EFSA Journal 2012;10(6):2738

SCIENTIFIC OPINION

Scientific Opinion on the safety and efficacy of ammonium chloride for

bovines, sheep, dogs and cats1
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3

European Food Safety Authority (EFSA), Parma, Italy

ABSTRACT
Ammonium chloride is applied as an acidity regulator of feed for bovines, sheep, dogs and cats. Its efficacy as an
acidity regulator of feed has not been demonstrated. However, ammonium chloride effectively reduces the pH of
the urine in ruminants, dogs and cats. The effective minimum dose depends on the anion–cation ratio of the diet.
The safety of ammonium chloride is assessed on the basis of open literature with a certain level of uncertainty.
The sensitivity of the target species to dietary ammonium chloride appears to be different, ruminants showing a
higher tolerance than dogs. High doses (> 1 % ammonium chloride in complete feed) result in metabolic acidosis
and an increase in renal excretion of calcium and magnesium, and also potassium in cats and dogs. A feed
concentration of 1 % ammonium chloride is considered safe for ruminants for approximately three months. For
an unlimited period of administration, 0.5 % ammonium chloride in complete feed for ruminants, cats and dogs
should not be exceeded. As both ions of ammonium chloride will be rapidly excreted, no increase in the
endogenous concentration of these ions in tissues and products is expected. The use of ammonium chloride in
animal nutrition does not therefore raise any concerns for consumer safety. Ammonium chloride is an eye
irritant, a potential irritant to skin and the digestive tract and potentially harmful if swallowed, may cause
systemic toxicity by acidosis, and should be considered as a skin sensitiser. Ammonium chloride fumes are
regarded as a potential respiratory sensitiser. Ammonium chloride will not be excreted as such, but rather as urea
and ammonium and chloride ions. All these compounds are natural substances in animal excreta. The use of
ammonium chloride at dietary levels considered safe for ruminants does not therefore pose a risk for the
environment.

© European Food Safety Authority, 2012

KEY WORDS
Technological additive, acidity regulator, ammonium chloride, safety, ruminants, cats, dogs

1
On request from the European Commission, Question No EFSA-Q-2010-01515, adopted on 24 May 2012.
2
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël
Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Lubomir Leng, Secundino López
Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria
Saarela, Kristen Sejrsen and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu
3
Acknowledgement: The Panel wishes to thank the members of the Working Group on Technological Additives, including
Reinhard Kroker and Carlo Nebbia, for the preparatory work on this scientific opinion.

Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific
Opinion on the safety and efficacy of ammonium chloride for bovines, sheep, dogs and cats. EFSA Journal 2012;10(6):2738.
[18 pp.] doi:10.2903/j.efsa.2012.2738. Available online: www.efsa.europa.eu/efsajournal

© European Food Safety Authority, 2012

 Ammonium chloride for bovines, sheep, dogs and cats

SUMMARY
Following a request from the European Commission, the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on an application
for the re-authorisation of ammonium chloride when used as an acidity regulator in feed for dogs and
cats, and for a new use of ammonium chloride as an acidity regulator in feed for bovines and sheep.

As no tolerance studies were provided, an assessment of the safety of ammonium chloride for the
target species had to be performed on the basis of the open literature. As all these studies were not
designed as tolerance studies, endpoints differing in their sensitivity were examined. The dog studies
showed weaknesses in design and reporting and had controversial results. All this together accounts
for a certain level of uncertainty, particularly in dogs.

A feed concentration of 1 % ammonium chloride is considered safe for ruminants for a restricted
period of time (approximately 3 months). For an unlimited period of administration 0.5 % ammonium
chloride in the complete feed for ruminants should not be exceeded, particularly considering the
variety of feedingstuffs with different anion–cation ratios.

For cats and dogs, 0.5 % ammonium chloride in the complete diet can be considered safe for an
unlimited period. Doses higher than 0.5  % ammonium chloride in complete feed for dogs and cats
should be restricted to veterinary treatment.

Since both ions of ammonium chloride will be rapidly excreted, predominantly via the kidney, no
increase in the endogenous concentration of these ions in tissues and products is expected. The use of
ammonium chloride in animal nutrition does not therefore raise any concerns for consumer safety.

Ammonium chloride is an eye irritant, a potential irritant to skin and the digestive tract, potentially
harmful if swallowed and may cause systemic toxicity by acidosis. Ammonium chloride fumes are
considered as a potential respiratory sensitiser. Ammonium chloride should also be considered a skin
sensitiser.

Ammonium chloride will not be excreted as such, but rather as urea and ammonium and chloride ions.
All are natural substances in animal excreta. The use of ammonium chloride at dietary levels
considered safe for ruminants does not therefore pose a risk for the environment.

The pH value of a dry cat feed was reduced and its buffering capacity increased by the addition of
increasing amounts of ammonium chloride but no significant relevant effects on pH values or on
buffering capacity were seen for other feed types (dog, cow, lamb). The FEEDAP Panel concluded
that the efficacy of ammonium chloride as an acidity regulator of feed was not demonstrated.

The FEEDAP Panel noted that dietary ammonium chloride is a potent urinary acidifier and that it
could be used for that purpose in ruminants, dogs and cats.

EFSA Journal 2012;10(6):2738 2

 Ammonium chloride for bovines, sheep, dogs and cats

TABLE OF CONTENTS
Abstract ....................................................................................................................................................1
Summary ..................................................................................................................................................2
Table of contents ......................................................................................................................................3
Background ..............................................................................................................................................4
Terms of reference....................................................................................................................................4
Assessment ...............................................................................................................................................6
1. Introduction ......................................................................................................................................6
2. Characterisation ................................................................................................................................6
2.1. Characterisation of the product .................................................................................................6
2.2. Stability and homogeneity ........................................................................................................7
2.3. Conditions of use ......................................................................................................................7
2.4. Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) 7
3. Safety ................................................................................................................................................7
3.1. Safety for the target species ......................................................................................................7
3.2. Safety for the consumer ..........................................................................................................13
3.3. Safety for the user ...................................................................................................................13
3.4. Safety for the environment......................................................................................................13
4. Efficacy ..........................................................................................................................................13
Conclusions ............................................................................................................................................15
Remarks ..................................................................................................................................................15
Documentation provided to EFSA .........................................................................................................15
References ..............................................................................................................................................16
Appendix ................................................................................................................................................18

EFSA Journal 2012;10(6):2738 3

 Ammonium chloride for bovines, sheep, dogs and cats

BACKGROUND
Regulation (EC) No 1831/20034 establishes the rules governing the Community authorisation of
additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any
person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an
application in accordance with Article 7 and Article 10(2) of that Regulation also specifies that for
existing products within the meaning of Article 10(1), an application shall be submitted in accordance
with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to
Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of
seven years after the entry into force of this Regulation for additives authorised without time limit or
pursuant to Directive 82/471/EEC.

The European Commission received a request from the company BASF SE5 for authorisation of the
product ammonium chloride, when used as a feed additive for bovines, sheep, dogs and cats (category:
technological additive; functional group: acidity regulator) under the conditions mentioned in Table 1.

