Webinar - REACH Registration 2018 Practical Approaches to Compliance Presented by: Bruce Calder VP Consulting Services
Overview - Agenda Introduction REACH 2018 Deadlines Key team members and data Compliance options Misconceptions about registrations Option 1 - Supplier Coverage Becoming a downstream user Option 2 - Letter of Access Registration via LOA Q&A Chemicals Chemicals Chemicals Webinar is 50 minutes with 10 minutes of Q&A (hopefully)
Claigan - REACH Registration Solving REACH 2018 compliance issues for companies A practical plan Supplier coverage / downstream user Letter of Access More results. Less journey.
Claigan Environmental - Difference Claigan s focus - Compliance - End Deliverables If a step or process does not contribute to compliance or end deliverables, then it needs to be justified More results. Less journey.
REACH Registration 2018 Registration deadline - May 31 2018 for non-cmr substances imported into the EU (or manufactured in the EU) between 1 and 100 tonnes per annum Related interim deadline - May 31 2017 for pre-registration of substances over 1 tonne per annum Options - Registration, or - Downstream User (Supplier Coverage)
Compliance Paths - Two Paths Supplier Coverage (Downstream User) Verify Supplier Inquiry Complete or Registration Verify Consortia Contact Supplier Inquiry Registration Complete
Compliance Team Members Key members of a corporate REACH 2018 team - Compliance / project prime - Representative from procurement Key data - Sales volumes (in tonnes) into the EU - concentrations in each product - and close enough is good enough. If you cannot figure it out, no one outside will either. - Ultimately - which substances are imported into the EU above 1 tonne per annum
Compliance Paths - Supplier Coverage Verify Supplier Inquiry Complete Identify Registered Supplier contact information Update substance information Contact Supplier Confirm as Original Manufacturer Repeat with Original Manufacturer Confirm Coverage
Compliance Paths - Registration Verify Consortia Contact Supplier Inquiry Registration Identify Registered Contact Consortia Supplier contact information Obtain LOA Update substance information Identify LOA requirements Contact Supplier Submit Registration Information Repeat with Original Manufacturer Identify Consortia and Registrant Information Update Preregistration Confirm as Original Manufacturer Confirm Registration = Fees Obtain Analytical Data Complete
1 - Supplier Coverage Path Verify Identify Registered Update substance information Verify - Identify registered version of the substance - Name - EC / CAS - Search of ECHA and consortia information Update substance information
Common REACH 2018 Error There are tens of thousands of substances that still need to be registered..not true
Groups Registrants have to pay a fee for each substance they register - Plus the cost and effort of working with peers to assemble a dossier Overall cost (for high tonnage substances) approaches hundreds of thousands of dollars per substance - And many chemical companies have hundreds of similar substances So
Groups (Mother Registrations) Mother Registrations - instead of registering each EC (CAS) number, large chemical companies identifies EC numbers that encompass whole families of EC numbers - And register a dossier for that group chemical - Making it look like tens of thousands of chemicals were not registered - but most are actually already registered under a mother submission
Example - Zeolite Zeolite - common in molecular sieves / desiccant packs of interest
Groups Pre-registered only. NOT registered yet.
Group - Zeolite
Mother registration - Zeolite Zeolite, cuboidal, crystalline, synthetic, non-fibrous Registered
1 - Supplier Coverage Path Supplier Inquiry Supplier contact information Contact Supplier Confirm as Original Manufacturer Confirm Coverage Repeat with Original Manufacturer Complete Supplier inquiry - Supplier contact information - Contact supplier - Determine if manufacturer is original manufacturer of substance - If not, request contact information of original manufacturer - Repeat contact with original manufacturer - Confirm coverage of OCD substance and tonnage - Request esds if applicable - Possibly over 10 tonnes per annum
Outcomes Typical outcomes - Out of scope - Supplier provides justification that the substance is out of scope of registration - Only Representative coverage - Supplier s Only Representative is registered and states that your tonnage and use is covered. Or intends to do so. - Supplier only covering EU tonnage - volumes sold outside the EU are not covered - Clueless - The supplier has no idea what you are talking about or has no plan.
Outcomes - Out of Scope - 1 NaCl (natural substance)
Outcomes - Out of Scope - 2 EU substance - was already imported (or manufactured) in the EU You are a downstream user of that substance
Outcomes - Only Representative Coverage Only Representative coverage - Statement - Your tonnage is covered in their registration - Your use is covered - Format - No mandatory format - Commitment by the supplier that their only representative(s) covers their tonnage and use should be sufficient - non-community manufacturer shall inform the importer(s) within the same supply chain of the appointment. - Common issue when original substance manufacturer is confidential or multiple - You are now a downstream user of that substance
Outcomes - Supplier Covering EU Only Supplier states - Only registering substances manufactured or purchased in the EU - non-eu tonnage not covered - Next step - Leverage your procurement group to pressure the supplier s customer service - Supplier registration - The supplier is already registered in the EU - no real additional cost to the supplier - If you were to instead buy a letter of access, you would likely be buying it from your supplier. - ie. You would be paying your supplier for the privilege of buying from them
2 - Registration Path Verify Identify Registered Update substance information Identify Consortia and Registrant Information Verify - Identify registered version of the substance - Name - EC / CAS - Search of ECHA and consortia information Update substance information Identify consortia info - Identify consortia information - contact information - Registered (Y/N)
2 - Registration Path Consortia Contact Contact Consortia Identify LOA requirements Update Preregistration Consortia - Contact consortia / lead registration Identify LOA requirements - Contract - Costs - Process - Analytical data - Confirm use Update pre-registration data - Update pre-registration data to conform with consortia / substance - May be at start of process if preregistration is best method to contact consortia / lead registrant
2 - Registration path Supplier Inquiry Supplier contact information Contact Supplier Confirm as Original Manufacturer Repeat with Original Manufacturer Supplier inquiry - Supplier contact information - Contact supplier - Determine if manufacturer is original manufacturer of substance - If not, request contact information of original manufacturer - Repeat contact with original manufacturer - Request analytical data - as required by consortia / LOA - or physical sample for testing Obtain Analytical Data
2 - Registration Path Registration Obtain LOA Submit Registration Information Confirm Registration Complete = Fees Registration - Obtain LOA from consortia - Sign contract - Pay dossier license fees - Obtain token and instructions - Obtain chemical safety report - Submit registration - Submit information into IUCLID - token - corporate information - analytical data - chemicals safety report - Confirm registration - Registration number
Claigan Environmental - Difference Claigan s focus - Compliance - End Deliverables If a step or process does not contribute to compliance or end deliverables, then it needs to be justified More results. Less journey.
Claigan - REACH Registration Solving REACH 2018 compliance issues for companies A practical plan Supplier coverage / downstream user Letter of Access Q&A More results. Less journey.