Risk Assessment of nanomaterials from an industry perspective. Jenny Holmqvist
|
|
- Berenice Caldwell
- 8 years ago
- Views:
Transcription
1 Risk Assessment of nanomaterials from an industry perspective Jenny Holmqvist
2 European Chemical Industry Council - Cefic We are the forum and the voice of the chemical industry in Europe With a Brussels based office of 160 people we are working with over industry experts across the chemical industry Cefic s membership entails around companies (96% have less than 250 employees) Together they have a direct employment of nearly 1.2 million people and represents 29% of the world production of chemicals Cefic represents the raw materials producers, of which some also provides finished products on the market In our membership less than 20 substances are produced at the nano scale Nanomaterial Nano products 2
3 The concept of Risk and Risk Assessment Hazard (source of potential harm) * Exposure (pathway) = Risk (the probability of an adverse effect to occur) Perception Risk Assessment is the process of identifying, analysing and evaluating the risks 3
4 How are uncertainties addressed Precautionary Principle; applies when there are grounds for concern due to insufficient, inconclusive or uncertain scientific evidence Risk assessment; not an exact science, built around estimations and correlations Impact of uncertainty; the use of assessment factors and the assumption that humans are the most sensitive species. Risk assessment; a moving target, development in methodologies, understanding and interpretation of results is a continuous process 4
5 Risk Assessment paradigm in REACH Collect available information Properties, manufacturing process, use, exposure, existing RMM Hazard Assessment Classification, PBT assessment, dose/concentration response characterisation Exposure Assessment Exposure scenarios (RMM and OC), estimate exposure levels Risk Characterisation Document & Communicate Yes Risk controlled? No Iteration CSR, SDS and label 5
6 Collection of available information Current industry practice; Data exists at company level For some materials there is comprehensive information dossiers containing Epi studies Information on the bulk can be used as a base for further assessment. Current publicly published data is often based on indicative studies rather than OECD protocols Further refinement of existing protocols; More information will be accessible in the public domain through the OECD Sponsorship Program, ongoing FP7 projects, REACH registrations and CLP notifications 6
7 Hazard Assessment Current industry practice; Generation of information in REACH is based on a tiered and risk based approach depending on volume Context of regulation adverse effects What is adverse? Case by case assessment Test methods are in general applicable with attention to dosing, characterisation and sample preparation Granulometry needs to be improved; additional phys-chem properties Read across from the bulk is possible with scientific justification Up to date, no new nano specific effects have been demonstrated Further refinement of existing protocols; - RIP-oNs (evaluation of existing guidance applicability to nanomaterials) - redraft of the chapter on granulometry, further research needs are identified - OECD thorough assessment of test methods - Preliminary results confirms the applicability with some adaptations regarding dosimetry and sample preparation - FP7 outcomes (MARINA, Nano Genotox) - Other metrics than mass could be useful for a small group of materials further research needed 7
8 Exposure Assessment Current industry practice; Determination of potential for exposure is essential, especially for the end use Manufacturing process in closed systems Tier 1 models can give an indication of the level of exposure The added contribution of ind. emissions is complex to measure in the env. Occupational measurements are possible but sensitive to background levels Majority of the products currently on the market uses nanomaterials incorporated into a matrix such as paint with negligible exposure to nano particles for the consumers Further refinement of existing protocols; - RIP-oNs (evaluation of existing guidance applicability to nanomaterials) - Tier 1 models results must be strengthened with measurements - Background levels addressed - FP7 projects with industry involvements aims at develop/improve methods for measuring exposure to nanomaterials. - NanEx - NanoCare 8
9 Documentation and Communication Extended SDS Reg. Dossier CLP not. SDS 9
10 Communication remains a challenge It is all about providing the right information to the right person at the right time whilst taking existing limitations into account. Emerging technologies have to be developed in a sustainable manner to be viable where communication is the most important tool Investments for future applications makes some information highly Confidential Business Information Organising and actively participating in dialogues Companies are increasingly publishing their toxicological test reports on their websites Voluntary programs to generate and increase information sharing, transparency and communication globally; GPS 10
11 Conclusion Nanomaterials can be assessed ; The risk assessment paradigm, its guidance and the existing test methods are in general applicable Research from both industry and public institutions should be decision-oriented and transparent and aim to bring further refinement of current risk assessment protocol To meet Europe s challenges, particularly in energy-efficiency, health and welfare, the development of nanotechnology is a must and will increasingly be needed for our leading technologies 11
12 Thanks for listening! Contact details; 12
13 This paper was produced for a meeting organized by Health & Consumers DG and represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumers DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof.
Chemical Safety Assessment
Guidance in a Nutshell Chemical Safety Assessment This document aims to explain in simple terms the main requirements under REACH regarding the Chemical Safety Assessment LEGAL NOTICE This document contains
More informationGuidance on information requirements and chemical safety assessment. Part A: Introduction to the Guidance document
Guidance on information requirements and chemical safety assessment Part A: Introduction to the Guidance document Version 1.1 December 2011 LEGAL NOTICE This document contains guidance on REACH explaining
More informationSafe Nanotechnology EU Industrial Research
Safe Nanotechnology EU Industrial Research Georgios Katalagarianakis EC, Research DG Industrial Technologies Directorate G4 Nanoscience - Nanotechnology 1 summary Policy; Towards a second Action Plan 2010-2015
More informationGuidance on information requirements and chemical safety assessment. Chapter R.2: Framework for generation of information on intrinsic properties
Guidance on information requirements and chemical safety assessment Chapter R.2: Framework for generation of information on intrinsic properties Version 2.1 December 2011 1 LEGAL NOTICE This document contains
More informationREACH Understanding the Risk Assessment Process
_experience the commitment TM REACH Understanding the Risk Assessment Process Introduction Across virtually every segment of society, we witness how chemicals have delivered significant benefits to society.
More informationExternal stakeholder events and projects on nanomaterials and nanotechnologies
BUSINESS AND INDUSTRY ADVISORY COMMITTEE (BIAC) PART I: ACC The American Chemistry Council Nanotechnology Panel (Panel) presented at numerous national and international presentations and workshops on nanotechnology
More informationNano-Titanium Dioxide in Sunscreens. Gerald Renner, Colipa
Nano-Titanium Dioxide in Sunscreens Gerald Renner, Colipa Cosmetic Use of Nanomaterials In 2008, a survey of nanomaterials sold in EU cosmetic products amongst member companies of Colipa and national trade
More informationREACH. Scope REGISTRATION. The Current EU Chemicals Policy REACH
Introduction to the New Chemicals Policy REACH REACH and Developing Countries Brussels 28-29 October 2004 Eva Sandberg DG Environment, European Commission The Current EU Chemicals Policy Problems Existing
More informationAntonia Reihlen, Ökopol GmbH
Roles and obligations Antonia Reihlen Ökopol GmbH Introduction The role of roles under REACH Types of roles and related obligations How to identify roles of the company The role of roles REACH aims to
More informationOverview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Summary This document examines the key aspects of the CLP
More informationHints and Tips on Physicochemical, and human health related endpoints
How to bring your registration dossier in compliance with REACH Tips and Hints Part 1 Hints and Tips on Physicochemical, environmental and human health related endpoints 27 September, 2012 15:00-17:00
More informationREGULATORY RISK ASSESSMENT OF NANOMATERIALS IN THE EU
REGULATORY RISK ASSESSMENT OF NANOMATERIALS IN THE EU Karin Aschberger 1, Nanna Hartmann 1,2, Stefania Gottardo 1, Zuzana Klöslova 3, Julia Fabrega Climent 3, Valeria Amenta 1, Frans M. Christensen 1,4
More informationIRGC Annual Event 2011 Roundtable 2
IRGC Annual Event 2011 Roundtable 2 EU Regulatory Context for Innovative Technologies Dr. Anna Gergely, Director EHS Regulatory agergely@steptoe.com 3 November 2011 Lausanne, Switzerland 1 CONTENT 1. Why
More informationCOMMUNICATION ALONG THE SUPPLY CHAIN how downstream users can/should play their role?
DUCC = platform for associations whose member companies use chemicals to formulate mixtures as finished products for end users (consumers and professional users) DUCC focuses on DU needs, rights, duties
More informationPolyOne FAQs for the Globally Harmonized System (GHS) Safety Data Sheets (SDS) and Product Labeling.
General information on GHS and timelines Q1: What is GHS? GHS is short for Globally Harmonized System for Classification and Labeling of Chemicals, a framework designed to harmonize the very different
More informationREACH Practical Guide on Exposure Assessment and Communication in the Supply Chains Part III: Mixtures under REACH
REACH Practical Guide on Exposure Assessment and Communication in the Supply Chains Part III: Mixtures under REACH March 2010 Copyright Copyright of CEFIC (AISBL) and VCI e.v., reproduction is authorised,
More informationDas Industrieportal zu REACH-Kommunikation
Das Industrieportal zu REACH-Kommunikation REACH: Kommunikation in der Lieferkette REACH@Baden-Württemberg 2 Dezember 2008 Dr. Ingo Richter BASF SE REACH-Implementation REACH communication requirements
More informationGHS - GLOBALLY HARMONIZED SYSTEM
GHS - GLOBALLY HARMONIZED SYSTEM of Classification and Labelling of Chemicals GHS is a system proposed by the United Nations (UN) for the harmonised world-wide classification and labelling of chemical
More informationECHA s Regulatory Science Strategy
ECHA s Regulatory Science Strategy 2 ECHA s Regulatory Science Strategy Reference: ECHA-15-A-03-EN Publ.date: February 2015 Language: EN European Chemicals Agency, 2015 If you have questions or comments
More informationCLP regulation & 2015 deadline for mixtures
CLP regulation & 2015 deadline for mixtures CEFIC REACH Information and Experience Exchange Forum Zaventem, 18 December 2013 Maurits-Jan Prinz European Commission DG Enterprise & Industry Table of contents
More informationSafety Assessment of Nanomaterials at the Joint Research Centre
3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March 2010 1 Safety Assessment of Nanomaterials at the Joint Research Centre Hermann Stamm Institute for Health and Consumer Protection Joint
More informationNewsletter Volume Two, 2010
Practical CLP Compliance Advice Given to EU Importers CLP stands for the Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures. CLP introduces the United
More informationGetting Ready for REACH Advanced Solutions for Compliance. John Phyper, CSO & EVP Atrion International Inc.
Getting Ready for REACH Advanced Solutions for Compliance John Phyper, CSO & EVP Atrion International Inc. Getting Ready for REACH Advanced Solutions for Compliance Introduction What is REACH? What Does
More informationChapter 12: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING A SINGLE EXPOSURE
Chapter 12: SPECIFIC TARGET ORGAN SYSTEMIC TOXICITY (TOST) FOLLOWING A SINGLE EXPOSURE DEFINITIONS 1. Classification identifies the chemical substance as being a specific target organ/systemic toxicant
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2006R1907 EN 20.02.2009 004.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B C1 REGULATION (EC) No 1907/2006 OF THE EUROPEAN
More informationEdward Odenkirchen, Ph.D. Office of Pesticide Programs US Environmental Protection Agency
Edward Odenkirchen, Ph.D. Office of Pesticide Programs US Environmental Protection Agency 1 Mission Statement Best possible regulatory decisions to protect public health and environment. Rely on all best
More informationAuthorisation and Restriction: Interplay and other Strategic Considerations
Authorisation and Restriction: Interplay and other Strategic Considerations Informa Conference on REACH Montfort, Jean-Philippe Partner +32 (0)2 551 5970 jpmontfort@mayerbrown.com Brussels, 5 March 2012
More informationTOWARDS A STRATEGIC NANOTECHNOLOGY ACTION PLAN (SNAP) 2010-2015
TOWARDS A STRATEGIC NANOTECHNOLOGY ACTION PLAN (SNAP) 2010-2015 1. Respondent profile For individuals: - Name, age, gender, country, e-mail. - From which perspective are you interested in nanotechnologies:
More informationChemical Risk Assessment in Absence of Adequate Toxicological Data
Chemical Risk Assessment in Absence of Adequate Toxicological Data Mark Cronin School of Pharmacy and Chemistry Liverpool John Moores University England m.t.cronin@ljmu.ac.uk The Problem Risk Analytical
More informationGPS Safety Summary. Dodecane-12-lactam
GPS Safety Summary Substance Name: Dodecane-12-lactam 1. General Statement Dodecane-12-lactam is used as a monomer in polymerisation or copolymerisation processes resulting in the manufacture of polyamides.
