Document bXpvDzj06v6ReaJJJgLw9yB3

- : i RIE . 0 Vo : : "hono o 4)sh: : BYon .00'' poMan"y a " i - T[nhe Allen " stai nab =or Crreema vot eeriewine- o---- =- 8 NOVEMBER 20: 22 - Agenda * Introduction of ASMoR + Exchange on a specific aspect of the Reform: + Generic Risk Approach and Essential Use Concept Point of particular attention: Need for derogations for safe (not only essential) uses + Exchange on the overall Reform of chemicals risk management + Conclusions Introduction of ASMoR MAOSo5R iBHeeonessenmeen.,"-SS1_8iigonnaattoorriies = omd IST QQ) he SO SOU Oi QECGA EFCC scow (Wms cvnoren comm 0 exer Gc door FEPA wisi @. mize (10 Que mi = Nes organ KOU A wowes my, uni) fm emu The Generic Risk Approach and the Essential Use Concept Considerations regarding the Application of the Essential Use Concept TARGETEDUSE WHERE OTHER SK GMT SHEEPING USE PROPOSEDUNDER THE + Montreal Protocol (ozone-depleting substances) Bin ocides Regulation + Proposal to ban all `Most Harmful Chemicals' (MHC) in consumer and professional articles + eEsxseemntpitailounsteosbe permitted only for + Even uses that do not lead to exposure and are safe would be prohibited Regulatory Purpose 1: Speeding up Regulation Some perceive that chemicals risk management is currently too slow. They argue that a blanket ban owiutrh perspective possible exemptionsfor essential uses will be "faster and simpler" * We recall that when REACH Authorisation was set up, the argument was similar. It was thought that the process would place the burden on industry and be simple for authorities. This has not been the + nGRdA/tEeUnCiiwovueldasrseequsimreenatuthEovreintioesrtpoprleavtieiwonalsl awphpelirceathieonsauftohroirririeelsevhanvcee -reetxatbrieemefloyrmgraatniuolnar that they are safe and useful. GRA/EUC is not a panacea for regulatory efficiency. Realistic impact assessment is needed. Reg. Purpose 2: Promotion er1rr LI of Substitution of MHCs = ey `Alban simply basedonhazardrun therisk of promoting regrettable substitution. ar | pa a A glimpse of the workload for assessing essentiality claims: A selection of uses of one of the concerned substance--s Nickel aa [Lali--e. iE f in LE A Ay al Jommanemmretoee Tan [1 BD RU l r (Guidanceofthe Nordic Counc onFood Contact Materia) . s[e=hi s4 Zp ez 2 XZ May-. =" kB TaSU Possible disproportionate impact of GRA on substances that may be classified in the future -- exampleofsilicone sealants Upcoming dsstcation ToiCrseei oanpn rpnontFotoednasatysrhnns oddest leat forSutaati 59deoon. goreroress sritterceosmhoevtSeOa TmbsRaeErsedetgeetsn! Sess esc pm em mst atte Err atsn ocabaotts fui td nsn dnfo dngconmarmethean + ira nrionctocsmstoaptmestaiee roHen pmofous ldnes listo sinsmises + e ntort modriamm etmeaemdmecttaatteion) Adjustments considered by the COM: safe uses and a more targeted approach CARACAL papers of EU Commission of 2022: V hE a the priority remains to first restrict substances on their own and in mixtures, although restrictions of (some) ci derogations upon SRE Derogations for minimal exposure Concept, as formulated in the GRA-survey: "Derogations from restrictions and/or authorisations granted if it is proven that emissions/exposure for uses of substances in articles and for industrial uses of substances in mixtures are absent/minimal throughout the lifecycle AND there are no suitable alternatives. "Minimal exposure" route" Demonstration of minimal exposure in the life-cycle NpbWoryetooftjesheseiceotnntaoilrae lbifreo-acydcelneisnhgouofldthbeeGcoAnsiadnedreEdU,Cbcuotnocnelpyttfhefacet<uaylluesepabsyetshetchaotnsaruemecrov(eorred AvoaiWflhaaeblritleeirtsnyautoeifvtensoohraalbttoetmrhnyHatHoirvaemndayENnoVtibnesaurveda,lth.doertogtaetiwonorskhoounlddfobe gnrdan+teadutrheograitridelsess oi crease an regretabie substation may b promoted The Revision of Chemical Risk Management should contribute to the Green Deal objectives + There appears to be a lack of consideration on how the revision of chemical policy (in particular a shift to hazard-based approaches) negatively correlates to other policy objectives (e.g. the reduction of greenhouse gas emissions / prevention of climate change, circularity or other sustainability considerations). + Furthermore, chemicals policy does not seem to sufficiently take into account other EC policy objectives, e.g. related to the resilience and strategic autonomy of EU markets (as outlined in the EU Industrial Strategy) Questions -- Essentiality * What will be the further process in establishing the definition of essentiality? + Regarding Analyses of Alternatives in the essentiality context Questions -- Hazard-based approach and prevention of regrettable substitution * Have you considered how to avoid negative trade-offs when pushing for substitution simply b~aTsiehdebopnueshhafzooarvresdnu?bhsteitnutionleofdsMtHoC in esentis and af uses wil be s0 trong that industry wil need to + ASMoR believes that upfront exemptions (based on screening) and further derogations (other than for essentiality) upon application are necessary * Howwill prioritisation be informed, if screenings for likelihood of risk / essentiality are not done upfront? Taxonomy: + On 3 August 2021, the Platform on Sustainable Finance ('PSF') published a draft Technical Report and