Title and commencement

1. These Regulations may be cited as the Miscellaneous Food Additives Regulations 1995, and shall come into force on 1st January 1996.

Interpretation

2.-(1) In these Regulations, unless the context otherwise requires-

"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;

"the Act" means the Food Safety Act 1990;

"anti-caking agent" means any substance which 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 1995(2);

"Directive 89/107/EEC" means Council Directive 89/107/EEC(3) 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/EEC(4) 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/EC(5) on food additives other than colours and sweeteners (as corrected)(6);

"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-

but does not include-

"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 twelve 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;

"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, and "unprocessed" shall be construed accordingly;

"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 processing aid;

"sell" includes possess for sale, and offer, expose or advertise for sale, and "sale" and "sold" shall be construed accordingly;

"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 1995(10);

"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, in so far as the context admits, the same meaning in these Regulations as they bear 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 numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations, and in the case of a Schedule shall be read with any note thereto.

(5) 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 satismeans 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 additives

3.-(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) below in an amount higher thanquantum satisor 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) below, 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 foods

4.-(1) Subject to paragraphs (3) and (4) below, 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) below, 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) above 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) above 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 additives

5.-(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 food

6. 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 section 9 of the Act (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 section 8(3) shall apply for the purposes of these Regulations as it applies for the purposes of the Act.

Offences, penalties and enforcement

7.-(1) If any person contravenes or fails to comply with 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) Where an offence under these Regulations is committed in Scotland by a Scottish partnership and is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, he as well as the partnership shall be guilty of the offence and be liable to be proceeded against and punished accordingly.

(3) Subject to paragraph (4) below, each food authority shall enforce and execute these Regulations in its area.

(4) In this regulation "food authority" does not include-

(a)the council of a district in a non-metropolitan county in England except where the county functions have been transferred to that council pursuant to a structural change,

(b)until 1st April 1996, the council of a district in Wales, or

(c)the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple).

Defence in relation to exports

8. 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 Act

9. The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of section 8, 14 or 15 of the Act and, unless the context otherwise requires, any reference in them to the Act shall be construed for the purposes of these Regulations as a reference to these Regulations-

(a)section 2 (extended meaning of "sale" etc.);

(b)section 3 (presumption that food intended for human consumption);

(c)section 20 (offences due to fault of another person);

(d)section 21 (defence of due diligence);

(e)section 22 (defence of publication in the course of business);

(f)section 30(8) (which relates to documentary evidence);

(g)section 33 (obstruction etc. of officers);

(h)section 36 (offences by bodies corporate);

(i)section 44 (protection of officers acting in good faith).

Revocations and amendments

10.-(1) The Regulations 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 1966(11), in regulation 3 (exemptions)-

(a)there shall be substituted for paragraph (1) the following paragraph-

"(1) Regulation 4 of these regulations 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 I of the Schedule to these regulations;

(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 1995, and complies with the provisions of those Regulations.";

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

(c)in paragraph (3), for the words "paragraph (1)(a) to (g)" there shall be substituted the words "paragraph (1)(a) to (c)".

(3) In the Mineral Hydrocarbons in Food (Scotland) Regulations 1966(12), in regulation 4 (exemptions)-

(a)there shall be substituted for paragraph (1) the following paragraph-

"(1) Regulation 5 of these regulations 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 I of the Schedule to these regulations;

(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 1995, and complies with the provisions of those Regulations.";

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

(c)in paragraph (3), for the words "paragraph (1)(a) to (g)" there shall be substituted the words "paragraph (1)(a) to (c)".

