Reports of the Scientific Committee for Food : Seventh seriesaei.pitt.edu/40818/1/7th_food.pdf ·...

COMMISSION OF THE EUROPEAN COMMUNITIES

REPORTS

OF THE SCIENTIFIC COMMITTEE

FOR FOOD

Seventh series

1978

COMMISSION OF THE EUROPEAN COMMUNITIES

REPORTS

OF THE SCIENTIFIC COMMITTEE

FOR FOOD

Seventh series

Manuscript finished in December 1978

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ISBN 92-825-0790-4 Catalogue number: CB-NW-78-007-EN-C

Composition of the Sc ien t i f i c Committee for Food

Messrs P. E l ias R. Franck F. Fairweather H. Gounelle de Pontanel L. Gatti F . Hi l l Α. Lafontaine P. Marquardt (vice-chairman)

A. Mariani E. Poulsen (vice-chairman) P. Schuller R. Truhaut (chairman) G.J. Van Esch B. Weedon

R. Wennig

REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON

BMULSIFIERS,STABILIZERS, THICKENERS AND GELLING AGENTS

(Opinion expressed 30 NovemLer 1978)

TERMS OF REFERENCE

To review certain aspects of the Directive on Emulsifiers, Stabilizers, Thickeners and Gelling Agents for use in Foodstuffs1, in particular the acceptability, from the point of view of safety in use, of substances listed in Annex II of the Directive.

BACKGROUND

When the Directive was agreed by the Council of Ministers in June 1974 a number of issues were left for future determination. Some substances, used only in a few Member States, were separately listed in Annex II of the Directive. Article 3 of the Directive permits Member States to authorise the use of these substances in food for a period of "five years from the notification" of the Directive. This period comes to an end in June 1979, and therefore the Commission is currently considering whether it would be appropriate to include these substances in Annex I (substances which may be authorised in the whole Community). In the case of some substances in Annex I namely E 408, E 450(c), E 460, E 48O , E 48I and E 482, the Council requested the Commission to reexamine their acceptability during the same period. The Commission has asked the Committee for its advice.

The basic Directive also requires that purity criteria for all substances be drawn up and the Committee notes with approval that such criteria have already been established for substances appearing in Annex I .

During preliminary discussions of the Commission's proposals between the Commission Services and experts from Member States, questions were raised about the toxicological acceptability of some of the purity criteria, and the Committee was asked for its advice on a number of points relating to:

- the identity of Ε 407/Έ 408

- the protein content of E 412

- the identity of E 440

- the maximum molecular weight for E 466

- the acceptability of the classification of E 472 The opinions of the Committee on these questions were submitted to the Commission early in 1977 and are reproduced in extenso in this Report (Annexes 3 to 6).

The Commission has also asked the opinion of the Committee on the use of E 413 following requests by European Parliament and Economic and Social Committee members.

CURRENT REVIEW

The Commission Services requested Member States to supply up-to-date information (toxicológica], technological and usage) on the substances under discussion. These date, in the main, were supplied as summaries. The Commission Services were also able to provide data, submitted to them by the industries concerned, on a number of substances.

174/329/EEC of 18 June 1974, OJ L 189 of 12.7.1974, P. 1 278/663/EEC of 25 July 1978, OJ L 223 of 14.8.1978, p. 7 *For easy reference to names of the substances, Annexes I and II are reproduced in Annexes 1 and 2 to this Report

**E 48O has since been deleted from the Directive

The Committee decided that it would be unnecessarily cumbersome to request that all data, previously submitted to national governments, be made available to each member. However, the Committee felt unable simply to rely on summaries of data submitted to other bodies. It was agreed therefore that designated members of the Committee should examine details of different submissions in full, but that the resulting assessment could be presented in summary form to the main Committee unless there was a particular reason to depart from this procedure. References to all the data examined in this way are given for each substance under the appropriate heading in Annexes 3 to 7·

The Community Directive does not in general refer to the foodstuffs in which particular emulsifiers, stabilizers, thickeners and gelling agents may be used. Nevertheless, Article 4 of the Directive requires that the Council "shall determine as soon as possible the foodstuffs to which these substances may be added and the conditions under which they may be added". The Committee recommends that steps be taken to implement these requirements, and draws attention to the fact that any misuse of the additives discussed in this Report may lead to excessive retention of water with a reduction in the nutritional value of the food on a weight for weight basis.

Hie Committee therefore confined its attention mainly to establishing whether, from the point of view of safety, individual emulsifiers, stabilizer, thickeners and gelling agents were acceptable. Nevertheless it seemed desirable to indicate in the report some technological a.pplications of which the Committee was informed although not all of these apply necessarily in the Community context. The Committee wishes to reiterate the point made in its Opinion on Fine Bakers' Wares, Rusks, Pastries and Biscuits l) that the setting of maximum levels of use of an additive in various foods is not a purely arithmetical exercise. The desired technological results must be achieved in a way that ensures that the ADI is unlikely to be exceeded. The Committee requests that it be kept informed by the Commission of proposals for the assignment of maximum levels of use for any food additive and be invited to comment from the point of view of safety in use.

ASSESSMENT OF TOXICOLOGICAL ACCEPTABILITY

The general criteria used in the present review for the evaluation of emulsifiers, stabilizers, thickeners and gelling agnets are comparable to those employed in the assessment of the safety of colouring matters, and are summarised in paragraph 10 of the Committee's first report on such substances 2). The Committee noted that in many instances compounds proposed for use as emulsifiers, stabilizers, thickeners and gelling agents were esters which during their metabolism hydrolysed into components for which global ADIs had been established by JECFA at various times. It wished to draw attention to these evaluations of JECFA and to the need for taking these into consideration when assigning levels of use.

CLASSIFICATION OF EMULSIFIERS, STABILIZERS, THICKENERS AND GELLING AGENTS

The classification used during the present review was similar to the one used for colouring matters (see paragraph 11 of the Committee's 1st report on colouring matters).

I. Substances for which an API could be established and which are therefore toxicologically acceptable for use in foods within these limits As a working principle, before a food aditive can be accepted for use in food, it is necessary to provide adequate toxicological data. Based on these data an ADI can be established using results obtained with the most sensitive animal species and using the most sensitive criterion.

II. Substances for which a temporary API could be established and which are toxicologically acceptable for use in food within these limits for a period of 3 years or 5 years depending on the types of information required Not later than one year before the end of the appropriate period, the Committee expects to be provided with a report on the tests indicated in Annex 7 as necessary.

1) Reports of the Scientific Committee for Food, 5th Series, May I978 2) Reports of the Scientific Committee for Food, 1st Series, December I975

Exceptionally the Committee would be prepared to consider recommending an extension of the period of validity of the temporary ADI, provided it was satisfied that substantial progress had been made with the tests required.

III. Substances for which an API could not be established but which are nevertheless considered acceptable or temporarily acceptable for use in food The Committee was unable to establish formal ADIs on the basis of the available toxicological information. However, some of these substances occur naturally and are consumed as part of the diet in some parts of the world. Others are used at very low levels in food, or are used only in products of low consumption. Most of the substances are known to hydrolyse into components to which the body is already exposed, or which are of known toxicity.

IV. Substances for which an API could not be established and which are not toxicologically acceptable for use in food Where a substance has been included in this category, the Committee believes that its use should be phased out. However, the Committee would be willing to reconsider its advice should adequate additional information become available.

Unless other requirements are stipulated with respect to particular substances the Committee believes that there is no objection to a gradual phase out over a period of 1 year or so.

Detailed comments on individual substances are given in Annex 7·

SUMMARY OF CONCLUSIONS

1. Substances for which an API could be established and which are therefore to:.icol ogically acceptable for use in food within these limits

Carrageenan (Ε 407/Έ 408) : ADI 0-75 mg/kg bw*

Pectin (E 440)(E 440a) : ADI not specified

Sodium and potassium polyphosphates (E 450c) : Acceptable total dietary phosphorus loan 0-70 mg/kg bw

Macrocrystalline cel lulose (E 460)/powdered ce l lu lose

Polyglycerol es ters of mono- and di-glycer ide of f a t t y acids (E 475)

Sodium stearoyl-2- lactyla . te (E 48I) Calcium stearoyl-2- lactyla . te (E 482)

Pa r t i a l polyglycerol es te rs of poly-condensed f a t ty acids of castor oil

Sorbitan monopalmitate Sorbitan rnonostearate Sorbitan t r i s t e a r a t e

Sorbitan monolaurate Sorbitan mono—oleate

Guar gum (E 412)

ADI not specified

: ADI O-25 mg/kg bw

) API 0-20 mg/kg bw singly or in ) combination

API O-7.5 mg/kg bw

API 0-25 rng/kg bw singly or in combination

ADI 0-5 rng/kg bw singly or in combination

ADI not spéc i f i e !

bw = body weight This estimate applies to the sum of added phosphate and food phosphate. Acceptable dai ly intake leve l s of phosphate depend on the amount of calcium in the 'd ie t . The leve ls stated apply to d ie t s that are nu t r i t i ona l l y adequate with respect t o calcium. However, i f the calcium intake were high, proport ional ly higher amounts of phosphate would be acceptable, and the reverse r e l a t i on would a lso apply.

Xanthan gum : ADI 0-10 mg/kg bw

Extract of Qui l la ia : ADI 0-5 mg spray dried ex t rac t /kg bw

Propane-l ,2-diol e s te r s of f a t t y acids

(E 477)'*; : ADI 0-25 mg/kg bw

Ammoiiium phosphatides : ADI 0—30 mg/kg bw

Fat ty acid es te r s of mono— and diglycerides

of f a t t y acids (E 472 a-d, f) : ADI not specified (E 472 Θ) : ADI 0-50 mg/kg bw

2 . Substances for which a temporary ADI could be established and which are tox ico log ica l ly acceptable for use in food within these l imi t s for a period of 3 years or 5 years depending on the types of information required

Amidated pect in (E 440b) : temporary ADI 0-25 nig/kg bw

Polysorbates (20, 40, 60, 65 and 80) : temporary ADI 0-25 mg/kg bw

Polyoxyethylene (40) s t éa r a t e : temporary ADI 0-25 mg/kg bw

Dioctyl sodium sulphosuccinate : temporary ADI 0—0.1 mg/kg bw

3 . Substances for which an API could not be establ ished but which are nevertheless considered temporarily acceptable for use i n food

Tragacanth (E 413)(temporary)

Propoane—1,2—diol e s t e r s of f a t t y acids (E 477) ** (temporary)

Polyoxyethylene (8) s t éa ra t e (temporary)

Oxidatively thermally polymerised soya bean o i l in te rac ted with mono— and di—glycerides (temporary)

Lactylated f a t t y acid es te r s of glycerol and propane—1,2—diol (temporary)

4· Substances for which an API could not be establ ished and which are not tox ico log ica l ly acceptable for use in food

Karaya gum

Ghatti gum

* with a t o t a l content of dimer and tr imer of propane-1,2-diol of 0.5>£or l ess ** with a t o t a l content of dimer and tr imer of propane-1,2-diol between 0 . 5 ^ and 4 $ .

10

ANNEX 1

EMULSIFIERS, STABILIZERS, THICKENERS AMD GELLING AGENTS WHICH MAY BE USED IN FOODSTUFFS

EEC No.

E 322 E 339 E 340 E 341 E 400 E 401 E 402 E 403 E 404 E 405 E 406 E 407 E 410 E 412 E 413 E 414 E 420

E 42I E 422 E 44O (a) E 440 (b) E 450 (a)

E 450 (b)

E 450 (e)

E 46O E 461 E 463 E 464 E 465 E 466 E 47O

Designation

Lecithins Sodium orthophosphates Potassium orthophosphates Calcium orthophosphates Alginic acid Sodium alginate Potassium alginate Ammonium alginate Calcium alginate Propane—1,2—diol alginate Agar Carrageenan Locust bean gum Guar gum Tragacanth Acacia or gum arabic (i) sorbitol (ii) sorbitol syrup Mannit ol Glycerol Pectin Amidated pectin (i) diSodium dihydrogen diphosphate (ii) triSodium diphosphate (iii) tetraSodium diphosphate (iv) tetraPotassium diphosphate (i) pentaSodium triphosphate (ii) pentaPotassium triphosphate (i) sodium polyphosphates (ii) potassium polyphosphates Microcrystalline cellulose Methylcellulose Hydroxypropylcellulose Hydroxypropylmethylcellulose Ethylmethylcellulose Carboxylmethylcellulose Sodium, potassium and calcium salts of fatty acids

Conditions of use

Exclusively in the manufacture of 'Dutch' type rusks up to a level singly or in combination of not more than 1.5^ of flour used

11

EEC No.

