COMMISSION DIRECTIVE 2011/12/EU  
of 8 February 2011  
amending Directive 98/8/EC of the European Parliament and of the Council to include fenoxycarb 
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 fenoxycarb.  
(2) Pursuant to Regulation (EC) No 1451/2007, fenoxycarb 
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) Germany was designated as Rapporteur Member State 
and submitted the competent authority report, together 
with a recommendation, to the Commission on 
12 September 2008 in accordance with Article 14(4) 
and (6) of Regulation (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 fenoxycarb 
may be expected to satisfy the requirements laid down 
in Article 5 of Directive 98/8/EC. It is therefore 
appropriate to include fenoxycarb in Annex I to that 
Directive.  
(6) Not all potential uses have been evaluated at Union level. 
It is therefore appropriate that Member States assess 
those uses or exposure scenarios and those risks to the environmental compartments and populations that have 
not been representatively addressed in the Union level 
risk assessment and, when granting product author- 
isations, ensure that appropriate measures are taken or 
specific conditions imposed in order to reduce the 
identified risks to acceptable levels.  
(7) In view of the assumptions made during the risk 
assessment, it is appropriate to require 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 fenoxycarb are collected 
for reuse or disposal.  
(8) In view of the risks identified for the aquatic 
compartment, appropriate measures should be taken to 
protect those compartments. Unacceptable risks were 
identified during the in-service use of treated wood not 
covered and not in contact with the ground, which is 
either continually exposed to the weather or protected 
from the weather but subject to frequent wetting (use 
class 3 as defined by OECD (  3 )) in the specific scenario 
bridge over pond. It is therefore appropriate to require 
that products are not authorised for the treatment of 
wood intended for outdoor constructions near or 
above water, 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.  
(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 fenoxycarb 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.EN 9.2.2011 Official Journal of the European Union L 34/49  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.  ( 3 ) OECD series on emission scenario documents, Number 2, Emission 
Scenario Document for Wood Preservatives, part 2, p. 64.(12) Directive 98/8/EC should therefore be amended 
accordingly.  
(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  
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 34/50 Official Journal of the European Union 9.2.2011ANNEX  
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 (*)  
‘40 Fenoxycarb  IUPAC name: Ethyl [2-(4- 
phenoxyphenoxy) 
ethyl]carbamate 
EC No: 276-696-7 
CAS No: 72490-01-8  960 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 en- 
vironmental 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: 
— 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 impermeable 
hardstanding under roof, 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. 
— Products shall not be authorised for 
treatment of wood that will be used in 
outdoor constructions near or above 
water, unless data is submitted demon ­
strating 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 9.2.2011 Official Journal of the European Union L 34/51