Document xk93G2Xb4onQMB9661kZ830y

EUROPEAN COMMISSION Brussels, XXX [...](2020) XXX draft COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a toxic-free environment EN EN 1. INTRODUCTION: BENEFITS AND RISKS OF CHEMICALS. 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B2h n EaSney t 3 neh0 cok, COMO for the sound management of chemicals globally, in international for a as well as with all its partners. This Strategy represents the necessary first step to moveing towards Europe's Zero Pollution ambition, enabling to achieve the related targets defined in the Biodiversity and Farm to Fork Strategies to be achieved, setting the foundations for the upcoming Zero Pollution Action Plan and ensuring the success of Europe's Beating Cancer Plan. By boosting the EU's capacity to produce and use chemicals in a sustainable way, this strategy is also complementary to the European Industrial Strategy23 and the Recovery plan for Europe24, and other European Green Deal strategies and initiatives such as the Pharmaceuticals Strategy, the Hydrogen Strategy, and the Batteries Initiative where chemicals are an inherent part of the EU industrial fabric. 2. THE VISION FOR 2030: TOWARDS A TOXIC-FREE ENVIRONMENT The goal of the EU's chemicals policy up to and beyond 2030 is to ensure a high level of protection of health and the environment from hazardous chemicals, while boosting competitiveness to develop safe and sustainable innovations, and serve the EU's open strategic autonomy. It will exploit the potential of the EU's internal market and reap the benefits of new materials, technologies and digitalisation to enable the overall shift towards a zero pollution, circular and climate neutral economy. It will provide clear and easily implementable rules within a transparent and predictable legal framework, also through strong and harmonised implementation and enforcement across the EU and at its borders. It will strengthen its science and knowledge base on chemicals and support the sound management of chemicals globally. A toxic-free hierarchy will guide policy action towards this vision, to prioritise safe and sustainable chemicals, based on the EU principles of precaution, prevention, rectifying pollution at source, and polluter pays.25 This entails means that substances of concern26 should be avoided for non-essential societal uses27 while appropriate control measures should allow the safe use of chemicals for societal needs and minimise exposure to hazardous chemicals. Through the application of those principles, elimination and remediation would in principle gradually be phased out. 23 COM/2020/102 final 24 Estimated prevention of 1 million new cancer cases in the EU over the last 20 years; SWD (2019)199 24 Which has been reduced by an estimated 89% in the EU between 1990 and 2011, resulting in a significant reduction in levels of lead in blood; SWD (2019)1 25 Art. 191 TFEU 26 The term `substances of concern' includes those substances identified as of very high concern under REACH (`candidate list substances') and those substances listed in Annex VI to the CLP Regulation for a chronic effect 27 The concept of `essential uses' was introduced by the Montreal Protocol on Substances that Deplete the Ozone Layer to assess whether the use of certain chemicals is actually necessary According to the Montreal Protocol, in order for a use to qualify as `essential': a) it must be necessary for the health, safety or is critical for the functioning of society; b) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health 3 roeteatreiseane [excm arcoem motomr 3 mr rpe ert pn er my wee | Pipe. 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It is for example the prerequisite to for achieveing the EU's commitment to reducinge the use of more hazardous pesticides by 50% by 203054, and it is relevant for all types of chemicals, including pharmaceuticals.55. It needs stronger policy and financial support, as well as advice and assistance, in particular for SMEs, and requires a concerted effort from all: authorities, businesses, investors and researchers. Available tools under REACH56 and other legislation, such as the Ecolabel Regulation, and the Ecodesign and Industrial Emissions Directives, need to be exploited or revised in order to ensure and reward safer chemicals and effective substitution of substances of concern. Furthermore, collaborations across supply chains and technology areas are needed to facilitate development and market uptake of substitutes, and incentivise the scaling up of green innovations and technologies is needed. SAFE AND SUSTAINABLE-BY-DESIGN Together with all the relevant actors, the Commission will: develop EU safe and sustainable-by-design criteria, in line with and complementing the EU Taxonomy Regulation57, as well as ongoing international work by OECD and UNEP; ensure financial support, in particular tofor SMEs, for the development, commercialisation and uptake of safe and sustainable-by-design substances, materials, products and processes through Horizon Europe, cCohesion policy, the LIFE Programme and other relevant EU funding and investment instruments, as well as through public-private partnerships; an EU-wide safe and sustainable-by-design Support Network, to promote cooperation, and sharing of information, on substitution, in particular of Substances of Very High Concern as well as technical expertise and training on the evaluation and adoption of alternatives; promote public-private partnerships - together with the European Institute of Innovation and Technology (EIT) - to facilitate development and market uptake of safe and sustainable chemicals and alternative solutions, and to map skills mismatches and support the enhancing of adequate skills at all levels. 