1. REACH Downstream Users Istanbul 21 st June 2010 Mike Potts UK REACH Competent Authority

2. Who are Downstream Users downstream user (Article 3(13): “any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user……”

3. Formulator End-User Industrial User Article Producer Craftsmen, micro enterprise, professional service providers Re-fillers Re-importers Warehousing (storage counts as use) Importers with non-EU supplier using an ‘only representative’ Who are Downstream Users:

4. Registration Supply chain End use Evaluation Authorisation Restriction (pre-registration)

5. Duties of Downstream Users (Title V) They do not have registration duties –(unless they are also manufacturers/importers) Supply Chain duties Use Duties Article 37 – DU CSAs and duty to identify, apply and recommend risk reduction measures Article 38 – Obligation for DU to report information Article 39 – Application of DU obligations Many of these duties are not new and existed under previous legislation

6. Supply Chain duties Requirements regarding supply – information conduit up and down the supply chain: Contact suppliers: - with any new information on hazards - if risk management measures not appropriate –Ensure uses are covered in the registration Provide customers with information: - formulators: SDS if substance/preparation is ‘dangerous’ Also information where an SDS is not required - producers of articles: if article contains ‘SVHCs’

7. Use related duties Requirements regarding use: Use chemicals safely and in accordance with supply information –Safety Data Sheet / Exposure Scenarios –Implement Risk Mitigation Measures or equivalent levels of control –Provide information on uses/hazards up the supply chain Take action if use is ‘outside’ registration –Use a different substance –Use a different supplier who will support the use –If necessary conduct CSA

8. General duties Obtain authorisation where required (or notify ECHA of use) Observe restrictions Provide workers access to information –For all substances/mixtures they may be exposed to Keep information –10 years

9. essentially a risk assessment, undertaken by the manufacturer / importer derived no-effect levels (DNELs) ‘exposure scenarios’ – a description of operational conditions and risk management measures exposure scenarios to be annexed to SDSs In certain situtions DU may develop their own Chemical Safety Assessments are required for +10 tpa registrations:

10. REACH repeals and replaces old requirements as regards safety data sheets Through registration, safety data sheets will contain more and better information about risk management measures (‘exposure scenarios’) Preparation of CSA and SDSs will be discussed later

11. Other relevant EU legislation Chemical Agents Directive CAD (98/24/EC) –It introduces minimum requirements for protection of the health and safety of workers encountering chemical substances at work in the EU Requires the employeer to: –Perform a risk assessment for all potentially exposed workers involved in all operations –Eliminate, or reduce to a minimum, the risk to workers Contains specific measures to explore: –Substitution –Minimise release of substance into workplace area –Ventilation –PPE –Adherence to national occupational exposure limits Make provision for accidents and emergencies Requires Information and training for workers Sits side by side with REACH

12. Guidance Guidance for DU http://guidance.echa.europa.eu/docs/guidance_ document/du_en.pdf?vers=29_01_08 http://guidance.echa.europa.eu/docs/guidance_ document/du_en.pdf?vers=29_01_08 Use descriptor system http://guidance.echa.europa.eu/docs/guidance_ document/information_requirements_r12_en.pdf

13. Your questions…