Können KMU mit REACH noch atmen?

Transcription

1 Können KMU mit REACH noch atmen? Chemisches Abendgespräch Wien, 30. Oktober 2014 Andreas Herdina KMU-Botschafter Europäische Chemikalienagentur

2 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

3 2013 und danach Aufmerksamkeit auf EU- Ebene wendet sich den KMU mehr zu

4 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 : 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

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6 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

7 2014 Unterstützung von KMU wo stehen wir jetzt?

8 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

9 Simplifying advice and access Shifting message from the we to the you

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11 Five clear steps (SME webpages) 11

12 Evaluation report 2013 Recommendations highlighted for easy reading 12

13 Low-tonnage recommendations 13

14 Newsfeed and RSS 28/10/

15 The process of classifying mixtures (new webpages since July, in all official EU languages since September 2014) xture-classification/where-do-i-start 15

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17 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 17

18 SDS eguide: Introductory 18

19 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 REACH 2018 Registration Roadmap end of

20 REACH 2018 Registration webpages (launched 13 October 2014) 20

21 REACH 2018 Registration webpages

22 Newcomer support webpage (to come) 22

23 Directors Contact Group (DCG)

24 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 24

25 Zulassung

26 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

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29 New AfA landing page All AfA-related information is accessible from here: «Regulation» section «Support» section «Addressing chemicals of concern» section 29

30 New support page 30

31 PSIS Status table is regularly updated on ECHA s website: 31

32 What 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 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. 32

33 Applicant 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) 33

34 Outreach

35 National Helpdesks the HelpNet 35

36 Nationale Auskunftstellen 36

37 Working 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) 37

38 Communications ECHA e-news (> subscribers), Newsletter, website, multimedia products, social media ECHAterm (multilingual terminology database) 38

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40 ECHA in social media Facebook: EUECHA LinkedIn: European Chemicals Agency YouTube: EUChemicals 40

41 2015 Weitere Schwerpunkte

42 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 42

43 Preparing 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) 43

44 Possibilities of Dissemination Portal

45 Dissemination: substance-centric model Identity Data EC # CAS # Index # EC Name IUPAC name(s) Public Name(s) Synonyms Trade Name(s) SMILES InChI NB: Only non- confidential data REACH PIC Registration Evaluation Authorisation Restriction CLP BPR Annex I Annex V Harmonised Notified Active Substance Authorised Product(s) Suppliers

46 Tiered approach Infocard Brief Profile Source Data Preregistration List Registration Dossiers Evaluation Decisions CoRAP List Authorisation List Restriction List Harmonised C&Ls Approved Active Substances PIC Annex I

47 Infocard

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49 Und mehr Vereinfachung der ECHA-Entscheidungen Mehrsprachigkeit Weitere Vereinfachung des Zulassungsverfahrens Durchführungs-Verordnung der Europäischen Kommission zu SIEF-Management und Kostenteilung 49

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