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
Date: 2000-02-28
Institutions: European Commission
Subjects: dangerous substance, health risk, marketing standard, plant health control, plant health product

29. 2. 2000

EN

Official Journal of the European Communities

L 55/25

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 1999/
80/EC (2), and in particular Article 8(2), second subparagraph,
thereof,

Whereas:

(1)

(2)

(3)

two years after

The Commission is to undertake a work programme for
the gradual examination of active substances on the
the date of notification of
market
Directive 91/414/EEC within a period of 12 years. The
first stage of the programme was laid down by Commis-
sion Regulation (EEC) No 3600/92 of 11 December
1992 laying down the detailed rules for the implementa-
tion of the first stage of the work programme 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
1972/1999 (4). The first stage is ongoing. It is necessary
the
to continue and speed up the examination of
remaining active substances, taking into account experi-
ence from the first stage.

Given the very high number of existing active substances
on the market still to be evaluated, a programme in
several phases must be established. Experience has
shown that the evaluation and decision-making on an
active substance is a time-consuming process. It is there-
fore not yet possible to provide for a detailed evaluation
of all the existing active substances.

Therefore the second stage will provide for the detailed
evaluation of a number of active substances comparable
to the number covered in the first stage whilst the third
stage will prepare for the subsequent evaluation of active
substances. For certain categories of active substances
further harmonisation is required concerning the dossier
to be provided and the evaluation to be carried out.
Those categories should therefore not be included in the
current proposed work programme but
should be
covered by further stages for their evaluation with a
view to their possible inclusion in Annex I to Directive
91/414/EEC.

(5)

(6)

(7)

(8)

(9)

(4)

For the second stage a selection should be made taking
into account,
in a balanced manner, such aspects as
health and/or environmental concern, possibility of
leaving residues in treated products, importance of the

(10)

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 210, 10.8.1999, p. 13.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 244, 16.9.1999, p. 41.

preparations containing these substances for agriculture,
any manifest data gaps and any similarity of chemical or
biological properties.

The relationships between producers, Member States and
the Commission and the obligations on each of the
parties for the implementation of the programme should
be laid down, taking into account experience gained
during the first stage of the programme. Close coopera-
tion between all parties involved is necessary to increase
the efficiency of the programme.

scientific information about an active
Technical or
substance,
in particular with regard to its potentially
dangerous effects or its residues, submitted within the
relevant
time limits by any other interested parties
should also be taken into consideration in the evalu-
ations.

A notification procedure should be provided by which
interested producers have the right
to inform the
Commission of their interest in securing the inclusion of
an active substance in Annex I to Directive 91/414/EEC
and of their undertaking to submit all the required infor-
mation for a proper evaluation of, and decision on, that
active substance in the light of the criteria for inclusion
set out in Article 5 of Directive 91/414/EEC. Therefore
the information submitted should include information
on a limited range of representative uses for which the
the data
notifier must demonstrate, on the basis of
submitted,
the
requirements of Directive 91/414/EEC in relation to the
criteria referred to in its Article 5 can be met.

for one or more preparations

that

It is necessary to define the obligations of notifiers with
regard to the formats, periods and recipient authorities
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 to examine and evaluate the infor-
mation submitted and to present to the Commission the
results of the evaluation and a recommendation for a
decision to be taken with regard to the active substance
concerned.

Rapporteur Member States should first examine dossiers
received, assess the completeness check provided by the
notifiers and report to the Commission. It should be
established that Member States should send draft reports
of their evaluations to the Commission generally within
12 months after the dossiers submitted by notifiers have
been considered complete.

L 55/26

EN

Official Journal of the European Communities

29. 2. 2000

(11)

(12)

(13)

(14)

The draft reports prepared by the rapporteur Member
States should, where necessary, be the subject of prelim-
inary examination by experts of other Member States
within a programme coordinated by the Commission
before they are submitted to the Standing Committee on
Plant Health.

In order to avoid duplication of work, and in particular
involving vertebrate animals, producers
experiments
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 Directive 91/414/EEC.
it should be possible for operators which
Therefore,
have not presented notifications to be informed at all
stages of the possible further requirements for continued
marketing of plant protection products containing an
active substance under evaluation.

The procedures provided for 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 of 21
December 1978 prohibiting the placing on the market
and use of plant protection products containing certain
active substances (1), as last amended by Commission
Directive 91/188/EEC (2), where information becomes
available to the Commission showing that its require-
ments may be satisfied.

(15) Directive 91/414/EEC provides in Article 8(2), second
subparagraph, a 12-year period for the work programme
concerning the evaluation of existing active substances.
The 12-year period may be extended by the Commission
subject to the conclusions of a progress report, referred
to in Article 8(2),
third subparagraph, on the
programme to the European Parliament and the Council.
On the expiry of the time limit, whether or not it was
extended, Member States will have to withdraw author-
isations of plant protection products containing the
active substances which were not included in Annex I to
Directive 91/414/EEC.

to the conclusions of

that
The Commission, subject
report, will adopt further detailed regulatory provisions
serving to finalise as soon as possible the evaluation and
decision making of active substances for which the
provisions of the present Regulation concerning noti-
fication and submission of complete dossiers axe satis-
fied.

fourth subparagraph, of Directive 91/
Article 8(2),
414/EEC provides for a Commission Decision not to
include in Annex I active substances in cases where the

(1) OJ L 33, 8.2.1979, p. 36.
(2) OJ L 92, 13.4.1991, p. 42.

requirements of Article 5 of Directive 91/414/EEC are
not satisfied or the requisite information and data have
not been submitted within the prescribed time period
and for the withdrawal by Member States of author-
isations of plant protection products containing such
active substances. However, subject to the conclusions of
the said report and if necessary, it may be appropriate to
re-examine these provisions for certain uses which are
essential and for which there is no alternative to protect
efficiently plants or plant products such as to allow the
development of alternatives replacing the use of with-
drawn products. The necessity of re-examining those
provisions will have to be demonstrated on a case-by-
case basis.

(16)

If, for a particular active substance, the requirements of
the present Regulation concerning notification and
submission of complete dossiers are not satisfied, inter-
ested parties are not prevented from seeking inclusion of
such active substances in Annex I
to Directive 91/
414/EEC,
in accordance with the procedures under
Article 6(2) of Directive 91/414/EEC, at a later date.

(17) A third stage of work is envisaged for all the active
substances not covered by the first and second stage of
the programme. Producers wishing to secure the inclu-
sion of such active substances in Annex I to Directive
91/414/EEC should provide detailed information relating
to the current stage of completeness of their dossiers
and on the endpoints, which would be useful for further
prioritisation of the work programme, and undertake to
provide a full data package. It is also appropriate to
indicate now the time limit for submission of the full
data package.