(4) In the Specified Sugar Products Regulations 1976(13) and the Specified Sugar Products (Scotland) Regulations 1976(14)-

(a)in regulation 2(1) (interpretation)-

(i)after the definition of "the Act" there shall be inserted the following definition-

• ""anti-caking agent" has the meaning assigned to it by the Miscellaneous Food Additives Regulations 1995;";

(ii)there shall be substituted for the definition of "anti-foaming agent" the following definition-

• ""anti-foaming agent" has the meaning assigned to it by the Miscellaneous Food Additives Regulations 1995;";

(iii)there shall be substituted for the definition of "appropriate designation" the following definition-

• ""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 the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

(b)there shall be substituted for paragraph (3) of regulation 2 the following paragraph-

"(3) Any permitted miscellaneous additive (other than E 220 sulphur dioxide) specified in Part B of Schedule 2 to the Miscellaneous Food Additives Regulations 1995, if calculated as, may be used in place of, E 220 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)there shall be substituted for sub-paragraph (c) the following sub-paragraph-

"(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)there shall be substituted for sub-paragraph (e) the following sub-paragraph-

"(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) there shall be substituted for the words "any anti-foaming agent in accordance with paragraph (d) of the proviso" the words "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) there shall be substituted for the words from "of which the sulphur dioxide" to "20 milligrammes per kilogramme" the words "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)there shall be substituted for paragraph (a) the following paragraph-

"(a)any specified sugar product may contain any permitted miscellaneous additive;";

(ii)there shall be substituted for paragraph (c) the following paragraph-

"(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.".

(5) In the Cocoa and Chocolate Products Regulations 1976(15) and the Cocoa and Chocolate Products (Scotland) Regulations 1976(16)-

(a)in regulation 2(1) (interpretation)-

(i)in the definition of "edible substance" there shall be substituted for paragraph (c) the following paragraph-

"(c)any permitted miscellaneous additive";

(ii)after the definition of "permitted cocoa butter" there shall be inserted the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

(b)in the proviso to regulation 15 (permitted additional ingredients in cocoa and chocolate products) there shall be substituted for paragraphs (a) to (c) the following paragraph-

"(a)any cocoa product or chocolate product may contain any permitted miscellaneous additive;".

(6) In the Fruit Juices and Fruit Nectars Regulations 1977(17) and the Fruit Juices and Fruit Nectars (Scotland) Regulations 1977(18)-

(a)in regulation 2(1) (interpretation) after the definition of "human consumption" there shall be inserted the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

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

(i)there shall be substituted for sub-paragraphs (a), (e), (g), (j) and (k) the following sub-paragraph-

"(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)there shall be substituted for sub-paragraph (f) the following sub-paragraph-

"(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)there shall be substituted 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) the following Schedule-

Regulation 11

"SCHEDULE 4FRUIT NECTARS WHICH MAY CONTAIN LEMON JUICE IN PLACE OF CITRIC ACID

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 above."

(7) In the Condensed Milk and Dried Milk Regulations 1977(19) and the Condensed Milk and Dried Milk (Scotland) Regulations 1977(20)-

(a)in regulation 2(1) (interpretation) there shall be substituted for the definition of "permitted miscellaneous additive" the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

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

(c)in the proviso to regulation 9 (permitted additional ingredients in condensed milk and dried milk) there shall be substituted for paragraphs (a) to (d) the following paragraph-

"(a)any condensed milk product or dried milk product may contain any permitted miscellaneous additive;".

(8) In the Coffee and Coffee Products Regulations 1978(21) and the Coffee and Coffee Products (Scotland) Regulations 1979(22)-

(a)in regulation 2(1) (interpretation) after the definition of "human consumption" there shall be inserted the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

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

(i)there shall be substituted for paragraphs (a), (b) and (e) the following paragraph-

"(a)any designated product may contain any permitted miscellaneous additive;"; and

(ii)in paragraph (d) there shall be inserted after the words "liquid coffee and chicory extract," the words "chicory and coffee essence,".

(9) In the Jam and Similar Products Regulations 1981(23) and the Jam and Similar Products (Scotland) Regulations 1981(24)-

(a)in regulation 2(1) (interpretation)-

(i)immediately before the definition of "permitted sweetener" there shall be inserted the following definition-

""permitted miscellaneous additive" means any miscellaneous additive in so far as its use in food is permitted by the Miscellaneous Food Additives Regulations 1995;";

(ii)after the definition of "prepacked" there shall be inserted the following definition-

• ""preservative" has the meaning assigned to it by the Miscellaneous Food Additives Regulations 1995;";

(b)in regulation 8(4) (miscellaneous labelling requirements) there shall be substituted for sub-paragraph (c) the following sub-paragraph-

"(c)the food contains a permitted miscellaneous additive used primarily as a preservative.";

(c)in regulation 14(1) (permitted additional ingredients) there shall be inserted at the end the words "or any permitted miscellaneous additive".

