EN    EN  COMMISSION OF THE EUROPEAN COMMUNITIES  
Brussels,  
COM(2007) XXX  
  
Draft  
COMMISSION DIRECTIVE .../…/EC  
of […]  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
tebuconazole as an acti ve substance in Annex I thereto  
EN  
EN 2   EN Draft  
COMMISSION DIRECTIVE .../…/EC  
of […]  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
tebuconazole  as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMISSI ON OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European Community,  
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 market1, and in 
particular the second subparagraph of Article 16(2) thereof , 
Whereas:  
(1) Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase 
of the 10 -year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Pa rliament and of the Council concerning the placing of biocidal 
products on the market and amending Regulation (EC) No 1896/20002 establishes a 
list of active substances to be assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Directi ve 98/8/EC. That list includes tebuconazole . 
(2) Pursuant to Regulation (EC) No 2032/2003, tebuconazole  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 Directive 9 8/8/EC.  
(3) Denmark  was designated as Rapporteur Member State  and submitted the competent 
authority report, together with a recommendation, to the Commission on 11 January 
2006  in accordance with Article 10(5) and (7) of Regulation  (EC) No 2032/2003 . 
(4) The compe tent authority report was reviewed by the Member States and the 
Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the 
findings of the review were incorporated , within  the Standing Committee on Biocidal 
Products on 29 November 2007, in an assessment report . 
                                                
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2007/20/EC (OJ L 94, 04.04.2007, p. 
23). 
2 OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2 006 (OJ L 355, 
15.12.2006, p. 63.   
EN 3   EN (5) The review of tebuconazole  did not reveal any open questions or concerns to be 
addressed by the Scientific Committee on Health and Environmental Risks.  
(6) It appears from the examinations made that biocidal products used as wood 
preservatives  and containing tebuconazole  may be expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC . It is therefore appropriate to include 
tebuconazole  in Annex I  for product type 8 , in order to ensure that in all Member 
State s authorisations for biocidal products used as  wood preservatives  and containing 
tebuconazole  can be gr anted, modified, or cancelled in accordance with Article 16(3) 
of Directive 98/8/EC. However, unacceptable risks were identified  for the in situ  
treatmen t of wood outdoors and for treated wood in continuous contact with water. 
Authorisation of these uses will require the submission of data demonstrating that the 
products can be used without unacceptable risks to the environment.  
(7) In the light of the finding s of the assessment report, it is appropriate to require that 
instructions are provided to indicate that treated timber must be stored after treatment 
on impermeable hard standing to prevent direct losses to soil and allow losses to be 
collected for re -use or disposal, in accordance with Article 10(2)(i)(d) of Directive 
98/8/EC.  
(8) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal treatment of biocidal products on the market 
contai ning the active substance tebuconazole  and also to facilitate the proper operation 
of the biocidal products market in general.  
(9) A reasonable period should be allowed to elapse before an active substance is included 
in Annex I in order to permit Member State s 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) o f Directive 98/8/EC, starts from the 
date of inclusion.  
(10) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel 
authorisations of biocidal products in product -type 8 containing tebuconazole  to 
ensure that they comply with Directive 98/8/EC.  
(11) Directive 98/8/EC should therefore be amended accordingly.  
(12) 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.   
EN 4   EN Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 March  2009  at the latest, the laws,  
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Commission the text of those provisions 
and a correlation table between those provisions and this Directive.  
They shall apply those provisions from 1 April  2010 . 
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 twentieth 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  
 Stavros Dimas  
 Member of the Commission   
EN 5   EN ANNEX  
 
The follow ing entry ‘No. 6’ is inserte d in Annex I to Directive 98/8/EC : 
  
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  (*) 
"6 tebuconazole  1-(4-chlorophenyl) -
4,4-dimethyl -3-
(1,2,4 -triazol -1-
ylmethyl)pentan -3-
ol 
EC No: 403-640-2 
CAS No: 107534 -
96-3 950 g/kg  1 April  2010  31 March  2012  31 March  
2020  8 Member States shall ensure that authorisations are subject 
to the following co nditions:  
 
In view of the risks identified for the soil and aquatic 
compartments appropriate risk mitigation measures must 
be taken to protect those compartments . In particular, 
labels and/or safety -data sheets of products authorised for 
industrial use ind icate that freshly treated timber must be 
stored after treatment under shelter or on impermeable 
hard standing to prevent direct losses to soil or water and 
that any losses must be co llected for reuse or disposal.  
 
In addition, products cannot be authorise d for t he in situ  
treatment of wood outdoors or for wood that will be in 
continuous contact with water unless data is submitted to 
demonstrate that the product will meet the requirements of 
Article 5 and Annex VI, if necessary by the application of 
appropr iate risk mitigation measures. " 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm