April 21 st, 2016 Webinar. registrations What is next for the industry?
|
|
- Jack Patterson
- 5 years ago
- Views:
Transcription
1 April 21 st, 2016 Webinar A look beyond REACH 2018 registrations What is next for the industry?
2 Some Notes It is assumed that attendees have basic knowledge about REACH. Let us make this webinar interactive, please send questions We try to answer during the webinar, if not possible, we will use 2
3 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?
4 REACHLaw in a nutshell What we do? We provide global regulatory compliance and environmental sustainability services to ensure market access and operational sustainability for global businesses KEY FACTS ABOUT US Established in Helsinki Offices in Brussels, New Delhi and Istanbul 30+ toxicologists, chemists, lawyers, socioecon. analysts, business and environmental specialists 20+ local partners in Europe, Asia, Latin-America and the USA 500+ REACH registrations Language support in 10+ different languages more info about Us: SERVICE AREAS Global chemicals regulatory compliance, e.g. REACH Biocides TCCA-Korea CLP China REACH Turkey We prepare the required dossiers to authorities, SDSs, labels and provide related business strategy, legal and monitoring support. OUR CLIENTS More than 350 customers from 40+ countries, from Fortune 100 companies to SMEs. Major industries served: Oil, chemicals, specialty chemicals, metals, space sector and other downstream users (DU) industries Our customers are manufacturers, importers, traders, DU s, industry associations and governmental organizations. 4
5 REACHLaw s Authorisation Experiences Substance(s) Activity Status As 2 O 3 DU authorisation application Authorisation granted As 2 O 3 DU authorisation application Authorisation granted MOCA Supplier authorisation application On-going Na 2 Cr 2 O 7 DU authorisation application Final opinion CrO 3 + other chromates CrO 3 Space task force use survey, scoping study and application preparation Joint DU authorisation application (CRAN) One application submitted Submitted CrO 3 DU authorisation application Submitted Na 2 CrO 4 DU authorisation application Final opinion CrO 3 DU authorisation application/csr (APEAL) On-going Na 2 Cr 2 O 7 Supplier authorisation application Submitted
6 REACHLaw s Advocacy Support Experience Substance(s) Activity Status PFOA DOTE Prepared public consultation input for the restriction proposal for two industry sectors Strategic planning and public consultation input Two derogations/ exemptions were granted. Re-classification ongoing DMTE Strategic planning for RMOA input SVHC process halted Other organotins N 2 H 4 Strategic planning for RMOA input Exemption study & position paper & SEA analysis No regulatory actions needed EC feedback pending
7 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?
8 REACH as commonly perceived Registration Courtesy of Cefic Page 8
9 REACH for advanced R 2010 R 2013 R 2018 CoRAP list? PACT list? ROI list? Candidate list? Annex XV list? Courtesy of Cefic Authorisation Screening Dossier Evaluation/ Compliance check Harmonized classification Update of dossiers Restriction Risk assessment challenged SVHC roadmap RMOA Substances in Articles Substance Evaluation ECHA? Registration D? Evaluation D? Risk managment D? European Commission? Member states? European Parliament? Page 9
10 How are all the other REACH processes linked? Registration D CoRAP list Evaluation D Candidate list Risk managment D Annex XIV list PACT list AfA Courtesy of ECHA ROI list 10 Source: ECHA(2015)
11 Decisions on Annex XIV listing and Authorisation Annex XIV Recommendation Regulatory procedure with scrutiny (Dec. 2006/512/EC) Draft decision REACH Committee Opinion Final decision RAC&SEAC Opinions on application for authorisation Examination procedure (Reg. (EU) 182/2011) Right of scrutiny* *Blocking right for Annex XIV only 11
12 REACH stands for Registration, Evaluation and Authorisation of Chemicals. The purpose is to collect information on substances and their uses; identify risks; and ultimately assure progressive replacement of substances of high concern (SVHCs) by suitable alternative substances/technologies where these are economically and technically viable.
13 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?
