Welcome to our Stakeholders’ Day5 April 2017
Ask questions and give feedback:
go to slido.com – type event codeSday12
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Geert DANCETExecutive DirectorECHA
• 2004-2007 - Head of the REACH Unit in the European Commission’s Directorate General for Enterprise and Industry
• 1986 - joined the European Commission
Opening address
12th Stakeholders’ Day
Geert Dancet
Executive Director
European Chemicals Agency
5 April 2017
Thank you for joining us
• 240 in the room – more online
• From 42 countries (Europe, Africa, Americas, Asia)
• 176 companies and 23 associations
• 35 SMEs
• 170 took part in IT tool training
• 80 one-to-one sessions
You want and we aim to provide
• More practical examples
• More interaction
• IT tool training web-streamed
• One-to-one sessions: more time and possibility to discuss in your own language
This is a crucial year
• Preparing your registration for 2018
• Pre-register by 31 May 2017
• Make sure your registration meets theREACH & CLP requirements
• Our completeness check is nowmore thorough to make sureyou get it right
You’re not alone…
• Thousands of companies have registered
• Help is there – online, helpdesks, sector bodies
• ECHA dispute resolution
• Directors’ group: ECHA, Commission and industry
• Identifies and resolves most challenging issues for REACH 2018 – for example access to finance and SIEFs after 2018
• Contact your industry association to raise issues
My last year as Executive Director
• Making REACH a success has been my mission
• Not going to stop now
• We are ready to help and receive registrations
• Things are achievable for small companies -cloud
• My successor will lead you to the deadline
• Safer chemicals by 2020 – we’ve all played ourparts!
10 years of REACH and ECHA
• Our story started 10 years ago
• Learning from the experience:
• Litigation seminar on 24 May
• Conference on 7 June
• Memory wall and video of staff
• Thank you all for ten cooperativeand productive years!
Save the dates for last minute help
REACH 2018 Spring School
15-19 May 2017
Stakeholders’ Day
30-31 January 2018
Wishing you a very successful year
Follow us!
News: echa.europa.eu/subscribe
Twitter: @EU_ECHA
Facebook: @EUECHA
LinkedIn: European Chemicals Agency
YouTube: EUchemicals
Christel
MUSSETDirector of RegistrationECHA
• Joined ECHA in 2007
• Responsible for all activities related to the registration process under REACH
• Before joining ECHA, worked at the European Chemicals Bureau (ECB) of the Joint Research Centre (JRC) where she coordinated the development of IT systems for REACH
Seven phases to successful registration
12th Stakeholders’ Day
Christel Musset
5 April 2017, Helsinki
echa.europa.eu/reach-2018
Registration at the core of REACH
What is at stake?
Better knowledge of hazards, uses and risks
Improved communication in the supply chain
Better safety and control measures
Reduce exposures and hence negative impacts
Substitute (gradually) hazardous substances with less hazardous ones
echa.europa.eu/reach-2018
Registration and classification: starting point for pro-active product stewardship
Registration dossier is vital
It demonstrates that:
• You know your portfolio
• All necessary information is available
• Your clients are informed adequately on how to safely use your substances
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Provides confidence to authorities, your investors and clients
And are watched by the authorities!
One year to go!
2017 2018 2019
8 350 registrations
4 250 substances
SepJun
Deadline
extended completeness check
(3 months)
Mar
60 000 dossiers 20 000 substances (estimates)
normal completeness
check(21 days)
350 dossiers/week
Number of dossiers
Deadline completed
>8 000dossiers/week
Mar
Know your portfolio
Find co-registrants
Share data
Prepare your dossier
Submit your registration
Keep your registration up-to-date
Assess hazards and risks
7 phases to get prepared
Know your portfolio
• Identify if you need to register and if the substances in your portfolio need to be registered
• Unambiguous substance identification
• Essential for data sharing and joint submission
• Letter of access: helps you verify that data from lead registrant is suitable for your substance
• Sector specific guidance on ECHA’s website
• Plan your work and inform your downstream users
echa.europa.eu/reach-2018
Substance identification
• Substance identity information is company-specific
• Detailed composition and analytical data
• More advice on specific cases: Q&As - Substance identity
• Improved format in IUCLID 6
• More transparent reporting
• Scope of joint submission in the substance identity profile (SIP)
• Specific fields for reporting information on nano forms
• May be checked manually during completeness check
• Inconsistencies e.g. between name and composition
• Manufacturing process for UVCB substances
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Nanos: updated guidance
• Existing guidance updated based on:
• Developments in regulatory science
• Increased knowledge at OECD level
• Experience gained in doing evaluations
• To be available by May 2017:
• Identification of nanoforms (new how to guide)
• Read across and grouping between nanoforms of the same substance (new guidance)
• Nano specific advice for human health and environmental endpoints (guidance update)
echa.europa.eu/reach-2018
Find your co-registrants
• Check your pre-registration
• Discuss substance sameness
• Joint submission for the same substance is mandatory - even in case of opt-out
• Opt-out
• Duly justified – this may trigger a compliance check
• Lead registrant
• You need the consent of the SIEF members
• Inform ECHA in case of difficulties and bring evidence
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List of lead registrants
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List of substances with lead registrants
Newcomer to the market?
• Pre-registration still possible until 31 May 2017 for substances with registration deadline on 31 May 2018
• After that, the substance needs to be registered before it can be manufactured/imported
• First step: inquiry to ECHA
• You will be in contact with existing registrants
• R&D substance or process in development?
• You can get a 5-year registration exemption (PPORD)
• Only to listed customers
echa.europa.eu/reach-2018
Data sharing
• Get organised and active in the SIEF
• Model data sharing agreements available with your sector organisations
• Make sure to cover future costs
• Negotiate costs in a fair, transparent and non-discriminatory manner
• But… there is a price to pay for quality dossiers
• Data sharing dispute can be submitted to ECHA
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Assess hazard and risk
• Information required depends on tonnage and uses
• 1-10 tonnes: possible reduced data requirements for less hazardous substances
• Verify Annex III inventory – ECHA
• Justification needed in IUCLID 6
• Get quality right: relevant, transparent, reliable
• Animal testing is a last resort
• Consider alternatives
• Use the QSAR Toolbox
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Guide for SME managers
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• Advice tailored to business managers
• Simple-term explanations of the information required
• 1 to 10 tonnes/year registrations
• 10 to 100 tonnes/year registrations
• Reference document for future business decisions
Chemical safety report
echa.europa.eu/reach-2018
• Step by step chemical safety assessment
• Comprehensive help text
• Synchronise with your IUCLID dossier
• Import use maps, standard phrases
• Generate automatic chemical safety report
• Prepare exposure scenarios for safety data sheets
• Facilitate updates
Needed for substances > 10 tonnes
Prepare your dossier
• Prepare your IUCLID dossier
• Identify the registrant• Identify the substance• Information on the substance’s intrinsic
properties• Information on use and exposure
• Chemical safety report annexed if above 10 tonnes/year
• IUCLID is free of charge
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Prepare your dossier
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• One-click installation
• Integrated help
• More structure for reporting substance identification, uses and hazard data and improving data quality
• Members who fully rely on lead registrant’s dossier can prepare their dossier in REACH-IT
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Latest version of IUCLID always
available
Data stored and backed up by ECHA)
Data access from anywhere anytime
Better online support
No cost for managing installations and
hardware
Less need for manual exchange of data
New in 2017!
