title: Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances  Text with EEA relevance

text:
               25.5.2013

               EN

               Official Journal of the European Union

               L 139/12

         COMMISSION IMPLEMENTING REGULATION (EU) No 485/2013
   of 24 May 2013
   amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated 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 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 substances clothianidin, thiamethoxam 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 (3), 2007/6/EC (4) and 2008/116/EC (5).

               (2)

               Commission Directive 2010/21/EU (6) amended Annex I to Directive 91/414/EEC as regards the specific provisions relating to the neonicotinoids 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 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 (7).

               (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 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 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 2013 (8).

               (6)

               The Authority identified for certain crops high acute risks for bees from plant protection products containing the active substances clothianidin, thiamethoxam or imidacloprid. The Authority identified in particular high acute risks for bees from exposure via dust as regards several crops, from consumption of residues in contaminated pollen and nectar as regards some crops and from exposure via guttation fluid as regards maize. 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 a number of data gaps for each of the evaluated crops. In particular as regards long term risk to honey bees from dust exposure, from residues in pollen and nectar and from exposure from guttation fluid.

               (7)

               In the light of the new scientific and technical knowledge, the Commission considered that there are indications that the approved uses of clothianidin, thiamethoxam and imidacloprid no longer satisfy 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 except by imposing further restrictions. In particular, pending the evaluation of the Authority on foliar uses it considered that the risk for bees from foliar applications is similar to the risk identified by the Authority for seed treatment applications and soil treatment, due to the systemic translocation of the active substances clothianidin, thiamethoxam and imidacloprid through the 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 15 March 2013 in the format of addenda to the review reports 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 approved 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, to provide for specific risk mitigation measures for the protection of bees and to limit the use of the plant protection products containing those active substances to professional users. In particular the uses as seed treatment and soil treatment of plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for crops attractive to bees and for cereals except for uses in greenhouses and for winter cereals. Foliar treatments with plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for crops attractive to bees and for cereals with the exception of uses in greenhouses and uses after flowering. Crops which are harvested before flowering are not considered attractive to bees.

               (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)

               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 several crops, from consumption of residues in contaminated pollen and nectar as regards some crops and from exposure via guttation fluid as regards maize. Taking into consideration those risks linked with the use of treated seeds, the use and the placing on the market of seeds treated with plant protection products containing clothianidin, thiamethoxam or imidacloprid should be prohibited for seeds of crops attractive to bees and for seeds of cereals except for winter cereals and seeds used in greenhouses.

               (15)

               Member States should be provided with time 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 any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 30 November 2013. Within two years from the date of entry into force of the present Regulation the Commission will initiate without undue delay a review of the new scientific information which it has received.

               (17)

               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 clothianidin, thiamethoxam or imidacloprid. Concerning the placing on the market and use of the seeds treated with plant protection products containing clothianidin, thiamethoxam or imidacloprid, Regulation (EC) No 1107/2009 provides for the possibility of Member States to take emergency measures pursuant to Article 71 thereof.

               (18)

               The prohibition of placing on the market of treated seeds should apply only as of 1 December 2013 in order to allow for a sufficient period of transition. National interim protective measures already taken pursuant to Article 71 of Regulation (EC) No 1107/2009 may be maintained until that date in accordance with Article 71(3) of that Regulation.

               (19)

               Seeds treated with plant protection products containing clothianidin, thiamethoxam or imidacloprid, 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 Standing Committee on the Food Chain and Animal Health did not deliver an opinion. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

         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 Annex I to this Regulation.
   Article 2
   Prohibition of placing on the market of treated seeds
   Seeds of crops listed in Annex II which have been treated with plant protection products containing clothianidin, thiamethoxam or imidacloprid shall not be used or placed on the market with the exception of seeds used in greenhouses.
   Article 3
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing clothianidin, thiamethoxam or imidacloprid as active substance by 30 September 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 November 2013 at the latest.
   Article 5
   Entry into force
   This Regulation shall enter into force on and apply from the day following that of its publication in the Official Journal of the European Union.
   However, Article 2 shall apply as of 1 December 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 24 May 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 187, 8.7.2006, p. 24.