(18)

(19)

about

future

is necessary to inform the producers as early as
It
possible
re-evaluation
programme by publishing the active substances which
will be included in the third stage of the programme in
order to facilitate the submission of collective dossiers
and the preparation of the necessary studies and data.

stages of

the

In order to ensure the proper implementation of this
work programme, a fee should be paid to the rapporteur
Member States for the detailed evaluation of notifica-
tions and dossiers. The cost structure in the Member
States is not the same. It is therefore not possible to
harmonise completely the amount of such fees. A fee
should also be paid to the authority designated by the
Commission to examine the notifications for the active
substances covered by the third stage.

(20)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Plant Health,

29. 2. 2000

EN

Official Journal of the European Communities

L 55/27

HAS ADOPTED THIS REGULATION:

CHAPTER 1

GENERAL PROVISIONS AND DEFINITIONS

Article 1

Scope

This Regulation lays down detailed rules for the imple-
1.
mentation of
the work
the second and third stages of
programme referred to in Article 8(2) of Directive 91/414/EEC,
hereinafter referred to as ‘the Directive’.

2.
The second stage concerns the evaluation of the active
substances listed in Annex I to this Regulation with a view to
their possible inclusion in Annex I to the Directive.

The third stage concerns the reporting of

3.
the active
substances referred to in Annex II to this Regulation with a
view to their possible inclusion at a later stage in a subsequent
priority list of active substances with a view to their possible
inclusion in Annex I to the Directive.

4.
Article 6(2), Article 6(3) and the second subparagraph of
Article 6(4) of the Directive shall not apply to a substance
listed in Annexes I and II to this Regulation as long as the
procedures provided for in this Regulation with regard to that
substance have not been finalised.

5.

This Regulation shall apply without prejudice to:

(a) reviews by Member States

to
renewals of authorisations in accordance with Article 4(4)
of the Directive;

in particular pursuant

— for active substances for which a joint notification or
joint dossier is submitted, the association of producers
established within the Community and designated by
the producers referred to in the first or second indent
for the purpose of compliance with this Regulation;

(b) ‘manufacturer’ means the person who manufactures the
active substance on his own or who contracts out
to
another party the manufacturing of the active substance on
his behalf;

(c) ‘committee’ means

the Standing Committee on Plant

Health, referred to in Article 19 of the Directive.

Article 3

Member State authority

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

In each Member State one authority, which is referred to
2.
in Annex III, shall coordinate and ensure all necessary contacts
with producers, other Member States and the Commission
pursuant to this Regulation. Each Member State shall inform
the Commission and the designated coordinating authority of
each other Member State of any modifications to the commu-
nicated
coordinating
authority.

concerning

designated

details

the

CHAPTER 2

SECOND STAGE OF THE WORK PROGRAMME

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

Directive;

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

Article 4

Notification

Article 2

Definitions

1.
For the purpose of this Regulation, plant protection prod-
ucts, substances, active substances, preparations and author-
isations of plant protection products shall have the meanings
defined in Article 2 of the Directive.

For the purpose of this Regulation, the following defini-

2.
tions shall also apply:

(a) ‘producer’ means:

— for active substances produced within the Community,
the manufacturer or a person established within the
Community designated by the manufacturer as his sole
representative for the purpose of compliance with this
Regulation,

— for active substances produced outside the Community,
the person established within the Community and
designated by the manufacturer as his sole repres-
entative within the Community for the purpose of
compliance with this Regulation,

1.
Any producer wishing to secure the inclusion of an active
substance referred to in Annex I to this Regulation, or any
variants thereof such as salts, esters or amines, in Annex I to
the Directive shall so notify, for each active substance sepa-
rately, the rapporteur Member State designated in Annex I to
this Regulation within six months after the date of entry into
force of this Regulation.

2.
Notification must be made on paper and sent by regis-
tered mail to the coordinating authority in the rapporteur
Member State, referred to in Annex III to this Regulation, in
accordance with the model notification as shown in Part 1 of
Annex IV to this Regulation. A copy of the notification shall be
to the European Commission, Health and Consumer
sent
Protection DG, Rue de la Loi/Wetstraat 200, B-1049 Brussels.

3.
Any producer who has not notified any given active
substance referred to in paragraph 1 within the time limit
referred to in that paragraph or whose notification was rejected
in accordance with the provisions of Article 5(2) shall be
permitted to participate in this programme only collectively
with one or more notifiers of the active substance, whose
notification was accepted in accordance with Article 5(2), in
submitting a joint dossier.

L 55/28

EN

Official Journal of the European Communities

29. 2. 2000

Article 5

Commission and the other Members States as soon as possible,
citing the reasons for its intended action.

Examination of notifications and request for submission
of dossiers to designated rapporteur Member States

1.
For each active substance for which a Member State has
been designated rapporteur, it shall examine the notifications
referred to in Article 4(2) and, at the latest three months after
the time limit referred to in Article 4(1), report to the Commis-
sion on the admissibility of the notifications received taking
into account the criteria as referred to in Annex V, Part 1.

2.
The Commission shall refer the reports referred to in
paragraph 1 within three months from the receipt thereof to
further examination concerning their
the committee for
admissibility, taking into account the criteria as referred to in
Annex V, Part 1.

Following that examination, a regulation shall be adopted in
accordance with the procedure laid down in Article 19 of the
Directive establishing the list of active substances, adopted for
evaluation with a view to their possible inclusion in Annex I to
the Directive. Only active substances for which at least one
notification was considered admissible in accordance with the
provisions of the first subparagraph shall be included in that
Regulation.

In the list referred to in paragraph 2, certain active
3.
substances with similar structures or chemical properties may
be grouped together; if an active substance has been notified
with different compositions which may lead to different toxico-
logical properties or have different environmental effects, those
compositions may be listed separately.

For each active substance adopted for assessment, the

4.
Regulation referred to in paragraph 2 shall specify:

(a) the names and addresses of all notifiers who have made
notifications in accordance with Article 4(1) and (2) and
which have been considered to be admissible following
their examination in accordance with the first subpara-
graph of paragraph 2;

(b) the name of the Member State designated as rapporteur;
this will be the same Member State as the one designated in
Annex I unless an imbalance has become apparent in the
number of active substances attributed to the different
Member States;

(c) the time limit for the submission to the rapporteur Member
State of the dossiers referred to in Article 6, which shall be
a period of 12 months;

(d) the same time limit for the submission to the rapporteur
Member States by any interested parties of relevant infor-
mation which may contribute to the evaluation, in partic-
ular with regard to the potentially dangerous effects of the
active substance or its residues on human and animal
health and on the environment.

