HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 312/18
EN
Official Journal of the European Union
21.11.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1175/2013
of 20 November 2013
approving the active substance benalaxyl-M, 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,
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 21 November
Having regard to the Treaty on the Functioning of the European
2003. This draft assessment report was reviewed by the
Union,
Member States and the European Food Safety Authority
(hereinafter ‘the Authority’). The Authority presented to
the Commission its conclusion ( 4 ) on the pesticide risk
Having regard to Regulation (EC) No 1107/2009 of the
assessment of the active substance benalaxyl-M on
European Parliament and of the Council of 21 October 2009
28 July 2007.
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)
thereof,
(4) In
its
conclusion,
the
Authority
did
not
take
into
account
all information submitted by the applicant and assessed
by the designated rapporteur Member State before that
date. The Commission requested the Authority to revise
Whereas:
its conclusion and to take into account all information
submitted.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
(5) The
designated
rapporteur
Member
State
assessed
all
approval, to active substances for which a decision has
information submitted by the applicant and submitted
been adopted in accordance with Article 6(3) of that
an Addendum to the draft assessment report on
Directive before 14 June 2011. For benalaxyl-M the
16 April 2012.
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
2003/35/EC ( 3 ).
(6) The
Addendum
to
the
draft
assessment
report
was
reviewed by the Member States and the Authority. The
Authority presented to the Commission a first version of
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
its conclusion ( 5 ) on the pesticide risk assessment of the
Portugal received on 22 February 2002 an application
active substance benalaxyl-M on 21 March 2013 and an
from Isagro SpA for the inclusion of the active substance
amended version on 25 March 2013. The updated draft
benalaxyl-M in Annex I to Directive 91/414/EEC.
assessment report and the conclusion of the Authority
Decision 2003/35/EC confirmed that the dossier was
were reviewed by the Member States and the
‘complete’ in the sense that it could be considered as
Commission within the Standing Committee on the
satisfying, in principle, the data and information
Food Chain and Animal Health and finalised on
requirements of Annexes II and III to Directive
3 October 2013 in the format of the Commission
91/414/EEC.
review report for benalaxyl-M.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
(7)
It has appeared from the various examinations made that
plant protection products containing benalaxyl-M may be
expected to satisfy, in general, the requirements laid
( 1 ) OJ L 309, 24.11.2009, p. 1.
down in Article 5(1)(a) and (b) and Article 5(3) of
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
Directive 91/414/EEC, in particular with regard to the
19.8.1991, p. 1).
uses which were examined and detailed in the
( 3 ) Commission Decision 2003/35/EC of 10 January 2003 recognising
Commission review report. It is therefore appropriate
in principle the completeness of the dossiers submitted for detailed
to approve benalaxyl-M.
examination in view of the possible inclusion of benalaxyl-M,
benthiavalicarb, 1-methylcyclopropene, prothioconazole and fluox
astrobin in Annex I to Council Directive 91/414/EEC concerning
( 4 ) EFSA Scientific Report (2007) 108, 1-86.
the placing of plant-protection products on the market (OJ L 11,
( 5 ) EFSA Journal 2013; 11(1):3052. Available online: www.efsa.europa.
16.1.2003, p. 52).
eu