      (4)  OJ L 43, 15.2.2007, p. 13.

      (5)  OJ L 337, 16.12.2008, p. 86.

      (6)  OJ L 65, 13.3.2010, p. 27.

      (7)  OJ L 153, 11.6.2011, p. 1.

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin. EFSA Journal 2013; 11(1):3066. [58 pp.] doi:10.2903/j.efsa.2013.3066.
   Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid. EFSA Journal 2013; 11(1):3068. [55 pp.] doi:10.2903/j.efsa.2013.
   Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam. EFSA Journal 2013; 11(1):3067. [68 pp.] doi:10.2903/j.efsa.2013.3067. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX I

         Amendments to the Annex to Implementing 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 professional uses as insecticide may be authorised.
                  Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:
                  barley, millet, oats, rice, rye, sorghum, triticale, wheat.
                  Foliar treatments shall not be authorised for the following cereals:
                  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 with the exception of foliar treatments after flowering:

                              Alfalfa (Medicago sativa)

                              almonds (Prunus amygdalus; P. communis; Amygdalus communis)

                              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)

                              avocados (Persea americana)

                              bananas (Musa sapientum; M. cavendishii; M. nana);

                              beans (Phaseolus spp.)

                              blackberry (Rubus fruticosus)

                              blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

                              broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

                              buckwheat (Fagopyrum esculentum)

                              carobs, carob-tree, locust bean (Ceratonia siliqua)

                              castor oil seed (Ricinus communis)

                              cherries (Prunus avium)

                              chestnuts (Castanea spp.)

                              chick peas (Cicer arietinum)

                              chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

                              clovers (Trifolium spp.)

                              coffee (Coffea spp. arabica, robusta, liberica)

                              cotton (Gossypium spp.)

                              cowpeas, black eyed peas (Vigna unguiculata)

                              cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

                              cucumbers (Cucumis sativus)

                              currants black (Ribes nigrum); red and white (R. rubrum)

                              dates (Phoenix dactylifera)

                              elderberries (Sambucus nigra)

                              gooseberries (Ribes uva-crispa)

                              grapefruit (C. paradisi)

                              grapes (Vitis vinifera)

                              groundnuts/peanuts (Arachis hypogea)

                              hazelnut (Corylus avellana)

                              hemp (Cannabis sativa)

                              japanese rose (Rosa rugosa)

                              kiwi fruit (Actinidia chinensis)

                              leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

                              lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

                              lentils (Lens esculenta; Ervum lens)

                              linseed (Linum usitatissimum)

                              lupins (Lupinus spp.)

                              maize/corn (Zea mays)

                              melon seeds (Cucumis melo)

                              mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

                              okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

                              olives (Olea europaea)

                              oranges: 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, gourds and marrows (Cucurbita spp.)

                              pyrethrum, (Chrysanthemum cinerariifolium)

                              quinces (Cydonia oblonga; C. vulgaris; C. japonica)

                              rapeseed (Brassica napus var. oleifera)

                              raspberries (Rubus idaeus)

                              safflower seed (Carthamus tinctorius)

                              serradella/birds foot (Ornithopus sativus)

                              sesame seed (Sesamum indicum)

                              soybeans (Glycine soja)

                              spices: 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)

                              tangerine (Citrus tangerina); mandarin (Citrus reticulata); clementine (C. unshiu);

                              turnips and turnip rapes (Brassica rapa var. rapifera and oleifera spp.)

                              vetches Spring/common vetch (Vicia sativa)

                              viper’s Grass (Scorzonera hispanica)

                              walnuts (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 Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the addendum of the review report on clothianidin as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of groundwater, when the active 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 available techniques in order to ensure that the release of dust during application to the 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 spillage and minimisation of dust emission,

                              —

                              the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees,

                              —

                              monitoring programmes are initiated to verify the real exposure of 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 pollinators other than honey bees;

                              (b)

                              the risk to honey bees foraging in nectar or pollen in succeeding crops;

                              (c)

                              the potential uptake via roots to flowering weeds;

                              (d)

                              the risk to honey bees foraging on insect honey dew;

                              (e)

                              the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (f)

                              the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (g)

                              the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

                        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 professional uses as insecticide may be authorised.
                  Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:
                  barley, millet, oats, rice, rye, sorghum, triticale, wheat.
                  Foliar treatments shall not be authorised for the following cereals:
                  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 with the exception of foliar treatment after flowering:

                              Alfalfa (Medicago sativa)

                              almonds (Prunus amygdalus; P. communis; Amygdalus communis)

                              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)

                              avocados (Persea americana)

                              bananas (Musa sapientum; M. cavendishii; M. nana)

                              beans (Phaseolus spp.)

