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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Pursuant to Regulation (EC) No 1451/2007, cis-Tricos-9-ene has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive.
Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 November 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in an assessment report.
It appears from the evaluations that biocidal products used as attractants and containing cis-Tricos-9-ene may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include cis-Tricos-9-ene in Annex I to that Directive.
Not all potential uses and exposure scenarios have been evaluated at Union level. For example, outdoor use and exposure of food or feeding stuff were not assessed. It is therefore appropriate to require that Member States assess 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 and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 19 containing the active substance cis-Tricos-9-ene and also to facilitate the proper operation of the biocidal products market in general.
A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.
Directive 98/8/EC should therefore be amended accordingly.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2
1.
Member States shall adopt and publish, by 30 September 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
They shall apply those provisions from 1 October 2014.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 23 November 2012.
For the Commission
The President
José Manuel Barroso
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
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
‘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.’