Service for SMEs:IUCLID online
Submit your registration
• Check and update the information in REACH-IT
• Carefully assess your SME status
• Set up or join the joint submission in REACH-IT
• Submit your registration dossier: first the lead registrant, then all co-registrants
• Manual step introduced in completeness check
• Follow up on the communication in the REACH-IT message box
echa.europa.eu/reach-2018
• More intuitive user interface
• Extensive help within the tool
• Help available in all EU languages
• Improved means to find existing joint submissions and lead registrants
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Submit your registration
Step-wise support available
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• Introduction to the topic
• Three levels of information
• Collection of links to more material
• Explanatory webinar
REACH 2018 Spring School
• Intensive REACH 2018 week
• Live Q&A tied to re-runs of our webinars
• Practical examples for each of the phases
• Animated videos
• Save the date: 15-19 May
echa.europa.eu/reach-2018
More help?
• National helpdesks central in supporting SMEs
• In your own language
• Contact ECHA if
• questions on your submission, e.g.
• your dossier is blocked or
• you don’t understand ECHA’s instructions for re-submission
• need technical support with the IT tools for registration
• Sector organisations
• For practical knowledge
• Can help harmonise information (exposure scenarios)
• Some have working groups or mentoring programmes
•37echa.europa.eu/reach-2018
Take home messages
• Registration is challenging but manageable
• Have a solid plan for managing your registrations by the 2018 deadline
• Support is available from ECHA, national authorities and industry organisations
Remember to keep your registration up-to-date!
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•Laurence HOFFSTADT•Evaluation, ECHA
• Contributes to the evaluation of registration dossiers and the development of supporting material for registrants
• Holds a PhD in toxicology
12th Stakeholders’ day 5 April 2017, Helsinki
Laurence Hoffstadt
Missing data? How to get it
Contents
• What information do I need?
• 1-10 tonnes per year (REACH Annex VII)
• Low risk substances
• 10-100 tonnes per year (REACH Annex VIII)
• How to fill in data gaps?
• Strategy for testing
• Animal testing as last resort
• Regulatory alternatives
• Cost and timelines
•echa.europa.eu/reach-2018
•echa.europa.eu/reach-2018
Support from ECHA
Roadmap 2018: phase 4 support material
Practical guide for SME managers and REACH coordinators: How to fulfil your information requirements
•echa.europa.eu/reach-2018
• Depends on your type of registration
• Intermediate, under strictly controlled conditions all available data (independent of tonnage)
• Standard registration depends on your tonnage band
What data do I need?
https://echa.europa.eu/support/registration/what-information-you-need
•echa.europa.eu/reach-2018
Annex VII: physico-chemical, environmental and mammalian properties
One test on an animal
Low risk substances
• If a low risk substance, reduced requirements = only physico-chemical properties
• Justification
• Criteria in Annex III
• List of substances requiring a full data set
1-10 tonnes per year
•echa.europa.eu/reach-2018
Annexes VII +VIII: physicochemical, environmental and mammalian properties
Updated requirements
• Irritation potential for skin and eye
• Sensitising potential for skin
• Accepted by ECHA
Fewer tests on animals – only as last resort
• If in vitro not allowing classification
• If no acceptable alternative
• Submit proposals for some tests
Submit a chemical safety report
10-100 tonnes per year
Tips
Main tests should be there – your right to be on the market
Good quality information – it will be reviewed by ECHA
• Alternatives to be used – recommendations in ECHA’s guide
• Reduces future work and costs
• Main aim is to use chemicals safely
Support is here – ECHA and helpdesks
echa.europa.eu/reach-2018
Overview
• What information do I need?
• 1-10 tonnes per year (REACH Annex VII)
• Low risk substances
• 10-100 tonnes per year (REACH Annex VIII)
• How to fill in data gaps?
• Strategy for testing
• Animal testing as last resort
• Regulatory alternatives
• Cost and timelines
•echa.europa.eu/reach-2018
•echa.europa.eu/reach-2018
Collect all available
information
Consider information
needs
Identify missing information
Data sharing within the
SIEF
Data of sufficient quality
Data from similar
substances (read-across)
Generate new information
Animal tests ‘as last resort’
‘Waivers’ scientifically
justified
Best strategy forward
Practical guide: How to use alternatives to animal testing
Practical guide: How to use and report QSARs
•echa.europa.eu/reach-2018
• Animal testing as last resort
• Share existing and reliable data and• Use alternative information, i.e. “waivers”
• Ensure scientific and regulatory acceptance • Submit good and reliable information• Provide a robust justification for not running the test - crucial
importance 1. explain in the dossier why the prediction obtained using a
computer model is reliable for your substance2. demonstrate that two existing studies cover the same
criteria as what is required in a newly performed study
Avoid unnecessary animal testing
Regulatory alternatives
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• In Annexes, Column 2: Specific rules for each endpoint
Rely e.g. on substance’s properties
When no need to perform a test if properly justified and meets all criteria e.g. C&L and/or risk assessment
• Annex XI – General rules
Rely on well-documented and science-based justification
+ other sections of Annex XI
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Weight of evidence
What is it?
= combination of several independent sources of information
When to use?
If a single piece of evidence is not sufficient to fulfil the need
If individual studies give conflicting results or are not of the highest quality
Example: Fulfil the requirement for a property by combining in vitro, read-across and (Q)SAR results
Ensure you submit a justification and supporting data
•echa.europa.eu/reach-2018
(Q)SAR
What is it?= Computer models predicting property based on structures, qualitative or quantitative structure-activity relationship
When can I use it? For simpler properties (e.g. physico-chemical properties)
For more complex properties (e.g. repeated dose toxicity)
Example: Use QSAR Toolbox to predict short term toxicity to fish
Always report the reliability and prediction of the model
Check our practical guide for SMEs to see which models are accepted
•echa.europa.eu/reach-2018
In vitro tests
What is it?
= experiments performed in a controlled environment
When can I use it?
If environment compatible with substance (e.g. solubility)
If method is well described
On its own
Example: For acute toxicity and as part of weight of evidence approach, neutral red uptake test can be used (see Guidance update)
Always report correctly the information
Always justify the relevant classification
•echa.europa.eu/reach-2018
Grouping and read across
What is it?
= Predict a property of a substance (“target”) from data on
one or more substances (“source”)
When can I use it?
If data of good quality; if I can classify
If “source” substances are similar/relevant to “target”
If data on source is not (yet) available
Always submit a scientifically well-documentedjustification
Always submit a data matrix and all supporting data
•echa.europa.eu/reach-2018
Costs and timelines
https://echa.europa.eu/support/registration/strategy-for-gathering-your-data
Often contracted out as package of tests – time and cost-efficient
Outcome of certain tests/waivers impact need to perform further tests
Take home…
Have a clear strategy
Animal testing as last resort: share data and consider waivers before testing
Don’t hesitate to challenge your consultant: not all endpoints can be fulfilled with “easier” options
Do a good job! It takes time and scientific input to fill in data gaps
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Fabrice BROECKAERTSenior Scientific Officer, Unit of classification and prioritisation, ECHA
• In charge of coordination of CLP classification dossiers
• European Registered Toxicologist
• 12 years of experience in industrial sectors as regulatory and registration toxicologist
• PhD in industrial toxicology
Classifying your substance: dos and don’ts
12th Stakeholders’ day
Fabrice Broeckaert
5 April 2017, Helsinki
Why classify and label?