More informationGPS Product Safety Summary
Document Number: GPSSR-106 SULFONIC ACIDS, C14-17-SEC-ALKANE, SODIUM SALTS GENERAL STATEMENT GPS summary is intended to provide a general overview of the chemical substances in context of ICCA Global Product
More informationAuthorisation and Restriction Newsletter
Authorisation and Restriction Newsletter August 2010, N 1 The information contained in this document is intended for guidance only and whilst the information is provided in utmost good faith and has been
More informationPractical Guide 6. How to report read-across and categories
Practical Guide 6 How to report read-across and categories 2 Practical Guide 6 2.0 Version Changes Date Version 1.0 First version. March 2010 Version 2.0 Revision of the Practical guide addressing structure
More informationREACH&CLP Coffee: REACH Authorisation: My substance is on Annex XIV what to do next?
REACH&CLP Coffee: : My substance is on Annex XIV what to do next? 1. REACH&CLP Helpdesk LU: Ruth Moeller process for substances of very high concern 2. ECHA: Christina Loukou (Helpdesk Unit) Application
More informationECHA s approach to SMEs
ECHA s approach to SMEs Ninth Stakeholders Day 21 May 2014 Andreas Herdina European Chemicals Agency 2013: studies and surveys 2013 studies on the impact on SMEs NL: Impact REACH op MKB UK: Business Task
More informationGuidance on information requirements and chemical safety assessment
Guidance on information requirements and chemical safety assessment Part D: Exposure Scenario Building October 2012 (version 1.2) Guidance for the implementation of REACH LEGAL NOTICE This document contains
More informationChemicals Regulation: A comparison of US and European Approaches. James Searles
Chemicals Regulation: A comparison of US and European Approaches James Searles April 11, 2011 www.steptoe.com April 11, 2011 TSCA vs.. REACH - OVERVIEW Both TSCA and REACH aim at gathering scientific information
More informationConversion template REACH dossier into GPS Safety Summary. 13 June 2013 Version 2: Final draft with comments
Conversion template REACH dossier into GPS Safety Summary 13 June 2013 Version 2: Final draft with comments Preface This document gives some practical advises as to what information could be provided in
More informationGuidance on Information Requirements and Chemical Safety Assessment. Chapter R.7a: Endpoint specific guidance
Version 3.0 August 2014 1 GUIDANCE Guidance on Information Requirements and Chemical Safety Assessment Version 3.0 August 2014 2 Version 3.0 August 2014 LEGAL NOTICE This document aims to assist users
More informationDISCUSSION NON-PAPER. How to put ideas for cooperation under TTIP into practice a few examples
1 DISCUSSION NON-PAPER How to put ideas for cooperation under TTIP into practice a few examples Introductory Note: This paper provides descriptions of various processes under REACH and CLP, and is destined
More informationSubmission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 1, 2
GUIDANCE OF EFSA - DRAFT Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 1, 2 ABSTRACT European Food Safety Authority
More informationGuidance on the preparation of dossiers for harmonised classification and labelling
GUIDANCE Guidance on the preparation of dossiers for harmonised classification and labelling Version 2.0 August 2014 2 Guidance on the preparation of CLH dossiers Version 2.0 August 2014 LEGAL NOTICE This
More informationGuidance on information requirements and chemical safety assessment
Guidance on information requirements and chemical safety assessment Chapter R.13: Risk management measures and operational conditions October 2012 (Version 1.2) Guidance for the implementation of REACH
More information2,2,2 trifluoroethanol
