title: The impact of REACH on classification for human health hazards.
abstract: The REACH Regulation represents a major piece of chemical legislation in the EU and requires manufacturers and importers of chemicals to assess the safety of their substances. The classification of substances for their hazards is one of the crucial elements in this process. We analysed the effect of REACH on classification for human health endpoints by comparing information from REACH registration dossiers with legally binding, harmonised classifications. The analysis included 142 chemicals produced at very high tonnages in the EU, the majority of which have already been assessed in the past. Of 20 substances lacking a harmonised classification, 12 chemicals were classified in REACH registration dossiers. More importantly, 37 substances with harmonised classifications for human health endpoints had stricter classifications in registration dossiers and 29 of these were classified for at least one additional endpoint not covered by the harmonised classification. Substance-specific analyses suggest that one third of these additional endpoints emerged from experimental studies performed to fulfil information requirements under REACH, while two thirds resulted from a new assessment of pre-REACH studies. We conclude that REACH leads to an improved hazard characterisation even for substances with a potentially good data basis.
authors.affiliation: Forschungs- und Beratungsinstitut Gefahrstoffe GmbH (FoBiG), Klarastraße 63, 79106 Freiburg, Germany. Electronic address: jan.oltmanns@fobig.de.
authors.forename: J
authors.initials: J
authors.lastname: Oltmanns
authors.affiliation: Öko-Institut e.V., Institut für angewandte Ökologie, Merzhauser Straße 173, 79100 Freiburg, Germany. Electronic address: d.bunke@oeko.de.
authors.forename: D
authors.initials: D
authors.lastname: Bunke
authors.affiliation: Öko-Institut e.V., Institut für angewandte Ökologie, Rheinstraße 95, 64295 Darmstadt, Germany. Electronic address: w.jenseit@oeko.de.
authors.forename: W
authors.initials: W
authors.lastname: Jenseit
authors.affiliation: European Commission, Eurostat, Office C2-617, BECH Building, 5 rue Alphonse Weicker, 2721 Luxembourg, Luxembourg. Electronic address: christian.heidorn@ec.europa.eu.
authors.forename: C
authors.initials: C
authors.lastname: Heidorn
mesh_terms: D002617:Chemical Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D015386:Hazardous Substances / Q000009:adverse effects* / Q000145:classification*; D006801:Humans; D018570:Risk Assessment / Q000379:methods
chemical_list: D015386:Hazardous Substances
keywords: Classification; Human health; Inventory; PRODCOM database; REACH Regulation; Statistical evaluation