Document b5KQL2NqMbLzQmQ1pymMrb79o

Sail & AAP " Z| % Ce AE 10)Strategy ustainability 4 7 i; Pr 4 3 Pp A) \ q 1) EELS TTEEESI "4 #EUGreenDeal 2 [7Ag, rl~ n pL 2'Maprcrh e20m22 frie] bh Planned Actions under REACH Revision Chemicals Strategy for Sustainability/REACH revision: Extend current use of generic (hazard-based) bans of most harmful chemicals, except for essential uses. + Auseis essential only if (Montreal Protocol): itis necesfsoartrhye health, safety or iasscpreicttisc)al; faonrdthefunctioning of society (encompassing cultural and intellectual + no available technically and economically feasiblealternatives that are acceptable from the standpoint of environmeandt health; Reform authorisation and restriction processes, which are too heavy to deal with current and future workload Le Why apply essential use criteria? Current criteria for REACH authorisation: Adequate control of risks + Socio-economic analysis to demonstrate that benefits outweigh risks Adequate control To befurther analysedwhether some form of "safe use" derogation should remain (outside the essential us framework) Socio-economic analysis: In principle covering most relevant factors, but: + Lengthy process and many non-quantifiable aspects Cannot deal with societal preferences + Sometimes misses the relevant questions Replace by essential use concept | Processes to assess derogations and authorisations Current process: First scientific/technical assessment by ECHA + Subsequently decisionby the Commission on the basis of ECHA opinions Why change the process for assessment of essentiality? + Current process takes a long time -- unnecessary for clearly essential and clearly non-essential uses + Essentiality criteria include both scientific/technical elements and societal preferences . rdos not make sense to put questions on societal preferencteos a scientific/technical ocly + It does not make sense to put scientific/technical questions to a general decision making body =Need to combine general and scientific assessments/putting the right questions to the right bodies |o Examples: Chrome plated lipstick cases C+ uPrarrteontafabpigprauotahocrhi:sation request : + Application to ECHA submitted in 2015 + ECHA Opinion given in 2016 still no decision, inter alia because there is lackof acceptance on utilisations such as chrome plated lipstick cases Scientific/technical assessment can identify whether the alternative works with| the same quality - It cannot address the question whether society is ready to accept any risks for workers, and whether we could not live with other types of lipstick cases =Apply essential use criteria to include question ofsocietal preferences to allowfaster and more relevant decisions Le Examples: Authorisation for OPE/NPE Used in medical products (vaccines, IVD kits) as a cleaning agent: Alternatives are in principle available but require approval by European Medicines Agency Current approach: + +]- 70 individual authorisation applications: Takes years and occupies a large number of agents and officials in ECHA, Commission and Member States + Addresses many standard issues but not necessarily the key question how as many alternative products can get EMA approvalasfast as possible Is it efficient to spend so much time/resources on this issue? Reform the authorisationrestriction process --generally applicable derogations Apply essential use criteria to allowfaster, moreflexible and relevant decisions Le Examples: Cobalt in car batteries Currentnloy plans to restrict cobalt in batteries Nevertheless, good example to illustrate choices: Electrical cars are high priority for society oAlternatives under development What are the relevant questions to be answered? oScientific/technical assessment of availability of alternatives? Criticality for society? What about providing the necessary investment security? Essential use concept and revisedprocesses could help to pose the right questions to the right levels | Proposed process to apply the essential use concept in REACH + Step one: Initial screening of alternatives, identifying if: + there is a clearly identifiable alternative in the same product category, or + not so clear-cut (remaining cases); to be discussed whether at this stage it would be possible to identify whether there is clearly no alternative Initial screening of criticality/necessity, identifying those cases where a use is: + clearly critcal/clearly necessary, or + clearly non-critical/unnecessary, or + not so clear-cut (remaining cases) dWehreorgeatnioonfuorrtahuerthsocriiesnatitfiiocn/tceocuhlndicaallraesasdeysbsemetnatkeins naetetdheids,stdaecgies(iSotnespo3n).the + aSftteeprtawdoj:uswthmeernetnoefeidnefdo,rmfautrtihoenrrsecqiuenitriefmiecn/tteschantitcahle asscsreeesnsimnegntst(aigfea)ppropriate + Step three: decision on the derogation or authorisation. LE Proposed process to apply the essential use concept in REACH Coa Nm > <>ff El | ----LE Z| > << \| a | oe Z SE B ankbi \ Bini < oY 4 aJ \ \ an JY for a4 als Strategy - Sustainability | "|