Australia New Zealand Food Authority Variations to the Food Standards Code (Amendment No. 38) 1. Preamble The variations set forth in the Schedule below are variations to the Food Standards Code (hereinafter called ``the code'') which was published by the National Health and Medical Research Council in the Commonwealth of Australia Gazette, No. P 27, on 27 August 1987, and which has been varied from time to time. The Schedule contains variations adopted by the Australia New Zealand Food Standards Council in February 1998. These variations are published, pursuant to section 32 of the Australia New Zealand Food Authority Act 1991. 2. Citation These variations may be collectively known as Amendment No. 38 to the code. 3. Commencement These variations commence on the date of publication of this New Zealand Gazette. Schedule 1 Standard A7 is varied by inserting into columns 2 and 3 respectively of the table to clause 4, in relation to the entries in column 1 for ``Tocopherols'', ``Phospholipids (including lecithin) from natural sources'', ``Ascorbic acid, erythorbic acid or a mixture of these'' and ``Ascorbyl palmitate'' ``Formulated supplementary sports foods No limit imposed''. 2 Standard A8 is varied by inserting into the table to clause (5) an entry for ``Formulate d supplementary sports foods 500 mg/kg 40 mg/kg 5 g/kg not permitted not permitted 200 mg/kg not permitted''. 3 Standard A11 is varied by 3.1 inserting in columns 1 and 2 respectively of the Schedule, entries for Choline bitartrate FCC p83 Ubiquinones Merck 9751 Creatine Merck 2570 gamma-Oryzinol Merck 6841 Inosine Merck 5005 L-Carnitine Martindale p1257 d-Biotin FCC p38 d-Calcium pantothenate FCC p57 dexpanthenol FCC p95 Chronic chloride USP(XXII) p306 High chromium yeast Addendum 4 Chromium picolinate Merck 2291 Cupric carbonate Merck 5699 Cupric citrate FCC p560 Cupric sulphate FNP(12) p881 Magnesium citrate Merck 5766 Magnesium hydroxide FNP(52) p881 Manganese carbonate Merck 5766 High molydenum yeast Addendum 5 Sodium molybdate BP pA37 Magnesium phosphate, FCC p249 monobasic Potassium phosphate, dibasic FCC p248 Potassium phosphate, tribasic FCC p249 Sodium phosphate, FCC p294 monobasicsodium phosphate, dibasic FCC p293 Sodium phosphate, tribasic FCC p294 L-Selenomethionine Addendum 3 Sodium selenate Merck 8820 Sodium selenite USP(XXII) p1773; 3.2 inserting after Addendum 2 ``ADDENDUM 3 SPECIFICATIONS FOR L-SELENOMETHIONINE Formula: CHNOSe Formula Weight 196.11 Physical Tests Appearance: Crystalline powder Colour: White to off-white Chemical Tests Identification: IR Spectrum conforms to reference standard. Melting Range: 260C to 266C (dec.) Sodium: Less than 0.1% Heavy Metals: Undetectable Assay by Titration: 98.0 to 101.0% Homogeneity: One spot on TLC plate using UV light, iodine and ninhydrin as detection methods. Solvent systems: 1. Phenol: water (100:20) 2. Butanol: acetic acid: water (90:20:20) Optical Rotation: 22/D 21.6 (c 0.5 in 2N HC1) ADDENDUM 4 SPECIFICATION FOR HIGH CHROMIUM YEAST Physical Tests Appearance: fine, free-flowing powder Colour: Light off-white or light tan Odour: Slight yeast aroma Particle size: Min. 90% through a 100 USS screen Chemical Tests Moisture: Maximum 6% Chromium: 1.82.25 g/kg ADDENDUM 5 SPECIFICATION FOR HIGH MOLYBDENUM YEAST Physical Tests Appearance: Fine, free-flowing powder Colour: Light off-white or light tan Odour: Slight yeast aroma Particular size: Min. 85% through a 100 USS screen Chemical Tests Moisture: Maximum 6% Molybdenum: 1.82.25 g/kg''; and 4. Standard P3 is varied by 4.1 inserting ``, subject to subsubclause (iii),'' in subsubclause (4) (c) (ii) before `` `CALVADOS' ''; and 4.2 inserting after subsubclause 4 (c) (ii) ``(iii) Apple brandy must not be represented as being `CALVADOS' or any word having the same or similar meaning unless it is produced wholly in the district of Calvados, France, as delineated by the Institut National des Appellations d'Origine.''. 