14 REACH timeline REACH Entry into force Preregistration Deadline 1000+/ SVHC registration Deadline 100+ registration Deadline 1+ registration Deadline Registration of Substances Evaluation by ECHA and Member States Candidate listing and Authorisation applications for SVHC SVHC Roadmap Restrictions for Chemical substances presenting an unacceptable risk NOW
15 Substance of Very High Concern (SVHC) roadmap Goal: To have all currently known SVHCs included in the candidate list by 2020 as the first step in selecting substances to be subject to authorisation. Which substances? CMRs (carcinogenic, mutagenic or toxic for reproduction), PBTs (Persistent, Bioaccumulative or Toxic for the Environment), vpvbs (very Persistent and very Bioaccumulative), substances of equivalent concern (such as endocrine disruptors or sensitisers). How to achieve this? Screening Risk Management Option Analysis (ROMA) The rest is defined by the legal text: Annex XV dossier, Candidate listing, Prioritisation and Annex XIV listing
16 # potential SVHCs Screening: Select potential SVHCs of highest priority Prioritizing potential SVHCs Estimate: Total amount of potential SVHCs for RMOA to be conducted by Member States; ~400 RMOAs in the period ~1.500 Effect Carcinogenic, mutagenic & Reprotoxic (CMR) Estimated # RMOAs 50 Manual screening potential SVHCs by Member States Short list of potential SVHCs based on hazard and non-hazard properties (ECHA IT Screening) Allergic (Sensitizing) 30 Endocrine disruption 40 PBT/vPvB 82 Petroleum streams 200
17 Annual screening Source: 17
18 RMOA Key questions: the available information does not demonstrate that there is a risk that is not adequately controlled and needs to be addressed at EU level, otherwise a restriction process should be started; the known uses of the substance are not exempted from the authorisation requirement and are not already regulated by specific EU legislation that provides a pressure for substitution Exception: PBT, vpvb, and endocrine (ED) substances Main conclusion Identification as SVHC (entering the Candidate List before prioritised for REACH authorisation) REACH restriction REACH substance evaluation CLP harmonized classification and labelling Other EU-wide measures No need for follow up regulatory action at EU level
19 IT Screening potential SVHCs Manual Screening potential SVHCs From potential SVHC to SVHC when to act Yearly 1 M Risk Management Option Analysis (RMOA) Comitology decision SVHC on Annex XIV 4M 1-6 M Start process prioritizing SVHC for Annex XIV 1 year 1 year Candidate listing SVHC Preparation Annex XV dossier SVHC 1 year 6 M 1 year Prioritizing SVHC for Annex XIV by ECHA and MSC Evaluation Annex XV dossier by MSC Authorization request by Industry PACT Publication RMOA intention 19 in Public Activity Coordination Tool Publication Annex XIV XM - X year ~5 years to Annex XIV
20 IT Screening potential SVHCs Manual Screening potential SVHCs From potential SVHC to SVHC your voice Information exchange Member State and Stakeholders Information exchange Member State and Stakeholders Risk Management Option Analysis (RMOA) Preparation Annex XV dossier SVHC Comitology decision SVHC on Annex XIV Start process prioritizing SVHC for Annex XIV Candidate listing SVHC Public consultation for CL SVHC Public consultation for Annex XIV PACT Publication RMOA intention in Public Activities Coordination 20 Tool Publication Annex XIV Authorization request by Industry
21 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?
22 What can I do? Pre-emptive RMOA approach CoRAP list PACT list Monitoring ECHA s dissemination tool Registration dossier up-todate PC: right information at the right time to the right party Intervening Analysing Information collection Mitigation of risks in supply chain Timely obsolescence management Cost-effective replacement plan Portfolio optimation Effective public communication Strategic planning
23 Contact details REACHLaw, the best partner in Global Compliance David Chatfield, VP EHS&S, Dorf Ketal REACHLaw Vänrikinkuja 3 FI Espoo Finland Ying Zhu, Ph.D, M.Sc (Econ.) COO, Partner ying.zhu@reachlaw.fi
24
9/10/2013. Contributions of ECHA to the achievement of the REACH goals. Content of Discussion
Contributions of ECHA to the achievement of the REACH goals 5 Jahre REACH und weitere Beitrage zur Nachhaltigen Chemie Darmstadt, Germany 4 September 2013 Geert Dancet Executive Director Content of Discussion
More informationSDS and what is new under REACH and EU GHS? PRISM2 Workshop Promoting Resposibility in SME s 08 April Slovakia. L. Heezen
SDS and what is new under REACH and EU GHS? PRISM2 Workshop Promoting Resposibility in SME s 08 April Slovakia L. Heezen Why do we need GHS? Substance - oral toxicity LD 50 = 257 mg/kg GHS Transport EU
