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26.2.2011 Official
Journal
of
the
European
Union L
53/51
COMMISSION REGULATION (EU) No 188/2011
of 25 February 2011
laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the
procedure for the assessment of active substances which were not on the market 2 years after the
date of notification of that Directive
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
HAS ADOPTED THIS REGULATION:
Article 1
Having regard to the Treaty on the Functioning of the European
Union,
Scope
This Regulation lays down detailed rules for the submission and
appraisal of applications for inclusion in Annex I to Directive
91/414/EEC of active substances which were not on the market
Having regard to Council Directive 91/414/EEC of 15 July
on 26 July 1993.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(5) thereof,
Article 2
Application
Whereas:
1. An
applicant
wishing
to
secure
the
inclusion
in
Annex
I
to Directive 91/414/EEC of an active substance covered by
Article 1 shall submit an application for that active substance
(1) It
is
necessary
to
adopt
rules
on
a
procedure
for
the to a Member State, hereinafter referred to as ‘rapporteur
submission and appraisal of applications for inclusion
Member State’, together with a summary dossier and a
in Annex I to Directive 91/414/EEC of active substances
complete dossier, as provided for in Article 3, or a scientifically
which were not yet on the market 2 years after the date
reasoned justification for not providing certain parts of those
of notification of that Directive. In particular periods
dossiers, demonstrating that the active substance fulfils the
should be set for the different steps of that procedure
criteria provided for in Article 5 of that Directive.
to ensure that they are carried out rapidly.
For the purposes of this Regulation ‘applicant’ means the person
who manufactures the active substance himself or who
(2) Additional
information
submitted
after
the
application contracts out the manufacturing to another party or a person
and the dossiers should only be taken into account if
designated by the manufacturer as his sole representative for the
it was requested by the European Food Safety Authority,
purpose of compliance with this Regulation.
hereinafter ‘the Authority’, or the rapporteur Member
State and submitted within the time period set.
2. When
submitting
his
application,
the
applicant
may,
pursuant to Article 14 of Directive 91/414/EEC, request
certain parts of the dossiers referred to in paragraph 1 of this
(3) As
regards
applications
submitted
before
the
entry
into
force of this Regulation transitional measures should be
Article to be kept confidential. The applicant shall explain for
provided for. In particular, it is appropriate to extend the
each document or each part of a document why it is to be
period which may be granted to the applicant to submit
considered as confidential.
additional information requested by the Authority or the
rapporteur Member State. As regards such applications, it
is further necessary to set periods for the circulation of
Member States shall assess the confidentiality requests. Upon a
the draft assessment report by the Authority and the
request for access to information, the rapporteur Member State
submission of comments by the Member States, other
shall decide what information is to be kept confidential.
than the rapporteur Member State, and the applicant.
The applicant shall submit separately the information to be kept
confidential.
(4) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
The applicant shall at the same time submit any claims for data
( 1 ) OJ L 230, 19.8.1991, p. 1.
protection pursuant to Article 13 of Directive 91/414/EEC.

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L 53/52
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Official Journal of the European Union
26.2.2011
Article 3
referred to in Article 2(2) and the list of tests and studies
submitted pursuant to Article 3(2).
Dossiers
1. The
summary
dossier
shall
include
the
following:
2. Where
one
or
more
of
the
elements
provided
for
in
(a) data with respect to one or more representative uses of at
Article 3 are missing, the rapporteur Member State shall
least one plant protection product containing the active
inform the applicant, setting a time period for their submission;
substance, demonstrating that the requirements of
such time period shall be no more than 3 months.
Article 5 of Directive 91/414/EEC are fulfilled;
3. Where at the end of the period, referred to in paragraph
(b) for each point of the data requirements for the active
2, the applicant has not submitted the missing elements, the
substance referred to in Annex II to Directive 91/414/EEC,
rapporteur Member State shall inform the applicant, the
the summaries and results of tests and studies, the name of
Commission and the other Member States that the application
their owner and of the person or institute that carried out
is rejected.
