Fact sheet:

Mineral salts

Version: 29/07/2009

GMP+ International B.V.

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 CONTENT
Chapter Page

Content 2

1. General information mineral salts 3

2. Type of hazard 3
3. Nature, history and prevalence of mineral salts and their contaminants 3
4. Transmission to the environment, plants, animals and humans 4
5. Diagnose of poisoning 5
6. Potential hazards and adverse effects 6
7. Severity of the hazard 7
8. Data with analysis results in food / feed materials 7
9. Standards 7
10. Analysis methods 9
11. Control measures 9
12. References 10
13. Websites 12

APPENDIX I CAS-numbers and synonyms

APPENDIX II Toxicity data
APPENDIX III EU Purity criteria for additives
APPENDIX IV JECFA Purity criteria for additives

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 Mineral salts

1. General information mineral salts

Mineral salts are used in the food and feed industry as, among others, fermentation nutrients,
carriers, binders, anti-caking agents, coagulants, acidity regulator or flocculants, but also as
mineral nutrient in food or feed. They can be classified as processing aid or additive.

Because of the numerous amount of mineral salts used in the food and feed industry and their
several applications a selection of studied mineral salts has been made. The studied mineral salts
do not give a complete overview of the mineral salts used in the food and feed industry.

For mineral salts in general, information is present in several chapters.

2. Type of hazard
Chemical

3. Nature, history and prevalence of mineral salts and their contaminants

The following products are known (not limitative):
Calcium sulphate dihydrate CaSO4 2 H2O: is found abundantly in many areas of the world,
where it is extracted by mining and can be obtained as a by-product by numerous industrial
applications. In natural deposits, the main form is the dihydrate, some hemihydrate is also
present in most areas, although to a lesser extent (Lancia et al, 2001).

It can be produced in several ways (AbsoluteAstronomy, 2009):

o In flue gas desulphurization, exhaust gases from fossil-fuel-burning power stations and
other processes (e.g. cement manufacture) are scrubbed to reduce their sulphur oxide
content by injecting finely ground limestone or lime. This produces an impure calcium
sulfite, which oxidizes on storage to calcium sulphate.

o In the production of phosphoric acid from rock phosphate, calcium phosphate is treated with
sulphuric acid and calcium sulphate precipitates.

o In production of hydrogen fluoride, calcium fluoride is treated with sulphuric acid and
precipitating calcium sulphate.

o In the refining of zinc, solutions of zinc sulphate are treated with lime to co-precipitate heavy
metals such as barium.

o From recovering and re-used scrap at construction sites

In case of precipitation processes there is a tendency to concentrate radioactive elements in

the calcium sulphate product. This is particularly the case with the phosphate by-product, since
phosphate rocks naturally contain actinides ((AbsoluteAstronomy, 2009). On average just 7%
of the amount of Cd2+ and Cr3+ in the phosphate ores is transferred to the precipitated gypsum
(Tinge, 2004). Several grades of calcium sulphate dihydrate are commercially available:
pharmaceutical, food and industrial grade.

Calcium sulphate dihydrate is primarily used to manufacture wallboard and plaster. It is also
used as a soil additive or conditioner for large areas of land in suburban and agricultural
regions. High-purity variety is used in several industrial operations, including the production of
foods, glass, paper, and pharmaceuticals. It is especially found in traditional (i.e., Chinese
herbal) medicines (Integrated Laboratory Systems, 2006).

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 In the European Union it is registered as a generally permitted food additive (European
Parliament2, 1998). In the food industry it is used as dough conditioner, firming agent, dietary
supplement in yeast raised bakery products, brewing and other fermentation processes,
stabilizer and thickener, pH control agent and carrier for a bleaching agent (Allied Custom
Gypsum, 2003). A specific application in the food industry is the use as a coagulant in soy
processing (OECD1, 2003).

In the feed industry calcium sulphate dihydrate is also a registered feed additive, E516, and
approved as binder, anti caking agent and coagulant (European Commission2, 2009).