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the
application to the European Food Safety Authority (EFSA) as an application under Article 4(1)
(authorisation of a feed additive or new use of a feed additive) and under Article 10(2) (re-evaluation
of an authorised feed additive). EFSA received directly from the applicant the technical dossier in
support of this application.6 According to Article 8 of that Regulation, EFSA, after verifying the
particulars and documents submitted by the applicant, shall undertake an assessment in order to
determine whether the feed additive complies with the conditions laid down in Article 5. The
particulars and documents in support of the application were considered valid by EFSA as of 15 May
2011.

Ammonium chloride is authorised for use as technological additive (acidity regulator) in dogs and
cats.

EFSA issued two opinions on the safety of ammonium chloride used in or on foodstuffs (EFSA, 2009;
EFSA, 2011) and one on the safety and efficacy of ammonium chloride as feed additive for lambs for
fattening (EFSA, 2012).

TERMS OF REFERENCE
According to Article 8 of Regulation (EC) No 1831/2003, EFSA shall determine whether the feed
additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the
safety for the target animal(s), consumer, user and the environment and the efficacy of the product
ammonium chloride, when used under the conditions described in Table 1.

4
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use
in animal nutrition. OJ L 268, 18.10.2003, p. 29.
5
BASF SE, Carl-Bosch-Str. 38, 67056, Ludwigshafen, Germany.
6
EFSA Dossier reference: FAD-2010-0242.

EFSA Journal 2012;10(6):2738 4

 Ammonium chloride for bovines, sheep, dogs and cats

Table 1: Description and conditions of use of the additive as proposed by the applicant

Additive Ammonium chloride

Registration number/EC No/No
(if appropriate)
Category(ies) of additive
Functional group(s) of additive
-
(a): technological feed additive
(j): acidity regulator

Description
Chemical Purity criteria Method of analysis
Composition, description
formula (if appropriate) (if appropriate)
ammonium chloride NH4Cl >99.0% -

Trade name (if appropriate) Ammonium Chloride AF

Name of the holder of
-
authorisation (if appropriate)

Conditions of use
Species or Minimum content Maximum content
Withdrawal period
category of Maximum Age mg or Units of activity or CFU/kg of complete (if appropriate)
animal feedingstuffs (select what applicable)
bovines (all
categories),
sheep (all
all ages 2 000 mg/kg 20 000 mg/kg -
categories),
and pets
(cats, dogs)

Other provisions and additional requirements for the labelling

Specific conditions or restrictions
-
for use (if appropriate)
Specific conditions or restrictions
see MSDS. Ammonium chloride should be labelled: R22-36, S22
for handling (if appropriate)
Post-market monitoring -
(if appropriate)
Specific conditions for use in
complementary feedingstuffs -
(if appropriate)

Maximum Residue Limit (MRL) (if appropriate)

Species or category of Target tissue(s) or Maximum content in
Marker residue
animal food products tissues
- - - -

EFSA Journal 2012;10(6):2738 5

 Ammonium chloride for bovines, sheep, dogs and cats

ASSESSMENT

1. Introduction
Ammonium chloride is currently listed in the European Union Register of Feed Additives as a
technological additive (functional group (j), acidity regulator) for dogs and cats, with no limits on age
and levels in feed.7

Ammonium chloride has been routinely used for its urine-acidifying property, which is one of the
essential nutritional characteristics listed in the Commission Directive 2008/38/EC8 on feed for
particular nutritional purposes. This characteristic is applicable to those feeds intended for reducing
the risk of renal calculi in ruminants and those intended for dissolving struvite stones and reducing the
occurrence of struvite stones in dogs and cats.

Ammonium chloride as a zootechnical additive for lambs for fattening was assessed by the EFSA
Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) (EFSA, 2012).

Ammonium chloride was assessed by the Joint FAO/WHO (Food and Agriculture Organization/World
Health Organization) Committee on Food Additives (JECFA) and an acceptable daily intake (ADI) of
„not limited‟ was established (JECFA, 1980).

Within the EU, ammonium chloride is listed in the register of flavouring substances.9 Ammonium
chloride as flavouring was assessed by the EFSA Panel on Food Additives, Flavourings, Processing
Aids and Materials in Contact with Food (CEF) in the opinion: Flavouring Group Evaluation 46
(FGE.46): Ammonia and two ammonium salts from chemical group 30 (EFSA, 2009; EFSA, 2011).

Ammonium chloride is listed as a pharmacologically active substance in veterinary medicinal

products, and it is not subject to maximum residue levels when used in food-producing animals
(Commission Regulation (EC) No 37/2010).10

The applicant is seeking the authorisation/re-evaluation of ammonium chloride as a technological

additive (functional group: acidity regulator) for cats and dogs, bovines and sheep.

2. Characterisation

2.1. Characterisation of the product

Ammonium chloride is produced by chemical synthesis from ammonia and sodium chloride in water
(in the so-called “modified Solvay process” (ammonium chloride–soda ash process)). After the
reaction, the product is crystallised and dried. To complete the production of the additive, a maximum
of 0.7 % tricalcium phosphate is added as an anticaking agent because the active substance is
hygroscopic. The active substance ammonium chloride contains by specification a minimum of
99.0 % of ammonium chloride (Chemical Abstracts Service (CAS) no 12125-02-9, molecular weight
53.94, molecular formula NH4Cl).

The analysis of five batches of the active substance11 showed a mean value of 99.4 %. The average
sodium chloride and tricalcium phosphate concentration was 0.48 % and 0.43 %, respectively.

7
European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003. Available at:
http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf
8
Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for
particular nutritional purposes. OJ L 62, 6.3.2008, p. 9.
9
Commission Decision of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up
in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996.
10
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their
classification regarding maximum residue limits in foodstuffs of animal origin. OJ L 15, 20.1.2010, p. 1.

EFSA Journal 2012;10(6):2738 6

 Ammonium chloride for bovines, sheep, dogs and cats

The specification of the applicant for arsenic (< 2 mg/kg), cadmium (< 0.5 mg/kg), lead (< 5 mg/kg)
and heavy metals (expressed as lead, < 5 mg/kg) were met in the five batches analysed.12

Analysis of two batches of the additive showed a mean concentration of 15 % (w/w) of particles
< 63 µm and a dusting potential of 1.4 g/m3.13

2.2. Stability and homogeneity

No data on shelf-life and stability in premixtures or feedingstuffs were provided. The applicant stated
that the shelf-life of the additive is several years when stored under ambient conditions.

The homogeneous distribution of the additive was demonstrated in a typical sheep feed and in a
typical dairy cow feed at the inclusion rate of both 1 % and 2 % (one batch each, two sets of five
subsamples).14 Ammonium chloride was determined by the analysis of chlorine and the NH4 ion. Total
recovery of ammonium chloride in dairy cow and sheep feeds (1 % and 2 % concentration) was
93.56 % (coefficient of variation (CV) 0.033 %), 95.48 % (CV 0.020 %), 96.94 % (CV 0.097 %) and
96.09 % (CV 0.043 %), respectively.

2.3. Conditions of use

Ammonium chloride is intended to be used as an acidity regulator in feedingstuffs for all species of
bovines, sheep, cats and dogs (without limitations of age) at a minimum content of 0.2 % and a
maximum content of 2 % of complete feedingstuff.

2.4. Evaluation of the analytical methods by the European Union Reference Laboratory
(EURL)
EFSA has verified the EURL report as it relates to the methods used for the control of ammonium
chloride in animal feed. The executive summary of the EURL report can be found in the Appendix.

3. Safety

3.1. Safety for the target species

As no specific studies with the additive under application were submitted and no typical tolerance
studies were provided, the findings in the available literature with ammonium chloride are described in
this section. A pH value of about 6.5 is considered sufficient to dissolve urinary (struvite) calculi. A
pH value of 5.8–6.0 in urine is considered as a sign of chronic metabolic acidosis and negative
calcium and potassium balance in cats (Ching et al., 1989).

3.1.1. Feeding studies with cattle

In an experiment with five Holstein steers (450 kg body weight (bw)) 0.8 % urea in a complete diet
was gradually replaced by ammonium chloride on an isonitrogeneous basis (Castañeda et al., 2009).
The study was designed in a 5 5 Latin square, and the duration of each feeding period amounted to a
minimum of 4 weeks. As the study was designed to investigate the nutritional value of ammonium
chloride as an non-protein nitrogen source, only a few results could be considered in this assessment.
0.35 % ammonium chloride in the complete diet reduced the pH value of urine from 6.9 in the control
to 5.9, and a higher ammonium chloride concentration up to 1.4 % did not exert an additional effect on
urinary pH. The design of the study did not allow any further conclusions to be drawn (e.g. on the
influence of ammonium chloride on feed intake and health status).

11
Technical dossier/Section II/Annex_Result of analyses Ammoniumchlorid AF.
12
Technical dossier/Section II/Annex_Result of analyses Ammoniumchlorid AF.
13
Technical dossier/Supplementary Information December 2011.
14
Technical dossier/Section II/Annex_Feed homogeneity analysis NH4Cl.

EFSA Journal 2012;10(6):2738 7

 Ammonium chloride for bovines, sheep, dogs and cats

Two levels of ammonium chloride (21.3 g/day or 85.1 g/day, approximately 0.2 % or 1 % in feed)
were added to the rations of commercial feeder cattle (Crookshank et al., 1973). The lower level of
ammonium chloride was the amount used to control calculi, while the higher level was used to test for
possible ammonia toxicity. The rations were made isonitrogenous, essentially isocaloric and contained
the same levels of calcium, phosphorus and salt. Total gain was essentially the same for all groups
over a 112-day feeding period. Feed conversion was increased only on the ration containing the higher
level of ammonium chloride. The authors concluded that ammonium chloride may be used as a source
of non-protein nitrogen without clinical signs of ammonia toxicity up to 1 % of the total ration.

Goff et al. (2004) investigated the relative acidifying capacity of various sulphate and chloride anion
sources in non-pregnant, non-lactating Jersey cows, using blood and urine pH to monitor effects on
acid–base balance. The cows were limit-fed 5.8 kg dry matter (DM)/day of a corn silage and alfalfa-
based diet. The ranking of the anion sources tested at a dose of 2 Eq/day (107 g ammonium chloride,
approximately 1.8 % of the diet), from most to least potent urine acidifier, was hydrochloric acid,
ammonium chloride, calcium chloride, calcium sulphate, magnesium sulphate and sulphur. The urine
pH of cows when fed the basal ration only was 8.26, while that of cows fed the ammonium chloride
diet was 7.05. The cows in this study continued to consume their entire ration, suggesting that they had
not entered a state of uncompensated metabolic acidosis.

Gelfert et al. (2009) evaluated whether different anionic salts used in the prevention of parturient
paresis have an impact on the ruminal pH and the production of short-chain fatty acids (SCFAs) in
mature non-pregnant, non-lactating cows. Eleven Holstein–Friesian crossbred cows were, among
others, administered 2 Eq/day ammonium chloride (107 g/day, approximately 1 % ammonium
chloride in the diet) via a ruminal cannula over a 14-day treatment period. The cows were fed daily
8 kg hay, 2.5 kg concentrate and 130 g lime. Feeding anionic salts did not change the ruminal pH, total
concentration of SCFAs or distribution pattern of the main SCFAs. Feeding anionic salts had no
negative side-effect on the ruminal pH and concentrations of SCFAs in mature non-pregnant, non-
lactating cattle. Impaired function of the rumen due to the feeding of anionic salts was considered
unlikely by the authors. They also concluded that cows have a high tolerance to oral ammonium
chloride.

In a study by Oetzel et al. (1988), 48 Holstein cows were assigned to one of four prepartum diets to
determine the effect of dietary supplementation with ammonium salts and calcium intake on serum
calcium concentrations at calving. Four total mixed rations provided either 53 g total dietary
calcium/day or 105 g calcium/day and were either supplemented with ammonium salts (100 g/day
each of ammonium chloride and ammonium salt, approximately 0.5 % ammonium chloride) or
unsupplemented. Anion–cation balance of the diet, calculated as milliequivalents ((Na + K) –
(Cl + S)), was –75 mEq/kg DM with ammonium salts and +189 mEq/kg DM without ammonium
salts. Cows fed diets containing ammonium salts had higher serum ionised and total calcium
concentrations at parturition. Serum concentrations of magnesium, phosphorus, sodium, potassium,
and chlorine on the day of parturition were unaffected by dietary treatment. The authors concluded
that anionic salts are apparently palatable and non-toxic when delivered in total mixed rations.

In a further study by Oetzel et al. (1991) six anionic salts, including ammonium chloride (amount of
107 g/day, approximately 0.5 % of the diet), were evaluated for their effects on dietary dry matter
intake, systemic acid–base balance, and urinary excretion of calcium. Each of the six salts was fed to
12 non-lactating, non-pregnant Holstein cows for one-week periods in two replicates of a 6 6 Latin
square design. All salts were fed at the rate of 2 Eq/cow per day. Anionic salt treatments did not
decrease dry matter intake compared with the control diet fed without salts. Blood pH was not affected
by the treatments. Urinary pH and urinary base excess were lowered. Fractional excretion of urinary
calcium was increased.

Wang and Beede (1992) used eight Jersey cows in a crossover experiment with two 28-day periods.
The control diet consisted of corn silage plus a concentrate mix (68 : 32, dry matter basis, 8.5 kg

EFSA Journal 2012;10(6):2738 8

 Ammonium chloride for bovines, sheep, dogs and cats

DM/day). Ammonium chloride and ammonium sulphate (98 g of each per day per cow, approximately
1 % in the diet) were added to the concentrate. Cows fed the treatment diet had lower blood pH, higher
ionised calcium in blood and greater urinary excretion of calcium than the cows fed the control diet.
Cows fed ammonium salts took longer to consume their ration completely compared with controls.
This suggests that diets containing ammonium salts were less palatable. According to the authors, this
may not be a problem considering that dry cows are usually fed at close to maintenance levels of
intake. The treatment diet induced a mild metabolic acidosis.

