Webinar - REACH Registration 2018
|
|
- Joleen Cobb
- 6 years ago
- Views:
Transcription
1 Webinar - REACH Registration 2018 Practical Approaches to Compliance Presented by: Bruce Calder VP Consulting Services
2 Overview - Agenda Introduction REACH 2018 Deadlines Key team members and data Compliance options Misconceptions about registrations Option 1 - Supplier Coverage Becoming a downstream user Option 2 - Letter of Access Registration via LOA Q&A Chemicals Chemicals Chemicals Webinar is 50 minutes with 10 minutes of Q&A (hopefully)
3 Claigan - REACH Registration Solving REACH 2018 compliance issues for companies A practical plan Supplier coverage / downstream user Letter of Access More results. Less journey.
4 Claigan Environmental - Difference Claigan s focus - Compliance - End Deliverables If a step or process does not contribute to compliance or end deliverables, then it needs to be justified More results. Less journey.
5 REACH Registration 2018 Registration deadline - May for non-cmr substances imported into the EU (or manufactured in the EU) between 1 and 100 tonnes per annum Related interim deadline - May for pre-registration of substances over 1 tonne per annum Options - Registration, or - Downstream User (Supplier Coverage)
6 Compliance Paths - Two Paths Supplier Coverage (Downstream User) Verify Supplier Inquiry Complete or Registration Verify Consortia Contact Supplier Inquiry Registration Complete
7 Compliance Team Members Key members of a corporate REACH 2018 team - Compliance / project prime - Representative from procurement Key data - Sales volumes (in tonnes) into the EU - concentrations in each product - and close enough is good enough. If you cannot figure it out, no one outside will either. - Ultimately - which substances are imported into the EU above 1 tonne per annum
8 Compliance Paths - Supplier Coverage Verify Supplier Inquiry Complete Identify Registered Supplier contact information Update substance information Contact Supplier Confirm as Original Manufacturer Repeat with Original Manufacturer Confirm Coverage
9 Compliance Paths - Registration Verify Consortia Contact Supplier Inquiry Registration Identify Registered Contact Consortia Supplier contact information Obtain LOA Update substance information Identify LOA requirements Contact Supplier Submit Registration Information Repeat with Original Manufacturer Identify Consortia and Registrant Information Update Preregistration Confirm as Original Manufacturer Confirm Registration = Fees Obtain Analytical Data Complete
10 1 - Supplier Coverage Path Verify Identify Registered Update substance information Verify - Identify registered version of the substance - Name - EC / CAS - Search of ECHA and consortia information Update substance information
11 Common REACH 2018 Error There are tens of thousands of substances that still need to be registered..not true
12 Groups Registrants have to pay a fee for each substance they register - Plus the cost and effort of working with peers to assemble a dossier Overall cost (for high tonnage substances) approaches hundreds of thousands of dollars per substance - And many chemical companies have hundreds of similar substances So
13 Groups (Mother Registrations) Mother Registrations - instead of registering each EC (CAS) number, large chemical companies identifies EC numbers that encompass whole families of EC numbers - And register a dossier for that group chemical - Making it look like tens of thousands of chemicals were not registered - but most are actually already registered under a mother submission
14 Example - Zeolite Zeolite - common in molecular sieves / desiccant packs of interest
15 Groups Pre-registered only. NOT registered yet.
16 Group - Zeolite
17 Mother registration - Zeolite Zeolite, cuboidal, crystalline, synthetic, non-fibrous Registered
18 1 - Supplier Coverage Path Supplier Inquiry Supplier contact information Contact Supplier Confirm as Original Manufacturer Confirm Coverage Repeat with Original Manufacturer Complete Supplier inquiry - Supplier contact information - Contact supplier - Determine if manufacturer is original manufacturer of substance - If not, request contact information of original manufacturer - Repeat contact with original manufacturer - Confirm coverage of OCD substance and tonnage - Request esds if applicable - Possibly over 10 tonnes per annum
19 Outcomes Typical outcomes - Out of scope - Supplier provides justification that the substance is out of scope of registration - Only Representative coverage - Supplier s Only Representative is registered and states that your tonnage and use is covered. Or intends to do so. - Supplier only covering EU tonnage - volumes sold outside the EU are not covered - Clueless - The supplier has no idea what you are talking about or has no plan.
