1996 No. 50

FOOD

Miscellaneous Food Additives Regulations (Northern Ireland) 1996

Made

Coming into operation

The Department of Health and Social Services and the Department of Agriculture being the Departments concerned1 in exercise of the powers conferred on them by Articles 15(1)(a), 16(1), 17(1), 25(1) and (3), 26(3) and 47(2) of, and paragraph 1 of Schedule 1 to, the Food Safety (Northern Ireland) Order 19912 and of all other powers enabling them in that behalf and after consultation in accordance with Article 47(3) of that Order with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations, hereby make the following Regulations:

Citation and commencement1

These Regulations may be cited as the Miscellaneous Food Additives Regulations (Northern Ireland) 1996 and shall come into operation on 22nd April 1996.

Interpretation2

1

In these Regulations—

  • “acid” means any substance which increases the acidity of a food or imparts a sour taste to it, or both;

  • “acidity regulator” means any substance which alters or controls the acidity or alkalinity of a food;

  • “anti-caking agent” means any substance which prevents or reduces the tendency of individual particles of a food to adhere to one another;

  • “anti-foaming agent” means any substance which prevents or reduces foaming;

  • “antioxidant” means any substance which prolongs the shelf-life of a food by protecting it against deterioration caused by oxidation, including fat rancidity and colour changes;

  • “bulking agent” means any substance which contributes to the volume of a food without contributing significantly to its available energy value;

  • “carrier” and “carrier solvent” mean any substance, other than a substance generally considered as food, used to dissolve, dilute, disperse or otherwise physically modify a miscellaneous additive, colour or sweetener, or an enzyme which is not acting as a processing aid, without altering its technological function (and without exerting any technological effect itself) in order to facilitate its handling, application or use;

  • “colour” has the same meaning as in the Colours in Food Regulations (Northern Ireland) 19963;

  • “Directive 89/107/EEC” means Council Directive 89/107/EEC4 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption;

  • “Directive 89/398/EEC” means Council Directive 89/398/EEC5 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses;

  • “Directive 95/2/EC” means European Parliament and Council Directive 95/2/EC6 on food additives other than colours and sweeteners (as corrected7);

  • “emulsifier” means any substance which makes it possible to form or maintain a homogenous mixture of two or more immiscible phases, such as oil and water, in a food;

  • “emulsifying salt” means any substance which converts proteins contained in cheese into a dispersed form, thereby bringing about homogenous distribution of fat and other components;

  • “firming agent” means any substance which makes or keeps tissues of fruit or vegetables firm or crisp or which interacts with a gelling agent to produce or strengthen a gel;

  • “flavour enhancer” means any substance which enhances the existing taste or odour, or both, of a food;

  • “foaming agent” means any substance which makes it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid food;

  • “food” means food sold, or intended for sale, for human consumption and in regulation 6 and for the purposes of regulation 9 includes a food additive;

  • “food additive” means—

    1. a

      any substance nor normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may reasonably be expected to result, in it or its by-products becoming directly or indirectly a component of such foods; or

    2. b

      a carrier or carrier solvent;

    but does not include—

    1. i

      any substance used for the treatment of drinking water as provided for in Council Directive 80/778/EEC8 relating to the quality of water intended for human consumption, as amended by Council Directive 81/858/EEC9 and Council Directive 91/692/EEC10;

    2. ii

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

    3. iii

      chewing gum bases;

    4. iv

      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;

    5. v

      ammonium chloride;

    6. vi

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

    7. vii

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

    8. viii

      caseinates and casein;

    9. ix

      inulin;

  • “gelling agent” means any substance which gives a food texture through the formation of a gel;

  • “glazing agent” means any substance which, when applied to the external surface of a food, imparts a shiny appearance or provides a protective coating, and includes lubricants;

  • “humectant” means any substance which prevents a food from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or which promotes the dissolution of a powder in an aqueous medium;

  • “infants” means children under the age of 12 months;

  • “member State” means a member State of the European Community;

  • “miscellaneous additive” means any food additive which is used or intended to be used primarily as an acid, acidity regulator, anti-caking agent, anti-foaming agent, antioxidant, bulking agent, carrier, carrier solvent, emulsifier, emulsifying salt, firming agent, flavour enhancer, foaming agent, gelling agent, glazing agent, humectant, modified starch, packaging gas, preservative, propellant, raising agent, sequestrant, stabiliser or thickener, but does not include any processing aid;

  • “modified starch” means any substance obtained by one or more chemical treatments of edible starch, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached;

  • “the Order” means the Food Safety (Northern Ireland) Order 1991;

  • “packaging gas” means any gas, other than air, which is introduced into a container before, during or after the placing of a food in that container;

  • “permitted miscellaneous additive” means any miscellaneous additive listed in Schedule 1, 2, 3 or 4, which satisfies the purity criteria (if any) for that additive;

  • “preservative” means any substance which prolongs the shelf-life of a food by protecting it against deterioration caused by micro-organisms;

  • “processed”, in relation to any food, means having undergone any treatment resulting in a substantial change in the original state of the food, but does not include dividing, parting, severing, boning, mincing, skinning, paring, peeling, grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, husking, packing or unpacking;

  • “processing aid” means any substance not consumed as a food by itself, intentionally used in the processing of raw materials, foods or their ingredients to fulfil a certain technological purpose during treatment or processing, and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product;

  • “propellant” means any gas, other than air, which expels a food from a container;

  • “purity criteria” means the purity criteria (if any) for that miscellaneous additive specified or referred to in Schedule 5;

  • “raising agent” means any substance or combination of substances which liberates gas and thereby increases the volume of a dough or a batter;

  • “relevant food additive” means any miscellaneous additive, colour or sweetener, or an enzyme which is not acting as a processed aid;

  • “sell” includes possess for sale, and offer, expose or advertise for sale;

  • “sequestrant” means any substance which forms a chemical complex with metallic ions;

  • “stabiliser” means any substance which makes it possible to maintain the physico-chemical state of a food, including any substance which enables a homogenous dispersion of two or more immiscible substances in a food to be maintained, and any substance which stabilises, retains or intensifies an existing colour of a food;

  • “sweetener” has the same meaning as in the Sweeteners in Food Regulations (Northern Ireland) 199611;

  • “thickener” means any substance which increases the viscosity of a food;

  • “young children” means children aged between one and three years.

2

Other expressions used in these Regulations and in Directive 95/2/EC have the same meaning in these Regulations as they have in that Directive.

3

Any reference in these Regulations to a Community instrument is a reference to it as amended, modified or otherwise adapted.

4

Any reference in these Regulations to—

a

a maximum level of permitted miscellaneous additive in or on a food, or in respect of a food additive, is to the maximum level of that permitted miscellaneous additive in or on the food, or in respect of the food additive, as sold, unless otherwise indicated;

b

quantum satis means that no maximum level of permitted miscellaneous additive in or on a corresponding food is specified but that in or on such food a permitted miscellaneous additive may be used in accordance with good manufacturing practice at a level not higher than is necessary to achieve the intended purpose and provided that such use does not mislead the consumer.

Use of miscellaneous additives3

1

No person shall use in or on any food any miscellaneous additive other than a permitted miscellaneous additive.

2

Subject to regulation 4(2) and Note 2 to Schedule 1, no person shall use any permitted miscellaneous additive listed in Schedule 1 in or on any food which is listed in Schedule 6 but not in column 1 of Schedule 7.

3

Subject to regulation 4(2) and Note 2 to Schedule 1, no person shall use any permitted miscellaneous additive listed in Schedule 1 in or on any food listed in column 1 of Schedule 7, except a permitted miscellaneous additive which is listed, or referred to, in relation to that food in column 2 of that Schedule in an amount not exceeding the maximum level (if any) for such additive in or on such food as listed in column 3 of that Schedule.

4

No person shall use any permitted miscellaneous additive listed in Schedule 1 in or on any food which is not listed in Schedule 6 or in column 1 of Schedule 7 and is not referred to in paragraph (7) in an amount higher than quantum satis or otherwise than in compliance with Notes 1 and 3 to Schedule 1.

5

Subject to paragraphs (1) and (2) of regulation 4, no person shall use any permitted miscellaneous additive listed in Schedule 2 or 3 in or on any food which is not referred to in paragraph (7), other than a food listed in either of those Schedules in relation to that additive and in accordance with the provisions contained in those Schedules governing the use of such additive in or on such food.

6

No person shall use any miscellaneous additive primarily as a carrier or carrier solvent unless that additive is a permitted miscellaneous additive listed in Schedule 4 and its use complies with the restrictions (if any) mentioned in relation to that additive in column 3 of that Schedule.

7

Subject to Note 2 to Schedule 1, no person shall use any permitted miscellaneous additive in or on any food for infants or young children as referred to in Directive 89/398/EEC (including any food for infants and young children not in good health) unless that additive is listed in Schedule 8, in which case it may be used only in accordance with the conditions contained in that Schedule.

8

No person shall use in or on any food for infants or young children as referred to in Directive 89/398/EEC (including any food for infants and young children not in good health) any relevant food additive in combination with a miscellaneous additive which has been used primarily as a carrier or carrier solvent unless that miscellaneous additive is listed in Schedule 8 and its presence in or on the food is in accordance with the conditions contained in that Schedule.

Use of miscellaneous additives in or on compound foods4

1

Subject to paragraphs (3) and (4), any food in or on which a permitted miscellaneous additive is used without contravening any of the provisions of paragraphs (2) to (5) or (7) of regulation 3 may itself be used as an ingredient in a compound food in or on which the use of such miscellaneous additive is not otherwise permitted; and the presence in or on that compound food of such miscellaneous additive as a result of its containing such an ingredient shall not constitute a contravention of any of the provisions of those paragraphs of regulation 3.

2

Subject to paragraph (4), there may be used in or on a food any permitted miscellaneous additive the use of which would otherwise constitute a contravention of any of the provisions of paragraphs (2) to (5) or (7) of regulation 3, where such a food is destined to be used solely in the preparation of a compound food and the resulting presence in or on that compound food of such miscellaneous additive does not itself constitute a contravention of any of the provisions of those paragraphs of regulation 3.

3

Paragraph (1) shall not apply in the case of any compound food listed in Schedule 6 or in column 1 of Schedule 7.

4

Paragraphs (1) and (2) shall not apply in the case of any food for infants or young children as referred to in Directive 89/398/EEC, except where specifically provided in these Regulations.

Sale of food additives and food containing miscellaneous additives5

1

No person shall sell any miscellaneous additive for use in or on food unless that additive is a permitted miscellaneous additive.

2

No person shall sell any miscellaneous additive for use primarily as a carrier or carrier solvent unless that additive is a permitted miscellaneous additive listed in Schedule 4.

3

No person shall sell directly to the consumer any miscellaneous additive other than a permitted miscellaneous additive.

4

No person shall sell any food having in it or on it any added miscellaneous additive other than a permitted miscellaneous additive which has been used, or is present, in or on that food without contravening any of the provisions of paragraphs (1) to (5), (7) or (8) of regulation 3.

5

No person shall sell any relevant food additive in combination with a miscellaneous additive which has been used primarily as a carrier or carrier solvent unless that miscellaneous additive has been used in respect of that relevant food additive without contravening the provisions of regulation 3(6).

Condemnation of food6

Where any food is certified by a food analyst as being food which it is an offence against these Regulations to sell, that food may be treated for the purposes of Article 8 of the Order (under which a food may be seized and destroyed on the order of a justice of the peace) as failing to comply with food safety requirements, and Article 7(2) of the Order shall apply for the purposes of these Regulations as it applies for the purposes of the Order.

Offences, penalties and enforcement7

1

If any person contravenes any of the provisions of these Regulations he shall be guilty of an offence, and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

2

Subject to paragraph (3), these Regulations shall be enforced and executed by each district council within its district.

3

The Department of Agriculture shall enforce and execute these Regulations in relation to milk in liquid milk plants.

Defence in relation to exports8

In any proceedings for an offence under these Regulations it shall be a defence for the person charged to prove—

a

that the food or, as the case may be, the food additive in respect of which the offence is alleged to have been committed was intended for export to a country which has legislation analogous to these Regulations and that such food or food additive complies with that legislation; and

b

in the case of export to another member State, that the legislation complies with Directive 89/107/EEC and Directive 95/2/EC.

Application of various provisions of the Order9

The following provisions of the Order shall apply for the purposes of these Regulations as they apply for the purposes of Articles 7, 13 and 14 of the Order and any reference in them to the Order shall be construed as a reference to these Regulations:

a

Articles 2(4) and 3 (extended meaning of “sale” etc.);

b

Article 4 (presumptions that food intended for human consumption);

c

Article 19 (offences due to fault of another person);

d

Article 20 (defence of due diligence);

e

Article 21 (defence of publication in the course of business);

f

Article 30(8) (which relates to documentary evidence);

g

Article 34 (obstruction, etc., of officers).

Revocation and amendments10

1

The Regulations and order specified in columns 1 and 2 of Schedule 9 shall be revoked to the extent specified in column 3 of that Schedule.

2

In the Mineral Hydrocarbons in Food Regulations (Northern Ireland) 196612, in regulation 3 (exemptions)—

a

there shall be substituted for paragraph (1)—

1

Regulation 4 shall not apply in relation to—

a

any food containing mineral hydrocarbon by reason not of the inclusion of mineral hydrocarbon as an ingredient in such food but because of the use of mineral hydrocarbon as a lubricant or greasing agent on some surface with which such food has necessarily to come into contact during the course of preparation if such food contains by reason thereof not more than 0.2 part by weight of mineral hydrocarbon per 100 parts by weight of the food;

b

any chewing compound which—

i

contains no more than 60 parts by weight of solid mineral hydrocarbon per 100 parts by weight of chewing compound, and

ii

contains no mineral hydrocarbon other than any mineral hydrocarbon which complies with the specification therefor set forth in paragraph 4 of Part 1 of the Schedule;

c

the rind of any whole pressed cheese;

d

any food containing mineral hydrocarbon where the use of that mineral hydrocarbon in or on that food is as a miscellaneous additive, as defined in the Miscellaneous Food Additives Regulations (Northern Ireland) 1996 and complies with the provisions of those Regulations.

b

in the proviso to paragraph (2), for “paragraph (1)(e)” there shall be substituted “paragraph (1)(b)”;

c

in paragraph (3), for “paragraph (1)(a) to (g)” there shall be substituted “paragraph (1)(a) to (c)”.

