REACH 2018 Steps to a Successful Registration. Thursday, October 8, 2015
|
|
- Jeffry Fowler
- 5 years ago
- Views:
Transcription
1 REACH 2018 Steps to a Successful Registration Thursday, October 8, 2015
2 Today s Speakers Steps to a Successful REACH 2018 Registration Sandra Meijer, The REACH Centre REACH Overview with Special Considerations for REACH 2018 Rosalinda Gioia, The REACH Centre Registration Process and Logistics Steps to the REACH Registration Timelines and costs Actions for a successful Registration Jiaru Zhang, Gradient Technical Issues 2 Copyright Gradient 2015
3 REACH Overview with Special Considerations for REACH 2018 Dr Sandra Meijer 8 October 2015
4 REACH Overview REACH Registration no data, no market Industry needs to demonstrate that the risks associated with the use of the substance are adequately controlled Manufacturers and importers of chemicals (substances on their own or in mixtures) > 1 tpa need to register the substance(s) with the European Chemicals Agency (ECHA) Both new and existing substances
5 Exempt from Registration Specific substances for defence purposes Polymers (but not monomers used in them!) Certain named substances (Annex IV) Certain groups of substances (Annex V) Certain uses (medicinal, veterinary, food and foodstuffs) R & D and PPORD Recovered materials Re-imports REACH Overview
6 REACH Overview Registration Timelines Pre-registration (phasein substances only) Registration of : 1 tonne/year CMRs 100 tonnes/year very toxic to the aquatic environment 1000 tonnes/year 100 tonnes/year 1 tonne/year New substances; before manufacturing, importing or placing on the market
7 REACH Overview Impact of REACH on US companies REACH requirements placed on EU companies mean that often full product composition is needed in order to determine compliance obligations This creates CBI issues for US companies wishing to sell into Europe US companies can take on registration obligations in order to safeguard CBI (via Only Representative) The OR carries out the REACH duties of an importer (but not the commercial activities of an importer such as customs clearance etc) The OR will submit the pre-registration and registration and will be the contact with the ECHA
8 REACH Overview Only Representative vs. Importer Non-EU manufacturer A Non-EU EU Take home: Be well aware of the supply chain and communicate with your EU client to ensure business continuity Trader EU manufacturer EU company Non-EU manufacturer B Only Rep
9 REACH Overview Late pre-registration It is possible to make a late pre-registration but only for new activities A late pre-registration must be made within 6 months of the activity commencing but cannot be made within 12 months of an applicable phase-in registration deadline (i.e. not after 1st June 2017 for registration deadline of 1 st June 2018) Phase-in substances which have not been pre-registered require immediate registration following the submission of an Inquiry to ECHA This can delay access to the EU market as processing of Inquiry dossiers by ECHA can be very slow! Take home: even if volumes are currently low (< 1t), consider a late pre-registration now in order to avoid delays later on
10 REACH Overview Inquiry Process Non phase-in substances and substances that have not been pre-registered require submission of an Inquiry to ECHA (Article 26); Inquiry dossier includes full characterisation which is assessed by ECHA before approving substance identity (so that correct SIEF can be identified) Inquiry dossiers often fail due to insufficient substance identity information No time limit on ECHA s assessment period Lengthy process compared to pre-registration Take home: Inquiry process can act as a barrier to EU market access
11 REACH 2018 Get ready for The final registration deadline is 31 May 2018 Tonnage bands: 1 10 tpa tpa ECHA is expecting up to 70,000 registrations More SMEs More niche chemicals this time Confidentiality issues OR solution Less data available Larger portfolios more time needed! Take home: Start now
12 Thank you Dr. Sandra Meijer twitter.com/thereachcentre
13 Registration Process and Logistics Dr Rosalinda Gioia 8 October 2015
14 Registration Process Main steps to a successful registration 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date
15 Registration Process Step 1: Know your portfolio 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date Registrants responsible for safe manufacture and use 1. Identify number of substances: How many do we need to register by 2018? 2. Identify your tonnage band: Are your tonnage band still valid? 3. Establish substance identity: Are these substances what we think they are? Point (3) and is the basis for all other activities
16 Registration Process Step 2. Find your co-registrants 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date Every company that has pre-registered a substance is automatically part of the pre-sief. Agree on substance sameness No need to apply to join a SIEF (& no cost attached) It is possible to change SIEFs e,g. if you realise your substance is different from what you thought or when SIEFs are split or merged
17 Registration Process Step 2. Find your co-registrants Substance NOT YET registered by industry Has anyone offered to take the lead? NO Do we want to take the lead? NO WAIT? < 1 TPA? REPLACE? OR Substance ALREADY registered by industry YES YES BUSINESS DECISION! Submit a Joint Registration Prepare and submit a Lead dossier; Act as Lead Registrant
18 Registration Process Step 2. Agree on Datasharing If your substance is already registered: Letter of Access costs need to be fair, equitable and nondiscriminatory Varies widely from 500 EUROS to 250,000 EUROS Cost divided by number of registrants (so # of registrants has big impact!) You can t negotiate a special price You shouldn t have to pay again for data you already own Most LRs envisage a refund possibility after 2018 (more registrants expected to come on board between now and 2018) Cost sharing SIEF members must reach an agreement on how to share the cost of data and the cost of SIEF administration [ ] Under REACH, the cost needs to be shared in a fair, transparent and non-discriminatory way
19 Registration Process STEP 2. Lead Registrant role If you are taking the LR role: Perform literature search and data gap assessment Plan to fill data gaps Prepare a SIEF agreement. Use model agreements and templates prepared by industry associations like CEFIC. Reach a general agreement on how to share the cost of data and the cost of SIEF administration (fair, transparent, non-discriminatory). Do you have the expertise to complete registration? For Lead Registration Time, Preparation and Expertise are important factors.
