EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
D0xxxx/01 CA-March12-Doc.4.4 
[…](2012) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
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) 
 EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
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, 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 Counc il concerning the pl acing 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 Directiv e 98/8/EC. That list 
includes cis-Tricos-9-ene. 
(2) 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 define d in Annex V to that Directive. 
(3) Austria was designated as Rapporteur Me mber State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
11 November 2009 in accordance with Article  14(4) and (6) of Regulation (EC) 
No 1451/2007. 
(4) The competent authority report was re viewed 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 [date of Standing Committee meeting to be inserted], in an assessment 
report. 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN (5) It appears from the evaluations that bi ocidal products used as attractants and 
containing cis-Tricos-9-ene may be expected to sa tisfy 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. 
(6) Not all potential uses have been  evaluated at Union level. 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 a ssessment and, when granting 
product authorisations, ensure that appropr iate measures are taken or specific 
conditions imposed in order to reduce th e identified risks to acceptable levels. 
(7) In the light of the possible indirect huma n exposure via consumption of food as a 
result of those uses represented in the a ssessment, it is appropriate to require, where 
relevant, verification of the need to set new or to amend existing maximum residue 
levels according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 la ying down Community proced ures for the establishment 
of residue limits of pharmacol ogically active substances in foodstuffs of animal origin, 
repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC 
of the European Parliament and of the Council and Regulation (EC) No 726/2004 of 
the European Parliament and of the Council
3 or Regulation (EC)  No 396/2005 of the 
European Parliament and of the Council of 23 February 2005 on maximum residue 
levels of pesticides in or on food and feed  of plant and animal origin and amending 
Council Directive 91/414/EEC4. Measures should be adopted ensuring that the 
applicable maximum residue levels are not exceeded. 
(8) 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 containi ng the active substance cis-Tricos-9-ene and also to facilitate 
the proper operation of the biocid al products market in general. 
(9) A reasonable period should be allowed to elap se 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 ne w 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. 
(10) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) In accordance with the Joint Political De claration of Member States and the 
Commission on explanatory documents of 28 September 20115, Member States have 
undertaken to accompany, in justified cases, the notification of their transposition 
measures with one or more documents explaining the relationship between the 
                                                 
3  OJ L 152, 16.6.2009, p. 11. 
4  OJ L 70, 16.3.2005, p. 1. 
5  OJ C 369, 17.12.2011, p. 14. EN 4   EN components of a directive and the corresponding parts of national transposition 
instruments. 
(13) The measures provided for in this Directiv e 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 a ccordance 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 nece ssary to comply with this Directive.  
They shall apply those pr ovisions 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 determin e 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 tw entieth 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,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
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 (*) 
"(**) 
[OPOC
E: please 
insert 
substance 
number] cis-
tricos-9-
ene 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 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 app licable MRLs are not  
EN 6   EN 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 (*) 
exceeded." 
(*) 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.htm