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 
propiconazole as an act ive 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 
propiconazole  as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMIS SION 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 marke t1, 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 Parliament 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 Direc tive 98/8/EC. That list includes propiconazole . 
(2) Pursuant to Regulation (EC) No 2032/2003, propiconazole  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 Directi ve 98/8/EC.  
(3) Finland  was designated as Rapporteur Member State  and submitted the competent 
authority report, together with a recommendation, to the Commission on 5 April 2006  
in accordance with Article 10(5) and (7) of Regulation  (EC) No 2032/2003 . 
(4) The comp etent 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 a s 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 1849/2006 (OJ L 355, 
15.12.2006, p. 63.   
EN 3   EN (5) The review of propiconazole  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 propiconazole  may be expected to satisfy the 
requirements laid down in Article 5 of Directive 98/8/EC . It is therefore appropriate to 
include propiconazole  in Annex I  for product type 8 , in order to ensure that in all 
Member S tates authorisations for b iocidal products used as  wood preservatives  and 
containing propiconazole  can be granted, modified, or cancelled in accordance with 
Article 16(3) of Directive 98/8/EC. However, unacceptable risks were identified  for the 
in situ  trea tment of wood outdoors and for treated wood exposed to weathering. 
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 findings of t he assessment report, it is appropriate to require that 
products containing propiconazole  and used as wood preservatives  must be used with 
appropriate personal protective equipment , that risk mitigation measures are applied to 
protect the soil and aquatic  compartments  and that related instructions are provided, 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 treatmen t of biocidal products on the market 
containing the active substance propiconazole  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 include d 
in Annex I 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, 
whic h, in accordance with Article 12 (1)(c)(ii) of 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 propiconazole  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 accordan ce 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 publi sh, 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 provision s 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. Memb er 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 i nto 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. 8’ is inserted 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 compli ance 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  (*) 
"8 propiconazole  1-[[2-(2,4-
dichlorophenyl) -
4-propyl -1,3-
dioxolan -2-
yl]methyl] -1H-
1,2,4 -triazole  
EC No: 262 -104-
4 
CAS No: 60207 -
90-1 
 930 g/kg  1 April 
2010  31 March 2012  31 March 
2020  8 Member States shall ensu re that authorisations are 
subject to the following conditions:  
1. In view of the assumptions made during 
the risk assessment, products authorised 
for industrial and/or professional use, must 
be used with appropriate personal 
protective equipment, unless it c an be 
demonstrated in the application for 
product authorisation that risks to 
industrial and/or professional users can be 
reduced to an acceptable level by other 
means.  
2. 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 pro ducts 
authorised for industrial use shall indicate 
that freshly treated timber must be stored 
after treatment under shelter or on 
imperm eable hard standing to prevent 
direct losses to soil or water and that any 
losses must be collected for reuse or 
disposal .   
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 compli ance 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  (*) 
In addition, products cannot be authorised for t he in 
situ treatment of wood outdoors or for wood that will 
be exposed to weathering  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 appropriate 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