FOOD Title, commencement and interpretation 1 1 These Regulations may be cited as the Miscellaneous Food Additives (Amendment) Regulations 1999 and shall come into force on 28th May 1999. 2 In these Regulations “the principal Regulations ” means the Miscellaneous Food Additives Regulations 1995 . Amendment of the principal Regulations 2 The principal Regulations shall be amended in accordance with regulations 3 to 13 below. 3 In regulation 2(1) (interpretation)– a in the definition of “Directive 95/2/ EC ” there shall be inserted at the end the words “and European Parliament and Council Directive 98/72/EC ”; b in the definition of “Directive 96/77/EC ” there shall be inserted at the end the words “, as amended by Commission Directive 98/86/EC ”; c after the definition of “flavour enhancer” there shall be inserted the following definition– “flour treatment agent” means a substance added to flour or dough to improve its baking quality, but does not include any emulsifier; ; d in the definition of “miscellaneous additive”– i there shall be inserted after the words “flavour enhancer,” the words “flour treatment agent,”; ii there shall be inserted at the end the words “or any enzyme except invertase or lysozyme”. 4 In regulation 3(4) (use of miscellaneous additives) there shall be substituted for the words “Notes 1 and 3” the words “Notes 1, 3 and 4”. 5 In regulation 11 (transitional provision and exemptions) there shall be inserted after paragraph (1A) the following paragraph– 1B In any proceedings for an offence under these Regulations in respect of any food additive or food, it shall be a defence to prove that– a the food additive or food concerned was put on the market or labelled before 1st July 1999 and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made by regulations 3(b) and 10 of the Miscellaneous Food Additives (Amendment) Regulations 1999 had not been made when the food additive or, as the case may be, the food was put on the market or labelled, or b the food additive or food concerned was put on the market or labelled before 4th November 2000 and the matter constituting the offence would not have constituted an offence under these Regulations or the Bread and Flour Regulations 1998 if the amendments made by regulations 3(c) and (d)(i), 7(b)(iii), 12 and 14(4) of the Miscellaneous Food Additives (Amendment) Regulations 1999 had not been made when the food additive or, as the case may be, the food was put on the market or labelled. . 6 In Schedule 1 (miscellaneous additives generally permitted for use in foods not referred to in Schedule 6, 7 or 8)– a after note (3) there shall be inserted the following note– 4 The substance E 920 may be used only as a flour treatment agent. ; b in the table there shall be inserted sequentially according to EC number the following entries– E 469 Enzymatically hydrolysed carboxy methyl cellulose , E 920 L-Cysteine , E 1103 Invertase and E 1451 Acetylated oxidised starch . 7 In Schedule 2 (conditionally permitted preservatives and antioxidants)– a in Part A (sorbates, benzoates and p-hydroxybenzoates)– i in the second table there shall be substituted for the entry relating to olives and olive-based preparations the following entry– Olives and olive-based preparations 1000 500 1000 ; ii in that table there shall be substituted for the entries relating to emulsified sauces with a fat content of 60% or more and emulsified sauces with a fat content less than 60% the following entries– Emulsified sauces with a fat content of 60% or more 1000 500 1000 Emulsified sauces with a fat content less than 60% 2000 1000 2000 ; iii in that table there shall be inserted at the end the following entries– … Mehu and Makeutettu … Mehu 500 200 Analogues of meat, fish, crustaceans and cephalopods and cheese based on protein 2000 Dulce de membrillo 1000 Marmelada 1500 Ostkaka 2000 Pasha 1000 Semmelknödelteig 2000 Cheese and cheese analogues (surface treatment only) quantum satis Cooked red beet 2000 Collagen-based casings with a water activity greater than 0.6 quantum satis ; b in Part B (sulphur dioxide and sulphites) in the second table– i there shall be substituted for the entries relating to crustaceans and cephalopods the following entries– * In edible parts. Crustaceans and cephalopods: fresh, frozen and deep-frozen 150(*) crustaceans, panaeidae solenceridae, aristeidae family: up to 80 units 150(*) between 