Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure for the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (Text with EEA relevance)
Date: 2007-06-27
Institutions: European Commission
Subjects: EU Member State, chemical product, environmental protection, evaluation method, exchange of information, pharmaceutical product, plant health product

L 169/10

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Official Journal of the European Union

29.6.2007

COMMISSION REGULATION (EC) No 737/2007

of 27 June 2007

on laying down the procedure for the renewal of the inclusion of a first group of active substances
in Annex I to Council Directive 91/414/EEC and establishing the list of those substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Articles 6(1) and (5) thereof,

(8)

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 91/414/EEC provides
the
inclusion of a substance can be renewed once or more
for a period not exceeding 10 years.

that on request,

The Commission has received a request
producers requesting a renewal
substances
91/414/EEC.

from certain
the seven active
for
included in Annex I of Directive

first

A procedure should be provided for by which all
interested producers have the right
to inform the
Commission of their interest in securing the inclusion
of
to Directive
91/414/EEC

in Annex I

an active

substance

Producers wishing to secure the renewal of inclusion of
active substances covered by this Regulation should be
required to notify the relevant rapporteur Member State.

The names and addresses of the producers whose notifi-
cation has been found admissible should be published by
the Commission in order to ensure that contacts can be
made for presenting joint dossiers.

Food

The relationship between producers, Member States, the
European
the
Safety Authority,
‘Authority’, and the Commission and the obligation on
each of
the
the parties
procedure should be laid down.

the implementation of

hereinafter

for

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

scientific information about an active
Technical or
in particular with regard to its potentially
substance,
dangerous effects or its residues, submitted within the
relevant
interested parties
should be taken into consideration in the evaluations.

time limits by any other

91/414/EEC,

included in Annex I

The information submitted should include new data
relevant to the active substance and new risk assessments
in data requirements under
to reflect any changes
Annexes II and III to Directive 91/414/EEC, and any
changes in scientific or technical knowledge since the
to
first
active substance was
Directive
guidance
as
documents from the Commission’s services and relevant
opinions from the Scientific Committee on Plants (SCP)
or the Authority. The range of uses submitted should
reflect
the representative use pattern. The producer
should demonstrate, on the basis of the data submitted,
that for one or more preparations the requirements of
Directive 91/414/EEC in relation to the criteria referred
to in its Article 5 can be met.

reflected

in

(9)

It should be established that rapporteur Member States
should send reports of their evaluations to the Authority
and the Commission as quickly as possible.

(10)

(11)

(12)

The assessment
reports prepared by the rapporteur
Member States may, where necessary, be the subject of
an examination by experts of other Member States within
a programme coordinated by the Authority before they
are submitted to the Standing Committee on the Food
Chain and Animal Health.

intended to provide

The rules on data protection under Article 13 of
Directive 91/414/EEC are
an
incentive to notifiers to assemble the detailed studies
required under Annexes II and III
to that Directive.
However, data protection should not be extended artifi-
cially by the production of new studies which are not
needed to decide on the renewal of an active substance.
To this end, notifiers should be required to identify
explicitly which studies are new compared to the
original dossier used for
the
substance in Annex I to Directive 91/414/EEC.

inclusion of

the first

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

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HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation lays down the procedure for the renewal of the
inclusion in Annex I to Directive 91/414/EEC of the active
substances listed in Annex I to this Regulation.

Article 2

Definition

For the purposes of this Regulation:

to this Regulation, or any variants
column A of Annex I
thereof such as salts, esters or amines, shall send a notification,
for each active substance separately, to the rapporteur Member
State listed in column B of that Annex and to the co-rapporteur
Member State listed in column C of that Annex by 6 October
2007 at
in Annex III. Such a
the latest, using the model
producer is referred to hereinafter as ‘the notifier’.

A copy of the notification shall be sent to the Commission.

2.
A joint notification may be submitted by an association of
producers designated by the producers for the purpose of
compliance with this Regulation.

