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Helsinki, 11/03/2015
Doc. CA/11/2015
17th Meeting of Competent Authorities for REACH and CLP
(CARACAL)
Open Session
26-27 March 2015
Room Sicco Mansholt (MANS), Building CHARLEMAGNE,
Brussels, Belgium
Concerns:
Update on the technical completeness check
process
Agenda Item:
Point 27
Action requested:
For information and discussion.
The CARACAL Member States are invited to take
note of this document for discussion.
This note informs on the progress made and
invites the CARACAL to provide comments by 27
April 2015 to Annika Malkia
([email protected])
Summary
In line with its work programme 2014, and further to the document submitted to the
CARACAL meeting of July 2014, ECHA has undertaken the review of the
completeness check process, both by reinforcing the completeness check rules and
by considering a manual verification for certain data requirements.
Background
The work carried out by ECHA on the completeness check of the registration dossiers
is in accordance with the intention expressed in the work programme 20141:
“ECHA will review the completeness check process based on the experience of the
first two registration deadlines and the outcome of screening and evaluation
activities. The review will address whether more information should be verified
and/or whether the information in the dossier should be presented differently. Based
on the outcome of this work, a plan for upgrading the technical completeness check
process will be prepared, as needed”.
This work has been undertaken as described in the work programme and the
following aspects were considered:
Stream 1
•
Review on how the information should be presented in the dossier, i.e. review
of the IUCLID data format
•
Based on this review, upgrade of the automated completeness check routines
Stream 2
•
Possibility of manual verification of certain requirements outside the reach of
automated rules
Regarding the first stream, the CARACAL were informed in its 15th meeting held in
July 2014 (CA/45/2014).
Important drivers for revisiting the IUCLID format and the completeness check
included:
•
Ensure that registrations are not accepted with inconsistencies or data gaps
which are not appropriately justified.
•
Address industry and authorities’ comments that, for certain information
requirements, there was a lack of clarity on how the information should be
provided. This especially concerns the substance identity sections, the use
description, the description of the test material used in the studies, and the
justification for deviating from standard requirements.
It is important to stress that the information requirements do not change. However,
the improvement of the data format and of the verifications conducted at
completeness check will make more explicit to the registrants how a dossier should
be filled in and which data should be present.
This will also greatly help the understanding and the assessment of the information
by ECHA and the Member States Competent Authorities. Finally, this should also
enhance the availability of high quality information published on the ECHA website.
Progress on the data format and the completeness check rules
IUCLID data format
The OECD Harmonised Templates (OHT) constitute the backbone of the IUCLID
format. For IUCLID 6, the hazard OHTs have been reviewed, and a new harmonised
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http://echa.europa.eu/documents/10162/13608/final_mb_39_2013_wp_2014_en.pdf
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template has been proposed for reporting the use and exposure information. The
review process has been coordinated by the OECD. Stakeholders from OECD
countries, as well as industry associations have been broadly consulted in this
context. The revised and new OHTs were endorsed by the OECD Joint Meeting in
February 2015.
The revised OHTs will be the basis for the data format of IUCLID 6 which will be
released in 2016. IUCLID 6 will be the format to be used for further submissions to
ECHA after that REACH-IT 3 is released by mid-2016.
Completeness check rules
By installing IUCLID 6, all the data and dossiers stored in the users’ own databases
will be automatically migrated to the new IUCLID 6 format.
ECHA is currently developing the migration rules, i.e. defining where the information
entered in a IUCLID 5 field is migrated to in the new IUCLID 6 format.
In parallel to preparing the migration rules, ECHA is also reviewing the completeness
check rules. The objective is that the new rules verify much better if companies have
provided the essential information to fulfil the requirements. The rules will be made
available to registrants as part of the Validation assistant tool, which will be released
with IUCLID 6 in 2016. The main purpose of this review is to ensure availability of
information, either in the form of data addressing the requirements or as justified
waiving, and to avoid the possibility of registrants passing the completeness check
without such information.
Impact on registrations
New registrations
The burden on preparing new registration dossiers is not increased; improved format
and refined rules do not mean more complexity. On the contrary, data entry has
been clarified in order to avoid some ambiguity that could exist in the IUCLID 5
format. The improved format, together with the Validation assistant tool (containing
both completeness check rules, business rules, and quality rules) are expected to
facilitate that new dossiers are generated to higher standards already from the first
submission.
Updates of existing registrations
Companies will not be required to update all of their dossiers in one go after
migration to the new format. Only those dossiers that are pending to be updated
either on a voluntary basis due to availability of new information in accordance with
REACH Article 22(1), further to an evaluation decision, or following another type of
request from ECHA are impacted by the new version of the rules.
While migration rule development is still ongoing, ECHA can share preliminary
results of the impact analysis. The work has progressed for about 20% and so far it
seems that in practice, dossiers that were complete in IUCLID 5 (i.e. containing the
appropriate data or waiving), will generally be complete in IUCLID 6.
For certain sections however, the following conditions should be fulfilled for adequate
migration and minimal impact of the change in completeness check rules:
•
Substance identification: Full concentration ranges are provided and required
analytical results are attached. If not available, adequate justification should
be provided. Note that many companies already updated their dossiers with
the concentration ranges following the information letter campaign in 2014.
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•
Test material information: Test materials have been explicitly identified either
by reference to section 1 (i.e. test material is the same as registered
substance), or by provision of standard identifier(s).
•
Results have been reported in the designated table(s).
One area where an impact is foreseen is the use of (Q)SAR and read-across
approaches to fulfil information requirements. In IUCLID 5 the rationale for using
these non-test approaches has been provided in varying locations of the dossier,
making its assessment difficult. Since robust and reliable documentation is key to
validate the obtained results, in IUCLID 6, the hazard templates contain a new
structure to document/justify non-standard information, and it is proposed that this
location should be checked by the completeness check for the specific types of study
records. For this reason, the migration of existing justification may have to be done
manually by registrants. ECHA is currently analysing the potential impact of this (i.e.
checking the full database to verify the number of dossiers concerned).
In general, for all rule proposals where a potential impact may exist (i.e. migration
cannot completely address the modified rule), ECHA is carrying out an analysis of
the database to quantify the proportion of dossiers impacted, to be used in assessing
the proportionality of adding the requirement.
Other aspects
In addition, analysis work is ongoing in relation to the completeness check on use
and exposure information. This section is important for the (de-)prioritisation of
substances for subsequent risk management work (e.g. prioritisation for the
candidate list). ECHA will carefully analyse to what extent completeness check rules
will be applied to this section.
Manual verification of certain data requirements
The objective of the manual verification is to ensure that when deviating from
required information, registrants submit meaningful information in their dossiers. It
aims at verifying that the omission of, or deviation from, the expected information is
accompanied by a robust justification.
The proposed manual verification entails no assessment of the quality and adequacy
of the justification, but a verification of its relevance for the deviation (does it refer
to a scientific or technical reasoning). The verification will be carried out in a
standardised manner to ensure consistency of outcomes.
Next steps
ECHA is starting the development of IUCLID 6 based on the revised format recently
endorsed by the OECD Joint Meeting. The development of the migration rules of the
revised IUCLID format and of the completeness check rules will continue in parallel.
One or two technical meetings with stakeholders are envisaged to discuss specific
topics. These meetings will be organised in Q2 and Q3/2015.
ECHA is also carrying out a cost/benefit analysis for implementing a manual
verification during the registration process.
The full approach on completeness check should be concluded at the June meeting of
ECHA Management Board.
The intention is to publish an information package on the expected changes and
their impact by Q4/2015.
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