Post Pre-Registration
description
Transcript of Post Pre-Registration
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
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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
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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
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8655
5526
4638
4409
3262
2632
1926
1275
941
853
715
639
575
535
505
468
403
393
241
234
189
175
153
139
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Legal entities signed up
total = 65655 (01.12.2008)
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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)
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4493
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7975
1891
3113
5607
1201
2992
080
7297
3
4403
839
760
3669
735
494
3053
624
477
1481
814
394
1048
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295
9323
7546
5189
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4430
4063
3375
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Pre-registration
total = 2,750,464 (12.12.2008)
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• 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
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• 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
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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
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Pre-registration experiences
• pre-SIEF size
91344353219810
39512112 1825
987226
110
2
1
10
100
1000
10000
100000
1-9
10-2
4
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9
50-7
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9
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-499
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number of participants in a pre-SIEF
nu
mb
er
of
pre
-SIE
Fs
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• 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
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Next steps
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• 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
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• Challenges for industry– SIEF facilitators – low percentage of pre-SIEFs
Pre-SIEFs
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• 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
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• 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
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• 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
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Thank you
for your attention