HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 219/22
EN
Official Journal of the European Union
15.8.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013
of 14 August 2013
amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the
active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection
products containing this active substance
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
Authority
presented
its
conclusion
on
the
risk
assessment of fipronil as regards bees on 27 May
2013 ( 6 ).
Having regard to the Treaty on the Functioning of the European
Union,
(6) The
Authority
identified
for
the
use
as
seed
treatment
in
maize, high acute risks for bees from plant protection
Having regard to Regulation (EC) No 1107/2009 of the
products containing the active substance fipronil. The
European Parliament and of the Council of 21 October 2009
Authority identified, in particular, a high acute risk for
concerning the placing of plant protection products on the
bees resulting from dust. In addition, unacceptable risks
market and repealing Council Directives 79/117/EEC and
due to acute or chronic effects on colony survival and
91/414/EEC (
development could not be excluded for several crops.

1 ), and in particular the first alternative of
Article 21(3), Article 49(2) and Article 78(2) thereof,
Furthermore, the Authority identified some missing
information for each of the evaluated uses, in particular
as regards long term risk to honeybees from dust
exposure, from potential exposure to residues in pollen
Whereas:
and nectar, from potential exposure to guttation fluid
and from exposure to residues in succeding crops,
weeds and soil.
(1)
The active substance fipronil was included in Annex I to
Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
(7) In the light of the new scientific and technical
the market ( 2 ) by Commission Directive 2007/52/EC ( 3 ).
knowledge, the Commission considered that there are
indications that some approved uses of fipronil do not
satisfy the approval criteria provided for in Article 4 of
(2) Commission
Directive
2010/21/EU
( 4 ) amended Annex I
Regulation (EC) No 1107/2009 with respect to the
to Directive 91/414/EEC as regards the specific
impact on bees and that the high risk for bees could
provisions relating to fipronil.
not be excluded except by imposing further restrictions.
(3) Active
substances
included
in
Annex
I
to
Directive (8) The
Commission
invited
the
notifier
to
submit
91/414/EEC are deemed to be approved under Regu
comments.
lation (EC) No 1107/2009 and are listed in Part A of
the Annex to Commission Implementing Regulation (EU)
No 540/2011 of 25 May 2011 implementing Regulation
(EC) No 1107/2009 of the European Parliament and of
(9) The
conclusion
of
the
Authority
was
reviewed
by
the
the Council as regards the list of approved active
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
substances ( 5 ).
Health and finalised on 16 July 2013 in the format of
an addendum to the review report for fipronil.
(4) Based
on
new
information
received
from
Italy
concerning
risks to honeybees caused by coated maize seeds treated
with plant protection products containing fipronil, the
(10) The Commission has come to the conclusion that a high
Commission decided to review the approval of that
risk for bees cannot be excluded except by imposing
active substance. The Commission, in accordance with
further restrictions.
Article 21(2) of Regulation (EC) No 1107/2009, asked
the European Food Safety Authority, hereinafter ‘the
Authority’, for scientific and technical assistance to
(11) It is confirmed that the active substance fipronil is
assess this new information and to review the risk
deemed to have been approved under Regulation (EC)
assessment of fipronil as regards its impact on bees.
No 1107/2009. In order to minimise the exposure of
bees, it is, however, appropriate to restrict the use of
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 214, 17.8.2007, p. 3.
the pesticide risk assessment for bees for the active substance
( 4 ) OJ L 65, 13.3.2010, p. 27.
fipronil. EFSA Journal 2013;11(5):3158. [51 pp.] doi:10.2903/
( 5 ) OJ L 153, 11.6.2011, p. 1.
j.efsa.2013.3158. Available online: www.efsa.europa.eu/efsajournal

