Health risk assessment van mengsels; voorbeelden uit de verfindustrie. Josje Arts Senior (inhalation) toxicologist / PSRA manager

Transcription

1 Health risk assessment van mengsels; voorbeelden uit de verfindustrie Josje Arts Senior (inhalation) toxicologist / PSRA manager

2 Health Risk Assessment of mixtures Tell me from your point of view 1. Priority Substances Program 2. LCId method / CCA / OHRM 3. SIRE code / INVECO (paints) 4. SWEDs / SUMIs (paints) What What is a priority substance? 2

3 1. Priority Substance Program Three elements for priority scoring: Priority score = 3

4 2. LCId / CCA / OHRM LCId (previous speaker) CCA = Critical Component Assessment Based on CCA, most critical component chosen Based on this component, hazard class determined 4

5 2. OHRM Occupational Hygiene Risk Management tool - developed based on 4-step approach Inspection SZW - Potential Degree of Exposure (PDE) Hazard Class (HC) ** Special attention Low Moderate High Risk Ranking Table 5

6 3. SIRE code / INVECO (2016) S = santé I = inflammable R = réactivité E = équipement 6

7 3. SIRE code / INVECO (2016) 7

8 4. SWEDs / SUMIs Downstream Communication of safe use information for mixtures for the Paint, Varnish, Printing Ink and Artists Colours Industry The SWED/SUMI approach SWED = Sector-specific Worker Exposure Description SUMI = Safe Use of Mixtures Information 8

9 4. Approach by mixture formulators A sectorial bottom-up approach is suited to end-use mixtures with clearly defined markets and uses Currently being developed by several sector associations in DUCC representing formulators of such mixtures Supported by ECHA 9

10 4. Approach by mixture formulators According to REACH Article 31(7): Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses. Options to include ES information: 1. Attach ES for relevant substance(s) to the SDS 2. Integrate (consolidated) ES information into the main body of the SDS 3. Add consolidated safe use information for the mixture as an appendix to the SDS This approach is one way of implementing either Option 2 or Option 3. 10

11 4. Current situation ES ES ES SD SD ES S SD S SDS SD S Registrant SD SD S SDS Formulator Sector association End-user Analysis of typical end-uses 11

12 4. Approach by mixture formulators SWEDs: Sector-specific Worker Exposure Descriptions DU sector association defines the boundaries of applicability for its SWEDs CEPE/EuPIA has categorised the various end-use scenarios most used by customers of its members products into SWEDs SWEDs are based on the REACH sector use maps are not substance-based require a validation step by the formulator Identifies exposure routes assumed for workers 12

13 4. CEPE Paint SWEDs (Use Groups) CEPE_IS_01_v1 CEPE_IS_02_v1 CEPE_IS_03_v1 CEPE_IS_04_v1 CEPE_IS_05_v1 CEPE_PW_01_v1 CEPE_PW_02_v1 Industrial spray painting, enclosed Industrial spray painting, walk-in booth Industrial spray painting, no booth Industrial low-energy painting, enclosed Industrial low-energy painting, no booth Professional spray painting, near-industrial setting Professional low-energy application, near-industrial setting CEPE_PW_03a_v1 Professional spray painting, indoor (Level I) CEPE_PW_03b_v1 CEPE_PW_04_v1 Professional spray painting, indoor (Level II) Professional painting, indoor brush/roller CEPE_PW_05a_v1 Professional spray painting, outdoor (Level I) CEPE_PW_05b_v1 CEPE_PW_06_v1 Professional spray painting, outdoor (Level II) Professional painting, outdoor brush/roller 13

14 4. EuPIA Ink SWEDs (Use Groups) EuPIA_IS_01_v1 Printing in an enclosed or extracted process EuPIA_IS_02_v1 Printing with enhanced (mechanical) room ventilation EuPIA_IS_03_v1 Printing with good general room ventilation EuPIA_IS_04_v1 Digital printing with good general room ventilation Associated with each of the 17 SWEDs is a SUMI 14

15 4. SWED Use Group Use identification and general description Use code CEPE_SWED _PW_04_v1 Use name [see Notes in Explanation tab] Professional painting, indoor brush/roller SWED table Brief description of use process Indoor painting by professionals with brush or roller, with general room ventilation (open doors/windows) Link activities to exposure assessment inputs contributing activity name Contributing activity descriptor (PROC) Operational Conditions (exposure modifiers) Duration (per day) Ventilation efficiency [see Notes] Risk Management Measures [see Notes] Respiratory protection Eye protection Hand protection (gloves) Preparation 5 30% N Y Y Loading 8a 30% N Y Y Application 10 30% N Y Y Film formation 4 30% N Y Y 4-8h (drying/curing) Cleaning 5 30% N Y Y Waste management 8a 30% N Y Y 15