5.
From the time of the adoption of the Regulation referred
to in paragraph 2, if a Member State envisages taking action to
withdraw from the market or to restrict severely the use of a
plant protection product containing an active substance listed
in that Regulation, where that action is based on information
contained in the dossiers referred to in Article 6 or the report
inform the
referred to in Article 8, the Member State shall

6. When, during the assessment and evaluation referred to
in Articles 6 and 7, an imbalance becomes apparent in the
responsibilities borne by the Member States as rapporteurs, it
may be decided, in accordance with the procedure laid down in
Article 19 of the Directive, to replace a Member State originally
designated as rapporteur for a particular active substance by
another Member State.

In such cases,
the original rapporteur Member State shall
inform the notifiers concerned and shall transfer to the newly
designated rapporteur Member State all correspondence and
information which it has received as rapporteur Member State
for the active substance concerned. The original Member State
shall return the fee referred to in Article 12, except the part
referred to in Article 12(2)(d) to the notifiers concerned. The
newly designated rapporteur Member State shall then require
the notifiers to pay the fee referred to in Article 12, except the
part referred to in Article 12(2)(d).

7. When a notifier decides to end its participation in the
work programme for an active substance, he shall inform at
the same time the rapporteur Member State, the Commission
and the other notifiers
concerned,
for
mentioning the reasons. Where a notifier ends his participation
or fails to fulfil his obligations provided for in this Regulation,
the procedures provided for in Article 7 or Article 8 shall not
be continued for his dossier.

substance

the

When a notifier agrees with another producer that the notifier
shall be replaced for the purposes of further participation in
the work programmes under this Regulation, the notifier and
the other producer shall inform the rapporteur Member State
and the Commission by a common declaration, agreeing that
the other producer shall replace the original notifier in carrying
out the notifier's duties as set out in Articles 6, 7 and 8; they
shall ensure that the other notifiers for the substance concerned
are informed 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 12.

Article 6

Submission of dossiers by notifiers

1. Within the time limit referred to in Article 5(4)(c), for
each active substance the notifiers specified in the Regulation
referred to in that Article shall,
individually or collectively,
submit to the designated authority of the rapporteur Member
State for any given active substance the complete dossier
referred to in paragraph 3,
including the summary dossier
referred to in paragraph 2.

Where for any substance the Regulation referred to in Article 5
indicates several notifications, the notifiers concerned shall take
all reasonable steps to present collectively the dossiers as
referred to in the first subparagraph.

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

29. 2. 2000

EN

Official Journal of the European Communities

L 55/29

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 4 and 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) a limited range of

representative uses of

the active
substance for which it has to be demonstrated by the
notifier, on the basis of the data submitted, that for one or
more preparations the requirements of the Directive in
relation to the criteria referred to in Article 5 thereof can
be met;

(c) — for each point of Annex II to the Directive, the summa-
ries and results of studies and trials, and the name of
the person or institute that has carried out the trials,

to the assessment of

— the same information for each point of Annex III to the
Directive relevant
the criteria
referred to in Article 5 of the Directive for one or more
preparations which are representative for
the uses
referred to in subparagraph (b) taking into account the
fact 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 in Annex I to the Directive,

— for studies not yet fully completed, the evidence that
these studies have been commissioned at
the latest
three months after the entry into force of this Regula-
tion with an undertaking that they will be submitted at
the latest within 12 months after the time limit referred
to in Article 5(4)(c);

(d) a check by the notifier of the completeness of the dossier.

3.
The complete dossier shall contain physically the indi-
vidual test and study reports concerning all the information
referred to in paragraph 2(c), or the protocols and the under-
takings referred to in paragraph 2(c) where work is in progress.

4. Member States shall determine the number of copies and
the format of the dossiers referred to to in paragraphs 2 and 3
to be submitted by the notifiers. In determining the format of
the dossier, Member States shall take the utmost account of the
recommendations made by the Commission in the framework
of the Standing Committee on Plant Health.

the dossiers
for any given active substance,
5. Where,
referred to in paragraph 1 are not sent within the time limit
referred to in Article 5 (4)(c), the rapporteur Member State shall
inform the Commission at the latest within three months,
giving the reasons pleaded by the notifiers.

6.
On the basis of the report of the rapporteur Member
State referred to in paragraph 5, a new time limit shall only be
established in accordance with the procedure laid down in
Article 19 of the Directive in the Regulation referred to in

Article 5 for the submission of a dossier fulfilling the require-
ments of paragraphs 2 and 3 where the delay is demonstrated
to have been caused by force majeure.

fourth subparagraph, of

After that examination, the Commission shall decide, as
7.
provided for in Article 8(2),
the
Directive, not to include in Annex I to the Directive an active
substance for which no notification or no dossier has been
submitted within the prescribed time limit mentioning the
reasons for the non-inclusion. Member States shall withdraw
by 25 July 2003 authorisations of plant protection products
containing those active substances.

Article 7

Completeness check of dossiers

For each active substance for which it has been desig-

1.
nated rapporteur, the Member State shall:

(a) examine the dossiers referred to in Article 6(2) and (3) and
assess the completeness check(s) provided by the notifiers;

(b) at the latest six months after the receipt of all dossiers for
an active substance, report
to the Commission on the
completeness of the dossiers; for those active substances for
which one or more dossiers are considered to be complete
within the meaning of Article 6(2) and (3), the rapporteur
Member State shall perform the evaluation as referred to in
Article 8, unless the Commission informs the rapporteur
Member State within two months that the dossier is not to
be considered complete. For those active substances for
which the dossier is to be completed, as provided for under
Article 6(2)(c), third indent, the report must confirm the
date by which the dossier is to be completed and from
which the evaluation as referred to in Article 8 will begin.

For

2.
those active substances for which a rapporteur
Member State or the Commission consider that no dossier is
complete within the meaning of Article 6(2) and (3),
the
Commission shall, within three months after the receipt of the
report of the rapporteur Member State referred to in paragraph
(1)(b), refer that report to the committee. In accordance with
the procedure laid down in Article 19 of the Directive it shall
be decided whether a dossier is considered complete within the
meaning of Article 6(2) and (3). Where the dossier is consid-
ered complete, the rapporteur Member State shall perform the
evaluation referred to in Article 8.

fourth subparagraph, of

After that examination, the Commission shall decide, as
3.
provided for in Article 8(2),
the
Directive, not to include in Annex I to the Directive active
substances for which no complete dossier has been submitted
within the prescribed time limit mentioning the reasons for the
non-inclusion. Member States shall withdraw by 25 July 2003
authorisations of plant protection products containing those
active substances.