3

In the Specified Sugar Products Regulations (Northern Ireland) 197613—

a

in regulation 2(1) (interpretation)—

i

before the definition of “anti-foaming agent” there shall be inserted—

  • “anti-caking agent” has the meaning assigned to it by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

ii

for the definition of “anti-foaming agent” there shall be inserted—

  • “anti-foaming agent” has the meaning assigned to it by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

iii

for the definition of “appropriate designation” there shall be substituted—

  • “appropriate designation”, as respects any colour, anti-caking agent or anti-foaming agent, means a name or description or a name and description sufficiently specific, in each case, to indicate to an intending purchaser the true nature of the colour, anti-caking agent or anti-foaming agent to which it is applied;

iv

after the definition of “loaf sugar” there shall be inserted—

  • “permitted miscellaneous additive” means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

for paragraph (2) of regulation 2 there shall be substituted—

2

Any permitted miscellaneous additive (other than E220 sulphur dioxide) specified in Part B of Schedule 2 to the Miscellaneous Food Additives Regulations (Northern Ireland) 1996, if calculated as, may be used in place of, E220 sulphur dioxide, and any reference in these regulations to the permitted miscellaneous additive sulphur dioxide shall be construed accordingly.

c

in regulation 5(3) (labelling and description of specified sugar products)—

i

for sub-paragraph (c) there shall be substituted—

c

for glucose syrup or dried glucose syrup containing more than 20 milligrams per kilogram of the permitted miscellaneous additive sulphur dioxide, a declaration that the product is not for sale by retail;

ii

for sub-paragraph (e) there shall be substituted—

e

for icing sugar or icing dextrose containing any permitted miscellaneous additive used primarily as an anti-caking agent or any starch in accordance with paragraph (a) or (c) of the proviso to regulation 9, the declaration “contains X” or “contains starch” respectively, the declaration in the former case being completed by inserting at X an appropriate designation or the common or usual name of each anti-caking agent present;

iii

in sub-paragraph (f), for “any anti-foaming agent in accordance with paragraph (d) of the proviso” there shall be substituted “any permitted miscellaneous additive used primarily as an anti-foaming agent in accordance with paragraph (a) of the proviso”;

d

in regulation 8 (declarations of sulphur dioxide in glucose syrup and dried glucose syrup), for the words from “of which the sulphur dioxide” to “20 milligrammes per kilogramme” there shall be substituted “containing more than 20 milligrams per kilogram of the permitted miscellaneous additive sulphur dioxide”;

e

in the proviso to regulation 9 (permitted additional ingredients in specified sugar products)—

i

for paragraph (a) there shall be substituted—

a

any specified sugar product may contain any permitted miscellaneous additive;

ii

for paragraph (c) there shall be substituted—

c

any icing sugar or icing dextrose which does not contain any permitted miscellaneous additive used primarily as an anti-caking agent may contain not more than 5 per centum of starch.

4

In the Cocoa and Chocolate Products Regulations (Northern Ireland) 197614—

a

in regulation 2(1) (interpretation)—

i

in the definition of “edible substance”, for paragraph (c) there shall be substituted—

c

any permitted miscellaneous additive

ii

after the definition of “permitted cocoa butter” there shall be inserted—

  • “permitted miscellaneous additive” means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in the proviso to regulation 15 (permitted additional ingredients in cocoa and chocolate products), for paragraphs (a) to (c) there shall be substituted—

a

any cocoa product or chocolate product may contain any permitted miscellaneous additive;

5

In the Fruit Juices and Fruit Nectars Regulations (Northern Ireland) 197715—

a

in regulation 2(1) (interpretation), after the definition of “honey” there shall be inserted—

  • “permitted miscellaneous additive” means any miscellaneous additive insofar as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in the proviso to regulation 11(1) (permitted additional ingredients in fruit juice, concentrated fruit juice, dried fruit juice and fruit nectar)—

i

for sub-paragraphs (a), (e), (g), (i) and (j) there shall be substituted—

a

any such food may contain any permitted miscellaneous additive, so however that no apple juice, grape juice, pineapple juice or concentrated pineapple juice shall contain both added sugar and added acid;

ii

for sub-paragraph (f) there shall be substituted—

f

the fruit nectars referred to in Schedule 4 may contain lemon juice, in total or partial replacement of citric acid, in a proportion not exceeding 5 grams per litre;

c

for Schedule 4 (fruit juices, concentrated fruit juices and fruit nectars which may contain added permitted acid and the nature and proportion of added permitted acid in each case) these shall be substituted—

SCHEDULE 4Fruit Nectars which may contain Lemon Juice in place of Citric Acid

Regulation 11

1

Apple nectar obtained exclusively from apple purée or concentrated apple purée or an admixture thereof.

2

Peach nectar obtained exclusively from peach purée or concentrated peach purée or an admixture thereof.

3

Pear nectar obtained exclusively from pear purée or concentrated pear purée or an admixture thereof.

4

Any admixture of the fruit nectars referred to in items 1 to 3.

6

In the Condensed Milk and Dried Milk Regulations (Northern Ireland) 197716—

a

in regulation 2(1) (interpretation), for “permitted miscellaneous additive” there shall be substituted—

  • “permitted miscellaneous additive” means any miscellaneous additive insofar as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in regulation 5(1) (labelling and description of condensed milk and dried milk products for retail sale), in sub-paragraph (b), for “paragraph (c)” there shall be substituted “paragraph (a)”;

c

in the proviso to regulation 9 (permitted additional ingredients in condensed milk and dried milk products), for paragraphs (a) to (d) there shall be substituted—

a

any condensed milk product or dried milk product may contain any permitted miscellaneous additive;

7

In the Coffee and Coffee Products Regulations (Northern Ireland) 197917—

a

in regulation 2(1) (interpretation), after the definition of “fig” there shall be inserted—

  • “permitted miscellaneous additive” means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in the proviso to regulation 8 (permitted additional ingredients in certain designated products)—

i

for paragraphs (a), (b) and (e) there shall be substituted—

a

any designated product may contain any permitted miscellaneous additive;

ii

in paragraph (d), after “liquid coffee and chicory extract,” there shall be inserted “chicory and coffee essence,”.

8

In the Jam and Similar Products Regulations (Northern Ireland) 198218—

a

in regulation 2(1) (interpretation)—

i

immediately before the definition of “permitted sweetener” there shall be inserted—

  • “permitted miscellaneous additive” means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

ii

after the definition of “prepacked” there shall be inserted—

  • “preservative” has the meaning assigned to it by the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in regulation 8(4) (miscellaneous labelling requirements), for sub-paragraph (c) there shall be substituted—

c

in regulation 14(1) (permitted additional ingredients) there shall be inserted at the end “or any permitted miscellaneous additive”

9

In the Meat Products and Spreadable Fish Products Regulations (Northern Ireland) 198419—

a

in regulation 2(1) (interpretation), in the definition of “additive”, for the words from “the Antioxidants in Food Regulations (Northern Ireland) 1978” to “the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981” there shall be substituted “the Miscellaneous Food Additives Regulations (Northern Ireland) 1996”;

b

in regulation 5(2) (name of the food for certain meat products), in sub-paragraph (b) after “the conditions” there shall be inserted “(if any)”;

c

in Schedule 1 (ingredients of cured meat)—

i

in the first division of ingredients in column 1, after “Water” there shall be inserted—

  • Additives other than flavourings, smoke and smoke solutions.

ii

in the third division of ingredients in column 1, for “Additives” there shall be substituted—

  • Flavourings, smoke and smoke solutions.

10

In the Food Additives Labelling Regulations (Northern Ireland) 199220—

a

in regulation 1(2) (interpretation), after the definition of “food additive” there shall be inserted—

  • “miscellaneous additive” has the same meaning as in the 1996 Regulations

  • “the 1996 Regulations” means the Miscellaneous Food Additives Regulations (Northern Ireland) 1996;

b

in Schedule 1 (categories of food additives), in Part I (list of food additives)—

i

for item 9 there shall be substituted—

9

Flavour enhancers

ii

for item 19 there shall be substituted—

19

Flour treatment agents.

iii

for item 25 there shall be substituted—

25

Propellants

iv

at the end there shall be inserted—

27

Carriers and carrier solvents

c

in Schedule 1, in Part II (supplementary)—

i

for sub-paragraphs (b) to (m) there shall be substituted—

b

“antioxidant”, “preservative”, “emulsifier”, “emulsifying salt”, “thickener”, “gelling agent”, “stabiliser”, “flavour enhancer”, “acid”, “acidity regulator”, “anti-caking agent” and “modified starch” mean any miscellaneous additive primarily used as an antioxidant, preservative, emulsifier, emulsifying salt, thickener, gelling agent, stabiliser, flavour enhancer, acid, acidity regulator, anti-caking agent or modified starch, as the case may be, as defined in the 1996 Regulations;

ii

for sub-paragraphs (o) to (q) there shall be substituted—

o

“raising agent”, “anti-foaming agent” and “glazing agent” mean any miscellaneous additive primarily used as a raising agent, anti-foaming agent or glazing agent, as the case may be, as defined in the 1996 Regulations;

iii

for sub-paragraphs (r) and (s) there shall be substituted—

r

“flour bleaching agent” means any substance primarily used to remove colour from flour;

s

“four treatment agent” means any substance which is added to flour or dough to improve its baking quality;

iv

for sub-paragraphs (t) and (u) there shall be substituted—

t

“firming agent” and “humectant” mean any miscellaneous additive primarily used as a firming agent or humectant, as the case may be, as defined in the 1996 Regulations;

v

for sub-paragraphs (w) to (z) there shall be substituted—

w

“sequestrant”, “bulking agent”, “propellant”, “packaging gas”, “carrier” and “carrier solvent” mean any miscellaneous additive primarily used as a sequestrant, bulking agent, propellant, packaging gas, carrier or carrier solvent, as the case may be, as defined in the 1996 Regulations.

d

in Schedule 3 (requirement for sales), in Part I in paragraph 2 and in Part II in paragraphs 1 and 7 for “European Economic Community” (wherever it occurs) there shall be substituted “European Community”.

Transitional provisions and exemptions11

1

In any proceedings for an offence against these Regulations it shall be a defence to prove that—

a

i

the act was committed before 1st July 1997, or

ii

the act was that of selling a food additive or a food which, in either case, was put on the market or labelled before 1st July 1997; and

b

the matter constituting the offence would not have constituted an offence under any Regulations now revoked or amended by these Regulations if those Regulations had been in operation (in the case of Regulations now being amended, as if such amendments had not been made) when the act was committed or the food additive or, as the case may be, the food was put on the market or labelled.

2

These Regulations shall not apply in respect of any food additive or, as the case may be, food which—

a

is brought into Northern Ireland before 1st July 1997 from a member State in which it was lawfully produced and sold or in which it was in free circulation and lawfully sold; and

b

is suitably labelled to give the nature of the food additive or, as the case may be, the food.

3

In so far as the purity criteria specified or referred to in Schedule 5 are not set out in any Community instrument, those purity criteria shall not apply in relation to any food additive or, as the case may be, food which—

a

is brought into Northern Ireland on or after 1st July 1997 from a member State in which it was lawfully produced and sold or in which it was in free circulation and lawfully sold; and

b

is suitably labelled to give the nature of the food additive or, as the case may be, the food.

4

For the purposes of paragraphs (2) and (3), “free circulation” shall be construed in accordance with Article 9.2 of the Treaty establishing the European Community.

Sealed with the Official Seal of the Department of Health and Social Services on 28th February 1996.

D. A. BakerAssistant Secretary

Sealed with the Official Seal of the Department of Agriculture on 28th February 1996.

P. T. ToalAssistant Secretary

SCHEDULE 1Miscellaneous Additives Generally Permitted for use in Foods not referred to in Schedule 6, 7 or 8

Regulations 2(1) and 3(2) to (4) and (7)

Notes:

1

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.

2

The substances E 290, E 938, E 939, E 941, E 942 and E 948 may also be used at quantum satis in the foods referred to in Schedules 6, 7 and 8.

3

The substances E 410, E 412, E 415 and E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion.

EC No.

Name

E 170

Calcium carbonates

  1. i

    Calcium carbonate

  2. ii

    Calcium hydrogen carbonate

E 260

Acetic acid

E 261

Potassium acetate

E 262

Sodium acetates

  1. i

    Sodium acetate

  2. 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

  1. i

    Ascorbyl palmitate

  2. 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

  1. i

    Monosodium citrate

  2. ii

    Disodium citrate

  3. iii

    Trisodium citrate

E 332

Potassium citrates

  1. i

    Monopotassium citrate

  2. ii

    Tripotassium citrate

E 333

Calcium citrates

  1. i

    Monocalcium citrate

  2. ii

    Dicalcium citrate

  3. iii

    Tricalcium citrate

E 334

Tartaric acid (L(+)–)

E 335

Sodium tartrates

  1. i

    Monosodium tartrate

  2. ii

    Disodium tartrate

E 336

Potassium tartrates

  1. i

    Monopotassium tartrate

  2. ii

    Dipotassium tartrate

E 337

Sodium potassium tartrate

E 350

Sodium malates

  1. i

    Sodium malate

  2. ii

    Sodium hydrogen malate

E 351

Potassium malate

E 352

Calcium malates

  1. i

    Calcium malate

  2. 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 arabic)

E 415

Xanthan gum

E 417

Tara gum

E 418

Gellan gum

E 422

Glycerol

E 440

Pectins

  1. i

    pectin

  2. ii

    amidated pectin

E 460

Cellulose

  1. i

    Microcrystalline cellulose

  2. 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 diglycerides of fatty acids

E 472a

Acetic acid esters of mono- and diglycerides of fatty acids

E 472b

Lactic acid esters of mono- and diglycerides of fatty acids

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

E 472d

Tartaric acid esters of mono- and diglycerides of fatty acids

E 472e

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

E 472f

Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids

E 500

Sodium carbonates

  1. i

    Sodium carbonate

  2. ii

    Sodium hydrogen carbonate

  3. iii

    Sodium sesquicarbonate

E 501

Potassium carbonates

  1. i

    Potassium carbonate

  2. ii

    Potassium hydrogen carbonate

E 503

Ammonium carbonates

  1. i

    Ammonium carbonate

  2. ii

    Ammonium hydrogen carbonate

E 504

Magnesium carbonates

  1. i

    Magnesium carbonate

  2. 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

  1. i

    Sodium sulphate

  2. ii

    Sodium hydrogen sulphate

E 515

Potassium sulphates

  1. i

    Potassium sulphate

  2. 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

SCHEDULE 2Conditionally Permitted Preservatives and Antioxidants

Regulations 2(1) and 3(5)

Part ASorbates, benzoates and p-hydroxybenzoates

EC No.

