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15.2.2014 Official
Journal
of
the
European
Union
L
45/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014
of 14 February 2014
approving the active substance pyridalyl, 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,
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
Having regard to the Treaty on the Functioning of the European
in accordance with the provisions of Article 6(2) and (4)
Union,
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 8 January 2009.
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
91/414/EEC ( 1 ), and in particular Articles 13(2) and 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 pyridalyl ( 4 ) on
24 May 2013. The draft assessment report and the
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
conclusion of the Authority were reviewed by the
1107/2009, Council Directive 91/414/EEC (
Member States and the Commission within the

2 ) is to apply,
with respect to the procedure and the conditions for
Standing Committee on the Food Chain and Animal
approval, to active substances for which a decision has
Health and finalised on 13 December 2013 in the
been adopted in accordance with Article 6(3) of that
format of the Commission review report for pyridalyl.
Directive before 14 June 2011. For pyridalyl the
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
2007/669/EC ( 3 ).
(5)
It has appeared from the various examinations made that
plant protection products containing pyridalyl may be
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
expected to satisfy, in general, the requirements laid
Austria received on 9 October 2006 an application from
down in Article 5(1)(a) and (b) and Article 5(3) of
Sumitomo Chemical Agro Europe S.A.S. for the inclusion
Directive 91/414/EEC, in particular with regard to the
of the active substance pyridalyl in Annex I to Directive
use which was examined and detailed in the Commission
91/414/EEC. Decision 2007/669/EC confirmed that the
review report. It is therefore appropriate to approve pyri
dossier was ‘complete’ in the sense that it could be
dalyl.
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
Directive 91/414/EEC.
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
( 1 ) OJ L 309, 24.11.2009, p. 1.
1107/2009 in conjunction with Article 6 thereof and in
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
the light of current scientific and technical knowledge, it
19.8.1991, p. 1).
is, however, necessary to include certain conditions and
( 3 ) Commission Decision 2007/669/EC of 15 October 2007 recog
restrictions. It is, in particular, appropriate to require
nising in principle the completeness of the dossiers submitted for
further confirmatory information.
detailed examination in view of the possible inclusion of Adoxophyes
orana granulovirus, amisulbrom, emamectin, pyridalil and Spodoptera
littoralis nucleopolyhedrovirus in Annex I to Council Directive
( 4 ) EFSA Journal 2013;11(6):3240. Available online: www.efsa.
91/414/EEC (OJ L 274, 18.10.2007, p. 15).
europa.eu

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L 45/2
EN
Official Journal of the European Union
15.2.2014
(7) 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 pyridalyl
(8) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
as an active substance by 31 December 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 pyridalyl.
identified in Part B of the column on specific provisions of that
Member States should, as appropriate, vary, replace or
Annex, and that the holder of the authorisation has, or has
withdraw authorisations. By way of derogation from
access to, a dossier satisfying the requirements of Annex II to
that deadline, a longer period should be provided for
Directive 91/414/EEC in accordance with the conditions of
the submission and assessment of the complete Annex
Article 13(1) to (4) of that Directive and Article 62 of Regu
III dossier, as set out in Directive 91/414/EEC, of each
lation (EC) No 1107/2009.
plant protection product for each intended use in
accordance with the uniform principles.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
(9) The
experience
gained
from
inclusions
in
Annex
I
to orised plant protection product containing pyridalyl 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 June 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 Part B of the column on
access to a dossier satisfying the requirements of Annex
specific provisions of Annex I to this Regulation. On the basis
II to that Directive. However, this clarification does not
of that evaluation, they shall determine whether the product
impose any new obligations on Member States or holders
satisfies the conditions set out in Article 29(1) of Regulation
of authorisations compared to the Directives which have
(EC) No 1107/2009.
been adopted until now amending Annex I to that
Directive or the Regulations approving active substances.
(10) 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 pyridalyl as the only
(11) The
measures
provided
for
in
this
Regulation
are
in
active substance, where necessary, amend or withdraw the
accordance with the opinion of the Standing
authorisation by 31 December 2015 at the latest; or
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing pyridalyl 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 pyridalyl, 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
45/3
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 45/4
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Pyridalyl
2,6-dichloro-4-(3,3-dichloroally
≥ 910 g/kg 1
July
2014 30
June
2024 PART
A
loxy)phenyl 3-[5-(trifluoromethyl)-
EN
CAS No 179101-81-6 2-pyridyloxy]propyl ether
Only uses in greenhouses with permanent structure may be authorised.

