EFSA Journal 2013;11(7):3283

SCIENTIFIC OPINION

Scientific Opinion on the safety and efficacy of potassium sorbate as a silage

additive for all animals except 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
Potassium sorbate is intended to be used as a technological additive to improve the ensiling process in the range
of 90 to 300 mg/kg fresh material. The application of potassium sorbate in the preparation of silage up to the
maximum proposed dose of 300 mg/kg forage is safe for the target animals. The additive, when used in silage, is
not expected to increase substantially consumer exposure to potassium sorbate. Therefore, the FEEDAP Panel
concludes that potassium sorbate, when used as a silage additive, is safe for consumers of food products from
animals fed treated silage. Potassium sorbate is a skin and eye irritant and a potential irritant to the respiratory
tract. Potassium sorbate is not regarded as a skin sensitiser. The dusting potential of the preparation tested
indicates that exposure of users via inhalation is possible. In view of the irritancy of potassium sorbate and the
absence of information on its inhalation toxicity, exposure to such dust is considered hazardous. There are no
safety concerns for the environment resulting from the use of potassium sorbate as a silage additive. Seven
laboratory-scale ensiling studies were reported, each lasting at least 90 days and using forages of different
origins. Once silos were opened, aerobic stability was determined. Potassium sorbate has the potential to
improve aerobic stability of silage with dry matter content between 21 and 38 % when used at the minimum
concentration of 90 mg/kg fresh material.
European Food Safety Authority, 2013

KEY WORDS
technological additives, silage additives, potassium sorbate, efficacy, safety

1
2

On request from the European Commission, Question No EFSA-Q-2011-00841, adopted on 18 June 2013.
Panel members: Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa,
Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino Lpez-Puente, Giovanna
Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van
Beelen, Robert John Wallace and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on Silage Additives, including Andrew
Chesson, Pier Sandro Cocconcelli and Mikls Mzes, for the preparatory work on this scientific opinion.

Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed),
2013. Scientific Opinion on the safety and efficacy of potassium sorbate as a silage additive for all animals except dogs and
cats. EFSA Journal 2013;11(7):3283, 12 pp. doi:10.2903/j.efsa.2013.3283
Available online: www.efsa.europa.eu/efsajournal

European Food Safety Authority, 2013

Potassium sorbate for all animals except dogs and cats

SUMMARY
Following a request from the European Commission, the European Food Safety Authority was asked
to deliver a scientific opinion on the safety for the target animals, consumer, user and for the
environment and on the efficacy of potassium sorbate, when used as a technological additive intended
to improve the ensiling process in the range of 90 to 300 mg/kg fresh material.
The application of potassium sorbate in the preparation of silage up to the maximum proposed dose of
300 mg/kg forage is safe for the target animals.
The additive, when used in silage, is not expected to increase substantially consumer exposure to
potassium sorbate. Therefore, the FEEDAP Panel concludes that potassium sorbate, when used as a
silage additive, is safe for consumers of food products from animals fed treated silage.
Potassium sorbate is a skin and eye irritant and a potential irritant to the respiratory tract. Potassium
sorbate is not regarded as a skin sensitiser. The dusting potential of the preparation tested indicates
that exposure of users via inhalation is possible. In view of the irritancy of potassium sorbate and the
absence of information on its inhalation toxicity, exposure to such dust is considered hazardous.
There are no safety concerns for the environment resulting from the use of potassium sorbate as a
silage additive.
Seven laboratory-scale ensiling studies were reported, each lasting at least 90 days and using forages
of different origins. Once silos were opened, aerobic stability was determined. Potassium sorbate has
the potential to improve aerobic stability of silage with dry matter content between 21 and 38 % when
used at the minimum concentration of 90 mg/kg fresh material.