More informationREACH/CLP Update. Roseleen Murphy IMFI 12 th May 2011
REACH/CLP Update Roseleen Murphy IMFI 12 th May 2011 Overview Update on REACH Registration Duties for Article producers and Importers Substances of Very High Concern and the Candidate List Authorisation
More informationASSESSMENT OF THE CONSOLIDATED ANNUAL ACTIVITY REPORT OF THE AUTHORISING OFFICER FOR THE YEAR 2014
Management Board Decision 07/2015 1(5) ASSESSMENT OF THE CONSOLIDATED ANNUAL ACTIVITY REPORT OF THE AUTHORISING OFFICER FOR THE YEAR 2014 THE MANAGEMENT BOARD, Having regard to Regulation (EC) No 1907/2006
More informationCHEMICALS (Classification, Labelling, Packaging of substances and mixtures -CLP) Screening Meeting EU Serbia June 2013
CHEMICALS (Classification, Labelling, Packaging of substances and mixtures -CLP) Screening Meeting EU Serbia June 2013 Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances
More informationCLP Regulation Recent implementation and issues. Workshop "Product Stewardship and PROCESS SAFETY 30/11/2017 Dr. Blanca Serrano
CLP Regulation Recent implementation and issues Workshop "Product Stewardship and PROCESS SAFETY 30/11/2017 Dr. Blanca Serrano CLP Regulation Introduction Introduction Regulation (EC) No 1272/2008 on classification,
More informationImplementation of REACH & CLP: common challenges of national authorities and ECHA
Implementation of REACH & CLP: common challenges of national authorities and ECHA Finnish Safety and Chemicals Agency (Tukes); Opening Seminar 9 February 2011, Tampere Geert Dancet Executive Director Content
More informationIntertek Health, Environmental & Regulatory Services
Intertek Health, Environmental & Regulatory Services Vai dove Ti porta la Chimica Go where the markets for Chemicals are! Workshop Centro REACH - 3 rd December 2014 Turkey - a country moving towards Europe
More informationECHA and the implementation of REACH,CLP and other tasks
ECHA and the implementation of REACH,CLP and other tasks Eva Sandberg International Unit www.kemi.se ECHA, its tasks and organisation European Chemicals Agency ECHA REACH Regulation entered into force
More informationCLP the implementation of GHS in the EU Facts and practical advice
CLP the implementation of GHS in the EU Facts and practical advice Seminar on the latest trend regarding revised CSCL, REACH and CLP 30 March 2010, Tokyo Gabriele Schöning ECHA Classification Unit Content
More informationState of play on the candidate list. of Substances of Very High Concern
State of play on the candidate list of Substances of Very High Concern Finn Pedersen, ECHA ECHA s First Stakeholders Day 10 October 2008, Helsinki Contents What is the candidate list? How will it be developed?
More informationUpdate from ECHA. REACH Implementation Workshop X. 13 December Laurence Hoffstadt ECHA Substance Identification & Data Sharing
Update from ECHA REACH Implementation Workshop X 13 December 2011 Laurence Hoffstadt ECHA Substance Identification & Data Sharing Overview Update registrations/ dissemination Summary Analysis 2010- substances
More informationBackground to CLP. Presentation Overview. Why Introduce GHS? Basic CLP requirements 8/30/2011
About the Speaker Classifications, Labeling & Packaging (CLP) Regulatory Compliance AHMP National Conference August 29, 2011 Isaac Powell Product Manager - Technical Services 3E Company Carlsbad, CA Isaac
More informationHazard Communication. Hazard Communication
Safety Data Sheets Hazard Communication Hazard Communication Overview Introduction Regulatory Requirements Suppliers Duties SDS and CLP Annex II changes (453/2010) Recipients Duties Summary and Guidance
More informationProcedure for handling applications for authorisation and review reports under REACH
Procedure for handling applications for authorisation and review reports under REACH 1. Purpose This procedure describes how to handle applications for authorisation (AfA) as established by the REACH Regulation
More informationGuidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)
G U I D A N C E Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) Version 2.1 October 2017 2 Guidance on Scientific Research and
More informationStrategies for REACH Compliance. Chicago 23 March 2012
Strategies for REACH Compliance Chicago 23 March 2012 Content Context of the proposal presentation Table of contents I. INTRODUCTION Who is EcoMundo? Why REACH affects U.S. companies? The basics to understand
More informationSecond REACH registration deadline a success. 3 Nearly more substances registered by industry. 10 Setting scientific. 14 Promoting substitution
1 3 June 2013 3 Nearly 3 000 more substances registered by industry By the second REACH registration deadline of 31 May, 3 215 companies submitted 9 084 registration dossiers for 2 923 substances to ECHA.