Disodium pyrophosphate Na2H2P2O7: phosphate salts are retrieved from naturally occurring
minerals, which are mined, refined, and purified for use in many applications. Starting with
naturally-occurring phosphate ore mined around the world, phosphoric acid is produced. Once
as phosphoric acid, it can be combined with other elements such as calcium, potassium and
sodium into salts of orthophosphates. The orthophosphates can be converted by heat into
pyrophosphate (PFA, 2009).

In the European Union it is registered as a food additive with restricted use (European
Parliament2, 1998). In the food industry it is used as buffer, emulsifier (Food-Info2, 2009) and
raising agent (JECFA1, 2000).

In the feed industry it is also a registered feed additive, E450(i), and approved as acidity
regulator in pet food for dogs and cats (European Commission2, 2009).

For synonyms and CAS-numbers of certain mineral salts, see Appendix I.

4. Transmission to the environment, plants, animals and humans

4.1 Environment
Calcium sulphate dihydrate: releases into the environment are expected to occur mainly during
processing with wastewater in the food industry. In the phosphatic fertilizer industry and gypsum
industry, wastewater containing calcium sulphate dihydrate, is recycled into the manufacturing
process. Thus there are no emissions of wastewater and exhaust gases to the environment from these
industries. Photo degradation and distribution modelling are not applicable since calcium sulphate
dihydrate is the salt of an inorganic substance. Mixed with water, calcium sulphate dihydrate
becomes a paste that can be spread, cast, or moulded and will then set to rocklike hardness
when dry (OECD1, 2003).
Calcium sulphate dihydrate is used for soil improvement: in the reclamation of sodic soils
where the exchangeable sodium percentage is too high. The calcium replaces the sodium held
on the clay-binding sites. The sodium can then be leached from the soil as sodium sulphate. It
also provides calcium, which is needed to flocculate clays in acid and alkaline soils. It is the
process in which many individual small clay particles are bound together to give much fewer
but larger particles, Such flocculation is needed to give favourable soil structure for root growth
and air and water movement (D.K.T. Co Ltd, 2009).
Disodium pyrophosphate: condensed phosphates, including pyrophosphates, will hydrolyse in
natural waters or during waste water treatment to the orthophosphate form. Phosphates
introduced into soil rapidly hydrolyze to orthophosphates by the activity of soil micro organisms
and chemical hydrolysis (European Commission, 2000). The relative amount of ionic species
in the soil solution depends on soil pH. Acid soils favour the H2PO4- species, and alkaline soils
favour the presence of HPO4 2-(Whitney, 1988).

4.2 Plants
Calcium sulphate dihydrate: interacts with soil selenium. Adding calcium sulphate dihydrate to
the soil, reduces the selenium concentration in plants (alfalfa) (Arthur et al, 1993). Other
interactions have also been reported in case calcium sulphate dihydrate is added to soil:
reduced plant dry weight and reduced nitrogen, phosphor, calcium, potassium, magnesium,

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 sulphur, manganese and zinc contents in the plants, as well as decreased phosphor and
nitrogen utilization, but increased iron content in plants (Muraoka and Santos,2001) .
Disodium pyrophosphate: since phosphates introduced into soil rapidly hydrolyse to
orthophosphates by the activity of soil micro organisms and chemical hydrolysis (European
Commission, 2000) this pathway should be studied. Plants take up phosphorus almost entirely
as the orthophosphate anion (HPO42- or H2PO4- ). Plants are able to absorb both species
effectively. Because the concentration of orthophosphate ions is quite low, absorption of the
orthophosphate ions in most cases occurs against a concentration gradient as the phosphorus
concentration is greater within the root than in the soil solution phase. Although most ions are
thought to be absorbed independently, there are some demonstrated interactions between
nutrients as competition for absorption sites on roots. The plant strives to maintain electrical
balance by absorption of positively and negatively charged ions and by exchange of ions from
the roots with the soil solution. The presence of ammonium ions (NH4+ ) has been shown to
have an enhancement effect on phosphorus. Phosphorus is known to move very little in soil
and roots must be very close to phosphorus in the soil for uptake to occur. Diffusion of
phosphorus to roots will occur over no more than 0,6 centimetres (Whitney, 1988). Phosphates
are known to play an essential role in photosynthesis en energy metabolism.