E 471 E 472 (a)

E 472 (b)

E 472 (c)

E 472 (d)

E 472 (e)

E 472 (f)

E 473

E 474 E 475 E 477 E 481 E 482 E 483

Designation

Mono— and diglycerides of fatty acids Acetic acid esters of mono- and diglycerides of fatty acids Lactic acid esters of mono- and diglycerides of fatty acids Citric acid esters of mono- and diglycerid of fatty acids Tartaric acid esters of mono— and. diglycerides of fatty acids Mono- and diacetyltartaric acid esters of mono— and diglycerides of fatty acids Mixed acetic and tartaric acid esters of mono— and diglycerides of fatty acids Sucrose esters of fatty acids

Sucroglycerides Polyglycerol esters of fatty acids Propane—1,2—diol esters of fatty acids Sodium stearoyl—2—lactylate Calcium stearoyl—2—lactylate Stearyl tartrate

es

)

Ì )

) ? )

Conditions of use

These substances may not be used in bread unless permitted under national law

These substances may not be used in bread unless permitted under national law

12

ANNEX 2

D e s i g n a t i o n

Karaya gum (synonym: s t e r c u l i a gum)

P a r t i a l p o l y g l y c e r o l e s t e r s of polycondensed f a t t y a c i d s of c a s t o r o i l

S o r b i t a n monopalmita te

S o r b i t a n monos tea ra t e

S o r b i t a n t r i s t e a r a t e

Po lyoxye thy lene (20) s o r b i t a n monolaura te (synonyms p o l y s o r b a t e 20)

Po lyoxye thy lene (20) s o r b i t a n monopalmitate (synonym: p o l y s o r b a t e 40)

Po lyoxye thy lene (20) s o r b i t a n monos tea ra t e (synonym: p o l y s o r b a t e óO)

Po lyoxye thy lene (20) s o r b i t a n t r i s t e a r a t e (synonym: p o l y s o r b a t e 65)

Po lyoxye thy lene (20) s o r b i t a n mono-olea te (synonym: p o l y s o r b a t e 80)

Po lyoxye thy lene (8) s t é a r a t e

Po lyoxye thy lene (40) s t é a r a t e

G l y c e r i c e s t e r s of f a t t y a c i d s ob ta ined from soya o i l ox id ized under hea t

G h a t t i gum

Xanthan gum

E x t r a c t of q u i l l a i a

L a c t y l a t e d f a t t y a c i d e s t e r s of g l y c e r o l and p ropy lene g l y c o l

S o r b i t a n monolaura te

S o r b i t a n mono-olea te

D i o c t y l sodium s u l p h o s u c c i n a t e

Ammonium p h o s p h a t i d e s (synonym: e m u l s i f i e r YN)

1.'!

ANNEX 3 REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON CARRAGEENAN (E 407)

AND FURCELLARAN (E 4O8) (Opinion expressed January, 1977)

TERMS OF REFERENCES

The Committee was asked to give its opinion on whether carrageenan and furcellaran can be included within a single specification of purity and, if so, whether substances complying with this specification can be recommended for acceptance on a Community basis beyond June 1979.

CONCLUSIONS

The Committee accepts that on the basis of the current information on source materials, production methods, chemical nature and toxicological information, a single combined specification for carrageenan and furcellaran for food use of high molecular weight is justified.

BACKGROUND

The Directive on the approximation of the laws of Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs (74/329/EEC of l8 June 1974) permits the use of carrageenan and furcellaran on a Community basis. However, within 5 years of the notification of the Directive (i.e. by June 1979) "the Council, on the basis of a proposal from the Commission, must decide whether to delete, retain or otherwise change the status of furcellaran. (Article 2.2.)

The Commission, in accord with Article 7 of "the Directive, is preparing specific criteria of purity for carrageenan and for furcellaran. The producers of carrageenan and furcellaran have stated that formerly these stabilisers were obtained from separate algae sources, but that currently they are both obtained from a wide but similar range of red algae. The producers have therefore suggested that a single combined specification for carrageenan/ furcellaran would now be more appropriate.

SOURCE MATERIALS FOR CARRAGEENAN AND FURCELLARAN

The Committee was informed that the source materials for both carrageenan and furcellaran are red algae of the Order Gigartinaes from the Class Rhodophyceae (l). Carrageenan was formerly obtained principally from algae of the Family Gigartinaceae, in particular, Chondrus crispus. However, the increasing scarcity of such algae has led to the use of red algae from other Families of the same Order — including Furcellariaceae. Furcellaran was originally obtained solely from the species Furoellaria fastigiata of the Order Furcellariaceae. The Committee was informed that this species is no longer available in sufficient quantities, so that the source material for furcellaran is often a mixture of Furcellaria fastigiata with Chondrus crispus and other similar red algae. Thus, there has been a considerable extension of the number of Families of red algae used in the production of carrageenan, one of the Families, Furcellariaceae, being that from which furcellaran is obtained; whilst furcellaran is currently obtained from mixtures of Furoellaria fastigiata and other red algae that are also used in the production of carrageenan.

PRODUCTION METHODS

The Committee was informed that carrageenan is obtained by extracting the red algae with hot water, filtering the extract and then precipitating the carrageenan with an alcohol (normally propan-2-ol but sometimes ethanol or methanol). Furcellaran can be obtained in similar fashion, though it is more usual to precipitate the furcellaran by addition of potassium chloride (l). The Committee noted that degraded carrageenan, prepared by the partial hydrolysis of Eucheumaspinosum, is not used for food purposes but is sold for medical use as an anti-peptic agent (2).

14

CHEMICAL NATURE OF CARRAGEENAN/FURCELLARAN

The product as obtained primarily from Chondrus crispus, consists chiefly of the calcium,

potassium, sodium and magnesium salts of polysaccharide sulphate esters, the dominant hexose

units of which are galactose and 3,6-anhydrogalactose. The sulphate content, as SO on a

dry-weight basis is between 18 and 40$ (3)(4).

However, the product obtained primarily from Furoellaria fastigiata, consists chiefly of the

potassium salts of polysaccharide sulphate esters, the dominant hexose units again being

galactose and 3,6—anhydrogalactose. The sulphate content, as SO on a dry-*reight basis,

ranges from I4 to 18 per cent (4). 4

The Committee was told that when alcohols are used for precipitation it is difficult to

redùce the level of residual solvent to below 1 per cent.

TOXICOLOGICAL EVALUATION AND CRITERIA OF PURITY

The Committee noted that in 1970 JECFA published separate specifications for carrageenan

and furcellaran (4)» 'the two substances were considered together for the purposes of

toxicological evaluation (5)· In 1973, JECFA reviewed the toxicology of the two substances

together (2) and in 1974 decided to put forward tentatively a single combined specification

(6).

The Committee accepts that on the basis of the current information on source materials,

production methods, chemical nature and toxicological information, a single combined

specification for carrageenan and furcellaran is justified stating that the minimum viscosity

of 1.5 per cent solution should not be less than 5 centipoises at 75°C.

The Committee gave attention to solvent residues and to the molecular weight restrictions.

The Committee recommends that the levels and kinds of residual solvent in the final product

should not exceed 1 per cent for methanol, ethanol or propan—2—ol (isoprooanol) singly or

in combination. The Committee considers that, if practicable the use of methanol should be

avoided and the product should only be obtained using ethanol or propan-2—ol.

The Committee noted the evidence summarised by JECFA (2) that degraded carrageenan has an

ulcerogenic effect in some animal species (rat, guinea pig, rabbit) but not others (mouse,

hamster, gerbil, ferret, pig, squirrel or monkey). On the other hand there is no evidence

that patients given degraded carrageenan for the treatment of peptic ulceration and

ulcerative colitis have suffered ill effects. Since then Engster and Abraham have

published their work on the caecal response to different molecular weights and types of

carrageenan in the female guinea pig (7)· Kappa (κ) and Lambda (̂ ) fractions were obtained

by treatment of Chondrus crispus extracts with alkali and precipitation by alcohol. Iota (i)

fractions were obtained from Eucheuma spinosum extracts after acid hydrolysis. Results

are summarised briefly in the following table :

Fract ion

Κ

Κ Κ

λ Χ κ i

i

i

i

i

I n t r i n s i c v i s c o s i t y

( d l / g )

11 .95

1.451 0.117

10.250

2 .243

0 .503

7 .51 5 .34

4 .19 1.62

O.685

Number average molecu la r weight

(Mn)

314.OOO

5I.5OO

8.5OO

275.OOO

74.800 20.800

I45.OOO

IO7.OOO 88.000

39.000

21.000

Response t o l'/j

s o l u t i o n i n d r i n k i n g wate r

(2 weeks)

n e g a t i v e

n e g a t i v e

n e g a t i v e

n e g a t i v e

n e g a t i v e n e g a t i v e

n e g a t i v e

+ +

+ + + +

Response t o 2'/o

l e v e l fed i n di (lO weeks)

n t

nt

nt

nt

nt nt

n e g a t i v e



et

Ιό

Fraction

i i

Intrinsic viscosity (dl/g)

0.285 0.113

Number average molecular weight

(Mn)

8.7OO ca 5.000

Response to 1% solution in drinking water (2 weeks)

+ negative

Response to 2% level fed in diet (lO weeks)

negative nt

Code: + epithelial thinning, slight erosion, cellular infiltration and crypt abscesses in caecum« -r + as above, plus ulceration of the caecal mucosa. nt not tested.

Pittman, Golberg and Coulston (8) give a va r i e ty of Io t a , Kappa and Lambda carrageenans t o guinea p igs , monkeys and r a t s , e i the r in drinking water or by gavage or i n the d i e t . Substant ia l amounts of carrageenan were found in the l i v e r s of guinea pigs and r a t s given 1σ«ί molecular weight i , Κ or , \ carrageenans (below 40.000 Mn). Intermediate amounts were found in the l i v e r s of animals given carrageenans ranging in number average molecular weights (Mn) between 4O.OOO and I5O.OOO. Degradation occurred on or a f t e r passage through the i n t e s t i n a l t r a c t since the Mn values of carrageenans from the l i v e r s of guinea pigs tended t o be about 10.000. Excretion of carrageenans in the ur ine was l imited t o values of Mn of probably 10.000 or l e s s . The authors calculated tha t i-carrageenans containing only molecules of Mn above 5O.OOO - 85.000 Mn would not be absorbed and found in the l i v e r .

The Commi-ctee was of the opinion tha t the evidence concerning possible adverse ef fec ts of degraded carrageenan in the human die t was inconclusive. However, as a matter of prudence the level of degraded carrageenan in carrageenan for food use should be kept t o a minimum. There i s no r e l i a b l e ana ly t ica l method for detect ing small amounts of degraded carrageenan in food grade carrageenan. But the Committee was informed that in p rac t ice t h i s does not present a problem since, for food use , undegraded carrageenan i s l e ss expensive and superior from a technological view poin t , process .

Degraded carrageenan i s made by a separate

Since suDmi-rting xhis report the Committee was informed about the adverse findings reported ta recent s tudies on degraded carrageenan ( 9 ) , which reinforce i t s opinion t ^ t food grad! carrageenan should conta η as low a level as possible of degraded mate r i a l . Í n o r d e f t o

Stafil ζ r s e a £ " k e " ? s and ? V " ^ P ™ " * « * * » i a " * ^ ^ * ^ °n Emulsifiers, bxab i i i z e r s . Thickeners, and Gelling Agents, the Committee wishes to record tha t i t does not object t o the endorsement of the ADI of 0 - 7 5 mg/kg bw establ ished by ÏECPA"

16

REFERENCES

1. Indus t r i a l Gums, Roy, L. Whistler (Editor), Second Edition (P. I50), Academic Press, New York and London, 1973.

2. Toxicological Evaluation of Some Food Additives, FAO Nutrition Meetings Report Series No. 53A, WHO Food Additives Series 1974, no. 5, FAO/WHO, Rome/Geneva, 1974.

3. Food Chemicals Codex, Second Edition 1972 and First Supplement, 1974. National Academy of Sciences, Washington D.C.

4. Specifications for the Identity and Purity of Some Food Colours, Emulsifiers, Stabilizers, Anti—caking Agents and Certain Other Substances. FAO Nutrition Meetings Report Series No. 46B, WHO Food Add/70.37. FAO/WHO Rome/Geneva, 1970.

5· Toxicological Evaluation of Some Food Colours, Emulsifiers, Stabilizers, Antioaking Agents and Certain other Substances, FAO Nutrition Meeting Report Series No. 46A, WHO/Food Add/70.36. FAO/WHO, Rome/Geneva, 1970.

6. Specifications for Identity and Purity of Some Food Additives, FAO Nutrition Meetings Report Series No. 54B, WHO/Food Add/7 FAO/WHO, Rome/Geneva, 1975·

7. Cecal Response to Different Molecular Weights and Types of Carrageenan in the Guinea Pig. Engster, M. and Abraham, R., Toxicology and Applied Pharmacology, 38, 265-282, 1976.

8. Carrageenan: The Effects of Molecular Weight and Polymer Type on its Uptake, Excretion and Degradation in Animals. Pittman K.A., Golberg L., and Coulston, F. Food and Cosmetics Toxicology, I4, 85-93, 1976.

9· Induction by Degraded Carrageenan of colorectal tumours in rats. Wakabayashi K., Inagaki T., Fujimoto Y., and Fukuda Y. Cancer letters, 4, I7I-I76, I978.

17

ANNEX 4 REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON GUAR GUM (E 412)

(Opinion expressed January 1977)

TERMS OF REFERENCE

The Committee was asked to express its opinion on the implications of a recent report on research on guar gum (l) in relation to proposed specifications for this substance and its continued inclusion on the Community list of acceptable emulsifiers, stabilisers, thickeners and gelling agents.

CONCLUSIONS

The Committee concluded on toxicological grounds that the protein content of guar gum for use in human food should be as low as possible. There was some evidence that a level of 5 per cent protein in guar gum should be technologically feasible, but, meanwhile, the Committee would not object to the continued inclusion of guar gum (milled endosperm of guar seed on the Community list of acceptable emulsifiers, stabilisers, thickeners and gelling agents provided that the protein level of the gum does not exceed 7 per cent.* This opinion on acceptability for use in food relates solely to use at the levels required for emulsifying, stabilising or thickening purposes, normally not exceeding 2 per cent. Further consideration would need to be given to the acceptability of guar gum for dietary products (e.g. as a bulking aid in low energy preparations) when levels of use could be in excess of 2 per cent.

BACKGROUND

The Council Direct ive on the approximation of the laws of Member Sta tes r e l a t i n g to emuls i f ie rs , s t a b i l i s e r s , thickeners and ge l l ing agents for use in foodstuffs ( 7 4 / 3 2 9 / E E C of 18 June 1974) permits the use of guar gum on a Community b a s i s . Ar t ic le 7 of 'the Direct ive requires tha t the Council on a proposal from the Commission, shal l lay down specif ic c r i t e r i a of p u r i t y . During discussions on these c r i t e r i a of pur i ty with experts from the Member Sta tes the Commission's a t t en t ion was drawn to a report by Feldheim and Stamm on animal feeding t r i a l s with guar seeds and guar seed f rac t ions Dy ί

(1). The Commission therefore requested the Committee's opinion on the implications of this report as regards both the proposed specification for guar gum and the continued acceptability of guar gum for inclusion in the Directive.