5 The Food Standards Code is varied by inserting after Standard R9 ``STANDARD R10 FORMULATED SUPPLEMENTARY SPORTS FOODS Purpose This Standard defines and regulates the composition and labelling of foods specially formulated to assist sports people in achieving specific nutritional or performance goals. Such foods are intended as supplements to a diet rather than for use as the sole or principal source of nutrition. Due to the particular physiological demands of sports people, this Standard provides for the addition to formulated supplementary sports foods of certain micronutrients and other ingredients which are not permitted to be added to other foods. This means that such products are not suitable for consumption by children. Table of Contents 1. Interpretation 2. Composition 3. Required labelling statements 4. Ingredient claims 5. Vitamin and mineral claims 6. Prohibition on representations 7. High carbohydrate supplement 8. Protein energy supplement 9. Energy supplement 10. Prescribed name Division 1 Formulated Supplementary Sports Foods Generally Interpretation 1. In this Standard `formulated supplementary sports food' is a food or mixture of food specifically formulated to assist sports people in achieving specific nutritional or performance goals. `one-day quantity' in relation to formulated supplementary sports food, is the amount of that food which is to be consumed in one day in accordance with directions specified in the label. Composition 2. A formulated supplementary sports food (a) may contain additives as follows (i) colourings; (ii) flavourings; (iii) antioxidants in accordance with Standard A7; (iv) artificial sweetening substances in accordance with Standard A8; (v) modifying agents listed in Table 1 of Standard A10; (b) may contain the vitamins and minerals specified in the Table to this paragraph provided that (i) the vitamin or mineral is added in a form listed in the Schedule to Standard A9 or in column 2 of the Schedule to this Standard; and (ii) the amount of the vitamin or mineral in the food does not exceed the amount, if any, specified in column 3 of the Table; TABLE TO PARAGRAPH 2 (b) Column 1 Column 2 Column 3 Micronutrient Maximum claimed amount per one-day quantity Maximum amount per one-day quantity Vitamin A 375 g 375 g Thiamin 2.2 mg Riboflavin 3.4 mg Niacin 20 mg Folate 400 g Vitamin B6 3.2 mg Vitamin B12 4.0 g Vitamin C 80 mg Vitamin D 2.5 g 2.5 g Vitamin E 20 mg Biotin 50 g Pantothenic acid 3.5 mg Calcium 1600 mg Chromium: inorganic forms 100 g 100 g organic forms 50 g 50 g Copper: inorganic forms 1.5 mg 1.5 mg organic forms 750 g 750 g Iodine 75 g 75 g Iron 12 mg Magnesium 640 mg Manganese: inorganic forms 2.5 mg organic forms 1.25 mg Molybdenum: inorganic forms 125 g organic forms 62.5 g Phosphorus 1000 mg Selenium: inorganic forms 52 g 52 g organic forms 26 g 26 g Zinc 12 mg (c) must not contain added amino acids as such, except for those specified in the Table to this paragraph, provided that the amount of the amino acid added to the food does not exceed the amount specified in column 2 of the Table; TABLE TO PARAGRAPH 2 (c) Column 1 Column 2 Amino Acid Maximum amount added per one-day quantity Alanine 1200 mg Arginine 1100 mg Aspartic acid 600 mg Cysteine 440 mg Glutamine 1900 mg Glutamic acid 1600 mg Glycine 1500 mg Histidine 420 mg Isoleucine 350 mg Leucine 490 mg Lysine 420 mg Methionine 180 mg Ornithine 360 mg Phenylalanine 490 mg Proline 1100 mg Serine 1400 mg Taurine 60 mg Threonine 245 mg Tyrosine 400 mg Tryptophan 100 mg Valine 350 mg (d) may contain the ingredients listed in the Table to this paragraph added as such, provided that the amount of each ingredient added does not exceed the amount specified in relation to that ingredient in column 2 of the Table; TABLE TO PARAGRAPH 2 (d) Column 1 Column 2 Ingredient Maximum amount added per one-day quantity L-carnitine 100 mg Choline 10 mg Inosine 10 mg Ubiquinones 15 mg Creatine 3 g Gamma-oryzinol25 mg (e) may contain the preservatives listed in the Table to this paragraph, provided that (i) the amount of the preservative added does not exceed the maximum permitted amount specified in column 2 of the Table; and (ii) where a food is to be prepared and consumed in accordance with the directions on the label, the maximum permitted amount applies to the food in its prepared form; TABLE TO PARAGRAPH 2 (e) Column 1 Column 2 Permitted preservative in