GPS Safety Summary 2,2,2 trifluoroethanol Chemical Identity Brand names 2,2,2 trifluoroethanol CAS number 75 89 8 Chemical name (IUPAC) 2,2,2 trifluoroethanol Molecular formula CF 3 CH 2 OH Synonyms TFE;
More informationREACH Project Aanpak Interactie Producenten - Afnemers
REACH Project Aanpak Interactie Producenten - Afnemers Cor Verhart, 6 Mei 2014 Introduction Cor Verhart Organic Chemist, 1994 PhD Henkel, Sales Manager 1995-96 TNO, Product & Sales Manager, 1996-2002 Heinz,
More informationU.S. EPA, Office of Pollution Prevention and Toxics (OPPT) Chemical Reviews and Tools Case Study Presentation Abstract
U.S. EPA, Office of Pollution Prevention and Toxics (OPPT) Chemical Reviews and Tools Case Study Presentation Abstract John Shoaff, International Teamr, Office of Pollution Prevention and Toxics U.S. Environmental
More informationEnvironmental footprinting of products The policy outlook
Environmental footprinting of products The policy outlook Mr Michele Galatola Product Team Leader DG Environment, C1 Sustainable Production and Consumption Unit The World is moving. Problem definition
More informationCompilation of safety data sheets
GUIDANCE IN A NUTSHELL Compilation of safety data sheets The document aims to explain in simple terms the main principles and obligations relating to the compilation and provision of safety data sheets
More informationREACH Exposure Scenarios for Fragrance Substances
REACH Exposure Scenarios for Fragrance Substances 19 April 2012 IFRA Operations Avenue des Arts, 6 1210 Brussels, Belgium Tel: +32-2 214 20 60 Fax: +32-2 214 20 69 www.ifraorg.org PREFACE This guidance
More informationGuidance on intermediates
Guidance on intermediates Version: 2 December 2010 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, users are reminded that the text
More informationThe importance of substance identity in ensuring a successful registration
The importance of substance identity in ensuring a successful registration Ninth Stakeholders Day 21 May 2014 Paweł Figiel European Chemicals Agency Key messages You need to know the identity of your substance
More informationGuidance on Process Safety Performance Indicators
Guidance on Process Safety Performance Indicators Table of contents 01 INTRODUCTION 02 OBJECTIVE 02 SCOPE 03 CRITERIA 06 DATA REPORTING 08 PROCESS SAFETY PERFORMANCE 08 CONCLUSIONS 09 DEFINITIONS 09 REFERENCES
More information3 Food Standards Agency, London, UK
Chapter six From Hazard to Risk e Assessing the Risk Charlotte Bernhard Madsen 1, Geert Houben 2, Sue Hattersley 3, Rene W.R. Crevel 4, Ben C. Remington 5, Joseph L. Baumert 5 1 DVM Research Leader Division
More informationRESPONSIBLE CARE GLOBAL CHARTER. A Special Supplement Presented with
RESPONSIBLE CARE GLOBAL CHARTER A Special Supplement Presented with GLOBAL CHARTER INTRODUCTION 4 ELEMENTS OF THE GLOBAL CHARTER 5 CORE PRINCIPLES 6 FUNDAMENTAL FEATURES 6 SUSTAINABLE DEVELOPMENT 8 CONTINUOUS
More informationSeptember 19, 1984 FOOD PRODUCTION AND DIRECTION GÉNÉRALE, SECTION INSPECTION BRANCH PRODUCTION ET INSPECTION PESTICIDES DES ALIMENTS TRADE MEMORANDUM
Agriculture Canada September 19, 1984 T-1-245 FOOD PRODUCTION AND DIRECTION GÉNÉRALE, SECTION INSPECTION BRANCH PRODUCTION ET INSPECTION PESTICIDES DES ALIMENTS TRADE MEMORANDUM RE: Guidelines for Developing
More informationMonomers and Polymers Hazard communication under REACH
Monomers and Polymers Hazard communication under REACH Prepared by the CEFIC Polymer Working Group November 2009 Disclaimer The information contained in this paper is intended for guidance only and whilst
More informationEvaluation: lessons learnt 2013
Evaluation: lessons learnt 2013 Ninth Stakeholders Day 21 May 2014 Rupert Simon European Chemicals Agency Evaluation 2013 what was new? Outline New procedural aspects in 2013 Substance evaluation Status
