FOOD, ENGLAND Title, commencement and application 1 These Regulations— a may be cited as the Miscellaneous Food Additives (Amendment) (England) Regulations 2005; b shall come into force on 19th April 2005; c shall apply in relation to England only. Amendment of the Miscellaneous Food Additives Regulations 1995 2 The Miscellaneous Food Additives Regulations 1995 shall be amended in accordance with regulations 3 to 14 below. 3 In paragraph (1) of regulation 2 (interpretation)— a after the definition of “colour”, there shall be inserted the following definition— Directive 88/388 EC means Council Directive 88/388/ EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ; b in the definition of “Directive 95/2/EC ” for the words “and European Parliament and Council Directive 2001/5/EC ” there shall be substituted the following words— , European Parliament and Council Directive 2001/5/EC and European Parliament and Council Directive 2003/114/EC ; ; c after the definition of flavour enhancer, there shall be inserted the following definition— “flavouring” bears the same meaning as in Article 1.2 of Directive 88/388/EEC ; ; d for the definition of “stabiliser”, there shall be substituted the following definition— “stabiliser” means any substance which makes it possible to maintain the physico-chemical state of a foodstuff; including any substance which enables the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff, substances which stabilise, retain or intensify an existing colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross-links between proteins enabling the binding of food pieces into re-constituted food; . 4 In paragraph (1) of regulation 4 (use of miscellaneous additives in or on compound foods), after the words “that compound food contains, as an ingredient, a food”, there shall be inserted the following words— or a flavouring . 5 After regulation 4 the following regulation shall be inserted— Use of permitted miscellaneous additives in flavourings 4A 1 Where— a a permitted miscellaneous additive is used in a flavouring; and b that flavouring is an ingredient of a compound food; and c the permitted miscellaneous additive performs a technological purpose in the final food; the permitted miscellaneous additive shall be regarded for the purposes of these Regulations as an additive of the final food. 2 No person shall use any permitted miscellaneous additive in or on any flavouring where— a the level of such additives used exceeds the minimum necessary to guarantee the safety and quality of the flavouring and to facilitate its storage; b the presence of such additives is a hazard to human health, or misleading to the consumer. . 6 In regulation 11 (transitional provision and exemptions), after paragraph (1E), there shall be inserted the following paragraph— 1F In any proceedings for an offence under these Regulations in respect of any food additives, food or flavouring, it shall be a defence to prove— a the food additive, food or flavouring concerned was put on the market or labelled before 27th January 2006; and b the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made by regulations 3 to 6, 7(b), 8(a), 8(b), 9(a), 10, 11 (a) to (c), (e) to (i) and (k) to (l) of the Miscellaneous Food Additives (Amendment) (England) Regulations 2005 had not been made when the food additive, food or flavouring was placed on the market or labelled. . 7 In Schedule 1 (miscellaneous additives generally permitted for use in foods not referred to in schedule 6, 7 or 8)— a for Note 1, there shall be substituted the following note— 1 The substances E407, E407a and E440 may be standardised with sugars, on condition that this is stated in addition to the number and designation. ; b in the entry relating to E170, in the second column, for the words “Calcium carbonates (i) calcium carbonate (ii) calcium hydrogen carbonate”, there shall be substituted the following words— Calcium carbonate ; c in the entry relating to E466, in the second column, the following words shall be added at the end— Cellulose gum ; d in the entry relating to E469, in the second column, the following words shall be added at the end— Enzymatically hydrolysed cellulose gum . 8 In Schedule 2 (conditionally permitted preservatives and antioxidants) part A (sorbates, benzoates and p-hydroxybenzoates)— a in the first column (entitled “Food”) of the second table, for the words “Partially baked, pre-packed bakery wares intended for retail sale”, there shall be substituted the following words— Partially baked, pre-packed bakery wares intended for retail sale and energy-reduced bread intended for retail sale ; b the following entries shall be added to the second table at the end: Crayfish tails, cooked and pre-packed Marinated cooked molluscs 2000 Flavourings 1500 9 Schedule 2 Part C (other preservatives)— a the entry relating to E230 shall be omitted; b in the entry relating to E1105, in the third and fourth columns (entitled respectively “Food” and “Maximum level”) there shall be added the following entries— Wine in accordance with Regulation (EC) No. 1493/1999 and its implementing Regulation (EC) No. 1622/2000 Pro memoria 10 In Schedule 2 Part D (other antioxidants)— a in the entry relating to E310, E311, E312 and E320, in the third and fourth columns (entitled respectively “Food” and “Maximum level (mg/ kg )”) the following entries shall be added— Essential oils 1000 mg/kg (gallates and BHA, individually or in combination) E310-E320 only Flavourings other than essential oils 100 mg/kg (gallates, individually or in combination) or 200 mg/kg (BHA)E310-E320 only b in the entry relating to E315 and E316, for the words “semi-preserved and preserved meat products”, there shall be substituted the following words— Cured meat products and preserved meat products . 