Können KMU mit REACH noch atmen? - Chemisches Abendgespräch Wien, 30. Oktober 2014
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Können KMU mit REACH noch atmen? Chemisches Abendgespräch Wien, 30. Oktober 2014 Andreas Herdina KMU-Botschafter Europäische Chemikalienagentur
Wie kann die Aufsichtsbehörde für
Luftzufuhr sorgen?
Indem ECHA
• die Bedürfnisse der KMU bestmöglich kennt
• das aufsichtsrechtliche Verfahren möglichst vorhersehbar,
erschwinglich und verständlich gestaltet
2
2013 und danach Aufmerksamkeit auf EU- Ebene wendet sich den KMU mehr zu
Studies and surveys
• 2013 studies on impact on SMEs
• NL: “Impact REACH op MKB”
• UK: Business Task Force “Cut EU Red Tape”; EEF-Manufacturers’
Organisation “awareness, activity and perceptions”; DEFRA
“survey on REACH business impacts”
• EP: ”The consequences of REACH for SMEs”
• CEPS: “REACH: A killer whale for SMEs”
• ECHA: “Survey of 2013 SME registrants”:
– https://echa.europa.eu/documents/10162/21332507/survey_2013_s
me_registrants_en.pdf
• 2014 Commission study (“impact of REACH on innovation,
competitiveness and SMEs”)
• 29 October 2014: NL workshop “opportunities for cost
reduction”
4
5
Main cost factors for SMEs
1. Cost of data sharing (i.e. meeting information
requirements, SIEF participation for
registration, Letters of Access)
2. Cost of communicating in the supply chain
(use of chemicals)
3. “Cost of ignorance”: futile or belated efforts of
taking the wrong route; cost of consultants;
accessibility of public information
4. Obligations under other EU and national
(environmental) laws
6
2014 Unterstützung von KMU – wo stehen wir jetzt?
Special cases, market uncertainty
• Fragrance industry (France and Mediterranean MS),
driver: UVCBs – workshop in Brussels, 8 April 2014
• Uncertainties regarding actual registration or
authorisation of certain substances, driver: cost/ effort –
meeting on chromium-VI authorisation, 28 May 2014
• Registrants of dyes; driver: large numbers of small
substances – meeting in Helsinki, 17 July 2014
• Formulators’ recipes (e.g. detergents); driver:
classification under REACH & CLP
• ECHA’s approach: provide predictability vs. nervous
market behaviour as well as clear and targeted
support
8
Simplifying advice and access Shifting message from the “we” to the “you”
10
Five clear steps (SME webpages)
11Evaluation report 2013
• Recommendations
highlighted for easy
reading
http://echa.europa.eu/documents/10162/13628/evaluation_report_2013_en.pdf
12“Low-tonnage” recommendations
http://echa.europa.eu/documents/10162/13628/eval_report_2013_facts_figures_en.pdf
13Newsfeed and RSS 28/10/2014 14
The process of
classifying mixtures
(new webpages since July, in all
official EU languages since
September 2014)
http://echa.europa.eu/web/guest/support/mi
xture-classification/where-do-i-start
1516
eGuide on safety data sheets
and exposure scenarios
• Multimedia tool, launched 18 August 2014
• By 30 September, over 13,000 visitors
from 80 countries
• Available at
echa.europa.eu/
downstream-users
=> Related documents
17SDS eGuide: Introductory
18Taking the 2018 registrants’ viewpoint
Registration
Pre-SIEF dossier
• Agree how to • Submit
• Does
work registration
Registration
• Find co- • Uses dossier
2018 concern • Data and
me? registrants cost sharing • Fill data gaps
• Substance • Hazard & risk
identity assessment
Scope Registration
SIEF number
“REACH 2018 Registration Roadmap” – end of 2014
19REACH 2018 Registration webpages
(launched 13 October 2014)
20REACH 2018 Registration webpages
“Newcomer” support webpage (to come)
22Directors’ Contact Group (DCG)
Third DCG mandate – focus on SMEs
• DCG responded to SME workshop expectations
by adopting four documents for orientation:
• Checklist to hire a good consultant (4 June 2014)
• Considerations to be made when joining an existing SIEF
• Recommendations on sound SIEF management (1
October)
• Fair, transparent and non-discriminatory cost sharing in
SIEFs
• Documents and communiqués on ECHA website
• http://echa.europa.eu/web/guest/about-us/partners-and-
networks/directors-contact-group
24Zulassung
SVHC Roadmap web pages
‘Substances of potential
concern’ sub-section
created under ‘Addressing
chemicals of concern’
landing page on ECHA
website
Went live in
December 2013
2627
28
New AfA landing page
http://echa.europa.eu/addressing-chemicals-of-
concern/authorisation/applications-for-authorisation/afa
All AfA-related
information is accessible
from here:
•
• « Regulation» section
• « Support» section
• « Addressing chemicals
of concern» section
•29New support page
http://echa.europa.eu/applying-for-authorisation
•30“PSIS”
Status table is regularly updated on ECHA’s website:
•31What ECHA has done to facilitate the applications of
SMEs using Chromates
1. Held over 10 seminars and given speeches/presentations in
industry-led workshops in several EU Member States
• Held a special training event in Germany for platers (VECCO) on how to use IUCLID
• Collaborated closely with aviation and space industries (which contract to SMEs) to better
understand their specific situations when applying
• Seminar (organised with Eurométaux/Cefic) on 6-7 November 2014
2. Simplified the information needs for SMEs who do not have access
to registration data: No need to provide hazard data!