type of formulated supplementary sports food Maximum permitted amount mg/kg Solid Formulated Supplementary Sports Food Propionic acids or its salts 2000 Sorbic acid or its salts 1000 Sulphur dioxide 200 Liquid Formulated Supplementary Sports Food Benzoic acid or its salts 400 Sorbic acid or its salts 400 Sulphur dioxide 115 (f) must not contain, in a one-day quantity, more than (i) 70 mmol sodium (ii) 95 mmol potassium. Required labelling statements 3. (1) The label on a formulated supplementary sports food must include statements to the effect that (a) the food is not a sole source of nutrition and should be consumed in conjunction with a nutritious diet; and (b) the food should be used in conjunction with an appropriate physical training or exercise program. (2) The label on a formulated supplementary sports food must include (a) directions stating the recommended quantity and frequency of intake of the food; (b) a statement of the recommended consumption in one day; and (c) a nutrition information panel in accordance with Standard A1. (3) The label on a formulated supplementary sports food must include, in standard type of 3 mm, the statement ``NOT SUITABLE FOR CHILDREN UNDER 15 YEARS OR PREGNANT WOMEN: SHOULD ONLY BE USED UNDER MEDICAL OR DIETETIC SUPERVISION''. (4) If a formulated supplementary sports food contains added phenylalanine then the label must include, in standard type of 3 mm, the statement ``PHENYLKETONURICS: CONTAINS PHENYLALANINE''. Ingredient claims 4. (1) If the label on a formulated supplementary sports food refers to the presence of a particular ingredient, other than (a) vitamins or minerals; or (b) in a statement required elsewhere in this Code the label must also include a statement of the amount by weight (expressed per 100 g food or as a percentage) of the ingredient in that food either (c) immediately after the statement referring to the presence of the ingredient; or (d) immediately following the name of that ingredient in the statement of ingredients. (2) Subclause (1) does not apply if the nutrition information panel lists the particular ingredient and the average quantity by weight of the ingredient in (a) a serving of the food; and (b) per 100 g or 100 mL of the food. Vitamin and mineral claims 5. (1) The label on a formulated supplementary sports food must not claim the presence of a vitamin or mineral unless (a) the reference is required elsewhere in this Code; or (b) the reference is specifically permitted by this clause. (2) The label on a formulated supplementary sports food may only claim the presence of a vitamin or mineral in the food if (a) the food contains (i) at least 10 percent of the recommended dietary intake for that vitamin or mineral in a serving of that food or, in relation to a food which requires dilution or preparation according to directions, the quantity of the food which when diluted or prepared produces a normal serving; or (ii) at least 10 percent of the amount specified in column 3 of the Schedule to this Standard for that vitamin or mineral in a normal serving of that food, or in relation to a food which requires dilution or preparation according to directions, the quantity of the food which when diluted or prepared produces a normal serving; and (b) the amount claimed does not exceed the amount specified in column 2 of the table to paragraph 11 (b); and (c) the label on the food includes a statement in accordance with clause 6 of Standard A9. Prohibition on representations 6. Unless specific permission is given in this Part, the label on a formulated supplementary sports food must not include an express or implied representation that relates any property or proposed use of the food to enhanced athletic performance or beneficial physiological effects. Division 2 Particular Formulated Supplementary Sports Foods High carbohydrate supplement 7. (1) A high carbohydrate supplement is a formulated supplementary sports food for which (a) not less than 90 percent of the energy yield of the product is derived from carbohydrate; and (b) more than 15 percent of the product by weight is carbohydrate when prepared as directed. (2) The label on a high carbohydrate