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22.2.2013 Official
Journal
of
the
European
Union L
49/47
COMMISSION IMPLEMENTING REGULATION (EU) No 159/2013
of 21 February 2013
concerning the authorisation of a preparation of sodium benzoate, propionic acid and sodium
propionate as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses and
amending Regulations (EC) No 1876/2006 and (EC) No 757/2007
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
on animal health, human health provided that adequate
measures to protect users are taken, or the environment,
Having regard to the Treaty on the Functioning of the European
and that it is efficacious in preserving cereals and
Union,
complete feedingstuff. The Authority does not consider
that there is a need for specific requirements of post-
market monitoring. It also verified the report on the
Having regard to Regulation (EC) No 1831/2003 of the
method of analysis of the feed additive in feed
European Parliament and of the Council of 22 September
submitted by the Reference Laboratory set up by Regu
2003 on additives for use in animal nutrition ( 1 ), and in
lation (EC) No 1831/2003.
particular Article 9(2) thereof,
(5)
The assessment of the preparation of sodium benzoate,
Whereas:
propionic acid and sodium propionate shows that the
conditions for authorisation, as provided for in
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
orisation of additives for use in animal nutrition and
Accordingly, the use of that preparation should be auth
for the grounds and procedures for granting such auth
orised as specified in the Annex to this Regulation.
orisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council
(6)
As a consequence of the granting of a new authorisation
Directive 70/524/EEC ( 2 ).
under Regulation (EC) No 1831/2003, Regulations (EC)
No 1876/2006 and (EC) No 757/2007 should therefore
(2) A
preparation
of
sodium
benzoate,
propionic
acid
and
be amended accordingly.
sodium propionate was authorised without a time limit
in accordance with Directive 70/524/EEC as a feed
additive for use on pigs and dairy cows by Commission
(7)
Since safety reasons do not require the immediate appli
Regulation (EC) No 1876/2006 (
cation of the modifications to the conditions of auth

3 ) and for cattle for
fattening by Commission Regulation (EC) No
orisation, it is appropriate to allow a transitional period
757/2007 (
for interested parties to prepare themselves to meet the

4 ). That preparation was subsequently
entered in the Register of feed additives as an existing
new requirements resulting from the authorisation.
product, in accordance with Article 10(1) of Regulation
(EC) No 1831/2003.
(8) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No

1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of that
HAS ADOPTED THIS REGULATION:
preparation of sodium benzoate, propionic acid and
sodium propionate as a feed additive for pigs and dairy
Article 1
cows and cattle for fattening and, in accordance with
Article 7 of that Regulation, for a new use for pigs,
Authorisation
poultry, bovines, sheep, goats, rabbits and horses,
requesting that additive to be classified in the additive
The preparation specified in the Annex, belonging to the
category ‘technological additives’. That application was
additive category ‘technological additives’ and to the functional
accompanied by the particulars and documents required
group ‘preservatives’, is authorised as an additive in animal
under Article 7(3) of Regulation (EC) No 1831/2003.
nutrition, subject to the conditions laid down in that Annex.

(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinions of 6 September 2011 ( 5 ) and
Amendments to Regulation (EC) No 1876/2006
24 April 2012 ( 6 ) that, under the proposed conditions of
use, the preparation of sodium benzoate, propionic acid
Article 4 of Regulation (EC) No 1876/2006 and Annex IV
and sodium propionate does not have an adverse effect
thereto are deleted.
( 1 ) OJ L 268, 18.10.2003, p. 29.
Article 3
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 360, 19.12.2006, p. 126.
Amendments to Regulation (EC) No 757/2007
( 4 ) OJ L 172, 30.6.2007, p. 43.
( 5 ) EFSA Journal 2011; 9(9):2357.
Article 1 of Regulation (EC) No 757/2007 and Annex I thereto
( 6 ) EFSA Journal 2012; 10(5):2681.
are deleted.

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L 49/48
EN
Official Journal of the European Union
22.2.2013
Article 4
Transitional measures
The preparation specified in the Annex and feed containing that preparation, which are produced and
labelled before 14 September 2013 in accordance with the rules applicable before 14 March 2013 may
continue to be placed on the market and used until the existing stocks are exhausted.
Article 5
Entry into force
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, 21 February 2013.
For the Commission
The President
José Manuel BARROSO

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22.2.2013 Off
ANNEX
Minimum
Maximum
Identifi
content
content
cation
Name of the
Species or
Maximum
number of
holder of
Additive
Composition, chemical formula, description,
analytical method
category of
age
Other provisions
End of period of
mg/kg of complete
authorisation
the additive authorisation
animal
feedingstuff with a
EN
moisture content of 12 %

Category of technological additives. Functional group: preservatives
1a700
— Preparation
of
Additive composition
Pigs
—
— 10
000 1.
Simultaneous
use
with
other
sources
of
the 14 March 2023
sodium benzoate,
active substances shall not exceed the auth
propionic acid
Preparation of:
Poultry
orised maximum content.
and sodium
propionate
sodium benzoate: 140 g/kg,
Bovines
2. Minimum content:
propionic acid: 370 g/kg
Sheep
— cereals with a moisture ≥ 15 % other
sodium propionate: 110 g/kg
than maize kernels: 3
000 mg/kg of
icial
Goats
Water: 380 g/kg
cereals;
Jour
Rabbits
— maize kernels with a moisture ≥ 15 %:
13 000 mg/kg of maize kernels;
nal
Characterisation of the active substances
Horses
of
— complete feed with a moisture ≥ 12 %:
Sodium benzoate (C
the

7H 5O 2Na) ≥ 99 %
5 000 mg/kg of complete feed.
after drying of two hours at 105 °C
European
Propionic acid (C
3. Maximum content in all cereals:

3H 6O 2) ≥ 99,5 %
22 000 mg/kg of cereals.
Sodium propionate (C 3H 5O 2Na) ≥ 99 %
after drying of four hours at 105 °C
4. For safety: it is recommended to use
Union
breathing and eyes protections and gloves
during handling.
Analytical method (1 )
Quantification in feed additive:
— determination of benzoate: reversed
phase chromatography with UV
detection (HPLC-UV)
— total propionate: ion exclusion High
Performance Liquid Chroma
tography with refractive index
(HPLC-RI)
— total sodium: atomic absorption
spectrometry, AAS (EN ISO 6869)
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
L
49/49

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Document Outline

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