S.I. No. 128/1997 - European Communities Detailed Provisions on the Control of Additives, Other Than Colours and Sweeteners For Use in Foodstuffs) Regulations, 1997


S.I. No. 128 of 1997.

EUROPEAN COMMUNITIES DETAILED PROVISIONS ON THE CONTROL OF ADDITIVES, OTHER THAN COLOURS AND SWEETENERS FOR USE IN FOODSTUFFS) REGULATIONS, 1997

The Minister for Health in exercise of the powers conferred on him by Section 3 of the European Communities Act, 1972 (No. 27 of 1972) hereby makes the following Regulations for the purpose of giving effect to European Parliament and Council Directive 95/2/EC1 on food additives, other than colours and sweeteners, for use in foodstuffs:

1O.J No. L61, 18.3.1995, pp. 140

1. These Regulations may be cited as the European Communities (Detailed Provisions on the Control of Additives, other than Colours and Sweeteners, for use in Foodstuffs) Regulations, 1997.

2. These Regulations shall come into force on the 25th day of March, 1997.

3. (1) In these Regulations any reference to an article or Schedule shall, except where otherwise indicated, be construed as a reference to an article contained in these Regulations or, as may be, to the Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

(2) In these Regulations words and phrases shall have the same meaning as in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

4. (1) These Regulations make detailed provisions for the use in foodstuffs of the categories of food additives defined in sub-article (2). The general provisions for the use of these food additives are laid down in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

(2) For the purpose of these Regulations

( a ) 'preservatives' are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by micro-organisms;

( b ) 'antioxidants' are substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes,

( c ) 'carriers', including carrier solvents, are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;

( d ) 'acids' are substances which increase the acidity of a foodstuff and/or impart a sour taste to it;

( e ) 'acidity regulators' are substances which alter or control the acidity or alkalinity of a foodstuff,

( f ) 'anti-caking agents' are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another;

( g ) 'anti-foaming agents' are substances which pre-vent or reduce foaming;

( h ) 'hulking agents' are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value;

( i ) 'emulsifiers' are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff;

( j ) 'emulsifying salts' are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components;

( k ) 'firming agents' are substances which make tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel;

( l ) 'flavour enhancers' are substances which enhance the existing taste and/or odour of a foodstuff;

( m ) 'foaming agents' are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;

( n ) gelling agents' are substances which give a foodstuff texture through formation of a gel,

( o ) 'glazing agents' (including lubricants) are substances which, when applied to the external surface offoodstuff, impart a shiny appearance or provide a protective coating;

( p ) 'humectants' are substances which pre-vent foodstuffs from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium;

( q ) 'modified starches' are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached:

( r ) 'packaging gases' are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container;

( s ) 'propellants' are gases other than air which expel a foodstuff from a container;

( t ) 'raising agents' are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;

( u ) 'sequestrants' are substances which form chemical complexes with metallic ions;

( v ) 'stabilisers' are substances which make it possible to maintain the physio-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff and include also substances which stabilise, retain or intensify an existing colour of a foodstuff; and

( w ) 'thickeners' are substances which increase the viscosity of a foodstuff.

(3) These Regulations do not apply to flour treatment agents, colours or sweeteners for use in foodstuffs for human consumption where

— flour treatment agents, other than emulsifiers, are substances which are added to flour or dough to improve its baking quality, and

— colours and sweeteners are as defined in and regulated by the European Communities (General Provisions on the Control of Additives, and in particular Colours and Sweeteners for use in Foodstuffs) Regulations, 1995 ( S.I. No. 344 of 1995 ).

(4) For the purposes of these Regulations the following are not considered as food additives:

( a ) substances used for treatment of drinking water as provided for in Directive 80/778/EEC 2

2O.J No. L 229. 30.8.1980. p. 11

( b ) products containing pectin and derived from dried apple pomace or peel of citrus fruits, or from a mixture of both, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (liquid pectin');

( c ) chewing gum bases;

( d ) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes,

( e ) ammonium chloride;

( f ) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten;

( g ) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts and having no additive function;

( h ) caseinates and casein; and

( i ) inulin.

5. (1) Only substances listed in Parts A, C, D and E of the Schedule may be used in foodstuffs for the purposes mentioned in Article 4(2).

(2) Subject to sub-articles (3) and (4), food additives listed in Part A of the Schedule are permitted in foodstuffs, for the purposes mentioned in Article 4(2), following the 'quantum satis' principle.

(3) Sub-article (2) does not apply in the case of foodstuffs listed in Part B of the Schedule.

(4) Except where specifically provided for, sub-article (2) does not apply to:

( a ) - unprocessed foodstuffs,

- honey as defined in Directive 74/409/EEC 3,

3O.J No. L 221. 12.8.1974. p. 11

- non-emulsified oils and fats of animal or vegetable origin,

- butter,

- pasteurised and sterilised (including UHT sterilisation) milk and cream (including skimmed, plain and semi--skimmed),

- unflavoured, live fermented milk products,

- natural mineral water as defined in Directive 80/777/EEC 4 and spring water,

4O.J No. L 229. 30.8. 1980. p. 1

- coffee (excluding flavoured instant coffee ) and coffee extracts,

- unflavoured leaf tea,

- sugars as defined in Directive 73/437/EEC 5

5O.J No. L 356. 27.12.1973. p. 1

- dry pasta

- natural unflavoured buttermilk (excluding sterilised buttermilk);

( b ) food for infants and young children as referred to in the Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ) including foods for infants and young children not in good health; these foodstuffs are subject to the provisions of Part F of the Schedule; and

( c ) the foodstuffs listed in Part B of the Schedule which may contain only those food additives referred to in that Part and those food additives referred to in Parts C and D under the conditions specified therein.

(5) Food additives listed in Parts C and D of the Schedule may only used in the foodstuff's referred to in those Parts and under the conditions specified therein.

(6) Only those food additives listed in Part E of the Schedule may be used as carriers or carrier solvents for food additives and must be used under the conditions specified therein.

(7) The provisions of these Regulations shall also apply to the corresponding foodstuffs intended for particular nutritional uses in accordance with the Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ).

(8) Maximum levels indicated in the Parts to the Schedule refer to foodstuff's as marketed, unless otherwise stated.

6. (1) These Regulations shall be enforced and executed by each health board, established in accordance with the Health Act 1970 (No. 1 of 1970) in respect of its functional area through its authorised officers and/or the officers of the Minister for Health who are authorised officers for the purposes of these Regulations.

(2) For the purposes of these Regulations, "authorised officer" means:

( a ) an officer of the Minister for Health who is authorised in writing by the Minister for Health to be an authorised officer for the purposes of these Regulations; or

( b ) an officer of a health board who is authorised in writing by the Chief Executive Officer of the health board to be an authorised officer for the purposes of these Regulations

7. For the purposes of ensuring compliance with the Regulations, the control system established under the provisions of the Health (Official Control of Food) Regulations, 1996 ( S.I. No. 241 of 1996 ) shall apply.

8. (1) Where an authorised officer reasonably suspects or believes that a foodstuff or food additive does not comply with these Regulations, the authorised officer may seize and/or remove and/or detain such foodstuffs or food additive as being a foodstuff or food additive which is unfit for human consumption.

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

(3) An authorised officer who has seized any foodstuff or food additive in pursuance of the provisions of this article may, on giving notice in writing to the owner or person responsible for such foodstuff or food additive apply to a Judge of the District Court for an Order directing that such food or food additive be destroyed or otherwise disposed of as being a foodstuff or food additive 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 foodstuff or food additive 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 a foodstuff or food additive which is unfit for human consumption and an officer shall destroy or dispose of it accordingly.

9. 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 relating to the composition and use of any foodstuff or food additive and the identity of the person from whom or the place from which any such foodstuff or food additive has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has been consigned or the manner in which it has otherwise been disposed of.

10. 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.

11. (1) Any person who contravenes any article or sub-article of these Regulations shall be guilty of an offence.

(2) A person guilty of an offence under these Regulations shall be liable on summary conviction to a Fine not exceeding £1.000 or at the discretion of the Court, to imprisonment for a term not exceeding 6 months or to both.

(3) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of a director, manager, secretary or other officer of the body corporate, the director, manager, secretary or other officer or any person purporting to act in such capacity shall, as well as the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished accordingly.

(4) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted within 12 months from the date of the offence.

12. An offence under these Regulations shall be prosecuted by the Minister for Health or by a health board in whose functional area the offence was committed.

