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1.2.2014 Official
Journal
of
the
European
Union L
32/19
COMMISSION IMPLEMENTING REGULATION (EU) No 93/2014
of 31 January 2014
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,
Standing Committee on Biocidal Products on
13 December 2013 in two assessment reports.
Having regard to the Treaty on the Functioning of the European
Union,
(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
Having regard to Regulation (EU) No 528/2012 of the
Article 5 of Directive 98/8/EC.
European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular the third subparagraph
of Article 89(1) thereof,
(6) It
is
therefore
appropriate
to
approve
octanoic
acid
for
use in biocidal products for product-type 4 and 18.
Whereas:
(7) Since
the
evaluations
did
not
address
nanomaterials,
the
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
approvals should not cover such materials pursuant to
lishes a list of active substances to be assessed, with a
Article 4(4) of Regulation (EU) No 528/2012.
view to their possible inclusion in Annex I, IA or IB to
Directive 98/8/EC of the European Parliament and of the
Council ( 3 ). That list includes octanoic acid.
(8) For
the
use
in
product-type
4,
the
evaluation
did
not
address the incorporation of biocidal products containing
(2) Octanoic
acid
has
been
evaluated
in
accordance
with
octanoic acid in materials and articles intended to come
Article 11(2) of Directive 98/8/EC for use in product-
into contact directly or indirectly with food within the
type 4, food and feed area disinfectants, and product-
meaning of Article 1(1) of Regulation (EC) No
type 18, insecticides, acaricides and products to control
1935/2004 of the European Parliament and of the Coun
other arthropods, as defined in Annex V to that
cil ( 4 ). Such materials may require the establishment of
Directive, which correspond respectively to product-
specific limits on the migration into food, as referred to
types 4 and 18 as defined in Annex V to Regulation
in Article 5(1)(e) of Regulation (EC) No 1935/2004. The
(EU) No 528/2012.
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
(3) Austria
was
designated
as
Rapporteur
Member
State
and
are not necessary.
submitted the competent authority reports, together with
recommendations, to the Commission on 7 December
2010 in accordance with Article 14(4) and (6) of Regu
lation (EC) No 1451/2007.
(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
(4) The
competent
authority
reports
were
reviewed
by
the
where appropriate, to prepare themselves to meet the
Member States and the Commission. In accordance with
new requirements entailed.
Article 15(4) of Regulation (EC) No 1451/2007, the
findings of the review were incorporated, within the
( 1 ) OJ L 167, 27.6.2012, p. 1.
(10) The
measures
provided
for
in
this
Regulation
are
in
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
accordance with the opinion of the Standing
on the second phase of the 10-year work programme referred to in
Committee on Biocidal Products,
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).
( 4 ) Regulation (EC) No 1935/2004 of the European Parliament and of
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
the Council of 27 October 2004 on materials and articles intended
16 February 1998 concerning the placing of biocidal products on
to come into contact with food and repealing Directives 80/590/EEC
the market (OJ L 123, 24.4.1998, p. 1).
and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

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L 32/20
EN
Official Journal of the European Union
1.2.2014
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 specifications and conditions set 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, 31 January 2014.
For the Commission
The President
José Manuel BARROSO

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1.2.2014 Off
ANNEX
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval
Product
substance (
type
Specific conditions (2 )
1 )
Octanoic acid IUPAC
Name:
993 g/kg 1
September
2015 31
August
2025
4 The
product
assessment
shall
pay
particular
attention
to
the EN
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.
n-Octanoic acid
Authorisations are subject to the following conditions:
EC No: 204-677-5
(1) For industrial or professional users, safe operational procedures
icial
CAS No: 124-07-2
and appropriate organizational measures shall be established.
Where exposure cannot be reduced to an acceptable level by
Jour
other means, products shall be used with appropriate personal
protective equipment.
nal
of
the
European
(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 (3 ) or Regulation (EC)
Union
No 396/2005 of the European Parliament and of the Council (4 )
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 incor
porated 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.
18 The
product
assessment
shall
pay
particular
attention
to
the
exposures, the risks and the efficacy linked to any uses covered by
L
an application for authorisation, but not addressed in the Union level
32/21
risk assessment of the active substance.

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L 32/22
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval
Product
substance (
type
Specific conditions (2 )
1 )
Authorisations are subject to the following conditions:
(1) Authorisations of products for non-professional use are subject to
EN
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 or Regulation
(EC) No 396/2005 shall be verified, and any appropriate risk
mitigation measures shall be taken to ensure that the applicable
Off
MRLs are not exceeded.
icial
(1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on
Jour
the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
(2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/
nal
biocides/index.htm
of
(3 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the 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,
the
16.6.2009, p. 11).
European
(4 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides 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).
Union
1.2.2014

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Document Outline

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