Name

Abbreviation

E 200

Sorbic acid

Sa

E 202

Potassium sorbate

Sa

E 203

Calcium sorbate

Sa

E 210

Benzoic acid

Ba1000

E 211

Sodium benzoate

Ba1000

E 212

Potassium benzoate

Ba1000

E 213

Calcium benzoate

Ba1000

E 214

Ethyl p-hydroxybenzoate

PHB

E 215

Sodium ethyl p-hydroxybenzoate

PHB

E 216

Propyl p-hydroxybenzoate

PHB

E 217

Sodium propyl p-hydroxybenzoate

PHB

E 218

Methyl p-hydroxybenzoate

PHB

E 219

Sodium methyl p-hydroxybenzoate

PHB

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

Notes

  1. 1

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

  2. 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. 3

    The maximum levels of use indicated refer to foods ready for consumption prepared following manfacturers' instructions.

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

Food

Sa

Ba

PHB

Sa + Ba

Sa + PHB

Sa + Ba + BHB

Wine-based flavoured drinks including products covered by Regulation (EEC) No. 1601/9121

200

Non-alcoholic flavoured drinks (excluding dairy-based drinks)

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. 822/8722; alcohol-free wine; fruit wine (including alcohol-free); made wine; cider and perry (including alcohol-free)

200

Sød . . . Saft or Sødet . . . Saft

500

200

Alcohol-free beer in keg

200

Mead Spirits with less than 15% alcohol by volume

200 200

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 glacé fruit and vegetablesMermeladas

1000

Dried fruit

1000Mermeladas

Frugtgrød and Rote Grütze

1000

500

Fruit and vegetable preparations including fruit-based sauces, excluding purée, 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

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

1000

Surface treatment of dried meat products

quantum satis

Semi-preserved fish products including fish roe products

2000

Salted, dried fish

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 foods

1000

Non-heat-treated dairy-based deserts

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 fat content of 60% or more

1000

Fat emulsions with a fat content less than 60%

2000

Emulsified sauces with a fat 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 — dietetic formulae for weight control intended to replace total daily food intake or an individual meal

1500

Part BSulphur dioxide and sulphites

EC 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

Notes

  1. 1

    Maximum levels are expressed as SO2 in mg/kg or mg/l as appropriate and relate to the total quantity, available from all sources.

  2. 2

    An SO2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present.

Food

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 Longaniza fresca and Butifarra fresca

450 450

Dried salted fish of the ‘Gadidae' species

200

Cruscaceans and cephalopods

— fresh, frozen and deep-frozen crustaceans, penaeidae solenceridae, aristeidae family:

15023

— up to 80 units

15023

— between 80 and 120 units

20023

— over 120 units

30023

— cooked

5023

Dry biscuit

50

Starches (excluding starches for weaning foods, follow-on furmulae 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

2000

— bananas

1000

— apples and pears

600

— other (including nuts in shell)

500

Dried coconut

50

Candied, crystallised or glacé fruit, vegetables, angelica and citcus peel

100

Jam, jelly and marmalade as defined in Directive 79/693/EEC24 (except extra jam and extra jelly) and other similar fruit spreads including low-calorie products

50

Jams, jellies and marmalades 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/EEC25 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; capilé 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. 4252/8826, (EEC) No. 2332/9227 and (EEC) No. 1873/8428 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. 337/7929

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 Dijon mustard

250 500

Gelatin

50

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

200

Part COther preservatives

EC No.

Name

Food

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

Surface treatment of citrus fruits

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

E 233

Thiabendazole

Surface treatment of:

  • citrus fruit

  • bananas

6 mg/kg

3 mg/kg

E 234

Nisin30

Semolina and tapioca puddings and similar products

3 mg/kg

Ripened cheese and processed cheese

12.5 mg/kg

Clotted cream

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)

4g/kg expressed as boric acid

E 285

Sodium tetraborate (borax)

Sturgeons' eggs (Caviar)

4g/kg expressed as boric acid

EC No.

Name

Food

Indicative ingoing amount mg/kg

Residual amount mg/kg

mg/kg

mg/kg

E 249

E 250

Potassium nitrite31

Sodium nitrite31

Non-heat-treated, cured, dried meat products

15032

5033

Other cured meat products

Canned meat products

Foie gras, foie gras entier, blocs de foie gras

15032

10033

Cured bacon

17533

E 251

E 252

Sodium nitrate

Potassium nitrate

Cured meat products

Canned meat products

300

250(34

Hard, semi-hard and semi-soft cheese

Dairy-based cheese analogue

5034

Pickled herring and sprat

20035

EC No.

Name

Food

Maximum level

E 280

Propionic acid36

E 281

Sodium propionate36

E 282

Calcium propionate36

E 283

Potassium propionate36

Pre-packed sliced bread and rye bread

3000 mg/kg expressed as propionic acid

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

Christmas pudding

Pre-packed bread

1000 mg/kg expressed as propionic acid

E 1105

Lysozyme

Ripened cheese

quantum satis

Part DOther antioxidants

EC No.

Name

Food

Maximum level (mg/kg)

E 310

E 311

E 312

E 320

E 321

Propyl gallate

Octyl gallate

Dodecyl gallate

Butylated hydroxyanisole (BHA)

Butylated hydroxytoluene (BHT)

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

Frying oil and frying fat, excluding olive pomace oil

Lard; fish oil; beef, poultry and sheep fat

20037 (gallates and BHA, individually or in combination)

10037 (BHT)

both expressed on fat

Cake mixes

200 (gallates and BHA, individually or in combination

Cereal-based snack foods

Milk powder for vending machines

Dehydrated soups and broths

expressed on fat

Sauces

Dehydrated meat

Processed nuts

Seasonings and condiments

Pre-cooked cereals

De-hydrated granulated potatoes

25 (gallates and BHA, individually or in combination)

Chewing gum

Dietary supplements

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

E 315

Erythorbic acid

Semi-preserved and preserved meat products

500 expressed as erythorbic acid

E 315

Erythorbic acid

Preserved and semi-preserved fish products

Frozen and deep-frozen fish with red skin

1500 expressed as erythorbic acid

E 316

Sodium erythorbate

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

SCHEDULE 3Other Permitted Miscellaneous Additives

Regulations 2(1) and 3(5)

The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers' instructions.

EC No.

Name

Food

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

  • E 339

Sodium phosphates

i

Monosodium phosphate

ii

Disodium phosphate

iii

Trisodium phosphate

  • E 340

Potassium phosphates

i

Monopotassium phosphate

ii

Dipotassium phosphate

iii

Tripotassium phosphate

  • E 341

Calcium phosphates

i

Monocalcium phosphate

ii

Dicalcium phosphate

iii

Tricalcium phosphate

  • E 450

Diphosphates

i

Disodium diphosphate

ii

Trisodium diphosphate

iii

Tetrasodium diphosphate

iv

Dipotassium diphosphate

v

Tetrapotassium diphosphate

vi

Dicalcium diphosphate

vii

Calcium dihydrogen diphosphate

  • E 451

Triphosphates

i

Pentasodium triphosphate

ii

Pentapotassium triphosphate

  • E 452

Polyphosphates

i

Sodium polyphosphate

ii

Potassium polyphosphate

iii

Sodium calcium polyphosphate

iv

Calcium polyphosphates

Non-alcoholic flavoured drinks

700 mg/l38

Sterilised and UHT milk

1 g/l

Partly dehydrated milk with less than 28% solids

1 g/kg

Partly dehydrated milk with more than 28% solids

1.5 g/kg

Dried milk and dried skimmed milk

2.5 g/kg

Pasteurised, sterilised and UHT creams

5 g/kg

Whipped cream and vegetable fat analogues

5 g/kg

Unripened cheese (except Mozzarella)

2 g/kg

Processed cheese and processed cheese analogues

20 g/kg

Meat products

5 g/kg

Sport drinks and prepared table waters

0.5 g/l

Dietary supplements

quantum satis

Salt and its substitutes

10 g/kg

Vegetable protein drinks

20 g/l

Beverage whiteners

30 g/kg

Beverage whiteners for vending machines

50 g/kg

Edible ices

1 g/kg

Desserts

3 g/kg

Dry powdered dessert mixes

7 g/kg

Fine bakery wares

20 g/kg

Flour

2.5 g/kg

Flour, self-raising

20 g/kg

Soda bread

20 g/kg

Liquid egg (white, yolk or whole egg)

10 g/kg

Sauces

5 g/kg

Soups and broths

3 g/kg

Tea and herbal infusions

2 g/l

Cider and perry

2 g/l

Chewing gum

quantum satis39

Dried powdered foods

10 g/kg40

Chocolate and malt dairy-based drinks

2 g/l

Alcoholic drinks (excluding wine and beer)

1 g/l

Breakfast cereals

5 g/kg

Snacks

5 g/kg

Surimi

1 g/kg

Fish and crustacean 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

5 g/kg

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

5 g/kg

E 431

Polyoxyethylene (40) stearate

(pro memoria) Wine in accordance with Reglation (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

E 353

Metatartaric acidE 353

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

E 356

Sodium adipate

E 357

Potassium adipate

Fillings and toppings for fine bakery wares

2 g/kg

Dry powdered dessert mixes

1 g/kg

Gel-like desserts

6 g/kg

Fruit-flavoured desserts

1 g/kg

Powders for home preparation of drinks

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 tetra-acetate (Calcium disodium EDTA)

Emulsified sauces

75 mg/kg

Canned and bottled pulses, legumes, mushrooms and artichokes

250 mg/kg

Canned and bottled crustaceans and molluscs

75 mg/kg

Canned and bottled fish

75 mg/kg

Minarine

100 mg/kg

Frozen and deep-frozen crustaceans

75 mg/kg

E 405

Propane-1,2-diol alginate

Fat emulsions

3 g/kg

Fine bakery wares

2 g/kg

Fillings, toppings and coatings for fine bakery wares and desserts

5 g/kg

Sugar confectionery

1.5 g/kg

Water-based edible ices

3 g/kg

Cereal- and potato-based snacks

3 g/kg

Sauces

8 g/kg

Beer

100 mg/l

Chewing gum

5 g/kg

Fruit and vegetable preparations

5 g/kg

Non-alcoholic flavoured drinks

300 mg/l

Emulsified liqueur

10 g/l

Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal

1.2 g/kg

Dietary food supplements

1 g/kg

E 416

Karaya gum

Cereal- and potato-based snacks

5 g/kg

Nut coatings

10 g/kg

Fillings, toppings and coatings for fine bakery wares

5 g/kg

Desserts

6 g/kg

Emulsified sauces

10 g/kg

Egg-based liqueurs

10 g/l

Dietary food supplements

quantum satis

Chewing gum

5 g/kg

E 420

Sorbitol

  1. i

    Sorbitol

  2. ii

    Sorbitol syrup

E 421

Mannitol

E 953

Isomalt

E 965

Maltitol

  1. i

    Maltitol

  2. ii

    Maltitol syrup

E 966

Lactitol

E 967

Xylitol

Foods in general (except drinks and those foods referred to in Schedules 6, 7 and 8)

Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods

Liqueurs

quantum satis (for purposes other than sweetening)

E 432

Polyoxyethylene sorbitan monolaurate (polysorbate 20)

E 433

Polyoxyethylene sorbitan monooleate (polysorbate 80)

E 434

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)

E 435

Polyoxyethylene sorbitan monostearate (polysorbate 60)

E 436

Polyoxyethylene sorbitan tristearate (polysorbate 65)

Fine bakery wares

3 g/kg

Fat emulsions for baking purposes

10 g/kg

Milk and cream analogues

5 g/kg

Edible ices

1 g/kg

Desserts

3 g/kg

Sugar confectionery

1 g/kg

Emulsified sauces

5 g/kg

Soups

1 g/kg

Chewing gum

5 g/kg

Dietary food supplements

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

1 g/kg Individually or in combination

E 442

Ammonium phosphatides

Cocoa and chocolate products as defined in Directive 73/241/EEC41

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

E 474

Sucroglycerides

Canned liquid coffee

1 g/l

Heat-treated meat products

5 g/kg (on fat)

Fat emulsions for baking purposes

10 g/kg

Fine bakery wares

10 g/kg

Beverage whiteners

20 g/kg

Edible ices

5 g/kg

Sugar confectionery

5 g/kg

Desserts

5 g/kg

Sauces

10 g/kg

Soups and broths

2 g/kg

Fresh fruits, surface treatment

quantum satis

Non-alcoholic aniseed-based drinks

5 g/l

Non-alcoholic coconut and almond drinks

5 g/l

Spirituous beverages (excluding wine and beer)

5 g/l

Powders for the preparation of hot beverages

10 g/l

Dairy-based drinks

5 g/l

Dietary food supplements

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

5 g/kg

Chewing gum

10 g/kg Individually or in combination

E 475

Polyglycerol esters of fatty acids

Fine bakery wares

10 g/kg

Emulsified liqueurs

5 g/l

Egg products

1 g/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 supplements

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

5 g/kg

Granola-type breakfast cereals

10 g/kg

E 476

Polyglycerol polyricinoleate

Low and very low fat spreads and dressings

4 g/kg

Cocoa-based confectionery, including chocolate

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

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

1 g/kg

E 479b

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

Fat emulsion for frying purposes

5 g/kg

E 481

Sodium stearoyl-2-lactylate

E 482

Calcium stearoyl-2-lactylate

Fine bakery wares

5 g/kg

Quick-cook rice

4 g/kg

Breakfast cereals

5 g/kg

Emulsified liqueur

8 g/l

Spirits with less than 15% alcohol by volume

8 g/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

2 g/l

Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal

2 g/kg

Bread (except that referred to in Schedule 7)

3 g/kg

Mostarda di frutta

2 g/kg Individually or in combination

E 483

Stearyl tartrate

Bakery wares (except breads referred to in Schedule 7)