Mellau et al. (2002) studying the effect of anionic salts in the prevention of hypocalcaemia in cows
administered ammonium chloride (approximately 0.6 % in the diet) via ruminal cannula for 2 days or
10 days. The pH of the urine of the control cows was around 8.0 throughout the experiment, and anion
supplementation reduced urinary pH to 5.5 to 7.0. The authors concluded that the ammonium chloride
dose given can normally be tolerated, at least for shorter periods, without noticeable clinical signs.

3.1.2. Feeding studies with lambs

In their first study (Bushman et al., 1967), 72 Hampshire lambs were divided into three groups (24
lambs per group, 29 kg bw) and fed a basal diet containing 0, 0.5 % and 1.5 % ammonium chloride for
84 days ad libitum. The diet, considered likely to induce urinary calculi formation, was formulated in
order to contain 0.62 % phosphorus, 0.37 % calcium, 0.19 % magnesium and 0.30 % chlorine
(confirmed by analysis). Both treatments numerically increased feed intake, average daily gain and
improved feed to gain ratio. Compared with the control and the 0.5 % group, the supplementation of
1.5 % ammonium chloride significantly reduced urinary pH values (8.24, 8.35 and 6.43, respectively).
The incidence of urinary calculi was not affected by 0.5 % ammonium chloride compared with the
control, but statistically reduced by 1.5 % ammonium chloride (12/24, 10/24 and 1/24, respectively).
Serum concentrations of calcium and phosphorus were not affected by the treatment, but serum
magnesium was significantly reduced (2.73 vs 2.37 and 2.33 mg/100 mL). Renal excretion of
phosphorus and magnesium was not affected by the treatments, whereas calcium and chlorine
excretion increased (calcium excretion increased significantly for the 1.5 % ammonium chloride group
and chlorine excretion increased due to the higher dietary exposure in both treatment groups).

In a second study of the same group (Bushman et al., 1968), 40 crossbreed lambs (38 kg bw) were
divided into two groups and fed a basal diet containing 0 or 1 % ammonium chloride, for 88 days ad
libitum. The diet, considered likely to induce urinary calculi formation, was formulated in order to
contain 0.64 % phosphorus, 0.33 % calcium, 0.67 % potassium, 0.87 % sodium and 0.30 % chlorine
(confirmed by analysis). The treatment did not result in any effect on zootechnical performance, but
significantly reduced the incidence of urinary calculi compared with the control (10/20 and 1/20,
respectively). In a separate part of this study, mineral balances were made. As in the first study,
urinary excretion of calcium and chlorine was increased. The urinary pH value was significantly
decreased by 1 % ammonium chloride (8.73 vs 8.35).

Two identical experiments were conducted by Crookshank (1970). In each trial, 40 wool wether lambs
(26 and 24.5 kg bw in both runs) were divided in two groups and received a diet with 0 and 0.5 %
ammonium chloride for 112 days. The diet consisted of ground sorghum (40 %), cottonseed hulls
(40 %), cottonseed meal (10 %) and molasses (10 %) and was considered likely to induce urinary
calculi formation. The treatment significantly improved feed to gain ratio in the second trial. The
occurrence of urolithiasis was numerically reduced in both trials by the treatment. The difference was
significant considering the cumulative data from the two trials (19/40 and 3/40, respectively).

Two 35-day experiments were conducted by Barlet et al. (1973). In the first experiment, two groups of
12 lambs (32–35 kg bw) were given either 0 or 1 % ammonium chloride in the diet. In the second
experiment the group size was 15 lambs (32–35 kg bw). A concentrated based on sorghum (70 %),
peanut cake (20 %), alfalfa meal (9 %) and mineral supplement (1 %) was offered ad libitum, and hay
was limited to 30 % of the intake of the concentrated feed. In the second experiment the concentrate
composition was slightly modified (sorghum was replaced by corn), and the intake of hay was limited

EFSA Journal 2012;10(6):2738 9

 Ammonium chloride for bovines, sheep, dogs and cats

to 50 % of the intake of the concentrated feed. Ammonium chloride was incorporated in the diet at the
expense of alfalfa meal. The treatment significantly reduced the incidence of urolithiasis (5/12 and
0/12, respectively) in the first experiment, and no signs of urolithiasis could be observed in both
groups of the second experiment. In experiment 1, weekly records of urinary pH values showed a
constant significant reduction by the treatment (at the end of the trial, 7.95 vs 6.9). Urinary excretion
of calcium and phosphorus was significantly increased, and serum levels of calcium, phosphorus,
magnesium and chloride remained unaffected. The only effect observed in the second experiment was
an improvement in average daily gain by the treatment (185 g/day vs 247 g/day).

The effect of diets containing 0 and 1 % ammonium chloride on the acid base status was investigated
by Abu Damir et al. (1991). No differences in the intestinal absorption of calcium and phosphorus
were found. Renal excretion was higher in the ammonium chloride group and consequently retention
lower. Plasma levels of calcium and phosphorus were not affected, but parathyroid hormone and 1,25-
dihydroxycholecalciferol levels were higher in treated lambs, while tartrate-resistant acid phosphatase
and alkaline phosphatase levels in rib samples indicated an increase in osteoclast and a reduction in
osteoblast activity. With a lower dietary ammonium chloride concentration (0.2 g/kg bw per day,
approximately 0.5 % in the diet) intestinal calcium absorption as well as renal excretion increased, but
bone resorption remained unaffected (Braithwaite, 1971)

3.1.3. Feeding studies with goats

Various nutritional and physiological parameters were studied in four goats fed diets without and with
approximately 2 % ammonium chloride (0.56 g/kg bw per day). A decrease in dry matter intake, a
reduction of the urinary pH value and an increase in the daily volume of urine and in the urinary
excretion of nitrogen, calcium, magnesium and chloride was found (Horst and Jorgensen, 1973).

Eight goats suffering from obstructive urolithiasis (after tube cystostomy) were administered orally via
drinking water a single dose of 500 mg/kg bw (approximately 2 % in feed). Urinary pH was
maintained in the acidic range up to day 5. A significant decrease in blood pH, PO2, haematocrit,
haemoglobin, sodium, bicarbonate and base excess was observed up to 24 hours. In contrast, a rise in
PCO2, potassium and chloride was recorded (Singh et al., 2007).

