HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 252/26
EN
Official Journal of the European Union
19.9.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 844/2012
of 18 September 2012
setting out the provisions necessary for the implementation of the renewal procedure for active
substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the
Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(11) Rules
should be set out to ensure an independent,
objective and transparent assessment of the active
Having regard to the Treaty on the Functioning of the European
substance.
Union,
(12) The applicant, the Member States, with the exception of
Having regard to Regulation (EC) No 1107/2009 of the
the rapporteur Member State, and the public should be
European Parliament and of the Council of 21 October 2009
given the opportunity to submit comments on the draft
concerning the placing of plant protection products on the
renewal assessment report.
market and repealing Council Directives 79/117/EEC and
91/414/EEC (
(13) The
European
Food Safety
Authority
should
provide

1 ), and in particular Article 19 thereof,
conclusions and organise consultations of experts,
Whereas:
except where the Commission informs it that a
conclusion is not necessary.
(1) Regulation
(EC)
No
1107/2009
provides
that
the
approval of an active substance may be renewed upon
(14) Rules
should
be
set
out
as
regards
the
renewal
report
and
the adoption of a regulation on the renewal of the
expiry.
approval of the active substance.
(2)
It is appropriate to set out the provisions necessary for
(15) Commission Regulation (EU) No 1141/2010 of
the implementation of the renewal procedure.
7 December 2010 laying down the procedure for the
renewal of the inclusion of a second group of active
(3)
In particular, periods should be set for the different steps
substances in Annex I to Council Directive 91/414/EEC
of the renewal procedure to ensure that it functions
and establishing the list of those substances ( 2 ) should
properly.
continue to apply with respect to the renewal of the
approval of the active substances listed in Annex I
(4) Rules
should
be
set
out
as
regards
confidentiality
and
the
thereto.
publication of the application for renewal, the supple
mentary dossiers and their updates.
(16) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(5)
Rules should also be set out as regards the submission of
Committee on the Food Chain and Animal Health,
the application for renewal and its contents and format.
The applicant should be obliged to justify the submission
HAS ADOPTED THIS REGULATION:
of new information and to list separately studies
concerning vertebrate animals that they intend to submit.
CHAPTER 1
ADMISSIBILITY
(6) Rules
should
be
set
out
as
regards
the
checking
of
the
application by the rapporteur Member State.
SECTION 1
Application for renewal
(7)
In order to ensure the proper functioning of the renewal
procedure, the rapporteur Member State should, at the
Article 1
applicant’s request, organise prior to the submission of
the supplementary dossier, a meeting to discuss the
Submission of the application
application.
1. An application for the renewal of an approval of an active
substance shall be submitted by a producer of the active
(8) The
supplementary
dossiers
submitted
for
renewal substance to the rapporteur Member State, as set out in the
should, in particular, include necessary new data and
second column of the Annex to Commission Implementing
new risk assessments and demonstrate why such data
Regulation (EU) No 686/2012 ( 3 ) and to the co-rapporteur
and risk assessments are necessary.
Member State, as set out in the third column of that Annex,
no later than three years before the expiry of the approval.
(9) Rules
should
be
set
out
as
regards
the
establishment
of
the admissibility of the application by the rapporteur
When submitting an application, the applicant may, pursuant to
Member State.
Article 63 of Regulation (EC) No 1107/2009, request certain
information to be kept confidential. In that event, the applicant
(10) Where
all
applications
submitted
are
inadmissible,
the
shall present such parts of the application physically separated,
Commission should adopt a Regulation on the non-
setting out the reasons for requesting confidentiality.
renewal of the active substance concerned.
( 2 ) OJ L 322, 8.12.2010, p. 10.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 3 ) OJ L 200, 27.7.2012, p. 5.

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19.9.2012 Official
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Union L
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At the same time, the applicant shall submit any data protection
the Commission, the other Member States and the Authority
claims pursuant to Article 59 of Regulation (EC) No
that the application is inadmissible and of the reasons why it is
1107/2009.
inadmissible.
