ACHIEVING TIMELY REACH-REGISTRATION. Options, tick lists and support resources to help you meet the 31 May 2018 deadline

Transcription

1 ACHIEVING TIMELY REACH-REGISTRATION Options, tick lists and support resources to help you meet the 31 May 2018 deadline Sandra Carey, IMOA REACH Molybdenum Consortium Secretariat 1

2 REACH Basics: Registration Evaluation Authorisation (and restriction) of Chemicals For large scale improvement of human health and the environment in Europe Hazard identification Risk Assessment Communication along the supply chain about safe handling and use of chemicals Substance-specific legislation: REACH Regulation no. 1907/2006 2

3 REACH & Brexit Final REACH-registration deadline is 31 May 2018 (1 100 tonnes) Brexit date set for 29 March 2019 but with transition period till end December 2020 where UK continues compliance with EU laws So : Need to proceed with your REACH-registrations for business continuity and compliance 3

4 In the REACH-registration context who are YOU today? Manufacturer Importer.. Trader Importer. Trade Distributor. Downstream User? Letter of Access purchaser? Lead Registrant? Passive SIEF member? Active SIEF member? Preference to outsource to REACH technical support providers? Few substances to register? Many substances to register? Inorganics? Organics? Reasonably along the road with the process? In a quandary and hardly know where to start? 4

5 Common concerns & challenges: Seeking REACH registration that is: Timely Compliant legally and technically Manageable cost-wise Manageable resource-wise Doesn t overly distract you from your core business Maintains business flexibility and feasibility 5

6 2018 REGISTRATION DEADLINE: 31 MAY 2018 Time is fast slipping away & running out! Dedicate priority resources to registration task Plenty of service-providers to outsource task to but heavy workload now Fast track payments for LoAs Additional manual verification by ECHA means earlier submission needed to ensure registration by end May

7 PATHWAYS TO REACH-REGISTRATION: If substance already registered : Buy a Letter of Access Co-register: Do-it-yourself via IUCLID6 & REACH-IT3 or just REACH-IT3, or IUCLID on the cloud Via a REACH registration service provider Options if substance NOT already registered : Do it yourself and take the lead as Lead Registrant Support the Lead Registrant to achieve registration by being active and cooperative in the SIEF you only succeed if LR succeeds!! Contract a REACH registration service provider to do it for you. but be aware this isn t a hands-off option either! 7 Recipe for disaster: Cross-fingers someone else will do it all so you can then purchase an LoA at the last moment.

8 LETTER OF ACCESS (LoA): LoA availability means a Lead Registrant has already registered the substance Least time/resource intensive option Complies with OSOR principle (One Substance, One Registration) An LoA is the right to refer to the Lead Registrant dossier for your coregistration Be aware: LoA agreements not uniform across substances Costs can differ significantly within same tonnage band LoA process takes some time identify LOA provider/order & contract/pay/receive deliverables/join joint submission/prepare coregistration and submit - do it sooner than later! 8

9 Where to find the Lead Registrant to purchase your LoA: Search points: REACH-IT3:.. (Closed weekends and public holidays!) ECHA Lead Registrant List: s_en.pdf/cf1c8cd9-890d-4277-bc1e-740bd6eab2bb ECHA List of Registered Substances: Sector/substance Trade Association 9

10 Example of a REACH Consortium LoA webpage: 10

11 Substance NOT already registered? Outline of trek for > 10 tonnes tonnage band: Reach Registration REACH dossiers CSRs Hazard &Risk Assessment Data interpretation Testing Base camp: Sameness & Data-Gathering & Gap Analysis 11

12 The Lead Registrant/SIEF pathway: Into Lead Registrant and SIEF territory Substance Information Exchange Forum: Participants self-organize to generate, compile and submit the technical dossier required for compliance with REACH. 12

13 Data Requirements: 13

14 Populating the dossier with data: Options for data-populating the dossier can include: Data from existing literature Generating data through testwork Reading-across data within a grouping of similar substances Buying a Licence to Use for core datasets to build a dossier: e.g. molybdate data for molybdenum compounds An LtU is an individually tailored data-package and agreement, giving you permission to use the data to build a dossier for REACH-registration purposes (only) 14

