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19.2.2014 Official
Journal
of
the
European
Union
L
48/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 151/2014
of 18 February 2014
approving the active substance S-abscisic acid, 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,
2011/253/EU confirmed that the dossier was ‘complete’
in the sense that it could be considered as satisfying, in
principle, the data and information requirements of
Having regard to the Treaty on the Functioning of the European
Annexes II and III to Directive 91/414/EEC.
Union,
(3) For
that
active
substance,
the
effects
on
human
and
Having regard to Regulation (EC) No 1107/2009 of the
animal health and the environment have been assessed,
European Parliament and of the Council of 21 October 2009
in accordance with the provisions of Article 6(2) and (4)
concerning the placing of plant protection products on the
of Directive 91/414/EEC, for the uses proposed by the
market and repealing Council Directives 79/117/EEC and
applicant. The designated rapporteur Member State
91/414/EEC (
submitted a draft assessment report on 21 May 2012.

1 ), and in particular Articles 13(2) and 78(2)
thereof,
(4) The
draft
assessment
report
was
reviewed
by
the
Member
States and the European Food Safety Authority (here
Whereas:
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion ( 4 ) on the pesticide risk
assessment of the active substance S-abscisic acid on
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
23 July 2013. The draft assessment report and the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
conclusion of the Authority were reviewed by the
with respect to the procedure and the conditions for
Member States and the Commission within the
approval, to active substances for which a decision has
Standing Committee on the Food Chain and Animal
been adopted in accordance with Article 6(3) of that
Health and finalised on 13 December 2013 in the
Directive before 14 June 2011. For S-abscisic acid the
format of the Commission review report for S-abscisic
conditions of Article 80(1)(a) of Regulation (EC) No
acid.
1107/2009 are fulfilled by Commission Implementing
Decision 2011/253/EU ( 3 ).
(5)
It has appeared from the various examinations made that
plant protection products containing S-abscisic acid may
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
be expected to satisfy, in general, the requirements laid
the Netherlands received on 9 December 2010 an appli
down in Article 5(1)(a) and (b) and Article 5(3) of
cation from Sumitomo Chemical Agro Europe SAS for
Directive 91/414/EEC, in particular with regard to the
the inclusion of the active substance S-abscisic acid in
uses which were examined and detailed in the
Annex I to Directive 91/414/EEC. Implementing Decision
Commission review report. It is therefore appropriate
to approve S-abscisic acid.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
1107/2009 in conjunction with Article 6 thereof and in
( 3 ) Commission Implementing Decision 2011/253/EU of 26 April
the light of current scientific and technical knowledge, it
2011 recognising in principle the completeness of the dossier
is, however, necessary to include certain conditions and
submitted for detailed examination in view of the possible
restrictions.
inclusion of metobromuron, S-Abscisic acid, Bacillus amyloliquefaciens
subsp. plantarum D747, Bacillus pumilus QST 2808 and Streptomyces
lydicus WYEC 108 in Annex I to Council Directive 91/414/EEC (OJ
( 4 ) EFSA Journal 2013; 11(8):3341. Available online: www.efsa.
L 106, 27.4.2011, p. 13).
europa.eu