(a)

‘producer’ means the person who manufactures the active
substance on his own or who contracts the manufacturing
to another party or a person designated by the manu-
facturer as his
the purpose of
sole representative for
compliance with this Regulation;

A producer who has not submitted a notification for the
3.
active substance concerned by 6 October 2007 at the latest or
whose notification was rejected as inadmissible, shall not parti-
cipate in the rest of the procedure, except together with another
producer who has submitted an admissible notification.

(b) ‘Committee’ means the Standing Committee on the Food
Chain and Animal Health, referred to in Article 19 of the
Directive 91/414/EEC;

Article 5

Admissibility of notifications and publication data
concerning notifiers

(c)

‘Notifier’ has the meaning given by Article 4(1) of
Regulation;

this

(d) ‘Original dossier’, in relation to an active substance, means
the dossier on the basis of which the active substance was
included in Annex I to Directive 91/414/EEC.

1.
For each active substance the rapporteur Member State
shall examine the notifications referred to in Article 4(1) and,
at
the latest one month after the date referred to in that
the notifications
admissibility
paragraph,
received, taking into account the criteria referred to in Annex
IV.
It shall communicate its assessment to the Commission,
which shall decide which notifications are admissible, taking
account of the rapporteur Member State’s assessment.

assess

the

of

Article 3

Designated Member State authority

The Commission shall publish, for each active substance,

2.
the names and the addresses of the notifiers concerned.

1.
Each Member State shall designate an authority or autho-
rities to carry out the obligations of the Member States as
defined in this Regulation.

2.
The national authorities listed in Annex II shall coordinate
and ensure all necessary contacts with notifiers, other Member
States, the Commission and the Authority, in accordance with
this Regulation.

State

Each Member
communicate modifications
concerning the designated national coordinating authority to
the Commission, the Authority and the designated coordinating
authority of the other Member States.

shall

Article 4

Notification

1.
A producer wishing to renew the inclusion in Annex I to
Directive 91/414/EEC of an active substance referred to in

Article 6

Submission of data

1.
By 31 August 2008 at the latest, the notifiers concerned
shall submit the following to the rapporteur Member State and
the co-rapporteur Member State:

(a) a copy of the notification and, in the case of a joint noti-
fication in accordance with Article 4(2), the name of the
person designated by the producers concerned as being
responsible for the joint dossier and the processing of the
dossier in accordance with this Regulation;

(b) any new data compared to the original dossier relevant to
the active substance and any new risk assessments to reflect
changes in data requirements under Annexes II and III to
Directive 91/414/EEC, or any changes in scientific and
technical knowledge since the active substance concerned
was first included in Annex I to Directive 91/414/EEC;

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(c) a checklist demonstrating that the dossier is complete, indi-

cating which data are new.

Article 8

End of participation

2. Where the dossier contains studies which are more recent
than those found in the original dossier,
the notifier must
explain for each new study why it is relevant.

1. When a notifier decides to end its participation in the
renewal procedure for an active substance, he shall inform the
the
rapporteur Member State, co-rapporteur Member State,
Commission and the other notifiers
substance
concerned, mentioning the reasons.

the

for

3.
The range of uses submitted should reflect a representative
use pattern. The data submitted by the notifier shall demon-
strate that, for one or more preparations, the active substance
in Article 5(1) of Directive
meets the requirements set out
91/414/EEC.

Where a notifier ends his participation or fails to fulfil his
obligations provided for in this Regulation,
the procedures
provided for in Articles 10 to 14 shall not be continued for
In particular, where a notifier does not submit,
his dossier.
where requested, the dossier referred to in Article 6(5), his
participation will be considered to have ended.

the notifiers concerned shall

4. Where for an active substance listed in Annex I there are
several notifications,
take all
reasonable steps to submit
the data collectively. Where the
data are not submitted jointly by all notifiers concerned, the
notification shall mention the efforts made and the reasons why
certain notifiers have not participated. For active substances
notified by more than one notifier, those notifiers shall for
each study involving vertebrate animals, give detailed expla-
nation on the attempts made to avoid duplication of testing
the reasons and a justification for
and give,
conducting a duplicate study.

if applicable,

If requested by the Authority or a Member State, the
5.
notifier shall make available the original dossier and subsequent
updates submitted for the first inclusion in Annex I to Directive
91/414/EEC.