More informationREACH and CLP an industrial perspective on registrations and notifications
REACH and CLP an industrial perspective on registrations and notifications Leendert van Dijk On behalf of EASTMAN REACH Team Agenda Introduction of Eastman Chemical Our REACH footprint REACH: what is new?
More informationVLARIP Netwerkevent. 24 januari 2013
VLARIP Netwerkevent 24 januari 2013 Omgaan met (uitgebreide) veiligheidsinformatiebladen Raf Leyman Regulatory Affairs Manager EMEA Agenda REACH@Buckman history Buckman REACH Safety Data Sheets (e)sds
More informationEurope Direct is a service to help you find answers to your questions about the European Union.
General Report 2015 Disclaimer The views or positions expressed in this Work Programme do not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals
More informationMulti-Annual Work Programme
Multi-Annual Work Programme 2009-2012 Европейска агенция по химикали Evropská agentura pro chemické látky Det Europæiske Kemikalieagentur Europäische Chemikalienagentur European Chemicals Agency Ευρωπαϊκός
More information1. Address by Dr. Chris SAID, Parliamentary Secretary for Consumers, Fair Competition and Public Dialogue
PUBLIC Helsinki, 4 st October 2011 PRELIMINARY CONCLUSIONS OF THE 23 RD MANAGEMENT BOARD MEETING ON 29.-30.9.2011 1. Address by Dr. Chris SAID, Parliamentary Secretary for Consumers, Fair Competition and
More informationREACH Pre-registration Questions and Answers
REACH Pre-registration Questions and Answers (RELEASE 5) You may continue to manufacture, import or use a chemical only if it is pre-registered and registered in time! Reference: ECHA-08-QA-01.5-EN Date:
More informationFuture road of REACH. Checking out the map. Fulvia Raffaelli Unit G.1 : Chemicals, REACH. European Commission Enterprise and Industry
Future road of REACH Checking out the map Fulvia Raffaelli Unit G.1 : Chemicals, REACH 1 A future in REACH A future of REACH 2 A future in REACH: We have passed first registration (4 000 substances 25
More informationGuidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No.
Guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No. 1272/2008 DRAFT LEGAL NOTICE This document contains guidance to the preparation of dossiers
More informationCHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015
CHEMICAL WATCH GLOBAL ENFORCEMENT SUMMIT 2015 NEW FOR 2015 LE CHATELAIN BOUTIQUE HOTEL, BRUSSELS A unique opportunity to join our panels: twenty-one+ experts including EU and Member State officials, regulatory
More informationFinal Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) October 2013
18 October 2013 ECHA/Forum-16/2013/A/final Final Draft Agenda Sixteenth meeting of the Forum for Exchange of Information on Enforcement (Forum-16) 28-31 October 2013 European Chemicals Agency Helsinki,
More informationNovità in materia di CLP : impatto sui biocidi. Maristella Rubbiani CSC/ISS
Novità in materia di CLP : impatto sui biocidi Maristella Rubbiani CSC/ISS REGULATION 1272/2008 - CLP - (REPLACED 67/548/EU DIRECTIVE) (REPLACING 99/45/EU DIRECTIVE) Professional/ non professional products
More informationREACH Evaluation. Graham Lloyd Regulatory/Technical. REACH in Practice Conference 1 June, Steptoe & Johnson LLP & Regulatory Compliance Ltd
REACH Evaluation Graham Lloyd Regulatory/Technical REACH in Practice Conference 1 June, 2007 REACH Evaluation What is to be evaluated Compliance check Substance evaluation Evaluation process and decisions
More informationRegulatory fitness check of chemicals legislation
Ref. Ares(2016)1888307-21/04/2016 Regulatory fitness check of chemicals legislation Stakeholder Workshop Diamant Conference Centre, Brussels 19 April, 2016 Meg Postle, Risk & Policy Analysts Ltd Summary
More informationBilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of substances and mixtures - CLP
REPUBLIC OF SERBIA Negotiating Group for the Chapter 27 Environment and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of
More informationREPORTING OF REACH IMPLEMENTATION
National Supervisory Authority for Welfare and Health Finnish Environment Institute Ref. Ares(2011)183072-18/02/2011 REPORTING OF REACH IMPLEMENTATION 2007 2009 FINLAND 28 MAY2010 MS REACH Reporting Questionnaire
More informationHealth and Safety Authority. Function and Scope of REACH and CLP Helpdesks
Rev 1. June 2009 Health and Safety Authority Function and Scope of REACH and CLP Helpdesks Introduction The EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
More informationNewsletter September 2017