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L 48/2
EN
Official Journal of the European Union
19.2.2014
(7) A
reasonable
period
should
be
allowed
to
elapse
before HAS ADOPTED THIS REGULATION:
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
Article 1
Approval of active substance
The active substance S-abscisic acid, as specified in Annex I, is
(8) Without
prejudice
to
the
obligations
provided
for
in approved subject to the conditions laid down in that Annex.
Regulation (EC) No 1107/2009 as a consequence of
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,
Article 2
however, apply. Member States should be allowed a
Re-evaluation of plant protection products
period of six months after approval to review authori
sations of plant protection products containing S-abscisic
1. Member
States
shall
in
accordance
with
Regulation
(EC)
acid. Member States should, as appropriate, vary, replace
No 1107/2009, where necessary, amend or withdraw existing
or withdraw authorisations. By way of derogation from
authorisations for plant protection products containing S-
that deadline, a longer period should be provided for the
abscisic acid as an active substance by 31 December 2014.
submission and assessment of the complete Annex III
dossier, as set out in Directive 91/414/EEC, of each
plant protection product for each intended use in
accordance with the uniform principles.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
(9) The
experience
gained
from
inclusions
in
Annex
I
to 91/414/EEC in accordance with the conditions of Article 13(1)
Directive 91/414/EEC of active substances assessed in
to (4) of that Directive and Article 62 of Regulation (EC) No
the framework of Commission Regulation (EEC) No
1107/2009.
3600/92 ( 1 ) has shown that difficulties can arise in inter
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further
difficulties it therefore appears necessary to clarify the
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
duties of the Member States, especially the duty to
orised plant protection product containing S-abscisic acid as
verify that the holder of an authorisation demonstrates
either the only active substance or as one of several active
access to a dossier satisfying the requirements of Annex
substances, all of which were listed in the Annex to Imple
II to that Directive. However, this clarification does not
menting Regulation (EU) No 540/2011 by 30 June 2014 at
impose any new obligations on Member States or holders
the latest, Member States shall re-evaluate the product in
of authorisations compared to the Directives which have
accordance with the uniform principles, as referred to in
been adopted until now amending Annex I to that
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
Directive or the Regulations approving active substances.
of a dossier satisfying the requirements of Annex III to Directive
91/414/EEC and taking into account the column on specific
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:
(a) in the case of a product containing S-abscisic acid as the
(11) The
measures
provided
for
in
this
Regulation
are
in
only active substance, where necessary, amend or withdraw
accordance with the opinion of the Standing
the authorisation by 31 December 2015 at the latest; or
Committee on the Food Chain and Animal Health,
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
(b) in the case of a product containing S-abscisic acid as one of
stage of the programme of work referred to in Article 8(2) of
several active substances, where necessary, amend or
Council Directive 91/414/EEC concerning the placing of plant
withdraw the authorisation by 31 December 2015 or by
protection products on the market (OJ L 366, 15.12.1992, p. 10).
the date fixed for such an amendment or withdrawal in the
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
respective act or acts which added the relevant substance or
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
substances to Annex I to Directive 91/414/EEC or approved
approved active substances (OJ L 153, 11.6.2011, p. 1).
that substance or those substances, whichever is the latest.

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EN
19.2.2014 Official
Journal
of
the
European
Union
L
48/3
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this
Regulation.
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, 18 February 2014.
For the Commission
The President
José Manuel BARROSO

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L 48/4
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
S-abscisic acid
(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-
960 g/kg 1
July
2014 30
June
2024
For the implementation of the uniform principles as referred to
trimethyl-4-oxocyclohex-2-en-1-yl]-
in Article 29(6) of Regulation (EC) No 1107/2009, the
EN
CAS No 21293-29-8
3-methylpenta-2,4-dienoic acid
conclusions of the review report on S-abscisic acid, and in

particular Appendices I and II thereof, as finalised in the
CIPAC No
or
Standing Committee on the Food Chain and Animal Health
on 13 December 2013, shall be taken into account.
Not allocated
(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-
apo-ε-caroten-11-oic acid
In this overall assessment Member States shall pay particular
attention to the protection of aquatic organisms.
Conditions of use shall include risk mitigation measures, where
appropriate.
Off
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
19.2.2014

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19.2.2014 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
‘65 S-abscisic
acid
(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-
960 g/kg 1
July
2014 30
June
2024 For the implementation of the uniform principles as referred to in

trimethyl-4-oxocyclohex-2-en-1-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CAS No
yl]-3-methylpenta-2,4-dienoic acid
review report on S-abscisic acid, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
21293-29-8
or
Animal Health on 13 December 2013, shall be taken into account.
CIPAC No
(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-
In this overall assessment Member States shall pay particular attention to
apo-ε-caroten-11-oic acid
the protection of aquatic organisms.
Not allocated
Conditions of use shall include risk mitigation measures, where appro
priate.’
icial
(*) Further details on identity and specification of active substance are provided in the review report.
Jour
nal
of
the
European
Union
L
48/5

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Document Outline

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