20 Outcomes - Out of Scope - 1 NaCl (natural substance)
21 Outcomes - Out of Scope - 2 EU substance - was already imported (or manufactured) in the EU You are a downstream user of that substance
22 Outcomes - Only Representative Coverage Only Representative coverage - Statement - Your tonnage is covered in their registration - Your use is covered - Format - No mandatory format - Commitment by the supplier that their only representative(s) covers their tonnage and use should be sufficient - non-community manufacturer shall inform the importer(s) within the same supply chain of the appointment. - Common issue when original substance manufacturer is confidential or multiple - You are now a downstream user of that substance
23 Outcomes - Supplier Covering EU Only Supplier states - Only registering substances manufactured or purchased in the EU - non-eu tonnage not covered - Next step - Leverage your procurement group to pressure the supplier s customer service - Supplier registration - The supplier is already registered in the EU - no real additional cost to the supplier - If you were to instead buy a letter of access, you would likely be buying it from your supplier. - ie. You would be paying your supplier for the privilege of buying from them
24 2 - Registration Path Verify Identify Registered Update substance information Identify Consortia and Registrant Information Verify - Identify registered version of the substance - Name - EC / CAS - Search of ECHA and consortia information Update substance information Identify consortia info - Identify consortia information - contact information - Registered (Y/N)
25 2 - Registration Path Consortia Contact Contact Consortia Identify LOA requirements Update Preregistration Consortia - Contact consortia / lead registration Identify LOA requirements - Contract - Costs - Process - Analytical data - Confirm use Update pre-registration data - Update pre-registration data to conform with consortia / substance - May be at start of process if preregistration is best method to contact consortia / lead registrant
26 2 - Registration path Supplier Inquiry Supplier contact information Contact Supplier Confirm as Original Manufacturer Repeat with Original Manufacturer Supplier inquiry - Supplier contact information - Contact supplier - Determine if manufacturer is original manufacturer of substance - If not, request contact information of original manufacturer - Repeat contact with original manufacturer - Request analytical data - as required by consortia / LOA - or physical sample for testing Obtain Analytical Data
27 2 - Registration Path Registration Obtain LOA Submit Registration Information Confirm Registration Complete = Fees Registration - Obtain LOA from consortia - Sign contract - Pay dossier license fees - Obtain token and instructions - Obtain chemical safety report - Submit registration - Submit information into IUCLID - token - corporate information - analytical data - chemicals safety report - Confirm registration - Registration number
28 Claigan Environmental - Difference Claigan s focus - Compliance - End Deliverables If a step or process does not contribute to compliance or end deliverables, then it needs to be justified More results. Less journey.
29 Claigan - REACH Registration Solving REACH 2018 compliance issues for companies A practical plan Supplier coverage / downstream user Letter of Access Q&A More results. Less journey.
PLANNING FOR REACH 2018 AS A NON-EU COMPANY
PLANNING FOR REACH 2018 AS A NON-EU COMPANY Joyce Borkhoff Vice President, Chemicals Group Intertek Scientific & Regulatory Consultancy AGENDA 01 02 Overview of REACH Requirements Specific to Non-EU Companies
More information1. THE 2010 DEADLINE AND FUNCTIONING OF THE OLD SYSTEM
1. THE 2010 DEADLINE AND FUNCTIONING OF THE OLD SYSTEM 2. BACKGROUND AND EXPECTATIONS AS SEEN BY ECHA 3. IMPLEMENTING REGULATION 4. NEGOTIATION ADVICE TO NEW REGISTRANTS 5. WHAT IF NEGOTIATIONS FAIL 6.