13. (1) The following Regulations are hereby revoked:

Health (Antioxidant in Food) Regulations, 1973 ( S.I. No. 148 of 1973 ),

Health (Antioxidant in Food) (Amendment) Regulations, 1983 ( S.I. No. 61 of 1983 );

Health (Antioxidant in Food) (Amendment) Regulations, 1992 ( S.I. No. 69 of 1992 ),

Health (Emulsifiers, Stabilisers, Thickening and Gelling Agents in Food) Regulations, 1994 ( S.I. No. 78 of 1994 );

Health (Preservatives in Food) Regulations, 1981 (S.I. No. 337 of 1981),

Health (Preservatives in Food) (Amendment) Regulations, 1989 ( S.I. No. 263 of 1989 );

Health (Preservatives in Food) (Amendment) Regulations, 1992 ( S.I. No. 66 of 1992 );

Health (Solvents in Food) Regulation, 1972 ( S.I. No. 340 of 1972 ); and

Health (Solvents in Food) (Amendment) Regulations. 1992 ( S.I. No. 70 of 1992 ).

(2) References in another instrument to any of the Regulations revoked under sub-article (1) shall be construed as references to these Regulations, as appropriate.

SCHEDULE

PART A

FOOD ADDITIVES GENERALLY PERMITTED FOR USE IN FOODSTUFFS NOT REFERRED TO IN ARTICLE 12 (3)

Notes

1. Substances on this list may be added to all foodstuffs with the exception of those referred to in Article 12(3) following the quantum satis principle.

2. The substances listed under numbers E 407 and E 440 may be standardised with sugars, on condition that this is stated in addition to the number and designation.

3. Explanation of symbols used:

* The substances E 290, E 93 8, E 939, E 94I, E 942 and E 948 may also be used in the foodstuffs referred to in Article 12 (3).

# The substances E410, E 412, E 415 and E 417 may not be used to produce dehydrated foodstuffs intended to rehydrate on ingestion.

E No

Name

E 170

Calcium Carbonates

(i) Calcium carbonate

(ii) Calcium hydrogen carbonate

E 260

Acetic acid

E 261

Potassium acetate

E 262

Sodium acetates

(i) Sodium acetate

(ii) Sodium hydrogen acetate (sodium diacetate)

E 263

Calcium acetate

E 270

Lactic acid

E 290

Carbon dioxide*

E 296

Malic acid

E 300

Ascorbic acid

E 301

Sodium ascorbate

E 302

Calcium ascorbate

E 304

Fatty acid esters of ascorbic acid

(i) Ascorbyl palmitate

(ii) Ascorbyl stearate

E 306

Tocopherol-rich extract

E 307

Alpha-tocopherol

E 308

Gamma-tocopherol

E 309

Delta-tocopherol

E 322

Lecithins

E 325

Sodium lactate

E 326

Potassium lactate

E 327

Calcium lactate

E 330

Citric acid

E 331

Sodium citrates

(i) Monosodium citrate

(ii) Disodium citrate

(iii) Trisodium citrate

E 332

Potassium citrates

(i) Monopotassium citrate

(ii) Tripotassium citrate

E 333

Calcium citrates

(i) Monocalcium citrate

(ii) Dicalcium citrate

(iii) Tricalcium citrate

E 334

Tartaric acid (L(+)—)

E 335

Sodium tartrates

(i) Monosodium tartrate

(ii) Disodium tartrate

E 336

Potassium tartrates

(i) Monopotassium tartrate

(ii) Dipotassium tartrate

E 337

Sodium potassium tartrate

E 350

Sodium malates

(i) Sodium malate

(ii) Sodium hydrogen malate

E 351

Potassium malate

E 352

Calcium malates

(i) Calcium malate

(ii) Calcium hydrogen malate

E 354

Calcium tartrate

E 380

Triammonium citrate

E 400

Alginic acid

E 401

Sodium alginate

E 402

Potassium alginate

E 403

Ammonium alginate

E 404

Calcium alginate

E 406

Agar

E 407

Carrageenan

E 410

Locust bean gum#

E 412

Guar gum#

E 413

Tragacanth

E 414

Acacia gum (gum arable)

E 415

Xanthan gum#

E 417

Tara gum#

E 418

Gellan gum

E 422

Glycerol

E 440

Pectins

(i) pectin

(ii) amidated pectin

E 460

Cellulose

(i) Microcrystalline cellulose

(ii) Powdered cellulose

E 461

Methyl cellulose

E 463

Hydroxypropyl cellulose

E 464

Hydroxypropyl methyl cellulose

E 465

Ethyl methyl cellulose

E 466

Carboxy methyl cellulose

Sodium carboxy methyl cellulose

E 470a

Sodium, potassium and calcium salts of fatty acids

E 470b

Magnesium salts of fatty acids

E 471

Mono- and di-glycerides of fatty acids

E 472a

Acetic acid esters of mono- and di-glycerides of fatty acids

E 472b

Lactic acid esters of mono- and di-glycerides of fatty acids

E 472c

Citric acid esters of mono- and di-glycerides of fatty acids

E 472d

Tartaric acid esters of mono- and di-glycerides of fatty acids

E 472e

Mono- and diacetyl tartaric acid esters of mono- and di-glycerides of fatty acids

E 472f

Mixed acetic and tartaric acid esters of mono- and di-glycerides of fatty acids

E 500

Sodium carbonates

(i) Sodium carbonate

(ii) Sodium hydrogen carbonate

(iii) Sodium sesquicarbonate

E 501

Potassium carbonates

(i) Potassium carbonate

(ii) Potassium hydrogen carbonate

E 503

Ammonium carbonates

(i) Ammonium carbonate

(ii) Ammonium hydrogen carbonate

E 504

Magnesium carbonates

(i) Magnesium carbonate

(ii) Magnesium hydroxide carbonate (syn.: Magnesium hydrogen carbonate)

E 507

Hydrochloric acid

E 508

Potassium chloride

E 509

Calcium chloride

E 511

Magnesium chloride

E 513

Sulphuric acid

E 514

Sodium sulphates

(i) Sodium sulphate

(ii) Sodium hydrogen sulphate

E 515

Potassium sulphates

(i) Potassium sulphate

(ii) Potassium hydrogen sulphate

E 516

Calcium sulphate

E 524

Sodium hydroxide

E 525

Potassium hydroxide

E 526

Calcium hydroxide

E 527

Ammonium hydroxide

E 528

Magnesium hydroxide

E 529

Calcium oxide

E 530

Magnesium oxide

E 570

Fatty acids

E 574

Gluconic acid

E 575

Glucono-delta-lactone

E 576

Sodium gluconate

E 577

Potassium gluconate

E 578

Calcium gluconate

E 640

Glycine and its sodium salt

E 938

Argon*

E 939

Helium*

E 941

Nitrogen*

E 942

Nitrous oxide*

E 948

Oxygen*

E 1200

Polydextrose

E 1404

Oxidised starch

E 1410

Monostarch phosphate

E 1412

Distarch phosphate

E 1413

Phosphated distarch phosphate

E 1414

Acetylated distarch phosphate

E 1420

Acetylated starch

E 1422

Acetylated distarch adipate

E 1440

Hydroxy propyl starch

E 1442

Hydroxy propyl distarch phosphate

E 1450

Starch sodium octenyl succinate

PART B

FOODSTUFFS IN WHICH A LIMITED NUMBER OF ADDITIVES OF PART A MAY BE USED

Foodstuff

Additive

Maximum Level

Cocoa and chocolate products as defined in Directive 73/241/EEC1

E 330 Citric Acid

E 322 Lecithins

E 334 Tartaric acid

0.5%

quantum satis

0.5%

E422 Glycerol

quantum satis

E 471 Mono-and di-glycerides of fatty acids

quantum satis

E 170 Calcium carbonates

)

E 500 Sodium carbonates

)

E 501 Potassium carbonates

)

E 503 Ammonium carbonates

)

E 504 Magnesium carbonates

) 7% on dry matter without

E 524 Sodium hydroxide

) fat expressed as

E 525 Potassium hydroxide

) potassium carbonates

E 526 Calcium hydroxide

)

E 527 Ammonium hydroxide

)

E 528 Magnesium hydroxide

)

E 530 Magnesium oxide

)

E414 Acacia gum

) as glazing agents only

E440 Pectins

) quantum satis

Fruit juices and nectars as defined in Directive 93/77/EEC2

E300 Ascorbic acid

quantum satis

Pineapple juice as defined in Directive 93/77/EEC

E296 Malic acid

3 g/l

Nectars as defined in Directive 93/77/EEC

Grape juice as defined in Directive 93/77/EEC

Fruit juices as defined in Directive 93/77/EEC

E 330 Citric acid

E270 lactic acid

5 g/l

5g/l

E 170 Calcium carbonates

E 336 Potassium tartrates

quantum satis

quantum satis

E 330 Citric acid

3g/l

Extra jam and extra jelly, as defined in Directive 79/693/EEC3

E440 Pectins

quantum satis

E 270 Lactic acid

quantum satis

E 296 Malic acid

E 300 Ascorbic acid

E 327 Calcium lactate

E 330 Citric acid

E 331 Sodium citrates

E 333 Calcium citrates

E 334 Tartaric acid

E 335 Sodium tartrates

E 350 Sodium malates

E 471 Mono- and di-glycerides of fatty acids

quantum satis

1O.J No. 228. 16.8.1973. p.23

Coca and chocolate products energy-reduced or with no added sugars are not covered by Schedule II