its Annex on preliminary recommendations for technical screening criteria for the EU Taxonomy environmental objectives 3 - 6. These documents reference to the EUC, which i still not defined/developed under EU chemical legislation. + cTohnedistaimonespuindeesr wthoitchheaanlreecaodnyoamdiocptcetdiiEtUyTqauaxloifnioemsysCcloinmtartiebuDteilneggastuebdstAacntteisatlabtloicsihminagtethcehtaencghenimcitaigcarteiorninorgcclriimtaertieacfhorandgeeteardmsiptnaitnigont)h.e hineDrNSeH)t.heTehseseeisieanltuasleucsoensccerpittearipapeaaerscuurnrdeenrtltyhuenAdnenredxe| vanedlAonpnmexenItdTetchhenriecfaslncordeefiinnitgiocnriyteertiaoffo "lessaenttiealcuhsaesn"gebemyioingadttihoenaanneduasdeadptianthioen MnoonttarteiaolnPrboototcholb,eimngitdeetriinmcenotpael.oHtohweevearc,hireevfeemreenntcionfgtlh aEduyroipneTanaxGorneoemnyDoealthgeosEsUC val limit the eb of numerous sectors and hamper AdSeMveRl,opmtehenrtesfworhei,chalrreeamdayininuDnedcefeimnbeedr320o2f1yer,ecoofmsmuebjnedcetdtothoantgtohiengColemgmiislsastiivoendPelbaattfeor-mianvhoiisdscparso,pathsrienvgimseiaosnuroefsexoinsttihnegcbhaesmsicoafls legistation Instead, wesuggest applying the Better Regulation principles fo th achievement of poitical goals. The reform of risk management Proposed Reform of the Candidate List + If candidate listing has too many different legal consequences, it cannot be used in a targeted fashion. "Better tools than the candidate list should be identified to trigger information from downstream users (DUs). (e.g., the PACT under "Assessment of Regulatory Needs"). + Data collection should be limited to information that is relevant. The timeframe for providing data should be limited. * We argue against a dynamic link between CLP and the candidate list. The MSC could carry out a relevancy assessment before adding a substance (or specific uses of a substance) to the candidate list. Proposed Reform of the Candidate List + We oppose the introduction of a general fee system for SVHCs. * It would be a continuous tax on the safe use of SVHCs where there is no alternative and whwehreeretthhee useuse maymay eveven be essenti+al for society + We are against the introduction of a list of alternatives * There is rarely "one" alternative for the use of "one" substance. - The analysis must be use-specific anad ist of alternatiio ves for a substance would be too simplistic and misleading. Policy options *PCWAReAbCAeAlLiepvCoeptehsatAwhoeulprnooptosmaalkseintthhee * etry sein 0 nude the open We propose to use the above-mentioned to limit authorisation to specific uses of SVHCs `where authorisation could really make a wdiofrfkerleonacde.isTmhaisnawgoeualbdlaelsfooreanustuhroreittiheast. the aTohtebheoSlaeveofosnklmeasnaigoamnenstoonpet.ion should * We advocate an early RMOA / Assessment of Regulatory Needs. * Art. 68 para. 1 could be revised to better distribute the burden of proof between authorities and industry. + We call for a better integration of REACH with other EU legislation (criteria for the selection of RMOs should be defined). Questions * What is the status of considerations on the Candidate List and the multiple functions that were considered to be assigned to it? + What is the current thinking about how to combine different elements of the policy options? * Has the Commission integrated suggestions made by MS / stakeholders (e.g. ASMoR on a reformof Authorisation / Article 68(1))? What do you think about these alternative reform ideas? ASMoR Recommendations for the way forward Recommendation 1 regarding derogations: There shouldbegeneric derogations (granted by authorities after screening process). For the rest, derogation maybe granted based on applications. (gain in efficiency, compared to derogations only based on application). Recommendation 2 regarding derogations: Two derogation routes should exist 1) for safe uses (/useswithminimal exposure]; (2) for essential uses cInonpcearnrtthaiftoccraaunrntloictalebsre,aAdrdtr.e6s8s(e2d)bryesmtroircetiotnasrgsehtoeudldRObeS.useTdarasgaetliaosntfgresseocrtto,rsLew.oounlldywhheelpreitnhtheirseresgaard.is / ATinghetaernlythsecrweoernkilnogadprfoocresbsot(hRiMnOdAus)trcyoualnddhaeultphodreiftiineesan appropriate scope and generic derogations, which would Further ASMoR recommendations + Object to the proposed broadening of the GRA to also cover industrial uses + Professional uses should not all be subjected to GRA. + We support the inclusion of concentration limits, but stress that for some substances release limits are more appropriate. + The burden of proof regarding alleged alternatives should be more fairly distributed (who claims that there is an alternative should be required to provide sufficient information to assess it) +Timeline and process * At the CARACAL meeting 2 proposals have been announced: PROPOSAL 1: ia comitology procedure (fst rocedurefo)rREACH Annex+eResstriction Ar. 631. What re theother aspects + PROPOSA2L:iaordinaryprocedure wi thisproposal contain themajorchatno thgeleegisslation (Auth4RestsGRAVEL)? * New engagement opportunities + Follow-up material Contact us I. |__| | How ASMOoR sees the GRA + EUC fitting into EU Chemicals Risk Management bat ni Exposure. Jose, AsseRsissmkent EEEED = P conslerr stions fo SRMeC EY === AS_ pens, MOR esensit EEE