the tests and studies;
(c) for each point of the data requirements for the plant
4. Where
the
dossiers
submitted
with
the
application
contain
protection product referred to in Annex III to Directive
all the elements provided for in Article 3, the rapporteur
91/414/EEC, the summaries and results of tests and
Member State shall notify the applicant, the Commission, the
studies, the name of their owner and of the person or
other Member States and the European Food Safety Authority,
institute that carried out the tests and studies relevant to
hereinafter ‘the Authority’, of the completeness of the appli
the assessment of the criteria referred to in Article 5 of that
cation. After receiving that notification, the applicant shall
Directive taking into account that data gaps in a dossier, as
immediately forward those dossiers to the other Member
set out in Annex II or Annex III to that Directive, resulting
States, the Commission and the Authority, including the
from the proposed range of representative uses, may lead to
information about those parts of the dossiers in respect of
restrictions in the inclusion in Annex I to that Directive;
which confidentiality has been requested as referred to in
Article 2(2).
(d) a checklist demonstrating that the dossier provided for in
paragraph 2 is complete;
5. Within 4 months from the date of receipt of the notifi
cation referred to in paragraph 4, a decision shall be adopted in
accordance with Article 6(3) of Directive 91/414/EEC estab
(e) the reasons why the test and study reports submitted are
lishing that the dossiers submitted fulfil the requirements of
necessary for inclusion of the active substance concerned;
Annexes II and III to that Directive, hereinafter ‘completeness
decision’.
(f) an assessment of all information submitted;
Article 5
(g) where relevant, a copy of an application for a residue level
Submission of information by third parties
as referred to in Article 7 of Regulation (EC) No 396/2005
of the European Parliament and of the Council ( 1 ) or a
1. Any person or Member State wishing to submit to the
justification for not supplying such copy of an application.
rapporteur Member State information which might contribute
to the assessment, in particular with regard to the potentially
dangerous effects of the active substance or its residues on
2. The
complete
dossier
shall
contain
the
full
text
of
the human and animal health and on the environment shall do
individual test and study reports concerning all the information
so, without prejudice to Article 7 of Directive 91/414/EEC,
referred to in points (b) and (c) of paragraph 1 with a list of
no later than 3 months after a completeness decision for the
those tests and studies.
active substance concerned has been published.
Article 4
2. The rapporteur Member State shall immediately
Completeness check of the dossiers
communicate any information received from third parties to
the Authority and the applicant.
1. Within
3
months
from
receiving
the
application,
the
rapporteur Member State shall check whether the dossiers
submitted with the application contain all the elements
provided for in Article 3, using the checklist referred to in
3. The applicant may submit its comments on the
Article 3(1)(d). It shall also check the requests for confidentiality
information referred to in paragraph 2 to the rapporteur
Member State and to the Authority at the latest 2 months
( 1 ) OJ L 70, 16.3.2005, p. 1.
after receiving that information.

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26.2.2011 Official
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Article 6
the other Member States within 30 days from its receipt. Where
within this 30-day period the Authority does not receive the
Assessment by the rapporteur Member State
dossier provided for in Article 6(1) it shall circulate that report
1. Within 12 months from the date of publication of the
as soon as it receives that dossier.
completeness decision, the rapporteur Member State shall
prepare and submit to the Commission, with a copy to the
Authority, a report assessing whether the active substance can
be expected to fulfil the conditions provided for in Article 5 of
The period for the submission of written comments to the
Directive 91/414/EEC, hereinafter referred to as ‘draft
Authority from Member States and the applicant shall be 2
assessment report’. It shall at the same time inform the
months.
applicant that the draft assessment report has been submitted
and request him to immediately forward to the Authority, the
other Member States and the Commission the updated dossiers,
where applicable.
2. The
Authority
shall
make
the
draft
assessment
report
available to the public, excluding any information in respect
of which confidential treatment has been requested and
justified by the applicant in accordance with Article 14 of
2. The
rapporteur
Member
State
may
consult
the
Authority.
Directive 91/414/EEC.
3. Where the rapporteur Member State needs additional
It shall grant a period of 2 weeks to the applicant to request
information, it shall request it from the applicant setting a
confidential treatment.
period of up to 6 months for it to be supplied. The rapporteur
Member State shall inform the Commission and the Authority.
In its assessment the rapporteur Member State shall only take
into account information which was requested and submitted
Article 8
within the period granted.