L 55/30

EN

Official Journal of the European Communities

29. 2. 2000

Article 8

Evaluation of dossiers by rapporteur Member States and
the Commission

information available

1.
The rapporteur Member State shall evaluate and report
only on those dossiers which are considered to be complete
within the meaning of Article 6(2) and (3). It shall for the other
dossiers check the identity and impurities of
the active
substance. The rapporteur Member State shall take into consid-
eration the
in the other dossiers
submitted by a notifier or by any interested party in accordance
with the provisions of Article 5(4)(d).
It shall send to the
Commission as quickly as possible, and at the latest 12 months
after the dossier has been considered to be complete, a report
on its evaluation of the dossier. The report shall be presented
in the format recommended by the Commission in the frame-
work of the Standing Committee on Plant Health and shall
include a recommendation:

— either to include the active substance in Annex I to the

Directive stating the conditions for inclusion,

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

The rapporteur Member State shall in particular include in the
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 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
the active
the other
shall also mention for
substances for which the dossier was considered not to be
complete whether
such active
substances are comparable within the meaning of Article 13(5)
of the Directive.

it can be concluded that

sources of

2. Without prejudice to Article 7 of the Directive, submis-
sion 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. The request by the
rapporteur Member State for the submission of further data
necessary to clarify the dossier 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 the exam-
ination, consult with experts from one or several Member
States and may request additional technical or scientific infor-
mation from other Member States in order to assist the evalu-
ation.

The rapporteur Member State shall ensure that notifiers submit
the updated summary dossiers to the Commission and the
other Member States at the same time as the rapporteur's
report of the evaluation of the updated dossiers is sent to the
Commission.

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

3.
After receiving the summary dossier and the report
referred to in paragraph 1, the Commission shall refer the

dossier and the report to the Standing Committee on Plant
Health for examination.

Before referring the dossier and the report to the Committee,
the Commission shall circulate the rapporteur's report to the
Member States for information and may organise a consulta-
tion of experts from one or several Member States. The
Commission may consult some or all of the notifiers of active
substances specified in the Regulation referred to in Article 5(2)
on the report or parts of the report on the relevant active
substance. The rapporteur Member State shall ensure the neces-
sary technical and scientific assistance during these consulta-
tions.

Without prejudice to Article 7 of the Directive, submission of
new studies will not be accepted except for the studies as
referred to in Article 6(2)(c),
third indent. The rapporteur
Member State, after consultation with the Commission, may
request the notifiers to submit further data necessary to clarify
the dossier.

shall

The Commission
scientific
consult
committee(s) on any matters relating to health and the environ-
ment before submitting to the committee the draft directive or
draft decision referred to in paragraph 4.

relevant

the

The rapporteur Member State shall make available on specific
request or keep available for consultation by interested parties
the following:

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

(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 in Annex I to the
Directive, first as contained in the rapporteur's report and
secondly as finalised after consultation by the Commission,
where appropriate, of the experts referred to in the second
subparagraph.

4.
After the examination referred to in paragraph 3, the
Commission shall, without prejudice to any proposal it may
submit with a view to amending the Annex to Directive 79/
117/EEC, adopt in accordance with the procedure laid down in
Article 19 of the Directive:

(a) a directive serving to include the active substance in Annex
I to the Directive, setting out where appropriate the condi-
tions,

including the time limit, for such inclusion; or

(b) a decision addressed to the Member States withdrawing 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.

5. When the Commission submits to the committee the
draft directive or draft decision referred to in paragraph 4, it
shall at the same time present the conclusions of the commit-
tee's examination in the format of an up-dated review report to
be noted in the summary record of the meeting.

29. 2. 2000

EN

Official Journal of the European Communities

L 55/31

The review report, excluding any parts which refer to confiden-
tial information contained in the dossiers and determined as
such in accordance with Article 14 of the Directive, shall be
made available by each Member State on specific request, or
shall be kept available for consultation by interested parties.

Article 9

Suspension of evaluation

referred to in paragraph 3, a later time limit may be established
in exceptional cases for the results of long-term studies, not
expected to be fully completed by that date, provided that the
data package contains:
— evidence that such studies have been commissioned at the
latest within 12 months of the date of the entry into force
of this Regulation,

— a due scientific justification,
— the protocol and a progress report of the study.

Where, in respect of a substance mentioned in Annex I to this
Regulation, the Commission presents 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 under
Directive 79/117/EEC,
the procedure under this Regulation
shall be terminated.

5.
Any producer who has not notified any given active
substance referred to in paragraph 1 within the time limits
referred to in paragraph 2 or whose notification was rejected in
accordance with Article 11 will be permitted to participate in
the review programme only collectively with one or more
notifiers of the active substance, whose notification was consid-
ered admissible in accordance with Article 11, in submitting a
joint dossier.

CHAPTER 3

Article 11

THIRD STAGE OF THE WORK PROGRAMME

Examination of notifications

Article 10

Notification

1.
Any producer wishing to secure the inclusion of an active
substance referred to in Annex II to this Regulation, in Annex I
to the Directive shall so notify the body referred to in Annex
VII
to this Regulation. The Commission shall give regular
follow-up of the tasks mentioned in Annex VII to this Regula-
tion entrusted to the body referred to in that Annex. In accord-
ance with the procedure laid down in Article 19 of
the
Directive it may be decided to designate another body if it
appears that the tasks are not adequately performed.

Notifications shall be submitted for each active substance

2.
separately, as follows:

(a) within three months of the date of entry into force of this
Regulation, a first notification in accordance with Section 1
of the model notification as shown in Annex IV, Part 2
hereto;

and

(b) within nine months of the date of entry into force of this
Regulation, a second notification in accordance with
Sections 1 and 2 of the model notification as shown in
Annex IV, Part 2 hereto, including a written commitment
to present a complete dossier.

Detailed provisions concerning the submission of such
3.
dossiers, the time limit(s) for their submission and the fee
regime for the active substances concerned shall be established
by the Commission in a Regulation to be adopted in accord-
ance with Article 8(2), second subparagraph, of the Directive.

4.
The time limit for the submission of a full data package
shall be 25 May 2003 at the latest. The full data package shall
contain physically the individual
test and study reports
concerning all the information referred to in Article 6(2)(c),
in the Regulation
first and second indents. Nevertheless,

1.
The Commission shall, within three months after the time
limit referred to in Article 10(2)(b), inform the committee of
the notifications received in time. At the latest eight months
after the receipt of the notifications, the commission will report
to the Committee for further examination on the admissibility
of the notifications received taking into account the criteria as
referred to in Annex V, Part 2.