More informationHow to Pass a Conflict Minerals Audit
How to Pass a Conflict Minerals Audit Process for Passing an IPSA Presented by: Bruce Calder VP Consulting Services Agenda - How to Pass an Audit Introduction Audit - When is it required? - Privately held
More informationRoHS in Regulatory changes in China RoHS and EU RoHS. Presented by: Bruce Calder VP Consulting Services
RoHS in 2019 Regulatory changes in China RoHS and EU RoHS Presented by: Bruce Calder VP Consulting Services Overview - Agenda Introduction China RoHS Overview First batch catalog Products under scope Tables
More informationREACH Services. Global Service Provider to the Chemical Industry
REACH Services Global Service Provider to the Chemical Industry Welcome to Eurofins REACH Services Eurofins is a global service provider to the chemical industry, offering a comprehensive range of REACH
More informationREACH SVHC Compliance
REACH SVHC Compliance How we do it Presented by: Bruce Calder VP of Consulting Services Overview - Agenda Introduction REACH SVHC Requirements Article definition Compliance Process Risk assessment High
More informationData Submission Manual Part 05 - How to complete a technical dossier for registrations and PPORD notifications Data Submission Manual
Data Submission Manual Part 05 - How to complete a technical dossier for registrations and PPORD Version: 2.8 Page 1 of 95 Document history Version Changes 2.8 04/2011 2.7 12/2010: 2.6 10/2010: 2.5 05/2010:
More informationREACH SVHC Definition of an Article
REACH SVHC Definition of an Article Ruling by the European Court of Justice (ECJ) Presented by: Bruce Calder VP of Consulting Services Agenda Introduction Ruling by European Court of Justice - Background
More informationCase Study Non-EU Manufacturers
Case Study Non-EU Manufacturers Dr. Rudolf Staab Vice Secretary of the Only Representative Organisation Managing Director, REACh ChemAdvice GmbH ECHA Stakeholder s Day Helsinki, 5 April 2017 Introduction
More informationFAQ - Conflict Minerals
FAQ - Conflict Minerals Responses to questions submitted by industry Presented by: Bruce Calder VP Consulting Services Agenda - Conflict Minerals FAQ Webinar Introduction Questions - Industry submitted
More informationREACH overview why, what s the objective?
REACH overview why, what s the objective? Chemical Watch Expo 2017 25 April 2017 István Mák Dossier Submission and PIC unit European Chemicals Agency Contents European Chemicals Agency the organisation
More information2018 shortlisting letter campaign to industry: scope and expected outcome
2018 shortlisting letter campaign to industry: scope and expected outcome Webinar: how are substances shortlisted and manually screened? 1 February 2018 Chrystele Tissier European Chemical Agency Content
More informationSVHC Authorisation and Restrictions
SVHC Authorisation and Restrictions GPS and REACH Chemicals Legislation Workshop 11 April 2013 Soporna Leo Heezen Content REACH Title VII and Title VIII SVHC Annex XIV Authorization process Restrictions
More informationREACH SVHC Definition of an Article
REACH SVHC Definition of an Article Opinion of the Advocate General of the ECJ Presented by: Bruce Calder VP of Consulting Services Agenda Introduction Opinion of Advocate General of ECJ - Context - Ruling
More informationREACH What it means for company practice
REACH What it means for company practice The Chemical Company What is REACH about? REACH stands for R egistration, E valuation, A uthorisation and Restriction of Chemicals. This new EU Chemicals Regulation
More informationEC-Regulation No.1907/2006 (REACH)
The EC-Regulation No.1907/2006 (REACH) generates new duties for producers, importers and suppliers. On 28 October 2008 the EU has released the Candidate List of substances of very high concern. What is
More informationThe European REACH Directive in a Nutshell
The European REACH Directive in a Nutshell 20.07.2006 ESTAL Congress in Innsbruck (5-6 October 2006) Dr. Uwe H. Wolfmeier Clariant International Content Clariant Group overview REACH in a nutshell REACH
More informationImpact of the REACH Regulation (EC) n 1907/2006
Impact of the REACH Regulation (EC) n 1907/2006 Analysis of the consequences of REACH on the supply chain from the exporter s point of view. www.tuv.com/reach Introduction The REACH regulation came into
More informationRegistration data and dossier handling
Guidance in a nutshell Registration data and dossier handling This document aims to explain in simple terms the main elements of the collection of information for registration dossiers and dossier evaluation.
