# L_2018132EN.01003501.xml

| 30.5.2018 | EN | Official Journal of the European Union | L 132/35 |
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30.5.2018

EN

Official Journal of the European Union

L 132/35

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/784

of 29 May 2018

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin

(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 21(3), Article 49(2) and Article 78(2) thereof,

Whereas:

| (1) | The active substance clothianidin was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2006/41/EC (3). |
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(1)

The active substance clothianidin was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2006/41/EC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | Commission Implementing Regulation (EU) No 485/2013 (5) amended the conditions of approval of the active substance clothianidin and required the applicants to provide confirmatory information as regards:






  (a) | the risk to pollinators other than honey bees; |
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(3)

Commission Implementing Regulation (EU) No 485/2013 (5) amended the conditions of approval of the active substance clothianidin and required the applicants to provide 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; |
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(b)

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

| (c) | the potential uptake via roots to flowering weeds; |
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(c)

the potential uptake via roots to flowering weeds;

| (d) | the risk to honey bees foraging on insect honey dew; |
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(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; |
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(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; |
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(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. |
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(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.

| (4) | In December 2014, the applicants submitted additional information concerning bees (i.e. honey bees, bumble bees and solitary bees) to the rapporteur Member State Belgium within the time period provided for its submission. They provided updated dossiers in March 2015 and June 2015. |
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(4)

In December 2014, the applicants submitted additional information concerning bees (i.e. honey bees, bumble bees and solitary bees) to the rapporteur Member State Belgium within the time period provided for its submission. They provided updated dossiers in March 2015 and June 2015.

| (5) | Belgium assessed the additional information submitted by the applicants. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 31 August 2015. |
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(5)

Belgium assessed the additional information submitted by the applicants. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 31 August 2015.

| (6) | The Commission consulted the Authority which presented its conclusion on the risk assessment of clothianidin on 13 October 2016 (6). The Authority identified for most crops high acute risks for bees from plant protection products containing the active substance clothianidin. In particular, as regards exposure via dust, the Authority identified high acute risks for bees for winter cereals and high chronic risks to bees cannot be excluded for sugar beets. For the consumption of residues in contaminated pollen and nectar, high acute and chronic risks were identified or a high risk cannot be excluded for most field uses. Chronic and acute risks to bees were also identified in the succeeding crops for all field uses. For forestry nursery, no data was provided by the applicants and risks to bees can therefore not be excluded. Furthermore the Authority identified a number of data gaps. |
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(6)

The Commission consulted the Authority which presented its conclusion on the risk assessment of clothianidin on 13 October 2016 (6). The Authority identified for most crops high acute risks for bees from plant protection products containing the active substance clothianidin. In particular, as regards exposure via dust, the Authority identified high acute risks for bees for winter cereals and high chronic risks to bees cannot be excluded for sugar beets. For the consumption of residues in contaminated pollen and nectar, high acute and chronic risks were identified or a high risk cannot be excluded for most field uses. Chronic and acute risks to bees were also identified in the succeeding crops for all field uses. For forestry nursery, no data was provided by the applicants and risks to bees can therefore not be excluded. Furthermore the Authority identified a number of data gaps.

| (7) | As foreseen in recital (16) of Implementing Regulation (EU) No 485/2013, the Commission initiated a review of new scientific information on 11 February 2015 by mandating EFSA to organise an open call for data. EFSA launched an open call for data which ended on 30 September 2015 (7). |
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(7)

As foreseen in recital (16) of Implementing Regulation (EU) No 485/2013, the Commission initiated a review of new scientific information on 11 February 2015 by mandating EFSA to organise an open call for data. EFSA launched an open call for data which ended on 30 September 2015 (7).

| (8) | On 13 November 2015, the Commission requested EFSA to provide conclusions concerning an updated risk assessment for bees as regards the use of clothianidin applied as a seed treatment or granules by organising a peer review and taking into account the data collected in the framework of the specific open call for data and any other new data from studies, research and monitoring activities that are relevant to the uses under consideration. The Authority presented its conclusion on the peer review of the updated pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatment and granules on 28 February 2018 (8). The applicants were given the opportunity to comment on this conclusion. The applicants submitted their comments which have been carefully examined. |
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(8)

On 13 November 2015, the Commission requested EFSA to provide conclusions concerning an updated risk assessment for bees as regards the use of clothianidin applied as a seed treatment or granules by organising a peer review and taking into account the data collected in the framework of the specific open call for data and any other new data from studies, research and monitoring activities that are relevant to the uses under consideration. The Authority presented its conclusion on the peer review of the updated pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatment and granules on 28 February 2018 (8). The applicants were given the opportunity to comment on this conclusion. The applicants submitted their comments which have been carefully examined.

| (9) | The draft assessment report, the addendum to the draft assessment report and the conclusions 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 27 April 2018 in the form of a revised addendum to the Commission review report for clothianidin. |
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(9)

The draft assessment report, the addendum to the draft assessment report and the conclusions 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 27 April 2018 in the form of a revised addendum to the Commission review report for clothianidin.

| (10) | The Commission invited the applicants to submit their comments on the revised addendum to the review report for clothianidin. The applicants submitted their comments which have been carefully examined. |
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(10)

