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,  
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 the first alternative of 
Article 21(3), Article 49(2) and Article 78(2) thereof,  
Whereas:  
(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 
the market (  2 ) by Commission Directive 2007/52/EC (  3 ). 
(2) Commission Directive 2010/21/EU (  4 ) amended Annex I 
to Directive 91/414/EEC as regards the specific 
provisions relating to fipronil.  
(3) Active substances included in Annex I to Directive 
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) 
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 (  5 ). 
(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 
Commission decided to review the approval of that 
active substance. The Commission, in accordance with 
Article 21(2) of Regulation (EC) No 1107/2009, asked 
the European Food Safety Authority, hereinafter ‘the 
Authority’, for scientific and technical assistance to 
assess this new information and to review the risk 
assessment of fipronil as regards its impact on bees.  (5) The Authority presented its conclusion on the risk 
assessment of fipronil as regards bees on 27 May 
2013 (  6 ). 
(6) The Authority identified for the use as seed treatment in 
maize, high acute risks for bees from plant protection 
products containing the active substance fipronil. The 
Authority identified, in particular, a high acute risk for 
bees resulting from dust. In addition, unacceptable risks 
due to acute or chronic effects on colony survival and 
development could not be excluded for several crops. 
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 
and nectar, from potential exposure to guttation fluid 
and from exposure to residues in succeding crops, 
weeds and soil.  
(7) In the light of the new scientific and technical 
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 
Regulation (EC) No 1107/2009 with respect to the 
impact on bees and that the high risk for bees could 
not be excluded except by imposing further restrictions.  
(8) The Commission invited the notifier to submit 
comments.  
(9) The conclusion of the Authority was reviewed by the 
Member States and the Commission within the 
Standing Committee on the Food Chain and Animal 
Health and finalised on 16 July 2013 in the format of 
an addendum to the review report for fipronil.  
(10) The Commission has come to the conclusion that a high 
risk for bees cannot be excluded except by imposing 
further restrictions.  
(11) It is confirmed that the active substance fipronil is 
deemed to have been approved under Regulation (EC) 
No 1107/2009. In order to minimise the exposure of 
bees, it is, however, appropriate to restrict the use ofEN L 219/22 Official Journal of the European Union 15.8.2013  
( 1 ) OJ L 309, 24.11.2009, p. 1.  
( 2 ) OJ L 230, 19.8.1991, p. 1.  
( 3 ) OJ L 214, 17.8.2007, p. 3.  
( 4 ) OJ L 65, 13.3.2010, p. 27.  
( 5 ) OJ L 153, 11.6.2011, p. 1.  ( 6 ) European Food Safety Authority; Conclusion on the peer review of 
the pesticide risk assessment for bees for the active substance 
fipronil.  EFSA Journal  2013;11(5):3158. [51 pp.] doi:10.2903/ 
j.efsa.2013.3158. Available online: www.efsa.europa.eu/efsajournalplant protection products containing fipronil and to 
provide for specific risk mitigation measures for the 
protection of bees. In particular the use of plant 
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, 
onions, shallots and the group of  Brassica  vegetables 
intended to be sown in fields and harvested before 
flowering. Crops which are harvested before flowering 
are not considered attractive to bees.  
(12) Concerning applications of fipronil which may be auth ­
orised under Implementing Regulation (EU) No 
540/2011, it is appropriate to require further 
confirmatory information.  
(13) Implementing Regulation (EU) No 540/2011 should 
therefore be amended accordingly.  
(14) Risks for bees from treated seeds have been identified in 
particular from exposure via dust as regards the use in 
maize. Taking into consideration the risks linked with the 
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 
sown in greenhouses and for treatment of seeds of leek, 
onions, shallots and the group of  Brassica  vegetables 
sown in fields and harvested before flowering. Pending 
submission of missing information regarding the use of 
treated sunflower seeds, it is appropriate to apply similar 
measures as for maize.  
(15) Member States should be provided with time to 
withdraw authorisations for plant protection products 
containing fipronil.  
(16) For plant protection products containing fipronil, where 
Member States grant any period of grace in accordance 
with Article 46 of Regulation (EC) No 1107/2009, this 
period should expire on 28 February 2014 at the latest. 
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.  
(17) Within two years from the date of entry into force of the 
present Regulation the Commission will initiate a review 
of the new scientific information, including new studies, 
information on new product formulations provided by 
the applicants, which it has received.  
(18) Article 36(3) of Regulation (EC) No 1107/2009 provides 
that Member States may, under certain circumstances, 
impose further risk mitigation measures or restrictions 
to the placing on the market or use of the plant 
protection products containing fipronil. Concerning the 
placing on the market and use of the seeds treated with 
plant protection products containing fipronil, Regulation (EC) No 1107/2009 provides for the possibility of 
Member States to take emergency measures pursuant to 
Article 71 thereof.  
(19) Seeds treated with plant protection products containing 
fipronil, which are subject to the restrictions referred to 
in Article 1 of this Regulation, may be used for 
experiments or tests for research or development 
purposes pursuant to Article 54 of Regulation (EC) No 
1107/2009.  
(20) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Implementing Regulation (EU) No 
540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is 
amended in accordance with the Annex to this Regulation.  
Article 2  
Prohibition of placing on the market of treated seeds  
Seeds of crops which have been treated with plant protection 
products containing fipronil shall not be used or placed on the 
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.  
Article 3  
Transitional measures  
Member States shall, in accordance with Regulation (EC) No 
1107/2009, where necessary amend or withdraw existing auth ­
orisations for plant protection products containing fipronil as 
active substance by 31 December 2013.  
Article 4  
Period of grace  
Any period of grace granted by Member States in accordance 
with Article 46 of Regulation (EC) No 1107/2009 shall be as 
short as possible and shall expire on 28 February 2014 at the 
latest.  
Article 5  
Entry into force  
This Regulation shall enter into force and apply from the day 
following that of its publication in the  Official Journal of the 
European Union . 
However, Article 2 shall apply from 1 March 2014.EN 15.8.2013 Official Journal of the European Union L 219/23This 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 BARROSOEN L 219/24 Official Journal of the European Union 15.8.2013ANNEX  
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.’EN 15.8.2013 Official Journal of the European Union L 219/25