HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 49/52
EN
Official Journal of the European Union
22.2.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 161/2013
of 21 February 2013
concerning the authorisation of a preparation of sodium hydroxide as a feed additive for cats, dogs
and ornamental fish
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
health, and that its function in feed is essentially the
same as in food as acidity regulator and therefore no
further demonstration of efficacy is necessary. It
Having regard to the Treaty on the Functioning of the European
concluded that no safety concerns would arise for users
Union,
provided that appropriate protective measures are taken.
It also verified the report on the method of analysis of
the feed additive in feed submitted by the Reference
Having regard to Regulation (EC) No 1831/2003 of the
Laboratory set up by Regulation (EC) No 1831/2003.
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
sodium
hydroxide
shows
that
the
conditions for authorisation, as provided for in
Whereas:
Article 5 of Regulation (EC) No 1831/2003, are satisfied.

Accordingly, the use of this preparation should be auth
orised as specified in the Annex to this Regulation.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(6)
Since safety reasons do not require the immediate appli
orisation. Article 10 of that Regulation provides for the
cation of the modifications to the conditions of auth
re-evaluation of additives authorised pursuant to Council
orisation, it is appropriate to allow a transitional period
Directive 70/524/EEC ( 2 ).
for the disposal of existing stocks of additive, pre-
mixtures and compound feed containing it, as authorised
by Directive 86/525/EEC.
(2) A
preparation
of
Sodium
hydroxide,
CAS
number
1310-
73-2, was authorised without a time limit in accordance
with Directive 70/524/EEC as a feed additive for use on
cats and dogs by Commission Directive 86/525/EEC (
(7) The
measures
provided
for
in
this
Regulation
are
in

3 ).
That preparation was subsequently entered in the
accordance with the opinion of the Standing
Community Register of feed additives as an existing
Committee on the Food Chain and Animal Health,
product, in accordance with Article 10(1) of Regulation
(EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:
(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
Article 1
sodium hydroxide, CAS number 1310-73-2, as a feed
The preparation specified in the Annex, belonging to the
additive for cats and dogs and, in accordance with
additive category ‘technological additives’ and to the functional
Article 7 of that Regulation, for a new use for orna
group ‘acidity regulators’, is authorised as an additive in animal
mental fish, requesting that additive to be classified in
nutrition subject to the conditions laid down in that Annex.
the additive category ‘technological additives’. That appli
cation was accompanied by the particulars and
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 2
The additive specified in the Annex and premixtures containing
it which are produced and labelled before 14 March 2014 in
(4) The
European
Food
Safety
Authority
(‘the
Authority’) accordance with the rules applicable before 14 March 2013
concluded in its opinion of 11 September 2012 ( 4 )
may continue to be placed on the market and used until the
that, taking into account the fact that this additive was
existing stocks are exhausted.
already authorised for food use with the same function
and under the proposed conditions of use, sodium
hydroxide does not have an adverse effect on animal
Compound feed containing the additive specified in the Annex
which is produced and labelled before 14 March 2015 in
( 1 ) OJ L 268, 18.10.2003, p. 29.
accordance with the rules applicable before 14 March 2013
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 310, 5.11.1986, p. 19.
may continue to be placed on the market and used until the
( 4 ) EFSA Journal 2012; 10(10):2882.
existing stocks are exhausted.

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EN
22.2.2013 Official
Journal
of
the
European
Union L
49/53
Article 3
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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L 49/54
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the additive authorisation
analytical method
animal
age
mg/kg of complete feedingstuff
authorisation
with a moisture content of
EN
12 %

Category of technological additives. Functional group: acidity regulators
1j524
— Sodium Additive composition
Cats, dogs
—
—
— 1.
For
safety:
breathing
protection,
14 March 2023
hydroxide
Sodium hydroxide 50 % w/w
and orna
eye protection, gloves and
mental
protective clothing shall be used
(water solution)
fish
during handling.
2. For use: the resulting total sodium
Characterisation of the active substance
concentration in feed shall not
Off
Sodium hydroxide ≥ 98,0 % total alkali (calculated
compromise the overall electrolyte
icial
as NaOH)
balance.
Jour
NaOH CAS No.: 1310-73-2
nal
Produced by chemical synthesis
of
the
Method of Analysis (1 )
European
Determination of sodium hydroxide in feed
additive: Titrimetry — FAO JECFA Combined
Compendium for Food Additive Specifications,
Monograph No 1 (2006) ‘sodium hydroxide’.
Union
(1 ) Details of the analytical methods are available at the following addresses: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx and http://www.fao.org/ag/jecfa-additives/details.html?id=400
22.2.2013

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Document Outline

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