Newsletter September 2017 Newsletter Summary Reach 2018 Reach & CLP Updates Restriction Regulation Updates Regulation Updates about products and Regulations EU Supply Chain Comunication Calls for Information
More informationPractical guide 7: How to notify substances in the Classification and Labelling Inventory
Practical guide 7: How to notify substances in the Classification and Labelling Inventory LEGAL NOTICE This document contains guidance on the CLP Regulation explaining the CLP obligations and how to fulfil
More informationFORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT. Disclaimer:
FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 Strategies for enforcement of Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation,
More informationHarmonisation of Information for Poison Centres
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Chemicals, metals, mechanical, electrical and construction industries; Raw materials Chemicals - Classification & Labelling, Specific Products,
More informationREPUBLIC OF SERBIA Bilateral screening: Chapter 1 Free Movement of Goods. C L P Classification, Labeling and Packaging of substances and mixtures
REPUBLIC OF SERBIA Bilateral screening: C L P Classification, Labeling and Packaging of substances and mixtures C O N T E N T STATE OF PLAY LEGISLATIVE FRAMEWORK COMPETENT AUTHORITY (CA) ADMINISTRATIVE
More informationThe Classification and Labelling Inventory. Cefic s viewpoint
The Classification and Labelling Inventory Cefic s viewpoint Marie-Pierre Rabaud RIEF III Brussels 24 June 2014 The C&L Inventory Improvement of the C&L Inventory is a need Industry to consider ways to
More informationITMA 2015 Textile Colourant & Chemical Leaders Forum. Updates on REACH Regulation. Dr Maurizio Colombo, REACH and CPL Coordinator, Federchimica
ITMA 2015 Textile Colourant & Chemical Leaders Forum Updates on REACH Regulation Dr Maurizio Colombo, REACH and CPL Coordinator, Federchimica Milano, 14 th November 2015 Federchimica Organisation More
More informationUpdate of the Work plan on international activities 2012
Helsinki, 15 December 2011 Doc.: MB/57/2011 final Update of the Work plan on international activities 2012 (Document endorsed by the Management Board) WORK PLAN FOR INTERNATIONAL ACTIVITIES OF ECHA 2012
More informationChanges to Chemical Labels and SDS - Speaker s notes
Slide 1 Changes to Chemical Labels and SDS Title slide. Slide 2 Changes to labels and SDS This presentation is intended to help those who need to give information about changes to the way that chemical
More informationGuidance on the Biocidal Products Regulation
G U I D A N C E Guidance on the Biocidal Products Regulation Volume V, Guidance on active substances and suppliers (Article list) Draft Version.0 September 0 DRAFT Volume V: Guidance on active substances
More informationLISAM SYSTEMS REACH Compliant SDSs: What s Changed and What s Coming
REACH Compliant SDSs: What s Changed and What s Coming Simon Bradshaw, June 2016 REACH Compliant SDSs: Structure, Content and Requirements Simon Bradshaw, June 2016 REACH... Regulation 1907/2006 Amendment
More informationGuidance on the Biocidal Products Regulation
G U I D A N C E Guidance on the Biocidal Products Regulation Volume V, Guidance on active substances and suppliers (Article 95 list) Version 2.1 March 2017 2 Guidance on BPR: Volume V Version 2.1 March
More informationREACH Forum, Compliance Control of REACH and CLP Regulations
REACH Forum, Compliance Control of REACH and CLP Regulations Szilvia Deim Vice-Chair of the Forum Forum for Exchange of Information on Enforcement 4 September 2018, Bratislava 1 Forum as a unique body
More informationMINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1
FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 MARCH 2011 1 First edition adopted at the 6
More informationEU Poison Centres Webinar. 27 May 2014, 9:00am BST
EU Poison Centres Webinar 27 May 2014, 9:00am BST Today s webinar aims v To hear about the current state of play on the changes that are likely to be proposed on the reporting of information to EU poison
More informationBiocidal product regulation the changes to come
Biocidal product regulation the changes to come The Biocidal Product Regulation, which came into force on 1 September 2013 is still changing. ECHA announced the evolutions of this changing regulation during
More informationGlobal REACH legal services
Global REACH legal services www.allenovery.com 2 Global REACH legal services REACH: How can Allen & Overy assist you? REACH is one of the most ambitious pieces of legislation to come out of Europe to date
