EN    EN   
 EUROPEAN COMMISSION   
Brussels, XXX  
DXXX/01 - CA-Sept11 -Doc.3   
[…](2011) XXX draft   
  
COMMISSION DIRECTIVE ../…/EU  
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include
flufenoxuron as an active substance for product-type 8 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 
flufenoxuron as an active substance for product-type 8 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 flufenoxuron. 
(2) Pursuant to Regulation (EC) No 1451/ 2007, flufenoxuron 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 
17 March 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 23 September 2011, in an assessment report. 
(5) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing flufenoxuron 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 therefore appropr iate to include flufenoxuron for 
use in product type 8 in A nnex I to that Directive. 
(6) In view of its characteristics, which render it persistent, liable to bioaccumulate and 
toxic, as well as very persistent and very  liable to bioaccumulate, in accordance with 
the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the C ouncil of 18 December 2006 concerning the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Ag ency, amending Directive 1999/45/EC and 
repealing Council Regulation (EEC) No 793/ 93 and Commission Re gulation (EC) No 
1488/94 as well as Council Di rective 76/769/EEC and Commission Directives 
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC3, flufenoxuron should be 
included in Annex I for five years only and should be made subject to a comparative 
risk assessment in accordance with the s econd subparagraph of Article 10(5)(i) of 
Directive 98/8/EC before its incl usion in Annex I is renewed. 
(7) Not all potential uses have been evaluate d at Union level. The Union level risk 
assessment only adressed professional or i ndustrial treatment of wood intended to be 
used indoors (use classes 1 and 2 as defined by OECD4)or to be not covered and not in 
contact with the ground and c ontinually exposed to  the weather, protected from the 
weather but subject to frequent wetting or in  contact with fresh water (use class 3 as 
defined by OECD5), which will not be used in animal housing or come into contact 
with food or feed. In view thereof, and of  the characteristics of  the flufenoxuron, it is 
appropriate to authorise onl u those uses and exposure sc enarios that have been 
representatively addressed in the Union level risk assessment, and for which no 
unacceptable risk was found. 
(8) Unacceptable risks for the environment were identified for the in situ  treatment of 
wood outdoors, as well as in various scenar ios for in-service us e of treated wood not 
covered and not in contact with the ground, wh ich is either conti nually exposed to the 
weather or protected from the weather but subj ect to frequent wetting (use class 3 as 
defined by OECD6). It is therefore appropriate to  require that products not be 
authorised for such use, or for the treatment of wood intended for those uses. 
(9) In view of the risks identified for human health for industrial and professional use, 
except for in situ  spraying, brushing and in jection, it is appropriate to require that safe 
operational procedures be esta blished for products authoris ed for such use, and that 
those products be used with appropriate pers onal protective equipment unless it can be 
demonstrated in the application for product authorisation that ri sks to industrial or 
professional users can be reduced to an acceptable level by other means. 
(10) In view of the risks identified for the a quatic and terrestrial compartments, it is 
appropriate to require that appropriate risk mitigation measures be taken to protect 
                                                 
3  OJ L 396, 30.12.2006, p. 1. 
4 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64. 
5 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64. 
6 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64.  
EN 4   EN those compartments, in particular that fres hly treated timber be stored after treatment 
under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood pr eservatives and cont aining flufenoxuron be 
collected for reuse or disposal.  
(11) The provisions of this Direct ive should be applied at the same time in all Member 
States in order to ensure equal treatment on the Union market of biocidal products of 
product-type 8 containing the active substa nce flufenoxuron and also to facilitate the 
proper operation of the biocidal products market in general. 
(12) 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. 
(13) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(14) Directive 98/8/EC should therefore be amended accordingly. 
(15) 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 2013 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 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.  
EN 5   EN 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 6   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] flufenox
uron 1-[4-(2-chloro-alpha, alpha,alpha-trifluoro-
para-tolyloxy)-2-fluorophenyl]-3-(2,6-
difluorobenzoyl)urea 
EC No: 417-680-3 
CAS No: 101463-69-8 950 g/kg 
1 February 
2014 31 January 2016 31 January 
2019 8 Flufenoxuron shall be subject to a 
comparative risk asse ssment in accordance 
with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC 
before its inclusion in this Annex is 
renewed. 
The Union level risk assessment adressed 
professional or industrial treatment of 
wood intended to be used indoors, which 
will not be used in animal housing or come 
into contact with food or  feed. Products shall not be authorised for  uses or 
exposure scenarios that have not been 
representatively addressed in the Union level risk assessment. 
Products shall not be authorised for in situ  
treatment of wood outdoors or for treatment of wood that will be continually  
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 (*) 
exposed to the weather, protected from the 
weather but subject to frequent wetting or 
in contact with fresh water, 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. 
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
(1) For products authorised 
for industrial or professional use, 
except for in situ  spraying, 
brushing and injection, safe 
operational procedures shall be 
established, and products shall 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  
EN 8   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 (*) 
level by other means. 
(2) Appropriate risk mitigation 
measures shall be taken to protect the soil and aquatic 
compartments. In particular, 
labels and, where provided, safety data sheets of authorised products 
shall indicate that freshly treated 
timber shall be stored after treatment under shelter or on 
impermeable hard standing 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."
 
(*) 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