4 g/kg

Desserts

5 g/kg

E 491

Sorbitan monostearate

E 492

Sorbitan tristearate

E 493

Sorbitan monolaurate

E 494

Sorbitan monooleate

E 495

Sorbitan monopalminate

Fine bakery wares

10 g/kg

Toppings and coatings for fine bakery wares

5 g/kg

Jelly marmalade

25 mg/kg42

Fat emulsions

10 g/kg

Milk and cream analogues

5 g/kg

Beverage whiteners

5 g/kg

Liquid tea concentrates and liquid and herbal infusions concentrates

0.5 g/l

Edible ices

0.5 g/kg

Desserts

5 g/kg

Sugar confectionery

5 g/kg

Cocoa-based confectionery, including chocolate

10 g/kg43

Emulsified sauces

5 g/kg

Dietary food supplements

quantum satis

Yeast for baking

quantum satis

Chewing gum

5 g/kg

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

(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 tin

E 520

Aluminium sulphate

E 521

Aluminium sodium sulphate

E 522

Aluminium potassium sulphate

E 523

Aluminium ammonium sulphate

Egg white

30 mg/kg

Candied, crystallised and glacé fruit and vegetables

200 mg/kg Individually or in combination, expressed as aluminium

E 541

Sodium aluminium phosphate, acidic

Fine bakery wares (scones and sponge wares only)

1 g/kg expressed as aluminium

E 535

Sodium ferrocyanide

E 536

Potassium ferrocyanide

E 538

Calcium ferrocyanide

Salt and its substitutes

20 mg/kg Individually or in combination. expressed as anhydrous potassium ferrocyanide

E 551

Silicon dioxide

E 552

Calcium silicate

E 553a

i

Magnesium silicate

ii

Magnesium trisilicate44

E 553b

Talc44

E 554

Sodium aluminium silicate

E 555

Potassium aluminium silicate

E 556

Calcium aluminium silicate

E 559

Aluminium silicate (Kaolin)

Dried powdered foods (including sugars)

10 g/kg

Salt and its substitutes

10 g/kg

Dietary food supplements

quantum satis

Foods in tablet and coated tablet form

quantum satis

Sliced hard cheese and sliced processed cheese

10 g/kg Individually or combination

Chewing gum

Rice

Sausages (surface treatment only)

Moulded jelly sweets (surface treatment only)

quantum satis45

E 579

Ferrous gluconate

E 585

Ferrous lactate

Olives darkened by oxidation

150 mg/kg as iron

E 620

Glutamic acid

E 621

Monosodium glutamate

E 622

Monopotassium glutamate

E 623

Calcium diglutamate

E 624

Monoammonium glutamate

E 625

Magnesium diglutamate

Foods in general (except those referred to in Schedules 6, 7 and 8)

10 g/kg Individually or in combination

Condiments and seasonings

quantum satis

E 626

Guanylic acid

E 627

Disodium guanylate

E 628

Dipotassium guanylate

E 629

Calcium guanylate

E 630

Inosinic acid

E 631

Disodium inosinate

E 632

Dipotassium inosinate

E 633

Calcium inosinate

E 634

Calcium 5'-ribonucleotides

E 635

Disodium 5'-ribonucleotides

Foods in general (except those referred to in Schedules 6, 7 and 8)

500 mg/kg individually or in combination, expressed as guanylic acid

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

Oil and fats for frying

10 mg/kg

Confectionery (excluding chocolate)

10 mg/kg

Non-alcoholic flavoured drinks

10 mg/l

Pineapple juice

10 mg/l

Canned and bottled fruit and vegetables

10 mg/kg

Chewing gum (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

100 mg/kg

Sød . . . saft

10 mg/l

Batters

10 mg/kg

E 901

Beeswax, white and yellow

E 902

Candelilla wax

E 903

Carnauba wax

E 904

Shellac

As glacing agents only for:

  • Confectionery (including chocolate)

  • Small products of fine bakery wares coated with chocolate

  • Snacks

  • Nuts

  • Coffee beans

quantum satis

Dietary food supplements

quantum satis

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

quantum satis

E 912

Montan acid esters

E 914

Oxidised polyethylene wax

Fresh citrus fruits, (surface treatment only)

quantum satis

E 927b

Carbamide

Chewing gum without added sugars

30 g/kg

E 950

Acesulfame-K

E 951

Aspartame

E 957

Thaumatin

Chewing gum with added sugars

800 mg/kg46 2500 mg/kg46 10 mg/kg46 (as flavour enhancer only)

E 959

Neohesperidine DC

Chewing gum with added sugars

150 mg/kg46

Margarine

Minarine

Meat products

Fruit jellies

Vegetable proteins

5 mg/kg (as flavour enhancer only)

E 999 extract

Quillaia extract

Water-based flavoured non-alcoholic drinks

200 mg/l calculated as anhydrous

E 1201

Polyvinylpyrrolidone

E 1202

Polyvinylpolypyrrolidone

Dietary food supplements

quantum satis in tablet and coated tablet form

E 1505

Triethyl citrate

Dried egg white

quantum satis

Propane47

Butane47

Iso-Butane47

Garlic flavoured oil spray for producing garlic bread and pizza

Vegetable oil pan spray for professional use only

quantum satis

SCHEDULE 4Permitted Carriers and Carrier Solvents

Regulations 2(1), 3(6) and 5(2)

EC No.

Name

Restricted use

Propane-1,2-diol (propylene glycol)

Colours, emulsifiers, antioxidants and enzymes (maximum 1 g/kg in or on the food)E 422 Glycerol

E 420

Sorbital

E 421

Mannitol

E 953

Isomalt

E 965

Maltitol

E 966

Lactitol

E 967

Xylitol

E 400-404

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

E 405

Propane-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 monolautate (polysorbate 20)

Antifoaming agents, colours and fat-soluble antioxidants

E 433

Polyoxyethylene sorbitan monooleate (polysorbate 80)

Antifoaming agents, colours and fat-soluble antioxidants

E 434

Polyoxyethylene sorbitan monopalmitate (polysorbate 40)

Antifoaming agents, colours and fat-soluble antioxidants

E 435

Polyoxyethylene sorbitan monostearate (polysorbate 60)

Antifoaming agents, colours and fat-soluble antioxidants

E 436

Polyoxyethylene sorbitan tristearate (polysorbate 65)

Antifoaming agents, colours and fat-soluble antioxidants

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

Colours and fat-soluble antioxidants

E 470b

Magnesium salts of fatty acids

Colours and fat-soluble antioxidants

E 471

Mono- and diglycerides of fatty acids

Colours and fat-soluble antioxidants

E 472a

Acetic acid esters of mono- and diglycerides of fatty acids

Colours and fat-soluble antioxidants

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

Colours and fat-soluble antioxidants

E 472e

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

Colours and fat-soluble antioxidants

E 473

Sucrose esters of fatty acids

Colours and fat-soluble antioxidants

E 475

Polyglycerol esters of fatty acids

Colours and fat-soluble antioxidants

E 491

Sorbitan monostearate

Colours and anti-foaming agents

E 492

Sorbitan tristearate

Colours and anti-foaming agents

E 493

Sorbitan monolaurate

Colours and anti-foaming agents

E 494

Sorbitan monooleate

Colours and anti-foaming agents

E 495

Sorbitan monopalminate

Colours and anti-foaming agents

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

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 triacetate (triacetin)

E 551

Silicon dioxide

Emulsifiers and colours, max. 5%

E 552

Calcium silicate

Emulsifiers and colours, max. 5%

E 553b

Talc

Colours, max. 5%

E 558

Bentonite

Colours, max. 5%

E 559

Aluminium silicate (Kaolin)

Colours, max. 5%

E 901

Beeswax

Colours

E 1200

Polydextrose

E 1201

Polyvinylpyrrolidone

Sweeteners

E 1202

Polyvinylpolypyrrolidone

Sweeteners

SCHEDULE 5Purity Criteria

Regulations 2(1) and 11(5)

Each miscellaneous additive for which specific purity criteria are specified or referred to below shall not contain—

a

more than 3 milligrams per kilogram of arsenic;

b

more than 10 milligrams per kilogram of lead;

c

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;

except in so far as those specific purity criteria provide otherwise or in the case of E 957 Thaumatin.

Calcium carbonateE 170(i)

Description

Fine white microcrystalline or amorphous powder

Content

Not less than 97 per centum of CaCO3 on a volatile matter-free basis

Volatile matter

Not more than 1 per centum (determined by drying at 105°C to constant weight)

Matter insoluble in hydrochloric acid

Shall comply with the requirement for aluminium, iron, phosphate and matter insoluble in hydrochloric acid in the monograph for chalk in the British Pharmacopoeia 1973 at page 93

Arsenic

Not more than 5 mg per kg.

Lead

Not more than 20 mg per kg.

Other inorganic impurities

Not more than 100 mg per kg of any of the following substances, namely antimony, copper, chromium, zinc or barium sulphate, or more than 200 mg per kg of any combination of those substances.

Sorbic acidE 200

Potassium sorbateE 202

Calcium sorbateE 203

Benzoic acidE 210

Sodium benzoateE 211

Potassium benzoateE 212

Calcium benzoateE 213

Ethyl p-hydroxybenzoateE 214

Synonyms

Ethyl 4-hydroxybenzoate

Ethyl ester of p-hydroxybenzoic acid

Sodium ethyl p-hydroxybenzoateE 215

Synonyms

Ethyl 4-hydroxybenzoate, sodium salt

Sodium ethyl para-hydroxybenzoate

Propyl p-hydroxybenzoateE 216

Synonyms

Propyl 4-hydroxybenzoate

Propyl para-hydroxybenzoate n-propyl p-hydroxybenzoate

Sodium propyl p-hydroxybenzoateE 217

Synonyms

Propyl 4-hydroxybenzoate, sodium salt

Sodium propyl para-hydroxybenzoate

Sodium n-propyl p-hydroxybenzoate

Methyl p-hydroxybenzoateE 218

Synonyms

Methyl 4-hydroxybenzoate

Methyl para-hydroxybenzoate

Sodium methyl p-hydroxybenzoateE 219

Synonyms

Methyl 4-hydroxybenzoate, sodium salt

Sodium methyl para-hydroxybenzoate

Sulphur dioxideE 220

Sodium sulphite (anhydrous or heptahydrate)E 221

Sodium hydrogen sulphiteE 222

Synonym

Acid sodium sulphite

Sodium metabisulphiteE 223

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.

Potassium metabisulphiteE 224

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC.

Calcium sulphiteE 226

Calcium hydrogen sulphiteE 227

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.

Potassium hydrogen sulphiteE 228

Synonyms

Potassium bisulhite

Potassium acid sulphite

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EEC51.

Biphenyl, diphenylE 230

Orthophenyl phenolE 231

Synonym

2-Hydroxybiphenyl

Sodium orthophenyl phenolE 232

Synonyms

Sodium biphenyl-2-yl-oxide

Sodium orthophenylphenate

ThiabendazoleE 233

Synonyms

2-(Thiazol-4-yl) benzimidazole

2-(4-thiazolyl) benzimidazole

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.

NisinE 234

The criteria in the monograph for nisin contained in the Nutrition Meetings Report Series No. 45A (1969) of the United Nations' Food and Agriculture Organisation at page 53.

Hexamethylene tetramineE 239

Synonym

Hexamine

Potassium nitriteE 249

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.

  • In the case of:—

Sodium nitriteE 250

Sodium nitrateE 251

Potassium nitrateE 252

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.

  • In the case of:—

Acetic acidE 260

Potassium acetateE 261

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC.

Sodium acetateE 262(i)

Sodium acetate, anhydrous

The criteria in the monograph for sodium acetate, anhydrous contained in the Food Chemicals Codex 1972 at page 718.

Sodium acetate

The criteria in the monograph for sodium acetate contained in the Food Chemicals Codex 1972 at page 717 except that the alkalinity shall be not more than 0.1 per centum (as sodium carbonate, Na2CO3).

In the case of:—

Sodium diacetateE 262(ii)

Synonym

Sodium hydrogen diacetate

Calcium acetateE 263

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC.

Lactic acidE 270

The specific purity criteria for lactic acid contained in Council Directive 65/66/EEC.

Propionic acidE 280

Sodium propionateE 281

Calcium propionateE 282

  • the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.

Potassium propionateE 283

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.

Carbon dioxideE 290

The specific purity criteria for carbon dioxide contained in Council Directive 65/66/EEC. Solid or liquid carbon dioxide shall be of equivalent purity to the gas.

Malic acidE 296

DL-Malic acid

The criteria in the monograph for malic acid contained in the Food Chemicals Codex 1972 at page 484 as amended by the Second Supplement to that Codex at page 27, except that the melting range shall be 130°C to 132°C (corrected) and that the method for determining the melting range shall be that specified or a method of equivalent accuracy.

L-Malic Acid

Description

White or nearly white crystalline powder or granules

Content Melting range

Not less than 99 per centum of C4H6O5. 99°C to 101°C.

Specific rotation [α] 20°C D

Not less than –2.4° and not more than –2.2° using a solution containing 8.5g L-malic and in 100 ml water.

Malic acid

Fumaric acid

Residue on ignition

Water insoluble matter

Shall comply with the limits given in the }monograph for malic acid in the Food Chemicals Codex 1972 at page 484.

Fumaric acidE 297

The criteria in the monograph for fumaric acid contained in the Food Chemicals Codex 1972 at page 331.

Ascorbic acidE 300

Sodium ascorbateE 301

Calcium ascorbateE 302

Fatty acid esters of ascorbic acidE 304

Ascorbyl palmitateE 304(i)

Tocopherol-rich extractE 306

Alpha-tocopherolE 307

Gamma-tocopherolE 308

Delta-tocopherolE 309

Propyl gallateE 310

Octyl gallateE 311

Dodecyl gallateE 312

Butylated hydroxyanisole (BHA)E 320

Butylated hydroxytoluene (BHT)E 321

  • the appropriate specific purity criteria contained in Council Directive 78/664/EEC52.

LecithinsE 322

  • The specific purity criteria for lecithins contained in Council Directive 78/664/EEC as amended by Article 1.2 of Council Directive 82/712/EEC53.

