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Update from ECHA
REACH Implementation Workshop X
13 December 2011
Laurence Hoffstadt
ECHA – Substance Identification & Data Sharing
http://echa.europa.eu 2
Overview
• Update registrations/ dissemination
– Summary
– Analysis 2010- substances not registered
– Dissemination
– C&L inventory
• ECHA priorities for 2012
• 2013 “Act Now” Campaign
– Dedicated webpage
– LR WS 2012
– Webinar programme
http://echa.europa.eu
http://echa.europa.eu 3
Registration - Dossiers
Cumulative Dossiers Registered by Month
24 164 24 507 24 726 25 029 25 231 25 456 25 682 25 925 26 144 26 383 26 585 26 735
0
5 000
10 000
15 000
20 000
25 000
30 000
Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11
Individual
Member
Lead
http://echa.europa.eu 4
Registration - Substances
Cumulative Substances Registered by Month
4 4204 548 4 626 4 711 4 791 4 852 4 907 4 995 5 071 5 138 5 208 5 242
0
1 000
2 000
3 000
4 000
5 000
6 000
Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11
NonPhaseIn
PhaseIn
http://echa.europa.eu 5
Registration - Statistics
Registered substances by registration type * Registered substances by category / class / source Top 10 countries by number of substances registered •
§ All numbers for 'Substances' are determined automatically using unique substance identifiers (EC Number / List Number). As substance identities are verified the numbers reported for substances may change.
* 'Full' indicates a registration under REACH Article 10 as a full dossier; 'OSII' under REACH Article 17 as an on-site isolated intermediate; 'TII' under REACH Article 18 as a transported isolated intermediate.
¶ Substances previously notified under Directive 67/548/EEC ('NONS' substances) which have been claimed and updated with a REACH registration dossier; these are counted with the 5242 REACH registrations
• Numbers indicated in this table are the number of substances registered in a country (by at least one legal entity) from the total figure of 5242 substances for which REACH registrations have been received.
Data as of 02 Dec 2011
5 242Registered Substances
(for which a REACH registration
dossier has been received)
+ 2 397Registered Substances
(Notified under Directive 67/548,
claimed since Jun 2008)
Only as Full * 2 842
Only as OSII * 422
Only as TII * 1 000
Full & OSII 118
Full & TII 335
OSII & TII 259
Full, OSII & TII 266
Registered as
Full Registration
Registered as
Intermediate Only
3 561
1 681
Phase-in substances 3 597
Non-phase-in 1 645
Total 5 242
Of which are NONS ¶ 1 175
EINECS substances 2 759
Substances from
Joint Submissions
Substances from
Individual Subm.
3 047
2 195
Germany 2 934
United Kingdom 1 343
France 1 073
Belgium 1 131
The Netherlands 1 047
Italy 917
Spain 828
Sweden 369
Poland 359
Finland 354
http://echa.europa.eu 6
• Overall number of registrations in line with expectations
• Number of substances registered is lower than expected
– Industry and ECHA surveys early 2010
– Gap of 1500 substances
• Analysis done to evaluate market impact
– Publication Autumn 2011
http://www.echa.europa.eu/chem_data/list_registration_2010_en.asp#download
– Explanations found for ca. 800 substances
• Registration postponed, better understanding of REACH obligations
(e.g. exemptions), merge/ split of SIEFs, etc.
• Conclusion
– Useful tool: 70% prediction
– Market surveys ahead of next deadline
Analysis after the 2010 deadline
http://echa.europa.eu 7
Dissemination - Dossiers % of Registered Dossiers Disseminated
Dissemination Progress
All Dossiers: 89%Target: 80%
JS Lead: 97%
JS Member: 93%
Individual: 55%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11
% o
f Regis
tere
d D
ossie
rs
http://echa.europa.eu 8
Dissemination – Substances
% of Registered Substances DisseminatedDissemination Progress
All Substances: 80%Target: 80%
Phase-in: 97%
Non-phase-in: 39%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11
% o
f Regis
tere
d S
ubsta
nces
http://echa.europa.eu 9
Dissemination – next developments
• http://apps.echa.europa.eu/registered/registered-sub.aspx
• Disclaimer: for information only- not for registration purposes
• Increase availability of information
– Decision taken to also publish
• company name
• registration number
• outcome of PBT / vPvB assessment
– Modifications to IUCLID and REACH-IT to prepare for broadening of the interpretation of “other information in the safety data sheet” and dissemination (Spring 2012)
– Transitional period foreseen: registrants to resubmit after tools available
• Assessment of confidentiality claims ongoing
– Ca. 1600 received of which 1000 assessed
– Ca. 50% decisions sent/ 50% await update from registrants
http://echa.europa.eu 10
Public C&L Inventory (1)
http://echa.europa.eu
• Basis – CLP regulation- Art. 58(7)(a)
– 2 phases: • only hazardous substances (IUPAC+EINECS names)
• Addition of substances with hazard classes not mentioned in Article 119(1)(a) (EINECS name)
