Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (Text with EEA relevance)
Date: 2002-08-14
Institutions: European Commission
Subjects: European Food Safety Authority, administrative formalities, animal health, dangerous substance, exchange of information, marketing standard, plant health product, report

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COMMISSION REGULATION (EC) No 1490/2002

of 14 August 2002

laying down further detailed rules for the implementation of the third stage of the programme of
work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No
451/2000

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant-protection products on
the market (1), as last amended by Commission Directive 2002/
48/EC (2), and in particular the second subparagraph of Article
8(2) thereof,

Whereas:

Regulation (EC) No 178/2002 of the European Parlia-
ment and of the Council of 28 January 2002 (6) created
the European Food Safety Authority (EFSA) to ensure
that the Community has access to high-quality, indepen-
in
dent and efficient scientific and technical support
order to achieve a high level of health protection in rela-
tion to legislation concerning safety of food and feed. It
is therefore appropriate to provide that the EFSA should
have a role in the programme of work on active
substances, and the scope of this involvement should be
defined as soon as possible.

(1)

(2)

(3)

(4)

The Commission is to undertake a programme of work
for the gradual examination of active substances on the
market two years after the date of notification of Direc-
tive 91/414/EEC within a period of 12 years. The first
stage of this programme was laid down by Commission
Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of
the first stage of the programme of work referred to in
Article 8(2) of Council Directive 91/414/EEC concerning
the placing of plant-protection products on the
market (3), as last amended by Regulation (EC) No 2266/
2000 (4). This first stage is ongoing.

The second stage of work was laid down by Commission
Regulation (EC) No 451/2000 of 28 February 2000
laying down the detailed rules for the implementation of
the second and third stages of the work programme
referred to in Article 8(2) of Council Directive 91/414/
EEC (5), and is also ongoing.

A third stage of work was provided for in Regulation
(EC) No 451/2000 for an additional number of active
substances not covered by the first and second stages of
the programme. Producers wishing to secure the inclu-
sion of these active substances in Annex I to Directive
91/414/EEC have provided detailed information relating
to the current stage of completeness of their dossiers and
on the endpoints and have undertaken to provide a full
data package.

(6)

(7)

(8)

concerning the

For the third stage of the work programme, Article 10(3)
of Regulation (EC) No 451/2000 specifies that detailed
complete
provisions
dossiers, the time limit(s) for their submission and the
fee regime for the active substances concerned have to
be established by the Commission in a Regulation to be
adopted in accordance with the second subparagraph of
Article 8(2) of Directive 91/414/EEC.

submission of

In order to ensure that dossiers are received by the
Member States
active
substances to be evaluated should be divided into two
groups with separate time limits for the submission of
dossiers.

in a manageable way,

the

Further, at an initial stage it should be sufficient that
notifiers provide only a list of the available tests and
studies to the rapporteur Member States,
in order to
permit the Member States to establish whether a full data
package is available to be submitted by the specified time
limit. Where such data will not be available by the time
limit, it will not be possible to complete re-evaluation of
the active substance within the timetable provided for in
Directive 91/414/EEC and a decision should therefore be
taken immediately not
substance
concerned in Annex I to the Directive. Authorisation of
products containing such active substance should be
withdrawn by Member States.

to include

the

them for the implementation of

The relationships between producers, Member States, the
Commission and the EFSA and the obligations on each
of
the programme
should be laid down, taking into account experience
gained during the first and second stages of
the
cooperation between all parties
programme. Close
involved and a scrupulous respect of time limits laid
down is necessary to ensure the efficiency of
the
programme. Strict time limits for all elements of the
third stage of the work programme should be set in
order to ensure its finalisation within an acceptable time
period. Where cooperation with notifiers ceases it is
impossible to continue further evaluation efficiently and
therefore the evaluation should be terminated.

(1) OJ L 230, 9.8.1991, p. 1.
(2) OJ L 148, 6.6.2002, p. 19.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 55, 29.2.2000, p. 25.

(6) OJ L 31, 1.2.2002, p. 1.

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(9)

(10)

(11)

In order to ensure that all relevant information on the
potentially dangerous effects of an active substance or its
residues are considered, technical or scientific informa-
tion submitted within the relevant time limits by any
person should also be taken into consideration in the
evaluations.

It is necessary to define the obligations of notifiers with
regard to the formats, time periods and recipient authori-
ties for the information to be submitted.

The task of evaluation should be distributed among the
competent authorities of the Member States. Therefore,
for each active substance a rapporteur Member State
should be designated. The rapporteur Member State
should assess the completeness check provided by the
notifier, and examine and evaluate the information
submitted. It should present to the EFSA the results of
the evaluation and make a recommendation to the
Commission concerning the decision to be taken with
regard to the active substance concerned.

(12) Member States should send draft reports of their evalua-
tions to the EFSA. The draft reports prepared by the
rapporteur Member States should be peer reviewed by
the EFSA before they are submitted to the Standing
Committee on the Food Chain and Animal Health.

(13)

(14)

(15)

In order to avoid duplication of work, and in particular
experiments
involving vertebrate animals, producers
should be encouraged to submit collective dossiers.

The notification and submission of a dossier should not
be a prerequisite for the possibility, after inclusion of the
active substance in Annex I to Directive 91/414/EEC, to
place plant-protection products on the market subject to
the provisions of Article 13 of that Directive. Therefore,
operators which have not submitted notifications should
be able to be informed at all stages of the evaluation
for
process of
continued marketing
of plant-protection products
containing an active substance under evaluation.

the possible

requirements

further

The procedures established in this Regulation should not
prejudice procedures and actions to be undertaken in the
framework of other Community legislation, in particular,
under Council Directive 79/117/EEC prohibiting the
placing on the market and use of plant-protection
products containing certain active substances (1), as last
amended by the Act of Accession of Austria, Finland and
Sweden, where information becomes available to the
Commission showing that its requirements may be satis-
fied.

(16)

The use of anti-microbials from classes, which are or
may be used in human or veterinary medicine for the
purpose of plant protection should be discouraged. Two
of the substances concerned by this Regulation — kasu-
gamycin and streptomycine — fall into this category (2).

(1) OJ L 33, 8.2.1979, p. 36.
(2) Opinion of the Scientific Steering Committee of 28 May 1999 on

anti-microbial resistance.

Pending eventual decisions on their inclusion in Annex I,
their uses should continue to be restricted and only be
permitted where essential. For the purpose of
their
evaluation, information on anti-microbial resistance will
be required.

This Regulation shall be without prejudice to Commu-
nity obligations regarding methyl bromide under the
Montreal Protocol.

In the case of an apparent imbalance in the responsibil-
ities borne by the Member States as rapporteur in the
assessment and evaluation,
it should be possible to
the Member State originally designated as
replace
rapporteur for a particular active substance by another
Member State.

To ensure the proper resourcing of this stage of the
programme of work, a fee should be paid to the Member
States for the handling and evaluation of dossiers in addi-
tion to the fee already paid for the evaluation of the noti-
fications pursuant to Article 13 of Regulation (EC) No
451/2000.

Regulation (EC) No 451/2000 provided that
for the
active substances covered by the third stage of the work
programme, the time limit for the submission of a full
data package was 25 May 2003 at the latest. That Regu-
lation also provided that detailed provisions concerning
the submission of complete dossiers would be estab-
lished at a later stage. In order to organise the work
programme efficiently, it is not necessary to submit full
data packages shortly before full dossiers have to be
submitted. However,
to ensure that active substances
without full data packages do not remain on the market,
a list of available data should be submitted, while the full
data packages should be submitted only in exceptional
cases and on request.

Regulation (EC) No 451/2000 should be amended
accordingly.

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

(17)

(18)

(19)

(20)

(21)

(22)

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.
This Regulation lays down further detailed rules for the
implementation of the third stage of the programme of work
referred to in Article 8(2) of Directive 91/414/EEC with respect
to the continued evaluation of the active substances notified
under Regulation (EC) No 451/2000.

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Article 6(2), (3) and (4), second subparagraph, of Directive
2.
91/414/EEC shall not apply to a substance listed in Annex I to
this Regulation as long as the procedures provided for in this
Regulation with regard to these substances have not been fina-
lised.

3.

