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1 JS LEAD registrant Dossier JS MEMBER Dossier Sections to be completed in the Joint Submission.

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Presentation on theme: "1 JS LEAD registrant Dossier JS MEMBER Dossier Sections to be completed in the Joint Submission."— Presentation transcript:

1 1 JS LEAD registrant Dossier JS MEMBER Dossier Sections to be completed in the Joint Submission

2 2 The lead creates the joint submission in REACH-IT Creating the joint submission Identify your substance

3 3 Joining the joint submission Enter exact name of the joint submission and token

4 4 Step 1: Complete submission form Submitting the dossier 1. Select the dossier type to submit 2. Complete the submission form

5 5 Manuals are available on ECHA website

6 6 Getting the registration number Technical Completeness Check (TCC) Check if payment was received in full + Maximum 2 cycles extended deadline if needed pass Rejection fail Registration number

7 7 The lead has to prepare the joint submission in REACH-IT before submitting the dossier. The lead has to communicate the joint submission name and token to the members. The members have to join the joint submission in REACH-IT and wait until the lead has registered before submitting the dossier (Note: this will be updated during early part of 2010). Carefully consult the relevant guidance and manuals. Technical Completeness Check tool will be available before the end of 2009 Key messages

8 8 Part IV Authorisation & Restriction Do you have a forbidden substance in your article? >0,1% >1t ?

9 9 Authorisation vs. Restriction Authorisation: industry (in the EU) is not allowed to place on the market or use a substance included in Annex XIV unless industry has an authorisation granted by the European Commission Restriction: industry has to comply with the conditions of the restriction in Annex XVII for the substance

10 10 Main objective: To ensure that: the risks from the most hazardous substances are properly controlled, these substances are progressively replaced by suitable alternatives. Scope: Substances of Very High Concern (SVHC), i.e.: CMR 1 and 2, PBT, vPvB, substances of equivalent concern. Main principle: after a certain date (sunset date), a substance subject to authorisation requirement (i.e. listed in Annex XIV of REACH) cannot be placed on the market and/or use by M/I/DU unless an authorisation has been granted for that specific use Authorisation

11 11 The authorisation procedure: a 2-steps approach Step 1: subjecting substances to authorisation requirements Step 2:authorisation applications and decisions candidate list ECHA Annex XV dossier MSs COMM (ECHA) Annex XIV recom. ECHA ECHAs MSC authorisation list (Annex XIV) COMM COMM decision Application Industry authorisation granted (or not) COMM Comments from interested parties (info. on alternatives) COMM decision RAC and SEAC opinions

12 12 The different lists under authorisation procedure Candidate ListAuthorisation List Registry of Intends Candidate List Authorisation List (Annex XIV) - list of substances identified as SVHC - it does not bring any obligation for authorisation applications, but information obligations for suppliers of article containing the substance - list of substances subject to authorisation application requirement - contains further details about the transitional arrangements (application / sunset dates) and specific uses exempted - list of substances for which Member States (or EC) have expressed their interest in developing (in the future) an Annex XV dossier for the identification as SVHC

13 13 Authorisation: what has been done so far? Identification of SVHC: in summer 2008, the first 17 Annex XV dossiers for the identification of SVHC were submitted by Member States; this led to the identification of 15 SVHC, listed in the Candidate List as published by ECHA on 28 October 2008; the second round of identification of SVHC has just started, with the publication of 15 new Annex XV dossiers on 31 August 2009 (public consultation until 15.10.09); this should lead to an update of the Candidate List by January 2010 Annex XIV recommendations: On 1 June 2009, ECHA sent its first recommendation for inclusion of substances in Annex XIV to the European Commission

14 14 Authorisation: whats next? Identification of SVHC : It has been agreed with MSCAs that Annex XV dossiers will be submitted twice a year, at fixed dates; the next agreed submission dates are: 08 February 2010 02 August 2010 Annex XIV recommendations : ECHA has to send to the European Commission new recommendations at least every 2 years. Annex XIV (authorisation list): The European Commission is currently working on the recommendation sent by ECHA; the adoption of the first Annex XIV list is expected for the beginning of 2010. Authorisation applications : ECHA has started to prepare for autorisation applications which can be in principle submitted as soon as Annex XIV has been published (for the substances it contains)

15 15 Les questions à se poser Si mon produit est une substance ou une préparation (dangereuse) – Une FDS doit-elle être communiquée en aval? – La C&E doit elle être notifiée? – Mes substances vont-elles faire lobjet de la procédure dautorisation? Consultez la liste des substances extrêmement préoccupantes (SVHC) pouvant être incluses dans lannexe XIV: – Des restrictions s'appliquent-t-elles (annexe XVII)? Colorants azoïques

16 16 Questions to ask Product =article? – Intention to release substances Ex: cosmetics in leggings check that your EU importator or Only Representative have (pre- )registered correctly these substances

17 17 – Article contains substances from Candidate list? 0.1%? (art.33) Check correct information to recipients/consumers upon request and > 1t/year (art.7.2) Check Notification to Agency by importator or OR (start June 2011) Questions to ask Candidate list: Recommended for authorisation: df

18 18 Substance Anthracene 4,4-Diamonodiphenylmethane * DBP * Cobalt dichloride Diarsenic pentaoxide Diarsenic trioxide Sodium dichromate Musk xylene * DEHP * HBCDD * (hexabromocyclododecane) SCCP * pentachlorophenol (leather) Bis(tributyltin)oxide Lead hydrogen arsenate BBP * (benzyl butyl phtalate) Triethyl arsenate Basis for SVHC PBT C cat 2 R cat 2 C cat 2 C cat 1 CMR cat 2 vPvB R cat 2 PBT PBT, vPvB PBT CR cat 1 R cat 2 C cat 1 * Included in 1st draft recommendation for authorisation, published 01/06/09 List of candidates substances