                              blackberry (Rubus fruticosus)

                              blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

                              broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

                              buckwheat (Fagopyrum esculentum)

                              carobs, carob-tree, locust bean (Ceratonia siliqua)

                              castor oil seed (Ricinus communis)

                              cherries (Prunus avium)

                              chestnuts (Castanea spp.)

                              chick peas (Cicer arietinum)

                              chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

                              clovers (Trifolium spp.)

                              coffee (Coffea spp. arabica, robusta, liberica)

                              cotton (Gossypium spp.)

                              cowpeas, black eyed peas (Vigna unguiculata)

                              cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

                              cucumbers (Cucumis sativus)

                              currants black (Ribes nigrum); red and white (R. rubrum)

                              dates (Phoenix dactylifera)

                              elderberries (Sambucus nigra)

                              gooseberries (Ribes uva-crispa)

                              grapefruit (C. paradisi)

                              grapes (Vitis vinifera)

                              groundnuts/peanuts (Arachis hypogea)

                              hazelnut (Corylus avellana)

                              hemp (Cannabis sativa)

                              japanese rose (Rosa rugosa)

                              kiwi fruit (Actinidia chinensis)

                              leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

                              lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

                              lentils (Lens esculenta; Ervum lens)

                              linseed (Linum usitatissimum)

                              lupins (Lupinus spp.)

                              maize/corn (Zea mays)

                              melon seeds (Cucumis melo)

                              mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

                              okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

                              olives (Olea europaea)

                              oranges: 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, gourds and marrows (Cucurbita spp.)

                              pyrethrum, (Chrysanthemum cinerariifolium)

                              quinces (Cydonia oblonga; C. vulgaris; C. japonica)

                              rapeseed (Brassica napus var. oleifera)

                              raspberries (Rubus idaeus)

                              safflower seed (Carthamus tinctorius)

                              serradella/birds foot(Ornithopus sativus)

                              sesame seed (Sesamum indicum)

                              soybeans (Glycine soja)

                              spices: 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)

                              tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu);

                              turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.)

                              vetches Spring/common vetch (Vicia sativa)

                              viper’s Grass (Scorzonera hispanica)

                              walnuts (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 Article 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 Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the addendum of the review report on thiamethoxam as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                              —

                              the protection of aquatic organisms,

                              —

                              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 available techniques in order to ensure that the release of dust during application to the 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 spillage and minimisation of dust emission,

                              —

                              the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees,

                              —

                              monitoring programmes are initiated to verify the real exposure of 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 pollinators other than honey bees;

                              (b)

                              the risk to honey bees foraging in nectar or pollen in succeeding crops;

                              (c)

                              the potential uptake via roots to flowering weeds;

                              (d)

                              the risk to honey bees foraging on insect honey dew;

                              (e)

                              the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (f)

                              the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (g)

                              the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

                        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 professional uses as insecticide may be authorised.
                  Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:
                  barley, millet, oats, rice, rye, sorghum, triticale, wheat.
                  Foliar treatments shall not be authorised for the following cereals:
                  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 with the exception of foliar treatment after flowering:

                              Alfalfa (Medicago sativa)

                              almonds (Prunus amygdalus; P. communis; Amygdalus communis)

                              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)

                              avocados (Persea americana)

                              bananas (Musa sapientum; M. cavendishii; M. nana)

                              beans (Phaseolus spp.)

                              blackberry (Rubus fruticosus)

                              blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum)

                              broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor)

                              buckwheat (Fagopyrum esculentum)

                              carobs, carob-tree, locust bean (Ceratonia siliqua)

                              castor oil seed (Ricinus communis)

                              cherries (Prunus avium)

                              chestnuts (Castanea spp.)