This Regulation shall apply without prejudice to:

(a) reviews by Member States of active substances in Annex I
to renewals of authorisations in

in particular pursuant
accordance with Article 4(4) of Directive 91/414/EEC;

(b) reviews by the Commission pursuant to Article 5(5) of

Directive 91/414/EEC;

(c) assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions in Directive
91/414/EEC shall apply.

The following definitions shall also apply:

(a) ‘notifier’ means the natural or legal person who submitted a
notification in accordance with the terms specified in Regu-
lation (EC) No 451/2000 as listed in Annex II;

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

(c) ‘data list’ means a list of all the data which is available to be

submitted in the full data package;

(d) ‘full data package’ means information and results of studies
sufficient to satisfy the requirements of Annexes II and III
to Directive 91/414/EEC in relation to a limited range of
representative uses of the active substance concerned.

Article 3

Member State authority

1. Member States shall allocate responsibility for the imple-
mentation of their obligations under the programme of work
referred to in Article 8(2) of Directive 91/414/EEC to an
authority or authorities.

2.
Each Member State shall designate one national authority,
referred to in Annex III, to coordinate and ensure all necessary
contacts with notifiers, other Member States, the Commission
and the European Food Safety Authority (EFSA) pursuant to
this Regulation. Each Member State shall
inform the details
concerning the designated coordinating national authority to
the Commission, the EFSA and the designated coordinating
national authority of each other Member State and of any
modifications thereof.

Article 4

Measures in case of imbalances

If, during the assessment and evaluation referred to in Articles
9 and 10, it becomes apparent that there is an imbalance in the
responsibilities borne and the work to be done or actually done
by the Member States as rapporteurs,
in
accordance with the procedure provided for in Article 19 of
Directive 91/414/EEC, to replace a Member State originally
designated as rapporteur for a particular active substance by
another Member State.

it may be decided,

In such cases the original rapporteur Member State shall inform
the notifiers concerned and shall transfer to the newly desig-
nated rapporteur Member State all correspondence and infor-
mation which it has received as rapporteur Member State for
the active substance concerned. The original Member State shall
return to the notifier the fee referred to in Article 17 except for
the part referred to in paragraph 2(d) thereof. The newly desig-
nated rapporteur Member State shall then require the notifiers
to pay the fee referred to in Article 17 except the part referred
to in paragraph 2(d) thereof.

Article 5

Withdrawal or replacement of notifier

1.
If a notifier decides to end its participation in the
programme of work for an active substance, it shall immedi-
ately inform the rapporteur Member State, the Commission, the
EFSA and all other notifiers of the substance concerned of its
decision, giving the reasons. Where a notifier ends its participa-
tion or fails to fulfil its obligations under this Regulation, the
procedures provided for in Article 9 or 10 shall be terminated
as regards its dossier.

2.
If a notifier agrees with another producer that the notifier
shall be replaced for the purposes of further participation in the
programme of work under this Regulation, the notifier and
such other producer shall inform the rapporteur Member State,
the Commission and the EFSA by a common declaration
agreeing that such other producer shall replace the original
notifier in carrying out the notifier’s duties pursuant to Articles
6, 7, 9, 10 or 11. They shall ensure that the other notifiers for
the substance concerned are informed at the same time. The
other producer in this case shall be jointly liable with the
original notifier for any fees remaining payable in relation to
the regime established by
the notifier’s application under
Member States pursuant to Article 17.

All information submitted shall remain available to the

3.
rapporteur Member States, the Commission or the EFSA.

Article 6

Submission and checking of data lists

1.
By 23 May 2003 at the latest, the notifier(s) shall submit
to the relevant rapporteur Member State the data lists for active
substances listed in Annex I, and submit a copy to the EFSA.

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Where, for any active substance listed in Annex I, there are
several notifications,
take all
the notifiers concerned shall
reasonable steps to submit these data lists collectively.

Annex I, part A, and by 30 November 2004 at the latest for
active substances listed in Annex I, part B.

Where a data list is not submitted by all notifiers concerned, it
shall mention the efforts made and the reasons why certain
notifiers have not participated.

Where for any active substance listed in Annex I there are
several notifications,
take all
the notifiers concerned shall
reasonable steps to submit these dossiers collectively.

For active substances notified by more than one notifier those
notifiers shall for each study involving vertebrate animals, detail
the attempts made to avoid duplication of testing and give, if
applicable, the reasons for conducting a duplicate study.

Where a dossier is not submitted by all notifiers concerned, it
shall mention the efforts made and the reasons why certain
notifiers have not participated.

2.
The data lists shall be prepared in the format specified in
accordance with the procedure provided for in Article 19 of
Directive 91/414/EEC. The full data package, as defined in
Article 10(4) of Regulation (EC) No 451/2000, shall be kept
available by the notifiers. On written request from the rappor-
teur Member State or the Commission, the notifier shall provide
without delay, the part of the data package or the full data
package requested.

3.
The rapporteur Member State shall examine the data lists
submitted to establish whether they indicate that a full data
package is available to be submitted. For those active substances
for which a rapporteur Member State considers that no full data
package is available to be submitted, the rapporteur Member
State shall request the notifier to submit without delay a full
data package and check whether it is complete. The rapporteur
Member State shall report the results of these checks to the
Commission at the latest within three months of receipt of the
data lists.

4.
For those active substances for which the rapporteur
Member State considers that no full data package is available it
shall inform the Commission without delay. In accordance with
the procedure provided for in Article 19 of Directive 91/414/
EEC, it shall be decided whether a full data package is available.

5. Where it is considered that no full data package is avail-
able for a particular active substance, the Commission shall
decide, as provided for in the fourth subparagraph of Article
to include the active
8(2) of Directive 91/414/EEC, not
substance concerned in Annex I to Directive 91/414/EEC.

6.
Unless the Commission informs the notifier that no full
data package is available for a particular active substance, the
notifier shall submit the dossiers referred to in Article 7(2) and
(3) by the time limits specified in Article 7(1).

Article 7

Submission of dossiers

1.
The notifier(s) shall submit to the relevant rapporteur
Member State the summary dossier referred to in paragraph 2
and the complete dossier referred to in paragraph 3, by 30
November 2003 at the latest for active substances listed in

For active substances notified by more than one notifier, those
notifiers shall for each study involving vertebrate animals, detail
the attempts made to avoid duplication of testing and give, if
applicable, the reasons for conducting a duplicate study.

2.

The summary dossier shall include the following:

(a) a copy of the notification; in the case of a joint application
made by several producers, a copy of the notifications made
in accordance with Article 10 of Regulation (EC) No 451/
2000 and the name of the person designated by the produ-
cers concerned as being responsible for the joint dossier
and the processing of the dossier in accordance with this
Regulation;

(b) a limited range of

representative uses of

the active
substance, in respect of which the data submitted by the
notifier in the dossier shall demonstrate that for one or
more preparations, the requirements set out in Article 5 of
Directive 91/414/EEC for inclusion of the active substance
in Annex I to Directive 91/414/EEC, can be met;

(c)

(i) for each point of Annex II to Directive 91/414/EEC,
the summaries and results of studies and trials, the
name of the person or institute that has carried out the
trials;

(ii) for each point of Annex III to Directive 91/414/EEC
the summaries and results of studies and trials, the
name of the person or institute that has carried out the
trials, relevant to the assessment of the criteria referred
to in Article 5 of Directive 91/414/EEC for one or
more preparations which are representative for the
uses referred to in subparagraph (b) taking into account
that data gaps in the information of the Annex II
dossier resulting from the proposed limited range of
representative uses of the active substance may lead to
restrictions in the inclusion into Annex I to Directive
91/414/EEC;

(iii) and for active substances listed in Annex I, part B, for
studies not yet fully completed the evidence that these
studies have been commissioned as required by Article
10(4) of Regulation (EC) No 451/2000 with an under-
taking that they will be submitted at the latest by 31
May 2005;

(d) a checklist to be filled in by the notifier, demonstrating that

the dossier is complete.

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The complete dossier shall physically contain the indivi-
3.
dual
the information
test and study reports concerning all
referred to in paragraph 2(c), or the evidence referred to in
paragraph 2(c)(iii) where work is in progress.

The EFSA shall assess the reports submitted to it by the rappor-
teur Member States and report to the Commission on the
completeness of the dossiers.

4.
Each Member State shall define the number of copies and
the format of the summary and the complete dossiers to be
submitted by the notifiers. In defining the format of the dossier
Member States shall
the recommendations
take account of
made in accordance with the procedure provided for in Article
19 of Directive 91/414/EEC.