20 Registration Process Fleisher Costs Data Costs Fleischer 1-10t t t 1000t+ Cost (EUR) Annex VII phys/chem $19,126 Annex VII tox endpoints $40,892 Annex VIII $322,266 Annex IX $690,690 Annex X $1,198,932 Total $2,271,906 Fleischer, M (2007) Testing Costs and Testing Capacity According to the REACH Requirements - Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland, 4(3), Journal of Business Chemistry, p In practice, a number of studies may not need to be performed Read across Data waiving Literature data available
21 Timelines for LR (1-10 tonnes) Registration Process Week Substance Characterisation Data Gap Analysis + ITS Quotes Physchem Human Toxicology (Phase 1) Human Toxicology (Phase 2) Ecotoxicology Dossier preparation and submission Shorter timeframe if not all tests are required
22 Registration Process STEP 3. Prepare and submit your dossier in IUCLID 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date IUCLID stands for International Uniform ChemicaL Information Database A database system for the storage and retrieval of detailed hazard information concerning chemical substances. Compliant with OECD Harmonised Data Formats and compatible with other pieces of legislation (e.g. the Biocidal Products Regulation) Can be installed as stand-alone or network systems Contains 9,000 data fields
23 Registration Process Step 3. Submit your dossier If you are a lead registrant Create the joint submission object in REACH-IT; Communicate the joint submission name and token generated by REACH-IT to the members; Submit the lead registration dossier in REACH-IT. ECHA will check if it can process your dossier (business rules). Only after this check, will members be able to submit their own dossiers. You are strongly advised to submit your lead dossier well before the end of May
24 Registration Process Step 3. Submit your dossier If you are a member registrant After receiving the joint submission token from your lead, confirm your membership in the joint submission in REACH- IT; Check in REACH-IT that the joint registration dossier submitted by the lead registrant has been accepted; Submit your IUCLID registration dossier in REACH-IT. ECHA will check if it can process your dossier (business rules). This is the check you need to pass by 31 May
25 Registration Process Step 4. Keep your registration up-to-date 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date What happens next? ECHA may examine any registration to verify if the information submitted by registrants is compliant with the legal requirements. The selection for compliance check is either random or concern-based (targeted).
26 Step 4: Changes requiring dossier update It is a legal requirement to keep your registration up-to-date For Lead Registrants this could include: New hazard data New uses (e.g. if new members join) New harmonised classification and labelling Also check ECHA's annual evaluation reports. Pro-actively improving your dossier may help to avoid a dossier evaluation. For Joint (and Lead) registrants this could include: Company size Tonnage band New uses Registration Process
27 Registration Process Take-home messages Identify number of substances to register and their identities- Start as early as possible. Establish if LR or JR - Business decision Consider time and costs required for studies. Start as early as possible to allow a sequential testing scheme-cost Minimization If you are a JR complete the relevant sections in IUCLID as soon as you receive the information from the LR
28 Thank you Dr Rosalinda Gioia twitter.com/thereachcentre
29 Steps to a Successful REACH 2018 Registration Technical Considerations Jiaru Zhang, MPH Gradient October 8 th, 2015
30 Main steps to a successful registration 1. Know your portfolio 2. Find your coregistrants and agree on data sharing 3. Prepare and submit your IUCLID dossier 4. Keep your registration up-to-date 30 Copyright Gradient 2015
31 Substance identification and characterization Why it s so important? 31 Copyright Gradient 2015
32 Substance Identification and Characterization Allow Joint Registration-Proves that your substance fits the Substance Identification Profile (SIP) developed by the Substance Information Exchange Forum (SIEF) Robust Hazard Identification It is the area most likely to be found to be inadequate during ECHA compliance checks 66% of dossiers reviewed in 2012 had short comings in substance identity Can lead to significant delays 32 Copyright Gradient 2015
33 Substance Identification Name (in IUPAC nomenclature, CAS RN, EINECS) Well-Defined Substances: Mono-constituents : Identify the constituent present at 80 % Multi-constituents: Identify all constituents present at 10% UVCB (Unknown or Variable composition, Complex reaction products or Biological materials) Identify all constituents 10% Identify by source, process, known composition, etc Molecular Information Molecular and structural formulas (SMILES notation) Molecular weight or range (difficult for polymers) Composition (must equal 100%) Purity Additives 33 Copyright Gradient 2015