(10) In the Meat Products and Spreadable Fish Products Regulations 1984(25)-

(a)in regulation 2(1) (interpretation) in the definition of "additive" there shall be substituted for the words from "the Antioxidants in Food Regulations 1978" to "the Miscellaneous Additives in Food Regulations 1980" the words "the Miscellaneous Food Additives Regulations 1995";

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

(c)in Schedule 1 (ingredients of cured meat)-

(i)in the first division of ingredients in column 1 there shall be inserted after the entry "Water" the following entry-

• "Additives other than flavourings, smoke and smoke solutions";

(ii)in the third division of ingredients in column 1 there shall be substituted for the entry "Additives" the following entry-

• "Flavourings, smoke and smoke solutions".

(11) In the Meat Products and Spreadable Fish Products (Scotland) Regulations 1984(26)-

(a)in regulation 2(1) (interpretation) in the definition of "additive" there shall be substituted for the words from "the Antioxidants in Food (Scotland) Regulations 1978" to "the Miscellaneous Additives in Food (Scotland) Regulations 1980" the words "the Miscellaneous Food Additives Regulations 1995";

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

(c)in Schedule 1 (ingredients of cured meat)-

(i)in the first division of ingredients in column 1 there shall be inserted after the entry "Water" the following entry-

• "Additives other than flavourings, smoke and smoke solutions";

(ii)in the third division of ingredients in column 1 there shall be substituted for the entry "Additives" the following entry-

• "Flavourings, smoke and smoke solutions".

(12) In the Food Additives Labelling Regulations 1992(27)-

(a)in regulation 2 (interpretation) after the definition of "food additive" there shall be inserted the following definitions-

• ""miscellaneous additive" has the same meaning as in the 1995 Regulations;

• "the 1995 Regulations" means the Miscellaneous Food Additives Regulations 1995;";

(b)in Schedule 1 (categories of food additives) in Part I (list of food additives)-

(i)there shall be substituted for item 9 the following item-

"9. Flavour enhancers.";

(ii)there shall be substituted for item 19 the following item-

"19. Flour treatment agents.";

(iii)there shall be substituted for item 25 the following item-

"25. Propellants.";

(iv)there shall be inserted at the end the following item-

"27. Carriers and carrier solvents.";

(c)in Schedule 1 in Part II (supplementary)-

(i)there shall be substituted for sub-paragraphs (b) to (m) the following sub-paragraph-

"(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 1995 Regulations;";

(ii)there shall be substituted for sub-paragraphs (o) to (q) the following sub-paragraph-

"(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 1995 Regulations;";

(iii)there shall be substituted for sub-paragraphs (r) and (s) the following sub-paragraphs-

"(r)"flour bleaching agent" means any substance primarily used to remove colour from flour;

(s)"flour treatment agent" means any substance which is added to flour or dough to improve its baking quality;";

(iv)there shall be substituted for sub-paragraphs (t) and (u) the following sub-paragraph-

"(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 1995 Regulations;";

(v)there shall be substituted for sub-paragraphs (w) to (z) the following sub-paragraph-

"(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 1995 Regulations.";

(d)in Schedule 3 (requirement for sales) in Part I in paragraph 2 and in Part II in paragraph 1 there shall be substituted for the words "EEC number" (wherever they occur) the words "EC number".

Transitional provision and exemptions

11.-(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 25th March 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 25th March 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 Great Britain before 25th March 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 Great Britain on or after 25th March 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) above, "free circulation" shall be construed in accordance with Article 9.2 of the Treaty establishing the European Community.

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

SCHEDULE 1MISCELLANEOUS ADDITIVES GENERALLY PERMITTED FOR USE IN FOODS NOT REFERRED TO IN SCHEDULE 6, 7 OR 8

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 atquantum satisin 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.

