Commission Directive 2010/21/EU
of 12 March 2010
amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to clothianidin, thiamethoxam, fipronil and imidacloprid
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and in particular the second indent of the second subparagraph of Article 6(1) thereof,
OJ L 230, 19.8.1991, p. 1.
Whereas:
(1) The active substances clothianidin, thiamethoxam, fipronil and imidacloprid were included in Annex I to Directive 91/414/EEC by Commission Directives 2006/41/EC, 2007/6/EC, 2007/52/EC and 2008/116/EC respectively.
OJ L 187, 8.7.2006, p. 24.
OJ L 43, 15.2.2007, p. 13.
OJ L 214, 17.8.2007, p. 3.
OJ L 337, 16.12.2008, p. 86.
(2) Accidental releases of those active substances recently reported by several Member States have resulted in substantial losses of honey bee colonies. As a consequence, the Member States concerned have taken precautionary measures to temporarily suspend the placing on the market of plant protection products containing those substances.
(3) Clothianidin, thiamethoxam, and imidacloprid may only be authorised for uses as insecticide, including the use as seed treatment. Fipronil, however, may only be authorised for uses as insecticide for use as seed treatment. The accidents reported by Member States concern the inappropriate use of those active substances to treat seeds.
(4) To avoid future accidents, additional provisions, including appropriate risk mitigation measures, should be laid down for clothianidin, thiamethoxam, fipronil and imidacloprid.
(5) Directive 91/414/EEC should therefore be amended accordingly.
(6) The measure provided for in this Directive is in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2 Member States shall adopt and publish by 31 October 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 November 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3 Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing clothianidin, thiamethoxam, fipronil and imidacloprid as active substances by 31 October 2010.
Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 5 This Directive is addressed to the Member States.
Done at Brussels, 12 March 2010.
For the Commission
The President
José Manuel Barroso
ANNEX Annex I to Directive 91/414/EEC is amended as follows:
1. in row 123 relating to clothianidin, in the column ‘Specific provisions’, Part A is replaced by the following:

‘PART A Only uses as insecticide may be authorised.
For the protection of non-target organisms, in particular honey bees, for use as seed treatment:
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.
Member States shall ensure that:
the label of the treated seed includes the indication that the seeds were treated with clothianidin and sets out the risk mitigation measures provided for in the authorisation,
the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,
monitoring programmes are initiated to verify the real exposure of honey bees to clothianidin in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.’;

2. in row 142 relating to thiamethoxam, in the column ‘Specific provisions’, Part A is replaced by the following:

‘PART A Only uses as insecticide may be authorised.
For the protection of non-target organisms, in particular honey bees, for use as seed treatment:
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.
Member States shall ensure that:
the label of the treated seed includes the indication that the seeds were treated with thiamethoxam and sets out the risk mitigation measures provided for in the authorisation,
the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,
monitoring programmes are initiated to verify the real exposure of honey bees to thiamethoxam in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.’;

3. in row 163 relating to fipronil, in the column ‘Specific provisions’, Part A is replaced by the following:

‘PART A Only uses as insecticide for use as seed treatment may be authorised.
For the protection of non-target organisms, in particular honey bees:
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.
Member States shall ensure that:
the label of the treated seed includes the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation,
monitoring programmes are initiated to verify the real exposure of honey bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.’;

4. in row 163 relating to fipronil, in the column ‘Specific provisions’, Part B the following sentence is deleted:

‘— the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application.’;

5. in row 222 relating to imidacloprid, in the column ‘Specific provisions’, Part A is replaced by the following:

‘PART A Only uses as insecticide may be authorised.
For the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment:
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.
Member States shall ensure that:
the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation,
the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,
monitoring programmes are initiated to verify the real exposure of honey bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.’;

6. in row 222 relating to imidacloprid, in the column ‘Specific provisions’, Part B the following sentence is deleted:

‘— the protection of honey bees, in particular for spray applications and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.’