Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substances (Text with EEA relevance)
Date: 2004-04-23
Institutions: European Commission
Subjects: exchange of information, marketing standard, plant health product

L 120/26

EN

Official Journal of the European Union

24.4.2004

COMMISSION DIRECTIVE 2004/58/EC

of 23 April 2004

amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil,
desmedipham, ioxynil and phenmedipham as active substances

(Text with EEA relevance)

(3)

(4)

(5)

(6)

(7)

(8)

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), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

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 (2), 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
alpha-cypermethrin, benalaxyl, bromoxynil,
desmedipham, ioxynil and phenmedipham.

For those active substances the effects on human health
and the environment has 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 Commission Regulation
(EEC) No 3600/92 (3), the following rapporteur Member
States were designated, which in turn submitted the rele-
vant assessment reports and recommendations to the
Commission in accordance with Article 7(1)(c) of Regu-
lation (EEC) No 3600/92. For alpha-cypermethrin the
rapporteur Member State was Belgium, and all relevant
information was submitted on 16 September 1999. For
benalaxyl the rapporteur Member State was Portugal,
and all relevant information was submitted on 27 April
2000. For bromoxynil the rapporteur Member State was
France, and all relevant formation was submitted on 16
March 2000. For desmedipham the rapporteur Member
State was Finland, and all relevant
information was
submitted on 8 May 2000. For ioxynil the rapporteur
Member State was France, and all relevant information
was submitted on 16 March 2000. For phenmedipham
the rapporteur Member State was Finland, and all rele-
vant information was submitted on 5 January 2000.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-
sion Directive 2004/60/EC (See page 39 of this Official Journal).
(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu-

lation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

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 13
February 2004 in the format of the Commission review
reports for alpha-cypermethrin, benalaxyl, bromoxynil,
desmedipham, ioxynil and phenmedipham.

The reviews of alpha-cypermethrin, benalaxyl, bromox-
ynil, desmedipham, ioxynil and phenmedipham did not
reveal any open questions or concerns, which would
have required a consultation of the Scientific Committee
on Plants.

It has appeared from the various examinations made
that plant protection products containing alpha-cyper-
ioxynil
methrin, benalaxyl, bromoxynil, desmedipham,
and phenmedipham 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.

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.

the

that

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 alpha-cypermethrin, benalaxyl,
ioxynil or phenmedipham,
bromoxynil, desmedipham,
and in particular, to review existing authorisations to
ensure
active
substances set out in Annex I to Directive 91/414/EEC
are satisfied. For efficiency reasons and considering the
short deadlines it
the rapporteur
Member State coordinate such reviews between Member
States. 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.

is appropriate that

regarding those

conditions

24.4.2004

EN

Official Journal of the European Union

L 120/27

(9)

(10)

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

The measures provided for in this Directive are in
accordance 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 31 August 2005 at
the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this Direc-
tive.

They shall apply those provisions from 1 September 2005.

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 alpha-cypermethrin, bena-
laxyl, bromoxynil, desmedipham, ioxynil and phenmedipham
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 31 August 2005 at the latest, they
shall amend or withdraw the authorisation.

The respective rapporteur Member State shall organise the co-
operation between Member States when carrying out such
review.

For each authorised plant protection product containing
2.
alpha-cypermethrin,
benalaxyl, bromoxynil, desmedipham,
ioxynil and phenmedipham 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 28 February 2005 at the
latest, Member States shall re-evaluate the product in accord-
ance 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 satis-
fies the conditions set out in Article 4(1)(b), (c), (d) and (e) of
Directive 91/414/EEC.

Following that determination Member States shall:

(a) in the case of a product containing alpha-cypermethrin,
benalaxyl, bromoxynil, desmedipham, ioxynil or phenme-
dipham as the only active substance, where necessary,
amend or withdraw the authorisation by 28 February 2009
at the latest; or

(b) in the case of a product containing alpha-cypermethrin,
benalaxyl, bromoxynil, desmedipham, ioxynil or phenme-
dipham as one of several active substances, where neces-
sary, amend or withdraw the authorisation by 28 February
2009 or by the date fixed for such an amendment or with-
drawal
in the respective Directive or Directives which
added the relevant substance or substances to Annex I to
Directive 91/414/EEC, whichever is the latest.