In the case of:—

Sodium lactateE 325

Potassium lactateE 326

Calcium lactateE 327

Citric acidE 330

Monosodium citrateE 331(i)

Synonym

Sodium dihydrogen citrate

Disodium citrateE 331(ii)

Trisodium citrateE 331(iii)

Monopotassium citrateE 332(i)

Synonym

Potassium dihydrogen citrate

Tripotassium citrateE 332(ii)

Monocalcium citrateE 333(i)

Dicalcium citrateE 333(ii)

Tricalcium citrateE 333(iii)

L-(+)-Tartaric acidE 334

Monosodium L-(+)-tartrateE 335(i)

Disodium L-(+)-tartrateE 335(ii)

Monopotassium L-(+)-tartrateE 336(i)

Dipotassium L-(+)-tartrateE336(ii)

Sodium potassium L-(+)-tartrateE 337

Synonym

Potassium sodium tartrate

Phosphoric acidE 338

Synonym

Orthophosphoric acid

Monosodium phosphateE 339(i)

Synonym

Monosodium orthophosphate

Disodium phosphateE 339(ii)

Synonym

Disodium orthophosphate Disodium hydrogen orthophosphate

Trisodium phosphateE 339(iii)

Synonym

Trisodium orthophosphate

Monopotassium phosphateE 340(i)

Synonyms

Monodipotassium orthophosphate Potassium dihydrogen orthophosphate

Dipotassium phosphateE 340(ii)

Synonyms

Dipotassium orthophosphate Dipotassium hydrogen orthophosphate

Tripotassium phosphateE 340(iii)

Synonym

Tripotassium orthophosphate

Monocalcium phosphateE 341(i)

Synonyms

Monocalcium orthophosphate Calcium tetrahydrogen diorthophosphate

Dicalcium phosphateE 341(ii)

Synonyms

Dicalcium orthophosphate Calcium hydrogen orthophosphate

Tricalcium phosphateE 340(iii)

Synonyms

Tricalcium orthophosphate Tricalcium diorthophosphate

  • the appropriate specific purity criteria contained in Council Directive 78/664/EEC.

Sodium malateE 350(i)

Description

Colourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.

Content

Not less than 59.5 per centum of C4H4O5Na2.

Maleic acid

Not more than 0.05 per centum calculated on the C4H4O5Na2 content.

Sodium hydrogen malateE 350(ii)

Description

White odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.

Content

Not less than 99 per centum of C4H5O5Na on a volatile matter-free basis.

Volatile matter

Not more than 2 per centum (determined by drying at 110°C for 3 hours)

Maleic acid

Not more than 0.05 per centum.

Potassium malateE 351

Description

Colourless or almost colourless aqueous solution. Potassium malate may be derived from either DL-malic acid or L-malic acid.

Content

Not less than 59.5 per centum of C4H4O5K2

Maleic acid

Not more than 0.05 per centum calculated on the C4H4O5K2 content.

Calcium malateE 352(i)

Description

White odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid

Content

Not less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.

Volatile matter

Not more than 2 per centum (determined by drying at 110°C for 3 hours)

Maleic acid

Not more than 0.05 per centum.

Fluoride

Not more than 30 mg per kg on a volatile matter-free basis

Calcium hydrogen malateE 352(ii)

Description

White odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid

Content

Not less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.

Volatile matter

Not more than 2 per centum (determined by drying at 110°C for 3 hours)

Maleic acid

Not more than 0.05 per centum.

Fluoride

Not more than 30 mg per kg on a volatile matter-free basis

Metatartaric acidE 353

Description

White or yellow powder which consists chiefly of a mixture of polyesters obtained by the controlled dehydration of L-(+)-tartaric acid together with unchanged L-(+)-tartaric acid.

Specific absorption 1 per centum E 1 cm

Not more than 1.5 × 10−2at 430 nm. (determined using a filtered aqueous solution).

Identification

Place 5 to 10 mg of sample in a test tube. Add 2 ml sulphuric acid (about 94 per centum H2SO4) plus two drops of resorcinol reagent (2 g. resorcinol dissolved in 100 ml water plus 0.5 ml sulphuric acid) and heat to 150°C. An intense violet colour is produced.

Content

Not less than the equivalent of 105 per centum of tartaric acid (C4H6O6). The esterified tartaric acid content shall be not less than 27 per centum and not more than 38 per centum of the tartaric acid equivalent when determined by the following method:

Add three drops of bromothymol blue indicator (0.04 per centum weight/volume solution of bromothymol blue in 95 per centum volume/volume ethanol) to 50 ml of freshly prepared 2 per centum weight/volume cold aqueous solution of metatartaric acid. Titrate with N aqueous sodium hydroxide solution to a blue-green colour (T1ml.). Add a further 20 ml of N aqueous sodium hydroxide solution and leave for 2 hours at room temperature.

Titrate with N aqueous sulphuric acid solution (T2ml).

Calculations:

Tartaric acid equivalent=7.5(T1+20-T2)per centummathEsterfied tartaric acid=100(20-T2)T1=20-T2per centummath

Specific rotation [α] 20°C D

Not less than + 12.5° and not more than + 13.5° (using a filtered 10 per centum weight/volume aqueous solution).

Matter insoluble in water (at about 20°C)

Not more than 2.5 per centum (insoluble matter weighed after drying for 3 hours at 70°C in a vacuum oven).

Pyruvic acid

Not more than 0.5 per centum.

Adipic acidE 355

The criteria in the monograph for adipic acid contained in the Food Chemicals Codex 1972 at page 21.

Succinic acidE 363

The criteria in the monograph for succinic acid contained in the Food Chemicals Codex 1972 at page 800.

Triammonium citrateE 380

Synonym

Ammonium citrate

The criteria in the monograph for ammonium citrate contained in the British Pharmaceutical Codex 1973 at page 830.

Calcium disodium ethylenediamine — N N N'N' — tetra-acetateE 385

Synonym

Sodium calciumedate

The criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.

Alginic acidE 400

Sodium alginateE 401

Potassium alginateE 402

Ammonium alginateE 403

Calcium alginateE 404

Propane-1,2-diol alginateE 405

Synonym

Propylene glycol alginate

AgarE 406

The specific purity criteria for agar contained in Council Directive 78/663/EEC.

CarrageenanE 407

The specific purity criteria for carrageenan contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC56.

Locust bean gumE 410

Synonym

Carob gum

Guar gumE 412

TragacanthE 413

AcaciaE 414

Synonym

Gum arabic

Xanthan gumE 415

The specific purity criteria for xanthan gum contained in Council Directive 78/663/EEC, as amended by Article 1.2(b) of Council Directive 82/504/EEC.

Karaya gumE 416

Synonym

Sterculia gum

The criteria in the monograph for karaya gum contained in the Food Chemicals Codex 1981 at page 157.

SorbitolE 420(i)

Sorbitol syrupE 420(ii)

MannitolE 421

  • the appropriate specific purity criteria contained in Commission Directive 95/31/EC57.

GlycerolE 422

As set out in the Annex to Council Directive 78/663/EEC.

Polyoxyethylene (20) sorbitan monolaurateE 432

Synonym

Polysorbate 20

The criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1981 at page 234.

Polyoxyethylene (20) sorbitan monooleateE 433

Synonym

Polysorbate 80

The criteria in the monograph for polysorbate 80 contained in the Food Chemicals Codex 1981 at page 236 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.

Polyoxyethylene (20) sorbitan monopalmitateE 434

Synonym

Polysorbate 40

The criteria in the monograph for polyoxyethylene (20) sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 278.

Polyoxyethylene (20) sorbitan monostearateE 435

Synonym

Polysorbate 60

The criteria in the monograph for polysorbate 60 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.

Polyoxyethylene (20) sorbitan tristearateE 436

Synonym

Polysorbate 65

The criteria in the monograph for polysorbate 65 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.

PectinE 440(i)

Amidated pectinE 440(ii)

  • the appropriate specific purity criteria contained in Council Directive 78/663/EEC.

Ammonium phosphatidesE 442

Description

Ammonium phosphatides exist as an unctuous semi-solid (at 25°C). They consist essentially of a mixture of the ammonium salts of phosphatidic acids derived from partially hardened rapeseed oil together with unreacted partially hardened rape-seed oil.

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

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

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 centum and not more than 3.4 per centum.

Ammonium nitrogen

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

Arsenic

Not more than 5 mg per kg.

Disodium diphosphateE 450(i)

Trisodium diphosphateE 450(ii)

Tetrasodium diphosphateE 450(iii)

Tetrapotassium diphosphateE 450(v)

  • the appropriate specific purity criteria contained in Council Directive 78/663/EEC.

Dicalcium diphosphateE 450(vi)

Synonyms

Dicalcium pyrophosphate Calcium pyrophosphate

The criteria in the monograph for calcium pyrophosphate contained in the Food Chemicals Codex 1972 at page 153.

Pentasodium triphosphateE 451(i)

Pentapotassium triphosphateE 451(ii)

Sodium polyphosphateE 452(i)

Potassium polyphosphateE 452(ii)

  • the appropriate specific purity criteria contained in Council Directive 78/663/EEC.

Calcium polyphosphatesE 452(iv)

Description

Calcium polyphosphates exist as a fine white powder or crystals or colourless glassy platelets. They are reproducible heterogeneous mixtures of calcium salts of condensed polyphosphoric acids of general formula:

H(n+2)PnO(3n+1)math

where

  • n shall be not less than 2

Content (expressed as P2O5)

Not less than 50 per centum and not more 71 per centum of an anhydrous basis.

pH (1 per centum aqueous solution)

For water soluble phosphates only: not less than 4.0 and not more than 9.0.

Cyclic phosphate

Not more than 8 per centum calculated on the P2O5 content.

Fluoride

Not more than 15 mg per kg calculated on the P2O5 content.

Microcrystalline celluloseE 460(i)

The specific purity criteria for microcrystalline cellulose contained in Council Directive 78/663/EEC, as amended by Article 1.2(c) of Council Directive 82/504/EEC.

Powdered celluloseE 460(ii)

Synonym

Alpha-cellulose

The criteria in the monograph for cellulose, powdered, contained in the Food Chemicals Codex 1981 at page 80. Additionally the level of lead present shall not exceed 1 mg per kg.

MethylcelluloseE 461

HydroxypropylcelluloseE 463

HydroxypropylmethylcelluloseE 464

EthylmethylcelluloseE 465

Synonym

Methylethylcellulose

CarboxymethylcelluloseE 466

Synonym

Sodium carboyxmethylcellulose

The specific purity criteria for carboxymethylcellulose contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.

Sodium, potassium and calcium salts of fatty acidsE 470a

Mono- and diglycerides of fatty acidsE 471

Acetic acid esters of mono- and diglycerides of fatty acidsE 472(a)

Synonym

Acetylated mono- and diglycerides

Lactic acid esters of mono- and diglycerides of fatty acidsE 472(b)

Synonyms

Lactylated mono- and diglycerides

Lactoglycerides

Citric acid esters of mono- and diglycerides of fatty acidsE 472(c)

Synonym

Citroglycerides

Tartaric acid esters of mono- and diglycerides of fatty acidsE 472(d)

Mono-and diacetyl tartaric acid esters of mono- and diglycerides of fatty acidsE 472(e)

Synonym

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

Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acidsE 472(f)

  • the appropriate specific purity criteria contained in Council Directive 78/663/EEC.

Sucrose esters of fatty acidsE 473

The specific purity criteria for sucrose esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC and Article 1 of Commission Directive 92/4/EEC58.

SucroglyceridesE 474

The specific purity criteria for sucroglycerides contained in Council Directive 78/663/EEC, as amended by Article 1.2(e) of Council Directive 82/504/EEC.

Polyglycerol esters of fatty acidsE 475

The specific purity criteria for polyglycerol esters of non-polymerised fatty acids contained in Council Directive 78/663/EEC.

Polyglycerol polyricinoleateE 476

Synonym of castor oil.

Polyglycerol esters of polycondensed fatty acids

Description

The polyglycerol esters of polycondensed fatty acids of castor oil exist as a highly viscous liquid (at 25°C). They are 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 centum of polyglycerols equal to or higher than heptaglycerol.

Refractive index, m65D°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 6 mg KOH per g.

Propane-1,2-diol esters of fatty acidsE 477

Synonym

Propylene glycol esters of fatty acids.

The specific purity criteria for propane-1,2-diol esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1.2(f) of Council Directive 82/504/EEC.

Sodium stearoyl-2-lactylateE 481

Calcium stearoyl-2-lactylateE 482

Stearyl tartrateE 483

  • the appropriate specific purity criteria contained in Council Directive 78/663/EEC.

Sorbitan monostearateE 491

The criteria in the monograph for sorbitan monostearate contained in the Food Chemicals Codex 1981 at page 307 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.

Sorbitan tristearateE 492

The criteria in the monograph for sorbitan tristearate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 297.

Sorbitan monolaurateE 493

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

Sorbitan monooleateE 494

The criteria in the monograph for sorbitan monooleate contained in the British Pharmaceutical Codex 1973 at page 466.

Sorbitan monopalmitateE 495

The criteria in the monograph for sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 293.

Sodium carbonateE 500(i)

Description

Colourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.

Content

Not less than 98 per centum of Na2CO2 on a volatile matter-free basis.

Volatile matter

  • Not more than:

    • 2 per centum for the non-hydrated substance;

    • 15 per centum for the monohydrate;

    • 65 per centum for the decahydrate; (determined by the method for loss on drying in the monograph for sodium carbonate in the Food Chemicals Codex 1972 at page 731.)

Matter insoluble in dilute ammonia solution

  • Not more than 0.12 per centum on a volatile matter-free basis, determined by the following method:

    • Boil 5 g of hydrated sodium carbonate, or 2.5 g of anhydrous sodium carbonate, with 50 ml of water and 10 ml of dilute ammonia solution (about 10 per centum NH3). Filter and wash the residue with water, then ignite to constant weight.

Sulphate

Not more than 0.4 per centum on a volatile matter-free basis.

Chloride

Not more than 0.4 per centum on a volatile matter-free basis

Iron

Not more than 40 mg per kg on a volatile matter-free basis.

Sodium hydrogen carbonateE 500(ii)

Synonym

Sodium bicarbonate

The criteria in the monograph for sodium bicarbonate contained in the Food Chemicals Codex 1972 at page 727.

Sodium sesquicarbonateE 500(iii)

The criteria in the monograph for sodium sesqicarbonate contained in the Food Chemicals Codex 1972 at page 765.

Potassium carbonateE 501(i)

Description

  • The anhydrous form is a white granular powder.

  • The hydrated form consists of small white translucent crystals or granules.

Content

Not less than 98 per centum K2CO3 on a volatile matter-free basis.

Volatile matter

  • Not more than:

    • 2 per centum for the non-hydrated substance;

    • 18 per centum for the hydrated substance; (determined by drying at 180°C for 4 hours)

Potassium hydrogen carbonateE 501(ii)

Synonym

Potassium bicarbonate

The criteria in the monograph for potassium bicarbonate contained in the Food Chemicals Codex 1972 at page 642.

