REACH: registration, evaluation & risk management update

Transcription

1 REACH: registratin, evaluatin & risk management update The Latest Trends in the EU Chemicals Management: REACH, CLP & BPR Petteri Mäkelä

2 Outline Eurpean Chemicals Agency Registratin Supply chain cmmunicatin Risk Management Authrisatin Restrictins Substances in articles PUBLIC 2

3 ECHA six years ld and grwing Started n 1 June 2007 Over 500 staff frm 27 cuntries Originally REACH Since 2009 Classificatin and Labelling Nw als Bicides and Imprt & Exprt Regulatin PUBLIC 3

4 Our missin Driving frce in implementing EU s chemicals legislatin fr the benefit f human health and the envirnment as well as cmpetitiveness and innvatin Help cmpanies t cmply Advance the safe use f chemicals Prvide infrmatin n chemicals Address substances f cncern PUBLIC 4

5 ECHA s internatinal activities Cllabratin n harmnising chemical management tls and appraches beneficial fr authrities and industry OECD-related wrk: e.g. IUCLID, QSAR tlbx, echemprtal Cperatin with peer regulatry authrities: Australia, Canada, Japan & the USA Supprt t Eurpean Cmmissin multilateral wrk e.g. UN Cnventins Awareness raising n requirements and hw t cmply in 3 rd cuntries Supprt t EU candidate cuntries Presentatins t authrities & industry in third cuntries PUBLIC 5

6 REACH What it s all abut Cmpanies t prve safe use f chemicals by Registratin Authrities t Evaluate registratins t ensure cmpliance Risk Management f mst hazardus substances thrugh Authrisatin that prmtes substitutin and prhibitin f risky uses thrugh Restrictins Safety, Cmpetitiveness & Innvatin PUBLIC 6

7 What t register Registratin nly cncern Substances nt preparatins and articles Substances ver 1 tn/year By EU manufacturers r imprters Nn-EU manufacturers can nminate an Only Representative PUBLIC 7

8 REACH Registratin deadlines Late pre-registratin registratin until 31 May 2017 New entrant registratin prir manufacture r imprt PUBLIC 8

9 Substance Identity Unambiguus identificatin is a prerequisite t mst f the REACH prcesses Cmpanies must have sufficient infrmatin n the identity f their substance Crrect identificatin enables: Sharing f infrmatin Assessment f the applicability f test data, read-acrss prpsals PUBLIC 9

10 SIEF agreement (1/2) REACH legal requirements Cperatin & cmmunicatin in the SIEF Data sharing (Ownership f data) Cst cmpensatin (Agreement n cst sharing) Jint submissin (except pt-ut claim) (Liability) Varying number f SIEF participants All SIEF participants nt familiar with REACH requirements > uncertainty SIEF Operating rules are strngly recmmended PUBLIC 10

11 Data sharing ECHA has a limited remit regarding data sharing Assists registrants invlved in disputes Prmtes best practice 2010/13 findings Data sharing prvisins presented sme challenges Arund 80% f the registratins submitted jintly The cmplexity f substance identificatin PUBLIC 11

12 Registratin milestnes 2010 ~ Dssiers ~ Substances Deadline 2010 Deadline Dssiers Substances 7/09 1/10 8/10 2/11 9/11 4/12 10/12 5/13 11/13 6/14 12/14 11/2010 5/2013 PUBLIC 12

13 Registratin dssiers verview Received Frecast Grand ttal ~9 300 Registratin type Standard registratins (all uses) Registratins fr intermediate uses nly Intermediate use: limited data requirements Specific cnditins Critical t ensure safe use Verificatin by ECHA PUBLIC 13

14 Cmpany Size Cmpany size % Registered by a large cmpany 80% Registered by an SME 19% Medium cmpany 11% Small cmpany 5.5% Micr cmpany 2.5% PUBLIC 14

15 Cmpany Type Rle in the supply chain % Manufacturer 40% Manufacturer and imprter 12% Imprter 25% Only Representative f a nn-eu manufacturer 23% Nn-EU cmpanies can exprt t the Eurpean Unin thrugh tw different rutes under REACH: either via an imprter wh has registered the substance, r by appinting an Only Representative. PUBLIC 15