2O.J. No L 244. 30.9.1993, p.23

3O.J. No. L205. 13. 8. 1979. p. 5

Foodstuff

Additive

Maximum Level

Jams, jellies and marmalades as defined in Directive 79/693/EEC and other similar fruit spreads including low-calorie products

E 440 Pectins

quantum satis

E 270 Lactic acid

quantum satis

E 296 Malic acid

E 300 Ascorbic acid

E 327 Calcium lactate

E 330 Citric acid

E 331 Sodium citrates

E 333 Calcium citrates

E 334 Tartaric acid

E 335 Sodium tartrates

E 350 Sodium malates

E 400 Alginic acid

10g/kg

E 401 Sodium alginate

E 402 Potassium alginate

(individually or in combination)

E 403 Ammonium alginate

E 404 Calcium alginate

E 406 Agar

E 407 Carrageenan

E 410 Locust bean gum

E 412 Guar gum

E 415 Xanthan gum

E 418 Gellan Gum

E 509 Calcium chloride

quantum satis

E 524 Sodium hydroxide

Partially dehydrated and dehydrated milk as detined in Directive 76/118/EEC'

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 304 Fatty acid esters of ascorbic acid

quantum satis

E 322 Lecithins

E 331 Sodium citrates

E 332 Potassium citrates

E 407 Carrageenan

E 500 (ii) Sodium bicarbonate

E 501 (ii) Potassium bicarbonate

E 509 Calcium chloride

Sterilised, pasteurised and UHT cream, low-calorie cream and pasteurised low-fat cream

E 270 Lactic acid

E 322 Lecithins

E 325 Sodium lactate

quantum satis

E 326 Potassium lactate

E 327 Calcium lactate

E 330 Citric acid

E 331 Sodium citrates

E 332 Potassium citrates

quantum satis

E 333 Calcium citrates

E 400 Alginic acid

E 401 Sodium alginate

E 402 Potassium alginate

E 403 Ammonium alginate

1 O.J. No L 24. 30.1.1976, p. 49

Foodstuff

Additive

Maximum Level

E 404 Calcium alginate

E 406 Agar

E 407 Carrageenan

E 410 Locust bean gum

E 415 Xanthan gum

E 440 Pectins

E 460 Celluloses

E 461 Methyl cellulose

E 463 Hydroxypropyl cellulose

E 464 Hydroxypropyl methyl cellulose

E 465 Ethyl methyl cellulose

E 466 Carboxy methyl cellulose

Sodium carboxy methyl cellulose

E 471 Mono- and di-glycerides of fatty acids

E 508 Potassium chloride

E 509 Calcium chloride

E 1404 Oxidised starch

E 1410 Monostarch phosphate

E 1412 Distarch phosphate

E 1413 Phosphated distarch phosphate

E 1414 Acetylated distarch phosphate

E 1420 Acetylated starch

E 1422 Acetylated distarch adipate

E 1440 Hydroxy propyl starch

E 1442 Hydroxy propyl distarch phosphate

E 1450 Starch sodium octenyl succinate

Frozen and deep-frozen unprocessed fruit and vegetables

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 302 Calcium ascorbate

quantum satis

E 330 Citric acid

Fruit compote

E 331 Sodium citrates

quantum satis

Unprocessed fish, crustaceans and molluscs, including such products frozen and deep-frozen

E 332 Potassium citrates

E 333 Calcium citrates

Quick-cook rice

E 471 Mono- and di-glycerides of fatty acids

quantum satis

E 472a Acetic acid esters of mono- and di-glycerides of fatty acids

Non emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils)

E 304 Fatty acid esters of ascorbic acid

E 306 Tocopherol-rich extract

E 307 Alphatocopherol

E 308 Gamma-tocopherol

E309 Deltatocopherol

quantum satis

E 322 Lecithins

30g/l

E 471 Mono and diglycerides of fatty acids

10 a/l

E 330 Citric acid

quantum satis

E331 Sodium citrates

E 332 Potassium citrates

E 333 Calcium citrates

Refined olive oil, including olive pomace oil

E 307 Alpha-tocopherol

200 mg/l

Ripened cheese

E 170 Calcium carbonates

quantum satis

E 504 Magnesium carbonates

E 509 Calcium chloride

E 575 Glucono-delta-lactone

Mozzarella and whey cheese

E 270 Lactic acid

quantum satis

E 330 Citric acid

E 575 Glucono-delta-lactone

Canned and bottled Fruit and vegetables

E 260 Acetic acid

quantum satis

E 261 Potassium acetate

E 262 Sodium acetates

E 263 Calcium acetate

E 270 Lactic acid

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 302 Calcium ascorbate

E 325 Sodium lactate

E 326 Potassium lactate

E 327 Calcium lactate

E 330 Citric acid

E 331 Sodium citrates

E 332 Potassium citrates

E 333 Calcium citrates

E 334 Tartaric acid

E 335 Sodium tartrates

E 336 Potassium tartrates

E 337 Sodium potassium tartrate

E 509 Calcium chloride

E 575 Glucono-delta-lactone

Gehakt

E 330 Citric acid

quantum satis

E 331 Sodium citrates

E 332 Potassium citrates

E 333 Calcium citrates

Pre-packed preparations of fresh minced meat

E 300 Ascorbic acid

E 301 Sodium ascorbate

quantum satis

E 302 Calcium ascorbate

E 330 Citric acid

E 331 Sodium citrates

E 332 Potassium citrates

E 333 Calcium citrates

Bread prepared solely with the following ingredients: wheatflour. Water, yeast or leaven, salt

E 260 Acetic acid

E 261 Potassium acetate

E 262 Sodium acetates

quantum satis

E 263 Calcium acetate

E 270 Lactic acid

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 302 Calcium ascorbate

E 304 Fatty acid esters of ascorbic acid

E 322 Lecithins

E 325 Sodium lactate

E 326 Potassium lactate

E 327 Calcium lactate

E 471 Mono- and di-glycerides of fatty acids

E 472a Acetic acid esters of mono- and di-glycendes of tatty acids

E 472d Tartaric acid esters of mono- and di-glycendes of tatty acids

E 472e Mono- and di-acetyl tartaric acid esters of mono and di-glycerides of fatty acids

E 472f Mixed acetic and tartaric acid esters of mono- and di-glycerides of fatty acids

Pain courant franais

E 260 Acetic acid

quantum satis

E 261 Potassium acetate

E 262 Sodium acetates

E 263 Calcium acetate

E 270 Lactic acid

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 302 Calcium ascorbate

E 304 Fatty acid esters of ascorbic acid

E 322 Lecithins

E 325 Sodium lactate

E 326 Potassium lactate

E 327 Calcium lactate

E 471 Mono- and di-glycerides of fatty acids

Fresh pasta

E 270 Lactic acid

quantum satis

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 322 Lecithins

E 330 Citric acid

E 334 Tartaric acid

E 471 Mono- and di-glycerides of fatty acids

E 575 Glucono-delta-lactone

Wines and sparkling wines and partially fermented grape must

Additives authorised:

in accordance with Regulations (EEC) No 822/871, (EEC) No 4252/882, (EEC) No 2332/923 and (EEC) No 1873/844 and their implementing regulations,

in accordance with Regulation (EEC) No 1873/84 authorising the oiler or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79

pro memoria

Beer

E 270 Lactic acid

E 300 Ascorbic acid

E 301 Sodium ascorbate

E 330 Citric acid

E 414 Acacia gum

Foie gras, foie gras enter, blocs de foie gras

E 300 Ascorbic acid

E 301 Sodium ascorbate

quantum satis

1 O.J. No L 84. 27.3.1987. p. 1

2 O.J. No L373. 31.12.1988. p.59

3 O.J. No L231.13.8.1992. p.1

4 O.J. No L 176, 3.7.1984. p.6

PART C

CONDITIONALLY PERMITTED PRESERVATIVES AND ANTIOXIDANTS

SECTION I

Sorbates, benzoates and p-hydroxybenzoates

E No

Name

Abbreviation

E 200

Sorbic acid

] Sa

E 202

Potassium sorbate

]

E 203

Calcium sorbate

]

E 210

Benzoic acid

]

E 211

Sodium benzoate

] Ba (1)

E 212

Potassium benzoate

]

E 213

Calcium benzoate

]

E 214

Ethyl p-hydroxybenzoate

]

E 215

Sodium ethyl p-hydroxybenzoate

]

E 216

Propyl p-hydroxybenzoate

] PHB

E 217

Sodium propyl p-hydroxybenzoate

]

E 218

Methyl p-hydroxybenzoate

]

E 219

Sodium methyl p-hydroxybenzoate

]

(1) Benzoic acid may be pre-sent in certain fermented products resulting from the fermentation process following good manufacturing practice.

