Test Method Regulation
The Institute for Health and Consumer Protection (IHCP) provides technical and scientific support to the European Commission and to Member States for the development, harmonisation and implementation of test methods for chemical substances.
The EU system of chemicals management sets out to ensure a high level of protection of human health and the environment. A major objective is also the promotion of alternative methods for assessment of dangers from chemical substances.
As part of its work the Institute is charged with the development of 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 methods have to allow identification of any adverse effects and also be able to assess the relationship between the level of exposure to a substance and the incidence and severity of an effect. On this basis of these factors and knowing the intended use of a particular product, a risk assessment of the chemical can be undertaken and risk management measures proposed.
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 EU.
The legally binding EU standardised Test Methods to determine the hazardous properties of chemicals are written into the Test Methods Regulation (TMR, Commission Regulation (EC) No 440/2008 of 30 May 2008).It currently contains 96 Test Methods. These will be regularly updated or new methods introduced as required.
The technical work to prepare new or updated methods is undertaken by the Institute.
This work is carried out through consultation meetings with the EU National Co-ordinators and competent authorities, national experts for each area of concern as well as participation in relevant working groups/meetings of OECD and other international organisations.
TSAR (Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals)
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, managed by the Institute, 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), as this Regulation only contains relevant methods for the assessment of properties of chemicals that fall directly under its remit.
In addition to the 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.
For more information, check the TSAR web site.