Jones et al. (2009) fed 24 goats (17–18 months old, mean bw 42.9 kg) individually a concentrate/hay
diet at 75  % of their energy requirement. After a one-week pre-period, the goats were randomly
assigned to four groups of six animals given by gavage doses corresponding to 1.47 %, 1.07 %,
0.68 % and 0.29 % dietary ammonium chloride (and dietary cation–anion difference of –150, –75, 0
and +75 mEq/kg feed). No adverse health effects were seen in any goat during the trial. Goats in the 0
DCAD group (0.68 % ammonium chloride) had a urine pH value of 6.0 to 6.5 at five days after
initiation of treatment; this pH value was maintained until day 7 without significant reduction in blood
pH (which was also unaffected by 1.07 %, but reduced by 1.47 % ammonium chloride). The authors
concluded that a dietary cation–anion difference of 0 mEq/kg feed (0.68 % ammonium chloride) could
be considered as a target for diet formulation in the prevention of urolithiasis.

3.1.4. Safety for cats

Ammonium chloride is commonly used in the treatment and prevention of feline urological syndrome.
This is a multifactorial disorder of the feline lower urinary tract characterised by difficulty, straining,
or increased frequency of urination, blood and/or crystals in the urine, cystitis, urethritis and/or
urethral obstruction. The incidence of struvite crystal formation and feline urological syndrome
increases when the urinary pH is greater than 6.4. Ammonium chloride has been demonstrated to be an
efficacious urinary acidifier in the management of this disorder and in most cases must be given for
long periods of time.

In a study by Taton et al. (1984), 24 cats were fed a dry commercial cat food with or without 1.5 %
ammonium chloride for 11 months. Ammonium chloride had no effect on food and water consumption
or body weight. Urine pH remained constant throughout the study when cats were fed the

EFSA Journal 2012;10(6):2738 10

 Ammonium chloride for bovines, sheep, dogs and cats

experimental diet with or without 1.5 % ammonium chloride, but was significantly lower in the
ammonium chloride group (5.9) than in the control group (7.0).

Izquierdo and Czarnecki-Maulden (1991) described a feeding study in cats, in which ammonium
chloride at concentrations up to 2.2 % was administered. The pH of urine and the acid–base balance
were examined. The urine pH of cats fed an unsupplemented diet was 6.87. Ammonium chloride
added at a dietary level of 0.4 % reduced the pH value of urine to 6.4, and a level of 1.1 % ammonium
chloride reduced the pH value to 5.9.

In a study by Ching et al. (1989), adult cats with normal renal function were fed diets with 1.5 %
ammonium chloride for 6 months. Dietary balance studies were performed monthly. The acidified diet
was palatable and the cats appeared clinically normal during the experimental period; no significant
differences in body weight were observed. Ammonium chloride-treated cats had significantly lower
blood and urinary pH and lower blood bicarbonate concentrations. Treated cats also had higher blood
ionised calcium concentrations, hypercalciuria and lower intestinal calcium absorption relative to that
measured prior to feeding the experimental diet and to control cats. Plasma parathyroid hormone
levels were unaffected by dietary acidification; however, 1,25-dihydroxycholecalciferol levels were
significantly decreased in treated cats. Treated cats had a negative potassium balance during the five
months of dietary acidification. Magnesium, sodium, and phosphorus balances were lower in treated
cats, but positive. The authors summarised that chronic dietary acidification with 1.5 % ammonium
chloride produced chronic metabolic acidosis and lower, or negative, calcium and potassium balance.
The treatment produced no significant changes in trabecular bone remodelling or bone mineral density
in adult cats (Ching et al., 1990).

Kienzle and Wilms-Eilers (1994) summarised their studies in cats with varying amounts or
combinations of acidifying and alkalising additives with the recommendation that diets intended to be
used in struvite prevention should first be formulated to have a low base excess (to contain as few
alkalising compounds as possible). Only when the possibility of this method has been exhausted
should acidifiers be used. Thus, the amount of acidifiers should be kept as low as possible.

The suggested increased renal magnesium excretion after consumption of acidifying diets in cats
(Ching et al., 1989, Kienzle and Wilms-Eilers, 1994) was confirmed by Kienzle et al. (1998) for 0.5 g
ammonium chloride/kg bw per day (approximately 4 % dietary ammonium chloride) and resulted in
the recommendation that ammonium chloride should not be used in the long-term feeding of diets low
in magnesium.

Dow et al. (1990) examined the effects of dietary acidification by ammonium chloride and potassium
depletion on acid–base balance, mineral metabolism and renal function. Groups of six cats each were
fed for eight weeks a potassium-restricted diet (0.2 % potassium) without or with 0.8 % ammonium
chloride. Both groups of cats were then fed the same diet supplemented with potassium gluconate
(0.7 % dietary potassium) for an additional four weeks. Serum potassium concentration had declined
in all cats by week 1 and was also lower in ammonium chloride-treated cats at two, three, six and eight
weeks than in control cats. Metabolic acidosis developed in both groups of cats. Dietary balance
studies indicated negative potassium balance in ammonium chloride-treated cats. Glomerular filtration
rate declined significantly in ammonium chloride-treated cats after 8 weeks but was unchanged in
control cats. The authors concluded that adding a dietary acidifier to a potassium-restricted diet
worsens hypokalaemia, and induces severe metabolic acidosis and renal dysfunction in adult cats.

Funaba et al. (2001) studied the effect of ammonium chloride (1.5 % in the diet) on the amount of
sediment in the urine of clinically normal cats. Six adult cats were used in a three-week crossover trial
and fed diets with or without ammonium chloride. All cats appeared to be healthy and did not manifest
any clinical abnormalities throughout the study. Daily food and water intake was similar in all groups.
Urinary pH was significantly decreased by supplementation with 1.5 % ammonium chloride. Struvite
crystals in urine were greatly reduced by the ammonium chloride supplement.

EFSA Journal 2012;10(6):2738 11

 Ammonium chloride for bovines, sheep, dogs and cats

3.1.5. Safety for dogs

Groups of five dogs (control group only four) of various breeds were fed diets containing 0, 50, 100,
200 and 400 mg ammonium chloride/kg bw per day for 30 days. The highest dose decreased blood pH
and bicarbonate significantly. Urine pH was decreased by 200 and 400 mg ammonium chloride/kg bw
per day. In all ammonium chloride groups, calcium and chlorine in urine was elevated (Börkü et al.,
1996). Magnesium in blood serum, faeces and urine remained unaffected by ammonium chloride;
however, serum potassium was decreased.

Shaw (1989) administered 11 mature beagle dogs (nine females, two males) a single dose of 200 mg
ammonium chloride/kg bw orally. The dose was expected to induce a mild acidaemia, hence
stimulating maximal renal hydrogen excretion. Systemic acidaemia developed as evidenced by a
significant decrease in blood pH one hour after ammonium chloride administration. Four hours after
treatment, urine pH was decreased to 5.2. The author concluded that distal renal tubular acidosis had
developed.

