COMMISSION DIRECTIVE 2009/151/EC  
of 27 November 2009  
amending Directive 98/8/EC of the European Parliament and of the Council to include tolylfluanid 
as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMISSION 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 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 tolylfluanid.  
(2) Pursuant to Regulation (EC) No 1451/2007, tolylfluanid 
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 
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 24 April 
2006 in accordance with Article 14(4) and (6) of Regu ­
lation (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 15 May 
2009, in an assessment report.  
(5) It appears from the examinations made that biocidal 
products used as wood preservatives and containing 
tolylfluanid may be expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC. It is 
therefore appropriate to include tolylfluanid in Annex I, 
in order to ensure that in all Member States authori ­
sations for biocidal products used as wood preservatives 
and containing tolylfluanid can be granted, modified, or 
cancelled in accordance with Article 16(3) of Directive 
98/8/EC.  
(6) However, unacceptable risks were identified for the  in situ  
treatment of wood outdoors and for treated wood 
exposed to weathering. Therefore, products containing 
tolylfluanid and used as wood preservatives should not 
be authorised for those uses.  
(7) In the light of the findings of the assessment report, it is 
appropriate to require that risk mitigation measures are 
applied at product authorisation level to products 
containing tolylfluanid and used as wood preservatives 
to ensure that risks are reduced to an acceptable level 
in accordance with Article 5 of Directive 98/8/EC and 
Annex VI thereto. In particular, it is appropriate to 
require that products intended for industrial or profes ­
sional use be used with appropriate protective equipment 
unless it can be demonstrated that risks for industrial or 
professional users can be reduced by other means. 
Appropriate measures should be taken to protect the 
soil and aquatic compartments since unacceptable risks 
to these compartments have been identified during the 
evaluation. Instructions should therefore be provided to 
indicate that treated timber must be stored after 
treatment under shelter and/or on impermeable hard 
standing and that any losses must be collected for 
reuse or disposal.  
(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 containing the active substance tolylfluanid and 
also to facilitate the proper operation of the biocidal 
products market in general.EN L 313/78 Official Journal of the European Union 28.11.2009  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(9) A reasonable period should be allowed to elapse before 
an active substance is included 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, which, 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 tolylfluanid 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.  Article 2  
1. Member States shall adopt and publish, by 30 September 
2010 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive.  
They shall apply those provisions from 1 October 2011.  
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, 27 November 2009.  
For the Commission  
Stavros DIMAS  
Member of the CommissionEN 28.11.2009 Official Journal of the European Union L 313/79ANNEX  
The following entry ‘No 29’ 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 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 (*)  
‘29 tolylfluanid  Dichloro-N- 
[(dimethylamino)sulp ­
honyl]fluoro-N-(p- 
tolyl)methanesulphe ­
namide 
EC No: 211-986-9 
CAS No: 731-27-1  960 g/kg  1 October 2011  30 September 2013  30 September 
2021  8 Products shall not be authorised for the  in situ  
treatment of wood outdoors or for wood that 
will be exposed to weathering. 
Member States shall ensure that authorisations 
are subject to the following conditions: 
1. In view of the assumptions made during the 
risk assessment, products authorised for 
industrial or professional use must 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 level by other 
means. 
2. In view of the risks identified for the soil and 
aquatic compartments, appropriate risk miti ­
gation measures must be taken to protect 
those compartments. In particular, labels 
and/or safety-data sheets of products auth ­
orised for industrial or professional use shall 
indicate that freshly treated timber must be 
stored after treatment under shelter and/or 
on impermeable hard standing to prevent 
direct losses to soil or water and that any 
losses must 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.htmEN L 313/80 Official Journal of the European Union 28.11.2009