34 Characterization Testing: Analytical Confirmation of Substance Identity Standard Tests for Organic Substances Standard Tests for Inorganic Substances Required Ultraviolet and Visible Absorption Spectroscopy (UV/Vis) Infrared Spectroscopy (IR) Nuclear Magnetic Resonance Spectroscopy (NMR) Required X-Ray Diffraction (XRD) X-Ray Fluorescence (XRF) Atomic Absorption Spectroscopy (AAS) When appropriate Gas Chromatography (GC) High-Performance Liquid Chromatography (HPLC) UVCBs and other difficult to characterize substances may require other tests Optical Activity 34 Copyright Gradient 2015
35 Data Requirements What are the data requirements for REACH 2018 registration substances? 35 Copyright Gradient 2015
36 Data Requirement (1-10 Tonnes/Year) Type Vertebrate (N=2) Non-vertebrate (N=6) Physical- Chemical (N=13) Data Acute toxicity oral (rat); In vivo skin sensitization (guinea pig) In vitro skin irritation/corrosion (Ex: OECD 439 Reconstructed Human Epidermis Test Method); In vitro eye irritation (Ex: OECD 437 Bovine Corneal Opacity and Permeability); In vitro gene mutation in bacteria (Ex: Ames Assay); Short-term toxicity on invertebrates (Ex: OECD 202 Daphnia Magna); Growth inhibition study aquatic plants (Ex: OECD 201 Algal); Ready biodegradability Melting/freezing point; Relative density; Water solubility; Partition coefficient; Flash-point; Flammability; Explosive properties; Self-ignition temperature; Oxidizing properties; Vapor pressure; Surface tension; Boiling point; Granulometry 36 Copyright Gradient 2015
37 Data Requirement ( Tonnes/Year) Type Data All data requirements from 1-10 tonnes/year (Max N=21), plus the following Vertebrate Short-term repeated dose toxicity (28-day); (N=8) Screening for reproductive/developmental toxicity (54-day); Acute toxicity inhalation + dermal; In vivo skin + eye irritation; Testing proposal for in vivo genotoxicity; Non-vertebrate (N=6) Chemical Safety Report (CSR) Short-term toxicity on fish or proposal for long-term toxicity on fish; etc In vitro mutagenicity study in mammalian cells or In vitro micronucleus study; In vitro gene mutation in mammalian cells; Hydrolysis; etc Calculate risk (Risk=Hazard x Exposure) Must know own exposure scenario (ECHA guidance available) CSR can be few pages long Must submit to ECHA a downstream user report Take Home: Registrants must use existing information and non-test methods to meet information requirements (Max N=35 tests + CSR). Testing on vertebrate animals should only be used as a last resort. 37 Copyright Gradient 2015
38 Hazard Assessment Required, but why should one care about getting this right? 38 Copyright Gradient 2015
39 Importance of Getting Hazards "Right" Correctly characterize risk in the chemical safety report (CSR), required for tonnes/year substances Hazard x Exposure = Risk Accurately convey hazards to workers and the public Ensure adequate worker protections Confidential Business Information (CBI) In many countries, specific hazards trigger mandatory safety datasheet (SDS) disclosure. This could lead to lose of proprietary information 39 Copyright Gradient 2015
40 Hazard Assessment What can I do to get it right? 40 Copyright Gradient 2015
41 Environment Human Health Physical Safety Acute Aquatic Toxicity Acute Toxicity Explosive Chronic Aquatic Toxicity Skin Damage Pyrotechnic Bioaccumulation Eye Damage Flammable Gas Biodegradation (persistent/inherent) Reproductive Toxicity Oxidizing Gas Ozone Hazard Mutagenicity Gases Under Pressure 41 Copyright Gradient 2015 Carcinogenicity Sensitizer Acute Target Organ Toxicity Chronic Target Organ Toxicity Aspiration Hazard Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Version 6 Flammable Liquid Flammable Solid Self-Reactive Substance Pyrophoric (Liquids and Solids) Self-Heating Substance Emit Flammable Gases in Contact with Water Oxidizing Liquid Oxidizing Solid Organic Peroxide Corrosive to Metals Desensitized Explosives (new) Pyrophoric Gases (new)
42 Hazard Determination Considerations 1. Conflicting Data 2. No data 3. Read-across 4. Structural alert/predictive toxicology software 5. Data-waiving 42 Copyright Gradient 2015
43 What to do With Conflicting Data? Chemical X (UVCB and with Impurities) Endpoint Company Own Data Publically Available Data on Chemical X Acute Aquatic Not Classified Aquatic Cat. 1 Acute (H400) Mutagenicity No Data Positive in vitro Ames test What would you do in this scenario? 43 Copyright Gradient 2015
44 What to do With Conflicting Data? Chemical X (UVCB with Impurities) Endpoint Acute Aquatic Mutagenicity Company Own Data Not Classified No Data Publically Available Data on Chemical X Aquatic Cat. 1 Acute (H400) Positive in vitro Ames test Hazard Determination Not Classified 1. Chemical X is a UVCB? 1. Get impurity data and study details for publically available study 2. Commission an in vitro Ames test Take Home: Not straight forward. Have a weight of evidence rationale for your hazard determination. Document! 44 Copyright Gradient 2015