                              chick peas (Cicer arietinum)

                              chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

                              clovers (Trifolium spp.)

                              coffee (Coffea spp. arabica, robusta, liberica)

                              cotton (Gossypium spp.)

                              cowpeas, black eyed peas (Vigna unguiculata)

                              cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus)

                              cucumbers (Cucumis sativus)

                              currants black (Ribes nigrum); red and white (R. rubrum)

                              dates (Phoenix dactylifera)

                              elderberries (Sambucus nigra)

                              gooseberries (Ribes uva-crispa)

                              grapefruit (C. paradisi)

                              grapes (Vitis vinifera)

                              groundnuts/peanuts (Arachis hypogea)

                              hazelnut (Corylus avellana)

                              hemp (Cannabis sativa)

                              japanese rose (Rosa rugosa)

                              kiwi fruit (Actinidia chinensis)

                              leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

                              lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta)

                              lentils (Lens esculenta; Ervum lens)

                              linseed (Linum usitatissimum)

                              lupins (Lupinus spp.)

                              maize/corn (Zea mays)

                              melon seeds (Cucumis melo)

                              mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

                              okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

                              olives (Olea europaea)

                              oranges: 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, gourds and marrows (Cucurbita spp.)

                              pyrethrum, (Chrysanthemum cinerariifolium)

                              quinces (Cydonia oblonga; C. vulgaris; C. japonica)

                              rapeseed (Brassica napus var. oleifera)

                              raspberries (Rubus idaeus)

                              safflower seed (Carthamus tinctorius)

                              serradella/birds foot (Ornithopus sativus)

                              sesame seed (Sesamum indicum)

                              soybeans (Glycine soja)

                              spices: 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)

                              tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu);

                              turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.)

                              vetches Spring/common vetch (Vicia sativa)

                              viper’s Grass (Scorzonera hispanica)

                              walnuts (Jugland spp.: J. regia)

                              watermelons (Citrullus vulgaris)

                              ornamentals flowering in year of treatment.

                        PART B
                  In assessing applications to authorise plant 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 Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee 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 15 March 2013 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                              —

                              the impact on aquatic organisms, non-target 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 available techniques in order to ensure that the release of dust during application to the 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 spillage and minimisation of dust emission,

                              —

                              the conditions of the authorisation, include, where appropriate, risk mitigation measures to protect bees,

                              —

                              monitoring programmes are initiated to verify the real exposure of bees to imidacloprid 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 risk to honey bees foraging in nectar or pollen in succeeding crops;

                              (c)

                              the potential uptake via roots to flowering weeds;

                              (d)

                              the risk to honey bees foraging on insect honey dew;

                              (e)

                              the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (f)

                              the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure;

                              (g)

                              the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.

                        The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014.’

      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, sorghum, triticale, wheat when such cereals are to be sown from January to June.

                  Alfalfa (Medicago sativa)

                  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)

                  beans (Phaseolus spp.)

                  broad beans, horse beans (Vicia faba var. major; var. equina; var. minor)

                  buckwheat (Fagopyrum esculentum)

                  castor oil seed (Ricinus communis)

                  chick peas (Cicer arietinum)

                  chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis)

                  clovers (Trifolium spp.). coffee (Coffea spp. arabica, robusta, liberica)

                  cotton (Gossypium spp.)

                  cowpeas, black eyed peas (Vigna unguiculata)

                  cucumbers (Cucumis sativus)

                  groundnuts, peanuts (Arachis hypogaea)

                  hemp (Cannabis sativa)

                  leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium)

                  lentils (Lens esculenta; Ervum lens)

                  linseed (Linum usitatissimum)

                  lupins (Lupinus spp.)

                  maize/corn (Zea mays)

                  melon seeds (Cucumis melo)

                  mustard seed white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra)

                  okra (Abelmoschus esculentus); gombo (Hibiscus esculentus)

                  peas garden pea (Pisum sativum); field pea (P. arvense)

                  peppermint (Mentha spp.: M. piperita)

                  poppy seed (Papaver somniferum)

                  pumpkins, squash, gourds and marrows (Cucurbita spp.)

