DIRECTIVES  
COMMISSION DIRECTIVE 2011/10/EU  
of 8 February 2011  
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 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 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, together with 
a recommendation, to the Commission on 3 January 
2008 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 wood preservatives and containing bifenthrin 
may be expected to satisfy the requirements laid down 
in Article 5 of Directive 98/8/EC. It is therefore appro ­
priate to include bifenthrin in Annex I to that Directive.  
(6) Not all potential uses have been evaluated at the Union 
level. It is therefore appropriate that Member States assess 
those uses or exposure scenarios and those risks to envi ­
ronmental compartments and populations 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.  
(7) Unacceptable risks were identified for non-professional 
users. It is therefore appropriate to require that product 
authorisations are limited to industrial or professional 
use, unless it is demonstrated in the application for 
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 the risk 
assessment, it is appropriate to require that products 
authorised for industrial or professional use are 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.EN 9.2.2011 Official Journal of the European Union L 34/41  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(9) In view of the risks identified for the soil and aquatic 
compartments, appropriate measures should be taken to 
protect those compartments. It is therefore appropriate 
to require that instructions are provided to indicate that 
freshly treated timber is stored after treatment under 
shelter or on impermeable hardstanding, or both, and 
that any losses from the application of products used 
as wood preservatives and containing bifenthrin are 
collected for reuse or disposal. Furthermore, it is appro ­
priate to require that products are not 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 (use class 3 as defined by OECD (  1 ), 
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 treatment 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 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.  
(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 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  
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 34/42 Official Journal of the European Union 9.2.2011  
( 1 ) OECD series on emission scenario documents, Number 2, Emission 
Scenario Document for Wood Preservatives, part 2, p. 64.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 (*)  
‘38 Bifenthrin  IUPAC name: 2-methyl ­
biphenyl-3-ylmethyl 
(1RS)-cis-3-[(Z)-2-chloro- 
3,3,3-trifluoroprop-1- 
enyl]-2,2-dimethylcyclo ­
propanecarboxylate 
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 
environmental compartments and populations that have not 
been representatively addressed in the Union level risk 
assessment. 
Member States shall ensure that authorisations are subject to 
the following conditions: 
— Products shall be authorised only for industrial or profes ­
sional use, unless it is demonstrated in the 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 appli ­
cation 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 and, where provided, safety data sheets of products 
authorised shall indicate that freshly treated timber shall 
be stored after treatment under shelter or on imper ­
meable hardstanding, or both, to prevent direct losses 
to soil or water, and that any losses from the application 
of the product shall be collected for reuse or disposal.EN 9.2.2011 Official Journal of the European Union L 34/43No 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 (*)  
— 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.htmEN L 34/44 Official Journal of the European Union 9.2.2011