S.I. No. 78/1994 - Health (Emulsifiers, Stabilisers, Thickeners and Gelling Agents in Food) Regulations, 1994.


S.I. No. 78 of 1994.

HEALTH (EMULSIFIERS, STABILISERS, THICKENERS AND GELLING AGENTS IN FOOD) REGULATIONS, 1994.

In exercise of the powers conferred on the Minister for Health, by sections 5 and 59 of the Health Act, 1947 (No. 28 of 1947), and section 54 of that Act as amended by the European Communities ( Health Act 1947 ), Amendment of Sections 54 and 61) Regulations, 1991 (S.I. 333 of 1991), and section 38 (3) of the Health Act, 1953 (No. 26 of 1953), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1993 ( S.I. No. 62 of 1993 ), I, WILLIAM O'DEA, Minister of State at the Department of Health and after consultation with the Minister for Enterprise and Employment and the Minister for Agriculture, Food and Forestry, hereby make the following Regulations:—

PART I PRELIMINARY AND GENERAL

1. These Regulations may be cited as the Health (Emulsifiers, Stabilisers, Thickeners and Gelling Agents in Food) Regulations, 1994.

2. These Regulations shall come into operation on the 11th day of April, 1994.

3. (1) In these Regulations, unless the context otherwise requires— "the Act" means the Health Act, 1947 ;

"appropriate description" means, as respects any permitted emulsifier or permitted stabiliser, a name or description or a name or description sufficiently specific in each case, to indicate to an intending purchaser the true nature of the permitted emulsifier or permitted stabiliser to which it is applied;

"authorised officer" means an authorised officer for the purposes of Part IX of the Act;

"bread" includes the following and any part of the following — baps, breadrolls, fancy bread, milk bread, malt bread and fruit bread;

"cheese spread" means cheese which has been melted and mixed with milk products other than cheese with or without the addition of emulsifying salts;

"processed cheese" means cheese which has been subjected to a process of melting and mixing with or without the addition of emulsifying salts;

"soft cheese" means cheese which is readily deformed by moderate pressure but does not include whey cheese, processed cheese or cheese spread and any reference to soft cheese includes a reference to cream cheese or curd cheese;

"whey cheese" means the product obtained by

(i) concentrating whey with or without the addition of milk and milk fat and moulding such concentrated whey, or

(ii) coagulating whey with or without the addition of milk and milk fat;

"container" includes any form of packaging of food and any wrapper or band;

"cream" means that portion of milk rich in milk-fat which has been separated by skimming or otherwise;

"emulsifier, stabiliser, thickener and gelling agent" mean, respectively, any substance which, when added to a food, is capable—

(a) in the case of an emulsifier, of aiding the formation of, and in the case of a stabiliser, of maintaining a uniform dispersion of two or more immiscible substances;

(b) in the case of a thickener, of increasing its viscosity; and

(c) in the case of a gelling agent, of giving it the consistency of a gel;

but do not in any case include:—

(i) any natural food substance;

(ii) products containing pectin and derived from dried apple pomace or dried peel of citrus fruits, or from a mixture of both, by the act ion of dilute acid followed by partial neutralization with sodium or potassium salts;

(iii) caseins and caseinates;

(iv) proteins, protein concentrates and protein hydrolysates;

(v) starches, whether modified or not;

(vi) normal straight chain fatty acids derived from food fats;

(vii) acids, bases and salts which, when added to a food during the process of manufacture, change or stabilise the Ph;

(viii) any substance, the use of which is permitted under Regulations, other than these Regulations, for the time being in force under Part V of the Act, with the exception of lecithin, potassium orthophosphates, sodium orthophosphates, calcium orthophosphates, potassium pyrophosphate, sodium pyrophosphate, sodium acid salt of pyrophosphoric acid and sodium tripolyphosphate.

"Food Chemicals Codex 1972", "First Supplement, 1974" and "Second Supplement, 1975" mean, respectively, the second edition of the Food Chemicals Codex published in 1972, the First Supplement to that edition published in 1974 and the Second Supplement to that edition published in 1975, in each case, by the National Academy of Sciences, Washington D.C., United States of America;

"food" has the meaning assigned to it in Part V of the Act;

"natural food substance" means any substance, suitable for use as food and commonly used as food, which is wholly a natural product, whether or not that substance has been subjected to any process or treatment, and includes malt extract and glucose syrup but does not include edible gums;

"permitted emulsifier" and "permitted stabiliser" mean, respectively, any emulsifier and any stabiliser in Part I of Schedule I which complies with the specific purity criteria in relation to that emulsifier or stabiliser referred to in part II of that Schedule and, so far as is not otherwise provided in any such specific purity criteria, with the general purity criteria in Part III of that Schedule, and includes any mixture of two or more such emulsifiers or stabilisers or emulsifiers and stabilisers;

"sell" includes supply, offer or expose for sale or have in possession for sale and cognate words shall be construed accordingly;

"specified food" means any food of a description specified in Column 1 of Part I or Part II of Schedule 2.

(2) Any reference in these Regulations to an emulsifier or stabiliser shall be construed as including a reference to a thickener or gelling agent.

(3) Unless a contrary intention is expressed, all proportions mentioned in these Regulations are proportions calculated by weight of the product as manufactured, prepared, imported, distributed or sold.

(4) Any reference to a label borne on a container shall be construed as including a reference to any legible marking on the container.

(5) For the purposes of these Regulations, the supply of food, otherwise than by sale, at, in or from any place where food is supplied in the course of a business, shall be deemed to be a sale of that food.

(6) Any reference in these Regulations to an owner or to a person responsible for food shall, in the case of food purchased from a vending machine, be construed as a reference—

( a ) where the name and address of the proprietor is stated on the machine and such address is in the State, to the proprietor of the machine;

( b ) in other cases, to the occupier of the premises at or on which the machine stands or to which it is affixed.

(7) Any reference in these Regulations to any other Regulations shall be construed as a reference to such Regulations as amended by subsequent Regulations.

(8) Any reference in these Regulations to a numbered article or schedule shall, unless the reference is to an article or schedule of specified Regulations, be construed as a reference to the articles or schedules bearing that number in these Regulations.

4. These Regulations shall be enforced and executed by health boards in their functional areas.

5. (1) Where a sample of any food has been certified under the Health (Official Control of Food) Regulations, 1991 ( S.I. No. 332 of 1991 ) not to comply with these Regulations, an authorised officer may seize, remove and detain such food as being food which is unfit for human consumption.

(2) With the consent in writing of the owner or person responsible for such food, an authorised officer may destroy or otherwise dispose of it so as to prevent its use for human consumption.

(3) An authorised officer who has seized any food in pursuance of this article may, on giving notice in writing to the owner or person responsible for such food of his intention to do so, apply to a Judge of the District Court for an order directing that such food be destroyed or otherwise disposed of as being food which is unfit for human consumption.

(4) A Judge of the District Court to whom the application is made for an order under sub-article (3) of this article shall, if satisfied that such food does not comply with these Regulations, order that it be destroyed or otherwise disposed of after such period, not exceeding fourteen days, as may be specified in such order, as being food which is unfit for human consumption and an authorised officer shall destroy or dispose of it accordingly.

6. A person shall give to any authorised officer all reasonable assistance that the officer may require in the performance of his duties under these Regulations and such assistance shall include the giving of information in relation to the composition and use of any food and the identity of the person from whom or the place from which any such food has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has otherwise been disposed of.

7. In any proceedings for an offence under these Regulations, it shall be a defence for the person charged to show that the food in respect of which the offence is alleged to have been committed was intended for export and complied with the domestic food legislation of the importing country relevant to the alleged offence.

PART II. SALE, DISTRIBUTION AND IMPORTATION OF FOOD CONTAINING EMULSIFIERS AND STABILISERS.

8. (1) Subject to the provisions of these Regulations no food which is manufactured, prepared, imported, distributed, or sold shall contain any added emulsifier or added stabiliser other than a permitted emulsifier or a permitted stabiliser.

(2) Subject to sub-article (4) of this article any specified food described in Column 1 of Part 1 of Schedule 2, but no other food, which is manufactured, prepared, imported, distributed or sold, may contain any permitted emulsifier or permitted stabiliser of the description and in the proportion specified in relation thereto in Column 2 and Column 3 respectively, of that Part of that Schedule.

(3) Subject to sub-article (5) of this article any specified food described in Column 1 of Part II of Schedule 2 which is manufactured, prepared, imported, distributed or sold may, subject to the provisions of the footnote to that Part, contain any permitted emulsifier or permitted stabiliser of the description and in the proportion specified in relation thereto in Column 2 and Column 3, respectively, of that Part of that Schedule, and any such specified food shall contain no other permitted emulsifier or permitted stabiliser.

(4) ( a ) Nothing in sub-articles (2) and (3) of this article shall prohibit the presence in or on any food, which contains any specified food as an ingredient, of any permitted emulsifier or permitted stabiliser of the description specified for, and in the amount appropriate to the quantity of that specified food in accordance with the said sub-articles.