45 What to do With No Data? Read-Across: Identification and evaluation of a similar chemical that informs the toxicity of the chemical of concern by chemists and toxicologist (not by software) Ex: 1-octanol as a read-across for 1-hexanol Advantage better informed hazard evaluation & SDS, ensure chemicals are used more safely, minimizes analytical costs and dependence on animal testing, and helps industry to comply with regulations Disadvantage required high-qualified chemists and toxicologist 45 Copyright Gradient 2015
46 What to do With No Data? (Read-Across) Chemical Y (ph=2) Chemical Y Read-across Toxicological Data Hazard Determination No Company Test Data No data Daphnia Magna 48 hr EC 50 = 0.66 mg/l (OECD 202); Corrosive to skin in rabbits with necrosis (OECD 404) Aquatic Acute 1 (H400); Skin Corrosive 1B (H314) What would you do in this scenario? 46 Copyright Gradient 2015
47 What to do With No Data? (Read-Across) Chemical Y (ph=2) Chemical Y Read-across Toxicological Data Hazard Determination No Company Test Data Aquatic? Skin Corrosive 1B (H314) Daphnia Magna 48 hr EC 50 = 0.66 mg/l (OECD 202); Corrosive to skin in rabbits (OECD 404) Aquatic Acute 1 (H400); Skin Corrosive 1B (H314) Take Home: No data is not an appropriate response. Registrants must use existing information and non-test methods to meet information requirements. Read-across can be employed as way to meet information requirement and minimize animal testing. 47 Copyright Gradient 2015
48 What to do With No Data? Structural Alert/Predictive Toxicology Software Identification of potential hazards for chemical of concern Ex: ToxTree, OECD QSAR Toolbox, DEREK, ECOSAR Advantage Cost (ToxTree, OECD QSAR Toolbox, ECOSAR); Quick turn around Disadvantage Cost (DEREK); Poor underlying dataset for polymers, UVCBs, niche chemicals; Require in-depth chemistry and toxicology knowledge; Not user friendly 48 Copyright Gradient 2015
49 What to do With No Data? Structural Alert/Predictive Toxicology Software Quote from ECHA Chapter R.4 Evaluation of Available Data "To be used as a replacement for experimental data, it is necessary, but not sufficient, for a (Q)SAR model to be valid. The (Q)SAR model should also be shown to be applicable to the substance of interest, to determine whether the model estimate is reliable for the intended purpose." Take Home: Usage of predicted hazards to toxicity profile is dependent on your company's risk tolerance. Keep in mind of all the implications of hazard assessment: Chemical Safety Report (Hazard x Exposure = Risk) and Confidential Business Information (CBI). 49 Copyright Gradient 2015
50 What to do With No Data? Data-waiving Testing for a specific endpoint may be omitted if testing is Technically not possible, or Not scientifically necessary, or Can prove exposure scenario does not apply to substance (only for endpoints in Annexes IX-X and sections 8.6 (repeated dose toxicity) and 8.7 (reproductive toxicity) in Annex VIII 50 Copyright Gradient 2015
51 Data-Waiving Examples Tonnes/Year Type Vertebrate Nonvertebrate Physical- Chemical Common reasons for waiving requirements in parenthesis Short-term repeated dose toxicity-28d (existing or planned 90d study, non-applicable exposure routes); In vivo skin sensitization (corrosive or <2 ph >11); Testing proposal for in vivo genotoxicity (no positive results from any of the in vitro or in vivo studies); Acute toxicity dermal (corrosive); etc In vitro skin irritation/corrosion (corrosive, no irritation observed up to dermal LD50 of 2,000 mg/kg bw); Short-term toxicity on invertebrates (highly insoluble); In vitro gene mutation in bacteria (Substance is antimicrobial); Degradation (inorganic); etc Partition coefficient (inorganic); Water solubility (hydrolytically unstable at ph 4, 7, and 9); Vapor pressure (MP > 300⁰C); Boiling point (gas or decomposes before boiling); etc Take Home: Need supporting evidence for your waiving basis. Cannot just be a statement. 51 Copyright Gradient 2015
52 Technical Conclusions for a Successful REACH 2018 Registration Substance characterization/identification 66% of dossiers reviewed in 2012 had short comings in substance identity. Registrants must clearly identify all constituents of their substances and provide rigorous analytical support (including raw data, instrument calibration, calculations) for their conclusions or face potential delays. Data-requirements Data requirement increase with higher tonnage. Registrants must use existing information and non-test methods to meet information requirements. Testing on vertebrate animals should only be used as a last resort. Assessing hazards and risks Getting the hazards "right" is important for worker safety, legal implications, and Confidential Business Information (CBI). Getting the hazards "right" depends on understanding nuances of GHS, underlying data source, multiple approach for data-gaps, etc. 52 Copyright Gradient 2015