Note

1. The levels of all substances mentioned above are expressed as the free acid.

2. The abbreviations used in the table mean the following:

-

Sa+Ba:

Sa and Ba used singly or in combination

-

Sa+PHB:

Sa and PHB used singly or in combination

-

Sa+Ba+PHB:

Sa, Ba and PHB used singly or in combination.

3. The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

FOODSTUFF

Maximum level (mg/kg or mg/l as appropriate)

Sa

Ba

PHB

Sa+ Ba

Sa + PHB

Sa+Ba+ PHB

Wine-based flavoured drinks including products covered by Regulation (EEC) No 1601/91

200

Non-alcoholic flavoured drinks(1)

300

150

250 Sa + 150 Ba

Liquid tea concentrates and liquid fruit and herbal infusion concentrates

600

Grape juice, unfermented, for sacramental use

2000

Wines as referred to in Regulation (EEC) No 822/87(2), alcohol-free wine: fruit wine (including alcohol-free): Made wine: cider and perry (including alcohol-free)

200

Sd Saft or Sidet Saft

500

200

Alcohol-free beer in keg

200

Mead

200

Spirits with less than 15% alcohol by volume

200

200

400

Fillings of ravioli and similar products

1000

Low-sugar jams, jellies, marmalades and similar low calorie or sugar-free products and other fruit-based spreads

Mermeladas

500

1000

Candied, crystallised and glace fruit and vegetables

1000

Dried truit

1000

Frugtgred and Rote Grtze

1000

500

Fruit and vegetable preparations including fruit-based sauces, excluding puree, mousse, compote, salads and similar products, canned or bottled

1000

Vegetables in vinegar, brine or oil excluding olives)

2000

Potato dough and pre-fried potato slices

2000

Gnocchi

1000

Polenta

200

Olives and olive-based preparations

1000

(1) This entry docs not include dairy-based drinks.

(2) O.J. No L 84. 27. 3.1987, p. 1.

FOODSTUFF

Maximum level (mg/kg or mg/l as appropriate)

Sa

Ba

PHB

Sa+Ba

Sa + PHB

Sa + Ba + PHB

Surface treatment of dried meat products

quantum satis

Jelly coatings of meat products (cooked, cured or dried), pat

1000

Semi-preserved fish products including fish roe products

2000

Salted, dried tish

200

Shrimps, cooked

2000

Crangon crangon and Crangon vulgaris, cooked

6000

Cheese, pre-packed, sliced

1000

Unripened cheese

1000

Processed cheese

2000

Layered cheese and cheese with added foodstuffs

1000

Non-heat-treated dairy-based desserts

300

Curdled milk

1000

Liquid egg (white, yolk or whole egg)

5000

Dehydrated, concentrated, frozen and deep-frozen egg products

1000

Pre-packed sliced bread and rye-bread

2000

Partially baked, pre-packed bakery wares intended for retail sale

2000

Fine bakery wares with a water activity of more than 0.65

2000

Cereal- or potato-based snacks and coated nuts

1000 (max. 300 PHB)

Batters

2000

Confectionery (excluding chocolate)

1500 (max. 300 PHB)

Chewing gum

1500

Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)

1000

Fat emulsions (excluding butter) with a tat content of 60% or more

1000

Fat emulsions with a fat content less than 60%

2000

Emulsified sauces with a tat content of 60% or more

1000

Emulsified sauces with a fat content less than 60%

2000

Non-emulsified sauces

1000

Prepared salads

1500

Mustard

1000

Seasonings and condiments

1000

Liquid soups and broths (excluding canned)

500

Aspic

1000

500

Liquid dietary food supplements

2000

Dietetic foods intended for special medical purposes excluding foods for infants and young children as referred to in Directive 89/398/EEC(1) - dietetic formulae for weight control intended to replace total daily food intake or an individual meal

1500

(1) O.J. No. L 186,30.6. 1989, p. 27

SECTION 2

Sulphur dioxide and sulphites

E NO

NAME

E 220

Sulphur dioxide

E 221

Sodium sulphite

E 222

Sodium hydrogen sulphite

E 223

Sodium metabisulphite

E 224

Potassium metabisulphite

E 226

Calcium sulphite

E 227

Calcium hydrogen sulphite

E 228

Potassium hydrogen sulphite

Note

1. Maximum levels are expressed as SO; in mg/kg or mg/l as appropriate and relate to the total quantity, available from all sources.

2. An SO2 content of not more than 10 mg/kg or 10 mg/l is not considered to be pre-sent.

FOODSTUFF

Maximum level (mg/kg or mg/l as appropriate)

Expressed as SO2

Burger meat with a minimum vegetable and/or cereal content of 4%

450

Breakfast sausages

450

Longaniza fresca and Butifarra fresca

450

Dried salted Fish of the 'Gadidae' species

200

Crustaceans and cephalopods

- fresh, frozen and deep-frozen

crustaceans, penaeidae solenceridae, aristeidae family:

- up to 80 units

- between 80 and 120 units

- over 120 units

- cooked

150(1)

150(1)

200(1)

300(1)

50(1)

Dry biscuit

50

Starches (excluding starches for weaning foods, follow-on formulae and infant formulae)

50

Sago

30

Pearl barley

30

Dehydrated granulated potatoes

400

Cereal- and potato-based snacks

50

Peeled potatoes

50

Processed potatoes (including frozen and deep-frozen potatoes)

100

Potato dough

100

White vegetables, dried

400

White vegetables, processed (including frozen and deep-frozen white vegetables)

50

Dried ginger

150

Dried tomatoes

200

Horseradish pulp

800

Onion, garlic and shallot pulp

300

Vegetables and fruits in vinegar, oil or brine (except olives and golden peppers in brine)

100

Golden peppers in brine

500

Processed mushrooms (including frozen mushrooms)

50

Dried mushrooms

100

Dried fruits

- apricots, peaches, grapes, prunes and figs

- bananas

- apples and pears

- other (including nuts in shell)

2000

1000

600

500

Dried coconut

50

Candied, crystallised or glace fruit, vegetables, angelica and citrus peel

100

Jam, jelly and marmalade as defined in Directive 79/693/EEC (except extra jam and extra jelly) and other similar fruit spreads including low-calorie products

50

Jams, jellies and marmelades made with sulphited fruit

100

Fruit-based pie fillings

100

Citrus-juice-based seasonings

200

Concentrated grape juice for home wine-making

2000

Mostarda di frutta

100

Jellying fruit extract, liquid pectin for sale to the final consumer

800

Bottled whiteheart cherries, rehydrated dried fruit and lychees

100

Bottled, sliced lemon

250

Sugars as defined in Directive 73/437/EEC except glucose syrup, whether or not dehydrated

15

Glucose syrup, whether or not dehydrated

20

Treacle and molasses

70

Other sugars

40

Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)

40

Orange, grapefruit, apple and pineapple juice for bulk dispensing in catering establishments

50

Lime and lemon juice

350

Concentrates based on fruit juice and containing not less than 2.5% barley (barley water)

350

Other concentrates based on fruit juice or comminuted fruit: capile groselha

250

Non-alcoholic flavoured drinks containing fruit juice

20

(Carry-over from concentrates only)

Non-alcoholic flavoured drinks containing at least 235 g/l glucose syrup

50

Grape juice, unfermented, for sacramental use

70

Glucose-syrup-based confectionery

50

carry-over from the glucose syrup only)

Beer including low-alcohol and alcohol-free beer

20

Beer with a second fermentation in the cask

50

Wines

In accordance with Regulations (EEC) No 822/87. (EEC) No 4252/88. (EEC) No. 2332/92 and (EEC) No 1873/84 and their implementing regulations:

(pro memoria) in accordance with Regulation (EEC) No 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79.

Alcohol-free wine

200

Made wine

260

Cider, perry, fruit wine. sparkling fruit wine (including alcohol-free products)

200

Mead

200

Fermentation vinegar

170

Mustard, excluding Dijon mustard

250

Dijon mustard

500

Gelatin

50

Vegetable- and cereal-protein-based meat, fish and crustacean analogues

200

(1) In edible parts.