2. The
applicant
shall
send
a
copy
of
the
application
to
the 4. Within
14
days
from
the
date
of
receipt
of
the
Commission, the other Member States and to the European
information that the application has been submitted by the
Food Safety Authority (‘the Authority’), including the
date provided for in the first subparagraph of Article 1(1) and
information on those parts of the application in respect of
that it contains all the elements provided for in Article 2, the
which confidentiality has been requested as referred to in
applicant shall submit to the Authority a copy of the appli
paragraph 1.
cation, including the information about those parts of the appli
3. A
joint
application
may
be
submitted
by
an
association
of cation in respect of which confidentiality has been requested
producers designated by the producers for the purpose of
and justified by the applicant pursuant to Article 63 of Regu
compliance with this Regulation.
lation (EC) No 1107/2009.
Article 2
At the same time, the applicant shall forward a copy of the
application to the Authority, excluding any information in
Format and contents of the application
respect of which confidentiality has been requested and
justified by the applicant pursuant to Article 63 of Regulation
1. The
application
shall
be
submitted
in
the
format
set
out
in (EC) No 1107/2009.
the Annex.
2. The application shall list the new information the
5. Where,
by
the
date
provided
for
in
the
first
subparagraph
applicant intends to submit. It shall demonstrate that such
of Article 1(1), two or more applications for the same active
information is necessary in accordance with the first
substance have been submitted separately and each of them
subparagraph of Article 15(2) of Regulation (EC) No
contains all the elements provided for in Article 2, the
1107/2009.
rapporteur Member State shall communicate the contact
details of each applicant to the other applicant(s).
The application shall list separately any new studies involving
vertebrate animals that the applicant intends to submit.
6. The
Commission
shall
publish,
for
each
active
substance,
the names and the addresses of the applicants whose appli
Article 3
cations have been submitted by the date provided for in the
first subparagraph of Article 1(1) and contain all the elements
Checking of the application
provided for in Article 2.
1. Where the application has been submitted by the date
provided for in the first subparagraph of Article 1(1) and
Article 4
contains all the elements provided for in Article 2, the
Contacts prior to submission of supplementary dossiers
rapporteur Member State shall, within one month of the date
of receipt of the application, inform the applicant, the co-
The applicant may request a meeting with the rapporteur
rapporteur Member State, the Commission and the Authority
Member State and the co-rapporteur Member State to discuss
of the date of receipt of the application and the fact that it has
the application.
been submitted by the date provided for in the first
If requested, such pre-submission contacts shall take place prior
subparagraph of Article 1(1) and contains all the elements
to the submission of supplementary dossiers, as provided for in
provided for in Article 2.
Article 6.
The rapporteur Member State shall assess any request for
confidentiality. Upon a request for access to information, the
Article 5
rapporteur Member State shall decide what information is to be
Access to the application
kept confidential.
Upon receipt of the application, as provided for in Article 3(4),
2. Where the application has been submitted by the date
the Authority shall make it available to the public without
provided for in the first subparagraph of Article 1(1) but one
delay, excluding any information in respect of which confiden
or more elements provided for in Article 2 are missing, the
tiality has been requested and justified by the applicant pursuant
rapporteur Member State shall, within one month of the date
to Article 63 of Regulation (EC) No 1107/2009, unless there is
of receipt of the application, inform the applicant which
an overriding public interest in its disclosure.
elements are missing and set a period of 14 days for the
submission of those elements to the Rapporteur Member
SECTION 2
State and to the co-rapporteur Member State.
Supplementary dossiers
Where the application contains all the elements provided
Article 6
for in Article 2 at the expiry of that period, the rapporteur
Member State shall, without delay, proceed in accordance
Submission of supplementary dossiers
with paragraph 1.
1. Where
the
rapporteur
Member
State
has
informed
the
3. Where the application has not been submitted by the date
applicant in accordance with Article 3(1) that its application
provided for in the first subparagraph of Article 1(1), or where
has been submitted by the date provided for in the first
the application still does not contain all the elements provided
subparagraph of Article 1(1) and that it contains all the
for in Article 2 at the expiry of the period set for the
elements provided for in Article 2, the applicant shall submit
submission of the missing elements in accordance with
the supplementary dossiers to the rapporteur Member State, the
paragraph 2, the rapporteur Member State shall, without
co-rapporteur Member State, the Commission and the Auth
delay, inform the applicant, the co-rapporteur Member State,
ority.

