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ACHIEVING TIMELY REACH-REGISTRATION

Options, tick lists and support resourcesto help you meet

the 31 May 2018 deadline

Sandra Carey, IMOA REACH Molybdenum Consortium Secretariat

www.imoa.info2

REACH Basics:

RegistrationEvaluationAuthorisation (and restriction) ofChemicals

For “large scale improvement of human health and the environment in Europe”

Hazard identificationRisk AssessmentCommunication along the supply chain about safe handling and use of chemicals

Substance-specific legislation:REACH Regulation no. 1907/2006

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REACH & Brexit

Final REACH-registration deadline is 31 May 2018 (1 – 100 tonnes)

Brexit date set for 29 March 2019 but with transition period till end December 2020 where UK continues compliance with EU laws

So ……:

Need to proceed with your REACH-registrations for business continuity and compliance

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In the REACH-registration context – who are YOU today?

Manufacturer ……… Importer …….. Trader Importer …. Trade Distributor …. Downstream User?

Letter of Access purchaser? Lead Registrant? Passive SIEF member? Active SIEF member? Preference to outsource to REACH technical support providers? Few substances to register? Many substances to register? Inorganics? Organics?

Reasonably along the road with the process? In a quandary and hardly know where to start?

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Common concerns & challenges:

Seeking REACH registration that is:

Timely

Compliant … legally and technically

Manageable cost-wise

Manageable resource-wise

Doesn’t overly distract you from your core business

Maintains business flexibility and feasibility

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Time is fast slipping away & running out!

Dedicate priority resources to registration task

Plenty of service-providers to outsource task to – but heavy workload now

Fast track payments for LoAs

Additional manual verification by ECHA means earlier submission needed to ensure registration by end May 2018

2018 REGISTRATION DEADLINE: 31 MAY 2018

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PATHWAYS TO REACH-REGISTRATION:

If substance already registered : Buy a Letter of Access Co-register:

Do-it-yourself via IUCLID6 & REACH-IT3 or ‘just’ REACH-IT3, or IUCLID on the cloud

Via a REACH registration service provider

Options if substance NOT already registered :

Do it yourself and take the lead as Lead Registrant

Support the Lead Registrant to achieve registration by being active and cooperative in the SIEF – you only succeed if LR succeeds!!

Contract a REACH registration service provider to do it for you …. but be aware this isn’t a hands-off option either!

Recipe for disaster: Cross-fingers someone else will do it all so you can then purchase an LoA at the last moment.

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LETTER OF ACCESS (LoA):

LoA availability means a Lead Registrant has already registered the substance

Least time/resource intensive option Complies with OSOR principle (One Substance, One Registration) An LoA is the right to refer to the Lead Registrant dossier for your co-

registration

Be aware: LoA agreements not uniform across substances Costs can differ significantly within same tonnage band LoA process takes some time – identify LOA provider/order &

contract/pay/receive deliverables/join joint submission/prepare co-registration and submit - do it sooner than later!

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Where to find the Lead Registrant to purchase your LoA:

Search points:

REACH-IT3: ….. (Closed weekends and public holidays!)https://reach-it.echa.europa.eu/reach/public/welcome.faces

ECHA Lead Registrant List:https://echa.europa.eu/-/list-of-substances-with-lead-registrants-available https://echa.europa.eu/documents/10162/5039569/registration_statistics_lr_js_en.pdf/cf1c8cd9-890d-4277-bc1e-740bd6eab2bb

ECHA List of Registered Substances:https://echa.europa.eu/information-on-chemicals/registered-substances

Sector/substance Trade Association

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Example of a REACH Consortium LoAwebpage:

http://www.molybdenumconsortium.org/letter-of-access.html

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Substance NOT already registered?Outline of trek for > 10 tonnes tonnage band:

Reach Registration

REACH dossiers

CSRs

Hazard &Risk Assessment

Data interpretation

Testing

Base camp: Sameness & Data-Gathering & Gap Analysis

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The Lead Registrant/SIEF pathway:

Into Lead Registrant and SIEF territory Substance Information Exchange Forum:

Participants ‘self-organize’ to generate, compile and submit the technical dossier required for compliance with REACH.

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Data Requirements:

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Populating the dossier with data:

Options for data-populating the dossier can include: Data from existing literature Generating data through testwork Reading-across data within a grouping of similar substances

Buying a Licence to Use for core datasets to build a dossier: e.g. molybdate data for molybdenum compounds

An LtU is an individually tailored data-package and agreement, giving you permission to use the data to build a dossier for REACH-registration purposes (only)

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REACH-Registration – helicopter view:

Prepare Inventory of Substances you seek to register Identify which ones already registered (LoA possible), and which aren’t REACH-IT account IUCLID 6 software (own computer or cloud) ….. Alternative: directly via

REACH-IT Get active in Pre-SIEF/SIEF Establish substance sameness Fulfill data requirements and chemical assessment processes inc:

Phys-Chem, Environment, Human Health endpoints for tonnage band * Uses and Exposure Hazard Assessment Risk Assessment Substance self-classification necessary? Exposure Scenarios for hazardous substances Generate Chemical Safety Report (> 10 tonnes tonnage bands)

* < 10 tonnes = ‘available’ information

Generate dossier and check it Submit Lt/co-registrant dossiers via REACH-IT3 Pay ECHA Registration fee

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Science – invest time & effort in:

READING ECHA GUIDANCE DOCUMENTS

SCOPING OUT THE SIZE OF THE TASK/LENGTH OF TIMELINE

SUBSTANCE IDENTITY AND SUBSTANCE SAMENESS

DATA-GATHERING, GAP ANALYSIS, DATA-SHARING

SCREENING STUDIES FOR SCIENTIFIC RELEVANCE & RELIABILITY

READ-ACROSS AND INTELLIGENT TESTING STRATEGY

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Science – invest time & effort in:

RANKING CRITERIA TO SELECT SERVICE PROVIDERS

IDENTIFICATION OF USES – REACH OUT EARLY ALONG THE SUPPLY CHAIN

KNOW HOW THE IUCLID SOFTWARE WORKS

PREPARING EXPOSURE SCENARIOS (FOR HAZARDOUS SUBSTANCES)

REVIEWING THE DRAFT CHEMICAL SAFETY REPORT

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THE CLOSER THE SUMMIT THE HARDER THE CHALLENGE! ….

…… Finishing Line Fatigue & Frustration

MAY 2018

IS JUST AROUND

THE CORNER!

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Where to look for support!

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ECHA Webinarshttps://echa.europa.eu/reach-2018/know-your-portfolio

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ECHA Webinars provide support to understand your taskshttps://echa.europa.eu/reach-2018

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IUCLID 6 SOFTWARE – CLOUD VERSION NOW AVAILABLE

No need to download software to own computer

Embedded guidance on dossier preparation

For dossier preparation:

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ECHA’s REACH 2018 Roadmaphttps://echa.europa.eu/press/press-material/pr-for-reach-2018

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ECHA’s REACH 2018 ROADMAPhttps://echa.europa.eu/press/press-material/pr-for-reach-2018

ECHA expecting ca. 60,000 registrations for up to 25,000 substances –many by REACH-inexperienced SMEs

Registration deadline 1 – 100 tonnes/year: 31 May 2018

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https://echa.europa.eu/support/registration/finding-your-co-registrants

More detailed support on ECHA Website:

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ECHA Guidance documents:https://echa.europa.eu/support/guidance

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Whole Library of Guidance Documents!

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https://echa.europa.eu/regulations/reach/registration/information-requirements/chemical-safety-report/csr-es-roadmap

CSR/Exposure Scenario Roadmap – continuous improvement

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USE MAPS: https://echa.europa.eu/csr-es-roadmap/use-maps/concept

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Data-Sharing:https://echa.europa.eu/regulations/reach/registration/data-sharing

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Implementing Regulation on Data-Sharing ….since January 2016

Existing guidance not considered sufficient to ensure costs associated with data-sharing are determined in ‘a fair, transparent and non-discriminatory manner’

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ECHA Weekly E-mail is a useful‘heads up’:

https://echa.europa.eu/subscribe

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REACH Metals Gateway (Eurometaux):

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REACH EU National Helpdesks:

https://echa.europa.eu/support/helpdesks

http://www.hse.gov.uk/reach/helpdesk.htm

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UK Chemicals Stakeholder Forum:https://www.gov.uk/government/groups/uk-chemicals-stakeholder-forum

Latest meeting:30 March 2018, LondonREACH Guidance Note Nov 2015

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2018

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Submitting your Registration Dossier:https://echa.europa.eu/reach-2018/submit-your-registration-dossier

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Good practice to review and update your dossier periodically. Relevant new science must be included ‘without undue delay’

Dossier is a ‘living document’, not a once-only static snapshot!

And later ….. Updating your REACH dossier:https://echa.europa.eu/reach-2018/keep-your-registration-up-to-date

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REACH – The Never-Ending Story:

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Worth keeping in mind ……

THE REACH DOSSIER YOU SUBMIT MAY BE USED

BY ECHA TO REGULATE YOUR INDUSTRY ……..

SO IN YOUR OWN INTERESTS ….

WORK TO INVEST MAKING IT A ROBUST ONE!

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Thank you for your attention!

Sandra CareyIMOA REACH Molybdenum ConsortiumE-mail: sandracarey@imoa.infowww.molybdenumconsortium.org

Views expressed in this presentation are those of the presenter and not necessarily those of IMOA.

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Examples of REACH registration service providers:

B-LandsYordas (formerly The REACH Centre)Knoell ConsultEcomundoCIRSAnthesis GroupRamboll UK

The above is simply a list of examples, not a list of recommendations

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Making an Inquiry:https://echa.europa.eu/regulations/reach/registration/data-sharing/inquiry