Commission Directive 2002/48/EC of 30 May 2002 amending Council Directive 91/414/EEC to include iprovalicarb, prosulfuron and sulfosulfuron as active substances
Date: 2002-05-30
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

6.6.2002

EN

Official Journal of the European Communities

L 148/19

COMMISSION DIRECTIVE 2002/48/EC

of 30 May 2002

amending Council Directive 91/414/EEC to include iprovalicarb, prosulfuron and sulfosulfuron as
active substances

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(prosulfuron), and 2 April 1998 (sulfosulfuron), respec-
tively.

Having regard to the Treaty establishing the European Commu-
nity,

(5)

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2002/
37/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

In accordance with Article 6(2) of Directive 91/414/EEC,
Ireland received on 30 March 1998 an application from
Bayer AG for the inclusion of the active substance ipro-
valicarb in Annex I to the Directive. By Commission
Decision 98/512/EC (3) it was confirmed that the dossier
was ‘complete’ in the sense that it could be considered as
satisfying, in principle, the data and information require-
ments laid down in Annexes II and III to Directive 91/
414/EEC.

France received a similar application on 14 May 1995
from Novartis, now Syngenta, concerning prosulfuron.
This application was declared complete by Commission
Decision 97/137/EC (4).

Ireland received a similar application on 24 April 1997
from Monsanto concerning sulfosulfuron. This applica-
tion was declared complete by Commission Decision 97/
865/EC (5).

For these three active substances, the effects on human
health and the environment have been assessed, in accor-
dance with Article 6(2) and (4) of Directive 91/414/EEC,
for the uses proposed by the applicant. The nominated
rapporteur Member States submitted draft assessment
reports concerning the substances to the Commission on
4 November 1999 (iprovalicarb), 18 January 1999

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 117, 4.5.2002, p. 10.
(3) OJ L 228, 15.8.1998, p. 35.
(4) OJ L 52, 22.2.1997, p. 20.
(5) OJ L 351, 23.12.1997, p. 67.

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
reviews were finalised on 26 February 2002 in the
format of the Commission review reports for iprovali-
carb, prosulfuron and sulfosulfuron.

(6)

The dossier and the information from each of
the
reviews were submitted to the Scientific Committee for
Plants. As regards iprovalicarb, the Committee was asked
to comment on the acceptability of the risk of metabolite
PMPA on earthworms and on the relevance to humans
of tumours which were observed in rats after lifetime
exposure to high doses.
the
Committee identified the need for further data on earth-
worms, which were subsequently provided and assessed,
and concluded that concerning the effects observed in
rats sufficient safety margins exist to ensure protection
of consumers and operators. The observations of the
Scientific Committee were taken into consideration in
formulating this Directive and the relevant review report.

In two opinions (6) (7),

(7) With respect to prosulfuron, the Committee was asked
to comment on the acceptability of the risk of two
breakdown products of the active substance to sediment
dwelling organisms and on possible hormonal disruption
effects observed in test animals. In its opinion (8) the
Committee concluded that certain uterine and mammary
changes, which were observed in rats after lifetime expo-
sure are not considered relevant for human risk assess-
ment of prosulfuron in the context of its intended uses.
The Committee further commented that risks of the two
breakdown products to sediment-dwelling species were
not yet adequately assessed and noted that other persis-
tent metabolites are formed in significant quantities in
sediment-water tests which also did not appear to have
been assessed. The pending information and assessments
were subsequently provided and the observations of the
Scientific Committee were taken into consideration in
formulating this Directive and the relevant review report.

(6) Opinion of the Scientific Committee on Plants on the evaluation of
iprovalicarb in the context of Directive 91/414/EEC concerning the
placing of plant protection products on the market (adopted 21
March 2001).

(7) Opinion of the Scientific Committee on Plants on an additional
question from the Commission on the evaluation of iprovalicarb
(SZX 0722) in the context of Directive 91/414/EEC (adopted 28
November 2001).

(8) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of prosulfuron (CGA 152005) in Annex I to Directive 91/414/
EEC concerning the placing of plant protection products on the
market SCP/PROSULF/002-Final 21 June 2001.