3.2.2. Achieving safe products and non-toxic material cycles A toxic-free environment is the pre-condition for a successful transition towards a clean circular economy where both primary and secondary materials and products are always safe. Avoiding substances of concern in materials and products is a necessary step towards achieveing non-toxic material cycles and to ensuringe a competitive market for secondary raw materials. The recently adopted Circular Economy Action Plan58 has shown that this 53 Safe and sustainable-by-design (SSBD) can be defined as a pre-market approach to chemicals that focuses on providing a function (or service), while avoiding volumes and chemical properties that may be harmful to human health or the environment, in particular groups of chemicals likely to be (eco) toxic, persistent, bio-accumulative or mobile Overall sustainability should be ensured by minimising the environmental footprint of chemicals in particular on climate change, resource use ecosystems and biodiversity from a lifecycle perspective 54 EU Biodiversity Strategy 2030, COM (2020) 380 final, and Farm to Fork Strategy, COM (2020) 381 final 55 In line with the Strategic Approach to Pharmaceuticals in the Environment, COM (2019)128, and related policy evaluations, in particular the findings of the Fitness Check of the EU Water Legislation, SWD (2019) 439, and of the Urban Waste Water Treatment Directive, SWD (2019) 700 56 In line with Review of REACH, COM (2018)0116, action 5 57 https://ec europa eu/info/publications/sustainable-finance-teg-taxonomy en (to be updated with link to adopted text) 58 COM (2020) 98 9 eoies:acaombidnaotionnoef.st1on tpest aa.sofpanudr shttperoedsdrmearseeandnsdstpirnbolce- | Hbiioenmggeuvaleto.twhieendfodmromawatniionbnyoocnhetmhiebceasrluolbyftsaancepsraefcyona5cn.edrsnFeoccrooncmdaaprnytmda,tIenrtieamlascnaaynrdpeprnroddIoentccshsoif TaCmopnernienrgswhheoTocaknmagameal sekievipeas sofevhaiscchiinnalctlorsnonnldetdeeofrdoesi1nof openoreoetoeThas stitteinrpyly worming for imports cen he C1Poamdpdairtoiomrn.iwfsherteanlyaepriao.dnudcwtgsibureeycbooemfveywtamestra.althoewTpsarmseTenhrceesoafirsosbsnaiadnopcnshopofetcaonnaseeoonbceaann oenateMamnayrcwia]ceyesandasyhbascroenctyam.iiftemcacnoy eassoacroesd.Ttomsurbesaonveaslosf | coa onceorniennprdodouctsbaatdrnecyeslehdomdataerpial oarricmninstdss.yAexdapritnceiplle,Hthowveanre tihne (| o omemoem ee eemt mmn--e?-- I T E r En E Tesp : | rsylemdematterldcormpearnedtosveinymasierL livjuioed L on thebwof 4 ieyele {gp pei| RetguelacthornyoaltctooiTaogdenidsnreCeesdetthoeisgsouboafne ldeignahcaB ynsdubwistthianencceeinssTehCdisoivsepamertpisceulttarflmyoniiemmsppnoorirttatasfvsnoetr r nEaip ce nasE fleatocoentam--inant--bot-- ro me-- rr itas--blSm onige e of m iocd liye perspec TheCommisiioln NONTOXIC NATERIAL CYTES 1] once pTroducTts, seoiquuggerehmietonhettsf1oarthcomosmieinnrgiosleeitshsaitpvreeepsnesnicsenfeeofcisooungbvsstueasnrscieinsale| DoEpeisaiigo.nscahwinlglaohoosde dpkhing.he hfigoh t.orcehsonfirescanodcICaTcoohnBstilsn, 5 Smga UmoEming CopmmoesmaepEAC ben etewes pe sf ot ke oy ghcoc csae EoTt ma ee EcE oE tMooT n8N. ree imSce RptpIcs TERedete cI t neEtY p Com rl eyNodeFeoeomart dre iyPbpe pu i i Sings | OtnEishl wreowlige smioiniiomhumtorfooreumcahathlieoognifeossrteaeqodnuihnegintntgosnhicihsemfioicriamilanitovineontoon 1 tveoinlPpo raodrosdut papas. suaeed it es Ciel Eero + cmaotrereialdstundaeurtRhoErAisCatHionaseaesncdeptdieornosgtatainadnsjusfiroimdsresections for rcyled + aiSpip.oert tveetnsttmevnstatseninSsaiitnnengo4antdvlersetetcohtnhsEcogociimpepeslrtehoftivnactahn.adnreecopofamrrietaecPhwsamsd vont cool proton I Tewoepea.nd .rey.Tebucycdledinogfounbv1tanocenss,emtateriwafsork oannd tphropdruocdtss ienclnudeingmthaeir| 323. eBoosetingnrsiliCnoceeaDndeEpU'spopetnsti atonomyforchemicalsin OC mveerritthe,pdastEndeE Scad,es, tsheiEeUhsaorE mcealcieTaunecearoendinshteismeheoamcrseee idvd---e -coLmi.riTrehnre OSVmIDTottsebssiehttheeimk epreodhbp y ceive ce onanhe aaafeabsyouosf RsmepdeoiineesotnoBvpaeaatrtsshyeaeeEureowpeoosrfudepoplnlifx4SEc58cUbnoea0meypr maap0gutpeerneetsdioaenaaLec. dsoys,FdQonulekyr "happy haotialnvlom,ceog0nropenert a ad Soat kinog.caoe fwlnles mechani to cee | eEnncnshaunrcilnoggetihsaetnvtheeeeEeU0daicsehsireedosvieluiettnhtettseoteasunppaplbyieldiyesrgupodtsionresnsoefhrcihenpmeipdcamlhse uEsxerdopienasnconGoernefiesnt eaecaolllogHgico,Eaps wL pel asv tnTeehiemygeisn.gtoah ahFtiesoan,ofmbaoxorl,oaen,nsgaideoonnr dmmeenldbecadifetogreisosvhearmanldel Te nE vonrtaalmifer oofnnordnoeda utcJo2nadEdtUtpkrs obmeartitsondpsroocselhse ses.onCstohasniodenms nrieietorne eig alse sndvernan lsti RESILIENCE AND EU OFEN STRATEGIC AUTONONY TheCommision + IdentKeEy vuTedcheaiin"s nd CthcehmniscoaglisesPwahtero sto.vevnasEeU d5 ssablle dialogue between the Commission and the industry producing, importing and using chemicals to strengthen the resilience and promote the EU's open strategic autonomy of chemicals used in essential applications and the uptake of safe and sustainable innovations; launch a broad alliance to promote the resilience of supply and the open strategic autonomy for basic chemicals essential for medicines, to complement and support the objectives of the upcoming EU Pharmaceuticals Strategy; promote inter-regional collaboration along sustainable chemicals value chains, through smart specialisation, to accelerate the development of joint investment projects; foster inter-sectoral symbiosis and mobilise EU funding and investment mechanisms - cohesion policy funds, Just Transition Mechanism, InvestEU, Strategic Investment Facility, ReactEU, Horizon Europe - to promote the resilience of supply and sustainability in Europe of chemicals used in essential applications for society. Thoese will support65, in particular, the production of health applications and of technologies critical tofor achieveing climate neutrality, clean and safe material circularity, and zero pollution. 