Ref. Ares(2014)78297 - 15/01/2014

REACH Workshop

Registration and Notification in practice
14 April 2008
Christel Musset

http://echa.europa.eu

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Contents• Overview of Registration in REACH– What substances should be registered?
– Who should register?
– When to register?
– How to register?

• New substances notified under 67/548/EEC• Notified polymers• PPORD Notifications–

http://echa.europa.eu

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Aim of Registration• Responsibility for management of risks of substancesis on the manufacturer, importer and those who place
the substance on the market or use it for professional
activities• Therefore they
– Gather and generate data on their substances– Use these data to assess the risks– Develop & recommend appropriate risk reduction measures– Document this information in a Registration dossier to besubmitted to ECHA
http://echa.europa.eu

3What to register
Biocides: Active• All substances manufactured or •imported
in volumes
included in≥ 1 tonne / year per manufacturersubstances
orimporter
Annex I, IA or IB (98/8/EC)– Substances on their own
or in the work programme• Pesticides: Active– Substances in preparations– Substances in articles intended to besubstances
releasedincludedin Annex I (91/414/EEC)
or in the work programme
for evaluation• About 30,000 substances concerned• Exemptions• New substances notified
under 67/548/EEC• Regarded as registered

http://echa.europa.eu

4Who should register• EU manufacturers and importers of substances on
their own or in preparations• EU producers and importers of articles(meeting criteria of Article 7(1))• EU-based “only representatives” appointed by amanufacturer, formulator or article producer
outside the EU to fulfil the registration obligationsof importers

http://echa.europa.eu

5When to register
Pre-registration

REACH entry into force

Phase-in≥1000 tonnes
CMRs ≥ 1 tonne
Very toxic to aquatic organisms (R50/53) ≥ 100 tonnes

Phase-in 100-1000 tonnes
Phase-in substances 1-100 tonnes
Non phase-in substances

1 June2008
1 Dec
1 June20082007

30 Nov
2010

31 May2013
http://echa.europa.eu

31 May20186

2 routes for registering• Non phase-in (or phase-in substance not pre-registered)
Inquiry

Information to be provided online inREACH-IT
9Contact details
9 (Detailed) information on
substance identity
9Relevant information requirements

http://echa.europa.eu

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2 routes for registering• Non phase-in (or phase-in not pre-registered)
Inquiry

http://echa.europa.eu

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2 routes for registering• Non phase-in
Inquiry

Contact ofprevious
registrants(if appropriate)

Datasharing(if appropriate)

Registration

Manufacture
or import

Wait for registration number• Phase-in
preregistration

Information to be provided online in
REACH-IT
9Contact details
9Information on substance identity
http://echa.europa.eu

92 routes for registering• Non phase-in
Inquiry

Contact ofprevious
registrants(if appropriate)

Registration(jointsubmission ifappropriate)

Datasharing(if appropriate)

Manufacture
or import

Wait for registration number• Phase-in
Preregistration

Contact details of:¾ other pre-registrants
List ofpre-registeredsubstances

pre-SIEF(ECHAwebsite)¾ early registrants¾ biocides, pesticides¾ Data holders after
1 Jan 09

http://echa.europa.eu

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2 routes for registering• Non phase-in
Inquiry

Contact ofprevious
registrants(if appropriate)

Registration(jointsubmission ifappropriate)

Datasharing(if appropriate)

Manufactureor import

Wait for registration number• Phase-in
Preregistration

List ofpre-registeredsubstances

pre-SIEF(ECHAwebsite)

SIEF(industryplatform)

Registration(jointsubmission)

Manufacture / import
http://echa.europa.eu

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Joint submission
Joint information

Hazard information & testing proposals
Classification and labelling

ChoiceChemical Safety Report
Guidance on safe use
Quality assessed

Company specificCompany and substance identity
Manufacture and uses
Exposure information
http://echa.europa.eu

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Joint submission
Joint informationChoiceThis part
must be submitted
by the Lead registrant
Chemical Safety Report
Guidance on safe use
Quality assessed

Company specificCompany and substance identity
Manufacture and uses
Exposure information
http://echa.europa.eu

13Separate submission• A registrant may submit information separately(opt-out) if:– Joint information would be disproportionally costly for him– Information is commercially sensitive– Disagreement with the lead on selection of this information• Justification of the above must be provided alongwith the dossier

http://echa.europa.eu

14How to prepare theregistration dossier• The only tool for preparing the dossier: IUCLID 5

Available free of charge on ECHA website
http://echa.europa.eu

15How to prepare theregistration dossier• Technical dossier: IUCLID 5 format– company identity & substance identity– manufacture & uses – guidance on safe use
C&L - exposure information– (robust) study summaries - testing proposals• Chemical Safety report (above 10 tonnes per year):– document created outside IUCLID but later is attached to it
One single file to be sent to ECHA
http://echa.europa.eu16

How to prepare theregistration dossier• Information is entered in the company IUCLID 5 database

Data requiredin REACH
Annexes VI-X
(depending ontonnage)• When the dossier is final, it is exported & sent to ECHA
(via REACH-IT)
http://echa.europa.eu

17Submission in REACH-IT

http://echa.europa.eu

18What happens next
• Completeness check• Invoice is generated based on a number of parameters:– Size of the company (reduced fees for SMEs)– Tonnage band
– Joint or individual submission– Request to confidentiality according to Art. 10(a)(xi)– Initial submission or update• Invoice is sent to the registrant (via REACH-IT and mail)• Submission report is available for download in REACH-IT• Registration number is sent when dossier is complete &fee is paid
http://echa.europa.eu

19Tracking system for industry

http://echa.europa.eu

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Notified substances• Considered as registered• ECHA must assign a registration number by 1
December 2008. To receive this number:– Notifiers must identify themselves in REACH-IT– Claim their registration number– If no issue with notifier identity, registration number is sent
– In case of problem, the Competent Authority is informedfor verification
Contact your Competent Authority:
your current notifications must be up-to-date,in particular the identity of the notifier!
http://echa.europa.eu

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Notified polymers• Considered as registered• Registration number assigned by ECHA (same asnotified substances)• When the notified polymer passes the next tonnage
threshold,– a registration is required for the monomer(s)Updated guidance available on ECHA website

http://echa.europa.eu

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PPORD notifications• 2 routes to prepare the notification– Offline in your IUCLID installation, starting now!
– Online in REACH-IT, starting 1 June 08– Submission process: same as for the registration dossier,incl. fee payment• Manufacture or import may start 2 weeks after
notification if no indication of the contrary by ECHA

http://echa.europa.eu

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PPORD notifications• Extension of current PORDs– Must be submitted as PPORD by 2 June 2008 at latest– with an indication of the current PORD number– Contact your Competent Authority for further information

http://echa.europa.eu

24Thank you for your attention

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