SECTION 3

OTHER PRESERVATIVES

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 230

Biphenyl. diphenyl

Surface treatment of citrus fruits

70 mg/kg

E 231

Orthophenyl phenol

]

Surface treatment of citrus fruits

12 mg/kg individually or in combination expressed as orthophenyl phenol

]

E 232

Sodium orthophenyl phenol

]

]

E 233

Thiabendazole

Surface treatment of:

- citrus fruit

- bananas

6 mg/kg

3 mg/kg

E 234

Nisin(1)

Semolina and tapioca puddings and similar products

Ripened cheese and processed cheese

Clotted cream

3 mg/kg

12.5 mg/kg

10 mg/kg

E 235

Natamycin

Surface treatment of:

- hard, semi-hard and semi-soft cheese

- dried, cured sausages

]

]

]

1 mg/dm2 surface (not present at a depth of 5 mm)

E 239

Hexamethylene tetramine

Provolone cheese

25 mg/kg residual amount, expressed as formaldehyde

E 242

Dimethyl dicarbonate

Non-alcoholic flavoured drinks

Alcohol-free wine

Liquid-tea concentrate

250 mg/l ingoing amount, residues not detectable

E 284

Boric acid

Sturgeons' eggs (Caviar)

4 g/kg expressed as boric acid

E 285

Sodium tetraborate (borax)

(1) This substance may be present naturally in certain cheeses as a result of fermentation processes.

E NO

NAME

FOODSTUFF

INDICATIVE INGOING AMOUNT

REDIDUAL AMOUNT

mg/kg

E 249

Potassium nitrite (1)

Non-heat-treated, cured, dried meat products

150 (2)

50 (3)

E 250

Sodium nitrite (1)

Other cured meat products

Canned meat products

foie gras, foie gras entier, blocs de foie gras

150 (2)

100 (3)

Cured bacon

175(3)

E 251

Sodium nitrate

Cured meat products

Canned meat products

300

250(4)

E 252

Potassium nitrate

Hard, semi-hard and semi-soft cheese

Dairy-based cheese analogue

50(4)

Pickled herring and sprat

200(5)

(1) When labelled 'for food use', nitrite may only be sold in a mixture with salt or a salt substitute.

(2) Expressed as NaNo2

(3) Residual amount at point of sale to the final consumer, expressed as NaNo2

(4) Expressed as NaNo3

(5)Residual amount, nitrite formed from nitrate included, expressed as NaNo2

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 280

Propionic acid

]

]

Pre-packed sliced bread and rye bread

3000 mg/kg expressed as propionic acid

E 281

Sodium propionate

]

E 282

Calcium propionate

]

Energy reduced bread

Partially baked, pre-packed bread

Pre-packed fine bakery wares (including flour confectionery) with a water activity of more than 0.65

Pre-packed Rolls, buns and pitta

]

]

]

]

]

]

2000 mg/kg expressed as propionic acid

E 283

Potassium propionate

(1)

]

]

Christmas pudding

1000 mg/kg expressed as propionic acid

Pre-packed bread

E 1105

Lysozyme

Ripened cheese

quantum satis

(1) Propionic acid and its salts may be pre-sent in certain fermented products resulting from the fermentation process following good manufacturing practice.

SECTION 4

OTHER ANTIOXIDANTS

Note

The * in the table refers to the proportionality rule: when combinations of gallates, BHA and BHT are used, the individual levels must be reduced proportionally.

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL (mg/kg)

E 310

Propyl gallate

]

]

Fats and oils for the professional manufacture of heat-treated foodstuffs

200* (galates and BHA individually or in combination)

E 311

Octyl gallate

]

]

E312

Dodecyl gallate

]

]

E 320

Butylated hydroxyanisole (BHA)

]

]

Frying oil and frying fat, excluding olive pomace oil

100* (BHT)

E 321

Butylated hydroxytoluene (BHT)

]

]

Lard; fish oil; beef, poultry and sheep fat

both expressed on fat

Cake mixes

Cereal-based snack foods

Milk powder for vending machines

Dehydrated soups and broths

Sauces

Dehydrated meat

Processed nuts

Seasonings and condiments

Pre-cooked cereals

200 (gallates and BHA, individually or incombination)

expressed on fat

Dehydrated granulated potatoes

25 (gallates and BHA. individually or in combination)

Chewing gum

Dietary supplements

400 (gallates, BHT & BHA, individually or in combination)

E 315

Erythorbic acid

Semi-preserved and preserved meat products

500 expressed as erythorbic acid

E 316

Sodium erythorbate

Preserved and semi-preserved fish products

Frozen and deep-frozen fish with red skin

1500 expressed as erythorbic acid

PART D

OTHER PERMITTED ADDITIVES

The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 297

Fumaric acid

(pro memoria)

Wine in accordance with Regulation (EEC) No 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79

Fillings and toppings for fine bakery wares

2.5 g/kg

Sugar confectionery

1 g/kg

Gel-like desserts

Fruit-flavoured desserts

Dry powdered dessert mixes

4 g/kg

Instant powders for fruit -based drinks

1 g/l

Instant tea powder

1 g/l

Chewing gum

2 g/kg

In the following applications, the indicated maximum quantities of phosphoric acid and the phosphates E 338, E 339, E 340, E 341, E 450, E 451 and E 452 may be added individually or in combination (expressed as P2O5)

E 338

Phosphoric acid

Non-alcoholic flavoured drinks

700mg/l(1)

E 339

Sodium phosphates

(i) Monosodium phosphate

(ii) Disodium phosphate

(iii) Trisodium phosphate

]

]

]

]

Sterilised and UHT milk

Partly dehydrated milk with less than 28% solids

Partly dehydrated milk with more than 28% solids

Dried milk and dried skimmed milk

1 g/l

1 g/kg

1.5 g/kg

2.5 g/kg

E 340

Potassium phosphates

(i) Monopotassium phosphate

(ii) Dipotassium phosphate

(iii) Tripotassium phosphate

]

]

]

]

Pasteurised, sterilised and UHT creams

Whipped cream and vegetable fat analogues

Unripened cheese (except Mozzarella)

Processed cheese and processed cheese analogues

Meat products

Sport drinks and prepared table waters

5 g/kg

5 g/kg

2 g/kg

20 g/kg

5 g/kg

0.5 g/1

(1) E only.

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 341

Calcium phosphates

]

Dietary supplements

quantum satis

(i) Monocalcium phosphate

]

(ii) Dicalcium phosphate

]

Salt and its substitutes

10 g/kg

(iii) Tricalcium phosphate

]

Vegetable protein drinks

20g/l

Beverage whiteners

30 g/kg

Beverage whiteners for vending machines

50 g/kg

E 450

Diphosphates

]

Edible ices

1g/kg

(i) Disodium diphosphate

]

Desserts

3 g/kg

(ii) Trisodium diphosphate

]

Dry powdered dessert mixes

7 g/kg

(iii) Tetrasodium diphosphate

]

Fine bakery wares

20 g/kg

(iv) Dipotassium diphosphate

]

Flour

2.5 g/kg

(v) Tetrapotassium diphosphate

]

Flour, self raising

20 g/kg

(vi) Dicalcium diphosphate

]

Soda bread

20 g/kg

(vii) Calcium dihydrogen

]

Liquid egg (white, yolk or whole egg)

10 g/kg

Diphosphate

]

Sauces

5 g/kg

E 451

Triphosphates

]

Soups and broths

3 g/kg

(i) Pentasodium triphosphate

]

Tea and herbal infusions

2g/l

(ii) Pemapotassium

triphosphate

]

]

Cider and perry

2g/l

E 452

Polyphosphates

]

Chewing gum

quantum satis(1)

(i) Sodium polyphosphate

]

Dried powdered foodstuffs

10 g/kg(2)

(ii) Potassium polyphosphate

]

Chocolate and malt dairy-based drinks

2g/l

(iii) Sodium calcium polyphosphate

]

Alcoholic drinks (excluding wine and beer)

1g/l

(iv) Calcium polyphosphates

]

Breakfast cereals

5 g/kg

Snacks

5 g/kg

Surimi

1g/kg

Fish and crustaccan paste

5 g/kg

Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream: similar products)

3 g/kg

Special formulae for particular nutritional uses

5 g/kg

Glazings for meat and vegetable products

4 g/kg

Sugar confectionery

5 g/kg

Icing sugar

10 g/kg

Noodles

2 g/kg

Batters

5 g/kg

Fillets of unprocessed fish, frozen and deep-frozen

5 g/kg

Frozen and deep-frozen crustacean products

3 g/kg

Processed potato products (including frozen deep-frozen, chilled and dried processed products)

5 mg/kg

E 431

Polyoxyethylene (40) stearate

(pro memoria)

Wine in accordance with Regulation (EEC) No 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79

(1) E 341 (ii) only.

