EN    EN  
 
     
SANCO/10262/2013  
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 substances clothi anidin, thiamethoxam and imidacloprid, and 
prohibiting the use and sale of seeds treate d with plant protection products containing 
those active substances 
(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 substances clothianidin, thiame thoxam and imidacloprid were 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 Directives 2006/41/EC, 
2007/6/EC, 2008/116/EC. 
(2) Commission Directive 2010/21/EU amended Annex I to Directive 91/414/EEC as 
regards the specific provisi ons relating to the neonic otinoids clothianidin, 
thiamethoxam and imidacloprid. 
(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 3. 
(4) In spring 2012, new scientific information on the sub-lethal effects of neonicotinoids 
on bees was published. The Commission, in  accordance with Article 21(2) of 
                                                 
1 OJ L 309, 24.11.2009, p. 1. 
2 OJ L 230, 19.8.1991, p. 1. 
3  OJ L 153, 11.6.2011, p. 1.  
EN 2   EN 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 asse ssment of neonicotinoids as regards their 
impact on bees. 
(5) The Authority presented its conclusions on the risk assessment for bees for 
clothianidin, thiamethoxam and imidacloprid on 16 January 20134.  
(6) The Authority identified for certain crops high acute risks for bees from plant 
protection products containing the active s ubstances clothianidin, thiamethoxam or 
imidacloprid. The Authority identified in pa rticular high acute ri sks for bees from 
exposure via dust as regards several cr ops, from consumption of residues in 
contaminated pollen and nectar as regard s some crops and from exposure via guttation 
fluid as regards maize. In addition, unaccepta ble risks due to acute or chronic effects 
on colony survival and development coul d not be excluded for several crops. 
Furthermore the Authority identified a number  of data gaps for each of the evaluated 
crops. In particular as rega rds long term risk to honey b ees from dust exposure, from 
residues in pollen and nectar and from exposure from guttation fluid . 
(7) In the light of the new scientific and t echnical knowledge, the Commission considered 
that there are indications th at the approved uses of cl othianidin, thiamethoxam and 
imidacloprid no longer satisfiy the approval criteria provided for in Article 4 of 
Regulation (EC) No 1107/2009 with respect to their impact on bees and that the high 
risk for bees could not be excluded ex cept by imposing furthe r restrictions. In 
particular, it considered that th e risk for bees from foliar applications is similar to the 
risk identified by the Authority for seed tr eatment applications a nd granular uses, due 
to the systemic translocation of the activ e substances clothianidin, thiamethoxam and 
imidacloprid through the whole plant. 
(8) The Commission invited the notifiers to submit their comments. 
(9) The conclusions of the Authority were reviewed by the Member States and the 
Commission within the Standing Committee on the Food Chain and Animal Health 
and finalised on XXXX in the format of addend a to the review repor ts for clothianidin, 
thiamethoxam and imidacloprid. 
(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 substances  clothianidin, thiamethoxam and imidacloprid 
are to be deemed to have been ap proved under Regulation (EC) No 1107/2009. In 
order to minimise the exposure of bees, it is , however, appropriate to restrict the uses 
of those active substances and to provide for specific risk mitigation measures for the protection of bees. In particular the us e of plant protection products containing 
                                                
 
4  European Food Safety Authority; Conclu sion on the peer review of the pe sticide risk assessment for bees 
for the active substance clothianidin. EFSA Jour nal 2013;11(1):3066. [58 pp.] doi:10.2903/j.efsa.2013.3066. 
Conclusion on the peer review of th e pesticide risk assessment for bees 
for the active substance imidacloprid. EFSA Jour nal 2013;11(1):3068. [55 pp.] doi:10.2903/j.efsa.2013.  
Conclusion on the peer review of th e pesticide risk assessment for bees 
for the active substance thiame thoxam. EFSA Journal 2013;11(1):3067. [68 pp.] doi:10.2903/j.efsa.2013.3067. 
Available online: www.efsa.europa.eu/efsajournal.htm  .  
EN 3   EN clothianidin, thiamethoxam or imidacloprid s hould be prohibited fo r crops attractive to 
bees except for uses in greenhouses and ex cept for uses for the production of seeds 
and plant propagating materials and for cereals except for winter cereals. In addition the use of the plant protect ion products containing clot hianidin, thiamethoxam or 
imidacloprid should be limited to professional users. 
(12) Concerning applications of clothianidin, thiamethoxam or imidacloprid which may be 
authorised under the present Regulation, it is appropriate to  require further 
confirmatory information. 