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EN
15.8.2013 Official
Journal
of
the
European
Union L
219/23
plant protection products containing fipronil and to
(EC) No 1107/2009 provides for the possibility of
provide for specific risk mitigation measures for the
Member States to take emergency measures pursuant to
protection of bees. In particular the use of plant
Article 71 thereof.
protection products containing fipronil should be
limited to the treatment of seeds intended to be sown
in greenhouses and to the treatment of seeds of leek,
(19) Seeds
treated
with
plant
protection
products
containing
onions, shallots and the group of Brassica vegetables
fipronil, which are subject to the restrictions referred to
intended to be sown in fields and harvested before
in Article 1 of this Regulation, may be used for
flowering. Crops which are harvested before flowering
experiments or tests for research or development
are not considered attractive to bees.
purposes pursuant to Article 54 of Regulation (EC) No
1107/2009.
(12) Concerning
applications
of
fipronil
which
may
be
auth
(20) The
measures
provided
for
in
this
Regulation
are
in
orised under Implementing Regulation (EU) No
accordance with the opinion of the Standing
540/2011, it is appropriate to require further
Committee on the Food Chain and Animal Health,
confirmatory information.
HAS ADOPTED THIS REGULATION:
(13) Implementing Regulation (EU) No 540/2011 should
therefore be amended accordingly.
Article 1
Amendment to Implementing Regulation (EU) No
(14) Risks
for
bees
from
treated
seeds
have
been
identified
in
540/2011
particular from exposure via dust as regards the use in
The Annex to Implementing Regulation (EU) No 540/2011 is
maize. Taking into consideration the risks linked with the
amended in accordance with the Annex to this Regulation.
use of treated seeds, the use and the placing on the
market of seeds treated with plant protection products
containing fipronil should be prohibited except for seeds
Article 2
sown in greenhouses and for treatment of seeds of leek,
onions, shallots and the group of Brassica vegetables
Prohibition of placing on the market of treated seeds
sown in fields and harvested before flowering. Pending
submission of missing information regarding the use of
Seeds of crops which have been treated with plant protection
treated sunflower seeds, it is appropriate to apply similar
products containing fipronil shall not be used or placed on the
measures as for maize.
market with the exception of seeds intended to be sown in

greenhouses and seeds of leek, onions, shallots, and the group
of Brassica vegetables intended to be sown in fields and
harvested before flowering.
(15) Member States should be provided with time to
withdraw authorisations for plant protection products
containing fipronil.
Article 3
Transitional measures
(16) For
plant
protection
products
containing
fipronil,
where
Member States shall, in accordance with Regulation (EC) No
Member States grant any period of grace in accordance
1107/2009, where necessary amend or withdraw existing auth
with Article 46 of Regulation (EC) No 1107/2009, this
orisations for plant protection products containing fipronil as
period should expire on 28 February 2014 at the latest.
active substance by 31 December 2013.
Accordingly, the prohibition of placing on the market of
treated seeds should apply as of 1 March 2014 in order
to allow for a period of transition.
Article 4
Period of grace
Any period of grace granted by Member States in accordance
(17) Within
two
years
from
the
date
of
entry
into
force
of
the
present Regulation the Commission will initiate a review
with Article 46 of Regulation (EC) No 1107/2009 shall be as
of the new scientific information, including new studies,
short as possible and shall expire on 28 February 2014 at the
information on new product formulations provided by
latest.
the applicants, which it has received.
Article 5
(18) Article
36(3)
of
Regulation
(EC)
No
1107/2009
provides
Entry into force
that Member States may, under certain circumstances,
This Regulation shall enter into force and apply from the day
impose further risk mitigation measures or restrictions
following that of its publication in the Official Journal of the
to the placing on the market or use of the plant
European Union.
protection products containing fipronil. Concerning the
placing on the market and use of the seeds treated with
plant protection products containing fipronil, Regulation
However, Article 2 shall apply from 1 March 2014.

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L 219/24
EN
Official Journal of the European Union
15.8.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 August 2013.
For the Commission
The President
José Manuel BARROSO

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EN
15.8.2013 Official
Journal
of
the
European
Union L
219/25
ANNEX
Amendments to the Annex to Implementing Regulation (EU) No 540/2011
The column ‘Specific provisions’ of row 157, fipronil, of Part A of the Annex to Implementing Regulation (EU)
No 540/2011 is replaced by the following:
‘PART A
Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds
intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables
intended to be sown in fields and harvested before flowering.
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 fipronil, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the
addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and
Animal Health on 16 July 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a) the packaging of the marketed products to avoid the generation of photodegradation products of concern;
(b) the potential for groundwater contamination, especially from metabolites which are more persistent than the
parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic
conditions;
(c) the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.
Member States shall also ensure that:
(a) the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the
best available techniques in order to ensure that the release of dust during application to the seed, storage, and
transport can be minimised;
(b) adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of
spillage and minimisation of dust emission;
(c) the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the
risk mitigation measures provided for in the authorisation;
(d) monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used
by bees for foraging or by beekeepers, where and as appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:
(a) the risk to pollinators other than honey bees;
(b) the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil
metabolites, except the soil photolysis metabolites;
(c) the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to
colony survival and development, and the risk to bee brood for situations where bees forage on vegetation
exposed to dust drift;
(d) the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on
insect honeydew;
(e) the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development,
and the risk to bee brood;
(f) the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or
weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).
The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March
2015.’

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Document Outline

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