( b ) Notwithstanding the provisions of paragraph (a) of this sub-article, where, by reason of the use of a tin-greasing emulsion in its preparation, any food contains—

(i) the permitted emulsifier oxidatively polymerised soya bean oil, that permitted emulsifier shall be present in a proportion not exceeding 50 milligrams per kilogram;

(ii) the permitted emulsifier polyglycerol esters of dimerised fatty acids of soya bean oil, that permitted emulsifier shall be present in a proportion not exceeding 20 milligrams per kilogram.

(5) Nothing in sub-article (3) of this article shall prohibit the presence in or on any bread, by reason of the use of a tin-greasing emulsion in its preparation, of any permitted emulsifier or permitted stabiliser not specified in the proviso to the preceding sub-article or in Column 2 of item (a) of Part II of Schedule 2 in a proportion not exceeding 50 milligrams per kilogram.

(6) No flour, intended for sale for human consumption, shall contain any emulsifier or stabiliser.

(7) Subject to the exception made in Part II of Schedule 2 for whipping cream or whipped cream which is sold, consigned or delivered to a manufacturer for the purposes of his manufacturing business or to a caterer for the purposes of his catering business no cream when sold as such shall contain an emulsifier or stabiliser.

(8) The emulsifiers listed in Part 1, Schedule 1 of these Regulations under serial numbers E407 and E440 may contain one or more of the sugars as defined in the Food Standards (Certain Sugars) (European Communities) Regulations 1975 ( S.I. No. 118 of 1975 ).

(9) A person shall not manufacture, prepare, import, distribute or sell any food which does not comply with these regulations.

PART III. SALE, ADVERTISEMENT AND LABELLING OF EMULSIFIERS AND STABILISERS.

9. (1) The package or container in which any permitted emulsifier or permitted stabiliser, either alone or in combination with any other substance, is imported, distributed or sold for use as an ingredient in the manufacture or preparation of food, shall bear a label containing the information specified in Schedule 3.

(2) A person shall not sell any permitted emulsifier or permitted stabiliser which does not comply with these Regulations.

(3) A person shall not publish any advertisement of any permitted emulsifier of permitted stabiliser for sale for use as an ingredient in the preparation of food, which bears or includes any words, device or description calculated to indicate either directly or indirectly that emulsifier or stabiliser is a nutritive substitute for fat or eggs.

PART IV. AMENDMENTS AND REVOCATIONS.

10. The Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) Regulations, 1980 ( S.I. No. 35 of 1980 ), the Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents) (Amendment) Regulations, 1982 ( S.I. No. 273 of 1982 ), the Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) (Amendment) Regulations, 1985 ( S.I. No. 186 of 1985 ), the Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) (Amendment) Regulations, 1990 ( S.I. No. 102 of 1990 ), and the Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) (Amendment) Regulations, 1992 ( S.I. No. 24 of 1992 ) are hereby revoked.

SCHEDULE I.

PART I.

PERMITTED EMULSIFIERS AND PERMITTED STABILISERS.

Name of Emulsifier or Stabiliser

Serial Number

1

2

Lecithins

E 322

Sodium orthophosphates

E 339

Potassium orthophosphates

E 340

Calcium orthophosphates

E 341

Alginic acid

E 400

Sodium alginate

E 401

Potassium alginate

E 402

Ammonium alginate

E 403

Calcium alginate

E 404

Propane-1,2—diol alginate

E 405

Agar

E 406

Carrageenan

E 407

Locust bean gum

E 410

Guar gum

E 412

Tragacanth

E 413

Acacia or gum arabic

E 414

Zanthan gum

E 415

Karaya gum or sterculia gum

E 416

(i) Sorbitol

E 420

(ii) Sorbitol syrup

E 420

Mannitol

E 421

Glycerol

E 422

Polyoxyethylene (20) sorbitan monolaurate or polysorbate 20

E 432

Polyoxyethylene (20) sorbitan monooleate or polysorbate 80

E 433

Polyoxyethylene (20) sorbitan monopalmitate or polysorbate 40

E 434

Polyoxyethylene (20) sorbitan monostearate or polysorbate 60

E 435

Polyoxyethylene (20) sorbitan tristearate or polysorbate 65

E 436

(i) Pectin

E 440

(ii) Amidated pectin

E 440

Ammonium phosphatides or Emulsifier YN

E 442

(i) diSodium dihydrogen diphosphate or sodium acid salt of pyrophosphoric acid

E 450 (a)

(ii) triSodium diphosphate or sodium pyrophosphate

(iii) TetraSodium diphosphate or tetraSodium pyrophosphate

(iv) tetraPotassium diphosphate or potassium pyrophosphate

(i) pentaSodium triphosphate or sodium tripelyphosphate

E 450 (b)

(ii) pentaPotassium triphosphate

(i) sodium polyphosphate

E 450 (c)

(ii) potassium polyphosphate

(i) Microcrystalline cellulose

E 460

(ii) Powdered cellulose

E 460

Methylcellulose

E 461

Hydroxypropylcellulose

E 463

Hydroxypropylmethylcellulose

E 464

Ethylmethylcellulose

E 465

Carboxymethylcellulose

E 466

Sodium, potassium and calcium salts of fatty acids

E 470

Mono and diglycerides of fatty acids

E 471

Acetic acid esters of mono- and diglycerides of fatty acids

E 472 (a)

Lactic acid esters of mono- and diglycerides of fatty acids

E 472 (b)

Citric acid esters of mono- and diglycerides of fatty acids

E 472 (c)

Tartaric Acid esters of mono- and diglycerides of fatty acids

E 472 (d)

Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids

E 472 (e)

Mixed acetic/tartaric acid esters of mono and diglycerides of food fatty acids

E 472 (f)

Sucrose esters of fatty acids

E 473

Sucroglycerides

E 474

Polyglycerol esters of fatty acids

E 475

Partial polyglycerol esters of polycondensed fatty acids of castor oil (polyglycerol polyricinoleate)

E 476

Propane-1, 2—diol esters of fatty acids

E 477

Oxidatively polymerised soya bean oil

E 479a

Polyglycerol esters of dimerised fatty acids of soya bean oil

E 479b

Sodium Stearoyl-2—lactylate

E 481

Calcium stearoly-2—lactylate

E 482

Stearyl tartrate

E 483

Sorbitan monostearate

E 491

Sorbitan tristearate

E 492

Sorbitan monolaurate

E 493

Sorbitan mono-oleate

E 494

Sorbitan monopalmitate

E 495

Restriction on use.

Restricted to the use of an amount not in excess of that required in accordance with good manufacturing practice, unless otherwise specified in these Regulations.

SCHEDULE I.

PART II.

SPECIFIC PURITY CRITERIA FOR PERMITTED EMULSIFIERS AND STABILISERS.

E 322 Lecithins.

Chemical Description

Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs. The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides.

Description

Brown liquid or viscous semi-liquid or powder.

Content

Not less than 60 per cent substances insoluble in acetone.

Volatile Matter

Not more than 2 per cent determined by drying at 105°C for 1 hour.

Substances insoluble in Toluene

Not more than 0.3 per cent.

Acid Number

Not more than 35mg potassium hydroxide per gramme.

Peroxide number

Equal to or less than 10, expressed as milliequivalents per kg.

E 339 A Monosodium orthophosphate.

Chemical Description

Monosodium monophosphate; acid monosodium monophosphate; monosodium orthophosphate; monobasic sodium phosphate; NaH2PO4; the substance is available commercially in anhydrous or hydrated form with 1 or 2 molecules of water.

Description

Slightly deliquescent white powder, crystals or granules.

Content

Not less than 97 per cent NaH2PO4 on a volatile matter-free basis.

Volatile Matter

Determined by drying at 60°C for 1 hour and then at 105°C for 4 hours

— anhydrous: not more than 2 per cent.

—with 1 molecule of water:

not more than 15 per cent.

—with 2 molecules of water:

not more than 25 per cent.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 339B Disodium orthophosphate

Chemical Description

Disodium monophosphate; secondary sodium phosphate; disodium orthophosphate; acid disodium phosphate; Na2HPO4. The substance is available commercially in anhydrous form or as a hydrate with 2, 7 or 12 molecules of water.

Description

—Anhydrous: white hygroscopic powder with 2 molecules of water: white crystalline solid,

—with 7 molecules of water: granular powder or white efflorescent crystals,

—with 12 molecules of water: white efflorescent powder orcrystals.

Content

Not less than 98 per cent Na2H PO4 on a volatile matter-free basis.

Volatile Matter

Determined by drying at 60°C for 1 hour and then at 105°C for 4 hours

—anhydrous: not more than 5 per cent

—with 1 molecule of water: not more than 21 per cent

—with 7 molecules of water: not more than 50 per cent

—with 12 molecules of water: not more than 61 per cent.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 339C Trisodium orthophosphates.

Chemical Description

Trisodium monophosphate; trisodium orthophosphate; Na3PO4; the substance is available commercially in anhydrous form or as a hydrate with 1 or 12 molecules or water.

Description

White powder, crystals or granules.