3. Simplifying on how submit applications (avoid using the
“registration” approach of IUCLID 5)
4. Simplify how SMEs can document information in their applications
• If small / niche users, use the “special case” template that is being developed with the
Commission services
• Make use of a combined version of the format for analysis of alternatives and
socio-economic analysis. This will make it easier for the applicants (including SMEs) to
document their analysis. Reduces application work considerably and makes also the
work of ECHA’s committees more efficient.
32Applicant feedback survey
• 22 responses (as of October 2014)
• Applicants thought they received very good support from ECHA
staff and PSISs
• Uncertainty related to final authorisation decision and acquiring
necessary expertise reported to be the most challenging aspects
of applying
• Estimated effort required to prepare an application for
authorisation (per applicant, per use)
• Applicants used on average 9 man-months of internal staff time
• In addition, applicants spent on average € 120,000 on
consulting fees and expenses (not including application fee)
33Outreach
National Helpdesks – the HelpNet
35Nationale Auskunftstellen
36Working with other partners
• Cooperation with European Enterprise
Network (EEN), e.g. joint workshop with
HelpNet in November 2013; EEN contact points;
• Guide for EEN advisors (October 2014)
• Communications network (using partner
platforms to reach SMEs)
• Presentations to various audiences
• Also in third countries (from which ~50% of
substances on Internal Market originate)
37Communications
• ECHA e-news (>17 000 subscribers),
Newsletter, website, multimedia products,
social media
• ECHAterm (multilingual terminology database)
3839
ECHA in social media
• Twitter: @EU_ECHA
• Facebook: EUECHA
• LinkedIn: European Chemicals Agency
• YouTube: EUChemicals
•402015 Weitere Schwerpunkte
Visits to SMEs (started 2014)
• Purpose: to gain “real hands-on” experience
on the usability of ECHA’s IT submission
tools and related guidance (manuals, etc.) by
“sitting behind an SME’s computer”
• Wuppertal (IUCLID use for AfA, September)
• Ireland (September 2014)
• Italy
• France
• Poland
42Preparing simpler IT tools for registration
• IUCLID, Chesar, REACH-IT
• Advance communication to
allow companies to prepare
• Latest: REACH-IT 2.7 for
easier communication
• IT upgrade in 2016 (e.g.,
IUCLID 6.0)
43Possibilities of Dissemination Portal
Dissemination: substance-centric model
• Registration
• Evaluation
REACH
• Authorisation
• Restriction
•Identity Data
•EC #
•CAS # • Harmonised
CLP
•Index # • Notified
•EC Name
•IUPAC name(s)
•Public Name(s) • Active
•Synonyms Substance
•Trade Name(s) BPR • Authorised
Product(s)
•SMILES
• Suppliers
•InChI
•NB: Only non-
•confidential data
• Annex I
PIC
• Annex VTiered approach
•Infocard
•Brief Profile
•Source Data
•CoRAP List •Authorisation •Restriction List •Harmonised •Approved •PIC Annex I
•Preregistration •Registration •Evaluation
Decisions List C&Ls Active
•List Dossiers
SubstancesInfocard
Und mehr…
• Vereinfachung der ECHA-Entscheidungen
• Mehrsprachigkeit
• Weitere Vereinfachung des
Zulassungsverfahrens
• Durchführungs-Verordnung der Europäischen
Kommission zu SIEF-Management und
Kostenteilung
• …
49Andreas.Herdina@echa.europa.eu www.echa.europa.eu Subscribe to our news echa.europa.eu/subscribe Follow us on Twitter @EU_ECHA
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