Chemical safety report (CSR) and exposure scenarios

Transcription

1 Chemical safety report (CSR) and exposure scenarios Semira Hajrlahović Mehić, LL.M. Tatjana Humar- Jurič, M.Sc. Chemicals Office of the Republic of Slovenia

2 Chemical Safety Report (CSR) and Safety Data Sheet (SDS) = informing of users = risk manegment

3 Informing of users CHEMICAL SAFETY REPORT (prof. users) SAFETY DATA SHEET (prof. users, DU, distrib.) LABELL (all users) extent of information, tonage.

4 Risk manegment Risk characterisation under REACH: Estimation of incidence and severity of adverse effects likely to occur in a population/ecosystem due to exposure to a substance Addressing several potential toxic effects and human (sub)populations, and considering each (sub)population s exposure by relevant exposure routes Focus on most critical effect (with consideration of time scale) Quantitative or qualitative

5 Risk manegment Risk characterisation under REACH: Environmental risk characterisation RCR PEC PNEC Risk controlled if <1 Human risk characterisation RCR = intake or concentration/dnel or DMEL

6 Informing of users CHEMICAL SAFETY REPORT (prof. users) SAFETY DATA SHEET (prof. users, DU, distrib.) LABELL (all users) extent of information, tonage.

7 Chemical Safety Report (CSR) - Document, which details the process and the results of Chemical Safety Assesment (CSA) - Documents the CSA for a substance on its own, in a preparation or in an article or a group of substances

8 Legal background REACH Regulation Chemical Safety Report (CSR): Art.14 - general provisions Art additional provisions on CSR Annex I general provisions for assessing substances and preparing CSR Annex XII - general provisions for downstream users to asses substances and prepare CSR

9 CSR framework Instructions for performing CSR: - Annex I of the REACH - general provisions with forat - ECHA website:

10 CSR framework CSR shall be : completed for all substances subject to registration in accordance with in quantities of 10 tonnes or more per year per registrant conducted in accordance with paragraphs 2 to 7 of Art.14 and with Annex I for: - either each substance on its own or - in a preparation or - in an article or a group of substances.

11 CSR framework CSR shall document the chemical safety assessment (CSA) which shall include the following steps: human health hazard assessment physicochemical hazard assessment environmental hazard assessment persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vpvb) assessment Aditional steps for dangerous substances or PBT or vpvb : exposure assessment including the generation of exposure scenario(s) risk characterisation

12 Scope of the CSA/CSR The CSA/CSR should focus on exposure to the substance released: during service life of the article (for industrial workers, professional use, consumers and environment), and during the subsequent waste stage Dispersive emissions to the environment including exposure of humans via the environment, depending on substance and matrix properties: CSR and the ESs (exposure scenarious) take into account potential ti for exposure by different or multiple l pathways, and the emissions from articles during their service-life and waste-stage

13 Format of CSR PART A 1. Summary of risk management measures 2. Declaration that risk management measures are implemented 3. Declaration that risk management measures are communicated PART B 1. Identification of the substance, its physical and chemical properties p 2. Manufacture and uses 3. Classification and labelling 4. Environmental fate properties 5. Human health hazard assessment 6. Human health hazard assessment of physicochemical properties 7. Environmental hazard assessment 8. PBT and vpvb assessment 9. Exposure assessment 10. Risk characterisation

14 Goals of Chemical Safety Assessment (CSA) To ensure that risks to workers, consumers and the environment are controlled (and identify and apply the appropriate measures accordingly Shall address all identified uses of the M/I or DU Develop exposure scenarios if substances are classified as dangerous or considered to be a PBT/vPvB Document e t the assessment e in the chemical ca safety report (CSR), including listing of the exposure scenarios, covering Risk Management Measures (including C&L and down stream consequences) To communicate information using the safety data sheet (SDS) according to REACH

15 CSA framework By whom/ when? By a manufacturer/importer, for a regular registration By a DU, for a so-far unsupported use by a producer or importer of articles from which substances are intended to be released or where the Agency has required a registration for substances in articles By a manufacturer/importer to support the request for authorisation of substances of very high concern

16 Steps in the CSA/CSR Collect and generate available and required information on intrinsic properties!!

17 REACH: general CSA overview Existing Information 7. Revise Hazard information Hazard Assessment[1-3] If classified Exposure Scenarios [5] PBT/vPvB dangerous Or PBT/vPvB Estimation of Assessment [4] Exposure [5] Risk Characterisation [6] based on control of risks: Expo-Human < DNEL or PEC < PNEC For non-threshold substances, assess likelihood that effects are avoided For PBT/vPvB substances: minimise emissions and exposure 7. Revise conditions of use or exposure information NO 6. Control of Risks? YES NO Make Chemical Safety Report (CSR) CSR includes Exposure Scenario with Risk Management Measures (RMM) Implement RMMs for own manufacture or use Communicate ES and RMM down the supplychainwith ith Safety Data Sheet (SDS) OC = operational conditions, ES = exposure scenario, RMM = risk management measures DNEL = derived no-effect level, PNEC = predicted no-effect concentrations, PEC = predicted environmental concentrations.

