EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2011) yyy final  
CA-Feb11-Doc.3.1  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
fipronil as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
fipronil as an active substance 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 fipronil for use in product-type 18, insecticides, acaricides and products to 
control other arthropods, as define d in Annex V to the Directive. 
(2) Pursuant to Regulation (EC)  No 1451/2007, fipronil has been evaluated in accordance 
with Article 11(2) of Directive 98/8/EC for use in product-type 18. 
(3) France was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recommendation, to the Commission in accordance 
with Article 14(4) and (6) of Regul ation (EC) No 1451/2007 on 6 February 2009. 
(4) The competent authority reports were 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 reviews were incorporate d, within the Standing Committee on Biocidal 
Products on 6 May 2011, in an assessment report. 
(5) It appears from the evaluati ons that biocidal products used as insecticides and 
containing fipronil may be expected to satisfy  the requirements laid down in Article 5 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN of Directive 98/8/EC. It is therefore appropria te to include fipronil in Annex I to that 
Directive. 
(6) Not all potential uses have been evaluated in the Union level assessment, which only 
addressed professional use indoors by applica tion in locations inaccessible to man and 
domestic animals. It is therefore appropria te to require that Member States assess 
those uses or exposure scenarios and t hose risks to human populations and to 
environmental compartments that have not  been representatively addressed in the 
Union level risk assessment and, when gr anting product authorisat ions, ensure that 
appropriate measures are taken or specific conditions imposed in order to reduce the 
identified risks to acceptable levels. 
(7) The provisions of this Direct ive should be applied at the same time in all Member 
States in order to ensure equal treatmen t on the Union market of biocidal products 
containing the active substance fipronil, and also to facil itate the proper operation of 
the biocidal products market in general. 
(8) 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. 
(9) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(10) Directive 98/8/EC should therefore be amended accordingly. 
(11) 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 
1. Member States shall adopt and publish, by 30 September 2012 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 2013. 
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.  
EN 4   EN 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 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC , the following entry is added:  
"(**) 
[OPOC
E: please 
insert 
substance 
number] fipronil (±)-5-amino-1-(2,6-dichloro- α,α,α,-trifluoro-
p-tolyl)-4-trifluoromethylsulfinylpyrazole-3-
carbonitrile 
EC No: 424-610-5 
CAS No: 120068-37-3 950 g/kg 
1 October 
2013 30 September 2015 30 September 
2023 18 Only professional use indoors by 
application in locations inaccessible to man 
and domestic animals has been addressed in the Union level risk assessment. When 
assessing the application for authorisation 
of a product in accord ance with Article 5 
and Annex VI, Member States shall assess, 
where relevant for the particular product, 
those uses or exposure scenarios and those 
risks to human populations and to 
environmental compartments that have not been representatively addressed in the 
Union level risk assessment." 
(*) 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