“Lo strumento di valutazione della completezza del Dossier ... · “Lo strumento di valutazione della completezza del Dossier di Registrazione (TCC)” “L’applicazione del

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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


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


Structure of a registration dossier

Dossier Preparation in

>10 tonnes:

Technical Dossier &

Chemical Safety Report

(CSR Tool)

1-10 tonnes:

Technical Dossier:


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


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


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


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


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)



Substance

composition

• Degree of purity

• Reference substance

information

• Concentration

• Same rules for

impurities and

additives (if any)



Regulatory identifier



Analytical information

• Analytical methods

• Analytical results



Name of joint submission



If box “Only representative” is ticked in section 1.1:

you should attach clear documentation of the

appointment of the Only Representative


• 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



• 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)


Manufacture, use and exposure


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


Endpoints



• 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


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!!


• 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


• Verify that you have indeed

included confidential

information that shall be part

of the registration dossier

ECHA recommendations


Data Submission Manual 5

Here you find information, which are minimum requirements for the

technical completeness under “Results and Discussion”


Data Submission Manuals are available on ECHA website


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)!


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



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


TCC tool - IUCLID 5 plug in:


Select substance data set

or dossier


Technical Completeness Check (TCC)

Link to data set


ECHA supports:

ECHA plans a series of webinars for leadregistrants starting this autumn


ECHA supports:

Contact ECHA - Helpdesk:


ThankThank You You

for for youryour attentionattention

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“Lo strumento di valutazione della completezza del Dossier ... · “Lo strumento di valutazione della completezza del Dossier di Registrazione (TCC)” “L’applicazione del