For those active substances for which one or more dossiers are
considered to be complete, the rapporteur Member State shall
perform the evaluation as referred to in Article 10, unless the
EFSA informs the rapporteur Member State and the Commis-
sion, within two months of receipt of the Member State report
on completeness, that it does not consider the dossier to be
complete.

5. Where the dossiers or any part of them are not sent
within the relevant time limit, the rapporteur Member State
shall inform the Commission and the EFSA within two months,
giving any justification for the delay provided by the notifiers.

On the basis of

the information transmitted by the
6.
rapporteur Member State in accordance with paragraph 5, the
Commission shall determine whether the notifier has demon-
strated that the delay in submission of the dossier was caused
by force majeure. In this case, it shall establish a new time limit
for the submission of a dossier fulfilling the requirements of
paragraphs 2 and 3 in accordance with the procedure provided
for in Article 19 of Directive 91/414/EEC.

7.
The Commission shall decide, as provided for in the
fourth subparagraph of Article 8(2) of Directive 91/414/EEC,
not to include in Annex I to Directive 91/414/EEC an active
substance for which no dossier has been submitted within the
established time limit.

For those active substances for which the dossier is to be
completed, as provided for under Article 7(2)(c)(iii), the report
must confirm the date by which the dossier will be completed
and by which date the evaluation as referred to in Article 10
will begin.

For

those active substances

2.
for which a rapporteur
Member State or the EFSA consider that the dossier is not
complete within the meaning of Article 7(2) and (3),
the
Commission shall, within three months after the receipt of the
report of the rapporteur Member State or the EFSA, refer such
report to the Committee. In accordance with the procedure
provided for in Article 19 of Directive 91/414/EEC, it shall be
decided whether a dossier is considered complete within the
meaning of Article 7(2) and (3).

3.
The Commission shall decide, as provided for in the
fourth subparagraph of Article 8(2) of Directive 91/414/EEC,
not to include in Annex I to Directive 91/414/EEC an active
substance for which no complete dossier has been submitted
within the prescribed time limit.

Article 8

Submission of information by third parties

Article 10

Any person wishing to submit information which might contri-
bute to the evaluation, in particular with regard to the poten-
tially dangerous effects of the active substance or its residues on
human and animal health and on the environment
to the
rapporteur Member States shall do so by 30 November 2003 at
the latest for substances listed in Annex I, part A, and by 30
November 2004 at the latest for substances listed in Annex I,
part B. The rapporteur Member State shall submit any informa-
tion received to the EFSA.

Article 9

Completeness check of dossiers

1.
For each active substance for which it has been designated
the Member State shall examine the dossiers
rapporteur,
referred to in Article 7(2) and (3) and assess the checklists
provided by the notifiers. The rapporteur Member State shall at
the latest six months after the receipt of all dossiers for an
active substance report to the EFSA and the Commission on the
completeness of the dossiers.

Evaluation by the rapporteur Member State

1.
The rapporteur Member State shall evaluate and report
only on those active substances for which at least one dossier
has been determined to be complete in accordance with Article
9. For such active substances it shall evaluate and report only
on the complete dossiers and for the other dossiers it shall
check the identity and impurities of the active substance. The
rapporteur Member State shall take into consideration the infor-
mation available on potentially dangerous effects in the other
dossiers submitted by any notifier or by any third party in
accordance with the provisions of Article 8. It shall send a draft
report of its assessment of the dossier to the EFSA as quickly as
possible, and at the latest 12 months after the dossier was
determined to be complete. The draft assessment report shall be
submitted in the format recommended in accordance with the
procedure provided for in Article 19 of Directive 91/414/EEC.

At the same time, the rapporteur Member State shall make a
recommendation to the Commission either:

— to include the active substance in Annex I to Directive 91/

414/EEC, stating the conditions for inclusion, or

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— not to include the active substance in Annex I to Directive
91/414/EEC, stating the reasons for the non-inclusion.

The rapporteur Member State shall in particular include in the
draft assessment report a reference to each test and study
report, for each point of Annex II and Annex III to Directive
91/414/EEC, relied on for the assessment. This reference shall
be made in the form of a list of test and study reports including
the title, the author(s), the date of the study or test report and
the date of publication, the standard to which the test or study
was conducted, the holder’s name and, if any, the claim made
by the holder or notifier for data protection.
It shall also
mention for the other notified sources of the active substances
to be complete
for which the dossier was considered not
whether it can be concluded that such active substances are
comparable within the meaning of Article 13(5) of Directive
91/414/EEC.

2. Without prejudice to Article 7 of Directive 91/414/EEC,
submission of new studies shall not be accepted except for the
studies as specified in Article 10(4) of Regulation (EC) No 451/
2000. The rapporteur Member State may however request the
notifiers to submit further data which are necessary to clarify
the dossier. When doing so the rapporteur Member State shall
set a time limit within which the information should be
provided; this time limit shall not affect the time limit for the
submission of the report referred to in paragraph 1.

The rapporteur Member State may, from the start of its exami-
nation of the dossier, consult with experts from the EFSA and
may request additional technical or scientific information from
other Member States to assist the evaluation. The rapporteur
Member State may perform the evaluation together with a co-
rapporteur Member State.

the notifiers to
The rapporteur Member State shall request
submit an updated summary dossier to the EFSA, the other
Member States and on request to the Commission at the same
time as the rapporteur’s draft assessment report is sent to the
EFSA.

The Member States, the Commission or the EFSA may request
through the rapporteur Member State that notifiers also send
them an updated complete dossier or parts thereof.

3.
As soon as it becomes evident to a rapporteur Member
State that it will be unable to comply with the time limit speci-
fied in paragraph 1 for the submission of the draft assessment
report to the EFSA, it shall inform the Commission and the
EFSA and give the reasons for the delay. Where necessary,
certain active substances may be reassigned to another Member
State in accordance with the procedure provided for in Article
19 of Directive 91/414/EEC.

Article 11

Evaluation by the EFSA

After receiving the updated summary dossier and the draft
1.
assessment report referred to in Article 10(1), the EFSA shall,

the report

to the
within 30 days, acknowledge receipt of
rapporteur Member State. In exceptional cases where the draft
assessment report clearly does not
the requirements
concerning the format recommended by the Commission, the
Commission shall agree with the EFSA and the rapporteur
Member State on a period for resubmission of an amended
report. This period shall not exceed four months.

fulfil

2.
The EFSA shall circulate the rapporteur’s draft assessment
report to the Member States and may organise a consultation of
experts including from the rapporteur Member State. The EFSA
may consult some or all of the notifiers of active substances
specified in Annex I on the report or parts of the report on the
relevant active substance.

Without prejudice to Article 7 of Directive 91/414/EEC,
submission of new studies shall not be accepted except for the
studies as referred to in Article 10(4) of Regulation (EC) No
451/2000. The rapporteur Member State, with the agreement
of the EFSA, may request the notifiers to submit within speci-
fied periods further data considered by the rapporteur Member
State or EFSA necessary to clarify the dossier.

The EFSA shall make available at specific request or keep

3.
available for consultation by any person the following:

(a) the information referred to in the last subparagraph of
Article 10(1), except the elements thereof which have been
accepted as confidential in accordance with Article 14 of
Directive 91/414/EEC;

(b) the name of the active substance;

(c) the content of the pure active substance in the manufac-

tured material;

(d) the list of any data required for consideration of

the
possible inclusion of the active substance into Annex I to
Directive 91/414/EEC, first as contained in the rapporteur’s
report and secondly as finalised by the EFSA;

(e) the draft assessment report, except the elements thereof
in accordance

which have been accepted as confidential
with Article 14 of Directive 91/414/EEC.

The EFSA shall evaluate the rapporteur’s draft assessment
4.
report and deliver its opinion on whether the active substance
can be expected to meet the safety requirements of Directive
91/414/EEC to the Commission at the latest one year after
receipt of the rapporteur Member State draft assessment report.
Where appropriate, the EFSA shall give its opinion on the avail-
able options claimed to meet
the safety requirements. The
Commission and the EFSA shall agree on a schedule for the
delivery of the opinions in order to facilitate the planning of
the work. The Commission and the EFSA shall agree on the
format in which the opinion of the EFSA is submitted.

