Commission Directive 2003/39/EC of 15 May 2003 amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances (Text with EEA relevance)
Date: 2003-05-15
Institutions: European Commission
Subjects: herbicide, marketing, marketing standard, pharmaceutical product, plant health product

L 124/30

EN

Official Journal of the European Union

20.5.2003

COMMISSION DIRECTIVE 2003/39/EC

of 15 May 2003

amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances

(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), as last amended by Commission Directive 2003/
31/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

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), establishes a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes propineb and propyzamide.

For those active substances 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 notifiers.
In accordance with Commission Regulation (EC) No
933/94 of 27 April 1994 laying down the active
substances of plant-protection products and designating
the rapporteur Member State for the implementation of
Commission Regulation (EEC) No 3600/92 (5), as last
amended by Regulation (EC) No 2230/95 (6),
the
following rapporteur Member States were designated,
which in turn submitted the relevant assessment reports
and recommendations to the Commission in accordance
with Article 7(1)(c) of Regulation (EEC) No 3600/92: for
propineb: rapporteur Member State Italy, all relevant
information was submitted on 17 July 1996; for propy-
zamide: rapporteur Member State Sweden, all relevant
information was submitted on 19 May 1998.

Those assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health.

In accordance with Article 6(4) of Directive 91/414/EEC
and in view of a possible unfavourable decision for
propineb, the Commission organised a tripartite meeting
with the main data submitter and the rapporteur

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 101, 23.4.2003, p. 3.
(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)

(7)

(8)

Member State on 4 December 1997. The main data
submitter provided further data in order to meet the
initial concerns.

The reviews of all active substances were finalised on 26
February 2003 in the format of the Commission review
reports for propineb and propyzamide.

The review of propyzamide did not reveal any open
questions or concerns, which would have required a
consultation of the Scientific Committee on Plants.

exposure

The report on propineb and further information were
also submitted to the Scientific Committee for Plants for
separate consultation. The Scientific Committee was
asked to comment on the long-term exposure assess-
ment for birds and on the appropriate animal model to
be used for derivation of the acceptable daily intake
(ADI) and the
level
acceptable operator
In its opinion (7) the Committee identified a
(AOEL).
number of respects in which the risks from propineb to
birds and from propineb and the metabolite PTU to wild
mammals have not been adequately addressed and also
indicated ways to improve the risk assessment. Addition-
ally, the Committee emphasised the necessity of a clear
expression and justification of all end points, data,
assumptions and rationales used for risk assessment. The
Committee considered that the rat is the appropriate
species for the derivation of ADI and AOEL. The recom-
mendations of the Scientific Committee were taken into
account during the further review and in this Directive
and in the review report. After the missing information
was subsequently delivered by the main notifier and
evaluated by the rapporteur Member State, the Member
States within the Standing Committee concluded that the
risk for birds and wild mammals would be acceptable if
appropriate risk-mitigation measures are applied.

in general,

It has appeared from the various examinations made that
plant-protection products containing propineb or propy-
zamide may be expected to satisfy,
the
requirements laid down in Article 5(1)(a) and (b) and
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
the Commission review report.
It is therefore appro-
priate to include these active substances in Annex I, in
order to ensure that in all Member States the authorisa-
tions of plant-protection products containing this active
substance can be granted in accordance with the provi-
sions of that Directive.

(7) Opinion of the Scientific Committee on Plants on specific questions
from the Commission regarding the evaluation of propineb in the
context of Council Directive 91/414/EEC (SCP/PROPINEB/002 final
adopted 8 November 2001).

20.5.2003

EN

Official Journal of the European Union

L 124/31

(9)

The Commission review report is required for the proper
implementation by the Member States, of
several
sections of the uniform principles laid down in Directive
91/414/EEC. It is, therefore, appropriate to provide that
the finalised review report, except for confidential infor-
mation, should be kept available or made available by
the Member States for consultation by any interested
parties.

(10) A reasonable period should be allowed to elapse 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 resulting from the inclusion.

(11) After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant-protec-
tion products containing propineb or propyzamide, and
in particular, to review existing authorisations to ensure
that the conditions regarding those active substances set
out in Annex I to Directive 91/414/EEC are satisfied. A
longer period should be provided for the submission and
assessment of the complete dossier of each plant-protec-
tion product in accordance with the uniform principles
laid down in Directive 91/414/EEC.

(12)

(13)

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

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

They shall apply those provisions from 1 October 2004.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 3

1. Member States shall review the authorisation for each
plant-protection product containing propineb or propyzamide
to ensure that the conditions relating to those active substances
set out in Annex I to Directive 91/414/EEC are complied with.
Where necessary and by 30 September 2004 at the latest, they
shall amend or withdraw the authorisation.

2. Member States shall, for each authorised plant-protection
product containing propineb or propyzamide 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 31
March 2004 at the latest, re-evaluate the product in accordance
with the uniform principles provided for in Annex VI to Direc-
tive 91/414/EEC, on the basis of a dossier satisfying the
requirements 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. Where necessary and by 31 March 2008 at
the latest, they shall amend or withdraw the authorisation.

Article 4

This Directive shall enter into force on 1 April 2004.

HAS ADOPTED THIS DIRECTIVE:

Article 5

Article 1

This Directive is addressed to the Member States.

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

Article 2

Done at Brussels, 15 May 2003.

Member States shall adopt and publish by 30 September 2004
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

For the Commission

David BYRNE

Member of the Commission

No

Common name,
identification Nos

‘54

Propineb

CAS No:
12071-83-9
(monomer),
9016-72-2
(homopolymer)

CIPAC No:
177

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EC

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Polymeric zinc 1,2-propyle-
nebis(dithiocarbamate)

The technical active substance
should comply with the FAO
specification

1 April 2004

31 March 2014

Only uses as fungicide may be authorised

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on propineb, and in particular
Appendices I and II thereto, as finalised in the Standing Committee
on the Food Chain and Animal Health on 26 February 2003 shall
be taken into account. In this overall assessment:
— Member States should pay particular attention to the potential
for ground water contamination when the active substance is
applied in regions with vulnerable soils and/or extreme climatic
conditions

— Member States should pay particular attention to the protection
of small mammals, aquatic organisms and non-target arthro-
pods. Conditions of authorisation should include risk mitigation
measures, where appropriate

— Member States should observe the acute dietary exposure situa-
tion of consumers in view of future revisions of maximum
residue levels

3,5-dichloro-N-(1,1-dimethyl-
prop-2-ynyl)benzamide

920 g/kg

55

Propyzamide

CAS No:
23950-58-5

CIPAC No:
315

1 April 2004

31 March 2014

Only uses as herbicide may be authorised

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on propyzamide, and in particular
Appendices I and II thereof, as finalised in the Standing Committee
on Plant Health 26 February 2003 shall be taken into account. In
this overall assessment, Member States:
— must pay particular attention to the protection of operators and
must ensure that conditions of authorisation include risk mitiga-
tion measures, where appropriate

— must pay particular attention to the protection of birds and wild
mammals in particular if the substance is applied during the
breeding season. Conditions of authorisation should include risk
mitigation measures, where appropriate

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

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