                  pyrethrum, (Chrysanthemum cinerariifolium)

                  rapeseed (Brassica napus var. oleifera)

                  safflower seed (Carthamus tinctorius)

                  sesame seed (Sesamum indicum)

                  soybeans (Glycine soja)

                  spices: 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)

                  turnips and turnip rapes (Brassica rapa var. rapifera and oleifera spp.)

                  vetches Spring/common vetch (Vicia sativa)

                  watermelons (Citrullus vulgaris)

                  ornamentals flowering in year of treatment.


title: Commission Implementing Regulation (EU) No 151/2014 of 18 February 2014 approving the active substance S-abscisic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               19.2.2014

               EN

               Official Journal of the European Union

               L 48/1

      COMMISSION IMPLEMENTING REGULATION (EU) No 151/2014
   of 18 February 2014
   approving the active substance S-abscisic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (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 Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For S-abscisic acid the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/253/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 9 December 2010 an application from Sumitomo Chemical Agro Europe SAS for the inclusion of the active substance S-abscisic acid in Annex I to Directive 91/414/EEC. Implementing Decision 2011/253/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 21 May 2012.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance S-abscisic acid on 23 July 2013. The draft assessment report and the conclusion 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 13 December 2013 in the format of the Commission review report for S-abscisic acid.

               (5)

               It has appeared from the various examinations made that plant protection products containing S-abscisic acid may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve S-abscisic acid.

               (6)

               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.

               (7)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing S-abscisic acid. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

               (11)

               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
   Approval of active substance
   The active substance S-abscisic acid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing S-abscisic acid as an active substance by 31 December 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing S-abscisic acid as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing S-abscisic acid as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

               in the case of a product containing S-abscisic acid as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   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 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 July 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Implementing Decision 2011/253/EU of 26 April 2011 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of metobromuron, S-Abscisic acid, Bacillus amyloliquefaciens subsp. plantarum D747, Bacillus pumilus QST 2808 and Streptomyces lydicus WYEC 108 in Annex I to Council Directive 91/414/EEC (OJ L 106, 27.4.2011, p. 13).

      (4)  EFSA Journal 2013; 11(8):3341. Available online: www.efsa.europa.eu

      (5)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

      (6)  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

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  S-abscisic acid
                  CAS No 21293-29-8
                  CIPAC No
                  Not allocated

                  (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid
                  or
                  (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid

                  960 g/kg

                  1 July 2014

                  30 June 2024

                  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 S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.
                  Conditions of use shall include risk mitigation measures, where appropriate.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘65

                     S-abscisic acid
                     CAS No
                     21293-29-8
                     CIPAC No
                     Not allocated

                     (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid
                     or
                     (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid

                     960 g/kg

                     1 July 2014

                     30 June 2024

                     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 S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.
                     Conditions of use shall include risk mitigation measures, where appropriate.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) No 1177/2013 of 20 November 2013 approving the active substance spirotetramat, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               21.11.2013

               EN

               Official Journal of the European Union

               L 312/28

      COMMISSION IMPLEMENTING REGULATION (EU) No 1177/2013
   of 20 November 2013
   approving the active substance spirotetramat, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (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 Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For spirotetramat the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/560/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Bayer CropScience AG for the inclusion of the active substance spirotetramat in Annex I to Directive 91/414/EEC. Decision 2007/560/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 5 May 2008.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance spirotetramat (4) on 27 May 2013. The draft assessment report and the conclusion 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 3 October 2013 in the format of the Commission review report for spirotetramat.

               (5)

               It has appeared from the various examinations made that plant protection products containing spirotetramat may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the use which was examined and detailed in the Commission review report. It is therefore appropriate to approve spirotetramat.

               (6)

               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. It is, in particular, appropriate to require further confirmatory information.

               (7)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing spirotetramat. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

               (11)

               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
   Approval of active substance
   The active substance spirotetramat, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing spirotetramat as an active substance by 31 October 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing spirotetramat as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 April 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing spirotetramat as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or

               (b)

               in the case of a product containing spirotetramat as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   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 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 May 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Decision 2007/560/EC of 2 August 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chlorantraniliprole, heptamaloxyglucan, spirotetramat and Helicoverpa armigera nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC (OJ L 213, 15.8.2007, p. 29).

