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Pre-registration, data-sharing and SIEFs

Geert Dancet

REACH Workshop – Brussels 18/09/2008


Pre-registration


Basics of pre-registration

Pre-registration is a duty under REACH

for every potential registrant of phase-in

substances, taking place between 1 June – 1

December 2008, granting them extended

deadlines for registration.


For information…

• Detailed information on ECHA website– Pre-registration section in 22 languages– “Presentation-type” user guides for sign-up and

online / bulk pre-registration in REACH-IT– Manuals for all temporary submission procedures

• Regular communication with stakeholders– News Alerts on ECHA website– Leaflet distributed to trade associations and MSCAs– First bimonthly ECHA newsletter available


Practicalities of pre-registration

• Potential registrants first need to sign-up to REACH-IT.

• Each legal entity must sign-up and pre-register separately.– an OR must sign-up and pre-register separately for each

non-EU manufacturer represented.

• Pre-registration is free of charge.• 2 ways to pre-register:

– on-line: pre-registrations created one at a time using REACH-IT

– bulk pre-registration: file prepared in a separate system (such as IUCLID) and submitted via REACH-IT


Pre-registration with REACH-IT

• REACH-IT went live on 31 May 2008 at 21:15 – The first company was signed up after 15 minutes– on 1 June, 1286 pre-registrations were submitted

• on 4 June, Norway, Iceland and Liechtenstein were added to the system

• on 22 July, bulk pre-registration was made available– Limited to substances (incl. similar substances) and

constituents with EC numbers.– up to 500 substances per bulk pre-registration file.– Bulk file must be compliant with the XML format

published on the IUCLID website.


REACH-IT for pre-registration

• company sign-up • third party representative sign-up• on-line and bulk pre-registration:

– creating a pre-registration on-line– submitting a pre-registration (on-line and bulk)– viewing and downloading submission reports– updating a pre-registration (except substance identity)– overview of all your pre-registrations– accessing the pre-SIEF– pre-SIEF functionalities


Legal entities signed up

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81

Cyp

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Fra

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Gre

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51

Hun

gary

, 65

Icel

and,

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56La

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Liec

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9P

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6S

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33

Slo

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9 Spa

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Germany, 1733

United Kingdom, 1207

Fin

land

, 325

0

400

800

1200

1600


0

5 000

10 000

15 000

20 000

25 000

30 000

35 000

22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

on-linebulk

Pre-registrations per week

total = 246794 (8.9.2008)111641 ↑


After 3 months of pre-registration

• 8.243 Legal entities have signed up from all 27 EU MSs + EEA– Germany 21% - UK 15% - Netherlands 10% - France 9%

• 246.794 pre-registrations received– UK 53% - Germany 20% - Netherlands 6,7% - Italy 5,3%– 110.664 substances pre-registered– 104.725 substances pre-registered by one UK company

• on-line pre-registration remains important: >6.000 pre-registrations per week

• bulk pre-registration: few rejections (198 out of 1.791 submissions,11% on 1.9.2008)


Experiences with pre-registration

• Substance name: no major problem so far– 97% of pre-registered substances are on EINECS– Remaining substances: 2% identified by a CAS number– 1% of substances identified only by chemical name

• sometimes unrightfully, even with the EINECS or CAS number mentioned in comments field

• Polymers– Monomers should be pre-registered

• Multi-constituent substances– preparations should NOT be pre-registered as multi-

constituent substances


Main recommendations

• Follow the Guidance on substance identification for naming your phase-in substance

• Respect the preferred order for substance identifiers to use: – 1. EC number

– 2. CAS number and CAS name

– 3. IUPAC name

• Specify the chemical name carefully: – use the IUPAC name in English,– add all other available numerical identifiers– if regarded necessary, add synonyms and/or chemical

names in other languages

• Fill in your company’s and contact person’s details


Data-sharing and SIEFs


What is a Pre-SIEF? • After pre-registration, a substance pre-SIEF webpage

will be formed for each EINECS n°/ CAS n°/ other identity code

• All potential registrants will be able to see:– each others contact details + contact details from data holders

– identified read-across possibilities

– remarks about the substance

• It is possible to navigate to the pre-SIEF web pages of

the substances identified for read-across (to and from)

• If you have concerns on confidentiality, use a third

party representative during pre-registration


SIEF Formation Facilitator

→ To initiate discussions after pre-registration a “SIEF formation facilitator” can be identified on the pre-SIEF webpage:

– Only potential registrants can volunteer to become SIEF

formation facilitator, on a first-come first-serve basis.

– Not legally binding, no additional obligations.

– Can post information to the other participants in a

separate text box on the pre-SIEF webpage,

e.g. on further communication tools to be used.


What Happens afterPre-registration?

• Industry needs to agree on SIEF formation and share data and costs within the SIEF

Pre- registration

List of pre-registered

substances

pre-SIEF (ECHA website)

SIEF (industry platform)


What is a SIEF?

• Obligatory platform to:– share data among potential registrants of the same phase-in

substances and data holders + avoid unnecessary testing

– agree on classification and labelling

• Suitable platform to organise the mandatory joint submission of data

• Potential registrants within a pre-SIEF must discuss whether their substances are the same or not.

• If agreement on the sameness: SIEF is ‘born’ (Article 29)


SIEF Formation – Key Issues

• Industry must assess the sameness (see guidance on substance identity)

No confirmation by ECHA!

• SIEF participants are free to organize themselves as they see fit

– Consortium is one possible form of co-operation

– Co-operation and collective approaches highly encouraged



• In many cases EINECS = SIEF, but:– substances within one EINECS number may, after detailed

examination, turn out to be so different in terms of composition that data from one substance may not be relevant to describe the profile of the other substance: several SIEFs may be formed.

– different EINECS numbers may reflect the same substance: one SIEF may be formed.

• Data sharing obligations must be respected! (it is not allowed to form 2 SIEFs for the same substance)



Cost sharing (see guidance on data sharing)

• Costs must only be shared for information:

– that a registrant is required to submit

– at the time when a registrant is required to submit the information

• Costs must be shared in a fair, transparent and non-discriminatory way

• If SIEF participants cannot reach an agreement, costs shall be shared equally


Publication of the list of pre-registered substances


Further steps in pre-registration

• Pre-registration is now open until 1 December 2008• ECHA will publish an intermediate list of pre-registered

substances in October 2008• ECHA will publish the list of pre-registered substances by 1

January 2009• DU can notify ECHA of their interest in a substance not on

the list• data holders can join the pre-SIEF• SIEF discussions can take place with the view of jointly

submitting data to ECHA


Questions

http://echa.europa.eu pre-registration, data-sharing and siefs geert dancet reach workshop –...

Documents

bulk preregistration

preregistered substances

substances preregistered104

online bulk preregistration

week bulk preregistration

reachitbulk preregistration

preregistrations receiveduk

months of preregistration8