Commission Directive 2001/21/EC of 5 March 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include amitrole, diquat, pyridate and thiabendazole as active substances
Date: 2001-03-05
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

10.3.2001

EN

Official Journal of the European Communities

L 69/17

COMMISSION DIRECTIVE 2001/21/EC

of 5 March 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include amitrole, diquat, pyridate and thiabendazole 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 2000/
80/EC (2), and in particular Article 6(1) thereof,

Whereas:

(EEC) No 3600/92 and Regulation (EC) No 933/94, in
particular with regard to the integration of the desig-
nated public authorities and the producers in Austria,
Finland and Sweden in the implementation of the first
stage of the programme of work referred to in Article
8(2) of the Directive. The rapporteur Member States
submitted the relevant assessment report and recom-
mendation to the Commission on 30 April 1996
(amitrole), on 2 April 1996 (diquat), on 18 November
1996 (pyridate) and 30 April 1996 (thiabendazole) in
accordance with Article 7(1)(c) of Regulation (EEC) No
3600/92.

(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 Directive 91/414/EEC
concerning the placing of plant protection products on
the market (3), as last amended by Regulation (EC) No
2266/2000 (4),
laid down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC
(hereinafter referred to as ‘the Directive’). Pursuant to
that Regulation, 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 State for the implementation of Regulation
(EEC) No 3600/92 (5), as last amended by Regulation
(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.

In accordance with Article 5(1) of the Directive, an
active substance should be included in Annex I for a
period not exceeding 10 years if it may be expected that
neither the use of, nor residues from, plant protection
products containing the active substance will have any
harmful effects on human or animal health or on
groundwater or any unacceptable influence on the envir-
onment.

For amitrole, diquat, pyridate and thiabendazole the
effects on human health and the environment have been
assessed in accordance with the provisions laid down in
Regulation (EEC) No 3600/92 for a range of uses
proposed by the respective notifiers. Under Regulation
(EC) No 933/94, France was designated as rapporteur
the United Kingdom for
Member State for amitrole,
diquat, and Spain for thiabendazole. Austria was desig-
nated as rapporteur Member State for pyridate under
Regulation (EC) No 491/95 (7) amending Regulation

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 9.12.2000, 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.
(7) OJ L 49, 4.3.1995, p. 50.

(4)

(5)

(6)

These assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health. The reviews were finalised
on 12 December 2000 in the format of the respective
Commission review reports for amitrole, diquat, pyridate
the review reports have to be
and thiabendazole.
updated to take account of technical and scientific devel-
opments,
the
substances concerned in Annex I to the Directive will
also need to be amended in accordance with the
Directive.

the inclusion of

the conditions

for

If

The dossier and the information from the review of
amitrole were submitted to the Scientific Committee for
Plants for consultation. In its opinion of 6 June 2000 (8),
the Committee
acceptable operator
exposure level selected and offered advice on the inter-
the long-term studies in rodents. The
pretation of
recommendations were taken into consideration in this
Directive and in the relevant review report.

confirmed the

The dossier and the information from the review of
diquat were also submitted to the Scientific Committee
for Plants for consultation. In its opinion of 5 April
2000 (9), the Committee offered advice on the inter-
pretation of the available studies on bird reproduction,
on potential long-term effects of residues bound to soil
particles, on the potential environmental
impact of
aquatic weed control, and on certain aspects of operator
and consumer exposure. The Committee offered its
interpretation of the bird reproduction studies available.
It concluded that there are no indications that residues
in soil will have unacceptable effects. Further,
the
Committee noted that aquatic weed control uses of
diquat may pose a high risk to non-target aquatic organ-
isms and insufficient data is available to demonstrate
that efficient risk mitigation measures can be applied.

(8) Scientific Committee on Plants SCP/AMITR/002 final.
(9) Scientific Committee on Plants SCP/DIQUAT/002 final.

L 69/18

EN

Official Journal of the European Communities

10.3.2001

of

non-professional

the Committee
With regard to operator exposure,
advised that measures should be considered to limit
exposure
the
Committee noted that insufficient information is avail-
able to fully assess the dietary exposure of consumers
related to uses as desiccant in small grain cereals. Those
opinions were taken into consideration in this Directive
and in the relevant review report.

Finally,

users.

(7)

(8)

(9)

For pyridate also, the dossier and the information from
the review were submitted to the Scientific Committee
for Plants for consultation.
In its opinion of 6 June
2000 (1), the Committee confirmed the validity of the
acceptable operator exposure level selected within the
Standing Committee on Plant Health.

For thiabendazole as well, the dossier and the informa-
tion from the review were submitted to the Scientific
Committee for Plants for consultation. In its opinion of
22 September 2000 (2), the Committee confirmed that
the intended post-harvest uses of thiabendazole for fruit
and potatoes will not pose an unacceptable risk to
aquatic organisms, provided that adequate risk mitiga-
tion measures are applied. This recommendation was
taken into consideration in this Directive and in the
relevant review report.

It has appeared from the various examinations made
that plant protection products containing the active
in
substances concerned may be expected to satisfy,
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

basis of a dossier satisfying the prescribed data require-
ments.

(12) 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 amitrole, diquat,
pyridate or thiabendazole. In particular, Member States
must, within that period, review existing authorisations
and, where appropriate, grant new authorisations in
the Directive. A
accordance with the provisions of
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
the
products
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

(13)

(14)

It is 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.

