Developments regarding SMEs RIEF III Brussels, 24 June 2014

Developments regarding
SMEs
RIEF III
Brussels, 24 June 2014
Laura Walin
Directorate of Registration
European Chemicals Agency
Content
• Access to ECHA information
• 2018 Registration Roadmap
• Cooperation with the stakeholders
2
2013: studies and surveys
• Commission workshop ”REACHing out to SMEs”
• 2013 Studies on impact on SMEs
• NL: “Impact REACH op MKB”
• UK: EEF-Manufacturers’ Organisation “awareness, activity
and perceptions”; Business Task Force “Cut EU Red Tape”
• EP: ”The consequences of REACH for SMEs”
• CEPS: “REACH: A killer whale for SMEs”
• ECHA: “Survey of first-time successful SME registrants”
• 2014 Commission study (“Impact of REACH on
innovation, competitiveness and SMEs”)
3
Continuously
improving
access to
ECHA information
Simplification of Guidance
• Simplification of access to Guidance
• ECHA’s old Guidance partly lengthy, heavy and
scientific
• Started as European Commission RIP guidance
• Focus on first duty holders: manufacturers of SVHCs
and large volume industrial chemicals
• More recent Guidance targets new users
• Guidance on registration, SDS, Downstream Users
(December 2013)
• Project: CLP Guidance
ECHA webpages
5
Recent Guidance (DUs)
•
Guidance for downstream
users (Version 2.0)
•
A full revision of the structure and
content of this guidance was
published on 5 December 2013.
•
Guidance in a Nutshell for
Downstream Users
•
This document was published
(simultaneously in all official EU
languages other than Gaelic) on 13
December 2013.
April 2014
6
7
New AfA landing page
http://echa.europa.eu/addressing-chemicals-ofconcern/authorisation/applications-for-authorisation/afa
•All AfA-related
information is accessible
from here:
•
•
•
•
« Regulation » section
« Support » section
« Addressing chemicals
of concern » section
•8
New support page
http://echa.europa.eu/applying-for-authorisation
•9
Classification of mixtures
http://echa.europa.eu/web/guest/support/mixtureclassification/where-do-i-start
10
Evaluation report
• Recommendations
• Ensure and demonstrate
intermediate status
• Ensure coherence between
endpoints and CSR
• Ensure consistency between
different properties
• Describe the uses assessed in
an unambiguous way
• Justify adaptations in a
scientifically solid way
• Keep your dossier up-to-date
• …and more
http://echa.europa.eu/documents/10162/13628/evaluation_report_2013_en.pdf
11
“Low-tonnage” recommendations
http://echa.europa.eu/documents/10162/13628/eval_report_2013_facts_figures_en.pdf
12
2018 REACH Registration
Roadmap
What do we expect in 2018?
Substances
Dossiers
2010
2013
2018 ?
~ 3 400
~ 3 000
Up to 25 000
plus intermediates
~ 20 000
~ 9 000
Up to 70 000
• Multitude of small SIEFs
• Individual registrants
• Higher % of SMEs
• Less information available, need to
generate new data
Taking the 2018 registrants’ viewpoint
• Does
Registration
2018 concern
me?
Scope
Pre-SIEF
• Find coregistrants
• Substance
identity
• Agree how to
work
• Data and
cost sharing
SIEF
Registration
dossier
• Uses
• Fill data gaps
• Hazard & risk
assessment
• Submit
registration
dossier
Registration
number
Support for each step towards registration needs to be there
15
Milestones
Subject to resource availability and annual review
Phase 1: Scope
• Publication of one-stop-shop web page for 2018 registration
information on the ECHA website (2014)
• Check list for selecting a good consultant (issued by Directors’
Contact Group DCG) (published on 11 June 2014)
• Joint information campaign together with national helpdesks and
ASOs (2015-2016)
Phase 2: Finding co-registrants
• Methodology for substance sameness established (2015)
• Industry led drafting and publication of sector specific
guidance on substance identification with support from
ECHA (2018)
• Improved accessibility to finding co-registrants (2016)
17
Phase 3: Cooperation with coregistrants
• Publication of ECHA data-sharing dispute decisions and
assessment criteria (2014)
• Publication of support material (2015) and provision of online
training (2016) for data-sharing negotiations
Phase 4: Documenting information in
registration dossier
• Strategy for supporting 2018 registrants in relation to REACH
Annex III (2015)
• Upgraded Chesar published (2016)
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Phase 5: Submitting the registration
• REACH-IT ready for the 2018 registration deadline (including
multilingual support as appropriate) (2016)
• Publication of IUCLID 6 (2016)
• Publication of revised Validation Assistant (completeness check
and dossier quality assistant) (2016)
• Publication of revised manuals for the IT tools (2016)
19
Cooperation with
the stakeholders
Directors’ Contact Group
• Informal platform for exchanging information on
industry preparedness and potential practical obstacles to
registration
• SME focus for the third term 2014-2018
• DCG adopted two documents in its last DCG meeting (4
June 2014)
• Considerations to be made when joining an existing
SIEF
• Checklist to hire a good consultant
• DCG Sherpas working on two other documents for
adoption later this year
• Recommendations on sound SIEF management
• Fair and transparent cost sharing in SIEFs
21
ENES
• Big challenge –
information flow in the
supply chain
• CSR/ES Roadmap
• ENES-7 in November
22
Working with partners
• Cooperation with European Enterprise
Network (EEN), e.g. joint workshop with
HelpNet in November 2013; EEN contact points
• Presentations to various audiences
• Also in third countries (from which ~50% of
substances on Internal Market originate)
• Communications network (using partner
platforms to reach SMEs)
23
Key messages
• ECHA’s efforts to simplify e.g. IT tools,
information and access to information benefits
companies of all sizes
• Provide feedback to ECHA on fine-tuning
support to SMEs and other action within
ECHA’s remit
• Mobilise your contacts as channels for
spreading information on REACH to SMEs
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