• Worker and consumer health and safety
• Environmental protection
• Ensure correct storage/handling/transport
• Prevent consumer access to most dangerous substances and mixtures
• Preventing and handling accidents
• Instructions for handling and discarding waste
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Classification and labelling vital for REACH
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Classification and labelling
Environmental properties
Human health properties
Consequences in other legislationPossible
authorisation
Need for exposure assessment
Physical properties
Classification leads to…
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• Effective communication of identified hazards in safety data sheets (SDS) and on labels• Hazard pictograms
• Signal word • Warning (Wng), Danger (Dgr)
• Hazard statement, e.g.• H200 – Unstable explosives
• H301 – Toxic if swallowed
• Precautionary statements, e.g.• P201 – Keep out of reach of children
• P372 – Explosion risk in case of fire
Classification leads to…
echa.europa.eu/reach-2018
• Solid basis for REACH registration dossier and chemical safety report
• Downstream consequences on uses of substances:
• CMRs: prohibited in toys, cosmetics, materials in contact with food, medical devices…
• CMRs exposure reduction at work, in particular for young people
• Active substances in plant protection or biocidal products
New hazard pictograms
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Dos: classification
• Apply existing harmonised classification and labelling (CLH) in Annex VI of CLP
• Verify existing harmonised classification and labelling (CLH):
• EURLEX
• Our search for chemicals
• C&L inventory
• REACH registration database
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Dos: classification
• Use decision scheme for revising existing (self)-classification
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Dos: self-classification
• Identically to other REACH registrants and/or notifiers of same substance
• Differently from registrants and/or notifiers only if justifiable, e.g. own data, constituents, impurities
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Self-classify if no harmonised classification exists
Dos: self-classification
• Collect and assess available data for:
• Physico-chemical hazard properties
• Human health hazard properties
• Environmental hazard properties
• Compare data with classification and labelling criteria
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Dos: self-classification
• Conclude on most appropriate classification and labelling. Record:
• Data lacking
• Data inconclusive
• Data conclusive but not sufficient for classification
• Fill in IUCLID using manual for preparing classification and labelling notifications
• Submit your classification and labelling as part of your REACH registration or update your notification
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Don’t…
• Use the Dangerous Substance Directive (DSD) system for classifying substances
• (Over)classify if your substance does not present hazardous properties
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Don’t…
• Forget to specify categories related to specific hazard classes, e.g: Skin Sens. 1A or 1B or 1
• Classify less severely in case of minimum classification in Annex VI of CLP
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Classify at least as Acute Tox. 3
Dos: after notification or registration
• Ensure registration and classification and labelling inventory notifications are up-to-date
• Submit a harmonised classification and labelling proposal to ECHA’s Risk Assessment Committee via a Member State or ECHA:• Industrial chemicals only and under certain conditions
(fees may apply)
• Possibility to classify, to update or to remove your substance from Annex VI of CLP
• Non-confidential data only, based on REACH dossier and possibly data submitted during Public Consultation
• Opinion by Risk Assessment Committee, decision by Commission
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Dos: classifying your mixture
• Classify all mixtures on the market according to legal deadline: 1 June 2017
• Classify all mixtures according to tieredapproach for hazard classes where appropriate
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Dos: classifying your mixtureTiered approach
Classification based on concentration of ingredients
• With formulas (acute toxicity, environmental hazards)
• With concentration limits as published in CLP
Bridging principles
• Annex I, part 1
• Sufficient data available for similar tested mixtures and individual hazardous ingredients
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Dos: classifying your mixtureTiered approach
Testing: conditional as per CLP and as the latest alternative
• Test data as primary source, when available
• Existing information on whole mixture, tested with adequate, reliable and scientifically valid method
• Classify according to same criteria as for substances
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Don’t…
• Use the Dangerous Preparation Directive (DPD) classification system
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Conclusions
• Communicate and assess consequences of classification and labelling for your workplace control scheme and for supply chain
• Anticipate possible regulatory actions by ECHA or Member States (restriction, authorisation) and consequences under other EU or national legislation
• Check regularly if your substance is under scrutiny on our website (CoRAP, PACT, Registry of intentions for CLH, SVHC or restriction)
• Investigate possible substitution
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Conclusions
• Health and safety concerns can be avoided
• Likelihood of unjustified regulatory attention reduced
• Helps you to be proactive: consider possible long-term consequences and innovation
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Take-home messages
• Compulsory to classify and label substances
• Better supply chain communication
• Better understanding of customer needs and demands
• Increased predictability of regulatory action
• Helps focus on marketing and safer use
• Better domestic and international reputation
• Better public perception
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Mercedes VINASHead of unit Dossier Submission and PIC, ECHA
• Oversees ECHA’s activities on the submission and processing of dossiers
• In charge of implementation of the regulations on PIC and CLP
• Working on the implementation of the REACH Regulation since 2004 in the European Commission
• Chemical Engineer with a masters in European Legislation
How to ensure a successful submission
12th Stakeholders’ day
Mercedes Viñas
5 April 2017, Helsinki
Contents
• Enhanced completeness check
• Overview
• Manual verification process
• Ensuring level playing field: retrospective checks
• Enforcing joint submission principle
• Ensuring your registration is complete: available help
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Completeness check
• Dossiers have to be complete to get a registration number
• “Technical completeness check rules” in place to know what information needs to be provided
• Used by us to verify completeness
• By industry to check before submission
• Completeness check enhanced in 2016 to improve availability of data
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Enhanced completeness check
• Since new IUCLID format in 2016
• Well ahead of 2018 registration deadline
• Based on our experience and stakeholder feedback
• Automatic rules reviewed
• New manual verification steps
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Manual verification
• Automatic rules have free text field limitations
• Prevents from bypassing the system
• Still in the scope of completeness check (no assessment of quality)
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Manual verification: areas of attention
• Unclear substance identity
• Information requirements waived by registrants
• Dossiers include testing proposals
• Chemical safety report missing
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Manual verification:first results
• 33% of all incoming dossiers manually verified
• 20% of verified dossiers failed first check
• 95% of failed dossiers successfully updated
• If new submissions fail, no registration number issued
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Retrospective checks
• Ensure level playing field for existing and upcoming registrations
• Pilot campaigns in 2016
• Study claimed ‘on-going’ for long time
• ‘Placeholder’ lead dossiers
• First results show registrants are able to fulfil information requirements, e.g. provide a missing study
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Enforcing OSOR principle
• One Substance One Registration: joint submission and data sharing a legal obligation in REACH
• Avoid duplication of animal studies
• Reduce costs
• Increase consistency of safe advice
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Enforcing OSOR principle
• Regulation in force since 2016 ECHA to
ensure joint submissions
• No submissions outside joint submission possible
• Leads acting without SIEF agreement can be demoted
• Contact us with a dispute in case of a difficult situation
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Make sure your dossier is complete
• Run the validation assistant tool in IUCLID: a ‘must’ before submitting
• Consult our help: tips on manual verification
• Follow our webinar on 20 April
• Contact our helpdesk
echa.europa.eu/reach-2018
Take-home messages
• We are taking action to increase availability of data
• Dossiers checked manually
• Actions address both existing and upcoming dossiers
• Joint submission mandatory
• Make use of available help to ensure a successful registration
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Mike PENMANManaging Director and founder, Penman Consulting
• 40 years experience in managing toxicology, regulatory affairs and information technology globally
• Involved in IUCLID, ECETOC TRA and REACH
• Awarded a UK civil honour for ‘Services to Environmental Safety’
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Mike Penman
ECHA 12th Stakeholders day 5th April 2017
Case Study: Substance Identity
•5 April 2017
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Why is it important?
Issues?
Case Studies
Conclusions
Outline - Substance ID
•5 April 2017
•ECHA Stakeholders Day
Page 100
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
REACH Information Requirement
Art 10 a ii, Annex 2 (2 – 2.3.7)
ECHA page -https://echa.europa.eu/regulations/reach/substance-identity
Explanation and Guidance
IUCLID
Section 1.2 - Composition
Section 1.4 - Analytical data
Substance Identity
•5 April 2017
•ECHA Stakeholders Day
Page 101
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Starting point for any REACH discussion
What is the substance?
Chemical Composition / Physical form
Substance type Mono, multi, UVCB
One Substance One Registration (OSOR)
Link to intrinsic hazard data
Grouping / Read Across / Alternatives
Substance ID - Why it is important
•5 April 2017
•ECHA Stakeholders Day
Page 102
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
“Historical” positions
EC List and global Inventories
Availability of analytical data
Complexity of different UVCBs*
Relationship with salts and isomers
Some issues encountered (not exhaustive!)
