title: Assessment strategies and decision criteria for pesticides with endocrine disrupting properties relevant to humans.
abstract: There is growing concern that environmental substances with a potential to modulate the hormonal system may have harmful effects on human health. Consequently, a new EU regulation names endocrine disrupting properties as one of the cut-off criteria for the approval of plant protection products, although it currently fails to provide specific science-based measures for the assessment of substances with such properties. Since specific measures are to be presented by the European Commission in 2013 the development of assessment and decision criteria is a key challenge concerning the implementation of this new EU regulation. Proposals of such decision criteria for substances with potential endocrine disrupting properties in human health risk assessment were developed by the German Federal Institute for Risk Assessment (BfR) and discussed at an expert workshop in November 2009. Under consideration of the requirements laid down within the new plant protection product legislation and the scientific discussions during the workshop, a conceptual framework on evaluation of substances for endocrine disrupting properties in a regulatory context is presented in this paper. Central aspects of the framework include assessment of adversity of effects, establishment of a mode/mechanism of action in animals, considerations concerning the relevance of effects to humans and two options for a regulatory decision.
authors.affiliation: Federal Institute for Risk Assessment (BfR), Thielallee 88-92, 14195 Berlin, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Marx-Stoelting
authors.forename: R
authors.initials: R
authors.lastname: Pfeil
authors.forename: R
authors.initials: R
authors.lastname: Solecki
authors.forename: B
authors.initials: B
authors.lastname: Ulbrich
authors.forename: K
authors.initials: K
authors.lastname: Grote
authors.forename: V
authors.initials: V
authors.lastname: Ritz
authors.forename: U
authors.initials: U
authors.lastname: Banasiak
authors.forename: B
authors.initials: B
authors.lastname: Heinrich-Hirsch
authors.forename: T
authors.initials: T
authors.lastname: Moeller
authors.forename: I
authors.initials: I
authors.lastname: Chahoud
authors.forename: K I
authors.initials: KI
authors.lastname: Hirsch-Ernst
mesh_terms: D000818:Animals; D057225:Data Mining; D016208:Databases, Factual; D003661:Decision Support Techniques; D052244:Endocrine Disruptors / Q000633:toxicity*; D004784:Environmental Monitoring / Q000331:legislation & jurisprudence / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D010575:Pesticides / Q000633:toxicity*; D018570:Risk Assessment; D018675:Toxicity Tests / Q000592:standards
chemical_list: D052244:Endocrine Disruptors; D010575:Pesticides