PRODUCTION TECHNOLOGY, TERMINOLOGY AND USAGE

The Committee were given details of the method of production of and terminology for the various guar seed products (2)(3). The guar seeds are crushed and the germ, endosperm and husks separated mechanically. The germ is milled to produce raw guar meal. This is usually heat treated prior to use as a protein source in animal feed. The endosperm is milled to give the product known as guar gum and the husks are discarded.

Guar meal has a protein content of about 45—50 per cent. Pure guar endosperm, separated by hand, has a protein content of about 4-5 per cent. However, commercial guar endosperm (guar gum) contains small residual amounts of germ and husk which it is claimed cannot be separated economically without substantial loss of endosperm. The Committee was informed that the maximum protein content of 7 per cent for guar gum suggested as practicable by the trade would imply that its germ content was no higher than 6 per cent. The Committee was provided with the following table showing the composition of guar seeds and their utilisable products (2):

calculated on the basis of total nitrogen determination and using the factor of 6.25 "to convert total nitrogen to protein.

18

Produc t

Guar seed

(cyamopsis t e t r a gono— l o b u s L ) .

Guar meal

(germ)

Guar gum

(endosperm)

— t e c h n i c a l g rade

— food grade

P r o t e i n Content (*)

28-34

45-50

6- 9

7

Galact omannan Content {$,)

30-35

6-10

65

75

Use

Source m a t e r i a l

Animal feed

pape r , t e x t i l e s mining

"öii eke ner and s t a b i l i s e r

As a t h i c k e n e r and s t a b i l i s e r , use l e v e l s i n food a r e g e n e r a l l y no more t h a n about 2 pe r cen t ,

TOXICOLOGICAL INFORMATION

I n 1975 "the FAO/WHO J o i n t Exper t Committee on Food A d d i t i v e s (JECFA) confirmed i t s e v a l u a t i o n of "ADI not s p e c i f i e d " f o r guar gum (5)*Feldheim and Stamm's r e p o r t ( l ) appeared i n I976 and was not t h e r e f o r e cons ide red by JECFA. Feldheim and Stamm summarised e a r l i e r f e e d i n g t r i a l s on c a t t l e , p o u l t r y and r a t s wi th guar seeds or t h e i r p r o t e i n - r i c h or carbohydra te- r ich f r a c t i o n s . The p r o t e i n - r i c h f r a c t i o n s caused t o x i c e f f e c t s which were d imin i shed i f h e a t e d f r a c t i o n s were f e d . C a r b o h y d r a t e - r i c h f r a c t i o n s dep res sed growth . According t o t h e a u t h o r s t h i s was p robab ly due t o poor u t i l i s a t i o n of galactomannans ( t h e main c a r b o h y d r a t e f r a c t i o n of guar ) by t h e an imals or t o a d e c r e a s e i n fodder consumption due t o expans ion of t h e fodder i n t h e g u t . Feldheim and Stamm c i t e d o t h e r s t u d i e s i n which i s o l a t e d guar p r o t e i n caused s w e l l i n g and inf lammat ion of t h e i n t e s t i n e s when fed t o r a t s . Raw guar meal ( t h e p r o t e i n - r i c h f r a c t i o n ) i s known t o c o n t a i n a t r y p s i n i n h i b i t o r ( 6 , 7 ) a s do many o t h e r p l a n t seeds ( e . g . soya b e a n s ) . The Committee was informed t h a t p r e l i m i n a r y t e s i s showed t h e t r y p s i n i n h i b i t o r a c t i v i t y of guar meal t o be about 20 per cent of t h e a c t i v i t y found i n soya p r o t e i n and t h a t no t r y p s i n i n h i b i t o r a c t i v i t y could be d e t e c t e d i n guar gums w i t h 4 t o 10 pe r cent p r o t e i n conten t ( 3 ) .

*In o rde r t o a l i g n t h i s e a r l i e r r e p o r t with t h e formal p r e s e n t a t i o n of i t s p r e s e n t Report on E m u l s i f i e r s , S t a b i l i z e r s , T h i c k e n e r s , and G e l l i n g Agents , t h e Committee wishes t o r e c o rd t h a t i t does not ob jec t t o t h e endorsement of t h e ADI "not s p e c i f i e d " e s t a b l i s h e d by JECFA.

19

REFERENCES

1. Guar II. Feeding Trials with Animals.

Feldheim., W., and Stamm, I.

Ζ Lebensm. Unters - Forsch, 160, 11-18 (1976).

2. Professor Dr. R. Franck (personal communication)

Max von Petterikofer Institute, Berlin 33.

Member of Scientific Committee for Food.

3» Unpublished information supplied to the Commission by Institute European des

Industries de la Gomme de guar et caroube.

4* Gum Technology in the Food Industry,

Martin Glicksman,

Academic Press, New York and London, I969.

5«. Toxicological evaluation of some food colours, thickening agents, and certain other

substances,

FAO Nutrition Meetings Report Series No. 55A.

WHO Food Additives Series No. 8.

FAO/VHO, Rome/Geneva 1975.

6o Couch J.R., Bakshi I.N., Prescott J.M., and Greger C.R.

Federation Proceedings ¿4, 687, I965·

7. Berichte, 1973.

Deutsche Forschungsanstalt für Lebensmittelchemie, München.

20

ANNEX 5 REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON ESTERS OF MONO-" ' AND DI-GLYCERIDES OF FOOD FATTY ACIDS (E 472)

(Opin ion expressed Janua ry 1977)

TERMS OF REFERENCE

To g i v e an op in ion on t h e adequacy of t h e c u r r e n t d e s i g n a t i o n f o r E 472 a t Annex I of t h e Counci l D i r e c t i v e on t h e approx imat ion of t h e laws of Member S t a t e s r e l a t i n g t o e m u l s i f i e r s , s t a b i l i z e r s , t h i c k e n e r s and g e l l i n g a g e n t s f o r use i n f o o d s t u f f s (74/329/EEC of l 8 June 1974) , and whether t h e mixed a c e t i c / t a r t a r i c e s t e r s a r e a c c e p t a b l e f o r use i n food from t h e po in t of v iew of t h e h e a l t h of t h e consumer.

CONCLUSIONS

1 . The D i r e c t i v e should be reworded so as t o permit only s p e c i f i c mono- and d i - g l y c e r i d e s

whether produced from one or more t h a n one of t h e s p e c i f i e d o rgan ic a c i d s .

2 . The Committee i s p repa red t o accep t t h e s p e c i f i c i n c l u s i o n of t h e mixed a c e t i c / t a r t a r i c a c i d e s t e r s on t h e Community l i s t of e m u l s i f i e r s ( e t c . ) .

BACKGROUND

The D i r e c t i v e p e r m i t s t h e use i n f o o d s t u f f s , on a Community b a s i s , of c e r t a i n e s t e r s of mono- and d i—glycer ides of food f a t t y a c i d s . These a r e :

( a ) A c e t i c a c i d e s t e r s ;

(b ) L a c t i c a c i d e s t e r s ;

( c ) C i t r i c a c i d e s t e r s ;

(d) T a r t a r i c a c i d e s t e r s ;

( e ) Mono and d i a c e t y l t a r t a r i c a c i d e s t e r s .

This wording h a s been i n t e r p r e t e d i n d i f f e r e n t ways i n v a r i o u s Member S t a t e s and t h i s has led

t o d i f f e r e n t a p p l i c a t i o n s of t h e D i r e c t i v e i n n a t i o n a l l e g i s l a t i o n .

One i n t e r p r e t a t i o n i s t h a t t h e s e mono- and d i - g l y c e r i d e s may only be e s t e r i f i e d with one of

t h e f i v e l i s t e d a c i d s a t a t i m e .

A second i n t e r p r e t a t i o n i s t h a t mono- and d i—glycerdies may be e s t e r i f i e d with one or any

combina t ion of t h e f i v e a c i d s l i s t e d above .

The f i r s t i n t e r p r e t a t i o n i s compl ica ted by t h e f a c t t h a t l a c t a t e , c i t r a t e , t a r t r a t e and

d i a c e t y l t a r t r a t e a l l have more t h a n one f u n c t i o n a l group which can t a k e p a r t i n e s t e r l i n k a g e s

- even though only one of t h e f i v e a c i d s i s used f o r e s t e r i f i c a t i o n . The same compl i ca t i on

a r i s e s f o r t h e second i n t e r p r e t a t i o n b u t , i n t h i s c a s e , t h e number of p o s s i b l e end -p roduc t s

can be even g r e a t e r when more t h a n one of t h e f i v e a c i d s i s used f o r e s t e r i f i c a t i o n .

OPINION ON THE CURRENT DESIGNATION FOR E 472

The Committee r e j e c t s t h e second i n t e r p r e t a t i o n and recommends t h a t t h e D i r e c t i v e be

re -worded so a s t o permi t only s p e c i f i c mono- and d i - g l y c e r i d e e s t e r s whether produced

from one or more t h a n one of t h e l i s t e d a c i d s . This means t h a t e s t e r s produced from one

of t h e a c i d s ( a ) - ( e ) above a r e cons ide red a c c e p t a b l e .

Other p r o d u c t s made from more t h a n one of t h e l i s t e d a c i d e w i l l have t o be cons ide red

i n d i v i d u a l l y on t h e i r m e r i t s . The Committee has only been asked t o c o n s i d e r t h e mixed

a c e t i c / t a r t a r i c a c i d e s t e r s .

* I n o r d e r t o a l i g n t h i s e a r l i e r r e p o r t wi th t h e formal p r e s e n t a t i o n of i t s p r e s e n t Report

on E m u l s i f i e r s , S t a b i l i z e r s , Th ickene r s and G e l l i n g Agen t s , t h e Committee wishes t o r e co rd

■foat i t does not ob je t t o t h e endorsement of t h e ADIs e s t a b l i s h e d by JECFA.

21

OPINION ON THE MIXED ACETIC/TARTARIC ACID ESTERS

The Committee was provided with the results of two long-term feeding studies using commercial

formulations based on the mixed acetic/tartaric esters, and with the composition of these

formulations. Mosinger (l) administered one formulation for 24 months to 15 male and 15

female Wistar rats at 5 g/kg body weight per day. The author reported normal growth rates,

no carcinogenic effect and no effects on reproduction and progeny over 2 generations.

Lang, Kieckebush and Griem (2) investigated another formulation reporting the LD^. for male

mice as greater than 20 g per kg body weight. Groups of 20 male and 20 female rats were

fed the substance in doses of 100 mg/kg body weight and 400 mg/kg body weight over a period

of 26 months. The authors reported no adverse effects in the rats with regard to growth,

food consumption, food efficiency, state of health, reproduction (two matings), survival and

gross and hi sto—pathology of the organs.

The toxicological data submitted, which relates to the same esters in two different

formulations, indicates that from the point of view of safety in use these esters are

comparable to substances already permitted by the Directive.

The Committee is therefore prepared to accept the specific inclusion of the mixed acetic/

tartaric acid esters on the Community list of emulsifiers, stabilisers, thickeners and

gelling agents for use in human food.

REFERENCES

1. Professor M. Mosinger

Effects of prolonged oral administrat ion of Τ 500 Puratos (unpublished report I965) .

I n s t i t u t de Médecine Légale et I n s t i t u t d'Hygiène Indus t r i e l l e et de Médecine du Travai l ,

Marsei l le 7

2. Lang Κ., Kieckebush W. and Griem W.

Long—term feeding t e s t s with baking aid Τ 500 S (unpublished report 1970).

Physiologish-Chemisches I n s t i t u t der Univers i t ä t , Mainz.

3 . Toxicological evaluation of some food colours , thickening agents , and ce r t a in other substances

FAO Nutr i t ion Meetings Report Series No. 55A WHO Food Additives Series No. 8 FA/OWHO Rome/Geneva 1975

t In order to align this earlier report with the formal presentation of its present Report

on Emulsifiers, Stabilizers, Thickeners and Gelling Agents, the Committee wishes to record

that it does not object to the endorsement of the ADI established by JECFA (3).

22

ANNEX 6 REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON PECTINS (E 440) (Opinion expressed February 1977)

TERMS OF REFERENCE

The Committee was asked to express an opinion on whether amidated pectin could be classified with "pectins" from the point of view of specifications and toxicology.

CONCLUSIONS

1. The Committee agreed that pectin and amidated pectin should be specified separately on the basis of present technological and toxicological evidence.

2. The Committee was prepared to accept a temporary ADI of 0—25 mg/kg body weight for amidated pectin provided that the results of further toxicological studies be received by I982. The Committee thought, that for it to be fully informed, these studies should include adequate reproduction, embryotoxicity and teratology studies in rats and an adequate long-term study in a rodent species preferably the rat.

3. The Committee endorsed the ADI "not specified" established by JECFA for non-amidated pectins,

BACKGROUND

The Council Directive on the approximation of the laws of Member States relating to emulsifers, stabilisers, thickeners and gelling agents for use in foodstuffs (74/329/EEC of 18 June 1974) authorises the use of "E 44O Pectins" (Annex ï). Article 7 of the Directive requires that the Council, acting unanimously on a proposal from the Commission, shall lay down specific criteria of purity for "Pectins". During discussions on these specifications, the Commission found that experts of certain Member States were reluctant to accept amidated pectin as falling within the designation "E 44O Pectins", partly for toxicological reasons and partly on the grounds that amidated pectin cannot be regarded as a "natural" pectin.

