THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European
Union,
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 Article 22(1) in conjunction with Article
13(2) thereof,
Whereas:
(1)
In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Belgium
received on 30 July 2012 an application from De Ceuster NV for the approval of
the active substance Pepino mosaic virus strain CH2 isolate 1906. In accordance
with Article 9(3) of that Regulation, Belgium, as rapporteur Member State,
notified the Commission on 10 January 2013 of the admissibility of the
application.
(2)
On 8 January 2014 the rapporteur Member State submitted a draft
assessment report to the Commission with a copy to the European Food Safety
Authority (hereinafter ‘the Authority’), assessing whether that active substance
can be expected to meet the approval criteria provided for in Article 4 of
Regulation (EC) No 1107/2009.
(3)
The Authority complied with Article 12(1) of Regulation (EC) No
1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it
requested that the applicant supply additional information to the Member States,
the Commission and the Authority. The assessment of the additional information
by the rapporteur Member State was submitted to the Authority in the format of
an updated draft assessment report in October 2014.
(4)
On 19 December 2014 the Authority communicated to the applicant, the
Member States and the Commission its conclusion on whether the active substance
Pepino mosaic virus strain CH2 isolate 1906 can be expected to meet the approval
criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The
Authority made its conclusion available to the public.
(5)
On 20 March 2015 the Commission presented to the Standing Committee on
Plants, Animals, Food and Feed the review report for Pepino mosaic virus strain
CH2 isolate 1906 and a draft Regulation providing that Pepino mosaic virus
strain CH2 isolate 1906 is approved.
(6)
The applicant was given the possibility to submit comments on the review
report.
(7)
It has been established with respect to one or more representative uses
of at least one plant protection product containing the active substance, and in
particular the uses which were examined and detailed in the review report, that
the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009
are satisfied. Those approval criteria are therefore deemed to be satisfied. It
is therefore appropriate to approve Pepino mosaic virus strain CH2 isolate
1906.
(8)
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in
conjunction with Article 6 thereof and in the light of current scientific and
technical knowledge, it is, however, necessary to include certain conditions and
restrictions.
(9)
The Commission further considers that Pepino mosaic virus strain CH2
isolate 1906 is a low-risk active substance pursuant to Article 22 of Regulation
(EC) No 1107/2009. Pepino mosaic virus strain CH2 isolate 1906 is not a
substance of concern and fulfils the conditions set in point 5 of Annex II to
Regulation (EC) No 1107/2009. Pepino mosaic virus strain CH2 isolate 1906 is a
naturally occurring plant virus strain. A plant virus does not replicate outside
the plant cell and the virus does not have a cellular structure and does not
produce metabolites. It is not pathogenic to humans or animals. The additional
exposure of humans, animals and the environment by the uses approved under
Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure
expected through realistic natural situations.
(10)
It is therefore appropriate to approve Pepino mosaic virus strain CH2
isolate 1906 as a low-risk substance. In accordance with Article 13(4) of
Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation
(EU) No 540/2011 (3) should be amended accordingly.
(11)
The measures provided for in this Regulation are in accordance with the
opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Approval of active substance
The active substance Pepino mosaic virus strain CH2 isolate 1906, as
specified in Annex I, is approved subject to the conditions laid down in that
Annex.
Article 2
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 3
Entry into force
This Regulation shall enter into force on the twentieth day following
that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.
Done at Brussels, 17 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 309, 24.11.2009, p. 1.
(2) EFSA Journal 2015;13(1):3977 Available online:
www.efsa.europa.eu
(3) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the
Council as regards the list of approved active substances (OJ L 153, 11.6.2011,
p. 1).
ANNEX I
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