Comments: 1. Comments on the European Community Strategy for Endocrine Disruptors 2.Application of the Three Rs Principle in the Compilation of “Technical Guidance Document in Support of Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, Part I, Guidance on Data Requirements for Active Substances and Biocidal Products”

1. Barry Phillips 2. Ursula G. Sauer, Manfred Liebsch and Roman Kolar

1. Public concern over the possible effects of chemicals that can interfere with the endocrine systems of humans and wild animals (endocrine disruptors [EDs]) has led to calls for immediate regulatory action in many parts of the world. In response, there has been an enormous increase in funding of research on this topic, and hurried attempts have been made to develop and validate methods for identifying EDs. Much of this activity involves experiments on live animals. In the haste to calm public concern over EDs, there is a great danger that animal welfare will be given too little consideration, and that research and testing involving animals will be greatly and unnecessarily increased. Recently, the European Commission published a Community Strategy for Endocrine Disruptors, which outlines actions to be taken to address concerns over EDs. In the short term, the strategy is to concentrate on specific chemicals of concern. Development of test methods is seen as a medium-term objective, linked to further research that will inform test selection and design. Adaptation and amendment of existing legislative instruments to cover endocrine-disrupting effects is envisaged as the long-term objective. The strategy makes no reference to the need to avoid unnecessary animal testing in ED research, test validation or chemical testing. It does, however, avoid the premature initiation of large-scale screening which, as is being promoted and planned in the USA, could involve the use of vast numbers of animals in tests of unproven validity or value.

2. In fulfilment of the aims of the European Union Biocidal Directive (Directive 98/8/EC), Technical Guidance Documents are currently being compiled. Part I of these Technical Guidance Documents covers data requirements for active substances and biocidal products. The Three Rs principle has been applied in certain parts of the toxicity and ecotoxicity testing scheme for pesticides, such as testing for acute oral toxicity, skin and eye irritation, skin sensitisation, and dermal absorption. Further recommendations on how to proceed with regard to the continuing replacement, reduction and refinement of animal experiments in this field of regulatory testing are included for consideration. In this context, besides stressing the necessity to validate and accept further alternatives, emphasis is placed on providing the possibility of waiving unnecessary tests and on the continuous evaluation of whether certain tests are needed at all.