Experiences with registrations - 5 years on the road On the REACH Road 23 November 2011 Kevin Pollard ECHA – Dossier Submission and Dissemination

Content Summary of the Registration Statistics Feedback from ECHA on preparing for the registration submission process

Registration: outcome of the 1 st 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 - Dossiers

Registration - Substances

Registration - Substances

Successful management of the deadline –ca 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 Recommendations  Market 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 Recommendations  Tools and Guidance stabilised well ahead of the deadline, e.g. 1 year earlier for certain tools  Continuation 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 Chemical Safety Assessment Lead Submission Member Submission Substance ID Data sharing Hazard Data 31 May Dec Mar May 2013 Deadline Start to Prepare 31 Dec 2011 Late Pre-registration DU request for identified uses

More information: ECHA website: 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

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

Registrants Is your substance already registered? –ECHA website: sub.aspxhttp://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”

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 trantNomination.aspx trantNomination.aspx Inform the supply chain that your SIEF is functioning and your substance will be registered

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 ( –Use Chesar for your chemical safety assessment and your CSR ( –Dossier submission ( –Data submission manuals ( –Understanding of the dossier processing by ECHA (

Thank you for your attention!