Registration deadline has passed, what now? Jan HOLOMEK, ReachSpektrum Chemicals Management Forum 2018 October, 1, 2018

REACH General remarks Transitional arrangements In force from 2007 Transitional arrangements Preregistration 3 registration deadlines – 2010, 2013, 2018 Authorisation of SVHC substance Restrictions Enough time to comply with obligations

Registration deadline 2018

REACH Registration 2018

REACH Registration 2018

What next? Registrations are NOT closed New substances > 1 tonne/year All companies can submit registration of their (new) substances Inquiry process applies before registration INTERMEDIATES under SCC (Art. 17/18), SCC must be demonstrated Substance ID supported by chemical analysis Assessed by ECHA Assignment to the “right” group of co-registrants by ECHA Registration must be achieved BEFORE production/marketing the substance. Before 2018 – substance might have been marketed based on pre-registration

What next? Registrations are NOT FINAL Existing substances > 1 tonne/year Must be already registered Registration dossiers are being checked for compliance by ECHA ECHA Decisions Substance ID Further information requests – more testing Precision of information in current dossier Discussions/teleconference/meeting with ECHA possible in some cases If deadline not met or request not fulfilled = cancelling the registration

What next? Dossier quality Industry made HUGE effort and invested millions/billions? EUR to comply with information requirements under REACH registration Industry is still committed to respond to ECHA decisions but wish to stay reasonable Still, ECHA finds the quality of dossier “not meeting ECHA expectations” ECHA evolves/increases criteria for dossier compliance https://echa.europa.eu/support/how-to-improve-your-dossier

What next? SIEF SIEFs exist no more Replaced by Joint Submissions or groups of companies “wandering in the space of pre-registration” SIEF agreements must be revised/ended Rules of Joint Submission operation must be agreed within members and Lead Registrant Cost sharing and reimbursement must be adjusted New registrants agenda…

Future issues (as seen by me) Operating costs disputes For running the Joint Submission/REACH Consortia For updating dossier (REACH obligation) Relevance and acceptability of costs Example: CONCAWE spent around 400 000 EUR for updating the dossier for one substance Data sharing disputes ECHA provides registrant in Joint Submission with endpoint, based on proof of payment Data holder (Lead Registrant) is not satisfied with the amount and raise court action

Future issues (as seen by me) Competitiveness or survival of European chemistry? Small businesses are severely affected by REACH costs and WILL remove a number of diverse substances from the market Opening for non-EU entities with strong funding Switch of enforcement from national Inspections to Customs Adaptation to new regulatory trends Nanoforms Circular economy = longer life cycle Waste reduction = more substances Recycling REACH issues = SVHC in plastics Ban of substances/products by restrictions

Thank you.