Content

Not less than 97 per cent Na3PO4 on a volatile matter-free basis.

Volatile matter

Determined by drying at 105°C for 1 hour, followed by calcination at 800°C + 25°C for 30 minutes—

—-anhydrous: not more than 2 percent

—with 1 molecule of water: not more than 9 per cent

—with 12 molecules of water: not more than 55 per cent.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 340 A Monopotassium orthophosphate

Chemical Description

Monopotassium monophosphate; acid monopotassium monophosphate; KH2PO4.

Description

Colourless crystals or white granular or crystalline powder, hydroscopic.

Content

Not less than 98 per cent KH2PO4 on a volatile matter-free basis.

Volatile matter

Not more than 2 per cent determined by drying at 105°C for 4 hours.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 340 B Dipotassium orthophosphate.

Chemical Description

Dipotassium monophosphate; secondary potassium phosphate; acid dipotassium orthophosphate; dipotassium phosphate; K2H PO4.

Description

Colourless or white granular deliquescent substance.

Content

Not less than 98 per cent K2H PO4on a volatile matter-free basis.

Volatile Matter

Not more than 2 per cent determined by drying at 105°C for 4 hours.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 340 C Tripotassium orthophosphate.

Chemical Description

Tripotassium monophosphate; tripotassium orthophosphate; K3PO4; the substance is available commercially in anhydrous form or hydrated form, the most common being that with 1 molecule of water of crystallization.

Description

White hygroscopic crystals or granules.

Content

Not less than 97 per cent K3PO4 on a volatile matter-free basis.

Volatile Matter

Determined by drying at 105°C for 1 hour followed by calcination at 800°C + 25°C for 30 minutes, —anhydrous: not more than 3 per cent—with one molecule of water: not more than 20 per cent.

Water-insoluble substances

Not more than 0.2 per cent of the volatile matter-free substance.

Flourides

Not more than 10 mg/kg expressed as flourine.

E 341 A Monocalcium orthophosphate.

Chemical Description

Monocalcium phosphate; CaH4(PO4)2; available commercially in anhydrous form or as the monohydrate.

Description

Granular powder or white, deliquescent crystals or granules.

Calcium Content

Anhydrous: not less than 23 per cent and not more than 25 per cent expressed as CaO. with one molecule of water: not less than 22.2 per cent and not more than 24.7 per cent expressed as CaO.

Volatile matter

Anhydrous: not less than 14 per cent and not more than 15.5 per cent determined after calcination at 800°C + 25°C for 30 minutes. With one molecule of water: not more than 0.6 per cent determined by drying at 60°C for 3 hours.

Flourides

Not more than 30 mg/kg expressed as flourine.

E 341B Dicalcium orthophosphate.

Chemical Description

Diabasic calcium phosphate Dicalcium phosphate; CaHPO4 available commercially in anhydrous and dihydrate form.

Description

Impalpable white powder.

Calcium content

Anhydrous: not less than 39 per cent and not more than 42 per cent expressed as CaO.

With two molecules of water: not less than 31.9 per cent and not more than 33.5 per cent expressed as CaO.

Volatile matter

Determined by calcination at 800°C + 25°C to constant weight.

Anhydrous: not less than 7 per cent and not more than 8.5 per cent.

Dihydrate: not less than 24.5 per cent and not more than 26.5 per cent.

Flourides

Not more than 50 mg/kg expressed as flourine.

E 400 Alginic acid.

Chemical Description

Linear glycuronoglycan consisting mainly of beta (1-4) linked D-mannuronic and alpha (1-4) linked L-glucuronic acid units in pyranose ring form. Hydrophillic colloidal carbohydrate extracted by the use of dilute alkali from various species of brown seaweeds.

Description

A nearly odourless, tasteless white to yellowish fibrous powder.

Content

Yields, on a volatile matter-free basis, not less than 20 per cent and not more than 23 per cent of carbon dioxide corresponding to not less than 91.0 per cent and not more than 104.5 per cent of alginic acid (equivalent weight 200).

Ash

Not more than 4 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Volatile matter

Not more than 15 per cent determined by drying at 105°C for 4 hours.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 401 Sodium alginate.

Chemical Name

Sodium salt of alginic acid.

Description

Nearly odourless, tasteless white to yellowish fibrous or granular powder.

Content

Yields, on a volatile matter-free basis, not less than 18 per cent and not more than 21 per cent of carbon dioxide corresponding to not less than 90.8 per cent and not more than 106.0 per cent of sodium alginate (equivalent weight 222).

Ash

Not less than 18.0 per cent and not more than 27.0 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Volatile matter

Not more than 15 per cent determined by drying at 105°C for 4 hours.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 402 Potassium alginate.

Chemical Name

Potassium salt of alginic acid.

Description

Nearly odourless, tasteless white to yellowish fibrous or granular powder.

Content

Yields, on a volatile matter-free basis, not less than 16.5 per cent and not more than 19.5 per cent of carbon dioxide corresponding to not less than 89.2 per cent and not more than 105.5 per cent of potassium alginate (equivalent weight 238).

Ash

Not less than 23 per cent and not more than 32 per cent on a volatile matter free basis determined at 600°C after drying at 105°C for 4 hours.

Volatile matter

Not more than 15 per cent determined by drying at 105°C for 4 hours.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 403 Ammonium alginate

Chemical Name

Ammonium salt of alginic acid.

Description

White to yellowish fibrous or granular powder.

Content

Yields, on a volatile matter-free basis, not less than 18 per cent and not more than 21 per cent of carbon dioxide corresponding to not less than 88.7 per cent and not more than 103.6 per cent of ammonium alginate (equivalent weight 217).

Ash

Not more than 4 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Volatile matter

Not more than 15 per cent when dried for 4 hours at 105°C.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 404 Calcium alginate

Chemical Name

Calcium salt of alginic acid.

Description

Nearly odourless, tasteless fibrous or granular powder.

Content

Yields, on a volatile matter-free basis, not less than 18 per cent and not more then 21 per cent of carbon dioxide corresponding to not less than 89.6 per cent and not more than 104.5 per cent of calcium alginate (equivalent weight 219).

Ash

Not less than 15 per cent and not more than 24 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Volatile matter

Not more than 15 per cent when dried for 4 hours at 105°C.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 405 Propane-1,2-diol alginate.

Chemical Description

Propane-1,2-diol ester of alginic acid varies in composition according to its degree of esterification and the percentages of free and neutralized carboxyl groups in the molecule.

Description

Nearly odourless and tasteless white to yellowish fibrous or granular powder.

Content

Yields, on a volatile matter-free basis, not less than 16 per cent and not more than 20 per cent of carbon dioxide.

Ash

Not more than 10 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Total propane 1,2-diol content

Not less than 15 per cent and not more than 20 per cent.

Free propane-1,2-diol content

Not more than 12 per cent.

Volatile Matter

Not more than 20 per cent when dried for 4 hours at 105°C.

Acid insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 2 per cent.

E 406 Agar.

Chemical Description

A hydrophillic colloidal polygalactoside, about 90 per cent of the galactose molecules being of the D-form and 10 per cent of the L-form. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain marine algae of the families Gelidiaceae and Sphaerococcaceae and related red algae of the class Rhodophyceae.

Description

White to pale yellow powder, fibres or flakes which are either odourless, or have a slight characteristic odour and a mucilaginous taste.

Ash (Total)

Not more than 6.5 per cent determined at 550°C on a volatile matter-free basis.

Acid insoluble ash (insoluble in approx. 3N hydrochloric acid).

Not more than 0.5 per cent determined at 550°C on a volatile matter-free basis.

Gelatin and Other Proteins

Dissolve about 1g agar in 100ml of boiling water and allow to cool to about 50°C. To 5ml of the solution add 5ml of trinitrophenol solution (l g of anhydrous trinitrophenol/100 ml hot water). No turbidity appears within 10 minutes.

Insoluble matter (in hot water)

Not more than 1 per cent.

Volatile matter

Not more than 20 per cent when dried for 5 hours at 105°C.

Starch and dextrins

Boil 100 mg agar in 100ml of water. Cool and add a few drops of iodine solution prepared by dissolving 14g I2 in a solution of 36g KI in 100ml H20. Add 3 drops HCL and dilute to 1,000ml. No blue or red colour is produced.

Water absorbtion

Place 5g agar in a 100ml graduated cylindner, fill to the mark with water, mix and allow to stand at about 25°C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100ml graduated cylinder. Not more than 75ml water is obtained.

E 407 Carrageenan.

Chemical Description

Obtained by aqueous extraction of seaweeds of GIGARTINACEAE, SOLIERIACEAE, HYPNEACHEAE, FURCELLARIACEAE and families of the class RHODOPHYCEAE (red seaweeds). No organic precipitants shall be used other than methanol, ethanol and isopropanol. Carrageenan consists chiefly of the calcium, potassium, sodium, and magnesium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3, 6 anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded.

Description

Yellowish to colourless, coarse to fine powder which is practically odourless and has a mucilaginous taste.

Volatile matter

Not more than 12 per cent determined by drying at 105°C for 4 hours.