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except 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 additive ................................................................................................... 6
2.2.
Production process ...................................................................................................................... 7
2.3.
Stability ....................................................................................................................................... 7
2.4.
Conditions of use ......................................................................................................................... 7
2.5.
Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) .. 7
3. Safety ............................................................................................................................................... 8
3.1.
Safety for the target species......................................................................................................... 8
3.2.
Safety for the consumer............................................................................................................... 8
3.3.
Safety for the user ....................................................................................................................... 9
3.4.
Safety for the environment .......................................................................................................... 9
4. Efficacy............................................................................................................................................ 9
Conclusions ............................................................................................................................................ 11
Documentation provided to EFSA ......................................................................................................... 11
References .............................................................................................................................................. 12

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except 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 10(2)/(7) of that Regulation specifies that for
existing products within the meaning of Article 10(1), an application shall be submitted in accordance
with Article 7, within a maximum of seven years after the entry into force of this Regulation.
The European Commission received a request from Volac International Ltd.5 for re-evaluation of the
product potassium sorbate, when used as a feed additive for all animal species except cats and dogs
(category: technological additive; functional group: preservative and silage additive) under the
conditions mentioned in Table 1.6
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 10(2)/(7)
(re-evaluation of an authorised feed additive). EFSA received directly from the applicant the technical
dossier in support of this application.7 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 30
September 2011.
Potassium sorbate is currently authorised for use in all animal species and categories as a preservative
(E 202) but not as a silage additive. Potassium sorbate is included in the catalogue of feed materials
(11.5.5) according to Regulation (EC) No 68/2013.8
EFSA issued an opinion on the safety and efficacy of potassium sorbate for dogs and cats (EFSA
FEEDAP Panel, 2012a). The joint FAO/WHO Expert Committee on Food Additives delivered a report
on food additives including sorbic acid and its calcium, potassium and sodium salts (JECFA, 1974).
The Scientific Committee for Food (SCF) issued an opinion on sorbic acid and its calcium and
potassium salts in 1994 (SCF, 1994). The European Chemicals Agency (ECHA) reported a proposal
for harmonised classification and labelling of potassium sorbate (ECHA, 2011).

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 animals, the consumer, user and the environment and the efficacy of the product
potassium sorbate, when used under the conditions described in Table 1.

4
5
6
7
8

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.
On 20/11/2012, EFSA was informed by the applicant that the applicant company changed to Volac International Ltd,
Roseberry Court, Ellerbeck Way, Stokesley, North Yorkshire, TS9 5QT.
During the course of the assessment the applicant requested to withdraw the application for use as preservative.
EFSA Dossier reference: FAD-2010-0241.
Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials. OJ L 29, 30.1.2013, p. 1.

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

Table 1:

Description and conditions of use of the additive as proposed by the applicant

Additive

Potassium sorbate

Registration number/EC
No/No

E 202

Category(-ies) of additive

Technological additives

Functional group(s) of additive

(a) preservative9
(b) silage additive
Description
Chemical
formula
C6H7KO2

Composition, description
Potassium sorbate

Purity criteria

Method of analysis

Min. 99.0 % (as dried)

Ph Eur

Trade name
Name of the holder of
authorisation
Conditions of use
Species or
category of animal

Maximum
Age

All species except

cats and dogs

Not
applicable

Minimum content

Withdrawal
period

Maximum content

mg/kg of complete feedingstuffs

90 g/tonne forage or
feedingstuff

300 g/tonne forage or

feedingstuff

Not applicable

Other provisions and additional requirements for the labelling

Specific conditions or restrictions for
use

None

Specific conditions or restrictions for

handling

Irritant. Avoid skin and eye contact and inhalation of dust.

Store solutions of the additive out of direct sunlight and use within
one week.

Post-market monitoring
Specific conditions for use in
complementary feedingstuffs

Not applicable
Not applicable

Maximum Residue Limit (MRL)

Marker residue

Species or category of
animal

Target tissue(s) or
food products

Maximum content in
tissues

The request for use as preservative was withdrawn during the course of the assessment.

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

ASSESSMENT
1.

Introduction

Potassium sorbate was originally intended to be used as a technological feed additive under the
functional groups of preservative and silage additive for all animal species expect cats and dogs.
During the course of the assessment, the applicant decided to withdraw the request for use as a
preservative.
Potassium sorbate is included in the European Union Register of Feed Additives pursuant to
Regulation (EC) No 1831/2003 as a technological additive (functional group: preservative) for all
animal species (E202). The FEEDAP Panel has re-evaluated this additive for use as a preservative in
semi-moist feed for dogs and cats at the recommended dose of 5 000 mg/kg complete feed (0.5 %).
Potassium sorbate is included in the catalogue of feed materials (11.5.5) according to Regulation (EC)
No 68/2013.10 Potassium sorbate is also authorised (E202) as a food additive (Directive No 95/2/EC11)
for use as preservative and antioxidant in a wide range of commonly consumed foods up to
2 000 mg/kg. The additive has been assessed by the Joint FAO/WHO Expert Committee on Food
Additives (JECFA, 1974). The Committee allocated an acceptable daily intake (ADI) of 25 mg/kg
body weight (bw) (expressed as sorbic acid). It is also included in the list of preservatives allowed in
cosmetic products (Regulation (EC) No 1223/200912) at a maximum concentration in ready-to-use
preparations of 0.6 % (as sorbic acid).
2.