80 and 120 units 200(*) over 120 units 300(*) cooked 50(*) ; ii in column 1 there shall be substituted for the words “Dehydrated granulated potatoes” the words “Dehydrated potatoes”; iii in the entry relating to sugars as defined in Directive 73/437/ EEC except glucose syrup, whether or not dehydrated, there shall be substituted in column 2 for the number “15” the number “10”; iv there shall be substituted for the entry relating to vegetable- and cereal-protein-based meat, fish and crustacean analogues the following entry– Analogues of meat, fish and crustaceans based on protein 200 ; v there shall be inserted at the end the following entries– Marinated nuts 50 Vacuum packed sweet corn 100 Distilled alcoholic beverages containing whole pears 50 ; c in Part C (other preservatives)– i in the first table the entry relating to E 233 Thiabendazole shall be omitted; ii in the first table in the entry relating to E 234 Nisin there shall be inserted at the end in column 2 the word “ Mascarpone ” and in column 3 opposite that word the words “10 mg/ kg ”; iii in the second table there shall be substituted for the entries relating to E 251 Sodium nitrate and E 252 Potassium nitrate the following entries– (*) Expressed as NaNO 3 . (**) Residual amount nitrite formed from nitrate included, expressed as NaNO 2 . E 251 Sodium nitrate } Cured meat products } 300 250(*) E 252 Potassium nitrate } Canned meat products } } Hard, semi-hard and semi-soft cheese } 50(*) } Dairy-based cheese analogue } } Pickled herring and sprat 200(**) } Foie gras, foie gras entier, blocs de foie gras 50(*) ; iv in the third table there shall be substituted for the entries relating to E 280 Propionic acid, E 281 Sodium propionate, E 282 Calcium proprionate and E 283 Potassium proprionate the following entries– (*) Propionic acid and its salts may be present in certain fermented products resulting from the fermentation process following good manufacturing practice. E 280 Propionic acid (*) } Pre-packed sliced bread and rye bread 3000 mg/kg expressed as propionic acid E 281 Sodium propionate (*) } E 282 Calcium propionate (*) } E 283 Potassium propionate (*) } Energy reduced bread } 2000 mg/kg expressed as propionic acid } Partially baked, pre-packed bread } } Pre-packed fine bakery wares (including flour confectionery) with a water activity of more than 0.65 } } Pre-packed Rolls, buns and pitta } } Pre-packed pølsebrød, boller and dansk flutes } } Christmas pudding } 1000 mg/kg expressed as propionic acid } Pre-packed bread } } Cheese and cheese analogues (surface treatment only) quantum satis ; d in Part D (other antioxidants) in the table there shall be substituted in column 3 for the words “Dehydrated granulated potatoes” the words “Dehydrated potatoes”. 8 There shall be substituted for Schedule 3 (other permitted miscellaneous additives) Schedule 1 to these Regulations. 9 In Schedule 4 (permitted carriers and carrier solvents) in the table there shall be inserted at the end the following entries– E322 Lecitbins } Glazing agents for fruit E 432–E 436 Polysorbates } E 470a Sodium potassium and calcium salts of fatty acids } E 471 Mono and diglycerides of fatty acids } E 491–E 495 Sorbitans } E 570 Fatty acids } E 900 Dimethylpolysiloxane } Polyethyleneglycol 6000 Sweeteners E 425 Konjac Konjac gum Konjac glucomannane E 459 Beta-cyclodextrine Maximum 1 g/kg in or on the food E 1451 Acetylated oxidised starch E 468 Cross linked sodium carboxy methyl cellulose Sweeteners E 469 Enzymatically hydrolysed carboxy methyl cellulose . 10 In Schedule 5 (purity criteria)– a the entries relating to the miscellaneous additives listed in Schedule 2 to these Regulations shall be omitted; b in the entry relating to Propane-1, 2-diol (propylene glycol) there shall be substituted for the words “Directive 78/663/EEC ” the words “Directive 78/664/EEC ”. 11 In Schedule 6 (foods in which miscellaneous additives listed in Schedule 1 are generally prohibited)– a there shall be substituted for the words from “Pasteurised and sterilised” to the words “and semi-skimmed)” the words “Pasteurised and sterilised (including UHT ) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream”; b after the words “Dry pasta” there shall be inserted the words “, excluding gluten-free pasta or pasta intended for hypoproteic diets, in accordance with Directive 89/398/EEC ”. 