Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (Text with EEA relevance)
Date: 2003-07-11
Institutions: European Commission
Subjects: market approval, pesticide, plant health control

L 177/12

EN

Official Journal of the European Union

16.7.2003

COMMISSION DIRECTIVE 2003/68/EC

of 11 July 2003

amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, meso-
trione, fenamidone and isoxaflutole as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Article 6(2) of Directive 91/414/EEC
the United Kingdom received on 28 January 1998 an
application from Novartis Crop Protection UK Ltd for
the inclusion of the active substance trifloxystrobin in
Annex I to Directive 91/414/EEC. The substance was
subsequently transferred to Bayer CropScience, which is
now acting as
the applicant. Commission Decision
1999/43/EC (3) confirmed that the dossier was ‘complete’
in the sense that it could be considered as satisfying, in
principle,
the data and information requirements of
Annexes II and III to Directive 91/414/EEC.

France received an application under Article 6(2) of
Directive 91/414/EEC on 14 February 1996 from FMC
Europe NV (now FMC Chemical sprl) concerning carfen-
trazone-ethyl. This application was declared complete by
Commission Decision 97/362/EC (4).

The United Kingdom received an application under
Article 6(2) of Directive 91/414/EEC on 23 April 1998
from Zeneca Agrochemicals UK (now Syngenta)
concerning mesotrione. This application was declared
complete by Commission Decision 1999/392/EC (5).

France received an application under Article 6(2) of
Directive 91/414/EEC on 15 September 1999 from
Rhone Poulenc Agri SA (now Bayer CropScience)
concerning fenamidone. This application was declared
complete by Commission Decision 2000/251/EC (6).

The Netherlands received an application under Article
6(2) of Directive 91/414/EEC on 6 March 1996 Rhône-
Poulenc Agro (now Bayer CropScience) concerning
isoxaflutole. This application was declared complete by
Commission Decision 96/524/EC (7).

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 124, 20.5.2003, p. 30.
(3) OJ L 14, 19.1.1999, p. 30.
(4) OJ L 152, 11.6.1999, p. 31.
(5) OJ L 148, 15.6.1999, p. 44.
(6) OJ L 78, 29.3.2000, p. 26.
(7) OJ L 220, 30.8.1996, p. 27.

(7)

(8)

(9)

For those active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants.
The nominated rapporteur Member States, submitted a
draft assessment report concerning the substance to the
Commission on 19 April 2000 (trifloxystrobin), 14 May
1998 (carfentrazone-ethyl), 17 December 1999 (meso-
trione), 14 May 1998 (fenamidone) and 20 February
1997 (isoxaflutole).

The draft assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 15 April 2003 in the format of
the Commission review reports for mesotrione, trifloxy-
strobin, carfentrazone-ethyl,
fenamidone and isoxaflu-
tole.

The review of trifloxystrobin and fenamidone did not
reveal any open questions or concerns, which would
have required a consultation of the Scientific Committee
for Plants.

For carfentrazone-ethyl the review and information were
also submitted to the Scientific Committee for Plants for
separate consultation. The Committee was asked to
comment on the relevance for humans of the elevated
levels of specific porphyrins detected in test animals. The
Committee expressed the opinion (8) that the effects of
the substance detected in test animals on porphyrin
levels are relevant for humans but saw no evidence that
humans are more sensitive to the effect than animals. In
addition,
three
unknown polar compounds were detected in a lysimeter.
The notifier was therefore requested to comment on the
relevance of these three compounds. Additional informa-
tion was subsequently provided by the notifier and eval-
uated by the Committee. In its assessment of the new
data
those polar
compounds will not cause an unacceptable ecotoxicolo-
gical or toxicological risk.

the Scientific Committee noted that

the Committee

concluded that

(8) Opinion of the Scientific Committee for Plants regarding the evalua-
tion of carfentrazone-ethyl in the context of Directive 91/414/EEC
concerning the placing of plant protection products on the market.
SCP/CARFEN/002-final adopted 26 January 2001.