53 Thank you! Questions?
54 Thank you! Jiaru Zhang Gradient 20 University Road Cambridge, MA Ari S. Lewis Gradient 20 University Road Cambridge, MA Sandra Meijer The REACH Centre Lancaster University Lancaster, Lancashire LA1 4YQ Rosalinda Gioia The REACH Centre Lancaster University Lancaster, Lancashire LA1 4YQ 54 Copyright Gradient 2015
Get ready for Meeting your information requirements. 11 th Stakeholder s Day. 25 May 2016
Get ready for 2018 Meeting your information requirements 11 th Stakeholder s Day 25 May 2016 Laurence Hoffstadt, PhD Senior Scientific Officer Evaluation Directorate Key messages It takes time Get organised
More informationPractical guide for SME managers and REACH coordinators. How to fulfil your information requirements at tonnages 1-10 and tonnes per year
Practical guide for SME managers and REACH coordinators How to fulfil your information requirements at tonnages 1-10 and 10-100 tonnes per year Version 1.0 July 2016 2 Practical guide for SME managers
More informationGuidance Documents for New Chemical Substance Notification in China (China REACH) Non Official
Guidance Documents for New Chemical Substance Notification in China (China REACH) Non Official On 19 Jan 2010, the Ministry of Environmental Protection (MEP) of China released the revised version (MEP
More informationData Requirements for New Chemical Notification in China Please go to for more info about China REACH
Data Requirements for New Chemical Notification in China Please go to http://www.cirs-reach.com/ for more info about China REACH Original Article by Chemical Inspection and Regulation Service (CIRS) in
More informationREACH 2018 Registration Deadline
Annual Conference & Networking Lunch REACH&CLP REACH 2018 Registration Deadline Dr. Dominik Kirf (ERT) CHEMSERVICE S.A. Luxembourg, 8 December 2016 1 CHEMSERVICE Group Consulting company founded in 2007
More informationTesting of chemicals for classification according to REACH and GHS
Testing of chemicals for classification according to REACH and GHS Norbert Bornatowicz, Head Toxicology Seibersdorf Labor GmbH 2444 Seibersdorf, AUSTRIA Overview on the presentation Classification: IUCLID
More informationTesting of chemicals for classification according to REACH and GHS
Testing of chemicals for classification according to REACH and GHS Norbert Bornatowicz, Head Toxicology Seibersdorf Labor GmbH 2444 Seibersdorf, AUSTRIA Overview on the presentation Classification: IUCLID
More informationDavid Owen Shell Chemicals Ltd ISRTP Workshop, Baltimore November 2005
REACH: alternatives and tiered strategies David Owen Shell Chemicals Ltd ISRTP Workshop, Baltimore November 2005 Contents Background and scope Components of REACH Information requirements Implementation
More informationPLANNING 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 informationGUIDANCE DOCUMENT ON APPLICATIONS FOR TECHNICAL EQUIVALENCE
G U I D A N C E GUIDANCE DOCUMENT ON APPLICATIONS FOR TECHNICAL EQUIVALENCE 1 1 2 3 4 5 6 7 8 9 10 LEGAL NOTICE This document contains guidance on Regulation (EU) No 528/2012 of the European Parliament
More informationGuidance on applications for technical equivalence
1 guidance Guidance on applications for technical equivalence Guidance on Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Version 1.0 August 2013
More informationTesting Methods and Directives
EUROPEAN COMMISSION DIRECTORATE GENERAL - JRC JOINT RESEARCH CENTRE Institute for Health and Consumer Protection Unit: Toxicology and Chemical Substances European Chemicals Bureau D:\My Documents\JR\Tables\OFFJOUR\Listofoj.doc
More informationChemical Safety Assessment Under REACH
Chemical Safety Assessment Under REACH Dinant Kroese TNO knowledge for business CONTENTS 1. Registration requirements 2. Core tools under REACH 3. Chemical Safety Assessment (CSA) Human Health 4. Our experience
More informationIntegrated Testing Strategies for REACH. Perspective from the European Chemicals Agency
Integrated Testing Strategies for REACH Perspective from the European Chemicals Agency Jack de Bruijn Directorate for Assessment European Chemicals Agency SETAC EUROPE Special Science Symposium, 23-24
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 informationCHEMICAL SAFETY REPORT. Substance Name: Glucose EC Number: CAS Number: Registrant's Identity: Example Company 1
CHEMICAL SAFETY REPORT Substance Name: Glucose EC Number: 200-075-1 CAS Number: 50-99-7 Registrant's Identity: Example Company 1 Table of Contents Part A... 1 1. SUMMARY OF RISK MANAGEMENT MEASURES...
More informationTypical Notification Service under China REACH
Typical Notification Service under China REACH China REACH applies to new chemical substances that are not currently listed on the Inventory of Existing Chemical Substances Produced or Imported in China
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 informationIntroduction to GHS. The Globally Harmonised System of Classification and Labelling of Chemicals. Cecilia Westöö April 2014 Bangkok
Introduction to GHS The Globally Harmonised System of Classification and Labelling of Chemicals Cecilia Westöö April 2014 Bangkok Introduction to GHS - Development of GHS - background and scope - Elements
More informationIs your next regulatory deadline within REACH?
Is your next regulatory deadline within REAC? 2018 500ml Smithers Viscient testing schedule REAC Annex VII/VIII Guideline Study Type Week Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
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 applications for technical equivalence Version 1.1 March 2017 2 Guidance on BPR: Volume V Version 1.1 March 2017 Legal
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 informationCost Reduction in REACH Alternatives to Testing ChemicalWatch EXPO Berlin, April 2017 Peter Jenkinson CEHTRA
Consultancy for Environmental and Human Toxicology and Risk Assessment Science Beyond Regulatory Compliance Cost Reduction in REACH Alternatives to Testing ChemicalWatch EXPO Berlin, April 2017 Peter Jenkinson
More informationGuidance on information requirements and chemical safety assessment Part F: Chemical Safety Report
Guidance on information requirements and chemical safety assessment Part F: Chemical Safety Report May 2008 Guidance for the implementation of REACH LEGAL NOTICE This document contains guidance on REACH
More informationLuisa Su, M.H.Sc. ROH. Whistler, British Columbia September 21, 2011
GHS the New WHMIS: Coming to Your Workplace Soon Luisa Su, M.H.Sc. ROH CSSE 2011 Whistler, British Columbia September 21, 2011 Today s presentation Differences in approaches WHMIS/GHS classification WHMIS/GHS
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 informationVersion 1.0 Revision Date Print Date SECTION 1: Identification of the substance/mixture and of the company/undertaking
SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : 1.2 Relevant identified uses of the substance or mixture and uses advised against Use
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 informationTechnical Notes for Guidance. on the assessment of technical equivalence of substances regulated under Directive 98/8/EC
Technical Notes for Guidance on the assessment of technical equivalence of substances regulated under Directive 98/8/EC These Technical Notes for Guidance were adopted during the 29 th meeting of representatives
More informationCOMMISSION REGULATION (EU) / of
EUROPEAN COMMISSION Brussels, 3.12.2018 C(2018) 7942 final COMMISSION REGULATION (EU) / of 3.12.2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration,
More informationREACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.
