De registratiedeadline: de laatste loodjes voor leveranciers én gebruikers Minisymposium stoffenbeleid: REACH 2018 11 April 2018

Catherine Cornu Europees Chemicaliën Agentschap (ECHA)

Contents

• Ensuring a successful submission

• How to deal with difficult situations

• REACH registration and the 2018 deadline

• Available help

• What comes after registration?

• Take-home messages

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49 days to the deadline…

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Status update: where we are

• Around 19 379 DL-2018 registrations received for 7 863 substances (i.e. for phase-in substances registered <100 tonnes/year). Expected: 60 000 DL-2018 for 20 000 substances by 31 May 2018

• Substances registered for the first time for DL-2018: 5 311

• Registrations from SMEs: 21% in March 2018

• Registrations from outside the EU: 43% from importers and 29% from only representatives

Figures as of 9 April 2018

Annual tonnage ≥ 1 tonne per year for uses that are not exempted (with separate calculation for intermediates under strictly controlled conditions) 5

Reminder: who needs to register

Role in the supply chain (in the EU/EEA) • Manufacturer • importer into the EEA • Only Representative • producer or importer of

an article from which a substance is released

Substances every substance unless exempted from registration

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1. Know your portfolio • Track your volumes per substance

• Identify if you need to register (role in the supply

chain) and if substances in your portfolio need to be registered

• Identify and name your substances • Is not a problem if your substance identity for

registration is different from what you pre-registered

• Plan your work and keep your downstream users informed

• Identify the lead registrant • List of lead registrants on ECHA website • Always available in REACH-IT to pre-registrants/inquirers • Role can be taken only with the consent of the SIEF

• If no lead, find your co-registrants • Agree to get going and share the work • Appoint a lead before submission and create a joint

submission in REACH-IT

• Newcomer to the market? • Inquiry to ECHA to be put in contact with co-registrants

2. Find your co-registrants

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3. Data and cost sharing

• Takes place in Substance Information Exchange Forum (SIEF) to prepare the joint submission

• Pay for the data you need to meet your information requirements

• Negotiate costs in a fair, transparent and non-discriminatory manner

• Implementing Regulation clarified: • You have the right to demand a breakdown of the costs • You have the right to challenge costs (incl. administrative

costs) for data you do not need for your registration

Difficulties in the SIEF?

• Make sure the lead has the SIEF’s support • If not, contact ECHA

• Discuss data and costs • Cost itemisation • Make every effort

• Read our examples of unfair practices

• Justified opt-out possible • Disputes at ECHA as

last resort • On data • On access to the joint submission

• Typically all co-

registrants agree and submit all information jointly

• Opt-outs – partial – full

• Disputes – on data – on token

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4. 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 on ECHA website • Justification needed

• > 10 tonnes: chemical safety report needed • tool available

• Get quality right: Relevant, transparent, reliable

• Animal testing is last resort: consider alternatives • For testing proposals: documentation needed

Use maps

• Consult the Use map library on the ECHA website

Information on safe use

Information on uses

How to register if your tests were ordered but will not be ready on time?

• Tests have to be ordered by 31 March 2018

• You need to contact us asap with evidence (latest by 24 May 2018) and follow our instructions

• Your dossier will fail the 1st round of completeness check and you will be given time to complete the dossier

• Your registration number will only be issued when your dossier is completed

• Members can submit after the lead has submitted

Start from the DCG web page: echa.europa.eu/about-us/partners-and-networks/directors-contact-group

Overview of all DCG solutions

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Nr Description of the issue 10.2 Mixture importer does not obtain substance

identification information from non-EU supplier 10.3 Delays in obtaining Annex VII and VIII test results 15.1-3 Legal entity change: one company without

pre-registration 20.1 Lead registrant disappears after a failed completeness

check, not completing the dossier 20.2 Lead registrant disappears before submitting the

registration 21 SIEF without EU manufacturer/importer: Downstream

user decides to start importing

Other difficult situations

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Description of the issue Delays in obtaining results from the analytical tests for substance identification data sharing disputes submitted close to the deadline (https://echa.europa.eu/-/is-your-dispute-pending-you-can-still-submit-a-dossier-by-31-may)

5. Prepare your dossier: which is the best tool for you?

• SMEs • Consultants

working for SMEs • Flow for dossier

creation • Always latest

version of IUCLID • Backups by ECHA

• Member registrants

• Agree with all information submitted by the lead

• Flow for dossier creation

• All others • One-click

installation

Review your dossier

• Run the validation assistant tool in IUCLID: a ‘must’ before submitting

• Consult our help: tips on manual verification and webinars

• Use the dissemination preview in IUCLID to see what information will be disseminated on ECHA’s website

• Use the fee calculator in IUCLID to find out the expected registration fee

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Check these before submitting

• In REACH-IT • Company contacts (so we can

call you if you need help)

• Billing address and VAT (for creating a correct invoice)

• Company size: assess your SME status according to the EU-criteria and upload in REACH-IT the documents proving your SME status for 2018

• Within your company • Is a purchase order needed?