More informationHaving regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of
More informationPOLLUTION INCIDENT RESPONSE MANAGEMENT PLAN
FUCHS LUBRICANTS (AUSTRALASIA) PTY LTD 2 HOLLAND STREET WICKHAM NSW POLLUTION INCIDENT RESPONSE MANAGEMENT PLAN ENVIRONMENTAL PROTECTION LICENCE No.10181 Pubic Version DOC REF:ENV228 ISSUE:1 DATE:21.11.13
More informationGuidance on the preparation of an Annex XV dossier for the identification of substances of very high concern
GUIDANCE Guidance on the preparation of an Annex XV dossier for the identification of Version 2.0 February 2014 2 Guidance on the preparation of an Annex XV dossier for the identification of Version 2.0
More informationRisk Assessment in Chemical Food Safety. Dept. of Food Safety and Zoonoses (FOS) http://www.who.int/foodsafety/en/
Risk Assessment in Chemical Food Safety Dept. of Food Safety and Zoonoses (FOS) http://www.who.int/foodsafety/en/ Risk Analysis Paradigm Internationally Scientific data analysis Risk Assessment WHO & FAO
More informationQuestions and Answers Regarding Eastman s Assistance in the Emergency Response to the Spill of Crude MCHM in Charleston, West Virginia
Updated February 27, 2014 Questions and Answers Regarding Eastman s Assistance in the Emergency Response to the Spill of Crude MCHM in Charleston, West Virginia What is the purpose of providing this Question
More informationInformation for Consumers on Nanomaterials Results of the FOPH NANO-Dialogue Platform
Federal Department of Home Affairs DHA Fereral Office of Public Health FOPH Publication of the FOPH NANO-Dialogue Platform Information for Consumers on Nanomaterials Results of the FOPH NANO-Dialogue Platform
More informationWaiving von Datenanforderungen und Optionen zum. Daten-Waiving bei Bioziden. Gegenbeispiele aus der Praxis
Waiving von Datenanforderungen und Optionen zum Daten-Waiving bei Bioziden Gegenbeispiele aus der Praxis Advanced Course AK Reg Tox, DGPT FJT, 09. März 2015, Kiel Dr. Michael Werner, SCC GmbH, Bad Kreuznach
More informationSIEFreach Kommunikationsplattform für alle SIEFs
Kommunikationsplattform für alle SIEFs Dr. Ingo Richter GUP/CR, REACH Implementation BASF SE, Ludwigshafen 9.06.009 1 for industry by industry Support of the Substance Information Exchange Forum (SIEF)
More informationREACH - Registration and enforcement. Latest trends in REACH and CLP Tokyo 30 March 2010. Laura Walin ECHA Guidance and helpdesk
REACH - Registration and enforcement Latest trends in REACH and CLP Tokyo 30 March 2010 Laura Walin ECHA Guidance and helpdesk REACH and ECHA REACH Regulation entered into force 1 June 2007 ECHA was created
More informationCONSOLIDATION OF INFORMATION FOR MIXTURES UNDER REACH
FKZ 3710 63 403 CONSOLIDATION OF INFORMATION FOR MIXTURES UNDER REACH ANALYSIS OF THE DPD + METHOD EXECUTIVE SUMMARY November, 2012 Ökopol GmbH Institut für Ökologie und Politik Nernstweg 32-34 D-22765
More informationRegulatory Risk Analysis in the European Union, United States, and Canada
Regulatory Risk Analysis in the European Union, United States, and Canada A Joint Presentation by: Takis Daskaleros, European Commission Nancy Beck, United States, Office of the Management of the Budget
More informationSAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use
Page 1 of 7 SECTION 1 : Identification of the substance/preparation and of the company/undertaking 1.1. Product identifier Product code Product name Product description : DM/32103 : : Light cured resin
More informationROADMAP. A. Context and problem definition
ROADMAP TITLE OF THE INITIATIVE Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation LEAD
More informationRegulatory Expectations for GMP: What s Happening. Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc.