(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 several crops, from consumpti on of residues in contaminated pollen and 
nectar as regards some  crops and from expo sure via guttation fluid as regards maize. 
Taking into consideration thos e risks linked with the use of treated seeds, the use and the 
placing on the market of seeds treated wi th plant protection products containing 
clothianidin, thiamethoxam or imidacloprid sh ould be prohibited for seeds of crops 
attractive to bees and for seeds of  cereals except winter cereals.  
(15) Member States should be provided with ti me to withdraw authorisations for plant 
protection products containing clothianidin, thiamethoxam or imidacloprid.  
(16) For plant protection products containing clothianidin, thiamethoxam or imidacloprid, 
where Member States grant an y period of grace in accor dance with Article 46 of 
Regulation (EC) No 1107/2009, this period should expire at the latest 30 June 2013. 
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 which it has received.  
(17) 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 
From 1 July 2013, seeds of crops listed in Annex II which have been treated with plant 
protection products containing cl othianidin, thiamethoxam or im idacloprid shall not be used 
or placed on the market with the exception of seeds used in greenhouses and of seeds used for 
the production of seeds.  
EN 4   EN Article 3  
Transitional measures 
Member States shall in accordance with Re gulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant pr otection products containing 
clothianidin, thiamethoxam or imidacloprid  as active substance by 30 April 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 30 June  2013 at the latest.  
Article 5 
Entry into force 
This Regulation shall enter in to force on the day following th at 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, 
 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 121, clothianidin , 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 pr ofessionals may be authorised.  
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following cereals, when such cereals are sown from January to June with the exception of 
uses for the production of seeds: 
barley, millet, oats, rice, rye,  sorghum, triticale, wheat. 
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following crops with the exception of uses in greenhouses and of uses for the production of 
seeds and plant propagating materials: 
Alfalfa Medicago sativa  
almonds Prunus amygdalus; P. communis; Amygdalus communis  
anise, badian, fennel, co rian. Including: anise ( Pimpinella anisum ); badian or star anise 
(Illicium verum ); caraway ( Carum carvi ); coriander ( Coriandrum sativum ); cumin ( Cuminum 
cyminum ); fennel ( Foeniculum vulgare ); juniper berries ( Juniperus communis ) 
apples Malus pumila ; M. sylvestris ; M. communis ; Pyrus malus  
apricots Prunus armeniaca  
artichokes Cynara scolymus  
asparagus Asparagus officinalis  
avocados Persea americana  
bananas Musa sapientum ; M. cavendishii ; M. nana  
beans Phaseolus  spp 
blueberries European blueberr y, wild bilberry, whortleberry (Vaccinium  myrtillus ); American 
blueberry ( V. corymbosum ) 
broad beans, horse beans, dry Vicia faba : horse-bean (var. equina); broad bean (var. major); 
field bean (var. minor) buckwheat Fagopyrum esculentum  (Polygonaceae) 
cabbages and other brassicas  chinese, mustard cabbage, pak-choi ( Brassica chinensis ) 
white, red, savoy cabbage, Brussels sprouts, coll ards, kale and kohlrabi (Brassica oleracea all 
var. except botrytis) carobs Ceratonia siliqua Carob-tree, locust bean carrots Daucus carota castor oil seed Ricinus communis  
cauliflowers and broccoli Brassica oleracea var. botrytis, subvariety cauliflora  and cymosa .  
cherries Mazzard, sweet cherry ( Prunus avium; Cerasus avium ); hardfleshed cherry (var. 
duracina); heart cherry (var. juliana) chestnuts ( Castanea sp ) 
chick peas Chickpea, Bengal gram, garbanzos ( Cicer arietinum ) 
chicory roots Cichorium intybus  subsp. sativum   
EN 6   EN chillies and peppers Red and cayenne pepper, paprika, chillies ( Capsicum frutescens; C. 
annuum ); allspice, Jamaica pepper ( Pimenta officinalis ) 
clover for forage and silage Trifolium spp.. Va rious species grown for pasture, green fodder 
or silage coffee, green Coffea spp. ( arabica, robusta, liberica ) 
cow peas Cowpea, blackeye pea/bean ( Vigna unguiculata ) 
cranberries American cra nberry (Vaccinium macrocarpon) ; European cranberry ( V. 