TECHNOLOGICAL INFORMATION (l)(2)(3)

Pectins are complex acidic polysaccharides which occur in varying amounts in plant cell walls and which have the ability to form gels with sugars plus acids. They are obtained by the extraction of plant materials (usually citrus fruits, apple pomace or sugar beet) with hot water or dilute acids and are concentrated by evaporation and sold as such, or dried, or recovered from extracts by precipitation with alcohol or salts of polyvalent metals, usually aluminium and then dried.

Pectins have for many years been used to improve the consistency of jellies, jams and marmalades prepared from fruits containing insufficient endogenous levels of pectins.

Pectins consist chiefly of the partial methyl esters of polygalacturonic acid and their calcium, potassium, sodium and ammonium salts. Normally pectinB contain 7 to 12 per cent methoxyl content by weight, implying that some 45 to 75 per cent of the carboxyl groups in the pectin are esterified. For gel formation with such pectins, sugar must be present in amounts of 50 per cent by weight or more and the pH must be below 3.5·

A major development has been the production of low-methoxyl pectins by partially de-methyl-ating normal pectins with acid, alkali or enzyme treatments. Methoxyl contents range from 2 to 7 per cent by weight. Low-methoxyl pectins require little or no sugar for gel formation and satisfactory gels can be prepared within a wide range of pH e.g. 2.5 to 6.5. They are however sensitive to high levels of calcium ions.

For amidated pectin partial de-methylation is achieved by the use of ammonia in alcoholic solution. Amidated pectin contains about 5 per cent of amide groups, which implies that about 20 per cent of the carboxyl groups have been amidated. Amidated pectins do not

2:i

however precipitate in the presence of high levels of calcium and can therefore be used in the production of milk—based products.

The Committee was informed that about 20 per cent of the pectin used commercially is of the low-*iethoxyl type (either amidated or non—amidated). The level of use is said to be about 0.3% for jams and jellies and up to 1% for other uses such as milk gels, fruit gels, ice cream, yogourt. The Committee was also informed that about 85—95% of all pectin is used in the production of jellies and jams.

TOXICOLOGICAL INFOMATION

The FAO/WHO Joint Expert Committee on Food Additives (JECFA) evaluated pectin in 1973 (4) and amidated pectin in 1975 (5). Though the evaluations differ - a temporary ADI of 0-25 mg/kg body weight for amidated pectin and an ADI "not specified" (ADI "not limited" in 1973)* for non—amidated pectins — JECFA have included both types within a single specification entitled "Pectin". (6)

In addition to the JECFA review, the Committee was provided with copies of the unpublished reports of Til, Seinen and de Groot (7), of Palmer, Jones and Abul Haj (8) and of Mosinger (9). The Committee was also provided with preliminary reports of long—term, teratology and reproduction studies on rats with pectin and amidated pectin now in progress in France (lO).

The Committee noted that in the studies by Til, Seinen and de Groot there was slight evidence that amidated pectin might be mere toxic to rats than ordinary pectins, in giving a slight degree of hyperkeratosis of the fore—stomach and increased leucocyte counts in femáis at dietary levels above 5 per cent, and more pronounced increases in caecum weights (7). Palmer, Jones and Abul Haj found no significant differences between rats fed pectin or amidated pectin for 2 years at dietary levels of 10 per cent (8). Mosinger administered amidated pectin in single doses of 100 mg/kg body weight daily to rats (approximately 0.2% in diet). There appeared to be no adverse effects at this low dietary level in comparison with available data from historical controls — no contemporary controls were used in the experiment (9). The results of these experiments were therefore difficult to interpret in a safety evaluation. The Committee was informed that no adverse effects had been noted in the study now in progress (lO). The Committee'agreed that neither of the completed long—term studies was adequate either in terms of number of animals used, levels fed or design of the experiments. The Committee was prepared to accept a temporary ADI of 0-25 mg/ kg body weight for amidated pectin provided that the results of further toxicological studies be received by I982.The Committee thought, that for it to be fully informed, these studies should include adequate reproduction, embryotoxicity and teratology studies in rats and an adequate long—term study in a rodent species preferably the rat. The Committee endorsed the ADI "not specified" established by JECFA for non-amidated pectins.

This te.™ was previously used by the JECFA Report of 1974.

24

REFERENCES

1, International Association of Pectin Producers

Evidence submitted to Commission,

2, Gum Technology in the Food Industry,

Martin Glicksman,

Academic Press, New York and London, I969.

3, Industrial Gums,

Editor, R.L. Whistler,

Academic Press, New York and London, 1973,

4, Toxicological Evaluation of Some Food Additives,

FAO Nutrition Meetings Report Series No. 53A,

WHO Food Additives Series No. 5, 1974. FAO/WHO, Rome/Geneva, 1974.

5, Toxicological evaluation of some food colours, thickening agents, and certain other

substances.

FAO Nutrition Meetings Report Series No. 55A,

WHO Food Additives Series No. 8, 1975,

FAO/WHO, Rome/Geneva, 1975.

6, Specifications for the identity and purity of some food colours, flavour enhancers,

thickening agents and certain other food additives,

FAO Nutrition Meetings Report Series No, 54B,

WHO Food Additives Series No, 7, 1976,

FAO/WHO, Rome/Geneva, 1976.

7, Sub—chronic (90 day) toxicity study with two samples of pectin in rats.

Til, H.P., Seinen W., and de Groot Α,Ρ., (

Unpublished Report No, R, 3843,

Centraal Institut voor Voedingsonderzoek TNO, 1972,

8, Two Year Pectin Feeding Study on Rats,

Palmer G.H,, Jones T.R,, and Abul Hajs S.K.,

Sunkist Growers Inc., 1974·

9, Effects of the prolonged oral administration of amidated pectin to rats,

Professor M, Mosinger,

Centre d'Explorations et de Recherches Médicales, Marseille, 1975·

10, Progress Report on long-term, teratology and reproduction studies on rats,

Professor M, Mosinger,

Centre d'Explorations et de Recherches Médicales, Marseille, November 1974·

2.1

ANNEX 7

Tragacanta (E 413)

Description

Tragacanth is considered to contain two primary constituents, bassorin and tragacanthin.

The lesser component, tragacanthin, is water soluble and contains 3 molecules of a

uronic acid and 1 molecule of arabinose, with a side chain of 2 molecules of arabinose.

The larger component, bassorin, which swells but is insoluble in water, has been shown to

contain polymethoxylated acids that yield tragacanthin upon demethoxylation,

A description and criteria of purity are specified in the EEC Directive 78/663/EEC.

Technological Application

Tragacanth has found application as a stabilizer in low pH salad dressings, as a thickener

and binder in confectionery, and as a stabilizer in ice—cream and essential oil emulsions.

Toxicological Evaluation

The Committee examined the available data which included preliminary metabolic studies,

short term studies in both the mouse and chicken, mutagenicity studies (host mediated assay,

cytogenetic studies and dominant lethal studies), teratogenicity studies in rats, mice,

hamsters and rabbits and studies on allergic response. The mutagenicity and teratogenicity

studies were all negative and showed no adverse findings. Nevertheless, because of the

absence of conventional 90 day and/or long term studies it was not possible to establish

an ADI, For that purpose a long term study is required,

Bachmann and Zbinden (l°78) carried out a special study to elucidate the mechanism of

action of tragacanth and a few other thickening agents (e.g. gum arabic) on cardiac function.

The authors studied dose levels ranging from 20 to 80 mg/kg body weight daily for a period

of 4 weeks on the biochemical functions of heart and liver mitochondria. The uncoupling

effect noted soon after administration disappeared during the second half of the experiment.

In the liver this uncoupling effect was moderate and progressive. The relevance of these

findings to human health should be studied more extensively before these findings can be

used in any evaluation of safety.

The Committee agreed to accept Tragacanth on a temporary basis for 5 years and expects to

receive the data requested within 4 years.

References

1. Brown, E.B., and Crepen, S.B., (1947) J. Allergy, 18(3), Ρ 214-5.

2. Fed.Reg., (1974), U.S. Fed.Reg., 39(l85), 28.9.1974, 34207.

3 . F rohbe rg Η . , O e t t e l Η . , and Z e l l e r Η . , ( l 9 6 9 ) , A r c h . T o x i c o l . , ρ 268-295 .

4 . Fujirnoto J . M . , ( 1965 ) , Tox .Appl .Pharmaco l . , 7_, p . 287-29Ο.

5 . G a l b r a i t h W,, Mayhew E . , and Roe E .M.F . , (1962) B r i t . J . C a n c e r , 1 6 , ( l ) , p . 1 6 3 - 1 6 9 .

6 . Gelfand H.H. , ( 1943 ) , J . A l l e r g y , I 4 , p . 203-219 .

7 . Gelfand H.H., ( 1949 ) , J . A l l e r g y , 2 0 ( 5 ) , P · 3 1 1 - 3 2 1 .

8 . R i c c a r d i Β .Α. , and Fahrenbach M . J . , ( I 9 6 5 ) , F e d . P r o c , 2 1 , ρ , 2 6 3 .

9 . Vohra P . , and K r a t z e r F . H . , ( 1 9 6 4 ) , P o u l t r y S o i . , ¿¡3(5), P . I I 6 4 - I I 7 O .

1 0 . Zawehry M.R., Fa t t a l i A.A. , and Bahnasawy M . A . , ( l 9 6 3 ) t I n d i a n J . Derm., 8 , p . 69

1 1 . Bachmann E . , and Zbinden G. , ( I 9 7 8 ) , A r c h . T o x i k o l . , Supp l . 1 , ρ , I 8 3 - I 8 7

2(i

Sodium and Potassium Polyphosphates (E 450c) Description

A desc r ip t ion and c r i t e r i a of pur i ty are specified in the EEC Directive 78/663/EEC.

Technol ogl cal App_l i cat i on

Sodium and potassium polyphosphates are used at l eve l s of 0.25-0.5% in various meat poultry and f i sh products . They are claimed t o contribute to colour, tenderness, ju ic iness and f lavour , and t o decrease cooking shrinkage. In sausages and s imilar meat products t h e i r use i s claimed t o increase the s t a b i l i t y of the fat emulsion and t o reduce the separation of fat during cooking. I t i s a lso claimed tha t polyphosphates afford some measure of microbial p ro tec t ion , p a r t i c u l a r l y against Gram posi t ive bac t e r i a .

Polyphosphates are used a lso in the processing of milk products, pa r t i cu l a r l y in the manufacture of processed cheese. At a level of about 3% in cheese processing they aid pH con t ro l , sequester calcium ions and act as emuls i f iers . They are also used at l eve l s from 0.02%-l% for milk ge l l ing preparations (such as ins tant puddings), for the s t ab i l i z a t i on of HTST s t e r l i z e d milk concentrate and tex ture s t ab i l i z a t i on of alginate-based ice-creams. Sodium polyphosphate also finds appl icat ion in coffee whiteners to s t a b i l i z e the milk pro te ins when the whitener i s added to hot l i q u i d s .

They are a l so used at varying leve l s in f r u i t and vegetable processing, where they act predominantly as séquestrants of t race amounts of heavy metals ( e . g . i ron, copper), t o enhance colour s t a b i l i t y and decrease oxidative spoilage.


The Committee had no objection t o t h e i r present use, as long as they complied with the ex i s t ing spec i f i ca t ion . I t endorsed the acceptable t o t a l dietary phosphorus load, established by JECFA, of 0—70 mg/kg bw. This estimate applies t o the sum of added phosphate and food phosphate. Acceptable dai ly intake leve l s of phosphate depend on the amount of calcium in the d i e t . The l eve l s s ta ted apply to d ie t s that are nu t r i t i ona l l y adequate with respect to calcium. However, i f the calcium intake were high, proport ionately higher intakes of phosphate xvould be acceptable, and the reverse r e l a t ion would also apply.

References

1. Toxicological Monographs Arising from the Fourteenth Meeting of the Joint FAO/WHO Expert Committee on Food Additives, WHO/Food Add/70.39, FAQ Nutri t ion Meetings Rep.Ser., No. 48A, (1970), p . 66.

2. Ivey F . J . , and Shaver K., (1977), J . Agric.Food Chem., 25.(2), p . 128-130

Microcrysta l l ine Cellulose (E 46O) - Powdered Cellulose Description

A de f in i t ion and c r i t e r i a of pur i ty are specified in the EEC Directive 78/663/EEC for microcrys ta l l ine ce l lu lose .


Microcrystalline/powdered cel lulose i s claimed to be pa r t i cu la r ly effective in affording s t a b i l i t y and melting res is tance to low solid products. Typical use l eve l s in food ere 5% in salad dress ings , 1.5% in whipped topping, 1.5% in synthetic cream, and 0.5%-1.5% in ice-cream.


The Committee agreed to endorse the ADI "not specified" established by JECFA but wished to be informed of any further work elucidating the problem of persorption. If any nevi findings became available the Committee would re-assess the scientific evidence. The Committee concluded that powdered cellulose could be considered toxicologically similar to microcrystalline cellulose and similarly acceptable for use in food, provided the specifications of these substances were comparable in all major respects.

References

1. Battista O.A., and Smith P.A., (1962) , Ind and Eng.Chem'., _5_4., p. 20

2. Toxicological Monographs Arising from the Fifteenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FAQ Nutrition Meetings Report Series, No. 50A, WHO Food Additives Series No 1, (1972), p. 8~3

3. Tusing T.W., Paynter O.E., and Battista O.A., (1964), Agric.Fd.Chem., 12, p. 284,

4. Hazlet on Laboratories Inc., Unpublished Report, (I963).

5. Hazleton Laboratories Inc., Unpublished Report, (1964)·

6. Hazleton Laboratories Inc., Unpublished Report, (1962).

7. Pahlke G., and Friedrich R., (1974), Naturwiss., 6l(2), p. 35

Carboxymethylcellulose (E 466) Description

A description and criteria of purity are specified in the EEC Directive 78/663/EEC


Carboxymethylcellulose is used as a stabilizer for frozen confectionery (e.g, ice—cream, sherbets, etc») to prevent ice crystal growth. It prevents syneresis in icings, meringues, jellies, pie fillings and in puddings. In cakes and other baked goods it finds application as a moisture retainer.


