EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) XXX final D004864/02  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
tolylfluanid as an active 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 
tolylfluanid as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 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 tolylfluanid. 
(2) Pursuant to Regulation (EC) No 1451/2007, tolylfluanid has b een 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) a nd (6) of Regulati on (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 15 May 2009, in an assessment report. 
(5) It appears from the examinations made  that biocidal products used as wood 
preservatives and containing to lylfluanid may be expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC . It is therefore a ppropriate to include 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN tolylfluanid in Annex I, in order to ensure that in all Member States authorisations for 
biocidal products used as wood preserva tives 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 weat hering. 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 au thorisation level to products containing 
tolylfluanid and used as w ood preservatives to ensure th at 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 a ppropriate to require that produ cts intended for industrial or 
professional use be used w ith appropriate pr otective 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. Instructi ons should therefore be provided to i ndicate that treated 
timber must be stored afte r treatment under sh elter 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 tr eatment of biocidal products on the market 
containing the active substance tolylfluanid and also to facilitat e the proper operation 
of the biocidal products market in general. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 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 bioc idal products in product-type 8 co ntaining 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 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. EN 4   EN Article 2  
1. Member States shall adopt and publish, by 30 September 2010 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those pr ovisions 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 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 
 Stavros DIMAS  Member of the Commission  
EN 5   EN ANNEX  
The following entry ‘No. 29’ is insert ed 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)sulpho
nyl]fluoro-N-(p-tolyl)methanesulphenam
ide 
EC No: 211-986-9 
CAS No: 731-27-1 960 g/kg  1 October 2011 30 Se ptember 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 mitigation measures must be taken to 
protect those compartments. 
In particular, labels and/or safety-data sheets of 
products authorised for 
industrial or professional use shall indicate that  
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 (*) 
 
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.htm