Article 7

Subsequent submission

1. Without prejudice to Article 7 of Directive 91/414/EEC,
the rapporteur Member State shall not accept the submission of
additional information after 31 August 2008.

2.
By way of derogation from paragraph 1, the rapporteur
Member State may request additional information setting a time
period for its submission ending on 31 March 2009 at the
inform the
latest. The
Commission and the Authority of any such request it makes.

rapporteur Member

State

shall

shall

2. When a notifier agrees with another producer that the
notifier shall be replaced for the purposes of further partici-
pation in the renewal procedure, the notifier and the other
inform the rapporteur Member State, co-
producer
rapporteur Member State and the Commission by a common
declaration, agreeing that the other producer shall replace the
notifier in carrying out the duties under this Regulation. They
shall inform any other notifiers for the substance concerned at
the same time. In such a case, the other producer may be liable
for any fees remaining payable under the regime established by
the rapporteur Member State pursuant to Article 15.

Article 9

Submission of information by third parties

to the
Any person or Member State wishing to submit
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
human and animal health and on the environment shall do
so by 31 May 2008 at the latest.

The rapporteur Member State shall submit without delay any
information received to the Authority and the notifier.

The notifier may send its comments on the submitted infor-
mation to the rapporteur Member State at the latest by 31
August 2008.

Information which has not been requested, or which has not
been submitted before 31 March 2009, shall not be taken into
account.

Article 10

Assessment by the rapporteur Member State

The

rapporteur Member

3.
inform the
Commission and the Authority of cases where it receives infor-
mation from the notifier, which it is required not to take into
account under the provisions of this article.

State

shall

1.
The rapporteur Member State shall assess the new data
and risk assessments submitted under Article 6(1), and if
information from the original dossier taking into
necessary,
consideration
potentially
the
available
submitted by any third party and any
dangerous effects
comments
in accordance with
Article 9.

received from the notifier

information

on

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The rapporteur Member State shall prepare an assessment report
in consultation with the co-rapporteur Member State, setting
out, where relevant, the points on which the co-rapporteur
Member State did not agree.

The report shall
include a recommendation concerning the
decision to be taken with regard to the renewal. The report
shall also assess whether
the new studies identified under
Article 6(2) are relevant for the evaluation.

The rapporteur Member State shall send the assessment report
to the Authority and the Commission by 31 May 2009 at the
latest. The report shall be submitted in the format defined in
accordance with the procedure referred to in Article 19(2) of
Directive 91/414/EEC.

2.
The rapporteur Member State may consult the Authority
and request additional technical or scientific information from
other Member States.

Article 11

Access to the assessment report

1.
After receiving the assessment report the Authority shall
communicate it to the other Member States and notifier(s) for
comments. Such comments shall be sent
to the Authority,
which shall collate them and forward them to the Commission.

2.
The Authority shall make the assessment report available
on request or keep it available for consultation by any person,
except the elements thereof which have been accepted as confi-
dential in accordance with Article 14 of Directive 91/414/EEC.

Article 12

Evaluation of the assessment report

1.
The Commission shall evaluate the assessment report and
the recommendation by the rapporteur Member State and the
comments received.

The Commission may consult the Authority. Such consultation
may, if appropriate, include a request to arrange a peer review
of the rapporteur Member State’s assessment report, to take the
form of a conclusion on that report.

In cases where the Commission consults the Authority,
six

2.
the Authority shall deliver
months after receipt of that report.

response at

the latest

its

shall agree on the format in which the conclusions of the
Authority are submitted.