Regulations 2(1) and 3(5)

SCHEDULE 2CONDITIONALLY PERMITTED PRESERVATIVES AND ANTIOXIDANTS

PART ASorbates, benzoates and p-hydroxybenzoates

Notes

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

2. The abbreviations used in the table mean the following: Sa + Ba: Sa and Ba used singly or in combination

Sa + PHB: Sa and PHB used singly or in combination

Sa + Ba + PHB: Sa, Ba and PHB used singly or in combination.

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

PART BSulphur dioxide and sulphites

Notes

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

PART COther preservatives

PART DOther antioxidants

Regulations 2(1) and 3(5)

SCHEDULE 3OTHER PERMITTED MISCELLANEOUS ADDITIVES

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

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

SCHEDULE 4PERMITTED CARRIERS AND CARRIER SOLVENTS

Regulations 2(1) and 11(3)

SCHEDULE 5PURITY CRITERIA

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.

• E 170(i) Calcium carbonate

• 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 inhydrochloric 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.

In the case of:-

• E 200 Sorbic acid

• E 202 Potassium sorbate

• E 203 Calcium sorbate

• E 210 Benzoic acid

• E 211 Sodium benzoate

• E 212 Potassium benzoate

• E 213 Calcium benzoate

• E 214 Ethyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Ethyl 4-hydroxybenzoate Ethyl ester of p-hydroxybenzoic acid

• E 215 Sodium ethyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Ethyl 4-hydroxybenzoate, sodium salt Sodium ethyl para-hydroxybenzoate

• E 216 Propyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Propyl 4-hydroxybenzoate Propyl para-hydroxybenzoate n-propyl p-hydroxybenzoate

• E 217 Sodium propyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Propyl 4-hydroxybenzoate, sodium salt Sodium propyl para-hydroxybenzoate Sodium n-propyl p-hydroxybenzoate

the appropriate specific purity criteria contained in Council Directive 65/66/EEC(55) as amended by Council Directive 67/428/EEC(56) and Council Directive 76/463/EEC(57).

In the case of:-

• E 218 Methyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Methyl 4-hydroxybenzoate Methyl para-hydroxybenzoate

• E 219 Sodium methyl p-hydroxybenzoate

  • Synonyms ... ... ... ... Methyl 4-hydroxybenzoate, sodium salt Sodium methyl para-hydroxybenzoate

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

In the case of:-

• E 220 Sulphur dioxide

• E 221 Sodium sulphite (anhydrous or heptahydrate)

• E 222 Sodium hydrogen sulphite

  • Synonym ... ... ... ... Acid sodium sulphite

• E 223 Sodium metabisulphite

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.

• E 224 Potassium metabisulphite

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

In the case of:-

• E 226 Calcium sulphite

• E 227 Calcium hydrogen sulphite

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

• E 228 Potassium hydrogen sulphite

  • Synonyms ... ... ... ... Potassium bisulphite Potassium acid sulphite

  • The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EEC(58).

In the case of:-

• E 230 Biphenyl, diphenyl

• E 231 Orthophenyl phenol

  • Synonym ... ... ... ... 2-Hydroxybiphenyl

• E 232 Sodium orthophenyl phenol

  • Synonyms ... ... ... ... Sodium biphenyl-2-yl oxide Sodium orthophenylphenate

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

• E 233 Thiabendazole

  • 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.

• E 234 Nisin

  • 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.

In the case of:-

• E 239 Hexamethylene tetramine

  • Synonym ... ... ... ... Hexamine

• E 249 Potassium nitrite

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

In the case of:-

• E 250 Sodium nitrite

• E 251 Sodium nitrate

• E 252 Potassium nitrate

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:-

• E 260 Acetic acid

• E 261 Potassium acetate

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

• E 262(i) Sodium acetate

• 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, Na2 CO3).

In the case of:-

• E 262(ii) Sodium diacetate

  • Synonym ... ... ... ... Sodium hydrogen diacetate

• E 263 Calcium acetate

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

• E 270 Lactic acid

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

In the case of:-

• E 280 Propionic acid

• E 281 Sodium propionate

• E 282 Calcium propionate

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.