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Official Journal of the European Communities

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Article 12

Presentation of a draft directive or draft decision

At the latest six months after receipt of the EFSA opinion
referred to in Article 11(4) the Commission shall submit a draft
review report. Without prejudice to any proposal it may submit
with a view to amending the Annex to Directive 79/117/EEC,
and on the basis of the finalised review report it shall submit to
the Committee:

(a) a draft directive to include the active substance in Annex I
to Directive 91/414/EEC, setting out where appropriate the
conditions, including the time limit, for such inclusion; or

(b) a draft decision addressed to the Member States to with-
authorisations of plant-protection products
draw the
containing the active substance, pursuant
to the fourth
subparagraph of Article 8(2) of Directive 91/414/EEC,
whereby that active substance is not included in Annex I to
Directive 91/414/EEC, mentioning the reasons for the non-
inclusion.

containing that substance, shall, as soon as possible, inform the
Commission, the EFSA, the other Members States and the noti-
fiers giving the reasons for its intended action.

Article 16

Interim progress report

All Member States shall provide to the Commission and the
EFSA a report of their progress on the evaluation of the active
substances for which they are rapporteur. Such report shall be
made by 30 November 2004 for
the active substances
mentioned in Annex I, part A, and by 30 November 2005 for
those of Annex I, part B.

Article 17

Fees

The directive or decision shall be adopted in accordance with
the procedure provided for in Article 19 of Directive 91/414/
EEC.

1. Member States shall establish a regime obliging the noti-
fiers to pay a fee or charge for the administrative treatment and
the evaluation of dossiers.

Article 13

2.

For this purpose, the Member States shall:

(a) require the payment of a fee or charge for each submission

Finalised review report

of a dossier;

Where the Commission submits a draft directive or a draft deci-
sion in accordance with Article 12, it shall at the same time
submit the conclusions of the Committee’s examination in the
format of a finalised review report to be noted in the summary
record of the meeting. The finalised review report, excluding
any parts which refer to confidential information contained in
the dossiers and determined as such in accordance with Article
14 of Directive 91/414/EEC, shall be made available for public
consultation.

Article 14

Suspension of time limits

Where, in respect of a substance listed in Annex I, the Commis-
sion submits a proposal for a total prohibition under Directive
79/117/EEC, the time limits provided for in this Regulation
shall be suspended until a decision on that proposal has been
taken. Where the Council decides on the total prohibition of
the substance in the Annex to Directive 79/117/EEC, the proce-
dure under this Regulation shall be terminated.

(b) ensure that the amount of the fee or charge shall be estab-
lished in a transparent manner with the view to correspond
to the real cost of the examination and administrative treat-
ment of a dossier; however this does not exclude that
Member States provide for a scale of fixed charges based on
average costs for the calculation of the total fee;

(c) ensure that the fee or charge is received in accordance with
the instructions given by the organisation in each Member
State listed in Annex IV and that the income of the fee or
charge is used to finance exclusively the costs actually
incurred by the Member State for the evaluation and admin-
istrative treatment of the dossiers for which that Member
State is rapporteur or to finance general actions for the
implementation of
their obligations as Member States
resulting from Articles 9 or 10;

(d) require that a first part of the fee or charge, covering the
costs of the rapporteur Member State’s obligations resulting
from Article 6 and Article 9 is paid at the time of the
submission of the data lists referred to in Article 6; this part
will not be refundable under any circumstance.

Article 15

Measures taken by Member States

Article 18

Other charges, taxes, levies or fees

Any Member State which, on the basis of
information
contained in the dossiers referred to in Article 7 or in the
report concerning an active substance referred to in Article 10,
envisages taking action to withdraw from the market or to
a plant-protection product
restrict

severely the use of

Article 17 is without prejudice to Member States’ rights to
maintain or introduce, to the extent permitted under the Treaty,
charges,
levies or fees with regard to authorisation,
placing on the market, use and control of active substances and
plant-protection products other than the fee provided for in
Article 17.

taxes,

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Official Journal of the European Communities

21.8.2002

Article 19

Temporary measures

sources of the active substances for which the dossier was
considered not to be complete whether it can be concluded
that such active substances are comparable within the
meaning of Article 13(5) of the Directive.

If necessary and on a case-by-case basis, the Commission may
take appropriate temporary measures as provided for by the
third subparagraph of Article 8(2) of Directive 91/414/EEC for
uses for which additional technical evidence has been provided
demonstrating the essential need for further use of the active
substance and that there is no efficient alternative.

Article 20

Amendment to Regulation (EC) No 451/2000

Regulation (EC) No 451/2000 is amended as follows:

1. Article 8 is replaced by the following:

‘Article 8

Evaluation of dossiers by rapporteur Member States
and the EFSA

The rapporteur Member State shall evaluate and report
1.
only on those active substances for which at
least one
dossier has been determined to be complete in accordance
with Article 6(2) and (3). For such active substances it shall
evaluate and report only on the complete dossiers and for
the other dossiers it shall check the identity and impurities
of the active substance. The rapporteur Member State shall
take into consideration the information available on poten-
tially dangerous effects in the other dossiers submitted by
any notifier or by any third party in accordance with the
provisions of Article 5(4)(d). It shall send a draft report of its
assessment of
the dossier to the European Food Safety
Authority (EFSA) as quickly as possible, and at the latest 12
months after the dossier was determined to be complete.
The draft assessment report shall be submitted in the format
recommended in accordance with the procedure provided
for in Article 19 of the Directive.

At the same time, the rapporteur Member State shall make a
recommendation to the Commission either:

— to include the active substance in Annex I to the Direc-

tive, stating the conditions for inclusion, or

— not to include the active substance in Annex I to the
Directive, stating the reasons for the non-inclusion.

The rapporteur Member State shall in particular include in
the draft assessment report a reference to each test and study
report, for each point of Annex II and Annex III to the
Directive, relied on for the assessment. This reference shall
be made in the form of a list of test and study reports
including the title, the author(s), the date of the study or test
report and the date of publication, the standard to which
the test or study was conducted, the holder’s name and, if
any, the claim made by the holder or notifier for data
It shall also mention for the other notified
protection.

2. Without prejudice to Article 7 of
the Directive,
submission of new studies shall not be accepted, except for
the studies as referred to in Article 6(2)(c), third indent. The
rapporteur Member State may request the notifiers to submit
further data which are necessary to clarify the dossier. When
doing so the rapporteur Member State shall set a time limit
within which the information should be provided; this time
limit shall not affect the time limit for the submission of the
report referred to in paragraph 1.

The rapporteur Member State may, from the start of this
examination, consult with experts from the EFSA and may
request additional technical or scientific information from
other Member States to assist the evaluation. The rapporteur
Member State may perform the evaluation together with a
co-rapporteur Member State.

The rapporteur Member State shall request the notifiers to
submit an updated summary dossier to the EFSA, the other
Member States and on request to the Commission at the
same time as the rapporteur’s draft assessment report is sent
to the EFSA.

the EFSA or the Commission may
The Member States,
request through the rapporteur Member State that notifiers
also send them the updated complete dossiers or parts
thereof.

3.
As soon as it becomes evident to a rapporteur Member
State that it will be unable to comply with the time limit
specified in paragraph 1 for the submission of the draft
assessment report to the EFSA, it shall inform the Commis-
sion and the EFSA and give the reasons for the delay. All
Member States shall provide to the Commission and the
EFSA a report of their progress on the evaluation of the
active substances for which they are rapporteur. Such report
has to be made by 30 April 2003.

4.
After receiving the updated summary dossier and the
draft assessment report referred to in paragraph 1, the EFSA
shall, within 30 days, acknowledge receipt of the report to
the rapporteur Member State. In exceptional cases where the
draft assessment report clearly does not fulfil the require-
ments concerning the format recommended by the Commis-
sion, the Commission shall agree with the EFSA and the
rapporteur Member State on a period for resubmission of an
amended report. This period shall not exceed four months.

The EFSA shall circulate the rapporteur’s draft assess-
5.
ment report
to the Member States and may organise a
consultation of experts including the rapporteur Member
State. The EFSA may consult some or all of the notifiers of
active substances specified in Annex I on the report or parts
of the report on the relevant active substance.

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Official Journal of the European Communities

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Without prejudice to Article 7 of the Directive, submission
of new studies shall not be accepted. The rapporteur
Member State, with the agreement of the EFSA, may request
the notifiers to submit within specified periods further data
considered by the rapporteur member state of the EFSA
necessary to clarify the dossier.