The review reports are required for the proper imple-
mentation by the Member States, of several sections of
the uniform principles laid down in the Directive, where
those principles refer to the evaluation of the data which
were submitted for the purpose of the inclusion of the
active substances in Annex I to the Directive.

(15)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health delivered on 12 December 2000,

(10) Article 5(5) of the Directive provides that the inclusion
of an active substance in Annex I can be reviewed at any
time if there are indications that the criteria for inclusion
are no longer satisfied. Therefore, the Commission will
reconsider the inclusion in Annex I of amitrole if the
requested additional information as outlined in point 7
of the review report were not submitted.

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

(11)

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

(1) Scientific Committee on Plants SCP/PYRID/002 final.
(2) Scientific Committee on Plants SCP/THIABEN/002-final.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, by 1 July 2002 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 amitrole,
diquat, pyridate or thiabendazole as active substances by that
date.

10.3.2001

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Official Journal of the European Communities

L 69/19

those provisions,

they shall
When Member States adopt
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
for plant protection products
withdrawing authorisations
containing amitrole, diquat, pyridate or thiabendazole as the
only active substance shall be 1 January 2006.

thiabendazole

For plant protection products containing amitrole, diquat,
3.
active
pyridate or
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.

together with another

4. Member States shall keep available the review reports for
amitrole, diquat, pyridate and thiabendazole (except for confi-
information within the meaning of Article 14 of
dential

for consultation by any interested
Directive 91/414/EEC)
parties or shall make it available to them on specific request.

inform the Commission if

the
5. Member States shall
requested additional
information outlined in point 7 of the
Review Report for amitrole is not submitted by 1 January
2002. In such case the Commission will reconsider the inclu-
sion of amitrole in Annex I to Directive 91/414/EEC.

This Directive shall enter into force on 1 January, 2002.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 5 March 2001.

For the Commission

David BYRNE

Member of the Commission

The following entries (numbered 14 to 17) shall be added at the end of the table in Annex I to Directive 91/414/EC:

ANNEX

No

Common name,
identification numbers

IUPAC name

Purity (1)

Entry into
force

Expiration
of inclusion

Specific provisions

‘14

Amitrole

H-[1,2,4]-triazole-3-ylamine

900 g/kg

1.1.2002

31.12.2011 Only uses as herbicide may be authorised

CAS No 61-82-5

CIPAC No 90

15

Diquat

CAS No 2764-72-9 (ion),
85-00-7 (dibromide)

CIPAC No 55

For the implementation of the uniform principles of Annex VI, the conclusions of the
review report on amitrole, and in particular Appendices I and II thereof, as finalised in
the Standing Committee on Plant Health on 12 December 2000 shall be taken into
account. In this overall assessment Member States:

— must pay particular attention to the protection of operators

— must pay particular attention to the protection of the groundwater in vulnerable

areas,

in particular with respect to non-crop uses

— must pay particular attention to the protection of beneficial arthropods

— must pay particular attention to the protection of birds and wild mammals. Use of
amitrole during the breeding season may only be authorised when an appropriate
risk assessment has demonstrated that there is no unacceptable impact and when
the conditions of authorisation include, where appropriate, risk mitigation meas-
ures

9,10-Dihydro-8a,10a-diazonia-
phenanthrene ion (dibromide)

950 g/kg

1.1.2002

31.12.2011 On the basis of currently available information, only uses as terrestrial herbicide and
desiccant may be authorised. Uses in aquatic weed control shall not be authorised

For the implementation of the uniform principles of Annex VI, the conclusions of the
review report on diquat, and in particular Appendices I and II thereof, as finalised in
the Standing Committee on Plant Health on 12 December 2000 shall be taken into
account. In this overall assessment Member States:

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

— must pay particular attention to operator safety as related to non-professional use
and must ensure that the conditions of authorisation include, where appropriate,
risk mitigation measures

16

Pyridate

CAS No 55512-33.9

CIPAC No 447

6-Chloro-3-phenylpyridazin-4-yl S-
octyl thiocarbonate

900 g/kg

1.1.2002

31.12.2011 Only uses as herbicide may be authorised

For the implementation of the uniform priciples of Annex VI, the conclusions of the
review report on pyridate, and in particular Appendices I and II thereof, as finalised in
the Standing Committee on Plant Health on 12 December 2000 shall be taken into
account. In this overall assessment Member States:

— must pay particular attention to the protection of groundwater

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

L

6
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No

Common name,
identification numbers

IUPAC name

Purity (1)

Entry into
force

Expiration
of inclusion

Specific provisions

17

Thiabendazole

2-Thiazol-4-yl-1H-benzimidazole

985 g/kg

1.1.2002

31.12.2011 Only uses as fungicide may be authorised. Foliar spray applications shall not be

CAS No 148-79-8

CIPAC No 323

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

authorised

For the implementation of the uniform priciples of Annex VI, the conclusions of the
review report on thiabendazole, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on Plant Health on 12 December 2000 shall be
taken into account. In this overall assessment Member States:

— must pay particular attention to the protection of aquatic and sediment-dwelling
organisms and must ensure that the conditions of authorisation include, where
appropriate, risk mitigation measures

Suitable risk mitigation measures (e.g. depuration with diatom earth or activated
carbon) have to be implemented to protect surface waters from unacceptable levels of
contamination via wastewater

.

.

1
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3
2
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