16 4. ECETOC exposure estimate: Example PROC7, inhalation 16

17 4. Example of the SWED concept Industrial spraying - default exposure estimate = 500 ppm (E est ) Local exhaust ventilation efficiency of 95% (only 5% of mixture available to be exposed to) F 1 = (100 95) 100 = Assumed actual exposure: E ass = 500 ppm = 25 ppm 17

18 4. Concentration factor In a mixture, a concentration-related modifying factor can be applied (cf. ECECTOC TRA) Substance in mixture Based % % 0.2 < 1% 0.1 Modifying factor 18

19 4. The Minimum Tolerable DNEL CEPE has calculated the assumed exposure for each activity in the process By comparing all activities in a SWED, the highest assumed exposure value can be ascertained - the Minimum Tolerable DNEL 19 19

20 4. Risk assessment Substance DNEL > Minimum Tolerable DNEL = SAFE USE i.e. the Risk Characterisation Ratio (RCR) is less than

21 4. Inhalation & dermal exposure For some substances, the combined systemic effect via both the inhalation and the dermal exposure route will not be considered as safe if the combined Risk Characterisation Ratio (RCR) is above 1. Safe use is proved if RCR<1 Spreadsheet does this automatically 21

22 4. Communication to end users SUMI: Safe Use of Mixtures Information Simplified, tailored information on safe use of mixtures SUMI gives OCs and RMMs for each activity May contain pictograms depicting the RMMs required Consistent communication to end users Supply in language of MS 22

23 SUMI Safe Use of Mixtures Information for end-users Title: Professional painting, indoor brush/roller This document is intended to communicate the conditions of safe use for the product and should always be read in combination with the product s Safety Data Sheet and labels. General description of the process covered Indoor painting by professionals with brush or roller, with general room ventilation (open doors/windows) This safe use information is linked to SWED CEPE_P_04_v1 Operational Conditions Maximum duration of individual exposure: covers daily use up to 8 hours, 225 days per year Contributing activity Ventilation Ventilation - air changes/hr Preparation of material for application Good general room ventilation (e.g. open windows) 3-5 Loading of application equipment Good general room ventilation (e.g. open windows) 3-5 Application Good general room ventilation (e.g. open windows) 3-5 Drying/curing Good general room ventilation (e.g. open windows) 3-5 Application equipment cleaning Good general room ventilation (e.g. open windows) 3-5 Waste management Good general room ventilation (e.g. open windows) 3-5

24 Risk Management Measures Contributing activity Respiratory Eye Hands Preparation of material for application None Use eye protection according to EN 166 Wear suitable gloves tested to EN374 Loading of application equipment None Use eye protection according to EN 166 Wear suitable gloves tested to EN374 Application None Use eye protection according to EN 166 Drying/curing None Use eye protection according to EN 166 Wear suitable gloves tested to EN374 Wear suitable gloves tested to EN374 Application equipment cleaning None Use eye protection according to EN 166 Wear suitable gloves tested to EN374 Waste management None Use eye protection according to EN 166 Wear suitable gloves tested to EN374 See chapter 8 of this Safety Data Sheet for specifications. Disclaimer The information in this Safe Use of Mixtures Information sheet is based on the data provided by the substance supplier for the substances in the product for which a chemical safety assessment has been carried out at the time of issue. It does not guarantee safe use of the product and does not replace any occupational risk assessment required by legislation. When developing workplace instructions for employees, SUMI sheets should always be considered in combination with the SDS and the label of the product. No liability is accepted for any damage, no matter of what kind, which is the direct or indirect consequence of acts and/or decisions (partly) based on the contents of this document.

25 4. SUMIs / SWEDs One SUMI for each SWED/end use Not one SUMI per SDS Use-orientated: one SUMI covers multiple products May need more than one SUMI per product Provided as appendix to, or integrated within, SDS of products Does not replace SDS! 2

26 4. With SWED/SUMI approach ES ES ES (SWED*) ) SDS SDS Registrant Use Map SWEDs: PROC/ SU OC/RMM Validation of incoming ES SD SD S SDS SUMI Formulator Sector association * SWED included in ES Enduser Analysis of typical end-uses 26

27 4. Summary objectives of SWED/SUMI approach To provide safe use information for classified mixtures To develop meaningful information for end-users of mixtures (by ensuring consistent translation of the substance s ES provided within the SDS) workers To simplify communication with raw material suppliers To cover the majority of uses within a sector Reminder: this approach does not cover - consumers (for which the label is the main information carrier) - the environment, which is being addressed by other projects 2

28 Thank you for your attention!