Informa Life Sciences 14th Annual Conference European Chemicals Policy , Berlin, 25-26 September 2007

1. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007

2. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 Information management in the supply chain downstream upstream within the supply chain (SIEFs) general/administration Who does what? suppliers (manufacturers/importers) downstream users distributors The importance of communication mandatory communication – safety data sheets voluntary communication - supplier/customer dialogue need for standardised communication (IT) tools working together

3. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHAT IS DUCC? Platform of 7 European Industry Associations whose member companies use chemicals to formulate preparations and place them on the market as finished products. Covers cosmetics, detergents and cleaning products, paints, adhesives, photographic materials and aerosol products. Represents over 3500 companies, many of these SMEs

4. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 INFORMATION MANAGEMENT IN THE SUPPLY CHAIN (1) Downstream: Safety Data Sheets (SDS) + Exposure Scenarios (ES), where applicable other information, where SDS are not required information on substances in articles updates for all of the above

5. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 INFORMATION MANAGEMENT IN THE SUPPLY CHAIN (2) Upstream: new information on hazardous properties new information affecting the appropriateness of risk management measures identified uses exposure information updates for all of the above

6. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 INFORMATION MANAGEMENT IN THE SUPPLY CHAIN (3) Within the supply chain (in the context of SIEFs): sharing of information / data / costs subject to specific SIEF management rules

7. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 INFORMATION MANAGEMENT IN THE SUPPLY CHAIN (4) General / administration mandatory information circulates in writing (on paper or electronically) mandatory information up and down the supply chain is provided free of charge (except within SIEFs) information necessary for the company’s compliance activities to be kept for at least 10 years after last manufacture/importation and to be submitted or to be made available to Competent Authorities upon request workers have access to all the information in the SDS or, where an SDS is not required, to the information supplied downstream

8. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (1) Suppliers of substances/preparations (mainly Manufacturers/Importers): Mandatory information: SDS (+ ES if substance is manufactured/imported in quantities = 10 tonnes/year) for substances/preparations that meet the criteria for classification as dangerous, for PBTs, vPvBs, other substances on the candidate list for inclusion in Annex XIV Upon recipient’s request: SDS (+ ES) for preparations not meeting the criteria for classification as dangerous but containing: at least a substance posing human health or environmental hazards (=1% in non-gaseous preparations; =0.2% in gaseous preparations) at least a substance that is PBT or vPvB or candidate (=0.1% in non-gaseous preparations) a substance for which there are workplace exposure limits

9. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (2) Suppliers (continued): SDS not needed where dangerous substances/preparations are sold to the public with sufficient information to enable safe use, unless required by a downstream user or distributor Where an SDS is not needed, the following information must be provided: details on substance autorisation (if applicable) details on substance restrictions (if applicable) any other relevant information that enables appropriate risk management measures to be identified and applied registration numbers for substances concerned above

10. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (3) Suppliers (continued): Provide sufficient information on substances in articles (where substances are identified as being of  very high concern and are present in the article at =  0.1%) to enable safe use by the recipient When carrying out a Chemical Safety Assessment (CSA), ensure consistency between the CSA and the SDS Update the SDS or other required information as soon as new hazard information becomes available that affects the appropriateness of risk management measures, or as soon as an autorisation is granted/refused or a restriction is imposed

11. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (4) Suppliers (continued): Information to be supplied to the next actor up the supply chain: new information on hazardous properties of substances/preparations (for all uses) any other information that may affect the the risk management measures included in the SDS supplied to them (only for identified uses) (this applies to all actors in the supply chain, including to distributors)

12. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (5)

13. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 WHO DOES WHAT? (6) Distributors: pass on relevant ES and use other relevant information from the SDS supplied to him, when compiling his own SDS for uses for which he has passed on information upstream may provide information to assist a M/I in preparing a registration file communicate to next actor up the supply chain: new information on hazardous properties of substances/ preparations (for all uses) any other information that may affect the the risk management measures included in the SDS supplied to them (only for identified uses

14. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 THE IMPORTANCE OF COMMUNICATION (1) Mandatory information: primary communication tool: the SDS guidelines for compiling a SDS: Annex II of REACH the information in the SDS must be consistent with that in the CSR, where a CSR is required where a CSR has been performed, the relevant ES(s) must be placed in an annex to the SDS

15. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 THE IMPORTANCE OF COMMUNICATION (2) Voluntary communication: Priority: preparation for pre-registration / registration supplier / customer meetings written (electronic) communication standardised questionnaire

16. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 THE IMPORTANCE OF COMMUNICATION (3) Standardised communication tools: IT tool for pre-registration (data exchange standard) IUCLID 5 (storing data, preparing and submitting dossiers) REACH IT Workflow System (control of all tasks triggered by REACH) SDS (appropriate safety information) supplier/downstream user questionnaire (CEFIC) others to be developed as we go along

17. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 THE IMPORTANCE OF COMMUNICATION (4) Working together REACH is both a challenge and an opportunity for industry companies must be/get ready for compliance working together and communicating constantly and efficiently are the only ways to optimise the process of compliance with REACH and to turn this massive challenge into a winning opportunity

18. Informa Life Sciences 14th Annual Conference « European Chemicals Policy », Berlin, 25-26 September 2007 CONCLUSION be aware ? communicate! prepare ? communicate! be positive ? communicate! join forces ? communicate!