REACH IRON PLATFORM MEETING, 30 JANUARY Sandra Carey Molybdenum Consortium Secretariat/IMOA HSE Executive

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1 REACH PRE-SIEF & SIEF COMMUNICATIONS IRON PLATFORM MEETING, 30 JANUARY 2009 Sandra Carey Molybdenum Consortium Secretariat/IMOA HSE Executive "The content t of this presentation ti represents the views of the speaker only. The information provided d in the presentation does not constitute legal advice. You should not act or rely on this information without consulting a legal counsel." 1

2 COMING SHORTLY:. 2 CLOSE ENCOUNTERS OF THE SIEF KIND!!!

3 SIEF S.I.E.F. = SUBSTANCE INFORMATION EXCHANGE FORUM WHERE SIEF PARTICIPANTS SELF-ORGANISE TO COMPILE AND SUBMIT THE DATA REQUIRED FOR COMPLIANCE WITH REACH 3

4 ESSENTIAL READING FOR SIEF MANAGEMENT: 4 DOWNLOAD AT: en htm

5 Extract from ECHA Practical Steps for REACH Pre-Registration : BE AWARE THE ENTIRE SIEF PROCESS IS THE RESPONSIBILITY OF INDUSTRY (!!) 5

6 WHO S SUPPOSED TO BE IN A SIEF? EU MANUFACTURERS EU IMPORTERS ONLY REPRESENTATIVES OF NON-EUROPEAN MANUFACTURERS DATA-HOLDERS (LIMITED PARTICIPATION) 6

7 LIKELY REALITY PRE-S.I.E.F & S.I.E.F. TENTATIVE ASSESSMENT OF CONTENTS: UVCB (!!) 7 UVCB = Unknown or Variable Composition

8 PURPOSE OF THE PRE-SIEF? TO AGREE SAMENESS OF SUBSTANCE PRIOR TO SIEF FORMATION (REACH REGULATION DOES NOT DEFINE SAMENESS ) 8

9 PRE-SIEF FACILITATOR: (E.G. IRON PLATFORM) ROLE: INITIATES AND CONDUCTS DISCUSSIONS AFTER PRE-REGISTRATION TO FACILATE THE EXCHANGE OF INFORMATION AND DATA REQUIRED ABOUT A SUBSTANCE TO FORM A SIEF. RESPONSIBILITIES: NOT LEGALLY BINDING, NO ADDITIONAL OBLIGATIONS CAN OPT TO STOP BEING FACILITATOR AT ANY TIME. 9 BUT, UNDOUBTEDLY, A GIANT TASK!

10 PRE-SIEF SIZES.. MANAGEABLE, OR MONSTERS? SIZES AS AT END NOV 08: MANGANESE SALTS: OVER 5000 PRE-REGISTRANTS MOLYBDENUM METAL OVER 2000 METALLIC IRON OVER 5000 NICKEL, COPPER, ZINC ALL HAVE SEVERAL THOUSAND PRE- SIEFERS 10 DO NOT UNDERESTIMATE THE CHALLENGE OF COMMUNICATING AND MANAGING THESE GIGANTIC GROUPS

11 PRE-SIEF COMMUNICATION TOOL-BOX: WEBSITE (AS YOUR PORTAL TO THE PRE-/SIEF COMMUNITY) MASS ING SYSTEM TRACKING SYSTEM SOFTWARE TO CREATE SURVEYS/QUESTIONNAIRES SOFTWARE TO EVALUATE SURVEY/Q RESPONSES 11 SENSE OF HUMOUR RESTORATION PASTILLES

12 PRELIMINARY REMARKS: AROUND 50% OF RECIPIENTS OPEN THEIR S, SO 50% ARE TOO BUSY OR DISINTERESTED? SOME S BOUNCE AS THE ADDRESSES DON T EXIST BECAUSE: THEY RE MIS-TYPED THEY FORGET TO CREATE THEM, E.G. REACH@GLOVERS.COM AROUND 40% OF SAMENESS SURVEY RESPONDENTS SELECTED DORMANT STATUS 12 NOT ENCOURAGING INDICATORS FOR FUTURE FAST & FLUENT COMMUNICATIONS!

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15 ESSENTIAL INGREDIENT FOR A WORKABLE S.I.E.F.: CONSENSUS-SEEKING PRAGMATISM WITHOUT THAT, WE RE DEAD IN THE WATER! 15

16 THANK YOU FOR YOUR ATTENTION SEE YOU SOON IN A SIEF! 16 "The content of this presentation represents the views of the speaker only. The information provided in the presentation does not constitute legal advice. You should not act or rely on this information without consulting a legal counsel."

17 17 ADDITIONAL SLIDES ON RELATED ISSUES:

18 PRE-SIEFERS NEED TO AGREE UPON: WHO WILL BE THE PRE-SIEF FACILITATOR HOW TO COMMUNICATE AMONGST EACH OTHER METHODOLOGY TO DETERMINE SAMENESS OF SUBSTANCE (RIP 3.10 SUBSTANCE IDENTIFICATION) 18

19 PURPOSE OF THE SIEF: AGREE UPON LEAD REGISTRANT AGREE UPON INFORMATION TO BE JOINTLY SUBMITTED: JOINT SUBMISSION OF HAZARD DATA-SET, AND TESTING PROPOSALS IS MANDATORY JOINT SUBMISSION OF CHEMICAL SAFETY REPORT AND GUIDANCE ON SAFE USE IS VOLUNTARY CONDUCT DATA-SHARING AGREE UPON CLASSIFICATION & LABELLING 19

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21 FACILITATING IN THE SIEF CAN BE DONE BY A SIEF FACILITATOR, WHO MAY OR MAY NOT BE THE LEAD REGISTRANT. SIEFERS HAVE DUTY TO COMMUNICATE WITHIN THE SIEF, BUT NOT A DUTY TO COMMUNICATE ACROSS SIEFS, ALTHOUGH IT IS ENCOURAGED. 21

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24 S.I.E.F. OUTLINE ROUTE-MAP: 1. INDIVIDUAL GATHERING OF AVAILABLE INFORMATION TO POTENTIAL REGISTRANTS 2. AGREEMENT ON THE FORM OF CO-OPERATION/COST- SHARING MECHANISM 3. COLLECTION & INVENTORY OF INFORMATION AVAILABLE TO POTENTIAL REGISTRANTS 4. EVALUATION OF AVAILABLE INFORMATION 5. CONSIDERATION OF INFORMATION NEEDS 24

25 Cont d: 6. IDENTIFICATION OF DATA-GAPS AND COLLECTION OF OTHER AVAILABLE INFORMATION 7. GENERATION OF NEW INFORMATION/TESTING PROPOSAL 8. SHARING OF DATA COSTS 9. CLASSIFICATION AND LABELLING OF SUBSTANCE 10. JOINT SUBMISSION OF DATA VOILA, C EST TOUT (!!) 25

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27 27 RESPOND TO REQUESTS FOR FURTHER INFO FROM ECHA UPDATE THE REGISTRATION DOSSIER

28 FOR MORE INFO ABOUT LEAD REGISTRANT ROLE, RESPONSIBILITIES, LIABILITIES SEE EUROMETAUX FACTSHEET ON LEAD REGISTRANTS 28