Regulatory Expectations for GMP: What s Happening Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc. Topics Background for changes and expectations of regulatory
More informationFrequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review
Frequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review BfR FAQ, 12 November 2015 Active substances used in pesticides are
More informationApplications of nanotechnology: Cosmetics
Applications of nanotechnology: Cosmetics Course on Health Effects of Engineered Nanomaterials Finnish Institute of Occupational Health, 23 April 2013 Sari Karjomaa Finnish Cosmetic, Toiletry and Detergent
More informationREACH and Safety Data Sheets
This leaflet explains the requirements for safety data sheets and how they will change in the future. What is REACH? REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the
More informationGerman proposal for the restriction of PAHs in consumer products
Federal Institute for Occupational Safety and Health Dortmund, 04/06/2010 German proposal for the restriction of PAHs in consumer products 1. Introduction The government of the Federal Republic of Germany
More informationSafety data sheet according to 1907/2006/EC, Article 31
Page 1/5 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article number: 070-B Registration number Not applicable Application of the substance / the preparation
More informationCosmetics Safety Bill Would Incorporate TSCA Bill Provisions
Beveridge & Diamond, P.C., August 2, 2010 Regulation of cosmetics by the Food and Drug Administration ( FDA ) would be thoroughly overhauled under a bill introduced on July 20, 2010, the Safe Cosmetics
More informationIMPURITIES IN NEW DRUG PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current
More informationORAL PRESENTATIONS RISK ASSESSMENT CHALLENGES IN THE FIELD OF ANIMAL WELFARE
ORAL PRESENTATIONS RISK ASSESSMENT CHALLENGES IN THE FIELD OF ANIMAL WELFARE Candiani D., Ribò O., Afonso A., Aiassa E., Correia S., De Massis F., Pujols J. and Serratosa J. Animal Health and Welfare (AHAW)
More informationREACH-like regulations around the world. Dr. Adriana Jalba Manager, International Chemicals Management (ICM) Cefic
REACH-like regulations around the world Dr. Adriana Jalba Manager, International Chemicals Management (ICM) Cefic Content Global trends and issues of concern Concept of recent REACH-like chemical control
More informationMay 10, 2013. Office of the United States Trade Representative 600 17 th Street NW Washington, D.C. 20508
Office of the United States Trade Representative 600 17 th Street NW Washington, D.C. 20508 May 10, 2013 Submitted electronically via www.regulations.gov Attn: Docket: USTR-2013-0019 Re: Trans-Atlantic
More informationCommittee for Risk Assessment RAC. Opinion proposing harmonised classification and labelling at EU level of ethylbenzene
Committee for Risk Assessment RAC Opinion proposing harmonised classification and labelling at EU level of ethylbenzene EC number: 202-849-4 CAS number: 100-41-4 ECHA/RAC/CLH-O-0000001542-81-03/F. Adopted
More informationDetermination and communication of safe use conditions of lubricants
Determination and communication of safe use conditions of lubricants Steven Van de Broeck svb@essenscia.be LAB/VSN 12/12/2014 Introduction Manufacturers of lubricants are formulators of mixtures according
More informationTrifluoroacetic acid
GPS Safety Summary Trifluoroacetic acid Chemical Identity Brand names Trifluoroacetic acid CAS number 76 05 1 Chemical name (IUPAC) 2,2,2 trifluoroacetic acid Molecular formula CF 3 COOH Synonyms TFA;
More informationREACH Practical Guide on Safe Use Information for Mixtures under REACH. The Lead Component Identification (LCID) Methodology
REACH Practical Guide on Safe Use Information for Mixtures under REACH The Lead Component Identification (LCID) Methodology Final version 6.1 25 February 2016 This REACH Practical Guide on Safe Use Information
More informationGuidance on data sharing
guidance Guidance on data sharing Version 2.0 April 2012 Guidance on data sharing 3 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However,
More informationEURegulatory Compliance: Challenges and Solutions, EU CLP Regulation Overview.
