Commission Directive 2012/41/EUDangos y teitl llawn

Commission Directive 2012/41/EU of 26 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2 (Text with EEA relevance)

ANNEX

The following is added to entry ‘No 41’ in Annex I to Directive 98/8/EC:

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

NoCommon NameIUPAC NameIdentification NumbersMinimum purity of the active substance in the biocidal product as placed on the marketDate of inclusionDeadline 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 inclusionProduct typeSpecific provisionsa
‘1 October 201430 September 201630 September 20242

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 of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.’