(2) E 341 (iii) only.

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 353

Metatartaric acid

Wine in accordance with Regulations (EEC) No 822/87, (EEC) No 4252/88, (EEC) No 2332/92 and (EEC) No 1873/84 and their implementing regulations

Made wine

100 mg/l

E 355

Adipic acid

]

]

Fillings and toppings for fine bakery wares

2 g/kg

E 356

Sodium adipate

]

]

Dry powdered dessert mixes

1 g/kg

E 357

Potassium adipate

]

]

Gel-like desserts

Fruit-flavoured desserts

Powders for home preparation of drinks

6 g/kg

1 g/kg

10 g/l

expressed as adipic acid

E 363

Succinic acid

Desserts

6 g/kg

Soups and broths

5 g/kg

Powders for home preparation of drinks

3 g/l

E 385

Calcium disodium ethylene diamine tetraacetate (Calcium disodium EDTA)

Emulsified sauces

Canned and bottled pulses, legumes mushrooms

and artichokes

Canned and bottled crustaceans and molluscs

Canned and bottled fish

Minarine

Frozen and deep-frozen crustaceans

75 mg/kg

250 mg/kg

75 mg/kg

75 mg/kg

100 mg/kg

75 mg/kg

E 405

Propane-1, 2—diol alginate

Fat emulsions

Fine bakery wares

Fillings, toppings and coatings for fine bakery wares and desserts

Sugar confectionery

Water-based edible ices

Cereal and potato-based snacks

Sauces

Beer

Chewing gum

Fruit and vegetable preparations

Non-alcoholic flavoured drinks

Emulsified liqueur

Dietetic foods intended for special medical purposes -

Dietitic formulae for weight control intended to replace total Daily food intake or an individual meal

Dietary food supplements

3 g/kg

2 g/kg

5 g/kg

1.5 g/kg

3 g/kg

3 g/kg

8 g/kg

100 mg/l

5 g/kg

5 g/kg

300 mg/l

10 g/l

1.2 g/kg

1.g/kg

E 416

Karaya gum

Cereal- and potato-based snacks

Nut coatings

Fillings, toppings and coatings for fine bakery wares

Desserts

Emulsified sauces

Egg-based liqueurs

Dietary food supplements

Chewing gum

5 g/kg

10 g/kg

5 g/kg

6 g/kg

10 g/kg

10 g/l

quantum satis

5 g/kg

E 420

Sorbitol

(i) Sorbitol

(ii) Sorbitol syrup

]

]

]

Foodstuffs in general (except drinks and those foodstuffs referred to in Article 2(3))

quantum satis

E 421

Mannitol

]

E 953

Isomalt

]

]

]

Frozen and deep-frozen unprocessed fish. crustaccans molluscs and cephalopods

(for purposes other than sweetening)

E 965

Maltitol

(i) Maltitol

(ii) Maltitol syrup

]

]

]

E 966

Lactitol

]

E 967

Xylitol

]

Liqueurs

E 432

Polyoxyethylene sorbitan monolaurate (polysorbate 20)

]

]

]

Fine bakery wares

Fat emulsions for baking purposes

Milk and cream analogues

3 g/kg

10g/kg

5 g/kg

E 433

Polyoxyethylene sorbitan monooleate (polysorbate 80)

]

]

]

]

]

Edible ices

Desserts

Sugar confectionery

Emulsified sauces

Soups

1g/kg

3 g/kg

1 g/kg

5 g/kg

1g/kg

E 434

E 435

E 436

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)

Polyoxyethylene sorbitan monostearate (polysorbate 60)

Polyoxyethylene sorbitan-tristearate (polysorbate 65)

]

]

]

]

]

]

]

]

Chewing gum

Dietary food supplements

Dietetic foods intended for special medical purposes -

Dietetic formulae for weight control intended to replace total Daily food intake or an individual meal

5 g/kg

quantum satis

1g/kg

individually or in combination

E 442

Ammonium phosphatides

Cocoa and chocolate products as defined in Directive 73/241/EEC

10 g/kg

Cocoa-based confectionery

10 g/kg

E 444

Sucrose acetate isobutyrate

Non-alcoholic flavoured cloudy drinks

300 mg/l

E 445

Glycerol esters of wood rosins

Non-alcoholic flavoured cloudy drinks

100 mg/l

E 473

Sucrose esters of fatty acids

]

]

Canned liquid coffee

Heat-treated meat products

1g/l

5 g/kg (on fat)

E 474

Sucroglycerides

]

Fat emulsions for baking purposes

Fine bakery wares

Beverage whiteners

Edible ices

Sugar confectionery

Desserts

Sauces

Soups and broths

Fresh fruits, surface treatment

Non-alcoholic aniseed-based drinks

Non-alcoholic coconut and almond drinks

Spirituous beverages (excluding wine and beer)

Powders for the preparation of hot beverages

Dairy-based drink

Dietary food supplements

10 g/kg

10 g/kg

20 g/kg

5 g/kg

5 g/kg

5 g/kg

10 g/kg

2 g/kg

quantum satis

5g/l

5g/l

5g/l

10g/1

5g/l

quantum satis

Dietetic foods intended for special medical purposes: dietetic formulae for weight control intended to replace total Daily food intake or an individual meal

Chewing gum

5 g/kg

10 g/kg

Individually or in combination

E 475

Polyglycerol esters of fatty acids

Fine bakery wares

10 g/kg

Emulsified liqueurs

5g/l

Egg products

1g/kg

Beverage whiteners

0.5 g/kg

Chewing gum

5 g/kg

Fat emulsions

5 g/kg

Milk and cream analogues

5 g/kg

Sugar confectionery

2 g/kg

Desserts

2 g/kg

Dietary food supplement

quantum satis

Dietetic foods intended for special medical purposes

5 g/kg

Dietetic formulae for weight control intended to replace total daily food intake or an individual meal

Granola-type breakfast cereals

10 g/kg

E 476

Polyglycerol polyricinoleate

Low and very low fat spreads and dressings

Cocoa-based confectionery, including chocolate

4 g/kg

5 g/kg

E 477

Propane-1.2—diol esters of fatty acids

Fine bakery wares

5 g/kg

Fat emulsions for baking purposes

10 g/kg

Milk and cream analogues

5 g/kg

Beverage whiteners

lg/kg

Edible ices

3 g/kg

Sugar confectionery

5 g/kg

Desserts

5 g/kg

Whipped dessert toppings other than cream

30 g/kg

Dietetic foods intended for special medical purposes

1 g/kg

Dietetic formulae for weight control intended to replace total daily food intake or an individual meal

E 479b

Thermally oxidised soya bean oil interacted with mono- and di-glycerides of fatty acids

Fat emulsions for frying purposes

5 g/kg

E 481

Sodium stearoyl-2—lactylate

]

Fine bakery wares

5 g/kg

]

Quick-cook rice

4 g/kg

E 482

Calcium stearoyl-2—lactylate]

]

Breakfast cereals

5 g/kg

Emulsified liqueur

8g/l

Spirits with less than 15% alcohol by volume

8g/l

Cereal-based snacks

2 g/kg

Chewing gum

2 g/kg

Fat emulsions

10 g/kg

Desserts

5 g/kg

Sugar confectionery

5 g/kg

Beverage whiteners

3 g/kg

Cereal-and potato-based snacks

5 g/kg

Minced and diced canned meat products

4 g/kg

Powders for the preparation of hot beverages

2g/l

Dietetic foods intended for special medical purposes -

2 g/kg

Dietetic formulae for weight control intended to replace total daily food intake or an individual meal.

Bread (except that referred to in Part B)

Mostarda di frutta

3g/kg

2g/kg

Individually or in combination

E 483

Stearyl tartrate

Bakery wares (except breads referred to in Part B)

Desserts

4g/kg

5g/kg

E 491

Sorbitan monostearate

]

Fine bakery wares

10g/kg

]

]

Toppings and coatings for fine bakery wares

5g/kg

E 492

Sorbitan tristearate

]

Jelly marmalade

25 mg/kg(1)

]

Fat emulsions

10g/kg

E 493

Sorbitan monolaurate

]

Milk and cream analogues

5g/kg

]

Beverage whiteners

5g/kg

E 494

Sorbitan monooleate

]

]

]

Liquid tea concentrates and liquid fruit and herbal infusions concentrates

0.5 g/l

E 495

Sorbitan monopalmitate

]

Edible ices

0.5 g/kg

Desserts

5g/kg

Sugar confectionery

5g/kg

Cocoa-based confectionery, including chocolate

10 g/kg(2)

Emulsified sauces

5g/kg

Dietary food supplements

quantum satis

Yeast for baking

quantum satis

Chewing gum

5g/kg

Dietetic foods intended for special medical purposes:

5g/kg

dietetic formulae for weight control intended to replace total Daily food intake or an individual meal

(pro memoria) For E 491 only, wine in accordance with Regulation (EEC) No 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79

Individually or in combination

E 512

Stannous chloride

Canned and bottled white asparagus

25 mg/kg as Sn

E 520

Aluminium sulphate

]

Egg white

30 mg/kg

]

]

Candied, crystallized and glacé fruit and vegetables.