• Current status
– Launch on 15 December 2011 (as part of new ECHA website)
– Contains information on ca. 105 000 substances (phase 1) • Substance name + numerical identifier
• Self-classification and labelling
• Whether it is a joint entry between registrants
• Harmonised classification and labelling
http://echa.europa.eu 11
Public C&L Inventory (2)
http://echa.europa.eu
Top 10 countries by % of notifications
Germany 37%
United Kingdom 20%
France 9%
Belgium 7%
Spain 6%
The Netherlands 6%
Italy 5%
Austria 2%
Poland 1%
Hungary 1%
All data as of 2 Dec 2011
C&L Inventory
Unique Substances Notified 115 971
C&L Notifications Submitted 3 438 860
Submitting Companies 12 754
All data as of 2 Dec 2011
http://echa.europa.eu 12
Overview
• Update registrations/ dissemination
– Summary
– Analysis 2010- substances not registered
– Dissemination
– C&L inventory
• ECHA priorities for 2012
• 2013 “Act Now” Campaign
– Dedicated webpage
– LR WS 2012
– Webinar programme
http://echa.europa.eu
http://echa.europa.eu 13
ECHA staff
• 494 (30Nov11)
• From 25 EU countries
(no Cypriot, no Luxembourger),
Iceland and Norway
http://echa.europa.eu 14
Challenges and Priorities for 2012
• Ensure readiness for 2013 of ECHA
– Enhance communication with the general public and SMEs & reinforce
involvement of stakeholders
– Optimise Guidance, IT tools and helpdesk for 2013 deadline
• Complete the dissemination portal & the assessment of confidentiality claims from the 2010 and 2013 deadlines
– Publish public information from all registrations
– C&L inventory
• Focus on Evaluation
– Dossier evaluation to meet deadlines of testing proposals, and the
compliance check target of 5% for highest tonnage bands
– Play central role in substance evaluation by prioritising substances, coordinating the process and supporting MSCAs (adoption of CoRAP)
• Support substantial increase of Committee work on SVHC and CLH dossiers, restrictions and possibly authorisation
• Prepare for new Biocides and PIC Regulations
http://echa.europa.eu
http://echa.europa.eu 15
Overview
• Update registrations/ dissemination
– Summary
– Analysis 2010- substances not registered
– Dissemination
– C&L inventory
• ECHA priorities for 2012
• 2013 “Act Now” Campaign
– Dedicated webpage
– LR WS 2012
– Webinar programme
http://echa.europa.eu
http://echa.europa.eu 16
2013 “Act Now” Campaign
• Five Scenarii
– 2010 LR
– 2013 registrants for substance registered in 2010
– 2013 LR
– 2013 registrants for substance to be registered in 2013
– 2013 registrants with no other interested SIEF participant
http://echa.europa.eu 17
SIEF progress (1Jun11 – 30 Nov11)
Date 2013 2018
04/03/2011 377 193
07/04/2011 459 201
29/04/2011 493 202
30/05/2011 532 204
04/07/2011 641 213
03/08/2011 767 232
31/08/2011 806 240
20/09/2011 857 222
17/10/2011 916 219
16/11/2011 1021 238
30/11/2011 1106 247
SIEF Progress - Notifications from lead registrants to ECHA
0
200
400
600
800
1000
1200
04/03/2011
01/04/2011
29/04/2011
27/05/2011
24/06/2011
22/07/2011
19/08/2011
16/09/2011
14/10/2011
11/11/2011
DL=2013 DL= 2018
https://comments.echa.europa.eu/Comments/LeadRegistrantNomination.aspx
http://echa.europa.eu 18
Lead registrants Notifications
• Purpose is to facilitate communication between SIEF members – Voluntary basis
– No endorsement of lead registrant information by ECHA
– ECHA encourages companies to de-activate pre-registrations if no intention to register in 2013
• Webform will be updated to increase information provided – ECHA welcome all information and their update until 2013
– If authorised, names of lead registrants to be forwarded to SIEF participants upon request
– If authorised, names of lead registrants to be published in list on ECHA website
• New list and numbers will be published in 2012
• Invitations to the 2013 campaign supporting activities
NB: please inform the supply chain that your SIEF is functioning and your substance will be registered
http://echa.europa.eu 19
2013 campaign supporting activities
• Webinars – For LR (9 in total)
• 2011: “Substance identification/ SIEF activities” and “Data sharing and disputes”
• Early 2012: Information requirements and chemical safety assessment
• Autumn 2012 - Spring 2013: Dossier preparation, tools and submission
– For other SIEF participants (3 in total) • Early 2012: Substance identification/ SIEF activities and Data sharing and
disputes
• Spring 2013: Dossier preparation, tools and submission
• LR workshops 2012 – By invitation only
– 2-3 February 2012 – in collaboration with industry associations • Feedback and lessons learnt from 2010
• Registration management: case studies related, substance identity and data sharing, data quality.
• SIEF formation and challenges: case studies and available tools
– Autumn 2012 • Chemical safety assessment, dossier compilation and successful submission
http://echa.europa.eu 20
535 days to 31 May 2013
http://echa.europa.eu