oxycoccus ) 
cucumbers and gherkins Cucumis sativus  
currants Black ( Ribes nigrum ); red and white ( R. rubrum ) 
dates Phoenix dactylifera  
garlic Allium sativum  
gooseberries Ribes grossularia  
grapefruit (inc. pomelos) Citrus maxima; C. grandis; C. paradisi  
grapes Vitis vinifera  
groundnuts, with shell Arachis hypogaea  
hazelnut ( Corylus aveliana ) 
hemp Cannabis sativa  
kiwi fruit Actinidia chinensis  
leeks, other alliaceous veg. Leeks ( Allium porrum ); chives ( A. schoenoprasum ); other alliac 
leguminous for Silage Including inter alia: bird sfoot, trefoil ( Lotus corniculatus ); lespedeza 
(Lespedeza spp .); kudzu ( Pueraria lobata ); sesbania ( Sesbania spp .); sainfoin, esparcette 
(Onobrychis sativa ); sulla ( Hedysarum coronarium ) 
leguminous vegetables, as Vicia faba  
lemons and limes Lemon ( Citrus limon ); sour lime ( C. aurantifolia ); sweet lime ( C. limetta ). 
lentils Lens esculenta; Ervum lens  
linseed Linum usitatissimum Flaxseed  
lupins Lupinus spp 
maize Zea mays Corn, Indian corn, mealies 
melonseed Cucumis melo
 
cucurbitaceae mustard seed White mustard ( Brassica alba; B. hirta; Sinapis alba ); black mustard ( Brassica 
nigra; Sinapis nigra ) 
okra Abelmoschus esculentus ; Hibiscus esculentus . Also called gombo. 
olives Olea europaea  
onions. Allium cepa  
oranges Common, sweet orange ( Citrus sinensis ); bitter orange ( C. aurantium ) 
peaches and nectarines Prunus persica ; Amygdalus persica ; Persica laevis  
pears Pyrus communis  
peas Garden pea ( Pisum sativum ); field pea ( P. arvense ) 
peppermint Mentha spp.: M. piperita  
persimmons Diospyros kaki : D. virginiana  
pistachios Pistacia vera  
plums and sloes Greengage, mirabelle, damson ( Prunus domestica ); sloe ( P. spinosa ) 
poppy seed Papaver somniferum  
pumpkins, squash and gourds Cucurbita spp . Includes marrows 
pyrethrum, Dried Chrysanthemum cinerariifolium  
quinces Cydonia oblonga ; C. vulgaris ; C. japonica  
rapeseed Brassica napus  var. oleifera. 
raspberries Rubus idaeus  
safflower seed Carthamus tinctorius   
EN 7   EN seed cotton Gossypium  spp 
sesame seed Sesamum indicum  
soybeans Glycine soja  
spices, including inter alia: bay leaves ( Laurus nobilis ); dill seed ( Anethum graveolens ); 
fenugreek seed ( Trigonella foenumgraecum ); saffron ( Crocus sativus ); thyme ( Thymus 
vulgaris ); turmeric ( Curcuma longa )  
strawberries Fragaria spp 
sunflower seed Helianthus annuus  
tangerines, mandarins, clem. Mandarin, tangerine ( Citrus reticulata ); clementine, satsuma ( C. 
unshiu ) 
tobacco, unmanufactured. Nicotiana tabacum  
turnips for Fodder. Brassica rapa var. rapifera  
vetches Spring/common vetch ( Vicia sativa ) 
walnuts, with shell Jugland  spp.: J. regia  
watermelons Citrullus vulgaris  
ornamentals flowering in year of treatment. 
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 clothianidi n, and in particular 
Appendices I and II thereof, as finalised in the Standing Committ ee on the Food Chain and 
Animal Health on 27 January 2006 and the conclu sions of the addendum of  the review report 
on clothianidin as finalised in the Standing Committee on the Food Chai n and Animal Health 
on xxxxxxx shall be taken into account. 
In this overall assessment Member States shall pay particular attention to: –– the protection of groundwater, when the activ e substance is applied in regions with 
vulnerable soil and/or climate conditions, 
–– the risk to granivorous birds and mammals  when the substance is used as a seed 
dressing. 
Member States shall ensure that:  – the seed coating shall only be performed in  professional seed treatment facilities. 
Those facilities must apply the best availabl e techniques in order to ensure that the 
release of dust during application to th e seed, storage, a nd transport can be 
minimised; 
– adequate seed drilling equipment shall be used to ensure a high degree of 
incorporation in soil, minimisation of sp illage and minimisation of dust emission.  