12 There shall be substituted for Schedule 7 (foods in which a limited number of miscellaneous additives listed in Schedule 1 may be used) Schedule 3 to these Regulations. 13 In Schedule 8 (miscellaneous additives permitted in foods for infants and young children)– a there shall be substituted for the first introductory note the following introductory 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 150 g/kg of E 414 and 10 g/kg of E 551, 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). The carry over of E 414 in the product ready for consumption shall not be more than 10 mg/kg. 1A Formulae and weaning foods for infants and young children may contain E 301 (sodium L-ascorbate), used at quantum satis level in coatings of nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301 in the product ready for consumption shall not be more than 75 mg/1. ; b in Part 1 (miscellaneous additives permitted in infant formulae for infants in good health)– i there shall be substituted for note (b) the following note– b If more than one of the substances E 322, E 471, E 472c and E 473 is added to a food, the maximum level established for that food for each of those substances is lowered by that relative part as is present of the other substances together in that food. ; ii in the table there shall be inserted at the end the following entries– E 304 L-ascorbyl palmitate 10 mg/1 E 331 Sodium citrates } 2 g/l E 332 Potassium citrates } Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC E 339 Sodium phosphates } 1 g/l expressed as P 2 O 5 E 340 Potassium phosphates } Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC E 412 Guar gum 1 g/l, where the liquid product contains partially hydrolysed proteins and is in conformity with the conditions set in Annex IV to Directive 91/321/EEC , as amended by Directive 96/4/EC E 472c Citric acid esters of mono- and diglycerides of fatty acids 7.5 g/l sold as powder 9 g/l sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in Annex IV to Directive 91/321/EEC , as amended by Directive 96/4/EC E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino acids ; c in Part 2 (miscellaneous additives permitted in follow-on formulae for infants in good health)– i there shall be substituted for note (b) the following note– b If more than one of the substances E 322, E 471, E 472c and E 473 is added to a food, the maximum level established for that food for each of those substances is lowered by that relative part as is present of the other substances together in that food. ; ii in note (c) there shall be substituted for the words “lowered with” the words “lowered by”; iii in the table there shall be inserted at the end the following entries– E 304 L-ascorbyl palmitate 10 mg/l E 331 Sodium citrates } 2 g/l E 332 Potassium citrates } Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC E 339 Sodium phosphates } 1 g/l expressed as P 2 O 5 E 340 Potassium phosphates } Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC E 472c Citric acid esters of mono- and diglycerides of fatty acids 7.5 g/l sold as power 9 g/l sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in Annex IV to Directive 91/321/EEC , as amended by Directive 96/4/EC E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino acids ; d in Part 3 (miscellaneous additives permitted in weaning foods for infants and young children in good health) in the table there shall be inserted at the end the following entries– (*) The note in Part 4 does not apply. E 333 Calcium citrates(*) Low-sugar fruit based products quantum satis E 341 Tricalcium phosphate(*) Fruit based desserts 1 g/kg as P 2 O 5 E 1451 Acetylated oxidised starch Weaning foods 50 g/kg ; e in Part 4 (miscellaneous additives permitted in foods for infants and young children for special medical purposes) there shall be inserted at the end the following table– EC No. Name Maximum level Special conditions E 401 Sodium alginate 1 g/l From 4 months onwards in special food products with adapted composition, required for metabolic disorders and for general tube feeding E 405 Propane 1,2-diolalginate 200 mg/l From 12 months onwards in specialised diets intended for young children who have cows' milk intolerance or inborn errors of metabolism E 410 Locust bean gum 10 g/l From birth onwards in products for reduction of gastro-oesophageal reflux E 412 Guar gum 10 g/l From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids in conformity with the conditions set in Annex IV to Directive 91/321/EEC , as amended by Directive 96/4/EC E 415 Xanthan gum 1.2 g/l From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastro-intestinal tract, protein mal-absorption or inborn errors of metabolism E 440 Pectins 10 g/l From birth onwards in products used in case of gastro-intestinal disorders E 466 Sodium carboxy methyl cellulose 10 g/l or kg From birth onwards in products for the dietary management of metabolic disorders E 471 Mono- and diglycerides of fatty acids 5 g/l From birth onwards in specialised diets, particularly those devoid of proteins E 1450 Starch sodium octenyl succinate 20 g/l In infant formulae and follow-on formulae . Consequential amendments 14 1 In the following Regulations references to the Miscellaneous Food Additives Regulations 1995 shall be construed as references to those Regulations as amended by the Miscellaneous Food Additives (Amendment) Regulations 1997 and these Regulations: the Mineral Hydrocarbons in Food Regulations 1966 the Mineral Hydrocarbons in Food (Scotland) Regulations 1966 the Specified Sugar Products Regulations 1976 the Specified Sugar Products (Scotland) Regulations 1976 the Cocoa and Chocolate Products Regulations 1976 the Cocoa and Chocolate Products (Scotland) Regulations 1976 the Fruit Juices and Fruit Nectars Regulations 1977 the Fruit Juices and Fruit Nectars (Scotland) Regulations 1977 the Condensed Milk and Dried Milk Regulations 1977 the Condensed Milk and Dried Milk (Scotland) Regulations 1977 the Coffee and Coffee Products Regulations 1978 the Coffee and Coffee Products (Scotland) Regulations 1979 the Jam and Similar Products Regulations 1981 the Jam and Similar Products (Scotland) Regulations 1981 the Meat Products and Spreadable Fish Products Regulations 1984 the Meat Products and Spreadable Fish Products (Scotland) Regulations 1984 the Food Additives Labelling Regulations 1992 the Food Labelling Regulations 1996 . 2 In the Food Additives Labelling Regulations 1992– a there shall be inserted after regulation 6 the following regulation– Transitional provision 6A In any proceedings for an offence under these Regulations in respect of any food additive, it shall be a defence to prove that the food additive concerned was put on the market or labelled before 4th November 2000 and the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made by regulation 14(1) and (2)(b) of the Miscellaneous Food Additives (Amendment) Regulations 1999 had not been made when the food additive was put on the market or labelled. ; b in Schedule 1 (categories of food additives) in Part II (supplementary)– i paragraph (s) shall be omitted; and ii in paragraph (t) there shall be inserted at the beginning the words ““flour treatment agent”,” and there shall be inserted after the words “used as a” the words “flour treatment agent,”. 3 In the Food Labelling Regulations 1996– a in regulation 14(11) (names of ingredients) the words “or in Schedule 3 to the Bread and Flour Regulations” shall be omitted; b in regulation 50 (transitional provision) there shall be inserted at the end the following paragraph– 8 In any proceedings for an offence under regulation 44(1)(a) as read with regulation 14(9) and (11), it shall be a defence to prove that the food concerned was prepacked before 4th November 2000 and the matter constituting the offence would not have constituted an offence under these Regulations if the amendment made by regulation 14(3)(a) of the Miscellaneous Food Additives (Amendment) Regulations 1999 had not been made when the food was prepacked. . 4 In the Bread and Flour Regulations 1998– a in regulation 5 (additional ingredients) there shall be substituted for paragraphs (1) and (2) the following paragraph– 1 No person shall use as an ingredient in the preparation of flour or bread any flour bleaching agent. ; b Schedule 3 (ingredients permitted in flour and bread) shall be omitted. Jeff Rooker Minister of State, Ministry of Agriculture, Fisheries and Food 25th March 1999 Signed by authority of the Secretary of State for Health: Tessa Jowell Minister for Public Health, Department of Health 24th March 1999 Signed by authority of the Secretary of State for Wales: Jon Owen Jones Parliamentary Under Secretary of State, Welsh Office 8th April 1999 Sam Galbraith Parliamentary Under Secretary of State, Scottish Office 23rd March 1999