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25.10.2013 Official
Journal
of
the
European
Union L
283/31
COMMISSION IMPLEMENTING REGULATION (EU) No 1035/2013
of 24 October 2013
approving benzoic acid as an existing active substance for use in biocidal products for product-
types 3 and 4
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) It
appears
from
those
reports
that
biocidal
products
used
for product-types 3 and 4 and containing benzoic acid
may be expected to satisfy the requirements laid down in
Having regard to the Treaty on the Functioning of the European
Article 5 of Directive 98/8/EC.
Union,
(6) It
is
therefore
appropriate
to
approve
benzoic
acid
for
Having regard to Regulation (EU) No 528/2012 of the
use in biocidal products for product-types 3 and 4.
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
(7) Since
the
evaluations
did
not
address
nanomaterials,
the
of Article 89(1) thereof,
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
adress the incorporation of biocidal products containing
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
benzoic acid in materials and articles intended to come
lishes a list of active substances to be assessed, with a
into contact directly or indirectly with food within the
view to their possible inclusion in Annex I, IA or IB to
meaning of Article 1(1) of Regulation (EC) No
Directive 98/8/EC of the European Parliament and of the
1935/2004 of the European Parliament and of the Coun
Council ( 3 ). That list includes benzoic acid.
cil ( 4 ). 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
(2) Benzoic
acid
has
been
evaluated
in
accordance
with
Commission has established such limits or it has been
Article 11(2) of Directive 98/8/EC for use in product-
established pursuant to that Regulation that such limits
type 3, veterinary hygiene biocidal products, and
are not necessary.
product-type 4, food and feed area disinfectants, as

defined in Annex V to that Directive, which correspond
respectively to product-types 3 and 4 as defined in
Annex V to Regulation (EU) No 528/2012.
(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
(3) Germany
was
designated
as
Rapporteur
Member
State
and submitted the competent authority reports,
new requirements entailed.
together with recommendations, to the Commission on
3 February 2011 in accordance with Article 14(4) and
(6) of Regulation (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
27 September 2013, in two assessment reports.
Article 1
( 1 ) OJ L 167, 27.6.2012, p. 1.
Benzoic acid shall be approved as an active substance for use in
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
biocidal products for product-types 3 and 4, subject to the
on the second phase of the 10-year work programme referred to in
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 283/32
EN
Official Journal of the European Union
25.10.2013
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, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

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25.10.2013 Off
ANNEX
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
EN
Benzoic acid IUPAC
Name:
Benzoic
acid
990 g/kg 1
July
2015 30
June
2025
3 The
product
assessment
shall
pay
particular
attention
to
the
exposures, the risks and the efficacy linked to any uses covered by
EC No: 200-618-2
an application for authorisation, but not addressed in the Union level
risk assessment of the active substance.
CAS No: 65-85-0
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.
icial
Jour
(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)
nal
in accordance with Regulation (EC) No 470/2009 of the
European Parliament and of the Council (3 ) or Regulation (EC)
of
No 396/2005 of the European Parliament and of the Council (4 )
the
shall be verified, and any appropriate risk mitigation measures
European
shall be taken to ensure that the applicable MRLs are not
exceeded.
Union
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 (MRLs)
in accordance with Regulation (EC) No 470/2009 or Regulation
L
(EC) No 396/2005 shall be verified, and any appropriate risk
283/33
mitigation measures shall be taken to ensure that the applicable
MRLs are not exceeded.

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L 283/34
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
(3) Products containing benzoic 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
EN
limits on the migration of benzoic acid into food or it has

been established pursuant to that Regulation that such limits
are not necessary.
(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.
(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/
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
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).
(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
Off
(OJ L 70, 16.3.2005, p. 1).
icial
Jour
nal
of
the
European
Union
25.10.2013

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Document Outline

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