• E 283 Potassium propionate

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

• E 290 Carbon dioxide

  • 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.

• E 296 Malic acid

• 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 ... ... ... ... Not less than 99 per centum of C₄H₆O₅.

  • Melting range ... ... ... ... 99°C to 101°C.

  • Specific rotation [α] 20°CD ... ... ... ... Not less than -2.4° and not more than -2.2° using a solution containing 8.5g L-malic and in 100 ml. water).

  • Maleic acid ... ... ... ... } ... ... ... ...

  • Fumaric acid ... ... ... ... } ... ... ... ... Shall comply with the limits given in the

  • Residue on ignition ... ... ... ... } ... ... ... ... monograph for malic acid in the Food

  • Water insoluble matter ... ... ... ... } ... ... ... ... Chemicals Codex 1972 at page 484.

• E 297 Fumaric acid

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

In the case of:-

• E 300 Ascorbic acid

• E 301 Sodium ascorbate

• E 302 Calcium ascorbate

• E 304 Fatty acid esters of ascorbic acid

• E 304(i) Ascorbyl palmitate

• E 306 Tocopherol-rich extract

• E 307 Alpha-tocopherol

• E 308 Gamma-tocopherol

• E 309 Delta-tocopherol

• E 310 Propyl gallate

• E 311 Octyl gallate

• E 312 Dodecyl gallate

• E 320 Butylated hydroxyanisole (BHA)

• E 321 Butylated hydroxytoluene (BHT)

the appropriate specific purity criteria contained in Council Directive No. 78/664/EEC(59).

• E 322 Lecithins

  • The specific purity criteria for lecithins contained in Council Directive No. 78/664/EEC as amended by Article 1.2 of Council Directive 82/712/EEC(60).

In the case of:-

• E 325 Sodium lactate

• E 326 Potassium lactate

• E 327 Calcium lactate

• E 330 Citric acid

• E 331(i) Monosodium citrate

  • Synonym ... ... ... ... Sodium dihydrogen citrate

• E 331(ii) Disodium citrate

• E 331(iii) Trisodium citrate

• E 332(i) Monopotassium citrate

  • Synonym ... ... ... ... Potassium dihydrogen citrate

• E 332(ii) Tripotassium citrate

• E 333(i) Monocalcium citrate

• E 333(ii) Dicalcium citrate

• E 333(iii) Tricalcium citrate

• E 334 L-(+)-Tartaric acid

• E 335(i) Monosodium L-(+)-tartrate

• E 335(ii) Disodium L-(+)-tartrate

• E 336(i) Monopotassium L-(+)-tartrate

• E 336(ii) Dipotassium L-(+)-tartrate

• E 337 Sodium Potassium L-(+)-tartrate

  • Synonym ... ... ... ... Potassium sodium tartrate

• E 338 Phosphoric acid

  • Synonym ... ... ... ... Orthophosphoric acid

• E 339(i) Monosodium phosphate

  • Synonym ... ... ... ... Monosodium orthophosphate

• E 339(ii) Disodium phosphate

  • Synonyms ... ... ... ... Disodium orthophosphate Disodium hydrogen orthophosphate

• E 339(iii) Trisodium phosphate

  • Synonym ... ... ... ... Trisodium orthophosphate

• E 340(i) Monopotassium phosphate

  • Synonyms ... ... ... ... Monopotassium orthophosphate Potassium dihydrogen orthophosphate

• E 340(ii) Dipotassium phosphate

  • Synonyms ... ... ... ... Dipotassium orthophosphate Dipotassium hydrogen orthophosphate

• E 340(iii) Tripotassium phosphate

  • Synonym ... ... ... ... Tripotassium orthophosphate

• E 341(i) Monocalcium phosphate

  • Synonyms ... ... ... ... Monocalcium orthophosphate Calcium tetrahydrogen diorthophosphate

• E 341(ii) Dicalcium phosphate

  • Synonyms ... ... ... ... Dicalcium orthophosphate Calcium hydrogen orthophosphate

• E 341(iii) Tricalcium phosphate

  • Synonyms ... ... ... ... Tricalcium orthophosphate Tricalcium diorthophosphate

the appropriate specific purity criteria contained in Council Directive no. 78/664/EEC.

