Document a4J334rGGEMRjKXqE9XeD9J1y

CSS and its impact on industry - part 1 GROUPING OF CHEMICALS AND GENERIC RISK ASSESSMENT - potential practical implications kopol - Institute for Environmental Strategies (Hamburg) Thursday 8 July 2021, Webinar Agenda Grouping of Chemicals Current situation and planned changes Challenges for industry Generic Risk assessment Current situation and planned changes Challenges for industry 2 Grouping of Chemicals Current Situation Grouping only in exemptional cases: Restriction more common based on hazard: e.g. certain CMR in consumer mixtures Substances/mixtures classifies for hazard categories in certain products (Annex XVII Entry number 3, ornamental articles, games etc,) Restriction more common based on structural relation (and resulting hazard) e.g. Cadmium, Arsenic, Mercury compounds SVHC identification usually for specific substances (structurally related often simultaneously but in separated processes) Some exemptions: OPE/NPE focus on a common degradation product Potential upcoming changes More use of grouping based on Structural relation of substances e.g. PFAS (characterised by Fluorine Carbon bound) Assumed risks effects E.g. Phthalates, exposure towards population can be shown, at least some members of group with adverse effects Functional relation of substances e.g. flame retardants in certain products, many with adverse effects (not always the same) prevention of regrettable substitution increased speed of overall substance evaluation and risk management process (Aim: non toxic environment) 3 Grouping of Chemicals - Challenges for the industry Adaptation of R&D strategies: Substances of one group will most likely be regulated together No "similar" substance available form the usual substance catalogue more fundamental product design changes needed Potentially high number of substances reflecting an even higher number of mixtures (products) may need to be substituted simultaneously (depending on product development and qualification timelines, usual REACH periods for substitution may not fit) More resources needed in R&D to react on loss of substances (even category 3 very ambitious timeline for adapting products when additional product approval legislation needs to be covered as well) Potential short coming of experts, research staff to support such activities Adaptation of Regulatory Affairs strategies: Interaction on technical issues in regulatory processes necessary (given that product adaptations may not be possible within timelines) stronger involvement of company units traditionally not involved in regulatory affairs e.g. sales (socio-economic effects), R&D (substitution potential), production (detailed information on condition of use, risk management, potentially introduction of processes to reduce exposure/emission) 4 Generic Risk assessment Current Situation Article 68 (2) defines a risk (assumption) per default if substances are CMR cat. 1A or 1B and are contained in consumer products REACH Articles 69 -73 do not apply no need to demonstrate exposure - large degree hazard based no need to demonstrate availability of alternatives no need to justify measure via socio-economic arguments No formalised public consultations (consultations may be initiated under COMs better regulation initiative) Potential upcoming changes Extending the generic risk approach to restrictions on new hazard categories endocrine disruptors, PBT/vPvB substances, immunotoxics, neurotoxics, respiratory sensitisers and substances affecting specific organs; Extending the generic risk approach to products marketed for professional use; Operationalising the concept of essential use in restrictions, including the criteria for granting exemptions. 5 Generic Risk assessment - Challenges for the industry May increase speed until regulation sector may be seen as professional use rather than industrial But: generic risk assumption might not be appropriate for sector with high benefits for public health (continuation of specific risk assessment according to "old" restriction approach - Article 68 (1) more appropriate follow discussion on new elements under CSS Prepare sector position with strong argumentation on Technical obstacles that prevent a generic risk approach (e.g. duration for product changes) Potentially increased acceptance of somewhat higher risk which is not reflected by generic risk assumption (low tonnage, benefit for public health) Note: also focus on environmental aspects during risk assessement (wastewater emissions, waste etc.) If essentiality becomes relevant discuss why substances function* is essential in their function not your business *maybe also based on grouping (e.g. detergents etc.) 6 OIknosptolfGrmOkbaHlogie und Poli Ne0m-2s2t7v6e5gHa3m2b:u3r4g TFaoc asug) E-Mail J 7 https:/ioekopol.de/ https:/ioekopol.defen/ Eoo k= dpn ol