– the label of the treated seed includes the i ndication that the seeds were treated with 
clothianidin and sets out the risk mitigation measures provided for in the authorisation;  
– the conditions of the authorisation, in particular for spray applications, include, 
where appropriate, risk mitigation measures to protect honey bees;   
EN 8   EN – monitoring programmes are ini tiated to verify the real exposure of honey bees to 
clothianidin 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 honey bees foraging in  nectar or pollen in succeeding crops; 
(b) the potential uptake via r oots to flowering weeds; 
(c) the risk to honey bees foraging on insect honey dew; (d) the potential guttation exposure and the acute and the long-te rm risk to colony 
survival and development, and the risk to  bee brood resulting from such exposure  
(e) Further information to address the acute and long term risk to colony survival and 
development and the risk to bee brood for honeybees from dust drift following drill. 
The notifier shall submit that information to  the Commission, the Member States and the 
Authority by 31 December 2014.' 
(2) The column 'Specific provisions' of row 140, thiamethoxam  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 pr ofessionals may be authorised.  
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following cereals, when such cereals are sown from January to June with the exception of 
uses for the production of seeds: 
barley, millet, oats, rice, rye,  sorghum, triticale, wheat 
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following crops with the exception of uses in greenhouses and of uses for the production of 
seeds and plant propagating materials:  
Alfalfa Medicago sativa  
almonds Prunus amygdalus; P. communis; Amygdalus communis  
anise, badian, fennel, co rian. Including: anise ( Pimpinella anisum ); badian or star anise 
(Illicium verum ); caraway ( Carum carvi ); coriander ( Coriandrum sativum ); cumin ( Cuminum 
cyminum ); fennel ( Foeniculum vulgare ); juniper berries ( Juniperus communis ) 
apples Malus pumila ; M. sylvestris ; M. communis ; Pyrus malus  
apricots Prunus armeniaca  
artichokes Cynara scolymus  
asparagus Asparagus officinalis  
avocados Persea americana  
bananas Musa sapientum ; M. cavendishii ; M. nana  
beans Phaseolus  spp  
EN 9   EN blueberries European blueberr y, wild bilberry, whortleberry (Vaccinium  myrtillus ); American 
blueberry ( V. corymbosum ) 
broad beans, horse beans, dry Vicia faba : horse-bean (var. equina); broad bean (var. major); 
field bean (var. minor) buckwheat Fagopyrum esculentum  (Polygonaceae) 
cabbages and other brassicas  chinese, mustard cabbage, pak-choi ( Brassica chinensis ) 
white, red, savoy cabbage, Brussels sprouts, coll ards, kale and kohlrabi (Brassica oleracea all 
var. except botrytis) carobs Ceratonia siliqua Carob-tree, locust bean carrots Daucus carota castor oil seed Ricinus communis  
cauliflowers and broccoli Brassica oleracea var. botrytis, subvariety cauliflora  and cymosa .  
cherries Mazzard, sweet cherry ( Prunus avium; Cerasus avium ); hardfleshed cherry (var. 
duracina); heart cherry (var. juliana) chestnuts ( Castanea sp ) 
chick peas Chickpea, Bengal gram, garbanzos ( Cicer arietinum ) 
chicory roots Cichorium intybus  subsp. sativum  
chillies and peppers Red and cayenne pepper, paprika, chillies ( Capsicum frutescens; C. 
annuum ); allspice, Jamaica pepper ( Pimenta officinalis ) 
clover for forage and silage Trifolium spp.. Va rious species grown for pasture, green fodder 
or silage coffee, green Coffea spp. ( arabica, robusta, liberica ) 
cow peas Cowpea, blackeye pea/bean ( Vigna unguiculata ) 
cranberries American cra nberry (Vaccinium macrocarpon) ; European cranberry ( V. 
oxycoccus ) 
cucumbers and gherkins Cucumis sativus  
currants Black ( Ribes nigrum ); red and white ( R. rubrum ) 
dates Phoenix dactylifera  
garlic Allium sativum  
gooseberries Ribes grossularia  
grapefruit (inc. pomelos) Citrus maxima; C. grandis; C. paradisi  
grapes Vitis vinifera  
groundnuts, with shell Arachis hypogaea  
hazelnut ( Corylus aveliana ) 
hemp Cannabis sativa  
kiwi fruit Actinidia chinensis  
leeks, other alliaceous veg. Leeks ( Allium porrum
); chives ( A. schoenoprasum ); other alliac 
leguminous for Silage Including inter alia: bird sfoot, trefoil ( Lotus corniculatus ); lespedeza 
(Lespedeza spp .); kudzu ( Pueraria lobata ); sesbania ( Sesbania spp .); sainfoin, esparcette 
(Onobrychis sativa ); sulla ( Hedysarum coronarium ) 
leguminous vegetables, as Vicia faba  
lemons and limes Lemon ( Citrus limon ); sour lime ( C. aurantifolia ); sweet lime ( C. limetta ). 
