reachFactsheet

ECHA-13-FS-05-EN

Follow up to dossier evaluation decisions

Dossier evaluation is designed to produce
further information on registrations,which do not yet comply with REACH
requirements. The examination of thedossier updates following a dossier
evaluation decision is the ﬁnal step of dossierevaluation. Firstly, it is to ensure that thecompliance with the issues addressed by the
dossier evaluation decision is achieved by
the registrant. Secondly, it is to identify andpossibly address issues arising from the new
information submitted.

The compliance check, initiated by ECHA, and thetesting proposal examination, initiated by theregistrant, may lead to decisions requesting further
information by a deadline. ECHA expects to receive
the information requested at the latest by thedeadline set in a registration dossier update. The
Agency will examine any information submitted inconsequence of a dossier evaluation decision. Oncethe dossier evaluation is completed, ECHA notiﬁes
the Commission and Member State competentauthorities of the information obtained andconclusions made.

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PROCESSECHA starts the follow-up step of the dossier
evaluation process when the deadline set in thedossier evaluation decision has expired.
ECHA investigates if the information requested in
the decision is provided in the latest dossier update.
ECHA’s dossier evaluation decisions – in order tobe enforceable – foresee speciﬁc methods andspeciﬁcations for how information requirements
should be fulﬁlled. For example, in cases wherea registrant has provided a study in response toan ECHA decision, ECHA inter alia establishes
whether the study has been performed according
to the speciﬁed test method, with the requested
substance, and whether a proper (robust) study
summary has been provided. ECHA also checks
whether conclusions of the registrant based on thenew information are reasonable.
Once it has been established, whether the
information requested has been provided or not, theoutcome is recorded in the appropriate outcome
documents.
OUTCOME
If the registrant updates its dossier withinformation that is assessed by the ECHA
Secretariat to comply with the information requiredin the Agency’s decision, an Article 42(2) notiﬁcationis sent to the MSCA concerned and to the European
Commission informing them of this fact. If theregistrant deviated from the information requested
in the decision, but still ensured compliance withthe relevant requirements of the REACH Regulation
by an alternative method or another adaptationargument (e.g. test not technicallypossible), ECHA will consider thedeviation from the request as
acceptable (see also the section“reminder for registrants” forthe documentation needed insuch cases).
If no update isreceived or the update
is assessed as
inadequate for anyof the requests in
the Agency’s decision,a “statement of non-compliance following a dossier evaluation decision”
is sent to the Member State concerned and theregistrant. This is a documentation of the ECHA
Secretariat’s assessment that a registrant did notcomply within the deadline set with one or moreof the information requests in this decision. The
statement is a communication package consisting ofa notiﬁcation letter addressing the legal backgroundand the assessment that the information request
was partly or not fulﬁlled, an attachment withthe scientiﬁc facts, the original notiﬁcation anddecision, and any relevant communication with theregistrant after the decision was submitted. TheArticle 42(2) notiﬁcation is kept on hold until all
requests of the decision have been satisfactorily
addressed by the registrant.
If the registrant complies with the Agency’s decisionbut other concerns regarding the same information
requirement are identiﬁed by the registrant or
the Agency, the Agency may issue a new dossier
evaluation decision pursuant to Article 42(1) of theREACH Regulation.
In addition, if an update is received that complies
with the Agency’s decision but new concerns withother information requirements are identiﬁed as aresult of the information received, the Agency may
open a new compliance check procedure on the basisof Article 41 of the REACH Regulation.
MEMBER STATE ACTIONS
The follow-up step in the dossier evaluation process
forms one of the interfaces between ECHA, theMember State competent authorities (MSCAs)
and the national enforcement authorities (NEAs),respectively.
The Article 42(2) notiﬁcation informs the MemberStates and the Commission of the results of thedossier evaluation. MSCAs may use this newinformation for the purposes of other REACH or CLP
processes (i.e. substance evaluation, authorisation,restriction, or harmonised classiﬁcation andlabelling).
The enforcement responsibility is attributed solely
to the Member States (REACH Title XIV). If theissue(s) covered by a decision are not addressed by
the deadline, ECHA informs the Member States ofthis fact through a “statement of non-compliancefollowing a dossier evaluation decision”. Its purpose

