DG-Joint Research Centre

The European Commission's Directorate General–Joint Research Center (DG-JRC) is mandated "to provide customer-driven scientific and technical support for the conception, development, implementation and monitoring of EU policies." To this end, the JRC functions in an advisory capacity to policymaking DGs such as Enterprise, Environment and Health & Consumer Protection, while serving also as the hub for intramural research at EU-level. The priorities and budget for the JRC and its sister division, DG-Research, reflect the themes defined in the EU's multi-annual Research Framework Programs. Among the JRC's seven institutes, most work related to regulatory toxicology is carried out by the Institute for Health and Consumer Protection and the following two divisions in particular:

• European Center for the Validation of Alternative Methods
• European Chemicals Bureau

ECVAM

The European Center for the Validation of Alternative Methods (ECVAM) was established in 1991 pursuant to a requirement in Directive 86/609/EEC that the Commission and Member States actively support the development, validation and acceptance of methods to replace, reduce or refine the use of animals in laboratories. The specific duties of ECVAM are "to:

• Coordinate the validation of alternative test methods at the European Union level
• Act as a focal point for the exchange of information on the development of alternative test methods
• Set up, maintain and manage a database on alternative procedures
• Promote dialogue between legislators, industries, biomedical scientists, consumer organizations and animal welfare groups, with a view to the development, validation and international recognition of alternative test methods." To this end, ECVAM has organized more than 60 scientific workshops and task forces.

In addition to these core activities, ECVAM has taken on a lead role in:

• Developing internationally recognized validation and regulatory acceptance criteria of new and revised test methods
• Establishing the European Reference Laboratory for Alternative Tests (CORRELATE) and advancing, as a project manager and/or lead laboratory, several multi-year, multi-million-Euro integrated research projects aimed at moving away from animal testing for such complex endpoints as acute toxicity, skin sensitization, and reproductive toxicity
• Coordinating international validation studies, including collaborative efforts in partnership with ICCVAM in the United States, JaCVAM in Japan, and the OECD
• Supporting the development of integrated testing strategies, including serving as the Commission lead for the REACH Implementation Project 3.3
• Sponsoring independent scientific peer reviews of alternative methods/strategies and publishing statements of validity issued by the ECVAM Scientific Advisory Committee (ESAC) to encourage regulatory acceptance and use of appropriate 3Rs methods

European Chemicals Bureau

The European Chemicals Bureau (ECB) is mandated to provide technical support for a variety of regulatory programs managed by DG-Environment, including:

• Notification and risk assessment of new chemicals to be placed on the EU market according to Directive 67/548/EEC, as amended. The ECB's work in this area includes maintenance of the New Chemicals and IUCLID databases, and preparation of the European List of Notified Chemical Substances (ELINCS)
• Authorization of biocides
• Information exchange on import and export of dangerous substances
• Legal classification and labeling of carcinogenic, mutagenic, reprotoxic, and other dangerous substances under Directive 67/548/EEC

The ECB also serves as the lead Commission service for coordinating the regulatory acceptance of new and revised testing methods, including the development of test guidelines, both at EU level and through the Organization for Economic Cooperation and Development (OECD). However, passage of the REACH regulation in December 2006 initiated a process whereby the ECB and its scientific support functions will be subsumed into the new European Chemicals Agency (ECHA).