16 Registratin Status Tw registratin deadlines passed ~7,400 substances registered; ~40,000 dssiers Substances ver 100 tpa; mst hazardus ver 1 tpa Mre than 100,000 substances in the C&L inventry Infrmatin published n ECHA website Eurstat study 5-year update revealed a marked increase in quality f data & better cntrl f risk Frm that perspective REACH is delivering PUBLIC 16

17 Registratin findings Timelines very challenging but achievable Cllabratin f authrities and industry befre the deadline imprtant in achieving a successful result The ne substance ne registratin cncept generally wrked well IT systems critical fr functining f the system PUBLIC 17

18 Disseminatin Infrmatin wned by the registrants identical as in registratin dssiers Cnfidential Business Infrmatin remved Infrmatin nw available nline Over 8,000 substances Always published (a) name in the IUPAC nmenclature (b) name as given in EINECS (c) classificatin and labelling (d) physicchemical data (e) txiclgical and ectxiclgical data (f) derived n-effect level (DNEL) r predicted n-effect cncentratin (PNEC) (g) guidance n safe use (h) analytical methds PUBLIC 18

19 Search substances n ECHA hme page PUBLIC 19

20 Disseminatin f infrmatin PUBLIC 20

21 Tips fr 2018 Registratin is a big but manageable task Thusands f cmpanies have already dne it Check if yur substance is already registered Already registered: cntact the lead registrant t verify substance sameness, make the SIEF agreement and t btain yur REACH-IT member tken Nt yet registered: cntact (pre)sief t establish sameness and agree n a lead registrant Substance Identity Unambiguus identificatin is a pre-requisite t mst f the REACH prcesses PUBLIC 21

22 Preparing the registratin dssier Chemical Safety Reprt Dssier in IUCLID 5 frmat fr substances at 1 t.p.a. submitted using REACH-IT Standard infrmatin linked t tnnage Chemical Safety Reprt fr substances > 10 t.p.a. Use the supprt tls (Plug-ins) befre submitting yur dssier TCC, Dssier Quality Assistant PUBLIC 22

23 Only Representatives Cncept A nn-eu manufacturer can appint an Only Representative t carry ut the registratin bligatins f the imprters Nn-EU manufacturer then needs t infrm all imprters abut the Only Representative Only Representative can be any legal entity established in the EU with sufficient skills & knwledge A nn-eu manufacturer can nly appint ne Only Representative per substance PUBLIC 23

24 Only Representatives Respnsibilities Need t: cmply with all bligatins f imprters under REACH (pre-registratin, data-sharing, ) keep up-t-date infrmatin n EU imprters and the quantities imprted which are cvered by the registratin cver in the dssier all uses f the substance by the imprters included in the registratin If an OR represents different nn-eu manufacturers, separate registratins are needed (trugh separate accunts in REACH-IT) PUBLIC 24

25 What happens after registratin? ECHA Verify cnfidentiality claims examine prpsals fr new tests n the 2013 substances by 1 June 2016 check cmpliance f at least 5% f dssiers per tnnage band (target end 2016) Member States: substance evaluatin Screening fr authrisatin/restrictin as part f 2020 Radmap Enfrcement: n registratin, n market PUBLIC 25

26 Requirement t spntaneusly updates Change in substance status Changes in tnnage band Change frm intermediate t nrmal registratin Change in cmpsitin New identified uses/uses advised against New knwledge n risks Change in classificatin and labelling CSR/Safe Use amendments Testing prpsal needed PUBLIC 26

27 Evaluatin 1.Prvide cnfidence that industry is meeting bligatins 2. Prevent unnecessary animal testing 3.Build up infrmatin basis fr eventual risk management measures at EU level PUBLIC 27

28 REACH - Evaluatin Member States Dssier evaluatin Substance evaluatin Testing prpsal examinatin Cmpliance check Examine any infrmatin n a substance Output accept/reject a testing prpsal request f infrmatin, because the dssier is nt cmpliant (CC) r the ptential risk needs clarificatin (SEV) 28

