Community Research and Development Information Service - CORDIS

Abstract

A possible future chemicals legislative system was presented by DO ENTR and DO ENV in May 2003 in their REACH Consultation Document. The proposed system requires that data must be available on intrinsic properties of all substances manufactured in volumes greater than 1 tonne/year.

The current report analyses the impact of the proposed REACH system on the need for further testing in addition to already existing obligations and voluntary initiatives under various assumptions regarding the use of estimation techniques such as (Q)SARs and the outcome of screening tests and risk assessments; An uncertainty analysis applying both a minimum and a maximum use of such techniques has been conducted. Uncertainties regarding the different outcomes of various tests influencing the further testing needs have also been included in this analysis.

According to the estimations, the highest numbers of tests are required for the endpoints skin sensitisation (for approximately 35% (26- 47%) of all substances), eye irritation (approximately 24% (20- 28%) of which 5% are in vivo tests) and the in vivo mutagenicity study (approximately 22%). For all other end-points, new testing is required for less that 20% of the substances. By combining the estimates of test needs with likely costs of individual tests, the direct testing costs in addition to existing obligations and voluntary initiatives have been estimated at 1.6 billion euros for the most likely scenario.

Additional information

Authors: PEDERSEN F, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra (IT);DE BRUIJN J, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra (IT);MUNN S, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra (IT);VAN LEEUWEN K, European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Ispra (IT)
Bibliographic Reference: EUR 20863 EN (2003), 48pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9843 or +39 033278 9864 Fax: +39 033278 9623 E-mail: jrc-publications-office@ec.europa.eu
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