2.
The Commission shall decide, as provided for in Article
8(2), fourth subparagraph of the Directive, not to include in
Annex I to the Directive active substances referred to in Annex
II to this Regulation for which no admissible notification or no
full data package has been submitted within the prescribed
time limit mentioning the reasons for
the non-inclusion.
Member States shall withdraw by 25 July 2003 authorisations
of
active
substances.

containing

protection

products

those

plant

CHAPTER 4

FEES

Article 12

Fees for the second priority list

1. Member States shall establish a regime obliging the noti-
fiers 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.

2.

For this purpose, the Member States shall:

(a) require the payment of a fee for each notification, whether
introduced by one notifier or collectively by several inter-
ested notifiers, as well as for each submission of a dossier
related thereto;

L 55/32

EN

Official Journal of the European Communities

29. 2. 2000

(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
notification 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 organisation in each Member
State listed in Annex VI and that the income from the fee is
used to finance exclusively the costs actually incurred by
the rapporteur Member State for
the evaluation and
administrative treatment of
the notifications and the
dossiers for which that Member State is rapporteur or to
finance general actions for the implementation of its obli-
gations as rapporteur Member State resulting from Article
7 or Article 8;

(d) require that a first part of the fee, covering the costs of the
rapporteur Member State's obligations
resulting from
Article 5(1) and Article 7, is paid at the time of the sub-
mission of the notification referred to in Article 4; this part
shall not be refundable under any circumstances.

Article 13

Fees for the notification for the third stage of the work
programme

Any producers submitting a notification in accordance with
Article 10 shall at the time of the submission of their first
notification, as referred to in Article 10(2)(a), pay a fee of
EUR 5 000 for each active substance to the body referred to in
Annex VII. The fee shall be used to finance exclusively the costs
actually incurred for the tasks referred to in Annex VII.

Article 14

Other charges, levies or fees

Articles 12 and 13 are 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 control of active substances and plant
protection products other than the fee provided for in Articles
12 and 13.

CHAPTER 5

FINAL PROVISIONS

Article 15

Temporary measures

The Commission shall report to the committee on the conclu-
sions of its progress report, referred to in Article 8(2), third
subparagraph, of the Directive.

If necessary and on a case-by-case basis, the Commission may
take appropriate temporary measures as provided for by Article
8(2), third subparagraph, of the Directive 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 16

Entry into force

This Regulation shall enter into force on 1 March 2000.

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

Done at Brussels, 28 February 2000.

For the Commission

David BYRNE

Member of the Commission

29. 2. 2000

EN

Official Journal of the European Communities

L 55/33

List of active substances to be covered by the second stage of the work programme provided for in Article 8(2)
of the Directive with the designated rapporteur Member State

ANNEX I

Name

PART A: ANTICHOLINESTERASE ACTIVE SUBSTANCES

Organophosphates

Rapporteur Member State

Azamethiphos

Ampropylfos

Bromophos

Bromophos-ethyl

Cadusafos

Carbophenothion

Chlorfenvinphos

Tetrachlorvinphos

Chlormephos

Chlorthiophos

Demeton-S-methyl

Demeton-S-methyl-sulphone

Oxydemeton-methyl

Dialifos

Diazinon

Dichlofenthion

Dichlorvos

Dicrotophos

Monocrotophos

Dimefox

Dimethoate

Omethoate

Formothion

Dioxathion

Disulfoton

Ditalimfos

Ethephon

Ethion

Ethoate-methyl

Ethoprophos

Etrimfos

Fenamiphos

Fenitrothion

Fonofos

Isazofos

Isoxathion

Heptenophos

Idofenphos

Isofenphos

Malathion

Mecarbam

Mephosfolan

Methidathion

Mevinphos

United Kingdom

Sweden

Austria

Austria

Greece

Luxembourg

Italy

Italy

Spain

Spain

France

France

France

France

Portugal

The Netherlands

Italy

Italy

Italy

Germany

United Kingdom

United Kingdom

United Kingdom

France

Greece

Austria

The Netherlands

France

Italy

United Kingdom

United Kingdom

The Netherlands

Denmark

Ireland

France

Spain

Austria

France

Austria

Finland

Spain

Ireland

Portugal

Sweden

L 55/34

EN

Official Journal of the European Communities

29. 2. 2000

Organophosphates

Rapporteur Member State

Naled

Phorate

Phosalone

Phosmet

Phosphamidon

Phoxim

Pirimiphos-ethyl

Pirimiphos-methyl

Profenofos

Propetamphos

Prothiofos

Prothoate

Pyraclofos

Pyridaphenthion

Quinalphos

Sulprofos

Sulfotep

Temephos

Terbufos

Thiometon

Thionazin

Tolclofos-methyl

Triazophos

Trichlorfon

Trichloronat

Vamidothion

Bendiocarb

Benfuracarb

Carbofuran

Carbosulfan

Furathiocarb

Butocarboxim

Butoxycarboxim

Carbaryl

Dioxacarb

Ethiofencarb

Formetanate

Methiocarb

Methomyl

Thiodicarb

Oxamyl

Pirimicarb

Promecarb

Propamocarb

Prothiocarb

Propoxur

Thiofanox

Triazamate

France

United Kingdom

Austria

Spain

Germany

Belgium

United Kingdom

United Kingdom

Germany

Luxembourg

Spain

Greece

Spain

Italy

France

Spain

Finland

Ireland

Austria

The Netherlands

Italy

The Netherlands

Greece

Portugal

Finland

Portugal

Carbamates

Rapporteur Member State

United Kingdom

Belgium

Belgium

Belgium

Belgium

Germany

Germany

Spain

Denmark

Germany

Italy

Germany

United Kingdom

United Kingdom

Ireland

Portugal

Portugal

Sweden

Sweden

Belgium

France

United Kingdom

29. 2. 2000

EN

Official Journal of the European Communities

L 55/35

1,3-dichloropropene

1,3-dichloropropene (cis)

Captan

Folpet

Clodinafop

Clopyralid

Cyanazine

Cyprodinil

Dichlorprop

Dichlorprop-P

Dimethenamid

Dimethomorph

Diuron

Fipronil

Fosetyl

Glufosinate

Haloxyfop

Haloxyfop-R

Metconazole

Methoxychlor

Metolachlor

Metribuzin

Prometryn

Pyrimethanil

Rimsulfuron

Terbutryne

Tolylfluanid

Tribenuron

Triclopyr

Trifluralin

Trinexapac

Triticonazole

Barban

Bromocyclen

Bronopol

Chloral-semi-acetal

Chloral-bis-acylal

Chlorfenprop

Chlorobenzilate

Chloroxuron

P-chloronitrobenzene

DADZ(Zinc-diethyldithiocarbamate)

