REACH requires industry to manufacture, import and use chemicals safely. To do so sufficient information on hazardous chemicals must be available. A large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, without sufficient information on the hazards that they pose to human health and the environment.
It has been public knowledge since the drafting of REACH that the need to gather information would result in an increased use of laboratory animals. The hazardous properties of chemicals cannot be sufficiently determined using currently available in vitro (non-animal) testing methods. Relying solely on such methods can underestimate the potentially hazardous properties of chemicals that could be harmful to humans and the environment.
However, the European Commission takes the concerns about the use of animals for testing seriously. Therefore REACH requires companies to share data and hence avoid unnecessary animal testing. Those wishing to perform tests must indicate to the European Chemicals Agency the tests they propose, for which they must then obtain approval before carrying them out. Under REACH, animal testing is to be avoided in favour of alternative methods and registrants can only carry out tests involving the use of animals as a last resort.
The Commission is also active in the field of developing alternative test methods, for example by the current Framework Programme for Research. The Commission operates the European Centre for the Validation of Alternative Methods (ECVAM), which is a global leader in the field. The Commission also created the TSAR tracking system to ensure that promising new methods can swiftly be adopted for regulatory use, including within REACH. The latest results of this work will be seen in the next amendment to the Test Methods Regulation.
Enforcement of REACH and CLP is a national responsibility; therefore each EU Member State as well as Norway, Iceland and Liechtenstein need to ensure that there is an official system of control and lay down legislation specifying penalties for non-compliance to the provisions of REACH.
ECHA hosts the Forum for Exchange for Information on Enforcement (Forum). This body is composed of representatives of the national enforcement authorities, which work towards coordinating the enforcement of REACH and CLP in the EU Member States, Norway, Iceland and Liechtenstein.
In addition, ECHA is in contact with the individual enforcement authorities and alerts them to any concerns or anomalies that there may be with dossiers coming from their country. For example, if ECHA observes that a test was performed for an endpoint for which a testing proposal is required under REACH, the Member States are informed and can take enforcement actions.
For information about horizontal legislation on the protection of animals used for scientific purposes (Directive 2010/63/EU) see:
Animals used for scientific purposes