Sulphate (expressed as SO4

Not less than 15 per cent and not more than 40 per cent on a volatile matter-free basis, expressed as SO4.

Acid insoluble ash (insoluble in 10 per cent w/v hydrochloric acid)

Not more than 1 per cent dry matter.

Acid insoluble matter (insoluble in 1 per cent v/v sulphuric acid)

Not more than 2 per cent dry matter.

Ash

Not less than 15 per cent and not more than 40 per cent determined at 550°C on a volatile matter-free basis.

Viscosity of a 1.5 per cent solution at 75°C

Not less than 5 centipoises.

Isopropanol

}

Ethanol

Not more than 1 per cent singly or in combination.

Methanol

Content

E 410 Locust bean gum.

Chemical Description

Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan.

Description

The ground endosperm of the seeds of the carob tree, Ceratonia siliqua (L.) Taub. (Fam. Leguminosae). A white to yellowish-white nearly odourless powder.

Galactopyranose and Mannopyranose content

Not less than 75 per cent.

Insoluble matter (in 0.4N Sulphuric acid):

Not more than 4 per cent after digestion for 6 hours.

Ash

Not more than 1.2 per cent determined at 800°C.

Volatile Matter

Not more than 14 per cent when dried to constant weight at 102°-105°C (3-5 hours).

Protein (Nx 6.25)

Not more than 7 per cent.

E 412 Guar gum.

Chemical description

Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycoside linkages, which may be described chemically as galactomannan.

Description

The ground endosperm of the seeds of the guar plant, Cyamopsis tetragonolobus (L) Taub. (Fam Leguminosae). A white to yellowish-white nearly odourless powder.

Galactopyranose content

Not less than 75 per cent.

Insoluble matter (in 0.4N sulphuric acid)

Not more than 4 per cent after digestion for 6 hours.

Ash

Not more than 1.5 per cent determined at 800°C.

Volatile matter

Not more than 14 per cent when dried to constant weight at 102°-105°C. (3-5 hours).

Protein (Nx 6.25)

Not more than 7 per cent.

E 413 Tragacanth.

Chemical Description

Consists mainly of high molecular weigh polysaccharides composed of galactoarabans and acidic polysaccharides containing galacturonic acid groups.

Description

A dried gummy exudate obtained from Astragalus gummifer Labillardiere, or other Asiatic species of Astragulus (Fam. Leguminosae).

Unground tragacanth occurs as flattened lamellated, frequently curbed fragments or straight or spirally twisted linear pieces from 0.5 to 2.3 mm in thickness which are white to pale yellow in colour. It is odourless and has an insipid, mucilaginous taste.

Powdered tragacanth is white to yellowish white in colour.

Viscosity of a 1 per cent Solution at 25°C

Not less than 250 centipoises.

Ash

Not more than 3.5 per cent at 550°C.

Acid insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 0.5 per cent at 550°C.

Karaya gum

Boil 1g with 20ml of water until a mucilage is formed. Add 5ml of hydrochloric acid and again boil the mixture for 5 minutes. No permanent pink or red colour develops.

E 414 Acacia.

Chemical Description

Consists mainly of high molecular weight polysaccharides and their calcium, potassium and magnesium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid. It is obtained as a dried gummy exudate from the stems and branches of Acacia senegal (L) Willd or of related species of Acacia (Fam. Leguminosae).

Description

Unground acacia occurs as white, yellowish-white or pale pinkish spheroidal tears of varying size or in angular fragments. It is also available commercially in the form of white or yellowish-white flakes, granules or powder.

Ash

Not more than 4 per cent at 550°C.

Insoluble matter (in approx. 3N hydrochloric acid)

Not more than 1 per cent.

Volatile matter

Not more than 15 per cent determined by drying at 105°C for 5 hours.

Starch or Dextrin

Boil a 1 in 50 solution of the gum and cool. To 5ml add one drop of iodine solution (14 g iodine in a solution of 36 g potassium iodine in 100ml water, add 3 drops hydrochloric acid and dilute to 1000ml). No bluish or reddish colour is produced.

Tannin

To 10ml of a 1 in 50 solution add about 0.1ml of ferric chloride solution (9g FeCl36H20 made up to 100ml with water). No blackish colouration or blackish precipitate is formed.

E 415 Xanthan Gum.

Chemical Description

Xanthan gum is a high molecular weight polysaccharide gum produced by pure-culture fermentation of a carbohydrate with Xanthomonas campestris, purified by recovery with ethanol or isopropanol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral.

Description

Cream-coloured powder.

Content

Xanthan gum yields, on a volatile matter-free basis, not less than 4.2 per cent and not more than 5.0 per cent of carbon dioxide.

Volatile matter

Not more than 15 per cent determined by drying at 105°C for 2½ hours.

Ash

Not more than 16 per cent on a volatile matter-free basis determined at 600°C after drying at 105°C for 4 hours.

Pyruvic acid

Not less than 1.5 per cent.

Nitrogen

Not more than 1.5 per cent.

Isopropanol

Not more than 750mg/kg.

Microbiological criteria

Viable cells of Xanthomonas campestris shall be absent.

E 416 Karaya gum or Sterculia Gum.

The criteria in the monograph for Karaya gum contained in the Food Chemicals Codex 1972 at page 423.

E 420 (i) Sorbitol.

Chemical Name

D-sorbitol.

Description

White hydroscopic crystalline powder, flakes or granules, having a sweet taste.

Content

Sorbitol contains not less than 98 per cent of glycitols and not less than 91 per cent of D-sorbitol, on a dry matter basis in each case. Glycitols are compounds with the structural formula CH2OH (CHOH) nCH2OH where 'n' is an integer. That part of the product which is not D-Sorbitol is composed mainly of mannitol together with small quantities of other glycitols, n

Water

Not more than 10 per cent [Karl Fischer].

Reducing sugars

Not more than 0.3 per cent on a dry-weight basis, expressed as dextrose.

Total sugars

Not more than 1 per cent on a dry-weight basis, expressed as dextrose.

Sulphated ash

Not more than 0.1 per cent at 800+25°C on a dry-weight basis.

Sulphate

Not more 0.01 per cent on a dry-weight basis.

Chloride

Not more than 0.005 per cent on a dry-weight basis, expressed as C1.

Nickel

Not more than 2 mg/kg, expressed as Ni.

E 420 (ii) Sorbitol Syrup.

Description

Clear colourless and sweet-tasting aqueous solution of sorbitol and hydrogenated oligosaccharides. That part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of other glycitols where n

Content

Not less than 69 per cent total solids and not less than 50 per cent of D-Sorbitol.

Sulphated Ash

Not more than 0.1 per cent on a dry-weight basis.

Sulphate

Not more than 0.01 per cent on a dry-weight basis.

Chloride

Not more than 0.005 per cent on a dry-weight basis.

Nickel

Not more than 2 mg/kg.

Reducing Sugars

Not more than 0.3 per cent on a dry-weight basis, expressed as dextrose.

E 421 Mannitol.

Chemical Name

D-mannitol.

Description

White crystalline solid which is odourless and has a sweet taste.

Content

Not less than 98 per cent of D-mannitol (C6H14O6) on a volatile matter-free basis.

Melting Range

165°C-168°C.

Specific Rotation [α]25D

Not less than + 23.0° and not more than + 24,3°.

Volatile Matter

Not more than 0.3 per cent determined by drying at 105°C for 4 hours.

Reducing Sugars

Not more than 0.05 per cent expressed as dextrose.

Chloride

Not more than 0.007 per cent, expressed as C1.

Sulphate

Not more than 0.01 per cent, expressed as SO4.

Ash

Not more than 0.1 per cent determined at 800 + 25°C.

Nickel

Not more than 2 mg/kg, expressed as Ni.

E 422 Glycerol.

Chemical Name

Glycerol.

Description

Clear, colourless hygroscopic syrupy liquid with a sweet taste accompanied by a sensation of heat to the tongue.

Content

Not less than 98 per cent of glycerol (C3H8O3).

Specific Gravity (25/25°C)

Not less than 1.25 per cent.

Refractive Index [n]30D

1.471-1.474.

Acrolein, Glucose and Ammonium compounds

Heat a mixture of 5ml glycerol and 5ml potassium hydroxide solution (1 in 10) at 60°C for 5 minutes. It neither becomes yellow nor emits an odour of ammonia.

Butanetriols

Not more than 0.2 per cent.

Chlorinated compounds (as cl)

Not more than 0.003 per cent.

Fatty acids and esters

Not more than 1 per cent calculated as butyric acid.

Sulphated Ash

Not more than 0.01 per cent determined at 800 + 25°C.

E 432 Polyoxyethylene (20) sorbitan monolaurate or polysorbate 20.

The criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1972 at page 632 as amended by the Second Supplement, 1975 at page 30.

E 433 Polyoxyethylene (20) sorbitan mono-oleate or polysorbate 80.

The criteria in the monograph for polysorbate 80 contained in the Food Chemicals Codex 1972 at page 637 as amended by the Second Supplement 1975 at page 30 except that the final sentence of the description shall be deleted.