The Committee was of the opinion, that there were no toxicological reasons for specifying a limit to the molecular weight. The Committee endorsed the ADI established by JECFA.

References

1. Toxicological Evaluation of some Food Additives,including Anticaking Agents, Antimicrobials, Antioxidants, Emulsifiers and Thickening Agents, WHO Food Additives Series, (1974), No. 5«

Polyglycerol Esters of Fatty Acids (E 475) Description

A description and criteria of purity are specified in the Pirective 78/663/EEC.

28


Polyglycerol esters of fatty acids are used at a level of 0.5-3% in fats, oils, margarine

and fat emulsions. They are claimed to be satisfactory for gelling oils in order to

reduce the quantity of hard fats in a margarine blend. In addition they are claimed to

reduce spattering during frying and the tendency for margarine to weep or show exudation

on storage. This emulsifier is very important in bakery products, particularly for high

ratio cake recipes where it also facilitates aeration.

Polyglycerol esters of fatty acids are also used in chocolate and chocolate coatings at a

level of up to 1%. They afford improved fat plasticity, an emulsion stabilizing effect,

and an improvement in the formation of mousses. Anti-fat bloom properties are also claimed.

Toxicológica! Evaluation

An apparent discrepancy exists between the FAO/WHO JECFA specification and that included in

the EEC Directive. According to the FAO/WHO specification "no polyglycerols higher than

hexaglycerols should be present" whereas the EEC specification permits the presence of

not more than 10% polyglycerols equal to or higher than heptaglycerol. The possible

difference in composition between the product studied toxicologically and evaluated by

JECFA and the material characterised by the EEC criteria prompted the Committee to request

further details. The Committee has now been informed that the emulsifier has been

manufactured continuously by the same process and that progress in analytical techniques

was the sole reason for the difference. On the basis of this evidence the Committee

concluded that the toxicity data was obtained on material described by the EEC specification.

The Committee considered the toxicological data to be acceptable and endorsed the API of

0-25 mg/kg bw established by JECFA.

References

1. Toxicological Monographs arising from the Seventeenth Report of the Joint FAO/WHO Expert

Committee on Food Additives; FAQ Nutrition Meetings Report Series No. 53A, WHO Food

Additives Series, No. 5, (1974J, p. 24I.

2. Unilever Research Laboratory, Unpublished Report, (1966).

3. BabayanV.K., Kaunitz H., and SI anot ε CA., (1964), J. Amer.Oil Chem.Soc, 4I, p. 434-

4. Ostertag H., and Wurziger J., (1965), Arzneimittel-Forsch., 1¿, p. 869.

5. Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, FAQ Nutriti on

Meetings Report Series No. 53, WHO Technical Report Series No. 539, 0974), p. 20.

Propane-1,2-diol Esters of Fatty Aoids (E 477)

Description

Propane-1,2-diol Esters of Fatty Acids are used in powdered and liquid cake shortenings to

improve texture and volume in baked goods and to improve whippability and stability in

powdered desserts and whipped toppings. In icings they improve aeration and stability.


The Committee noted that the evaluation carried out on the substance by JECFA was based

primarily on the biochemical evidence that the compound is hydrolysed into fatty aoids and

propylene glycol. The JECFA assessment appears to have been made on a product which did

not contain appreciable quantities of dimer and trimer. The Committee was provided with a

summary of data from a thirteen week rat feeding study on propylene glycol monostearate

said to be produced by the propylene oxide route, with the implication that at least 4%

dimer and trimer would be present. These data lacked information on histopathology. The

Committee was unable to decide on the basis of this information, whether indeed dimer and

trimer were present in appreciable quantities.

2 (J

Tlie Committee decided: 1 . To endorse the ADI establ ished by JECFA for the compound containing l e s s than 0.5% dimer

and t r imer and t o accept temporarily for use in food, without es tab l i sh ing an ADI, the compound containing more than 0.5% t o 4% dimer and t r imer .

2 . A metabolic study on the f a t e of propylene glycol dimer and t r imer i s requi red .

3 . If fu l l réévaluat ion of the ra t study shows i t t o be unsa t i s fac tory another 90 day study would be required on the product containing more than 0.5% dimer and t r ime r . This , together with the metabolic study should be avai lable for assessment within two yea r s .

References

1. Toxicological Monographs a r i s ing from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Addit ives, FAQ Nutr i t ion Meeting Report Series No. 53A, WHO Food Additives Ser ies , No. 5, (1974), P· 505.

Sodium S tea roy l -2 - l ac ty la te (E 48I) Description

A descr ip t ion and c r i t e r i a of pur i ty are specified in the Directive 78/663/EEC.


Sodium s t ea roy l -2 - l ac ty l a t e has the a b i l i t y t o bond with both prote ins and s tarches and, unlike calcium s t e a r o y l - 2 - l a c t y l a t e , i t i s an effect ive emulsifier in water-oi l systems. This substance therefore f inds appl ica t ion as a dough condi t ioner /emulsif ier in h igh - fa t , yeast-leavened baked goods. I t s use at a level of about 0.5% (based on f lour weight) in baked goods, i s considered t o improve volume and keeping qua l i ty and to give a f i n e r , more uniform crumb. I t i s a l s o , at a level of about 0.5% used as an aera t ing agent in both diary and non-dairy whipped toppings and d e s s e r t s . I t has been used at a level of 0.2% in non—dairy coffee creamers where i t functions both as a surfactant and complexing agent .


The Committee endorsed the ADI establ ished by JECFA.

References

1. Toxicological Monographs a r i s ing from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, FAQ Nutr i t ion Meeting Report Ser ies , No. 53A, WHO Food Additives Series No. 5, (1974) p . 505

2. Hodge H.C., (1953), Unpublished Report dated 2 April 1953 submitted by C.J. Pa t te rson Co.

3 . Hodge H.C., (1955), Unpublished Report dated I7 June 1955 submitted by C.J. Pa t te rson Co,

Calcium Stea roy l -2 - lac ty la te (E 482) Description

A descr ip t ion and c r i t e r i a of pur i ty are specified in the EEC Direct ive 78/663/EEC.

Technological Applications

Calcium stearoyl-2—lactylate i s used at a level of 0,5% (based on f lour weight) i n y e a s t -leavened bakery products such as bread, buns, cakes, e t c , , and aleo in t h e i r respect ive ready—to—use mixes. As a component of the dough calcium stearoyl—2-lactylate ac ts in combination with gluten to give the dough grea ter tolerance to v i r t u a l l y a l l processing

'Mi

v a r i a b l e s , and thus contr ibutes t o the production of baked products of more uniform q u a l i t y . The use of t h i s substance i s considered to impart many desirable cha rac t e r i s t i c s to baked goods, such as more uniform overall qua l i ty , an improved volume, a f i ne r , more uniform gra in and t e x t u r e , a more tender crus t , and improved keeping p rope r t i e s . Calcium s t e a r o y l - 2 - l a c t y l a t e may also be used at a level of 0.5% as an egg-white whipping a id .


The Committee endorsed the ADI established by JECFA.

References

1. Toxicological Monographs a r i s ing from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FAQ Nutr i t ion Meetings Report Ser ies , No. 53A, WHO Food Additives Ser ies , NO. 5, (1974), p . 505.

2. Hodge H.C.,(1953), Unpublished Report dated 18 July 1953 submitted by C.J. Patterson Co.

3 . Wisconsin Alumni Research Foundation (1955), Unpublished Report submitted by C.J. Pat terson.

4 . Hodge H.C., (1956), Unpublished Report dated 7 November 1956 submitted by C.J. Patterson Co.

5. Hodge H.C., (1959), Unpublished Report dated 12 March I959 submitted by C.J. Pat terson Co.

6. Hodge H.C., ( i960) , Unpublished Report dated 2 August i960 submitted by C.J. Patterson Co.

7 . Hodge H.C., (1955), Unpublished Report dated I7 June 1955 submitted by C.J. Pat terson Co.

Karaya Gum Description

Karaya gum i s the dried exudate obtained from Stercul ia urens Roxburgh and other species of S te rcu l i a (fam. S tercul iaceae) , or from Cochlospermum gossypium A.P. De Condolle, or otner species of Cochlospermum Kunth (fam. Bixaceae).

I t i s a complex, p a r t i a l l y acetylated polysaccharide of extremely high molecular weight (Ca 9,500,000). Hydrolytic s tudies have yielded L-rhamnose, P-galactose and D-galacturonic acid i n an apparent molecular r a t i o of 4 :6 :5 . I t has an acid number varying from 13.4 t o 22.7 and tends t o re lease ace t ic acid e .g . on s torage. The Committee was informed that the mater ia l on the market conforms with the specif icat ion in the Food Chemicals Codex, 1.972, p . 423.


Karaya gum has uses based primarily upon i t s cold-water-swelling and suspending p roper t i e s . I t has been used at about 0.4% level as a s t a b i l i z e r for ice-cream and frozen drinks on s t i cks and at up to 1% level as a binder in sausage meat and bologna where i t provides water r e t en t ion and cohesive p roper t i e s , giving a f inal product with a smooth appearance. I t has also been used as a s t ab i l i z e r for whipped cream products, and i s used at up t o 0.8% in cheese spreads t o prevent water separation and increase the ease of spreading. Karaya gum has a lso been used as a s t a b i l i z e r in mayonnaise and French dressings where i t functions by increasing the v i scos i ty of the oil-water emulsion, thereby preventing or slowing separat ion .

Toxicological Evaluation^

The Committee considered that t h i s product was not acceptable for use in food on the bas is of ex i s t ing toxicological da ta . Establishment of an API would require at leant a metabolic study, a 90 day study in a rodent species and a long term study in an appropriate species . Bearing i n mind the t r a d i t i o n a l usage of t h i s substance in food, and provided the r e su l t s

of the metabolic and 90 day study become available within one year, the Committee would be prepared to reassess the present classification of this substance.

References

1. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additives Series (1974), No. 5, FAQ Nutrition Meetings Report Series, No. 53A, p. 324.

2. Extra Pharmacopoeia, Martindale, 25th Edition, The Pharmaceutical Press, London 1967·

Partial Polyglycerol Esters of Polycondensed Fatty Acids of Castor Oil Pescription

The product is a highly viscous liquid, consists of a complex mixture of partial esters of polyglycerol with linearly esterified fatty acids derived from castor oil and conforms to the general formula:

OR R- (0CHo - CH - CH„0) - R v 2 2 'n

where R=H or a fatty acyl group derived from polycondensed ricinoleic acid and n = degree of polymerisation of glycerol.

It is prepared by the esterification of condensed castor oil fatty acids with polyglycerol. The polyglycerol is made by heating glycerol under vacuum with a catalyst whilst the condensed acids are made by heating castor oil fatty acids in an inert atmosphere and have an average of about five fatty acid residues per molecule.

The polyglycerol moiety is predominantly di, tri- and tetra—glycerol. The Committee was informed that the toxicological evaluation was carried out on material conforming to the FAO specification.


Polyglycerol esters of polycondensed fatty acids of castor oil are used for the production of water oil emulsions and as such are suitable for use in the baking trade as tin—greasing emulsions at a maximum level of 50 parts per million. This emulsifier is also used in chocolate couverture (up to 0.3%) or in block chocolate (up to 0.4%) and it is claimed to be more effective than lecithin in lowering the viscosity of chocolate.


The Committee noted the development of hepatomegaly in the studies on rats fed a dietery level of 18% of the above compound and noted that this effect was reversible. Furthermore, histpathological studies failed to reveal any significant abnormalities in the enlarged livers. The observed hepatomegaly was not associated with hyperplasia. The Committee established an ADI of 7»5 mg/kg "bw.

References

1. Unpublished data submitted to UK Government by Unilever Ltd.

2. Toxicological Evaluation of Some Food Colours, Emulsifiers, Stabilizers, Anticaking Agents and certain other Food Additives. FAQ Nutrition Meetings Report Series No. 46A, p. 105, WHO/Food Add/7Q¿6.

3. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Food Additives Series, (1974), No. 5, FAQ Nutrition Meetings Report Series No. 53A, p. 246.

32

4. Jenkins F . P . , and Philp J.McL., ( l 9 6 i ) , Unpublished report of Unilever Research Labs. , submitted to FAO/WHO by Unilever Ltd.

5 . Watson W.C., and Gordon R.S . , (1962), Biochem.Pharmac,·11..p. 229,

6. Rutherford T. , and Jones P . , (1967), Unpublished report of Unilever Res. Labs. , submitted t o FAO/WHO by Unilever Ltd.

7 . Howes D., and James C.T., (1968), Unpublished report of Unilever Res. Labs. , submitted to FAO/WHO by Unilever Ltd.

% 8. Jenkins F.P., and Fnilp J.McL., (1968), Unpublished report of Unilever Res. Labs.,

submitted to FAO/WHO by Unilever Ltd. 9. Jenkins F.P. and Philp J.McL., (1967), Unpublished Report of Unilever Res. Labs.,

submitted to FAO/WHO by Unilever Ltd.

10. Wilson R., and Jenkins F.P», (1968), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

11. Kirkby W., et al, (l9ó9), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

12. Wilson R., Kirkby W., and Philp J.McL., (I967), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

13. Philp J.McL., and Jenkins F.P., (196I), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

14. Philp J.McL., et al, (I961), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

15. Wilson R., Kirkby W., and Ashmole R., (1967), Unpublished report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

16. Wilson R., Kirkby W., and Ashmole R«, (1967), Unpublished report of Unilever Hes. Labo., submitted to FAO/WHO by Unilever Ltd.

