EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.3.3 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving octanoic acid as an existing active  substance for use in biocidal products for 
product-types 4 and 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving octanoic acid as an existing active  substance for use in biocidal products for 
product-types 4 and 18 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes octanoic 
acid. 
(2) Octanoic acid has been evaluated in acco rdance with Article 11(2) of Directive 
98/8/EC for use in product-type 4, food and feed area disinfectants, and product-type 
18, insecticides, acaricides and products to control other arthropods, as defined in 
Annex V to that Directive, which corres pond respectively to produc t-types 4 and 18 as 
defined in Annex V to Regulation (EU) No 528/2012. 
(3) Austria was designated as Rapporteur Me mber State and submitted the competent 
authority reports, together  with recommendations, to the Commission on 7 December 
2010 in accordance with Article 14(4) a nd (6) of Regulati on (EC) No 1451/2007. 
(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 review were incorporated, within the Standing Committee on Biocidal 
Products on [date SCB], in two assessment reports. 
(5) It appears from those reports that biocidal  products used for product-types 4 and 18 
and containing octanoic acid may be expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC.  
(6) It is therefore appropriate to  approve octanoic acid for use in biocidal products for 
product-type 4 and 18.  
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 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 Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
3 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 (OJ L 123, 24.4.1998, p. 1) .  
EN 3   EN (7) Since the evaluations did not address nanom aterials, the approvals should not cover 
such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. 
(8) For the use in product-type 4, the evalua tion did not address th e incorporation of 
biocidal products containing octanoic acid in  materials and articles intended to come 
into contact directly or indi rectly with food within the meaning of Article 1(1) of 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council4. Such 
materials may require the establishment of specific limits on the migration into food, 
as referred to in Article 5(1)(e) of  Regulation (EC) No  1935/2004. The approval 
should therefore not cover such use unless the Commission has established such limits 
or it has been established pursuant to that Regulation that such limits are not 
necessary.  
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit Member States, interested parties, and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed.  
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Octanoic acid shall be approved as an active substance for use in biocidal products for 
product-types 4 and 18, subject to the specifica tions and conditions se t out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President 
 José Manuel BARROSO  
                                                 
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact  with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).  
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
Octanoic 
acid 
 IUPAC Name :  
n-Octanoic acid  EC No : 204-677-5 CAS No : 124-07-2 
 993 g/kg 1 
September 
2015  31 August 
2025
 4 The product assessment shall pay particular 
attention to the exposures, the risks and the efficacy linked to any uses covered by an 
application for authorisation, but not 
addressed in the Union level risk 
assessment of the active substance. 
Authorisations are subject to the following 
conditions: 
(1) For industrial or professional 
users, safe operational procedures and appropriate 
organizational measures shall be 
established. Where exposure cannot be reduced to an 
acceptable level by other means, 
products shall be used with appropriate personal protective 
equipment. 
(2) For products that may lead to 
residues in food or feed, the 
need to set new or to amend 
existing maximum residue levels 
                                                 
5 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 of Regulation (EU) 
No 528/2012. The active substance in the product placed on the market  can be of equal or different  purity if it has been proven  technically equivalent with the evaluated 
active substance. 
6 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm   
EN 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
(MRLs) in accordance with 
Regulation (EC) No 470/2009 of the European Parliament and of 
the Council
7 or Regulation (EC) 
No 396/2005 of the European Parliament and of the Council
8 
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to 
ensure that the applicable MRLs are not exceeded. 
(3) Biocidal products containing 
octanoic acid shall not be incorporated in materials and 
articles intended to come into 
contact with food within the meaning of Article 1(1) of 
Regulation (EC) No 1935/2004, 
unless the Commission has established specific limits on the 
migration of octanoic acid into 
food or it has been established pursuant to that Regulation that 
such limits are not necessary.
 
                                                                                                                                                                                                                                                    
7 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
8 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
EN 6   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
18 The product assessment shall pay particular 
attention to the exposures, the risks and the efficacy linked to any uses covered by an 
application for authorisation, but not 
addressed in the Union level risk assessment of the active substance. 
Authorisations are subject to the following 
conditions: 
(1) 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. 
(2) For products that may lead to 
residues in food or feed, the 
need to set new or to amend 
existing maximum residue levels (MRLs) in accordance with 
Regulation (EC) No 470/2009 of 
the European Parliament and of the Council or Regulation (EC) 
No 396/2005 of the European 
Parliament and of the Council 
shall be verified, and any 
appropriate risk mitigation  
EN 7   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
measures shall be taken to 
ensure that the applicable MRLs are not exceeded.