experiences with registrations - 5 years on the road on the reach road 23 november 2011 kevin...

Experiences with registrations- 5 years on the road

On the REACH Road

23 November 2011

Kevin PollardKevin PollardECHA – Dossier Submission and DisseminationECHA – Dossier Submission and Dissemination

http://echa.europa.eu

Content

• Summary of the Registration Statistics

• Feedback from ECHA on preparing for the registration submission process



Registration: outcome of the 1st deadline

• Phase-in substances– over 1000 tonnes per

annum (tpa)

– Substances very toxic to aquatic environment (R50/53) over 100 tpa

– CMRs over 1 tpa


Registration - Dossiers


Registration - Substances


Successful management of the deadline– ca. 25 000 dossiers corresponding to 4300 substances– Majority of large companies: 86 %– Submission by Only Representatives: 19 %– Joint Registrations: 94 %– 25% substances with intermediate use only

Major co-operation effort– Excellent commitment by industry– Close cooperation between key players to narrow down

uncertainties & clarify open questions (Directors’ Contact Group)

Outcome


• Overall number of registrations in line with expectations • Number of substances registered is lower than announced

by industry in April 2010 surveys– Gap of 1500 substances

• Analysis done to evaluate market impact – Explanations found for majority of substances:

later registration, better understanding of REACH obligations (e.g. exemptions), merge/split of SIEFs, etc.

– Results should be communicated to give certainty to Downstream users

Some analysis


• Data Sharing– Pre-registration managed successfully but failed to meet its aims

• Due to millions of pre-registrations, no clear picture of real intentions to register; no market certainty for downstream users

– Despite challenges in SIEF formation, 94 % joint registrations– Challenges on data & cost sharing for smaller players or non EU

manufacturers

• RecommendationsMarket surveys for next deadline; Encourage companies to de-

activate pre-registration if no intention to register in 2013 Start SIEF work for 2013 deadline early enough; Encourage early

nomination of Lead Registrants Increase transparency, promote best practices and fairness

Lessons learnt


• Registration– Stability of legal interpretations & guidance is fundamental – Availability & stability of IT tools

• Helped industry to pass the registration process • 98 % success rate for dossier completeness checks in Nov 2010• Still challenge for newcomers, time needed to know the tools

– Active communication and intensive dialogue• Helped raising awareness & addressing concerns

• RecommendationsTools and Guidance stabilised well ahead of the deadline,

e.g. 1 year earlier for certain toolsContinuation of the DCG until September 2013 to address concerns

Lessons learnt


Content

• Summary of the Registration Statistics

• Feedback from ECHA on preparing for the registration submission process



Finally: Less than 2 years to the next deadline!

• Phase-in substances over 100 tonnes per annum

• Preparations should be underway!

• Non EU manufacturers:

make sure that your Only Representative gets ready


Important to know

• Check if your substance is already registered on ECHA website or with Industry organisations

• Less data requirements than for 2010 deadline: cost sharing only for data needed for your tonnage band

• If your substance is not registered:– Create/join the SIEF immediately and start discussion on

substance sameness and data sharing– Refer to Industry organisations to get advice on advice, model

agreements and standard letters to manage the SIEF– Nominate/find the Lead registrant and make sure that he is known

from ECHA to benefit from special services and create transparency for other market players


Countdown: optimal situation

ChemicalSafety Assessment

LeadSubmission

MemberSubmissi

on

Substance ID

Data sharingHazard Data

31May2012

31Dec2012

31Mar2013

31 May 2013Deadline

Start toPrepare

31Dec2011

Late Pre-registration

DU request for identified uses


More information:

• ECHA website: http://echa.europa.eu/

• Basic and detailed explanations on REACH and CLP• Guidance documents and other supporting

documentation• Formats and Tools for registration and notification• Entry to the Helpdesk• News and Events; e.g. info on Stakeholder days

http://echa.europa.eu/


2010 Lead Registrants

• You hold obligations to the next registrants wishing to register the same substance as you– You remain Lead of the joint submission beyond 1 June 2018– Inform (pre-)SIEF members of your existence– Ensure that data sharing conditions are fair, transparent and non

discriminatory– Newcomers only required to share costs of data needed for their

tonnage band: Annex 10 not required– You will need to distribute the tokens to new registrants– Document your communications with the SIEF


2013 Registrants• Is your substance already registered?

– ECHA website:

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

• Some substances may not appear on the list, if the registrant has requested confidentiality on the name

– Verify within SIEF or industry associations– Contact the Lead Registrant– Verify whether you have the same substance – Start data sharing negotiations– Ask for your token to join the “joint submission”

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

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


2013 Registrants

• Your substance is not registered yet– Some 2013 SIEFs already exist, the Lead may have been

nominated already

• Verify on ECHA website or with industry associations

– If not, start the process of SIEF formation

• Verify whether a SIEF Formation Facilitator (SFF) exists for your substance in REACH-IT (nb. some poor experiences in this area)

• If not, contact pre-SIEF members to identify those registering in 2013


New SIEFs

• Verify substance sameness before forming the SIEF• Nominate a Lead Registrant• Collect data needed for Annexes 6-9

– target end 2011• Inform your downstream users

– their uses must be known to you before 30 May 2012• Prepare Chemical Safety Assessment

– target end 2012


New Leads

• Nominate yourselves to ECHA to benefit from special services, e.g. webinars https://comments.echa.europa.eu/Comments/LeadRegistrantNomination.aspx

• Inform the supply chain that your SIEF is functioning and

your substance will be registered

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

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


Practical recommendations

• Make sure you are aware of all tools and guidance available– Some tools are critical to the success of your submission:

IUCLID 5, Technical completeness check, fee calculator, & dissemination tools (http://www.iuclid.eu/)

– Use Chesar for your chemical safety assessment and your CSR (http://chesar.echa.europa.eu/)

– Dossier submission (http://echa.europa.eu/reachit_en.asp) – Data submission manuals (

http://echa.europa.eu/reachit/dsm_en.asp) – Understanding of the dossier processing by ECHA (

http://echa.europa.eu/reachit/dossier_processing_en.asp)

http://www.iuclid.eu/



http://chesar.echa.europa.eu/

http://echa.europa.eu/reachit_en.asp

http://echa.europa.eu/reachit/dsm_en.asp

http://echa.europa.eu/reachit/dossier_processing_en.asp


Thank you for your attention!


experiences with registrations - 5 years on the road on the reach road 23 november 2011 kevin...

Documents

registration process

later registration

echa website

data cost sharing

majority of substances

market certainty

toolshelped industry

sief formation