4.3 Animals
Calcium sulphate dihydrate: bioavailability studies in pigs have been conducted. The bioavailability
of calcium in calcium sulphate dihydrate was similar to that for limestone, oyster shell flour, marble
dust, and aragonite, ranging from 85 to 102% (Integrated Laboratory Systems, 2006).
Disodium pyrophosphate: in the animal body diphosphate is formed from adenosyl
triphosphate (ATP) in many enzymatic reactions. It is either utilized by entering phosphorolytic
reactions, or it is hydrolysed by an inorganic diphosphatase to monophosphate. Ingested
diphosphate is readily converted to monophosphate. In these experiments diphosphate was
almost completely absorbed by the gut and excreted as monophosphate in the urine (JECFA 2,
1970).

4.4 Humans via animal products

Calcium sulphate dihydrate: no data found.
Disodium pyrophosphate: no specific data found. It is not expected to accumulate in the food
chain (European Commission, 2000).

4.5 Humans
Calcium sulphate dihydrate: there was no information found in terms of toxicokinetics,
metabolism and distribution of oral intake of calcium sulphate dihydrate (OECD1, 2003). When
inhaled, it is very soluble in the body; its half-life in the lungs has been estimated as minutes. In
four healthy men receiving calcium supplementation with calcium sulphate (CaSO41/2H2O)
(200 or 220 mg) for 22 days, an average absorption of 28.3% was reported (Integrated
Laboratory Systems, 2006).
Disodium pyrophosphate: Metabolically, the phosphate salts provide a source of the various
cations (sodium) and the phosphate ion (JECFA3, 1982).

5. Diagnose of poisoning
For the studied mineral salts no specific diagnosis have been found. Diagnose should be made
based on general symptoms which relate to the in table 2 mentioned possible dangers in
combination with the presence of the mineral salt.

5.1 Animals
No specific data found.

5.2 Humans
No specific data found.

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 6. Potential hazards and adverse effects
Calcium sulphate dihydrate: is currently of low priority for further work because of its low hazard
profile for the OECD (OECD1, 2003). Natural calcium sulphate dihydrate contains radionuclides.
Thus, the presence of a radioactive decay chain of terrestrial radionuclides can be a source of
radiation exposure which can induce deleterious effects (Msaki and Banzi, 2000).
Disodium pyrophosphate: since its origin can be rock phosphate, undesirable possible
contaminant of rock phosphate and phosphoric acid should be taken into account (see table 1).

For potential contaminants see table 1 and for more toxicological information, see Appendix II.

Table 1. Potential contaminants in mineral salts

Mineral salts Heavy Dioxin and PAHs PCBs Radioactivity Product
metals* dioxin like itself
PCBs
Disodium x x x x x x
pyrophosphate
Calcium sulphate x x x x x x
dihydrate
* Heavy metals = one or a combination of the following heavy metals: arsenic, cadmium, lead, mercury

6.1 Environment
Calcium sulphate dihydrate: bioaccumulation is not expected (OECD1, 2003). Since it is widely
used as soil additive and OECD has stated that because of the low hazard profile calcium
sulphate dihydrate is currently of low priority for further work.
Disodium pyrophosphate: will hydrolyse to orthophosphates, the toxicity of phosphates should
be studied. Phosphates in the environment cause eutrophication. Eutrophication means the
enrichment of natural waters with plant nutrients, in this case phosphorus. In first instance, an
increase in the availability of phosphorus leads to increased productivity in the aquatic food
chain. But given a sustained high level over a prolonged period of time, together with optimal
conditions of light, warmth, low wind and water turbulence, there can be permanent changes in
the types and diversity of plants and higher organisms which inhabit the water body. In
particular, the growth of algae can be favoured over other plants. This becomes problematic if
potentially toxic blue-green algal strains predominate. In extreme cases, there can be a
proliferation of algal blooms which severely attenuate light penetration, making surface layers
warmer and inhibiting vertical convection. This can lead to stratification of the water body and
the formation of a hypolimnion (a colder bottom layer) which may become de-oxygenated,
leading to the loss of various bottom-dwelling plant and animal species (CEEP, 2001).

