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7.7.2012 Official
Journal
of
the
European
Union L
177/19
COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012
of 6 July 2012
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
2 December 2011 and for plant oils/spearmint oil ( 8 ) on
16 December 2011. The draft review reports and the
views of the Authority were reviewed by the Member
States and the Commission within the Standing
Having regard to the Treaty on the Functioning of the European
Committee on the Food Chain and Animal Health and
Union,
finalised on 1 June 2012 in the format of the
Commission review reports for denathonium benzoate,
methyl nonyl ketone and plant oils/spearmint 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
(3) The
Authority
communicated
its
views
on
denathonium
market and repealing Council Directives 79/117/EEC and
benzoate, methyl nonyl ketone and plant oils/spearmint
91/414/EEC (
oil to the notifiers, and the Commission invited them to

1 ), and in particular Article 13(2)(c) thereof,
submit comments on the review reports.
Whereas:
(4)
It is confirmed that the active substances denathonium
benzoate, methyl nonyl ketone and plant oils/spearmint
oil are to be deemed to have been approved under
Regulation (EC) No 1107/2009.
(1) The
active
substances
denathonium
benzoate,
methyl
nonyl ketone and plant oils/spearmint oil were included
in Annex I to Council Directive 91/414/EEC ( 2 ) by
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Commission Directive 2008/127/EC ( 3 ) in accordance
1107/2009 in conjunction with Article 6 thereof and in
with the procedure provided for in Article 24b of
the light of current scientific and technical knowledge, it
Commission Regulation (EC) No 2229/2004 of
is necessary to amend the conditions of approval of
3 December 2004 laying down further detailed rules
denathonium benzoate, methyl nonyl ketone and plant
for the implementation of the fourth stage of the
oils/spearmint oil. It is, in particular, appropriate to
programme of work referred to in Article 8(2) of
require further confirmatory information as regards
Council Directive 91/414/EEC ( 4 ). Since the replacement
methyl nonyl ketone. The use of plant oils/spearmint
of Directive 91/414/EEC by Regulation (EC) No
oil should be restricted to postharvest treatment of
1107/2009, these substances are deemed to have been
potatoes.
approved under that Regulation and are listed in Part A
of the Annex to Commission Implementing Regulation
(EU) No 540/2011 of 25 May 2011 implementing
(6) A
reasonable
period
of
time
should
be
allowed
before
the
Regulation (EC) No 1107/2009 of the European
application of this Regulation in order to allow Member
Parliament and of the Council as regards the list of
States, notifiers and holders of authorisations for plant
approved active substances ( 5 ).
protection products to meet the requirements resulting
from amendment to the conditions of the approval.
(2) In
accordance
with Article 25a of Regulation (7) The
measures
provided
for
in
this
Regulation
are
(EC) No 2229/2004, the European Food Safety
in accordance with the opinion of the Standing
Authority, hereinafter ‘the Authority’, presented to the
Committee on the Food Chain and Animal Health,
Commission its views on the draft review reports for
denathonium benzoate ( 6 ), methyl nonyl ketone ( 7 ) on
HAS ADOPTED THIS REGULATION:
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 344, 20.12.2008, p. 89.
Article 1
( 4 ) OJ L 379, 24.12.2004, p. 13.
( 5 ) OJ L 153, 11.6.2011, p. 1.
Part A of the Annex to Implementing Regulation (EU) No
( 6 ) Conclusion on the peer review of the pesticide risk assessment of
540/2011 is amended in accordance with the Annex to this
the active substance denatonium benzoate, EFSA Journal
Regulation.
2012;10(1):2483. Available online: www.efsa.europa.eu/efsajournal.
htm
( 7 ) Conclusion on the peer review of the pesticide risk assessment of
( 8 ) Conclusion on the peer review of the pesticide risk assessment of
the active substance methyl nonyl ketone, EFSA Journal
the active substance plant oils/spearmint oil, EFSA Journal
2012;10(1):2495. Available online: www.efsa.europa.eu/efsajournal.
2012;10(1):2541.Available online: www.efsa.europa.eu/efsajournal.
htm
htm

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L 177/20
EN
Official Journal of the European Union
7.7.2012
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 July 2012.
For the Commission
The President
José Manuel BARROSO

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7.7.2012 Off
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Row 226 on the active substance denathonium benzoate is replaced by the following
EN
Number
Common Name,

Identification Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
'226 Denathonium Benzyldiethyl[[2,6- ≥ 975g/kg 1
September
31 August
PART A
benzoate
xylylcarbamoyl]
2009
2019
methyl]ammonium
Only uses as repellent may be authorised.
CAS No 3734-33-6 benzoate
PART B
CIPAC No 845
In assessing applications to authorise plant protection products containing denathonium
benzoate for uses other than brushing with automatic rolling equipment in forestry,
Member States shall pay particular attention to the criteria in Article 4(3) of Regulation
(EC) No 1107/2009, and shall ensure that any necessary data and information is
icial
provided before such an authorisation is granted.
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium
benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised
of
in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall
the
be taken into account.
European
In this overall assessment Member States must pay particular attention to the protection
of the operators. Authorised conditions of use must prescribe the application of adequate
personal protective equipment.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.'
(*) Further details on identity and specification of active substance are provided in their review report.
(2) Row 238 on the active substance methyl nonyl ketone is replaced by the following:
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
'238 Methyl
nonyl
ketone
Undecan-2-one
≥ 975g/kg 1
September
31 August
PART A
2009
2019
CAS No 112-12-9
Only uses as repellent may be authorised.
CIPAC No 846
PART B
L
For the implementation of the uniform principles as referred to in Article 29(6) of
177/21
Regulation (EC) No 1107/2009, the conclusions of the review report on methyl
nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof,

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L 177/22
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June
2012 shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures. Contact
with food and feedcrops shall be avoided.
EN
The notifier shall submit confirmatory information as regards:

(a) the specification of the material tested in the mammalian toxicology and ecot
oxicology studies;
(b) the specification with suporting batch data and validated methods of analysis;
(c) an appropriate assessment of the fate and behaviour of methyl nonyl ketone and
potential transformation products in the environment;
(d) the risk to aquatic and to soil living organisms.
Off
The notifier shall submit to the Commission, the Member States and the Authority the
information set out in points (a) and (b) by 30 April 2013 and the information set out
icial
in points (c) and (d) by 31 December 2015.'
Jour
(*) Further details on identity and specification of active substance are provided in their review report.
nal
of
the
(3) Row 243 on the active substance plant oils/spearmint oil is replaced by the following:
European
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
'243 Plant
oils/spear
mint
Spearmint oil
≥ 550 g/kg as
1 September
31 August
PART A
Union
oil
(R)-Carvone
2009
2019
Only uses as plant growth regulator for postharvest treatment of potatoes may be
CAS No 8008-79-5
authorised.
CIPAC No 908
Member States shall ensure that authorisations provide that hot fogging is performed
exclusively in professional storage facilities and that the best available techniques are
applied to exclude the release into the environment of the product (fogging mist) during
storage, transport, waste disposal and application.
PART B
For the implementation of the uniform principles, as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant
oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on 1 June
2012 shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.'
7.7.2012
(*) Further details on identity and specification of active substance are provided in their review report.

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