Exposure scenarios II Tony Newbould, BCF Consultant Eastwood Hall, Nottingham Wednesday 30 March

What to do if your use is not covered? 2

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 Overview of process

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 What is a use?

5 REACH use descriptors TermExplanationExample SUSector of use Indicator of where substance is used or type of user: industrial, professional, consumer SU 3 Industrial manufacture (all) PROCProcess category Indicator of how substance is handled in occupational uses – human exposure PROC 7 Industrial spraying PCProduct category Indicator of product type in which substance used for consumer applications - human exposures PC 9a Coatings ACArticle 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 ERCEnvironmental release category Indicator of how substance may be released to environment ERC 2 Formulation

What to do regarding on-site activities 6

Step 1: inventory of own uses (SU, PROC, ERC) – use CEPE webpage for sector uses: emplate_im=100087&eas:dat_im=101AED emplate_im=100087&eas:dat_im=101AED Step 2a: are any uses advised against in the SDS Step 2b: 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 – PROC: hierarchy [next slide] 7 Own manufacture

8 PROC hierarchy PROC 5** PROC 4 PROC 3* PROC 20 PROC 2 PROC 1 ** not true for dermal exposure with LEV * not true for dermal exposure PROC 8a PROC 8b PROC 9 PROC 15 (except for industrial use of solids with LEV)

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 Own manufacture 9

10 Key itemWhatWhere 4-part9-part are my uses covered?- sector of use - PROCs - ERC 1 and 21 are my OCs covered?- duration of exposure - frequency of exposure amount used environmental emissions 2.25 what are the exposure RMMs?- dermal/inhalation what are the emission RMMs?- air/water/soil how are wastes handled?- disposal 2.27 what can I scale, and how?- basis of M/I’s assessment 38 - scaling algorithms 4 9 What to look for in an ES

11 Key itemWhatAction 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 Compare and contrast with current controls. Take appropriate action to comply with REACH 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 What to look for in an ES

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 Own manufacture 12

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 Own manufacture 13 Reminder: - have 12 months from receipt of Registration Number in an SDS to implement controls...

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 Own manufacture

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