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is to support national enforcement actions andtherefore it is addressed to the relevant NEA andto the MSCA. The national authorities are asked toaddress the issues identiﬁed by ECHA in their own
competence and, if found appropriate, to adopt
enforcement measures. The registrant receives acopy so that all actors have the same starting point.
Once the case has been handed over to the nationalauthorities, ECHA expects that any further
communication on the case will be between theMember State authorities and the registrant.
A communication system has been set up toallow ECHA and the Member States to exchange
information on such cases. This allows ECHA toplan the examination of dossier udpates in theappropriate time once the missing information has
been provided in a dossier update.
COMMUNICATION WITH REGISTRANTS AFTERADOPTION OF A DOSSIER EVALUATION DECISION
Unless an appeal is ﬁled, a legally binding decision
is in place and ECHA’s possible actions in such cases
are limited.
Where registrants seek clariﬁcation on theirobligations pursuant to the decision, such help canbe provided by ECHA in the form of contextual
guidance useful for the execution of the decision.
The ECHA Helpdesk should be contacted for suchcases and concrete questions should be posed. The
decision content cannot be changed by ECHA.
In some cases, registrants would like to discuss
whether the way they want to fulﬁl the information
requirements is acceptable (e.g. by using generalor speciﬁc adaptations). ECHA cannot provide
advice or comments on any alternative strategies
or approaches that the registrant considers to use
to fulﬁl the request in the decision. As mentioned,the ECHA Secretariat only starts its assessment
as to whether a registration dossier complied with
the information requests in the decision when thedeadline has passed, and based on the latest versionof the registration dossier.
In some cases, registrants ask ECHA to postpone
the deadline for various reasons. ECHA does nothave the authority to alter the deadline speciﬁedin the decision since that deadline has been agreed
unanimously by the Member States. Furthermore,
the REACH Regulation does not provide for thepostponement of the deadline of a decision on
dossier evaluation.
Once a “statement of non-compliance following
a dossier evaluation decision” has been sent, theregistrant should communicate with the nationalauthorities.
REMINDERS FOR REGISTRANTS
Registrants must submit the information requested
in a dossier evaluation decision as soon as theyreceive that new information (Article 22(1)) andat the latest by the deadline set. If the decision
requests the generation of new hazard information,
the information submitted should also comply with
Article 10 of the REACH Regulation (submission of(robust) study summaries). The update of the dossiershould also include any changes to the registration
dossier that are in light of this new information
required pursuant to REACH (e.g. with regard toclassiﬁcation and labelling, the chemical safety
report, or submission of testing proposals).

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If registrants encounter difﬁculties in submitting
the requested information in due time, they
are encouraged to update their registration
dossier at the latest by the given deadline and,if necessary, include any relevant explanations
and proof concerning the status and timing ofpending information requirements so that these
explanations can be considered by the relevant
national enforcement authorities.

MORE INFORMATION
Evaluation and its steps
http://echa.europa.eu/regulations/reach/evaluation/steps
Procedure on dossier evaluation
http://echa.europa.eu/documents/10162/13607/
procedure_dossier_evaluation_20110329_en.pdf
ECHA Helpdesk
http://echa.europa.eu/support/helpdesks/echahelpdesk© European Chemicals Agency - October 2013

annankatu 18 , p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu

ED-03-13-542-EN-N - DoI: 10.2823/21340 - ISBN: 978-92-9244-096-1

Registrants may, under their own responsibility
and risk, decide to fulﬁl the information
requirements in an alternative way than requested
in the decision. Thus, notwithstanding the dossier
evaluation decision, registrants may seek to
fulﬁl the information gap identiﬁed by ECHA
in the dossier evaluation decision by providing
justiﬁed adaptations of the standard information
requirements. For instance, they might predictthe results of the requested study by using
information from a structurally similar substance(read-across). The use of such adaptations to thestandard information requirements must fulﬁlthe rules outlined in Annexes VI to X and/or thegeneral rules in Annex XI. Any adaptation needs tobe accompanied by sound scientiﬁc reasoning anddocumented comprehensively and transparently. If
these conditions are not met, the adaptation would
not be accepted by ECHA and a “statement of noncompliance following a dossier evaluation decision”
would be issued.