6.2 Animals
In table 2 an overview is given of potential hazards of mineral salts themselves.

Table 2. Potential hazards of mineral salts themselves.

Mineral salts Nervous Respira- Cardio- Irritating Damage Carcino Reproduc- Death
system tory vascular to skin / to -gen tive system /
system system eyes organs birth defects
Disodium x x
pyrophosphate
Calcium sulphate x x x
dihydrate

Calcium sulphate dihydrate: one study on acute oral toxicity in animals is available. No dead
animals were observed at the limit test exposed to 2.000 mg/kg bodyweight, so oral LD50 for
rats was greater than 2.000 mg/kg body weight. One study on oral repeated dose toxicity in
animals (rats) is available. In this test calcium sulphate, dihydrate had no critical influence on
test items such as mortality, body weights (organ weight), food consumption, necropsy and
behaviour of the animals. However, the values of total protein), albumin, blood urea nitrogen),
and creatinine were decreased significantly. There are no indications that calcium sulphate
dihydrate induces abnormal chromosomal changes. There was no information found regarding
of carcinogenicity. There are no significant treatment-related changes up to 1,000 mg/kg

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 bodyweight / day (highest dose tested) in terms of pregnancy; index of copulation, fertility and
gestation; examination of the external surface of pups; and clinical signs (OECD1, 2003).
Disodium pyrophosphate: Sodium acid pyrophosphate was not mutagenic in a number of tests.
Rats fed diphosphate diets showed a significantly decreased growth and nephrocalcinosis
appeared as the main toxic effect. No specific long term studies with diphosphates have been
made (JECFA3, 1982).

6.3 Humans via animal products

Calcium sulphate dihydrate: no data found.
Disodium pyrophosphate: no data found.

6.4 Humans
Calcium sulphate dihydrate: is skin, eye, mucous membrane, and respiratory system irritant.
Other symptoms humans may exhibit from exposure are coughing, sneezing, or rhinorrhea .
Several studies in humans (as well as animals) showed no lung fibrosis produced by natural
dusts of calcium sulphate (Integrated Laboratory Systems, 2006).
Disodium pyrophosphate: Of greatest concern is the toxicity arising from phosphate imbalance
in the diet. Phosphate salts were not mutagenic in a number of test systems. Teratogenic
effects have not been observed in mammalian test systems (JECFA3, 1982).

7. Severity of the hazard

The severity of contamination of food and / or feed materials with mineral salts and their
contaminants is based on several items:
a. Toxicity of mineral salts themselves;
b. Toxicity of possible contaminants presents in mineral salts;
c. Worst case scenario
Since the severity is based on multiple factors, the severity is estimated as HIGH, as stated in table
3.

For the severity of contaminants which might be present in mineral salts, see fact sheet specific
contaminant.

Table 3. Severity of mineral salts and their contaminants

Severity
Low Medium High
Livestock x
Humans x

8. Data with analysis results in food / feed materials

See references.

9. Standards
.

9.1 GMP+standards (Appendix 1)

There are no specific GMP+ standards for mineral salts as such. However there is a GMP+
standard for sodium in feed materials which are delivered directly to farmers. Action level is at 8
gram sodium per kilogram dry matter. Maximum level is 80 gram sodium per kilogram dry matter
(PDV4, 2008).
For some contaminants which might be present in mineral salts, standards are also laid down in
GMP+ Appendix 1.

