ECHA

REACH strikes a balance between the need of information to increase our understanding of the hazards of chemical substances, and the aim of avoiding unnecessary testing on animals in generating such information. New tests may only be carried out when all other sources of data have been exhausted. Vertebrate animal testing under REACH is only possible as a last resort.

For many substances, information on properties such as organ toxicity after long term exposure to chemicals, the potential to induce cancer, the toxic damage to reproductive functions and to the developing foetus and long term aquatic toxicity has often not been available. Filling such information gaps will allow industry to understand the risks of the chemicals they produce and use, to propose sound risk management measures and to replace them over time with safer alternatives.

To fill the gaps, new studies on chemical substances may have to be conducted, some of them using experimental animals. There are two ways that REACH keeps to a minimum the number of animal tests required.

• Data sharing: REACH encourages that information from tests to establish hazardous properties of chemical substances is shared between registrants as much as possible. Sharing of the results of vertebrate animal tests is mandatory. Such studies should not be repeated.
• Alternative methods and approaches: REACH offers alternatives that can replace some new tests on vertebrate animals, provided that these alternatives are suitable to generate the data required to ensure a high level of protection of human health or the environment. For example, companies can use existing animal studies, conducted before REACH. They can also predict the properties of substances by comparing one substance with another similar one where test data are already available (read-across).

All actors in REACH can play an important part in avoiding unnecessary animal tests. Your role is especially important, if you are:

• Companies producing or importing chemicals, as REACH registrants, have to gather all available relevant information, share data and decide on how to generate information seeking to avoid animal testing. If companies consider there are data gaps in the higher tier information requirements for their substance which cannot be filled by non-animal testing approaches, companies make testing proposals for agreement by ECHA.
• Member States who are consulted on all ECHA's draft decisions requesting additional animal tests and are responsible for implementing legislation concerning the protection of animals used for scientific purposes.
• Non-government organisations, scientists or citizens able to make available scientifically relevant information, which can be taken into account when deciding on testing proposals on vertebrate animals for specific substances.

Role of ECHA

ECHA needs to agree before a new higher-tier study can be conducted. The Agency studies all the testing proposals to check that the proposed test is suitable to generate reliable data for fulfilling the standard information requirement and hereby prevents unnecessary animal testing. Every proposal that involves vertebrate animals is published on the Agency's website and third parties are invited to submit scientifically valid information and studies addressing the substance.

ECHA also facilitates the sharing of available data and information by companies, scientists and citizens. The eChemPortal hosted by ECHA allows ECHA to verify if information on animal tests is already available from other authorities and thereby helps in avoiding unnecessary animal tests.

Finally, ECHA contributes to the development of alternative methods and promotes their use. For example, the Agency develops, in cooperation with the OECD, the QSAR Toolbox, a software application intended to be used by governments, chemical industry and other stakeholders in filling gaps in (eco)toxicity data needed for assessing the hazards of chemicals.

Test requirements

Where animal tests prove essential, REACH requires that the minimum of pain, distress and suffering is caused to the animals. The legislation stipulates that toxicological and ecotoxicological tests have to meet the basic requirements for the care and accommodation of laboratory animals provided in the Directive 2010/63/EU on the protection of animals used for scientific purposes and implementing measures adopted by the Member States in accordance with the directive.

Depending on the hazardous property requiring investigation, the standard tests use in vitro tests (e.g. using bacteria and animal cells) and in vivo tests in animals, such as rats, rabbits and fish, bred specifically for use in experiments. Furthermore, REACH applies the concept of "the three Rs" - replacement, reduction, refinement of animal use. This is a set of of guiding ethical principles which are applied in the alternative methods and approaches stipulated under the REACH Regulation and that help to minimise the harm caused to animals used in science.