•5 April 2017
•ECHA Stakeholders Day
Page 103
*Unknown, of Variable Composition, or of Biological Origin
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Manufactures of novel fuels via co-processing with non-traditional feedstocks: vegetable and animal oils
For many fuels, existing EC names reflect feedstock
Also included process description
Addition of non traditional feedstock to the process results in the existing substance name being inaccurate
•5 April 2017
•ECHA Stakeholders Day
Page 104
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Resolution Investment in extensive analytical work on all member
substances Pilot and production
Analytically similar substances “grouped” together Early discussion with ECHA Substance ID unit on naming Development of new names and process descriptors that
reflect emerging industry practice
•5 April 2017
•ECHA Stakeholders Day
Page 105
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Subsequent actions Each Member company
Enquiry process to ECHA Pre discussion allowed for quick response and approval
Basis for OSOR Lead registrants agreed in RFC
Dossier development on basis of analytical data and enquiry process Allowed clear read across to existing data
Registration by Lead and Co-registrants
•5 April 2017
•ECHA Stakeholders Day
Page 106
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Manufactures of Rosins and Rosin derivatives
UVCBs - Complex chemistry
Diterpenic monocarboxylic acids
Neutral fraction
No single constituents present at concentration > 10 %
Thousands of potential component structures
Different categories of derivative depending upon treatment
•5 April 2017
•ECHA Stakeholders Day
Page 107
Hydrocarbon Resins & Rosin Resins REACH Consortium
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
28 Substance registrations in 2010
ECHA 2011
Questions on Substance ID and read across of data
H4R
Appreciation that the Substance ID was critical to plausibility of a category approach for read across
How to approach when it is so complex?
Hydrocarbon Resins & Rosin Resins REACH Consortium
•5 April 2017
•ECHA Stakeholders Day
Page 108
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Resolution - H4R developed a common position on identification methodology Reviewed available technologies, made recommendations Gave detailed model spectra and structures Common reference substances for classes
Provided the basis for Individual registrant analysis Common text and interpretation for use in updating dossiers for all
registrants Substance Information Profiles (SIP)
Published on SIEF information pages Allowed development, with other biological data and discussion with ECHA,
consistent and plausible test strategy
Hydrocarbon Resins & Rosin Resins REACH Consortium
•5 April 2017
•ECHA Stakeholders Day
Page 109
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Good quality data and practices critical to success - not just for registration SIEF / Joint Registration communications / understanding Registration (OSOR) Test and read across strategies
Registrant / SIEF led - cooperative working is key Data led - agree on what is required All need to be able to work to the same standard – not exclusive Needs to be understood - over complexity excludes - but some complexity may be necessary! Fit for purpose
Supports confidence in the intrinsic hazard data Current data and any testing plans
Use the tools and help that is available
Observations on Substance ID
•5 April 2017
•ECHA Stakeholders Day
Page 110
Penman Consulting LtdStanford Mill, Faringdon Road,
Stanford in the Vale, SN7 8NP, United Kingdom +44 (0) 1367 718474
Penman Consulting bvbaAvenue des Arts 10 1210 Brussels Belgium +32 (0) 2 305 0698
Thank You
•5 April 2017
•ECHA Stakeholders Day
Page 111
Wera TEUBNERRegulatory toxicologist in the product safety department, BASF Switzerland
• EUROTOX-registered toxicologist
• Specialised in human health hazard, risk assessment of industrial chemicals and (Q)SAR modelling, as well as the application of in-vitro methods
• Diploma in biochemistry and PhD at the German Institute of Human Nutrition
CASE STUDYS:
APPLYING ALTERNATIVE APPROACHES
Dr. Wera Teubner, BASF Schweiz AG
12th Stakeholders` Day, April 5th, 2017 at ECHA, Helsinki, Finnland
Case study 1: In-vitro methods
Alternative methods have become OECD testing guidelines
– In-vitro skin irritation -> OECD 439 since 2010
– In-vitro eye irritation for non-irritants -> OECD 492
since July 2015
- in-vitro/in-chemico skin sensitization assays since
2015 /2016
Today these are standard information requirements
BASF studies were done under GLP and according to
validated protocols
No challenge by ECHA so far
Case study 2: Structural similarity with
mechanistic considerations
Strontium salt (1:1)
Literature/database search
Substance itself
structural analogues
azo reduction products
soluble strontium salts
OECD Toolbox / QSAR
protein binding alerts
genotoxicity alerts
BfR inclusion/exclusion rules for
irritation
CAS 67828-72-2
Identification of structural analogues
and the amine
Data matrix for Annex VII tox endpoints
WoE / read-across for acute oral toxicity
Consistent hazard profile for structural analogues
– covers b-naphthoic acid (BONA) and Strontium
– No mortality observed at or above limit dose in acute
oral studies
Absence of hazard for sulfonated aromatic amine (acute
and subacute oral study)
Poor solubilities in water and octanol point to low uptake
after ingestion, consistent with coloration of feces
Azo bond reduction well described in the literature
WoE / read-across for irritation
Consistent absence of hazard for structural analogues
Differing substitutents do not influence pH or surface activity
Consistent alert pattern (inclusion rules)
– Only alert is «phenols», present in all analogues
Physico-chemical parameters in support of «non irritating»
– BfR Skin and Eye exclusion rules (not corrosive:
octanol solubility of 0.2 mg/L and Tm> 200°C; not
irritating: water solubility <5mg/L)
WoE / read-across for the Ames test
Consistent hazard profile for structural analogues
– covers BONA and Strontium
Absence of hazard for differing sulfonated aromatic amine
Azo bond reduction well described in the literature
Ames tests done with Prival modification
Comparable physico-chemical properties
Approach worked because…
Physico-chemical data on all structural analogues available
prior to decision making
Letter of Access (LoA) / ownership for all data available
(category)
Data holders/registrants experienced in consortia work
Robust study summaries for analogues already written
Also of note: Sweat equity costs spread over several endpoints
Other considerations
standard information alternative strategy
Number of Robust
study summaries oneone for each
contributing study
Need for special
justificationno yes
Risk of challenge no yes
Suitability for other
legislations (eg Water
endangering class,
sensitive application
legislations, Korea-
REACH, registrations
outside EU, etc)
Accepted without
discussion
Might not be accepted, or will
require re-writing according to
new templates/guidance,
LoA for contributing studies if
REACH-only.
Analytics and physico-
chemical properties
needed for one
substance
needed for any contributing
substance
§
Case study 3:
Common dissociation products
Behavior in aqueous solution:
Dissociation into NH4+, CO3
2-, HCO3- (formation of several
equilibria)
source substances:
– ammonium chloride
– ammonium hydrogen carbonate
– sodium hydrogen carbonate
– ammonium sulfate
Ammonium carbamate
CAS 1111-78-0
Finding hints in the OECD toolbox
… or talk to your
production chemist
Human health endpoints
Alternative assessment applied for
– Acute inhalation toxicity
– Clastogenicity
– 90 day study (oral)
– Teratogenicity(oral)
Available studies on the substance itself:
– Ames, HPRT
– Acute oral and dermal toxicity (H302)
– Skin and eye irritation (H318)
– Skin sensitization
– Physico-chemical properties (high water solubility, solid that decomposes prior to melting)
Bridging study requested for proof of concept
13C{1H}-NMR in D20 solutions of ammonium carbamate
– 1% (pH 9-9,5) complete dissociation within
several minutes
10% formation of an equilibrium, no complete
dissociation
– 10%, acidified with DCl (stomach acid) complete
dissociation immediately after acidification
Approach was easy because
No relevant by-products/impurities
Data on source substances published or available at BASF
Expertise and experience available (regulatory and
experimental)
Reaction chemistry described in the literature
OECD SIDS available for source substances
Summary
Alternative approaches
– Offer an opportunity to avoid (animal) testing
– Can only be applied under certain conditions
– Require expertise in chemistry/toxicology/analytics
– Require extensive efforts in documentation, LoA and
justification
– Are a moving target
Monica LOCATELLIFounder of REACH Mastery
• Implementation of REACH regulation since 2001
• Specialises in risk assessment and toxicology
• Degree in chemistry and 10 years in chemical industry
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Case study: cost and data sharing
Monica Locatelli – TEAM mastery s.r.l.
