COMMISSION DIRECTIVE 2011/11/EU  
of 8 February 2011  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
(Z,E)-tetradeca-9,12-dienyl acetate as an active substance in Annexes I and IA thereto  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Directive 98/8/EC of the European Parliament 
and of the Council of 16 February 1998 concerning the placing 
of biocidal products on the market (  1 ), and in particular the 
second subparagraph of Article 16(2) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 1451/2007 of 
4 December 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 
98/8/EC of the European Parliament and of the Council 
concerning the placing of biocidal products on the 
market (  2 ) establishes a list of active substances to be 
assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Directive 98/8/EC. That list 
includes (Z,E)-tetradeca-9,12-dienyl acetate.  
(2) Pursuant to Regulation (EC) No 1451/2007, (Z,E)- 
tetradeca-9,12-dienyl acetate 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.  
(3) Austria was designated as Rapporteur Member State and 
submitted the competent authority report, together with 
a recommendation, to the Commission on 23 February 
2009 in accordance with Article 14(4) and (6) of Regu ­
lation (EC) No 1451/2007.  
(4) 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 
24 September 2010, in an assessment report.  
(5) It appears from the evaluations that biocidal products 
used as attractants and containing (Z,E)-tetradeca-9,12- 
dienyl acetate may be expected to satisfy the 
requirements laid down in Article 5 of Directive 
98/8/EC. It is therefore appropriate to include (Z,E)- 
tetradeca-9,12-dienyl acetate in Annex I to that Directive.  
(6) It also appears from the evaluations that biocidal 
products used as attractants and containing (Z,E)- tetradeca-9,12-dienyl acetate may be expected to present 
only low risk to humans, animals and the environment 
and to satisfy the requirements laid down in Article 5 of 
Directive 98/8/EC, in particular with regard to the use 
which was examined and detailed in the assessment 
report, i.e. in traps for indoor use containing a 
maximum of 2 mg of the active substance. It is 
therefore appropriate to include (Z,E)-tetradeca-9,12- 
dienyl acetate in Annex IA to Directive 98/8/EC.  
(7) Not all potential uses have been evaluated at Union level. 
It is therefore appropriate that Member States, when 
granting product authorisations, assess those uses or 
exposure scenarios and those risks to the environmental 
compartments and populations that have not been repre ­
sentatively addressed in the Union level risk assessment 
and ensure that appropriate measures are taken or 
specific conditions imposed in order to reduce the 
identified risks to acceptable levels.  
(8) In the light of the assumptions made during the 
evaluation, it is appropriate to require that (Z,E)- 
tetradeca-9,12-dienyl acetate is not applied where food 
or feed is stored unless the food or feed packaging is 
closed or re-closed. Labels should therefore indicate that 
biocidal products containing (Z,E)-tetradeca-9,12-dienyl 
acetate are not to be used in spaces where un-packaged 
food or feed is kept.  
(9) It is important that the provisions of this Directive be 
applied simultaneously in all Member States in order to 
ensure equal treatment of biocidal products on the 
market containing the active substance (Z,E)-tetradeca- 
9,12-dienyl acetate and also to facilitate the proper 
operation of the biocidal products market in general.  
(10) 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 the 
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.  
(11) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.  
(12) Directive 98/8/EC should therefore be amended 
accordingly.EN 9.2.2011 Official Journal of the European Union L 34/45  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(13) 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  
Annexes I and IA to Directive 98/8/EC are amended in 
accordance with the Annex to this Directive.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 January 
2012 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive.  
They shall apply those provisions from 1 February 2013.  
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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 8 February 2011.  
For the Commission  
The President  
José Manuel BARROSOEN L 34/46 Official Journal of the European Union 9.2.2011ANNEX  
(1) In Annex I to Directive 98/8/EC, the following entry is added:  
No Common Name  IUPAC Name 
Identification 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 (*)  
‘39 (Z,E)-tetradeca-9, 
12-dienyl acetate  (9Z,12E)-Tetradeca-9, 
12-dien-1-yl acetate 
EC No: n.a. 
CAS No: 30507-70-1  977 g/kg  1 February 2013  31 January 2015  31 January 2023  19  When assessing the application for authorisation of 
a product in accordance with Article 5 and Annex 
VI, Member States shall assess, when relevant for 
the particular product, those uses or exposure 
scenarios and those risks to environmental 
compartments and populations that have not been 
representatively addressed in Union level risk 
assessment. 
Member States shall ensure that authorisations are 
subject to the following condition: 
— Labels for biocidal products containing (Z,E)- 
tetradeca-9,12-dienyl acetate shall indicate that 
those products shall not be used in spaces 
where un-packaged food or feed is kept.’,  
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN 9.2.2011 Official Journal of the European Union L 34/47(2) In Annex IA to Directive 98/8/EC, the following entry is added:  
No Common Name  IUPAC Name 
Identification 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 (*)  
‘2 (Z,E)-tetradeca-9, 
12-dienyl acetate  (9Z,12E)-tetradeca-9, 
12-dien-1-yl acetate 
EC No: n.a. 
CAS No: 30507-70-1  977 g/kg  1 February 2013  31 January 2015  31 January 2023  19  Member States shall ensure that registrations are 
subject to the following conditions: 
— Only for traps containing a maximum of 2 mg 
of (Z,E)-Tetradeca-9,12-dienyl acetate for indoor 
use, 
— Labels for biocidal products containing (Z,E)- 
tetradeca-9,12-dienyl acetate shall indicate that 
those products shall only be used indoors, and 
shall not be used in spaces where un-packaged 
food or feed is kept.’,  
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN L 34/48 Official Journal of the European Union 9.2.2011