minimise new tests on animals, REACH contains a number of specific measures and general provisions designed to establish and enforce the requirement that tests on animals must be performed only as a last resort.

    Alternative methods to testing on animals:

  • Weight of evidence
  • Reading-across
  • Non-animal laboratory tests
  • Computer models

All animal tests conducted under REACH in the Member States must be carried out in accordance with the European Directive 2010/63/EU on the protection of animals used for scientific purposes. The Directive stipulates that experiments on animals should not be performed if the results can be obtained by another scientifically valid method.

To help prevent avoidable experiments on animals, Member States, ECHA and the European Commission must work to actively promote non-animal methods.

TAKE ACTION: Urge national competent authorities to actively promote non-animal methods

Please contact the relevant authorities in your country and find out how they are working to ensure animals are used only as a last resort and that alternative methods are used wherever possible. REACH national contact points can be found here and Directive 2010/63/EU national contact points can be found here.

Enforcement of the Last Resort Requirement

Reports published by ECHA on The Use of Alternatives to Testing on Animals for the REACH Regulation in 2011, 2014 and 2017 corroborate our long-standing concern that tests on animals continue to occur without prior performance of the relevant in vitro tests and that avoidable tests on animals may be occurring despite the availability of non-animal assessment approaches.

EVIDENCE: Failure to investigate potential avoidable tests on animals

ECHA notified National Enforcement Authorities of 121 instances of potential non-compliance with the registrant’s obligations to submit a testing proposal before conducting an animal study. Disgracefully, less than half of the contacted Member States feedback to ECHA. One case of non-compliance was confirmed and an additional case may have been subject to enforcement action, if time hadn’t run out to initiate proceedings. Shamefully, German national laws do not allow sanctions in relation to these specific violations.

Member States have varying approaches to the enforcement of REACH and the requirement to test on animals only as a last resort is not flagged as a priority for enforcement. This lack of harmonisation is concerning, not only because one of the objectives of REACH is to promote alternative methods for hazard assessment but also because following a complaint filed by PETA UK, the European Ombudsman stated that it is the responsibility of the Member States to investigate and sanction non-compliance with the provisions of REACH.

Member States must implement appropriate penalties that are effective, proportionate and dissuasive to deter companies from breaching the requirement that tests on animals be conducted only as a last resort. Reminding registrants to observe their REACH obligations is not enough and ignorance of the law is not an acceptable excuse.

TAKE ACTION: Ensure that suitable penalties for breaches of the REACH regulation regarding animal testing are implemented by Member States.

Member States are advised under Recital 122 of REACH that “[i]n order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment.” Please contact the enforcement authorities for both REACH and Directive 2010/63/EU within your country and urge them to thoroughly investigate any potential non-compliance of the last resort requirement and to implement suitable penalties.

The REACH Refit Evaluation

The REACH Regulation includes the obligation for a ‘REACH Refit Evaluation’ every five years to monitor progress in the achievement of its objectives. The refit evaluation is intended to provide information to identify needs for adjustment and to propose recommendations to improve the implementation of the regulation or the need to consider modifications. However, recommendation from the European Commission fail to make a significant impact on improving the functioning of the regulation.

The PETA International Science Consortium Ltd. detailed concerns regarding ECHA’s prioritization of arbitrary deadlines over animal lives, their reluctance to accept non-animal testing approaches and a disproportionate demand for testing cosmetics ingredients, as part of the stakeholder consultation process. You can read the Science Consortium’s position paper here and the recommendations made to improve the functioning of REACH.

More Than 100,000 People Demand That Europe Lead the Way in Animal-Free Science

Upon hearing about the refit evaluation, more than 100,000 compassionate supporters of PETA and its international affiliates signed an open letter to the Commission and ECHA demanding that Europe become a world leader in progressive and innovative science by ending cruel experiments on animals and accepting cutting-edge, non-animal research methods. This open letter has been submitted to the European Parliament Petitions Committee for consideration. View our open letter to the Commission and ECHA here.

TAKE ACTION: Urge the European Commission to seize the REACH refit evaluation as an opportunity for Europe to lead the world in progressive and innovative science by ending cruel experiments on animals and accepting cutting-edge non-animal research methods.

PETA supports the principle of ensuring that the chemicals we are exposed to every day are not harmful to our health or the environment. So long as REACH relies on animal tests, however, that goal will never be “reached”. Enlightened scientists and regulators around the world recognise that in addition to being unethical, animal tests simply can’t do the job. We welcome the steps that have been taken under REACH to use alternative methods and prevent pointless, duplicative tests from being carried out, but it is critical that we make absolutely sure that every opportunity to avoid animal testing for REACH be taken.

Ultimately, Europe must transition to chemical legislation that relies on 21st century animal-free toxicology tests, which will enhance the competitiveness of the chemicals sector while ensuring better protection of human health and the environment.