- Related terms
The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a voluntary collaboration between the European Commission, European trade associations, and companies from seven industry sectors. The partners are committed to pooling knowledge and resources to accelerate the development, validation and acceptance of alternative approaches to further the reduction, refinement and replacement (3Rs) of animal use in regulatory testing.
Source: EPAA web site
The formerly known European Chemicals Bureau (ECB) was part of the Institute for Health and Consumer Protection (IHCP), which is one of the seven scientific institutes in the European Commission's Joint Research Centre (JRC).
ECB's mission was to provide scientific and technical support to the conception, development, implementation and monitoring of EU policies on chemicals and consumer products. This included managing the risk assessment process, the development of guidance documents and tools in support of the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation, the Testing Methods Regulation, the Global Harmonised System (GHS) for the classification and labelling of hazardous chemicals. Since 2008, these tasks have been taken over by the European Chemicals Agency (ECHA)
The remaining tasks of Ex-ECB at IHCP comprise inter alia the risk assessment of nanomaterials, the Review Programme on the risk assessment of Biocides, the development of methodology for the future Regulation on the Prioritisation of Chemical Substances and its corresponding environmental quality standards (EQS) and harmonisation of testing methods and non-testing methods (e.g. QSARs), etc.
Source: ex-ECB web site
The General Product Safety Directive (GPSD)
A revised GPSD (2001/95/EC) is applicable as from 15 January 2004. The objectives of the Directive are both to protect consumer health and safety and to ensure the proper functioning of the internal market.
The GPSD is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by specific sector legislation (e.g. toys, chemicals, cosmetics, machinery). The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to producers’ obligations and the authorities’ powers and tasks.
The Directive provides a generic definition of a safe product. Products must comply with this definition. If there are no specific national rules, the safety of a product is assessed in accordance with European standards, Community technical specifications, codes of good practice. the state of the art and the expectations of consumers.
Source: Europa, DG Consumers Affair website.
Independent Scientific Committees, & the European Commission
When preparing its policy and proposals relating to consumer safety, public health and the environment, the Commission relies on independent Scientific Committees to provide it with sound scientific advice and draw its attention to new and emerging problems. The Scientific Committees can call on additional expertise from a pool of scientific advisors and a database of experts.
in silico methods
An expression used to mean "performed on computer or via computer simulation." The phrase was coined in 1989 as an analogy to the Latin phrases in vivo and in vitro which are commonly used in biology and refer to experiments done in living organisms and outside of living organisms, respectively.
The use of cells or tissues derived where possible from humans that are cultured under laboratory conditions.
In vivo (Latin for "within the living") is experimentation using a whole, living organism as opposed to a partial or dead organism, or an in vitro controlled environment. Animal testing and clinic trials are two forms of in vivo research
The "systematic study of the unique chemical fingerprints that specific cellular processes leave behind" - specifically, the study of their small-molecule metabolite profiles. The metabolome represents the collection of all metabolites in a biological organism, which are the end products of its gene expression. Metabonomics is defined as "the quantitative measurement of the dynamic multiparametric metabolic response of living systems to pathophysiological stimuli or genetic modification". This approach is increasingly used in toxicology, disease diagnosis and a number of other fields including nutrition. One of the challenges of systems toxicology, and more generally systems biology, is to integrate proteomic, transcriptomic and metabolomic information to give a more complete picture of living organisms. Metabolomics and metabonomics provide an overview of the metabolic status and global biochemical events associated with a cellular or biological system. They can accurately and comprehensively depict both the steady-state physiological state of a cell or organism and of their dynamic responses to genetic, abiotic and biotic environmental modulation. An increasing focus in metabo(l/n)omics research is now evident in academia, industry and government.