More informationessenscia SME projects to improve REACH & CLP implementation: VLARIP & WALRIP
essenscia SME projects to improve REACH & CLP implementation: VLARIP & WALRIP Ir. Tine Cattoor Advisor Product Policy VLARIP projectleader tcattoor@essenscia.be 7/10/2014 content essenscia & members REACH
More informationGlobal Market Expansion Services for Safety, Environment, Quality, and Regulatory Affairs (SEQRA)
Global Market Expansion Services for Safety, Environment, Quality, and Regulatory Affairs (SEQRA) Business Line lorem Ipsum Market Expansion Services: dedicated to growing business We help companies to
More informationA look into the PCN format, UFI generator and EU PCS
A look into the PCN format, UFI generator and EU PCS Dijana Spasojevic, Principal consultant, and Philippe Boveroux, Project manager 7 th BfR User conference 15 November, 2015 Who we are Dijana Spasojevic
More informationIII-V Materials, KETs and CLP/REACH Procedures
Soitec is member of III-V Materials, KETs and CLP/REACH Procedures Entreprise Policy Group Reach Sub Group Meeting November 30th 2012 Summary 1. From III-V Materials to Key Enabling Technologies (KETs)
More informationIntroduction UN GHS. CLP outline. Requirement for SDS. Measures needed GHS CLP SDS. Transition from DSD/DPD to CLP DSD/DPD CLP
Introduction UN GHS GHS CLP outline CLP Transition from DSD/DPD to CLP DSD/DPD CLP EU own Hazard Statements Classification & Harmonized classification & Requirement for SDS SDS Measures needed P23 Example
More informationNSF Dietary Supplement Complete Service Offering. Experts in supplement auditing, consulting, testing and training.
NSF Dietary Supplement Complete Service Offering Experts in supplement auditing, consulting, testing and training www.nsf.org Dietary Supplement Quality Training NSF Dietary Supplement Quality Training
More informationFinal Minutes. Minutes of the 12th Meeting of the Member State Committee (MSC-12) 9-10 June 2010
MSC/M/012/2010 Final Adopted by written procedure, 1 September 2010 Final Minutes Minutes of the 12th Meeting of the Member State Committee (MSC-12) 9-10 June 2010 I. Summary Record of the Proceedings
More informationREACH-IT Industry User Manual
REACH-IT Industry User Manual Part 16 - How to create and submit a C&L notification using the REACH-IT online Version (1.0) Page 1 of 68 Document History Version Changes 1.0 First release Reference: ECHA-10-B-31-EN
More informationHelpdesk report 2016 (art. 24 REACH)
Helpdesk report 2016 (art. 24 REACH) Activities 2015 & 2016 FPS Economy, SMEs, Self-employed and Energy In Belgium, the national helpdesk REACH, as foreseen in article 124 of Regulation 1907/2006, has
More informationFrom pre-registration to joint submission Hendrik Abma Director General European Association of Chemical Distributors (FECC)
From pre-registration to joint submission Hendrik Abma Director General European Association of Chemical Distributors (FECC) Commission REACH Workshop 14 April 2008 AGENDA FECC Pre-registration - Pre-SIEF
More informationProgramme Officer International Development
Programme Officer International Development CONTEXT Cooperative enterprises enable people around the world to become protagonists of their own social and economic development. The ICA- EU partnership programme
More informationStandard operating procedure
Standard operating procedure Title: Evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs) Status: PUBLIC Document no.: SOP/V/4150 Lead author
More informationFinal report on the Forum Pilot Project on CLP focusing on control of internet sales. Reporting period: January October 2017
Final report on the Forum Pilot Project on CLP focusing on control of internet sales Reporting period: January October 2017 2 Forum Pilot Project on CLP focusing on control of internet sales Disclaimers
More informationFirst inspection of a Legal Representative in the EU by local authority
First inspection of a Legal Representative in the EU by local authority Michael Gierend, DVM PhD on behalf of Edgar Fenzl, MD, PhD FGK Representative Service GmbH ( www.fgk-rs.com ) Munich, Germany CEMO
More informationCEF Telecom calls , , & : the evaluation process
CEF Telecom calls 2018-2, 2018-3, & 2018-5: the evaluation process 2018-2/3/5 CEF Telecom call virtual info day 17 May 2018 Anita Kucharska INEA Deputy Head of Unit Programme Support, Coordination & Communication
More informationECHA Helpdesk Support to National Helpdesks
ECHA Helpdesk Support to National Helpdesks 48 th Biocides CA meeting 19-21 September 2012 Brussels Dr. Henna Piha ECHA Helpdesk Unit A1 ECHA Helpdesk - Support to National Helpdesks What ECHA offers to