29 Evaluatin the mechanics PUBLIC 29

30 Dssier Evaluatin: cmpliance check ECHA questins ECHA examinatin cnclusins Numbers and timelines Inf requirements adequately fulfilled? Adaptatins adequately justified? CSA & CSR cmply with Annex I? Risk Management Measures are adequate? Explanatins fr separate submissin Decisin: 1. Request further infrmatin 2. N further actin Select at least 5% f ttal received fr each tnnage band Draft decisin within 12 mnths frm starting the evaluatin 1,200 registratin dssiers frm 2010 deadline will be checked fr cmpliance by end f 2013 PUBLIC 30

31 Cmpliance Check The Agency may perfrm n any registratin dssier Sme pririty setting is suggested in the legislatin: Dssiers submitted separately (pting-ut f jint submissin) Dssiers [1, 10t], nt fully falling under Annex VII Substance is n Cmmunity Rlling Actin Plan Randm selectin Cncern-driven selectin PUBLIC 31

32 Cmpliance Check Findings Cmmn shrtcmings in dssiers Substance identity (66 %) Expsure assessment & risk characterisatin (23 %) Prenatal develpmental txicity study (26 %) Sub-chrnic txicity study (18 %) PUBLIC 32

33 2013 Dssier Infrmatin Quality Detailed infrmatin nt yet available ECHA s actins t imprve quality: New IT tls e.g. Dssier Quality Assistant IT screening: persnalised advice fr registrants Mre experience Mre supprt available Screening will be dne n key issues Substance identificatin Use as intermediate PUBLIC 33

34 Dssier Evaluatin: testing prpsals ECHA questins ECHA examinatin cnclusins Numbers and timelines Prpsed test adequate and justified? Unnecessary animal testing avided? 3rd party inf valid? Decisin: 1. Accept testing 2. Reject testing 3. Change test cnditins 4. Request additinal testing All testing prpsals Nn phase-in: draft decisin in 6 mnths Phase-in submitted accrding t schedule Over 1,100 testing prpsals frm 2010 have been prcessed PUBLIC 34

35 Testing Prpsal Assessment Stimulates and supprts industry twards efficient testing Ensures that testing cnducted nly if needed, in particular n vertebrate animal testing PUBLIC 35

36 Testing Prpsal Assessment Required by REACH Annexes IX & X: Registrants identify a data gap and cannt therwise fulfil the REACH infrmatin requirements; Additinal testing is triggered by risk: available infrmatin f the substance is incnclusive; further investigatin is needed Deadlines: fr nn phase-in substances: 180 days after receipt fr phase-in substances: by 1 Dec 2012 (if received by 1 Dec 2010) by 1 Jun 2016 (if received by 1 Jun 2013) by 1 Jun 2022 (if received by 1 Jun 2018) PUBLIC 36

37 Substance Evaluatin MSCA questins MSCA examinatin cnclusins Numbers and timelines Is there a suspected risk? Wuld further data clarify the cncern related t the substance? Decisin: Request additinal testing Other utcmes: Substance evaluatin reprt Cnclusins fr further actins (risk management) Substances in the CRAP; abut 50 per year Draft decisin within 12 mnths frm the publicatin f the CRAP CRAP = Cmmunity Rlling Actin Plan PUBLIC 37

38 Substance Evaluatin Selected in cllabratin with the Member States Based n the agreed risk-based criteria r ther risk-based natinal pririties Criteria cver: hazard infrmatin expsure infrmatin tnnage (incl. aggregated tnnage) Ways t find substances: IT-based screening Member States make ntificatins Via dssier evaluatin PUBLIC 38

39 Cmmunity Rlling Actin Plan Duratin 3 years CRAP lists f substances & evaluating Member States and initial cncerns Substance specific justificatin dcuments published (frm 2013) Cnsequences f inclusin int CRAP N legal impact n the substance/registrant Substances need t be evaluated within 12 mnths frm the publicatin f the CRAP Evaluatin f substances listed fr the 2nd and the 3rd year nly starts frm the publicatin f CRAP updates in thse years PUBLIC 39