19 19 Restriction – Principles (1/2) Definition: Restriction means prohibition Restrictions may be imposed on: – manufacture, use and/or placing on the market – a substance on its own, in preparation or in an article when: – an unacceptable risk to human health or the environment exist – this risk needs to be addressed on a Community- wide basis

20 20 Restriction – Principles (2/2) Restrictions are: – proposed by Member States or the European Commission (Annex XV dossiers for restrictions), – decided by the European Commission, on the basis of ECHAs scientific committees (RAC / SEAC) opinions No dossiers/applications to be developed by industry Community-wide action: the same requirements apply to whole EU from entry into force

21 21 Restriction: what has been done so far and next steps Restriction title entered into force on 01 June 2009, (Annex XVII) takes over the restrictions adopted under the previous legislation Annex XVII (list of restrictions) has already been updated by Commission Regulation (EC) No 552/2009 of 22 June 2009 2 countries have already expressed they intention to submit Annex XV dossiers (3 in total) for new restrictions in April and June 2010

22 22 Nickel (buttons, zippers..) Textile: Azo-colourants, Tris(azirdinyl)phosphinoxide; Polybromobiphenyls (PBB), Cadmium, perfluooctane sufonate (PFOS), Mercury (industrial) Leather: Cadmium (imitation leather), Alkanes short/medium chain chlorinate paraffins (fat liquoring of leather), Azo-colourants, nonylphenol (leather & textile process) Check restrictions /your article:

23 23 How to contact ECHA Webmaster ECHA Communication ECHA Helpdesk

24 24 Challenge dun Helpdesk 1) MANAGEMENT DES RESSOURCES (hommes, IT) – Équipe (expert vs généralistes; pic dun sujet) – IT, outils (tél, email...) 2) INFORMER/ COMMUNIQUER – En amont de la question – Trouver la réponse (et qui répond?) – Quel niveau de risque juridique? – Partager la réponse (interne, externe) – Et si la réponse change?

25 25 Messages clés pour déclarants (en retard)… …ou lead registrants (en avance) SIEF: le lapin hypnotisé

26 26 BXL 11/09/2009 Saccorder vite sur lidentité: EINECS CEFIC subst ID profile (compromis sur impuretés, CLP) Accord sur administration SIEF (communication: 10% dactifs, papier?; coût, quand, quoi ensemble, facturation, 5000eur) Dossier énormes > 1 CD rom, 400p Date pertinente: soumission du dossier ou opportunité commerciale Revue Data peut changer CLP et date limite

27 27 Dans mon dossier information suffisante sur lidentité de la substance justification et documentation suffisante pour les QSAR, Read across, grouping and exposure-based waiving Tests Eco-toxico et toxico suivant les GLP (01/06/2008) Plus dinformation, cest mieux que pas assez Lisez le rapport annuel sur lévaluation publié par ECHA le 28 février de chaque année

28 28 Webinars Lead Registrants only 2/month Up to 1,000 participants Up to 2 hours Led by ECHA Interactive

29 29 Webinar programme 2009 General principles of dossier preparation and submission Information requirements - part I – e.g. Robust study summaries, waiving information requirements and justification Information requirements - part II – e.g. QSARs, read-across, categories and in vitro data

30 30 Webinar programme 2010 Substance identity Technical completeness check (TCC tool) Chemical Safety Report (CSR) and CSA - part I – e.g. CSA tool and human health end points Chemical Safety Report (CSR) and CSA - part II – e.g. CSA tool and environmental end points Business rules Classification & Labelling notifications

31 31 Webinar for all registrants How to get started in your SIEF without a Lead Registrant: how 'multipliers' can help October 2009 Delivered by Cefic

32 32 The Forum

33 33 Special service in 2010 ECHA focuses on Lead Registrants National helpdesks support other registrants Collective service has priority – Q&A addressing specific problems – Newsflashes If needed, time limited outbound phone service National Helpdesks prepared to intensify service

34 34 Numbers of Lead Registrants climbing…

35 35 Registrations too 240 registration dossiers for phase-in substances received already 74 complete

36 36 All registrations…

37 37 What next? Workshop slides uploaded - DG Enterprises REACH events cals/reach/events/index_en.htm cals/reach/events/index_en.htm Web streaming continues Feedback please Register for webinars

38 38 Hot topics addressed by ECHA

39 39 Hot topics Pre-SIEF and SIEF formation: News Alert 13.2.2009; 24.4.2009 Updated list of pre-registered substances (27.3.2009) Online dossier submission: – Industry User Manual outlining the checks made by ECHA (REACH IT Data Submission Manual 8 of 15.4.2009) – Online inquiry submission available since 17.4.2009 Change of name and legal entity (17.4.2009)

40 40 Hot topics NONS <1t update Intermediates (non EU confirmation aussi?) Polémique sur les tests animaux (sept09) Date-limite Utilisateur aval Annexe V, recyclage (huiles) Alliages Continuer ou arrêter production/import OR ne peut pas déclarer Classification

41 41 3) Guides dorientation (guidance) Registration (incl. Polymers, PPORD, Intermediates) Substance Identity Data Sharing (including pre-registration) Information Requirements and Chemical Safety Assessment Classification and Labelling (expected 2009) Substances in Articles (for textile see appendix 3&4, p86-87;p96-99)

42 42 Information sur les mises à jour?

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