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EN
21.11.2013 Official
Journal
of
the
European
Union L
312/19
(8) A
reasonable
period
should
be
allowed
to
elapse
before
Article 2
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
Re-evaluation of plant protection products
new requirements resulting from the approval.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
(9) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
benalaxyl-M as an active substance by 31 October 2014.
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
By that date they shall in particular verify that the conditions in
period of six months after approval to review authori
Annex I to this Regulation are met, with the exception of those
sations of plant protection products containing
identified in the column on specific provisions of that Annex,
benalaxyl-M. Member States should, as appropriate,
and that the holder of the authorisation has, or has access to, a
vary, replace or withdraw authorisations. By way of dero
dossier satisfying the requirements of Annex II to Directive
gation from that deadline, a longer period should be
91/414/EEC in accordance with the conditions of Article 13(1)
provided for the submission and assessment of the
to (4) of that Directive and Article 62 of Regulation (EC) No
complete Annex III dossier, as set out in Directive
1107/2009.
91/414/EEC, of each plant protection product for each
intended use in accordance with the uniform principles.
2. By way of derogation from paragraph 1, for each auth
(10) The
experience
gained
from
inclusions
in
Annex
I
to
orised plant protection product containing benalaxyl-M as either
Directive 91/414/EEC of active substances assessed in
the only active substance or as one of several active substances,
the framework of Commission Regulation (EEC) No
all of which were listed in the Annex to Implementing Regu
3600/92 ( 1 ) has shown that difficulties can arise in inter
lation (EU) No 540/2011 by 30 April 2014 at the latest,
preting the duties of holders of existing authorisations in
Member States shall re-evaluate the product in accordance
relation to access to data. In order to avoid further
with the uniform principles, as referred to in Article 29(6) of
difficulties it therefore appears necessary to clarify the
Regulation (EC) No 1107/2009, on the basis of a dossier
duties of the Member States, especially the duty to
satisfying the requirements of Annex III to Directive
verify that the holder of an authorisation demonstrates
91/414/EEC and taking into account the column on specific
access to a dossier satisfying the requirements of Annex
provisions of Annex I to this Regulation. On the basis of that
II to that Directive. However, this clarification does not
evaluation, they shall determine whether the product satisfies
impose any new obligations on Member States or holders
the conditions set out in Article 29(1) of Regulation (EC) No
of authorisations compared to the Directives which have
1107/2009.
been adopted until now amending Annex I to that
Directive or the Regulations approving active substances.
(11) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
Following that determination Member States shall:
1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(a) in the case of a product containing benalaxyl-M as the only
active substance, where necessary, amend or withdraw the
(12) The
measures
provided
for
in
this
Regulation
are
in
authorisation by 31 October 2015 at the latest; or
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing benalaxyl-M as one of
HAS ADOPTED THIS REGULATION:
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
Article 1
the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant
Approval of active substance
substance or substances to Annex I to Directive 91/414/EEC
The active substance benalaxyl-M, as specified in Annex I, is
or approved that substance or those substances, whichever
approved subject to the conditions laid down in that Annex.
is the latest.
( 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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L 312/20
EN
Official Journal of the European Union
21.11.2013
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 May 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 November 2013.
For the Commission
The President
José Manuel BARROSO

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21.11.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Benalaxyl-M
Methyl N-(phenylacetyl)-N-(2,6-
≥ 950 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred to in
xylyl)-D-alaninate
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
EN
CAS No 98243-83-5
the review report on benalaxyl-M, and in particular Appendices I

CIPAC No 766
and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 3 October 2013 shall be taken into
account.
In this overall assessment Member States shall pay particular
attention to:
— the protection of workers at re-entry,
— the risk to groundwater from the metabolites BM-M2 (N-
(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-
(2,6-xylyl)-D-alanine), when the substance is applied in regions
icial
with vulnerable soil and/or climatic conditions.
Conditions of use shall include risk mitigation measures, where
Jour
appropriate.
nal
of
(1 ) Further details on identity and specification of active substance are provided in the review report.
the
European
Union
L
312/21

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L 312/22
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
‘58 Benalaxyl-M
Methyl N-(phenylacetyl)-
≥ 950 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred

N-(2,6-xylyl)-D-alaninate
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 98243-83-5
conclusions of the review report on benalaxyl-M, and in
CIPAC No 766
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 3 October 2013 shall be taken into account.
In this overall assessment Member States shall pay particular
attention to:
— the protection of workers at re-entry,
Off
— the risk to groundwater from the metabolites BM-M2
(N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3
icial
(N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance
Jour
is applied in regions with vulnerable soil and/or climatic
conditions.
nal
Conditions of use shall include risk mitigation measures,
of
where appropriate.’
the
European
(*) Further details on identity and specification of active substance are provided in the review report.
Union
21.11.2013

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