3.2.4. Recover and contribute to the green and smart industrial transition The consequences of the COVID-19 crisis on the EU industry producing and using chemicals vary depending on their economic focus. Companies that are supplying food, healthcare, plastic packaging, medical equipment, disinfectants and active pharmaceutical ingredients had to increase their production capacity to respond to the increase in demand. Other chemical companies, e.g. those supplying the construction sector, had to reduce or even stop their production because of the decrease in demand from manufacturing or retailers. The new recovery instruments together with the reinforced long-term EU budget represent a major opportunity not only to repair the damages suffered during the crisis but also to bounce fast-forward the industrial transition. The Commission invites the Member States and all the interested actors to seize the opportunities offered by those financial instruments to help the recovery of the EU's economy and society while accelerating the green and smart transition of the industry producing and using chemicals. Chemical production is one of the most polluting, energy and resource intensive sectors,66 and is closely integrated with other energy intensive sectors and processes. Although the environmental and carbon footprints of the EU chemicals industry have been reduced over time, the green and digital transition still requires significant investments for the sector. Energy efficiency must be prioritised in accordance with the ambition of the European Green Deal and for the sustainability of energy sources, fuels such as renewable hydrogen and sustainably produced biomethane could play a decisive role.67. The EU needs novel industrial processes and cleaner technologies not only to reduce the environmental footprint of the EU industry producing and using chemicals, but also to reduce costs, improve market readiness and create new markets. Digital technologies, such as the internet of things, big 65 Subject to compliance with State aid rules when they apply 66 In 2017, the EU chemicals industry was the 2nd largest emitter of PM10 emissions Chemical production was also responsible for the largest share of industrial releases to water (51%), EEA, Industrial pollution in Europe 67The hydrogen strategy underlines the need for demand-side support measures, and for an uptake of renewable hydrogen in specific end-use sectors such as the chemical sector. Such quotas or minimum shares could also be considered for other renewable fuels such as biomethane. Reference when adopted 12 data, artificial intelligence, smart sensors and robotics, greening manufacturing processes. also play an important role in Beyond the role played by technology, innovations in business models can be an important driver for the green transition of the industry producing and using chemicals. Opportunities to shift traditional chemical production and use of chemicals as a product to chemicals as a service68 should be explored and promoted. Theose could optimise the use of expertise and ensure resource efficiency during the entire lifecycle, as well as encourage place-based innovation and the involvement of SMEs. GREEN AND SMART TRANSITION Through its financial and investment instruments - in particular the cohesion policy funds, the Just Transition Mechanism, InvestEU, Strategic Investment Facility, React-EU, Horizon Europe, Digital Europe Programme - the Commission will: promote the re-skilling and upskilling of the workforce involved in the production and use of chemicals for it to acquire the digital skills, and knowledge and skills necessary to design and use safe and sustainable chemicals; facilitate access to risk finance and investments in R&D, in particular for SMEs and start-ups; promote the development of green and smart technologies and innovative business models - e.g. chemicals as a service - to enable the transition towards low-carbon and low environmental impact manufacturing processes of the chemical sector and its value chain, including by increasing its energy efficiency, the use, and transport and storage capacity of renewable energy and CO2, and by bringing sustainable solutions across sectors. 3.3. Simplification for a coherent legal framework on chemicals The EU regulatory framework for hazard and risk assessment, and management of chemicals is comprehensive and complex at the same time. Overall, the EU chemicals legislation delivered results as intended and is fit-for-purpose. However, a number of important weaknesses were identified to be holding the EU chemicals legislation back from delivering its full potential.69 If not rapidly addressed, the framework will struggle to timely and efficiently cope with the current and future production chemicals. The complexity of the legal framework represents a specific challenge for authorities and stakeholders, and can lead to inconsistencies, slow procedures, inefficient use of resources and unnecessary burdens. A key ambition of this strategy is to ensure simplification of this framework, which will in turn result in burden reduction for all actors, more consistent and faster decision-making and greater predictability. Therefore, the Commission will initiate a transparent process to simplify the way chemical risk assessment and management is done across EU legislation, and to gradually movinge away from assessing and regulating substance-by-substance into regulating them by groups, This will be complemented with stepped-up action to promote full implementation, compliance and enforcement of the EU rules on chemicals. 