Document jB7L1rdKgaxvdMvren2vXmoeQ

ceric IB ewes. sno: Director General Brussels, 30 August 2022 Dear Ms Braun, 1 3m writing{0you regarding the ongoing revision of the Casiicaton, Labeling and Packaging (CLP) rReegguullaattoiroynsttoepss.hare key considerations from the European Chemical industry, ahead of the next C1e0fiwcosrukppwoirtths tthheegoCaolmsiofsitohenCthoemiicmaplrsovSetrCaLtPe,gyafdodrrSeussstianignabtihleitayr(eCa5s5)t,haantdrweqeuirreemauipngrcaodmimnigtatnedd proposingsolutionstha buildon the curren EU strongframeworkor regulating chemicals. Tahned rwieleveiotfsnLoiPtomonanlyy nathepcpehaermtiocbealtiencdhusntircyalbmuattaecrr,osyseatlthseecitmoprascrt oef thliosnyrcehfeiomrinmcailsgfsa.reaching AWhbartoaidsesroAmpeptriomaecshforgotten s tha the changesin casiicaton under CLPwill automatically igger sAtirriacdtyiotondaayn,d dbeacnissiaosnsfotraekseenenubnydetrheCgLePnelreiacd atpopraouatcohma0tircisbkamnasnaangdemreensttri(cGtRiAo)n ufnodrewrhtihcehCtS5h.e Commissionispowerlesstointrveneon.cosmetic,biocidal andplant protection products, tc), Acshamnagneyos25CL1P2,30n0d0GRsuAb,satcacnocred,inoguttootfh2e4E,c0o0n0ormegiicsAtnearleyds,iasocfteshteimaitempact0s obfethaeffCehcetmeidcbaylsprStorpaotseegdy fIomrpaScusttAaisnsaebsilsimteynbtydiRdicnaortdcoonEsneirdgeyr tEhneviimrpoancmteonft.thUenfcohratnugneatseolny,owtheerunsedcetrosrtaalnedgitthetiCoonm.mission's A"A rumbeerqfoofuMlearmefbiecstriSotntaotnestahenDdelMeEgPastehdaAvcetraised concerns about the proposed delegated act on tehwe ohrdaiznaarrdyclaesgiessl.atiTvheepirroccoendcuerren.isWtehaartetcisoins acn eessrtenhnttietalhdeelpeomleincta,lthastensshiotiuvledmbaettdeearlotfwdietlheugnadteerd ahctocothuilsdssceonwardioowconpulrdogbreeasvsooifdtehd baresveidsioonn.thWeecownocullusdiboneogftrheaCteofumlmfyiosusoiulodLnce'agrasliySwnhiecteh.er and rLePf,ortmogmeetahenrswcihtahngRiEnAgCtHh, ffoorumntdhateicoonronfertshteomnoesotftcohmepreUhecnhsemiivceaclhselmeigciasllatlieognisalantdiotnhienutphecowmoirnlgd waintdhpimpahctsoafgouipnscgobmeiiynogncndhatnhgegecshetmotihcaelitnwdousrtergyulaaltoinoens.,Trheesipmepcacttiviaelnlddyeipnceonmdboinnattihoens,coTpie,stsimwihnyg claounnscihdienrgedbiontdheeRd.EACH and CLP reform in a package at the same time is something that could be In the Annex we have detaled a few pints, including practicalsuggestionsand solutions. fWuerthweorudlidscaupspsretchieasteektehyeaospppeoctrst.unity to have an exchange with ou at your earest convenience to 1 3mookingforward to hearing fromyou. SReopoai Cbhrais8mn5yuC1 itosmSneogemsn o ovr eg SAE ocraamsn Ww Annexes to this letter: Technical aspects for the proposal. UN GHS first, then CLP? Understanding the need for action, we believe that the EU needs to do much more to secure that the proposed changes for new hazard classes will be agreed at the UN level (UN GHS). While it is possible for the EU to propose an update to UN GHS in line with the updated CLP, there is so far no guarantee that the EU proposal will be accepted by all parties (a previous attempt by the EU on PBT failed).A temporary divergence could then become a long-term deviation. This is in contradiction with the `G' and the `H' of GHS. A stand-alone CLP proposal will disrupt global value chains and contradicts the Strategic Approach to International Chemicals Management (SAICM) negotiations which calls for all countries to implement the global UN GHS classification. If the Commission is serious in its commitment to use the CSS to promote global standards, more needs to be done. Please be aware that EU REACH already regulates all substances that would be covered by new hazard classes under CLP (e.g. 57 substances have already been put on REACH Candidate List either for their endocrine disrupting properties, PBT/vPvB or high persistence and mobility properties). Assessment criteria For substances with Endocrine Disrupting properties, we call for criteria that fully reflect the WHO (UN World Health Organisation) definition, both for category 1 and for category 2 sub-divisions, taking into consideration the fact that the adverse effect should be a consequence of an endocrine mode of action, with corresponding evidence available. As to the classification of mixtures, we ask for pragmatic concentration limits to be introduced, consistent with the classification of adverse effects (0.1% or higher, depending on the adverse effect which, in principle, should already be classified under CLP). We support the PBT/vPvB criteria consistent with existing REACH requirements. However, we need a cautious approach for PMTs/vPvM. Several technical and policy discussions over the last two years showed the complexity of defining mobility criteria under CLP. Unlike bioaccumulation (B) assessment which includes a robust and definitive approach with enough discriminatory power, the same does not apply for mobility (M) assessment. Because of that, it should be allowed to use additional data when assessing mobility. Transition periods The introduction of new hazard classes will require a reassessment of all existing data on all substances, as a basis to re-classify substances (as applicable). Once substances are reclassified and relabelled, mixtures will have to be reclassified and relabelled in turn as well. The information on substances will be delivered to downstream users (mixture formulators) over a certain period. It is therefore essential to introduce two successive transition periods for new hazard classes, in line with the approach taken initially for CLP and later under the 2nd ATP to CLP when aquatic toxicity criteria were introduced: at least two years for substances and, as a second step, at least three years for mixtures.