Annex

United Kingdom

In Annex I to Directive 98/8/EC, the following is added to entry No 14:

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 11. 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 substance.

For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

No Common Name IUPAC NameIdentification Numbers Minimum degree of purity of the active substance^f1 Date of inclusion Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies^f2 Expiry date of inclusion Product type Specific provisions^f3
‘980 g/kg 1 February 2015 31 January 2017 31 January 2025 18
The Union level risk assessment did not address all potential uses; certain uses, such as outdoor application and use by non-professionals, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.

Products shall not be authorised for application by brushing, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

For products containing thiamethoxam that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.

Products applied in such a way that emission via a sewage treatment plant or directly to surface water cannot be prevented shall not be authorised, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

Products authorised for professional use 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 other means.

(2)

Where appropriate, measures shall be taken to protect honey bees.’

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 11. 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 substance.
For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).
For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
No	Common Name	IUPAC NameIdentification Numbers	Minimum degree of purity of the active substance^f1	Date of inclusion	Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies^f2	Expiry date of inclusion	Product type	Specific provisions^f3
			‘980 g/kg	1 February 2015	31 January 2017	31 January 2025	18	The Union level risk assessment did not address all potential uses; certain uses, such as outdoor application and use by non-professionals, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Products shall not be authorised for application by brushing, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. For products containing thiamethoxam that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded. Products applied in such a way that emission via a sewage treatment plant or directly to surface water cannot be prevented shall not be authorised, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures. Member States shall ensure that authorisations are subject to the following conditions: (1) Products authorised for professional use 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 other means. (2) Where appropriate, measures shall be taken to protect honey bees.’

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 11. 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 substance.
f2: For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).
f3: For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm