
Article 1 
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2 

1. Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.They shall apply those provisions from 1 November 2012.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.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3 
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 4 November 2010.
For the Commission
The President
José Manuel BARROSO
ANNEX

In Annex I to Directive 98/8/EC, the following entry for the substance spinosad is added:

No Common name IUPAC nameIdentification numbers Minimum purity of the active substance in the biocidal product as placed on the market Date of inclusion Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) Expiry date of inclusion Product type Specific provisions
‘37 Spinosad EC No: 434-300-1CAS No: 168316-95-8Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D.
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-60-7

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-63-0
 850 g/kg 1 November 2012 31 October 2014 31 October 2022 18 When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment.Member States shall ensure that authorisations are subject to the following conditions:
— Authorisations shall be subject to appropriate risk mitigation measures. In particular, products authorised for professional use by spraying shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.
— For products containing spinosad that may lead to residues in food or feed, Member States shall verify the need to set new and/or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 and/or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’