      (4)  EFSA Journal (2013) 11(6):3243. Available online: www.efsa.europa.eu.

      (5)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

      (6)  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

                  Common name, identification numbers

                  IUPAC name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Spirotetramat
                  CAS No 203313-25-1
                  CIPAC No 795

                     cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one

                  ≥ 970 g/kg

                  1 May 2014

                  30 April 2024

                  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 spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘60

                     Spirotetramat
                     CAS No 203313-25-1
                     CIPAC No 795

                        cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one

                     ≥ 970 g/kg

                     1 May 2014

                     30 April 2024

                     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 spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) No 1334/2014 of 16 December 2014 approving the active substance gamma-cyhalotrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance  Text with EEA relevance

text:
               17.12.2014

               EN

               Official Journal of the European Union

               L 360/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 1334/2014
   of 16 December 2014
   approving the active substance gamma-cyhalotrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that 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 Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For gamma-cyhalothrin the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2004/686/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 4 November 2003 an application from Cheminova A/S for the inclusion of the active substance gamma-cyhalothrin in Annex I to Directive 91/414/EEC. Decision 2004/686/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State, the United Kingdom, submitted a draft assessment report on 25 January 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant. The evaluation of the additional data by the United Kingdom was submitted in the format of addenda to the draft assessment report on 13 September 2012.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance gamma-cyhalothrin (5) on 4 February 2014. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 10 October 2014 in the format of the Commission review report for gamma-cyhalothrin.

               (5)

               It has appeared from the various examinations made that plant protection products containing gamma-cyhalothrin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve gamma-cyhalothrin.

               (6)

               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. It is, in particular, appropriate to require further confirmatory information.

               (7)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (8)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing gamma-cyhalothrin. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

               (11)

               It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing gamma-cyhalothrin in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.

               (12)

               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 gamma-cyhalothrin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing gamma-cyhalothrin as an active substance by 30 September 2015.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing gamma-cyhalothrin as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 2015 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing gamma-cyhalothrin as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or

               (b)

               in the case of a product containing gamma-cyhalothrin as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   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 4
   Extension of existing provisional authorisations
   Member States may extend existing provisional authorisations for plant protection products containing gamma-cyhalothrin for a period ending on 30 September 2016 at the latest.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 April 2015.
   However, Article 4 shall apply from the date of the entry into force of this Regulation.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 16 December 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Decision 2004/686/EC of 29 September 2004 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of proquinazid, IKI-220 (flonicamid) and gamma-cyhalothrin in Annex I to Council Directive 91/414/EEC (OJ L 313, 12.10.2004, p. 21).

      (4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

      (5)  European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance gamma-cyhalothrin. EFSA Journal 2014;12(2):3560, 93 pp. doi:10.2903/j.efsa.2014.3560.

      (6)  Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).

      (7)  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

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Gamma-cyhalothrin
                  CAS No 76703-62-3
                  CIPAC No 768

                  (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or
                  (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate

                  ≥ 980 g/kg

                  1 April 2015

                  31 March 2025

                  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 gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the safety of operators and workers;

                              (b)

                              the risk to aquatic organisms.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (1)

                              analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;

                              (2)

                              the toxicity profile of the metabolites CPCA, PBA and PBA(OH);

                              (3)

                              the long-term risk to wild mammals;

                              (4)

                              the potential for biomagnification in terrestrial and aquatic food chains.

                        The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘82

                     Gamma-cyhalothrin
                     CAS No 76703-62-3
                     CIPAC No 768

                     (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or
                     (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate

                     ≥ 980 g/kg

                     1 April 2015

                     31 March 2025

                     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 gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the safety of operators and workers;

                                 (b)

                                 the risk to aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;

                                 (2)

                                 the toxicity profile of the metabolites CPCA, PBA and PBA(OH);

                                 (3)

                                 the long-term risk to wild mammals;

                                 (4)

                                 the potential for biomagnification in terrestrial and aquatic food chains.

                           The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.’

         (1)  Further details on identity and specification of active substance are provided in the review report.