Annex

United Kingdom

The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
Common Name	IUPAC NameIdentification Numbers	Minimum degree of purity of the active substance^f1	Date of approval	Expiry date of approval	Product type	Specific conditions
Hexaflumuron	IUPAC Name: 1-[3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea EC No: 401-400-1 CAS No: 86479-06-3	984 g/kg	1 April 2017	31 March 2022	18	Hexaflumuron is considered a candidate for substitution in accordance with Article 10(1)(a) and (d) of Regulation (EU) No 528/2012. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied. The authorisations of biocidal products are subject to the following conditions. (1) Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (3) As hexaflumuron is considered to be very persistent, very bioaccumulative and toxic, exposure of non-target animals and the environment should be minimised by considering and applying all appropriate risk mitigation measures. These include the restriction to professional use only and the obligation to use confined bait stations. The placing on the market of treated articles is subject to the following condition. The person responsible for the placing on the market of a treated article treated with or incorporating hexaflumuron shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

Common Name

IUPAC NameIdentification Numbers

Minimum degree of purity of the active substance^f1

Date of approval

Expiry date of approval

Product type

Specific conditions

Hexaflumuron

IUPAC Name:

1-[3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea

EC No: 401-400-1

CAS No: 86479-06-3

984 g/kg

1 April 2017

31 March 2022

Hexaflumuron is considered a candidate for substitution in accordance with Article 10(1)(a) and (d) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

The authorisations of biocidal products are subject to the following conditions.

(1)

Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met.
(2)

For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
(3)

As hexaflumuron is considered to be very persistent, very bioaccumulative and toxic, exposure of non-target animals and the environment should be minimised by considering and applying all appropriate risk mitigation measures. These include the restriction to professional use only and the obligation to use confined bait stations.

The placing on the market of treated articles is subject to the following condition.

The person responsible for the placing on the market of a treated article treated with or incorporating hexaflumuron shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

Annotations

Footnotes

f1: The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.