Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances
Date: 2001-11-20
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 304/14

EN

Official Journal of the European Communities

21.11.2001

COMMISSION DIRECTIVE 2001/99/EC

of 20 November 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include glyphosate and thifensulfuron-methyl as active substances

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

on 29 June 2001 in the format of the Commission
review reports for glyphosate and thifensulfuron-methyl.

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

Whereas:

(1)

(2)

the first

the implementation of

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 (3), as last amended by Regula-
tion (EC) No 2266/2000 (4), laid down the detailed rules
for
the
programme of work referred to in Article 8(2) of
Directive 91/414/EEC (hereinafter referred to as ‘the
Directive’). Pursuant to Regulation (EEC) No 3600/92,
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
States for the implementation of Commission Regula-
tion (EEC) No 3600/92 (5), as last amended by Regula-
tion (EC) No 2230/95 (6), laid down the list of active
substances of plant protection products to be assessed,
with a view to their possible inclusion in Annex I to the
Directive.

stage of

For glyphosate and thifensulfuron-methyl the effects on
human health and the environment have been assessed
in accordance with the provisions laid down in Regula-
tion (EEC) No 3600/92 for a range of uses proposed by
the notifiers. Under Regulation (EC) No 933/94,
Germany and France were designated as rapporteur
Member States for glyphosate and thifensulfuron-methyl,
respectively. The rapporteur Member States submitted
the relevant assessment reports and recommendations to
the Commission on 1 February 1999 (glyphosate) and
on 30 April 1996 (thifensulfuron-methyl) in accordance
with Article 7(1)(c) of Regulation (EEC) No 3600/92.

(3)

These assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health. The reviews were finalised

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 19.10.2001, p. 17.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(4)

(5)

(6)

(7)

and

thifensulfuron-methyl were

The dossiers and the information from the reviews of
also
glyphosate
submitted to the Scientific Committee for Plants. 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
to the
context of a possible inclusion in Annex I
Directive (7). The Committee noted that absence of
comment should only be interpreted as an indication of
no obvious reasons necessitating comment.

It has appeared from the various examinations made
that plant protection products containing the active
substances concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1)(a)
and (b) of the Directive, in particular with regard to the
uses which were examined and detailed in the Commis-
sion review report. It is therefore appropriate to include
the active substances concerned in Annex I, in order to
ensure that in all Member States the authorisations of
plant
active
substances concerned can be granted in accordance with
the provisions of the said Directive.

containing

protection

products

the

The Directive provides that after inclusion of an active
substance in Annex I, Member States must, within a
prescribed period, grant, vary or withdraw, as appro-
priate, the authorisations of the plant protection prod-
ucts containing the active substance. In particular, plant
protection products should not be authorised unless
account is taken of the conditions associated with the
inclusion of the active substance in Annex I and the
uniform principles laid down in the Directive on the
basis of a dossier satisfying the prescribed data require-
ments.

A reasonable period must be provided for 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. Moreover, after inclusion,
a reasonable period is necessary to permit Member
States to implement the provisions of the Directive on
plant protection products containing glyphosate or
In particular, Member States
thifensulfuron-methyl.

(7) Minutes of the plenary of the Scientific Committee on Plants from

March 7, 2001 (glyphosate).
Minutes of the plenary of the Scientific Committee on Plants from
June 7, 2001 (thifensulfuron-methyl)

21.11.2001

EN

Official Journal of the European Communities

L 304/15

must, within that period, review existing authorisations
and, where appropriate, grant new authorisations in
accordance with the provisions of
the Directive. 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 prin-
ciples laid down in the Directive. For plant protection
products
the
complete evaluation on the basis of the uniform princi-
ples can only be carried out when all
the active
substances concerned have been included in Annex I to
the Directive.

containing several

substances,

active

(8)

The review report is required for the proper imple-
mentation by the Member States, of several sections of
the uniform principles laid down in the Directive. It is,
therefore, appropriate to provide that
the finalised
review reports (except for confidential information) 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
to the
the substance concerned in Annex I
Directive should also be amended in accordance with
the Directive.

(9)

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

in accordance with Directive 91/
In particular they shall,
414/EEC, where necessary, amend or withdraw existing author-
isations for plant protection products containing glyphosate or
thifensulfuron-methyl as active substance by that date.

When Member States adopt this provision, 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. 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 require-
ments of Annex III thereto, the deadline for amending or
withdrawing authorisations
for plant protection products
containing glyphosate or thifensulfuron-methyl as the only
active substance shall be 1 July 2006.

3.
For plant protection products containing glyphosate or
thifensulfuron-methyl together with another active substance
which is in Annex I to Directive 91/414/EEC, the period for
amending or withdrawing authorisations shall expire four years
after the entry into force of the Directive which amended
Annex I so as to add the last of those substances to it.

4. Member States shall keep available the review reports for
glyphosate and thifensulfuron-methyl (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.

This Directive shall enter into force on 1 July 2002.

Article 3

Article 4

Annex I to Directive 91/414/EEC shall be amended in accord-
ance with the Annex hereto.

This Directive is addressed to the Member States.

Article 2

Done at Brussels, 20 November 2001.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, by 1 January 2003 at the latest. They shall forthwith
inform the Commission thereof.

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/EEC:

ANNEX

No

Common name,
identification Nos

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

25

Glyphosate

N-(phosphonomethyl)-glycin

950 g/kg

1 July 2002

30 June 2012

Only uses as herbicide may be authorised

CAS No 1071-83-6

CIPAC No 284

26

Thifensulfuron-methyl

CAS No 79277-27-3

CIPAC No 452

Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-
ylcarbamoyl-sulfamoyl)
thiophene-2-carboxy-
late

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on glyphosate, and in particular Appen-
dices I and II thereof, as finalised in the Standing
Committee on Plant Health on 29 June 2001
shall be taken into account. In this overall assess-
ment Member States:

— must pay particular attention to the protec-
tion of the groundwater in vulnerable areas,
in particular with respect to non-crops uses

960 g/kg

1 July 2002

30 June 2012

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 thifensulfuron-methyl, and in partic-
ular Appendices I and II thereof, as finalised in
the Standing Committee on Plant Health on 29
June 2001 shall be taken into account. In this
overall assessment Member States:

— must pay particular attention to the protec-

tion of groundwater,

— must pay particular attention to the impact
on aquatic plants and must ensure that the
conditions of authorisation include, where
appropriate, risk mitigation measures

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

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