Document Lg5oRxJJzn8QgDJ32B8n8po3Q

cefic REFLECTION PAPER ocrosea 2018 Cefic reflections on the current process suggesting to identify Substances of Very High Concern (SVHC) based on their Equivalent Level of Concern (ELoC) to PBT/vPvB substances "This paper aims to share Cefics general consideratioonns the process and approach proposed to identify SVHCs based on equivalent level of concern related to human and environmental effects, in order to protect ground and drinking water. Beside other regulatory actions, an industry commitment exists already towards the protection of drinking water resources from chemical contamination. SVHC identification is one route under REACH to target chemicals based on specific hazardous properties. However, considering the direct impact on the market, regulatory consequences, etc. SVHC identification should remain a case-by-case assessment based on well-defined criteria --which is currently not the case for the useof Article 57faddressing ELOC for environmental purposes. 1. Processtransparencyand predictability Inorderto ensure transparency and predictability in the REACH process, al requirements needed to fulfil the identification assessment should be clearly identified and defined before any dossier development. Art 57f of REACH allows the identification of SVHC, based on the Equivalent LevelofConcern (ELoC) route. However, the way to determine this equivalence is open to interpretation. + human health efects vith he identificationof sen: -discuwsitshiMeomnbesr State Competent Authorities, the Commission and ECHA resulted in an ECHA authored paper in 2012 entitled "Identificationof substances as SVHC dus to equivalent levelof concern to CMRs (Article 77) -- sensitisors as an example". tof europeculdocuments/10162/13657/euhe ant S78 sesitsers en ptfaS0T3Ace 6514485 9108 193088bcse Thi discussion paper elaborated on factors to consider when assessing whether a substance with those properties could be identified a asensitser with ELoC to CMRs, was the outcome of a yearlong discussion in the RIME meeting (Risk Management Expert meating), the CARACAL and the MSC (Member State Competent Authority meeting). For the environmental effects, a similar approach, including stakeholder consultation, is requested to develop a number of key elements on the basis of which it may be determined, whether they may be regarded as giving rise to an "equivalent levelofconcen' to those of PET/VPB substances. A policy paper dosn't exist yet for environmental effects. Currently, creating uncartainty in the approach proposed. A paper should be developed and discussed together with stakeholders wall before any application in Annex XV dossier proposal. cetic REFLECTION PAPER rm encom ave reas T r s Reo So e Soe esoaEt a ee I rei? in point (a) to (oft)hat artic." C a ee FeE Tr aeflfseocbtsegsicvieenitsifeictoeavnideeqnucieva(lseuncthlaesveelxopfocsounrec,erenmitsosCiMonR,/PnBoTr/mavlPvrBislkisatsesdeisnsAmretnitc,lee5t7c()at-hea)tofthRoEsAeCHs"er.ious The hazard assessment as indicated in the guidance to prepare Annex XV dossier for ELoC to CMRs, should Er i of pemaarytE ocder he b SDA EDHeTRsSFT YeSArT Or UR consider the seriousness of the effect, the irreversibility of the effect, the nature of the effect, the PBT/vPvB before an SVHC proposal is submitted. The assessment should eat) include - Ademonstrationofthe serious effect caused on human health and/or the environment by the substance OE Aanim - Ascientific evidence supporting that these serious effects provide equivalent levelof concern to - Anassessmentofthe reversibility/irreversibilityof the effect - Athorough risk management option analysis (RMOA) based on all available information. = By Defining intrinsic properties and es criteria giving rise to the equivalent concern to PBT/vPvB require Once agreed, the set of criteria proposed for consideration to identify SVHC based on ELoC for a E SL eoa e B a Enr ray Po mes environmental purposes should be combined. All available data should contributtoe determinethe hazard E a E a Bcesic 5. Coneusion REFLECTION PAPER