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6. Submit your registration • Before submitting: set up the joint submission in

REACH-IT or join with the token provided by the lead

• Submit your registration dossier in REACH-IT: first the lead registrant, then all co-registrants as soon as the lead has passed the business rules check

• REACH-IT is now open 24/7

• Submissions as of 1 April 2018: outcome of completeness check latest by 31 August 2018

• Registration date will be the submission date

Registrants can follow the progress in REACH-IT

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Checks by ECHA Business rules check Completeness check To make sure our system understands the dossier

To make sure all required elements are included

Must be passed for us to consider dossier submitted before the deadline

Must be passed to get a registration number

• Technical and financial parts

As many submissions as needed after being informed of failure

• One re-submission allowed

Most rules are in the validation assistant

Automated rules are in the validation assistant (not the manual checks by ECHA staff)

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Completeness check

• Dossiers have to be complete before ECHA assigns a registration number

• Includes automated checks and manual checks • Manual verification focusses on

• Unclear substance identity • Where information requirements have been waived • Testing proposals include considerations for animal testing • Justification if Chemical Safety Report is not provided

• 30% of all incoming dossiers are manually verified. 25% of these fail in the first completeness check. 95% of these are corrected and successfully submitted

Incomplete dossier?

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If ’technical completeness check’ fails: • You will receive a letter: check your key

documents in REACH-IT • Deadline to submit an

improved dossier and instructions what to fix

• If not clear, contact us • No need to rush to submit:

this step does NOT need to be completed before 31 May

Pay your invoice on time: fee payment is part of the completeness check

How DU can check progress

Lead creates joint submission

Lead submits the dossier

Lead registers successfully

Members register successfully

List of lead registrants

List of lead registrants

List of lead registrants

Registered substances on ECHA website

Communication in the supply chain: • Tell your supplier you want him to register and cover your uses • Supplier informs of appointment of OR (if the case) and • Registration number needs to be listed in the SDS

If your supplier does not register

• Find a supplier that registered or is willing to register

• Can use stocks from your supplier manufactured/ imported before 31 May under the pre-registration

• If you need <1 ton/year: • can import < 1 ton/year from outside EU without

registration • Can try to find EU-M/I < 1 ton/year (e.g. toll

manufacturing) • If you need >1 ton/year:

• can find multiple EU-M/I < 1 ton/year or • you can become a new importer

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Becoming a new importer

• If the substance has been registered: • Inquiry, buy LoA and register • If the data has been submitted >12 years ago: available

for free for registration • If the substance has not been registered: you

need to generate data • If you find out before the DL use DCG issue 21: can

start M/I and will need to complete the registration by the deadline set by ECHA. You will need to provide evidence so keep track of correspondence

• After the DL: inquiry, data generation and registration needed before the start of M/I > 1 ton/year

• In any case consider informing your national enforcement authorities

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Contents

• Ensuring a successful submission

• How to deal with difficult situations

• REACH registration and the 2018 deadline

• Available help

• What comes after registration?

• Take-home messages

Available help • ECHA’s one-stop-shop for REACH 2018, with templates

and practical examples: echa.europa.eu/reach-2018

• Guide for SME managers (phase 4 essential reading)

• IUCLID validation assistant

• Tips to pass the manual completeness check

• Webinars: next webinar on 19 March (Q&A session)

• IUCLID and REACH2018 video tutorials

• DCG solutions page

• Practical advice on data-sharing and disputes page

• Contact ECHA in case of questions or difficulties • DU: send us by sector the list of critical substances not registered

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Recommendation to help small volume and SME registrants Scope: Companies joining existing registrations 1. Explore if adequate to submit only physico-

chemical information reduced or no costs 2. Rely on data sharing dispute if negotiations

come to a standstill. Submitting a registration dossier is possible.

