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21.11.2013 Official
Journal
of
the
European
Union L
312/33
COMMISSION IMPLEMENTING REGULATION (EU) No 1178/2013
of 20 November 2013
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance ethoprophos
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
Commission
consulted
the
Authority
which
presented its opinion on the risk assessment of etho
prophos on 30 January 2013 ( 5 ). The draft assessment
Having regard to the Treaty on the Functioning of the European
report, the addendum and the opinion of the Authority
Union,
were reviewed by the Member States and the
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
Having regard to Regulation (EC) No 1107/2009 of the
3 October 2013 in the format of the Commission
European Parliament and of the Council of 21 October 2009
review report for ethoprophos.
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
Articles 21(3) and 78(2) thereof,
(6) The
Commission
invited
the
notifier
to
submit
its
comments on the review report for ethoprophos.
Whereas:
(7) The
Commission
has
come
to
the
conclusion
that
the
further confirmatory information showed that a high risk
(1) Commission
Directive
2007/52/EC
( 2 ) included etho
for birds and earthworm eating mammals cannot be
prophos as active substance in Annex I to Council
excluded except by imposing further restrictions.
Directive 91/414/EEC ( 3 ), under the condition that the
Member States concerned ensure that the notifier at
whose request ethoprophos was included in that Annex
provides further confirmatory information in the form of
(8)
It is confirmed that the active substance ethoprophos is
studies on the risk for birds and earthworm eating
to be deemed to have been approved under Regulation
mammals.
(EC) No 1107/2009. In order to minimise the exposure
of birds and earthworm eating mammals, it is, however,
appropriate to further restrict the uses of this active
(2) Active
substances
included
in
Annex
I
to
Directive
substance and to provide for specific risk mitigation
91/414/EEC are deemed to have been approved under
measures for the protection of those species.
Regulation (EC) No 1107/2009 and are listed in Part A
of the Annex to Commission Implementing Regulation
(EU) No 540/2011 ( 4 ).
(9) The
Annex
to
Implementing
Regulation
(EU)
No
540/2011 should therefore be amended accordingly.
(3) The
notifier
submitted
additional
information
taking
the
form of studies concerning the risk for birds and
earthworm eating mammals to the rapporteur Member
(10) Member
States
should
be
provided
with
time
to
amend
State United Kingdom within the time period provided
or withdraw authorisations for plant protection products
for its submission.
containing ethoprophos.
(4) The
United
Kingdom
assessed
the
additional
information
submitted by the notifier. It submitted its assessment, in
(11) For
plant
protection
products
containing
ethoprophos,
the form of an addendum to the draft assessment report,
where Member States grant any grace period in
to the other Member States, the Commission and the
accordance with Article 46 of Regulation (EC) No
European Food Safety Authority, hereinafter ‘the Auth
1107/2009, this period should expire at the latest 18
ority’, on 5 September 2011.
months after the entry into force of the Regulation.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Commission Directive 2007/52/EC of 16 August 2007 amending
(12) The
measures
provided
for
in
this
Regulation
are
in
Council Directive 91/414/EEC to include ethoprophos, pirimiphos-
accordance with the opinion of the Standing
methyl and fipronil as active substances (OJ L 214, 17.8.2007, p. 3).
Committee on the Food Chain and Animal Health,
( 3 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
( 5 ) Conclusion on the peer review of the pesticide risk assessment of
( 4 ) Commission Implementing Regulation (EU) No 540/2011 of
confirmatory data submitted for the active substance ethoprophos.
25 May 2011 implementing Regulation (EC) No 1107/2009 of
EFSA Journal 2013; 11(2):3089. [27 pp.] doi:10.2903/
the European Parliament and of the Council as regards the list of
j.efsa.2013.3089. Available online: www.efsa.europa.eu/efsajournal.
approved active substances (OJ L 153, 11.6.2011, p. 1).
htm

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L 312/34
EN
Official Journal of the European Union
21.11.2013
HAS ADOPTED THIS REGULATION:
authorisations for plant protection products containing etho
prophos as active substance by 11 June 2014.
Article 1
Article 3
Amendment to Implementing Regulation (EU)
No 540/2011
Grace period
Part A of the Annex to Implementing Regulation (EU) No
Any grace period granted by Member States in accordance with
540/2011 is amended in accordance with the Annex to this
Article 46 of Regulation (EC) No 1107/2009 shall be as short
Regulation.
as possible and shall expire by 11 June 2015 at the latest.
Article 4
Article 2
Entry into force
Transitional measures
This Regulation shall enter into force on the twentieth day
Member States shall in accordance with Regulation (EC) No
following that of its publication in the Official Journal of the
1107/2009, where necessary, amend or withdraw existing
European Union.
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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EN
21.11.2013 Official
Journal
of
the
European
Union L
312/35
ANNEX
The column ‘Specific provisions’ of row 155, ethoprophos, of Part A of the Annex to Implementing Regulation (EU) No
540/2011 is replaced by the following:
‘PART A
Only uses as nematicide and insecticide in soil application may be authorised. Only one application per season may
be authorised, at a rate not exceeding 6 kg active substance/ha.
Authorisations shall be limited to professional users.
PART B
In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes
not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in
Article 29(1) 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 ethoprophos, and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health on 16 March 2007, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a) the dietary exposure of consumers;
(b) the operator safety, ensuring that the conditions of use prescribe the application of adequate personal and
respiratory protective equipment and other risk mitigation measures such as the use of a closed transfer
system for the distribution of the product;
(c) the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions.
Conditions of authorisation shall include risk mitigation measures, such as buffer zones and the achievement of
complete incorporation of granules in the soil.’

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Document Outline

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