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

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JS LEAD registrant Dossier

JS MEMBER Dossier

Sections to be completed in the Joint Submission

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The lead creates the joint submission in REACH-IT

Creating the joint submission

Identify your substance

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Joining the joint submission

Enter exact name of the joint submission and token

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Step 1: Complete submission form

Submitting the dossier

1. Select the dossier type to submit

2. Complete the submission form

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Manuals are available on ECHA website

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Getting the registration number

Technical Completeness Check (TCC)

Check if payment was received in full

+Maximum

2 cycles

extendeddeadlineif needed

pass

Rejection

fail

Registrationnumber


• 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


Part IV

Authorisation & Restriction

Do you have a “forbidden” substance in your article?

>0,1% >1t ?


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


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


The authorisation procedure: a 2-steps approach

• Step 1: subjecting substances to authorisation requirements

• Step 2: authorisation applications and decisions

candidate list

ECHA

Annex XVdossier

MSsCOMM

(ECHA)

AnnexXIV

recom.

ECHA

ECHA’s MSC

authorisation list(Annex XIV)

COMM

COMM decision

Application

Industry authorisation granted(or not)

COMM

Comments frominterested

parties(info. on

alternatives)

COMM decision

RAC and SEAC

opinions


The different lists under authorisation procedure

Registry of Intends ≠ Candidate ListCandidate List ≠ Authorisation Authorisation ListList (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


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


Authorisation: what’s 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)

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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

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– 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:http://echa.europa.eu/chem_data/candidate_list_en.asp

Recommended for authorisation:http://echa.europa.eu/doc/authorisation/annex_xiv_rec/annex_xiv_subst_inclusion.pdf

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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 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


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


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 ECHA’s 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


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


• 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:

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How to contact ECHA

Webmaster

ECHA Communication

ECHA Helpdesk

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Challenge d’un Helpdesk

1) MANAGEMENT DES RESSOURCES (hommes, IT)

– Équipe (expert vs généralistes; pic d’un 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?

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Messages clés pour déclarants

(en retard)…

…ou lead registrants (en avance)

SIEF: le lapin hypnotisé

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BXL 11/09/2009

• S’accorder vite sur l’identité: EINECS CEFIC subst ID profile (compromis sur impuretés, CLP)

• Accord sur administration SIEF(communication: 10% d’actifs, 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

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Dans mon dossier

• information suffisante sur l’identité 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 d’information, c’est mieux que pas assez• Lisez le rapport annuel sur l’évaluation publié

par ECHA le 28 février de chaque année

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Webinars

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

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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

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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

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Webinar for all registrants

“How to get started in your SIEF without a Lead Registrant: how 'multipliers' can help”

October 2009Delivered by Cefic

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http://lr.echa.europa.eu

The Forum

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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

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Numbers of Lead Registrants climbing…

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Registrations too

• 240 registration dossiers for phase-in substances received already

• 74 complete

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What next?

• Workshop slides uploaded - DG Enterprise’s REACH events http://ec.europa.eu/enterprise/sectors/chemicals/reach/events/index_en.htm

• Web streaming continues • Feedback please • Register for webinars

http://echa.europa.eu/webinars_en.asp

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Hot topics addressed by ECHA

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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)

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Hot topics

NONS <1t updateIntermediates (non EU confirmation aussi?) Polémique sur les tests animaux (sept09)Date-limite Utilisateur avalAnnexe V, recyclage (huiles)AlliagesContinuer ou arrêter production/importOR ne peut pas déclarer Classification

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3) Guides d’orientation (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)

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Information sur les mises à jour?

http://guidance.echa.europa.eu/guidance4_en.htm