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 9.2 EU-legislation
The use of mineral salts as additives which are registered as food additives is regulated in
Directive 95/2 and its several amendments (European Parliament2, 1998). For disodium
pyrophosphate maximum levels are stated in Directive 95/2. Maximum levels are stated for soup
and bouillon ( 3 g/kg) and for e.g. biscuits ( 5 g/kg). Also a maximum level of diphosphate in
sauces is stated ( 5 g/kg). No maximum levels are stated for use in food of calcium sulphate
dihydrate. The purity criteria of food additives are laid down in Directive 2008/84//EC (European
Commission6, 2008) and its amendment in Directive 2009/10/EC (European Commission7, 2009.
For purity criteria of specific mineral salts see Appendix III.
The use of mineral salts which as feed additives is regulated in regulation 1831/2003 (European
Parliament3, 2003). These additives are registered in the Community Register of Feed Additives
(European Commission4, 2009). Disodium pyrophosphate application in feed is permitted as an
acidity regulator in dog and cat food, with no maximum level stated (European Commission3,
2003).
For calcium sulphate dihydrate a maximum level as feed additive (group binders, anti-caking
agents, coagulants) of 30.000 ppm is stated, with no animals excluded (European Commission3,
2003).
In Regulation 2092/91 the use of certain additives in organic production is stated. In organic
productions calcium sulphate dihydrate used as fertilizer or soil conditioner must be of natural
origin. The use of calcium sulphate is allowed in food stuffs of vegetable origin, restricted to the
use as carrier. As processing agent it is approved as coagulation agent (European Commission5,
2006).]

The use of mineral salts as technical processing aids or as nutritional element in fermentation in
food and feed is not specifically legally regulated within the European Union. The use as additives
is legally regulated by Directive 95/2. Purity criteria, when used as additives are legally regulated
by Commission Directive 2008/84/EC and Commission Directive 2009/10/EC. The use as additives
in feed is legally regulated by Regulation 1831/2003/EC where feed additives are registered in the
Community Register of Feed Additives. These directives and regulation do not legally apply in case
of use as processing aids, but can be used as guidelines.

For some products, like wine, there is a code of practice and the use of mineral salts is legally
regulated (European Parliament, 1999).

Regulation 1272/2008/EC, also known as REACH, is a new European Community Regulation on

chemicals and their safe use. It deals with the Registration, Evaluation, Authorisation and
Restriction of Chemical substances. The new law entered into force on 1 June 2007. The aim of
REACH is to improve the protection of human health and the environment through the better and
earlier identification of the intrinsic properties of chemical substances. REACH does not include all
chemical substances, e.g. food and feed additives are excluded since they are regulated via
various other European directives and regulations. Besides these exceptions, chemicals should be
registered in Regulation 1272/2008/EC. Purity criteria in this regulation are generally stated,
however contaminants are not included.

So mind that processing aids which are also used as additives are not regulated within Regulation
1272/2008/EC and also that the feed and food additives legislation do not legally apply!

9.3 Other standards

The FAO / WHO Joined Expert Committee on Food Additives (JECFA) has laid down
specifications for specific mineral salts when used as food additive. For specifications concerning
impurities, see Appendix IV. Mind that these purity criteria do not apply when mineral salts are
used as processing aids, however they can be used as guidelines.

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 The U.S. Food and Drug Administration (FDA) has regulated the use of disodium pyrophosphate,
called sodium acid pyrophosphate, in the Code of Federal Regulations, Title 21, subchapter E, part
582 sodium acid pyrophosphate (part 582.1087) and calcium sulphate (part 582.5230), have been
Generally Recognised as Safe (GRAS). Disodium pyrophosphate has been stated as a general
purpose food additive in subpart B. Calcium sulphate has been stated as a Nutrient and/or Dietary
Supplements in subpart F (FDA, 2008).

No other standards were studied.

10. Analysis methods

Assay methods and identification tests can be used to determine (European Commission6, 2008):

Calcium sulphate dihydrate: should test positive for calcium and sulphate. Calcium sulphate
content should not be less than 99% on the anhydrous basis

Disodium pyrophosphate: should test positive for sodium and phosphate. A 1% solution should
have pH between 3,7 an 5,0. Content of disodium diphoshpate should not be less than 95%
and P2O5 content should be between 63,0 en 64,5%.

JECFA has also stated methods of assay and identification test for calcium sulphate dihydrate
(JECFA4, 2004 and disodium pyrophosphate (JECFA1, 2000).

