Chemical Safety Report

Transcription

1 Chemical Safety Report Andreas Ahrens (ECHA) Peter van der Zandt (COM) 3 rd India-EU Environment Forum Mumbai, 16 September 2008

2 Contents Information requirements (IR) under REACH Chemicals Safety Assessment and Report (CSA/CSR) Exposure Scenario building Guidance on IR and CSA Who is expected to use the CSA guidance? What is in the guidance? Conclusions and summary

3 REACH obligations Registration of all substances manufactured or imported in volumes 1 tonne/year per manufacturer/importer No data, no market Registration consists of: Technical dossier for all substances Chemicals Safety Assessment and Report (CSA/CSR) for substances manufactured/imported in volumes 10 tonnes/year

4 Registration Substance to be registered > 10 tons per year 2 1 Also Information in Technical Dossier, i.e. Substance and registrant id Manufacture and use of the substance Classification and labelling Guidance on safe use of the substance Study summaries substance properties Test proposals (if relevant) exposure Chemical Safety Report Hazard and PBT Assessment Dangerous or PBT/vPvB or expo based waiving 3 Also Chemical Safety Report Exposure Assessment Exposure Scenarios Exposure Estimation Risk Characterisation

5 Overall Frame Work Information: available required/needed collect all available information consider information needs identify information gaps generate new data/propose testing 2 3 Hazard Assessment (HA) 1 1 Exposure Assessment (EA) 1,2 Document in Registration Dossier 1 and SDS n Y Risk Characterisation (RC) 2 y n Iteration

6 Aim of the CSA Process Identify the conditions ensuring control of risks arising from manufacture and use(s) of a substance. Prepare a set of corresponding information on operational conditions and risk management measures to be communicated to the users of the substance (for dangerous substances). Document the assessment in a CSR for the companies own documentation. Submit CSR to the authorities as part of the registration.

7 Information: available required/needed substance intrinsic properties manufacture, use, tonnage, exposure, risk management Hazard Assessment (HA) Hazard Classification and PBT conclusion Dose/Concentration-Response Characterization Exposure Assessment (EA)* Build Exposure Scenarios (RMM and OC) Estimate Exposure Level 1 Stop n Dangerous or PBT? y Risk Characterization (RC)* Document in CSR Communicate ES via esds * y Risk n Iteration controlled? Required if substance is dangerous or PBT/vPvB, or exposure based waiving according to annex XI 1 For PBT/vPvB: emission characterisation only Required for all CSAs

8 Exposure Scenario describes the condition of use ensuring the control of risks operational conditions (incl. quantity used, frequency and duration of activity/exposure) risk management measures, e.g. product safety measures, exhaust ventilation, emission prevention and control, personal protected equipments waste management measures to be assessed and documented in the CSR to be communicated as annex to the SDS

9 ES format for communication Title and covered activities 1 Short title of the exposure scenario 2 Processes and activities covered Operational Conditions 3 Duration and frequency of use 4.1 Physical form of substance or preparation; 4.2 Concentration of substance in preparation or article 4.3 Amount used per time or activity 5 Other relevant operational conditions of use Risk Management Measures 6.1 Risk management related to human health (workers, consumers) 6.2 Risk management measures related to the environment 7 Waste management measures Reference to exposure prediction 8 9 Exposure prediction and reference to its source Guidance to DU to check whether he is working within ES

10 Overall process of ES building Identification of uses ES building Conduct CSA Making use known to M/I Information on conditions of use Giving feed back to ES M/I-DU dialogue DU-DU dialogue substance producer formulator formulator final DUs Associations

11 Build Exposure Scenarios Initial Exposure Scenarios Short title Operational conditions (OC) Risk management measures (RMM) Final Exposure Scenarios Short title Operational conditions (OC) Risk management measures (RMM) If risk not demonstrated to be controlled Decisions by M/I Refine hazard assessment Refine exposure estimate Modify RMM or OC Advise against use

12 CSR Format in Annex I Part A: Summary of RMM and declarations that measures are implemented and communicated Part B: 1. Identity of substance and chemical properties 2. Manufacture and use 3. Classification and labelling 4. Environmental fate properties 5. Human health hazard assessment 6. Human health hazard assessment for physicochemical properties 7. Environmental hazard assessment 8. PBT and vpvb assessment 9. Exposure assessment 10. Risk characterisation

13 ECHA guidance Guidance on Information Requirements and Chemicals Safety Assessment Published in May uirements_en.htm?time=

14 Who will use the Guidance? Manufacturers of substances 10 t/a Importers of substances as such or preparations 10 t/a Downstream users who need or want to make their own safety assessment Producers and importers of articles containing substances intended for release Only Representatives registering substances 10 t/a Manufacturers, importers and downstream users preparing a CSA as part of an authorisation application Authorities using the Guidance as a reference for assessment activities (e.g. evaluation, restriction).

15 Two types of guidance Reference guidance Technical and scientific details of hazard and exposure assessment Concise guidance Focus on processes and dialogues Guidance where to find more in depth information in the reference part, and when it is needed Both guidance parts addressed to trained persons.

16 R7 R3,4,6 R2 R5 Information: available required/needed Hazard Assessment (HA) Exposure Assessment (EA) B C R8-10 R11.1 D R12 R13 R11.2 R14-R18 E R19 Stop n Dangerous Or PBT? Y Risk Characterisation (RC) F Document in CSR y Risk controlled? n Iteration G Communicate ES via esds

17 Challenges Mind set: Risk management to become integral part of the assessment process Organising the communication up and down the supply chain before registration Control of Risk approach for threshold substances and non-threshold substances Identification of exposure estimation methodology allowing high throughput without being overly conservative Translating exposure scenarios for substances into guidance for safe use of preparations

18 THANK YOU