• E 350(i) Sodium malate

  • 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.

• E 350(ii) Sodium hydrogen malate

  • 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.

• E 351 Potassium malate

  • 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 0.05per centum calculated on the C₄H₄O₅K₂ content.

• E 352(i) Calcium malate

  • 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.

• E 352(ii) Calcium hydrogen malate

  • 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.

• E 353 Metatartaric acid

  • 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

    

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

  • Identification ... ... ... ... Place 5 to 10mg 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 metartartaric 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:

    
    

  • Specific rotation [α] 20°CD ... ... ... ... 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.

• E 355 Adipic acid

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

• E 363 Succinic acid

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

• E 380 Triammonium citrate

  • Synonym ... ... ... ... Ammonium citrate

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

• E 385 Calcium disodium ethylenediamine N N N'N' tetra-acetate

  • Synonym ... ... ... ... Sodium calciumedetate.

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

In the case of:-

• E 400 Alginic acid

• E 401 Sodium alginate

• E 402 Potassium alginate

• E 403 Ammonium alginate

• E 404 Calcium alginate

• E 405 Propane-1,2-diol alginate

  • Synonym ... ... ... ... Propylene glycol alginate

the appropriate specific purity criteria contained in Council Directive 78/663/EEC(61) as amended by Article 1.2(a) of Council Directive 82/504/EEC(62).

• E 406 Agar

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

• E 407 Carrageenan

  • The specific purity criteria for carrageenan contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC(63).

In the case of:-

• E 410 Locust bean gum

  • Synonym ... ... ... ... Carob gum

• E 412 Guar gum

• E 413 Tragacanth

• E 414 Acacia

  • Synonym ... ... ... ... Gum arabic

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

• E 415 Xanthan gum

  • 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.

• E 416 Karaya gum

  • Synonym ... ... ... ... Sterculia gum.

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

In the case of:-

• E 420(i) Sorbitol

• E 420(ii) Sorbitol syrup

• E 421 Mannitol

the appropriate specific purity criteria contained in Commission Directive 95/31/EC(64).

• E 422 Glycerol

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

• E 432 Polyoxyethylene (20) sorbitan monolaurate

  • Synonym ... ... ... ... Polysorbate 20.

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

• E 433 Polyoxyethylene (20) sorbitan monooleate

  • 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.

• E 434 Polyoxyethylene (20) sorbitan monopalmitate

  • 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.

• E 435 Polyoxyethylene (20) sorbitan monostearate

  • 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.

• E 436 Polyoxyethylene (20) sorbitan tristearate

  • 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.

In the case of:-

• E 440(i) Pectin

• E 440(ii) Amidated pectin

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

• E 442 Ammonium phosphatides

  • 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 rapeseed 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.

In the case of:-

• E 450(i) Disodium diphosphate

• E 450(ii) Trisodium diphosphate

• E 450(iii) Tetrasodium diphosphate

• E 450(v) Tetrapotassium diphosphate

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

• E 450(vi) Dicalcium diphosphate

  • Synonyms ... ... ... ... Dicalcium pyrophosphate Calcium pyrophosphate

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

In the case of:-

• E 451(i) Pentasodium triphosphate

• E 451(ii) Pentapotassium triphosphate

• E 452(i) Sodium polyphosphate

• E 452(ii) Potassium polyphosphate

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

• E 452(iv) Calcium polyphosphates

  • 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:

    

    where

    • n shall be not less than 2.

  • Content (expressed as P₂O₅) ... ... ... ... Not less than 50 per centum and not more than 71 per centum on 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.

• E 460(i) Microcrystalline cellulose

  • 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.

• E 460(ii) Powdered cellulose

  • 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.

In the case of:-

• E 461 Methylcellulose

• E 463 Hydroxypropylcellulose

• E 464 Hydroxypropylmethylcellulose

• E 465 Ethylmethylcellulose

  • Synonym ... ... ... ... Methylethylcellulose

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

• E 466 Carboxymethylcellulose

  • Synonym ... ... ... ... Sodium carboxymethylcellulose.