68 `Chemicals as a service' includes chemicals leasing (e g if the function of a chemical is to clean or protect a surface, a company will be paid depending on the number of pieces cleaned or the extent of area coated), but also the leasing of services such as logistics, development of specific chemical processes and application, and waste management 69 COM (/2019)/264 final 13 3.3.1. One substance, one assessment Chemical safety assessments include assessments of hazards and environmental fate, of exposures from uses and of the resulting risks to human health and the environment. Such assessments are being initiated under various pieces of legislation, by various actors and at different points in time and they are performed by various EU agencies70, scientific committees71, expert groups or Commission services. Thoese assessments use various methodologies and data, which vary in terms availability, accessibility, quality and formats. In addition, different transparency rules and practices are applied to the way assessments are initiated and performed and to how data are used for the assessments. These variabilities may lead to situations where risks are not assessed for all relevant uses, to overlaps or to incoherent outcomes. Also, available resources and expertise are not fully optimised, and overall, the general public and stakeholders struggle to keep track of those regulatory processes. All actors - including citizens, industries and authorities at all levels - would strongly benefit from moving towards a process that increases the efficiency, coherence, transparency, predictability and scientific quality of chemical safety assessments across the various pieces of legislation and, at the same time, ensures timely, effective and consistent protection of consumers and the environment. The Commission will initiate a `one substance, one assessment' process, which will plans to establish a step-wise approach to ensuringe that the initiation and priority setting of the safety assessments is coordinated and, to the extent possible, synchronised, that responsibilities are clear, that available expertise and resources are optimally used and that there is good cooperation among all actors. In addition, access to all available data will be ensured without technical or administrative obstacles, and safety assessments should guarantee full transparency and the possibility to provide input by all interested parties in line with the relevant international commitments be based on coherent and, to the extent possible, harmonised methodologies. ONE SUBSTANCE, ONE ASSESSMENT The Commission will: an EU mechanism for better coordination, prioritisation and increased transparency of safety assessment work by expanding the (Public) Activities Coordination Tool72 to other pieces of legislation and by developing an associated governance structure leading to improved coordination, cost saving and enhanced predictability of authorities' interventions. review the attribution of technical and scientific work on chemicals performed under the relevant pieces of legislation and propose re-attribution to make the best use of expertise and resources in European Agencies. In particular, as a first step, the Commission will consider the reattribution of the work of SCHEER73 and the SCCS74 to ECHA75; 70 The European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the European Medicines Agency (EMA) and the European Environment Agency (EEA) 71 Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), Scientific Committee on Consumer Safety (SCCS) 72 The Public Activities Coordination Tool is a successful mechanism in place to provide an overview of the substancespecific activities by authorities under REACH and CLP Regulation 73 Scientific Committee on Health, Environmental and Emerging Risks 74 Scientific Committee on Consumer Safety 14 : Chemie Aftnc+y parnodptoe]sutosssniranbgythoenifthBensngcoivnegrnmaondceel of the Enropean + B propose amendments to he CLP Regulation ogi the Commi3msaindotento {EN S-- | SWEtCodHeveAlop harmonised shocton ovis iconvierontmheendtealveelsiotphmbeoanfstedceHnitrtalviasleudesu.d2caurarotfedthEeUworrekproitocroymomfouniompaenn adantds | ffosot raeo"nccxhpemoincraels.veo.sechvienngheforhtahremopnriostaetctiioonnosnfduclonhreraebnlceeogfroauppp.raTshcehsees ales, derived o validated by relevant mk ascent experts wii the EU a"eagaugleiorrsyafnreamsewhorrks, sshnouelxdplbiecitavssleabnleifoesns enoamon1g EU risk assessors and | + EcMoA aundabwEoErAlk)ihtnogsrgcogtrhoefnCocooomrmudiinsaitpioonn aSceerovsictehseadufdcAegenncpiiecss(oEFfSAg, iECoHnA | inndclutdoinvgewroske osnudthpordolmoogtitehse uprnocdesis f5oswaardt`neprstb,osfanhce,sopneraescent TI3 AsipleandacnecoachTomanage DheepeEnUdiarngkonenthebansaetduroenoefthme eBarzasaonndoifdhoe sexrpoasumressp,eicskimoaknasgeemaemntenm,esIen msosat cies. theEU chemicals egnlation sc combination ofbo ofthes spproschen Gtoenemriacgsepprothsechersktso ifsrkommancaagrceimneongetn"s.vemcaugreatnlsy sauncdessrfeuplrloytaopxpclaitc. siEtUholuegghislsaotimoen | roicnoghesruecnigebaeensilel pirnefscet soosf slimepgliifoinca.tiTonh,--fsucsaeprpraocatcihoens ohadvegesneriahllyhpermoivceatnso picrso)vionngthcelayrpe sogfaahbaszatrodosuls ascbtiorasns(easfofroebcennatvssduehdiaennd,avnudruisngypareddicdtoabwislittcyaosf p Re reety entDa LE no "TP EERI rcceI rembI ps Co KkAtechore1tr meaa,Sopproecsadnto2setbtmmsSiFeesssh1SladFgaotb0 | e o oee onefte poe re,Fd oe e k patexeetT .dofero toerimr) s.eSsAt1Ft0 ESrnaEoRhemi ps er of oh ci boBe JSrk management pA rocesseAs. FhPsO-P shauD d-harA or-1bsnhl-dshisndsobds Cotsen pasicla to enure protection from substances with exitcl rand pSxrpoonpueerits oifceosncen.t13bwellpaa0iprlotecmt svuldnereablseogsreoqwpu:ncascs.dsuwchho sssehcldo,n | CRpa0rs1eahtrpowpwooemrsed nlaengcdacwyyhporsoepbelrieocmkpslcaas ntbhneooby twneoawpfcxrtivsalfyoyccoc roals cehd0it SSeulcmhv ainadmssbpwepitrohsscpcrhroctenoct Senincomptes and endengerd pases. TpheunREyACaHcoaunthovar.iscathioenmiandriresstrwiocrtlidownidsey,steNmevbaasthpltsht.hethEoUseatptrheofcrcoenssof | siumbpslteamnetinatlataidomniniosftrtahteiveREbAuCrdHe.n afwobrhoaruitshaoiroint.iessaynmd.fordeisnpdiutsetyo.s