REACH REGULATION: the new management of chemicals in Europe and operational tools R egistration E valuation A Ch uthorisation emicals Index of topics Set of rules before REACH Regulation REACH REGULATION
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 informationMATERIAL SAFETY DATA SHEET SDS/MSDS. HEPES CAS No
HEPES CAS No 7365-45-9 MATERIAL SAFETY DATA SHEET SDS/MSDS SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifiers Product name : HEPES CAS-No. : 7365-45-9
More informationANNEX. 1. Annex I to Regulation (EC) No 1907/2006 is amended as follows:
Ref. Ares(2017)4925011-09/10/2017 EN ANNEX 1. Annex I to Regulation (EC) No 1907/2006 is amended as follows: (a) Subsection 0.1. is replaced by the following: "0.1. The purpose of this Annex is to set
More informationSAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Product name: Eastman Amphora(TM) 3D Polymer AM3300 Product No.: AM3300, 50183228,
More informationGuidance on information requirements and chemical safety assessment Part B: Hazard assessment
Guidance on information requirements and chemical safety assessment Part B: Hazard assessment Version 2 August 2011 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations
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 information: UV737 Fluorescent Invisible Crayons
SECTION 1: Identification 1.1. Identification Product form Product name Product code : Mixture : UV737 Fluorescent Invisible Crayons : UV737 1.2. Relevant identified uses of the substance or mixture and
More informationProduct safety summary
Product safety summary Dibutyl fumarate (DBF) 1. General Statement DBF is produced for the use as monomer for production of polymers and as intermediate for synthesis of chemical intermediates or chemical
More informationSAFETY DATA SHEET QSR OVEN CLEANER
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Cleaning product Restrictions on use : Reserved for industrial and professional
More information-REACH - Hazard Data: Requirements and Closing Gaps
-REACH - Hazard Data: Requirements and Closing Gaps Presented By: Tony Mallett Experien Health Sciences Houston London Philadelphia Cincinnati What s changed with REACH? Manufacturers and importers must:
More informationDisclaimer: The document does not represent a formal draft Commission proposal which may differ from the elements presented.
EUROPEAN COMMISSION Directorate General for Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environment and Health Technologies REACH Chemicals Directorate General for Environment Green
More informationSAFETY DATA SHEET. Version 1.0 Revision Date: 07/11/ Identification. 2. Hazard(s) Identification 1/6. Material name: ImmerSeal HD
SAFETY DATA SHEET 1. Identification Material name: ImmerSeal HD Recommended use and restriction on use Recommended use: Extrudate Restrictions on use: Not known Manufacturer/Importer/Supplier/Distributor
More informationOfficial Journal of the European Union. (Non-legislative acts) REGULATIONS
4.12.2018 L 308/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the
More informationSCOTT Golden Lotion Soap
SECTION 1. IDENTIFICATION Product name : Product code : 91437 Manufacturer or supplier's details Company name of supplier : Kimberly-Clark Corporation Address : 14 Holcomb Bridge Road, Roswell, GA 376-2199
More informationMSDS Material Safety Data Sheet Ammonium Sulfate
1.1. Product identifier Product name : Ammonium Sulfate Chemical family : Inorganic compound 1. Identification of the substance/mixture 1.2. Relevant identified uses of the substance or mixture and advised
More informationAppendix 9B: HSNO Classification for Assistance in Rating of Hazardous
Appendix 9B: HSNO Classification for Assistance in of Hazardous Substances in the HFSP The full description of HSNO classes, sub-classes and categories, as well as explanations of terms used, is contained
More informationICCA s Contribution to SAICM: (GPS)
ICCA s Contribution to SAICM: The Global Product Strategy The Global Product Strategy (GPS) About ICCA The International Council of Chemical Associations (ICCA) is the world-wide voice of the chemical
More informationSafety Data Sheet 3057 according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Date of issue: 07/21/2015
SECTION 1: Identification 1.1. Identification Product form Product name CAS No POLAR ICE MELT 3057 Date of issue: 07/21/2015 : Mixture : POLAR ICE MELT : x Product code : 3057 1.2. Relevant identified
More informationProduct Safety Summary
Product Safety Summary Phenol, 2-(1-methylpropyl)- This product safety summary is intended to provide a general overview of the chemical substance. The information on the Summary is basic information and
More informationSafety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Date of issue: 09/02/2015
Date of issue: 09/02/2015 SECTION 1: Identification 1.1. Identification Product form Product name Product code Other means of identification : Mixture : 1200WR-A : 1200WR-A : 1200WR-A/1,1200WR-A/55, 1200WR-A/Q
More informationNB: Unofficial translation; legally binding texts are those in Finnish and Swedish Ministry of the Environment, Finland
NB: Unofficial translation; legally binding texts are those in Finnish and Swedish Ministry of the Environment, Finland Ministry of the Environment Decree on the Applications and Notifications Concerning
More information- A6/18 - Format for the listing of test and study reports and other documentation PART 4
- A6/18 - PART 4 OECD, EU, US, CANADIAN, JAPANESE AND AUSTRALIAN NUMBERING SYSTEMS FOR DATA AND INFORMATION ON PHEROMONE AND OTHER SEMIOCHEMICAL ACTIVE SUBSTANCES 1. As indicated in subparagraph 3.1.1