lentils Lens esculenta; Ervum lens  
linseed Linum usitatissimum Flaxseed  
lupins Lupinus spp 
maize Zea mays Corn, Indian corn, mealies 
melonseed Cucumis melo  
cucurbitaceae mustard seed White mustard ( Brassica alba; B. hirta; Sinapis alba ); black mustard ( Brassica 
nigra; Sinapis nigra )  
EN 10   EN okra Abelmoschus esculentus ; Hibiscus esculentus . Also called gombo. 
olives Olea europaea  
onions. Allium cepa  
oranges Common, sweet orange ( Citrus sinensis ); bitter orange ( C. aurantium ) 
peaches and nectarines Prunus persica ; Amygdalus persica ; Persica laevis  
pears Pyrus communis  
peas Garden pea ( Pisum sativum ); field pea ( P. arvense ) 
peppermint Mentha spp.: M. piperita  
persimmons Diospyros kaki : D. virginiana  
pistachios Pistacia vera  
plums and sloes Greengage, mirabelle, damson ( Prunus domestica ); sloe ( P. spinosa ) 
poppy seed Papaver somniferum  
pumpkins, squash and gourds Cucurbita spp . Includes marrows 
pyrethrum, Dried Chrysanthemum cinerariifolium  
quinces Cydonia oblonga ; C. vulgaris ; C. japonica  
rapeseed Brassica napus  var. oleifera. 
raspberries Rubus idaeus  
safflower seed Carthamus tinctorius  
seed cotton Gossypium  spp 
sesame seed Sesamum indicum  
soybeans Glycine soja  
spices, including inter alia: bay leaves ( Laurus nobilis ); dill seed ( Anethum graveolens ); 
fenugreek seed ( Trigonella foenumgraecum ); saffron ( Crocus sativus ); thyme ( Thymus 
vulgaris ); turmeric ( Curcuma longa )  
strawberries Fragaria spp 
sunflower seed Helianthus annuus  
tangerines, mandarins, clem. Mandarin, tangerine ( Citrus reticulata ); clementine, satsuma ( C. 
unshiu ) 
tobacco, unmanufactured. Nicotiana tabacum  
turnips for Fodder. Brassica rapa var. rapifera  
vetches Spring/common vetch ( Vicia sativa ) 
walnuts, with shell Jugland  spp.: J. regia  
watermelons Citrullus vulgaris  
ornamentals flowering in year of treatment. 
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 thiamethoxam, and in particular 
Appendices I and II thereof, as finalised in the Standing Committ ee on the Food Chain and 
Animal Health on 14 July 2006 and the conclusi ons of the addendum of the review report on 
thiamethoxam as finalised in the Standing Committee on the Food Chain and Animal Health on xxxxxxx shall be taken into account. 
In this overall assessment Member Stat es must pay particular attention to: 
the potential for groundwater contamination, part icularly of the active substance and its 
metabolites NOA 459602, SYN 501406 and CGA 32270 4, when the active substance is 
applied in regions with vulnerable  soil and/or climatic conditions, 
the protection of aquatic organisms,  
EN 11   EN the long-term risk to small herbivorous animals if the substance is used for seed treatment. 
Member States shall ensure that:  – the seed coating shall only be performed in  professional seed treatment facilities. 
Those facilities must apply the best availabl e techniques in order to ensure that the 
release of dust during application to th e seed, storage, a nd transport can be 
minimised; 
– adequate seed drilling equipment shall be used to ensure a high degree of 
incorporation in soil, minimisation of sp illage and minimisation of dust emission.  
– the label of the treated seed includes the i ndication that the seeds were treated with 
thiamethoxam and sets out the risk m itigation measures provided for in the 
authorisation;  
– the conditions of the authorisation, in particular for spray applications, include, 
where appropriate, risk mitigation measures to protect honey bees;  
– monitoring programmes are ini tiated to verify the real exposure of honey bees to 
thiamethoxam 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 honey bees foraging in  nectar or pollen in succeeding crops; 
(b) the potential uptake via r oots to flowering weeds; 
(c) the risk to honey bees foraging on insect honey dew; (d) the potential guttation exposure and the acute and the long-te rm risk to colony 
survival and development, and the risk to  bee brood resulting from such exposure  
(e) Further information to address the acute and long term risk to colony survival and 
development and the risk to bee brood for honeybees from dust drift following drill. 