(b) a draft decision addressed to the Member States to with-
draw the authorisations of plant-protection products
containing the active substance, pursuant to the fourth
subparagraph of Article 8(2) of the Directive, whereby
that active substance is not included in Annex I to the
Directive, mentioning the reasons for the non-inclusion.

6.
The EFSA shall make available at specific request or
keep available for consultation by any person the following:

The directive or decision shall be adopted in accordance
with the procedure provided for in Article 19 of the Direc-
tive.

(a) the information referred to in the last subparagraph of
paragraph 1, except the elements thereof which have
been accepted as confidential in accordance with Article
14 of the Directive;

9. Where the Commission submits a draft directive or a
draft decision in accordance with paragraph 8, it shall at the
same time submit the conclusions of the Committee’s exami-
nation in the format of a finalised review report to be noted
in the summary record of the meeting.

(b) the name of the active substance;

(c) the content of the pure active substance in the manufac-

tured material;

(d) the list of any data required for consideration of the
possible inclusion of the active substance into Annex I
to the Directive, first as contained in the rapporteur’s
report and secondly as finalised by the EFSA;

The finalised review report, excluding any parts which refer
to confidential
information contained in the dossiers and
determined as such in accordance with Article 14 of the
Directive, shall be made available for public consultation.’

2. In Article 10(4),

the first sentence is replaced by the

following:

‘The time limit for the submission of a list of available
studies shall be 23 May 2003. A full data package shall be
available on 23 May 2003 at the latest.’

(e) the draft assessment report, except the elements thereof
which have been accepted as confidential in accordance
with Article 14 of the Directive.

3. In Article 11(2), the second sentence is replaced by the

following:

7.
The EFSA shall evaluate the rapporteur’s draft assess-
ment report and deliver its opinion on whether the active
substance can be expected to meet the safety requirements
of the Directive to the Commission at the latest one year
after receipt of the rapporteur Member State draft assess-
ment report. Where appropriate, the EFSA shall give its
opinion on the available options claimed to meet the safety
requirements. The Commission and the EFSA shall agree on
a schedule for the delivery of the opinions in order to facili-
tate the planning of the work. The Commission and the
EFSA shall agree on the format in which the opinion of the
EFSA is submitted.

8.
At the latest six months after receipt of the EFSA
opinion referred to in paragraph 7, the Commission shall
submit the draft review report. Without prejudice to any
proposal it may submit with a view to amending the Annex
to Directive 79/117/EEC, and on the basis of the finalised
review report it shall submit to the Committee:

containing

‘Member States shall withdraw by 25 July 2003 authorisa-
tions of plant-protection products
active
substances for which no admissible notification has been
submitted. Authorisations of plant-protection products
containing active substances for which no list of available
studies has been submitted or for which no full data package
is available shall be withdrawn by the deadline referred to in
the Decision on the non-inclusion of the active substance
concerned.’

4. In Annex I, part A,

in relation to the active substance

Tolclofos-methyl ‘The Netherlands’ is replaced by ‘Sweden’.

Article 21

Entry into force

(a) a draft directive to include the active substance in Annex
I to the Directive, setting out where appropriate the
conditions, including the time limit, for such inclusion,
or

This Regulation shall enter into force on the seventh day
following its publication in the Official Journal of the European
Communities.

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Official Journal of the European Communities

21.8.2002

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 August 2002.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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Official Journal of the European Communities

L 224/33

List of active substances (column A), rapporteur Member States (column B) and notifying producers (code
identification) (column C)

ANNEX I

PART A

A

Name

B

C

Rapporteur Member State

Notifiers

Abamectin

Netherlands

Acetochlor

Spain

Amidosulfuron

Benfluralin

Bifenox

Bifenthrin

Bitertanol

Bromuconazole

Buprofezin

Butralin

Carbetamide

Chlorflurenol

Chloridazon

Chloropicrin

Chlorthal-dimethyl

Cinosulfuron

Clethodim

Clofentezine

Clomazone

Coppercompounds

Cresylic acid

Cyanamide

Cycloxydim

Dichlorophen

Diclofop

Austria

Belgium

Belgium

France

United Kingdom

Belgium

Finland

France

France

Germany

Germany

Italy

Greece

Italy

Netherlands

United Kingdom

Denmark

France

Netherlands

Germany

Austria

Ireland

France

IBE-ES

PRO-ES

SNO-FR

SYN-GB

DAS-GB

MON-BE

RIV-IE

AVS-DE

DAS-GB

MAK-BE

FSG-DE

FMC-BE

BAY-DE

AVS-FR

NIH-GB

CFP-FR

FSG-DE

SCC-DE

BAS-DE

EBR-NL

RIV-IE

AMV-GB

SYN-GB

TOM-FR

MAK-BE

FMC-BE

EUC-GB

ASP-NL

DUS-DE

BAS-DE

CCD-GB

AVS-DE

PPC-ES

L 224/34

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Official Journal of the European Communities

21.8.2002

A

Name

B

C

Rapporteur Member State

Notifiers

Dicloran

Diflubenzuron

Diflufenican

Dimethipin

Dithianon

Epoxiconazole

Etofenprox

Fenazaquin

Fenbuconazole

Fenoxaprop-P

Fenpropidin

Fenpropimorph

Fenpyroximate

Fluazifop-P

Fluazinam

Fludioxonyl

Fluometuron

Fluquinconazole

Flurenol

Flutolanil

Fuberidazole

Hexaflumuron

Hexythiazox

Imidacloprid

Kasugamycin

Mefluidide

Mepiquat

Metaldehyde

Metazachlor

Spain

Sweden

United Kingdom

Greece

Greece

Germany

Italy

Greece

United Kingdom

Austria

Sweden

Germany

Germany

France

Austria

Denmark

Greece

Ireland

Germany

Finland

United Kingdom

Portugal

Finland

Germany

Netherlands

Ireland

United Kingdom

Austria

United Kingdom

Methyl bromide

United Kingdom

MAI-PT

UNI-NL

AVS-DE

HRM-BE

MAK-BE

CRO-GB

BAS-BE

HRM-BE

BAS-DE

MAK-BE

LKC-UK

DAS-GB

DAS-GB

AVS-DE

SYN-GB

BAS-DE

NIH-GB

SYN-GB

ISK-BE

SYN-GB

MAK-BE

NLI-AT

AVS-FR

SCC-DE

NIH-GB

BAY-DE

DAS-GB

NPS-DE

BAY-DE

LAI-ES

MKC-BE

BAS-DE

LON-DE

BAS-DE

FSG-DE

MAK-BE

EBR-NL

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Official Journal of the European Communities

L 224/35

A

Name

B

C

Rapporteur Member State

Notifiers

Myclobutanil

Napropamide

Nicosulfuron

Nuarimol

Pencycuron

Polyoxin

Pretilachlor

Propaquizafop

Prosulfocarb

Pyriproxyfen

Quinoclamine

Streptomycine

Tebufenozide

Teflubenzuron

Tetraconazole

Thiobencarb

Tralkoxydim

Triadimefon

Triadimenol

Tridemorph

Triflumizole

Triflumuron

Triflusulfuron

Zeta-Cypermethrin

DAS-GB

UPL-GB

ISK-BE

DAS-GB

BAY-DE

LAI-ES

SYN-GB

MAK-BE

SYN-GB

SUM-FR

AKA-DE

DSM-NL

DAS-GB

BAS-BE

ISA-IT

KCI-GB

SYN-GB

BAY-DE

BAY-DE

MAK-BE

BAS-DE

CRE-NL

BAY-DE

DPD-FR

FMC-BE

Belgium

Denmark

United Kingdom

Portugal

Netherlands

Spain

Italy

Italy

Sweden

Netherlands

Sweden

Netherlands

Germany

France

Italy

Spain

United Kingdom

United Kingdom

United Kingdom

Germany

Netherlands

Italy

France

Belgium

PART B

A

Name

B

C

Rapporteur Member State

Notifiers

8-Hydroxyquinoline

Spain

Aclonifen

Acrinathrin

Aluminium phosphide

Ammonium sulphamate

Germany

France

Germany

Ireland

ASU-DE

PRO-ES

AVS-DE

AVS-DE

DET-DE

DAP-GB

L 224/36

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Official Journal of the European Communities

