ANNEXU.K.

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

^a 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 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^a
‘58	DDACarbonate	Reaction mass of N,N-Didecyl-N,N-dimethylammonium Carbonate and N,N-Didecyl-N,N-dimethylammonium Bicarbonate EC No: 451-900-9 CAS No: 894406-76-9	Dry weight: 740 g/kg	1 February 2013	Not applicable	31 January 2023	8	The Union level risk assessment did not address all potential uses; certain uses, such as 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. Member States shall ensure that authorisations are subject to the following conditions: (1) for industrial users safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means; (2) labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal; (3) products shall not be authorised for treatment of wood that will be in contact with fresh water or used for outdoor constructions near or above water, or for treatment by dipping of wood that will be continually exposed to the weather or subject to frequent wetting, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.’

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

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^a

‘58

DDACarbonate

Reaction mass of N,N-Didecyl-N,N-dimethylammonium Carbonate and N,N-Didecyl-N,N-dimethylammonium Bicarbonate

EC No: 451-900-9

CAS No: 894406-76-9

Dry weight: 740 g/kg

1 February 2013

Not applicable

31 January 2023

The Union level risk assessment did not address all potential uses; certain uses, such as 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.

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

(1)

for industrial users safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means;

(2)

labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal;

(3)

products shall not be authorised for treatment of wood that will be in contact with fresh water or used for outdoor constructions near or above water, or for treatment by dipping of wood that will be continually exposed to the weather or subject to frequent wetting, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.’