What about animal testing?
The European chemicals legislation REACH strives for a balance: increase our understanding of the hazards of chemicals whilst at the same time, avoid unnecessary animal testing. Learning more about chemicals by testing them on animals is a last resort – registrants may only carry out new tests when they have exhausted all other relevant and available data sources.
For some chemicals, information on their impact, for example the potential to cause cancer, is still missing. Industry must therefore fill information gaps to understand the hazards of the chemicals they produce and use, to ensure safe use and manage the potential risks, and to possibly replace chemicals of high concern over time with safer alternatives. For this reason, new studies on chemical substances may have to be conducted, some of them using animals.
Two ways that REACH aims to keep the number of animal tests to an essential minimum are:
- Data sharing
Companies registering chemicals must share information on their hazardous properties and jointly submit this hazard information to ECHA. Companies producing or importing the same substance must work together and share the results of tests on vertebrate animals, such as fish, rabbits or rats. Reliable and adequate studies must not be repeated.
- Alternative methods and approaches
REACH offers several alternatives to testing on animals. 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. This approach is called read-across.
When registering their substance, if companies believe that they need to do more tests to gather the required information, they must give details on their plans for testing on animals to ECHA. The Agency and the Member States authorities need to agree on these so called testing proposals before any new higher-tier test (for substances registered in above 100 tonnes) can be conducted.
To prevent any unnecessary testing, ECHA looks at all the testing proposals to check that the proposed test is likely to produce reliable and adequate data.
ECHA also publishes on its website every testing proposal involving vertebrate animals. This is an opportunity for citizens or organisations to provide scientifically valid information and studies about the substance. If ECHA receives information from these consultations, it informs the company and takes any scientifically valid information and studies into account in preparing its decision.
ECHA also helps to share the available data and information on testing. For example, the eChemPortal allows the registrants to verify whether information on animal tests is already available from other authorities.
Furthermore, ECHA's dissemination webpage (link) gives citizens and organisations an insight into the information included in registration dossiers.
Finally, ECHA contributes to the development of alternative methods to testing and promotes their use. As one example, the Agency develops and manages, in cooperation with the OECD, the QSAR Toolbox. It is a software application which supports companies to identify data which may be relevant for assessing the hazards of chemicals.
Roles of different actors
To avoid unnecessary testing on animals, many actors play an important part:
As REACH registrants, the companies have to gather all available information on the safe use of their substance, share the data and decide how to generate any missing information. Wherever possible, they should do that in ways which will not require them to test on animals. If that is not possible, they need to either conduct the tests or, for the higher tier requirements, make a testing proposal for agreement by ECHA.
They can provide scientifically valid information in response to public consultation on testing proposals. This information will be taken into account when ECHA decides on the need for new tests. All testing proposals on vertebrate animals are published on ECHA's website for commenting within a deadline of 45 days.
The EU Member States competent authorities are consulted on all of ECHA's draft decisions requesting additional animal tests. They are also responsible for implementing and enforcing the legislation to protect animals used for scientific purposes.
Analysis of higher tier studies submitted without testing proposals
ECHA has analysed reasons why some registrants have submitted studies on vertebrate animals without having a testing proposal. The Member States have been informed about the findings so they can decide on any follow-up measures.
ECHA report: The use of alternatives to testing on animals for the REACH regulation
Every three years, ECHA reports to the European Commission on the use of methods to generate information which has been used instead of tests on animals. The report shows that many companies have already used alternatives to animal testing, such as information sharing and using the read-across approach.
One of the aims of the new Biocidal Products Regulation is also to avoid unnecessary testing on animals.
Before carrying out any tests on animals, companies need to send an inquiry to ECHA to find out whether a test or study addressing the same information requirement has already been conducted and submitted. If such information exists, companies are required to share the data. Biocides applicants may also inquire about tests and studies not involving tests on vertebrate animals. New studies involving animals should be conducted only as a last resort.
- QSAR Toolbox
- Evaluation decisions
- Testing proposals
- The use of alternatives to testing on animals for the REACH Regulation 2011, video interviews
- Information toolkit to help in using of existing information and non-test methods
- REACH legislation, including Test Methods Regulation
- CLP legislation
- Biocidal Products Regulation
- European Ombudsman
- Survey results - Analysis of higher tier studies submitted without testing proposals [PDF]
- Report on non-standard methods for assessment of chemicals [PDF]
- Report on Alternatives to Animal Testing (2014) [PDF]
- Summary of the report on Alternatives to Animal Testing (2014) [PDF]
- Report on Alternatives to Animal Testing (2011) [PDF]
- Summary of the report on Alternatives to Animal Testing (2011) [PDF]
- How to use alternatives to animal testing to fulfil your information requirements for REACH registration [PDF] [EN]
- Directive 2010/63/EU of The European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes [PDF]
- The fact sheet on "Role of Animal Testing in ensuring the Safe Use of Chemical Substances" [PDF]
- Reply letter to PETA's petition about animal testing [PDF]