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Potassium Sorbate EFSA
Potassium Sorbate EFSA
SCIENTIFIC OPINION
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
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.
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
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.
Additive
Potassium sorbate
Registration number/EC
No/No
E 202
Category(-ies) of additive
Technological additives
(a) preservative9
(b) silage additive
Description
Chemical
formula
C6H7KO2
Composition, description
Potassium sorbate
Purity criteria
Method of analysis
Ph Eur
Trade name
Name of the holder of
authorisation
Conditions of use
Species or
category of animal
Maximum
Age
Not
applicable
Minimum content
Withdrawal
period
Maximum content
Not applicable
None
Post-market monitoring
Specific conditions for use in
complementary feedingstuffs
Not applicable
Not applicable
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.
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.
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
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.
The EURL considered that the conclusions and recommendations reached in the previous assessment
are valid and applicable for the current application.25
18
Safety
3.1.
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
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.
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
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.
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
Study No
(duration, days)
128
(118)
229
(327)
330
(103)
431
(127)
532
(104)
633
(90)
734
(269)
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
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
10
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
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.
2.
11
REFERENCES
Cigic IK, Plavec J, Mozina SS and Zupancic-Kralj L, 1991. Characterisation of sorbate geometrical
isomers. Journal of Pharmaceutical and Biomedical Analysis, 9, 20472010.
ECHA (European Chemicals Agency), 2011. CLH-Report. Proposal for harmonised classification and
labelling. Potassium sorbate. Available online:
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),
2012b. Guidance for the preparation of dossiers for additives already authorised for use in food.
EFSA Journal 2012;10(1):2538, 4 pp. doi:10.2903/j.efsa.2012.2538
JECFA (Joint FAO/WHO Expert Committee on Food Additives), 1974. Toxicological evaluation of
some food additives including anti-caking agents, antimicrobials, antioxidants, emulsifiers and
thickening agents. Seventeenth Report of the Joint FAO/WHO Expert Committee on Food
Additives. World Health Organisation Technical report series, 1974, No 539; FAO Nutrition
Meetings Report Series, 1974, No 53. Available online:
http://www.inchem.org/documents/jecfa/jecmono/v05je18.htm
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.
12