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L 252/28
EN
Official Journal of the European Union
19.9.2012
2. The
contents
of
the
supplementary
summary
dossier
and
(f) for each point of the data requirements for the plant
the supplementary complete dossier shall comply with Article 7.
protection product, as set out in a Regulation setting out
data requirements for plant protection products under
3. The
supplementary
dossiers
shall
be
submitted
no
later
Regulation (EC) No 1107/2009, for which new data are
than 30 months before the expiry of the approval.
necessary in accordance with point (d), the summaries and
results of tests and studies, the name of their owner and of
4. Where
there
is
more
than
one
applicant
requesting
the person or institute that has carried out the tests and
renewal of the approval of the same active substance, those
studies, for one or more plant protection products which
applicants shall take all reasonable steps to submit their
are representative of the supported uses, and the reason
dossiers jointly.
why each test or study is necessary;
Where such dossiers are not submitted jointly by all the
(g) where relevant, documented evidence as referred to in
applicants concerned, the reasons shall be set out in the
Article 4(7) of Regulation (EC) No 1107/2009;
dossiers.
(h) for each test or study involving vertebrate animals, a
5. When submitting the supplementary dossiers, the
description of the steps taken to avoid animal testing on
applicant may pursuant to Article 63 of Regulation (EC) No
vertebrate animals;
1107/2009 request certain information, including certain parts
of the dossier, to be kept confidential and shall physically
(i) where relevant, a copy of an application for maximum
separate that information.
residue levels as referred to in Article 7 of Regulation
(EC) No 396/2005 of the European Parliament and of
Article 7
the Council ( 1 );
Contents of supplementary dossiers
(j) where relevant, a copy of the proposal for classification
1. The
supplementary
summary
dossier
shall
include
the
where it is considered that the substance has to be classified
following:
or reclassified in accordance with Regulation (EC) No
1272/2008 of the European Parliament and of the Coun
(a) a copy of the application;
cil ( 2 );
(b) where the applicant is joined or replaced by one or more
(k) an assessment of all information submitted;
other applicants, the name and address of that applicant or
those other applicants and, if applicable, the name of the
(l) a checklist demonstrating that the supplementary dossier
association of producers provided for in Article 1(3);
provided for in paragraph 3 is complete in view of the
uses applied for and indicating which data are new;
(c) information with respect to one or more representative
uses on a widely grown crop in each zone of at least
(m) the summaries and results of scientific peer-reviewed open
one plant protection product containing the active
literature, as referred in Article 8(5) of Regulation (EC) No
substance, demonstrating that the approval criteria
1107/2009.
provided for in Article 4 of Regulation (EC) No
1107/2009 are fulfilled; where the information submitted
2. The
uses
referred
to
in
paragraph
1(c)
shall,
where
appro
does not cover all zones or does not concern a widely
priate, include the uses evaluated for the approval or subsequent
grown crop, a justification shall be submitted;
renewals. At least one plant protection product referred to in
paragraph 1(c) shall contain no other active substance, where
(d) data and risk assessments which were not part of the
such a product exists for a representative use.
approval dossier or subsequent renewal dossiers and
which are necessary:
3. The
supplementary
complete
dossier
shall
contain
the
full
(i) to reflect changes in legal requirements which have
text of each test and study report referred to in paragraph 1(e),
occurred since the approval or last renewal of the
(f) and (m).
approval of the active substance concerned;
It shall not contain any reports of tests or studies involving the
(ii) to reflect changes in scientific and technical knowledge
deliberate administration of the active substance or the plant
since the approval or last renewal of the approval of
protection product containing it to humans.
the active substance concerned;
Article 8
(iii) to reflect changes to representative uses; or
Admissibility of the application
(iv) because the application is for an amended renewal;
1. Where
the
supplementary
dossiers
have
been
submitted
by
the date provided for in Article 6(3) and contain all the
(e) for each point of the data requirements for the active
elements provided for in Article 7, the rapporteur Member
substance, as set out in a Regulation setting out data
State shall, within a period of one month, inform the applicant,
requirements for active substances under Regulation (EC)
the co-rapporteur Member State, the Commission and the
No 1107/2009, for which new data are necessary in
Authority of the date of receipt of the supplementary dossiers
accordance with point (d), the summaries and results of
and of the admissibility of the application.
tests and studies, the name of their owner and of the
person or institute that has carried them out and the
( 1 ) OJ L 70, 16.3.2005, p. 1.
reason why each test or study is necessary;
( 2 ) OJ L 353, 31.12.2008, p. 1.

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European
Union L
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The rapporteur Member State shall assess any requests for
the other Member States, the Authority and any other
confidentiality. In the event of a request for access to
applicants that have submitted an application for the same
information, the rapporteur Member State shall decide what
active substance of the replacement.
information is to be kept confidential.
Article 10
2. Where
the
supplementary
dossiers
have
been
submitted
by
the date provided for in Article 6(3), but one or more elements
Adoption of non-renewal Regulation
provided for in Article 7 are missing, the rapporteur Member
The Commission shall adopt a Regulation on the non-renewal
State shall, within a period of one month from the date of
of the approval of an active substance in accordance with
receipt of the supplementary dossiers, inform the applicant
Article 20(1)(b) of Regulation (EC) No 1107/2009 where all
which elements are missing and set a period of 14 days for
of the applications submitted for that active substance are inad
the submission of those elements to the rapporteur Member
missible in accordance with Article 3(3) of this Regulation or
State and co-rapporteur Member State.
Article 8(6) thereof.
Where at the expiry of that period the supplementary dossiers
CHAPTER 2
contain all the elements provided for in Article 7, the
rapporteur Member State shall, without delay, proceed in
ASSESSMENT
accordance with paragraph 1.
Article 11
3. After
receiving
the
information
that
the
application
is Assessment by the rapporteur Member State and the
admissible, the applicant shall immediately forward the supple
co-rapporteur Member State
mentary dossiers to the other Member States, the Commission
1. Where the application is admissible in accordance with
and the Authority, including the information about those parts
Article 8(1), the rapporteur Member State shall, after consulting
of the dossier in respect of which confidentiality has been
the co-rapporteur Member State, at the latest 12 months after
requested and justified by the applicant pursuant to Article 63
the date referred to in Article 6(3), prepare and submit to the
of Regulation (EC) No 1107/2009.
Commission, with a copy to the Authority, a report assessing
whether the active substance can be expected to meet the
At the same time, the applicant shall forward the supplementary
approval criteria, as provided for in Article 4 of Regulation
summary dossiers to the Authority, excluding any information
(EC) No 1107/2009 (‘the draft renewal assessment report’).
in respect of which confidentiality has been requested and
justified by the applicant pursuant to Article 63 of Regulation
2. The draft renewal assessment report shall also include the
(EC) No 1107/2009.
following:
4. The
Authority
shall
make
the
supplementary
summary (a) a recommendation with regard to the renewal of the
dossier available to the public, without delay, excluding any
approval;
information in respect of which confidentiality has been
requested and justified by the applicant pursuant to Article 63
(b) a recommendation on whether the substance should be
of Regulation (EC) No 1107/2009, unless there is an overriding
considered a ‘low-risk’ substance;
public interest in its disclosure.
(c) a recommendation on whether the substance should be
5. At the request of the Authority or a Member State, the
considered a candidate for substitution;
applicant shall make available the dossiers submitted for the
approval and subsequent renewals of the approval, where it
(d) where relevant, a proposal to set maximum residue levels;
has access to them.
(e) where relevant, a suggestion for the classification or reclas
6. Where the supplementary dossiers have not been
sification of the active substance in accordance with Regu
submitted by the date referred to in Article 6(3), or where at
lation (EC) No 1272/2008;
the end of the period set for the submission of the missing
elements in accordance with paragraph 2 of this Article the
(f) a conclusion on which of the new studies included in the
supplementary dossiers still do not contain all the elements
supplementary dossiers are relevant for the assessment;
provided for in Article 7, the rapporteur Member State shall,
without delay, inform the applicant, the co-rapporteur Member
(g) a recommendation as to the parts of the report on which a
State, the Commission, the other Member States and the
consultation of experts is to be organised in accordance
Authority that the application is inadmissible and of the
with Article 13(1);
reasons why it is inadmissible.
(h) the points on which the co-rapporteur Member State did
Article 9
not agree with the assessment by the rapporteur Member
Replacement of the applicant
State, where relevant.
An applicant may be replaced by another producer in respect of
3. The
rapporteur
Member
State
shall
make
an
independent,
all of its rights and obligations under this Regulation by
objective and transparent assessment in the light of current
informing the rapporteur Member State, through a joint
scientific and technical knowledge. It shall take into account
declaration by the applicant and the other producer. In that
the supplementary dossiers, and, where appropriate, the
case, the applicant and the other producer shall, at the same
dossiers submitted for the approval and subsequent renewals
time, inform the co-rapporteur Member State, the Commission,
of approval.

