Animal testing under REACH
REACH aims to ensure a high level of protection of human health and the environment from effects of hazardous chemicals. It strives for a balance: to increase our understanding of the possible hazards of chemicals while at the same time avoiding unnecessary testing on animals. Learning more about chemicals sometimes requires testing them on animals as a last resort. Registrants may only carry out new tests when they have exhausted all other relevant and available data sources.
The main means provided by REACH to keep the number of animal tests to an essential minimum are:
Companies producing or importing the same substance must work together and share information on the intrinsic properties of their substance. Companies registering the same chemicals must share the results of tests on vertebrate animals, and must jointly submit all information to ECHA. Adequate and reliable studies on animals must not be repeated. Companies are also encouraged to share any available data they possess.
Alternative methods and approaches
REACH encourages companies to use other means before deciding on any testing on vertebrate animals.
ECHA contributes to the development of alternative methods and approaches and promotes their use – for example:
- The read-across approach is the most commonly used alternative method under REACH. It allows the use of relevant information from analogous substances to predict properties of the target substances. ECHA has developed a read-across assessment framework (RAAF) and published it together with an example to illustrate its use.
- Companies are encouraged to share any available data on their substance if requested by a registrant of an analogue substance.
- The QSAR Toolbox is a software application which supports companies in identifying data that may be relevant for assessing the hazards of chemicals. ECHA develops and manages the tool in cooperation with the OECD.
- ECHA organises trainings, webinars and workshops on alternative methods. The Agency also publishes advice on their use, including guidance, factsheets, and practical guides such as the practical guide on how to avoid animal testing. The specialised report “The use of alternatives to testing on animals for the REACH Regulation” is published every three years.
- A large proportion of the data that ECHA receives from registrations is published on the Agency’s website. This helps existing and future registrants to identify additional data which they may wish to use in their registrations.
- ECHA provides expert advice and technical support to develop alternative test methods.
When the registrants have identified which information on the intrinsic properties of the registered substance is needed, depending on the tonnage level, new studies may need to be conducted.
The registrants must first collect and assess all existing data, using, for example:
- existing in vivo animal studies;
- ex vivo studies (for example, tissues from animals);
- in vitro studies (for example, using bacteria or cultured cells);
- information from human exposure;
- predictions based on information from structurally related substances (read-across and chemical categories);
- predictions from computational prediction methods, for example, quantitative structure activity relationships (QSAR); or
- existing literature.
It is also possible to combine these approaches to gain more certainty on the information (weight-of-evidence approach).
Registrants then have to consider whether the existing data is of sufficient quality to fill in the gaps in the information needed. Only then can the registrants confirm that studies using vertebrate animals need to be conducted, as a last resort.
If companies need to do new higher-tier tests (i.e. tests listed in REACH Annexes IX and X for substances registered at above 100 tonnes) to gather the required information, they must give details on their plans for testing to ECHA. Companies also have to explain how they considered alternative methods when proposing a new animal test.
In certain cases, such higher-tier tests are necessary for substances supplied at lower tonnages. For example, if the non-animal tests using cells or bacteria indicate that the substance may alter genetic material, the registrant also needs to submit a testing proposal to investigate if these effects are hazardous to animals.
To prevent any unnecessary testing, ECHA and Member States authorities need to agree on these testing proposals before any new higher-tier test can be conducted.
For that, they check whether the proposed test is likely to produce reliable and adequate data. They can reject, modify or accept the test. If needed, they can also request for additional studies to be conducted.
ECHA publishes on its website every proposal submitted by registrants that will involve testing on vertebrate animals. This is an opportunity for citizens or organisations to provide scientifically valid information and studies about the given substance. If ECHA receives information from these consultations, it informs the company that submitted the testing proposal and takes any scientifically valid information and studies into account in preparing its decision.
- Report on the regulatory applicability of non-animal approaches [PDF]
- Report on Alternatives to Animal Testing (2017) [PDF]
- Summary of the report on Alternatives to Animal Testing (2017) [PDF]
- Reports from Member State investigations on testing proposals [PDF]
- Survey results - Analysis of higher tier studies submitted without testing proposals [PDF]
- Report on non-standard methods for assessment of chemicals [PDF]
- How to use alternatives to animal testing to fulfil your information requirements for REACH registration [PDF] [EN]
- Fact sheet on "Role of Animal Testing in ensuring the Safe Use of Chemical Substances" [PDF]