EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D/ 
CA Sept10-Doc.3  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
bifenthrin as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
bifenthrin 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 bifenthrin. 
(2) Pursuant to Regulation (EC) No 1451/2007, bifenthrin has been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood 
preservatives, as defined in Annex V to that Directive. 
(3) France was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
3 January 2008 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 23 September 2010, in an assessment report. 
(5) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing bifenthrin may be expected to sa tisfy the requirements laid down in Article 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN 5 of Directive 98/8/EC. It is therefore appropriate to include  bifenthrin in Annex I to 
that Directive. 
(6) Not all potential uses have been evaluate d at the Union level. It is therefore 
appropriate that Member States assess thos e uses or exposure scenarios and those risks 
to compartments and populations that have not been representative ly addressed in the 
Union level risk assessment and, when gr anting product authorisat ions, ensure that 
appropriate measures are taken or specific conditions imposed in order to reduce the 
identified risks to acceptable levels 
(7) Unacceptable risks were identified for non- professional users. It is therefore 
appropriate to require that  product authorisations ar e limited to industrial or 
professional use, unless it is demonstrated in the application fo r product authorisation 
that risks to non-professional users can be reduced to acceptable levels in accordance 
with Article 5 of, and Annex VI to, Directive 98/8/EC. 
(8) In view of the assumptions made during th e risk assessment, it is appropriate to 
require that products author ised for industrial or prof essional use are used with 
appropriate personal protective equipment, unless it can be demonstrated in the 
application for product authoris ation that risks to industria l or professional users can 
be reduced to an acceptable level by other means. 
(9) In view of the risks identified for the soil and aquatic compartments, appropriate 
measures should be taken to protect those co mpartments. It is therefore appropriate to 
require that instructions are provided to indicate that fres hly treated timber is stored 
after treatment under sh elter or on impermeable hard standing, or both, and that any 
losses from the application of products us ed as wood preservatives and containing 
bifenthrin are collected for reuse or disposal . Furthermore, it is appropriate to require 
that products are not authorised for the in situ treatment of wood outdoors, or for 
treatment of wood that will be either conti nually exposed to the weather or protected 
from the weather but subject to frequent  wetting (use class 3 as defined by OECD3), 
unless data is submitted demonstrating that  the product will meet the requirements of 
Article 5 of, and Annex VI to, Directive 98 /8/EC, if necessary by the application of 
appropriate risk mitigation measures.  
(10) It is important that the provisions of this  Directive be applied simultaneously in all 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance bifenthrin and also to facilitate the proper operation of 
the biocidal products market in general. 
(11) 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. 
                                                 
3 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64.  
EN 4   EN (12) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(13) Directive 98/8/EC should therefore be amended accordingly. 
(14) 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 
 
Transposition 
1. Member States shall adopt and publish, by 31 January 2012 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions 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 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] Bifenthri
n IUPAC name: 2-methylbiphenyl-3-ylmethyl 
(1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-
1-enyl]-2,2-dimethylcyclopropanecarboxylate 
EC No: n.a. 
CAS No: 82657-04-3 911 g/kg 
1 February 
2013 31 January 2015 31 January 
2023 8 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 compartments and populations that have not been 
representatively addressed in the Union 
level risk assessment. Product authorisation 
can only be granted where the application 
demonstrates that risks can be reduced to acceptable levels. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
• Products shall be authorised only 
for industrial or professional use, unless it is demonstrated in the  
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 (*) 
application for product 
authorisation that risks to non 
professional users can be reduced to acceptable levels in accordance 
with Article 5 and Annex VI. 
• Products authorised for industrial 
or professional use must be used 
with appropriate personal 
protective equipment, unless it can 
be demonstrated in the application 
for product authorisation that risks to industrial or professional users 
can be reduced to an acceptable 
level by other means. 
• Appropriate risk mitigation 
measures shall be taken to protect 
the soil and aquatic compartments. In particular, labels or safety data 
sheets of products authorised shall 
indicate that freshly treated timber shall be stored after treatment 
under shelter or on impermeable 
hard standing, or both, to prevent  
EN 7   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 (*) 
direct losses to soil or water, and 
that any losses from the 
application of the product shall be collected for re-use or disposal. 
• Products shall not be authorised 
for the in situ treatment of wood outdoors, or for treatment of wood 
that will be either continually 
exposed to the weather or 
protected from the weather but 
subject to frequent wetting, unless data have been submitted 
demonstrating that the product 
will meet the requirements of Article 5 and Annex VI, if 
necessary by the application of 
appropriate risk mitigation measures." 
(*) 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