2008/967/EC: Commission Decision of 12 December 2008 concerning the non-inclusion of carbon monoxide in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2008) 8077) (Text with EEA relevance)
Date: 2008-12-12
Institutions: European Commission
Subjects: health legislation, market approval, marketing standard, pharmaceutical product, plant health product, toxic substance

20.12.2008

EN

Official Journal of the European Union

L 344/121

COMMISSION DECISION

of 12 December 2008

concerning the non-inclusion of carbon monoxide in Annex I to Council Directive 91/414/EEC and
the withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2008) 8077)

(Text with EEA relevance)

(2008/967/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

lation (EC) No 2229/2004. For carbon monoxide the
rapporteur Member State was Italy and all relevant infor­
mation was submitted in November 2007.

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
fourth subparagraph of
Article 8(2) thereof,

the

Whereas:

(1)

(2)

(3)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
that Directive, authorise
following the notification of
the placing on the market of plant protection products
containing active substances not listed in Annex I to that
Directive that are already on the market two years after
the date of notification, while those substances are
gradually being examined within the framework of a
programme of work.

Commission Regulations (EC) No 1112/2002 (2) and (EC)
No 2229/2004 (3) lay down the detailed rules for the
implementation of the fourth 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
Annex I
includes
carbon monoxide.

to Directive 91/414/EEC. That

list

laid down in Regulations

For carbon monoxide the effects on human health and
the environment have been assessed in accordance with
(EC) No
the provisions
1112/2002 and (EC) No 2229/2004 for a range of
uses proposed by the notifier. Moreover, those Regu­
lations designate the rapporteur Member States which
reports and
have to submit
Safety
recommendations
Authority (EFSA) in accordance with Article 20 of Regu­

the relevant assessment

European

Food

the

to

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 168, 27.6.2002, p. 14.
(3) OJ L 379, 24.12.2004, p. 13.

(4)

(5)

(6)

(7)

(8)

examined

carbon monoxide

The Commission
in
accordance with Article 24a of Regulation (EC) No
2229/2004. A draft review report
for that substance
was reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and finalised on 26 September 2008 in
the format of the Commission review report.

During the examination of this active substance by the
Committee, taking into account comments received from
Member States,
there are clear
it was concluded that
indications that it may be expected that it has harmful
effects on human health and in particular the crucial
missing data does not allow to set a reliable and
(AOEL) and such
acceptable operator exposure level
value is necessary to conduct
the risk assessment.
Moreover, other concerns which were identified by the
rapporteur Member States in its assessment report are
included in the review report for the substance.

to submit

arguments put

The Commission invited the notifier
its
comments on the results of the examination of carbon
monoxide and on its intention or not to further support
the substance. The notifier
submitted its comments
which have been carefully examined. However, despite
the notifier,
the
the
and
eliminated,
identified could not be
concerns
the information
assessments made on the basis of
submitted have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing carbon monoxide
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

forwards by

requirements

Carbon monoxide should therefore not be included in
Annex I to Directive 91/414/EEC.

Measures should be taken to ensure that authorisations
granted for plant protection products containing carbon
monoxide are withdrawn within a fixed period of time
and are not renewed and that no new authorisations for
such products are granted.

L 344/122

EN

Official Journal of the European Union

20.12.2008

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

carbon monoxide are withdrawn by 12 June 2009;

(b) no authorisations for plant protection products containing
carbon monoxide are granted or renewed from the date of
publication of this Decision.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be as short as possible and shall expire on 12 June
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 12 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(9)

(10)

(11)

Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
carbon monoxide should be limited to 12 months in
order to allow existing stocks to be used in one further
growing season, which ensures that plant protection
products containing carbon monoxide remain available
for 18 months from the adoption of this Decision.

This Decision does not prejudice the submission of an
application for carbon monoxide in accordance with
Article 6(2) of Directive 91/414/EEC and Commission
Regulation (EC) No 33/2008 of 17 January 2008
application of
laying down detailed rules
Council Directive 91/414/EEC as regards a regular and
an accelerated procedure for the assessment of active
substances which were part of the programme of work
referred to in Article 8(2) of that Directive but have not
been included into its Annex I (1), in view of a possible
inclusion in its Annex I.

the

for

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

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Carbon monoxide shall not be included as an active substance
in Annex I to Directive 91/414/EEC.

(1) OJ L 15, 18.1.2008, p. 5.