Characterisation

2.1.

Characterisation of the additive

The additive is identical to the active substance (International Union of Pure and Applied Chemistry
(IUPAC) chemical name potassium (2E,4E)-hexa-2,4-dienoate, Chemical Abstracts Service (CAS) No
24634-61-5, European Inventory of Existing Commercial chemical Substances (EINECS) No 246376-1, empirical formula C6H7O2K, molecular weight 150). Potassium sorbate is a colourless salt with
a pK = 4.75 and a solubility in water of 582 g/L at 20 C (Sofos, 1989).13 Potassium sorbate is
described in the European Pharmacopoeia monograph (Ph Eur 5.0, 0618) as having a purity of 99.0 to
101.0 % (dried substance).14
By specification, the additive contains at least 99.0 % potassium sorbate and is routinely screened for
impurities. Analysis of three batches of the additive from three different suppliers showed that the
content of potassium sorbate was 100 %.15 Levels of heavy metals (Pb, Cd and Hg < 1 mg/kg), arsenic
(< 2 mg/kg), aldehydes (< 0.15 % expressed as formaldehyde) and dioxins (total polychlorinated
dibenzyl dioxins (PCDDs) = 0.330.44 ng WHO-TEQ (toxic equivalents)/kg, total polychlorinated
dibenzofurans (PCDFs) = 0.0860.095 ng WHO-TEQ/kg and total dioxin-like polychlorinated
biphenyls (PCBs) = 0.0135 ng WHO-TEQ/kg) were in compliance with specifications of potassium
sorbate as a food additive16 and those of the European Pharmacopoeia.17

10

Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials. OJ L 29, 30.1.2013, p. 1.
European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and
sweeteners. OJ No L 61, 18.3.1995, p. 1.
12
Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products.
OJ L 342, 22.12.2009, p. 193.
13
Technical dossier/Section II/Annex II.17.2.1.5.j.
14
Technical dossier/Section II/Annex II.5.2.1.3.b
15
Technical dossier/Section II/Annex II.7.2.1.4.b.
16
European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and
sweeteners. OJ L 61, 18.3.1995, p. 1.
17
Technical dossier/Section II/Annex II.5.2.1.3.b.
11

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

Based on the data from 15 batches from different suppliers, the average bulk density of the additive
was 446 g/L (range 385606 g/L).18 Since in the field the additive may be dissolved in very cold
water, the solubility of the additive at 5, 10 and 20 C was determined, with values ranging between
564 g/L and 581 g/L.19
Potassium sorbate is usually produced in the form of powder or extruded cylindrical granules. The
mean dusting potential of three batches of potassium sorbate using the StauberHeubach test was
determined to be 0.08 % (equivalent to 2 g/m3).20 The percentage of particles in 12 batches (on a
weight basis using a sieve stack) with a diameter < 150 m was < 2 %, with < 0.5 % particles being
< 90 m and < 0.4 % of particles < 45 m.21 This particle distribution was confirmed by an analysis
using air-brushed sieves of three batches of the additive, which showed that < 0.5 % of material has a
particle size < 50 m.22
2.2.

Production process

The manufacturing process is described in detail in the dossier.23 Sorbic acid is synthesised from
ketene and 2-butenal (crotonaldehyde), reacting to form a polymeric ester of 3-hydroxy-4-hexenoic
acid. This polyester is cleaved to give sorbic acid. The crude sorbic acid thus produced is purified by
different procedures. In a second step, potassium sorbate is produced by neutralising sorbic acid with
aqueous potassium hydroxide. The product is purified to limit potential impurities and then
crystallised and granulated at low temperature to a residual moisture level of < 0.2 %. Material safety
data sheets (MSDSs) for all the chemicals required in this manufacturing process are provided.
2.3.