Four adult mongrel dogs (two females, two males) received orally 200 mg ammonium chloride/kg bw
per day for 14 days, followed by 100 mg ammonium chloride/kg bw per day for seven days (Senior et
al., 1984). Venous blood pH was unchanged during the trial, and the average daily urinary pH was
maintained at less than 6.0 in dogs when given 200 mg ammonium chloride/kg bw and less than 6.2
when the dose was reduced to 100 mg ammonium chloride/kg bw per day. Renal compensation with a
return to pre-treatment urinary pH was not observed after 5–6 days. All dogs developed diarrhoea
during treatment, which was refractory to oral treatment with bismuth subsalicylate solution.
Ammonium chloride effectively acidified the urine of dogs when given 200 mg ammonium
chloride/kg bw per day. The authors noted that the intestinal irritation observed during treatment may
preclude administration of this dose.

3.1.6. Conclusion on the safety of ammonium chloride for the target species
Although none of the studies reviewed (eight with cattle, six with sheep, three with goats, seven with
cats and three with dogs) could be described as a tolerance study, they allow conclusions to be drawn
on the ammonium chloride level that is safe for the target animals. However, the different sensitivity
of the endpoints examined (e.g. feed or water consumption, parameters of metabolic acidosis, mineral
status) causes a certain level of uncertainty. Design (short duration) and reporting of the dog studies,
as well as the small number of studies available, together with controversial results, accounts for a
higher level of uncertainty in the conclusions for dogs.

Ammonium chloride effectively reduced the urinary pH and the formation of urinary calculi in all
animal species reviewed. The effective minimum dose depends on the acid–base balance (the anion–
cation ratio) of the diets. The sensitivity of the various target species to dietary ammonium chloride
appears to be different, ruminants showing a higher tolerance than dogs and probably also cats. High
doses (> 1 % ammonium chloride in complete feed) result in metabolic acidosis and an increase in
renal excretion of calcium and magnesium, as well as of potassium in cats and dogs.

A feed concentration of 1 % ammonium chloride is considered safe for ruminants but only for a
restricted period (approximately 3 months). For a longer period of administration 0.5 % ammonium
chloride in the complete feed for ruminants should not be exceeded, particularly considering the
variety of feedingstuffs with different (and often uncalculated) anion–cation ratios.

Studies on cats indicated that 1.5 % ammonium chloride in complete feed was tolerated for 6–11
months without symptoms of overt toxicity, but it affected mineral balance. Consequently, 1 %
ammonium chloride could be considered safe for cats for a limited time period; however, sufficient
data to establish the duration of the time period are not available. Only 0.5 % ammonium chloride in
the complete diet can be considered safe for an unlimited period. For dogs, only 0.5 % ammonium
chloride in the complete diet can be considered safe. This conclusion is based on the occurrence of
severe adverse effects (diarrhoea) at approximately 1 % ammonium chloride in the diet in one study

EFSA Journal 2012;10(6):2738 12

 Ammonium chloride for bovines, sheep, dogs and cats

and the absence of more relevant information in the others. Higher dosages than 0.5 % ammonium
chloride in complete feed for dogs and cats should be restricted to veterinary treatment.

3.2. Safety for the consumer

Ammonium chloride will dissociate in the rumen, and the ammonium ion (NH4+), which is not used
for microbial protein synthesis, will cross the rumen wall entering the liver via the bloodstream, where
it is converted to urea. Urea can be reused by the ruminohepatic cycle for protein synthesis. The
liberated proton accounts for the systemic acidifying effect of the substance. In the kidney of healthy
animals, ammonia (NH3) is formed de novo by deamination of glutamine and other amino acids and
excreted as NH4+ with the ultrafiltrate. Owing to its rather poor diffusion potential a major part of
ammonium stays in the urine, thereby decreasing its pH.

As both ions of ammonium chloride will be rapidly excreted predominantly via the kidney, no increase
in the endogenous concentration of these ions in tissues and products is expected. The use of
ammonium chloride in animal nutrition does not therefore raise any concerns for consumer safety.

3.3. Safety for the user

Ammonium chloride is an eye irritant, a potential irritant to skin and the digestive tract, potentially
harmful if swallowed and may cause systemic toxicity by acidosis. Ammonium chloride fumes are
considered as a potential respiratory sensitiser. Ammonium chloride should also be considered as a
skin sensitiser. These hazards are reflected in the safety material data sheet.

Occupational exposure limits in different countries (UK, USA) are set for ammonium chloride with a
time-weighted average (TWA) of 10 mg/m3 and a short-term exposure limit (STEL) of 20 mg/m3.15

3.4. Safety for the environment

Ammonium chloride will not be excreted as such, but rather as urea, ammonium and chloride ions. All
these compounds are natural substances in animal excreta. Considering the restricted use of the
additive in isonitrogenous diets for ruminants, it will not substantially contribute to the environmental
concentration of chlorine or nitrogen. The use of ammonium chloride at the proposed level in
feedingstuffs for ruminants does therefore not pose a risk for the environment.

4. Efficacy
Ammonium chloride is applied for as a “technological additive”, functional group (j) acidity
regulators: substances that adjust the pH of feedingstuffs. The applicant provided on request studies
with four different types of dry feedingstuffs (for cats, dogs, cows and lambs) to demonstrate the
influence of the additive at different doses (1 000 and 2 000 mg/kg) on the pH value and the buffering
capacity of the feed.16

For measuring the buffering capacity, 25 g of each feed sample were dissolved in 300 mL of deionised
water, the respective quantity of the additive was added. The suspension was kept under constant
stirring and titrated with NaOH (0.1 N) until pH values of 7, 8, 9, 10, 11 and 12 were reached. The
results are summarised in Table 2.

15
http://www.inchem.org/documents/icsc/icsc/eics1051.htm
16
Technical dossier/Supplementary Information December 2011.

EFSA Journal 2012;10(6):2738 13

 Ammonium chloride for bovines, sheep, dogs and cats

Table 2: The pH values and buffering capacity of different dry feeds with the addition of 0 (0 AC),
1 000 (1 AC), and 2 000 mg ammonium chloride/kg feed (2 AC). The figures are averages
of two measurements for two batches each

Species Dose Initial pH mL of 0.1 N NaOH required to increase the pH value by one step
Initial to 7 7 to 8 8 to 9 9 to 10 10 to 11 11 to 12
Cat feed 0 AC 5.80 19.90 21.20 20.24 32.22 31.81 111.29
1 AC 5.72 20.27 23.02 31.41 54.69 41.89 116.15
2 AC 5.61 25.24 26.74 45.23 81.08 53.25 133.97
Dog feed 0 AC 5.80 9.89 12.24 9.98 16.77 21.56 96.55
1 AC 5.78 6.73 12.92 20.15 41.04 33.00 92.34
2 AC 5.63 9.74 16.16 30.85 65.83 44.05 103.16
Cow 0 AC 5.25 38.77 15.58 17.07 25.24 37.71 156.41
feed
1 AC 5.33 37.82 16.37 27.01 49.93 50.52 152.32
2 AC 5.25 39.68 17.71 37.81 74.42 60.64 159.73
Lamb 0 AC 5.73 20.53 12.57 15.05 27.45 31.70 132.00
feed
1 AC 5.63 21.74 14.12 26.92 51.75 43.71 151.33
2 AC 5.65 21.74 15.64 35.97 75.80 53.25 154.90

The pH value was reduced by increasing concentrations of ammonium chloride only in the cat feed
(statistically significant difference compared with control feed only for 2 000 mg NH4Cl/kg). In this
feed type, an increase in the buffering capacity due to ammonium chloride supplementation could be
seen too. However, this increase was not evident for 1 000 mg NH4Cl/kg for the step from initial to pH
7. For all other feed types an influence on the pH value and the buffering capacity for the step up to
pH 7 was not demonstrated and for the step pH 7 to pH 8 only marginally. From a pH value of 8
onwards the buffering capacity was increased in all feed types by graded additions of ammonium
chloride; however, this finding is far from any practical relevance.

