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27.7.2013 Official
Journal
of
the
European
Union L
202/17
COMMISSION IMPLEMENTING REGULATION (EU) No 725/2013
of 26 July 2013
concerning the authorisation of ammonium chloride as a feed additive for ruminants, cats and dogs
(holder of the authorisation BASF SE)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
under the proposed conditions of use, the ammonium
chloride does not have an adverse effect on animal
health, human health or the environment. It recognised
that the ammonium chloride is a potent urinary acidifier
Having regard to the Treaty on the Functioning of the European
and a supplementation of feed for ruminants, cats and
Union,
dogs results in a decrease of the urinary pH. The
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
Having regard to Regulation (EC) No 1831/2003 of the
verified the report on the method of analysis of the feed
European Parliament and of the Council of 22 September
additive in feed submitted by the Reference Laboratory
2003 on additives for use in animal nutrition (
set up by Regulation (EC) No 1831/2003.

1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
the
ammonium
chloride
shows
that
Whereas:
the conditions for authorisation, as provided for in

Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that additive should be authorised
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
orisation. Article 10 of that Regulation provides for the
(6)
Since safety reasons do not require the immediate appli
re-evaluation of additives authorised pursuant to Council
cation of the modifications to the conditions of auth
Directive 70/524/EEC (
orisation, it is appropriate to allow a transitional period

2 ).
for interested parties to prepare themselves to meet the
new requirements resulting from the authorisation.
(2) Ammonium
chloride
was
authorised
in
accordance
with
Directive 70/524/EEC as a feed additive, without a time
limit, for use on cats and dogs and with a time limit for
(7) The
measures
provided
for
in
this
Regulation
are
in
all pets with the exception of cats and dogs by
accordance with the opinion of the Standing
Commission Directive 86/525/EEC (
Committee on the Food Chain and Animal Health,

3 ). That additive was
subsequently entered in the Register of feed additives as
an existing 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
Article 1
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
Authorisation
of ammonium chloride as a feed additive for cats and
dogs and, in accordance with Article 7 of that Regu
The ammonium chloride specified in the Annex, belonging to
lation, for a new use for ruminants, requesting that
the additive category ‘zootechnical additives’ and to the func
additive to be classified in the additive category ‘tech
tional group ‘other zootechnical additives’, is authorised as an
nological additives’. That application was accompanied
additive in animal nutrition, subject to the conditions laid down
by the particulars and documents required under
in that Annex.
Article 7(3) of Regulation (EC) No 1831/2003.
Article 2
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Transitional measures
concluded in its opinion of 24 May 2012 ( 4 ) that,
The additive specified in the Annex for use for cats and dogs
and feed containing that additive, which are produced and
( 1 ) OJ L 268, 18.10.2003, p. 29.
labelled before 16 August 2015 in accordance with the rules
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 310, 5.11.1986, p. 19.
applicable before 16 August 2013 may continue to be placed
( 4 ) EFSA Journal 2012; 10(6):2738.
on the market and used until the existing stocks are exhausted.

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L 202/18
EN
Official Journal of the European Union
27.7.2013
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, 26 July 2013.
For the Commission
The President
José Manuel BARROSO

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27.7.2013 Off
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
mg/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (reduction of urinary pH)
4d8 BASF
SE Ammonium
Additive composition
Ruminants
—
— 10
000
for
a
1. The additive shall be incorporated into
16 August
chloride
period not
feed in the form of a premixture.
2023
Ammonium chloride ≥ 99,0 %
exceeding
2. For safety: breathing protection, eye
(Solid form)
three
months
protection, gloves and protective
Characterisation of the active substance
clothing shall be used during
5 000 for a
handling.
Ammonium chloride ≥ 99,0 %
period
3. The mixture of different sources of
icial
NH
exceeding
4Cl CAS No: 12125-02-9
three
ammonium chloride shall not exceed
Jour
Sodium chloride ≤ 0,5 %
months
the permitted maximum levels in
complete feedingstuffs for ruminants.
Produced by chemical synthesis
nal
of
Method of analysis (
Cats and
5 000
1 )

dogs
the
Quantification of ammonium chloride in
European
feed additive: titration with sodium
hydroxide (European Pharmacopoeia,
monograph 0007) or titration with silver
nitrate (JECFA monograph ammonium
Union
chloride).
(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
202/19

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Document Outline

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