EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
CA-May12-Doc.4.1 
[…](2011) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
chlorfenapyr as an active substance in Annex I thereto 
(Text with EEA relevance) 
 EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
chlorfenapyr 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 chlorfenapyr. 
(2) Pursuant to Regulation (EC) No 1451/2007, chlorfenapyr 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 that Directive. 
(3) Portugal was designated as Rapporteur Me mber State and submitted the competent 
authority report, together with a recommendation, to the Commission in August 2006 
in accordance with Article 10(5) and (7) of 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 1896/20003. 
(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 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3  OJ L 307, 24.11.2003, p.1. EN 3   EN Products on [date of Standing Committee meeting to be inserted], in an assessment 
report. 
(5) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing chlorfenapyr may be expected to  satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is therefore appropriate to include chlorfenapyr for use in product type 8 in A nnex I to that Directive. 
(6) Not all potential uses and expos ure scenarios have been evalua ted at Union level. It is 
therefore appropriate to requi re that Member States asse ss those uses or exposure 
scenarios and those risks to  human populations and to environmental compartments 
that have not been represen tatively addressed in the Union level risk assessment and, 
when granting product authorisations, ensure that appropriate meas ures are taken or 
specific conditions imposed in order to reduce the identified risks to acceptable levels. 
(7) The provisions of this Directive should be  applied simultaneously in all Member 
States in order to ensure equal treatment on the Union market of biocidal products of 
product-type 8 containing the active substance chlorfenapyr and also to facilitate 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) In accordance with the Joint Political De claration of Member States and the 
Commission on explanatory documents of 28 September 2011
4, Member States have 
undertaken to accompany, in justified cases, the notification of their transposition 
measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition 
instruments. 
(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. 
                                                
 
4 OJ C 369, 17.12.2011, p. 14. EN 4   EN Article 2 
1. Member States shall adopt and publish, by 31 January 2014 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 February 2015. 
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 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC , the following entry is added:  
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 (*) 
"(**) 
[OPOC
E: please 
insert 
substance 
number] chlorfen
apyr IUPAC name: 4-bromo-2-(4-chlorophenyl)-1-
ethoxymethyl-5-trifluoromethylpyrrole-3-
carbonitrile 
EC No: Not allocated CAS No: 122453-73-0 940 g/kg 
1 February 
2015 31 January 2017 31 January 
2025 8 The Union level risk assessment did not 
address all potential uses and exposure 
scenarios. When asse ssing the application 
for authorisation of a product in accordance 
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