The notifier shall submit that information to  the Commission, the Member States and the 
Authority by 31 December 2014.' 
(3) The column 'Specific provisions' of row 216, imidacloprid,  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 pr ofessionals may be authorised.  
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following cereals, when such cereals are sowed from January to June with the exception of 
uses for the production of seeds:  
EN 12   EN barley, millet, oats, rice, rye,  sorghum, triticale, wheat 
Uses as seed treatment, soil treatment or foliar application shall not be authorised for the 
following crops with the exception of uses in greenhouses and of uses for the production of 
seeds and plant propagating materials:  
Alfalfa Medicago sativa  
almonds Prunus amygdalus; P. communis; Amygdalus communis  
anise, badian, fennel, co rian. Including: anise ( Pimpinella anisum ); badian or star anise 
(Illicium verum ); caraway ( Carum carvi ); coriander ( Coriandrum sativum ); cumin ( Cuminum 
cyminum ); fennel ( Foeniculum vulgare ); juniper berries ( Juniperus communis ) 
apples Malus pumila ; M. sylvestris ; M. communis ; Pyrus malus  
apricots Prunus armeniaca  
artichokes Cynara scolymus  
asparagus Asparagus officinalis  
avocados Persea americana  
bananas Musa sapientum ; M. cavendishii ; M. nana  
beans Phaseolus  spp 
blueberries European blueberr y, wild bilberry, whortleberry (Vaccinium  myrtillus ); American 
blueberry ( V. corymbosum ) 
broad beans, horse beans, dry Vicia faba : horse-bean (var. equina); broad bean (var. major); 
field bean (var. minor) buckwheat Fagopyrum esculentum  (Polygonaceae) 
cabbages and other brassicas  chinese, mustard cabbage, pak-choi ( Brassica chinensis ) 
white, red, savoy cabbage, Brussels sprouts, coll ards, kale and kohlrabi (Brassica oleracea all 
var. except botrytis) carobs Ceratonia siliqua Carob-tree, locust bean 
carrots Daucus carota 
castor oil seed Ricinus communis  
cauliflowers and broccoli Brassica oleracea var. botrytis, subvariety cauliflora  and cymosa .  
cherries Mazzard, sweet cherry ( Prunus avium; Cerasus avium ); hardfleshed cherry (var. 
duracina); heart cherry (var. juliana) chestnuts ( Castanea sp ) 
chick peas Chickpea, Bengal gram, garbanzos ( Cicer arietinum ) 
chicory roots 
Cichorium intybus  subsp. sativum  
chillies and peppers Red and cayenne pepper, paprika, chillies ( Capsicum frutescens; C. 
annuum ); allspice, Jamaica pepper ( Pimenta officinalis ) 
clover for forage and silage Trifolium spp.. Va rious species grown for pasture, green fodder 
or silage coffee, green Coffea spp. ( arabica, robusta, liberica ) 
cow peas Cowpea, blackeye pea/bean ( Vigna unguiculata ) 
cranberries American cra nberry (Vaccinium macrocarpon) ; European cranberry ( V. 
oxycoccus ) 
cucumbers and gherkins Cucumis sativus  
currants Black ( Ribes nigrum ); red and white ( R. rubrum ) 
dates Phoenix dactylifera  
garlic Allium sativum  
gooseberries Ribes grossularia  
grapefruit (inc. pomelos) Citrus maxima; C. grandis; C. paradisi  
grapes Vitis vinifera   
EN 13   EN groundnuts, with shell Arachis hypogaea  
hazelnut ( Corylus aveliana ) 
hemp Cannabis sativa  
kiwi fruit Actinidia chinensis  
leeks, other alliaceous veg. Leeks ( Allium porrum ); chives ( A. schoenoprasum ); other alliac 
leguminous for Silage Including inter alia: bird sfoot, trefoil ( Lotus corniculatus ); lespedeza 
(Lespedeza spp .); kudzu ( Pueraria lobata ); sesbania ( Sesbania spp .); sainfoin, esparcette 
(Onobrychis sativa ); sulla ( Hedysarum coronarium ) 
leguminous vegetables, as Vicia faba  
lemons and limes Lemon ( Citrus limon ); sour lime ( C. aurantifolia ); sweet lime ( C. limetta ). 
