Exposure scenarios II Tony Newbould BCF Consultant Eastwood
Exposure scenarios II Tony Newbould, BCF Consultant Eastwood Hall, Nottingham Wednesday 30 March 2011 1
What to do if your use is not covered? 2
Overview of process • M/I sets DNEL(s)/PNEC(s) for the substance • M/I carries out risk assessments for each use – uses standard tool e. g. ECETOC TRA: emission/exposure factors • • • M/I determines safe use OCs/RMMs (RCR<1) M/I communicates safe use conditions in ES if use already safe, no DU action if easy, DU adopts OC/RMM within defined time if disproportionate/inappropriate, DU – uses own OCs/RMMs in scaling algorithms • If RCR<1 , no DU action • If RCR>1, action needed – resorts to more drastic solutions 3
What is a use? • historically: – technical function: solvent, hydraulic fluid, extraction agent – product: organic solvent borne PVC plastisol – application process: airless spray • REACH definition: how substance is handled any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation translates into process steps/tasks described by use descriptor codes 4
REACH use descriptors Term Explanation Example SU Sector of use Indicator of where substance is used or type of user: industrial, professional, consumer SU 3 Industrial manufacture (all) PROC Process category Indicator of how substance is handled in occupational uses – human exposure PROC 7 Industrial spraying PC Product category Indicator of product type in which substance used for AC Article category Indicator of how substance used in articles - with no intended release AC 11 Wooden e. g. toy - with intended release AC 32 Scented eraser ERC Environmental release category Indicator of how substance may be released to environment ERC 2 Formulation 5 consumer applications - human exposures PC 9 a Coatings
What to do regarding on-site activities 6
Own manufacture • Step 1: inventory of own uses (SU, PROC, ERC) – use CEPE webpage for sector uses: http: //www. cepe. org/EPUB/easnet. dll/Exec. Req/Page? eas: template_im=100087&eas: dat_im=101 AED • Step 2 a: are any uses advised against in the SDS • Step 2 b: compare inventory with uses in ES – interpret liberally: another use may apply if OC/RMM appropriate – ERC: can only be 2 - formulation – SU: SU 3 covers SU 2, SU 4 - 17 – PROC: hierarchy [next slide] 7
PROC hierarchy PROC 8 a PROC 5** PROC 4 PROC 8 b PROC 9 PROC 3* PROC 15 (except for industrial use of solids with LEV) PROC 20 PROC 2 PROC 1 ** not true for dermal exposure with LEV * not true for dermal exposure 8
Own manufacture • Step 3: uses not covered in the ES? – contact M/I to include in dossier and to issue additional ES – find alternative supplier who has covered – carry out own CSA/CSR and prepare ES – substitute the substance • Step 4: extract the OCs and RMMs, and waste handling instructions, relevant to your PROCs/ERCs 9
What to look for in an ES Key item What Where 4 -part 9 -part are my uses covered? - sector of use - PROCs - ERC 1 and 2 1 are my OCs covered? - duration of exposure - frequency of exposure 2. 1 3 - amount used 4. 3 - environmental emissions 2. 2 5 what are the exposure RMMs? - dermal/inhalation 2. 1 6. 1. 1 what are the emission RMMs? - air/water/soil 2. 2 6. 2 how are wastes handled? - disposal 2. 2 7 what can I scale, and how? - basis of M/I’s assessment 3 8 - scaling algorithms 4 9 10
What to look for in an ES Key item What Action are my uses covered? - sector of use - PROCs - ERC ES can be used if your sector of use, PROCs and ERCs are covered are my OCs covered? - duration of exposure - frequency of exposure If OCs outside those in ES, scaling may be an option (para 9/section 4) - amount used - environmental emissions what are the exposure RMMs? - dermal/inhalation what are the emission RMMs? - air/water/soil how are wastes handled? - disposal what can I scale, and how? - basis of M/I’s assessment Identifies risk assessment approach - scaling algorithms Use to assess own situation Compare and contrast with current controls. Take appropriate action to comply with REACH 11
Own manufacture • Step 5: compare OCs/RMMs with what you currently do – yours: better or as good as – no action, but record – yours: less than M/I – action required 12
Own manufacture • Step 5: compare OCs/RMMs with what you currently do – yours: better or as good as – no action, but record – yours: less than M/I – action required Reminder: - have 12 months from receipt of Registration Number in an SDS to implement controls. . . 13
Own manufacture • Step 6: options if supplier OCs/RMMs not feasible: – scale show are operating within ES conditions • uses own OCs/RMMs in scaling algorithms • If RCR<1 , no DU action • If RCR>1, action needed – change process to accommodate – M/I to redo risk assessment • using sector OCs – Tier 2 assessment • using own site data – Tier 3 assessment – identify alternative supplier who covers uses – change formulation – do own CSA • resource and cost implications 14
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