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23.4.2013 Official
Journal
of
the
European
Union L
111/27
COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013
of 22 April 2013
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance glufosinate
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
Commission
consulted
the
Authority
which
presented its opinion on the risk assessment of
glufosinate on 8 March 2012 ( 5 ). The draft assessment
Having regard to the Treaty on the Functioning of the European
report, the additional report and the opinion of the
Union,
Authority were reviewed by the Member States and the
Commission within the Standing Committee on the Food
Chain and Animal Health and finalised on 15 March
Having regard to Regulation (EC) No 1107/2009 of the
2013 in the format of the Commission review report
European Parliament and of the Council of 21 October 2009
for glufosinate.
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 the second alternative of
(6) In
the
light
of
the
additional
information
provided
by
the
Articles 21(3) and 78(2) thereof,
notifier, the Commission considered that the further
confirmatory information required had not been
provided and that a high risk for mammals and non-
Whereas:
target arthropods could not be excluded except by
imposing further restrictions.
(1) Commission Directive 2007/25/EC
( 2 ) included
glufosinate as active substance in Annex I to Council
(7) The
Commission
invited
the
notifier
to
submit
its
Directive 91/414/EEC of 15 July 1991 concerning the
comments on the review report for glufosinate.
placing of plant protection products on the market ( 3 ),
under the condition that the Member States concerned
ensure that the notifier at whose request glufosinate was
(8)
It is confirmed that the active substance glufosinate is to
included in that Annex provide further confirmatory
be deemed to have been approved under Regulation (EC)
information on the risk for mammals and non-target
No 1107/2009. In order to minimise the exposure of
arthropods in apple orchards.
mammals and non-target arthropods, it is, however,
appropriate to further restrict the uses of this active
substance and to provide for specific risk mitigation
(2) Active
substances
included
in
Annex
I
to
Directive
measures for the protection of those species.
91/414/EEC are deemed to be approved under Regu
lation (EC) No 1107/2009 and are listed in Part A of
the Annex to Commission Implementing Regulation (EU)
(9) Implementing
Regulation
(EU)
No
540/2011
should
No 540/2011 of 25 May 2011 implementing Regulation
therefore be amended accordingly.
(EC) No 1107/2009 of the European Parliament and of
the Council as regards the list of approved active
substances ( 4 ).
(10) Member States should be provided with time to
withdraw authorisations for plant protection products
containing glufosinate.
(3) The
notifier
submitted
additional
information
taking
the
form of studies with a view to confirm the risk
assessment for mammals and non-target arthropods in
(11) For
plant protection products containing glufosinate,
apple orchards to the rapporteur Member State Sweden
where Member States grant any period of grace in
within the time period provided for its submission.
accordance with Article 46 of Regulation (EC) No
1107/2009, this period should expire at the latest one
year after the withdrawal of the authorisations.
(4) Sweden
assessed
the
additional
information
submitted
by
the notifier. It submitted its assessment, in the form of an
addendum to the draft assessment report, to the other
(12) The
measures
provided
for
in
this
Regulation
are
in
Member States, the Commission and the European Food
accordance with the opinion of the Standing
Safety Authority, hereinafter ‘the Authority’, on 9 March
Committee on the Food Chain and Animal Health,
2010.
( 5 ) European Food Safety Authority; Conclusion on the peer review of
( 1 ) OJ L 309, 24.11.2009, p. 1.
the pesticide risk assessment of confirmatory data submitted for the
( 2 ) OJ L 106, 24.4.2007, p. 34.
active substance glufosinate. EFSA Journal 2012; 10(3):2609. [14
( 3 ) OJ L 230, 19.8.1991, p. 1.
pp.] doi:10.2903/j.efsa.2012.2609. Available online: www.efsa.
( 4 ) OJ L 153, 11.6.2011, p. 1.
europa.eu/efsajournal.htm

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L 111/28
EN
Official Journal of the European Union
23.4.2013
HAS ADOPTED THIS REGULATION:
Article 3
Article 1
Period of grace
Amendment to Implementing Regulation (EU) No
Any period of grace granted by Member States in accordance
540/2011
with Article 46 of Regulation (EC) No 1107/2009 shall be as
short as possible and shall expire 12 months after withdrawal of
The Annex to Implementing Regulation (EU) No 540/2011 is
the respective authorisation at the latest.
amended in accordance with the Annex to this Regulation.
Article 2
Article 4
Transitional measures
Entry into force
Member States shall in accordance with Regulation (EC) No
1107/2009, where necessary amend or withdraw existing auth
This Regulation shall enter into force on the twentieth day
orisations for plant protection products containing glufosinate
following that of its publication in the Official Journal of the
as active substance by 13 November 2013.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 April 2013.
For the Commission
The President
José Manuel BARROSO

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EN
23.4.2013 Official
Journal
of
the
European
Union L
111/29
ANNEX
The column ‘Specific provisions’ of row 151, glufosinate, of Part A of the Annex to Implementing Regulation (EU)
No 540/2011 is replaced by the following:
‘PART A
Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active
substance/ha (treated surface) per application and maximum two applications per year.
PART B
In assessing applications to authorise plant protection products containing glufosinate, notably as regards the
operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of
Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an
authorisation is granted.
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 glufosinate, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In
this overall assessment Member States shall pay particular attention to:
(a) the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where
appropriate;
(b) the potential for groundwater contamination, where the active substance is applied in regions with vulnerable
soil or climatic conditions;
(c) the protection of mammals, non-target arthropods and non-target plants.
Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide
for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures,
where appropriate.’.

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Document Outline

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