Commission Directive 2005/57/EC of 21 September 2005 amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances   (Text with EEA relevance)
Date: 2005-09-21
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product

L 246/14

EN

Official Journal of the European Union

22.9.2005

COMMISSION DIRECTIVE 2005/57/EC

of 21 September 2005

amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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:

It has appeared from the various examinations made that
plant protection products containing MCPA or MCPB
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 examined and detailed in the Commission
review reports. 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.

(1)

(2)

(3)

(4)

3600/92

Regulation

(EEC) No

Commission
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 MCPA and MCPB.

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 1994 laying down the active substances of
plant protection products and designating the rapporteur
Member State for
the implementation of Regulation
(EEC) No 3600/92 (3), Italy was designated as rapporteur
Member State. On 5 April 2001 and 19 December 2001
Italy submitted the relevant assessment
reports and
recommendations
to the Commission in accordance
with Article 7(1)(c) of Regulation (EEC) No 3600/92.

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 15 April 2005 in
the format of the Commission review reports for MCPA
and MCPB.

The reviews of MCPA and MCPB did not reveal any open
question to be addressed by the Scientific Committee on
Plants or the European Food Safety Authority (EFSA)
which has taken over the role of the latter.

(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).

(6)

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

a

six months after

in Annex I, Member States

(7) Without prejudice to the obligations defined by Directive
including an active
consequence of
91/414 as
should be
substance
inclusion to
allowed a period of
review existing
authorisations of plant protection
products containing MCPA or MCPB to ensure that the
in
requirements laid down by Directive 91/414/EEC,
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary,
existing
in accordance with the provisions of
authorisations
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,

(8)

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

22.9.2005

EN

Official Journal of the European Union

L 246/15

(9)

(10)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

By derogation from paragraph 1, for each authorised plant
2.
protection product containing MCPA or MCPB 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 April 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 concerning MCPA and MCPB respectively. On the
basis of
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

that evaluation,

Article 2

Following that determination Member States shall:

Member States shall adopt and publish by 31 October 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.

They shall apply those provisions from 1 November 2006.

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.

(a)

in the case of a product containing MCPA or MCPB as the
only active substance, where necessary, amend or withdraw
the authorisation by 30 April 2010 at the latest; or

(b) in the case of a product containing MCPA or MCPB as one
of several active substances, where necessary, amend or
withdraw the authorisation by 30 April 2010 or by the
in the
date fixed for such an amendment or withdrawal
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

Article 4

Article 3

This Directive shall enter into force on 1 May 2006.

shall

States

they shall

in accordance with Directive
1. Member
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing MCPA
or MCPB as active substances by 31 October 2006. By that
the conditions in
in particular verify that
date,
Annex I to that Directive relating to MCPA and MCPB respec-
tively are met, with the exception of those identified in part B of
the entry concerning those active substances, and that
the
holder of 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.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 21 September 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 246/16

EN

Official Journal of the European Union

22.9.2005

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