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
TEAM mastery
• TEAM mastery is an italian company, born in 2008 as a dedicated REACH consultant company
• It is based in COMO, near to one of the cores of manufacturing chemistry in Europe
Consortia
Lead Registration dossiers
InquiriesJoint submissions
Authorisation dossiers
Disputes
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Data sharing in the REACH Regulation
Article 11 Joint submission of data by multiple registrants.....the information specified .......shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant). .....Each registrant shall subsequently submit separately .........
Article 26 Studies involving vertebrate animals shall not be repeated.
Article 29 Substance Information Exchange Forums
Article 30 Sharing of data involving tests If they cannot reach such an agreement, the cost shall be shared equallyRegistrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Implementing Regulation on joint submission and data sharing
justification of any cost a cost-sharing model, which shall
include a reimbursement mechanism
documentation shall be kept for 12 years
One substance, one registration
Itemisation of the data to be shared
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Guidance on Data Sharing
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Transparent
Transparency can be demonstrated :
Regular and open SIEF communications
Clear spreadsheets with costs related to the studies
Clear spreadsheets with costs related to admin an technical work
Clear communication of the number of registrants
Clear communication on the cost-sharing system, overall
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Fair and not discriminatory
“NOT FOR PROFIT” PRINCIPLE
“REIMBURSEMENT”
The guidance of 2016 is clearly defining “Fair and non discriminatory” in the following two principles:
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Case study: REACH Dyes Consortia
– three consortia with about 600 substances to be registered,
– mainly < 10 tons/year (deadline 2018),
– complex for analytical identification,
– huge number of existing studies to be managed (over 10.000)
– over 1700 different chemical structures to be analysed
“Technical comprehensive work:” since 2009 !!!
EPCG Paper
TextileDyes
Leather Dyes
The three Consortia operate independently, but they have common rules :
• Legal framework (contract)
• General rules on costs and cost-sharing
• Development of ad-hoc softwares
• Studies/data gathering, evaluation and data entry
• Grouping of chemical structures, read-across and QSAR
• SIEF communications and administration
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
REACH Dyes Consortia Overview
ONLY THE KEY STUDY is valued for compensation (notmandatory: see Guidance on data sharing)
Replacement cost, based on FLEISCHER LIST paper, 2007 (Officialreference, fair, not varying by lab/data owner…..)
Studies are valued with correcting factors increasing anddecreasing the value, as per Guidance on data sharing
Co-registrants only pay ACCESS to data FOR THEIR REQUIREDTONNAGE BAND (fair, non discriminatory)
Rules on Study Value
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
REACH Dyes Consortia Overview
Calculated on the HOURS OF WORK FOR EACH ACTIVITY by the LeadRegistrant and the consultant
Shared using a POINT SYSTEM, proportionate according to lowertonnage bands compared with the higher ones
Separate administrative COST FOR LOA MANAGEMENT
Separate administrative COST FOR SIEF MANAGEMENT
Technical and administrative work
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Costs and mark-ups
– Other voices for mark-up:
– All charges are re-allocated every year among all the previous registrants (SIEF and Consortium Members)
Interest (itemisation, a special cases)
Inflation (to be considered when using historical costs)
Risk Premium (when present must be justified)
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Data sharing disputes
What to do in case a SIEF member asks for an access and receives a cost that is not fair, not transparent or discriminatory?
1. Ask for explanations
2. Discuss a way forwards
3. As a last resort: open a dispute
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Data sharing disputes
• What to do: Collect all written documentationhttps://comments.echa.europa.eu/comments_cms/article303.aspx
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Data sharing disputes
• What to do: Collect all written documentation
https://comments.echa.europa.eu/comments_cms/article303.aspx
• What can be asked for:Access to tests on vertebrate
• What a SIEF member obtainsA token to joint the Lead dossier
A code to indentify the studies with access granted in IUCLID
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
• Opt outFor all non-vertebrate tests the member has to
provide his own data
• The member has to – perform a number of data independently
– compile a complete IUCLID dossier
– fill up the summaries, derive PNEC and DNEL
– If applicable, make its own CSR and Risk Assessment
Data sharing disputes
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
LEAD election
What happens if a dossier is sent without Lead Election,very poor, not compliant and the real Lead can not registerits dossier?
NOT SOLUTION YET
NO LEGAL FRAMEWORK
ECHA IS WORKING TO FIND THE BEST SOLUTION ……
The link to report a case is:https://echa.europa.eu/it/contact/reach
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Read Across
• Obligation on data-sharing is applied when the substance is the same
• It is not mandatory for participants in different SIEFs to share data
• It is in line with the objectives of reduction of animal
• Every request for access to studies across different SIEFs will have to be negotiated on a case-by-case basis
• 12-year-rule applies also for read-across purposes.
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Recommendations
If you are a Lead Registrant:
• Keep track of all your expenses bound to your dossier, be ready to communicated them in a clear way
• Objectively evaluate your expenses also if they are bound to internal resources
• Answer on time to the requests of data sharing
• Keep track of all the documentation you exchanged with SIEF members
• As soon as you can, communicate with the SIEF for Lead Election and open the Joint submission
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Recommendations
If you are a Joint member:
• Be aware of all the related costs behind a dossier
• Ask clear questions and set reasonable deadlines for answers
• Open a dispute only as a last resort
ECHA Stakeholders' Day 2017, Helsinki, 4 – 5 April 2017
Thank you for attention and.....
good luck for the 2018 deadline!
Rudolf StaabPartner at ChemAdvice GmbH
• Founded REACH ChemAdvice in 2007
• Vice-secretary and founding member of Only Representative Organisation
• PhD in inorganic chemistry
• 25 years of experience in chemical industry
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
REACH introduced globally a new area of chemicals management.
REACH applies to legal entities in the European Community only,
companies located outside but exporting into the EU customs territory
are not bound by REACH obligations. Authorities have no competence to
enforce on operators outside EU.
Responsibility for fulfilling REACH requirements is with EU-importers,
jurisdiction is limited to EU territory.
Non-EU Manufacturer (NEM) export into the EU via several importers,
each importer shall make a separate (pre-)registration.
If NEM prefers to register on behalf of his EU-importer, REACH allows
appointing an Only Representative (OR) located in EU (REACH Article 8).
OR takes over certain obligations on behalf of the exporter. This relieves
(eventually) EU importers within same supply chain from their
registration duties; hence they become downstream users.
REACH Article 8
Many Non-EU manufacturers are hesitating to finally register
their products under REACH…
Some quotes from our clients after our recent survey:
“The business in Europe is too small to justify the investment…”
“We don’t have any commitment from our clients that they will continue
buying from us…”
“More and more clients are pushing us to register…”
“The test cost for our small volumes do not justify a registration…”
“ We will discontinue our business in Europe…”
Only Representatives (ORS) have several duties under REACH
As a natural or legal person within the EU the OR is the legal representative
for a Non-EU manufacturer
An OR has to have the capabilities to handle huge amounts of substances
and must have the skills to understand the REACH legislation
OR acts as a trusty versus Importers, Non-EU manufacturer and authorities
OR has to take record of all imported substances and importers
OR has to have the latest update of the SDS on file.
