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1.2.2014 Official
Journal
of
the
European
Union L
32/9
COMMISSION IMPLEMENTING REGULATION (EU) No 90/2014
of 31 January 2014
approving decanoic acid as an existing active substance for use in biocidal products for product-
types 4, 18 and 19
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) It
appears
from
those
reports
that
biocidal
products
used
for product-types 4, 18 and 19 and containing decanoic
acid may be expected to satisfy the requirements laid
Having regard to the Treaty on the Functioning of the European
down in Article 5 of Directive 98/8/EC.
Union,
(6) It
is
therefore
appropriate
to
approve
decanoic
acid
for
Having regard to Regulation (EU) No 528/2012 of the
use in biocidal products for product-types 4, 18 and 19.
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,
(7) Since
the
evaluations
did
not
address
nanomaterials,
the
approvals should not cover such materials pursuant to
Article 4(4) of Regulation (EU) No 528/2012.
Whereas:
(8) For
the
use
in
product-type
4,
the
evaluation
did
not
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
address the incorporation of biocidal products containing
lishes a list of active substances to be assessed, with a
decanoic acid in materials and articles intended to come
view to their possible inclusion in Annex I, IA or IB to
into contact directly or indirectly with food within the
Directive 98/8/EC of the European Parliament and of the
meaning of Article 1(1) of Regulation (EC) No
Council ( 3 ). That list includes decanoic acid.
1935/2004 of the European Parliament and of the Coun
cil ( 4 ). Such materials may require the establishment of
specific limits on the migration into food, as referred to
(2) Decanoic
acid
has
been
evaluated
in
accordance
with
in Article 5(1)(e) of Regulation (EC) No 1935/2004. The
Article 11(2) of Directive 98/8/EC for use in product-
approval should therefore not cover such use unless the
type 4, food and feed area disinfectants, product-type
Commission has established such limits or it has been
18, insecticides, acaricides and products to control
established pursuant to that Regulation that such limits
other arthropods, and product-type 19, repellents and
are not necessary.
attractants, as defined in Annex V to that Directive,
which correspond respectively to product-types 4, 18
and 19 as defined in Annex V to Regulation (EU) No
(9) A
reasonable
period
should
be
allowed
to
elapse
before
528/2012.
an active substance is approved, in order to permit
Member States, interested parties, and the Commission
where appropriate, to prepare themselves to meet the
(3) Austria
was
designated
as
rapporteur
Member
State
and
new requirements entailed.
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.
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on Biocidal Products,
(4) The
competent
authority
reports
were
reviewed
by
the
Member States and the Commission. In accordance with
Article 15(4) of Regulation (EC) No 1451/2007, the
HAS ADOPTED THIS REGULATION:
findings of the review were incorporated, within the
Standing Committee on Biocidal Products on
13 December 2013, in two assessment reports.
Article 1
( 1 ) OJ L 167, 27.6.2012, p. 1.
Decanoic acid shall be approved as an active substance for use
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
in biocidal products for product-types 4, 18 and 19, subject to
on the second phase of the 10-year work programme referred to in
the specifications and conditions set out in the Annex.
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 32/10
EN
Official Journal of the European Union
1.2.2014
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
Common Name
IUPAC Name
of purity of the
Identification Numbers
active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
EN

Decanoic acid IUPAC
Name:
985 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 auth
orisation, but not addressed in the Union level risk assessment of the active
n-Decanoic acid
substance.
EC No: 206-376-4
Authorisations are subject to the following conditions:
CAS No: 334-48-5
For industrial or professional users, safe operational procedures and appro
priate organisational measures shall be established. Where exposure cannot
be reduced to an acceptable level by other means, products shall be used
icial
with appropriate personal protective equipment.
Jour
For products that may lead to residues in food or feed, the need to set new or
nal
to amend existing maximum residue levels (MRLs) in accordance with Regu
of
lation (EC) No 470/2009 of the European Parliament and of the Council (3 ) or
the
Regulation (EC) No 396/2005 of the European Parliament and of the Coun
cil (4 ) shall be verified, and any appropriate risk mitigation measures shall be
European
taken to ensure that the applicable MRLs are not exceeded.
Biocidal products containing decanoic acid shall not be incorporated in
Union
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 decanoic 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 an application for auth
orisation, but not addressed in the Union level risk assessment of the active
substance.
Authorisations are subject to the following conditions:
Authorisations of products for non-professional use are subject to the
packaging being designed to minimise user exposure, unless it can be demon
L
strated in the application for product authorisation that risks for human health
32/11
can be reduced to acceptable levels by other means.

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L 32/12
Minimum degree
Common Name
IUPAC Name
of purity of the
Identification Numbers
active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
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 Regu
lation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified,
EN
and any appropriate risk mitigation measures shall be taken to ensure that the

applicable MRLs are not exceeded.
19 The
product
assessment
shall
pay
particular
attention
to
the
exposures,
the
risks and the efficacy linked to any uses covered by an application for auth
orisation, but not addressed in the Union level risk assessment of the active
substance.
(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
the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
Off
(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/
icial
biocides/index.htm
(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
Jour
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,
16.6.2009, p. 11).
nal
(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).
of
the
European
Union
1.2.2014

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Document Outline

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