Conclusion by the Authority
1. Within
4
months
from
the
end
of
the
period
provided
for
In cases where the rapporteur Member State requests additional
the submission of written comments, the Authority shall adopt
information, the 12-month period provided for in paragraph 1
a conclusion on whether the active substance can be expected
for the submission of the draft assessment report shall be
to meet the conditions provided for in Article 5 of Directive
extended by the period granted by the rapporteur Member
91/414/EEC and shall communicate it to the applicant, the
State for the submission of the additional information. If the
Member States and the Commission and shall make it
requested information is submitted to the rapporteur Member
available to the public.
State before the end of the period granted the extension shall
correspond to the part of that period actually used.
Where appropriate, the Authority shall address in its conclusion
the risk mitigation options in relation to the intended uses set
4. Where at the end of the period referred to in the first
out in the draft assessment report.
subparagraph of paragraph 3, the applicant has not submitted
all of the additional information requested in accordance with
paragraph 1, the rapporteur Member State shall inform the
applicant, the Commission, the other Member States and the
2. The
Authority
shall,
where
appropriate,
organise
a
con
Authority and shall state the missing elements in the draft
sultation of experts, including experts from the rapporteur
assessment report.
Member State.
5. If,
after
giving
the
applicant
an
opportunity
to
comment, In that case the 4-month period for the adoption of the
the Commission determines that the applicant has failed to
conclusion, as set out in paragraph 1, shall be extended by 2
submit elements necessary for the assessment referred to in
months.
paragraph 1, it shall adopt a decision in accordance with
Article 9(2)(b), providing that the active substance concerned
is not to be included in Annex I to Directive 91/414/EEC.
3. Where
the
Authority
needs
additional
information,
it
shall,
in consultation with the rapporteur Member State, set a period
of a maximum of 3 months for the applicant to submit that
Article 7
information to the Member States, the Commission and the
Circulation of and access to the draft assessment report
Authority. It shall inform the applicant, the Commission and
the Member States. In respect of applications for which a
1. The
Authority
shall
circulate
the
draft
assessment
report completeness decision was published by 31 December 2005,
received from the rapporteur Member State to the applicant and
the maximum period shall be 5 months.

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L 53/54
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4. Within 2 months after receipt of the additional
Article 10
information the rapporteur Member State shall assess that
information and submit an addendum to the draft assessment
Access to the review report
report to the Authority. In respect of applications for which a
The finalised review report, excluding any parts which refer to
completeness decision was published by 31 December 2005,
confidential information contained in the dossiers and
that period shall be 3 months.
determined as such in accordance with Article 14 of Directive
91/414/EEC, shall be made available to the public.
5. Where
the
Authority
requests
additional
information
in
accordance with paragraph 3, the period from the date of
Article 11
that request to the date of the submission of the addendum
to the draft assessment report shall not be taken into account
Transitional measures
for the calculation of the period for the adoption of the
1. Articles
2,
3
and
Article
4(1)
shall
not
apply
to
appli
conclusion, as provided for in paragraphs 1 and 2.
cations for inclusion of active substances in Annex I to
Directive 91/414/EEC for which the application was received
by the rapporteur Member State by 17 March 2011 but for
which no completeness check had been made by that date.
6. In
its
conclusion
the
Authority
shall
only
take
into
account additional information requested by it or by the
rapporteur Member State and submitted within the period
granted.
For such applications the rapporteur Member State shall
perform the completeness check provided for in Article 4(1)
by 18 June 2011 at the latest.
7. The Authority shall establish the format for its conclusion
which shall include details concerning the appraisal procedure
and the properties of the active substance concerned.
2. Articles 2, 3 and 4 shall not apply to applications for
inclusion of active substances in Annex I to Directive
91/414/EEC for which the dossier was referred to the
Committee in accordance with Article 6(2) of that Directive
Article 9
by 17 March 2011 but for which no completeness decision
Presentation of a draft act
had been adopted by that date.
1. The
Commission
shall,
at
the
latest
6
months
after
receipt
of the conclusion of the Authority, submit to the Standing
Committee on the Food Chain and Animal Health, hereinafter
For such applications a completeness decision shall be adopted
‘the Committee’, a draft review report to be finalised at its
in accordance with Article 6(3) of Directive 91/414/EEC by
meeting.