Di-allate

Difenoxuron

(2-dithiocyanomethylthio)benzothiazol

Fluorodifen

Furfural

PART B

Spain

Spain

Italy

Italy

The Netherlands

Finland

Sweden

France

Denmark

Denmark

Germany

Germany

Denmark

France

France

Sweden

Denmark

Denmark

Belgium

Italy

Belgium

Germany

Greece

Portugal

Germany

Germany

Finland

Sweden

Ireland

Greece

The Netherlands

Austria

PART C

Belgium

Denmark

Germany

Germany

Germany

Greece

Spain

Spain

Spain

France

France

Ireland

Italy

Italy

Luxembourg

L 55/36

EN

Official Journal of the European Communities

29. 2. 2000

Isocarbamide

Naphthylacetic acid hydrazide

Noruron

Pentachlorophenol

4-t-pentylphenol

Propazine

Sodium diacetoneketogulonate

Sodium dimethyldithiocarbamate

2,4,5-T

The Netherlands

Austria

Portugal

Finland

Sweden

United Kingdom

United Kingdom

United Kingdom

France

29. 2. 2000

EN

Official Journal of the European Communities

L 55/37

ANNEX II

Active substances covered by the third stage of the work programme provided for in Article 8(2) of the
Directive

All active substances (including any variants thereof such as salts, esters or amines) that were on the market before 25 July
1993 with the exception of the following active substances:

1. the active substances listed in the Annex to Regulation (EEC) No 3600/92;

2. the active substances listed in Annex I to this Regulation;

3. active substances which are micro-organisms including viruses;

4. active substances of which the use is authorised in human foodstuffs or animal feeding stuffs in accordance with EU

legislation;

5. active substances which are plant extracts;

6. active substances which are animal products or derived thereof by simple processing;

7. active substances which are or will be exclusively used as attractants or repellants (including pheromones). Active
substances which are or will be exclusively used in traps and/or dispenses, in conformity with Council Regulation
(EEC) No 2092/91 (1) concerning organic farming;

8. active substances which are or will be exclusively used as rodenticides;

9. active substances which are or will exclusively be used on stored plants or plant products;

10. the following commodity substances:

aluminium sulphate

calcium chloride

CO

2

EDTA and salts thereof

ethanol

grease (bands, fruit trees)

fatty alcohols

iron sulphate

lime phosphate

lime sulphur

nitrogen

paraffin oil

petroleum oils

potassium permanganate

propionic acid

resins and polymers

sodium chloride

sodium hydroxide

sulphur and sulphur dioxide

sulphuric acid

waxes.

(1) OJ L 36, 10.2.1998, p. 16.

L 55/38

EN

Official Journal of the European Communities

29. 2. 2000

ANNEX III

Coordinating authority in the Member States

AUSTRIA

Bundesamt und Forschungszentrum für Landwirtschaft
Spargelfeldstraße 191
A-1226 Wien

BELGIUM

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

Ministerie van Middenstand en Landbouw
Dienst Kwaliteit van de grondstoffen en analyses
WTC 3, 8e verdieping
Simon Bolivarlaan 30
B-1000 Brussel

DENMARK

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

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft (BBA)
Abteilung für Pflanzenschutzmittel und Anwendungstechnik (AP)
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 de Medios de Producción Agrícolas
c/Ciudad de Barcelona, 118-120
E-28007 Madrid

FINLAND

Plant Production Inspection Centre
Pesticide Division
P.O. BOX 42
FIN-00501 Helsinki

FRANCE

Ministère de l'agriculture
Service de la protection des végétaux
251, rue de Vaugirard
F-75732 Paris Cedex 15

29. 2. 2000

EN

Official Journal of the European Communities

L 55/39

IRELAND

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

ITALY

Ministero della Sanità
Dipartimento degli Alimenti, Nutrizione e Sanità Pubblica Veterinaria
Ufficio XIV
Piazza G. Marconi, 25
I-00144 Roma

LUXEMBOURG

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

NETHERLANDS

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

PORTUGAL

Direcção-Geral de Protecção das Culturas,
Quinta do Marquês
P-2780-155 Oeiras

SWEDEN

Kemikalieinspektionen
Box 1384
S-171 27 Solna

UNITED KINGDOM

Pesticides Safety Directorate
Ministry of Agriculture, Fisheries and Food
Mallard House
Kings Pool
3 Peasholme Green,
York YO1 7PX
United Kingdom

L 55/40

EN

Official Journal of the European Communities

29. 2. 2000

ANNEX IV

PART 1

Notification of an active substance according to Article 4

MODEL

The notification must be made on paper and sent by registered mail.

The notification shall contain the following information:

1.

Identification data on the notifier

1.1. Manufacturer of the active substance as defined in Article 2(2)(a) (name, address, including location of plant):

1.2.

Name and address of the producer as defined in Article 2(2)(a) including the name of the (physical) person
responsible for the notification and further engagements resulting from this Regulation:

1.2.1.

(a) Telephone No:

(b) Fax No:

(c) E-mail address:

1.2.2.

(a) Contact:

(b) Alternative:

2.

Information to facilitate identification

2.1.

Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters
or amines 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 the active substance in accordance with the provisions of Council Directive
67/548/EEC (health and environment effects) (OJ 196, 16.8.1967, p. 1):

3. Undertaking

The notifier undertakes to submit to the designated coordinating authority of the designated rapporteur Member State
the dossiers as set out in Article 6 of this Regulation within the time limit provided for in the regulation to be adopted
according to Article 5(2). Whenever this Regulation mentions several notifiers for this active substance, the notifier
agrees to make all reasonable efforts to present a single dossier collectively with the other notifiers.

The notifier undertakes to pay the remaining part of the fee as provided for in Article 12(2) in accordance with the
instructions given by the organisation of the designated rapporteur Member State referred to in Annex VI at the time
of the submission of the full dossier for active substances covered by the regulation meant in Article 5(2). In case a
new rapporteur Member State is designated in accordance with Article 5(6), the notifier undertakes to pay the
remaining part of the fee as provided for in Article 12(2) to the newly designated rapporteur Member State in
accordance with the instructions given by the organisation of the newly designated rapporteur Member State referred
to in Annex VI.

The notifier confirms that he has paid the first part of the fee as provided for in Article 12(2)(d) at the time of the
submission of the notification in accordance with the instructions of the organisation of the designated rapporteur
Member State referred to in Annex VI, or undertakes to pay it immediately where the designated rapporteur Member
State has instructed him to wait with the payment until requested to do so.

The notifier declares that an authorisation by the manufacturer to act as his sole representative for the purpose of
complying with this Regulation is enclosed if necessary.

