TSAR 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.
This tracking system intends to cover all steps, from the initial submission for pre-validation until final adoption by inclusion in the EU legislation and/or related Guidance Documents, when appropriate. It is worth mentioning that not all alternative methods will or need to be included in the Test Methods regulation (TMR, Commission Regulation (EC) No 440/2008 of 30 May 2008), as this Regulation only contains relevant methods for the assessment of properties of chemicals that fall directly under its remit (see below some links to relevant legislation that contains data requirements). In addition to TMR, a number of methods are used on a day to day basis in a regulatory context through other product related guidance, as part of intelligent testing strategies or as pre-screening methods. Regardless of the way of implementation, they all contribute to the replacement, reduction and refinement of the use of animals in scientific procedures.
The process of validation and regulatory approval has been broken down into a number of steps. Although this is a continuous process that may, sometimes, also involve some iterations, for practical reasons it has been broken down in two parts:
A) Review and Validation.
B) Regulatory Approval (see simplified scheme for alternative methods).
These have, on its turn, been broken down into several stages. An explanation of each stage can be found by clicking on the submenus of the "The Process" menu on the left side of the screen.
The methods whose status of validation or regulatory acceptance are tracked here have been grouped by the relevant endpoint they cover, as can be seen in the left side menus.
However, currently, the system only contains information tracking specific alternative methods in terms of the regulatory approval part from the stage "Validation statement" onwards. The remaining parts of the TSAR web site dealing with the other stages in the process of validation and regulatory approval are under construction and it is foreseen that they will be added in the near future. Some other utilities as site searching capabilities will also be added in future.
The drop-down menus on the left hand side of the screen allow the user to display the information on individual alternative methods by just clicking on them.
The test methods have been classified according to a simple colour code:
Green: Already in the EU legislation or other regulatory use.
Orange: Undergoing process to be incorporated in the EU regulatory context.
Purple: No regulatory use identified.
Background: The work on Test Methods for chemical substances in Institute for Health and Consumer Protection (IHCP).
The Test Methods work area of IHCP provides technical and scientific support to Commission Services (mainly DG Environment and DG Enterprise and Industry) and to Member States Authorities concerning the development, harmonisation and implementation of test methods for chemical substances.|
The objectives of the EU system of chemicals management include ensuring a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. A major objective is, as well, the promotion of alternative methods for assessment of hazards of substances and this website contributes directly to achieving that objective.
The Test Methods working area of the IHCP is charged with the development of standardised Methods for the determination of the intrinsic properties of chemicals. The knowledge of these properties allows the identification and assessment of the hazards that chemicals may have and provides information needed for exposure assessment as well as fate and pathways of chemicals in the environment. The methods should allow identification of any adverse effects that the chemical has an inherent capacity to cause and, when appropriate, estimation of the relationship between dose, or level of exposure to a substance, and the incidence and severity of an effect.
On this basis, and using several criteria, the chemicals can be classified in different hazard classes.
Taking into account the intended uses of any particular chemical, the foreseen exposure of human populations or environmental compartments as well as the estimated incidence and severity of the predicted effects likely to occur to an exposed human population or environmental compartment, a risk assessment of the chemical can be done.
On the basis of the risk assessment and integrating socio-economic considerations, proper risk management measures can be taken.
All this is summarized in the following illustration:
The whole system relies on the determination of the potential hazardous properties of chemicals and for this it is crucial to have appropriate and standardised test methods.|
Standardised Test Methods:
Having standardised Test Methods for chemicals at the EU level is also important for ensuring the internal market and free trade inside the Union because the free movement of goods between the Member States relies on data generated with harmonised methods. For the above reasons and because of the global relevance of the subject, the work is closely linked and co-ordinated with the parallel OECD Test Guidelines programme.
The Test Methods Regulation:
The legally binding EU standardised Test Methods to determine the hazardous properties of chemicals are contained in the Annex to the Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (O.J. L 142, 31.5.2008, p. 1) and its Corrigendum. They play a central role in the EU policy on chemicals management and they are referred in many other pieces of EU legislation (e.g. REACH Regulation and Corrigendum, Plant Protection Products (PPP), Cosmetics and Biocidal Products also refer to these methods).
