http://echa.europa.eu 1

Post Pre-Registration

Christel MussetDirectorate Registration & IT tools

SIEF Management

Brussels, 30 January 2009

http://echa.europa.eu 2

Content

1. State of play of pre-registration / pre-SIEF

2. Next steps

http://echa.europa.eu 3

Principle of pre-registration

• Pre-registration: option for potential registrants of phase-in substances, to benefit from extended deadlines for registration

• 1 June to 1 December 2008: phase-in substances already manufactured / imported / placed on the market

• After 1 December 2008: “late” pre-registration for phase-in substances manufactured / imported / placed on the market for the 1st time

• When omitted, companies can no longer manufacture, import or place on the market phase-in substances or preparations containing those substances until they have registered them

http://echa.europa.eu 4

Pre-registration state-of-play

at the end of the pre-registration period:

– more than 65,000 companies from all 27 MS + EAA– more than 2,700,000 pre-registrations received– more than 150,000 different substances pre-registered

• Complete EC inventory• 17,000 identified by CAS numbers• 9,500 identified by chemical names• 14,500 multi-constituent substances

• 1105 pre-registrations submitted through back-up procedure on 1 December 2008

http://echa.europa.eu 5

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5526

4638

4409

3262

2632

1926

1275

941

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715

639

575

535

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403

393

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189

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153

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Legal entities signed up

total = 65655 (01.12.2008)

http://echa.europa.eu 6

Pre-registration state of play

• Legal entities signed up in REACH-IT:– Expected companies (manufacturers, importers,

distributors, OR, consultants, etc…– But also:

• testing system (blocked in Dec 08)• foreign or non-existing address (blocked in Dec 08)• high number of legal entities:

OR not yet representing a non-EU company???• ~ 20% of companies have not pre-registered

– company size (35% of companies are micro-sized)

http://echa.europa.eu 7

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Pre-registration

total = 2,750,464 (12.12.2008)

http://echa.europa.eu 8

• in the last weeks of pre-registration, ECHA received a very high number of users

Pre-registration: pattern

0

5000

10000

15000

20000

01-Jun 01-Jul 01-Aug 01-Sep 01-Oct 01-Nov 01-Dec

http://echa.europa.eu 9

• Bulk pre-registrations / day

Pre-registration: pattern

0

500

1000

1500

2000

01-Jun 01-Jul 01-Aug 01-Sep 01-Oct 01-Nov 01-Dec

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Pre-registration experiences

• Substances pre-registered:– high number of pre-registrations by some companies

• Purpose? Secure business, double pre-registration…

– CAS n° does not correspond to chemical name• Corrected with the support of CAS: correct CAS

names in the list of pre-registered substances published on ECHA web site

• Wrong CAS names provided by companies transferred into the synonym list

– substances having EINECS n° pre-registered using only CAS number or chemical name duplicate pre-SIEF

• Check ongoing with CAS for substances with only chemical names

http://echa.europa.eu 11

Pre-registration experiences

• Substances pre-registered:

– preparations (and alloys) pre-registered as multi-constituent substances ???

– use of non-English chemical names

• translations done as far as possible

– poor identification of substances: especially for pigments (orange 79, yellow 104)

– polymers pre-registered

– articles pre-registered

http://echa.europa.eu 12

Pre-registration experiences

• pre-SIEF size

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http://echa.europa.eu 13

• List of pre-registered substances published on 19 December 2008

• Since 5 January:– Using REACH-IT

• First-time manufacturers or importers can pre-register (art. 28.6)

• Data holders may indicate that they have data on pre-registered substances (art. 28.5)

– ECHA-CHEM (web forms on ECHA web site)

• Third parties may submit information on pre-registered substances (art 41.6)

• DU can notify ECHA of their interest in not listed substances

Steps after 1 December 2008

http://echa.europa.eu 14

Next steps

http://echa.europa.eu 15

• Challenges for industry– Some SIEFs have more than 1000 participants

• CEFIC initiative for organising the SIEFs– Feedback from associations

• Companies using the system for proposing services• SIEF Formation Facilitators blocked by companies

– Access to REACH-IT problematic• System overloaded by users performing complex

searches and downloading enormous amount of data → system slow and unstable

Pre-SIEFs

http://echa.europa.eu 16

• Challenges for industry– SIEF facilitators – low percentage of pre-SIEFs

Pre-SIEFs

http://echa.europa.eu 17

• Challenges for ECHA– List of pre-registered substances

• Corrections were suggested to companies during pre-registration (9,000 emails) – very few feedback from companies

→ quality of the list?→ data sharing issue? (wrong / duplicate pre-SIEFs)→ SIEF is industry responsibility… ECHA’s role?

Pre-SIEFs

http://echa.europa.eu 18

• Challenges for ECHA– REACH-IT

• Scalability of the system: need for substantial performance improvement

→ 1st Improvement: January 26→ Next planned for 2nd week of February→ will continue in the next months to ensure

performance and stability for the 2010 peak– Registrations and C&L notifications expected to follow the

same pattern as pre-registrations: high peak in the last 3 months

• System needed to regulate the flow of submissions and ensure registrants meet the deadline

Pre-SIEFs

http://echa.europa.eu 19

• Challenges for ECHA– Workload in 2010

• Commission estimations in 2003: 25.000 registrations in 2010

• Real number of dossiers? Feedback necessary from industry on the number and size of SIEFs

– Quality of dossiers• Essential to have high quality dossiers to ensure

maximum throughput of submissions• Technical completeness check module to be released

as an plug-in to IUCLID 5 in Autumn 2009• User manuals and guidance

Pre-SIEFs

http://echa.europa.eu 20

Thank you

for your attention