17· Gellatly J.B.M., and Jenkins F.P., (1968), Unpublished report of Unilever Hese Labs., submitted to FAO/WHO by Unilever Ltd.

18. Wilson R., Ashmole R., and Gellatly J.B.M., (1968), Unpublished Report of Unilever Res. Labs., submitted to FAO/WHO by Unilever Ltd.

19. Croger W,, Philp J.McL,, and Wilson R,, (1968), Unpublished report of Unilever Ren. Labs., submitted to FAO/WHO by Unilever Ltd.

Sorbitan Monopalmitate Sorbitan Monostearate Sorbitan Tristearate Sorbitan Monolaurate Sorbitan Mono—oleate Description

The sorbi tan es te r s of f a t t y acids consist of the pa r t i a l estero of sorbi to l and i t s mono-and di-anhydrides with palmit ic , s t e a r i c , l aur ic and oleic aoids . The;/ are prepared by the simple e s t e r i f i c a t i o n of food-grade sorbi tol with the appropriate food-grade f a t t y acid in the presence of an acidic catalyst at temperatures in the range 225-250°C, Under these conditions in t e rna l ether formation as well as e s t e r i f i ca t ion takes place.

The Committee was informed that the toxicological evaluations of sorbitan monopalmitate and sorbi tan t r i s t e a r a t e were carried out on material conforming to tue FAO spec i f ica t ions , in the case of sorbi tan monostearate on material conforming to the specif icat ions in the Food Chemicals Codex 1972, and in the case of sorbitan monolaurate and sorbitan mono-oleate on mater ia l s conformine: t o the specif icat ions in the Br i t i sh Pharmaceutical Codez 1972.

33


The sorbi tan es te r s of f a t t y acids are general ly insoluble or d i spers ib le in water and soluble in most organic so lven t s . These substances function both as emulsif iers and as anti-foaming· agents , they are p a r t i c u l a r l y useful for the production of water—in—oil emulsions.

They are used at l eve l s of 0.4 t o 1.0% as antibloom agents in chocolate and chocolate couverture and as b a t t e r aera t ing agents at l eve l s of 0.3% t o 0.4% in sponges, cakes and cake mixes.

The surface act ive proper t ies of the sorbi tan es te r s may be u t i l i s e d in a number of miscellaneous app l i ca t ions . In p a r t i c u l a r , they are used to supress foam i n l i qu id glucose/ sugar mixture or sucrose, and in the subsequent preparat ion of jams, preserves or boi led sweets. They are a lso used t o prevent foaming of meat curing br ines in modern high speed i n j e c t o r s . In each case the amount used i s small and residues in the f ina l product do not exceed 15-20 mg/kg.

In addi t ion , the sorbi tan e s t e r s are used t o s t a b i l i z e flavour emulsions intended for use in soft d r inks ; l eve l s in the f i na l product do not exceed I50 mg/l .


Sorbitan Monopalmitate / Sorbitan Monostearate / Sorbitan T r i s t e a r a t e : The Committee endorsed the global ADIs establ ished by JECFA of 25 mg/kg bw for a l l t h ree addi t ives s ingly or in combination, calculated as sorbi tan monolaurate.

Sorbitan Monolaurate / Sorbitan Mono-oleate: The Committee reviewed the s tudies of Krantz and two new short-term s t u d i e s . On t h i s evidence, the Committee establ ished a global ADI of 5 mg/kg bw for both addi t ives s ingly or in combintation, calculated as sorbi tan monolaurate.

References Sorbitan Monopalmitate 1. Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives; Wld.Hlth.Org.Techn.

Report Se r i e s , (1964), 281, FAQ Nutr i t ion Meetings Report Series No. 35, P« 11°.

2. Toxicological Monographs r e su l t i ng from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Addit ives, WHO Food Additives Series (1974), No. 5, FAQ Nutr i t ion Meetings Report Series No. 53A, p . 278,

3 . Krantz J .C. jn r , (1947), Unpublished report No. WER-149-126 t o the Atlas Chemical Co.

4 . Krantz J .C, j n r , , (1947), Unpublished report N o s . W E R - 1 4 9 - 1 7 1 / 2 0 1 / 2 3 2 / 2 3 2 A / 2 3 2 B t o the Atlas Chemical Co,

5 . Unpublished report of the Atlas Chemical Co.

6. Schwartz L , , Unpublished Report t o the Atlas Chemical Co,

7 . Unpublished report of the Atlas Chemical Co.

Sorbitan Monostearate 1, Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives; Wld,Hlth.Org.

Techn.Report Ser ies , (1964), 281, FAQ Nutr i t ion Meetings Report Series No. 35, p . 110

2. Toxicological Monographs r e su l t i ng from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additives Ser ies , (1974), No. 5, FAQ Nutr i t ion Meetings Report Scries No» 53A, P . 278.

34

3 . Kran tz J . C . j n r . , ( 1946 ) , Unpublished r e p o r t No. WER-149-102 t o t h e A t l a s Chemical Co.

4 . Brandner J . D . , ( 1973 ) , Unpublished r e p o r t submit ted t o FAO/WHO by ICI America I n c .

5 . Kran tz J . C . j n r . , ( 1951) , Unpublished r e p o r t No. WER-I49-315 t o t h e A t l a s Chemical Co.

6 . Kran tz J . C . j n r . , ( 1947 ) , Unpublished r e p o r t s Nos. WER-I49-I87/245/245A t o t h e A t l a s Chemical Co.

7 . B a r b o r i a c k J . J . , Kreh l W.A., Cowgill G.R., and Whedon A.D. , ( I P 5 9 ) , Unpublished r e p o r t No. WER-I49-454 t o t h e A t l a s Chemical Co.

8 . Kran tz J . C . j n r . , ( 1945) , Unpublished Repor ts t o t h e A t l a s Chemical Co.

9 . B u t t e r w o r t h K .R . , ( 1 9 7 7 ) , Unpublished Informat ion from BIBRA.

S o r b i t a n T r i s t e a r a t e

1 . Seventh Report of t h e J o i n t FAO/WHO Expert Committee on Food A d d i t i v e s ; Wld .Hl th .Org . Techn. Report S e r i e s , ( 1964 ) , 281 , FAQ N u t r i t i o n Meetings Report S e r i e s No. 35 , p . 110 .

2 . T o x i c o l o g i c a l Monographs r e s u l t i n g from t h e Seventeenth Report of t h e J o i n t FAO/WHO Exper t Committee on Food A d d i t i v e s , WHO Food A d d i t i v e s S e r i e s , (1974) , No. 5 , FAQ N u t r i t i » Meetings Report S e r i e s No. 53A, p . 278.

3 . Kran tz J . C . j n r . , ( 1947 ) , Unpublished r e p o r t No. WER-I49-I45 t o t h e A t l a s Chemical. Co.

4 . Kran tz J . C . j n r . , ( 1947 ) , Unpublished r e p o r t s Nos. WER-I49-I72/202/230/23OA/23OB t o t h e A t l a s Chemical Co»

5 . B a r b o r i a k J . J . , Krehl W.A., Cowgill G.R., and Whedon A . P . , (1959) , Unpublished r e p o r t No, WER-149-454 t o t h e A t l a s Chemical Co.

S o r b i t a n Monolaura te

1 . Kran tz J . C . j n r · , Unpublished r e p o r t t o t h e Atlan Chemical Co,

2 . Unpubl i shed r e p o r t of t h e A t l a s Chemical Co.

3 . Kran tz J . C . j n r . , Unpublished r e p o r t t o t h e A t l a s Chemical Co.

4« Kran tz J . C . j n r . , Unpublished r e p o r t t o t h e A t l a s Chemical Co.

5 . Kran tz J . C . j n r . , Unpublished r e p o r t t o t h e A t l a s Chemical Co.

6 . B a r b o r i a k J . J . , Krehl W.A., Cowgill G.R., and Whedon A.D. , (1959) , Unpublished r e p o r t No. WER-149-454 t o t h e A t l a s Chemical Co.

7 . B u t t e r w o r t h K.R. , Unpubl ished in fo rma t ion from BIBRA, March 1977.

S o r b i t a n Mono—oleate 1 . T o x i c o l o g i c a l Monographs r e s u l t i n g from t h e Seventeenth Report of t h e J o i n t FAO/WHO Expert

Committee on Food A d d i t i v e s ; WHO Food A d d i t i v e s S e r i e s , (1974) , No. 5; FAQ N u t r i t i o n Mee t ings Report S e r i e s No. 53A, p . 278

2 . K r a n t z J . C . j n r . , ( 1947 ) , Unpublished r e p o r t No. WER-149-150 t o t h e At lan Chemical Co.

3 . Quig ly A . B . , ( 1968 ) , Unpublished r e p o r t , "Span βΟ-Acute I n t r a v e n o u s T o x i c i t y i n R a t s " , , of t h e A t l a s Chemical Co.

4 . Kran tz J . C . j n r . , ( l 9 5 0 ) , Unpublished r e p o r t s Non. WER-I49-205/240/24OA/24OB t o t h e A t l a s Chemical Co.

5. Ingram A.J., Butterworth K.R., Gaunt I.F., Grasso P., and Gangolli S.D., (1977), Unpublished BIBRA Research Report No. 2,

Polyoxyethylene (20^ Sorbitan Monolaurate Polyoxyethylene (20) Sorbitan Monopalmitate Polyoxyethylene (20) Sorbitan Monostearate Polyoxyethylene (20) Sorbitan Tristearate

Description

The polyoxyethylene sorbi tan es te r s of f a t t y acids consist of the p a r t i a l e s t e r s of so rb i to l and i t s mono- and di-anhydrides with pa lmi t ic , s t e a r i c , l au r i c or ole ic ac ids , condensed with ethylene oxide.

Sorbitan es te r s of f a t t y acids are prepared by the e s t e r i f i c a t i o n of food-grade s o r i t o l with the appropriate food—grade ac id . These es te rs are then t r ea ted with ethylene oxide in the presence of an a lka l ine ca ta lys t at temperatures ranging from 130-170°C.

The Committee had avai lable the spec i f ica t ion in the Nutr i t ion Meeting Report Series No. 35, (1964), of FAO for polyoxyethylene (20) sorbi tan monopalmitate and the spec i f ica t ions in the Food Chemicals Codex 1972 for the other four polyoxyethylene sorbi tan e s t e r s .


Polyoxyethylene sorbi tan es te r s of f a t t y acids function primari ly as emuls i f ie rs , although they have appl ica t ion as softeners in bread, cakes and similar products . These substances are general ly soluble or d i spers ib le in water and d i f fer widely in t h e i r s o l u b i l i t i e s in organic so lven t s . They are p a r t i c u l a r l y effective in producing oil—in—water emulsions.

They are used ice-creams at a level of 0.04% t o improve tex ture and body. In chocolate and chocolate couverture they are used as antibloom agents at a level of 0.4 t o 1.0%, They are also used in non—vitamini sed margarines and fa t s for the baking and ca te r ing t r a d e s . In several appl icat ions these substances are used in conjunction with sorb i tan e s t e r s of f a t t y acids»


No s tudies other than those submitted to JECFA were avai lable to the Committee on these compounds. On t h i s basis the Committee establ ished a temporary ADI of 25 mg/kg bw, A metabolic study and a 90 day study in a rodent species are required within two yea r s .

The Committee noted tha t during the development of skin co—carcinogenicity t e s t s , some special polysorbates were used and had been found t o be weak promoters under these experimental condi t ions . I t concluded that these observations had no relevance t o the safety evaluation for food addit ive use of these substances.

References

Polyoxyethylene (20) Sorbitan Monolaurate 1. Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives; Wld.Hlth.Org.

Techn.Report Ser ies , (1964), 281; FAQ Nutr i t ion Meetings Report Series No. 35, p . I40 ,

2. Toxicological Monographs re su l t ing from the Seveneenth Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Food Additives Series (1974), No. 5, FAQ Nutr i t ion Meetings Report Series No. 5.3A, p . 254·

3 . Treon J . F . , Gongwer L.E. , Nelson M.F., and Kirschman J . C , Application of surface act ive substances p . 38I, Vol, I I I of Chemistry, Physics and Application of surface act ive substances, Gordon and Breach, New· York (1967).

4 . Krantz J .C. jnr», (194-3), Unpublished report No. WER-I24-88 t o the Atlas Chemical Co.

36

5 . K r a n t z J . C . j n r . , ( 1947) , Unpublished r e p o r t No. WER-149-123 t o t h e Ailan Chemical. Co.

Po lyoxye thy l ene (20) S o r b i t a n Monopalmitate

1 . Seventh Report of t h e J o i n t FAO/WHO Expert Committee on Food Adii l i v e s ; W l d . h l t h . O r g .

Techn. Report S e r i e s , ( 1964 ) , 2 8 l , FAQ N u t r i t i o n Meetings Report S e r i e s No. 3 5 , p . 140,

2 . T o x i c o l o g i c a l Monographs r e s u l t i n g from t h e Seventeenth Report of t h e J o i n t FAO/WHO Exper t Committee on Food A d d i t i v e s , WHO Food A d d i t i v e s S e r i e s ( 1974 ) , No. ^5, FAO Nul, r i t i on Meet ings Report S e r i e s No. 53A, p . 254.

3 . Treon J . F . , Gongwer L . E . , Nelson M . F . , and Kirschman J . C , A p p l i c a t i o n of s u r f a c e a c t i v o

s u b s t a n c e s , p . 3 8 I , V o l , I I I of Chemistry, Phys ics and A p p l i c a t i o n of nurfaoe a c t i v e

s u b s t a n c e s , Gordon and Breach, New York (1967 ) .

Po lyoxye thy lene (20) S o r b i t a n Monos teara te

1 . Seventh Report of t h e J o i n t FAO/WHO Expert Committee on Food A d d i t i v e s ; Wld .Hl th .Org .