E 434 Polyoxyethylene (20) sorbitan monopalmitate or polysorbate 40.

The criteria in the monograph for polyoxyethylene (20) sorbitan monopalmitate contained in the Nutrition Meetings Report Series No. 35 (1964) of the United Nations' Food and Agriculture Organisation at page 135.

E 435 Polyoxyethylene (20) sorbitan monostearate or polysorbate 60.

The criteria in the monograph for polysorbate 60 contained in the Food Chemicals Codex 1972 at page 634 except that the final sentence of the description shall be deleted.

E 436 Polyoxyethylene (20) sorbitan tristearate or polysorbate 65.

The criteria in the monograph for polysorbate 65 contained in the Food Chemicals Codex 1972 at page 635 except that the final sentence of the description shall be deleted.

E 440 Pectin.

Chemical Description

Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their sodium, potassium, calcium and ammonium salts. Pectin is obtained by aqueous extraction of appropriate edible plant material, usually citrus fruits or apples. No organic precipitants shall be used other than methanol, ethanol and isopropanol.

Description

White, light yellow, light grey or light brown powder.

Galacturonic acid

Not less than 65 per cent calculated on an ash and volatile matter-free basis after washing with acid and alcohol.

Volatile matter

Not more than 12 per cent after drying at 105°C for 2 hours.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 1 per cent.

Free Methanol, Ethanol and Isopropanol content

Not more than 1 per cent singly or in combination on a volatile matter-free basis.

Sulphur Dioxide Residue

Not more than 50 mg/kg on a volatile matter-free basis.

Nitrogen content

Not more than 0.5 per cent determined after washing with acid and alcohol [Kjeldahl].

E 440 Amidated Pectin.

Chemical Description

Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium sodium, potassium and calcium salts. It is obtained by aqueous extraction of appropriate edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitants shall be used other than methanol, ethanol and isopropanol.

Description

White, light yellow, light grey or light brown powder.

Degree of amidation

Not more than 25 per cent of total carboxyl groups.

Galacturonic acid

Not less than 65 per cent calculated on an ash and volatile matter-free basis determined after washing with acid and alcohol.

Volatile matter

Not more than 12 per cent after drying at 105°C for 2 hours.

Acid-insoluble ash (insoluble in approx. 3N hydrochloric acid)

Not more than 1 per cent.

Free Methanol, Ethanol and Isopropanol content

Not more than 1 per cent singly or in combination on a volatile matter-free basis.

Sulphur Dioxide residue

Not more than 50 mg/kg on a volatile matter-free basis.

Nitrogen content

Not more than 2.5 per cent after washing with acid and alcohol [Kjeldahl].

E 442 Ammonium phosphatides.

Description

An unctuous semi-solid (at 25°C.) and consisting essentially of a mixture of the ammonium salts of phosphatidic acids derived from partially hardened rapeseed oil together with unreacted partially hardened rapeseed oil.

Matter insoluble in petroleum ether (40°C-60°C)

Total: Not more than 2.5 per cent Inorganic matter: not more than 0.2 per cent.

pH of an aqueous extract of melted ammonium phosphatides

Not less than 6.0 and not more than 8.0.

Phosphorus

Not less than 3.0 per cent and not more than 3.4 per cent.

Ammonium nitrogen

Not less than 1.2 per cent and not more than 1.5 per cent.

Arsenic

Not more than 5 mg/kg.

E 450 (a) (i) disodium dihydrogen diphosphate (Na2H2P2O7) or Sodium acid salt of pyrophosphoric acid.

Description

White powder or grains.

Content

Not less than 95 per cent of Na2H2P2O7.

Content in P2O5

Not less than 63.0 per cent and not more than 64.0 per cent.

Loss on drying

Not more than 0.5 per cent after drying for 4 hours at 105°C.

pH of 1 per cent solution

Not less than 2.7 and not more than 4.4.

Water insoluble matter

Not more than 0.6 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (a) (ii) Trisodium diphosphate (Na3HP2O7) or sodium pyrophosphate.

Description

White powder or grains. Occurs anhydrous or as a monohydrate.

Content

Not less than 95 per cent of Na3HP2O7 or of Na3HP2O7H2O.

Content in P2O5

Not less than 57.5 per cent and not more than 58.5 per cent for the anhydrous salt. Not less than 53.6 per cent and not more than 54.6 per cent for the monohydrate.

Ph of a 1 per cent solution

Not less than 6.7 and not more than 7.3.

Volatile matter

Not more than 0.5 per cent determined by drying at 105°C for 4 hours.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (a) (iii) Tetra Sodium diphosphate (Na4P2O7) or tetra sodium pyrophosphate.

Description

White, crystalline or granular powder. Occurs anhydrous or as a decahydrate.

Content

Not less than 95 per cent of Na4P2O7, or Na4P2O7.10H2O.

Content in P2O5

Not less than 52.5 per cent and not more than 54.0 per cent for the anhydrous salt.

Not less than 31.5 per cent and not more than 32.5 per cent for the decahydrate.

Loss on ignition

Not more than 0.5 per cent for the anhydrous salt, not less than 38 per cent and not more than 42 per cent for the decahydrate, in both cases determined after drying at 105°C for 4 hours, followed by ignition at 550°C for 30 minutes.

Ph of a 1 per cent solution

Not less than 9.9 and not more than 10.7.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (a) (iv) tetra Potassium diphosphate (K4P2O7) or potassium pyrophosphate.

Description

Colourless crystals or white, very hygroscopic powder.

Content

Not less than 95 per cent of K4P2O7.

Content in P2O5

Not less than 42.0 per cent and not more than 43.7 per cent.

Loss on ignition

Not more than 2 per cent after drying for 4 hours at 105°C followed by ignition at 550°C for 30 minutes.

Ph of a 1 per cent solution

Not less than 10.0 and not more than 10.7.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (b) (i) pentasodium triphosphate (Na5P3O10) or sodium tripolyphosphate.

Description

White, slightly hygroscopic granules or powder. Occurs anhydrous or as an hexahydrate.

Content

Not less than 85.0 per cent of Na5P3O10 or of Na5P3O106H2O remainder being principally other sodium phosphates (E450).

Content in P2O5

Not less than 56.0 per cent and not more than 58.0 per cent for the anhydrous salt. Not less than 43.0 per cent and not more than 45.0 per cent for the hexahydrate.

Loss on Ignition

For the anhydrous salt not more than 0.5 per cent and for the hexahydrate not more than 23.2 per cent in both cases determined after drying for 4 hours at 105°C followed by ignition at 550°C for 30 minutes.

Ph of a 1 per cent solution

Not less than 9.3 and not more than 10.1.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (b) (ii) pentapotassium triphosphate (K5P3O10).

Description

White, very hygroscopic powder.

Content

Not less than 85 per cent of K5P3O10 after ignition at 550°C for 30 minutes, the remainder being principally other potassium phosphates (E450).

Content in P2O5

Not less than 46.5 per cent and not more than 48.0 per cent.

Loss on Ignition

Not more than 0.5 per cent calculated on the P2O5 content after drying for 4 hours at 105°C followed by ignition at 550°C for 30 minutes.

pH of a 1 per cent solution

Not less than 9.3 and not more than 10.1.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

E 450 (c) (i) sodium polyphosphates.

Chemical Description

Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n-2)PO(3n+1) where 'n' is not less than 2.

Description

Fine white powders or crystals or colourless glassy platelets.

Content in P2O5

Not less than 59.5 per cent not more than 70.0 per cent calculated on the ignited basis.

Loss on Ignition

Not more than 0.5 per cent after drying at 105°C for 4 hours followed by ignition at 550°C for 30 minutes.

pH of a 1 per cent solution

Not less than 3.6 and not more than 9.0.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as flourine.

Cyclic phosphates

Not more than 8 per cent.

E 450 (c) (ii) Potassium polyphosphates.

Chemical Description

Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where 'n' is not less than 2.

Description

Fine white powders or crystals or colourless glassy platelets.

Content in P2O5

Not less than 53.5 per cent and not more than 61.5 per cent on the ignited basis.

Loss on Ignition

Not more than 2 per cent after drying for 4 hours at 105°C followed by ignition at 550°C for 30 minutes.

pH of a 1 per cent solution

Not more than 7.8.

Water insoluble matter

Not more than 0.2 per cent.

Flouride

Not more than 10 mg/kg, expressed as fluorine.

Cyclic phosphates.

Not more than 8 per cent.

35 E 460 (i) Microcrystalline cellulose.

Chemical Description

Purified partially depolymerised cellulose prepared by acid hydrolysis of alpha-cellulose obtained directly from fibrous plant material. It has a molecular weight of about 36,000.

Description

A fine white or almost white odourless powder.

Volatile matter

Not more than 5 per cent determined by drying to constant weight at 105°C.

pH

Shake about 5g with 40ml of carbon dioxide free water for 20 minutes and centrifuge. The pH of the supernatant liquid is between 5.5 and 7.0.