PDV has stated the following methods of analysis:

Calcium: AAS method (PDV1, 2006);

Sodium: AES method (PDV2, 2006);

Sulphate: gravimetric (PDV3, 2006).

The above mentioned analysis methods are prescribed for mineral salts used as additives, for use
as processing aids the above mentioned methods can be used as guidelines.

11. Control measures

11.1 Avoid ability

Mineral salts are natural components and can be chemically synthesized. Their presence in nature
and products is not likely to be avoidable. Key is to minimize residual levels to levels which cause
no danger or adverse effects. Focus should be on the origin of mineral salts, their purity and
contaminants mentioned in this fact sheet.

11.2 Possible control measures

1. Verification if / which mineral salts are used during processing of feed / food material.

2. Verify if by-products / waste products are added to the feed material, which might contain
mineral salts or residual mineral salts.

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 3. Verify what grade of mineral salts are used: food, feed, pharmaceutical or a grade not related
to food, feed or pharmacy.

4. Verify if a product specification is present, what is specified and if regular checks are installed
to verify if the mineral salts used, meet this specification. Pay special attention to impurities and
contaminants which might give an indication what grade is used.

5. Pay special attention to mineral salts which also have non-food / non-feed applications, like
aluminium sulphate (also used in water treatment) in relation to the grade which is used.

6. Food / feed material producers should verify if residual mineral salts are present in food / feed
material. A HACCP risk analyses should be made.

7. Determine which contaminants might be present in the mineral salts. Mineral salts which are
used as additives should comply with Directive 2008/84/EC and Directive 2009/10/EC criteria
of purity (see Appendix III). For mineral salts used as processing aids, these criteria of purity do
not legally apply, but they can be used as guidelines. Also JECFA purity criteria (Appendix IV)
can be used as guidelines. Mind that not all possible contaminants are included in the criteria
of purity. The use of certain mineral salts as additives in feed should comply with Regulation
1831/2003/EC and feed additives should be registered in the Community Register of Feed
Additives. This regulation does not legally apply in case of use as processing aids, but can be
used as guideline.

Food / feed producers should therefore verify how the mineral salts are produced (starting at
point of origin). The origin should be specified (e.g. producer, surplus material, recycled
material, natural origin, chemical origin etc.). For each mineral salt supplier combination a
HACCP risk analyses should be made to determine the possible contaminants.

8. Food / feed producers should verify how the mineral salts are produced (starting at point of
origin). The origin should be specified (e.g. producer, surplus material, recycled material,
natural origin, chemical origin etc.). For each mineral salt supplier combination a HACCP risk
analyses should be made to determine the possible contaminants.

9. Food / feed producers should verify if / how these contaminants transfer to food / feed products
using the HACCP risk analysis system.

10. Food / feed producers should verify if it is possible that mineral salts might interact / react with
other components (e.g. other contaminants) to synthesize new components during processing
and if these new components end up in the feed material.

11. Exclude adding of by-products / waste products which might contain mineral salts or residual
mineral salts.

12. Verify yourself if possible contaminants are present in the product you bought / will buy from
the supplier who is using mineral salts during production.

12. References

1 AbsoluteAstronomy, Calcium sulphate, AbsoluteAstronomy.com, 2009

2 Allied Custom Gypsum, Food and Pharmaceutical Calcium Sulphate: Calcium Sulphate
dihydrate, 2003
3 Arthur et al, Gypsum amendment to soil can reduce selenium uptake by alfalfa
grown in the presence of coal fly ash, Plant and Soil, Volume 148, pages 83-90,
1993

