Commission Directive 2003/70/EC of 17 July 2003 amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as active substances (Text with EEA relevance)
Date: 2003-07-17
Institutions: European Commission
Subjects: exchange of information, market approval, marketing standard, plant health product

23.7.2003

EN

Official Journal of the European Union

L 184/9

COMMISSION DIRECTIVE 2003/70/EC

of 17 July 2003

amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as
active substances

(Text with EEA relevance)

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 2003/
68/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

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 Regula-
tion (EC) No 2266/2000 (4), establishes a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes mecoprop, mecoprop-P and propiconazole.

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulation (EEC) No
3600/92 for a range of uses proposed by the notifiers.
By Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant protec-
tion products and designating the rapporteur Member
State for the implementation of Regulation (EEC) No
3600/92 (5), as last amended by Regulation (EC) No
2230/95 (6),
the following rapporteur Member States
were designated, which in turn submitted the relevant
assessment
to the
Commission in accordance with Article 7(1)(c) of Regu-
lation (EEC) No 3600/92: mecoprop: Rapporteur
Member State Denmark, all relevant information was
submitted on 31 August 1999; mecoprop-P: Rapporteur
Member State Denmark, all relevant information was
submitted on 7 January 1999; propiconazole: Rappor-
teur Member State Finland, all relevant information was
submitted on 30 November 1998.

recommendations

reports

and

Those assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health.

The reviews of all active substances were finalised on 15
April 2003 in the format of the Commission review
reports for mecoprop, mecoprop-P and propiconazole.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 177, 16.7.2003, p. 12.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(5)

(6)

(7)

(8)

(9)

The reviews of mecoprop, mecoprop-P and propicona-
zole did not reveal any open questions or concerns,
which would have required a consultation of the Scien-
tific Committee on Plants.

It has appeared from the various examinations made that
plant protection products containing mecoprop, meco-
prop-P or propiconazole may be expected to satisfy, in
general, the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC,
in particular with
regard to the uses which were examined and detailed in
the Commission review report.
It is therefore appro-
priate to include these active substances in Annex I, in
order to ensure that in all Member States the authorisa-
tions of plant protection products containing these
active substances can be granted in accordance with the
provisions of that Directive.

The Commission review report is required for the proper
implementation by the Member States, of
several
sections of the uniform principles laid down in Directive
91/414/EEC. It is, therefore, appropriate to provide that
the finalised review report, except for confidential infor-
mation, should be kept available or made available by
the Member States for consultation by any interested
parties.

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements which
will result from the inclusion.

After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant protec-
tion products containing mecoprop, mecoprop-P or
propiconazole, and in particular,
to review existing
authorisations to ensure that the conditions regarding
those active substances set out in Annex I to Directive
91/414/EEC are satisfied. A longer period should be
provided for the submission and assessment of
the
complete dossier of each plant protection product in
accordance with the uniform principles laid down in
Directive 91/414/EEC.

(10)

It is therefore appropriate to amend Directive 91/414/
EEC accordingly.

L 184/10

EN

Official Journal of the European Union

23.7.2003

(11)

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 2

Member States shall adopt and publish by 30 November 2004
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 December 2004.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing mecoprop, mecoprop-P or
propiconazole to ensure that the conditions relating to those
active substances set out in Annex I to Directive 91/414/EEC
are complied with. Where necessary and by 30 November
2004 at the latest, they shall amend or withdraw the authorisa-
tion.

2. Member States shall, for each authorised plant protection
product containing mecoprop, mecoprop-P or propiconazole
as either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive 91/
414/EEC by 31 May 2004 at the latest, re-evaluate the product
in accordance with the uniform principles provided for in
Annex VI to Directive 91/414/EEC, on the basis of a dossier
satisfying the requirements of Annex III to that Directive. On
the basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c), (d)
and (e) of Directive 91/414/EEC. Where necessary and by 31
May 2008 at the latest, they shall amend or withdraw the
authorisation.

Article 4

This Directive shall enter into force on 1 June 2004.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 17 July 2003.

For the Commission

David BYRNE

Member of the Commission

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC.

ANNEX

.

.

2
3
7
2
0
0
3

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

No

Common name,
identification numbers

‘56 Mecoprop

CAS No 7085-19-0
CIPAC No 51

(RS)-2-(4-chloro-o-tolyloxy)-
propionic acid

930 g/kg

57 Mecoprop-P

CAS No 16484-77-8
CIPAC No 475

(R)-2-(4-chloro-o-tolyloxy)-
propionic acid

860 g/kg

1 June 2004

31 May 2014

Only uses as herbicide may be authorised.

the implementation of

the uniform principles of
For
Annex VI, the conclusions of the review report on meco-
prop, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain
and Animal Health on 15 April 2003 shall be taken into
account. In this overall assessment:
— Member States should pay particular attention to the
potential
for groundwater contamination, when the
active substance is applied in regions with vulnerable
soil and/or climatic conditions. Conditions of authori-
sation should include risk mitigation measures, where
appropriate,

— Member States should pay particular attention to the
protection of non-target arthropods. Risk mitigation
measures should be applied, where appropriate.

1 June 2004

31 May 2014

Only uses as herbicide may be authorised.

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on meco-
prop-P, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain
and Animal Health on 15 April 2003 shall be taken into
account. In this overall assessment:
— Member States should pay particular attention to the
potential
for groundwater contamination, when the
active substance is applied in regions with vulnerable
soil and/or climatic conditions. Conditions of authori-
sation should include risk mitigation measures, where
appropriate.

E
N

O

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No

58

Common name,
identification numbers

Propiconazole
CAS No 60207-90-1
CIPAC No 408

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

(±)-1-[2-(2,4-dichloro-
phenyl)-4-propyl-1,3-diox-
olan-2-ylmethyl]-1H-1,2,4-
triazole

920 g/kg

1 June 2004

31 May 2014

Only uses as fungicide may be authorised.

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on propi-
conazole, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain
and Animal Health on 15 April 2003 shall be taken into
account. In this overall assessment:
— Member States should pay particular attention to the
protection of non-target arthropods and aquatic organ-
isms. Conditions of authorisation should include risk
mitigation measures, where appropriate,

— Member States should pay particular attention to the
protection of soil organisms for applications rates
exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions
of
risk mitigation
measures (e.g. spotwise application scheme), where
appropriate.

authorisation should

include

(1) Further details on identity and specification of active substance are provided in the review report.’

L

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2
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