Ammonium carbonateE 503(i)

The criteria in the monograph for ammonium carbonate contained in the Food Chemicals Codex 1972 at page 45.

Ammonium hydrogen carbonateE 503(ii)

Synonym

Ammonium bicarbonate

The criteria in the monograph for ammonium bicarbonate contained in the Food Chemicals Codex 1972 at page 44.

Magnesium carbonatesE 504

Magnesium carbonate, heavy

The criteria in the monograph for heavy magnesium carbonate contained in the European Pharmacopoeia Vol. 1, 1969 at page 322.

Magnesium carbonate, light

The criteria in the monograph for light magnesium carbonate contained in the European Pharmacopoeia Vol. 1, 1969 at page 321.

Hydrochloric acidE 507

The criteria in the monograph for concentrated hydrochloric acid contained in the European Pharmacopoeia Vol. II, 1971 at page 145.

Potassium chlorideE 508

The criteria in the monograph for potassium chloride contained in the Food Chemicals Codex 1972 at page 646.

Calcium chlorideE 509

Calcium chloride, anhydrous

The criteria in the monograph for calcium chloride, anhydrous contained in the Food Chemicals Codex 1972 at page 124.

Calcium chloride

Description

The dihydrate consists of deliquescent white odourless fragments or granules. The hexahydrate consists of deliquescent colourless and odourless crystals.

Content

  • Not less than:

    • 98 per centum of CaCl2. 2H2O for the dihydrate;

    • 97 per centum of CaCl2. 6H2O for the hexahydrate.

Magnesium and alkali salts

Not more than 2 per centum, determined by the method in the monograph for calcium chloride contained in the Food Chemicals Codex 1972 at page 123 except that the weight of the residue shall not exceed 10 mg.

Fluoride

Not more than 40 mg per kg on an anhydrous basis.

Sulphuric acidE 513

The criteria in the monograph for sulphuric acid contained in the Food Chemicals Codex 1972 at page 802.

Sodium sulphateE 514(i)

The criteria in the monograph for sodium sulphate contained in the Food Chemicals Codex 1972 at page 775.

Potassium sulphateE 515(i)

The criteria in the monograph for potassium sulphate contained in the Food Chemicals Codex 1972 at page 670.

Calcium sulphateE 516

The criteria in the monograph for calcium sulphate contained in the Food Chemicals Codex 1972 at page 163.

Aluminium potassium sulphateE 522

Synonyms

Potassium aluminium sulphate Potash alum.

The criteria in the monograph for alum contained in the European Pharmacopoeia Vol. 1, 1969 at page 243.

Sodium hydroxideE 524

The criteria in the monograph for sodium hydroxide contained in the Food Chemicals Codex 1972 at page 743.

Potassium hydroxideE 525

The criteria in the monograph for potassium hydroxide contained in the Food Chemicals Codex 1972 at page 652.

Calcium hydroxideE 526

Description

Soft white powder.

Solubility

1 g dissolves in 630 ml of water at 25°C, and in 1300 ml of boiling water. Soluble in glycerol and in a saturated solution of sucrose. Insoluble in ethanol.

Content

Not less than 92 per centum of Ca(OH)2.

Matter insoluble in dilute Hydrochloric acid (about 10 per centum weight/ volume HCL)

Not more than 0.5 per centum.

Magnesium and alkali salts

Not more than 6 per centum, determined by the method in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 131 except that the weight of the residue shall not exceed 15 mg.

Carbonate

When 2 g of calcium hydroxide is mixed with 50 ml of water and an excess of dilute hydrochloric acid (approximately 2N) is added, no more than a slight effervescence is produced.

Sulphate

Not more than 0.35 per centum.

Fluoride

Not more than 50 mg per kg.

Ammonium hydroxideE 527

The criteria in the monograph for ammonium hydroxide contained in the Food Chemicals Codex 1972 at page 48.

Magnesium hydroxideE 528

The criteria in the monograph for magnesium hydroxide contained in the British Pharmaceutical Codex 1973 at page 277.

Calcium oxideE 529

The criteria in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 138.

Magnesium oxideE 530

Magnesium oxide, heavy

Description

White fine odourless powder.

Solubility

  • Practically insoluble in water.

  • Soluble in dilute acids with, at most, slight effervescence.

Apparent volume

20 g of heavy magnesium oxide occupies a volume of about 50 ml.

Content

Not less than 98 per centum of MgO calculated with reference to the ignited substance and determined by the assay method contained in the monograph for light magnesium oxide in the European Pharmacopoeia Vol. I, 1969 at page 319.

Loss on ignition

Not more than 5 per centum (determined by ignition at 900°C to 950°C to constant weight).

Matter soluble in water

Not more than 2 per centum, determined by the method for soluble substances contained in the monograph for light magnesium oxide in the European Pharmacopoeia Vol. I, 1969 at page 319.

Matter insoluble in acetic acid

  • Not more than 0.1 per centum when determined by the following method:

  • Dissolve 5 g heavy magnesium oxide in a mixture of 70 ml acetic acid (see Note 1) and 30 ml water. Heat to boiling for 2 minutes, cool and dilute to 100 ml with dilute acetic acid (see Note 2). Filter through a sintered glass filter. Any residue, after washing with water, drying and ignition at 600°C, shall weigh not more than 5 mg.

Sulphate

Not more than 0.75 per centum.

Chloride

Not more than 0.07 per centum.

Calcium

Not more than 2 per centum.

Iron

Not more than 0.1 per centum.

Arsenic

Not more than 4 mg per kg.

Heavy metals

Not more than 40 mg per kg.

Note 1:

Acetic acid: contains not less than 29 per centum weight/volume and not more than 31 per centum weight/volume of C2H4O2. Dilute 30 g glacial acetic acid (98 per centum weight/volume C2H4O2) to 100 ml with water.

Note 2:

Dilute acetic acid: contains not less than 11.5 per centum weight/volume and not more than 12.5 per centum weight/volume of C2H4O2. Dilute 12 g or 11.7 ml glacial acetic acid (98 per centum weight/volume C2H4O2) to 100 ml with water and, if necessary, adjust the concentration of the solution.

Magnesium oxide, light

The criteria in the monograph for light magnesium oxide contained in the European Pharmacopoeia Vol I, 1969 at page 319.

Sodium ferrocyanideE 535

Synonyms

Sodium hexacyanoferrate (II)

The criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.

Potassium ferrocyanideE 536

Synonym

Potassium hexacyanoferrate (II)

Description

Odourless lemon yellow crystals.

Solubility

Soluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.

Content

Not less than 98 per centum of K4Fe(CN)6. 3H2O.

Free moisture

Not more than 1 per centum (determined by the method for free moisture in the monograph for sodium ferrocyanide in the Food Chemicals Codex 1972 at page 741).

Chloride

Not more than 0.1 per centum.

Sulphate

Not more than 0.1 per centum.

Sodium aluminium phosphate, acidicE 541

The criteria in the monograph for sodium aluminium phosphate, acidic contained in the Food Chemicals Codex 1972 at page 722.

Silicon dioxideE 551

Synonym

Silica, chemically prepared.

Description

Silica aerogel is a whie fluffy powdered or granular microcellular silica. Hydrated silica is a precipitated hydrated silicon dioxide occurring as a fine white amorphous powder or as beads or granules.

Content

  • Silica aerogel: not less than 90 per centum of SiO2.

  • Hydrated silica: not less than 91 per centum of SiO2 on a volatile matter-free basis.

Volatile matter

Hydrated silica: not more than 7 per centum (determined by drying at 105°C for 2 hours).

Loss on ignition

Not more than 13 per centum (determined by ignition at 1000°C to constant weight).

Soluble ionisable salts (expressed as Na2SO4)

Not more than 5 per centum.

Calcium silicateE 552

Description

White to off-white free-flowing powder.

Solubility

  • Insoluble in water.

  • Forms a gel with mineral acids.

Content:

(expressed as SiO2)

Not less than 72 per centum and not more than 78 per centum on a volatile matter-free basis.

(expressed as CaO)

Not less than 16 per centum and not more than 21 per centum on a volatile matter-free basis.

(expressed as Na2O)

Not less than 2 per centum and not more than 4 per centum on a volatile matter-free basis.

Volatile matter

Not more than 6 per centum (determined by drying at 105°C for 2 hours).

Loss on ignition

Not less than 7 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).

Magnesium silicateE 553a(i)

The criteria in the monograph for magnesium silicate contained in the Food Chemicals Codex 1972 at page 479.

Magnesium trisilicateE 553a(ii)

The criteria in the monograph for magnesium trisilicate contained in the British Pharmacopoeia 1973 at page 276.

TalcE 553b

Description

Talc is a native hydrous magnesium silicate sometimes containing a small proportion of aluminium silicate

It shall comply with the requirements for appearance, characteristics and limits of impurities in the monograph for magnesium silicate contained in the Nutrition Meetings Report Series 46B 1970 of the Food and Agriculture Organisation of the United Nations at page 114. The amount of material soluble in dilute hydrochloric acid shall be not more than 2 per centum and the amount of water soluble substances shall be not more than 0.2 per centum.

Sodium aluminium silicateE 554

Synonyms

  • Aluminium sodum silicate.

  • Sodium aluminosilicate.

  • Sodium silicoaluminate.

Description

Fine white amorphous powder or beads.

Content:

(expressed as SiO2)

Not less than 70 per centum and not more than 80 per centum on a volatile matter-free basis.

(expressed as Al2O3)

Not less than 8 per centum and not more than 11 per centum on a volatile matter-free basis.

(expressed as Na2O)

Not less than 5 per centum and not more than 10 per centum on a volatile matter-free basis.

Volatile matter

Not more than 8 per centum (determined by drying at 105°C for 2 hours)

Loss on ignition

Not less than 10 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).

Calcium aluminium silicateE 556

Synonyms

  • Aluminium calcium silicate.

  • Calcium aluminosilicate.

  • Calcium silicoaluminate.

Description

Fine white free-flowing powder.

Content:

(expressed as SiO2)

Not less than 44 per centum and not more than 50 per centum on a volatile matter-free basis.

(expressed as Al2O3)

Not less than 3 per centum and not more than 5 per centum on a volatile matter-free basis.

(expressed as CaO)

Not less than 32 per centum and not more than 38 per centum on a volatile matter-free basis.

(expressed as Na2O)

Not less than 0.5 per centum and not more than 4 per centum on a volatile matter-free basis.

Volatile matter

Not more than 10 per centum (determined by drying at 105°C for 2 hours).

Loss on ignition

Not less than 14 per centum and not more than 18 per centum (determined by ignition at 1000°C to constant weight).

Aluminium silicate (Kaolin)E 559

Kaolin, heavy

The criteria in the monograph for heavy kaolin contained in the British Pharmaccopoeia 1968 at page 538 as amended by the 1969 Addendum at page 54.

Kaolin, light

The criteria in the monograph for light kaolin contained in the British Pharmacopoeia 1968 at page 539 as amended by the 1969 Addendum at page 54.

Glucono-delta-lactoneE 575

Synonym

D-Glucono-l,5-lactone

The criteria in the monograph for glucono delta-lactone contained in the Food Chemicals Codex 1972 at page 346.

Sodium gluconateE 576

The criteria in the monograph for sodium gluconate contained in the Food Chemicals Codex 1972 at page 742.

Potassium gluconateE 577

Description

White free-flowing powder.

Solubility

Freely soluble in water. Practically insoluble in ethanol and in ether.

Content

Not less than 97 per centum of C6H11O7K on a volatile matter-free basis.

Volatile matter

Not more than 3 per centum (determined by drying in a vacuum at 105°C for 4 hours).

Reducing substances (expressed as glucose)

Not more than 0.5 per centum.

Calcium gluconateE 578

The criteria in the monograph for calcium gluconate contained in the Food Chemicals Codex 1972 at page 129.

Monosodium glutamateE 621

Synonyms

  • Sodium hydrogen L-glutamate.

  • Sodium glutamate.

  • Glutamic acid, sodium salt.

Formula

C5H8NNaO4.H2O (molecular weight 187.13).

The criteria in the monograph for monosodium L-glutamate contained in the Food Chemicals Codex 1981 at page 203.

Disodium guanylateE 627

Synonyms

  • Guanosine 5' -(disodium phosphate)

  • Sodium 5'-guanylate.

  • Disodium guanosine 5'-monophosphate.

Formula

C10H12N5Na2O8P.xH2O (molecular weight (anhydrous) 407.20).

The criteria in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105.

Disodium inosinateE 631

Synonyms

  • Inosine 5'-(disodium phosphate)

  • Sodium 5'-inosate.

  • Disodium inosine 5'-monophosphate.

Formula

C10H11N4Na2O8P.xH2O (molecular weight (anhydrous) 392.19).

The criteria in the monograph for disodium inosinate contained in the Food Chemicals Codex 1981 at page 106.

Disodium 5' -ribonucleotidesE 635

Description

  • White or nearly white crystalline powder consisting of a mixture of guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate) in approximately equal proportions.

  • Soluble in water, practically insoluble in ethanol.

Content

Not less than 97% and not more than 102% of C10H12N5Na2O8P and C10H11N4Na2O8P, and not less than 47% and not more than 53% of C10H12N5Na2O8P or of C10H11N4Na2O8P, in every case calculated on an anhydrous basis.

Moisture

Not less than 22% and not more than 26% (Karl Fischer).

pH (5% aqueous solution)

Not less than 7.0 and not more than 8.5.

Ammonium salts

  • Place 100 mg of sample in a test tube.

  • Add 50 mg magnesium oxide plus 1 ml of water.

  • Heat on a water bath for 5 minutes; the vapour evolved does not affect the colour of moist litmus paper.

Amino acids

Place 5 ml of a 0.1% (weight/volume) solution in a test tube. Add 1 ml of a 2% (weight/volume) solution of ninhydrin and heat for 3 minutes; no blue colour is produced.

Other nucleotides

The paper chromatogram obtained when sodium 5' -ribonucleotide is analysed using the procedure described for “other nucleotides” in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105 shall show no spots other than those for guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate).

GlycineE 640

The criteria in the monograph for glycine contained in the Food Chemicals Codex 1972 at page 359.

DimethylpolysiloxaneE 900

Synonym

Dimethyl silicone.