Msourcccoevsesr,inthieggceurmienngt | shuibchsctriewtstuoutanvicotoiandinltatieorsrbeoguhlaotoryrcosnsoesquhernciesn,ehsasAldTtodelaaysiPnroegvul.atory decisions. SIVFALNDIFAFSTIERED RIKNANAGENENT | The CommisionwilSE N + snimtplibfytimn aancdssweielnhgethekniidhedmearsougraersiteosparezveontttesraiskslsosgocaintdowsit8hftohte| I Srteopnextsenedsathe lusgeohiftgoenneritco apaprosaches oomrisk amanpageemen:t hereWs0E0roprYin I fmreoapordocntoetxynicdtaym,iaiedsndioomcrninee ditsrupetors,wePtBeTsSeEryan,d pvPavtBs:BRES|T arta soeceon)d satnedp | + oeecsewaarsy:dteoCcLaPeeetheey afdoeequeulypsltow efaornndthseicehnoirYheni,,onsofd sheesdubtthascees + Siutchaghtheenh.a.zaprrdoptercotipoenro;f workers agaist hrf chemicals by extending, fn + rREeAiCtHi,ntghe paroptercotipoon ftlordsxeidcntdactheoTony sSafuetytompDirroeefcetsrisvieosntalowoartkoersi:nclude Sainldoorns haercpoa a. Soe omisaany or sh. ronetion of Shien fom + ofontihmepblaemienft thhe dcoenceiptninfdeifsfesreent]psiecsesntofheleMgoisnleatliPornotioncopl,arvccaedherr BEACH muboruaion tod ricer' peecnes to" secu mad spume | BETm aEe -- eneeLm -- ie -- B E Ee e tceeGgeeThat aoad mesmtt o e iEsee Voecmon coSooerEsL.T omSm oTeeSae TrcmmmcS imgrp pconnsfoocoeoeede pot mece I -- -- I | + rTraedefioncgrsamfstotmhoefiiRpEcAmtCaanHalgaemumtpehlnoetrimeseantcitoanoonanonandcSrhehistnergiictlioncrpreocesssels bSaosneddioonnskfeoyr EU sd nonEU ocr fo hemi mais lcod EU met I 0 chem2i00,maH e nd produc ot vecE plo a Sn hes. ego, | eEurroepean mAackes act tl Lope is ic Ela-tion1 SaO msieU no 3t0L % Fireson npn OBS LL Tah dt10chemo', adshes | e5v0i%soifonthdososprhoduocftsthcosmehferoem uoubtsstidaenstshereEpiUs.trsEdqubayllys. oyaly twwaodstRinEdAoCfH trhee SC`cuoolmrppcliahamnetntwitohafltihacsehermaeiqcuailrnseid liiennfgorimoatnnionwnreequairlementss.e"clSetdepplinog uvp implcemlenctaitiooin ianed A TPE ot ke heat, 2 wa for theTol ser ce aonmpddhios npceo for iiTmompeoprllteveeedlmoefancroitoemafsphtleionaoanwcnd oRofnelgionpedlti,aoenswiMitorkeexpnrtiesSnengtiancgesva.seapnsaadr,Ciocmfnnup.alriaheneccyheaelopefnePgeer..odwuTichte hhexEUasn cpanoalrbotnd1oi Sano8 ,willesfaibitabnhcewid so1ahpestiognleektmte maandke | MSuorrveeoivlelra,nceshanodpecnusitnogmsCoumbmourintiiccnsi,onanodnaCsotnensgthpenecdsrtokemfaonsaagneomuennctt mferasmeowsork0 |`bripnrgttehetEEUUCcusatnomssaUmndiohnetoEtUh gle rk. e next levelso thatAcutstoonms]autmhiorsiteiess awrielbleattoer qousipptped 1 hTplavcoeebbykyMtchaeeonmCeoonrmaamtiSistosniswoniattrohesntresongtathbeenetnpheioerfnfnoosrcCdehmeeEontUofmrRaEpipAdCoHrlaatteithoenmSEU'sReAbEoRrnderst", 2R0AdPtEhSeeannvdiRonAmeFnFt faromochcemicnalscin preoiducctnsiloanceodfohn tpeiEUrkkesrfo. man bath h1eadEUd.ind.ueetnfootrecehmentrof tcheapchaecmiicaalds erlestuosn isoatneaquaelleylfeTchtisivceathernodug1h0o4u0t {ocean ppieaion 1the EU lov with amy save Conse nce on the oe E EicehCA cEeceT ope,aKE EcEtNsreR atd pS eethetpsi dsr EEyt EepreeRscoS8s3e yteoCoe oF0eeoffeo oek Apend a ns r The ws SaneABeomostd geweohoememenls BCtAadeeceuesCsaossemsom.eBae Pmt 1Cto t pes ve ot ES comes 3 lsPi on reeo ncept os i ispet et Scns -- gras of gots wit i. 5, rp eb i i, nig 0 | differnt levele s ofi proe tection eoS sf EmU citeize ens. oMteSmotbpererapSta attets mehustlti0ncir7epatSseEtthei2r eeN topa ed? Btr a m i sotto eeA to chemicals A good example is the Environmental Compliance and Governance De L SI y TheupcomingZeroPollution Action Planwillinitiatefutherspecificactionsfo sonrl_- ction sp legislation. or spewmisse bskw a ire iesnBpotogimveer 0 tie figsoa | ofthe collective in ERG TOL terestsofconsumer*s- ETORWONACONNFLCIAECE | he Conmicion SENN +I ceos orf compliesm by somd a apeson, divegh fraepwoe 0 1 a REACH, in particular. by requiring complianceofall registration ans dossiers and | . a rBeOmnanr t eetofip e nn, oa eeREAnCH Tr I possibility for the Commission to carry out audits in Member i ra nn r A t m eg Eo TEERn EEa Set pnee3e e EEe Eea S tu I iofceea epin DoveE 005 CEtOEVAEIENEfYorETaii TvE. e  the coordination and investigation mandate of the European Anti-Fraud Office (`OLAF'), to also include the circulation of illicit chemical products internally in the EU.100. Enabling complementary actions on chemicals, while ensuring a harmonised EU- wide response and coordinated exchange of information based on all relevant Commission IT platforms; access to justice on behalf of environmental and consumer interests, including through an amendment to the Aarhus Regulation.101. 3.4. Provide a comprehensive and transparent knowledge base on chemicals The sound management of chemicals in Europe depends on the ability of the EU and its Member States to make their decisions based on robust and relevant, up-to-date knowledge. The EU has, over time, developed world-class knowledge on chemicals' properties and risks, also thanks to the work carried out by its scientific bodies, and this knowledge base has been widely used also in other parts of the world. StillNevertheless, there is much knowledge to be acquired by authorities on the intrinsic properties of a vast majority of chemicals, including polymers and chemicals that are not manufactured in high volumes. Equally, knowledge on uses is fragmented, in particular as it relies on industry's willingness to provide accurate hazard and exposure information. The sheer number of chemicals on the market represents an immense knowledge challenge, and the expected future rise in chemical production and use risks further widening the 'unknown territory of chemical risks'. Figure 2 The unknown territory of chemical risks, EEA102 3.4.1. Improved access, availability and sharing of chemical data for citizens, authorities and industries 100 Drawing inspiration from the rules on mutual administrative assistance in customs matters 101 Regulation (EC) No 1367/2006 102 EEA, The European