title: Animal testing and alternative approaches for the human health risk assessment under the proposed new European chemicals regulation.
abstract: During the past 20 years the EU legislation for the notification of chemicals has focussed on new chemicals and at the same time failed to cover the evaluation of existing chemicals in Europe. Therefore, in a new EU chemicals policy (REACH, Registration, Evaluation and Authorization of Chemicals) the European Commission proposes to evaluate 30,000 chemicals within a period of 15 years. We are providing estimates of the testing requirements based on our personal experiences during the past 20 years. A realistic scenario based on an in-depth discussion of potential toxicological developments and an optimised "tailor-made" testing strategy shows that to meet the goals of the REACH policy, animal numbers may be significantly reduced below 10 million if industry would use in-house data from toxicity testing, which are confidential, if non-animal tests would be used, and if information from quantitative structure activity relationships (QSARs) would be applied in substance-tailored testing schemes. The procedures for evaluating the reproductive toxicity of chemicals have the strongest impact on the total number of animals bred for testing under REACH. We are assuming both an active collaboration with our colleagues in industry and substantial funding of the development and validation of advanced non-animal methods by the EU Commission, specifically in reproductive and developmental toxicity.
authors.affiliation: Bundesinstitut für Risikobewertung (BfR), Thielallee 88-92, 14195, Berlin, Germany. thomas.hoefer@bfr.bund.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Höfer
authors.forename: Ingrid
authors.initials: I
authors.lastname: Gerner
authors.forename: Ursula
authors.initials: U
authors.lastname: Gundert-Remy
authors.forename: Manfred
authors.initials: M
authors.lastname: Liebsch
authors.forename: Agnes
authors.initials: A
authors.lastname: Schulte
authors.forename: Horst
authors.initials: H
authors.lastname: Spielmann
authors.forename: Richard
authors.initials: R
authors.lastname: Vogel
authors.forename: Klaus
authors.initials: K
authors.lastname: Wettig
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence* / Q000379:methods*; D000818:Animals; D005062:European Union; D015386:Hazardous Substances / Q000633:toxicity*; D006801:Humans; D007390:International Agencies / Q000331:legislation & jurisprudence*; D018570:Risk Assessment; D018675:Toxicity Tests
chemical_list: D015386:Hazardous Substances