EN 1   EN  
Draft 
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX 
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 Direct ives 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 incl uded in Annex I to Council Directive 
91/414/EEC of 15 July 1991 concerning the pl acing of plant protection products on 
the market
2 by Commission Directive 2007/52/EC3. 
(2) Commission Directive 2010/21/EU4 amended Annex I to Directive 91/414/EEC as 
regards the specific provisi ons relating to fipronil. 
(3) Active substances included in Annex I to Directive 91/414/EEC are deemed to be 
approved under Regulation (EC) No 1107/2009 a nd are listed in Part A of the Annex 
to Commission Regulation (EU) No 540/2011 of 25 May 2011 implementing 
Regulation (EC) No 1107/2009 of the Europe an Parliament and of the Council as 
regards the list of a pproved active substances 5. 
(4) Based on new information received from Italy concerning risks to honeybees caused 
by coated maize seeds treated with plant pr otection products contai ning fipronil, the 
Commission decided to revi ew the approval of that active substance. The 
                                                 
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. 31 
4  OJ L 65, 13.3.2010, p. 27 
5  OJ L 153, 11.6.2011, p. 1. EN 2   EN Commission, in accordance with Article 21( 2) of Regulation (EC) No 1107/2009, 
asked the European Food Safety Authority, he reinafter '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 th e 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 cont aining the active s ubstance fiproni. The 
Authority identified, in partic ular, a high acute ri sk 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 se veral 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 t echnical knowledge, the Commission considered 
that there are indications that some a pproved uses of fipronil do not satisfy the 
approval criteria provided for in Articl e 4 of Regulation (E C) 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 were re viewed 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 fi pronil 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 of  plant 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 fi pronil should be limited to 
the treatment of seeds intended to be sown  in greenhouses and to  the treatment of 
seeds of leek, onions and shallo ts intended to be sown in the field and harvested before 
flowering. Crops which are harvested before flowering are not considered attractive to 
bees.  
(12) Concerning applications of fipronil which may be authorised under Regulation (EU) 
No 540/2011, it is appropriate to requir e further confirmatory information. 
                                                
 
6  European Food Safety Authority; Conclusion on the peer re view of the pesticide risk assessment for bees for the 
active substance fipronil. EFSA J ournal 2013;11(5):3158. [51 pp.] doi:10.2903/ j.efsa.2013.3158. Available online: 
www.efsa.europa.eu/efsajournal  
. EN 3   EN (13) Regulation (EU) No 540/2011 should therefore be amended accordingly. 
(14) Risks for bees from treated seeds have been identified in particul ar from exposure via 
dust as regards the use in maize.  Taking into consideration th e risks linked w ith the use of 
treated seeds, the use and the placing on the market of seeds treated with plant protection 
products containing fipronil should be pr ohibited except fo r seeds sown in 
greenhouses and for treatment of seeds of l eek, onions and shallots  sown in the field 
and harvested before flowering. Pending s ubmission 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 ti me to withdraw authorisations for plant 
protection products containing fipronil.  
(16) For plant protection products containing fi pronil, where Member States grant any 
period of grace in accordan ce with Article 46 of Regulation (EC) No 1107/2009, this 
period should expire on 28 February 2014 at th e latest. Accordingly, the prohibition of 
of placing on the market of treated seeds s hould apply as of 1 Ma rch 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 initiat e a review of the ne w scientific inform ation, including new 
studies, information on new product formulatio ns provided by the applicants, which it 
has received.  
(18) Article 36(3) of Regulati on (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 pl ant protection products containing fipronil. 
Concerning the placing on the market and use of the seeds treated with plant protection 
products containing fipronil, Regula tion (EC) No 1107/2009 provides for the 
possibility of Member States to take em ergency measures pursuant to Article 71 
thereof. 
(19) The measures provided for in this Regulati on 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 Regulation (EC) No 540/2011 
The Annex to Regulation (EU) No 540/2011 is am ended in accordance with  Annex I to this 
Regulation. 
Article 2  
Prohibition of placing on th e market of treated seeds 
Seeds of crops which have been  treated with plant protecti on products containing fipronil 
shall not be used or placed on the market with the exception of seeds intended to be sown in EN 4   EN greenhouses and seeds of leek, onions and shallots 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 authorisations fo r 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 fo llowing that of its publication 
in the Official Journal of the European Union . 
However, Article 2 shall apply from 1 March 2014. This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
 
  Done at Brussels, 
 For the Commission 
 The President   José Manuel BARROSO  EN 5   EN ANNEX I  
Amendments to the Annex to Regulation (EU) No 540/2011  
(1) 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 tr eatment may be authorised. Uses shall only be 
authorised for seeds intended to be sown in gr eenhouses and seeds of leek, onions and shallots 
intended to be sown in fields and harvested before flowering.  
PART B  For the implementation of the uniform principles as referred to in Artic le 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 Committ ee 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 market ed 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 techniqu es in order to ensure that the release of 
dust during application to the seed, stor age, 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 in itiated to verify the real e xposure 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. EN 6   EN 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 dus t drift emitted during the dril ling 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 re sidues in nectar and polle n, 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.