Sulphated ash

Not more than 0.1 per cent determined at 800 + 25°C.

Water soluble substances

Not more than 0.16 per cent.

Diethyl ether extractable matter

Not more than 200 mg/kg.

Chloride

Not more than 350 mg/kg expressed as Cl.

Sulphate

Not more than 600 mg/kg expressed as SO4

E 460 (II) Powdered Cellulose.

Chemical Description

Powdered cellulose is purified mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained directly from fibrous plant material. It has a molecular weight of 1.6 x 105 or greater.

Description

A white, odourless powder.

Content

Not less than 92 per cent (C12H20O10) n.

Volatile matter

Not more than 7 per cent determined by drying at 105°C for three hours.

pH

Shake about 5g with 40ml of carbondioxide-free water for 20 minutes and centrifuge. The pH of the supernatant liquid is between 5.0 and 7.5.

Sulphated ash

Not more than 0.3 per cent determined at 800 + 25°C.

Water-soluble substances

Not more than 1 per cent.

E 461 Methylcellulose.

Chemical Description

Obtained directly from fibrous plant material and partially etherified with methyl groups.

Description

A slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless granular or fibrous powder.

Chemical Formula

The polymers contain substituted glucose units with the following general formula: C6H7O2 (OR1) (OR2) (OR3).

where R1, R2 and R3 each may be -H or -CH3 or -CH2CH2OH.

Molecular weight

From about 20,000 to 380,000.

Content of substituted groups

Not less than 25 per cent and not more than 33 per cent of methoxyl groups (-OCH3), No more than 5 per cent of hydroxyethoxyl groups (-OCH2CH2CH).

Volatile matter

Not more than 10 per cent determined by drying to constant weight at 105°C.

Sulphated ash

Not more than 1.5 per cent determined at 800 + 25°C.

pH of a 1 per cent solution

Not less than 5 and not more than 8

E 463 Hydroxypropylcellulose.

Chemical Description

Obtained directly from fibrous plant material and partially etherified with hydroxypropyl group.

Description

Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.

Chemical Formula

The polymers contain substituted glucosidic units with the following general formula:

C6H7O2 (OR1) (OR2) (OR3).

where R1, R2 and R3 each may be any one of the following:

—H

—CH2CHOHCH3

—CH2CHO (CH2 CHOHCH3) CH3

—CH2 CHO [CH2CHO (CH2 CHOHCH3)CH3]CH3-

Molecular weight

From about 30,000 to 1,000,000.

Content of substituted groups

Not more than 80.5 per cent of hydroxypropoxyl groups (-OCH2CHOHCH3) on a volatile matter-free basis, equivalent to not more than 4.6 hydroxyparopyl groups per anhydroglucose unit.

pH of a 1 per cent solution

Not less than 5.0 and not more than 8.0.

Volatile matter

Not more than 10 per cent determined by drying to constant weight at 105°C.

Sulphated ash

Not more than 0.5 per cent determined at 800 + 25°C.

E 464 Hydroxyparopylmethylmethylcellulose.

Chemical Description

Obtained directly from fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution.

Description

Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.

Chemical formula

The polymers contain substituted anhydroglucose units with the following general formula:

C6H7O2 (OR1) (OR2) (OR3)

where R1, R2 and R3 each may be any one of the following:

—H CH3

—CH2CHOHCH3

—CH2CHO (CH2 CHOHCH3) CH3

—CH2 CHO [CH2CHO (CH2 CHOHCH3)CH3] CH3

Molecular weight

From about 13,000 to 200,000.

Content of substituted groups

Not less than 19 per cent and not more than 30 per cent of methoxyl groups (OCH3) and not less than 3 per cent and not more than 12 per cent hydroxypropoxyl groups (OCH2CHOHCH3) on a volatile matter-free basis.

pH of a 1 per cent solution

Not less than 5.0 and not more than 8.0.

Volatile matter

Not more than 10 per cent after drying to constant weight at 105°C.

Sulphated ash

Not more than 1.5 per cent for products with viscosities greater than 50cP and not more than 3.0 per cent for products with viscosities of 50cP or less, determined at 800 ± 25°C.

E 465 Ethylmethylcellulose.

Chemical Description

Obtained directly from fibrous plant material and partially etherified with methyl and ethyl groups.

Description

Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless granular of fibrous powder.

Chemical Formula

The polymers contain substituted anhydroglucose units with the following general formula:

C6H7O2 (OR1) (OR2) (OR3).

where R1, R2 and R3 each may be any one of the following:

—H

—CH3

—CH2 CH3)

Molecular weight

From about 30,000 to 40,000.

Content of substituted groups

Not less than 14.5 per cent and not more than 19 per cent of ethoxyl groups (-OCH2H5) and not less than 3.5 per cent and not more than 6.5 per cent of methoxyl groups (-OCH3) on a volatile matter-free basis.

Volatile matter

Fibrous form: Not more than 15 per cent. Powdered form: not more than 10 per cent. Determined by drying to constant weight at 105°C in each case.

Sulphated ash

Not more than 0.6 per cent determined at 800 ± 25°C.

pH of a 1 per cent solution.

Not less than 5 and not more than 8.

E 466 Carboxymethylcellulose.

Chemical Description

The partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from fibrous plant material.

Description

Slightly hygroscopic white or slightly yellowish or greyish, odourless and tasteless, granular or fibrous powder.

Chemical formula

The polymers contain substituted glucosidic units with the following general formula:

C6H7O2 (OR1) (OR2) (OR3).

where R1, R2 and R3 each may be any one of the following:

—H

—CH2COONa

—CH1 COOH

Molecular weight

Higher than approximately 17,000 (degree of polymerisation approximately 100).

Content

Not less than 99.5 per cent of carboxymethylcellulose calculated on a volatile matter-free basis.

Sodium Chloride and Sodium Glycolate

Not more than 0.5 per cent total and not more than 0.4 per cent of sodium glycolate.

Degree of Substitution

Not less than 0.2 and not more than 1.0 carboxymethyl groups (CH2 COOH) per anhydroglucose unit.

Sodium

Not more than 9.7 per cent on a volatile matter-free basis.

Volatile matter

Not more than 12 per cent determined by drying to constant weight at 105°C.

pH of a 1 per cent solution

Not less than 6 and not more than 8.5.

E 470 Sodium, Potassium and Calcium salts of food fatty acids.

Chemical Description

Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats or from distilled food fatty acids.

Description

White or creamy white light powders, flakes or semi-solids.

Unsaponifiable matter

Not more than 2 per cent.

Free fatty acids

Not more than 3 per cent estimated as oleic acid.

Free Alkali

Not more than 0.1 per cent expressed as NaOH.

Total Glycerol (combined and free)

Not more than 1 per cent.

Matter insoluble in Alcohol

Not more than 0.2 per cent (sodium and potassium salts only).

Loss on drying

Not more than 3 per cent.

Content of sodium or Potassium or Calcium

Sodium: 9 per cent to 14 per cent expressed as Na2O.

Potassium: 13 per cent to 21.5 per cent expressed as K2O.

Calcium: 8.5 per cent to 13 per cent expressed as CaO.

E 471 Mono- and diglycerides of food fatty acids*

Chemical Description

Mixtures of glycerol mono-, di - and tri-esters of fatty acids occurring in food fats. They may contain amounts of free fatty acids and glycerol.

Description

The product varies from a pale straw to brown oily liquid to a white or slightly off-white hard waxy solid. These solids may be in the form of flakes, powders or small beads.

Mono- and di- ester content

Not less than 70 per cent.

Free fatty acids

Not more than 3 per cent estimated as oleic acid.

Free glycerol

Not more than 7 per cent.

Total glycerol

Not less than 16 per cent and not more than 33 per cent.

Polyglycerols

Not more than 4 per cent diglycerol and not more than 1 per cent higher polyglycerols both based on total glycerol content.

Water

Not more than 2 per cent [Karl Fischer].

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

*Note: These criteria are based on the product without E470.

E 472 (a) Acetic acid esters of mono- and diglycerides of fatty acids.

Chemical Description

Esters of glycerol with acetic acid and fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free acetic acid, and free glycerides.

Description

Clear, mobile liquids to solids and white to pale yellow in colour.

Total acetic acid content

Not less than 9 per cent and not more than 32 per cent.

Free fatty acids (and acetic acid)

Not more than 3 per cent estimated as oleic acid.

Free glycerol

Not more than 2 per cent.

Total glycerol

Not less than 14 per cent and not more than 31 per cent.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

E 472 (b) Lactic Acid esters of mono- and diglycerides of food fatty acids*

Chemical Description

Esters of glycerol with lactic acid and forming fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free lactic acid, and free glycerides.

Description

Soft to hard waxy solids.

Total lactic acid content

Not less than 13 per cent and not more than 45 per cent.

Free fatty acids Free glycerol

Not more than 3 per cent estimated as oleic acid. Not more than 2 per cent.

Total glycerol

Not less than 13 per cent and not more than 30 per cent.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

*Note: These criteria are based on the product without added E 470.