Source: IHCP, JRC Project Browser
PIC - Prior Informed Consent Procedure for the export of chemicals
The Rotterdam Convention was signed by the European Community on 11 September 1998. This Decision, approving the Rotterdam Convention on behalf of the European Community, is accompanied by a Council Regulation to implement the Convention's provisions within the European Union. This Decision replaces Decision 2003/106/EC, which was annulled by the Court of Justice (see “Related Acts”). The Convention regulates the import and export of certain hazardous chemicals and pesticides. It is based on the fundamental principle of Prior Informed Consent (PIC), meaning that under the Convention, a chemical listed in the Convention may only be exported with the importer's prior consent. The Convention establishes a procedure to disseminate the decisions taken by the importing countries, thus implementing the PIC principle in the international trade in chemicals. It contains provisions requesting detailed information on the chemicals so that these decisions may be taken once data are available on the properties and the incidence of these products in particular on human health and the environment.
Source: Europa Web site, Legislation Summaries
A JRC-IHCP initiative contributing to effective high throughput detection of unauthorised GMOs, the pre-spotted plates are used to analyse event-specific targets of EU approved and unapproved GM events. They contain, in lyophilized format, all primers and probes for the individual detection of several GM events and of the corresponding plant species (e.g. maize, cotton, rice, oilseed rape, soybean, sugar beet, potato...).
(Q)SARs - (Quantitative) Structure-Activity Relationships
(Q)SARs are methods for estimating properties of a chemical from its molecular structure and have the potential to provide information on hazards of chemicals, while reducing time, monetary cost and animal testing currently needed.
To facilitate practical application of (Q)SAR approaches in regulatory contexts by governments and industry and to improve their regulatory acceptance, the OECD (Q)SAR project has developed various outcomes such as the principles for the validation of (Q)SAR models, guidance documents as well as the (Q)SAR Application Toolbox. The OECD (Q)SAR Project is carried out with the financial assistance of the EU.
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
In principle REACH applies to all chemicals: not only chemicals used in industrial processes but also in our day-to-day life, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.
REACH makes industry bear most responsibilities to manage the risks posed by chemicals and provide appropriate safety information to their users. In parallel, it foresees that the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action at EU level. REACH also creates the European Chemicals Agency (ECHA) with a central coordination and implementation role in the overall process.
Source: ECHA web site
Scientific Committee on Emerging and Newly Identified Health Risks
See also Independent Scientific Committees, & the European Commission
The "3 Rs principle" (Replace, Reduce, Refine)
Methods that could replace or reduce laboratory animal use in specific procedures or refine such use so that animals experience less suffering.
Source: M. L. Stephens, A. M. Goldberg and A. N. Rowan, "The first forty years of the alternatives approach"
The "3 Rs principle" (Replace, Reduce, Refine)
The DB-ALM (Database on Alternative Methods) was established in 1996 to achieve a principal objective of ECVAM (formerly known as Scientific Information Service-SIS), as required by the European Commission and Parliament, to establish, maintain and manage a database on alternative procedures to animal experiments (SEC(91)1794).
To date, DB-ALM has 1801 registered users from 75 countries, from regulatory authorities, academia, industry, European and International institutions, and animal welfare organisations. It includes summaries of 139 in vitro methods and 63 validation studies / method evaluations. At present, 129 INVITTOX protocols can be downloaded.
The DB-ALM provides ready-to-use information presented as evaluated data-sheets in the form of summary records and detailed information on various aspects of animal alternatives with focus on toxicology assessments.
More info on the DB-ALM website http://ecvam-dbalm.jrc.ec.europa.eu/
The Institute for Health and Consumer Protection (IHCP) hosts the European Centre for the Validation of Alternative Methods (ECVAM), which has a long tradition in the development of methods which reduce, refine or replace the use of animals for safety testing and efficacy/potency testing of chemicals, biologicals and vaccines. Research laboratories across the EU are able to submit to ECVAM for scientific validation the alternative methods to animal testing that they have developed. ECVAM also promotes the development and dissemination of alternative methods and approaches, their application in industry and their acceptance by regulators. More information on ECVAM website: http://ecvam.jrc.ec.europa.eu/
In vitro methods
The term in vitro ("in the glass") refers to the technique of performing a given experiment in a test tube, or, generally, in a controlled environment outside a living organism. In IHCP, in vitro methods are based on the use of cells or tissues which are cultured under controlled conditions in flasks and plates. Cells/tissues are exposed to chemicals and their toxic effect is measured. Increasingly, human cells are used since they better predict possible effects on humans.
Source: IHCP, In Vitro Methods Unit