EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D/ 
CA May10-Doc.4.3  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
fenoxycarb 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 
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 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 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 Me mber State and submitted the competent 
authority report, togeth er 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 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 fenoxycarb may be expected to satisfy the requirements laid down in 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN Article 5 of Directive 98/8/EC. It is ther efore 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 
compartments and populations that have not been representatively addressed in 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) In view of the assumptions made during th e risk assessment, it is appropriate to 
require that freshly treated timber is st ored after treatment under shelter or on 
impermeable hard standing, or both, and th at any losses from the application of 
products used as wood preservatives and c ontaining fenoxycarb are collected for reuse 
or disposal. 
(8) In view of the risks identified for the a quatic compartment, appropriate measures 
should be taken to protect those compar tments. 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 OECD3) in the 
specific scenario bridge over pond. It is ther efore appropriate to require that products 
are not authorised fo r the treatment of w ood intended for outdoor c onstructions 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 tr eatment 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 elap se 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 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. 
(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. 
(13) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                
 
3 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64.  
EN 4   EN 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] Fenoxyc
arb 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 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: 
– Appropriate risk mitigation measures 
shall be taken to protect the soil and aquatic compartments. In particular,  
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 (*) 
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 under roof 
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 
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