This Directive shall enter into force on 1 March 2005.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 23 April 2004.

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/EC.

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

No

Common name, identifica-
tion numbers

‘84

alpha-cypermethrin

CAS No 67375-30-8

CIPAC No

Racemate comprising
(S)-α-
(1R)-cis-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropane carboxylate

phenoxybenzyl-

cyano-3

and
(R)-α-
(1S)-cis-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropane carboxylate

phenoxybenzyl-

cyano-3

(= cis-2 isomer pair of cyperme-
thrin)

85

benalaxyl

CAS No 71626-11-4

CIPAC No 416

Methyl N-phenylacetyl–N-2, 6–
xylyl–DL-alaninate

86

bromoxynil

CAS No 1689-84-5

CIPAC No 87

3,5 dibromo – 4- hydroxybenzoni-
trile

930 g/kg CIS-2

1 March 2005

28 February 2015

Only uses as insecticide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on alpha-cypermethrin,
and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal
Health on 13 February 2004 shall be taken into account. In
this overall assessment:
— Member States must pay particular attention to the protec-
tion of aquatic organisms, bees and non-target arthropods
and must ensure that
the conditions of authorisation
include risk mitigation measures.

— Member States must pay particular attention to the
operator safety and must ensure that the conditions of
authorisation include appropriate protective measures.

960 g/kg

1 March 2005

28 February 2015

Only uses as fungicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on benalaxyl, and in par-
ticular Appendices I and II thereto, as finalised in the Standing
Committee on the Food Chain and Animal Health on 13
February 2004 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 authorisation should include
risk mitigation measures, where appropriate.

970 g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on bromoxynil, and in
particular Appendices I and II
thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health on
13 February 2004 shall be taken into account. In this overall
assessment Member States must pay particular attention to the
protection of birds and wild mammals,
in particular if the
substance is applied in winter, and of aquatic organisms.
Conditions of authorisation should include risk mitigation
measures, where appropriate.

L

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No

Common name, identifica-
tion numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

87

desmedipham

CAS No 13684-56-5

CIPAC No 477

ethyl 3'-phenylcarbamoyloxycarba-
nilate

3-phenylcarbamoyloxyphe-

ethyl
nylcarbamate

88

ioxynil

CAS No 13684-83-4

CIPAC No 86

4- hydroxy- 3,5- di-iodobenzoni-
trile

89

phenmedipham

CAS No 13684-63-4

CIPAC No 77

methyl 3-(3-methylcarbaniloylox-
y)carbanilate;

3-methoxycarbonylaminophenyl
3'-methylcarbanilate

Min. 970 g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on desmedipham, and in
particular Appendices I and II
thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health on
13 February 2004 shall be taken into account. In this overall
assessment Member States should pay particular attention to
the protection of aquatic organisms and earthworms. Risk
mitigation measures should be applied if appropriate

960 g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on ioxynil, and in particu-
lar Appendices I and II thereto, as finalised in the Standing
Committee on the Food Chain and Animal Health on 13
February 2004 shall be taken into account. In this overall
assessment Member States must pay particular attention to the
protection of birds and wild mammals in particular if the
substance is applied in winter and to aquatic organisms.
Conditions of authorisation should include risk mitigation
measures, where appropriate.

Min. 970 g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on phenmedipham, and
in particular Appendices I and II thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health on
13 February 2004 shall be taken into account. In this overall
assessment Member States should pay particular attention to
the protection of aquatic organisms. Conditions of authorisa-
tion should include risk mitigation measures, where appro-
priate.

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

.

.

2
4
4
2
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0
4

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9