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Official Journal of the European Union
19.9.2012
4. The
rapporteur
Member
State
shall
first
establish
whether requested and justified by the applicant pursuant to Article 63
the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7
of Regulation (EC) No 1107/2009, unless there is an overriding
of Annex II to Regulation (EC) No 1107/2009 are satisfied.
public interest in its disclosure.
Where those criteria are not satisfied, the draft renewal
Article 13
assessment report shall be limited to those parts of the
assessment, unless Article 4(7) of Regulation (EC) No
Conclusion by the Authority
1107/2009 applies.
1. Within five months from the expiry of the period referred
to in Article 12(3), the Authority shall adopt a conclusion in
5. Where
the
rapporteur
Member
State
requires
additional the light of current scientific and technical knowledge using
information, it shall set a period for the applicant to supply
guidance documents applicable at the date of the submission
that information. That period shall not lead to an extension of
of the supplementary dossiers on whether the active substance
the period of 12 months provided for in paragraph 1. The
can be expected to meet the approval criteria provided for in
applicant may, pursuant to Article 63 of Regulation (EC) No
Article 4 of Regulation (EC) No 1107/2009. The Authority
1107/2009, request such information to be kept confidential.
shall, where appropriate, organise a consultation of experts,
including experts from the rapporteur Member State and co-
6. The
rapporteur
Member
State
may
consult
the
Authority rapporteur Member State. The Authority shall communicate its
and request additional technical or scientific information from
conclusion to the applicant, the Member States and the
other Member States. Such consultations and requests shall not
Commission.
lead to an extension of the period of 12 months provided for in
paragraph 1.
By way of derogation from the first subparagraph, the
Commission may inform the Authority without delay after
7. Information
submitted
by
the
applicant
without
having the period referred to in Article 12(3) has expired that a
been requested, or provided after the expiry of the period set
conclusion is not necessary.
for its submission in accordance with the first sentence of
paragraph 5, shall not be taken into account, unless it is
submitted in accordance with Article 56 of Regulation (EC)
2. After
giving
the
applicant
two
weeks
to
request,
pursuant
No 1107/2009.
to Article 63 of Regulation (EC) No 1107/2009, that certain
parts of the conclusion be kept confidential, the Authority shall
8. When
submitting
the
draft
renewal
assessment
report
to make its conclusion available to the public, excluding any
the Commission, the rapporteur Member State shall request the
information in respect of which confidentiality has been
applicant to submit the supplementary summary dossiers,
granted by the Authority, unless there is an overriding public
updated to include the additional information requested by
interest in its disclosure.
the rapporteur Member State in accordance with paragraph 5
or submitted in accordance with Article 56 of Regulation (EC)
3. Where
the
Authority
considers
that
additional
information
No 1107/2009, to the co-rapporteur Member State, the
from the applicant is necessary, it shall, in consultation with the
Commission, the other Member States and to the Authority.
rapporteur Member State, set a period not exceeding one month
for the applicant to supply such information to the Member
The applicant may pursuant to Article 63 of Regulation (EC) No
States, the Commission and the Authority. The rapporteur
1107/2009 request such information to be kept confidential.
Member State shall, within 60 days from the date of receipt
Any such requests shall be addressed to the Authority.
of the additional information evaluate the information received
and send its evaluation to the Authority.
Article 12
Where the first subparagraph applies, the period referred to in
Comments on the draft renewal assessment report
paragraph 1 shall be extended by the periods referred to in the
1. The
Authority
shall
circulate
the
draft
renewal
assessment first subparagraph of this paragraph.
report received from the rapporteur Member State to the
applicant and to the other Member States at the latest 30
4. The
Authority
may
ask
the
Commission
to
consult
a
days after its receipt.
European Union reference laboratory designated, pursuant to
Regulation (EC) No 882/2004 of the European Parliament
2. The
Authority
shall
make
the
draft
renewal
assessment and of the Council ( 1 ), for the purposes of verifying whether
report available to the public, after giving the applicant two
the analytical method for the determination of the residues
weeks to request, pursuant to Article 63 of Regulation (EC)
proposed by the applicant is satisfactory and complies with
No 1107/2009, that certain parts of the draft renewal
the requirements in Article 29(1)(g) of Regulation (EC) No
assessment report are kept confidential.