More informationREACH with Ecolab REACH CENTRE OF EXCELLENCE
REACH CENTRE OF EXCELLENCE OUR COMMITMENT It is Ecolab s commitment to comply fully with Regulation (EC) No 1907/2006 (REACH). Our commitment includes securing the long-term future of the cleaning, sanitizing,
More informationACHIEVING TIMELY REACH-REGISTRATION. Options, tick lists and support resources to help you meet the 31 May 2018 deadline
ACHIEVING TIMELY REACH-REGISTRATION Options, tick lists and support resources to help you meet the 31 May 2018 deadline Sandra Carey, IMOA REACH Molybdenum Consortium Secretariat 1 REACH Basics: Registration
More informationECHA Stakeholders Day 2017
ECHA Stakeholders Day 2017 Session: Using Chemicals Safer in Europe Tips & Tools for Chemical Safety Reports (CSRs) Dr. Dirk Schwartz (ERT) Bruno Bock Chemische Fabrik GmbH & Co. Head of Product Safety
More informationHow to bring your registration dossier in compliance with REACH Tips and Hints - Part 5
How to bring your registration dossier in compliance with REACH Tips and Hints - Part 5 Read-across Niklas Andersson 12 February Read-across - Definition Read-across is a technique for predicting endpoint
More informationDear precious client :
Dear precious client : Last year, Chemtopia received 1 st Korea joint registration No. and the certificate of registration result for HBr joint registration. This newsletter analyzes and shares the important
More informationPrinciples of REACH. Andrew Fasey AIHce 2006 Chicago, USA 16 May 2006
Principles of REACH Andrew Fasey andrew.fasey@ptkltd.com AIHce 2006 Chicago, USA 16 May 2006 Why I am here PTK Ltd: consultancy on regulatory chemicals issues (e.g. REACH, GHS, SAICM) DG ENTR (until September
More informationData Sharing Under the BPR and Supply Chain Strategy
Data Sharing Under the BPR and Supply Chain Strategy Darren Abrahams Indiana de Seze Annual Chemicals Regulation Seminar Product Defense for REACH and Biocides April 2, 2015 Brussels Copyright 2015 Steptoe
More information3: REACH Case Story Summaries
3: REACH Case Story Summaries Inauguration Event 3 June 2003 1 Reference: ECHA-08-PM-03-EN Date: 03-06-2008 Language: EN If you have questions or comments in relation to this document please send them
More informationREACh : Device Maker Perspective
REACh : Device Maker Perspective SESHA TEXAS CHAPTER MEETINGS September 2008 Dawn Speranza Global Fab Materials Intel Corporation 1 Agenda REACh and its effect on semiconductor manufacturers Main REACH
More informationSME Issues. webinar, 02 July 2013, 2pm BST
SME Issues webinar, 02 July 2013, 2pm BST Today s webinar aims Learn practical ways to ensure SMEs can meet REACH deadlines; Hear first hand from an SME with experience of REACH compliance both as a manufacturer
More informationRegulatory priorities/needs linked to Grouping (EU) Celia Tanarro ECHA Scientific Workshop - Grouping of Nanomaterials
Regulatory priorities/needs linked to Grouping (EU) Celia Tanarro ECHA Scientific Workshop - Grouping of Nanomaterials 13 of September 2018 Outline REACH and nanomaterials Read-across, grouping and categories
More informationFormat for CHEMICAL SAFETY REPORT [LOW VOLUME] USE
Format for CHEMICAL SAFETY REPORT [LOW VOLUME] USE Legal name of applicant: [Legal name of applicant] Substance: [Include Annex XIV substance name, EC and CAS number] Use title: [Use title] Date CHEMICAL
More informationREACH: how to deal with 30,000 chemicals
REACH: how to deal with 30,000 chemicals Challenging boundaries in risk assessment sharing experiences EFSA s 10 Year Anniversary Parma, 7-8 November 2012 Dr Pilar Rodríguez Iglesias Head of Unit Committees
More informationFeedback from ECHA on dossier and substance evaluation
Feedback from ECHA on dossier and substance evaluation REACH Implementation Workshop X 13 December 2011 Wim De Coen ECHA Evaluation Unit I Overview Directorate of Evaluation Dossier evaluation Compliance
More informationAUTHORISATION UNDER REACH UPSTREAM SUPPLY CHAIN APPLICATIONS
AUTHORISATION UNDER REACH UPSTREAM SUPPLY CHAIN APPLICATIONS DR. MARTINA VOSTEEN RAMBOLL ENVIRON, MUNICH, GERMANY ECHA REACH AUTHORISATION SEMINAR, HELSINKI, 18 APRIL 2017 RAMBOLL WORLDWIDE Our markets
More informationUS implication when purchasing ARTICLES from EU. Suppliers in the EU will provide this information to you.
Key dates from the Downstream User s Guidelines for REACH Bold text indicates a clear legal obligation or the high expectation of due diligence from the regulator Date Activity Downstream User in EU buying
More informationAssess hazards and risks What does it mean?