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

In the case of:-

• E 470a Sodium, potassium and calcium salts of fatty acids

• E 471 Monoand diglycerides of fatty acids

• E 472(a) Acetic acid esters of monoand diglycerides of fatty acids

  • Synonym ... ... ... ... Acetylated monoand diglycerides

• E 472(b) Lactic acid esters of monoand diglycerides of fatty acids

  • Synonyms ... ... ... ... Lactylated monoand diglycerides Lactoglycerides

• E 472(c) Citric acid esters of monoand diglycerides of fatty acids

  • Synonym ... ... ... ... Citroglycerides

• E 472(d) Tartaric acid esters of monoand diglycerides of fatty acids

• E 472(e) Monoand diacetyl tartaric acid esters of monoand diglycerides of fatty acids

  • Synonym ... ... ... ... Monoand diacetyl tartaric acid esters of monoand diglycerides.

• E 472(f) Mixed acetic and tartaric acid esters of monoand diglycerides of fatty acids

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

• E 473 Sucrose esters of fatty acids

  • 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/EEC(65).

• E 474 Sucroglycerides

  • 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.

• E 475 Polyglycerol esters of fatty acids

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

• E 476 Polyglycerol polyricinoleate

  • Synonym ... ... ... ... Polyglycerol esters of polycondensed fatty acids of castor oil

  • 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-, triand tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.

  • Refractive index, n65D°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.

• E 477 Propane-1,2-diol esters of fatty acids

  • 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.

In the case of:-

• E 481 Sodium stearoyl-2-lactylate

• E 482 Calcium stearoyl-2-lactylate

• E 483 Stearyl tartrate

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

• E 491 Sorbitan monostearate

  • 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.

• E 492 Sorbitan tristearate

  • 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.

• E 493 Sorbitan monolaurate

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

• E 494 Sorbitan monooleate

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

• E 495 Sorbitan monopalmitate

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

• E 500(i) Sodium carbonate

  • 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 5g of hydrated sodium carbonate, or 2.5g of anhydrous sodium carbonate, with 50ml of water and 10ml 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 40mg per kg on a volatile matter-free basis.

• E 500(ii) Sodium hydrogen carbonate

  • Synonym ... ... ... ... Sodium bicarbonate.

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

• E 500(iii) Sodium sesquicarbonate

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

• E 501(i) Potassium carbonate

  • 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)

• E 501(ii) Potassium hydrogen carbonate

  • Synonym ... ... ... ... Potassium bicarbonate.

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

• E 503(i) Ammonium carbonate

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

• E 503(ii) Ammonium hydrogen carbonate

  • Synonym ... ... ... ... Ammonium bicarbonate.

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

• E 504 Magnesium carbonates

• Magnesium carbonate, heavy

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

• Magnesium carbonate, light

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

• E 507 Hydrochloric acid

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

• E 508 Potassium chloride

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

• E 509 Calcium chloride

• 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.

• E 513 Sulphuric acid

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

• E 514(i) Sodium sulphate

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

• E 515(i) Potassium sulphate

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

• E 516 Calcium sulphate

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

• E 522 Aluminium potassium sulphate

  • Synonyms ... ... ... ... Potassium aluminium sulphate. Potash alum.

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

• E 524 Sodium hydroxide

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

• E 525 Potassium hydroxide

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

• E 526 Calcium hydroxide

  • 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 50ml 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.

• E 527 Ammonium hydroxide

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

• E 528 Magnesium hydroxide

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

• E 529 Calcium oxide

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

• E 530 Magnesium oxide

• Magnesium oxide, heavy

  • Description ... ... ... ... White fine odourless powder.

  • Solubility ... ... ... ... Practically insoluble in water. Soluble in dilute acids with, at most, slight effervescence.

  • Apparent volume ... ... ... ... 20g 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 5g 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 0.07per 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.

