EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D/ 
CA Sept10-Doc.3  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
nonanoic acid 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 
nonanoic acid 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 nonanoic acid. 
(2) Pursuant to Regulation (E C) No 1451/2007, nonanoic acid has been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 19, 
repellents and attractants, as define d in Annex V to that Directive. 
(3) Austria was designated as Rapporteur Me mber State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
10 October 2008 in accordance with Articl e 14(4) and (6) of Regulation (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 23 September 2010, in an assessment report. 
(5) It appears from the evaluations that biocidal products used as repellents and containing 
nonanoic acid may be expected to satisfy th e requirements laid down in Article 5 of 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN Directive 98/8/EC. It is therefore appropria te to include nonanoic acid in Annex I to 
that Directive. 
(6) Not all potential uses have been evaluated at  Union level. It is therefore appropriate 
that Member States assess those uses or exposure scenarios and those risks to the 
compartments and populations that have not been representatively addressed in Union 
level risk assessment and, when granting  product authorisations, ensure that 
appropriate measures are taken or specific conditions imposed in order to reduce the 
identified risks to acceptable levels. 
(7) It is important that the provisions of this  Directive be applied simultaneously in all 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substanc e nonanoic acid and also to facilitate the proper 
operation of the biocidal pr oducts 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 the 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 
 
Transposition 
1. Member States shall adopt and publish, by 31 January 2012 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 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:  
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] Nonanoi
c acid, 
Pelargonic acid IUPAC name: Nonanoic acid 
EC No: 203-931-2 
CAS No: 112-05-0 896 g/kg 
1 February 
2013 31 January 2015 31 January 
2023 19 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member States shall assess, when relevant for the 
particular product, those uses or exposure 
scenarios and those risks to compartments and populations that have not been 
representatively addressed in Union level 
risk assessment. Produ ct authorisation can 
only be granted where the application 
demonstrates that risks can be reduced to acceptable levels." 
(*) 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