Assess hazards and risks What does it mean? 20 July 2016 Catherine Cornu European Chemicals Agency Phase 4: Assess hazard and risk Activities: 1. Understand your information requirements 2. Gather hazard
More informationIntertek Regulatory Services
Intertek Regulatory Services How Executive Management is redefining its Strategy regarding Regulatory Affairs Dr. Marc Thouin June 14th, 2011 Workshop Centro Reach 1 Eco-Management Topics REACH Restricted
More informationAT Experiences with the Zonal Evaluation Process (2)
AT Experiences with the Zonal Evaluation Process (2) Christian Prohaska Austrian Agency for Health and Food Safety (AGES) CEUREG 2012, Vienna www.ages.at Österreichische Agentur für Gesundheit und Ernährungssicherheit
More informationREACH-Code-Model Solution for the non-eu supply chain with final export to the EU
REACH-Code-Model Solution for the non-eu supply chain with final export to the EU Dr. Dieter Drohmann Managing Director Chemservice S.A. 5, an de Laengten, L-6776 Grevenmacher, Luxembourg d.drohmann@chemservice-group.com
More informationBPR update: Union Authorisation, Families and Same Biocidal Product
BPR update: Union Authorisation, Families and Same Biocidal Product Marcel Hulsman Ctgb Account Manager Biocides Brussels, 24 November 2016 Outline Ctgb Union Authorisation Biocidal Product Family Same
More informationREACH & CLP Consequences for Plastics Converters, Compounders & Masterbatchers and Recyclers
REACH & CLP Consequences for Plastics Converters, Compounders & Masterbatchers and Recyclers Downstream Users as Formulators Targets of Inspections 2 nd Enforcement Workshop with Stakeholder Organisations
More informationREACHing the 2020 goals
REACHing the 2020 goals Break-out group - 1 Data quality and availability Chairs: - Henrik Søren Larsen (DK) - Szilvia Deim (HU) Rapporteurs: - Christel Musset (ECHA) - Leena Ylä-Mononen (ECHA) Key areas
More informationPreparations for the 2018 REACH Registration deadline 48 th Meeting of the Management Board December 2017
1 (12) MB/55/2017 final Brussels, 15.12.2017 PUBLIC Preparations for the 2018 REACH Registration deadline 48 th Meeting of the Management Board 14-15 December 2017 Key messages The Management Board is
More informationUnion Authorization for a Biocidal Product Family
Union Authorization for a Biocidal Product Family ECHA s Biocides Stakeholders Day 26 September 2017 Caroline Hall 1 Content 1. Introduction 2. Why choosing Union Authorization of a Biocidal Product Family?
More informationREACH A Jotun Perspective
REACH A Jotun Perspective Aims of this presentation To identify key stages of what needs to be done to achieve compliance with REACH (Registration, Evaluation, Authorisation of Chemicals) Regulations To
More informationDISCOVER OUR SEGMENT CHEMICALS/ REACH
DISCOVER OUR SEGMENT CHEMICALS/ REACH Our focus Dr Thomas Roth Head of Chemicals, Cosmetics, Consumer Products and Feed & Food Additives In SCC, you have found the perfect partner for your substance rollout
More informationNecessary preparation before you start
Necessary preparation before you start IUCLID 5 Basics training by ECHA 27 September 2011 Charis Vezyridou ECHA Helpdesk Unit Training objectives This presentation is targeted to the HelpNet-4 hands-on
More informationIT tools: new features for registrants
IT tools: new features for registrants 11 th Stakeholders Day 25 May 2016 Mike Rasenberg Head of Unit - Computational Assessment and Dissemination Objective of the changes Make the tools clearer and easier
More informationWebinar - POP, REACH 67, Prop 65, IATA, Canada
Webinar - POP, REACH 67, Prop 65, IATA, Canada Lesser Known. High Impact Legislations. Presented by: Bruce Calder VP Consulting Services Overview - Agenda Introduction EU POP SCCPs Stockholm Convention
More informationThe new Biocidal Products Regulation. Outline and key elements
The new Biocidal Products Regulation Outline and key elements Istituto Superiore di Sanità 19 December 2013 Rome Pierre Choraine European Commission DG Environment, Unit A.3 Main principles Introduction
More informationArchivio Europeo delle miscele pericolose: aggiornamenti ed operatività
Archivio Europeo delle miscele pericolose: aggiornamenti ed operatività Maristella Rubbiani Istituto Superiore di Sanità - Roma Milano 03.10.2018 Contents The notification format The notification portal
More informationREACH & CLP implementation EU chemical industry view
REACH & CLP implementation EU chemical industry view REACH Conference 2018 3 4 September 2018, Bratislava Dr. Erwin Annys REACH In 1967 Europe got its first legislation on chemicals In 2006 the European