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 informationProduct Stewardship Summary
Product Stewardship Summary Bisphenol A Epoxy Diacrylate General Statement Bisphenol A epoxy diacrylate is an epoxy acrylate oligomer that provides high gloss, imparts excellent reactivity and features
More informationProduct Stewardship Summary N-vinyl-2-pyrrolidone
Product Stewardship Summary N-vinyl-2-pyrrolidone General Statement N-vinyl-2-pyrrolidone (VP) is commonly used as a reactive diluent for radiation curing in UV-coating, UV-inks, and UVadhesives. It is
More informationGPS Safety Summary. 1,7-Octadiene
GPS Safety Summary 1,7-Octadiene This Product Safety Summary is intended to provide a general overview of the chemical substance in the context of ICCA Global Product Strategy. The information on the summary
More informationSAFETY DATA SHEET by Commission Regulation (EC) No 830/2015 (REACH)
SECTION 1: IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY/UNDERTAKING 1.1 Identification of the substance / preparation Product name: Flexfill 98A 3D printing filament 1.2 Application Use of the
More informationGPS Safety Summary. Polysulfides, di-tert-dodecyl
GPS Safety Summary Substance Name: Polysulfides, di-tert-dodecyl 1. General Statement Polysulfides, di-tert-dodecyl is a colourless liquid organic compound, with a slight characteristic odour. It is used
More informationOECD, EU, US, CANADIAN, JAPANESE AND AUSTRALIAN NUMBERING SYSTEMS FOR DATA AND INFORMATION ON PHEROMONE AND OTHER SEMIOCHEMICAL FORMULATED PRODUCTS
- A6/52 - Appendix 6 Format for the listing of test and study reports and PAT 5 OECD, EU, US, CANADIAN, JAPANESE AND AUSTALIAN NUMBEING SYSTEMS FO DATA AND INFOMATION ON PHEOMONE AND OTHE SEMIOCHEMICAL
More informationSAFETY DATA SHEET. Restrictions on use : Reserved for industrial and professional use. : ,
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Air Freshener Restrictions on use : Reserved for industrial and professional
More information: Epsom Salt pure, technical
1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : Magnesium Sulphate Heptahydrate (MgSO 4 7H 2 O) 1.2 Relevant identified uses of the substance
More informationProduct Stewardship Summary
Product Stewardship Summary Sodium xylene sulfonate General Statement Sodium xylene sulfonate is a hydrotrope, an organic compound that increases the ability of water to dissolve other molecules. Sodium
More informationSAFETY DATA SHEET. 1. Identification. 2. Hazard(s) identification. 3. Composition/information on ingredients. 4. First-aid measures
1. Identification SAFETY DATA SHEET Material name: TR0643E 70 DURO EPDM WEDGE GASKET Material: 0020643E7Z Recommended use and restriction on use Recommended use: Article Restrictions on use: Not known.
More informationSAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier Product name: Pamolyn(TM) 347 Fatty Acid Product No.: EAN 800533. P7550300 Synonyms,
More informationProduct Safety Summary for Cyclohexanone
Product Safety Summary for SUBSTANCE NAME Cyclohexanon (7CI, 8CI, 9CI) Anon Anone Pimelin ketone Pimelic ketone GENERAL STATEMENT is a light yellow liquid with an odor that resembles peppermint oil. It
More informationSAFETY DATA SHEET. Restrictions on use : Reserved for industrial and professional use. : ,
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Skin-care Restrictions on use : Reserved for industrial and professional
More informationSAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier Product name: Pamolyn(TM) 100 FGK Kosher Oleic Acid Product No.: EAN 800525. E7549501
More informationSILVER FERN CHEMICAL
SILVER FERN CHEMICAL Safety Data Sheet (DOTP) SECTION 1: IDENTIFICATION Product Name: CAS Number: 6422-86-2 Chemical Name: bis (2-ethylhexyl) terephthalate Synonyms: Bis(2-ethylhexyl) terephthalate; DOTP
More informationGuidance on information requirements and chemical safety assessment
Guidance on information requirements and chemical safety assessment Appendix to Part F CSR Template with explanation July 2008 Guidance for the implementation of REACH Guidance on Information Requirements
More informationMixture Hazard Assessment Methodology
Mixture Hazard Assessment Methodology March 2018 Written in collaboration with ToxServices LLC Copyright 2017 Cradle to Cradle Products Innovation Institute No part of this publication is to be reproduced
More informationSAFETY DATA SHEET. Restrictions on use : Reserved for industrial and professional use. : ,
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Skin-care Restrictions on use : Reserved for industrial and professional
More informationSAFETY DATA SHEET. Restrictions on use : Reserved for industrial and professional use. : ,
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Instrument cleaner Restrictions on use : Reserved for industrial and professional
More informationKLEENEX Moisturizing Hand and Body Lotion (6372/6373)
SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : 1.2 Relevant identified uses of the substance or mixture and uses advised against Use
More informationSAFETY DATA SHEET PINNACLE GROUT LINE IMPREGNATOR
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other means of identification : Not applicable. Recommended use : Floor care product Restrictions on use : Reserved for industrial and professional
More informationph as supplied: 7.3 2
Health 0 Flammability 1 Reactivity 0 SECTION 6 ACCIDENTAL RELEASE MEASURES General: Hydro Green Plus with takifier is biodegradable and will not cause damage to trees or vegetation by root absorption.
