The Europe Commission (EC) is divided into more than 40 services and departments known as Directorate Generals (DGs), each responsible for managing and/or providing technical support to different EU regulatory sectors.
DGs with the greatest influence on the use of animals in laboratories are:
The objective of the Directorate General of the Environment is “to protect, preserve and improve the environment for present and future generations.” The DG Environment’s website includes information on their policies and actions.
DG Environment activities to achieve this objective include the following:
Chemicals legislation in the EU covers many specific groups of chemicals including industrial chemicals, endocrine disruptors, and nanomaterials.
EU chemicals regulation include:
The DG ENV webpage, Animals used for scientific purposes, covers important information on EU legislation related to the protection and welfare of “wildlife, zoo animals, farm animals, animals in transport, and animals used for scientific purposes.” On September 22, 2010, Directive 2010/63/EU replaced the 1986 Directive 86/609/EEC; the new legislation took full effect on January 1, 2013. Directive 2010/63/EU firmly anchors the principle of the 3Rs in EU legislation and further improves the welfare of animals used.
The aims of the DG Health and Food Safety (DG SANTE) include:
DG SANTE acts by monitoring implementation of EU laws on food and product safety by national and local governments, listening to stakeholder concerns on matters such as on trade and competitiveness, and by taking action for the EU or supporting national authorities when needed.
The Directorate General–Joint Research Centre (DG-JRC) functions in an advisory capacity to the European Commission and its policy-making Directorate-Generals. The DG JRC is under the responsibility of Commissioner for Education, Culture, Youth & Sport. Its Board of Governors assists and advises on matters relating to the role and the scientific, technical, and financial management of the JRC. The priorities and budget for the JRC and the DG Research & Innovation reflect the themes defined in the EU’s multi-annual Research Framework Programmes.
The JRC is composed of seven scientific institutes:
Among JRC’s institutes, the work related to alternative methods to animal testing for regulatory toxicology is carried out by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), a division of the Institute for Health and Consumer Protection (IHCP). EURL ECVAM as part of the IHCP is “the EU’s principal organisation for the scientific validation of alternative methods to animal testing.” [Also see: EU Validation Center]
The Institute for Health and Consumer Protection (IHCP) “currently serves its customers, mainly specific Directorates-General of the European Commission, on issues requiring scientific analysis or operational support within the framework of EU legislation on chemicals, food and consumer products.”
The JRC-IHCP supports five main policy areas:
The European Union (EU) 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’s DGs. Agencies are staffed by a combination of EC 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. Agencies with the greatest influence on the use of animals in laboratories are the European Chemicals Agency, the European Food Safety Authority, and the 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 EC’s Directorate General-Joint Research Center, were 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 REACH’s technical, scientific, and administrative aspects, including:
Minimizing animal testing under REACH:
The European chemicals legislation REACH is required to avoid unnecessary testing on animals – “registrants may only carry out new tests when they have exhausted all other relevant and available data sources.” A company’s plans for additional testing on animals must be presented to the ECHA before conducting the studies. Approaches to minimize animal testing for REACH include data sharing and the use of alternative test methods. ECHA, in cooperation with the Organisation for Economic Cooperation and Development (OECD), also participates in developing and managing the QSAR Toolbox, a software tool intended to reduce animal testing.
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 does not grant market authorization, but is broadly responsible for providing scientific advice and implementation tools necessary to support effective implementation of all EU-wide legislation developed by the EC’s Health & Food Safety Directorate General (DG-SANTE).
Based in Parma, Italy, EFSA’s specific responsibilities include:
The EFSA Animal Welfare page explains the EU regulatory framework on animal welfare and relevant EFSA activities.
The 2010 technical report, Database of guidance on different toxicity end-points, risk assessment methodologies and data collection related to food, feed, animal health and welfare and plant health (EFSA Journal 2010; 8(3):1518), was developed with the purpose of providing “an inventory of guidance and test methodologies that have been developed or are in the process of being developed on risk assessment related to food and feed safety” covering scientific aspects, procedural aspects, and quality assurance.
The hazard characterization methods covered include the following:
The EFSA Applications Helpdesk provides access to the current guidance documents applicable to the risk assessment of the products it reviews, including those for pesticides, food ingredients, feed additives, and food contact materials.
European Medicines Agency
The European Medicines Agency (EMA) is responsible for the protection and promotion of human and animal health through the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995 and is based in London.
Safety monitoring of medicines
EMA established in 2011, the Joint Committee for Medicinal Products for Veterinary Use/Committee for Medicinal Products for Human Use Ad-hoc Expert Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products (JEG 3Rs). JEG 3Rs provides advice and recommendations to the Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) on all matters relating to the use of animals and the application of the ‘3 R’ principles (replacement, reduction, and refinement) in the testing of medicines for regulatory purposes.
The Council of Europe is an international organization located in Strasbourg (France) and comprises 48 countries of which 28 are EU member states. “It was set up to promote democracy and protect human rights and the rule of law in Europe.”
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe. The EDQM was formally established in 1996, but traces its origins to a convention that elaborated a European Pharmacopoeia in 1964.
EDQM’s mission comprises the following:
EDQM supplies over 2600 reference standards that can be purchased through the EDQM Store.
The EDQM Annual Report (2014) provides an excellent overview of the activities of EDQM and, in particular, the European Pharmacopoeia.
The European Pharmacopoeia (Ph. Eur.) publishes official standards (general texts and monographs) that provide a legal and scientific basis for quality control during the development, production, and marketing processes of medicines. The standards cover the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines, and on the intermediates of synthesis. These standards are legally binding in the signatory states of the European Pharmacopoeia Convention, including the EU.
Some of tests to be carried out involve the use of animals. EDQM’s Alternatives to Animal Testing webpage provides information and meeting summaries related to 3Rs activities at EDQM and the European Pharmacopoeia.
The main areas of activity at the EDQM that are actively involved in the application of 3Rs principles include:
The European Pharmacopoeia Commission continuously revises general texts and monographs, re-evaluates the relevance of animal tests mentioned and if deemed appropriate includes alternative methods. The public can contribute to this work by proposing and/or commenting on draft monographs and general texts or by requesting revisions of monographs and general texts (more details).
The Biological Standardisation Programme (BSP) aims at validating new pharmacopoeial methods and establishing European Pharmacopoeia reference preparations for the quality control of biological medicines. The programme is particularly committed to consider promising 3R methods and study reports are published in Pharmeuropa Bio & Scientific Notes.
EU legislation on biological products (human and veterinary vaccines and blood-derived products) provides that a laboratory of a Member State may – but is not required to – test batches of biological products before they are placed on the market. Networks for this Official Control Authority Batch Release (OCABR) are in place for human and veterinary biologicals, each operating with a number of general administrative procedure and guidelines for individual products. OCABR performed by any given Member State must be mutually recognized by all other member states requiring OCABR for that product. Further testing is not required.
The OCABR guidelines are revised on a regular basis and should consider 3Rs approaches.