More informationA part of BMT in Energy and Environment REACH Guidelines for the Ministry of Defence
A part of BMT in Energy and Environment REACH Guidelines for the Ministry of Defence Client: Report no.: A.BMT.115-001 Date: 22 January 2008 Unclassified Intentionally blank page Report Title Client BMT
More informationREACH Review: Industry activities and views
REACH Review: Industry activities and views Christian Gründling International Chemical Policy from a European Perspective; October 24, 2018 Chemical Industry in Austria Facts and Figures 2017 250 Companies
More informationGLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE
GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE Medical Device Product Questionnaire This questionnaire is used to collect information from vendors with regards to medical devices that fall in any of the
More informationEvaluation under REACH
Evaluation under REACH Progress Report 2009 DISCLAIMER The report includes recommendations to potential registrants in order to improve the quality of future registrations. However, users are reminded
More informationChemical Risk Services
Chemical Risk Services Why Use IOM? IOM is a leading international provider of health and safety solutions to industry, commerce, public sector and professional bodies. We have an international reputation
More informationChemical Risk Services
Chemical Risk Services Why Use IOM? IOM is a leading international provider of health and safety solutions to industry, commerce, public sector and professional bodies. We have an international reputation
More informationThe EU REACH Regulation
The EU REACH Regulation CMS Supply Chain Innovation Workshop WSP Environmental Strategies October 25, 2007 Agenda Introduction How Will REACH Impact Industry? Key Elements and Timetable Potential Consequences
More informationNew China RoHS Standard and REACH SVHCs
New China RoHS Standard and REACH SVHCs SJ/T 11364-2014 and December 2014 SVHCs Presented by: Bruce Calder VP of Consulting Services Agenda Introduction New China RoHS Standard - Entry into force - Changes
More informationThe consequences of REACH for SMEs
The consequences of REACH for SMEs Jacques Pelkmans Lorna Schrefler Ineke Gubbels Committee on Industry, Research and Energy (ITRE), European Parliament, 23 January 2014 1 STRUCTURE REACH, pain or even
More informationGuidance for downstream users
Guidance for downstream users January 2008 Guidance for the implementation of REACH LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However,
More informationWork Programme Working for the safe use of chemicals across the EU
Work Programme 2010 Working for the safe use of chemicals across the EU LEGAL NOTICE The views or positions expressed in this Work Programme do not necessarily represent in legal terms the official position
More informationSetting priorities and processes at EU level to address dossier compliance
Setting priorities and processes at EU level to address dossier compliance BfR Berlin, August 2018 Andrej Kobe European Commission Outline Case for compliance REACH review Activities 2 Case for compliance
More informationPublic Consultation in relation to the REACH REFIT evaluation
Public Consultation in relation to the REACH REFIT evaluation A copy of the on-line Questionnaire sent by the Swedish Chemicals Agency enlarged with explanations to some provided answers. to: GROW-ENV-REACH-REVIEW@ec.europa.eu
More informationEU Regulation on the making available and use of biocidal products (BPR)
EU Regulation on the making available and use of biocidal products (BPR) Workshop on antifoulings SeaEurope 23/09/2016 M. Ludovic Chatelin European Commission 1 I Objectives and main provisions of the
More informationContents. 1. Certification of Materials 2. Supply of Materials
September 2013 1 Contents 1. Certification of Materials 2. Supply of Materials 2 1. CERTIFICATION OF MATERIALS The European standard which specifies the different types of inspection documents supplied
More informationQUALITY AGREEMENT. This Quality Agreement is made between. (Customer Legal Entity Name Hereinafter called CUSTOMER ) And
QUALITY AGREEMENT This Quality Agreement is made between (Customer Legal Entity Name Hereinafter called CUSTOMER ) And (Pall Legal Entity Name Hereinafter called PALL ) 1. Table of Contents 1. Table of
More informationIDMP update: A practical approach to IDMP implementation and the impact of the possible new phasing
IDMP update: A practical approach to IDMP implementation and the impact of the possible new phasing Frits Stulp Managing Director Iperion Life Sciences Consultancy Samarind Webinar July 29th, 2015 CONTENTS