21.8.2002

A

Name

B

C

Rapporteur Member State

Notifiers

Asulam

Azocyclotin

Bensulfuron

Bupirimate

Calcium phosphide

Carboxin

Chlorate

Chlormequat

Chlorsulfuron

Cyhexatin

Cymoxanil

Cyproconazole

Cyromazine

Dazomet

Dicamba

Dichlobenil

Dichlorobenzoic acid methylester

Dicofol

Diethofencarb

Difenoconazole

Dimethachlor

Diniconazole

Diphenylamine

Dodemorph

Dodine

Ethalfluralin

United Kingdom

Italy

Italy

Netherlands

Germany

United Kingdom

France

United Kingdom

Greece

Italy

Austria

Ireland

Greece

Belgium

Denmark

Netherlands

Germany

Spain

France

Sweden

Germany

France

Ireland

Netherlands

Portugal

Greece

AVS-DE

CRX-FR

DPD-FR

MAK-BE

CFW-DE

CRO-GB

ATO-FR

BCL-IE

CTF-AT

FSG-DE

PUS-FR

DPD-FR

CRX-FR

OXO-IT

CAL-FR

DPD-FR

OXO-IT

PUS-FR

SYN-GB

SYN-GB

BAS-DE

GHA-GB

SYN-GB

UNI-NL

ASU-DE

DAS-GB

MAK-BE

SUM-FR

SYN-GB

SYN-GB

SUM-FR

CRX-FR

CSI-UK

BAS-DE

CAG-BE

OXO-IT

DAS-GB

21.8.2002

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Official Journal of the European Communities

L 224/37

A

Name

B

C

Rapporteur Member State

Notifiers

Etridiazole

Fenbutatin oxide

Fenoxycarb

Flamprop-M

Flufenoxuron

Flurochloridone

Flurprimidole

Flutriafol

Guazatine

Hexaconazole

Hymexazol

Imazamethabenz

Imazaquin

Imazethapyr

Isoxaben

Lenacil

Lufenuron

Magnesium phosphide

Metam

Netherlands

Belgium

Netherlands

Sweden

France

Spain

Finland

United Kingdom

United Kingdom

Italy

Finland

United Kingdom

Belgium

Italy

Sweden

Belgium

Portugal

Germany

Belgium

Metamitron

United Kingdom

Methabenzthiazuron

Metosulam

Monocarbamide-dihydrogensulphate

Oryzalin

Sweden

France

Spain

France

UNI-NL

BAS-BE

CRX-FR

SYN-GB

BAS-BE

BAS-BE

MAK-BE

DAS-GB

CHE-DK

MAK-BE

IQV-ES

SYN-GB

TSG-GB

BAS-BE

BAS-BE

BAS-BE

DAS-GB

HRM-BE

SCH-DE

SYN-GB

DET-DE

FMF-ES

LAI-ES

MAK-BE

UCB-BE

BAY-DE

BCL-IE

EXC-BE

FSG-DE

HRM-BE

MAK-BE

PUS-FR

UPL-GB

PUS-FR

BAY-DE

AGX-GB

DAS-GB

L 224/38

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Official Journal of the European Communities

21.8.2002

A

Name

B

C

Rapporteur Member State

Notifiers

Oxadiazon

Oxyfluorfen

Paclobutrazol

Penconazole

Picloram

Primisulfuron

Prochloraz

Propachlor

Propanil

Propargite

Pyridaben

Quinclorac

Quinmerac

Quizalofop-P

Sintofen

Sodium 5-nitroguaiacolate

Sodium o-nitrophenolate

Sodium p-nitrophenolate

Sodium tetrathiocarbonate

Sulcotrione

Tau-fluvalinate

Tebuconazole

Tebufenpyrad

Tefluthrin

Italy

Spain

United Kingdom

Germany

United Kingdom

Austria

Ireland

Netherlands

Italy

France

Netherlands

Portugal

United Kingdom

Finland

France

Greece

Greece

Greece

Spain

Germany

Denmark

Denmark

Germany

Germany

AVS-DE

DAS-GB

MAK-BE

PPC-ES

SYN-GB

SYN-GB

DAS-GB

SYN-GB

AVS-FR

BCL-IE

MAK-BE

PUS-FR

SPC-FR

MAK-BE

MON-BE

DAS-GB

MAK-BE

RCO-PT

CRO-GB

PPC-ES

NCI-DE

BAS-DE

BAS-DE

CRO-GB

MAK-BE

NCI-DE

DPD-FR

CAL-FR

CAL-FR

CAL-FR

AGX-GB

BAY-DE

MAK-BE

BAY-DE

MAK-BE

BAS-BE

SYN-GB

21.8.2002

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Official Journal of the European Communities

L 224/39

A

Name

B

C

Rapporteur Member State

Notifiers

Terbuthylazine

United Kingdom

Thidiazuron

Tri-allate

Triazoxide

Tricyclazole

Spain

United Kingdom

United Kingdom

France

MAK-BE

OXO-IT

SYN-GB

AVS-FR

MON-BE

BAY-DE

DAS-GB

L 224/40

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Official Journal of the European Communities

21.8.2002

ANNEX II

List of notifiers' code identification, names and addresses

Code identification

Name

Address

AGX-GB

Agrilex UK Ltd

AKA-DE

Agro-Kanesho Co., Ltd, European Branch

AMV-GB

Amvac Chemical UK Ltd

ASP-NL

Asepta BV

ASU-DE

Stähler Agrochemie GmbH & Co. KG

ATO-FR

Atofina

AVS-DE

Aventis CropScience GmbH

AVS-FR

Aventis CropScience SA

BAS-BE

BASF (Belgium)

BAS-DE

BASF AG (Deutschland)

BAY-DE

Bayer AG

PO Box 31
Robertsbridge
TN32 5ZL
United Kingdom
Tel. (44-1580) 88 20 59
Fax (44-1580) 88 20 57

Stader Elbstraße
D-21683 Stade
Tel. (49-41) 41 40 83 88
Fax (49-41) 41 40 83 90

Surrey Technology Centre,
40 Occam Rd
The Surrey Research Park
Guildford,
Surrey GU2 5YG
United Kingdom
Tel. (44-1483) 29 57 80
Fax (44-1483) 29 57 81

Cyclotronweg 1 / P.O. Box 33
2600 AA Delft
Nederland
Tel. (31-15) 256 92 10
Fax (31-15) 257 19 01

Postfach 2047
D-21680 Stade
Tel. (49-41) 41 92 04-0
Fax (49-41) 41 92 04-10

4-8, cours Michelet
F-92800 Puteaux
Tel. (33-1) 49 00 80 80
Fax (33-1) 49 00 88 80

Industriepark Höchst
Gebäude K 607
D-65926 Frankfurt am Main
Tel. (49-69) 305 66 99
Fax (49-69) 305 176 69

14-20, rue Pierre Baizet
BP 9163
F-69263 Lyon Cedex 09
Tel. (33-4) 72 85 25 25
Fax (33-4) 72 85 30 81

Global Regulatory Affairs — APD/RF
Avenue Hamoir, 14
B-1180 Bruxelles
Tel. (32-2) 373 27 11
Fax (32-2) 373 27 00

Agricultural Center
PO Box 120
D-67114 Limburgerhof
Tel. (49-621) 60-0
Fax (49-621) 60-27701

Business Group Crop Protection
Agricultural Centre Monheim
D-51368 Leverkusen
Tel. (49-2173) 38 49 28
Fax (49-2173) 38 37 35

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Official Journal of the European Communities

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Code identification

Name

Address

BCL-IE

Barclay Chemicals Ltd

CAG-BE

Chimac-Agriphar SA

CAL-FR

Calliope SAS

CCD-GB

Coalite Chemicals Division

CFP-FR

CFPI Nufarm

CFW-DE

Chemische Fabrik Wülfel GmbH & Co. KG

CHE-DK

Cheminova A/S

CRE-NL

Certis Europe BV

CRO-GB

Crompton Europe Ltd

CRX-FR

Cerexagri

Tyrellstown Way
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland
Tel. (353-18) 42 57 55
Fax (353-18) 42 53 81

26, rue de Renory
B-4102 Ougrée
Tel. (32-4) 385 97 46
Fax (32-4) 385 97 49

Route d'Artix
BP 80
F-64150 Noguères
Tel. (33-5) 59 60 92 92
Fax (33-5) 59 60 92 19

PO Box 152
Buttermilk Lane
Bolsover
Chesterfield
Derbyshire S44 6AZ
United Kingdom
Tel. (44-1246) 82 68 16
Fax (44-1246) 24 03 09