Stability

No data on shelf-life were provided; however, the applicant states that the additive containing
potassium sorbate is stable for at least 18 months, although its stability in the solid state depends on its
purity.
Potassium sorbate can be isomerised under the influence of ultraviolet radiation (Cigic et al., 1991).24
The isomers have different antimicrobial properties. However, the conditions under which
isomerisation occurs appear to be extreme. As a precaution, the applicant recommends that the solid
product and the made-up solution do not be exposed to direct sunlight.
2.4.

Conditions of use

The additive is intended for use as a solid or in solution (of up to 30 % w/v) in forages at
concentrations in the range of 90 to 300 mg/kg fresh material.
2.5.

Evaluation of the analytical methods by the European Union Reference Laboratory

(EURL)

The EURL considered that the conclusions and recommendations reached in the previous assessment
are valid and applicable for the current application.25

18

Technical dossier/Section II/Annexes II.11.2.1.5.d and II.12.2.1.5.e.

Technical dossier/Section II/Annex II.16.2.1.5.i.
20
Technical dossier/Section II/Annex II.13.2.1.5.f.
21
Technical dossier/Section II/Annex II.8.2.1.5.a.
22
Technical dossier/Section II/Annex II.10.2.1.5.c.
23
Technical dossier/Section II.
24
Technical dossier/Section II/Annex II.20.2.4.1.a.
25
The full report is available on the EURL website: http://irmm.jrc.ec.europa.eu/SiteCollectionDocuments/FinRep-FAD2010-0145-plus-0193.pdf
19

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

3.

Safety

3.1.

Safety for the target species

Acute, subchronic and chronic toxicity studies reviewed by JECFA (1974) and SCF (1994) have
demonstrated the relative low toxicity of sorbates. JECFA concluded that the use of sorbic acid in
foods poses no appreciable risk to health, identifying a no observed adverse effect level (NOAEL) of
2 500 mg/kg bw per day (highest dose tested in two generations of rats for up to their entire lifespan).
From this value, an ADI of 25 mg/kg bw for sorbates (expressed as sorbic acid) was derived for
humans.
In the absence of tolerance studies, the maximum safe concentration in feed can be derived from the
NOAEL, applying an uncertainty factor of 100 according to the guidance on additives already
authorised in foods (EFSA FEEDAP Panel, 2012b). The maximum safe concentration of potassium
sorbate in feed for three major species is presented in Table 2.
Exposure of target animals to potassium sorbate via the additive and maximum safe
concentration in feed

Table 2:

Animal
category

Body
weight
(kg)

Mean feed
intake (kg
dry
matter/day)

%
Silage
in diet
(dry
matter
basis)

% Dry
matter
of the
silage

Maximum
proposed use
level of
potassium
sorbate
(mg/kg silage)

Maximum
safe
concentration
in feed
(mg/kg dry
matter feed)

300

Proposed
maximum
concentration
of potassium
sorbate in feed
(mg/kg dry
matter feed)
600

Dairy
cows
Cattle for
fattening
Pigs for
fattening
Laying
hens

650

20

50

25

400

75

25

300

900

1 250

100

60

50(a)

300

360

833

0.12

10

25

300

120

417

813

(a): Maize cob mix.

The calculations above show that the estimated exposure of dairy cows, cattle for fattening, laying
hens and pigs to potassium sorbate would be below the calculated maximum safe concentration in
feed. However, in the case of dairy cows, the intake of silage may have to be restricted not to exceed
the maximum safe concentration of potassium sorbate in feed.
Based on the assessment from dairy cows and cattle for fattening, safety for other ruminants can be
reasonably assumed. As silage use in horse (and rabbit) nutrition is much lower than in ruminants, the
use of potassium sorbate for these species can be considered safe.
The FEEDAP Panel concludes that potassium sorbate used as silage additive is safe for all target
animals at the proposed use level (300 mg/kg fresh matter).
All the above considerations are made assuming that potassium sorbate is given only through silage,
and that complementary feed does not contain potassium sorbate used as a preservative.
3.2.

Safety for the consumer

In studies in mice and rats after oral ingestion, potassium sorbate is almost completely absorbed as
sorbic acid by the usual routes for fatty acid absorption. Sorbic acid, in common with other short-chain
fatty acids, is metabolised by -oxidation to carbon dioxide and water, and this has been confirmed in

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

studies using 14C-labelled sorbic acid.26 The results have shown that the compound is almost entirely
absorbed from the intestine and about 85 % of the total amount is oxidised in a period of a few hours.
By extrapolating this to all species, it is inferred that no residues of potassium sorbate are expected in
animal tissues and products. Consequently, the exposure of the consumer to potassium sorbate is not
expected to be increased when this compound is used as a silage additive.
3.3.