More informationSUBPART ACQUISITION PLANS (Revised January 10, 2008)
SUBPART 207.1--ACQUISITION PLANS (Revised January 10, 2008) 207.103 Agency-head responsibilities. (d)(i) Prepare written acquisition plans for (A) Acquisitions for development, as defined in FAR 35.001,
More informationCommunication performed for Magnesium Zirconium Oxide
Substance: Magnesium Zirconium Oxide CAS: - EC: 939-960-9 Registration deadline : 2013 Dossier type : Full dossier (dopant) Lead registrant : Treibacher Schleifmittel GmbH (Imerys) Communication performed
More informationNon-exclusive right to handle the marketing and distribution for sale of reference materials from the JRC world-wide
EUROPEAN COMMISSION DIRECTORATE-GENERAL JOINT RESEARCH CENTRE Directorate F Health, Consumers & Reference Materials Unit F.6 Reference Materials Non-exclusive right to handle the marketing and distribution
More informationREGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC
REGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC Luxembourg, 8 December 2016 Annual Conference REACH&CLP Ruth MOELLER CONTENT ECHA and its Committees How substances of concern are regulated
More informationOzone as active substance under the Biocidal Products Regulation
Ozone as active substance under the Biocidal Products Regulation International Ozone Association World Congress & Exhibition Barcelona June 28 July 3, 2015 Bernhard Paolini Chairman EurO 3 zon Chairman
More information1. INTRODUCTION TO HANDBOOK 5
CONTENTS 1. INTRODUCTION TO HANDBOOK 5 1.1. Background of the handbook 5 1.2. Target group of the handbook 5 1.3. How to use the handbook? 5 1.4. Authors team 5 2. INTRODUCTION TO REACH 7 2.1. Meaning
More informationUKAS Supplement for the Accreditation of Environmental Verifiers for EMAS (the EU Eco Management and Audit Scheme Regulation 1221/2009)
CIS 11 Edition 1 September 2016 UKAS Supplement for the Accreditation of Environmental Verifiers for EMAS (the EU Eco Management and Audit Scheme Regulation 1221/2009) CIS 11 / Edition: 1 Page 1 of 7 Contents
More informationChanges to the Medical Devices Directive and affect on Manufacturers
TÜV Product Service Ltd Webinar 18 th November 2009 Changes to the Medical Devices Directive and affect on Manufacturers Henry Sibun Manager, Medical & Health Services UK CONTENTS / 1. Introduction 1.
More informationPDA & West Present: Combination Products Combination Product Hot Topics: Post Approval Device Changes and the New EU MDR Article 117 Requirements
PDA & West Present: Combination Products Combination Product Hot Topics: Post Approval Device Changes and the New EU MDR Article 117 Requirements Doug Mead, Sr. Director, CMC RA, Devices and Combination
More informationREACH Copper Overview: Pre-Registration & Cu Consortium
REACH Copper Overview: Pre-Registration & Cu Consortium REACH Application Substances will fall into one of the following routes A B C Registration Authorization Restriction Evaluation Authorization Restriction
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 October 2005 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
More informationRegulations that may surprise you
Regulations that may surprise you EU POP, Australia Asbestos, Canadian Prohibition, and Brazil Medical Eco Design Presented by: Bruce Calder VP Consulting Services Overview - Agenda Introduction Australia
More informationA study to gather insights on the drivers, barriers, costs and benefits for updating REACH registration and CLP notification dossiers
European Chemicals Agency A study to gather insights on the drivers, barriers, costs and benefits for updating REACH registration and CLP notification dossiers Final Report Amec Foster Wheeler Environment
More informationImplementing REACH - Safer chemicals in Europe
Implementing REACH - Safer chemicals in Europe 5 September 2013 Reykjavik - Iceland Maria O Shea ECHA Helpdesk European Chemicals Agency Outline Introduction: REACH in brief and what it means for your
More informationREACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group
REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group Agenda Overview REACH RoHS Related regulations Discussion: Key Risks Key Considerations Overview We have witnessed an unprecedented
More informationNO DATA, NO MARKET? REACH Compliance A workshop on data quality in registration Dossiers August 2018, Berlin. Dolores Romano
NO DATA, NO MARKET? REACH Compliance A workshop on data quality in registration Dossiers 23 24 August 2018, Berlin Dolores Romano EUROPEAN ENVIRONMENTAL BUREAU (EEB) Europe s largest network of environmental
More informationWhy Products are Failing RoHS Compliance?