More informationHorizon Health
Horizon 2020- Health 2018-2020 Ms Sasha Hugentobler, PhD., National Contact Point Health, Demographic change and well being Ms Agnes Szeberenyi, Scientific Collaborator Health Euresearch Head Office health@euresearch.ch
More informationThe EU Integration Centre coordinates activities of the Chamber of Commerce and Industry of Serbia (CCIS) in the field of European integration for
The EU Integration Centre coordinates activities of the Chamber of Commerce and Industry of Serbia (CCIS) in the field of European integration for the purpose of representing interests of the Serbian business
More informationEuropean IVD Regulations and Risk Based Classification. An Overview for Global Quality Professionals
European IVD Regulations and Risk Based Classification An Overview for Global Quality Professionals Anna Sadio IVD Technical Expert/Project Manager Oct 2013 Caution The new regulations are draft and subject
More informationIVD Regulatory Update February 2015
IVD Regulatory Update February 2015 Sue Spencer Head of IVD Notified Body Copyright 2015 BSI. All rights reserved. Content IVD proposals Expected timelines Impacts: Re-classification Clinical evidence
More informationThe implementation of the Clinical Trial Regulation (CTR, n 536/2014) in Belgium. and impact on the ethical review process
1 The implementation of the Clinical Trial Regulation (CTR, n 536/2014) in Belgium and impact on the ethical review process 2 1. Clinical Trials on Medicinal Products for Human Use: Change of the Legal
More informationGlobal challenges with European solutions: The fundamental role of EFIC
EFIA General Assembly Tartu, 26 October 2017 Global challenges with European solutions: The fundamental role of EFIC Ms. Roberta Dessí, Secretary General Mr. Egil Sundet, Board member About EFIC: - Members
More informationThe CLP Regulation: origin, scope and evolution
126 Ann Ist Super Sanità 2011 Vol. 47, No. 2: 126-131 DOI: 10.4415/ANN_11_02_02 The CLP Regulation: origin, scope and evolution Paola Di Prospero Fanghella and Tiziana Catone Centro Nazionale Sostanze
More informationGuidance for the conduct of good clinical practice inspections
23 August 2017 EMA/839541/2015 Guidance for the conduct of good clinical practice inspections Adopted by GCP Inspectors Working Group (GCP IWG) 4 September 2017 Keywords Conduct of GCP inspections 30 Churchill
More informationAgenda. Workflows and Software Tools for the Process of Registration, Evaluation, Authorisation and Restriction of European Chemicals
Workflows and Software Tools for the Process of Registration, Evaluation, Authorisation and Restriction of European Chemicals Gerlinde Knetsch Federal Environment Agency Unit IV2.1- Information Systems
More informationBrokerage for the first ProSafe Call Dina Carrilho Call Secretariat Foundation for Science and Technology (FCT), Portugal
Brokerage for the first ProSafe Call Dina Carrilho Call Secretariat ProSafe@fct.pt Foundation for Science and Technology (FCT), Portugal ProSafe is offering two main opportunities for the implementation
More informationEnergy Efficiency in EU buildings
Energy Efficiency in EU buildings CPI WORKSHOP, BERLIN 18 FEBRUARY 2011 Dr Marina Economidou Expert in Energy Efficiency Buildings Performance Institute Europe Overview A Few Words about EU Buildings:
More informationEDQM roadmap for electronic submissions
EDQM roadmap for electronic submissions Cornelia Bigler Weber scientific assistant Certification Department, EDQM 19 September 2017 1 Agenda esubmissions Roadmap for CEP applications with its major changes
More informationANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices
ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices Balbiana Verazez Sampaio Oliveira AGENDA 1. Strategic Plan 2016-2019 objectives
More informationThe European Fund for Strategic Investments (EFSI) and the European Investment Advisory Hub (EIAH) - Drivers for the real economy
The European Fund for Strategic Investments (EFSI) and the European Investment Advisory Hub (EIAH) - Drivers for the real economy Workshop Financing opportunities for projects in agriculture and rural
More informationQCF Unit and Assessment Specification
QCF Unit and Assessment Specification Unit title Ofqual Unit code Develop Health and Safety and Risk Management Policies, Procedures and Practices in Health and Social Care or Children and Young People
More informationControl of Substances Hazardous to Health (COSHH) Policy & Procedure
