HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 44/40
EN
Official Journal of the European Union
14.2.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 141/2014
of 13 February 2014
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance plant oils/clove oil
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
view on the draft review report for plant oils/clove oil ( 6 )
on 16 December 2011. The Authority communicated its
view on plant oils/clove oil to the notifier. The
Commission invited the notifier to submit comments
on the draft review report for plant oils/clove oil. The
Having regard to the Treaty on the Functioning of the European
draft review report and the view of the Authority were
Union,
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and the draft review report was finalised
on 13 December 2013 in the format of the Commission
review report for plant oils/clove oil.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
(3)
It is confirmed that the active substance plant oils/clove
91/414/EEC ( 1 ), and in particular Article 13(2)(c) and
oil is to be deemed to have been approved under Regu
Article 78(2) thereof,
lation (EC) No 1107/2009.
(4) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Whereas:
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
is necessary to amend the conditions of approval. It is, in
particular, appropriate to require further confirmatory
information.
(1) The
active
substance
plant
oils/clove
oil
was
included
in
Annex I to Council Directive 91/414/EEC
( 2 ) by
Commission Directive 2008/127/EC ( 3 ) in accordance
with the procedure provided for in Article 24b of
(5) The
Annex
to
Implementing
Regulation
(EU)
No
Commission Regulation (EC) No 2229/2004 ( 4 ). Since
540/2011 should therefore be amended accordingly.
the replacement of Directive 91/414/EEC by Regulation
(EC) No 1107/2009, this substance is deemed to have
been approved under that Regulation and is listed in Part
A of the Annex to Commission Implementing Regulation
(6) Member
States
should
be
provided
with
time
to
amend
(EU) No 540/2011 ( 5 ).
or withdraw authorisations for plant protection products
containing plant oils/clove oil.
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No (7) For plant protection products containing plant oils/clove
2229/2004, the European Food Safety Authority, here
oil, where Member States grant any grace period in
inafter ‘the Authority’, presented to the Commission its
accordance with Article 46 of Regulation (EC) No
1107/2009, this period should expire at the latest
( 1 ) OJ L 309, 24.11.2009, p. 1.
eighteen months after the date of entry into force of
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
the regulation.
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
( 3 ) Commission Directive 2008/127/EC of 18 December 2008
amending Council Directive 91/414/EEC to include several active
substances (OJ L 344, 20.12.2008, p. 89).
(8) The
measures
provided
for
in
this
Regulation
are
in
( 4 ) Commission Regulation (EC) No 2229/2004 of 3 December 2004
accordance with the opinion of the Standing
laying down further detailed rules for the implementation of the
Committee on the Food Chain and Animal Health,
fourth stage of the programme of work referred to in Article 8(2)
of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p. 13).
( 5 ) Commission Implementing Regulation (EU) No 540/2011 of
( 6 ) Conclusion on the peer review of the pesticide risk assessment of the
25 May 2011 implementing Regulation (EC) No 1107/2009 of
active substance plant oils/clove oil. EFSA Journal 2012;10(1):2506.
the European Parliament and of the Council as regards the list of
[43 pp.] doi:10.2903/j.efsa.2012.2506. Available online: www.efsa.
approved active substances (OJ L 153, 11.6.2011, p. 1).
europa.eu/efsajournal

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EN
14.2.2014 Official
Journal
of
the
European
Union L
44/41
HAS ADOPTED THIS REGULATION:
authorisations for plant protection products containing plant
oils/clove oil as active substance by 6 September 2014.
Article 1
Amendment to Implementing Regulation (EU) No
Article 3
540/2011
Grace period
Part A of the Annex to Implementing Regulation (EU) No
Any grace period granted by Member States in accordance with
540/2011 is amended in accordance with the Annex to this
Article 46 of Regulation (EC) No 1107/2009 shall be as short
Regulation.
as possible and shall expire on 6 September 2015 at the latest.
Article 2
Article 4
Transitional measures
This Regulation shall enter into force on the twentieth day
Member States shall in accordance with Regulation (EC)
following that of its publication in the Official Journal of the
No 1107/2009, where necessary, amend or withdraw existing
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 February 2014.
For the Commission
The President
José Manuel BARROSO

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L 44/42
ANNEX
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 241 on the active substance plant oils/clove oil is replaced by the following:
Number
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
EN

‘241 Plant
oils/clove
oil Clove Oil is a complex ≥ 800 g/kg
1 September 2009 31
August
2019 PART
A
mixture of chemical
CAS No 84961-50-2 substances.
Relevant impurity:
Only indoor uses as post-harvest fungicide and bactericide may be auth
(clove oil)
methyl eugenol
orised.
The main component maximum 0,1 % of
97-53-0 (Eugenol — is eugenol.
the technical material
PART B
main component)
For the implementation of the uniform principles as referred to in
CIPAC No 906
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the review report on clove oil (SANCO/2622/2008) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on
Off
the Food Chain and Animal Health shall be taken into account.
icial
In this overall assessment Member States shall pay particular attention to
Jour
the protection of operators and workers ensuring that conditions of use
include the application of adequate personal protective equipment, where
nal
appropriate.
of
the
The notifier shall submit confirmatory information as regards
European
(a) the technical specification;
(b) data comparing natural background exposure situations of plant
oils/clove oil, eugenol and methyl eugenol in relation to exposure
Union
from the use of plant oils/clove oil as a plant protection product.
This data shall cover human exposure.
The notifier shall submit to the Commission, the Member States and the
Authority that information by 30 April 2016.’
14.2.2014

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Document Outline

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