Article 13

Presentation of a draft directive or draft decision

amending

1. Without prejudice to any proposal it may submit with a
to Council Directive
the Annex
view to
79/117/EEC (1), the Commission shall, at the latest six months
after receipt of the assessment report or the conclusion of the
Authority, submit to the Committee a draft review report to be
finalised at its meeting.

That report shall be accompanied by one of the following:

(a) a draft directive to renew the inclusion of

the active
substance concerned in Annex I to Directive 91/414/EEC,
setting out, where
and
appropriate,
restrictions, including the period, for such inclusion; or

conditions

the

(b) a draft decision addressed to the Member States to withdraw
the authorisations of plant protection products containing
the active substance concerned, whereby the inclusion of
that active substance in Annex I to Directive 91/414/EEC
is not
the non-
inclusion.

renewed, setting out

the reasons for

2.
The directive or decision referred to in paragraph 1 shall
be adopted in accordance with the procedure referred to in
Article 19(2) of Directive 91/414/EEC.

Article 14

Access to review report

The finalised review report, excluding any parts which refer to
confidential
and
determined as such in accordance with Article 14 of Directive
91/414/EEC, shall be made available for public consultation.

information contained

dossiers

in the

Article 15

Fees

1. Member States
shall establish a regime obliging the
notifiers to pay a fee for the administrative treatment and the
evaluation of notifications as well as the dossiers related thereto,
which have been submitted to them in accordance with Article
4 or Article 6 in each case where the Member State has been
designated as the rapporteur Member State or co-rapporteur
Member State.

3.
The Commission and the Authority shall agree on a
schedule for the delivery of the conclusions in order to facilitate
the planning of the work. The Commission and the Authority

2. Member States
evaluation of the notification.

shall establish a specific fee for

the

(1) OJ L 33, 8.2.1979, p. 36.

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For this purpose, the Member States and co-rapporteur

3.
Member States shall:

(a) require the payment of a fee corresponding as far as
the different
each
introduced by one

possible to their costs in carrying out all
procedures
submission of a dossier, whether
notifier or collectively by several interested notifiers;

associated with the

evaluation for

(b) ensure that the amount of the fee is established in a trans-
parent manner with a view to corresponding to the real cost
of the examination and administrative treatment of a noti-
fication and a dossier; however, Member States may provide
for a scale of fixed charges based on average costs for the
calculation of the total fee;

(c) ensure that

the fee is received in accordance with the
instructions given by the authority in each Member State
listed in Annex II and that the income from the fee is used
to finance exclusively the costs actually incurred by the
rapporteur Member State and co-rapporteur Member State
for the evaluation and administrative treatment of the noti-

fications and the dossiers for which that Member State is
rapporteur or co-rapporteur Member State or to finance
general actions for the implementation of its obligations
as rapporteur Member State and co-rapporteur Member
State.

Article 16

Other charges, levies or fees
Article 15 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 market, use
and
plant protection products other than the fee provided for in
Article 15.

and control of

substances

active

Article 17

Entry into force

This Regulation shall enter into force on the seventh day
following 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, 27 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

List of active substances referred to in Article 1 and their rapporteur Member States and co-rapporteur
Member States

A. Active substance

B. Rapporteur Member State

C. Co-rapporteur Member State

azoxystrobin

imazalil

kresoxim-methyl

spiroxamin

azimsulfuron

prohexadion-calcium

fluroxypyr

United Kingdom

Czech Republic

The Netherlands

Belgium

Germany

Sweden

France

Ireland

Spain

Lithuania

Hungary

Slovenia

Slovakia

Poland

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ANNEX II

Coordinating authority in the Member States

BELGIUM

HUNGARY

Service Public Fédéral Santé publique, Sécurité de la
chaîne alimentaire et Environnement, Eurostation
Bloc II, 7e étage
Place Victor Horta 40 boîte 10
1060 Bruxelles
Belgium