3. Request payment for letter of access in instalments

4. Request a low-cost affordable lump sum payment option for 1-10 tonne registrants echa.europa.eu/reach-2018

Contents

• Ensuring a successful submission

• How to deal with difficult situations

• REACH registration and the 2018 deadline

• Available help

• What comes after registration?

• Take-home messages

Dissemination

• Your dossier is published on ECHA’s website • Aim: all dossiers (non-confidential parts) published by end

of 2018

• Tips • Use dissemination preview tool to verify what is published

• Confidentiality claims • We will assess all the claims • Additional justification may be requested by ECHA • Check your REACH-IT account regularly: you may have

requests from ECHA

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SME status check

• If you have registered as an SME, your status will be verified • Systematic check • This will run over several years • If you are an Only Representative: size

of the non-EU company counts • Companies are contacted via REACH-IT

• Tips • Upload documentary evidence in REACH-IT before

submitting your registration • Keep your contact details up-to-date in REACH-IT • Check your account regularly: you may have requests

from ECHA

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Retrospective checks

• Your older dossiers may be checked retrospectively for completeness and fulfilling OSOR • Enhanced completeness check introduced in 2016 • Dossiers rarely updated are targeted for retrospective

checks to ensure level playing field • First campaigns showed that registrants were able to fulfil

information requirements, e.g. provide a missing study • Some registration decisions were revoked • One substance, one registration (OSOR):

Implementing Regulation from 2016 tasked ECHA to ensure joint submission

• You will be informed of a retrospective check via REACH-IT

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Enforcement by national authorities

• REF-7 Project of inspections in 2019 (reporting in 2020)

• All EU countries foreseen to participate • Scope:

• Registration obligations after the last deadline in cooperation with customs authorities

• This includes verification of intermediate status and strictly controlled conditions applicable to substances registered as intermediates echa.europa.eu/reach-2018

Compliance checks

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If ECHA is not convinced by the information provided or your assessment

• You normally get a chance to update your dossier before formal process starts • Substances potentially picked for compliance check

published on our website: echa.europa.eu/regulations/reach/evaluation/compliance-checks

• Recommendations in annual Evaluation reports: echa.europa.eu/evaluation

• Evaluation decisions affect all registrants, not only the lead

Substance evaluation and risk management

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If further information is needed to clarify a concern or further risk management at EU level is needed

• Focus on substances that matter • Higher-tonnage registrations with important data gaps

and with exposure potential

• Common screening in cooperation with Member States • Most suitable route to address concern is identified

• Short-listed substances • Letter sent to each registrant concerned, with advice

and an update deadline before formal process starts • Webinar organised for more advice

Keep up-to-date: PACT

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• Public activities coordination tool: echa.europa.eu/pact

• Find out: nature of our concern (CMR, PBT…), on-going activities, authority in charge and outcome

7. Keep your dossier up-to-date

• Updating is a legal obligation

• Ensure that you and the authorities assess safe use based on up-to-date and reliable data

• Obligation to all!

• Make sure you have a process to keep track of changes in volumes, uses etc.

• Make sure you have agreed in the JS how to share costs in case new info is requested by authorities

• The reality: • 67% of all dossiers have never been updated

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REACH is not over after May 2018

What else to expect?

REACH review

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• Report published 5 March 2018 • Action 1: Encourage updating of registration dossiers

• Nano-forms: review of REACH Annexes • Changes will enter into force January 2020 • ECHA will develop guidance to ensure sufficient support

• 1-10 tonnes information requirements and polymers • Studies show benefits are higher than costs, but further

assessment needed on economic impact on SMEs

UK withdrawal from the EU

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• Prepare for withdrawal date: 30 March 2019

• UK-based registrants obliged to register under REACH for 2018, subsequently subject to UK law

• All registrants (within EU-27/EEA and UK) will be affected in various ways

• See details and follow developments on ECHA’s website: echa.europa.eu/uk-withdrawal-from-the-eu

Contents

• Ensuring a successful submission

• How to deal with difficult situations

• REACH registration and the 2018 deadline

• Available help

• What comes after registration?

• Take-home messages

Take home messages

• Use our available help and run the available tools to check your dossier before submitting, in particular the validation assistant

• As DU, inform your suppliers of which substances you need and follow the progress of registration

• Contact ECHA in case of questions or difficulties • DCG solutions are now available for companies in

exceptional situations for the 2018 deadline • Registration is not over by May 2018 • You need to update your dossier: make sure you have a

structure in place to handle updates • Legislation evolves: sign up to ECHA’s weekly newsletter

to stay up-to-date

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catherine.cornu(at)echa.europa.eu