Sweeteners in Food Regulations 1987

Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Regulations made under sections 6, 8 and 58. SWEETENERS IN FOOD REGULATIONS, 1987 (LN. 1987/045) 1.8.1987 Amending enactments Relevant current provisions Commencement date 1990/064 reg. 2 and Schedule 1 1.7.1990 EU Legislation/International Agreements involved: Directive 74/329/EEC Directive 78/663/EEC ARRANGEMENT OF REGULATIONS. Regulation 1. Title and Commencement. 2. Interpretation. 3. Exemptions. 4. Sale and importation of food containing added sweeteners. 5. Sale, importation and advertisement of sweeteners. 6. Food for babies and young children. 7. Labelling provisions. 8. Condemnation of food. 9. Penalties. 10. Application of various sections of the Act. 11. Revocation. SCHEDULE 1. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Title and commencement. 1.(1) These regulations may he cited as the Sweeteners in Food Regulations 1987. (2) These regulations shall come into operation on the 1st day of August, 1987. Interpretation. 2. (1) In these regulations, unless the context otherwise requires “the British Pharmacopoeia 1980” means the edition of the British Pharmacopoeia published in 1980 in London by the Department of Health and Social Security; “the British Pharmacopoeia 1980 Addendum 1982” means the Addendum to the British Pharmacopoeia 1980 published in 1982 in London by the Department of Health and Social Security; “carbohydrate” means a substance which contains carbon, hydrogen and oxygen only, and in which the hydrogen and oxygen occur in the same proportion as in water; “natural food substance” means any substance, suitable for use as food and commonly used as food, which is wholly a natural product, whether or not that substance has been subjected to any process or treatment; “the Act” means the Food and Drugs Act; “permitted antioxidant” means any antioxidant in so far as its use is permitted by the Antioxidants in Food Regulations 1987; “permitted bleaching agent” means any bleaching agent in so far as its use is permitted by the Bread and Flour Regulations 1987; “permitted colouring matter” means any colouring matter in so far as its use is permitted by the Colouring Matter in Food Regulations 1980, as amended; “permitted emulsifier” means any emulsifier in so far as its use is permitted by the Emulsifiers and Stabilisers in Food Regulations 1990; “permitted improving agent” means any improving agent in so far as its use is permitted by the Bread and Flour Regulations1987; Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 “permitted miscellaneous additive” means any miscellaneous additive in so far as its use is permitted by the Miscellaneous Additives in Food Regulations 1987; “permitted preservative” means any preservative in so far as its use is permitted by the Preservatives in Food Regulations 1987; “permitted solvent” means any solvent in so far as its use is permitted by the Solvents in Food Regulations 1987; “permitted stabiliser” means any stabiliser in so far as its use is permitted by the Emulsifiers and Stabilisers in Food Regulations 1990; “permitted sweetener” means any Sweetener specified in Part I of Schedule 1 which satisfies the specific purity criteria for that sweetener specified or referred to in Part II of that Schedule and, so far as is not otherwise provided for by any such specific purity criteria, satisfies the general purity criteria specified in Part III of that Schedule; “sell” includes offer or expose for sale and includes have in possession for sale, and 'sale' shall be construed accordingly; “sweetener” means any substance, other than a carbohydrate, whose primary organoleptic characteristic is sweetness, but does not include– (a) any natural food substance, (b) any permitted antioxidant, (c) any permitted bleaching agent, (d) any permitted colouring matter, (e) any permitted emulsifier, (f) any permitted improving agent, (g) any permitted miscellaneous additive, (h) any permitted preservative, (i) any permitted solvent, (j) any permitted stabiliser, (k) any starch, whether modified or not; Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 (2) For the purposes of these regulations, the supply of food, otherwise than by sale, at, in or from any place where food is supplied in the course of a business shall be deemed to be a sale of that food. (3) Unless a contrary intention is expressed, all proportions mentioned in these regulations are proportions calculated by weight of the product as sold. (4) Any reference in these regulations to a numbered regulation or schedule shall, unless the reference is to a regulation of, or schedule to, specified regulations, be construed as a reference to the regulation on schedule so numbered in these regulations. Exemptions. 