Commission Directive 2006/16/EC of  7 February 2006  amending Council Directive 91/414/EEC to include oxamyl as active substance   (Text with EEA relevance)
Date: 2006-02-07
Institutions: European Commission
Subjects: health control, health risk, market approval, pesticide, plant health legislation, plant health product

8.2.2006

EN

Official Journal of the European Union

L 36/37

COMMISSION DIRECTIVE 2006/16/EC

of 7 February 2006

amending Council Directive 91/414/EEC to include oxamyl as active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Health and finalised on 15 July 2005 in the format of
the Commission review report for oxamyl.

Having regard to the Treaty
Community,

establishing the European

(4)

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:

(b)

and

It has appeared from the various examinations made that
plant protection products containing oxamyl may be
the requirements laid
in general,
expected to satisfy,
down
of Directive
5(1)(a)
in Article
91/414/EEC,
in particular with regard to the uses
which were examined and detailed in the Commission
is therefore appropriate to include
review report.
oxamyl
in all
in order
Member States the authorisations of plant protection
can be
products
this
that
granted in accordance with the provisions of
Directive.

to ensure that

in Annex I,

containing

substance

active

It

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3)
lay down the detailed rules for the
implementation of the second stage of the programme
of work referred to in Article 8(2) of Directive
91/414/EEC and establish a list of active substances to
be assessed, with a view to their possible inclusion in
includes
Annex I
oxamyl.

to Directive 91/414/EEC. That

list

(5) 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
oxamyl should be subjected to further testing for confir-
mation of the risk assessment for some issues and that
such studies should be presented by the notifier.

For oxamyl, the effects on human health and the envir-
onment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
Rapporteur Member States which have to submit the
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
oxamyl the Rapporteur Member State was Ireland and all
relevant information was submitted on 25 August 2003.

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on 14
January 2005 in the format of
the EFSA Scientific
Report for oxamyl (4). This report has been reviewed by
the Member States and the Commission within the
Standing Committee on the Food Chain and Animal

(6)

(7)

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2006/6/EC (OJ L 12, 18.1.2006, p. 21).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.
(4) EFSA Scientific Report (2005) 26, 1-78, Conclusion on the peer
the active substance

the pesticide risk assessment of

review of
Oxamyl (finalised: 14 January 2005).

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 (5) has shown that difficulties can arise in inter-
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further diffi-
culties it therefore appears necessary to clarify the duties
of the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that
Directive. However, this clarification does not impose any
new obligations on Member States or holders of author-
isations compared to the directives which have been
adopted until now amending Annex I.

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

(5) 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. 27).

(1)

(2)

(3)

L 36/38

EN

Official Journal of the European Union

8.2.2006

to

ensure

containing

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
the
products
oxamyl
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
existing
vary,
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
for each
dossier of each plant protection product
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

replace or withdraw, as appropriate,

that

(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.

Article 2

Member States shall adopt and publish, by 31 January 2007 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.

By that date, they shall in particular verify that the conditions in
Annex I to that Directive relating to oxamyl are met, with the
exception of those identified in part B of the entry concerning
that active substance, 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 of that Directive.

the

latest, Member States

2.
By derogation from paragraph 1, for each authorised plant
protection product containing oxamyl 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 July
2006 at
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 oxamyl. On the basis of that evaluation,
they shall determine whether the product satisfies the conditions
set out
(d) and (e) of Directive
(c),
91/414/EEC.

in Article 4(1)(b),

re-evaluate

shall

Following that determination Member States shall:

(a)

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

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

Article 4

This Directive shall enter into force on 1 August 2006.

They shall apply those provisions from 1 February 2007.

Article 5

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

This Directive is addressed to the Member States.

Done at Brussels, 7 February 2006.

shall

States

in accordance with Directive
1. Member
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
oxamyl as an active substance by 31 January 2007.

protection

products

plant

for

For the Commission

Markos KYPRIANOU

Member of the Commission

8.2.2006

EN

Official Journal of the European Union

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