E 472 (c) Citric acid esters of mono- and diglycerides of food fatty acids.

Chemical Description

Esters of glycerol with citric acid and fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid, and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide.

Description

Yellowish or light brown liquids to waxy solids or semi-solids.

Total citric acid content

Not less than 13 per cent and not more than 50 per cent.

Free fatty acids Free glycerol

Not more than 3 per cent estimated as oleic acid. Not more than 2 per cent.

Total glycerol

Not less than 11 per cent and not more than 29 per cent.

Sulphated ash

Not more than 0.5 per cent for the non-neutralised products and not more than 10.0 per cent for the partially or wholly neutralised products determined at 800 ± 25°C.

pH of a 1 per cent solution

Not less than 3 and not more than 7.3.

E 472 (d) Tartaric acid esters of mono- and diglycerides of food fatty acids.

Chemical Description

Esters of glycerol with tartaric acid (E 334) and fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid, and free glycerides.

Description

Sticky viscous yellowish liquids to hard yellow waxes.

Total tartaric acid content

Not less than 15 per cent and not more than 50 per cent.

Free fatty acids Free glycerol

Not more than 3 per cent estimated as oleic acid. Not more than 2 per cent.

Total glycerol

Not less than 12 per cent and not more than 29 per cent.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

E 472 (e) Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids.

Chemical Description

Esters of glycerol with mono- and diacetyl tartaric acids (obtained from E 334 tartaric acid) and fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acid and their combinations, and free glycerides.

Description

Sticky viscous liquids through to fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid.

Total tartaric acid content

Not less than 10 per cent and not more than 40 per cent.

Total acetic acid content

Not less than 8 per cent and not more than 32 per cent.

Free fatty acids

Not more than 3 per cent estimated as oleic acid.

Free glycerol

Not more than 2 per cent.

Total glycerol

Not less than 11 per cent and not more than 28 per cent.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

E 472 (f) Mixed acetic and tartaric acid esters of mono and diglycerides of fatty acids.

Chemical Description

Esters of glycerol with acetic and tartaric acids (E 334) and fatty acids occurring in food fats. They may contain small amounts of free glycerol, free fatty acids, free acetic and tartaric acid, and free glycerides.

Description

Clear mobile liquids to solids and from white to pale yellow in colour.

Total acetic acid

Not less than 10 per cent and not more than 20 per cent.

Free tartaric acid

Not less than 20 per cent and not more than 40 per cent.

Free acetic acid

Not less than 5.5 per cent and not more than 8.5 per cent.

Free tartaric acid

Not more than 1 per cent.

Free fatty acids

Not more than 3 per cent estimated as oleic acid.

Free glycerol

Not more than 2 per cent.

Total glycerol

Not less than 12 per cent and not more than 27 per cent.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

E 473 Sucrose esters of food fatty acids.

Chemical Description

Essentially the mono- and di-esters of sucrose with fatty acids occurring in food fats. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, isopropanol, isobutanol and methylethylketon may be used in their preparation.

Description

Soft solids, stiff gels or white to greyish-white powders.

Total Sucrose fatty acid ester content

Not less than 80 per cent.

Total glyceride content

Not more than 20 per cent.

Free sucrose content

Not more than 5 per cent.

Free fatty acid content

Not more than 3 per cent estimated as oleic acid.

Sulphated ash

Not more than 2 per cent determined at 800 ± 25°C.

Dimethylsulphoxide content

Not more than 2 mg/kg.

Methanol content

Not more than 10 mg/kg.

Isobutanol content

Not more than 10 mg/kg.

Methylethylketon content

Not more than 10 mg/kg.

Dimethylformamide content

Not more than 1 mg/kg.

Total Ethyl acetate and isopropanol content

Not more than 350 mg/kg singly or in combination.

*Note: These criteria are based on the product without E 470.

E 474 Sucroglycerides*

Chemical Description

Produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono- and di-esters of sucrose and fatty acids together with residual mono-, di- and tri-glycerides from that fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, isobutanol and isopropanol.

Description

Soft solids masses, still gels or white to off-white powders.

Total Sucrose fatty acid ester content

Not less than 40 per cent and not more than 60 per cent.

Total glyceride content

Not less than 10 per cent and not more than 60 per cent.

Free sucrose content

Not more than 5 per cent.

Free fatty acid content

Not more than 3 per cent estimated as oleic acid.

Sulphated ash

Not more than 2 per cent determined at 800 ± 25°C.

Dimethylformamide content

Not more than 1 mg/kg.

Total ethyl acetate and isopropanol content

Not more than 350 mg/kg singly or in combination.

Methanol content

Not more than 10 mg/kg.

Total cyclohexane and isobutanol content

Not more than 10 mg/kg singly or in combination.

*Note: These criteria are based on the product without E 470.

E 475 Polyglycerol esters of non-polymerised food fatty acids*.

Chemical Description

Produced by the esterification of polyglycerol with food fats or with fatty acids occurring in food fats. The polyglycerol moiety is predominantly di-, tri-, and tetra-glycerol and contains not more than 10 per cent of polyglycerols equal to or higher than heptaglycerol.

Description

Yellow or light brown liquids or semi-solids.

Total fatty acid ester content

Not less than 90 per cent.

Free fatty acids

Not more than 6 per cent estimated as oleic acid.

Total glycerol and polyglycerol

Not less than 18 per cent and not more than 60 per cent.

Free glycerol and polyglycerol

Not more than 7 per cent.

Sulphated ash

0.5 per cent determined at 800 ± 25°C.

*Note: These criteria are based on the product without E 470.

E 476 Partial polyglycerol esters of polycondensed fatty acids of castor oil.

Description

A highly viscous liquid at 25°C being essentially a complex mixture of the partial esters and ethers of polyglycerol with linearly interesterified (polycondensed) fatty acids derived from castor oil. The polycondensed castor oil fatty acids are prepared by condensation in the absence of oxygen and have an average of about 5 fatty acid residues per molecule. The polyglycerol moiety is predominantly di-, tri- and tetra-glycerol and contains not more than 10 per cent of polyglycerols equal to or higher than heptaglycerol.

Refractive index, ND 65°C

Not less than 1.4630 and not more than 1.4665.

Hydroxyl value

Not less than 80 and not more than 100.

Iodine value

Not less than 72 and not more than 103 [Wijs].

Acid value

Not more than 6mg KoH per g.

E 477 Propane-1, 2-diol esters of food fatty acids*.

Chemical Description

Consists chiefly of mixtures of propane-1, 2-diol mono- and di-esters of fatty acids occurring in food fats. The alcohol moiety is exclusively propane-1, 2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent.

Description

Waxy white flakes, beads or solids.

Total fatty acid ester content

Not less than 85 per cent.

Free propane -1,2-diol

Not more than 5 per cent.

Dimer and trimer of Propane-1, 2-Diol:

Not more than 0.5 per cent.

Free fatty acids

Not more than 6 per cent estimated as oleic acid.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

Total paropane-1,2-diol content

Not less than 11 per cent and not more than 31 per cent.

*Note: These criteria are based on the product without E 470.

E 479a Oxidatively polymerised soya bean oil.

Description

A highly viscous liquid at 25°C obtained by blowing air into edible soya bean oil at a temperature not exceeding 250°C.

Combined oxidised fatty acids

Not more than 30 per cent.

Urea non-adduct content of total fatty acid methyl esters.

Not more than 42 per cent.

Refractive Index, ND40°C

Not less than 1.475 and not more than 1.485.

Saponification value

Not more than 220.

Iodine value

Not less than 75 and not more than 85 [Wijs].

Hydroxyl value

Not less than 30 and not more than 70.

Acid value

Not more than 6mg KOH per g.

E 479b Polyglycerol esters of dimerised fatty acids of soya bean oil.

Description

A viscous oil obtained by the inter-esterification of polyglycerol with refined soya bean oil thermally polymerised in vacuo. The polyglycerol moiety is predominantly di-, tri- and tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.

Urea non-adduct content of total fatty acid methyl esters

Not more than 65 per cent.

Saponification value

Not less than 15 per cent and not more than 175.

Iodine value

Not less than 78 and not more than 82 [Wijs].

Hydroxyl value

Not less than 60 and not more than 70.

Acid value

Not more than 6mg KOH per g.

E 481 Sodium Stearoyl-2-Lactylate.

Chemical Description

A mixture of the sodium salts of stearoyl lactylic acids and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present free or esterified due to their presence in the stearic acid used.

Description

Cream coloured powder or brittle solid with a characteristic odour.

Sodium content

Not less than 2.5 per cent and not more than 5 per cent.

Ester value

Not less than 90 and not more than 190mg KOH/g.

Total lactic acid (free and combined)

Not less than 15 per cent and not more than 40 per cent.

Acid value

Not less than 60 and not more than 130mg KOH/g.

E 482 Calcium stearoyl-2-lactylate.

Chemical Description

A mixture of calcium salts of stearoyl lactylic acids with minor amounts of calcium salts of other related acids manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used.

Description

White or slightly yellowish powder or brittle solid with a characteristic odour.