Environment - State and outlook report, 2020, p 239 19 A comprehensive information base on all substances placed on the market is still missing in the EU, and this hinders the proper management of chemicals and products. In particular, polymers, which are the fundamental building blocks of plastics, are not subject to registration under REACH. As a general rule, only available information is required for substances in the lowest tonnages, while there are limited requirements to identify substances with critical hazard properties for the medium tonnage substances.103. Strengthening information requirements on the carcinogenicity of substances and on other critical hazards at all production levels plays a fundamental role to in succeeding in the fight against illnesses such as cancer, as it would allow for better and faster identification of substances that may cause them.104. In addition, the efficiency and effectiveness of the evaluation procedures, implemented by ECHA, its Committees, the Member States and the Commission, need to be improved.105. DATA REQUIREMENTS The Commission will : makeing a proposal to extend the duty of registration under REACH also to certain polymers of concern; proposeing to amending REACH data requirements to enable an effective identification of substances with critical hazard properties, drawing from advancements in innovative tools, and being mindful of the aim to move away from dependency on animal data; proposinge to amending REACH data requirements to allow for the identification of all carcinogenic substances manufactured or imported into the EU; stepping up measures to track harmful chemicals through the lifecycle of materials and products106, including the waste phase, and to make this information available to value chain actors and, upon request, consumers. These tracking systems will build upon current efforts107 and be developed in synergy with the future Digital Product Passports108, taking into account the ongoing work on supply chain communication for substances and mixtures.109. Past evaluation identified shortcomings in interoperability, discoverability and accessibility of good-quality and reliable chemical data. Interested parties are sometimes not aware of what information is available and where and how the existing data can be used and accessed, and re-use rights are sometimes too restrictive. Peer-reviewed studies are not easily available and discoverable and as a consequence they are not fully exploited in the regulatory work. There is a need to better implement the EU Data Strategy principles for chemical data, to ensure that data are created and reported once and used many times, and that data and information are shared and re-used as widely as possible, also in line with the `one substance, one assessment' process. Digital technologies offer the potential to improve the access and re-use for data, in particular, for authorities and industry. Building on the 103 Accompanying SWD on Art 138 of REACH 104 Review of REACH, COM (2018) 0116 105 Ibid. 106 In line with the Circular Economy Action Plan, COM (2020) 98, and the REACH review, Action 4, COM (2018)0116 107 Notably, ECHA's SCIP database 108 COM (2020)66 109 Review of REACH review, COM (2018)0116, Action 3 20 important steps in terms of transparency put in place in the EU food safety sector110, it is also urgent to strengthen trust in the scientific underpinning of the overall EU decision-making process for chemicals risk management. ACCESS AND SHARING OF DATA The Commission will as part of the European Green Deal Data Space111, developing a common open data platform on chemicals to facilitate sharing, access and re-use of all information on chemicals coming from regulatory and non-regulatory sources, including from the private sector and civil society organisations. makinge a legislative proposal, where relevant and necessary, to remove legislative obstacles for re-use of data and to streamline the flow of chemical data among agencies, commission services and national authorities; developing a new tool for making all relevant academic data easily and readily accessible for the assessment and decision-making processes; consider establishing a new tool to enable the Commission, EU agencies and national authorities to generate hazard and occurrence data when further information is considered necessary, building on existing practices112; makeing a legislative proposal to extend the principle of open data and the relevant transparency principles from the EU food safety sector to other pieces of chemical legislation. Data will be progressively made available in appropriate formats to ensure interoperability. IUCLID113 and OECD Harmonised Templates will be promoted and progressively used as the principal format and tool to share chemical hazard and use data and classifications, while IPCHEM114 will be used for sharing chemical occurrence data. The aim is to have Tthoese efforts will feed into, and be complemented by, a comprehensive system of indicators to monitor the drivers and impacts of chemical pollution as part of a wider Zero Pollution Monitoring and Outlook framework as well as to measure the effectiveness of chemicals legislation, through the implementation of the upcoming 8th Environment Action Programme and the Environment Implementation Review.115. 3.4.2. A strengthened chemical science-policy interface Several efforts have been put in place to improve the scientific understanding of the impacts of chemicals on health and the environment. Monitoring the presence of 110 In particular in terms of mandatory notification of commissioned studies as well as in terms of the obligation to proactively make publically accessible all scientific data and information; on the transparency and sustainability of the EU risk assessment in the food chain 111 Announced under the EU data strategy 112 Such as the REACH substances evaluation, the watch lists under the water framework and the ground water directives, Land Use and Coverage Area frame Survey, HBM4EU, the European Partnership for Risk Assessment 113 ECHA, IUCLID 114 European Commission, IPCHEM 115 European Commission, Environment Implementation Review. 