How to avoid unnecessary testing on animals
The purpose of this practical guide is to highlight the opportunities & obligations that registrants have to avoid unnecessary new animal studies, yet still assessing the properties of their substances adequately for classification and hazard communication and also for a satisfactory risk assessment to enable appropriate risk management measures to be taken to manage any risks that arise from manufacture or use. The guide explains alternative and non-test methods of assessing the properties of chemical substances in order to provide the information required by the REACH Regulation. The... resulting data can be used for REACH registration and CLP classification. More detailed explanations of the methods involved are provided in the European Chemicals Agency’s (ECHA) guidance documents which are referenced at the end of this paper. The overall purpose of both the REACH and the CLP Regulations is to ensure a high level of protection of human health and the environment. One of the main reasons for developing and adopting the REACH Regulation was to fill the data gaps for the large number of substances already in use. For many of these substances there is inadequate information on the hazards they pose to human health and the environment. Filling the data gaps will enable industry to assess hazards and risks, and to identify and implement any risk management measures that are necessary to protect human health and the environment. A primary means of avoiding unnecessary tests on animals is the requirement that REACH registrants share test data with one another. This means that any existing studies involving tests on vertebrate animals conducted by one registrant must be shared for use by all registrants of that substance. Also, information from any new animal studies will need to be provided to all registrants that need them for registration. While data sharing will influence the number of animals tests, that process is only briefly described here as much greater detail is already available in “Guidance for the implementation of REACH – Guidance on data sharing” (2007). Many of the standard test methods use vertebrate animals as a model to predict the effects of chemicals on humans and the environment. However, there are other means to assess the properties of substances without using tests on animals. Hence another key means of avoiding unnecessary testing on animals is to use what are called alternative methods for assessing the hazards of substances – the rationale for this guide.
- Corporate author(s): European Chemicals Agency (EU body or agency) Themes: Chemical industry, Scientific and technical research
- Subject: access to information, chemical product, dangerous substance, data collection, environmental risk prevention, European Chemicals Agency, guide, scientific research