Commission Directive 2001/103/EC of 28 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include 2,4-dichlorophenoxy acetic acid (2,4-D) as an active substance (Text with EEA relevance)
Date: 2001-11-28
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product

30.11.2001

EN

Official Journal of the European Communities

L 313/37

COMMISSION DIRECTIVE 2001/103/EC

of 28 November 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include 2,4-dichlorophenoxy acetic acid (2,4-D) as an active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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/
1999/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

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), provides for the adoption of
a list of certain active substances of plant protection
products to be assessed with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
is contained in Commission Regulation (EC) No 933/94
of 27 April 1994 laying down the active substances of
plant protection products and designating the rappor-
teur Member States for the implementation of Commis-
sion Regulation (EEC) No 3600/92 (5), as last amended
by Regulation (EC) No 2230/95 (6), and includes 2,4-
dichlorophenoxy acetic acid (‘2,4-D’).

For 2,4-D the effects on human health and the environ-
ment have been assessed in accordance with the provi-
sions laid down in Regulation (EEC) No 3600/92 for a
range of uses proposed by the notifiers. Under Regula-
tion (EC) No 933/94, Greece was designated as rappor-
teur Member State for 2,4-D. The rapporteur Member
State submitted the relevant assessment
report and
recommendations to the Commission on 17 January
1997 in accordance with Article 7(1)(c) of Regulation
(EEC) No 3600/92.

report has been reviewed by the
This assessment
Member States and the Commission within the Standing
Committee on Plant Health. The review was finalised on
2 October 2001 in the format of
the Commission
review report for 2,4-D.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 304, 21.11.2001, p. 14.
(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.

(5)

(6)

The dossiers and the information from the review of
2,4-D were also submitted to the Scientific Committee
for Plants.
In its opinion (7) of 21 May 2001 the
Committee commented on the selection of a suitable
animal model to be used for human risk assessment. The
recommendation was taken into consideration in formu-
lating this Directive and the relevant review report.

It has appeared from the various examinations made
that plant protection products containing 2,4-D may be
expected to satisfy,
in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
in particular with regard to the uses which were exam-
ined and detailed in the Commission review report. It is
therefore appropriate to include the active substance
concerned in Annex I to that Directive,
in order to
ensure that in all Member States the authorisations of
plant protection products containing 2,4-D can be
granted in accordance with the provisions of Directive
91/414/EEC.

protection

A reasonable period should be provided for before an
active substance is included in Annex I to Directive
91/414/EEC in order to permit Member States and the
interested parties to prepare themselves to meet the new
requirements which will result from the inclusion. More-
over, Directive 91/414/EEC provides that after inclusion
of an active substance in Annex I thereto, Member States
must, within a prescribed period, review and grant, vary
or withdraw, as appropriate, the authorisations of the
plant
active
substance. It is therefore necessary to stipulate such a
period. 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 principles laid down in Directive 91/414/EEC.
For plant protection products containing several active
substances, the complete evaluation on the basis of the
uniform principles can only be carried out when all the
active substances concerned have been included in
Annex I to Directive 91/414/EEC.

containing

products

the

(7)

The review report is required for the proper imple-
mentation by the Member States, of several sections of
the uniform principles laid down in Directive 91/
414/EEC. The finalised review report, except for confi-

(7) Opinion of the Scientific Committee on Plants regarding the evalua-
tion of 2,4-dichlorophenoxy acetic acid (2,4-D)
in the context of
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market — SCP/2,4d/002-final.

L 313/38

EN

Official Journal of the European Communities

30.11.2001

dential information, should be kept available or made
available by the Member States for consultation by any
interested parties. If the review report has to be updated
to take account of technical and scientific developments,
the conditions
the substance
concerned in Annex I to Directive 91/414/EEC should
also be amended in accordance with that Directive.

the inclusion of

for

(8)

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

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 2

for confidential

Member States shall keep available the review report for 2,4-D,
except
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

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

In particular they shall,
in accordance with Directive 91/
414/EEC, where necessary, amend or withdraw existing author-

isations for plant protection products containing 2,4-D as
active substance by that date.

When Member States adopt these 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. 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 time limit for amending or
withdrawing authorisations
for plant protection products
containing 2,4-D as the only active substance shall be 1
October 2006.

3.
For plant protection products containing 2,4-D together
with another active substance which is in Annex I to Directive
91/414/EEC, the period for amending or withdrawing author-
isations 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.

This Directive shall enter into force on 1 October 2002.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 28 November 2001.

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 numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘27

2,4-D

(2,4-dichlorophenoxy) acetic acid

960 g/kg

1.10.2002

30.9.2012

Only uses as herbicide may be authorised

CAS No 94-75-7

CIPAC No 1

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

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on 2,4-D, and in particular Appendices I
and II
thereof, as finalised in the Standing
Committee on Plant Health on 2 October 2001
shall be taken into account.
In this overall
assessment Member States:

— must pay particular attention to the protec-
tion of the groundwater, when the active
substance is applied in regions with vulner-
able soil and/or climatic conditions

— must pay particular attention to the dermal

absorption

— must pay particular attention to the protec-
tion of non-target arthropods and must
ensure that the conditions of authorisation
include, where appropriate, risk mitigation
measures

.

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