21 chemicals in humans and ecosystems is particularly key to improve the understanding of their impact, and should be further promoted, including to understand the links between chemicals and gender.116 . Building on acquired experience and knowledge, the Commission will continue to support research to understand and prevent chemicals-related risks and drive innovation in chemical risk assessment to protect citizens and the environment through its future framework programme for research and innovation, and the newly established EU4Health programme. Despite a strong EU policy for the protection of animals used for scientific purposes, adopted ten years ago, which makes full replacement of animal testing its ultimate goal, animals are still required to be used systematically in the field of chemicals.117 In 2017, over 230 .000 animal uses were carried out in the EU for satisfying requirements under chemicals legislation.118 Safety testing and chemical risk assessment need to innovate in order to reduce dependency on animal testing, but also to be able to face persistent and emerging challenges, and to overall improve overall the quality, efficiency and speed of chemical hazard and risk assessments on humans (with a focus on specific population groups), ecosystems and biodiversity. KNOWLEDGE NEEDS The Commission will : establishing a long term research and innovation agenda for chemicals under Horizon Europe, with significant funding, driven by a EU-level Coordination Group [placeholder to insert name for the Group, e.g. from a famous woman chemist] that will involve EU and mMember sStates' representatives, and liaise with relevant stakeholders. The group will regularly identify and define how to address knowledge gaps jointly at EU-level and promote the regulatory uptake of research findings, including how best to foster new approaches to reduce animal testing; supporting multidisciplinary research as well as digital transformations in order to provide advanced tools, methods and models, new data and data analysis capacities119 to move away from animal testing. Better science-policy interfaces and reinforced skills would also help to promote their regulatory recognition and uptake; supporting the development of EU-wide human and environmental (bio)monitoring capacities with harmonised governance, collection and storage (biobanks), to feed into and complement existing and future ecosystem monitoring initiatives120, and their use to support early regulatory action in response to scientific evidence; developing an EU Early Warning and Action System for chemicals, building on and in connection with ongoing initiatives121, to ensure that EU policies address emerging chemical risks as soon as they are identified through monitoring and 116 While policymakers begin to understand the role played by the sound management of chemicals in economic and social development, it is also important to recognize the significant linkages between gender and chemicals, but gender specific data on the exposure to and impact of chemicals is still largely missing UNDP, Chemicals and Gender, 2015 117 Directive 2010/63/EU 118 SWD/2020/10 final 119 E g predictive toxicology or virtual human platforms 120 E g monitoring initiatives under EU environment legislation and monitoring schemes such as LUCAS, EMBAL, the upcoming EU Soil Observatory and the EU pollinator monitoring 121 Such as the RAPEX safety gate 22 research initiatives. 3.5. The EU setting the example and leading policies for the sound chemicals management globally The Global Chemicals Outlook122 has highlighted how production, use and trade of chemicals are growing in all regions, driven by global megatrends. The size of the global chemical industry exceeded EUR 4 trillion euros in 2017 and is projected to double by 2030.123. Chemical-intensive sectors (e.g. construction, agriculture, electronics) are growing, raising the demand for chemicals and creating both risks and opportunities. Chemical pollution has been identified as a significant and "almost certainly underestimated" contributor to the global burden of disease124, threatening the right to life and, in particular, the right to a life with dignity, notably for children.125. A UN report highlights that exposure to hazardous substances is the single largest source of premature death in the world, causing and contributing to a silent pandemic of diseases and disabilities126, with strongest impacts happening in low and middle-income countries.127. The benefits of actions to minimise adverse impacts have been estimated in the high tens of billions of euros annually.128. The sound management of chemicals and waste has been recognised as an essential crosscutting element to implement the 2030 Agenda and meet the Sustainable Development Goals (SDGs). Although much has been done at all levels and many international instruments are in place, it is widely acknowledged that the global commitment to reach the sound management of chemicals and waste by 2020129 will not be met.130. A real sense of urgency is needed. Progress remains slow and insufficient and enhanced efforts at multilateral, regional and national levels are required to meet the 2020 goal without further delay. Governments, international and regional organisations, the industry, consumers and civil society, scientists, and academia and all other relevant stakeholders need to significantly step up their efforts to ensure the sound management of chemicals throughout their lifecycle. The European Union can and has to play a leading role globally, in particular, to