Commission Directive 2004/62/EC of 26 April 2004 amending Council Directive 91/414/EEC to include mepanipyrim as active substance (Text with EEA relevance)
Date: 2004-04-26
Institutions: European Commission
Subjects: marketing standard, plant health product

L 125/38

EN

Official Journal of the European Union

28.4.2004

COMMISSION DIRECTIVE 2004/62/EC

of 26 April 2004

amending Council Directive 91/414/EEC to include mepanipyrim as active substance

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

Whereas:

(1)

(2)

(3)

(4)

In accordance with Article 6(2) of Directive 91/414/EEC
Italy received on 24 October 1997 an application from
Kumiai Chemical Industry Co., Ltd for the inclusion of
the active substance mepanipyrim (former name: KIF
3535) in Annex I to Directive 91/414/EEC. Commission
Decision 98/676/EC (2) confirmed that the dossier was
in the sense that it could be considered as
‘complete’
satisfying, in principle, the data and information require-
ments of Annexes II and III to Directive 91/414/EEC.

For this active substance, 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 designated rapporteur Member State submitted a
draft assessment report concerning the substance to the
Commission on 12 July 2000.

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 30 March 2004 in the format of
the Commission review report for mepanipyrim.

The dossier and the information from the review were
also submitted to the Scientific Panel on Plant Health,
Plant Protection Products and their Residues. The report
this Panel was formally adopted on 23 October
of
2003 (3).

The Panel was asked to comment on the liver tumors
found in rats and mice exposed to mepanipyrim and to
give its opinion on the question whether a threshold of
tumor formation can be assumed.

(1) OJ L 230, 19.08.1991, p. 1. Directive as last amended by Commis-

sion Directive 2004/30/EC (OJ L 77, 13.3.2004, p. 50).

(2) OJ L 317, 26.11.1998, p. 47.
(3) Opinion of the Scientific Panel on Plant Health, Plant Protection
Products and their Residues on a request
from the European
Commission related to the evaluation of mepanipyrim in the
Context of Council Directive 91/414/EEC, The EFSA Journal (2003)
4, 1-14.

currently unknown but nevertheless

In its opinion the Panel concluded that mepanipyrim
induces tumors in rats and mice by a mechanism which
is
involves a
threshold below which tumors are not expected to
develop and that therefore a safe level of human expo-
sure can be assigned.

The recommendations of the Scientific Panel were taken
into account during the further review and in this Direc-
tive and in the Review Report. The evaluation within the
Standing Committee concluded that there would be no
unacceptable human exposure under
the proposed
conditions of use.

(5)

(6)

It has appeared from the various examinations made
that plant protection products containing the active
substance 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 par-
ticular with regard to the uses which were examined and
detailed in the Commission review report. It is therefore
appropriate to include mepanipyrim in Annex I, in order
to ensure that in all Member States the authorisations of
active
plant
substance may be granted in accordance with the provi-
sions of that Directive.

containing

protection

products

this

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 mepanipyrim and in particular to review
existing provisional authorisations and, by the end of
this period at the latest, to transform those authorisa-
tions into full authorisations, to amend them or to with-
draw them in accordance with the provisions of Direc-
tive 91/414/EEC.

(7)

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

(8)

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

28.4.2004

EN

Official Journal of the European Union

L 125/39

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

the latest

1. Member States shall adopt and publish by 31 March
the laws, regulations and administrative
2005 at
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 Directive.

They shall apply those provisions from 1 April 2005.

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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing mepanipyrim to ensure
that the conditions relating to this active substance 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 2005 at
the latest.

2.
For each authorised plant protection product containing
mepanipyrim 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 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 Direc-
tive 91/414/EEC.

Following that determination Member States shall:

(a) in the case of a product containing mepanipyrim as the
only active substance, where necessary, amend or withdraw
the authorisation by 31 March 2006 at the latest; or

(b) in the case of a product containing mepanipyrim as one of
several active substances, where necessary, amend or with-
draw the authorisation by 31 March 2006 or by the date
fixed for such an amendment or withdrawal in the respec-
tive Directive or Directives which added the relevant
substance or substances to Annex I to Directive 91/414/
EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 October 2004.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 26 April 2004.

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

‘91

Common Name, Identification
Numbers

Mepanipyrim
CAS No 110235-47-7
CIPAC No 611

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

N-(4-methyl-6-prop-1-ynyl-
pyrimidin-2-yl)aniline

960 g/kg

1 October 2004

30 September 2014

the implementation of

Only uses as fungicide may be authorised.
the uniform principles of
For
Annex VI, the conclusions of the review report on mepani-
pyrim, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain
and Animal Health on 30 March 2004 shall be taken into
account.
In this overall assessment Member States should pay par-
ticular attention to the protection of aquatic organisms.
Risk mitigation measures should be applied where appro-
priate.

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

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