Agencies

Over the past dozen years, the EU has restructured its regulatory programs in certain sectors by establishing arm's-length Agencies to manage the day-to-day implementation and enforcement of laws and policies created by the European Commission Directorate Generals. Agencies are staffed by a combination of Commission civil servants and experts drawn from regulatory authorities in EU member countries, who together are responsible for such implementation functions as test guideline development, regulatory hazard and risk assessments, provision of objective scientific advice to EU institutions and member countries, and maintenance of transparent communications with the regulated community, stakeholders, and the public at large. Agencies with the greatest influence on the use of animals in laboratories are:

• European Chemicals Agency
• European Food Safety Authority
• European Medicines Agency

European Chemicals Agency

The European Chemicals Agency (ECHA) was established in 2006 pursuant to Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorization and restriction of chemicals (REACH). Under REACH, the scientific support and regulatory functions previously performed by the European Chemicals Bureau (ECB), a division of the Commission’s Directorate General-Joint Research Center, will be subsumed into the Helsinki-based ECHA, together with many staff from the ECB and EU member state chemical regulators. The ECHA is broadly responsible for ensuring the effective management of the technical, scientific and administrative aspects of REACH, including:

• Establishing and maintaining of a new EU Test Methods Regulation (to replace Annex V of Directive 67/548/EEC) listing accepted methodologies for the evaluation of toxic effects on humans, wildlife and the environment
• Examining registration materials and chemical safety reports to check for completeness and ensure that duplicate animal testing has not been performed
• Providing for public comment on proposals for new animal testing, whereby "the Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision…."
• "Establishing and maintaining database(s) with information on all registered substances, the classification and labeling inventory and the harmonized classification and labeling list."
• "Providing technical and scientific guidance and tools where appropriate for the operation of [the REACH] regulation in particular to assist the development of chemical safety reports."
• Establishing various committees, including a Committee for Risk Assessment, which is "responsible for preparing the opinion of the Agency on evaluations, applications for authorization, proposals for restrictions, and proposals for classification and labeling" under REACH
• Developing "appropriate contacts between the Agency and relevant stakeholder organizations."
• And otherwise providing "the member states and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit."

European Food Safety Authority

The European Food Safety Authority (EFSA) was established in 2002 in response to food scares such as BSE (Bovine Spongiform Encephalitis or "Mad Cow Disease") and avian influenza. EFSA is broadly responsible for providing scientific advice and implementation tools necessary to support effective implementation of all EU-wide legislation developed by the European Commission's Health & Consumer Protection Directorate General, Based in Parma, Italy, EFSA's specific responsibilities include:

• Operating a number of Expert Panels and a multi-sectoral Scientific Committee to conduct or coordinate risk assessments and independent scientific reviews of agrochemials, food additives and flavorings, nutritional supplements, genetically modified organisms, and other substances of concern that may enter the food chain
• Providing objective information and scientific advice to other EU institutions and member countries in support of sound food safety policy and legislation. For example, the opinion of the EFSA Panel on plant protection products and their residues was sought regarding the revision of health and ecotoxicological data requirements for agrochemicals
• Commenting on nutritional issues in relation to Community legislation
• Promoting effective communication with EU citizens, member states and stakeholders through provision of "timely, reliable, objective and meaningful information."

European Medicines Agency

The European Medicines Agency (EMEA) was established in the mid-1990s to administer the multitude of EU laws developed by the European Commission Directorate General for Enterprise in relation to the evaluation and authorization of pharmaceutical products and biologics destined for human and/or veterinary use. The specific responsibilities of the London-based Agency include:

• Representing the EU technical perspective in tripartite meetings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), which determine common information requirements and testing guidelines to demonstrate product quality, safety and efficacy among key pharmaceutical markets in Europe, Japan and the United States. EMEA also provides scientific advice and protocol assistance to companies on an individual basis, and publishes a variety of non-binding concept papers, such as the highly relevant draft Guideline on Requirements for First-In-Man Clinical Trials, which reflects a growing recognition on the part of regulatory authorities that "pre-clinical" animal studies are less reliable indicators of human safety than originally thought.
• Scientifically evaluating "centralized" applications for an EU marketing authorization, by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP), as applicable. All pharmaceuticals intended to treat HIV/AIDS, cancer, diabetes or neurodegenerative diseases, as well as products of biotechnology, are required by law to undergo centralized review by EMEA; for most other medicinal products, a marketing authorization may also be granted by an EU member country authority.
• More recently, providing for the scientific review of traditional/natural remedies by the Committee on Herbal Medicinal Products (HMPC), and for the review of applications for the development of medicines for rare diseases (known as "orphan drugs") by the Committee for Orphan Medicinal Products (COMP).
• Managing a post-marketing "pharmacovigilance" network to detect and record incidents of adverse drug reactions.
• Establishing safe limits for residues of veterinary pharmaceuticals in foods of animal origin.