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 4 Bollinger et al, Toxicity of sodium chloride to house sparrows (Passer Domesticus)
Journal of Wildlife Diseases, 41(2), 2005, pages 363370
5 CEEP (= Centre Europeen dEtudes des Polyphosphates), Phosphates and
eutrophication, Part 4: Improvement Analysis, Section 4, pages 11 - 15
6 D.K.T. Co Ltd, Gypsum for Sustainable Agriculture, 2009
7 European Commission, Disodium dihydrogenpyrophosphate, IUCLID dataset, 2000
8 European Commission2, Community Register of Feed Additives
pursuant to Regulation (EC) No 1831/2003, Appendixes 3 & 4, Annex : List of
additives, Revision 39, 2009
9 European Commission3, Council Directive of 23 November 1970 concerning
additives in feeding-stuffs (70/524/EEC), 2003
10 European Commission4, Community Register of Feed Additives
pursuant to Regulation (EC) No 1831/2003, Appendixes 3 & 4, Annex : List of
additives, Revision 39, 2009
11 European Commission5, Council Regulation (EEC) No 2092/91 of 24 June 1991 on
organic production of agricultural products and indications referring thereto on
agricultural products and foodstuffs, 2006
12 European Commission6, Commission Directive 2008/84/EC of 27 August 2008
laying down specific purity criteria on food additives other than colours and
sweeteners, 2008
13 European Commission7, Commission Directive 2009/10/EC of 13 February 2009
amending Directive 2008/84/EC laying down specific purity criteria on food
additives other than colours and sweeteners, 2009
14 European Parliament, Council Regulation (EC) No 1493/1999 of 17 May 1999 on
the common organization of the market in wine, Official Journal of the European
Communities, 1999
15 European Parliament2, Directive No 95/2/EC of 20 February 1995 on food additives
other than colours and sweeteners, 1998.
16 European Parliament3, Regulation 1831/2003 of 22 September 2003 on additives
for use in animal nutrition, 2003
17 FDA, Code of Federal Regulations, Title 21, Volume 6, 2008
18 Integrated Laboratory Systems, Chemical Information Review Document for
Synthetic and Naturally Mined Gypsum (Calcium Sulphate Dihydrate) [CAS No.
13397-24-5]: Supporting Nomination for Toxicological Evaluation by the National
Toxicology Program, 2006
19 JECFA1, Disodium pyrophosphate, Monograph 1, 2000
JECFA2, Phosphoric acid, Phosphates and Polyphosphates, Fourteenth report of
the Joint FAO/WHO Expert Committee on Food Additives, FAO Nutrition Meetings
Report Series, 1970
20 JECFA3, Phosphoric acid and Phosphate salts, Toxicological evaluation of certain
food additives. WHO Food Additives Series, No. 17, 1982
21 JECFA4, Calcium sulphate, Monograph 1, 2004
22 Lancia et al, Calcium sulphate, Kirk-Othmer Encyclopedia of Chemical Technology,
2001
23 The Merck Veterinary Manual, Salt toxicity, Ninth edition, 2005, page 2514
24 Msaki and Banzi, Radioactivity in products derived from gypsum in Tanzania,
Radiation Protection Dosimetry, Volume 91, Number 4, pages 409 412, 2000
25 Muraoka and Santos, Nutrition of vigna plants on a gypsum amended saline-sodic
soil, Plant nutrition Food security and sustainability of agro-ecosystems, pages
438 - 439, 2001
26 NRC (National Research Council), Mineral Tolerance of Animals, 2nd revised
edition, 2005
27 OECD1, Calcium sulphate, dihydrate, SIDS Initial Assessment Report for SIAM 17,
UNEP Publications, 2003
28 PDV1, WM-12 Diverse mineralen en spoorelementen, Onderzoekmethoden, deel
III, 2006
29 PDV2, WM-09 Natrium, Onderzoekmethoden, deel III, 2006

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 30 PDV3, OSP-24 Sulfaat, Onderzoekmethoden, deel II, 2006
31 PDV4, Appendix 1: Product standards (incl. residue standards), 2008
32 PFA (= Phosphate Forum of the Americas), What are phosphates?, 2009
33 PDV, Fact Sheet Flocculants, 2008
34 Tinge, Cadmium and chromium present in calcium sulphate dihydrate produced by
the nitrophosphate process, Separation and purification technology, Volume 38,
Number 1, pages 75 83, 2004
35 Whitney, Phosphorus Facts: soil, plant and fertilizer, Kansas State University, 1988
36 WHO, Salt as a vehicle for fortification, Report of a WHO Expert Consultation, 2008