This Regulation completely replaces the Annex V to Council Directive 67/548/EEC of 27 June 1967.
The Annex to the TMR is divided in three parts which contain Test Methods for chemicals that address all areas of concern:
The texts of the individual Test Methods are available so they can be downloaded, as well as, in future, a list of the regulatory acts that will update the annex. Only the English versions of the methods are available in this site. The other linguistic versions are available on the EurLex web site.
- Part A contains methods for the determination of PHYSICO-CHEMICAL properties (e.g. melting and boiling point, density, flash point, flammability, explosivity, oxidizing power, etc...).
- Part B contains methods for the determination of effects on HUMAN HEALTH (e.g. acute or chronic toxicity, skin sensitisation, irritancy, corrosivity, carcinogenicity, neurotoxicity, etc..., they include also in vitro or alternative methods).
- Part C contains methods for ENVIRONMENTAL EFFECTS, ecotoxicity and environmental fate (e.g. toxicity to fish, daphnia or algae, bioconcentration, biodegradability, etc..).
The methods in the Annex to the Test Methods Regulation do not yet perfectly cover the data requirements included e.g. in Regulation 1907/2006. The continuous progress of science allows the development of new methods which may be suitable for regulatory purposes as well as for the new refinements of existing methods. Additionally, progress is made in the introduction of methodologies that allow a reduction in the use of animals for testing, to refine the methods by using less painful or distressing procedures or even completely to replace and eliminate animal testing. Accordingly new or revised methods need to be continuously developed. At present, ca 40 Test Methods or Guidance Documents are currently under development or revision (including e.g. a Guidance document on granulometry, and several methods to characterize man made mineral fibres (MMMF) or to detect their hazardous properties).
In total, Annex to the TMR contains about 96 Test Methods. They will be regularly updated or new methods introduced as required using a formal procedure called Adaptation to Technical Progress (ATP) of the Regulation. Although all the technical work to prepare the new or updated methods is done by IHCP, the procedure for the Adaptation to Technical Progress can only be initiated by DG Environment - Chemicals Unit and DG Enterprise and Industry - REACH Unit which are the Commission DGs responsible for policy in this area.
The process of regulatory approval:
The duties of the Test Methods work area of the IHCP are to co-ordinate the development, introduction and adaptation to technical progress of Test Methods for the Annex to the TMR/EC in order to establish and maintain it as the standard set of tests for chemicals management in the EU, as well as to ensure the harmonisation with other relevant international test programmes (OECD, UN, ...).
The work is carried out through consultation meetings with the EU National Co-ordinators and Competent Authorities, national experts for each area of concern and participation in relevant working groups/meetings of OECD and other international organisations. Particular attention is paid to the promotion of validation and regulatory approval of alternative methods. Additional details on the EU Procedures and a Summarised Scheme are available. Due to the high priority given by the EU to the adoption of validated and relevant alternative methods and the advantages of coordinating with the OECD Test Guidelines programme to secure a global harmonisation and acceptance, projects regarding alternative methods are preferentially submitted to the OECD process. Nevertheless, in case of undue delay in that forum or urgent needs in the EU the work on adoption of a new alternative method can be conducted in parallel or fed directly into the EU process only. If that the method is later agreed in the OECD, then the EU method will be updated accordingly. See scheme of relationship between EU and OECD processes.
The work includes:
Coordinating the adoption within EU legislation and OECD TG programme of Test Methods, including alternative Test Methods by:
- Promoting Test Methods development for EU legislation.
- Co-ordinating EU needs and input into OECD Test Guidelines Programme.
- Preparing for the transfer of internationally accepted standards into the annex to the TMR (e.g. OECD accepted Test Guidelines).
- Co-operating with the JRCS's European Centre for validation of Alternative Methods (ECVAM) to promote development of alternative Test Methods.
- Participating in UN activities for global harmonisation.
- Organising, supporting and evaluating ring tests or validation studies.
- Organising and hosting expert meetings and workshops.
- Developing review and guidance documents.