Essential data for a complete dossier

Slides:

Advertisements

Similar presentations

Health and Safety Executive Ecotoxicology Annex II and III data requirements Mark Clook Chemicals Regulation Directorate Health and Safety Executive UK.

Advertisements

Bioaccumulation Criteria Jon Arnot Frank Gobas Barry Kelly James Armitage.

Summary Slide Some Industry views on POP/PBT identification in Europe.

CE Introduction to Environmental Engineering and Science Readings for This Class: O hio N orthern U niversity Introduction Chemistry, Microbiology.

Use of pesticides and residues in wine Patrizia Restani SCRAISIN - March 2009 Patrizia Restani SCRAISIN - March 2009.

Occurrences, (eco)toxicity and relevance for water quality in Europe Chemical Mixtures Thomas Backhaus University of Gothenburg

CONFERENCE ON “ FOOD ADDITIVES : SAFETY IN USE AND CONSUMER CONCERNS“ JOMO KENYATTA UNIVERSITY OF AGRICULTURE AND TECHNOLOGY NAIROBI, 24 JUNE 2014.

Environmental risk assessment of chemicals Paul Howe Centre for Ecology & Hydrology, UK.

1 Development & Evaluation of Ecotoxicity Predictive Tools EPA Development Team Regional Stakeholder Meetings January 11-22, 2010.

Methods for Incorporating Aquatic Plant Effects into Community Level Benchmarks EPA Development Team Regional Stakeholder Meetings January 11-22, 2010.

Bioassessment and biomonitoring: some general principles.

NORMAN Association N° W The NORMAN approach for setting priorities among emerging contaminants in Europe Working Group 1 Valeria Dulio (INERIS),

NSF/ANSI STANDARD 61 FRAMEWORK FOR RISK ASSESSMENTS For use by Toxicology Sub-committee only Please do not copy or distribute.

1 Persistent, Bioaccumulative and Toxic Pollutants Persistent, Bioaccumulative and Toxic Pollutants Programme (PBT) launched by the EPA in 1998: - Reduce.

and Environmental Risk Assessment

1 REACh Registration, Evaluation and Authorization of Chemicals and Restriction! Ohio Valley SOT Wednesday, August 26, 2009 REACh: The New Toxicology Frontier.

PROTECTFP Numerical Benchmarks for protecting biota against radiation in the environment Methodology to derive benchmarks, selected methods used.

National Institute for Public Health and the Environment Thanks to Fiji Government Risk Assessment for BWMS Jan Linders, RIVM-SEC, Bilthoven GESAMP37,

Introduction to Ecotoxicology Francesca Tencalla Beltox Seminar, Part 6.1.

CVM’s Procedure for Setting Tolerances

Training Session Product File Notes and Registration Reports, 23 October Product File Note Part Ecotoxicology Ilse Pittomvils Federal Public Service.

Training Session Product File Notes and Registration Reports, 23 October Product File Note Part Residues Frédéric Joris and Bruno Dujardin Federal.

Exposure Assessment by Multi-media modelling. Cause-effect chain for ecosystem and human health as basis for exposure assessment by multi-media modelling.

Physical, chemical and biological characteristics defined as suitable for a certain use of a water resource Domestic use (human consumption and hygienic.

International Initiatives and the U.S. HPV Challenge Program Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell.

U.S. High Production Volume (HPV) Challenge Program Diane Sheridan U.S. Environmental Protection Agency October 25, 2005 Region 2 Emerging Chemicals Workshop.

“The Dose makes the Poison”

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Environmental Processes Partitioning of pollutants 3.iii Sorption in living media (bioavailability)

Charge Question 4-1: Please comment on the ecotoxicity studies selected to represent the most sensitive species in each of the risk scenarios (acute aquatic,

Development of an integrated database for the management of accidental spills (DIMAS) Katrien Arijs Bram Versonnen Marnix Vangheluwe Jan Mees Ward Vandenberghe.

MODELKEY ( GOCE) is a research project funded by Prioritisation of potential river basin specific pollutants in four European.

Risk Assessment Nov 7, 2008 Timbrell 3 rd Edn pp Casarett & Doull 7 th Edn Chapter 7 (pp )

MAIN TOXICITY TESTING. TESTING STRATEGIES A number of different types of data are used in order to establish the safety of chemical substances for use.

Prof. Dr. Wolfgang Dekant Department of Toxicology University of Würzburg Germany Risk, Hazard, and Innovation.

Water Quality Criteria: Implications for Testing Russell Erickson U.S. Environmental Protection Agency Mid-Continent Ecology Division, Duluth, MN, USA.

McKim Conference on Predictive Toxicology

Setting Standards: The Science of Water Quality Criteria EA Engineering, Science, and Technology ® Presented by: James B. Whitaker Review of Annex 1 of.

