EU Regulation 1907/2006 on the Registration Evaluation and Authorisation of CHemicals

1. EU Regulation 1907/2006on the Registration Evaluation and Authorisation of CHemicals R E A CH REACH Lunch & Learn Beach Ballroom, Aberdeen 29th August 2007

2. Outline • What is REACH? • What are the implications? • REACH timetable • Chemical usage • How does it effect us? • REACH for suppliers (Huw Jones, Nalco) • BMT Cordah & REACH

3. REACH • Registration, Evaluation and Authorisation of Chemicals • “The biggest shake-up in chemical legislation in 30 years” • “REACH replaces 40 existing legal acts and creates a single system for the assessment of all chemical substances” • Why new legislation? • Over 30,000 substances on the EU market above 1 tonne per year • Very limited information available on hazards and risks • Current system very slow – 200 substances fully assessed in 20 years

4. Implications of REACH • Substances may be withdrawn • Chemical Industry estimate 40% of chemicals on the EU market could be withdrawn. • No registration – no market • Failure to register a substance means that the supplier cannot market the substance until it has been registered. • Downstream Users (DU) have specific obligations • DU must support risk assessment process.Estimated cost to all DU of chemicals €2.8 – 5.2 billion.

5. Slide taken from Chemical Business Association conference, January 2006 So What Does That Mean • Will lead to product rationalisation (biocide example) • Product costs from suppliers are likely to increase by on average 10% • Suppliers may deal direct with customers reducing many distributor SMEs to agents • LOSS not gain of intellectual development MELVYN WHYTE MD WHYTE CHEMICALS LIMITED 9

6. REACH Registration Deadlines 1 –10 t 10 –100 t 100 –1000 t >1000 t >100 t N:R50-53 > 1 t CMR Set-up Agency Pre-reg. June2007 June2008 Nov.2008 Nov.2010 June2013 June2018 REACH Timetable

7. Chemical Usage • Currently proposed chemical usage is notified through the PON system. • Risk assessments are performed (generally on a PEC/PNEC basis) for the worst case component (WCC) only, using CHARM. • REACH will require assessment of all components. • Exposure modelling and risk assessment is required for all component substances • DU may choose to perform their own exposure modelling • Different timescales for registration based on annual tonnage and PBT properties

8. Downstream Users (DUs) • Draft Guidance – RIP 3.5.1 Annex 3 • http://ecb.jrc.it/documents/REACH/ • A DU is defined by REACH as someone, other than a manufacturer or importer, “who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities”. The guidance identifies a number of types of DUs, Industrial User 1 (IU1): “actor using substances/preparations not incorporated into articles (in a preparatory process or as a processing aid)”

9. DU - Obligations • Determine whether your use is included in the exposure scenarios in safety data sheet (SDS) • If use not covered, will supplier include use or undertake own assessment (Chemical Safety Report, CSR) • Apply operational conditions and risk management measures detailed in SDS • Keep CSRs up to date • Comply with any restrictions on use of substance/preparation • Use authorised substances only within conditions of authorisation

10. DU - Communication • Provide information to assist supplier in the preparation of registration • Have the right to make use known to supplier for inclusion as an identified use • Must provide information where risk management measures are inappropriate • Inform supplier of any new information on hazardous properties of substance/preparation • If you supply substances/preparations to further DUs you have further obligations

11. Operator’s Chemical Usage Quantities in tonnes • Specific Chemical Details • Chemical 1 • WCC - 30-60% (285 T) • ESIS data suggests there may be data availability issues?

12. REACH Registration Deadlines 1 –10 t 10 –100 t 100 –1000 t >1000 t >100 t N:R50-53 > 1 t CMR Set-up Agency Pre-reg. June2007 June2008 Nov.2008 Nov.2010 June2013 June2018 How does REACH effect us? • Must make inventory of substances • Must gain assurance that suppliers will meet REACH obligations (Reg. & RA) • Gap analysis of data • Implement REACH Strategy • Suppliers must prepare and submit registration • Check your use is covered, consider own exposure model • 11 year phase-in period to harmonise OCNS (PON15s)

13. REACH from a Supplier’s point of view Huw Jones REACH Programme Manager Nalco

14. BMT Cordah & REACH • Experienced and trained staff in the field of REACH • Guide operators in producing a REACH strategy and assessing supplier commitment to product registration • Highlight and address chemicals that are at risk of not being registered • Assistance with risk assessment & exposure modelling if required • Consortia management for chemical suppliers • BMT Cordah act as Only Representative • BMT Cordah committed to staying on top of changes to risk assessment process and the harmonisation of OCNS with REACH

15. Thank you