Thresholds for Endocrine Disrupters and Related Uncertainties

The European Commission, under Directorate-General for Environment (DG ENV) created an ad hoc group of Commission Services and Member States to serve the EU Community Strategy on Endocrine Disrupters. The ad hoc group created the Endocrine Disrupters Expert Advisory Group (ED EAG) in November 2011 to provide detailed reflections on scientific issues relevant to identifying and assessing endocrine disrupting substances, not specific to any regulatory framework. The European Commission's Joint Research Centre was tasked with facilitating and chairing meetings of the ED EAG and preparing this report. The scope of the present report is to capture the experts' opinions on scientific issues relevant to the likelihood of the existence of thresholds for a biological response of an organism to an ED, in particular considering thresholds of adversity and the uncertainties associated with reliably estimating such thresholds from experimental data. The question although relevant to the evaluation of EDs per se was specifically raised by the ad hoc group in relation to a review of the REACH regulation with respect to treatment of EDs under authorisation (Article 138 (7)).JRC.I.5-Systems Toxicolog

Key scientific issues relevant to the identification and characterisation of endocrine disrupting substances - Report of the Endocrine Disrupters Expert Advisory Group

The European Commission, under Directorate-General for Environment (DG ENV) as file leader of the Community Strategy on Endocrine Disrupters, In 2010, DG ENV created an ad hoc group of Commission Services and Member States on the EU Community Strategy on Endocrine Disrupters. The ad hoc group created the Endocrine Disrupters Expert Advisory Group (ED EAG) in November 2011 to provide scientific advice on the development of criteria for identification of EDs. The European Commission's Joint Research Centre was tasked with running the expert sub-group, consisting of around 40 experts nominated by Member State regulatory authorities, relevant industry associations and non-governmental consumer/environmental protection organisations. This report captures the experts' opinions on key scientific issues relevant to the identification and characterisation of endocrine disrupting substances (EDs). It provides one input to the Commission’s decisions on the establishment of horizontal criteria for the identification of EDs to be applied as appropriate across all relevant pieces of legislation concerning the control and risk management of chemicals substances (including pesticides, biocides, pharmaceuticals, industrial chemicals, controls on water quality, occupational exposure, etc).JRC.I.5-Systems Toxicolog

Alternative methods for regulatory toxicology – a state-of-the-art review

This state-of-the art review is based on the final report of a project carried out by the European Commission’s Joint Research Centre (JRC) for the European Chemicals Agency (ECHA). The aim of the project was to review the state of the science of non-standard methods that are available for assessing the toxicological and ecotoxicological properties of chemicals. Non-standard methods refer to alternatives to animal experiments, such as in vitro tests and computational models, as well as animal methods that are not covered by current regulatory guidelines. This report therefore reviews the current scientific status of non-standard methods for a range of human health and ecotoxicological endpoints, and provides a commentary on the mechanistic basis and regulatory applicability of these methods. For completeness, and to provide context, currently accepted (standard) methods are also summarised. In particular, the following human health endpoints are covered: a) skin irritation and corrosion; b) serious eye damage and eye irritation; c) skin sensitisation; d) acute systemic toxicity; e) repeat dose toxicity; f) genotoxicity and mutagenicity; g) carcinogenicity; h) reproductive toxicity (including effects on development and fertility); i) endocrine disruption relevant to human health; and j) toxicokinetics. In relation to ecotoxicological endpoints, the report focuses on non-standard methods for acute and chronic fish toxicity. While specific reference is made to the information needs of REACH, the Biocidal Products Regulation and the Classification, Labelling and Packaging Regulation, this review is also expected to be informative in relation to the possible use of alternative and non-standard methods in other sectors, such as cosmetics and plant protection products.JRC.I.5-Systems Toxicolog