200 mg/kg

E 521

Aluminium sodium sulphate

]

Individually or in combination, expressed as aluminium

]

E 522

Aluminium potassium sulphate

]

]

E 523

Aluminium ammonium sulphate

]

E 541

Sodium aluminium phosphate, acidic

Fine bakery wares (scones and sponge wares only)

1g/kg

expressed as aluminium

(1) E 493 only (2) E 492 only

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 535

Sodium ferrocyanide

]

]

Individually orin combination, 20 mg/kg expressed as anhydrous potassium ferrocyanide

E 536

Potassium ferrocyanide

]

]

Salt and its substitutes

E 538

Calcium ferrocyanide

]

E 551

Silicon dioxide

]

]

]

Dried powdered foodstuffs (including sugars)

Salt and its substitutes

10g/kg

10g/kg

E 552

Calcium silicate

]

]

]

Dietary food supplements Foodstuffs in tablet and coated tablet form

quantum satis

quantum satis

E 553a

(i) Magnesium silicate

]

]

Sliced hard cheese and sliced processed cheese

10g/kg

(ii) Magnesium trisilicate(1)

]

E 553b

Talc (1)

]

E 554

Sodium aluminium silicate

]

E 555

Potassium aluminium silicate

]

E 556

Calcium aluminium silicate

]

]

]

Individually or in combination

quantum satis (2)

E 559

Aluminium silicate (Kaolin)]

]

Chewing gum

Rice

Sausages (surface treatment only)

Moulded jelly sweets (surface treatment only)

E 579

Ferrous gluconate]

]

Olives darkened by oxidation

150 mg/kg as Fe

E 585

Ferrous lactate]

]

E 620

Glutamic acid

Foodstuffs in general (except those referred to in Article 2 (3))

10g/kg

Individually or in combination

E 621

Mono-sodium glutamate

E 622

Monopotassium glutamate

E 623

Calcium diglutamate

Condiments and seasonings

quantum satis

E 624

Mono-ammonium glutamate

E 625

Magnesium diglutamate

E 626

Guanylic acid

]

500 mg/kg

E 627

Disodium guanylate

]

individually or in combination expressed as guanylic acid

E 628

Dipotassium guanylate

]

]

foodstuffs in general (except those referred to in in Article 2(3))

E 629

Calcium guanylate

]

E 630

Inosinic acid

]

E 631

Disodium inosinate

]

(1) Asbestos free.

(2) E553b only.

E NO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 632

Dipotassium inosinate

]

E 633

Calcium inosinate

]

E 634

Calcium 5'-ribonucleotides

]

E 635

Disodium 5'-ribonucleotides

]

Seasonings and condiments

quantum satis

E 900

Dimethyl polysiloxane

Jam, jellies and marmalades as defined in Directive 79/693/EEC and similar fruit spreads, including low calorie products

10 mg/kg

Soups and broths

10 mg/kg

Oils and fats for frying

10 mg/kg

Confectionery (excluding chocolate)

10 mg/kg

Non-alcoholic flavoured drinks

10mg/l

Pineapple juice

10mg/l

Canned and bottled fruit and vegetables

10 mg/kg

Chewing gum

100 mg/kg

(pro memoria) Wine in accordance with Regulation (EEC) No 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No 337/79

Sod..saft

10mg/1

Batters

10 mg/kg

E 901

Beeswax, white and yellow

]

As glazing agents only for:

quantum satis

E 902

Candelilla wax

]

]

- Confectionery (including chocolate)

]

]

- Small products of fine bakery wares coated with chocolate

E 903

Carnauba wax

]

- Snacks

]

- Nuts

]

- Coffee beans

]

E 904

Shellac

]

Dietary food supplements

quantum satis

Fresh citrus fruits, melons, apples and pears (surface treatment only)

quantum satis

E 912

Montan acid esters

Fresh citrus fruits (surface treatment only)

quantum satis

E 914

Oxidised polyethylene wax

E 927b

Carbamide

Chewing gum without added sugars

30g/kg

E 950

Acesulfame-K

Chewing gum with added sugars

800 mg/kg

E 951

Aspartame

2500 mg/kg

E 957

Thaumatin

10 mg/kg

(as flavour enhancer only(1)

(1) If E 950, E 951, E 957 and E 959 are used in combination in chewing gum. the maximum level for each is reduced proportionally.

ENO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 959

Neohesperidine DC

Chewing gum with added sugars

150 mg/kg(1)

Margarine

5 mg/kg

Minarine

(as flavour enhancer only)

Meat products

Fruit jellies

Vegetable proteins

E 999

Quillaia extract

Water-based flavoured non-alcoholic drinks

200 mg/l

calculated as anhydrous extract

E 1201

Polyvinylpyrrolidone

Dietary food supplements in tablet and coated

Quantum satis

E 1202

Polyvinylpolypyrrolidone

tablet form

E 1505

Triethyl citrate

Dried egg white

quantum satis

PART E

PERMITTED CARRIERS AND CARRIER SOLVENTS

Notes

Not included in this list are:

1. Substances generally considered as foodstuffs:

2. Substances referred to in Article 1 1 (4);

3. Substances having primarily an acid or acidity regulator function, such as citric acid and ammonium hydroxide.

E NO

NAME

RESTRICTED USE

Propan1.2—diol (propylene glycol)

Colours, emulsifiers, antioxidants and enzymes (maximum 1 g/kg in the foodstuff)

E 422

Glycerol

E 420

Sorbitol

E 421

Mannitol

E 953

Isomalt

E 965

Mannitol

E 966

Lactitol

E 967

Xylitol

E 400—404

Alginic acid and its sodium, potassium, calcium and ammonium salts

E 405

Propan-1.2—diol alginate

E 406

Agar

E 407

Carrageenan

E 410

Locust bean gum

E 412

Guar gum

E 413

Tragacanth

E 414

Acacia gum (gum arabic)

E 415

Xanthan gum

E 440

Pectins

E 432

Polyoxyethylene sorbitan monolaurate (polysorbate 20)]

]

]

E 433

Polyoxyethylene sorbitan monooleate (polysorbate 80)]

]

]

E 434

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)]

]

]

Antifoaming agents

E 435

Polyoxyethylene sorbitan monostearate (polysorbate 60)]

]

]

E 436

Polyoxyethylene sorbitan tristearate (polysorbate 65)]

]

Antifoaming agents

E 442

Ammonium phosphatides

Antioxidants

E 460

Cellulose (microcrystalline or powdered)

E 461

Methyl cellulose

E 463

Hydroxypropyl cellulose

E 464

Hydroxypropyl methyl cellulose

E 465

Ethyl methyl cellulose

E 466

Carboxy methyl cellulose

Sodium carboxy methyl cellulose

E 322

Lecithins

]

E 432—436

Polysorbates 20, 40, 60, 65 and 80

]

E 470b

Magnesium salts of fatty acids

]

E 471

Mono- and di-glycendes of fatty acids

]

E 472a

Acetic acid esters of mono- and di-glycerides of fatty acids

]

]

E 472c

Citric acid esters of mono- and di-glycerides of fatty acids

]

]

Colours and fat-soluble antioxidants

E 472c

Mono- and di-acetyl tartaric acid esters of mono- and di-glycerides of fatty acids

]

]

E 473

Sucrose esters of fatty acids

]

E 475

Polyglycerol esters of fatty acids

]

E 491

Sorbitan monostearate

]

E 492

Sorbitan tristearate

]

E 493

Sorbitan monolaurate

]

Colours and anti-foaming agents

E 494

Sorbitan monooleate

]

E 495

Sorbitan monopalmitate

]

