The Directorate General for the Environment (DG-Environment) of the European Commission (EC) contributes to European Union (EU) policy on a number of cross-cutting issues, including air and water pollution, waste prevention, recycling, pesticide and chemical regulation, resource use, and the urban environment. In the context of regulatory toxicology, DG-Environment was responsible for preparing the initial draft of the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation, and is the EC lead in developing frameworks for:
Whereas agricultural pesticides fall within the jurisdiction of DG-SANCO, nonagricultural pesticides, or biocides, are regulated by DG-Environment pursuant to Directive 98/8/EC. This directive recognizes 23 classes of biocidal products, including antibacterial disinfectants, preservatives, antifouling agents, and wild animal repellants and lethal control measures such as rodenticides. In regard to the latter category, the Directive states that it “is necessary, when biocidal products are being authorized, to make sure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on the target organisms such as resistance or unacceptable tolerance and, in the case of vertebrate animals, unnecessary suffering and pain….” To this end, the biocides directive calls for extensive animal-based testing to evaluate both the safety and efficacy of biocidal products and their active ingredients. Although data requirements differ somewhat for chemical versus microbial (i.e., fungi, viruses, and microorganisms) agents, standard testing requirements for “active ingredients” include many or all of the following:
In addition, each formulated biocidal product is required to undergo separate efficacy and acute toxicity testing via the oral, dermal, and inhalation routes; skin and eye irritation; and skin sensitization (known as the acute toxicity “six-pack”) for labeling purposes. The following studies may also be conditionally required for chemical ingredients and/or formulated products:
Many thousands of animals may be consumed in the toxicological evaluation of each biocidal product on the EU market. Such costs could be reduced through the adoption of tiered testing strategies developed by a multistakeholder technical committee under the auspices of the ILSI Health and Environmental Sciences Institute (HESI) for the similar purpose of evaluating the safety of agricultural pesticides. Regulatory authorities in the EU and globally have widely recognized the scientific soundness of these alternative testing strategies, as well as their capacity to minimize redundancies, use fewer animals, and use resources more wisely.
Directive 86/609/EEC, regarding the protection of animals used for experimental and other scientific purposes, stipulates that “[a]n experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available,” and further, “[i]n a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected.” The 3Rs mandate imposed by Directive 86/609 applies to all EC services, EU member state authorities, and animal users throughout Europe. Accordingly, new and revised EC and member state legislation must conform to the letter and spirit of this directive.
Since the adoption of the 1986 directive, there have been advancements both in technology and in societal attitudes towards animals, neither of which are adequately reflected in the current legislation. DG-Environment has therefore initiated a process to revise the directive, including:
On the basis of these and other activities, DG-Environment has identified the following as potential revisions to the directive: