• Overview
• DG-Enterprise
• DG-Environment
• DG-Joint Research Centre
• DG-Research
• DG-SANCO
• EU Agencies

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:

• Biocides
• Protection of Animals in Laboratories

Biocides

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:

• Acute systemic toxicity in rodents and/or rabbits via oral, inhalation, and dermal routes
• Eye and skin irritation in rabbits
• Skin (and possibly respiratory) sensitization in mice or guinea pigs
• Subchronic (40-90 day) studies in rodents and dogs via one or more exposure routes
• Chronic (12-24 month) feeding studies in rodents and dogs
• Lifetime (18-24 month) carcinogenicity studies in rats and mice
• Mutagenicity and genotoxicity studies of at least two varieties
• Reproductive toxicity in at least two generations of rodents
• Prenatal developmental toxicity in rodents and rabbits
• Metabolism, toxicokinetic, and dermal absorption studies in rodents
• Acute aquatic toxicity to fish

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:

• Neurotoxicity studies in hens
• Immunotoxicity studies in rodents
• Studies in livestock and/or companion animals
• Partial or full life-cycle toxicity in fish
• Aquatic bioconcentration in fish
• Acute and/or dietary toxicity to birds
• Reproductive toxicity to birds
• Toxicity to terrestrial vertebrates other than birds

Recognized testing methods include the internationally harmonized OECD Test Guidelines, as well as methods published in Annex V of Directive 67/548/EEC.

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.

Protection of Animals in Laboratories

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:

• Convening a Technical Expert Working Group (TEWG) to collect scientific and technical background information for the revision of the directive
• Obtaining the opinionof the Animal Health and Animal Welfare Panel of the European Food Safety Authority (EFSA) as to whether the scope of the directive should include some invertebrate species and fetal/embryonic forms; which animals should be purpose bred; and which euthanasia methods are humane
• Obtaining the opinionof the Scientific Committee on Animal Health and Animal Welfare (SCAHAW) on the welfare of nonhuman primates used in experiments
• Performing an initial impact assessmentin consultation with member states and key stakeholders to critically review and assess policy options and their impacts, as well as to test their conclusions and provide justifiable and quantitative (where possible) indications as to the related benefits and costs
• Undertaking a broad-based public consultation to solicit the views of citizens and experts concerning the use of animals in experiments, ways to improve their welfare, and reactions to the results of the initial impact assessment

On the basis of these and other activities, DG-Environment has identified the following as potential revisions to the directive:

• Extending the scope to cover animals used in basic research, education, and training and for the primary purpose of harvesting their tissues and organs for experiments or other scientific purposes; selected invertebrate species; and fetal and embryonic forms from the last third of gestation until birth
• Requiring authorization of individual projects with compliance checks
• Instituting compulsory national and/or institutional ethical evaluation of projects with minimum requirements (e.g., adherence to the 3Rs, harm-benefit analysis, severity classification of procedures, and retrospective analysis of all projects to record deviations and evaluate factual harm and realized benefits)
• Enhancing housing and care standards
• Improving transparency and access to information (e.g., making nonconfidential information from the ethical evaluation reports and project authorization decisions publicly available)
• Banning the use of great apes and moving away from use of wild-caught nonhuman primates in general
• Requiring twice-yearly inspections by national authorities, of which one is unannounced
• Establishing minimal legal requirements for the education, training, and competence of persons involved in animal experiments
• Instituting measures to avoid duplication of animal experiments
• Prohibiting the use of CO₂for euthanasia without first rendering an animal unconscious by another more humane method (e.g., anesthetic gas)
• Improving statistical reporting through inclusion of genetically modified animals; covered invertebrate species and fetal forms; animals killed primarily to obtain their tissues or organs; and figures concerning severity classes, numbers of projects, and types of institutions