Why Products are Failing RoHS Compliance? RoHS Failures Detected During Testing - January 15 2014 Presented by: Bruce Calder VP Consulting Services Agenda Introduction RoHS failures - Statistics - Most
More informationREACH: What ITI members need to know to limit business risk
REACH: What ITI members need to know to limit business risk Insert then choose Picture select your picture. Right click your picture and Send to back. Sarah Medearis ERM Partner, Product Stewardship Services
More informationData quality in CSR. Use, exposure and risk information. Andreas Ahrens (Unit C3) Lead registrant workshop Helsinki
Data quality in CSR Use, exposure and risk information Andreas Ahrens (Unit C3) 02.02.2012 Lead registrant workshop Helsinki Why emphasis on Chemical Safety Report? CSRs document how the substance can
More informationORPHAN DESIGNATION BY THE EMA. Paillard Juliette M2 AREIPS 15/11/2016
ORPHAN DESIGNATION BY THE EMA Paillard Juliette M2 AREIPS 15/11/2016 Legal basis 1. Legal background 2. Criteria SUMMARY Procedure 1. Prior to the submission 2. Submission and validation 3. Evaluation
More informationhromium Trioxide Authorization Consortium CTAC
hromium Trioxide Authorization Consortium CTAC hallenge of a uniform, europe-wide, supply chain intergrated dossier eminar on Applications for Authorization, Helsinki, 2012-10-01 r. Martin Kleban, LANXESS
More informationRecommendations for registrants to improve data quality in registration dossiers for chemicals 1000 tpa Based on the project REACH Compliance
TEXTE 65/2018 Recommendations for registrants to improve data quality in registration dossiers for chemicals 1000 tpa Based on the project REACH Compliance TEXTE 65/2018 Environmental Research of the
More informationOn-Call Management & Economic Development Consultant RFP Info Session. November 2018
On-Call Management & Economic Development Consultant RFP Info Session November 2018 Agenda Retainer overview Selection criteria Scope of services MWBE requirements Timeline Q&A Mixer 2 This contract will
More informationREACH REGISTRATION 2018 WHAT TO KNOW ABOUT THE COMPLIANCE DEADLINE International Aerospace Environmental Group. All rights reserved.
REACH REGISTRATION 2018 WHAT TO KNOW ABOUT THE COMPLIANCE DEADLINE REACH is the European Union (EU) law that ensures safe use of chemicals. It applies to products manufactured in or imported to the European
More informationAdopted by CHMP for release for consultation 15 December Start of public consultation 15 December 2016
1 September 2017 EMA/CHMP/ICH/809509/2016 Committee for Human Medicinal Products ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological
More informationRSC/CT Det. no. 1/2013
RSC/CT Det. no. 1/2013 Protocol 1631-P The English version of this Determination was prepared in order to help comprehension by non-italian mother tongue users, but is NOT an official document. Please
More information2. Explanation of law that the proposals amend and summary of the proposals
CHEMICALS - NOTIFICATION TO THE SCOTTISH PARLIAMENT The REACH (Amendment) (EU Exit) Regulations 2019 1. Name of instrument and summary of proposal: The REACH (Amendment) (EU Exit) Regulations 2019 will
More informationECHA policy for prevention of conflicts of interest
ECHA policy for prevention of conflicts of interest EP workshop 21 February 2013 Geert Dancet Executive Director ECHA INTERNAL 2/21/2013 2 Driving Legislation for ECHA REACH adopted in December 2006 ECHA
More informationCHEMICAL SAFETY REPORT Update 2: Submitted March 2016 (Replaces 1st Update of May 2013, and original version submitted 2010)
CHEMICAL SAFETY REPORT Update 2: Submitted March 2016 (Replaces 1st Update of May 2013, and original version submitted 2010) Substance Name: EC Number: CAS Number: Registrant's Identity: Climax Molybdenum
More informationISCC 204 AUDIT REQUIREMENTS AND RISK MANAGEMENT. Version 3.0
ISCC 204 AUDIT REQUIREMENTS AND RISK MANAGEMENT Version 3.0 II Copyright notice 2016 ISCC System GmbH This ISCC document is protected by copyright. It is freely available from the ISCC website or upon
More information