Calcium content

Not less than 1.0 per cent and not more than 5.2 per cent.

Ester value

Not less than 125 and not more than 190mg KoH/g.

Total lactic acid (free and combined)

Not less than 15 per cent and not more than 40 per cent.

Acid value

Not less than 50 and not more than 130 mg/KOH/g.

E 483 Stearyl tartrate.

Chemical Description

Produced by the esterification of tartaric acid (E 334) with stearyl alcohol, consisting chiefly of the di-ester with minor amounts of mono-ester, tartaric acid and free stearyl alcohol. Other esters may also be present due to the presence in the stearyl alcohol used of alcohols derived from food fatty acids other than stearic acid.

Description

A cream coloured unctuous solid (at 25°C).

Total ester content

Not less than 90 per cent.

Total tartaric acid content

Not less than 18 per cent and not more than 35 per cent.

Unsaponifiable matter

Not less than 77 per cent and not more than 83 per cent.

Melting range

67°C-77°C.

Ester value

Not less than 163 and not more than 180 mg KOH/G.

Iodine value

Not more than 4 (Wijs).

Acid value

Not more than 6 mg KOH/g.

Sulphated ash

Not more than 0.5 per cent determined at 800 ± 25°C.

E 491 Sorbitan monostearate.

The criteria in the monograph for soribtan monostearate contained in the Food Chemicals codex 1972 at page 784 except that the final sentence of the description shall be deleted.

E 492 Sorbitan tristearate.

The criteria in the monograph for sorbitan tristearate contained in the Nutrition Meetings report Series No. 35 (1964) of the United Nations' Food and Agriculture Organisation at page 108.

E 493 Sorbitan monolaurate.

The criteria in the monograph for sorbitan monolaurate contained in the British Pharmaceutical Codex 1973 at page 465.

E 494 Sorbitan mono-oleate.

The criteria in the monograph for sorbitan mono-oleate contained in the British Pharmaceutical codex 1973 at page 466.

E 495 Sorbitan monopalmitate.

The criteria in the monograph for sorbitan monopalmitate contained in the Nutrition Meetings Report Series No. 35 (1964) of the united Nations' Food and Agriculture Organisation at page 102.

SCHEDULE 1.

PART III.

General purity criteria applicable to permitted emulsifiers and permitted stabilisers except where otherwise provided by specific purity criteria.

Each emulsifier and stabiliser shall not contain—

( a ) a toxicologically dangerous amount of any element, in particular heavy metals;

( b ) more than 3 milligrams per kilogram of arsenic;

( c ) more than 10 milligrams per kilogram of lead;

( d ) more than 50 milligrams per kilogram of copper, or 25 milligrams per kilogram of zinc, or 50 milligrams per kilogram of any combination of copper and zinc.

SCHEDULE 2.

PART I.

EMULSIFIERS AND STABILISERS PERMITTED ONLY IN CERTAIN FOOD.

Specified food

Permitted emulsifier or permitted stabiliser

Milligrams per kilogram not exceeding

1

2

3

(a) Dutch type rusks

Sodium, potassium and calcium salts of fatty acids

15,000 (calculated as sodium oleate, C18H33NaO2, and on the weight of the flour)

(b) The permitted emulsifiers or permitted stabilisers:—

Sodium, potassium and calcium salts of fatty acids

60.000 (calculated as sodium oleate C18H33NaO2)

Mono- and diglycerides of fatty acids; lactic 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

(c) tin-greasing emulsions

Oxidatively polymerised soya bean oil Polyglycerol esters of dimerised fatty acids of soya bean oil

}

In accordance with good manufacturing practice

SCHEDULE 2.

PART II.

FOODS IN WHICH THE USE OF PERMITTED EMULSIFIERS AND PERMITTED STABILISERS IS LIMITED.

Specified food

Permitted emulsifier or permitted stabiliser

Milligrams per kilogram not exceeding

1

2

3

(a) Bread

Lecithins

/images/si078y94p0054a.gif

In accordance with good manufacturing practice

Mono- and diglycerides of fatty acids

Lactic acid esters of mono- and diglycerides of fatty acids

Citric acid esters of mono- and diglycerides of fatty acids

Mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids

Stearyl tartrate

Sodium stearoyl 2-lactylate

/images/si078y94p0054b.gif

Calcium stearoyl-2-lactylate

Alginic acid

Sodium alginate

Calcium alginate

Carrageenan

Locust bean gum

Tragacanth

Acacia

Karaya gum or

Sterculia gum

Xanthan gum

Guar gum

Sodium orthophosphates

Sodium & Potassium polyphosphates (E 450)

(c) Cream which contains not less than 35 per cent milk-fat and which is sold as whipping cream or whipped cream

Alginic acid

/images/si078y94p0055.gif

Sodium alginate

TetraSodium-diphosphate or tetraSodium-pyrophosphate

Sodium carboxymethyl-cellulose carrageenan

Footnote: The permitted emulsifiers or permitted stabilisers mono- and diglycerides of fatty acids, lactic acid esters of mono- and diglycerides of fatty acids, citric acid esters of mono- and diglycerides of fatty acids and mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids shall, when used in bread, have a hydroxyl value of the free combined fatty acids not exceeding 2.

SCHEDULE 3.

LABELLING OF PERMITTED EMULSIFIERS AND PERMITTED STABILISERS.

1. (1) Each container to which article 9 (1) relates shall bear a label on which is printed a true statement:—

( a ) in respect of each permitted emulsifier or permitted stabiliser present, of the serial number, if any, as specified in relation thereto in column 2 of Part I of Schedule 1, and of the common or usual name or an appropriate designation of that permitted emulsifier or permitted stabiliser;

( b ) where any other substance or substances is or are present:—

(i) of the common or usual name or an appropriate designation of each such substance;

(ii) of the proportion of each such substance in respect of which any Regulations, other than these Regulations, made under the Act contain a requirement to that effect; and

( c ) in the case of emulsifiers to which sugars have been added, the statement "standardised with sugar" shall be added to the designation on the label.

(2) The said statement shall be headed or preceded by the words "for foodstuffs (restricted use)".

(3) The container shall have on it the name and address of the person importing or the person selling the substance in the container or, if the substance is manufactured within the State, the name of the manufacturer of the substance.

2. Any statement required by the preceding paragraph—

( a ) shall be clear and legible;

( b ) shall be in a conspicuous position on the label which shall be marked on, or securely attached to, the container in such a manner that it will be readily discernible and easily read by an intending purchaser under normal conditions of purchase;

( c ) shall not be in any way hidden or obscured or reduced in conspicuousness by any other matter, whether pictorial or not, appearing on the label.

3. The figures and letters in every word in any statement to which the preceding paragraph applies—

( a ) shall be in characters of uniform colour and size (being not less than 1.5 millimetres in height for a label on a container of which the greatest dimension does not exceed 12 centimetres and not less than 3 millimetres in height for a label on a container of which the greatest dimension exceeds 12 centimetres), but so that the initial letter of any word may be taller than any other letter in the word;

( b ) shall appear on a contrasting ground, so however that where there is no ground other than such as is provided by a transparent container and the contents of that container are visible behind the letters, those contents shall be taken to be the ground for the purposes of this paragraph;

( c ) shall be within a surrounding line and no other written or pictorial matter shall appear within that line.

4. For the purposes of this Schedule—

( a ) the height of any lower case letter shall be taken to be the height thereof, disregarding any ascender or descender thereof;

( b ) any requirement that figures or letters shall be of uniform height, colour or size, shall be construed as being subject to the saving that any inconsiderable variation in height, colour or size, as the case may be, may be disregarded.

Dated this 8th day of April, 1994.

WILLIAM O'DEA,

Minister of State at the Department of Health.

EXPLANATORY NOTE.

These Regulations consolidate the law on emulsifiers, stabilisers, thickeners and gelling agents. They also implement Council Directive 74/329/EEC as amended by Council Directive 78/612 on the approximation of the laws of the Member States relating to emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs, Council Directive 78/663/EEC as last amended by Council Directive ????2/4/EEC laying down specific criteria of purity for emulsifiers, stabilisers, thickeners and gelling agents for use in foodstuffs.

The Regulations prohibit the manufacture, importation, distribution or sale of food which contains any emulsifier or stabiliser other than a permitted emulsifier or stabiliser and prescribe criteria of purity for these substances. In addition, the Regulations specify that certain emulsifiers and stabilisers may be used only in particular foodstuffs and restrict other specified foods to containing only particular permitted emulsifiers and stabilisers, subject to prescribed limits in each case.

The Regulations prohibit the manufacture, importation, distribution, sale or advertisement for sale of any emulsifier or stabiliser for use as an ingredient in the preparation of food, other than a permitted emulsifier or stabiliser. Also, the Regulations prescribe labelling requirements for permitted emulsifiers and stabilisers to be sold as ingredients in the preparation of food and prohibit the labelling or advertising of any permitted emulsifier or stabiliser to be sold as an ingredient in the preparation of food which would indicate that the substance is a nutritive substitute for fat or eggs.