Techn. Report S e r i e s , ( 1 9 6 4 ) , 281 ; FAQ N u t r i t i o n Meetings Report Se r i en No. 35 , p . 140.

2 . T o x i c o l o g i c a l Monographs r e s u l t i n g from t h e Seventeenth Report of t h e J o i n t FAû/WHO

Exper t Committee on Food A d d i t i v e s , WHO Food Add i t i ve s S e r i e s , (1974) , No«__2; FAQ N u t r i t i o n

Meet ings Report S e r i e s No. 53A, p . 254.

3 . Treon J . F . , Gongwer L . E . , Nelson M . F . , and Kirnchman J . C , A p p l i c a t i o n of s u r f a c e a c t i v e

s u b s t a n c e s , p . 3 8 1 , V o l . I l l , of Chemistry, Phys ics and A p p l i c a t i o n of s u r f a c e a c t i v e

s u b s t a n c e s , Gordon and Breach , New York, ( 1967 ) .

4 . Kran tz J . C . j n r . , ( 1947) , Unpublished r e p o r t s Nos. W E R - 1 4 9 - 1 6 4 / 1 9 3 / 2 3 5 / A / B t o t h e A t l a s

Chemical Co.

5 . K r a n t z , J . C . j n r . , ( 1949 ) , Unpublished r e p o r t No. WER-149-270/A/33 t o t h e A t l a s Chemical Co.

6 . Kran tz J . C j n r . , Unpublished Report t o t h e A t l a s Chemical Co.

7 . Kran tz J . C j n r . , Musser R . P . , and Knapp N, J* , (1952) , P r o c . S o o . E x p l . B i o l , and Med., 8 1 ,

p . 640 .

8 . D e l l a P o r t i G., T e r r a c i n i Β . , Dammert Κ . , and Shubik P . , ( i 9 6 0 ) , J . l l a t . C a n e . I n s t i . , j2J¿,

P . 573-605 .

Po lyoxye thy l ene (2θ) S o r b i t a n mono-olea te

1 . Seventh Report of t h e J o i n t FAO/WHO Expert Committee on Food Add i tves ; tfld.Hltn.Org.

Techn. Report S e r i e s , ( I 9 6 4 ) , 281 ; FAQ N u t r i t i o n Meetings Report Ser ien No... .3,5, p . 14-0.

2 . T o x i c o l o g i c a l Monographs r e s u l t i n g ' from t h e Seventeenth r e p o r t of t h e J o i n t FAO/WHO Kapert,

Committee on Food A d d i t i v e s , WHO Food Add i t ive S e r i e s , ( 1974 ) . No«. .5, FAQ n u t r i t i o n

Mee t ings Report S e r i e s No. 3.3A, p . 254.

3 . Treon J . F , , Gongwer L . E . , Nelson M.F . , and Kirschman J . C , A p p l i c a t i o n of nurfaoe a c t i v e

s u b s t a n c e s , p . 3 8 1 , V o l . I l l ' of Chemistry. Phys ics and A p p l i c a t i c i : of nurfaco a c t i v o

s u b s t a n c e s , Gordon and Breach, New York, (1967) ·

4 . Kran tz J . C . j n r . , ( 1946) , Unpublinhed r e p o r t n Non. WER-149-1.iO/l23/A/B t o t h e A t l a s

Chemical Co,

5 . Kran tz J . C . j n r . , ( 1943) , Unpublished r e p o r t No. WER-124-88 t o t h e Al lan Chemical Co.

6 . Kran tz J . C j n r . , ( 1947) , Unpublished r e p o r t No, WER-149-123 t o tho Allan Chemical Co.

7 . Dubos R . J . , ( 1949 ) , Unpublished d a t a , r e p o r t e d in record of h e a r i n g s or. d e f i n i t i o n and

s t a n d a r d f o r b r e a d . F . D . C Docket No. 3 l ( b ) , September 12 .

Polyoxye thy lene (20) S o r b i t a n T r i s t e a r a t e 1 . Seventh Report of t h e J o i n t FAO/WHO Exper t Committee on Food A d d i t i v e s , Wld .Hea l th .Org .

Techn.Repor t S e r i e s , ( 1 9 6 4 ) , 2 8 l , FAQ N u t r i t i o n Meet ings Report S e r i e s No. 3 5 , P · 140 .

2 . T o x i c o l o g i c a l Monographs r e s u l t i n g from t h e Seven teen th Report of t h e J o i n t FAO/WHO Exper t Committee on Food A d d i t i v e s , WHO Food A d d i t i v e s S e r i e s , ( 1 9 7 4 ) , No. 5 , FAQ N u t r i t i o n Meet ings Report S e r i e s No. 53A, p . 254·

3 . Treon J . F . , Gongwer L . E . , Nelson M . F . , and Kirschman J . C , ( 1967 ) , A p p l i c a t i o n of s u r f a c e a c t i v e s u b s t a n c e s , p . 3 8 I , V o l . I l l of Chemis t ry , Phys i c s and A p p l i c a t i o n of s u r f a c e a c t i v e s u b s t a n c e s , Gordon and Breach , New York.

4 . Kran tz J . C . j n r . , Unpubl ished Report No. WER-149-153 t o t h e A t l a s Chemical Co.

5 . Kran tz J . C . j n r . , Unpubl ished Report t o t h e A t l a s Chemical Co.

Po lyoxye thy lene (8) S t e a r a t e Po lyoxye thy lene (4P) S t é a r a t e

B e s c r i p t i o n

The p r o d u c t s a r e composed of p a r t i a l e s t e r s of s t e a r i c a c i d d e r i v e d from food f a t s and mixed po lyoxye thy l ene d i o l s .

The s t r u c t u r a l formulae of t h e p r i n c i p a l components a r e :

H0(CHoCHo0) H RC00(CHoCHo0) H RC00(CHoCHo0) OCR v 2 2 n v 2 2 n 2 2 n

f r e e po lyo l monoes ter d i e s t e r

Where RCOO i s t h e f a t t y a c i d moie ty and n h a s an average v a l u e of app rox ima te ly 7 . 5 i n t h e case of Po lyoxye thy lene (8) s t é a r a t e and 40 i n t h e case of Po lyoxye thy lene (40) s t é a r a t e . The Committee was informed t h a t t h e t o x i c o l o g i c a l e v a l u a t i o n s were based on m a t e r i a l s confom-ing t o t h e FAO s p e c i f i c a t i o n s .

Techno log ica l A p p l i c a t i o n

These two e s t e r s a r e used i n b r e a d , r u s k , b i s c u i t s and o t h e r baked foods t o improve s h e l f — l i f e .

T o x i c o l o g i c a l E v a l u a t i o n

The Committee reviewed t h e a v a i l a b l e d a t a i n exper imenta l an imals and e s t a b l i s h e d a t emporary API of 25 mg/kg bw f o r Po lyoxye thy lene (40) s t é a r a t e bu t t h e Committee r e q u i r e s a m e t a b o l i c s tudy and a 90 day s tudy i n a roden t s p e c i e s t o become a v a i l a b l e w i t h i n 2 y e a r s .

I n t h e case of Po lyoxye thy lene (8) s t é a r a t e , t h e Committee r e q u i r e s two s t u d i e s t o be a v a i l a b l e w i t h i n 4 y e a r s . One t o e l u c i d a t e t h e mechanisms of s tone f o r m a t i o n i n t h e u r i n a r y b l a d d e r , t h e o t h e r t o be a conven t i ona l long term s t u d y . I n t h e fo rmer , t h e Committee would expect t o r e c e i v e i n t e r i m r e p o r t s . Meanwhile, t h e Committee c o n s i d e r s t h e use of t h i s s u b s t a n c e t e m p o r a r i l y a c c e p t a b l e .

Refe rences_

1. Birkmeer R.L., and Brandner J.D., (1958), Agrie, and Food Chem., 6, p. 471.

2. Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives; Wld.Hlth.Org. Techn. Report Series, (1964), 281, FAQ Nutrition Meetings Report Series No. 35, p. 124.

3. Toxicological Monographs resulting from the Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Food Additives Series, (1974), No. 5, FAQ Nutrition Meetings Report Series No. 53A, p. 264.

38

4. Oler W.M., and CraemerV.C, (1955), Gastroenterology. 28, ρ. 2δ1.

5. Graham W.D., Teed Η., and Grice H.C., (1954), J . Pharmacol., 6, p . 534.

6. Graham W.D., and Grice U.C., (1955), J . Pharmacol.. J_, p . 126.

7 . Krantz J .C. j n r . , (1947), Unpublished report No. WER-149-122 to the Allan Chemical Co.

Glyceric Es ters of Fat ty Acids obtained from Soya Oil Oxidized under heat

Pescr ip t ion

The nomenclature in connection with commercially available mixtures i s complicated and the following c lasses have been suggested to the Committee by the manufacturers:

A. Oxidatively thermally polymerised Soya Bean Oi l .

B. Oxidatively thermally polymerised Soya Bean Oil interacted with mono- and d i -g lycer ides .

C. Oxidatively thermally polymerised Soya Bean Oil interacted with t r i g l y c e r i d e s .

I t was noted tha t in compound Β a small percentage of t r ig lyce r ides i s present .


The Committee was informed that mixtures f a l l i ng in to class A are used primarily in t in greasing emulsions and are excluded from the scope of the Directive 7 4 / 3 2 9 / E E C

Mixtures f a l l i n g in to classes Β and C are used as emulsifying and an t i -npa t te r ing agents in pa r t i cu l a r for protein containing margarine, ( e .g . those containing; milk sol ids in the aqueous phase) at a level of use of 0.3 to 0.5% (maximum).


The Committee was provided with a report of metabolic studies on mixtures of class Β in the r a t , guinea—pig and mouse. A specif icat ion has also been provided which l i m i t s , in pa r t i cu l a r , the temperature range for the polymerisation of the soya bean oil to between I90 and 200°C The Committee was unable to establ ish an API but agreed that mixtures of class Β could be temporarily acceptable for use in food, for 5 years . This will allow time for the completion of a 90-day study in the rat and a long term study in a rodent species .

References

1. Unpublished information submitted to the Commission of the European Communities through the Danish Government by Grindstedværket, Denmark, December 1977·

2. Toxicological evaluation of some enzymes, modified starches and cer ta in other substances; WHO Food Additives Series No. 2; FAQ Nutri t ion Meetings Report Scries Ho. 50A, ( l °72) ,

P. 67.

3 . Toxicological evaluation of some food addit ives including anticaking agento, ant i in i crobial η, an t iox idan ts , emulsifiers and thickening agents; WHO Food Additives Serien No. 5; FAQ Nutr i t ion Meetings Report Ser ies , No. 53A, (1974), P· 225

4 . Unpublished Report of the Br i t i sh Indus t r ia l Biological Research Association (BIBRA) (I97O), submitted to the Commission of the European Communities through the Danish Government by Grindstedværket, Denmark.

5. Dam, H., (1952), Unpublished Report submitted to the Commission of the European Communities through the Danish Government by Grindstedværket, Denmark.

6. Aaes-Jorgensen E. , Funch J . P . , Engel P .F . , and Dani Η., (1954), Unpublished Report submitted t o the Commission of the European Communities through the Danish Government by Grindstedværket, Denmark.

3v

7. Gyrd-Hansen N., and Rasmussen F . , (1968), Fd.Cosmet.Toxicol., 6, p . 163.

8. Harmsen Η., ( l 9 6 l ) , Unpublished report submitted t o the Commission of the European Communities through the Danish Government by Grindstedværket, Denmark.

Ghat t i Gum

Description

Ghatti gum i s an amorphous t ranslucent exudate of the Anogeissus l a t i f o l i a t r e e of the family Combretaceae. This i s a large t r e e found in the dry deciduous fo res t s of India and Ceylon. The gum exudate occurs in rounded t e a r s and ha.s a glassy f r a c t u r e . I t s colour va r ies from very l igh t brown t o dark brown with the l i g h t e r mater ia l y ie ld ing a b e t t e r grade of gum.

Ghatti gum i s bas ica l ly the calcium sa l t of an acidic polysaccharide, gha t t i c ac id . The purif ied acid has an equivalent weight reported t o be between 1340 and 1735, however more recent s tudies have indicated tha t gha t t i gum i s a heterogeneous polymer. Frac t ionat ion by alcohol ic p r e c i p i t a t i o n or by chromatographic separation on s i l i c a gels yielded three f rac t ions with equivalent weights of 1750, I8OO and 204O.

The Committee was provided with the speci f ica t ion for gha t t i gum l a id down in the UK Emulsifiers and S t ab i l i z e r s in Food Regulations 1975, S . I . 1975 No. i486.


Ghatti gum has been u t i l i s e d in foods as an effective emulsifier for o i l - in -water emulsions. In addi t ion, the gum acts as a natural buffer and small amounts of acid or a l k a l i wi l l not affect i t . I t has been used as an emulsifier and s t a b i l i z e r in maple syrups containing bu t te r for use on pancakes and waffles.


The Committee considered t h i s compound tox ico logica l ly unacceptable for use in food on the basis of ex i s t ing da ta . The compound should be phased out, unless a def in i t e assurance was received tha t within 4 years the following s tudies would be avai lable for assessment:

1 . Metabolic s tudies in 2 spec ies .

2 . 90—day s tudies in a rodent and non—rodent.

3 . A long—term study in the r a t ,

4 . Studies on the a l l e r g i c response, i f known, in animals and man.

5· Data on intake from food and other sources.