L 148/20

EN

Official Journal of the European Communities

6.6.2002

(8) With respect to sulfosulfuron the Committee was asked
for its opinion on the occurrence of bladder tumours in
the 18 months mouse study; to consider whether it
would be appropriate to establish an acute reference
dose for sulfosulfuron; to confirm that a sub-lethal study
is unnecessary, notwithstanding the
for earthworms
persistence of the soil metabolites. In its opinion (1) the
Committee considered that the lesions observed in mice
do not predict a carcinogenic hazard to humans and saw
no need to establish an acute reference dose. It was
further concluded that no significant long term risks to
earthworms are likely to arise. The Committee further
highlighted the need to assess the potential environ-
impact of three unidentified metabolites. This
mental
the
subsequently
information was
requested assessments were made.

provided

and

(9)

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
and detailed in the Commission review reports.
It is
therefore appropriate to include these active substances
in Annex I, in order to ensure that in all Member States
the
products
containing the active substances concerned, can be
granted in accordance with the provisions of the said
Directive.

authorisations

protection

plant

of

(10)

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 reports, except for confidential infor-
mation, should be kept available or made available by
the Member States for consultation by any interested
parties.

(11) 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 iprovalicarb, prosulfuron or sulfosulfuron and
in particular to review existing provisional authorisations
and, by the end of this period at the latest, to transform
those authorisations into full authorisations, to amend
them or to withdraw them in accordance with the provi-
sions of Directive 91/414/EEC.

(12)

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

(13)

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,

(1) Opinion of the Scientific Committee on Plants regarding the evalua-
tion of MON 37500 (sulfosulfuron) in the context of Directive 91/
414/EEC concerning the placing of plant protection products on the
market (SCP/SULFO/002-final dated 11 December 2000).

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 keep available the review reports for ipro-
valicarb, prosulfuron, and sulfosulfuron, except for confidential
information within the meaning of Article 14 of Directive 91/
414/EEC, for consultation by any interested parties or shall
make it available to them on specific request.

Article 3

Member States shall adopt and publish by 31 December 2002
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 January 2003.

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.

Article 4

1. Member States shall review the authorisation for each
plant protection product containing iprovalicarb, prosulfuron,
or sulfosulfuron, 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 with-
draw the authorisation in accordance with Directive 91/414/
EEC before 31 December 2002.

2. Member States shall, for each authorised plant protection
product containing iprovalicarb, prosulfuron, or sulfosulfuron,
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 1 July 2002, re-evaluate the product in accordance
with the uniform principles provided for in Annex VI to Direc-
tive 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 conditions set
out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Where necessary and by 31 December 2003 at the latest, they
shall amend or withdraw the authorisation for each such plant
protection product.

6.6.2002

EN

Official Journal of the European Communities

L 148/21

This Directive shall enter into force on 1 July 2002.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 30 May 2002.

For the Commission

David BYRNE

Member of the Commission

In Annex I the following rows are added to the end of the Table:

ANNEX

No

Common name, identification
numbers

‘30

Iprovalicarb

CAS No 140923-17-7

CICAP No 620

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl]
propyl}-carbamic acid isopropylester

950 g/kg
(provisional
specification)

1 July 2002

30 June 2011

Only uses as fungicide may be authorised.

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on iprovalicarb, and in particular Appen-
dices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 26 February 2002 shall be taken into
account. In this overall assessment:

— the specification of the technical material as
be
commercially manufactured must
confirmed and supported by apporpriate
analytical data. The test material used in the
toxicity dossier should be compared and
verified against this specification of the tech-
nical material,

— Member States must pay particular attention

to the protection of operators.

31

Prosulfuron

CAS No 94125-34-5

CICAP No 579

1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-
[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea

950 g/kg

1 Juli 2002

30 June 2011

Only uses as herbicide may be authorised.

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on prosulfuron, and in particular Appen-
dices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 26 February 2002 shall be taken into
account.
In this overall assessment Member
States:

— must carefully consider the risk to aquatic
plants if the active substance is applied adja-
cent to surface waters. Risk mitigation meas-
ures should be applied where appropriate,

groundwater, when the

— must pay particular attention to the protec-
tion of
active
substance is applied in regions with vulner-
able soil and/or climate conditions. Risk
mitigation measures should be applied where
appropriate.

L

1
4
8
/
2
2

E
N

O

f
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i
a
l

J
o
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a
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.

6
6
2
0
0
2

No

Common name, identification
numbers

32

Sulfosulfuron

CAS No 141776-32-1

CICAP No 601

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

1-(4,6-dimethoxypyrimidin-2-yl)-3-
[2-ethanesulfonyl-imidazo[1,2-a]pyridine)
sulfonyl]urea

980 g/kg

1 July 2002

30 June 2011

Only uses as a herbicide may be authorised.

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on sulforsulfuron,
and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 26 February 2002 shall be
taken into account. In this overall assessment:

— Member States must pay particular attention
to the protection of aquatic plants and algae.
Where apporpriate, risk mitigation measures
should be applied,

— Member States must pay particular attention
to the protection of the groundwater, when
the active substance is applied in regions
with vulnerable soil and/or climatic condi-
tons.

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

.

.

6
6
2
0
0
2

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N

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C
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e
s

L

1
4
8
/
2
3