The FEEDAP Panel concludes that the efficacy of ammonium chloride as an acidity regulator of feed
was not demonstrated.

However, the FEEDAP Panel notes that dietary ammonium chloride is a potent urinary acidifier (see
EFSA, 2012). The publications reviewed under section 3.1 clearly indicate that ammonium chloride
supplementation of feed for ruminants, cats and dogs results in a decrease in the urinary pH value.

The minimum dose that was effective in reducing the urinary pH value in cats was 0.4 % (Izquierdo
and Czarnecki-Maulden, 1991), and in dogs it was approximately 0.6 %. The minimum effective dose
in cattle to prevent urinary calculi is reportedly 0.2 % in a complete diet (Crookshank, 1973), and the
lowest experimentally demonstrated dose to reduce urinary pH value is 0.35 % (Castañeda et al.,
2009). Experimental evidence for efficacy in reducing urinary pH value for lambs is given at 1 % in
the diet (Barlet et al., 1973; Bushman et al., 1968), and for goats it is 0.7 % in the diet (Jones et al.,
2009).

However, as it is the case that for all animal species to which the application applies the minimum
effective dose depends on the diet composition, in particular on the cation–anion ratio (or the base

EFSA Journal 2012;10(6):2738 14

 Ammonium chloride for bovines, sheep, dogs and cats

excess, which is another expression for the cation–anion ration), it seems that it would not be
advisable to establish a minimum level for ammonium chloride in feed legislation.

CONCLUSIONS
A feed concentration of 1 % ammonium chloride is considered safe for ruminants for a restricted
period of time (approximately 3 months). For an unlimited period of administration, 0.5 % ammonium
chloride in the complete feed for ruminants should not be exceeded, particularly considering the
variety of feedingstuffs with different anion–cation ratios.

For cats and dogs, 0.5 % ammonium chloride in the complete diet can be considered safe for an
unlimited period. Doses higher than 0.5 % ammonium chloride in complete feed for dogs and cats
should be restricted to veterinary treatment.

As both ions of ammonium chloride will be rapidly excreted, predominantly via the kidney, no
increase in the endogenous concentration of these ions in tissues and products is expected. The use of
ammonium chloride in animal nutrition does therefore not raise any concerns for consumer safety.

Ammonium chloride is an eye irritant, a potential irritant to skin and the digestive tract, potentially
harmful if swallowed and may cause systemic toxicity by acidosis. Ammonium chloride fumes are
considered as a potential respiratory sensitiser. Ammonium chloride should also be considered as a
skin sensitiser.

Ammonium chloride will not be excreted as such, but rather as urea, ammonium and chloride ions. All
are natural substances in animal excreta. The use of ammonium chloride at dietary levels considered
safe for ruminants does therefore not pose a risk for the environment.

The pH value of a dry cat feed was reduced and its buffering capacity increased by the addition of
increasing amounts of ammonium chloride, but no significant relevant effects on pH values or on
buffering capacity were seen for other feed types (dog, cow, lamb). The FEEDAP Panel concludes that
the efficacy of ammonium chloride as an acidity regulator of feed was not demonstrated.

REMARKS

The FEEDAP Panel notes that dietary ammonium chloride is a potent urinary acidifier. The
publications reviewed in the section on the safety for the target animals clearly indicate that
supplementation of feed for ruminants, cats and dogs with ammonium chloride results in a decrease in
the urinary pH value.

As it is the case that for all animal species to which the application applies the minimum effective dose
depends on the diet composition, in particular on the cation–anion ratio, it seems that it would not be
advisable to establish a minimum (effective) level for ammonium chloride in feed legislation.

DOCUMENTATION PROVIDED TO EFSA

1. Ammonium chloride for bovine, sheep, dogs and cats. October 2010. Submitted by BASF SE.

2. Ammonium chloride for bovine, sheep, dogs and cats. Supplementary information. December
2011. Submitted by BASF SE.

3. Ammonium chloride for bovine, sheep, dogs and cats. Supplementary information. April 2012.
Submitted by BASF SE.

4. Ammonium chloride for bovine, sheep, dogs and cats. Supplementary information. February 2012.
Submitted by BASF SE.

EFSA Journal 2012;10(6):2738 15

 Ammonium chloride for bovines, sheep, dogs and cats

5. Evaluation report of the European Union Reference Laboratory for Feed Additives on the
methods(s) of analysis for ammonium chloride.

6. Comments from Member States received through the ScienceNet.

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containing either NaHCO3 or NH4Cl on indices of bone formation and resorption and on mineral
balance in the lamb. Experimental Physiology, 76, 725–732.
Barlet JP, Theriez M and Molenat G, 1973. L‟urolithiase ovine effets d‟un phosphonate de sodium et
du chlorure d‟ammonium. Annales de Biologie Animale Biochimie Biophysique, 13, 627–641.
Börkü MK, Kurtede A, Imren HY, Kalinbacak A, Tanyel B and Ilhan T, 1996. The effect of long term
usage of ammonium chloride on some parameters in blood, urine and feces in dogs. Ankara
University Veterinary Faculty Journal, 43, 235–246.
Braithwaite GD, 1972. The effect of ammonium chloride on calcium metabolism in sheep. British
Journal of Nutrition, 27, 201–209.
Bushman DH, Embry LB and Emerick RJ, 1967. Efficacy of various chlorides and calcium carbonate
in the prevention of urinary calculi. Journal of Animal Science, 26, 1199–1204.
Bushman DH, Emerick RJ and Embry LB, 1968. Effect of various chlorides and calcium carbonate on
calcium, phosphorus, sodium, potassium and chloride balance and their relationship to urinary
calculi in lambs. Journal of Animal Science, 27, 490–496.
Castañeda RD, Branco AF, Coneglian SM, Barreto JC, Granzotto F and Teixeira S, 2009. Replacing
urea with ammonium chloride in cattle diets: digestibility, synthesis of microbial protein, and
rumen and plasma parameters. Acta Scientiarum – Animal Sciences, 31, 271–277.
Ching SV, Fettman MJ, Hamar DW, Nagode LA and Smith KR, 1989. The effect of chronic dietary
acidification using ammonium chloride on acid–base and mineral metabolism in the adult cat.
Journal of Nutrition, 119, 902–915.
Ching SV, Norrdin RW, Fettman MJ and LeCouteur RA, 1990. Trabecular bone remodeling and bone
mineral density in the adult cat during chronic dietary acidification with ammonium chloride.
Journal of Bone and Mineral Research, 5, 547–556.
Crookshank HR, 1970. Effect of ammonium salts on the production of ovine urinary calculi. Journal
of Animal Science, 30, 1002–1004.
Crookshank HR, Smalley HE, Furr D and Ellis GF Jr, 1973. Ammonium chloride and ammonium
sulfate in cattle feedlot finishing rations. Journal of Animal Science 36,1007–1009.
Dow SW, Fettman MJ, Smith KR, Hamar DW, Nagode LA, Refsal KR, Wilke WL. 1990. Effects of
dietary acidification and potassium depletion on acid–base balance, mineral metabolism and renal
function in adult cats. Journal of Nutrition, 120, 569–578.
EFSA (European Food Safety Authority), 2009. Opinion of the Panel on Food Additives, Flavourings,
Processing Aids and Materials in Contact with Food (AFC) on Flavouring Group Evaluation 46
(FGE.46)1: Ammonia and two ammonium salts from chemical group 30. The EFSA Journal, 955,
1–34.
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2011.
Scientific opinion on Flavouring Group Evaluation 46, Revision 1 (FGE.46Rev1): Ammonia and
three ammonium salts from chemical group 30. EFSA Journal, 9(2):1925, 35 pp.
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2012.
Scientific opinion on ammonium chloride (Amoklor) for lambs for fattening. EFSA Journal,
10(2):2569, 11 pp.