Control of Substances Hazardous to Health (COSHH) Policy & Procedure Policy Number: 703 Supersedes: N/A Classification Corporate Version No Date of EqIA: Approved by: Date of Approval: Date made Active:
More informationCommission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics Oslo
Commission Guidelines for the implementation of the Clinical Trials Regulation NTA Ethics 30.1.2017 Oslo 3.2.2017 O. Konttinen 1 Background Based on directive 2001/20/EC of the clinical trials on medicinal
More informationGuidance for applicants requesting scientific advice
7 December 2017 EMEA/CVMP/SAWP/172329/2004 Rev. 5 Veterinary Medicines Division Introduction The Scientific Advice Working Party (SAWP-V) of the Committee for Medicinal Products for Veterinary Use (CVMP)
More informationFast Track to Innovation Pilot ( ) January 2014
Fast Track to Innovation Pilot (2015-2016) January 2014 Fast Track to Innovation Pilot - the concept in a nutshell The FTI pilot (2015-2016) is the only fully bottom-up measure in Horizon 2020 promoting
More informationIVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices. Med-Info. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices The current regulatory framework
More informationEU harmonization of the information for emergency health response (Art. 45 Regulation 1272/2008 )
EU harmonization of the information for emergency health response (Art. 45 Regulation 1272/2008 ) 6th BfR-Nutzerkonferenz Produktmeldungen 10 November 2015, Berlin-Marienfelde Roberto Scazzola DG Internal
More informationLAUNCH EVENT Fast Track to Innovation
LAUNCH EVENT Fast Track to Innovation Pilot (2015-2016) Brussels, Belgium 9 January 2014 Welcome by Mr Robert-Jan Smits, Director-General, DG Research and Innovation Opening Speech Europe on a Fast Track
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 26 July 2012 EMA/118465/2012 3 4 Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication 5 Draft finalised by the Agency in collaboration with Member States and submitted
More informationClassification & Labelling and ECHA Support to Industry
Classificatin & Labelling and ECHA Supprt t Industry Seminar t Japanese Industry n the EU Chemicals Legislatin: REACH, CLP & BPR 3 April 2015 / Tky, Japan Petteri Mäkelä ECHA Internatinal Relatins CLP
More informationGUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/3 December 2010 GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS
More informationCALL FOR EXPRESSION OF INTEREST. Seconded National Experts for the ERCEA ERCEA/SNE/143/2017
Ref. Ares(2017)837877-15/02/2017 CALL FOR EXPRESSION OF INTEREST Seconded National Experts for the ERCEA ERCEA/SNE/143/2017 The European Research Council Executive Agency (ERCEA) is organising a call for
More informationCOMMISSION DELEGATED DIRECTIVE../ /EU. of
EUROPEAN COMMISSION Brussels, 18.10.2013 C(2013) 6835 final COMMISSION DELEGATED DIRECTIVE../ /EU of 18.10.2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU
More informationGuideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted
More informationEUROPEAN PARLIAMENT Committee on the Environment, Public Health and Food Safety
EUROPEAN PARLIAMT 2009-2014 Committee on the Environment, Public Health and Food Safety 2012/0266(COD) 12.4.2013 ***I DRAFT REPORT on the proposal for a regulation of the European Parliament and of the
More informationWRITTEN HAZARD COMMUNICATION PROGRAM. Prepared for: BORO OF
Prepared for: BORO OF 2013 TABLE OF CONTENTS INTRODUCTION...1 POLICY:...1 OBJECTIVE:...1 PURPOSE:...1 RESPONSIBLE PERSONS:...2 HAZARD DETERMINATION...3 PHYSICAL HAZARDS:...3 HEALTH HAZARDS:...4 EXEMPT
More informationOfficial Journal of the European Union. (Non-legislative acts) REGULATIONS
4.1.2017 L 1/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMTING REGULATION (EU) 2017/1 of 3 January 2017 on procedures for watercraft identification under Directive 2013/53/EU of the European
More informationBarcelona. The New EU Regulation 2017/745 on Medical Devices. Wednesday 14 and Thursday 15 November and 15 November Barcelona.
Understanding the Regulation and its impact on Industry Course Language: English 210 Early Bird discount for enrolment by 17 th October 2018 Barcelona Spain Wednesday 14 and Thursday 15 November 2018 10:00
More informationAn initiative of the EC. Angelo Riccaboni Chair Fundación PRIMA
An initiative of the EC Angelo Riccaboni Chair Fundación PRIMA Index What PRIMA is? PRIMA Programme Euro-Mediterranean Conference on R&I in Barcelona 2-3 April 2012 Positive opinion by Regulatory Scrutiny
More information