EU s REACH REGULATION

Transcription

1 John D. Mikan, CIH - President, Experien Health Sciences Inc. EU s REACH REGULATION And Its Impact on Supply Chain Management ISM Chemical Group Winter Conference San Luis Resort - Galveston, TX February 28, 2008

2 Overview / Outline REACH Basics / Regulatory Overview Critical Impacts on the Supply Chain Q/A Session Take-Home Message! REACH is not just an EH&S regulation. Its impact on the global chemical supply network is without precedent.

3 John D. Mikan, CIH - President, Experien Health Sciences Inc. Part I - REACH Basics

4 News Headline Chemical Industry Must Demonstrate Products Can be Used Safely! Or stop doing business in Europe!

5 What is REACH? REACH Registration Evaluation Authorisation of Chemicals

6 The Invisible R in REACH RESTRICTION

7 Part I - Overview / Outline Brief History / Timeline Who, What, When, Where, & How? Key Elements of REACH Resources Caution!: We re only touching the surface

8 History / Timeline Policy Review Decision 1998 Stakeholder Consultation 2002 Council Issues Opinion 2004 Council Common Position 2005 Final Text Published Commission White Paper 2003 Commission Proposal 2005 Parliament s First Reading 2006 Parliament s Second Reading

9 Regulation vs. Directive REACH is a Regulation! Not a Directive

10 Who Must Comply? All EU Chemical Manufacturers and Importers! or their Only Representatives

11 The Only Representative Non-EU Manufacturer 1 1,000 tpa Non-EU Manufacturer 2 1,000 tpa Importer 1 Importer 2 Importer 3 Importer 4 Non-EU Formulator Non-EU Distributor 1,000 tpa ECHA Member State CA

12 What is Covered? Substance Driven Existing Phase-In Substances Listed in EINECS ( 30,000( substances) s New Substances Whether or not classified as dangerous M/I >1tpa Alone or in preparations or polymers Substances articles Exemptions

13 Registration - When? New substances: Before 1 st M/I - June 1, 2008 Existing Phase-In Substances: Pre Registration: June 1 - Dec 1, 2008 Full Registration: Volume & Hazard Based

14 Registration When? Existing Phase-In Substances November 30, 2010 >1,000 tpa,, or >1 tpa and CMR, or >100 tpa and PBT/vPvB November 30, tpa and not a SVHC November 30, tpa and not a SVHC

15 Registration - Where? European Chemicals Agency (ECHA( ECHA) Central Agency Helsinki Finland Efficiency and Consistency! At least that s the idea.

16 Registration - How? REACH-IT System Formation of SIEF Technical Dossier Chemical Safety Report (CSR)

17 Registration What s s a SIEF? SIEF Substance Information Exchange Forum Substance Identification Mandatory Data Sharing Joint Submittals Joint Testing Cost Sharing

18 Registration Technical Dossier General Information Classification / Labeling Manuf.. / Use / Exposure PhysChem Properties Env.. Fate & Pathways Ecotox Data Toxicological Data Analytical Methods Other

19 Registration - CSR Substances M/I at >10 tonnes in any year IUCLID attached CSR PART A 1. Summary of Risk Management Measures (RMMs) 2. Declaration that RMMs are implemented 3. Declaration that RMMs are communicated CSA tool: Exposure estimation + risk characterization E S CSR generator PART B 1. Substance ID & physical and chemical properties 2. Manufacture and uses 3. Classification and labeling 4. Environmental fate properties 5. Human health hazard assessment 6. Physicochemical properties 7. Environmental hazard assessment 8. PBT and vpvb assessment 9. Exposure assessment 10. Risk characterisation?? Additional text

20 Registration Remember! One Substance One Registration! No Pre-Registration No Phase-In Relief

21 Registration Remember! Not Just Substances Also Uses / Exposures No Registration No EU Market!

22 Evaluation Initial Completeness Check Followed by risk-based review and a compliance check.

23 Authorisation Or Authorization? Only Substances of Very High Concern List Driven Must Prepare an Application Specific Uses Must Be Authorized alone, in preparations, and in articles Purpose: To Stimulate Safer Alternatives

24 Restriction Not Much Different From Current Process Triggered By Commission, Central Agency, or a Member State List Driven Will Only Rarely Be Used When risks cannot be controlled, and When safer alternatives are available Includes Provisions For 360º Review / Input

25 Resources ECHA Website ec.europa.eu/echa/ REACH Navigator reach.jrc.it/ EC Joint Research Center (JRC) ecb.jrc.it/reach/ Consultants / Only Representatives

26 Part II Critical Impacts on the Supply Chain

27 Chemical Accounting Accounting for the source, destination, and use of every pound, of every substance, is at the heart of REACH! Toluene (Reg. #XX-XX-X) Non-EU Manufacturer tpa Customer 1 Toluene (Reg. #XX-XX-X) Non-EU Manufacturer 1 Excess Volume EU BORDER Customer 2 Customer 3 Toluene (not registered) Non-EU Manufacturer 2 Only Rep

28 Chemical X Accounting X X 100 tpa Reg. # X X X X 100 tpa Reg. # EU BORDER Customer 1 Customer 2 Customer 3 Only Rep

29 Chemical X Accounting Chemical Supplier/Customer Reg. # Volume (tpa( tpa) x Customer x Customer x Customer x EU Supplier (100) Balance (100 tpa limit) 50 Do you have the IT systems to deal with this?

30 Formulated Products A X-Y B C D PAINT 1,000 drums/yr EU BORDER Customer 1 Customer 2 Customer 3 X-Y X-Y Y is a polymer Only Rep

31 Supply Agreements Beware of the Following: An absence of REACH language Overly broad REACH language REACH Compliant / Registered products Warranty language or guarantees That make or imply REACH promises That guarantee continuity of supply

32 Supply Continuity Have a Backup Plan: ID your mission-critical EU raw materials Be careful of US-Supplied Supplied but EU-Produced Gauge your supplier s s REACH Readiness ID alternate suppliers, where appropriate Including EU suppliers Get Confirmation of Pre-Registration

33 Critical Next Steps Get Expert Help To establish your substance list Identify your Only Representative Get them under contract Get Your Substances Pre-Registered Obtain Confirmation of Pre-Registration By October 2008 at the latest

34 John D. Mikan, CIH - President, Experien Health Sciences Inc. Q&A

35 THANK YOU John D. Mikan - President, Experien Health Sciences Inc. jmikan@experienhealthsciences.com London Houston Cincinnati Philadelphia Chicago