The content of the SDS stays with the Non-EU manufacturer
OR manages the supply chain and authority communication as it pertains to
REACH compliance
Only Representatives have to fulfil the obligations of an
Importer but there are some differences…
Importer
Gets ownership of all imported substances and has to take record of them
Has the registration obligation according to the imported quantities and the resp.
deadline
Has to have the latest update of the SDS on file and is responsible for the content
Can develop his business according to his strategy
Only Representative
Has no ownership in the imported substances
Is not involved in business development and day-to-day business
On request of his Non-EU manufacturer the OR has registration obligations
Through the registration the Importers become Downstream Users
Appointment of an Only Representative is a strategic decision
of a Non-EU manufacturer…
A Non-EU manufacturer depend on the Importers and cannot develop the
business independently
Through an OR the Non-EU manufacturer can export to whom he wants
according to (pre-) registrations done by its OR
Aim should be a long-term relationship between Non-EU manufacturer and
OR; precondition for that is trust
Non-EU manufacturer must provide all required data to the OR (quantities,
client lists, updated SDS) otherwise OR needs to terminate the OR contract
The right choice of the OR is key for own business…
How to find my OR?
ORO is a good place to find a reliable and capable OR
Search on ECHA webpage whether the OR has successfully register
substances
Lead Registrations are a good indicator for the capabilities of an OR
Talk to companies which have experience with ORs
OR Fees should not be the main decision factor
The Registration Strategy is the key for a successful business
development…
Non-EU manufacturer and OR should work intensively together.
Prioritize the product portfolio
Define the own role for all substances
Analyze the SIEF and find potential co-registrants
Decide early to take the Lead Registrant role
Prepare the budget for the registrations and register as early as possible
Try to establish a strategic partnership with Importers for cost sharing or
volume commitment
The test cost are the biggest burden for SMEs and small volume
registrations…
Example 1 (Lead Registrant;Tonnage band 1-10 t/a; Substance; SME)
Test cost: ca. 25,000 € (Annex VII, Sameness, Literature search)
OR fees: ca. 5,000 - 10,000 € (dossier preparation and submission)
ECHA fees: 64 – 1,114 €
Example 2 (Lead Registrant;Tonnage band 10-100 t/a; Substance; SME)
Test cost: ca. 250,000 € (Annex VII and VIII, Sameness,
Literature search)
OR fees: ca. 15,000 - 30,000 € (dossier preparation and submission)
ECHA fees: 173 – 2,993 €
Joint Submissions
diminish the cost
The lower the volume and the margin the less profitable is a
registration …
Example 1 (SME; 5 t/a; Margin 2 €/kg; Lead Registrant)
Total Margin: 10,000 €/a
Registration cost: ca. 35,000 €
Loss first year: ca. - 25,000 €
Example 2 (SME; 95 t/a; Margin 4 €/kg; Lead Registrant)
Total Margin: 380,000 €/a
Registration cost: ca. 270,000 €
Profit first year: ca. 110,000 €
REACH can be a threat for many supply chains in Europe…
Conclusions
SMEs are hesitating to register their substances and will stop business in
Europe
Importers may lose their supply of chemicals
Downstream users may lose supply of chemicals and can no longer
manufacture their own products
A shift of supply chains to countries outside the EU may happen with all
consequences for the economy
Only Representative Organisation
(ORO) AISBL
Chaussée de Roodebeek 206
B-1200 Brussels, Belgium
www.onlyrepresentatives.org
www.reach-chemadvice.com
Thank you for your attention
Interact with us!
1. Go to slido.com and type event code: Sday12
2. Send your questions
3. Give a thumbs-up to the best questions – we will ask
them in that order
4. Give us feedback
We are on a break and will return shortly
Jack DE BRUIJNDirector of Risk ManagementECHA
• Joined ECHA in 2007
• Responsible for identifying and implementing the authorisation and restrictions processes under REACH and managing classification tasks from the CLP Regulation
• Before joining ECHA he worked at the European Chemicals Bureau (ECB) of the Joint Research Centre
Improving supply chain communication: now to 2020
Jack de Bruijn
12th Stakeholders’ Day
5 April 2017, Helsinki
Contents
• Why we care about improving supply chain communication
• Where we are now
• What is planned for 2017-2020
Basic pillars of chemicals legislation
Safe use
Supply chain communication
KnowledgeRegulatory
action
Communication in the supply chain
Conclusions – first REACH review (2013)
• Increased communication in the supply chain
• Suppliers more informed about customer uses and needs
• Significant implementation problems:
• Safety data sheets not of appropriate quality
• Large and complicated exposure scenarios
• Registrants not sufficiently aware of uses and use conditions, not able to properly link hazards and risk (in CSA) to appropriate exposure scenarios
Roadmap for supply chain communication
• Ensuring assessments are accurate, realistic and relevant and based on sector information on good practices
• Harmonisation of format and content
• Development of standard phrases (new ESComPackage)
• Annotated templates and examples
• Automated IT communication
• Developing methodologies to identify and communicate safe use information of mixtures
Chemical safety assessment
Exposure scenarios
Mixtures
Exchange Network on Exposure Scenarios
• Joint initiative with industry associations and Member States.
• 10 meetings with around 120 participants from industry, Member States’ authorities and European Commission
• Aims to identify and share good practice on preparing and implementing exposure scenarios
• Forum to discuss output of the CSR/ES Roadmap
http://echa.europa.eu/enes
http://echa.europa.eu/csr-es-roadmap
Downstream users
End users
Downstream users
Formulators
Registrants
UsesExisting conditions
Exposure Scenarios
= Safe conditions of use
Improved supply chain communication
• What are the existing uses (customer groups)?
• Under which conditions do they take place?
Use maps developed by downstream user associations: • What are the uses
relevant in one sector?• Under which conditions
do they take place?
ToolsRegistrationdossier
PublicECHA and Member States
Exposure scenarios: describing the conditions for safe use for individual DU
ESCom XML and phrase catalogue
Harmonised format
Safe use information for mixtures
Harmonised format
Safe use information for substances
SUMI
Library
Downstream users
End users
Downstream users
Formulators
Registrants
Key findings from evaluation
• CSR Roadmap/ENES is considered relevant by both Member States and industry
• Limited knowledge of what tools are available, how they work and how they can be used
• Frustration that the ENES tools are not being consistently adopted, worked or maintained by different industry sectors/companies/consortia
• Many downstream users consider that the translation of the roadmap products into other EU languages will enhance implementation
For details: https://echa.europa.eu/-/tenth-meeting-of-enes
2017-2020 programme for improving the information on uses and risk management advice
1. Maintain and adapt the key tools for supply chain communication
2. Support active sectors to set up and publish use maps for registrants’ chemical safety assessment
• Generate use maps in Chesar format
• Support active registrants to incorporate use map information in dossiers
3. Promote the use of the tools to different groups: registrants, Member States, end users based on market research
4. Include the end-user perspective
• Better understand needs and opportunities related to information on safe use of substances and mixtures
• Make more effective use of REACH information in the supply chain, e.g. in improving workplace health and safety and then broadening to the environment and consumer product safety
2017-2020 programme for improving the information on uses and risk management advice
These tools will help you
https://echa.europa.eu/communication-in-the-supply-chain-infographic
Why good communication matters
Good communication in the supply chain
• Protects human health and the environment
• Saves time
• Saves money
• Can be good for business
Registrant
Distributor
FormulatorArticle
producer
End user
Take home messages
• Supply chain communication a key pillar of REACH make sure it works
• Registrants: tools and support exist make full use
• Your safety data sheet is one of your business cards
• Downstream users: be critical to what you receive – create a demand for good quality information
• Downstream user sector organisations: develop use maps
Thank you
Follow us!