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)

29. 2. 2000

EN

Official Journal of the European Communities

L 55/41

Notification of an active substance according to Article 10

PART 2

The notification shall be presented in two sections:

MODEL

Sections 1 and 2 have to be submitted both on paper and as a computer readable file. The detailed format will be defined
by the body designated in Annex VII in consultation with the Commission.

Reference No:

1.

Identification data on the notifier

SECTION 1

1.1. Manufacturer of the active substance as defined in Article 2(2)(a) (name, address, including location of plant):

1.2.

Name and address of the producer as defined in Article 2(2)(a) including the name of the (physical) person
responsible for the notification and further engagements resulting from this Regulation:

1.2.1.

(a) Telephone No:

(b) Fax No:

(c) E-mail address:

1.2.2.

(a) Contact:

(b) Alternative:

2.

Information to facilitate identification

2.1. Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters

or amines 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 the active substance in accordance with the provisions of Directive 67/548/EEC
(health and environment effects):

3. Undertaking

The notifier confirms that the information submitted in Section 2, points 3 and 8, of the notification is based on
studies which are available to the notifier and which will be submitted to the rapporteur Member State as part of the
dossier referred to in Article 11(3).

The notifier undertakes to submit to the designated coordinating authority of the designated rapporteur Member State
the dossiers within the time limit provided for in the Regulation to be adopted according to Article 10(3) of this
Regulation. Whenever this Regulation mentions several notifiers for this active substance, the notifier agrees to make
all reasonable efforts to present a single dossier collectively with the other notifiers.

The notifier undertakes to pay a fee as provided for in Article 13 at the time of the submission of the notification to
the body designated in Annex VII.

The notifier declares that he is aware that he will be charged a fee by a designated rapporteur Member State at the
time of the submission of the full dossier for active substances covered by the Regulation meant in Article 11.

The notifier confirmes that the above information and the information which is submitted on . . . . . . . . . (date) as
Section 2 is honest and correct.

The notifier declares that an authorisation by the manufacturer to act as his sole representative for the purpose of
complying with this Regulation is inclosed if necessary.

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

L 55/42

EN

Official Journal of the European Communities

29. 2. 2000

Reference No:

SECTION 2

The notifier has to resubmit in points 1 and 2 the same information as already submitted as part of his notification in
accordance with Section 1, points 1 and 2. Changes,

if any, should be clearly marked.

1.

Identification data on the notifier

1.1. Manufacturer of the active substance as defined in Article 2(2)(a) (name, address, including location of plant):

1.2.

Name and address of the producer as defined in Article 2(2)(a) including the name of the (physical) person
responsible for the notification and further engagements resulting from this Regulation:

1.2.1.

(a) Telephone No:

(b) Fax No:

(c) E-mail address:

1.2.2.

(a) Contact:

(b) Alternative:

2.

Information to facilitate identification

2.1.

Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters
or amines 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 lebelling of the active substance in accordance with the provisions of Directive 67/548/EEC
(health and environment effects):

3. Completeness check

A completeness check has to be presented in the format recommended at the time of entry into force of this
Regulation by the Commission in the framework of the Standing Committee on Plant Health for each point of Annex
II and Annex III to the Directive relevant for the limited range of representative uses of the active substance for which
the notifier intends to demonstrate, on the basis of the data that will be submitted, the acceptability in relation to the
assessment of the criteria referred to in Article 5 of the Directive for one or more preparations.

The notifier has to identify these representative uses.

4. List of available studies

— A list of all studies available to the notifier and which will be submitted to the rapporteur Member States as part of

the dossier.

— A detailed provisional plan including engagements for the performance of further studies in order to complete the

dossier.

— A separate list of all the studies performed since 1 August 1994 (with the exception of studies on efficacy referred

to in Annex III, Section 6, of the Directive).

5. For each Member State a list of crops in which plant protection products containing the active substance are currently:

authorised.

6. Date of the most recent review of the active substance in a Member State of the European Union.

7. Date of the most recent review of the active substance in an OECD country.

8. List of endpoints

A list of all the following endpoints has to be presented relevant for the limited range of uses of the active substance
for which it has to be demonstrated by the notifier, on the basis of the data that will be submitted, that for one or
more preparations the requirements of the Directive in relation to the criteria referred to in its Article 5 can be met:

29. 2. 2000

EN

Official Journal of the European Communities

L 55/43

IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES

Common name (ISO)

Chemical name (IUPAC)

Chemical name (CA)

CIPAC No

CAS No

EEC No

FAO specification

Minimum purity

Molecular formula

Molecular mass

Structural formula

Melting point

Boiling point

Appearance

Relative density

Vapour pressure

Henry's law constant

Solubility in water

Solubility in organic solvents

Partition coefficient (log P

OW

)

Hydrolytic stability (DT50)

Dissociation constant

Quantum yield of direct photo transformation in water at Σ >
290 nm

Flammability

Explosive properties

UV/VIS absorption (max.)

Photostability (DT

50

)

Absorption, distribution, excretion and metabolism in mammals

TOXICOLOGY AND METABOLISM

Rate and extent of absorption

Distribution

Potential for accumulation

Rate and extent of excretion

Toxicologically significant compounds

Metabolism in animals

L 55/44

EN

Official Journal of the European Communities

29. 2. 2000

Acute toxicity

Rat oral

(1)

Rat LD

50

dermal

Rat LC50 inhalation

Skin irritation

Eye irritation

Skin sensitisation (test method used and result)

Short term toxicity

Target/critical effect

Lowest relevant oral NOAEL/NOEL

Lowest relevant dermal NOAEL/NOEL

Lowest relevant inhalation NOAEL/NOEL

Genotoxicity

Long-term toxicity and carcinogenicity

Target/critical effect

Lowest relevant NOAEL

Carcinogenicity

Reproductive toxicity

Target/critical effect — reproduction

Lowest relevant reproductive NOAEL/NOEL

Target/critical effect — developmental toxicity

Lowest relevant developmental NOAEL/NOEL

Delayed neurotoxicity

Other toxicological studies

Medical data

(1) May include a point estimate or a range estimate.

29. 2. 2000

EN

Official Journal of the European Communities

L 55/45

Value

Study

Safety factor

Summary

ADI

AOEL systemic

AOEL inhalation

AOEL dermal

ArfD (acute reference dose)

Dermal absorption

FATE AND BEHAVIOUR IN THE ENVIRONMENT

Fate and behaviour in soil

Route of degradation

Aerobic

Mineralisation after 100 days

Non-extractable residues after 100 days

Relevant metabolites: name and/or code % of applied rate (range
and maximum)

Supplemental studies

Anaerobic

Soil photolysis

Remarks

Rate of degradation (1)

Laboratory studies

DT

50

lab (20 °C, aerobic)

DT90lab (20 °C, aerobic)

DT50lab (10 °C, aerobic)

DT

50

lab (20 °C, anaerobic)

(1) Specify method of calculation and order of reaction.

