Authorisation Applications becoming a reality

Transcription

1 Authrisatin Applicatins becming a reality Eighth Stakehlders Day 26 March 2013 Matti Vaini Head f Unit, Risk Management Implementatin Eurpean Chemicals Agency 1

2 Outline 1. Aim f authrisatin and status f applicatins 2. Why and when shuld yu apply? 3. ECHA Cmmittees set the scene 4. Rle f applicant, third parties and stakehlders 5. Dwnstream users will play a key rle 6. Take hme 2

3 Aim f authrisatin Ensure gd functining f the internal market Assure risks frm SVHCs are prperly cntrlled and Assure SVHCs are: prgressively replaced by suitable alternative substances/technlgies where these are ecnmically and technically viable (Art. 55 REACH) 3

4 First applicatins expected in May Received ntificatins t submit *) Situatin as f 20 March 2013 Presubmissin infrmatin sessins held Submitted applicatins Names f substances n.a *) n.a. Ttal Names f substance(s) public nce the applicatin has been submitted. 4

5 Other factrs affecting the applicatin Why decisin shuld yu apply? Cmpiling an applicatin might still require significant staff and ther resurces The applicatin fee is nt insignificant and nly guarantees an pinin, nt authrisatin Authrisatin is temprary applicatin csts have t be incurred again and again, and justifying the authrisatin might get harder ver time Cmpetitr, supplier and market trends if everyne else is substituting, will yu get left behind? 5 5

6 Yu shuld apply if the use f the substance clearly adds value in the Eurpean Unin and the risks related t its use are very small Yu shuld nt apply if the use f the substance des nt add a lt f value in the Eurpean Unin and the risks are relatively high 6

7 The key questin What will be the impact n my business if the substance can n lnger be used in the EU? Relevant questin, if the substance is listed in Annex XIV and is subject t authrisatin yu manufacture the substance, imprt it, use it in yur prcesses, if it is present in the prducts yu prduce r use yu want t assess whether the impacts f authrisatin wuld be bigger r smaller than the benefits yu need t decide t apply r t substitute 7

8 Substitutin ptins and their impacts These are cre business issues relating t Business strategy Cmmercial interests Technical pssibilities t substitute Nt nly cmplying with envirnmental, health r safety regulatins Lk wider Clients, cmpetitrs, pssible cllabratrs Direct and indirect csts f dwntream users Substitutin in shrt r lnger term? 8

9 Case fr authrisatin, if benefits > risks Benefits Avided cst increases and/r reductins in prfit Avided reductins in ecnmic perfrmance, emplyment, investment Avided envirnmental impacts: e.g. CO 2, air pllutin frm energy use, transprt Current risks Envirnmental and health impacts frm using the substance (Can be zer if risks are adequately cntrlled) Authrisatin mre likely when csts f the alternatives are higher and/r current risks are mre cntrlled Authrisatin mre likely when the case is clearer a strnger case is likely t be a simpler case 9

10 Cnsider als Applicatin requires staff and ther resurces Applicatin fee nly guarantees an pinin, nt authrisatin Authrisatin is temprary applicatin csts have t be incurred again and again, justifying the authrisatin might get harder ver time Cmpetitr, supplier and market trends if everyne else is substituting, will yu get left behind? 10

11 When shuld yu apply? When yu are ready N need t wait fr the latest applicatin windw ECHA s Cmmittees will start pinin making immediately after the receipt f the payment The earlier yu apply the earlier yu will get the pinins f ECHA s Cmmittees, and the Cmmissin decisin 11

12 Other factrs affecting the applicatin ECHA decisin Cmmittees set the scene Cmpiling an applicatin might still require significant staff and ther resurces The applicatin fee is nt insignificant and nly guarantees an pinin, nt authrisatin Authrisatin is temprary applicatin csts have t be incurred again and again, and justifying the authrisatin might get harder ver time Cmpetitr, supplier and market trends if everyne else is substituting, will yu get left behind? 12 12

13 ECHA Cmmittees set the scene Established in 2012 hw t evaluate applicatins Key dcuments published n ECHA s website Ecnmic feasibility SEAC published hw this will be evaluated Setting DNELs and dse-respnse functins in advance t evaluate remaining risks RAC establishing reference DNELs fr DEHP and DBP Substitutin: transparent, efficient and trustwrthy invlvement f applicants, third parties and stakehlders Publicatin f cmments n ECHA s web (weekly) Trialgues with the applicant t clarify prpsals fr alternatives 13

14 Other factrs affecting the applicatin Rle decisin f applicant, third parties and stakehlders Cmpiling an applicatin might still require significant staff and ther resurces The applicatin fee is nt insignificant and nly guarantees an pinin, nt authrisatin Authrisatin is temprary applicatin csts have t be incurred again and again, and justifying the authrisatin might get harder ver time Cmpetitr, supplier and market trends if everyne else is substituting, will yu get left behind? 14 14

15 Public cnsultatin and Trialgue BIU published Submitted cmments published weekly Applicant s respnse published Public Cnsultatin n Alternatives Trialgue with the applicant Week 8 ~ Week mnths Date f receipt SEAC s and RAC s pssible additinal questins t applicants and third parties RAC & SEAC pinins 15

16 Trialgue Opprtunity fr SEAC and RAC rapprteurs t discuss issues raised by an applicatin Open t SEAC and RAC members and bservers Vluntary Held in persn r ver vide r phne Applicant s view Will use as input the applicatin cmments made during the public cnsultatin questins made by RAC and SEAC and any written respnses by the applicant and third parties 16

17 Other factrs affecting the applicatin Dwnstream decisin users will play a key rle Cmpiling an applicatin might still require significant staff and ther resurces The applicatin fee is nt insignificant and nly guarantees an pinin, nt authrisatin Authrisatin is temprary applicatin csts have t be incurred again and again, and justifying the authrisatin might get harder ver time Cmpetitr, supplier and market trends if everyne else is substituting, will yu get left behind? 17 17

18 Demand pull: Dwnstream users are in key rle Dwnstream user needs ften drive the applicatin Dwnstream user: be sure that yur supplier applies therwise, yu will have t apply yurself In 2013, ECHA fcuses n hw dwnstream users can be better infrmed Cannt d this alne. Needs help. Supply-chain cverage in REACH: Tp-dwn but nt bttm-up! 18

19 Supply-chain cverage: three examples 19

20 Take hme

21 Key messages Apply if the use f the substance clearly adds value and the remaining risks are small: ne aim f Authrisatin is substitutin The questin is what will happen t my business if the Annex XIV substance can n lnger be used in the EU? Authrisatin cncerns yur cre business : Own it! Think utside yur business A strng case fr authrisatin prbably means an easier applicatin The mre marginal the case becmes, the mre resurces, time, analysis etc. the applicatin will need Yu may knw mre than yu thught Yur challenge is t persuade independent, scientific Cmmittees Understand hw the Cmmittees frmulate their pinins 21

22 Advice Start t prepare early N need t wait fr the latest date! Get familiarised with: Hw RAC and SEAC will evaluate the applicatins Questins and Answers (currently 54) Guidance Dcuments (cntent / prcedure) Submissin tls and user manuals Frmats and templates Invlve yur supply chain (up and dwn) Be «use-riented» Yur definitin may differ frm hw REACH defines the use Ntify ECHA, and request fr a «pre-submissin infrmatin sessin» (six t seven mnths befre), if needed Ask ECHA fr technical advice (e.g. thrugh Helpdesk) make suggestins t. 22

23 Thank yu