More informationSAFETY DATA SHEET LIQUID HAND SOAP
Section: 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Other name : 3072120 5L 3072114 25L Recommended use : Concentrated neutral detergent. Supplier Name : Reward Distribution (ABN 40 010 183 669)
More informationCEFIC LRI Project EEM9.3
REACH INFORMATION & EXPERIENCE EXCHANGE FORUM IV 19 JUNE 2015 CEFIC LRI Project EEM9.3 Linking LRI AMBIT Chemoinformatic System with the IUCLID Substance Database to Support Read across of Substance Endpoint
More informationGPS Safety Summary. Sodium Perchlorate
GPS Safety Summary Substance Name: Sodium Perchlorate 1. General Statement Sodium Perchlorate is a white inorganic solid. Products containing sodium perchlorate (powder and solutions) are only used at
More informationPHENOL RED PHOTOMETER
1. Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name : Substance name : Sodium chloride EC-No. : 231-598-3 1.2. Relevant identified uses of the substance
More informationSynonyms : Active ingredient: Dabigatran Etexilate Pradaxa capsules
1. Identification of the substance/mixture and of the company/undertaking Designation : Pradaxa 150 mg and 75 mg Capsules Synonyms : Active ingredient: Dabigatran Etexilate Pradaxa capsules Identified
More informationSAFETY DATA SHEET OxyBac Fresh Foam Wash
SECTION 1: Identification of the substance/mixture and of the company/undertaking Page 1 of 6 1.1. Product identifier Product name Product number OXYFR1L, 1.2. Relevant identified uses of the substance
More informationSAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier Product name: Eastman(TM) Cellulose Acetate Propionate (CAP-482-20) Product No.: EAN
More informationREACH challenge: can ECHA deal with it? ecopa 29 November Brussel. Dr. Erwin Annys
REACH challenge: can ECHA deal with it? ecopa 29 November Brussel Dr. Erwin Annys 1 REACH Registration Evaluation Authorisation and Restriction of Chemical substances 2 Registration Pre-registration >1000
More informationSAFETY DATA SHEET OxyBac Extra Foam Wash
SECTION 1: Identification of the substance/mixture and of the company/undertaking Page 1 of 6 1.1. Product identifier Product name Product number OXYEX2LT 1.2. Relevant identified uses of the substance
More information: AB Cherry Fresh Deodorant
SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Product name : Mixture Product code : 690-301 : AB Cherry Fresh Deodorant 1.2. Relevant
More informationGPS Safety Summary. 1-Butene. Technical information. Substance name. 1-Butene CAS-No General Statement
Technical information GPS Safety Summary Substance name CAS-No. 106-98-9 General Statement is a colorless, combustible gas with a characteristic odor. It is easily condensable under pressure. is soluble
More information: Hematology Basofix Pre-Dip Fixative Concentrate
Hematology Basofix Pre-Dip Fixative Concentrate SECTION 1: Identification 1.1. Identification Product form Product name Product code : Mixture : Hematology Basofix Pre-Dip Fixative Concentrate : SS-149P
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 information: Standard BLUE Formula and F-14 Formula
MachinableWax.com Standard BLUE Formula and F-14 Formula Revision Date: 12/6/2016 SECTION 1: Identification 1.1. Identification Product name : Standard BLUE Formula and F-14 Formula 1.2. Relevant identified
More informationSAFETY DATA SHEET <#####> Marquis (Ponazuril) EPM Paste Version 2.0 Revision Date 07/31/2015
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product information Product Name: SDS Number: 122000007040 Use : veterinary medicine Company BAYER HEALTHCARE LLC Animal Health
More informationSafety Data Sheet Ammonium sulfate special grade Revision date : 2013/02/15 Page: 1/7
Revision date : 2013/02/15 Page: 1/7 1. Product and Company Identification Company BASF Canada Inc. 100 Milverton Drive Mississauga, ON L5R 4H1, CANADA 24 Hour Emergency Response Information CANUTEC (reverse
More informationProduct Safety Summary
Product Safety Summary Phenol, 2,6-bis-(1,1-dimethylethyl)- This product safety summary is intended to provide a general overview of the chemical substance. The information on the Summary is basic information
More informationSAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking
SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Product name: Velate(TM) 368 Coalescent Product No.: EAN 985134. 32634-00, P3263400,
More informationGPS Safety Summary. Substance Name: Di-tert-butyl peroxide
GPS Safety Summary Substance Name: Di-tert-butyl peroxide 1. General Statement Di-tert-butyl peroxide is primarily used as a polymerisation initiator and cross-linking agent. The substance is used as an
More informationBath Salts Fine Scrub (Epsom)
1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : chemically pure, FCC 1.2 Relevant identified uses of the substance or mixture and uses advised
More informationGuidance on Information Requirements and Chemical Safety Assessment
G U I D A N C E Guidance on Information Requirements and Chemical Safety Assessment Part C: PBT/vPvB assessment Version 3.0 June 2017 2 Part C: PBT/vPvB Assessment Version 3.0 June 2017 Legal notice This
More information