References

1. Elsworthy P.H., and George T.M., (1963), J . Pharm. Pharmacol., 1¿, p. 78I

Xanthan Gum

Description

Xanthan gum i s a high molecular weight ( 1,000,000) l i nea r polymer with a./D-linked backbone containing P-glucose, D-mannose, and D—glucuronic acid with one D-mannose s ide-chain uni t for every 8 sugar residues and one D-glucose side—chain for every 16 sugar r e s idues . The polysaccharide i s p a r t i a l l y acetylated and contains between 3,0 and 3.5% pyruvic ac id . The molar r a t i o D-glucose: D-mannose: D-glucuronic acid i s I . 4 : 1.0: 1.0.

to


Xanthan gum functions as a hydrophilic col lo id . Nether pH nor temperature have much effect on the v i s c o s i t y of solut ions of xanthan gum. I t i s soluble and stable in acid and alkal ine so lu t ions , and in solut ions containing high concentrations of various s a l t s . The gam i s soluble in hot or cold water and i s heat s t ab le , even at very high temperatures. Solutions of xanthan gum have extreme pseudoplast ic i ty (high v i scos i ty under low shear but low v iscos i ty under high shear) and high v i scos i ty at low concentrat ions.

I t i s used at up to approximately 0.5% in a var ie ty of foods such as sauces and salad dress ings , ins tan t puddings, milk drinks and dairy products.


The Committee was informed that the toxicological evaluation was carried out on material conforming with the FAO spec i f ica t ion . The Committee considered the avai lable tox ico logica l information to be adequate and endorsed the API established by JECFA of 10 mg/kg bw.

However, the Committee drew a t t en t ion to the fact that in i t s opinion a specif icat ion for Xanthan gum should also prescribe that no viable micro-organisms should be present and tha t the nitrogen content of Xanthan gum should be controlled by s t i pu l a t i ng , in the spec i f i ca t ion , a maximum nitrogen l e v e l .

References

1. Technical bulletin on "Keltral" (Xanthan gum), Kelco Co., San Diego, California, USA.

2. Toxicological Monographs resulting from the Eighteenth Report of the Joint FAO/WHO Export Committee on Food Additives, WHO Food Additives Series, (1975), No. 6, FAQ Nutrition Meetings Report Series No. 55, P« 155·

3. Booth A.N., Hendrickson A.P., and Beedo F., (1963), Toxicol.Appi.Pharmacol., 5, p. 478.

4. Gumbmann M.R., Research Report, (1964), "Metabolism of Carbon-14 Polysaccharide, B-1459, (Xanthan gum), by the Rat", of the Western Regional Research Laboratory, submitted to JECFA by Kelco Co., San Diego, California, USA.

5. Hendrickson A.P., and Booth A.N., Research Report (1964), "Supplementär;' Acute Toxicological Studies of Polysaccharide B-1459", of the Western Regional Research Laboratory, submitted to JECFA by Kelco Co., San Diego, California, USA.

6. Purloo R., Woodard M.W., and Woodard G., Research Report (1968), "Xanthan Cum, Acute Oral Toxicity to Rats" of the Woodard Research Corporation, submitted to JECFA by Kelco Co,, San Piego, California, USA.

7. Jackson N.N., Woodard M.W., and Woodard G., Research Report (1968), "Xanthan Gum, Acute Oral Toxicity to Pogs", of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Piego, California, USA.

8. Robbins D.J., Moulton J.E., and Booth A.N., (1964), Fd.Cosmet.Toxicol., 2, p. 545·

9. Booth A.N., and Moulton J.E., Research Report (1965), "Safety Evaluation of Polysaccharide B-1459 (Xanthan gum) in Laboratory Animals" of the Western Regional Research Laboratory, submitted to JECFA by Kelco Co., San Diego, California, USA.

10. Woodard G., Woodard M.W., McNeely W.H., Kovacs P., and Cronin M.T.I,, (1973), Toxicol. Appi.Pharmacol., 24, p. 30.

11. Howard D.J., Banerjee B.N., Woodard M.W., and Woodard G., Research Report (1968), "Xanthan Gum, Safety Evaluation by Oral Administration to Rats for IO4-IO5 weeks", of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

12. Banerjee B.N., Rav/lins G., Doneso J., Woodard M.W., and Woodard G., Research Report, (1968), "Xanthan Gum, Safety Evaluation by Oral Administration to Dogs for IO7 weeks", of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

13. Leigh C , Shaffer B.C., Woodard M.W., and Woodard G., Research Report (1968), "Xanthan Gum, Three Generation Reproduction Study in Rats, of the Woodard Research Corporation, submitted to JECFA by Kelco Co., San Diego, California, USA.

Extract of Qui11aia Description

Quillaia is the dried inner part of the bark of Quillaia saponaria Molina and of other species of Quillaia.

Quillaia extract is an aqueous extract of the dried inner part of the bark of Quillaia saponaria Molina and other species of Quillaia (Rosaceae) and contains three or possibly four saponins (tv;o major, one minor, one trace) constituting about 10% of the extract. The sugars glucose, galactose, arabinose, xylose, rhamnose and two further unidentified sugars are also present. The two major saponins are quillaia sapogenin which has a triterpenoid structure and quillaic acid.

The Committee was informed that the toxicological evaluation was carried out on natural extract of quillaia bark as specified in the British Pharmacopoeia 1973.


Quillaia extract is used in the soft drink industry to give a good head of foam in ginger beer, shandy, cream soda and lemonade. These products may contain up to 200 ppm of the dry matter content of the extract. The spray dried aqueous extract of quillaia bark is prepared in such a manner that 100 parts by weight of bark yield approximately 15 parts of spray dried extract.


The Committee considered in detail the composition of this product, its pharmacological properties, the source of the material, and the results of two long-term studies in the mouse and rat. For the spray-dried extract the Committee established an ADI of 5 mg/kg bw.

References

1. Vacek L . , and Sedlak B . , (1962), Gunma J.Med.Sci. , 11 , p . 1 .

2 . George A.J . , (1965), Fd.Cosmet.Toxicol., 3 , p . 85.

3 . Peterson D.A., ( l950) , J .Nu t r . , 42 , p . 597.

4 . Osor B.L. , (1966), Fd.Cosmet.Toxicol., 4 , p . 57.

5. Gaunt I . F . , Grasso P . , and Gangolli S.D., (1974), Fd.Cosmet.Toxicol., 12, p . 64I .

6. Butterworth K.R., (1977), The r e s u l t s of an 84 week study in mice with Qui l l a ia ex t r ac t , 'Unpublished information from BIBA, March 1977.

7 . Butterworth K.R., ( l °77 ) , The r e s u l t s of a long-term t o x i c i t y study of Qui l l a i a ext rac t in the r a t , Unpublished information from BIBRA, March 1977,

42

Lactylated Fa t ty Acid Esters of Glycerol and Propylene Glycol Descript ion

A mixture of p a r t i a l l a c t i c and f a t t y acid es te r s of propylene glycol (propane-1,2-diol) and glycerol produced by the l a c ty l a t i on of a product obtained by react ing edible f a t s or o i l s with propane-1,2-diol . I t va r i es in consistency from a soft so l id t o a hard, waxy s o l i d . I t i s d i spers ib le i n hot water and i s moderately soluble in hot isopropanol, benzene, chloroform and soya bean o i l .

The Committee was provided with a specif icat ion for lac ty la ted f a t t y acid es te rs of glycerol and propylene glycol from the Food Chemicals Codex 1972.


The l a c ty l a t ed f a t t y acid es te r s of glycerol and propylene glycol are used in cake shortenings t o improve tex ture and volume in the baked goods, in powder desser ts and whipped toppings t o improve whippability and s t a b i l i t y and in dessert mixes t o improve consistency and s t a b i l i t y of pudding and other s imilar products. The main use i s in whippable fat powders, which are used to make synthetic creams, desserts and dessert mixes.


The Committee was of the opinion that the speci f ica t ion should r e s t r i c t the content of propylene glycol dimers and t r imers t o a maximum of 0.5%. I t considered the compound temporari ly acceptable for use in food, but requested a metabolic study and a 90-day study in a rodent species within 2 years .

References

1 . Lactylated f a t t y acid es te rs of glycerol and propylene glycol , A Report Prepared for JECFA, 1973.

2 . Wolf C., Fancher O.E., and Calandra J .C . , (I967), Unpublished Report, "90 day Subacute Oral Toxicity of PGLS - Albino Rats" of Indus t r ia l Bio-Test Laboratories Inc.

3 . Baran J . , Fancher O.E., and Calandra J .C , , (1967), Unpublished Report, "90-day Subacte Oral Toxicity of PGLS - Beagle Dogs" of Indus t r ia l Bio-Test Laboratories Inc .

Dioctyl Sodium Sulphosuccinate Descript ion

Dioctyl sodium sulphosuccinate may be produced by es ter i fying maleic anhydride with 2-ethyl hexanol and t r e a t i n g the product with sodium hydrogen su lph i t e .

The Committee was informed that the toxicological evaluation was carr ied out on material conforming t o the FAO speci f ica t ion , 1975»


I t has been claimed tha t dioctyl sodium sulphosuccinate (OSS) has useful proper t ies in the food industry as a so lub i l i ze r for various hard-to-wet substances. These include fumarie acid and various natural and synthet ic gums which form hydrophilic co l lo id s . Applications of DSS t o powdered mater ia ls at l eve l s of about 0.5% by weight causes marked changes in the s o l u b i l i t y cha rac t e r i s t i c s of the mate r ia l s .

I t i s used as a processing aid in the sugar industry . DSS i s also used as a flavour and. aroma modifer. When used at leve ls of about 10 ppm in the f ina l food, many t a s t e q u a l i t i e s are a l t e r e d , e .g . c i t r u s flavours are enhanced. At t h i s lov; level the b i t t e r t a s t e of DSS i t s e l f i s not de tec tab le . This b i t t e r t a s t e i s a se l f - l imi t ing factor which would not normally allow quan t i t i e s grea ter than 50 ppm DSS to be used in food and s t i l l give a. pa la tab le produce.

43


Tho Committee establ ished a temporary API of 0,1 mg/kg bw. The r e s u l t s of a long-term study in a rodent species are required within a period, of 4 yea r s .

References

1. Technical Bulletin on "Complemix" (Dioctyl sodium sulphosuccinate) supplied by the

American Gyanamid Company.

2. Toxicological Monographs resulting from the Eighteenth report of the Joint FAO/WHO Expert

Committee on Food Additives; FAQ Nutrition Meetings Report Series Ho. 55. WHO Food

Additives Series No. 6, (l°76), p. 175»

3. Taylor R.E., (1966), Unpublished Report from Harris Laboratories, submitted to JECFA.

4. Fitzhugh O.G., and Nelson A.A., (1948), J.Am.Pharm.Assoc., 37. Ρ» 29.

5. Benaglia A.E., Robinson E.J., Utley E., and Gleverdon M.A., (1943), J.Ind.Hyg.Tox., 25,

P. 175.

6. Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives; FAQ Nutrition

Meetings Report Series No. 54, WHO Technical Report Series No. 557. Ρ« 24,

7. Moffat R.E., Kramer L.L., Lerner D., and Jones R,, (1975), Can. J. Comp.Med., 39, P. 434.

Ammonium Phosphatides

Description

Ammonium phosphatides consist essentially of a mixture of the ammonium salts of phosphatidic

acids derived from edible fat (usually partially hardened rapeseed oil). They are similar

in composition to commercial lecithins and consist of approximately 60% phospholipids and

40̂ 0 unreacted triglyceride.

The Committee was informed that the material toxicologically evaluated for use in foodstuffs

conforms to the manufa.cturer's specification and may be described as a mixture of ammonium

salts of phosphatidic acids derived from rapeseed oil, with a proportion of triglycerides

from the partially—hardened oil. The impurities did not exceed 0.2% water, 2.5% matter

insoluble in light petroleum (b.p. 40-60°C), 0.2% inorganic matter insoluble in light

petroleum (b.p, 40—60°c), 42% unreacted triglyceride, 3.0—3.4% phosphorus, 2.5 ppm arsenic,

2 ppm lead and 2 ppm copper; the pH of the mixture was between 6 and 8.


Ammonium phosphatides are used principally in the manufacture of chocolate at a level of

approximately 0.5%.


The Committee established an API of 30 mg/kg bw.

References

1. Bradford L., (1976), International Fragrances and Flavours, p. I77.

2. Toxicological Monographs resulting from the Eighteenth Report of the Joint FAO/WHO Expert

Committee on Food Additives} FAQ Nutrition Meetings Report Series No. 55; WHO Food

Additives Series No. 6, (l976j¡

U

3 . Frazer A.C., ( l954) , Unpublished report submitted to JECFA.

4 . Feuer G., (1967), Fd.Cosmet.Toxicol., ¿ , p . 631.

5. Gaunt I . F . , Grasso P . , and Gangolli S.B., (1967), F.d.Conmet.Toxicol., ¿ , p . 623.

6. Branton P.G., Gaunt I . F . , Hardy J . , Grasso P . , and Gangolli S.B., (1973), Fd.Comnet. Toxicol . , 11 , p . 755.

7 . Ph i l ips J . C , Gaunt I . F . , and Gangolli S.D., (1975), Fd.Cosmet.Toxicol., 13, p . 23.

8 . Unpublished Report No. 123/l/75 from BIBRA to Cadbury Ltd . , Bournville, England, 1975·

i.l

European Communities — Commission Reports of the Scientific Committee for Food Seventh series

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The Scientific Committee for Food was established by Commission Decision 74/234/EEC of 16 April 1974 (OJ No. L 136 of 20.5.1974 page 1) to advise it on any problem relating to the protection of the health and safety of persons arising from the consumption of food, and in particular the composition of food, processes which are liable to modify food, the use of food additives and other processing aids as well as the presence of contaminants.

The Members are independent persons, highly qualified in the fields associated with medicine, nutrition, toxicology, biology, chemistry, or other similar disciplines.

The present series relates to opinions on certain aspects of the Directive on Emulsifiers, Stabilizers, Thickeners and Gelling Agents for use in Foodstuffs (74/329/EEC of 18 June 1974, OJ L 189 of 12.7.1974, p. 1), in particular the acceptability, from the point of view of safety in use, of substances listed in Annex II of the Directive.

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