1107/2009. The applicant shall, if requested by the European
Union reference laboratory, provide samples and analytical stan
3. The
Authority
shall
allow
a
period
of
60
days
from
the dards.
date the report is made available to the public for the
submission of written comments. Such comments shall be
5. Information
submitted
by
the
applicant
without
having
communicated to the Authority, which shall collate and
been requested, or provided after the expiry of the period set
forward those comments, including its own comments, to the
for its submission in accordance with the first subparagraph of
Commission.
paragraph 3, shall not be taken into account, unless it is
submitted in accordance with Article 56 of Regulation (EC)
4. The
Authority
shall
make
the
updated
supplementary No 1107/2009.
summary dossiers available to the public, excluding any
information in respect of which confidentiality has been
( 1 ) OJ L 165, 30.4.2004, p. 1.

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European
Union L
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Article 14
period referred to in the third subparagraph of paragraph 1, the
Commission shall adopt a Regulation in accordance with
Renewal report and renewal Regulation
Article 20(1) of Regulation (EC) No 1107/2009.
1. The
Commission
shall
present
to
the
Committee
referred
to in Article 79(1) of Regulation (EC) No 1107/2009 a renewal
CHAPTER 3
report and a draft Regulation within six months from the date
TRANSITIONAL AND FINAL PROVISIONS
of receipt of the conclusion of the Authority or in cases where
there is no such conclusion of the Authority, the expiry of the
Article 15
period referred to in Article 12(3) of this Regulation.
Transitional provisions
The renewal report and the draft Regulation shall take into
Regulation (EU) No 1141/2010 shall continue to apply with
account the draft renewal assessment report of the rapporteur
respect to the renewal of the approval of active substances listed
Member State, the comments referred to in Article 12(3) of this
in Annex I thereto.
Regulation and the conclusion of the Authority, where such a
conclusion has been submitted.
Article 16
Entry into force and application
The applicant shall be given the possibility to submit comments
on the renewal report within a period of 14 days.
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Union.
2. On the basis of the renewal report and taking into
account comments submitted by the applicant within the
It shall apply from 1 January 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO

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L 252/32
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Official Journal of the European Union
19.9.2012
ANNEX
Format for applications, as provided for in Article 2(1)
The application shall be in writing, signed by the applicant, and sent to the rapporteur Member State and to the co-
rapporteur Member State.
A copy of the application shall be sent to the European Commission, DG Health and Consumers, 1049 Brussels, Belgium,
to the European Food Safety Authority, Via Carlo Magno 1/A, 43126 Parma, Italy and to the other Member States.
MODEL
1. Information
concerning
the
applicant
1.1. Name and address of the applicant including the name of the natural person responsible for the application and
other obligations resulting from this Regulation:
1.1.1. (a) Telephone No:
(b) E-mail address:
1.1.2. (a) Contact:
(b) Alternative contact:
2. Information
to
facilitate
identification
2.1. Common
name
(proposed
or
ISO-accepted)
specifying,
where
relevant,
any
variants
thereof
such
as
salts,
esters
or
amines manufactured by the producer.
2.2. Chemical
name
(IUPAC
and
CAS
nomenclature).
2.3. CAS,
CIPAC
and
EC
numbers
(if
available).
2.4. Empirical
and
structural
formula,
molecular
mass.
2.5. Specification of purity of the active substance in g/kg which must be, whenever possible, identical or already
accepted as equivalent to the one listed in the Annex to Commission Implementing Regulation (EU) No
540/2011 ( 1 ).
2.6. Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No
1272/2008 of the European Parliament and of the Council ( 2 ) (health and environment effects).
3. New
information
3.1. List of new information intended to be submitted together with a justification showing that they are considered
necessary, in accordance with Article 15(2) of Regulation (EC) No 1107/2009.
3.2. List
of
new
studies
intended
to
be
submitted
on
vertebrate
animals.
3.3. Timetable
of
any
new
and
ongoing
studies.
The applicant confirms that the above information submitted included in the application is correct.
Date and signature (of the person competent to act for the applicant referred to under point 1.1).
( 1 ) OJ L 153, 11.6.2011, p. 1.
( 2 ) OJ L 353, 31.12.2008, p. 1.

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