In addition to the directives, regulations, and implementing tools developed by European Union (EU) institutions, a number of nonlegislative communitywide strategies and action plans have been proposed to address issues that cut across a number of regulatory sectors. Examples relevant to regulatory toxicology include:
Community Strategy for Endocrine Disruptors
"Endocrine disruption" refers to adverse effects on reproduction, development, or health resulting from chemically induced interactions with the body's hormone system. A range of synthetic as well as naturally occurring agents have been identified as potential "endocrine disruptors," including pesticides, pharmaceuticals, plastics, and other chemicals. Given the range of European Community legislation under which these substances are regulated, the European Parliament in 1998 called on the European Commission (EC) to examine the many research and regulatory questions related to endocrine disruption. The following year, the EC published its proposed Community Strategy for Endocrine Disrupters.
In contrast to programs under development in the United States and elsewhere to screen and test thousands of chemicals, the EC strategy called for a number of more moderate activities, including:
- "Establishment of a priority list of substances for further evaluation of their role in endocrine disruption." On the basis of independent reviews of peer-reviewed scientific literature, and in consultation with the Commission's Scientific Committee on Toxicity, Ecotoxicity and the Environment, a candidate list of 553 synthetic agents and 9 hormones was published in 2000, together with a series of actions proposed to further evaluate the role of these substances in endocrine disruption.
- "Use of legislative instruments," such as "classification using existing test results for reproductive toxicity, carcinogenicity and danger to the environment."
- "Establishment of monitoring programs to estimate exposure to and effects of the substances on the ED [endocrine disrupter] priority list."
- "Identification of specific cases of consumer use for special action."
- "Information exchange and international coordination."
- "Communication to the public."
Medium-term actions include "research and development" and "identification and assessment of endocrine disrupters." In 2001, the EC convened a European workshop on endocrine disrupters to address topics such as biomonitoring, research and development, testing methods and strategies, and international cooperation. Recommendations emerging from this workshop have helped to shape the EU's research program on endocrine disruption, which has received extensive funding under the Fourth and Fifth Research Framework Programmes administered by the EC's Research Directorate General. In addition, as members of the Organization for Economic Cooperation and Development (OECD), the EU and many of its member countries are de facto partners in the work of the OECD Task Force on Endocrine Disrupters Testing and Assessment, which is coordinating the international development of numerous in vitro and in vivo screening and testing methods.
The final long-term goals of the Community Strategy are "legislative actions" to control substances exhibiting demonstrably harmful effects on humans, wildlife, and/or the environment. To this end, endocrine disruptors have been classified under the new EU Registration, Evaluation, Authorisation and Res regulation as "substances of equivalent concern" to carcinogenic, mutagenic, and reprotoxic (CMR) agents, which are subject to the most stringent requirements for authorization or complete marketing bans. Similar provisions are expected to be introduced into EU agrochemicals and related legislation as it is revised.
Community Action Plan for the Welfare and Protection of Animals
The Treaty Establishing the European Community includes a Protocol on Protection and Welfare of Animals, which "recognizes animals as sentient beings and requires that full regard is paid to their welfare requirements in formulating and implementing the Community's policies." This protocol applies to all areas of animal use, including agriculture, transportation, and testing and research. However, given that Community policies in the field of animal welfare are fragmented among various European Commission Directorates General, the EC in January 2006 proposed a Community-wide Action Plan for the Welfare and Protection of Animals in order to clearly map future activities in this area and to ensure a coordinated, coherent approach across the EC.
In the context of animal use in testing and research, the Commission's 2006 working document acknowledged the lack of coherence between EU legislation and Community strategies that mandate or sanction animal experiments and the requirements of Directive 86/609/EEC 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 working document commits all EC services to the philosophy whereby the "final aim is to replace animal experiments with methods not entailing the use of an animal." In the interim, "[f]urther work will need to be carried out to reinforce a full implementation of the 3Rs in all areas of animal use, ensure coherence between Directive 86/609/EEC and legislation requiring animal experiments, as well as examining in more detail the mutual acceptance of data and mutual recognition agreements as a means of reducing the numbers of animals used in experiments." To this end, the working document outlines the following five broad areas as priorities for action by the EC:
- "Upgrading existing minimal standards for animal protection and welfare."
- "Giving a high priority to promoting policy-oriented future research on animal protection and welfare and application to the 3Rs principle."
- "Introducing standardized animal welfare indicators."
- "Ensuring that animal keepers/handlers as well as the general public are more involved and informed on current standards of animal protection and welfare and fully appreciate their role in promoting animal protection and welfare."
- "Continue to support and initiate further international initiatives to raise awareness and create a consensus on animal welfare."
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