16.7.2003

EN

Official Journal of the European Union

L 177/13

(10)

(11)

(12)

For mesotrione, the Scientific Committee was asked to
comment on the suitability of the rat as an animal model
for the extrapolation of the toxicological properties of
mesotrione in humans and was
invited to assess,
whether the onset of adverse effects in target organs (in
animal models as well as humans) can be linked to a
certain threshold concentration of tyrosine in plasma. In
its opinion (1), the Committee concluded that due to the
similarities
in tyrosine kinetics between mice and
humans, the mouse can be considered a better animal
model than the rat for human risk assessment purposes.
The Committee further concluded that no signs or symp-
toms of adverse effects are to be expected in humans at
plasma tyrosine levels below 800 to 1 000 nmol/ml.

For isoxaflutole the Scientific Committee was asked to
comment on the toxicological and ecotoxicological
effects of a degradation product of the active substance
(RPA 203328); on statistical analyses of tumour inci-
dence in the two-year rat study; and on the observation
of developmental effects in laboratory animals.
In its
opinion (2), the Committee noted that the degradation
product RPA 203328 under worst-case conditions might
leach into groundwater with expected concentrations
exceeding 0,1 ppb. The Committee identified no toxico-
logical or ecotoxiclogical concern with regard to this
degradation product. The Committee also identified no
concern for humans related to possible carcinogenic or
developmental effects.

In a second consultation on the same substances the
Scientific Committee was asked to comment on the
appropriate degradation kinetics to be assumed in model
calculations of the leaching behaviour. The Committee
found certain parameters used in the modelling were
insufficiently justified and the half life time of degrada-
tion for the RPA 203328 metabolite may have been
under-estimated (3).

The model calculations of the leaching behaviour of
isoxaflutole and its degradation products were subse-
quently revised along the lines suggested by the Scien-
tific Committee.

the

products

protection

containing

It has appeared from the various examinations made that
active
plant
substances concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1)(a)
and (b) and Article 5(3) of Directive 91/414/EEC,
in
particular with regard to the uses which were examined
It
and detailed in the Commission review report.
is
therefore appropriate to include mesotrione,
trifloxy-
strobin, carfentrazone-ethyl, fenamidone and isoxaflutole
in Annex I, in order to ensure that in all Member States

authorisations

products
the
containing these active substance can be granted in
accordance with the provisions of that Directive.

protection

plant

of

(13) After inclusion, Member States should be allowed a
reasonable period to implement the provisions of Direc-
tive 91/414/EEC as regards plant protection products
containing trifloxystrobin, carfentrazone-ethyl, meso-
trione, fenamidone and isoxaflutole and in particular to
review existing provisional authorisations and, by the
end of
to transform those
authorisations into full authorisations, to amend them or
to withdraw them in accordance with the provisions of
Directive 91/414/EEC.

this period at

the latest,

(14)

(15)

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

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 31 March 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 April 2004.

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

(1) Opinion of the Scientific Committee for Plants on the evaluation of
mesotrione in the context of Directive 91/414/EEC concerning the
placing of plant protection products on the market. SCP/MESOTRI/
002-final of 18 July 2002.

(2) Opinion of the Scientific Committee for Plants regarding the inclu-
sion of isoxaflutole in Annex 1 of Directive 91/414/EEC concerning
the placing of plant protection products on the market. SCP/ISOXA/
012-final of 3 June 1999.

(3) Opinion of the Scientific Committee for Plants on additional ques-
tions from the Commission concerning the evaluation of isoxaflu-
tole in the context of Directive 91/414/EEC. SCP/ISOXAFLUTOLE-
bis-002 final of 30 January 2003.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing trifloxystrobin, carfentra-
zone-ethyl, mesotrione, fenamidone or isoxaflutole to ensure
that the conditions relating to these active substances set out in
Annex I to Directive 91/414/EEC are complied with. Where
necessary,
they shall amend or withdraw authorisations in
accordance with Directive 91/414/EEC by 31 March 2004 at
the latest.