The Commission invited the applicants to submit their comments on the revised addendum to the review report for clothianidin. The applicants submitted their comments which have been carefully examined.

| (11) | Having reviewed the information submitted by the applicants in 2014 and 2015 the Commission has concluded that the further confirmatory information required by Implementing Regulation (EU) No 485/2013 has not been provided, and having also considered the conclusion on the updated risk assessment for bees, the Commission has concluded that further risks to bees cannot be excluded without imposing further restrictions. Bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the Union, it is appropriate to prohibit all outdoor uses. Therefore, it is appropriate to limit the use of clothianidin to permanent greenhouses and to require that the resulting crop stays its entire life cycle within a permanent greenhouse, so that it is not replanted outside. |
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(11)

Having reviewed the information submitted by the applicants in 2014 and 2015 the Commission has concluded that the further confirmatory information required by Implementing Regulation (EU) No 485/2013 has not been provided, and having also considered the conclusion on the updated risk assessment for bees, the Commission has concluded that further risks to bees cannot be excluded without imposing further restrictions. Bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the Union, it is appropriate to prohibit all outdoor uses. Therefore, it is appropriate to limit the use of clothianidin to permanent greenhouses and to require that the resulting crop stays its entire life cycle within a permanent greenhouse, so that it is not replanted outside.

| (12) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(12)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (13) | Taking into account the risks for bees from treated seeds, the placing on the market and the use of seeds treated with plant protection products containing clothianidin should be subject to the same restrictions as the use of clothianidin. It is therefore appropriate to provide that seeds treated with plant protection products containing clothianidin shall not be placed on the market or used, except where the seeds are intended to be used only in permanent greenhouses and the resulting crop stays within a permanent greenhouse during its entire life cycle. |
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(13)

Taking into account the risks for bees from treated seeds, the placing on the market and the use of seeds treated with plant protection products containing clothianidin should be subject to the same restrictions as the use of clothianidin. It is therefore appropriate to provide that seeds treated with plant protection products containing clothianidin shall not be placed on the market or used, except where the seeds are intended to be used only in permanent greenhouses and the resulting crop stays within a permanent greenhouse during its entire life cycle.

| (14) | Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing clothianidin. |
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(14)

Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing clothianidin.

| (15) | For plant protection products containing clothianidin, where Member States grant a grace period pursuant to Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 19 December 2018. |
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(15)

For plant protection products containing clothianidin, where Member States grant a grace period pursuant to Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 19 December 2018.

| (16) | The prohibition of placing on the market and use of treated seeds should apply only as of 19 December 2018 in order to allow for a sufficient period of transition. |
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(16)

The prohibition of placing on the market and use of treated seeds should apply only as of 19 December 2018 in order to allow for a sufficient period of transition.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(17)

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

Amendment to Implementing Regulation (EU) No 540/2011

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Prohibition of the placing on the market and use of treated seeds

Seeds treated with plant protection products containing clothianidin shall not be placed on the market or used, except where:

| (a) | the seeds are intended to be used only in permanent greenhouses, and |
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(a)

the seeds are intended to be used only in permanent greenhouses, and

| (b) | the resulting crop stays within a permanent greenhouse during its entire life cycle. |
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(b)

the resulting crop stays within a permanent greenhouse during its entire life cycle.

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 as active substance by 19 September 2018 at the latest.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 19 December 2018 at the latest.

Article 5

Amendment to Implementing Regulation (EU) No 485/2013

As regards seeds which have been treated with plant protection products containing clothianidin, Article 2 of Implementing Regulation (EU) No 485/2013 is deleted.

Article 6

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

However, Article 2 and Article 5 shall apply as of 19 December 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 May 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  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).

2

(3)  Commission Directive 2006/41/EC of 7 July 2006 amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances (OJ L 187, 8.7.2006, p. 24).

3

(4)  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).

4

(5)  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 (OJ L 139, 25.5.2013, p. 12).

5

(6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment for the active substance clothianidin in light of confirmatory data submitted. EFSA Journal 2016;14(11):4606, 34 pp. doi:10.2903/j.efsa.2016.4606.

6

EFSA Journal

(7)  EFSA (European Food Safety Authority), 2015. Technical report on the open call for new scientific information as regards the risk to bees from the use of the three neonicotinoid pesticide active substances clothianidin, imidacloprid and thiamethoxam applied as seed treatments and granules in the EU. EFSA supporting publication 2015:EN-903. 8pp.

7

(8)  EFSA (European Food Safety Authority), 2018. Conclusions on the peer review of the pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatments and granules. EFSA Journal 2018;16(2):5177. 86 pp.

8

EFSA Journal

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ANNEX

The text of 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, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

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 revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the risk to groundwater; |
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—

the risk to groundwater;

| — | the risk to bees and bumble bees released for pollination in permanent greenhouses; |
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—

the risk to bees and bumble bees released for pollination in permanent greenhouses;

| — | the exposure of bees via the consumption of contaminated water from the permanent greenhouses. |
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—

the exposure of bees via the consumption of contaminated water from the permanent greenhouses.

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.

Conditions of use shall include risk mitigation measures, where appropriate.’

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