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LinkedIn: European Chemicals Agency
YouTube: EUchemicals
Geert DANCETExecutive DirectorECHA
• 2004-2007 - Head of the REACH unit in the European Commission’s Directorate General for Enterprise and Industry
• 1986 - Joined the European Commission
Marten KOPSManager Scientific & Regulatory Affairs at NVZ, the Dutch Detergents Association
• Responsible for several regulatory dossiers like REACH, CLP and the Occupational Health & Safety legislation
• Chairman of the REACH Implementation Working Group of A.I.S.E., the International Association for Soaps, Detergents and Maintenance Products
How use maps help improve supply chain communication
ECHA Stakeholder Day5 April 2017
M. Kops MSc
NVZ, on behalf of A.I.S.E.
The Detergents sector
Professional Cleaning & Hygiene
• Broad range of products
• Many different product uses
• Many SME end-user customers– NL: >10.000 SME cleaning
companies
REACH Supply Chain Communication
Manufacturer
Formulator
End-user
SDS
ESSDS
Use infor-
mation
Use infor-
mation
Safe Use Info
Chemical Safety
Assessment
SDSSDSSDSIdenti-fiedUses
Common issues
Manufacturer
• Differences in use information received
‒ Format & type of information
• Limited information on actual usesituations
• Time-consuming safe use assessment
Common issues
Formulator
• Several (end)uses not covered in Exposure Scenario’s
• Unrealistic safe use conditionsdescribed
Mixture SDSs often do not yetcontain ES-related safe use information
Common issues
End-user
• Limited resources‒ Many SME companies
• Often lack of sufficiently educated personnel
• Determining safe use conditions difficult
‒ Own safety assessment needed
‒ Chemical/toxicological knowledge needed
Sector use maps
Manufacturer
Formulator
End-user
SDS
ESSDS
Use infor-
mation
Use infor-
mation
Safe Use Info
Chemical Safety
Assessment
SDSSDSSDSIdenti-fiedUses
Sector use map
Sector association
Analysis of typical end-uses
•192
Sector use maps
• Overview of typical uses within sector
• Describes actual use situation
– Duration? Ventilation? Protective equipment?
• Standardized format used by all sector associations
Example uses
Example uses from detergents sector use maps: professional cleaning
• Diluting a product in a spray flask‒ Max. 1 hour per day, no LEV possible, …
• Spraying a product on a surface‒ Max. 1 hour per day, no LEV possible, …
• Brushing a product on a surface byhand
‒ Max. 8 hours per day, no LEV possible, …
Use maps benefits
Manufacturer
• Detailed information on actual use
– Reliable safety assessments
• Harmonized information format
– Harmonization between industrysectors
• Standardized use map format enables automation of assessments
– Saving time and resources
Use maps benefits
Formulator
• Reliable, high-quality exposure scenarios
• Realistic use conditions described
• Standardized communication to end-users possible
– Safe Use of Mixtures Information (SUMI)
Use maps benefits
End-user
• Reliable, realistic conditions of safe use
• Standardized, harmonized communication between suppliers
– SUMIs, tailored information for end-users
• Using the results of a chemical safety assessment done at manufacturer level
– Dutch OHS inspectorate: A.I.S.E. SUMIs can be used as a basis for the (OHS) chemical risk assessment (translation to practice required)
Closing remarks
• Use maps improve upstream communication…‒ More detailed information on actual uses
• …and therefore also downstream communication…‒ High quality, reliable exposure scenarios
• …which enables safer workplaces, especially at end-user level.‒ Using the assessment results from a more
knowledgeable player in supply chain• Acceptance from OHS authorities required
Thank you!
Thank you for your attentionUseful links:
• ECHA webpage on use maps
• ECHA use maps library
‒ Sectors with use maps available or in preparation:
Mike RASENBERGHead of Computational Assessment & DisseminationECHA
• Joined ECHA in 2011
• Before joining ECHA, worked in the area of international chemicals management, with the European Commission, chemical industry, industry associations and as a consultant
Chemical safety report as a company asset
12th Stakeholders’ Day
Mike Rasenberg
5 April 2017, Helsinki
Chemical safety assessment
• Aims to determine the conditions under which asubstance can be used safely during its entire life cycle
• Is to be documented in a chemical safety report – part of REACH registration
• Conditions for safe use should be communicated with a safety data sheet to all the commercial users of the substance (as such and in mixture)
When full safety assessment needed?
• You manufacture or import substances 10 or more tonnes per year (non-intermediates)
• Where the substance meets the criteria to be classified hazardous or PBT (based on the required test data)
• Duty of each registrant, but co-registrants can delegate to a lead registrant (joint chemical safety report)
• Safety report needs to cover all uses of the substance you are aware of
• For imported mixtures: for substances present above the concentration levels defined in Article 14(2)
How to assess?
Uses and condition of use
Substance properties: Hazard assessment
Risk controlled?
Substance properties: Distribution and fate assessment
Exposure estimates
Chemical safety report authorities own documentation
Exposure scenarios (conditions for safe use) annexed to SDS
Iterate…
NoYes
Use advised against communicated in safety data sheet
204
Manufacturer
Knows the properties of the substance
Downstream user
Knows how thesubstance is used
What is needed?
Communication in the supply chain is key
Safety assessment requires information on substance properties and conditions of use
Life cycle
M/I of substance
as such
User 1 produces a
mixture
M/I sells substance in
mixture
User 2 produces a
mixture
End-use of mixture by
user 3 – industrial siteEnd-use of mixture by
consumer
Substance in article
service life
End-use of mixture by
user 3 – professional
M/I of substance
as such
User 1 produces a
mixture
M/I sells substance in
mixture
User 2 produces a
mixture
End-use of mixture by
consumer
User 1 produces a
mixture
M/I sells substance in
mixture
M/I of substance
as such
User 2 produces a
mixture
Company asset
• On-site safety is the starting point
• True responsible care includes the full life cycle
• ‘Care’ includes
• impact on human health and the environment
• short term and long term
requires knowledge and ‘care’ about the substanceand its use
• Your chemical safety report is
• documented proof of this assessment and the positive outcome
• Starting point to tell customers how to use the substance safely
Risks for business
• Registration dossier is incompliant due to inconsistencies between IUCLID, chemical safety report and safety data sheet
• Customers complain about wrong or unhelpful safety data sheets
• Customers use wrong safety information
• Similar customers have to do the same assessments (efficiency lost)
• Maintenance and updating of documents is burdensome/costly:
• Registration dossier
• All safety data sheets for products containing the substance
• Authorities pick the substance for further regulatory action for “wrong” reasons
The risks are collective - affect everyone in the supply chain (substance, mixture, article)
Tools to help: Chesar
• Supports in preparing the chemical safety assessment and safety report and exposure scenarios for communication
• Supports electronic transfer of data: from use map to registration dossier (IUCLID), exposure scenario for safety data sheet
• Consistent and efficient
• Standardised workflow/document generated – efficiency gain for all actors
• Efficiency in single assessment
• Integrated exposure estimation tools
• Re-use of information across substances
• Automated generation of documents
• Facilitated updates
Chesar
• Increasing number of Chesar users: 40% of safety reports submitted since June 2016
• Next release in June 2017
• Improved support to use maps
• Editable chemical safety report
• Training programme for users
• Potential future developments:
• Update of embedded exposure tools
• Integration of other exposure tools
• More support for assessment of article service life
Improved chemical safety
Registrants
• Robust hazard data and good understanding of uses – basis for robust chemical safety assessment:
• to serve customers (via safety data sheets)
• to provide transparency to authorities and increase trust by the general public
• To reduce the risk of regulatory scrutiny or other liability
Downstream users
• Upwards communication (e.g. via use maps) isthe basis for useful information coming back
• can be used for own workplace assessment
• can be efficiently forwarded to own customers
Take-home messages
• Good chemical safety assessment is an asset for all companies using the substance throughout the supply chain
• Shared implementation efforts lead to increased safety at lower overall costs
Thank you!
