De registratiedeadline: de laatste loodjes voor leveranciers én gebruikers - Minisymposium stoffenbeleid: REACH 2018 11 April 2018 - Chemische ...
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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
49 days to the deadline…
•echa.europa.eu/reach-2018
Status update: where we are • Around 19 379 DL-2018 registrations received for 7 863 substances (i.e. for phase-in substances registered
Reminder: who needs to register
Role in the supply chain Substances Annual tonnage
(in the EU/EEA) every substance ≥ 1 tonne per year
• Manufacturer unless exempted for uses that are
• importer into the EEA from registration not exempted
• Only Representative (with separate
calculation for
• producer or importer of
intermediates
an article from which a
under strictly
substance is released
controlled
conditions) 5
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
6
2. Find your co-registrants
• 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
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
8
Difficulties in the SIEF? • Make sure the lead has the SIEF’s support • Typically all co- • If not, contact ECHA registrants agree and • Discuss data and costs submit all information • Cost itemisation jointly • Make every effort • Opt-outs • Read our examples of – partial unfair practices – full • Justified opt-out possible • Disputes • Disputes at ECHA as – on data last resort – on token • On data • On access to the joint submission
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
10Use maps Information Information on uses on safe use • Consult the Use map library on the ECHA website
How to register if your tests were
ordered but will not be ready on time?
Start from the DCG web page:
echa.europa.eu/about-us/partners-and-networks/directors-contact-group
• 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 submittedOverview of all DCG solutions
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
echa.europa.eu/reach-2018Other difficult situations
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)
echa.europa.eu/reach-20185. Prepare your dossier: which is the best tool for you? • SMEs • Member • All others • Consultants registrants • One-click working for SMEs • Agree with all installation • Flow for dossier information creation submitted by • Always latest the lead version of IUCLID • Flow for dossier • Backups by ECHA creation
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
echa.europa.eu/reach-2018Check 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?
echa.europa.eu/reach-20186. 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
18Registrants can follow the
progress in REACH-IT
•echa.europa.eu/reach-2018Checks by ECHA
Business rules check Completeness check
To make sure our system To make sure all required
understands the dossier elements are included
Must be passed for us to Must be passed to get a
consider dossier submitted registration number
before the deadline
• Technical and financial
parts
As many submissions as needed • One re-submission
after being informed of failure allowed
Most rules are in the validation Automated rules are in the
assistant validation assistant (not the
manual checks by ECHA staff)
echa.europa.eu/reach-2018Completeness 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 21
Incomplete dossier?
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
echa.europa.eu/reach-2018How DU can check progress
Lead creates joint List of lead registrants
submission
Lead submits the dossier List of lead registrants
Lead registers
successfully List of lead registrants
Members register Registered substances
successfully 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 SDSIf 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 find multiple EU-M/I < 1 ton/year or
• you can become a new importer
echa.europa.eu/reach-2018Becoming 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
echa.europa.eu/reach-2018Contents • 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
echa.europa.eu/reach-2018Recommendation 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-2018Contents • 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
echa.europa.eu/reach-2018SME 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
echa.europa.eu/reach-2018Retrospective 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
echa.europa.eu/reach-2018Enforcement 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-2018Compliance checks
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
echa.europa.eu/reach-2018Substance evaluation and
risk management
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
echa.europa.eu/reach-2018Keep up-to-date: PACT
• Public activities coordination tool:
echa.europa.eu/pact
• Find out: nature of our concern (CMR, PBT…), on-
going activities, authority in charge and outcome
echa.europa.eu/reach-20187. 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
echa.europa.eu/reach-2018REACH is not over after May 2018
What else to expect?
REACH review
• 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
echa.europa.eu/reach-2018UK withdrawal from the EU
• 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
echa.europa.eu/reach-2018Contents • 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
echa.europa.eu/reach-2018catherine.cornu(at)echa.europa.eu Follow our news News: echa.europa.eu/subscribe Twitter: EU_ECHA Facebook: EUECHA YouTube: EUchemicals LinkedIn: European Chemicals Agency
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