Alternatives to animal testing under REACH
Alternatives to animal testing under REACH
Chemicals can cause cancer; affect the immune, respiratory, endocrine, reproductive or cardiovascular systems; weaken human resilience and the capacity to respond to vaccines; and increase vulnerability to diseases.
The European Parliament and Council adopted chemicals legislation to protect people and the environment from such harm and to promote alternative test methods.
In practice, this means companies must test their chemicals for safety – by using alternative methods or – as a last resort – testing on animals. Animal tests are only permitted if there is no alternative way to gather the safety information.
The law requires companies to use alternative methods whenever possible – so companies should only ever test on animals as a last resort.
At the moment, accepted alternative methods, as direct replacement of animal testing, only exist for acute and short-term effects, such as eye irritation, skin sensitisation, or bioaccumulation testing. Animal tests are often still essential for assessing the long-term effects, such as organ damage, weakening of the immune system, development of allergies or asthma or reproductive problems and birth defects.
Unnecessary testing can, however, be avoided also in areas where no internationally accepted alternative methods exist, by sharing data or predicting the effects from what is known about similar chemicals.
ECHA is active in all these areas. The Agency works closely with the European Commission and Member States when deciding if a test is needed.
ECHA avoiding unnecessary testing on animals
ECHA works to avoid unnecessary testing on animals and promotes alternative test methods. It acts proactively to ensure that animal testing is used only as a last resort, providing regulatory expertise and investing in worldwide platforms on chemicals data, such as IUCLID and the QSAR Toolbox.
- critically examine proposals from companies to test substances on animals and involve stakeholders in the decision making to make sure alternatives have been considered and the test will be effective;
- support companies in sharing data to avoid duplicate testing, and take decisions if they fail to agree on sharing test data;
- develop, fund and promote tools and methods for computer modelling of data on chemicals which can be used as an alternative to testing;
- contribute to research and cooperate with authorities world-wide to exchange data, best practices and advance the development and acceptance of alternatives to animal testing;
- share on our website information about properties of chemicals that can be used by researchers in developing alternatives to animal testing; and
- advise companies on relevant alternative methods to animal testing that are, or will become, available and report publicly on the progress made.
The main means within ECHA’s mandate to keep the number of animal tests to an essential minimum are:
Data sharing reduces animal testing as it avoids the need for studies on animals to be repeated.
Companies producing or importing the same chemical 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. ECHA supports companies to share data with guidance, helpdesk and tools, and also takes decisions if they fail to agree.
Adequate and reliable studies on animals must not be repeated. Companies are also encouraged to share any available data they possess.
Companies must use all other relevant and available data sources before testing on animals. ECHA contributes to the development of alternative methods and approaches and promotes their use – for example:
- The read-across approach is the most used alternative method under REACH. It uses relevant information from analogous substances to predict the properties of target substances. To help companies to benefit from this option, ECHA has developed a read-across assessment framework (RAAF) and published it together with an example to illustrate its use.
- ECHA provides hands-on support to companies – through collaboration with industry sector associations – to develop testing strategies for groups of substances based on read-across, so companies can avoid unnecessary animal testing and costs.
- Companies are encouraged to share any available data on their substance if requested by a registrant of an analogue substance. This helps to avoid duplicate animal tests.
- The QSAR Toolbox is a software application that supports companies to identify data that may be relevant for assessing the hazards of chemicals. It enables industry and authorities to fill information gaps and assess properties of chemicals without relying on animal testing. ECHA funds, develops and manages the toolbox in cooperation with the OECD.
- IUCLID is a universal platform to store and share data on chemicals which is used by many regulatory bodies, thereby avoiding duplicate tests on animals. ECHA co-develops the software 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. It shows that companies are making use of alternatives, sharing data and using adaptations foreseen under REACH, where possible, to avoid animal testing.
- The Agency is actively involved in developing OECD test guidelines, the development of which adheres to the requirements of refining, reducing and replacing animal tests. ECHA contributed to the adoption of the OECD test guidelines for in vitro tests for skin and eye irritation (2016) and skin sensitisation (2017). These test guidelines have been widely used.
- ECHA has joined efforts with the United States Environmental Protection Agency (US EPA) and Health Canada to further investigate the use of new approach methodologies for generating exposure and hazard information on chemicals in regulatory processes.
- Within the frameworks of the Seventh Framework Programme (FP7) and Horizon 2020, ECHA has been involved in steering research projects (SEURAT56 and EUToxRisk57) with the aim of developing suitable alternatives for regulatory needs. ECHA also contributes to the European Platform for Alternatives to Animal testing and its related activities.
- A large proportion of the data that ECHA receives from registrations is published on the Agency’s website. This helps existing and future registrants identify additional data for their registrations. The data may also be used by researchers in developing new non-animal testing methods.
When 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.
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 for assessing the safety of chemicals they import or manufacture (i.e. tests listed in REACH annexes IX and X for substances registered at above 100 tonnes), they must give details on their plans for testing to ECHA. They 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 needs to agree on these testing proposals before any new higher-tier test can be conducted.
For that, ECHA checks whether the proposed test is likely to produce reliable and adequate data. The Agency can reject, modify or accept the test. If needed, ECHA can also request for additional studies to be conducted.
Every proposal submitted by registrants that will involve testing on vertebrate animals is published on ECHA’s website. This gives citizens and organisations the opportunity 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 when preparing its decision.
- Report on the regulatory applicability of non-animal approaches [PDF]
- Report on Alternatives to Animal Testing (2020) [PDF]
- Summary of the report on Alternatives to Animal Testing (2020) [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]