L 177/14

EN

Official Journal of the European Union

16.7.2003

For each authorised plant protection product containing
2.
trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or
isoxaflutole 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 30 September 2004 at the latest.
Member States shall 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 require-
ments of Annex III thereto. On the basis of that evaluation,
they shall determine whether the product satisfies the condi-
tions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/
414/EEC. Where necessary and by 31 March 2005 at the latest,
they shall amend or withdraw the authorisation for each such
plant protection product.

This Directive shall enter into force on 1 October 2003.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 11 July 2003.

For the Commission

David BYRNE

Member of the Commission

In Annex I the following rows are added at the end of the table:

ANNEX

No

‘59

Common name,
identification numbers

Trifloxystrobin
CAS No 141517-21-7
CIPAC No 617

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Methyl (E)-methoxyimino-
{(E)-a-[1-a-(a,a,a-trifluoro-m-
tolyl)ethylideneaminooxyl]-o-
tolyl}acetate

960 g/kg

1 October 2003

30 September 2013

Only use as fungicide may be authorised.

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on trifloxy-
strobin, 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 groundwater, when the active substance
is applied in regions with vulnerable soil and/or climate
conditions.

Risk mitigation measures should be applied and/or moni-
toring programs may be initiated where appropriate.

60

Carfentrazone ethyl
CAS No 128639-02.1
CIPAC No 587

Ethyl (RS)-2-chloro-3-[2-
chloro-5-(4-difluoromethyl-
4,5-dihydro-3-methyl-5oxo-
1H 1,2,4-triazol-1-yl)-4-
fluorophenyl]propionate

900 g/kg

1 October 2003

30 September 2013

Only use as herbicide may be authorised.

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on carfen-
trazone-ethyl, 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 groundwater, when the active substance
is applied in regions with vulnerable soil and/or climate
conditions.

Risk mitigation measures should be applied where appro-
priate.

61 Mesotrione

CAS No 104206-8
CIPAC No 625

2-(4-mesyl-2-nitrobenzoyl)
cyclohexane -1,3-dione

920 g/kg

1 October 2003

30 September 2013

Only use as herbicide may be authorised.

The manufacturing impurity
1-cyano-6-(methylsulfonyl)-
7-nitro-9H-xanthen-9-one is
considered to be of toxicolo-
gical
and must
remain below 0.0002 % (w/
w) in the technical product.

concern

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on meso-
trione, 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.

.

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No

62

Common name,
identification numbers

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Fenamidone
CAS No 161326-34-7
CIPAC No 650

(S)-5-methyl-2-methylthio-5-
phenyl-3-phenylamino-3,5-
dihydroimidazol-4-one

975 g/kg

1 October 2003

30 September 2013

Only use as fungicide may be authorised.

the implementation of

the uniform principles of
For
Annex VI, the conclusions of the review report on fenami-
done, and in particular Appendices I and II thereof, as fina-
lised 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
groundwater, when the active substance is applied in
regions with vulnerable soil and/or climate conditions,
— should pay particular attention to the protection of

non-target arthropods,

— should pay particular attention to the protection of

aquatic organisms.

Risk mitigation measures should be applied where appro-
priate.

63

Isoxaflutole
CAS No 141112-29-0
CIPAC No 575

5-cyclopropyl-4-(2-methyl-
sulfonyl-4-trifluoromethyl-
benzoyl) isoxazole

950 g/kg

1 October 2003

30 September 2013

Only use as herbicide may be authorised.

the implementation of

For
the uniform principles of
Annex VI, the conclusions of the review report on isoxa-
flutole, 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:
— must pay particular attention to the protection of
groundwater, when the active substance is applied in
regions with vulnerable soil and/or climate conditions.
Risk mitigation measures or monitoring programs
should be applied where appropriate.

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

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