supplement must include statements to the effect that (a) if used during exercise, the food should be consumed in accordance with directions, to avoid the possibility of gastrointestinal upset; and (b) the food must be consumed with an appropriate fluid intake. (3) The label on a high carbohydrate supplement may include statements to the effect that (a) the product is useful either before, during and/or after sustained strenuous exercise; and (b) appropriate usage may assist in the provision of energy in the form of carbohydrates. Protein energy supplement 8. (1) A protein energy supplement is a formulated supplementary sports food for which (a) not more than 30 percent and not less than 15 percent of the energy yield of the product is derived from protein; (b) not more than 25 percent of the energy yield of the product is derived from fat; and (c) not more than 70 percent of the energy yield of the product is derived from carbohydrate. (2) The label on a protein supplement must include a statement to the effect that the food must be consumed with an appropriate fluid intake. (3) The label on a protein supplement may include statements to the effect that (a) the product may assist in providing a low-bulk diet as may be required during training; (b) the product may assist in supplementing the diet with a high energy source as may be required during training; (c) usage as directed may assist in the development of muscle bulk; and (d) the product is useful either before, during and/or after sustained strenuous exercise. Energy supplement 9. (1) An energy supplement is a formulated supplementary sports food for which not more than 20 percent of the energy yield of the product is derived from protein. (2) The label on an energy supplement must include statements to the effect that (a) if used during exercise, the food should be consumed in accordance with directions, to avoid the possibility of gastrointestinal upset; and (b) the food must be consumed with an appropriate fluid intake. (3) If more than 30 percent of the energy yield of the energy supplement is derived from fat, the label on the energy supplement must include a statement to the effect that the product is a high fat food and should be used for special fat loading strategies rather than everyday use. (4) The label on an energy supplement may include statements to the effect that (a) the product may assist in supplement the diet with an energy source as may be required during training; and (b) the product is useful either before, during and/or after the sustained strenuous exercise. Prescribed name 10. The names by which particular formulated supplementary sports foods are defined in this Division are not prescribed names. Schedule Additional Permitted Forms and Intake Amounts for Vitamins and Minerals in Formulated Supplementary Sports Foods Column 1 Column 2 Column 3 Vitamin or Mineral Permitted forms Amount Biotin d-biotin 100 g Pantothenic d-calcium pantothenate 7 mg acid dexpanthenol d-sodium pantothenate Calcium calcium hydroxide 800 mg calcium oxide calcium sulphate Chromium Inorganic forms: 200 g chromic chloride Organic forms: high chromium yeast chromium picolinate chromium nicotinate chromium aspartate Copper Inorganic forms: 3.0 mg cupric carbonate cupric sulphate Organic forms: copper gluconate copper-lysine complex cupric citrate Magnesium magnesium citrate 320 mg magnesium hydroxide Manganese Inorganic forms: 5.0 mg manganese carbonate manganese chloride manganese sulphate Organic forms: manganese citrate Molybdenum Inorganic forms: 250 g sodium molybdate Organic forms: high molybdenum yeast Phosphorus magnesium phosphate, monobasic 1000 mg phosphoric acid potassium phosphate, dibasic potassium phosphate, tribasic sodium phosphate, dibasic sodium phosphate, monobasic sodium phosphate, tribasic Selenium Inorganic forms: 70 g sodium selenate sodium selenite Organic forms: selenomethionine The amount represents the recommended dietary intake for the permitted forms of calcium, magnesium, phosphorus, selenium and zinc and the estimated safe and adequate daily dietary intake for the remaining minerals listed in column 1 of the Schedule.''.