40 Substances in the CRAP CRAP CRAP Draft CRAP Published 29 Feb 2012 Published 20 March 2013 T be published in March 2014 Cntains 90 substances: 36 fr 2012; 23 fr 2013; 31 fr 2014 Cntains 115 substances: 46 fr 2013; 46 fr 2014; 23 fr 2015 Cntains 125 substances: 56 fr 2014; 49 fr 2015; 20 fr 2016 Draft decisins fr 32 substances 17 Member States 21 Member States 20 Member States PUBLIC 40

41 Interactin with Registrants Frmally pprtunity t cmment n a draft decisin Value f a c-rdinated respnse frm registrants Infrmally Registrants can cntact the Member States (details n the CRAP) Member States can cntact registrant(s) (issues with submissin f updates/pending studies) Cmmunicatin t the registrants and Dwnstream Users n hw t act during Substance Evaluatin A leaflet Substance Evaluatin: Tips fr Registrants and Dwnstream Users Wrk n-ging n a harmnised plicy acrss Member States PUBLIC 41

42 Fllw up t Substance evaluatin Member State evaluates new data prvided (12 mnths) New infrmatin submitted within deadline given (dssier update) N further actin N Cncern(s)? Ptentially Needs further infrmatin 2 nd draft decisin Finalise the evaluatin reprt. C&L Harmnisatin? Restrictin? YES Authrisatin? Vluntary actin by registrant? Other legislatin? The MSCA infrms ECHA f its cnclusins as t whether r hw t use the infrmatin btained (Art. 48 Fllw-up). ECHA infrms the Cmmissin, the Rregistrant and the ther MSCAs. PUBLIC 42

43 New factsheet n Dssier Evaluatin Decisins Published n 15 Octber Describes the prcess steps and the pssible utcme dcuments Addresses cmmunicatin issues after the decisin has been received Prvides useful reminders fr registrants PUBLIC 43

44 Reprting Annual Evaluatin reprts since 2008 Reprts available n ECHA website Infrms registrants n cmmn pitfalls ECHA recmmendatins All registrants shuld read 2011 Reprt n animal testing Use f alternative methds PUBLIC 44

45 Elements f supply chain cmmunicatin Chemical safety reprt including expsure scenaris Safety data sheet Expsure scenaris Apprpriate and relevant infrmatin t prtect human health and the envirnment PUBLIC 45

46 Imprving quality CSR & ES quality ENES: Exchange Netwrk fr Expsure Scenaris ENES Nvember PUBLIC 46

47 Imprving quality f chemical safety reprt - Illustrative example CSR Part 1: General advice (8 pages) Part 2: Wrked example f chemical safety reprt Part 3: IUCLID dataset fr chemical safety reprt Part 4: Chesar dataset fr generating CSR PUBLIC 47

48 Difference between Restrictins & Authrisatin Restrictins Authrisatin Restricted uses Authrised uses General exemptins = frbidden/restricted = nt restricted/authrised 48 PUBLIC

49 REACH des nt stand n its wn Other sectral chemicals legislatin exists: Plant Prtectin Prducts - pesticides Bicidal Prducts - bicides Other imprtant plicy areas with links t chemicals management: Envirnment (Water - pririty hazardus substances, Waste -use f hazardus substances in electrnic equipment, Air - quality bjectives) Wrker prtectin legislatin (Framewrk Directive n Health and Safety at Wrk, Occupatinal expsure limits, Carcingens and Mutagens Directive) Cnsumer Prtectin (General Prduct Safety Directive, Tys, Csmetics) Health (Medicinal prducts and medical devices) Fd (Fd cntact materials) 49 PUBLIC

50 Authrisatin (1/2) Fcus n: mst hazardus substances = Substances f Very High Cncern (SVHC) Carcingens, Mutagens and txic fr Reprductin: CMRs Human Health Persistent, Biaccumulative and Txic fr the envirnment: PBTs Envirnment very Persistent and very Biaccumulative: vpvbs Envirnment Substances f equivalent level f cncern (e.g. endcrine disruptrs, ptent respiratry sensitisers) fr which uses may lead t significant expsure Principle: after a certain date sunset date the use f an Annex XIV substance is frbidden unless specifically authrised (r exempted) Ultimate gal: substitutin by safer alternatives 50 PUBLIC