3. These regulations do not apply to any food (including any sweetener) which is (a) not intended for sale for human consumption; or (b) intended at the time of sale or importation, as the case may be, for exportation to any place outside Gibraltar. Sale and importation of food containing added sweeteners. 4. No person shall sell or import any food which has in it or on it any added sweetener other than a permitted sweetener. Sale, importation and advertisement of sweeteners. 5.(1) No person shall sell or import any sweetener (including any sweetener with which any other substance has been mixed) which is intended for use in a catering establishment or for use by the ultimate consumer other than a permitted sweetener. (2) No person shall sell or advertise for sale any sweetener (including any sweetener with which any other substance has been mixed) for use as an ingredient in the preparation of food unless the sweetener is a permitted sweetener. Food for babies and young children. 6.(1) No person shall sell any food that is specially prepared for babies or young children if it has in it or on it any added sweetener. (2) Paragraph (1) of this regulation shall not apply to food specially prepared for babies or young children with special dietary requirements. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Labelling provisions. 7.(1) No person shall sell a permitted sweetener (including a permitted sweetener with which any other substance has been mixed) which is not ready for delivery to the ultimate consumer or a catering establishment unless it is marked or labelled with (a) the name of the permitted sweetener; (b) the serial number, if any, specified for the permitted sweetener in column 2 of Part I of Schedule 1; (c) the words 'for foodstuffs (restricted use)'; (d) the name or business name and an address or registered office of the manufacturer or packer, or of a seller established within the European Economic Community; and (e) in the case of the permitted sweetener sorbitol syrup (E420) which contains after hydrolysis a level of total sugars exceeding 1%, the words 'contains after hydrolysis a level of total sugars of more than 1%' or substantially similar words. (2) Without prejudice to paragraph (1) of this regulation, no person shall sell a permitted sweetener with which any other substance (including another permitted sweetener) has been mixed and which is not ready for delivery to the ultimate consumer or a catering establishment unless it is marked or labelled with the name of every other substance in the mixture. (3) A permitted sweetener (including a permitted sweetener with which any other substance has been mixed) shall not be regarded as being marked or labelled in accordance with the foregoing paragraphs of this regulation unless the particulars with which it is required to be marked or labelled by those paragraphs appear (a) on the packaging, or (b) on a label attached to the packaging, or (c) on a label that is clearly visible through the packaging, in such a way that they are easy to understand, clearly legible and indelible and are not hidden, obscured or interrupted by any other written or pictorial matter. Condemnation of food. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 8. Where any food is certified by a public analyst as being food which it is an offence against regulation 4 to sell or import, that food may be treated for the purposes of section 10 of the Act (under which food may be seized and destroyed on the order of a justice of the peace) as being unfit for human consumption. Penalties. 9. If any person contravenes or fails to comply with any of the foregoing provisions of these regulations he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000. Application of various sections of the Act. 10.Sections 46(2) and (3) (which relate to prosecutions), 47(1) and (2) (which relate to evidence of analysis), 49 (which relates to the power of a court to require analysis by the Government Chemist in the United Kingdom), 50 (which relates to a contravention due to some person other than the person charged), 51(2) (which relates to the conditions under which a warranty may be pleaded as a defence) and 52 (which relates to offences in relation to warranties and certificates of analysis) of the Act shall apply for the purposes of these regulations as if references therein to proceedings, or a prosecution, under or taken or brought under the Act included references to proceedings, or a prosecution as the case may be, taken or brought for an offence under these regulations and as if the reference in the said Section 49 to subsection (3) of Section 46 included a reference to that subsection as applied by these regulations. Revocation. 11. The Artificial Sweeteners in Food Regulations are hereby Revocation. revoked. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 SCHEDULE 1 PART I PERMITTED SWEETNERS Column 1 Column 2 Name of Sweetener Serial Number Acesulfame potassium Aspartame Hydrogenated glucose syrup Isomalt Lactitol – Mannitol E421 Saccharin Sodium saccharin Calcium saccharin Sorbitol E420 Sorbitol syrup E420 Thaumatin Xylitol PART II SPECIFIC PURITY CRITERIA FOR PERMITTED SWEETENERS Acesulfame potassium Synonym Chemical name Potassium 3 ,4-dihydro-6-methyl-2 ,2, 4-trioxo 1,26 3-oxathiazin-3-ide. Empirical formula C4H4KNO4S. Molecular weight 201.2 Description White, odourless, crystalline powder or granules with an intensely sweet taste. Content Not less than 99.0% of C4H4KNO4S on a volatile matter-free basis. Volatile matter Not more than 1.0% (determined by drying at1500C to constant weight). pH of a 1% aqueous solution Not less than 6.5 and not more than 7.5. Potassium acetate Not more than 0.5%. Fluoride Not more than 30 mg/kg. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Aspartame. Chemical name (3s)-3-Amino-N[(x)-x methoxycarbonyl phenethyl] succinamic acid Synonym L-Aspartyl-L-phenylalanine methyl ester Empirical formula C14H18N2O5. Moecular weight 294.3. Description White, odourless, crystalline powder with an intensely sweet taste. Content Not less than 98.0% of C14H18N2O5 on a volatile matter-free basis. Volatile matter Not more than 4.5% (determined by drying at 1050C to constant weight). Specific rotation, [x] 200 C D Not less than +12.50 and not more than +17.5° (determined using a 4% weight/volume solution on a volatile matter-free basis in 15M formic acid). pH of a 0.8% aqueous solution Not less than 4.0 and not more than 6.5. Sulphated ash Not more than 0.2% after ignition at 800 + 25°C 5-Benzyl-3,6-dioxo-2 piperazineacetic acid Not more than 1.5%. Hydrogenated glucose syrup Synonym Hydrogenated high maltose glucose syrup. Description Clear, colourless, sweet-tasting, aqueous solution of sorbitol, hydrogenated oligosac charides and hydrogenated polysaccharides prepared by the catalytic hydrogenation of glucose syrup. When dried or crystallised the product is white and crystalline Content D-glucitol: not more than 8%. 4-O-x-D glucopyransoyl-D-glucitol: not less than 50% and not more than 90%.0-x-D-glucopyranosyl-(1-4)-0 x-D- glucopyranosyl-(1-4)-D-glucitol: not less than 5% and not more than 20% -Hydrogenated tetrasaccharides and hydrogenated higher polysaccharides: not less than 2% and not more than 30%. Hydrogenated polysaccharides containing 21 or more D glucopyranosyl or D-glucitol units: not more than 3%. The percentages referred to are calculated on a dry weight basis in each case. Water Not more than 26% (Karl Fischer). Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Reducing sugars Not more than 0.3% on a dry weight basis, expressed as dextrose. pH of a 40% aqueous solution Not less than 4.0 and not more than 7.0 Sulphur dioxide Not more than 10 mg/kg on a dry weight basis. Sulphated ash Not more than 0.1% after ignition at 800 + 25°C calculated on a dry weight basis. Sulphate Not more than 0.01% on a dry weight basis, expressed as SO4. Chloride Not more than 50 mg/kg on a dry weight basis, expressed as Cl. Nickel Not more than 2 mg/kg on a dry weight basis, expressed as Ni. Lead Not more than 1 mg/kg on a dry weight basis, expressed as Pb. Isomalt Chemical description An approximately equimolar mixture of 6-0-x-D glucopyranosyl-D-glucitol and 1-0-x-D glucopyranosyl-D-mannitol. Emperical formula C12H24O11 Molecular weight 6-0-x-D- glucopyranosyl-D-glucitol (C12H24O11): 344.3 1-0-cx-D- glucopyranosyl-D-mannitol. (C12H24O112H2O):380.3. Description White, ordourless, crystalline. slightly hygroscopic solid with a sweet taste. Content Not less than 98.0% of 6-0-x-D- glucopyranosyl D-glucitol and 1-0-cx-D- glucopyranosyl-D mannitol; ech shall be present in a proportion of not less than 43% (on a dry weight basis in each case). Water Specific rotation, [x] 200 C D Not more than 7.0% (Karl Fisher). Not less than +91.5° (using a 4% weight/volume aqueous solution). Reducing sugars Not less than 1.5% on a dry weight basis, expressed as dextrose. D-Mannitol Not less than 0.5% on a dry weight basis. D-Sorbitol Not less than 0.5% on a dry weight basis. Ash Not more than 50 mg/kg after ignition at 800+25° C, calculated on a dry weight basis. Nickel Not more than 2 mg/kg on a dry weight basis, expressed as Ni. Lead Not more than 1 mg/kg on a dry weight basis, expressed as Pb. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Lactitol Synonyms Lactit, Lactositol, l,actobiosit. Chemical name 4-0-(β-D-galactopyranosyl)-D-glucitol Empirical formula C12H24O11 Molecular weight 344.32. Specific rotation, [x] 20°C D + 13 to +,15° (using a 10% weight to D volume aqueous solution). Water Lactitol monohydrate not more than 5.5% (Karl Fischer). Lactitol dihydrate not more than 10.5% (Karl Fischer). Description Colourless, aqueous syrup with a sweet taste. When dried, the resulting products, lactitol monohydrate and lactitol di hydrate, are white, odourless and crystalline. Content Not less than 97.5% 4-0-( β -D-galactopyra nosyl)-D-glucitol on a dry weight basis. Other polyols Not more than 2.5% on a dry weight basis. Reducing sugars Not more than 0.2% on a dry weight basis, expressed as lactose. Chlorides Not more than 100 mg/kg on a day weight basis, expressed as Cl. Sulphate Not more than 100 mg/kg on a dry weight basis, expressed as S04 Arsenic Not more than 1 mg/kg on a dry weight basis, expressed as As. Nickel Not more than 1 mg/kg on a dry weight basis, expressed as Ni. Lead Not more than 1 mg/kg on a dry weight basis, expressed as Pb. Ash Not more than 0.1% after ignition at 800 ± 25°C calculated on a dry weight basis. E421 Mannitol The criteria for mannitol contained in Council Directive 78/663/EEC and in article 6(1)(a) of Council Directive 74/329/EEC, as amended. Saccharin The criteria in the monograph for saccharin contained in the British Pharmacopoeia 1980 at page 393. Sodium saccharin Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 The criteria in the monograph for saccharin sodium contained in the British Pharmacopoeia 1980 at page 394, as amended by the British Pharmacopoeia 1980 Addendum 1982 at page 99. Calcium saccharin Chemical name 1 ,2 Benzisothiazol-3(2H)-one 1,1-dioxide,calcium salt. Empirical formula C14H8CaN2O6S2 Molecular weight 404.4. Description White crystals or a white, crystalline powder; odourless or with a faint aromatic odour; with an intensely sweet taste. Content Not less than 99.0% of C14H8CaN2O6S2 on a volatile matter-free basis. Volatile matter Not less than 11.0% and not more than 15.0%(determined by drying at 1050C to constant weight) Free acid or alkali Complies with the test in the monograph for saccharin sodium in the British Pharmacopoeia 1980. Melting point of isolated saccharin Complies with the test in the monograph for saccharin sodium in the British Pharmacopoeia 1980. Related substances Complies with the test in the monograph for saccharin sodium in the British Pharmacopoeia 1980. Arsenic Complies with the test in the monograph for saccharin sodium in the British Pharmacopoeia 1980 Heavy metals Complies with the test in the monograph for saccharin sodium in the British Pharmacopoeia 1980. E420 Sorbitol The criteria for sorbitol contained in Council Directive 78/663/EEC and in article 6(1)(a) of Council Directive 74/329/EEC, as amended E420 Sorbitol syrup The criteria for sorbitol syrup contained in Council Directive 78/663/EEC and in article 6(1)(a) of Council Directive 74/329/EEC, as amended Thaumatin Description Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 Odourless, cream coloured, proteinaceous powder with an intensely sweet taste obtained from aqueous extracts of the arils of the fruit of Thaumatococcus daniellii (Benth). Specific absorption, E1% Not less than 12.0 and not more than 12.5(determined at the wavelength of maximum absorbance, about 279 nm, using a 0.1% weight/volume aqueous solution at pH 2.7). Nitrogen Not less than 16.0% on a volatile matter-free basis Carbohydrate Not more than 3.0% on a volatile matter-free basis. Volatile matter Not more than 9.0% (determined by drying at 1050C to constant weight) Sulphated ash Not more than 2.0% after ignition at 800 ± 25°C calculated on a volatile matter-free basis. Aluminium Not more than 0.01% on a volatile matter-free basis. Xylitol Chemical name meso-Xylitol Empirical formula C5H12O5 Description White, odourless, crystalline powder or crystals. with a sweet taste Content Not less than 98.0% of meso-xylitol, C5H12O5.on a volatile matter-free basis Volatile matter. Not more than 0.5% (determined by drying at 60°C over phosphorus pentoxide in a vacuum for 4 hours). Reducing sugar Not more than 0.2% on a volatile matter-free basis, expressed as dextrose. pH of a 10% aqueous solution Not more than 0.5% singly and not more than 1.0% in total on a volatile matter-free basis Other polyols 1.0% in total on a volatile matter-free basis Ash Not more than 0.1% after ignition at 800 ± 25°C Nickel Not more than 2 mg/kg on a volatile matter-free basis, expressed as Ni. Lead Not more than 1 mg/kg on a volatile matter-free basis, expressed as Pb PART III. Food and Drugs SWEETENERS IN FOOD REGULATIONS, 1987 © Government of Gibraltar (www.gibraltarlaws.gov.gi) 1964-07 Subsidiary 1987/045 GENERAL PURITY CRITERIA APPLICABLE TO PERMITTED SWEETENERS EXCEPT WHERE OTHERWISE PROVIDED BY SPECIFIC PURITY CRITERIA. No permitted sweetener shall contain more than (a) 3 milligrams per kilogram of arsenic; (b) 10 milligrams per kilogram of lead.