Appearance

Clear colourless odourless liquid free from extraneous matter.

Solubility

  • Insoluble in water.

  • Soluble in most aliphatic and aromatic hydrocarbon solvents.

Volatile matter

Not more than 2 per centum (determined by drying at 200°C for 4 hours).

Identification

Shall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.

Acidity

Shall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.

Total silicon

Not less than 37.3 and not more than 38.5 per centum.

Refractive index n 25°C D

Not less than 1.400 and not more than 1.405.

Viscosity (25°C)

Not less than 300 and not more than 1050 centistokes.

Relative density d 20°C 4°C

Not less than 0.960 and not more than 0.980.

Beeswax, white and yellowE 901

Beeswax, white

The criteria in the monograph for beeswax, white contained in the Food Chemicals Codex 1972 at page 75, except that the ester value shall be not less than 70 and not more than 80.

Beeswax, yellow

The criteria in the monograph for beeswax, yellow contained in the Food Chemicals Codex 1972 at page 77, except that the ester value shall be not less than 70 and not more than 80

Carnauba waxE 903

The criteria in the monograph for carnauba wax contained in the Food Chemicals Codex 1972 at page 170.

ShellacE 904

The standard for machine-made shellac contained in British Standard 3722:1964.

NitrogenE 941

The standard for nitrogen type 2 contained in British Standard 4366:1968.

Nitrous oxideE 942

The criteria in the monograph for nitrous oxide contained in the European Pharmacopoeia Vol. II 1971 at page 316.

OxygenE 948

The criteria in the monograph for oxygen contained in the European Pharmacopoeia Vol. II 1971 at page 328.

Acesulfame potassiumE 950

AspartameE 951

IsomaltE 953

ThaumatinE 957

Neohesperidine DCE 959

MaltitolE 965(i)

Maltitol syrupE 965(ii)

LactitolE 966

XylitolE 967

  • the appropriate specific purity criteria contained in Commission Directive 95/31/EEC.

Extract of QuillaiaE 999

The aqueous extract of the product complying with the monograph for Quillaia or for powdered Quillaia, in each case, contained in the British Pharmacopoeia 1980, at page 382.

PolydextroseE 1200

Description

Polydextrose is an off-white to light tan coloured, water-soluble powder. It consists of a randomly bonded condensation polymer produced by the reaction of D-glucose with sorbitol and citric acid. Free acid groups may be neutralised with potassium hydroxide.

Content

Not less than 90% of polymer on an ash-free and water-free basis.

Free glucose

Not more than 4% of an ash-free and water-free basis.

Free 1,6 anhydro-D-glucose

Not more than 4% on an ash-free and water-free basis.

Free sorbital

Not more than 2% on an ash-free and water-free basis.

Water

Not more than 4% (Karl Fischer).

pH (10% aqueous solution)

Not less than 2.5 and not more than 3.5 (not less than 5.0 and not more than 6.0 for the neutralised product).

Sulphated ash

Not more than 0.3% (not more than 3.0% for the neutralised product).

Arsenic

Not more than 1 mg/kg.

Lead

Not more than 1 mg/kg.

Propane-1,2-diol (propylene glycol)

As set out in the Annex to Council Directive 78/663/EEC.

SCHEDULE 6Foods in which Miscellaneous Additives listed in Schedule 1 are generally prohibited

Regulations 3(2) and (4) and 4(3)

  • Unprocessed foods

  • Honey as defined in Directive 74/409/EEC59

  • 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/EEC60 and spring water

  • Coffee (excluding flavoured instant coffee) and coffee extracts

  • Unflavoured leaf tea

  • Sugars as defined in Directive 73/437/EEC

  • Dry pasta

  • Natural unflavoured buttermilk (excluding sterilised buttermilk)

SCHEDULE 7Foods in which a limited number of Miscellaneous Additives listed in Schedule 1 may be used

Regulations 3(2) to (4) and 4(3)

Column 1

Column 2

Column 3

Food

Additive

Maximum level

Cocoa and chocolate products as defined in Directive 73/241/EEC61

E 330

Citric acid

0.5%

E 322

Lecithins

quantium satis

E 334

Tartaric acid

0.5%

E 422

Glycerol

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

E 170

Calcium carbonates

7% on dry matter without fat expressed as potassium carbonates

E 500

Sodium carbonates

7% on dry matter without fat expressed as potassium carbonates

E 501

Potassium carbonates

7% on dry matter without fat expressed as potassium carbonates

E 503

Ammonium carbonates

7% on dry matter without fat expressed as potassium carbonates

E 504

Magnesium carbonates

7% on dry matter without fat expressed as potassium carbonates

E 524

Sodium hydroxide

7% on dry matter without fat expressed as potassium carbonates

E 525

Potassium hydroxide

7% on dry matter without fat expressed as potassium carbonates

E 526

Calcium hydroxide

7% on dry matter without fat expressed as potassium carbonates

E 527

Ammonium hydroxide

7% on dry matter without fat expressed as potassium carbonates

E 528

Magnesium hydroxide

7% on dry matter without fat expressed as potassium carbonates

E 530

Magnesium oxide

7% on dry matter without fat expressed as potassium carbonates

E 414

Acacia gum

as glazing agents only quantum satis

E 440

Pectins

as glazing agents only quantum satis

Fruit juices and nectars as defined in Directive 93/77/EEC62

E 300

Ascorbic acid

quantum satis

Pineapple juice as defined in Directive 93/77/EEC

E 296

Malic acid

3 g/l

Nectars as defined in Directive 93/77/EEC

E 330

Citric acid

5 g/l

E 270

Lactic acid

5 g/l

Grape juice as defined in Directive 93/77/EEC

E 170

Calcium carbonates

quantum satis

E 336

Potassium tartrates

quantum satis

Fruit juices as defined in Directive 93/77/EEC

E 330

Citric acid

3 g/l

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

E 270

Lactic acid

quantum satis

E 296

Malic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 327

Calcium lactate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 333

Calcium citrates

quantum satis

E 334

Tartaric acid

quantum satis

E 335

Sodium tartrates

quantum satis

E 350

Sodium malates

quantum satis

E 440

Pectins

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

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

E 270

Lactic acid

quantum satis

E 296

Malic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 327

Calcium lactate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 333

Calcium citrates

quantum satis

E 334

Tartaric acid

quantum satis

E 335

Sodium tartrates

quantum satis

E 350

Sodium malates

quantum satis

E 400

Alginic acid

10 g/kg (individually or in combination)

E 401

Sodium alginate

10 g/kg (individually or in combination)

E 402

Potassium alginate

10 g/kg (individually or in combination)

E 403

Ammonium alginate

10 g/kg (individually or in combination)

E 404

Calcium alginate

10 g/kg (individually or in combination)

E 406

Agar

10 g/kg (individually or in combination)

E 407

Carrageenan

10 g/kg (individually or in combination)

E 410

Locust bean gum

10 g/kg (individually or in combination)

E 412

Guar gum

10 g/kg (individually or in combination)

E 415

Xanthan gum

10 g/kg (individually or in combination)

E 418

Gellan gum

10 g/kg (individually or in combination)

E 440

Pectins

quantum satis

E 509

Calcium chloride

quantum satis

E 524

Sodium hydroxide

quantum satis

Partially dehydrated and dehydrated milk as defined in Directive 76/118/EEC63

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 304

Fatty acid esters of ascorbic acid

quantum satis

E 322

Lecithins

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 407

Carrageenan

quantum satis

E 500

(ii) Sodium bicarbonate

quantum satis

E 501

(ii) Potassium bicarbonate

quantum satis

E 509

Calcium chloride

quantum satis

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

E 270

Lactic acid

quantum satis

E 322

Lecithins

quantum satis

E 325

Sodium lactate

quantum satis

E 326

Potassium lactate

quantum satis

E 327

Calcium lactate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

E 400

Alginic acid

quantum satis

E 401

Sodium alginate

quantum satis

E 402

Potassium alginate

quantum satis

E 403

Ammonium alginate

quantum satis

E 404

Calcium alginate

quantum satis

E 406

Agar

quantum satis

E 407

Carrageenan

quantum satis

E 410

Locust bean gum

quantum satis

E 415

Xanthan gum

quantum satis

E 440

Pectins

quantum satis

E 460

Celluloses

quantum satis

E 461

Methyl cellulose

quantum satis

E 463

Hydroxypropyl cellulose

quantum satis

E 464

Hydroxypropyl methyl cellulose

quantum satis

E 465

Ethyl methyl cellulose

quantum satis

E 466

Carboxy methyl cellulose Sodium carboxy methyl cellulose

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

E 508

Potassium chloride

quantum satis

E 509

Calcium chloride

quantum satis

E 1404

Oxidised starch

quantum satis

E 1410

Monostarch phosphate

quantum satis

E 1412

Distarch phosphate

quantum satis

E 1413

Phosphated distarch phosphate

quantum satis

E 1414

Acetylated distarch phosphate

quantum satis

E 1420

Acetylated starch

quantum satis

E 1422

Acetylated distarch adipate

quantum satis

E 1440

Hydroxy propyl starch

quantum satis

E 1442

Hydroxy propyl distarch phosphate

quantum satis

E 1450

Starch sodium octenyl succinate

quantum satis

Frozen and deep-frozen unprocessed fruit and vegetables Fruit compote Unprocessed fish, crustaceans and molluscs, including such products frozen and deep-frozen

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 302

Calcium ascorbate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

Quick-cook rice

E 471

Mono- and diglycerides of fatty acids

quantum satis

E 472a

Acetic acid esters of mono- and diglycerides of fatty acids

quantum satis

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

E 304

Fatty acid esters of ascorbic acid

quantum satis

E 306

Tocopherol-rich extract

quantum satis

E 307

Alpha-tocopherol

quantum satis

E 308

Gamma-tocopherol

quantum satis

E 309

Delta-tocopherol

quantum satis

E 322

Lecithins

30 g/l

E 471

Mono- and diglycerides of fatty acids

10 g/l

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

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

quantum satis

E 509

Calcium chloride

quantum satis

E 575

Glucono-delta-lactone

quantum satis

Mozzarella and whey cheese

E 270

Lactic acid

quantum satis

E 330

Citric acid

quantum satis

E 575

Glucono-delta-lactone

quantum satis

Canned and bottled fruit and vegetables

E 260

Acetic acid

quantum satis

E 261

Potassium acetate

quantum satis

E 262

Sodium acetates

quantum satis

E 263

Calcium acetate

quantum satis

E 270

Lactic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 302

Calcium ascorbate

quantum satis

E 325

Sodium lactate

quantum satis

E 326

Potassium lactate

quantum satis

E 327

Calcium lactate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

E 334

Tartaric acid

quantum satis

E 335

Sodium tartrates

quantum satis

E 336

Potassium tartrates

quantum satis

E 337

Sodium potassium tartrate

quantum satis

E 509

Calcium chloride

quantum satis

E 575

Glucono-delta-lactone

quantum satis

Gehakt

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

Pre-packed preparations of fresh minced meat

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 302

Calcium ascorbate

quantum satis

E 330

Citric acid

quantum satis

E 331

Sodium citrates

quantum satis

E 332

Potassium citrates

quantum satis

E 333

Calcium citrates

quantum satis

Bread prepared solely with the following ingredients: wheat-flour, water, yeast or leaven, salt

E 260

Acetic acid

quantum satis

E 261

Potassium acetate

quantum satis

E 262

Sodium acetates

quantum satis

E 263

Calcium acetate

quantum satis

E 270

Lactic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 302

Calcium ascorbate

quantum satis

E 304

Fatty and acid esters of ascorbic acid

quantum satis

E 322

Lecithins

quantum satis

E 325

Sodium lactate

quantum satis

E 326

Potassium lactate

quantum satis

E 327

Calcium lactate

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

E 472a

Acetic acid esters of mono- and diglycerides of fatty acids

quantum satis

E 472d

Tartaric acid esters of mono- and diglycerides of fatty acids

quantum satis

E 472e

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

quantum satis

E 472f

Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids

quantum satis

Pain courant français

E 260

Acetic acid

quantum satis

E 261

Potassium acetate

quantum satis

E 262

Sodium acetates

quantum satis

E 263

Calcium acetate

quantum satis

E 270

Lactic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 302

Calcium ascorbate

quantum satis

E 304

Fatty acid esters of ascorbic acid

quantum satis

E 322

Lecithins

quantum satis

E 325

Sodium lactate

quantum satis

E 326

Potassium lactate

quantum satis

E 327

Calcium lactate

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

Fresh pasta

E 270

Lactic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 322

Lecithins

quantum satis

E 330

Citric acid

quantum satis

E 334

Tartaric acid

quantum satis

E 471

Mono- and diglycerides of fatty acids

quantum satis

E 575

Glucono-delta-lactone

quantum satis

Wines and sparkling wines and partially fermented grape must

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

pro memoria

Beer

E 270

Lactic acid

quantum satis

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbate

quantum satis

E 330

Citric acid

quantum satis

E 414

Acacia gum

quantum satis

Foie gras, foie gras entier, blocs de foie gras

E 300

Ascorbic acid

quantum satis

E 301

Sodium ascorbat

quantum satis

SCHEDULE 8Miscellaneous Additives permitted in Foods for Infants and Young Children

Regulation 3(7) and (8)

Notes

1

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 1 part vitamin B 12 to 1000 parts mannitol).

2

The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturer’s instructions.

Part IMiscellaneous additives permitted in infant formulae for infants in good health

Notes

a

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

b

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

EC 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 1 to Directive 91/321/EEC

E 306

Tocopherol-rich extract

10 mg/l individually or in combination

E 307

Alpha-tocopherol

10 mg/l individually or in combination

E 308

Gamma-tocopherol

10 mg/l individually or in combination

E 309

Delta-tocophorol

10 mg/l individually or in combination

E 322

Lecithins

1 g/l

E 471

Mono- and diglycerides of fatty acids

4 g/l

Part IIMiscellaneous additives permitted in follow-on formulae for infants in good health

Notes

a

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

b

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

c

If more than one of the substances E 407, E 410 and E 412 is added to a food, the maximum level established for that food for each of those subsances is lowered with that relative part as is present of the other substances together in that food.

EC No.