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16 REACH-Registration helicopter view: 16 Prepare Inventory of Substances you seek to register Identify which ones already registered (LoA possible), and which aren t REACH-IT account IUCLID 6 software (own computer or cloud).. Alternative: directly via REACH-IT Get active in Pre-SIEF/SIEF Establish substance sameness Fulfill data requirements and chemical assessment processes inc: Phys-Chem, Environment, Human Health endpoints for tonnage band * Uses and Exposure Hazard Assessment Risk Assessment Substance self-classification necessary? Exposure Scenarios for hazardous substances Generate Chemical Safety Report (> 10 tonnes tonnage bands) Generate dossier and check it Submit Lt/co-registrant dossiers via REACH-IT3 Pay ECHA Registration fee * < 10 tonnes = available information

17 Science invest time & effort in: READING ECHA GUIDANCE DOCUMENTS SCOPING OUT THE SIZE OF THE TASK/LENGTH OF TIMELINE SUBSTANCE IDENTITY AND SUBSTANCE SAMENESS DATA-GATHERING, GAP ANALYSIS, DATA-SHARING SCREENING STUDIES FOR SCIENTIFIC RELEVANCE & RELIABILITY READ-ACROSS AND INTELLIGENT TESTING STRATEGY 17

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19 Science invest time & effort in: RANKING CRITERIA TO SELECT SERVICE PROVIDERS IDENTIFICATION OF USES REACH OUT EARLY ALONG THE SUPPLY CHAIN KNOW HOW THE IUCLID SOFTWARE WORKS PREPARING EXPOSURE SCENARIOS (FOR HAZARDOUS SUBSTANCES) REVIEWING THE DRAFT CHEMICAL SAFETY REPORT 19

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21 THE CLOSER THE SUMMIT THE HARDER THE CHALLENGE!. Finishing Line Fatigue & Frustration MAY 2018 IS JUST AROUND THE CORNER! 21

22 Where to look for support! 22

23 ECHA Webinars 23

24 ECHA Webinars provide support to understand your tasks 24

25 IUCLID 6 SOFTWARE CLOUD VERSION NOW AVAILABLE For dossier preparation: No need to download software to own computer Embedded guidance on dossier preparation 25

26 ECHA s REACH 2018 Roadmap 26

27 ECHA s REACH 2018 ROADMAP ECHA expecting ca. 60,000 registrations for up to 25,000 substances many by REACH-inexperienced SMEs Registration deadline tonnes/year: 31 May

28 More detailed support on ECHA Website: 28

29 ECHA Guidance documents: 29

30 Whole Library of Guidance Documents! 30

31 CSR/Exposure Scenario Roadmap continuous improvement 31

32 USE MAPS: 32

33 Data-Sharing: 33

34 Implementing Regulation on Data-Sharing.since January 2016 Existing guidance not considered sufficient to ensure costs associated with data-sharing are determined in a fair, transparent and nondiscriminatory manner 34

35 ECHA Weekly is a useful heads up : 35

36 REACH Metals Gateway (Eurometaux): 36

37 REACH EU National Helpdesks: helpdesks 37

38 UK Chemicals Stakeholder Forum: Latest meeting: 30 March 2018, London REACH Guidance Note Nov

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40 Submitting your Registration Dossier: 40

41 And later.. Updating your REACH dossier: Good practice to review and update your dossier periodically. Relevant new science must be included without undue delay Dossier is a living document, not a once-only static snapshot! 41

42 REACH The Never-Ending Story: 42

43 Worth keeping in mind THE REACH DOSSIER YOU SUBMIT MAY BE USED BY ECHA TO REGULATE YOUR INDUSTRY.. SO IN YOUR OWN INTERESTS. WORK TO INVEST MAKING IT A ROBUST ONE! 43

44 Thank you for your attention! Sandra Carey IMOA REACH Molybdenum Consortium Views expressed in this presentation are those of the presenter and not necessarily those of IMOA. 44

45 Examples of REACH registration service providers: B-Lands Yordas (formerly The REACH Centre) Knoell Consult Ecomundo CIRS Anthesis Group Ramboll UK The above is simply a list of examples, not a list of recommendations 45

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47 Making an Inquiry: 47