lentils Lens esculenta; Ervum lens  
linseed Linum usitatissimum Flaxseed  
lupins Lupinus spp 
maize Zea mays Corn, Indian corn, mealies 
melonseed Cucumis melo  
cucurbitaceae mustard seed White mustard ( Brassica alba; B. hirta; Sinapis alba ); black mustard ( Brassica 
nigra; Sinapis nigra ) 
okra Abelmoschus esculentus ; Hibiscus esculentus . Also called gombo. 
olives Olea europaea  
onions. Allium cepa  
oranges Common, sweet orange ( Citrus sinensis ); bitter orange ( C. aurantium ) 
peaches and nectarines Prunus persica ; Amygdalus persica ; Persica laevis  
pears Pyrus communis  
peas Garden pea ( Pisum sativum ); field pea ( P. arvense ) 
peppermint Mentha spp.: M. piperita  
persimmons Diospyros kaki : 
D. virginiana  
pistachios Pistacia vera  
plums and sloes Greengage, mirabelle, damson ( Prunus domestica ); sloe ( P. spinosa ) 
poppy seed Papaver somniferum  
pumpkins, squash and gourds Cucurbita spp . Includes marrows 
pyrethrum, Dried Chrysanthemum cinerariifolium  
quinces Cydonia oblonga ; C. vulgaris ; C. japonica  
rapeseed Brassica napus  var. oleifera. 
raspberries Rubus idaeus  
safflower seed Carthamus tinctorius  
seed cotton Gossypium  spp 
sesame seed Sesamum indicum  
soybeans Glycine soja  
spices, including inter alia: bay leaves ( Laurus nobilis ); dill seed ( Anethum graveolens ); 
fenugreek seed ( Trigonella foenumgraecum ); saffron ( Crocus sativus ); thyme ( Thymus 
vulgaris ); turmeric ( Curcuma longa )  
strawberries Fragaria spp 
sunflower seed Helianthus annuus  
tangerines, mandarins, clem. Mandarin, tangerine ( Citrus reticulata ); clementine, satsuma ( C. 
unshiu ) 
tobacco, unmanufactured. Nicotiana tabacum  
turnips for Fodder. Brassica rapa var. rapifera  
vetches Spring/common vetch ( Vicia sativa ) 
walnuts, with shell Jugland  spp.: J. regia  
watermelons Citrullus vulgaris   
EN 14   EN ornamentals flowering in year of treatment. 
PART B 
In assessing applications to authorise plan t protection products containing imidacloprid, 
Member States shall pay particular attention to the criteria in Article 4(3) 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 Artic le 29(6) of Regulation 
(EC) No 1107/2009, the conclusions  of the review report on im idacloprid, and in particular 
Appendices I and II thereof, as finalised in the Standing Committ ee on the Food Chain and 
Animal Health on 26 September 2008 and the conclusions of the addendum of the review report on imidacloprid as finalised in the Standing Committee on the Food Chain and Animal Health on xxxxxxx shall be taken into account. 
In this overall assessment Member Stat es must pay particular attention to: 
–– the operator and worker safe ty and ensure that condit ions of use prescribe the 
application of adequate pe rsonal protective equipment, 
–– the impact on aquatic organisms, non-ta rget arthropods, earthworms, other soil 
macroorganisms and must ensure that the conditions of authorisation include, where 
appropriate, risk mitigation measures. 
Member States shall ensure that:  – the seed coating shall only be performed in  professional seed treatment facilities. 
Those facilities must apply the best availabl e techniques in order to ensure that the 
release of dust during application to th e seed, storage, and transport can be 
minimised; 
– adequate seed drilling equipment shall be used to ensure a high degree of 
incorporation in soil, minimisation of sp illage and minimisation of dust emission.  
– the label of the treated seed includes the i ndication that the seeds were treated with 
imidacloprid and sets out the risk m itigation measures provided for in the 
authorisation;  
– the conditions of the authorisation, in particular for spray applications, include, 
where appropriate, risk mitigation measures to protect honey bees;  
– monitoring programmes are ini tiated to verify the real exposure of honey bees to 
imidacloprid in areas extensively used by b ees 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 honey bees foraging in  nectar or pollen in succeeding crops;  
EN 15   EN (b) the potential uptake via r oots to flowering weeds; 
(c) the risk to honey bees foraging on insect honey dew; (d) the potential guttation exposure and the acute and the long-te rm risk to colony 
survival and development, and the risk to  bee brood resulting from such exposure; 
(e) Further information to address the acute and long term risk to colony survival and 
development and the risk to bee brood for honeybees from dust drift following drill. 