Name

Maximum level

E 270

Lactic acid (L(+)-form only)

quantum satis

E 330

Citric acid

quantum satis

E 306

Tocopherol-rich extract

10 mg/l individually or in combination

E 307

Alpha-tocopherol

10 mg/l individually or in combination

E 308

Gamma-tocopherol

10 mg/l individually or in combination

E 309

Delta-tocopherol

10 mg/l individually or in combination

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

1 g/l

E 471

Mono- and diglycerides of fatty acids

4 g/l

E 407

Carrageenan

0.3 g/l

E 410

Locust bean gum

1 g/l

E 412

Guar gum

1 g/l

Part IIIMiscellaneous additives permitted in weaning foods for infants and young children in good health

EC No.

Name

Food

Maximum level

E 170

Calcium carbonates

Weaning foods

quantum satis (only for pH adjustment)

E 260

Acetic acid

Weaning foods

quantum satis (only for pH adjustment)

E 261

Potassium acetate

Weaning foods

quantum satis (only for pH adjustment)

E 262

Sodium acetates

Weaning foods

quantum satis (only for pH adjustment)

E 263

Calcium acetate

Weaning foods

quantum satis (only for pH adjustment)

E 270

Lactic acid64

Weaning foods

quantum satis (only for pH adjustment)

E 296

Malic acid64

Weaning foods

quantum satis (only for pH adjustment)

E 325

Sodium lactate64

Weaning foods

quantum satis (only for pH adjustment)

E 326

Potassium lactate64

Weaning foods

quantum satis (only for pH adjustment)

E 327

Calcium lactate64

Weaning foods

quantum satis (only for pH adjustment)

E 330

Citric acid

Weaning foods

quantum satis (only for pH adjustment)

E 331

Sodium citrates

Weaning foods

quantum satis (only for pH adjustment)

E 332

Potassium citrates

Weaning foods

quantum satis (only for pH adjustment)

E 333

Calcium citrates

Weaning foods

quantum satis (only for pH adjustment)

E 507

Hydrochloric acid

Weaning foods

quantum satis (only for pH adjustment)

E 524

Sodium hydroxide

Weaning foods

quantum satis (only for pH adjustment)

E 525

Potassium hydroxide

Weaning foods

quantum satis (only for pH adjustment)

E 526

Calcium hydroxide

Weaning foods

quantum satis (only for pH adjustment)

E 500

Sodium carbonates

Weaning foods

quantum satis (only as raising agents)

E 501

Potassium carbonates

Weaning foods

quantum satis (only as raising agents)

E 503

Ammonium carbonates

Weaning foods

quantum satis (only as raising agents)

E 300

L-ascorbic acid

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

Fat-containing cereal-based foods including biscuits and rusks

0.3 g/kg

0.2 g/kg individually or in combination, expressed as ascorbic acid

E 301

Sodium L-ascorbate

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

Fat-containing cereal-based foods including biscuits and rusks

0.3 g/kg

0.2 g/kg individually or in combination, expressed as ascorbic acid

E 302

Calcium L-ascorbate

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

Fat-containing cereal-based foods including biscuits and rusks

0.3 g/kg

0.2 g/kg individually or in combination, expressed as ascorbic acid

E 304

L-ascorbyl palmitate

Fat-containing cereals, biscuits, rusks and baby foods

0.1 g/Kg individually or in combination

E 306

Tocopherol-rich extract

Fat-containing cereals, biscuits, rusks and baby foods

0.1 g/Kg individually or in combination

E 307

Alpha-tocopherol

Fat-containing cereals, biscuits, rusks and baby foods

0.1 g/Kg individually or in combination

E 308

Gamma-tocopherol

Fat-containing cereals, biscuits, rusks and baby foods

0.1 g/Kg individually or in combination

E 309

Delta-tocopherol

Fat-containing cereals, biscuits, rusks and baby foods

0.1 g/Kg individually or in combination

E 338

Phosphoric acid

Weaning foods

1 g/kg as P2O5 (only for pH adjustment)

E 339

Sodium phosphates

Cereals

1 g/kg individually or in combination, expressed as P2O5

E 340

Potassium phosphates

Cereals

1 g/kg individually or in combination, expressed as P2O5

E 341

Calcium phosphates

Cereals

1 g/kg individually or in combination, expressed as P2O5

E 322

Lecithins

Biscuits and rusks Cereal-based foods Baby foods

10 g/kg

E 471

Mono- and diglycerides of fatty acids

Biscuits and rusks Cereal-based foods Baby foods

5 g/kg individually or in combination

E 472a

Acetic acid esters of mono- and diglycerides 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 diglycerides of fatty acids

Biscuits and rusks Cereal-based foods Baby foods

5 g/kg individually or in combination

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

Biscuits and rusks Cereal-based foods Baby foods

5 g/kg individually or in combination

E 400

Alginic acid

Desserts

Puddings

0.5 g/kg individually or in combination

E 401

Sodium alginate

Desserts

Puddings

0.5 g/kg individually or in combination

E 402

Potassium alginate

Desserts

Puddings

0.5 g/kg individually or in combination

E 404

Calcium alginate

Desserts

Puddings

0.5 g/kg individually or in combination

E 410

Locust bean gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 412

Guar gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 414

Acacia gum (gum arabic)

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 415

Xanthan gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 440

Pectins

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 551

Silicon dioxide

Dry cereals

2 g/kg

E 334

Tartaric acid65

Biscuits and rusks

5 g/kg as a residue

E 335

Sodium tartrate65

Biscuits and rusks

5 g/kg as a residue

E 336

Potassium tartrate65

Biscuits and rusks

5 g/kg as a residue

E 354

Calcium tartrate65

Biscuits and rusks

5 g/kg as a residue

E 450a

Disodium diphosphate

Biscuits and rusks

5 g/kg as a residue

E 575

Glucono-delta-lactone

Biscuits and rusks

5 g/kg as a residue

E 1404

Oxidised starch

Weaning foods

50 g/kg

E 1410

Monostarch phosphate

Weaning foods

50 g/kg

E 1412

Distarch phosphate

Weaning foods

50 g/kg

E 1413

Phosphated distarch phosphate

Weaning foods

50 g/kg

E 1414

Acetylated distarch phosphate

Weaning foods

50 g/kg

E 1420

Acetylated starch

Weaning foods

50 g/kg

E 1422

Acetylated distarch adipate

Weaning foods

50 g/kg

E 1450

Starch sodium octenyl succinate

Weaning foods

50 g/kg

Part IVMiscellaneous additives permitted in foods for infants and young children for special medical purposes

The tables in Parts 1 to 3 of this Schedule are applicable.

SCHEDULE 9Revocations

Regulation 10(1)

Column 1

Column 2

Column 3

Regulations and order revoked

References

Extent of revocation

The Meat (Treatment) Regulations (Northern Ireland) 1964

S.R. & O. (N.I.) 1964 No. 6

The whole Regulations

The Mineral Hydrocarbons in Food Regulations (Northern Ireland) 1966

S.R. & O. (N.I.) 1966 No. 200

In regulation 2(1), the definition of “dried fruit”

The Solvents in Food Regulations (Northern Ireland) 1967

S.R. & O. (N.I.) 1967 No. 282

The whole Regulations

The Specified Sugar Products Regulations (Northern Ireland) 1976

S.R. 1976 No. 165

In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted anti-foaming agent”, “permitted emulsifier” and “permitted preservative”. In the proviso to regulation 9, paragraph (d). Schedule 3.

The Cocoa and Chocolate Products Regulations (Northern Ireland) 1976

S.R. 1976 No. 183

In regulation (2)1, the definitions of “permitted acid”, “permitted base” and “permitted emulsifier”. In Schedule 2, Part I.

The Fruit Juices and Fruit Nectars Regulations (Northern Ireland) 1977

S.R. 1977 No. 182

In regulation 2(1), the definitions of “anti-foaming agent”, “permitted acid”, “permitted anti-foaming agent” and “permitted preservative”. Regulation 2(2). Regulation 6(a). In Part III of Schedule 2, in the definition of “sucrose solution”, paragraph (e). Schedule 3

The Condensed Milk and Dried Milk Regulations (Northern Ireland) 1977

S.R. 1977 No. 196

In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted antioxidant” and “permitted emulsifier” . Regulation 2(4). Regulation 5A(e). Schedule 2.

The Antioxidants in Food Regulations (Northern Ireland) 1978

S.R. 1978 No. 112

The whole Regulations.

The Coffee and Coffee Products Regulations (Northern Ireland) 1979

S.R. 1979 No. 51

In regulation 2(1), the definitions of “permitted anti-caking agent” and “permitted preservative”. Regulation 5A(d)

The Antioxidants in Food (Amendment) Regulations (Northern Ireland) 1981

S.R. 1981 No. 191

The whole Regulations.

The Solvents in Food (Amendment) Regulations (Northern Ireland) 1981

S.R. 1981 No. 192

The whole Regulations.

The Miscellaneous Additives in Food Regulations (Northern Ireland) 1981

S.R. 1981 No. 193

The whole Regulations.

The Jam and Similar Products Regulations (Northern Ireland) 1982

S.R. 1982 No. 105

Regulation 11(5). Regulation 12(2). In regulation 12(2C), the words “Subject to paragraph (2D),”. Regulation 12(2D) and (3). In regulation 14(1) and (2), the figure “, II”. Regulation 15. In Schedule 1, in entry 13 relating to mincemeat, in column 2, paragraph (c). Schedule 2, Part II. In Schedule 2, Part III, in the heading the words “, other than preservatives,” and all the entries following the entry for edible oils and fats, except the entry for liquid pectin. The Note to Schedule 2. Schedule 3. In Schedule 4, paragraph (e).

The Miscellaneous Additives in Food (Amendment) Regulations (Northern Ireland) 1982

S.R. 1982 No. 258

The whole Regulations.

The Cocoa and Chocolate Products (Amendment) Regulations (Northern Ireland) 1982

S.R. 1982 No. 349

Regulation 2(5). The Schedule.

The Fruit Juices and Fruit Nectars (Amendment) Regulations (Northern Ireland) 1983

S.R. 1983 No. 48

Regulation 8.

The Meat Products and Spreadable Fish Products Regulations (Northern Ireland) 1984

S.R. 1984 No. 408

In regulation 2(1), in the definition of “additive”, the words from “in so far as their use” to the end.

The Food (Revision of Penalties and Mode of Trial) Regulations (Northern Ireland) 1987

S.R. 1987 No. 38

In Schedule 1, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978 and the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981.

The Condensed Milk and Dried Milk (Amendment) Regulations (Northern Ireland) 1987

S.R. 1987 No. 65

Regulation 2(b).

The Preservatives in Food Regulations (Northern Ireland) 1989

S.R. 1989 No 152

The whole Regulations.

The Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989

S.R. 1989 No. 308

The whole Regulations.

The Preservatives in Food (Amendment) Regulations (Northern Ireland) 1989

S.R. 1989 No. 460

The whole Regulations.

The Jam and Similar Products (Amendment) Regulations (Northern Ireland) 1990

S.R. 1990 No. 388

Regulation 2(6)(a) and (c), (7), (9)(c) and (d).

The Food Safety (Northern Ireland) Order 1991 (Consequential Modifications) Order (Northern Ireland) 1991

S.R. 1991 No. 203

Article 12. In Part I of Schedule 1, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 2, the references to the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 3, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978 and the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981. In Schedule 4, the reference to the Meat (Treatment) Regulations (Northern Ireland) 1964. In Schedule 5, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 6, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 10, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989.

The Fruit Juices and Fruit Nectars (Amendment) Regulations (Northern Ireland) 1991

S.R. 1991 No. 251

Regulation 2(5)(a) and (7).

The Food Safety (Exports) Regulations (Northern Ireland) 1991

S.R. 1991 No. 344

In the Schedule, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989

The Antioxidants in Food (Amendment) Regulations (Northern Ireland) 1991

S.R. 1991 No. 495

The whole Regulations.

The Emulsifiers and Stabilisers in Food (Amendment) Regulations (Northern Ireland) 1992

S.R. 1992 No. 67

The whole Regulations.

The Food Additives Labelling Regulations (Northern Ireland) 1992

S.R. 1992 No. 417

Regulation 7(2), (3) and (5).

The Emulsifiers and Stabilisers in Food (Amendment) Regulations (Northern Ireland) 1993

S.R. 1993 No. 236

The whole Regulations.

(This note is not part of the Regulations.)

These Regulations implement European Parliament and Council Directive 95/2/EC (O.J. No. L61, 18.3.95, p. 1) on food additives other than colours and sweeteners (which has to be read with Council Directive 89/107/EEC (O.J. No. L40, 11.2.89, p. 27) on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption.

The principal provisions of the Regulations—

1

prohibit the use in or on any food of any miscellaneous additive (as defined in regulation 2(1)) other than a permitted miscellaneous additive (also defined in regulation 2(1)) (regulation 3(1));

2

prohibit the use in or on any food of any permitted miscellaneous additive otherwise than in accordance with the Regulations (regulation 3(2) to (5) and (7));

3

restrict the use of miscellaneous additives primarily as a carrier or carrier solvent (regulation 3(6)) and the presence of such additives in certain food (regulation 3(8));

4

prohibit the sale for use in or on food, or the sale direct to the consumer, of any miscellaneous additive other than a permitted miscellaneous additive (regulation 5(1) and (3));

5

restrict the sale of miscellaneous additives for use primarily as a carrier or carrier solvent (regulation 5(2)) and the sale of food additives in combination with miscellaneous additives which have been so used (regulation 5(5));

6

prohibit the sale of any food containing any added miscellaneous additive other than a permitted miscellaneous additive used or present in accordance with regulation 3 (regulation 5(4)).

Pending adoption of specific purity criteria for all permitted miscellaneous additives in accordance with Article 3(3)(a) of Directive 89/107/EEC, the purity criteria specified or referred to in Schedule 5 apply (definition of “purity criteria” in regulation 2(1)).

The Regulations also—

a

make provision in relation to compound foods (regulation 4);

b

make provision in relation to the condemnation of food (regulation 6);

c

create offences, prescribe a penalty and provide for enforcement of the Regulations (regulation 7);

d

provide a defence in relation to exports, in implementation of Articles 2 and 3 of Council Directive 89/397/EEC (O.J. No. L186, 30.6.89, p. 23) on the official control of foodstuffs, as read with the ninth recital to that Directive (regulation 8);

e

incorporate specified provisions of the Food Safety (Northern Ireland) Order 1991 (regulation 9);

f

revoke the Regulations and order specified in Schedule 9 to the extent specified in that Schedule, and make consequential amendments (regulation 10);

g

contain a transitional provision and exemptions (regulation 11).