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 Ammonium chloride for bovines, sheep, dogs and cats

Funaba M, Yamate T, Narukawa Y, Gotoh K, Iriki T, Hatano Y and Abe M, 2001. Effect of
supplementation of dry cat food with d,l methionine and ammonium chloride on struvite activity
product and sediment in urine. Journal of Veterinary Medical Science, 63, 337–339.
Gelfert CC, Engel M, Manner K and Staufenbiel R, 2009. The effect of various anionic salts on
ruminal pH and shortchain fatty acids in non-pregnant and non-lactating cows. New Zealand
Veterinary Journal, 57, 225–228.
Goff JP, Ruiz R and Horst RL, 2004. Relative acidifying activity of anionic salts commonly used to
prevent milk fever. Journal of Animal Science, 87, 1245–1255.
Horst RL, Jorgensen NA. 1974. Effect of ammonium chloride on nitrogen and mineral balance in
lactating and nonlactating goats. Journal of Dairy Science, 57, 683–688.
Izquierdo JV and Czarnecki-Maulden GL, 1991. Effect of various acidifying agents on urine pH and
acidbase balance in adult cats. Journal of Nutrition, 121, S89–S90.
Joint FAO/WHO Expert Committee on Food Additives (JECFA), 1980. Evaluation of certain food
additives. World Health Organisation Technical Report Series 648. Geneva: World Health
Organisation. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_648.pdf
Jones ML, Streeter RN and Goad CL, 2009. Use of dietary cation anion difference for control of
urolithiasis risk factors in goats. American Journal of Veterinary Research, 70, 149–155.
Kienzle E and Wilms-Eilers S, 1994. Struvite diet in cats: effect of ammonium chloride and
carbonates on acid base balance of cats. Journal of Nutrition, 124, 2652S–2659S.
Kienzle E, Thielen C and Janowicz P, 1998. Effect of urinary acidification using ammonium chloride
on renal magnesium excretion in cats. Journal of Animal Physiology and Animal Nutrition, 80,
130–133.
Mellau LSB, Jurgensen RJ and Kambarage DM, 2002. The influence of short-term anion salt exposure
on urine pH and on resistance to experimentally induced hypocalcaemia in cows. Journal of
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Oetzel GR, Olson JD, Curtis CR and Fettman MJ, 1988. Ammonium chloride and ammonium sulfate
for prevention of parturient paresis in dairy cows. Journal of Dairy Science, 71, 3302–3309.
Oetzel GR, Fettman MJ, Hamar DW and Olson JD, 1991. Screening of anionic salts for palatability,
effects on acid–base status, and urinary calcium excretion in dairy cows. Journal of Dairy Science,
74, 965–971.
Senior DF, Merchant SR and Sundstrom DA, 1984. Ammonium chloride as a long-term urinary
acidifier in the dog. California Veterinarian, 11, 7–9.
Shaw DH, 1989. Acute response of urine pH following ammonium chloride administration to dogs.
American Journal of Veterinary Research, 50, 1829–1830.
Singh T, Amarpal Kinjavdekar P, Aithal HP, Pawde AM and Pratap K, 2007. Blood acid–base and
electrolyte changes following oral administration of ammonium chloride in goats suffering from
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Taton GF, Hamar DW and Lewis LD, 1984. Evaluation of ammonium chloride as a urinary acidifier
in the cat. Journal of the American Veterinary Medical Association, 184, 433–436.
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EFSA Journal 2012;10(6):2738 17

 Ammonium chloride for bovines, sheep, dogs and cats

APPENDIX
Executive Summary of the Evaluation Report of the European Union Reference Laboratory for
Feed Additives on the Method(s) of Analysis for Ammonium Chloride17,18

In the current applications authorisation is sought: - under articles 4(1) and 10(2) for ammonium
chloride (E510) under the category "technological additives", functional group 1j "acidity regulators"
by Applicant I (FAD-2010-0242), and - under articles 4(1) for Amoklor (ammonium chloride) under
the category "zootechnical additives", functional group 4d "other zootechnicals", by Applicant II
(FAD-2010-0037) according to the classification system of Annex I of Regulation (EC) No
1831/2003. According to Applicants I and II, the feed additive is a white, crystalline powder with a
minimum purity of 99.0 and 99.5%, respectively.

Specifically, authorisation is sought for the use of the feed additive for bovines, sheep, cats and dogs
by Applicant I and lambs for fattening by Applicant II. The feed additive is intended to be used in
feedingstuffs. Applicant I and II suggested for ammonium chloride a concentration in feedingstuffs
ranging from 2 to 20 g/kg and from 5 to 10 g/kg, respectively, while no limits were set in previous
regulations.

For the quantification of ammonium chloride in the feed additive, Applicant I proposes a method
similar to the method described in the European Pharmacopoea Monograph 0007. The EURL
recommends for official control the internationally recognised European Pharmacopoeia method or the
internationally recognised JECFA method to determine ammonium chloride in the feed additive.

The unambiguous quantification of ammonium chloride in feedingstuffs is not achievable by analytical

methods. Hence, the EURL does not recommend for official control any methods for the
quantification of ammonium chloride in feedingstuffs.

Further testing or validation of the methods to be performed through the consortium of National
Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not
considered necessary.

17
The EURL produced a combined report for the additives Amoklor and ammonium chloride (E510).
18
The full report is available on the EURL website: http://irmm.jrc.ec.europa.eu/SiteCollectionDocuments/FinRep-FAD-
2010-0242+0037.pdf

EFSA Journal 2012;10(6):2738 18