The notifier shall submit that information to  the Commission, the Member States and the 
Authority by 31 December 2014.'  
EN 16   EN  
Annex II  
List of seeds, as referred to in Article 2  
Seeds treated with plant protection products containing clothianidin, thiametoxam or 
imidacloprid whose use and placing on the market is prohibited: 
Barley, millet, oats, rice, rye, so rghum, triticale, wheat when such  cereals are to be sown from 
January to June. 
Alfalfa Medicago sativa  
anise, badian, fennel, co rian. Including: anise ( Pimpinella anisum ); badian or star anise 
(Illicium verum ); caraway ( Carum carvi ); coriander ( Coriandrum sativum ); cumin ( Cuminum 
cyminum ); fennel ( Foeniculum vulgare ); juniper berries ( Juniperus communis ) 
asparagus Asparagus officinalis  
beans Phaseolus  spp 
broad beans, horse beans, dry Vicia faba : horse-bean (var. equina); broad bean (var. major); 
field bean (var. minor) buckwheat Fagopyrum esculentum  (Polygonaceae) 
cabbages and other brassicas  chinese, mustard cabbage, pak-choi ( Brassica chinensis ) 
white, red, savoy cabbage, Brussels sprouts, coll ards, kale and kohlrabi (Brassica oleracea all 
var. except botrytis) carrots Daucus carota castor oil seed Ricinus communis  
cauliflowers and broccoli Brassica oleracea var. botry tis, subvariety cauliflora  and cymosa . 
Includes headed broccoli chick peas Chickpea, Bengal gram, garbanzos ( Cicer arietinum ) 
chicory roots Cichorium intybus  subsp. sativum  
chillies and peppers Red and cayenne pepper, paprika, chillies ( Capsicum frutescens; C. 
annuum ); allspice, Jamaica pepper ( Pimenta officinalis ) 
clover for forage and silage Trifolium  spp.. Various species grown for pasture, green fodder or 
silage coffee, green Coffea spp . (arabica, robusta, liberica ) 
cow peas Cowpea, blackeye pea/bean ( Vigna unguiculata ) 
cucumbers and gherkins Cucumis sativus  
garlic Allium sativum  
groundnuts, with shell Arachis hypogaea  
hemp Cannabis sativa  
leeks, other alliaceous veg. Leeks ( Allium porrum ); chives ( A. schoenoprasum ); other alliac 
leguminous for Silage Including inter alia: bird sfoot, trefoil ( Lotus corniculatus
); lespedeza 
(Lespedeza spp .); kudzu ( Pueraria lobata ); sesbania ( Sesbania spp .); sainfoin, esparcette 
(Onobrychis sativa ); sulla ( Hedysarum coronarium ) 
leguminous vegetables, as Vicia faba  
lentils Lens esculenta; Ervum lens  
linseed Linum usitatissimum Flaxseed  
lupins Lupinus spp 
maize Zea mays Corn, Indian corn, mealies 
melonseed Cucumis melo  
cucurbitaceae  
EN 17   EN mustard seed White mustard ( Brassica alba; B. hirta; Sinapis alba ); black mustard ( Brassica 
nigra; Sinapis nigra ) 
okra Abelmoschus esculentus ; Hibiscus esculentus . Also called gombo. 
onions. Allium cepa  
peas Garden pea ( Pisum sativum ); field pea ( P. arvense ) 
peppermint Mentha spp.: M. piperita  
poppy seed Papaver somniferum  
pumpkins, squash and gourds Cucurbita spp . Includes marrows 
pyrethrum, Dried Chrysanthemum cinerariifolium  
rapeseed Brassica napus  var. oleifera. 
safflower seed Carthamus tinctorius  
seed cotton Gossypium  spp 
sesame seed Sesamum indicum  
soybeans Glycine soja  
spices, including inter alia: bay leaves ( Laurus nobilis ); dill seed ( Anethum graveolens ); 
fenugreek seed ( Trigonella foenumgraecum ); saffron ( Crocus sativus ); thyme ( Thymus 
vulgaris ); turmeric ( Curcuma longa )  
strawberries Fragaria spp  
sunflower seed Helianthus annuus  
tobacco, unmanufactured. Nicotiana tabacum  
turnips for Fodder. Brassica rapa var. rapifera  
vetches Spring/common vetch ( Vicia sativa ) 
watermelons Citrullus vulgaris  
ornamentals flowering in year of treatment.