Regulatory Affairs Dept.
28, boulevard Camélinat
F-92230 Gennevilliers
Tel. (33-1) 40 85 50 20
Fax (33-1) 40 85 51 56

Hildesheimer Straße 305
D-30519 Hannover
Tel. (49-511) 98 49 60
Fax (49-511) 984 96 40

Thyborønvej 76-78
DK-7673 Harboøre
Tel. (45) 96 90 96 90
Fax (45) 96 90 96 91

Straatweg 30B
PO Box 1180
3600 BD Maarssen
Nederland
Tel. (31-346) 55 24 00
Fax (31-346) 55 42 74

Registration Department
Kennet House
4 Langley Quay
Slough
Berkshire
SL3 6EH
United Kingdom
Tel. (44-17) 53 60 30 00
Fax (44-17) 53 60 30 77

Registration Department
1, rue des Frères Lumière
F-78370 Plaisir
Tel. (33-1) 30 81 73 00
Fax (33-1) 30 81 72 51

L 224/42

EN

Official Journal of the European Communities

21.8.2002

Code identification

Name

Address

CSI-UK

CSI-Europe

CTF-AT

CCC Task Force

DAP-GB

Dax Products Ltd

DAS-GB

Dow AgroSciences

DET-DE

Detia Freyberg GmbH

DPD-FR

DuPont de Nemours (France) SAS

DSM-NL

DSM Food Specialties, Agri Ingredients

DUS-DE

Degussa AG

EBR-NL

Eurobrom BV

EUC-GB

European Union Copper Task Force

Pentlands Science Park
Penicuik
Edinburgh
EH26 0PZ
United Kingdom
Tel. (44-131) 445 60 82
Fax (44-131) 445 60 85

c/o Nufarm GmbH & Co KG
St.-Peter-Straße 25
A-4021 Linz
Tel. (43-732) 69 18 23 13
Fax (43-732) 69 18 20 04

76 Cyprus Road
Nottingham
NG3 5ED
United Kingdom
Tel. (44-11) 59 26 9996
Fax (44-11) 59 66 1173

Letcombe Laboratory
Letcombe Regis
Wantage
Oxon
OX12 9JT
United Kingdom
Tel. (49-69) 78 99 60
Fax (49-69) 97 84 24 77

Dr.-Werner-Freyberg-Straße 11
D-69514 Laudenbach
Tel. (49-6201) 70 80
Fax (49-6201) 70 84 27

Crop Protection Products
137, rue de l'Université
F-75334 Paris Cedex 07
Tel. (33-1) 45 50 65 50
Fax (33-1) 45 50 60 05

Alexander Fleminglaan 1
PO Box 1
2600 MA Delft
Nederland
Tel. (31-15) 279 91 11
Fax (31-15) 279 34 82

Dr.-Albert-Frank-Straße 32
D-83308 Trostberg
Tel. (49-8621) 86-0
Fax (49-8621) 86 22 52

Regulatory Affairs Department
Verrijn Stuartlaan 1c
2288 EK Rijswijk
Nederland
Tel. (31-70) 3 408 408
Fax (31-70) 3 999 035

c/o TSGE
Conyngham Hall
Knaresborough
North Yorkshire
HG5 9AY
United Kingdom
Tel. (44-1423) 79 91 51
Fax (44-1423) 79 91 55

21.8.2002

EN

Official Journal of the European Communities

L 224/43

Code identification

Name

Address

EXC-BE

Excel Industries Ltd

FMC-BE

FMC Chemical SPRL

FMF-ES

FMC Foret SA

FSG-DE

Feinchemie Schwebda GmbH

GHA-GB

Gharda Chemicals Ltd Europe

HRM-BE

Hermoo Belgium NV

IBE-ES

Iberotam SA

IQV-ES

Industrias Químicas del Vallés SA

ISA-IT

Isagro SPA

ISK-BE

ISK Biosciences Europe SA

KCI-GB

Kumiai Chemical Industry Co., Ltd

Luithagen Haven 9
B-2030 Antwerpen
Tel. (32-3) 239 82 24
Fax (32-3) 239 82 69

Agricultural Products Group
Boulevard de la Plaine 9/3
B-1050 Bruxelles
Tel. (32-2) 645 95 84
Fax (32-2) 645 96 55

Córcega 293
E-08008 Barcelona
Tel. (34) 934 16 75 17
Fax (34) 934 16 74 13

Straßburger Straße 5
D-37269 Eschwege
Tel. (49-221) 94 98 14-0
Fax (49-221) 94 98 14 15

Holbrook House
72 Lower Addiscombe Road
Croydon
CR9 6AD
United Kingdom
Tel. (44-2086) 55 41 03
Fax (44-2086) 55 41 02

Zepperenweg 257
B-3800 Sint-Truiden
Tel. (32-11) 68 68 66
Fax (32-11) 70 74 84

Muntaner, 322, 12a
E-08021 Barcelona
Tel. (34) 934 54 34 64
Fax (34) 934 54 89 21

Av. Rafael Casanova 81
E-08100 Mollet del Vallès (Barcelona)
Tel. (34) 935 79 66 77
Fax (34) 935 93 80 11

Registration Department
Centro Uffici San Siro Fabbricato D ala 3 Via
Caldera, 21
I-20153 Milano
Tel. (39-02) 40 90 11
Fax (39-02) 40 90 12 87

Tour ITT
Avenue Louise 480 bte 12
B-1050 Bruxelles
Tel. (32-2) 627 86 11
Fax (32-2) 627 86 00

London Liaison Office
35 Piccadilly
London
W1J 0DW
United Kingdom
Tel. (44-2077) 34 72 82
Fax (44-2077) 34 45 61

L 224/44

EN

Official Journal of the European Communities

21.8.2002

Code identification

Name

Address

LAI-ES

Lainco, SA

LKC-UK

Landis Kane Consulting

LON-DE

Lonza GmbH

MAI-PT

Margarita Internacional

MAK-BE

Makhteshim Agan

MKC-BE

McKenna & Cuneo, L.L.P.

MON-BE

Monsanto Europe SA

NCI-DE

Nissan Chemical Europe GmbH

NIH-GB

Nihon Nohyaku Co., Ltd

NLI-AT

Nufarm GmbH & Co KG

NPS-DE

Nisso Chemical Europe GmbH

Polígono Can Jardí
Av. Bizet 8-12
E-08191 Rubí (Barcelona)
Tel. (34) 935 86 20 15
Fax (34) 935 86 20 16

PO Box 383
Cheltenham
Gloucestershire
GL52 6WD
United Kingdom
Tel. (44-4161) 906 85 04
Fax (44-4161) 906 85 09

Morianstraße 32
Postfach 13 14 53
D-42041 Wuppertal
Tel. (49-202) 245 38-0
Fax (49-202) 245 38 10

Comércio e Serviços, Limitada
Rua do Bom Jesus, 18-3.o Esq.o
P-9050-028 Funchal
Tel. (351-291) 23 24 84

International Coordination Center (MAICC)
Avenue Louise 283
B-1050 Bruxelles
Tel. (32-2) 646 86 06
Fax (32-2) 646 91 52

56, rue des Colonies, Box 14
B-1000 Bruxelles
Tel. (32-2) 278 12 11
Fax (32-2) 278 12 00

Regulatory Department
Avenue de Tervuren 270-272
B-1150 Bruxelles
Tel. (32-10) 49 42 11
Fax (32-10) 49 42 42

Deutsch-Japanisches Center
Immermannstraße 45
D-40210 Düsseldorf
Tel. (49-211) 17 22 70
Fax (49-211) 16 22 43

8 Cork Street
Mayfair
London
W1S 3LJ
United Kingdom
Tel. (44-2074) 34 00 33
Fax (44-2072) 87 13 35

St.-Peter-Straße 25
A-4021 Linz
Tel. (43-73) 26 91 80
Fax (43-73) 26 91 82 004

Berliner Allee 29/Ecke Steinstraße
D-40212 Düsseldorf
Tel. (49-211) 323 01 35
Fax (49-211) 32 82 31

