EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
D0xxx/01 CA-May12-Doc.3 
[…](2012) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to extend 
the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2
(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 extend 
the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2 
(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) Commission Directive 2011/13/EU of 8 Fe bruary 2011 amending Directive 98/8/EC 
of the European Parliament and of the Council to include nonanoic acid as an active 
substance in Annex I thereto3 included nonanoic acid as an active substance in 
Annex I to Directive 98/8/EC for use in pr oduct-type 19, repellents and attractants, as 
defined in Annex V to Directive 98/8/EC. 
(3) Pursuant to Regulation (EC)  No 1451/2007, nonanoic acid has now been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private 
area and public health area di sinfectants and other biocid al products, as defined in 
Annex V to that Directive. 
(4) Austria was designated as Rapporteur Me mber State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
6 August 2010 in accordance with Article 14(4) and (6) of Regulation (EC) 
No 1451/2007. 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3 OJ L 34, 9.2.2011, p. 52.  
EN 3   EN (5) 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 [date of Committee meeting to be  inserted], in an assessment report. 
(6) It appears from the evaluations that biocidal  products used as private area and public 
health area disinfectants and other bioc idal products as defined in Annex V to 
Directive 98/8/EC and containing nonanoic acid may be expected to satisfy the requirements laid down in Articl e 5 of Directive 98/8/EC. It is therefore appropriate to 
extend the inclusion of nonanoic acid in Anne x I to that Directive to product-type 2. 
(7) Not all potential uses have been  evaluated at Union level. It  is therefore appropriate to 
require that Member States assess 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 a ssessment and, when granting 
product authorisations, ensure that appropr iate measures are taken or specific 
conditions imposed in order to reduce th e identified risks to acceptable levels. 
(8) In view of the irritant prope rties of the substance, it is  appropriate to  require that 
exposure during non-professional use is minimised through the design of the 
packaging, unless it can be demonstrated in  the application for product authorisation 
that risks for human health can be reduced  to acceptable levels by other means. 
(9) 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 2 containing the active substance nonanoic acid and also  to facilitate the 
proper operation of the biocidal products market in general. 
(10) 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. 
(11) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(12) Directive 98/8/EC should therefore be amended accordingly. 
(13) 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. 
(14) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                 
4  OJ C 369, 17.12.2011, p. 14.  
EN 4   EN 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 2013 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 2014. 
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  
The following is added to entry ‘No 41’  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 (*) 
    "1 October 2014 30 Septem ber 2016 30 september 2024 2 When assessing 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. 
Member States shall ensure that authorisations 
of products for non-professional use are subject to the packaging being designed to minimise 
user exposure, unless it can be demonstrated in 
the application for product authorisation that risks for human health can be reduced to 
acceptable levels by other means. " 
(*) 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