Commission Directive 2012/38/EU of 23 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include cis-Tricos-9-ene as an active substance in Annex I thereto (Text with EEA relevance)

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
‘59	cis-tricos-9-ene (Muscalure)	cis-Tricos-9-ene; (Z)-Tricos-9-ene EC No: 248-505-7 CAS No: 27519-02-4	801 g/kg	1 October 2014	30 September 2016	30 September 2024	19	The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as outdoor use and exposure of food or feed, 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. For products containing cis-tricos-9-ene 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) according to 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.’

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

‘59

cis-tricos-9-ene (Muscalure)

cis-Tricos-9-ene; (Z)-Tricos-9-ene

EC No: 248-505-7

CAS No: 27519-02-4

801 g/kg

1 October 2014

30 September 2016

30 September 2024

The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as outdoor use and exposure of food or feed, 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.

For products containing cis-tricos-9-ene 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) according to 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.’

Commission Directive 2012/38/EUDangos y teitl llawn

ANNEXU.K.