13. Websites

1 http://www.pdv.nl/
2 http://ec.europa.eu/food/food/animalnutrition/feedadditives/legisl_en.htm
3 http://www.food-info.net/uk/
4 http://www.codexalimentarius.net/gsfaonline/additives/index.html
5 http://www.who.int/ipcs/food/en/
6 http://www.fao.org/ag/agn/jecfa-additives/index.html
7 http://ec.europa.eu/food/fs/sfp/flav_index_en.html

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 APPENDIX 1 CAS-NUMBERS AND SYNONYMS

Calcium sulphate dihydrate

CAS-number 10101-41-4
Synonyms Alabaster; Annaline; C.I. Pigment white 25; Gypsum; Gypsum
stone; Land and plaster; Light spar; Magnesia white
Mineral white; Native calcium sulphate; Precipitated calcium
sulphate; Sainite; Satin spar; Sulphuric acid, calcium(2+) salt,
dihydrate; Terra alba, E516

Disodium pyrophosphate
CAS-number : 7758-16-9
Synonyms : Diphosphoric acid, disodium salt; Disodium dihydrogen
pyrophosphate; Disodium diphosphate; Sodium Acid
pyrophosphate; SAPP, E450(i)

Fact sheet: Mineral salts 13 / 16

Version: 29/07/2009 GMP+ International B.V.
 APPENDIX II Toxicity data mineral salts

NOEL (mg/kg BW) ADI (mg/kg BW) LD50 (mg/kg BW) Dose clinical symptoms Deadly dosis (mg/kg BW)
(mg/kg BW)
Sodium chloride (during 3000 (rat/bird) (Bollinger, 1500 (bird)(Bollinger, 2005) 8000 (bird) (Bollinger 2005)
water deprivation) 2005) 6000 (sheep) (Merck, 2005)
2200 (pig, horse, cattle)
(Merck, 2005)

Sodium chloride (access to > 4.000 mg/l water (duck) < 5 gram/day (WHO, 2008)
water) (NRC, 2005)1
> 1,7% in diet (turkey) (NRC,
2005)2
> 9,1% in diet (ewes) (NRC,
2005)3
> 5,85% in diet (lambs)
(NRC, 2005)4
Calcium sulphate dihydrate 100 (rat) (OECD1, 2003)5 Not limited (JECFA4, 2004) 2000 (rat) (OECD1, 2003) 300 (rat) (OECD1, 2003)
Disodium pyrophosphate No data found MTDIX of 70 mg/kg BW 2650 (mouse) (European
expressed as phosphorus Commission, 2000)
from all food sources
(JECFA1, 2000)
1
= during 21 days
2
= during 14 days
3
= during 253 days
4
= during 119 days
5
= during 35 days
X
MTDI = Maximum Tolerable Daily Intake

Fact sheet: Mineral salts 14 / 16

Version: 29/07/2009 GMP+ International B.V.
 APPENDIX III EU Purity criteria for additives (European Commission1, 2008)

Calcium sulphate dihydrate Disodium pyrophosphate

Loss on drying 23% 0,5%
Fluoride 30 ppm 10 ppm (as fluorine)
Selenium 30 ppm
Arsenic 3 ppm 3 ppm
Cadmium 1 ppm
Lead 5 ppm 4 ppm
Mercury 1 ppm 1 ppm

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Version: 29/07/2009 GMP+ International B.V.
 APPENDIX IV JECFA Purity criteria for additives
4 1
Contaminant Calcium sulphate dihydrate (JECFA , Disodium pyrophosphate (JECFA ,
2004) 2000)
Loss on drying 19 23%
Water insoluble 1%
matter
Arsenic 3 ppm
Lead 2 ppm 4 ppm
Fluoride 30 ppm 10 ppm
Selenium 30 ppm

Fact sheet: Mineral salts 16 / 16

Version: 29/07/2009 GMP+ International B.V.