11 In Schedule 3 (other permitted miscellaneous additives)— a in the entry relating to E338, E339, E340, E341, E343, E450, E451 and E452— i in the third and fourth columns (entitled respectively “Food” and “Maximum level”) the following entries shall be added— “Flavourings” “40g/kg” ii in the third column, the words “cider and perry” and in the corresponding entry in the fourth column, the words “2g/l” shall be omitted; b in the entry relating to E416, in the third and fourth columns, the following entries shall be added— “Flavourings” “50g/kg” c in the entry relating to E432, E433, E434, E435 and E436, in the third and fourth columns, the following entries shall be added— “Flavourings, except liquid smoke flavourings and flavourings based on spice oleoresins” “10g/kg” “Foodstuffs containing liquid smoke flavourings and flavourings based on spice oleoresins” “1g/kg” d in the entry relating to E444, in the third and fourth columns, the following entries shall be added— “Flavoured cloudy spirit drinks containing less than 15% alcohol by volume” “300 mg/l” e in the entry relating to E459, in the third and fourth columns, the following entries shall be added— “Encapsulated flavourings in “500mg/l — flavoured teas and flavoured powdered instant drinks 1g/kg in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer” — flavoured snacks*rdquo; f in the entry relating to E551, in the third and fourth columns, the following entries shall be added— Flavourings 50g/kg E551 only g in the entry relating to E900, in the third and fourth columns, the following entries shall be added— “Flavourings” “10 mg/kg” h in the entry relating to E901, E902, E903 and E904, the words “E903 Carnauba wax” shall be omitted; i after the entry relating to E901, E902 and E904, as amended by paragraph (h) above, the following entry shall be inserted— E903 Carnauba wax As glazing agents only: — confectionery (including chocolate) 500 mg/kg 1200 mg/kg (only for chewing gum) — small products of fine bakery wares coated with chocolate 200 mg/kg — snacks 200 mg/kg — nuts 200 mg/kg — coffee beans 200 mg/kg — dietary food supplements 200 mg/kg — fresh citrus fruits, melons, apples, pears, peaches and pineapples (surface treatment only) 200 mg/kg j after the entry for E905, the following entry shall be inserted— E907 Hydrogenated poly-1-decene As glazing agent for — sugar confectionery 2g/kg — dried fruits 2g/kg k the following entries shall be added to the table at the end— E1505 Triethyl citrate Flavourings 3g/kg from all sources in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer; individually or in combination. In the case of beverages, the maximum level of E1520 shall be 1g/l E1517 Glyceryl diacetate (diacetin) E1518 Glyceryl triacetate (triacetin) E1520 Propan-1,2-diol (propylene glycol) E1519 Benzyl alcohol Flavourings for 100 mg/l — liqueurs, aromatised wines, aromatised wine-based drinks and aromatised wine-products cocktails 250 mg/kg from all sources in foodstuffs as consumed or as reconstituted according to the instruction of the manufacturer — confectionery including chocolate and fine bakery wares l at the end of the Schedule, after the table, the following words shall be added— Note: Spice oleoresins are defined as extracts of spices from which the extraction solvent has been evaporated leaving a mixture of the volatile oil and resinous material from the spice. . 12 In Schedule 4 (permitted carriers and carrier solvents)— a in the entry relating to E468, in the second column the following entry shall be added— Cross-linked cellulose gum ; b the following entry shall be added to the table at the end— E555 Potassium aluminium silicate In E171 titanium dioxide and E172 iron oxides and hydroxides (max 90% relative to the pigment) 13 In Schedule 7 (foods in which a limited number of miscellaneous additives listed in Schedule 1 may be used)— a in the entry relating to cocoa and chocolate products as defined in Directive 2000/36/EC , in the second and third columns (entitled respectively “Additive” and “Maximum level”) after the entry relating to E471, the following entries shall be added— E472c Citric acid esters of mono- and diglycerides of fatty acids quantum satis b in the entry relating to cocoa and chocolate products as defined in Directive 2000/36/EC , the entry relating to grape juice as defined in Directive 2001/112/EC , the entry relating to ripened cheese and the entry relating to sliced and grated ripened cheese, in the second column, for the words “E170 Calcium carbonates”, there shall be substituted in each case the following words— E170 Calcium carbonate c in the entry relating to frozen and deep-frozen unprocessed fruit and vegetables; pre-packed, refrigerated unprocessed fruit and vegetables ready for consumption and pre-packed, unprocessed and peeled potatoes, to the second and third columns, the following entries shall be added— E296 Malic acid quantum satis (only for peeled potatoes) d in the entry relating to fruit compote, to the second and third columns, the following entries shall be added— E440 Pectin quantum satis (only for fruit compote other than apple) E509 Calcium chloride e in the entry relating to mozzarella and whey cheese, in the second and third columns, the following entries shall be added— E460ii Powdered cellulose quantum satis (only for grated and sliced cheese) f the following entry shall be added to the table at the end— UHT goat milk E331 Sodium citrates 4g/l Chestnuts in liquid E410 Locust bean gum E412 Guar gum E415 Xanthane gum quantun satis 14 In Schedule 8 (miscellaneous additives permitted in foods for infants and young children)— a in the Notes, after note 1A there shall be inserted the following note— 1B Formulae and weaning foods for infants and young children may contain E1450 starch sodium octenyl succinate resulting from the addition of vitamin preparations or polyunsaturated fatty acid preparations. The carry over of E1450 in the product ready for consumption is not to be more than 100 mg/kg from vitamin preparations and 1000 mg/kg from polyunsaturated fatty acid preparations. ; b in Part 3 (miscellaneous additives permitted in weaning foods for infants and young children in good health), in the entry relating to E170, in the second column, for the words “Calcium carbonates” there shall be substituted the word— Calcium carbonate ; c in Part 4 (miscellaneous additives permitted in foods for infants and young children for special medical purposes), for the title, the following words shall be substituted— MISCELLANEOUS ADDITIVES PERMITTED IN DIETARY FOODS FOR INFANTS AND YOUNG CHILDREN FOR SPECIAL MEDICAL PURPOSES AS DEFINED IN DIRECTIVE 1999/21/EC ; d in Part 4, the following entry shall be added to the table at the end— E472c Citric acid esters of mono-and diglycerides of fatty acids 7.5g/l sold as powder 9g/l sold as liquid From birth onwards Signed by the authority of the Secretary of State for Health Melanie Johnson Parliamentary Under Secretary of State, Department of Health 4th April 2005