HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 203/16
EN
Official Journal of the European Union
6.8.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 787/2011
of 5 August 2011
approving the active substance 1-naphthylacetic 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 and Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing
these substances ( 6 ) was adopted on the non-inclusion
Having regard to the Treaty on the Functioning of the European
of 1-naphthylacetic acid.
Union,
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
Having regard to Regulation (EC) No 1107/2009 of the
original notifier (hereinafter ‘the applicant’) submitted a
European Parliament and of the Council of 21 October 2009
new application requesting the accelerated procedure to
concerning the placing of plant protection products on the
be applied, as provided for in Articles 14 to 19 of Regu
market and repealing Council Directives 79/117/EEC and
lation (EC) No 33/2008 laying down detailed rules for
91/414/EEC ( 1 ), and in particular Article 13(2) and
the application of Directive 91/414/EEC as regards a
Article 78(2) thereof,
regular and an accelerated procedure for the assessment
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
Whereas:
have not been included into its Annex I.
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC) (5) The
application
was
submitted
to
France,
which
had
been
No 1107/2009, Council Directive 91/414/EEC ( 2 ) is to
designated rapporteur Member State by Regulation (EC)
apply to active substances for which completeness has
No 2229/2004. The time period for the accelerated
been established in accordance with Article 16 of
procedure was respected. The specification of the active
Commission Regulation (EC) No
33/2008
( 3 ), with
substance and the supported uses are the same as were
respect to the procedure and the conditions for
the subject of Decision 2008/941/EC. That application
approval. 1-naphthylacetic acid, previously referred to
also complies with the remaining substantive and
as ‘naphthylacetic acid’, is an active substance for which
procedural requirements of Article 15 of Regulation
completeness has been established in accordance with
(EC) No 33/2008.
that Regulation.
(6)
France evaluated the additional data submitted by the
(2) Commission
Regulations
(EC)
No
1112/2002
( 4 ) and (EC)
applicant and prepared an additional report. It
No 2229/2004 ( 5 ) lay down the detailed rules for the
communicated that report to the European Food Safety
implementation of the fourth stage of the programme
Authority (hereinafter ‘the Authority’) and to the
of work referred to in Article 8(2) of Directive
Commission on 12 March 2010. The Authority
91/414/EEC and establish a list of active substances to
communicated the additional report to the other
be assessed, with a view to their possible inclusion in
Member States and the applicant for comments and
Annex I to Directive 91/414/EEC. That list included
forwarded the comments it had received to the
1-naphthylacetic acid.
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
(3) In
accordance
with
Article
24e
of
Regulation
(EC)
1-naphthylacetic acid to the Commission on 15 February
No 2229/2004 the notifier withdrew its support of the
2011 ( 7 ). The draft assessment report, the additional
inclusion of that active substance in Annex I to Directive
report and the conclusion of the Authority were
91/414/EEC within 2 months from receipt of the draft
reviewed by the Member States and the Commission
assessment report referred to in Article 24(2) of that
within the Standing Committee on the Food Chain and
Regulation. Consequently, Commission Decision
Animal Health and finalised on 17 June 2011 in the
2008/941/EC of 8 December 2008 concerning the
format of the Commission review report for 1-naphthy
non-inclusion of certain active substances in Annex I
lacetic acid.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) OJ L 335, 13.12.2008, p. 91.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance 1-naphthylacetic
( 4 ) OJ L 168, 27.6.2002, p. 14.
acid. EFSA Journal 2011;9(2):2019. [54 pp.]. doi:10.2903/
( 5 ) OJ L 379, 24.12.2004, p. 13.
j.efsa.2011.2019. Available online: www.efsa.europa.eu

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EN
6.8.2011 Official
Journal
of
the
European
Union L
203/17
(7)
It has appeared from the various examinations made that
an authorisation demonstrates access to a dossier
plant protection products containing 1-naphthylacetic
satisfying the requirements of Annex II to that Directive.
acid may be expected to satisfy, in general, the
However, this clarification does not impose any new
requirements laid down in Article 5(1)(a) and (b) of
obligations on Member States or holders of authori
Directive 91/414/EEC, in particular as regards the uses
sations compared to the directives which have been
which were examined and detailed in the Commission
adopted until now amending Annex I to that Directive
review report. It is therefore appropriate to approve
or the Regulations approving active substances.
1-naphthylacetic acid in accordance with Regulation
(EC) No 1107/2009.
(13) In
accordance
with
Article
13(4) of Regulation
(EC)
No 1107/2009 the Annex to Commission Implementing
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
Regulation (EU) No 540/2011 of 25 May 2011 imple
No 1107/2009 in conjunction with Article 6 thereof
menting Regulation (EC) No 1107/2009 of the European
and in the light of current scientific and technical
Parliament and of the Council as regards the list of
knowledge, it is, however, necessary to include certain
approved active substances
( 2 ) should be amended
conditions and restrictions.
accordingly.
(14) Decision
2008/941/EC
provides
for
the
non-inclusion
of
(9) Without
prejudice
to
the
conclusion
that
1-naphthy
1-naphthylacetic acid and the withdrawal of authori
lacetic acid should be approved, it is, in particular, appro
sations for plants protection products containing that
priate to require further confirmatory information.
substance by 31 December 2011. It is necessary to
delete the line concerning ‘naphthylacetic acid’ in the
Annex to that Decision. It is therefore appropriate to
amend Decision 2008/941/EC accordingly.
(10) A
reasonable
period
should
be
allowed
to
elapse
before

approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
(15) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(11) Without
prejudice
to
the
obligations
defined
by
Regu
lation (EC) No 1107/2009 as a consequence of the
approval, taking into account the specific situation
HAS ADOPTED THIS REGULATION:
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
Article 1
period of 6 months after approval to review authori
sations of plant protection products containing 1-naph
Approval of active substance
thylacetic acid. Member States should, as appropriate,
vary, replace or withdraw existing authorisations. By
The active substance 1-naphthylacetic acid, as specified in
way of derogation from the above deadline, a longer
Annex I, is approved subject to the conditions laid down in
period should be provided for the submission and
that Annex.
assessment of the update of the complete Annex III
dossier, as set out in Directive 91/414/EEC, of each
plant protection product for each intended use in
Article 2
accordance with the uniform principles.
Re-evaluation of plant protection products
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
(12) The
experience
gained
from
inclusions
in
Annex
I
to
authorisations for plant protection products containing 1-naph
Directive 91/414/EEC of active substances assessed in
thylacetic acid as an active substance by 30 June 2012.
the framework of 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
By that date they shall in particular verify that the conditions in
Council Directive 91/414/EEC concerning the placing of
Annex I to this Regulation are met, with the exception of those
plant protection products on the market ( 1 ) has shown
identified in Part B of the column on specific provisions of that
that difficulties can arise in interpreting the duties of
Annex, and that the holder of the authorisation has, or has
holders of existing authorisations in relation to access
access to, a dossier satisfying the requirements of Annex II to
to data. In order to avoid further difficulties it therefore
Directive 91/414/EEC in accordance with the conditions of
appears necessary to clarify the duties of the Member
Article 13(1) to (4) of that Directive and Article 62 of Regu
States, especially the duty to verify that the holder of
lation (EC) No 1107/2009.
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.

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L 203/18
EN
Official Journal of the European Union
6.8.2011
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
or substances to Annex I to Directive 91/414/EEC or
orised plant protection product containing 1-naphthylacetic acid
approved that substance or substances, whichever is the
as either the only active substance or as one of several active
latest.
substances all of which were listed in the Annex to Imple
menting Regulation (EU) No 540/2011 by 31 December
2011 at the latest, Member States shall re-evaluate the
Article 3
product in accordance with the uniform principles, as referred
Amendments to Implementing Regulation (EU) No
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
540/2011
basis of a dossier satisfying the requirements of Annex III to
Directive 91/414/EEC and taking into account Part B of the
The Annex to Implementing Regulation (EU) No 540/2011 is
column on specific provisions of Annex I to this Regulation.
amended in accordance with Annex II 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. Following that determination
Article 4
Member States shall:
Amendments to Decision 2008/941/EC
The line concerning ‘naphthylacetic acid’ in the Annex to
(a) in the case of a product containing 1-naphthylacetic acid as
Decision 2008/941/EC is deleted.
the only active substance, where necessary, amend or
withdraw the authorisation by 31 December 2015 at the
latest; or
Article 5
Entry into force and date of application
(b) in the case of a product containing 1-naphthylacetic acid as
This Regulation shall enter into force on the 20th day following
one of several active substances, where necessary, amend or
its publication in the Official Journal of the European Union.
withdraw the authorisation by 31 December 2015 or by the
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 August 2011.
For the Commission
The President
José Manuel BARROSO

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6.8.2011 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
1-naphthylacetic acid
1-naphthylacetic acid
≥ 980 g/kg 1
January
2012 31
December
2021 PART
A
EN
CAS No 86-87-3
Only uses as plant growth regulator may be authorised.

CIPAC No 313
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 1-naphthylacetic
acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
In this overall assessment Member States:
(a) shall pay particular attention to the risk to operators and workers and shall ensure
that conditions of use include the application of adequate personal protective
icial
equipment, where appropriate;
Jour
(b) shall pay particular attention to the dietary exposure situation of consumers in view of
nal
future revisions of maximum residue levels;
of
(c) shall pay particular attention to the protection of groundwater, when the active
the
substance is applied in regions with vulnerable soil and/or climatic conditions;
European
(d) shall pay particular attention to the risk to aquatic organisms;
(e) shall pay particular attention to the risk to birds.
Union
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
(1) the route and rate of degradation in soil including an assessment of the potential for
photolysis;
(2) the long-term risk to birds.
The applicant shall submit to the Commission, the Member States and the Authority such
information by 31 December 2013.
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
203/19

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L 203/20
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
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘13 1-naphthylacetic
acid
1-naphthylacetic acid
≥ 980 g/kg 1
January
2012 31
December
2021 PART
A

CAS No 86-87-3
Only uses as plant growth regulator may be authorised.
PART B
CIPAC No 313
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 1-naphthylacetic acid, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health on 17 June 2011 shall be taken into account.
In this overall assessment Member States:
Off
(a) shall pay particular attention to the risk to operators and workers and shall
icial
ensure that conditions of use include the application of adequate personal
Jour
protective equipment, where appropriate;
(b) shall pay particular attention to the dietary exposure situation of consumers
nal
in view of future revisions of maximum residue levels;
of
the
(c) shall pay particular attention to the protection of groundwater, when the
active substance is applied in regions with vulnerable soil and/or climatic
European
conditions;
(d) shall pay particular attention to the risk to aquatic organisms;
(e) shall pay particular attention to the risk to birds.
Union
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
(1) the route and rate of degradation in soil including an assessment of the
potential for photolysis;
(2) the long-term risk to birds.
The applicant shall submit to the Commission, the Member States and the
Authority such information by 31 December 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
6.8.2011

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