Central Agricultural Office
Directorate of Plant Protection, Soil Conservation and
Agri-environment
Budaörsi ùt 141–145
H-1118 Budapest
Hungary

CZECH REPUBLIC

State Phytosanitary Administration
Section PPP
Zemědělská 1a
613 00 BRNO
Czech Republic

GERMANY

für Verbraucherschutz und Lebensmittel-

Bundesamt
sicherheit (BVL) — Abteilung Pflanzenschutzmittel
Messeweg 11—12
38104 Braunschweig
Germany

THE NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen
Postbus 217
6700 AE Wageningen
The Netherlands

POLAND

Ministerstwo Rolnictwa i Rozwoju Wsi
Departament Hodowli i Ochrony Roślin
ul. Wspólna 30
00-930 Warszawa
Poland

IRELAND

SLOVENIA

Pesticide Control Service
Department of Agriculture and Food
Backweston Campus
Youngs Cross
Celbridge
Co. Kildare
Ireland

SPAIN

Ministerio de Agricultura, PESCA y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
c/Alfonso XII, 62
ES-28071 Madrid
Spain

FRANCE

Ministère de l’agriculture et de la pêche
Bureau de la réglementation des produits antiparasitaires
251, rue de Vaugirard
F-75732 Paris Cedex 15
France

LITHUANIA

State Plant Protection Service
Kalvarijų str. 62
09304 Vilnius
Lithuania

Ministry Of Agriculture Forestry and Food
PHYTOSANITARY ADMINISTRATION REPUBLIC OF
SLOVENIA
Einspielerjeva 6
SI-1000 Ljubljana
Slovenia

SLOVAKIA

Central Controlling and Testing Institute in Agriculture
Department of Registration of Pesticides
Matuskova 21
833 16 Bratislava
Slovakia

SWEDEN

Kemikalieinspektionen
P. O. Box 2
172 13 Sundbyberg
Sweden

UNITED KINGDOM

Pesticides Safety Directorate
Mallard House
Kings Pool
3 Peasholme Green,
York YO1 7PX
United Kingdom

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ANNEX III

Notification of an active substance according to Article 4

The notification shall be made on paper and sent by registered mail to European Commission, DG Health and Consumer
Protection, unit E3, B-1049 Brussels,

The notification shall be submitted in accordance with the following model.

1.

Identification data on the notifier

MODEL

1.1. Name and address of the producer including the name of the natural person responsible for the notification and

further engagements resulting from this Regulation:

1.1.1. (a) Telephone No:

(b) Fax No:

(c) E-mail address:

1.1.2. (a) Contact:

(b) Alternative:

2.

Information to ensure identification

2.1.

Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or
amines produced by the manufacturer:

2.2.

Chemical name (IUPAC and CAS nomenclature):

2.3.

CAS, CIPAC and EEC numbers (if available):

2.4.

Empirical and structural formula, molecular mass:

2.5.

Specification of purity of the active substance in g/kg or g/l as appropriate:

2.6.

Classification and labelling of
67/548/EEC (1) (health and environment effects).

the active substance in accordance with the provisions of Council Directive

The notifier confirms that the above information submitted on … (date) is honest and correct.

Signature (of the person competent to act for the company mentioned under 1.1).

. . . . . . . . . . . . . . . . . . . . . . . . .

(1) OJ 196, 16.8.1967, p. 13. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council

(OJ L 396, 30.12.2006, p. 850), as corrected by OJ L 136, 29.5.2007, p. 281.

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ANNEX IV

Criteria for the admissibility of notifications referred to in Article 4

A notification shall only be considered admissible if the following conditions are satisfied:

1.

it is presented within the time limit referred to in Article 4(1);

2.

it is introduced by a notifier who is a producer of an active substance listed in Annex I;

3.

it is presented in the format as provided for in Annex III;

4. a fee as referred to in Article 5 has been paid.