Post on 03-Dec-2018
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“Lo strumento di valutazione della completezza del Dossier di
Registrazione (TCC)”“L’applicazione del REACH: i problemi emersi, le esperienze delle Imprese e il ruolo delle Autorità
Competenti.”Milano, 29 ottobre 2009
Doris HirmannDoris HirmannEuropean Chemicals Agency
This presentation represents the position of its author and is not an official position of the European Chemicals Agency. The European Chemicals Agency does not assume any legal liability or responsibility for the accuracy or completeness of the content of this presentation
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Technical Completeness Check
Carried out according to Article 20:
„The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required […], as well as the registration fee[…] have been provided.
Dossier processing at ECHA
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Workflow
Check of Business Rules
(ensure that dossiers can be processed by the system)
Technical Completeness Check (TCC)
Check if payment was
received in full
Completeness check:
Registration number Rejection (rare cases)
(Request to complete dossier
+ 2nd Completeness Check)
+
pass fail
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Structure of a registration dossier
Dossier Preparation in
>10 tonnes:
Technical Dossier &
Chemical Safety Report
(CSR Tool)
1-10 tonnes:
Technical Dossier:
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Technical dossier
Annex VI of REACH: Identity of registrant, Identity of
substance, Information about uses, C&L, Guidance on safe use …
Annexes VII to X: Physicochemical, toxicological and ecotoxicological studies requested depends on tonnage:
• 1-10 tons: Annex VII
• 10-100 tons: Annex VII + VIII
• 100-1000 tons: Annex VII + VIII + IX
• >1000 tons: Annex VII + VIII + IX + X
PS: Annex XI: general rules for adaptation of Annexes VII to X
Information Requirements
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Complete Dossiers in 2009*:
Notification
– 157 PPORDs
Registration
– 193 Isolated Intermediates
(41 on-site,
123 transported)
– 125 Registrations
Registered substances
* Numbers are given for submitted Dossiers between 5 January and 5
October
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= Set of pre-requisites that must be fulfilled before ECHA can establish whether the dossier can be handled properly and whether the required regulatory processes can be successfully carried out.
Three main criteria:
• Format - e.g. inquiry dossier in a registration template
• Administrative - e.g. registration update does not provide registration number
• Technical – REACH-IT cannot ‘understand’ the substance identifiers
Business rules
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ECHA experience: 'Business Rule’ failures:
• Initial vs. update submissions:
– Invalid previous reference numbers (submission no. and previous
communication no.) given in dossier header
• Regulatory identifiers:
– Invalid pre-registration/inquiry/registration numbers given in Section
1.3
• Confidentiality claim with no justification:
– Invoice is based on chargeable services. Without justification is it a
genuine claim or a mistake?
• Production site not defined (for a manufacturer):
– REACH-IT cannot determine the ‘relevant‘ Member State
Business rules
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Business rules
Further information: Data Submission Manual 8: Business Rules validation
Lists all Business rules and indicates how to avoid errors:
http://echa.europa.eu/doc/reachit/reachit_data_submission_manual_8_business
_rules_validation_20090417.pdf
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Technical Completeness
Reference substance information
• EC number
• CAS number and CAS name
• IUPAC name
• Molecular formula & Molecular weight range
• SMILES notation if available
• Structural formula
• Remarks if necessary
Type of substance
• Composition
(see Data Submission Manual 5)
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Technical Completeness
Substance
composition
• Degree of purity
• Reference substance
information
• Concentration
• Same rules for
impurities and
additives (if any)
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Technical Completeness
Regulatory identifier
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Technical Completeness
Analytical information
• Analytical methods
• Analytical results
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Technical Completeness
Name of joint submission
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Technical Completeness
If box “Only representative” is ticked in section 1.1:
you should attach clear documentation of the
appointment of the Only Representative
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• Section 2.1 (CLP regulation): all hazards have to be
addressed (classification and hazard statement OR
“Reason for no classification”).
• Don‘t forget Carcinogenicity and Specific target organ
toxicity (click on the green cross to create a new block);
Verify that Effects on or via lactation is also included
• Section 2.2: mandatory at the moment
Technical Completeness
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• Section 3.1 - Technological Process
• Section 3.2 – Estimated quantities (year and
tonnage)
• Section 3.3 – Sites (registrant‘s production and own
sites)
• Section 3.4 – Form in the supply chain
• Section 3.5 – Identified use, overall use and
exposure
• Section 3.6 – Uses advised against (if any)
• Section 3.7 – Waste from production and use (if any)
Technical Completeness
Manufacture, use and exposure
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Endpoint study records:
• Purpose flag
• Data waiving and Justification for data waiving
• Study result type
• Reference
• Data access
• Test guideline
• GLP
• Test materials
• Results and discussions
Endpoint summaries
• PNECs, D(M)NELs
Technical Completeness
Endpoints
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Technical Completeness
• Guidance on safe use
• First aid measures,
• Fire fighting
• …
• Chemical Safety Report ( > 10 tonnes
per year)
Data Submission Manual 5:
http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf
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ECHA recommendations
Endpoint study records: section 4-7
“Purpose flag”: all “key studies”, “weight of evidence”, “data waivers”
and “testing proposals” per endpoint have to be complete. This rule
applies for all endpoint study records in the dossier, also for isolated
intermediate dossiers.
TipTip: :
““SupportingSupporting
studiesstudies”” areare notnot
checkedchecked forfor
technicaltechnical
completenesscompleteness!!
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• Inconsistent information creates problems at TCC: “Key study (KS)"/
“Weight of evidence (WoE)” cannot not be “Data waiving (DW)” or
“Testing proposal (TP)” at the same time
– If you want to use DW or TP, then keep „Purpose flag” empty
– If you want to use WoE, either submit a DW and let „Purpose flag”
empty
– or select "WoE" in the "Purpose flag", let DW fields empty and provide
further information on the data used for the WoE.
ECHA recommendation
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• Verify that you have indeed
included confidential
information that shall be part
of the registration dossier
ECHA recommendations
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Data Submission Manual 5
Here you find information, which are minimum requirements for the
technical completeness under “Results and Discussion”
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Data Submission Manuals are available on ECHA website
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ECHA supports:
Questions and Answers for NONS:
• Tonnage band updates of NONS need to fully comply with REACH
• Includes information on how to update your confidentiality claims made
under Directive 67/548/EEC (Dangerous Substance Directive)!
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Supporting IT Tools:
TCC Tool for PPORD dossiers:http://iuclid.echa.europa.eu/index.php?fuseaction=hom
e.completenesscheck&type=public
Inquiry Dossier Preliminary Check Tool:http://iuclid.echa.europa.eu/index.php?fuseaction=hom
e.inquiry&type=public
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Supporting IT Tools:
TCC Tool for Registration Dossiers:
• It will offer the possibility to companies to check on their ownthe completeness before submitting to ECHA
• Tool is developed as a IUCLID 5 plug-in
• Release to the public at ECHA website before end 2009
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TCC tool - IUCLID 5 plug in:
Supporting IT Tools:
Select substance data set
or dossier
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Technical Completeness Check (TCC)
Link to data set
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ECHA supports:
ECHA plans a series of webinars for leadregistrants starting this autumn
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ECHA supports:
Contact ECHA - Helpdesk:
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ThankThank You You
for for youryour attentionattention