A Global Review of Methodologies for Aquatic Ecological Risk Assessment.

Criteria for Inherently toxic (iT) in CEPA, UNEP Proposed iT criteria for non-human organisms –aquatic acute effects levels of < 1 mg/L –above 1 mg/L.

Biology-Based Modelling Tjalling Jager Bas Kooijman Dept. Theoretical Biology.

1 State of Play Prioritisation of Substances By modelling Hazard & Exposure Klaus Daginnus Institute for Health & Consumer Protection Joint Research Centre,

ECB INFODAYS, Zagreb, Croatia, December 2006 EU Notification Scheme (New Substances) and New Chemicals Database ECB INFODAYS, Zagreb, December.

International Office for Water Alice James - WG E (6), Brussels, 6 July 2009 International Office for Water Alice James - WG E (6), Brussels, 6 July 2009.

The new chemicals risk matrices. Workshop focus use of new online categorisation tools criteria used to categorise new chemicals under the proposed framework.

Transforming Our World: Delivering affordable medicines to anyone, anywhere, any day 1 Environmental hazards of substances Annex 1 – Part 4 of CLP Date:

Use of Borates in Swimming Pools: Consideration of Health Effects

SESSION (Planning and management of Official controls)

General Concepts in QSAR for Using the QSAR Application Toolbox

Ecotoxicological characterisation of pharmaceuticals during regulatory assessments state of the art, options for improvement - Thomas Backhaus.

Ecotoxicology Day 2. Adam Peters and Graham Merrington 2017.

Human Health & Aquatic Life Criteria

GC Chemical Characteristics Task Group

QSAR Application Toolbox: Step 12: Building a QSAR model

MID-COURSE REPORT Risk Assessment and Monitoring for Environmental Chemicals ( JICA HIC, 1st June 2007) MUCHLIS (INDONESIA)

Introduction to Environmental Engineering and Science (3rd ed.)

Identification of River Basin Specific Pollutants and Derivation of Environmental Quality Standards under Water Framework Directive: Turkish Experience.

Chemicals and their properties Day 1.

Review of the list of priority substances (Decision 2455/2001/EC)

Législation | Confidentiel

Information Sources Day 1.

DK project on national EQS’s

Derivation of ecotoxicological quality standards for PAHs

Nickel Risk Assessment

International Initiatives and the U.S. HPV Challenge Program

Pelagic community Quality Standards for Cyanides for EQS setting under WFD Udo Hommen.

Sub-Group on Review of Priority Substances – state of play

EFSA’s Chemical Hazards Database

Jos van Gils, Elena Semenzin, Muriel Gevrey, Peter Von der Ohe,

VICH GL 54, Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish an Acute Reference Dose (ARfD)

Presentation transcript:

Essential data for a complete dossier so that this dossier can also be a strong basis for the derivation of EQS

Validity and sources of data All data shall be quoted with exact and complete bibliographic reference, and the level of validation. All data presented shall be validated: at a European and/or international level (EU, OECD, US-EPA, etc.) OR by the Stakeholders presenting the data Any new data not validated at a European/international level but deemed to be of good quality and usable for the derivation of the EQS shall be reported, underlined and quoted, including the acceptance by any national program associated to a Klimisch code (Klimisch et al., 1997) Klimisch, H. J., M. Andreae, et al. (1997). "A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data." Regulatory Toxicology and Pharmacology 25: 1-5.

Physico-chemical properties: Solubility/Lipophility (KOW) [experimental/calculated – QSAR used, reference] Adsorption capacity (KOC) Bioaccumulation (BCF) Biomagnification (BMF1, BMF2) [experimental / default value]

(Eco)toxicological data for derivation of QSwater_eco (If available) Ecotoxicological data necessary for derivation of a PNEC -> an EQS, i.e. at least: 1 acute ecotoxicity data on algae [ 1 acute ecotoxicity data on invertebrates (crustaceans) 1 acute ecotoxicity data on fish If possible: As many chronic data as possible [For all data, report : species, duration of the test, effect and no effect concentration, validation status, reference]

Toxicological data for derivation of Quality standards for protection of human health At least 1 NOAEL or NOEC for derivation of QSbiota_sec pois (If available) a toxicological reference value to evaluate the impact of the substance on mammalian species and the human, e.g.: (Acute) Reference Dose ((A)RfD) Tolerable/Acceptable Daily Intake (TDI/ADI) Minimal Risk Level (MRL) The most secure data shall be underlined in order to be used for the derivation of the QSbiota_hh Any (regulatory) standard for water intended for human consumption for derivation of QSdw_hh [For all data, report : species, duration of the test, dose, effect and no effect concentration, validation status, reference]

Do you have questions ? Contact INERIS: Alice James (alice.james@ineris.fr) Sandrine Andres (Sandrine.ANDRES@ineris.fr)