EURegulatory Compliance: Challenges and Solutions, EU CLP Regulation Overview. Chris Sowden 3E Company 3E Company Provider of EH&S compliance and risk information management solutions Global EH&S domain
More informationREGULATORY RISK ASSESSMENT: Trends and paradigm shifts are needed
REGULATORY RISK ASSESSMENT: Trends and paradigm shifts are needed Kees van Leeuwen & Steven Bradbury (European Commission & USEPA) CONTENTS I. Lessons learned in the last decade II. REACH: key elements
More informationQuestions and Answers on the European Commission Communication: The Paris Protocol A blueprint for tackling global climate change beyond 2020
European Commission - Fact Sheet Questions and Answers on the European Commission Communication: The Paris Protocol A blueprint for tackling global climate change beyond 2020 Brussels, 25 February 2015
More informationREACH 2018 and beyond how the EU legislation is shaping the future of metalworking fluids globally
REACH 2018 and beyond how the EU legislation is shaping the future of metalworking fluids globally 5 th International Conference on Metal Removal Fluids, September 27-30, 2015 Mick Wragg Agenda Impact
More informationHerbert Desel 2015-11-10
BUNDESINSTITUT FÜR RISIKOBEWERTUNG 6. BfR-Nutzerkonferenz European Cosmetic Products Notification Portal CPNP Erfahrungen mit der europäischen Datenbank zu Kosmetikmeldungen Modell für nationale Datenbank
More informationCederroth Corporate Code of Conduct
Cederroth Corporate Code of Conduct Introduction Cederroth believes that we have an important role to play in the deve lopment of a sustainable society. We therefore work with a strong commitment to environmental
More informationJune 2010 HEALTH, SAFETY, AND ENVIRONMENT MANAGEMENT SYSTEM (HSEMS)
June 2010 HEALTH, SAFETY, AND ENVIRONMENT MANAGEMENT SYSTEM (HSEMS) TABLE OF CONTENTS PAGE PART I INTRODUCTION Corporate Health, Safety and Environment Policy.. 1 Purpose... 2 HSEMS Framework... 3 PART
More informationAh-Reum Seo of Chemservice Asia introduces the forthcoming chemicals regulation for South Korea
Environment & Regulations The best strategy to implement K-REACH Ah-Reum Seo of Chemservice Asia introduces the forthcoming chemicals regulation for South Korea Most existing chemicals on the market have
More informationNanotechnology and human health: Scientific evidence and risk governance. Report of the WHO expert meeting 10 11 December 2012, Bonn, Germany
Nanotechnology and human health: Scientific evidence and risk governance Report of the WHO expert meeting 10 11 December 2012, Bonn, Germany Nanotechnology and human health: Scientific evidence and risk
More informationSafety data sheet according to 1907/2006/EC, Article 31
Page 1/6 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Article number: 1431345, 10024513, 9701421 1.2 Relevant identified uses of the substance
More informationRoHS RIA November 2003
PARTIAL REGULATORY IMPACT ASSESSMENT ON DIRECTIVE 2002/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON THE RESTRICTION OF THE USE OF CERTAIN HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT
More informationBT s supply chain carbon emissions a report on the approach and methodology
BT s supply chain carbon emissions a report on the approach and methodology April 2015 1 BT s supply chain emissions metrics approach and methodology 1 Are supply chain emissions really the essential,
More informationEuropean Conference on Safe Use of Plant Protection Products
European Conference on Safe Use of Plant Protection Products Conference Report, 18 June 2014 In June 2014, the Federal Institute for Risk Assessment in Germany (BfR) and the European Commission hosted
More information