champion the strengthening of international standards, to promote the highest standards for chemicals management in the multilateral arena, and to cooperate with third countries by sharing knowledge, data and experience 3.5.1. Strengthening international standards on chemicals management A wide diversity of international, regional and national instruments, and responses associated with the sound management of chemicals and waste are already in place. However, the global 122 UNEP, Global Chemicals Outlook II, 2019 123 Ibid. 124 The Lancet Commission on health and pollution, 2017 125 Human Rights Committee, general comment No 36 on the right to life, 2018 126 Report of the Special Rapporteur on the implications for human rights of the environmentally sound management and disposal of hazardous substances and wastes, A/74/480, 2019 127 UNEP, Global Chemicals Outlook II, 2019 128 Ibid. 129 Target 12 4 of the Sustainable Development Goals, 2030 Agenda for Sustainable Development: `By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment' 130 UNEP, Global Chemicals Outlook II, 2019 23 J agcorrosesrcuoaucreiucs.iTehtsefxraegimnedntiaptiroonghiabseuhaemdpesriedtphaeovdersal 2idmpascottgoldafefefevctrisvenweisseohfy eCxiostuinngsorghaandisnaottioinm,pplreomgernatmedmetshaendGlonbiatlaliyveHsa.rAmsoonfize20d15,SyfsoiremexoafmpCllea.smiobreeatihoann a1n2d0 LabellingofChemicals s"TohuendEmUawnialglesmoenntt ofctoheJmaicdaflosnatnds twoawsatr.dswahnicahbaididornesssieesrtahaeicounmeanltffarprseamttefioorrntbhkey foostrergingacnohiearsnednwtinaisniorducnmoemnsptlemebnytgaorvycpromleicnetssaannddbyatlilosniabkyshoalldreesl,eivnacnlutdfinrgmdautstoyn.l `tAoacTusnctoetriuaaltcohnmaelntChsemoicraelssch Mmaunlaigelmternltag(SrAeICeVDo.n troenfuelwlyedaSdtdrraetesgsictAhpeprsooaucnhd mmcaraneaangdoehfmicheewmainsctatlsphthar.ouIgnhaodudtithioen.rteheeyEcUl.e.toigentchherinwgihhetrsuMceamlbien rprSotdautcet, 1wnildl Hiafdevcoyceatleeitnotmahiensp1trreamothgesorundamamnagmemeoefntsaolfcrheelemviacnatlisnemuadtwioanasl otrhgraoautghioountst.hiinr pMoratnala.tghoepfarCmihseeinpsnaitaitnlo(rgiIatiSOouncMhomfatiOhnesntre)era.m.OirnggawniizlaltipornomPortoegcraommbefeorotfehpSlnioccuineeds andactions derthe2030 Agenda for Sustiable Development INTERNATIONAL LEADERSHIP | The Eu wilBE SSotuernpuodimmieanun,pa1ig0tesmmeieennttteorhafteicgohoneaslmliacadanvlodsca(tcahyrrgioetnnsgohvfoatrnithoteuhse2fl0or3r0lAaisgcyencndldeta,hrrieongcualgurhddivinangrgifothuhsee + pE romotionof rit striinze for the adoption ofglobal -- Swthreartee-- rgeilcevOab-- njtecEtiU-- ve"saannd-- daTra,r-- getssuifdodrintcth| |Tuk191pte eocmonsis 1 Sound management of chemicals and waste beyond 2020, to reflect lifecycle| |Sages Toe dot emt I aSphporukodacbheecsnfdoorrcshcedmbicyalasn,drienfclleucdtiendgiwnithhethperpoogsrta-m2m0e20s boifoadliverreslietvyanttargientst.enTthioosnsael o3r0g30miAsgaentdoan:to support the schihementofth respecive goss nd trl of the I + spTnradboemcloltienosgo;fmthCehemwmsietcuoaolafspnte(hseGtioGHrlo,Swbc)aolrlktayeherHsasatnrnmdsoSinfoiozonedeunnsSiy:fstceimoonfofClacshseimfiiccaaltiaonzaanrd I + hasnatdzraernmdgobtcihleinty.a.thfseonsrUdPNBsGTteueHpvSPbuyspByast,huebemmisptritortiiencagtliaosno.pvroifpeootsmaelnhdtaoozcaririndntoeruodsdiumccpheteonmreiscw,aclprseirtsteirhsirtaoeoungcrhy RintoerntaticonaanrldMidinnsatumruammteantCsonvinentfiheon:area of chemical, nobly he Sockboln, + pSersoesmsometnet totohles idnetverenlaotpimoneanltly.ofnocbolymmwoinisttahendOaErdCsD,aannddpriommpootvaettvheiersiek drelet.erby toalSadptinamethvorUkN fGHocShrifttraviaytfosoimevraanseisv maerthyosdsa; l sing. E[rErOeRWp DL,-- I:r MadBk ECD,SICHME I + trackiu and assessingprogresswad:by the EU anditspartnersinrelationfo cEE EEoEpEr r Lha StHrT b a br | ihe BU chemical ndoviry fnexpectedtodink 1about 10.7% 15 Muchofthe cxpected ne Fo. = 3 yr OB, RQ 66 ten | ine. Pecadoinwordchemical, 0172030EopeanChemical sy FfaT S SB iAiSS peeimrEerLE lteBrEH Teetednr a eti S tnneolH :yh tV rteSbadpS n"TdTSnnL rS S TIot h be eahtoeant countries, but also. oE r kiaE e d Ee eme w we ee ulationamongst the benefit ofrsmcimpreocaelcixc--hasngee eepimmee--doetfe OECD and otherrelevantcountries.Thisiskeytoavoid; duplication - |CommentedIA34]:Is issomethingforeseen?Wouldit REI OES Jsvt To 0 il sh sts soporte conf.ttheyinp esaof | tp he Soundd mangement pis of crhemiceals snd wate. stplished vader fo UN. Eisonment em nat COOPERATIONWITH HRD COTTRIES he vitTE hySNp TagMS A Saigse,ilne,sd11. mg n] Ts il ble TE compen ih Af neis heECdbesnBSreass r E Emr T meen itoe mo as Mali | Eo anrepo e ss 1 1] Se naeet raitt LoIL purripoitaelhbeimnest 1the mor i TiCeogpnvnmetgp voi1.,eSti tsyl ge fgets A a Er ene coi me nsmlooifnedmBeonmo pE ri otectioe nfformomnhaazearsdous chlemim calsdndt 1e ppreomsosE tho e EU y industrySmo aggleobalfionhea aensin Te eyee deE mos oe oonehenbenrsori ps -- "I C mr ae a t pest |o08ve maha an) The Commission invites the European Parliament and the Council to endorse this strategy and to contribute to its implementation. The Commission will reach out to citizens and stakeholders in a coordinated way to encourage them to actively participate. The Commission will ensure that this strategy is implemented in close coherence with the other elements of the Green Deal, in particular the EU Biodiversity Strategy for 2030, the new Circular Economy Action Plan, the Climate Law, the Farm to Fork Strategy, and the Zero Pollution Action Plan, as well as with the Industrial Strategy, the Digital Agenda, the Pharmaceuticals Strategy and the Europe's Beating Cancer Plan, and in line with its international obligations. The measures presented in this strategy will all need to be taken forward in line with the better regulation principles, including evaluations and impact assessments as appropriate, and will need to live up to the green oath of: `do no harm'. 27