Update from ECHA - Cefic · 25 029 25 231 25 456 25 682 25 925 26 144 26 383 26 585 26 735 0 5 000 ... ... 97…

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


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


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


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


• 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://www.echa.europa.eu/chem_data/list_registration_2010_en.asp


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


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


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://apps.echa.europa.eu/registered/registered-sub.aspx




Public C&L Inventory (1)


• 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


Public C&L Inventory (2)


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


Overview


– Summary


– Dissemination

– C&L inventory




– LR WS 2012




ECHA staff

• 494 (30Nov11)

• From 25 EU countries

(no Cypriot, no Luxembourger),

Iceland and Norway


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



Overview


– Summary


– Dissemination

– C&L inventory




– LR WS 2012




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


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

https://comments.echa.europa.eu/Comments/LeadRegistrantNomination.aspx


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


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


535 days to 31 May 2013


Documents

Update from ECHA - Cefic · 25 029 25 231 25 456 25 682 25 925 26 144 26 383 26 585 26 735 0 5 000 ... ... 97…