18 July 2011.
The applicant shall be given the possibility to submit comments
3. Articles 2, 3 and 4 shall not apply to applications for
on the draft review report within a period, of up to 30 days, set
inclusion of active substances in Annex I to Directive
by the Commission.
91/414/EEC for which a completeness decision was adopted
but not published by 17 March 2011.
2. On the basis of the draft review report and taking into
account any comments submitted by the applicant within the
4. Articles 2 to 6 shall not apply to applications for
period set by the Commission in accordance with paragraph 1,
inclusion of active substances in Annex I to Directive
an act shall be adopted in accordance with the procedure
91/414/EEC for which a completeness decision was published
referred to in Article 19(2) of Directive 91/414/EEC,
by 17 March 2011 but no draft assessment report had been
providing that:
submitted to the Commission by that date.
(a) an active substance is included in Annex I to Directive
For such applications the rapporteur Member State shall prepare
91/414/EEC subject to conditions and restrictions, where
and submit the draft assessment report to the Commission, with
appropriate;
a copy to the Authority by 18 March 2012. It shall at the same
time inform the applicant that the draft assessment report has
been submitted and request him to immediately forward to the
Authority, the other Member States and the Commission the
(b) an active substance is not included in Annex I to that
updated dossiers, where applicable. Article 6(2) to (5) shall
Directive.
apply mutatis mutandis.

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5. Articles 2 to 6 and the first subparagraph of Article 7(1)
7. The
Commission
shall
set,
and
publish
on
its
website,
the
shall not apply to applications for which the draft assessment
dates for the circulation of the draft assessment reports referred
report had been received by the Authority but not circulated to
to in paragraphs 5 and 6. Where a draft assessment report has
the applicant and the other Member States for comments by
been updated, as provided for in paragraph 6, it shall be
17 March 2011.
circulated as updated. The Commission shall at the same time
set, and publish on its website, the dates for the submission of
comments thereon.
6. By
way
of
derogation
from
paragraph
5,
for
applications
for which the draft assessment report had been submitted to the
Article 12
Commission and the Authority by 31 December 2009 at the
latest, Articles 2 to 6 and the first subparagraph of Article 7(1)
Fees
shall not apply. In such cases, the following procedure shall
apply.
1. Member
States
may
recover
the
costs
associated
with
any
work they carry out within the scope of this Regulation, by
means of fees or charges.
By 18 April 2011, the rapporteur Member State shall request
the applicant to inform that Member State and the Authority,
2. Member States shall ensure that the fees or charges
within 1 month, in case the applicant considers that
referred to in paragraph 1:
information that had not been submitted for the preparation
of the draft assessment report and that might influence the
outcome of the assessment, is available, specifying the nature
(a) are established in a transparent manner; and
of that information and its possible influence on the assessment.
(b) correspond to the actual total cost of the work involved
except if it is in public interest to lower the fees and
Within 2 months from receiving the reply of the applicant, the
charges.
Authority shall decide whether that information might influence
the outcome of the assessment. If so, the Authority shall,
without undue delay, ask the rapporteur Member State to
Article 13
request the submission of that information by the applicant.
The rapporteur Member State shall update the draft assessment
Other charges, levies or fees
report where appropriate in the light of that information.
Article 12 is without prejudice to Member States rights to
maintain or introduce, in accordance with the Treaty, charges,
levies or fees with regard to the authorisation, placing on the
The Authority shall set a period of up to 6 months for the
market, use and control of active substances and plant
rapporteur Member State to prepare and submit to the
protection products other than the fee provided for in that
Commission that updated draft assessment report, with a
Article.
copy to the Authority. It shall at the same time inform the
applicant that the draft assessment report has been submitted
and request him to immediately forward to the Authority, the
Article 14
other Member States and the Commission the updated dossiers,
Entry into force
where applicable. Article 6(2) to (5) shall apply mutatis mutandis,
whereby the period referred to in the first subparagraph of
This Regulation shall enter into force on the 20th day following
Article 6(3) shall not exceed 3 months.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 February 2011.
For the Commission
The President
José Manuel BARROSO

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