CIPAC No 792
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
review report on pyridalyl, 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:
Off
icial
(a) the risk to re-entry workers;
Jour
(b) the risk to groundwater when the substance is applied in regions with
vulnerable soils and/or climatic conditions;
nal
(c) the risk to birds, mammals and aquatic organisms.
of
the
Conditions of authorisation shall include risk mitigation measures, where
European
appropriate.
The applicant shall submit confirmatory information as regards:
Union
(1) the toxicological and ecotoxicological information to address the
relevance of impurities 4, 13, 16, 22 and 23;
(2) the relevance of the metabolite HTFP and, concerning that metabolite,
the groundwater risk assessment for all uses on crops in greenhouse;
(3) the risk to aquatic invertebrates.
The applicant shall submit to the Commission, the Member States and the
Authority the relevant information as regards point (1) by 31 December
2014 and information as regards point (2) and (3) by 30 June 2016.
The applicant shall present to the Commission, the Member States and the
Authority a monitoring programme to assess the potential groundwater
contamination from the metabolite HTFP in vulnerable zones, by 30 June
2016. The results of that monitoring programme shall be submitted as a
monitoring report to the rapporteur Member State, the Commission and
the Authority by 30 June 2018.
15.2.2014
(1 ) Further details on identity and specification of active substance are provided in the review report.

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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
‘64 Pyridalyl
2,6-dichloro-4-(3,3-dichloroally
≥ 910 g/kg 1
July
2014 30
June
2024 PART
A

loxy)phenyl 3-[5-(trifluoromethyl)-2-
CAS No 179101-81-6
pyridyloxy]propyl ether
Only uses in greenhouses with permanent structure may be
authorised.
CIPAC No 792
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 review report on pyridalyl, and in
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
icial
on 13 December 2013, shall be taken into account.
Jour
In this overall assessment Member States shall pay particular
attention to:
nal
(a) the risk to re-entry workers;
of
the
European
(b) the risk to groundwater when the substance is applied in
regions with vulnerable soils and/or climatic conditions;
Union
(c) the risk to birds, mammals and aquatic organisms.
Conditions of authorisation shall include risk mitigation
measures, where appropriate.
The applicant shall submit confirmatory information as
regards:
(1) the toxicological and ecotoxicological information to
address the relevance of impurities 4, 13, 16, 22 and 23;
(2) the relevance of the metabolite HTFP and, concerning
that metabolite, the groundwater risk assessment for all
uses on crops in greenhouse;
L
45/5
(3) the risk to aquatic invertebrates.

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L 45/6
Number Common
Name,
Identification
Numbers IUPAC
Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
The applicant shall submit to the Commission, the Member
States and the Authority the relevant information as regards
point (1) by 31 December 2014 and information as regards
point (2) and (3) by 30 June 2016.
The applicant shall present to the Commission, the Member
EN
States and the Authority a monitoring programme to assess

the potential groundwater contamination from the metabolite
HTFP in vulnerable zones by 30 June 2016. The results of
that monitoring programme shall be submitted as a moni
toring report to the rapporteur Member State, the
Commission and the Authority by 30 June 2018.’
(*) Further details on identity and specification of active substance are provided in the review report.
Off
icial
Jour
nal
of
the
European
Union
15.2.2014

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