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15.2.2014 Official
Journal
of
the
European
Union
L
45/7
COMMISSION IMPLEMENTING REGULATION (EU) No 144/2014
of 14 February 2014
approving the active substance valifenalate, in accordance with Regulation (EC) No 1107/2009 of
the European Parliament and of the Council concerning the placing of plant protection products on
the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
applicant. The designated rapporteur Member State
submitted a draft assessment report on 19 February
2008. In accordance with Article 11(6) of Commission
Having regard to the Treaty on the Functioning of the European
Regulation (EU) No 188/2011 ( 5 ) additional information
Union,
was requested from the applicant on 18 July 2011. The
evaluation of the additional data by Hungary was
submitted in the format of an updated draft assessment
Having regard to Regulation (EC) No 1107/2009 of the
report in April 2012.
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
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
(4) The
draft
assessment
report
was
reviewed
by
the
Member
thereof,
States and the European Food Safety Authority (here
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion on the pesticide risk
Whereas:
assessment of the active substance valifenalate ( 6 ) on
31 May 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Member States and the Commission within the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
Standing Committee on the Food Chain and Animal
with respect to the procedure and the conditions for
Health and finalised on 13 December 2013 in the
approval, to active substances for which a decision has
format of the Commission review report for valifenalate.
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For valifenalate the
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
(5)
It has appeared from the various examinations made that
2006/586/EC ( 3 ).
plant protection products containing valifenalate may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Directive 91/414/EEC, in particular with regard to the
Hungary received on 2 September 2005 an application
uses which were examined and detailed in the
from Isagro S.p.A. ( 4 ) for the inclusion of the active
Commission review report. It is therefore appropriate
substance valifenalate in Annex I to Directive
to approve valifenalate.
91/414/EEC. Decision 2006/586/EC confirmed that the
dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Directive 91/414/EEC.
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
(3) For
that
active
substance,
the
effects
on
human
and
restrictions. It is, in particular, appropriate to require
animal health and the environment have been assessed,
further confirmatory information.
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
( 1 ) OJ L 309, 24.11.2009, p. 1.
(7) A
reasonable
period
should
be
allowed
to
elapse
before
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
approval in order to permit Member States and the
placing of plant protection products on the market (OJ L 230,
interested parties to prepare themselves to meet the
19.8.1991, p. 1).
new requirements resulting from the approval.
( 3 ) Commission Decision 2006/586/EC of 25 August 2006 recognising
in principle the completeness of the dossier submitted for detailed
examination in view of the possible inclusion of chromafenozide,
( 5 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus
laying down detailed rules for the implementation of Council
— weak strain in Annex I to Council Directive 91/414/EEC (OJ
Directive 91/414/EEC as regards the procedure for the assessment
L 236, 31.8.2006, p. 31).
of active substances which were not on the market 2 years after the
( 4 ) On 17 June 2013, Isagro S.p.A. informed the Commission that the
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
ownership of the active substance was transferred to Belchim Crop
( 6 ) EFSA Journal 2013; 11(6):3253. Available online: www.efsa.europa.
Protection SA/NV.
eu

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L 45/8
EN
Official Journal of the European Union
15.2.2014
(8) Without
prejudice
to
the
obligations
provided
for
in
Article 2
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
Re-evaluation of plant protection products
created by the transition from Directive 91/414/EEC to
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Regulation (EC) No 1107/2009, the following should,
No 1107/2009, where necessary, amend or withdraw existing
however, apply. Member States should be allowed a
authorisations for plant protection products containing valife
period of six months after approval to review authori
nalate as an active substance by 31 December 2014.
sations of plant protection products containing valife
nalate. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
for the submission and assessment of the complete
By that date they shall in particular verify that the conditions in
Annex III dossier, as set out in Directive 91/414/EEC,
Annex I to this Regulation are met, with the exception of those
of each plant protection product for each intended use
identified in the column on specific provisions of that Annex,
in accordance with the uniform principles.
and that the holder of the authorisation has, or has access to, a

dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
(9) The
experience
gained
from
inclusions
in
Annex
I
to 1107/2009.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 ( 1 ) has shown that difficulties can arise in inter
preting the duties of holders of existing authorisations in
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
relation to access to data. In order to avoid further
orised plant protection product containing valifenalate as either
difficulties it therefore appears necessary to clarify the
the only active substance or as one of several active substances,
duties of the Member States, especially the duty to
all of which were listed in the Annex to Implementing Regu
verify that the holder of an authorisation demonstrates
lation (EU) No 540/2011 by 30 June 2014 at the latest,
access to a dossier satisfying the requirements of Annex
Member States shall re-evaluate the product in accordance
II to that Directive. However, this clarification does not
with the uniform principles, as referred to in Article 29(6) of
impose any new obligations on Member States or holders
Regulation (EC) No 1107/2009, on the basis of a dossier
of authorisations compared to the Directives which have
satisfying the requirements of Annex III to Directive
been adopted until now amending Annex I to that
91/414/EEC and taking into account the column on specific
Directive or the Regulations approving active substances.
provisions of Annex I to this Regulation. On the basis of that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 29(1) of Regulation (EC) No
1107/2009.
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
Following that determination Member States shall:
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(a) in the case of a product containing valifenalate as the only
Committee on the Food Chain and Animal Health,
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing valifenalate as one of
several active substances, where necessary, amend or
Article 1
withdraw the authorisation by 31 December 2015 or by
the date fixed for such an amendment or withdrawal in the
Approval of active substance
respective act or acts which added the relevant substance or
substances to Annex I to Directive 91/414/EEC or approved
The active substance valifenalate, as specified in Annex I, is
that substance or those substances, whichever is the latest.
approved subject to the conditions laid down in that Annex.
( 1 ) Commission Regulation (EEC) No 3600/92 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
Article 3
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
Amendments to Implementing Regulation (EU) No
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
540/2011
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
The Annex to Implementing Regulation (EU) No 540/2011 is
approved active substances (OJ L 153, 11.6.2011, p. 1).
amended in accordance with Annex II to this Regulation.

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EN
15.2.2014 Official
Journal
of
the
European
Union
L
45/9
Article 4
Entry into force and date of application
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 July 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 February 2014.
For the Commission
The President
José Manuel BARROSO

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L 45/10
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Valifenalate
Methyl N-(isopropoxycarbonyl)-L-valyl-
≥ 980 g/kg 1
July
2014 30
June
2024 For
the
implementation
of
the
uniform
prin
CAS No 283159-90-0
(3RS)-3-(4-chlorophenyl)-β-alaninate
ciples as referred to in Article 29(6) of Regu
EN
lation (EC) No 1107/2009, the conclusions of
CIPAC No 857

the review report on valifenalate, and in
particular Appendices I and II thereof, as
finalised in the Standing Committee on the
Food Chain and Animal Health on 13 December
2013 shall be taken into account.
In this overall assessment Member States shall
pay particular attention to the risk to aquatic
organisms.
Conditions of use shall include risk mitigation
Off
measures, where appropriate.
icial
The applicant shall submit confirmatory
information as regards the potential of meta
Jour
bolite S5 to contaminate groundwater.
nal
The notifier shall submit to the Commission, the
of
Member States and the Authority the relevant
the
information by 30 June 2016.
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
15.2.2014

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15.2.2014 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘70 Valifenalate
Methyl N-(isopropoxycarbonyl)-L-valyl-
≥ 980 g/kg 1
July
2014 30
June
2024
For the implementation of the uniform prin

(3RS)-3-(4-chlorophenyl)-β-alaninate
ciples as referred to in Article 29(6) of Regu
CAS No 283159-90-0
lation (EC) No 1107/2009, the conclusions of
CIPAC No 857
the review report on valifenalate, and in
particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food
Chain and Animal Health on 13 December
2013 shall be taken into account.
In this overall assessment Member States shall
pay particular attention to the risk to aquatic
organisms.
icial
Conditions of use shall include risk mitigation
measures, where appropriate.
Jour
The applicant shall submit confirmatory
nal
information as regards the potential of meta
bolite S5 to contaminate groundwater.
of
the
The notifier shall submit to the Commission, the
Member States and the Authority the relevant
European
information by 30 June 2016.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
L
45/11

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