Chemical safety assessment has traditionally been based on animal testing but the EU has been promoting for many years the replacement, reduction, and refinement of animal testing. Further it is also considered that
traditional risk assessment approaches are insufficient to adequately predict the potential risk associated with any given substance, especially when considering normal life low-dose exposure. Therefore new prediction models are needed in a new intelligent and more efficient safety assessment, based on in vitro testing in combination with computational modelling. VIDEO
Directive on the protection of animals used for scientific purposes (2010/63), the Regulation on cosmetic products (1223/2009), REACH (2007/2006) and Classification, Labelling and Packaging (CLP) (1272/2008) are examples of EU legislation that require, or strongly encourage, the replacement of animal testing. The EU policies on endocrine disruptors, combination effects of chemicals and nanomaterials are all examples of areas of concern where traditional risk assessment is coming to an end.
New integrated methods based on in-depth biological knowledge are needed. Therefore the JRC is developing and testing new animal-free methods, alternatives to animal-based tests, to be applied in an integrated safety assessment of chemicals. JRC is also providing informatics tools and databases to support this approach.
EURL ECVAM, the European Union Reference Laboratory for Alternatives to Animal Testing The JRC, Institute for Health and Consumer Protection is host to the EU’s principal organisation for the scientific validation of alternative methods to animal testing – EURL , formally established in 2011. EURL ECVAM is actively involved in the search for ECVAM, the European Union Reference Laboratory for Alternatives to Animal Testing test methods which replace, reduce or refine (the 'Three Rs') the use of laboratory animals in the test process. Methods developed by research laboratories are submitted to EURL ECVAM whose assessment of the robustness, reliability and predictive capacity of the methods is based on independent peer review of validation study reports.
EURL ECVAM Improved safety assessment of chemicals without relying on animal testing One of the activities of the Institute for Health and Consumer Protection is to support the implementation of EU chemicals policy (including the safety assessment of industrial chemicals, chemicals in consumer products, pesticides and biocides). Using their knowledge about physical, chemical and biological processes, the IHCP teams adopt a hypothesis-driven, multi-disciplinary approach integrating in vitro methods with computational based methodologies (in silico) together with 'omics' approaches. This is aimed at identifying potential toxicants on the basis on an understanding of their mechanisms of biological action.
Improved safety assessment of chemicals without relying on animal testing New approaches to toxicology
Recent advances in toxicological science, bioinformatics, and systems biologyhave provided means to transform toxicology into a predictive science founded on a combination of
in vitro and computational ( in silico) methods, held together by a detailed mechanistic understanding of how chemicals interact with organisms.
New approaches to toxicology International cooperation The JRC, through its Institute for Consumer and Health Protection (IHCP) , is involved in various international collaboration initiatives in the context of the Organisation for Economic Cooperation and Development (OECD), the World Health Organisation (WHO) and with US governmental organisations.
International cooperation Joint initiative on alternative approaches to animal testing
A joint initiative from the European Commission, European trade associations from seven industry sectors and individual companies in 2005 led to the creation of the
. Its purpose is to promote the development and implementation of new methods to replace, reduce, refine (the '3 Rs') animal testing with modern alternative approaches. European Partnership for Alternative Approaches to Animal Testing (EPAA) Activities and facilities The JRC's main fields of activity and facilities related to new approaches in safety assessment of chemicals: Predictive toxicology and informatic systems The High Throughput Screening facility The compound management activity The cell culture laboratories Areas of activity: Endocrine Disruptors More information: Activities and facilities Alternatives to animal testing of chemicals under REACH legislation
The EU Regulation on chemicals and their safe use -
REACH ( Registration, Evaluation, Authorisation and Restriction of Chemical substances) - which came into force in 2007 has implications for the testing methods used for evaluating the effects of chemical substances.
To minimise the number of animal tests required in implementing the REACH Regulation, provision has been made to provide a number of possibilities for adapting the testing requirements, and to use existing data and alternative assessment approaches instead.
Alternatives to animal testing of chemicals under REACH legislation Information system
The former ECVAM established a comprehensive information system, the
. The DB-ALM provides ECVAM DataBase Service on ALternative Methods (DB-ALM) ready-to-use information presented as factual and evaluated data-sheets in the form of summary records and detailed information on various aspects of animal alternatives with focus on toxicology assessments. Alternative tests methods and cosmetics The safety of cosmetic and personal care products is covered by the EU’s Cosmetics Directive which obliges manufacturers to utilise the best science and latest available research data to substantiate the safety of their cosmetic products before they are placed on the market. EURL ECVAM supports the post-validation regulatory acceptance process at both the European Union and international levels such as the Organisation for Economic Co-operation and Development (OECD). More information: Alternative tests methods and cosmetics Test method regulation The JRC develops standardised methods for determining the intrinsic properties of chemicals. Good knowledge of these properties helps identify and assess any potential dangers and provide information needed for risk assessment. The legally binding EU standardised Test Methods to determine the hazardous properties of chemicals are written into the Test Methods Regulation ( ). Test methods are regularly updated or new methods introduced as required. The technical work to prepare new or updated methods is undertaken by the JRC. TMR, Commission Regulation (EC) No 440/2008 of 30 May 2008 More information: Test method regulation TSAR TSAR stands for Tracking System for Alternative Test Methods Review, Validation and Approval in the context of the EU regulations on chemicals. It is a tool to provide a transparent view on the status of alternative methods as they progress from purely scientific protocols submitted for pre-validation, to being actively used in a regulatory context. More information: TSAR JRC (Q)SAR Model Database Quantitative Structure-Activity Relationship (QSAR) models can be used to obtain information on the properties and activities of substances from chemical structure alone, and can thus be used to fill data gaps in the safety assessment of chemicals. The JRC QSAR Model Inventory is an inventory of information on the validity of (Q)SAR models that have been submitted to the JRC. More information: JRC (Q)SAR Model Database Alternative test methods & Biologicals/Vaccines Traditionally, laboratory animals have played a major role in quality control of vaccines. Still, many laboratory animals used in Europe are required for testing the safety and potency of batches of vaccines for veterinary and human application. The former ECVAM has been involved as sponsor, coordinator and participating laboratory in a number of pre-validation and validation studies on alternative methods for the quality control of human vaccines and veterinary vaccines. More information: Alternative test methods & Biologicals / Vaccines