L 55/46

EN

Official Journal of the European Communities

29. 2. 2000

Field studies (1)

DT

50f

from soil dissipation studies

DT90f from soil dissipation studies

Soil accumulation studies

Soil residue studies

Remarks

For example, effect of soil pH on degradation rate

Adsorption/desorption

K
f

Kd

K

oc

PH dependence

Mobility

Laboratory studies

Column leaching

Aged residue leaching

Field studies

Lysimeter/field leaching studies

Remarks

Abiotic degradation

Hydrolytic degradation

Relevant metabolites

Photolytic degradation

Relevant metabolites

(1) Specify country or region.

Fate and behaviour in water

29. 2. 2000

EN

Official Journal of the European Communities

L 55/47

Biological degradation

Readily biodegradable

Water/sediment study:

DT
50 water
water
DT90
DT50 whole system
whole system
DT90
Distribution in water/sediment systems (active substance)
Distribution in water/sediment systems (metabolites)

Accumulation in water and/or sediment

Fate and behaviour in air

ECOTOXICOLOGY

Degradation in the saturated zone

Remarks

Volatility

Vapour pressure

Henry's law constant

Photolytic degradation

Direct photolysis in air

Photochemical oxidative degradation in air
DT50

Remarks

Terrestrial vertebrates

Acute toxicity to mammals

Longterm toxicity to mammals

Acute toxicity to birds

Dietary toxicity to birds

Reproductive toxicity to birds

Semi-field/field study

(1) Specify country or region.

L 55/48

EN

Official Journal of the European Communities

29. 2. 2000

Aquatic organisms

Acute toxicity to fish

Long-term toxicity to fish

Bioaccumulation in fish

Acute toxicity to invertebrates

Chronic toxicity to invertebrates

Acute toxicity to algae

Acute toxicity to aquatic plants

Chronic toxicity to sediment dwelling organisms

Micro/mesocosm study

Honeybees

Acute oral toxicity

Acute contact toxicity

Semi-field/field study

Other arthropod species (1)

Test species

Earthworms

Acute toxicity

Reproductive toxicity

Field study

Soil micro-organisms

Nitrogen mineralisation

Carbon mineralisation

(1) Specify type of study:

laboratory/extended laboratory/semi-field/field study.

% effect

29. 2. 2000

EN

Official Journal of the European Communities

L 55/49

ANNEX V

PART 1

Criteria for the admissibility of notifications referred to in Article 4

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

1.

2.

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

it is introduced by a notifier who is a producer as defined in Article 2(2)(a) for an active substance as defined by the
Directive;

3.

it is presented in the format as provided for in Annex IV, Part 1;

4. a fee as referred to in Article 12(2)(d) has been paid.

PART 2

Criteria for the admissibility of notifications referred to in Article 10

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

1.

2.

3.

4.

it is presented within the time limit referred to in Article 10(2);

it is introduced by a notifier who is a producer as defined in Article 2(2)(a) for an active substance as defined by the
Directive;

it is presented in the format as provided for in Annex IV, Part 2;

it appears from the completeness check that the dossier currently available is sufficiently complete or a time plan to
complete it is proposed;

5. the list of endpoints is sufficiently complete;

6. a fee as referred to in Article 13 has been paid.

L 55/50

EN

Official Journal of the European Communities

29. 2. 2000

Organisations in the Member States to be contacted concerning further details on the payment of the fees
referred to in Article 12 and to which such fees have to be paid

ANNEX VI

AUSTRIA

Bundesamt und Forschungszentrum für Landwirtschaft
Spargelfeldstraße 191
A-1226 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 Simon Bolivar 30
B-1000 Bruxelles

Account number 679-2005985-25 (Banque de la Poste)

Begrotingsfonds voor de grondstoffen
Ministerie van Middenstand en Landbouw
Inspectie-generaal Grondstoffen en verwerkte producten, WTC 3
Simon Bolivarlaan 30
B-1000 Brussel

Account number 679-2005985-25 (Bank van De Post)

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 Anwendungstechnik
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 de Medios de Producción Agrícolas
c/Ciudad de Barcelona, 118-120
ES-28007 Madrid

FINLAND

Plant Production Inspection Centre
Pesticide Division
P.O. Box 42
FIN-00501 Helsinki

Bank and account:
Leonia Bank plc
PSP BFIHH
800015-18982

29. 2. 2000

EN

Official Journal of the European Communities

L 55/51

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

IRELAND

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

ITALY

Tesoreria Provinciale dello Stato di Viterbo
post current account n. 11281011

LUXEMBOURG

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

NETHERLANDS

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

PORTUGAL

Direcção-Geral de Protecção das Culturas,
Quinta do Marquês
P-2780-155 Oeiras

Account number: 003505840003800793097

Bank: Caixa Geral de Depósitos

SWEDEN

Kemikalieinspektionen
Box 1384
S-171 27 Solna

National Giro Account: 4465054-7

UNITED KINGDOM

Pesticides Safety Directorate
Ministry of Agriculture, Fisheries and Food
Mallard House
Kings Pool
3 Peasholme Green,
York YO1 7PX
United Kingdom

L 55/52

EN

Official Journal of the European Communities

29. 2. 2000

ANNEX VII

Designated body referred to in Article 10

The following body is designated to perform on behalf of the Commission the tasks referred to in Article 11: Biologische
Bundesanstalt für Land und Forstwirtschaft (RENDER PROJECT), Messeweg 11-12 D-38104 Braunschweig (Internet:
http://www.bba.de/english/render.htm or e-mail: render@bba.de). The fee referred to in Article 13 has to be paid to
account No 250 010 00, BLZ 250 000 00, Landeszentralbank Hannover (reference ‘BBA-RENDER’ mentioning the
reference number of the notification).

This body will:

1. examine the notifications referred to in Article 10;

2. make available to the notifiers the format of the notification referred to in Article 10(2);

3. examine the notifications and consult with experts from other Member States in the light of the acceptability criteria

referred to in Annex V, Part 2;

4. report to the Commission within six months from the time limit referred to in Article 10(2)(b) on the acceptability of

the notifications received;

5. make available to the Commission the notifications received;

6. make a detailed account available to the Commission;

7.

if the total amount of fees paid by all notifiers exceeds the real cost of the examination and administrative treatment of
all notifications, refund the balance to the notifiers in equal shares.