51 Authrisatin (2/2) Sme general exemptins: scientific Research & Develpment all intermediates substances fr which management f risks fr human health and/r envirnment are already cvered by ther relevant Cmmunity legislatin (medicinal prducts, csmetic prducts, fd and feed, fd cntact material, bicides and pesticides, fuels) NOT cvered by the authrisatin requirement: manufacturing prcesses imprted articles cntaining the substance 51 PUBLIC

52 Step 1: Identificatin f SVHC Substances f Very High Cncern (SVHC) MS Preparatin f Annex XV SVHC dssier [Art.59(2),(3)] Public cnsultatin Identificatin f SVHC & Candidate list inclusin [Art.59(1)] Candidate list f SVHC fr Annex XIV inclusin Step 2: Inclusin f SVHC in Annex XIV MS Priritisatin f Candidate list substances [Art.58(3)] Public cnsultatin Inclusin f Candidate list SVHC in Annex XIV [Art.58(1)] Authrisatin list f SVHC (Annex XIV) Step 3: Applicatin fr Authrisatin MS Applicatin fr Authrisatin t use Annex XIV SVHC [Art.62] Public cnsultatin RAC & SEAC Cmmittees draft pinins COM decisin Authrisatin granted (r nt) fr a use f an SVHC [Art.60] 52

53 Step 1a: Candidate List - Implicatins Directly after inclusin in the Candidate List Suppliers f the substance: prvide their custmers with a safety data sheet Suppliers f articles cntaining the substance: prvide infrmatin t allw safe use f the article t custmers r t cnsumers, upn request (45 days!) Six mnths after the inclusin: Prducers/imprters f articles have t ntify ECHA if their article cntains a substance n the Candidate List 53 PUBLIC

54 Step 1b: Annex XIV listing - implicatins After the «sunset date», industry is nt allwed t place an Authrisatin Annex (XIV) substance n the market r use it unless cmpanies have an authrisatin granted by the Cmmissin 54 PUBLIC

55 Step 1a: Candidate List & 1b: Authrisatin List 138 Substances ECHA website 14 Substances Official Jurnal (ECHA website) Examples: Phthalates Arsenates Cbalt cmpunds Lead cmpunds (Di)chrmates Examples: Musk Xylene MDA HBCDD Phthalates (DEHP, BBP, DBP) 55 PUBLIC

56 Step 2: Applicatins fr authrisatin An applicant can be: manufacturer imprter dwnstream user any cmbinatin f these An applicatin can be submitted: fr ne r several uses fr ne r a «grup f» substance(s) Fee» Fee Regulatin 56 PUBLIC

57 Factsheet published in late 2013 PUBLIC 57

58 When will an authrisatin be granted? The Cmmissin shall grant an authrisatin if: risks are adequately cntrlled adequate cntrl rute!nb: nt applicable fr substances with PBT, vpvb prperties and nn-threshld CMRs The Cmmissin may grant an authrisatin if: sci-ecnmic benefits utweigh the risks and there are n alternatives available that (1) reduce the verall risk and (2) are technically and ecnmically feasible fr the applicants sci-ecnmic rute PUBLIC 58

59 Authrisatin decisins An authrisatin is substance, use and supply-chain specific Cmmissin decisins will specify: the identity f the substance(s) the persns t whm the authrisatin is granted the uses fr which it is granted any cnditins under which it is granted, incl. any mnitring arrangement a time-limited review perid (case-by-case apprach) 59 PUBLIC

60 Authrisatin Prcedure includes public cnsultatins Step 1a Step 1b Step 2 Identificatin f Substances f Very High Cncern Subjecting pririty substances t authrisatin Granting authrisatin Candidate List REACH Annex XIV Authrisatin decisin 5 mnths mnths up t 2 years PUBLIC 1/29/

61 Restrictins Ensure prtectin f human health and r the envirnment, where Manufacturing, placing n the market r use causes unacceptable risk These risks need t be addressed n Cmmunity-wide basis Ensure functining f the internal market Can cver any substance n its wn, in mixtures and/r in articles manufacturing f substances Imprt f articles cntaining substance 61 PUBLIC

62 Restrictins Sme general exemptins Scientific research and develpment Risks t human health due t use in csmetic prducts On site islated intermediates Restrictin entries (Annex XVII) Inherited frm previus legislatin (Dir 76/769/EEC) New restrictins (amendments f existing restrictins and new entries) 62 PUBLIC

