Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances   (Text with EEA relevance)
Date: 2005-10-21
Institutions: European Commission
Subjects: environmental protection, market approval, marketing standard, pesticide, pharmaceutical product, plant health product, safety standard

22.10.2005

EN

Official Journal of the European Union

L 279/63

COMMISSION DIRECTIVE 2005/72/EC

of 21 October 2005

amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb,
maneb, and metiram as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

information was submitted on 3 October 2000, 29
November 2000 and 22 August 2000 respectively.

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

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 (2), 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
the
spelling
chlorpyriphos-methyl)
and
mancozeb, maneb and metiram.

chlorpyrifos,
chlorpyriphos

chlorpyrifos-methyl

(under

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.
By Commission Regulation (EC) No 933/94 of 27 April
substances of plant
1994 laying down the active
protection products and designating the Rapporteur
Member States for the implementation of Commission
following
Regulation
Rapporteur Member States were designated, which
submitted the relevant assessment reports and recom-
mendations
to the Commission in accordance with
Article 7(1)(c) of Regulation (EEC) No 3600/92. For
chlorpyrifos and chlorpyrifos-methyl
the Rapporteur
Member State was Spain, and all relevant information
was submitted on 16 September 1997 and 7 May
1999. For mancozeb, maneb and metiram Italy was
designated as Rapporteur Member State and all relevant

3600/92 (3),

(EEC) No

the

(3)

(4)

(5)

reports have been reviewed by the
The assessment
Member
the Commission within the
and
States
Standing Committee on the Food Chain and Animal
Health. The reviews were finalised on 3 June 2005 in
the format of the Commission review reports for chlor-
chlorpyrifos-methyl, mancozeb, maneb and
pyrifos,
metiram.

of

reviews

chlorpyrifos,

chlorpyrifos-methyl,
The
reveal any
mancozeb, maneb and metiram did not
the Scientific
open question to be
Committee on Plants or
the European Food Safety
Authority (EFSA) which has taken over the role of that
Committee.

addressed by

and

It has appeared from the various examinations made, that
plant protection products containing chlorpyrifos, chlor-
pyrifos-methyl, mancozeb, maneb and metiram may be
the requirements laid
in general,
expected to satisfy,
down
of Directive
5(1)(a)
in Article
in particular with regard to the uses
91/414/EEC,
which were examined and detailed in the Commission
review report. 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 these active substances can be
granted in accordance with the provisions of
that
Directive.

(b)

(6) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points.
Article 6(1) of Directive 91/414/EEC provides
that
inclusion of a substance in Annex I may be subject to
conditions. Therefore it is appropriate to require that
chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and
metiram should be subjected to further testing for con-
firmation of
for some non-target
organisms and in case of maneb, and mancozeb also
for developmental toxicity, and that such studies should
be presented by the notifiers.

the risk assessment

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation
(EC) No 396/2005 of the European Parliament and of the Council
(OJ L 70, 16.3.2005, p. 1).

(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu-

lation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

(7)

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
the new requirements
which will result from the inclusion.

themselves

to meet

L 279/64

EN

Official Journal of the European Union

22.10.2005

six months after

in Annex I, Member States

(8) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant protection
review existing
products containing chlorpyrifos, chlorpyrifos-methyl,
the
mancozeb, maneb or metiram to ensure that
requirements laid down by Directive 91/414/EEC,
in
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary,
existing
authorisations
in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
dossier of each plant protection product
for each
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

replace or withdraw, as appropriate,

(9)

(10)

(11)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Regulation (EEC) No 3600/92 has
shown that difficulties can arise in interpreting the duties
of holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
to a dossier
an authorisation demonstrates
to that
satisfying
Directive. However,
impose
any new obligations on Member States or holders of
authorisations compared to the directives which have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

is

therefore
It
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

They shall apply those provisions from 1 January 2007.

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

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing chlor-
pyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram as
active substances by 31 December 2006. By that date they shall
to that
in particular verify that
Directive
chlorpyrifos-methyl,
to
mancozeb, maneb and metiram are met, with the exception
of those identified in part B of the entries concerning those
active substances, and that
the authorisation
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
Article 13.

the conditions in Annex I

the holder of

chlorpyrifos,

relating

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing chlorpyrifos,
chlorpyrifos-methyl, mancozeb, maneb or metiram 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
30 June 2006 at the latest, Member States shall re-evaluate the
product in accordance with 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 to that Directive and
taking into account part B of the entry in Annex I to that
Directive
chlorpyrifos-methyl,
mancozeb, maneb and metiram respectively. On the basis of
that evaluation,
the product
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
(e) of Directive 91/414/EEC.

they shall determine whether

chlorpyrifos,

concerning

HAS ADOPTED THIS DIRECTIVE:

Following that determination Member States shall:

Article 1

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

(a)

in the case of a product containing chlorpyrifos, chlor-
pyrifos-methyl, mancozeb, maneb or metiram as the only
active substance, where necessary, amend or withdraw the
authorisation by 30 June 2010 at the latest; or

Article 2

Member States shall adopt and publish by 31 December 2006
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

active

substances, where necessary,

(b) in the case of a product containing chlorpyrifos, chlor-
pyrifos-methyl, mancozeb, maneb or metiram as one of
amend or
several
withdraw the authorisation by 30 June 2010 or by the
date fixed for such an amendment or withdrawal
in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

22.10.2005

EN

Official Journal of the European Union

L 279/65

This Directive shall enter into force on 1 July 2006.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 21 October 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 279/66

EN

Official Journal of the European Union

22.10.2005

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