E 1404

Oxidised starch

E 1410

Monostarch phosphate

E 1412

Distarch phosphate

E 1413

Phosphated distarch phospate

E 1414

Acetylated distarch phosphate

E 1420

Acetylated starch

E 1422

Acetylated distarch adipate

E 1440

Hydroxy propyl starch

E 1442

Hydroxy propyl distarch phosphate

E 1450

Starch sodium octenyl succinate

E 170

Calcium carbonates

E 263

Calcium acetate

E 331

Sodium citrates

E 332

Potassium citrates

E 341

Calcium phosphates

E 501

Potassium carbonates

E 504

Magnesium carbonates

E 508

Potassium chloride

E 509

Calcium chloride

E 511

Magnesium chloride

E 514

Sodium sulphate

E 515

Potassium sulphate

E 516

Calcium sulphate

E 517

Ammonium sulphate

E 577

Potassium gluconate

E 640

Glycine and its sodium salt

E 1505

Triethyl citrate

E 1518

Glyceryl triacctate (triacctin)

E 551

Silicon dioxide

]

Emulsifiers and colours, max. 5%

E 552

Calcium silicate

]

E 553b

Talc

]

E 558

Bentonite

]

Colours, max. 5%

E 559

Aluminium silicate (Kaolin)

]

E 901

Beeswax

Colours

E 1200

Polydextrose

E 1201

Polyvinylpyrrolidone

]

E 1202

Polyvinylpolypyrrolidone

]

Sweeteners

PART F

FOOD ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN

Note

Formulae and weaning foods for infants and young children may contain E 414 acacia gum (gum arabic) and E 551 silicon dioxide resulting from the addition of nutrient preparations containing not more than 10 g/kg of each of these substances, as well as E 421 mannitol when used as a carrier for vitamin B 12 (not less than I part vitamin B 12 to 1000 parts mannitol).

The maximum levels of use indicated refer to foodstuffs ready for consumption pre-pared following manufacturers' instructions.

SECTION 1

FOOD ADDITIVES PERMITTED IN INFANT FORMULAE FOR INFANTS IN GOOD HEALTH

Notes

1. For the manufacture of acidified milks, non-pathogenic L(+)lactic acid producing cultures may be used.

2. If more than one of the substances E 322 and E 471 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substance in that foodstuff.

E NO

NAME

MAXIMUM LEVEL

E 270

Lactic acid (L(+)—form only)

quantum satis

E 330

Citric acid

quantum satis

E 338

Phosphoric acid

In conformity with the limits set in Annex I to Directive 91/321/EEC

E 306

Tocopherol-rich extract

]

E 307

Alpha-tocopherol

]

10 mg/l individually or in combination

E 308

Gamma-tocopherol

]

E 309

Delta-tocopherol

]

E 322

Lecithins

1g/l

E 471

Mono and di-glycerides

4g/l

SECTION 2

FOOD ADDITIVES PERMITTED IN FOLLOW-ON FORMULAE FOR INFANTS IN GOOD HEALTH

Note

1. For the manufacture of acidified milks, non-pathogenic L(+)lactic acid producing cultures may be used.

2. If more than one of the substances E 322 and E 471 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substance in that foodstuff.

3. if more than one of the substances E 407, E 410 and E 412 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is pre-sent of the other substances together in that foodstuff.

E NO

NAME

MAXIMUM LEVEL

E 270

Lactic acid (L(+)—form only)

quantum satis

E 330

Citric acid

quantum satis

E 306

Tocopherol-rich extract

]

E 307

Alpha-tocopherol

]

10 mg/l individually or in combination

E 308

Gamma-tocopherol

]

E 309

Delta-tocopherol

]

E 338

Phosphoric acid

In conformity with the limits set in Annex II to Directive 91/321/EEC

E 440

Pectins

5 g/l in acidified follow-on formulae only

E 322

Lecithins

1g/l

E 471

Mono-and di-glycerides

4g/l

E 407

Carrageenan

0.3 g/l

E 410

Locust bean gum

1g/l

E 412

Guar gum

1g/l

SECTION 3

FOOD ADDITIVES PERMITTED IN WEANING FOODS FOR INFANTS AND YOUNG CHILDREN IN GOOD HEALTH

ENO

NAME

FOODSTUFF

MAXIMUM LEVEL

E 170

Calcium carbonates

]

E 260

Acetic acid

]

E 261

Potassium acetate

]

E 262

Sodium acetate

]

E 263

Calcium acetate

]

E 270

Lactic acid *

]

quantum satis

E 296

Malic acid *

]

Weaning foods

(only for pH adjustment)

E 325

Sodium lactate *

]

E 326

Potassium lactate *

]

E 327

Calcium lactate *

]

E 330

Citric acid

]

E 331

Sodium citrates

]

E 332

Potassium citrates

]

E 333

Calcium citrates

]

E 507

Hydrochloric acid

]

E 524

Sodium hydroxide

]

E 525

Potassium hydroxide

]

E 526

Calcium hydroxide

]

* L(+)—form only

E 500

Sodium carbonates

]

quantum satis

E 501

Potassium carbonates

]

Weaning foods

(only as raising agents)

E 503

Ammonium carbonates

]

Individually or in combination expressed as ascorbic acid

E 300

L-ascorbic acid

]

Fruit- and vegetable -based drinks, juices and baby foods

0.3 g/kg

E 301

Sodium L-ascorbate

]

E 302

Calcium L-ascorbate

]

]

]

Fat-containing cereals, biscuits, rusks and baby foods

0.2 g/kg

E 304

L-ascorbyl palmitate

]

E 306

Tocopherol-rich extract

]

0 1 g/kg individually or in combination

E 307

Alpha-tocopherol

]

E 308

Gamma-tocopherol

]

E 309

Delta-tocopherol

]

E 338

Phosphoric acid

Weaning foods

1 g/kg as P2O5

(only for pH adjustment)

E 339

Sodium phosphates

]

1 g/kg

individually or in combination expressed as P2O5

E 340

Potassium phosphates

]

Cereals

E 341

Calcium phosphates

]

E 322

Lecithins

Biscuits and rusks

Cereal-based foods

Baby foods

]

]

]

10 g/kg

E 471

Mono and di-glycerides of fatty acids

]

]

E 472a

Acetic acid esters of mono and di-glycerides of fatty acids

]

]

]

Biscuits and rusks

Cereal-based foods

Baby foods

]

]

]

5 g/kg

individually or in combination

E 472b

Lactic acid esters of mono- and di-glycerides of fatty acids

]

]

]

E 472c

Citric acid esters of mono- and di-glycerides of fatty acids

]

]

]

E 400

Alginic acid

]

E 401

Sodium alginate

]

]

Desserts

Puddings

]

]

0.5 g/kg

individually or in combination

E 402

Potassium alginate

]

E 404

Calcium alginate

]

E 410

Locust bean gum

]

Weaning foods

10g/kg

individually or in combination

E 412

Guar gum

]

E 414

Acacia gum (gum arabic)

]

E 415

Xanthan gum

]

]

]

Gluten-free cereal-based foods

20 g/kg

individually or in combination

E 440

Pectins

]

E 551

Silicon dioxide

Dry cereals

2 g/kg

E 334

Tartaric acid *

]

E 335

Sodium tartrate *

]

E 336

Potassium tartrate *

]

Biscuits and rusks

5 g/kg

as a residue

E 354

Calcium tartrate *

]

E 450a

Disodium diphosphate

]

E 575

Glucono-delta-lactone

]

* L(+)—form only

E 1404

Oxidised starch

]

E 1410

Monostarch phosphate

]

E 1412

Distarch phosphate

]

E 1413

Phosphated distarch phosphate

]

]

E 1414

Acetylated distarch phosphate

]

]

Weaning foods

50g/kg

E 1420

Acetylated starch

]

E 1422

Acetylated distarch adipate

]

E 1450

Starch sodium octenyl succinate

]

]

SECTION 4

FOOD ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN FOR SPECIAL MEDICAL PURPOSES

The tables in Sections 13 of Part F are applicable.

GIVEN under the official seal of the Minister for Health this 21st day of March, 1997.

MICHAEL NOONAN. T.D.

Minister for Health

EXPLANATORY NOTE

These Regulations are cited as the European Communities (Detailed Provisions on the Control of Additives, other than Colours and Sweeteners, for use in Foodstuffs) Regulations, 1997 and come into force on the 25th day of March, 1997.

These Regulations implement European Parliament and Council Directive 95/2/EC1 on food additives, other than colours and sweeteners, for use in foodstuffs, which is commonly known as the "Miscellaneous Additives Directive"

These Regulations set out the detailed provisions which apply to the use in food for human consumption of the categories of food additive specified in Article 4(2). The general provisions which apply to these, and to all other food additives, are set out in the European Communities (General Provisions on the Control of Additives and in Particular, Colours and Sweeteners, for use in Foodstuffs) Regulations, 1995 (S.I. 344 of 1995).

1O.J No. L 61. 18.3.1995. pp. 140