63 Restrictin prcedure (1/2) Registry f Intentins (RI) Member States have t ntify their intentins t prepare a restrictin dssier ECHA frm the request f the Cmmissin Annex XV dssier (technical dssier and Annex XV reprt) submissin t ECHA MSs within 12 mnths frm the ntificatin ECHA within 12 mnths frm the request Cnfrmity check Legal requirement fr Cmmittee fr Risk Assessment RAC and Cmmittee fr Sci-ecnmic Analysis SEAC t check if the dssier cnfrms with the requirements 63 PUBLIC

64 Restrictin prcedure (2/2) Cnsultatin f interested parties Cnfrming Annex XV reprts n ECHA s website Interested parties have 6 mnths t prvide cmments Develping the pinins RAC has t give its pinin in 9 mnths frm publicatin Is the suggested restrictin apprpriate in reducing the risk? SEAC gives first draft pinin, interested parties have 2 mnths time t cmment n the draft pinin, final pinin within 12 mnths Are the csts as a result f a restrictins prprtinate t the reduced risk? Cmmissin decisin 64 PUBLIC

65 Specific restrictins CMR substances categry 1A and 1B used by cnsumers (substance as such, in mixture r in articles) Cmmissin prpses the restrictin withut ECHA invlvement Authrisatin list substances (Annex XIV ) After sunset date ECHA cnsiders if the use f the substance in articles causes risk that is nt adequately cntrlled and prepares an Annex XV prpsal 65 PUBLIC

66 Restrictins All restrictins listed in Annex XVII Full ban r ban n certain uses Certain dergated uses Specific cnditins f use Currently 63 entries in Annex XVII New/revised entries under scrutiny and under cnsideratin Obligatin t: Cmply with any cnditins set ut in Annex XVII Update Safety Data Sheet 66 PUBLIC

67 Recently adpted restrictins Lead and its cmpunds in jewellery articles Dimethylfumarate in articles Mercury in measuring devices 4 Phenylmercury cmpunds Cadmium and its cmpunds 67 PUBLIC

68 Restrictins under cnsideratin Opinins submitted t the Cmmissin 4 classified phthalates in certain articles (pinins: n basis fr restrictin) Chrmium VI in leather articles Under cnsideratin in ECHA/Cmmittees 1,4 -dichlrbenzene in tilet blcks Lead and its cmpunds in cnsumer articles Ntified intentins t submit a restrictin dssier 1-methyl-2-pyrrlidne (NMP) (April 2013) 68 PUBLIC

69 Restrictins Prcedure includes public cnsultatins Step 1 Step 2 Step 3 Identificatin f interest Substance assessment ECHA review Cmmissin decisin Registry f intent Dssier Opinin REACH Annex XVII update 12 mnths 12 mnths 3 mnths PUBLIC 69

70 Substances f Very High Cncern in Articles Article Definitin - REACH an bject which during prductin is given a special shape, surface r design which determines its functin t a greater degree than its chemical cmpsitin Prducers, imprters r suppliers f articles may have legal bligatins under REACH if a Candidate List substance (SVHC) is cntained in their articles Decisin-making scheme 70

71 Ntificatin f substances in articles Purpse f ntificatin: -Ensure that sufficient infrmatin is available n use f substances f very high cncern (SVHCs) in articles nt cvered by registratins -T supprt the identificatin f cases which may require regulatry risk management ECHA must cnsider restrictin f Annex XIV substances in articles after the sunset date Infrmatin n SVHCs in imprted articles imprtant t allw ECHA t understand pssible needs fr dergatins frm such restrictins Only a few ntificatins received (xxx by December 2013) Need fr imprvement PUBLIC 71

72 Online ntificatin webfrm PUBLIC 72

73 Wrth t Remember Registratin is a way t ensure safe use f chemicals 1-substance-1-registratin applies A wealth f registratin infrmatin is available nline Authrisatin & Restrictin are regulatry instruments fr risk management at EU level Candidate Listing f a substance creates cmpliance requirements petteri.makela@echa.eurpa.eu Thank yu!