21.8.2002

EN

Official Journal of the European Communities

L 224/45

Code identification

Name

Address

OXO-IT

Oxon Italia SpA

PPC-ES

Proplan-Plant Protection Company, SL

PRO-ES

Probelte, SA

PUS-FR

Phytorus SA

RCO-PT

Rice Madeira Company Europe

RIV-IE

Rivendell Consulting Ltd

SCC-DE

SCC Scientific Consulting Company GmbH

SCH-DE

Dr. Schirm AG

SNO-FR

SINON EU Corporation

SPC-FR

Sipcam-Phyteurop

SUM-FR

Sumitomo Chemical Agro Europe SA

Via Sempione, 195
I-20016 Pero (MI)
Tel. (39-02) 35 37 81
Fax (39-02) 339 02 75

Vía de las dos Castillas 11. Bloque 3, 1º C.
E-28224 Pozuelo de Alarcón (Madrid)
Tel. (34) 913 52 29 60
Fax (34) 913 52 72 82

Ctra. Madrid Km. 384.6
Polígono Industrial El Tiro
E-30100 Espinardo (Murcia)
Tel. (34) 968 30 72 50
Fax (34) 968 30 54 32

Parc d'Ariane, Bât B
11, boulevard de la grande Thumine
F-13090 Aix-en-Provence
Tel. (33-1) 60 27 26 26
Fax (33-4) 42 52 68 52

Comércio Internacional e Serviços, Sociedade
Unipessoal Lda.
Rua 31 de Janeiro n.o 81-A, 5.o E
PT-9050-011 Funchal (Madeira)
Tel. (351-291) 22 77 44
Fax (351-291) 22 66 31

Rivendell House
Stamullen
County Meath
Ireland
Tel. (353-18) 41 52 95
Fax (353-18) 41 47 68

Mikroforum Ring 1
D-55234 Wendelsheim
Tel. (49-67) 34 91 90
Fax (49-67) 34 91 91 91

Kipper Straße 9-11
D-44147 Dortmund
Tel. (49-392) 845 63 02
Fax (49-392) 845 63 00

170, boulevard Haussmann
F-75008 Paris
Tel. (33-5) 59 60 92 92
Fax (33-5) 59 60 92 19

Courcellor 2
35, rue d'Alsace
F-92531 Levallois-Perret Cedex
Tel. (33-1) 47 59 77 00
Fax (33-1) 47 37 54 52

2, rue Claude Chappe
F-69370 Saint-Didier-au-Mont-d'Or
Tel. (33-4) 78 64 32 60
Fax (33-4) 78 47 70 05

L 224/46

EN

Official Journal of the European Communities

21.8.2002

Code identification

Name

Address

SYN-DE

Syngenta Agro GmbH

SYN-GB

Syngenta Europe Ltd

TOM-FR

Tomen France

TSG-GB

Sankyo Company Ltd

UCB-BE

UCB Chemicals NV

UNI-NL

Uniroyal Chemical Europe BV

UPL-GB

United Phosphorus Ltd

Am Technologiepark 1-5
Postfach 110353
D-63477 Maintal
Tel. (49-6971) 55-0
Fax (49-6971) 55-319

European Regional Centre
Priestley Road
Surrey Research Park
Guildford
Surrey
GU2 7YH
United Kingdom
Tel. (44-1483) 26 00 00
Fax (44-1483) 26 00 19

18, avenue de l'Opéra
F-75001 Paris
Tel. (33-1) 42 96 14 56
Fax (33-1) 42 97 52 91

C/o TSGE
Conyngham Hall
Knaresborough
North Yorkshire
HG5 9AY
United Kingdom
Tel. (44-1423) 79 91 51
Fax (44-1423) 79 91 55

Allée de la Recherche 60
B-1070 Bruxelles
Tel. (32-2) 559 99 99
Fax (32-2) 559 99 00

Registration Department
Ankerweg 18
1041 AT Amsterdam
Nederland
Tel. (31-20) 587 18 60
Fax (31-20) 587 18 68

Chadwick House
Birchwood Park
Warrington
Cheshire
WA3 6AE
United Kingdom
Tel. (44-1925) 81 99 99
Fax (44-1925) 81 74 25

21.8.2002

EN

Official Journal of the European Communities

L 224/47

ANNEX III

Coordinating authority in the Member States (more details are available at the following website: http://www.euro-
pa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm)

AUSTRIA

FRANCE

Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung
Wein
Spargelfeldstraße 191
A-1220 Wien

BELGIUM

Ministère des classes moyennes et de l’agriculture
Service Qualité des matières premières et analyses
WTC 3, 8e étage
Boulevard S. Bolivar 30
B-1000 Bruxelles

DENMARK

Ministry of Environment and Energy
Danish Environmental Protection Agency
Pesticide Division
Strandgade 29
DK-1401 Copenhagen K

GERMANY

Ministère de l’agriculture, de l’alimentation, de la pêche
et des affaires rurales
Sous-direction de la qualité et de la protection des
végétaux
Bureau de la réglementation et de la mise sur le marché
des intrants
251, rue de Vaugirard
F-75732 Paris Cedex 15

IRELAND

Pesticide Control Service
Department of Agriculture and Food
Abbotstown Laboratory Complex
Abbotstown, Castleknock
Dublin 15
Ireland

ITALY

Ministero della Salute
Direzione generale della Sanità pubblica veterinaria degli
alimenti e della nutrizione
Piazza G. Marconi, 25
I-00144 Roma

Biologische Bundesanstalt für Land- und Forstwirtschaft
(BBA)
Abteilung für Pflanzenschutzmittel und Anwendung-
stechnik (AP)
Messeweg 11-12
D-38104 Braunschweig

LUXEMBOURG

Administration des services techniques de l’agriculture
Service de la protection des végétaux
Boîte postale 1904
16, route d’Esch
L-1019 Luxembourg

GREECE

NETHERLANDS

Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens

SPAIN

Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General
Agrícolas
Ciudad de Barcelona, 118-120
E-28007 Madrid

de Medios

de

Producción

FINLAND

Kasvintuotannon tarkastuskeskus
Torjunta-aineet
PL 42
FIN-00501 Helsinki

College voor de Toelating van Bestrijdingsmiddelen
Postbus 217
6700 AE Wageningen
Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas
Quinta do Marquês
P-2780 Oeiras

SWEDEN

Kemikalieinspektionen
Box 1384
S-17127 Solna

UNITED KINGDOM

Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House
Kings Pool
3 Peasholme Green
York YO1 7PX
United Kingdom

L 224/48

EN

Official Journal of the European Communities

21.8.2002

ANNEX IV

Organisations in the Member States to be contacted concerning further details on the payment of the fees
referred to in Article 17 and to which such fees have to be paid

AUSTRIA

FRANCE

Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung
Wein
Spargelfeldstraße 191
A-1220 Wien

BELGIUM

Fonds budgétaire des matières premières
Ministère des classes moyennes et de l’agriculture
Inspection générale des matières premières et produits
transformés, WTC 3
Boulevard S. Bolivar 30
B-1000 Bruxelles
Account number 679-2005985-25 (Banque de la Poste)

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

IRELAND

Pesticide Control Service
Department of Agriculture, Food and Rural Develop-
ment
Abbotstown Laboratory Complex
Abbotstown, Castleknock
Dublin 15
Ireland

DENMARK

Ministry of Environment and Energy
Danish Environmental Protection Agency
Strandgade 29
DK-1401 Copenhagen K

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft
Abteilung für Pflanzenschutzmittel und Anwendung-
stechnik
Messeweg 11-12
D-38104 Braunschweig

GREECE

Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens

SPAIN

Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General
Agrícolas
Ciudad de Barcelona, 118-120
E-28007 Madrid

de Medios

de

Producción

FINLAND

Kasvintuotannon tarkastuskeskus
Torjunta-aineet
PL 42
FIN-00501 Helsinki
Bank and account:
LEONIA BANK PLC
PSP BFIHH
800015-18982

ITALY

Tesoreria provinciale dello Stato di Viterbo
Post current account number: 11281011

LUXEMBOURG

Administration des services techniques de l’agriculture
Boîte postale 1904
L-1019 Luxembourg

THE NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen
Postbus 217
6700 AE Wageningen
Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas
Quinta do Marquês
P-2780 Oeiras
Account number: 003505840003800793097
Bank: Caixa Geral de Depósitos

SWEDEN

Kemikalieinspektionen
Box 1384
S-17127 Solna
National Giro Account: 4465054-7

UNITED KINGDOM

Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House
Kings Pool
3 Peasholme Green
York YO1 7PX
United Kingdom