• E 535 Sodium ferrocyanide

  • Synonym ... ... ... ... Sodium hexacyanoferrate (II)

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

• E 536 Potassium ferrocyanide

  • 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.

• E 541 Sodium aluminium phosphate, acidic

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

• E 551 Silicon dioxide

  • Synonym ... ... ... ... Silica, chemically prepared.

  • Description ... ... ... ... Silica aerogel is a white 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.

• E 552 Calcium silicate

  • 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).

• E 553a(i) ... ... ... ... Magnesium silicate

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

• E 553a(ii) Magnesium trisilicate

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

• E 553b Talc

  • 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.

• E 554 Sodium aluminium silicate

  • Synonyms ... ... ... ... Aluminium sodium 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).

• E 556 Calcium aluminium silicate

  • 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).

• E 559 Aluminium silicate (Kaolin)

• Kaolin, heavy

  • The criteria in the monograph for heavy kaolin contained in the British Pharmacopoeia 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.

• E 575 Glucono-delta-lactone

  • Synonym ... ... ... ... D-Glucono-1,5-lactone

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

• E 576 Sodium gluconate

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

• E 577 Potassium gluconate

  • 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.

• E 578 Calcium gluconate

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

• E 621 Monosodium glutamate

  • 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.

• E 627 Disodium guanylate

  • 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.

• E 631 Disodium inosinate

  • 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.

• E 635 Disodium 5' -ribonucleotides

  • 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).

• E 640 Glycine

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

• E 900 Dimethylpolysiloxane

  • 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 n25°CD ... ... ... ... 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°C₄°C ... ... ... ... Not less than 0.960 and not more than 0.980.

• E 901 Beeswax, white and yellow

• 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.

• E 903 Carnauba wax

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

• E 904 Shellac

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

• E 941 Nitrogen

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

• E 942 Nitrous oxide

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

• E 948 Oxygen

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

In the case of:-

• E 950 Acesulfame potassium

• E 951 Aspartame

• E 953 Isomalt

• E 957 Thaumatin

• E 959 Neohesperidine DC

• E 965(i) Maltitol

• E 965(ii) Maltitol syrup

• E 966 Lactitol

• E 967 Xylitol

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

• E 999 Extract of Quillaia

  • 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.

• E 1200 Polydextrose

  • 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 1mg/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.

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

SCHEDULE 6FOODS IN WHICH MISCELLANEOUS ADDITIVES LISTED IN SCHEDULE 1 ARE GENERALLY PROHIBITED

Unprocessed foods

Honey as defined in Directive 74/409/EEC(66)

Non-emulsified oils and fats of animal or vegetable origin

Butter

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

Unflavoured, live fermented milk products

Natural mineral water as defined in Directive 80/777/EEC(67) 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)

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

SCHEDULE 7FOODS IN WHICH A LIMITED NUMBER OF MISCELLANEOUS ADDITIVES LISTED IN SCHEDULE 1 MAY BE USED

Regulation 3(7) and (8)

SCHEDULE 8MISCELLANEOUS ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN

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 manufacturers' instructions.

PART 1MISCELLANEOUS 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.

PART 2MISCELLANEOUS ADDITIVES PERMITTED IN FOLLOW-ON 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.

(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 substances is lowered with that relative part as is present of the other substances together in that food.

PART 3MISCELLANEOUS ADDITIVES PERMITTED IN WEANING FOODS FOR INFANTS AND YOUNG CHILDREN IN GOOD HEALTH

PART 4MISCELLANEOUS 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.

Regulation 10(1)

SCHEDULE 9REVOCATIONS

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which apply to Great Britain, implement European Parliament and Council Directive 95/2/EC (OJ 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 (OJ 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 the Regulations to be enforced by food authorities (regulation 7);

(d)provide a defence in relation to exports, in implementation of Articles 2 and 3 of Council Directive 89/397/EEC (OJ 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 Act 1990 (regulation 9);

(f)revoke the Regulations 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).

A compliance cost assessment of the effect that this instrument would have on the cost of business is available from Branch B of the Additives and Novel Foods Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, c/o Nobel House, 17 Smith Square, London SW1P 3JR.