Commission Directive 2001/87/EC of 12 October 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances
Date: 2001-10-12
Institutions: European Commission
Subjects: European standard, marketing, pharmaceutical product, plant health product

19.10.2001

EN

Official Journal of the European Communities

L 276/17

COMMISSION DIRECTIVE 2001/87/EC

of 12 October 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine
and pyraflufen-ethyl as active substances

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 2001/
49/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

for the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC
(hereinafter referred to as ‘the Directive’) France received
on 15 October 1996 an application from Novartis (now
Syngenta)
the active substance
acibenzolar-s-methyl (CGA 245704) in Annex I to the
Directive. By Commission Decision 97/865/EC (3) it was
confirmed that the dossier was ‘complete’ i.e. it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annex II and Annex III to the
Directive.

Greece received a similar application on 27 March 1996
from Rhône Poulenc Agrochimie SA (now Aventis
CropScience), concerning cyclanilide (RPA 090946).
This application was declared complete by Commission
Decision 97/137/EC (4).

On 27 August 1998, Germany received an application
from W. Neudorff GmbH KG, concerning ferric phos-
phate. This application was declared complete by
Commission Decision 1999/43/EC (5).

Germany also received on 4 September 1996 an applica-
tion from Novartis
(CGA
215944). By Commission Decision 97/865/EC this
application was declared complete.

concerning pymetrozine

On 16 June 1997, Belgium received an application from
Nihon Nohyaku Co. Ltd, concerning pyraflufen-ethyl.
This application was declared complete by Commission
Decision 98/242/EC (6).

For these five 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

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 176, 29.6.2001, p. 61.
(3) OJ L 351, 23.12.1997, p. 67.
(4) OJ L 52, 22.2.1997, p. 20.
(5) OJ L 14, 19.1.1999, p. 30.
(6) OJ L 96, 28.3.1998, p. 45.

the Directive, for the uses proposed by the respective
applicant. The nominated rapporteur Member States,
submitted draft assessment
reports concerning the
substances to the Commission on 17 December 1998
(acibenzolar-s-methyl), 11 February 1998 (cyclanilide),
30 July 1999 (ferric phosphate), 28 May 1998 (pymeth-
rozine) and 8 July 1999 (pyraflufen-ethyl), respectively.

The draft assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health. The reviews were finalised
on 29 June 2001 in the format of
the individual
Commission review reports for acibenzolar-s-methyl,
cyclanilide,
ferric phosphate, pymethrozine and pyra-
flufen-ethyl.

The dossier and the information from each of
the
reviews were submitted to the Scientific Committee for
Plants. As regards acibenzolar-s-methyl and ferric phos-
phate, no specific questions were addressed to the
Committee. The Committee considered that there were
no issues that it wished to raise regarding the active
substances in the context of a possible inclusion in
Annex I to the Directive (7). The Committee noted that
absence of comment should only be interpreted as an
indication of no obvious reasons necessitating comment.

In its opinion (8) concerning cyclanilide the Committee
provided its interpretation of certain effects observed in
mice and rabbits and recommended a reassessment of
the degradation of the soil metabolite 2,4-dichloraniline.
The recommendations of
the Committee have been
taken into consideration.

the Committee
In its opinion (9) on pymetrozine
assessed certain effects in the context of deriving an
acceptable daily intake and an acute reference dose for
consumers.

In its opinion (10) on pyraflufen-ethyl the Committee
concluded that
there is generally negligible risk of
groundwater contamination for the parent compound
and its breakdown products. However, under extreme
the fate of certain breakdown products
conditions
should be assessed carefully.

(7)

(8)

(9)

(10)

(11)

(7) Minutes of

the plenary meeting of
Plants from 7 March 2001 (acibenzolar-s-methyl).
Minutes of
the plenary meeting of
Plants from 4 June 2001 (ferric phosphate).

the Scientific Committee for

the Scientific Committee for

(8) Opinion of the Scientific Committee for Plants regarding the evalua-
tion of cyclanilide in the context of Directive 91/414/EEC concer-
ning the placing of plant protection products on the market. SCP/
CYCLAN/002-final dated 11 December 2000.

(9) Opinion of the Scientific Committee for Plants regarding the evalua-
tion of pymetrozine in the context of Directive 91/414/EEC concer-
ning the placing of plant protection products on the market. SCP/
PYMETR/002-final dated 31 January 2001.

(10) Opinion of

the Scientific Committee for Plants

regarding the
evaluation of pyraflufen-ethyl
in the context of Directive 91/
414/EEC concerning the placing of plant protection products on
the market. SCP/PYRA/-final dated 7 March 2001.