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Dirk SchwartzHead of Product Safety & Regulations at Bruno Bock Thiochemicals
• In charge of coordinating activities related to chemical inventories and regulations worldwide
• European-registered toxicologist
• Academic background in chemistry and molecular biology
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
Session: Using Chemicals Safer in Europe
ECHA Stakeholders‘ Day 2017
Dr. Dirk Schwartz (ERT)Bruno Bock Chemische Fabrik GmbH & Co.Head of Product Safety & RegulationsTel: +49 4176 909 822Email: [email protected]
„Tips & Tools for Chemical Safety Reports (CSRs)“
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
Agenda
(1) The Company: at a glance
(2) REACH Deadlines and their consequences
(3) Tips and Tools
(4) Feedback and Outlook
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(1) At a glance: the companyBruno Bock Thiochemicals & Evans Chemetics
Preeminent suppliers of organic sulfur specialty chemicals
2 production sites (3 locations) in Germany and the USA with>170 employees
not micro (< 10), not small (< 50), but mid-sized < 250
Worldwide network of agents and distributors to serve customersin >45 countries
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(1) At a glance: Our Products
Organic sulfur specialty chemicals: Mercaptocarboxylic acids and derivatives
salts esters
Thio dicarboxylic estersDithio dicarboxylic esters
Polythiols
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(1) At a glance: Applications
Personal & Home Care(Hair Cosmetics, Cleaners, Leather)
Plastics(Antioxidants, PVC stabilizers)
Coatings, Adhesives, Sealants(Hardeners, Binders, Crosslinkers)
Polymer Synthesis(Chain Transfer Agents)
Organic Sulfur Specialty Chemicals
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(1) At a glance: The REACH TeamCoordination of Projects and Mgmt of Communication
REACHTeam Leader
SIEF costcalculations,
LoA, DSA, Consortia
IT support: installation andupdates of the
tools
Production, Salesand Use: tracking
substanceamounts/y and
customer ES
Consistencybetween
eSDS (CLP) andSDS (global)
IUCLIDChesar
REACH-IT
Externalpartners:
Consultants, Association
work (e.g. VCI) and CROs
Substance IDs, compositions, phys-chem., (eco)tox data
Production conditions, transportation,
environmental andoccupational safety
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(1) At a glance: Our Role under Reach
• SME, Lead Registrant and OR• Manufacturer and importeur• Pure substances, no complex formulations• No CMRs• No PBTs
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(2) REACH Deadlines and their consequences
2010 Company Target: • Collect experience with REACH and be on the safe site. • only one consultant company doing the main work (communicate within the
supply chain/customers, monitor experimental studies, submit the dossiers)• 1 Co-registration• 4 as transported isolated Intermediate under SCC• 3 full registrations >1000 t/y
2013 Company Target: • Under REACH an SME should be able to submit a complete dossier• only marginal consultant work, main work by the internal REACH team
• 0 Co-registration• 2 as transported isolated Intermediate under SCC• 8 full registrations >100 t/y
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
SME: Summary of the Deadlines 2010 and 2013• A submission is not an easy job especially for SMEs• Specific expertise not always in-house available• The real exposure situation related to occupational health and the environment at Bruno
Bock which is historically controlled by national laws is not well reflected under REACH• The downstream use of our products are in some cases not realistic described by our
customers. Risks were therefore overestimated under REACH (conditions of use and riskmanagement measures)
• External support seems to be strongly recommended, but depends on the situation of theSME and their obligations under REACH
(2) REACH Deadlines and their consequences
2018 Company Target: • Avoid animal experiments, close data gaps by using data from 2010 / 2013 registrations.• Many consultants involved: QSAR, Read-across, Weight-of-Evidence approaches
• 4 Co-registration• 2 as transported isolated Intermediate under SCC• 4 full registrations >1 t/y (no CSR)• 10 full registrations >10 t/y
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(3) Use Maps
Customer-site (Use of ourproducts):
REACH–SECTOR USE MAPS: ECHA and Industry Collaboration
Sector use maps describethe uses of the chemicaland also have links to theinformation needed tocarry out exposureassessments.
On-site: Manufacture and Fillings:
Documentation of the real exposure situations for the environment and for theworkers, which can be used under REACH (via Chesar) as well as under national law.
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(3) IUCLID 6: Hazard Tool
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(3) Chesar: Exposure Tool
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(3) Chesar: Exposure Tool
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(3) Outcome: CSR and the „e“ of the eSDS
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(4) SME Feedback 2014
Interview given forECHA Newsletter 2/2014:
Get wise – use Chesar
Main advantages:• Tool from ECHA itself• CSR- and eSDS
preparation by oneklick
• Inhouse database• Data exchange
format with partnersand consultants
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
(4) How can SMEs be supported?
1. Memorandum for shortlistings and compliance checks until 1 June 2018SMEs do not have the power to cope with all other REACH tasks duringregistration work and consultants are fully booked until June 2018
2. More support from national authorities for the ECHA toolChesarIn the past 3 years, Chesar was not even mentioned at national workshops and conferences.
3. Report-Generation in IUCLID of chapters 1 to 16 of the SDS• Full legal document from authorized (ECHA) software• Complete eSDS based on submitted data• Only one system no transfer work between different IT systems• No exchange formats needed• Safe of time and money• UN and OECD supported
BRUNO BOCKTHIOCHEMICALS
EVANSCHEMETICS
Thank you for your attention
BRUNO BOCK Chemische Fabrik GmbH & Co. KG
Eichholzer Str. 23, D-21436 Marschacht, Tel. +49-4176-9098-0 Fax: +49-4176-1396, www.brunobock.de
Interact with us!
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2. Send your questions
3. Give a thumbs-up to the best questions – we will ask
them in that order
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Jukka MALMDeputy Executive DirectorECHA
• Joined ECHA in 2008
• Director of Regulatory Affairs
• Responsible of the overall coordination of regulatory decision making and opinion forming of the Agency
• Before joining ECHA, was Director of Expert Services at the Finnish Environment Institute
Closing remarks
12th Stakeholders’ Day
Jukka Malm
Deputy Executive Director
European Chemicals Agency
5 April 2017
2
Thank you for sharing with us
• 190 of you here
• Over 170 online
• 25% from beyond EU
• Over 60 questions submitted
• 22,000 reached on Twitter
3
REACH 2018 – challenges you raised
• Substance identity takes time and effort
• Registering jointly:
• if poor quality, cost unfairness, substance sameness questions
• Substances not being registered – what to do?
• Diverging classifications
• Getting info from customers and non-EU suppliers
• Using alternatives to testing on animals
• Too busy before June 2018 – don’t ask for more!
4
Your advice to one another..
• Get going now!
• SMEs can register, but should consider help
• Get wise – use CHESAR and IUCLID
• Use the use maps – they help, and you avoid risk
• Be demanding! Of information, fairness, transparency
• Communicate:
• up – and then down – the supply chain
• in SIEFs
• Invest in data – it’s your business card
5
After 2018
• Your dossiers will be screened and evaluated
Keep it up to date, don’t wait for our letter…..
• We tackle substances of concern – theymay be yours!
Follow our news
• Information on all substances >1 tonne in the EU
Freely available
6
Upcoming
• REACH Spring school, 15-19 May
• Litigation seminar, 24 May
• Old CLP labels off the shelves, 1 June
• Nano observatory, June
• REACH review
• Endocrine disruptor guidance, Autumn
• Biocides Stakeholders’ Day, 26-27 September
• REACH Stakeholders’ Day, 30-31 January2018
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