Exposure scenarios, main challenges and solutions for different steps in the chain

Transcription

1 Exposure scenarios, main challenges and solutions for different steps in the chain 4th Annual Conference on Exposure Scenario 01 March 2016 Mercedes Viñas European Chemicals Agency

2 Supply chain communication: why is it needed? Manufacturer Downstream user Knows the properties of the substance Physico-chemical Toxicological Ecotoxicological Knows how the substance is used Operational conditions Applied risk management measures Foreseen products Concentrations Substance properties + conditions of use = assessment of safe use 2

3 Supply chain communication: a key feature in REACH Access to nonconfidential information General public Authorities Further regulatory action Manufacturers/ Importers Assessment of the potential risks for all known uses Information on uses of the chemicals up the supply chain Formulators Helpful information on safe use down the supply chain End-users of chemicals 3

4 SDS and Exposure Scenarios Substance-specific information Properties and classification Regulatory information (e.g. registration number) Overview of registered Uses Format: 16 sections harmonised at global level (GHS) Use-specific information Operational conditions Risk management measures Exposure estimations (if relevant for recipient/du) Format: recommended 4 sections format (templates and examples available on ECHA website) SDS + ES = extended SDS 4

5 How is it working? challenges Unstructured communication up the supply chain Extended SDS are often too extended Lack of format for Exposure Scenarios Information down the supply chain perceived as difficult to use/process Supply chain communication identified as one of the points for improvement in REACH Review

6 How is it working? solutions ECHA and Stakeholders decided to work together to address challenges: CSR/ES Roadmap is a joint action plan towards 2018 ( Exchange Network on Exposure Scenarios (ENES) meets twice a year to discuss and identify good practices ( 6

7 Different challenges and solutions for different parts of the supply chain General public Authorities Manufacturers/ Importers Formulators End-users of chemicals 7

8 Sector use maps Challenge: unstructured communication on uses up and unrealistic ES down in supply chain Solution: use maps Description of common uses and conditions of use agreed at sector level Sector Use Maps INFORMATION FOR REGISTRANTS SWED Workers SCED Consumers SpERC Environment Includes input to CSA: Worker/SWED: Specific Worker Exposure Description Consumer/SCED: Specific Consumer Exposure Determinant Environment/SpERC: Specfic Environmental Release Category 8

9 Sector use maps (cont.) Benefits for all! Manufacturers Structured information in a way that can be used as input for CSA Overview of common uses (less risk to miss out) Avoids unnecessary contacts with individual customers Standard phrases already selected Downstream users Harmonised ES from different suppliers on the same use Based on realistic conditions ES based on standard phrases Easier to recognise e.g. ES name 9

10 ES template Challenge: lack of defined format for ES Annotated templates and ES example available Follow recommended 4-sections format Manufacturers to decide what to include in the ES for communication and in which format Downstream users to understand what to expect in each ES section 10

11 Challenge: processing ES information received in pdf, word formats Solution: ESCompackage for electronic sending of Exposure scenarios in the supply chain : Catalogue of standard phrases XML format for ES ESCom 11

12 ESCom(cont.) Benefits both Manufacturers and Downstream users : Standard phrases: same text across companies supports translations XML format: avoids manual typing of ES into company systems allows processing of ES information 12

13 ESCom(cont.) Release 2.1 in January 2016 Two releases per year of ESCom catalogue XML format frozen for two years to support implementation Contact your IT provider to discuss implementation! 13

14 Structured Short titles Challenge: finding relevant ES in long ext-sds Solution: structured short titles Used for Table of content between SDS and ES Allows DU to quickly identify relevant ES Built from use descriptors following agreed rules: Life cycle stage Market information: PC/AC, SU Additional information (if necessary) E.g. Use at industrial sites; manufacture of fine chemicals; closed process 0publication% %20final.pdf 14

15 Chesar Challenge: complex CSA process Solution: Chesar ECHA IT tool for CSA and ES Supports CSA process with step-by-step approach Consistency between: IUCLID and CSR CSR sent to authorities and ES communicated in supply chain Facilitates updates Free and easy to install 15

16 Chesar (cont.) Chesar allows the use of: Standard phrases Exposure assessment inputs ES format New version 3 to be released in April 2016! Extended to cover more complex substances Improvements to assessment More training planned, stay tuned! 16

17 Formulators Challenge: how to combine information and produce a useful format for end users Supplier 2 Substance A Supplier 1 Substance A Supplier 3 Substance B Mixture C What to communicate and how? Mixture D (=A+B+C) 17

18 Safe use information of mixture (SUMI) Generated at sector level for common uses Simple 1-2 pages format for end users Harmonised content Use of pictograms 18

19 Lead Component Identification method Identification of lead component in the mixture Combination of risk management measures for these substances = safe use information on mixture Harmonisation from the top will help

20 eguideon safety data sheets and exposure scenarios Challenge: understand the received ext-sds Solution: eguide Aimed at recipients of extended safety data sheets Workers Environmental, health and safety managers Examples of SDS and exposure scenario How to understand and use them uide1-1/issue1 20

21 Authorities: screening Screening of all available data to identify cases of concern Allocate identified substances to the appropriate follow-up regulatory process Interest in Wide dispersive uses: widespread (used at many sites, by many users) and potential for release to environment and/or potential for human exposure Appropriate use and exposure information in registration dossiers ensures meaningful screening 21

22 Authorities: enforcement Enforcement is a competence of each EU country Coordination via Forum for Exchange of Information on REACH/CLP Enforcement REACH-EN-FORCE (REF) coordinated enforcement projects across EU REF-5: Focus on generation and communication of Exposure Scenarios Inspections to be carried out in

23 Key messages Information in the supply chain what goes up, comes down Harmonisation and standarisation are key. Initiatives are underway under CSR/ES Roadmap Follow the developments, get involved!

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