L 276/18

EN

Official Journal of the European Communities

19.10.2001

(12)

It has appeared from the various examinations made
that plant protection products containing any of the
active substances concerned may be expected to satisfy,
in general, the requirements laid down in Article 5(1)(a),
(b) and (3) of the Directive, in particular with regard to
the uses which were examined and detailed in the
respective 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
authorisations of plant protection products containing
the active substances concerned can be granted in
accordance with the provisions of the said Directive.

(13) After inclusion, a reasonable period is necessary to
permit Member States to implement the provisions of
the Directive on plant protection products containing
acibenzolar-s-methyl,
phosphate,
cyclanilide,
pymetrozine or pyraflufen-ethyl and in particular to
review, within this period, existing provisional author-
isations or to grant, by the end of this period at the
latest, new authorisations in accordance with the provi-
sions of the Directive. A longer period may also be
required for plant protection products containing any of
the active
concerned and other active
substances included in Annex I.

substances

ferric

(14)

The review report is required for the proper imple-
mentation by the Member States, of several sections of
the uniform principles laid down in Annex VI to the
Directive, where those principles refer to the evaluation
of the data which were submitted for the purpose of the
inclusion of the active substance in Annex I to the
Directive. It is, therefore, appropriate to provide that the
finalised review reports (except for confidential informa-
tion in the meaning of Article 14 of the Directive) are
kept available or made available by the Member States
for consultation by any interested parties. If a review
report has to be updated to take account of technical
and scientific developments, the conditions for the inclu-
sion of the active substance concerned in Annex I to the
Directive should also be amended in accordance with
the Directive.

(15)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The table in Annex I to Directive 91/414/EEC shall be amended
as set out in the Annex hereto.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, at the latest by 31 March 2002. They shall forthwith
inform the Commission thereof.

those provisions,

When Member States adopt
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.
However, with regard to evaluation and decision-making
pursuant to 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 thereto, the period laid down in the
first paragraph is extended for existing provisional author-
isations of plant protection products containing acibenzolar-s-
methyl, cyclanilide,
ferric phosphate, pymetrozine or pyra-
flufen-ethyl to 31 March 2003.

3.
However for plant protection products containing aciben-
zolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or
pyraflufen-ethyl together with another active substance which
is in Annex I to Directive 91/414/EEC, the period referred to in
paragraph 1 is extended to the extent that a longer imple-
mentation period is provided for by the provisions laid down
in the Directive amending Annex I to Directive 91/414/EEC to
include the substance in the Annex.

4. Member States shall keep available the review reports for
acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine
and pyraflufen-ethyl (except for confidential information within
the meaning of Article 14 of the Directive) for consultation by
any interested parties or shall make it available to them on
specific request.

Article 3

This Directive shall enter into force on 1 November 2001.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 12 October 2001.

For the Commission

David BYRNE

Member of the Commission

ENTRIES TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Benzo[1,2,3]thiadiazole-7-carbothioic acid S-
methyl ester

970 g/kg

1 November 2001

31 October 2011

Only uses as a plant activator may be authorised.

No

Common name, identification
numbers

‘20

Acibenzolar-s-methyl

CAS No 135158-54-2

CIPAC No 597

21

Cyclanilide

Not available

960 g/kg

1 November 2001

31 October 2011

CAS No 113136-77-9

CIPAC No 586

Date of Standing Committee on Plant Health at
which the review report was finalised: 29 June
2001.

Only uses as a plant growth regulator may be
authorised.

The maximum content of
the impurity 2,4-
dichloroaniline (2,4-DCA) in the active substance
as manufactured should be 1 g/kg.

Date of Standing Committee on Plant Health at
which the review report was finalised: 29 June
2001.

22

Ferric phosphate

Ferric phosphate

990 g/kg

1 November 2001

31 October 2011

Only uses as a molluscicide may be authorised.

CAS No 10045-86-0

CIPAC No 629

23

Pymetrozine

CAS No 123312-89-0

CIPAC No 593

(E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-
4,5-dihydro-2H-[1,2,4]-triazin-3 one

950 g/kg

1 November 2001

31 October 2011

Only uses as an insecticide may be authorised.

Date of Standing Committee on Plant Health at
which the review report was finalised: 29 June
2001

In decision-making according to the uniform
principles Member States must pay particular
attention to the protection of aquatic organisms.

Date of Standing Committee on Plant Health at
which the review report was finalised: 29 June
2001.

.

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Pyraflufen-ethyl

CAS No 129630-19-9

CIPAC No 605

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-
1-mhypyrazol-3-yl)-4-fluorophenoxyacetate

956 g/kg

1 November 2001

31 October 2011

Only uses as a herbicide may be authorised.

In decision-making according to the uniform
principles Member States must pay particular
attention to the protection of algae and aquatic
plants and should apply, where appropriate, risk
mitigation measures.

Date of Standing Committee on Plant Health at
which the review report was finalised: 29 June
2001.

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

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