EU Validation Center: EURL ECVAM

European Union: Programs & Policies

EU Validation Center: EURL ECVAM

Last updated: March 11, 2014

The European Centre for the Validation of Alternative Methods (ECVAM) was established in 1991 pursuant to a requirement in Directive 86/609/EEC that the European Commission (EC) and its member states actively support the development, validation, and acceptance of methods to replace, reduce, or refine the use of animals in laboratories.  The activities of ECVAM were assumed by the European Union Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM), which was formally established in 2011 as the Union Reference Laboratory specified in section 47, Article 48, and Annex VII of the European Commission’s Directive 2010/63/EU.

EURL ECVAM is one of the Reference Laboratories at the European Commission’s Joint Research Centre (EC-JRC) Institute for Health and Consumer Protection (IHCP) located in Ispra, Italy. The IHCP hosts the EURL ECVAM web presence.

The aim of EURL ECVAM is twofold:

  • to promote the scientific and regulatory acceptance of non-animal tests which are of importance to biomedical sciences, through research, test development and validation and the establishment of a specialised database service
  • to co-ordinate at the European level the independent evaluation of the relevance and reliability of tests for specific purposes, so that chemicals and products of various kinds, including medicines, vaccines, medical devices, cosmetics, household products and agricultural products, can be manufactured, transported and used more economically and more safely, whilst the current reliance on animal test procedures is progressively reduced.

Major categories of EURL ECVAM activities:

  • Test method development, prevalidation, and validation activities
  • Database services, including the alternatives database DB-ALM
  • ECVAM workshops and task forces
  • Scientific and technical advice to Commission services (DG Environment, DG Enterprise, DG Health and Consumer Protection, DG Research)

Duties and tasks of the Union Reference Laboratory as specified in Annex VII of Directive 2010/63/EU are the following:

  • Coordinating and promoting the development and use of alternatives to procedures including in the areas of basic and applied research and regulatory testing
  • Coordinating the validation of alternative approaches at Union level
  • Acting as a focal point for the exchange of information on the development of alternative approaches
  • Setting up, maintaining and managing public databases and information systems on alternative approaches and their state of development
  • Promoting dialogue between legislators, regulators, and all relevant stakeholders, in particular, industry, biomedical scientists, consumer organisations and animal-welfare groups, with a view to the development, validation, regulatory acceptance, international recognition, and application of alternative approaches
  • Participating in the validation of alternative approaches.
Validation and Regulatory Acceptance of Alternative Test Methods

EURL ECVAM’s validation process, from submission of a test method to final ECVAM recommendations, was updated in March 2013 as explained on the “EURL ECVAM Validation Process” page.

Information on the validation and regulatory acceptance status and related documents for alternative methods reviewed and/or endorsed by ECVAM can be found on the “Validation & regulatory acceptance” page. Links to individual pages for different types of toxicity testing provide additional information on the toxicity endpoint, and related ECVAM validated methods, research, development, publications, and workshops.

Publications/reports of ECVAM progress on the development, validation, and regulatory acceptance of alternative methods include the following:

EURL ECVAM Stakeholder Advisory Groups

ESAC: The EURL ECVAM Scientific Advisory Committee (ESAC) consists of 15 external scientists from academia, industry, and other organizations whose primary function is to serve as ECVAM’s independent scientific peer review body for validation studies conducted by or submitted to ECVAM. An ESAC Opinion is to specify the scientific rationale for the position taken, the capacity and limitations of the test method(s), and possibly its potential application(s). New ESAC members were appointed in 2013, and the committee will be renewed every three years. The ESAC, when requested by ECVAM, may also provide scientific and technical advice on other issues. The ESAC Statements and Opinions and ESAC biannual meeting minutes are published on the ECVAM website.

ESTAF: The EURL ECVAM Stakeholder Forum (ESTAF) is composed of 16 non-governmental stakeholders.  The ESTAF was established in April 2011 “to foster participatory engagement with its non-regulatory stakeholders.” The stakeholder community is a major source of test submissions for ECVAM validation. Organizations submit self-nominations to become members of ESTAF, but the final decision resides with EURL ECVAM. ESTAF meets once per year to participate in advocacy and dialogue on ECVAM’s activities.

PARERE: The Preliminary Assessment of Regulatory Relevance (PARERE) is EURL ECVAM’s regulatory advisory network that was established in May 2011. PARERE “will allow EURL ECVAM to gather regulatory views on the relevance and potential suitability of promising methods for input into EURL ECVAM’s priority setting process.” PARERE representatives consist of one member from each Member State “to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation” as well as representatives from EU regulatory agencies (EFSA, ECHA, EMA and the DG SANCO). PARERE will meet once per year and will have joint meetings with ESTAF.

European Collaborations

In addition to their work with other European Commission services, EURL ECVAM collaborates on various projects with laboratories and organizations in the EU Member States and internationally.

EURL ECVAM is a member of the European Partnership for Alternative Approaches to Animal Testing (EPAA), created in 2005 as a European Commission and industry joint initiative “to promote the development and implementation of new methods to replace, reduce, refine animal testing with modern alternative approaches.”

EURL ECVAM is a participant in the Framework Programme 7 Research Initiative, “Safety Evaluation Ultimately Replacing Animal Testing (SEURAT).” SEURAT-1 is a first step to addressing the long-term strategic target of replacing in vivo repeated dose systemic toxicity testing currently used for the assessment of human safety.

The SEURAT-1 Research Initiative is composed of six research projects, which started on January 1, 2011 and will continue for five years. These projects, working collaboratively to achieve a common goal, combine the research efforts of over 70 European universities, public research institutes, and companies.

Horizon 2020 is “The EU Framework Programme for Research and Innovation” to be funded 2014 – 2020. The proposed Horizon 2020 €80 billion budget will combine the research and innovation funding currently provided through the Framework Programmes for Research and Technical Development, the Competitiveness and Innovation Framework Programme, and the European Institute of Innovation and Technology.

International Collaborations

ICATM: EURL ECVAM is one of the five validation bodies that are members to the 2009 agreement, the International Cooperation on Alternative Test Methods (ICATM), with the goal of promoting international cooperation on the validation of methods that replace and reduce animals in toxicity testing.

ICCR: EURL ECVAM is a partner of the International Cooperation on Cosmetics Regulation (ICCR), an international group of cosmetic regulatory authorities from the EU, United States, Japan, and Canada. “The purpose of the multilateral framework of the ICCRF is to maintain the highest level of global consumer protection, while minimizing barriers to international trade.”

OECD: EURL ECVAM scientists participate in various Organisation for the Economic Co-operation and Development (OECD) activities, including expert groups and the development of OECD Test Guidelines for validated alternative test methods.