Safety for the user

No data have been provided by the applicant other than the MSDSs of the additive, in which it is
classified as an irritant to eyes and skin and in which the appropriate worker safety recommendations
are provided.27
ECHA reported that potassium sorbate is of low acute toxicity when applied dermally or by inhalation
(ECHA, 2011).
Potassium sorbate was non-irritant to the skin of New Zealand White rabbits when tested in
accordance with the Organisation for Economic Co-operation and Development (OECD) Guideline
404 (ECHA, 2011). However, it was reported as being irritant to the skin of exposed workers (ECHA,
2011). It caused irritation to the eyes of rabbits when tested according to OECD Guideline 405 and has
caused irritation to the exposed eyes of humans by both immunological and non-immunological
modes of action (ECHA, 2011). Consequently, potassium sorbate is classified as a skin and eye
irritant, and is regarded as a potential irritant for the respiratory tract.
No information on inhalation toxicity of the additive is available in the literature. Although the
additive contains few particles of respirable size (< 0.4 % of particles < 45 m), considering the
dusting potential of the preparation tested (2 g/m3), a possible risk of inhalation exposure cannot be
excluded.
The skin-sensitising potential of sorbic acid was tested in guinea pigs according to a maximisation
procedure following OECD Guideline 406. The proportion of animals with positive skin findings
resulting from the first intradermal challenge application was below the threshold for classification for
skin sensitisation (ECHA, 2011).
3.4.

Safety for the environment

In the animal, potassium sorbate is metabolised to carbon dioxide and water. Excretion proceeds with
8086 % via the lungs as CO2. About 210 % is excreted in the urine as urea and in minor
concentrations as sorbic acid and muconic acid (ECHA, 2011). Therefore, the determination of
predicted environmental concentrations of sorbate in soil and groundwater is not considered necessary.
It is not expected that the use of potassium sorbate as silage additive will substantially increase the
background concentrations of sorbates in the environment.
The FEEDAP Panel concludes that the use of potassium sorbate as silage additive is of no
environmental concern.
4.

Efficacy

The additive is intended for use in silage to improve the aerobic stability. A total of seven studies were
conducted, in which the effects of adding potassium sorbate to forage at either 91 mg/kg (studies 15)
or 300 mg/kg (studies 6 and 7) of fresh forage were compared with untreated control materials.
Forages of different botanical origin and different dry matter (DM) and water-soluble carbohydrate
(WSC) contents were ensiled, representing materials easy (studies 2, 5 and 6) and moderately difficult
(studies 1 and 4) to ensile, as defined in Regulation (EC) No 429/2008 (see Table 3). WSC content
was not specified for forages used in studies 3 and 7. Three replicates (studies 1 and 2) or five
26
27

Technical dossier/Section III/Annex III.4.3.1.1.d.

Technical dossier/Section III/Annex III.11.3.3.1.a.

EFSA Journal 2013;11(7):3283

Potassium sorbate for all animals except dogs and cats

replicates (studies 37) were used for control and treated silages. In each case, a solution of potassium
sorbate was made up in water and applied by spraying with continuous mixing. Forages for the control
silos were sprayed with an equal volume of water but without the additive.
Fresh forages (1.52.5 kg fresh matter) were shredded to a chop length of 210 cm, thoroughly mixed
and packed in 5-L buckets. The silos were stored for at least 90 days (90327 days; see Table 3) under
ambient conditions in a shaded place.
Table 3:

Characteristics of the forage samples and duration of the ensiling studies

Study No
(duration, days)
128
(118)
229
(327)
330
(103)
431
(127)
532
(104)
633
(90)
734
(269)

Dry matter content

(%)

Water-soluble
carbohydrate
content
(% fresh matter)

Maize

32

2.1

Wilted grass

32

3.0

Wilted grass

37

Wilted grass

21

2.6

Wilted grass

38

8.2

1st First cut grass (wilted)

22

7.1

Maize

26

Test material

Replicate silos were opened at the end of each experiment and the contents were analysed for DM
content, pH, lactic and volatile fatty acids (VFA) concentration, ammonia and total nitrogen (studies 1,
4, 6 and 7) (Table 4). In addition, DM losses during fermentation were determined in studies 1 and 6.
Aerobic stability of silages was determined in all the studies. After opening the silos, silage was placed
in stability boxes equipped with a probe to record temperature data at hourly intervals. The stability
boxes were stored at ambient laboratory conditions (2025 C) for at least 10 days (240296 hours).
The aerobic stability of the silage was calculated as the time (hours) to observe an increase of 2 C
above ambient temperature, considered as indication of deterioration. Statistical analysis was by the
non-parametric WilcoxonKruskalWallis (rank sum) test with chi-squared approximation.
Significance was declared at P 0.05.

28

Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 1.

Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 2.
30
Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 3.
31
Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 4.
32
Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 5.
33
Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 6.
34
Technical dossier/Supplementary information No12/Annexes Suppl Data File No 1/Annex 7.
29

EFSA Journal 2013;11(7):3283

10

Potassium sorbate for all animals except dogs and cats

Table 4:

Summary of the analysis of ensiled material recovered at the end of the experiment with
potassium sorbate
Potassium
sorbate
(mg/kg)

Dry
matter
loss (%)

pH

Lactic acid
(% DM)

Acetic acid
(% DM)

Ammonia-N
(% total N)

Aerobic
stability
(hours)

0
91

11.0
3.5*

5.2
4.0

3.4
4.1

0.6
0.5

2.9
3.4

30
96*

0
91

110
224*

0
91

40
109*

0
91

4.2
4.2

4.5
3.0

2.3
3.3

10.7
13.5

39
220*

0
91

47

121*

0
300

13.4
11.1*

3.8
3.8

11.7
11.3

2.3
2.3

0.1
0.1

45
145*

0
300

3.8
3.7

4.9
6.4*

1.7
1.9

4.8
4.9

133
234*

Study
No

*Significantly different from the control group (P < 0.05).

DM, dry matter.

The additive did not significantly affect the silage pH and fermentation end-products (lactic and acetic
acid, ammonia-N) contents. Potassium sorbate consistently improved aerobic stability of silage in all
forages tested at both addition rates (91 and 300 mg/kg fresh material) tested.

CONCLUSIONS
The application of potassium sorbate in the preparation of silage up to the maximum proposed dose of
300 mg/kg forage is safe for the target animals.
The use of potassium sorbate as a silage additive is not expected to increase consumer exposure to this
compound. Therefore, potassium sorbate, when used as a silage additive, is considered safe for
consumers of food products from animals fed treated silage.
Potassium sorbate is a skin and eye irritant and a potential irritant to the respiratory tract. Potassium
sorbate is not regarded as a skin sensitiser. The dusting potential of the preparation tested indicates
that exposure of users via inhalation is possible. In view of the irritancy of potassium sorbate and the
absence of information on its inhalation toxicity, exposure to such dust is considered hazardous.
The FEEDAP Panel concludes that there are no safety concerns for the environment resulting from the
use of potassium sorbate as a silage additive.
Potassium sorbate has the potential to improve aerobic stability of silage with dry matter content
between 21 and 38 % when used at the minimum concentration of 90 mg/kg fresh material.

DOCUMENTATION PROVIDED TO EFSA

1.

Potassium sorbate (E202) Technological additive/Silage additive. November 2010. Submitted

by Ecosyl Products Ltd.

2.

Potassium sorbate (E202) Technological additive/Silage additive. Supplementary information.

November 2012. Submitted by Volac International Ltd.

EFSA Journal 2013;11(7):3283

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Potassium sorbate for all animals except dogs and cats

3.

Comments from Member States received through the ScienceNet.

REFERENCES
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ECHA (European Chemicals Agency), 2011. CLH-Report. Proposal for harmonised classification and
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http://echa.europa.eu/documents/10162/13626/clh_potassium_sorbate_en.pdf
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed),
2012a. Scientific Opinion on the safety and efficacy of potassium sorbate for dogs and cats. EFSA
Journal 2012;10(6):2735, 10 pp. doi:10.2903/j.efsa.2012.2735
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed),
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EFSA Journal 2012;10(1):2538, 4 pp. doi:10.2903/j.efsa.2012.2538
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SCF (Scientific Committee for Food), 1994. Opinion on sorbic acid and its calcium and potassium
salts. Reports of the Scientific Committee for Food, Thirty-fifth series, 1922.
Sofos JN, 1989. Sorbate food preservatives. CRC Press, Inc., Boca Raton, Florida, USA.

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