18 Hazard assessment & PBT assessment 1. Human health hazard assessment; including classification and derivation of derived no effect levels (DNELs) or derived minimum effect level (DMEL). 2. Physicochemical hazard assessment; including classification. 3. Environmental hazard assessment; including classification and derivation of predicted no effect concentrations (PNECs). 4. PBT assessment

19 Exposure assessment If a substance: meets the criteria for classification as dangerous (according to the criteria of Dir. 67/548/EEC or 1999/45/EC or GHS Regulation), or is a PBT, or vpvb substance, Exposure Assessment is required! Development of : exposure scenarios and exposure estimation

20 Risk Characterisation & Iteration 6. Risk characterization required for each ES 7. CSA iterations may be needed to show that risks are controlled

21 CSA Iterations assumptions in the CSA can be iterated Improving hazard information Improving exposure information (refine assumptions) Improve data or exposure assumptions Model M d l definition iti or complexity Data to replace exposure estimation Improving p g operational or use conditions to reduce exposure Improving risk management to reduce exposure Document findings in CSR and SDS if required!!!!

22 What is an exposure scenario? The Exposure Scenario (ES) describes the conditions under which a substance (as such, in a preparation or in an article) or a group of substances can be safely used. The ES is a major element in the CSA on which the exposure assessment and the risk characterisation is based The ES is an instrument for communicating i operational conditions of use and risk management measures that are suitable to ensure adequate control of risk in the supply chain (the ES is integrated t into the Safety Data Sheet (SDS) system in Annex!!). ESs shall be developed for both the manufacturer s own manufacturing process and for identified uses; including both uses by the manufacturer or importer and uses further down the chemical supply chain

23 Exposure scenario terminology The Initial Exposure Scenario is the starting point for the exposure assessment and risk characterisation. An initial ES is a set of assumptions (using the determinants of exposure) on how a process is conducted and which risk management measures that are used or should be implemented. The Final Exposure Scenario is the outcome of the initial ES and dthe subsequent exposure estimate t and risk characterisation ti in the CSA process. It specifies the operational conditions and risk management measures required for adequate control of risks.

24 Steps in exposure scenario development Identify Uses Build Initial Exposure Scenario Iterative process Exposure estimation Risk Characterisation Final ES if risks are controlled

25 Identify Uses Registrant's own use: means an industrial or professional use by the registrant (REACH Article 3(25)); Identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user (REACH Article 3(26)); The Use Descriptor System was developed: 1. To describe a use in general terms in the context of Annex VI in the registration dossier, 2. For use-identification from DU to supplier 3. Give the exposure scenario a name. 4. Link the categories of the system to pre-set initial exposure scenarios

26 Content t of an exposure scenario The operational conditions (e.g. amount used, application process, temperature, duration and frequency of use), The risk management measures (e.g. waste water treatment or local exhaust ventilation), The inherent properties of the substance (e.g. volatility, water solubility) and The local conditions (e.g., specifics of the worker area, waster water treatment etc.) that determine the level of emissions to environmental compartments (air, water, soil) and exposure of target groups such as consumers and workers.

27 Exposure tools Existing E i exposure tools are applicable for simple assessments for each of the protection targets Occupational, Consumer and Environment Analysis of strengths, weaknesses and compensation for weaknesses Guidance is available on how to manipulate and make the tools fit with REACH requirements General limitations of existing tools Not targeted to REACH Need for facilities to apply standard use descriptor system Need for more efficient use of determinants, including RMM

28 Documentation of findings in CSR CSR template was developed to import and process the findings from the different databases, tools and models Import hazard data, PNEC, DNEL and comment fields on hazard into the template Results that are exported by the individual exposure models will be imported into the CSR template Interpretation p etat o parts on PBT, exposure e and risk need to be added manually

29 Example of CSR template Occupational exposure, Short term Table 1: Acute exposure concentrations to workers Estimated Measured exposure Exposure concentrations Concentrations Routes of exposure value unit Value unit Explanation / source of measured data Dermal exposure Inhalation exposure Explanations on estimation means (model description, model defaults values) and on representativity of measured values should be reported. Only one single value will be used for risk characterisation and documented from the table.

30 Conclusions: Chemical Safety Report (CSR) and Safety Data Sheet (SDS) = informing of users = risk manegment

31 Thank you!