Dietary Foods for Special Medical Purposes Regulations, 2001 (L.N. No. 309 of 2001)

B 3268 Citation and commencement. Scope and Applicability, Definitions. L.N. 309 of 2001 FOOD, DRUGS AND DRINKING WATER ACT (CAP.231) Dietary Foods for Special Medical Purposes Regulations, 2001 IN exercise of the powers conferred by article 12 of the Food, Drugs and Drinking Water Act, the Minister of Health, on the advice of the Malta Standards Authority, has made the following regulations: 1. The title of these regulations is the Dietary Foods for Special Medical Purposes Regulations 2001 and shall come into force on the 1st January, 2002. 2.1 These regulations lay down compositional and labelling requirements for dietary foods for special medical purposes as defined in paragraph 3 .1 and presented as such. 3.1 In these regulations, unless the context otherwise requires, the following definitions shall apply: (a) 'infants' means children under the age of 12 months; (b) 'dietary foods for special medical purposes' means a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two. 3 .2 Dietary foods for special medical purposes are classified in the following three categories: (a) nutritionally complete foods with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended; (b) nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended; (c) nutritionally incomplete foods with a standard formulation or a nutrient~adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment. 3 .3 The foods referred to in points (b) and ( c) of paragraph 3 .2 may also be used as a partial replacement or as a supplement to the patient's diet. B 3269 4.1 Dietary foods for special medical purposes may be marketed ~eting of only if they comply with the rules laid down in these Regulations. :~=!t '.Purposes. 5.1 The formulation of dietary foods for special medical purposes Formulation of shall be based on sound medical and nutritional principles. Their use, = =::!fr in accordance with the manufacturer's instructions, shall be safe and Purposes. beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. 5 .2 Dietary foods for special medical purposes must comply with the compositional criteria specified in the Schedule. 6.1 The name under which dietary foods for special medical Labelling ofDietary Foods for Special purposes are sold shall be respectively: Medical Purposes. in Maltese; 'Ikel inti:i ghal skopijiet medici specjali' in English: 'Food(s) for special medical purposes• in Italian: 'Alimento dietetico destinato a fini medici speciali' 6.2 The labelling shall bear, in addition to the particulars provided for in the Labelling and Presentation of Foodstuffs Regulations., 1992, the following mandatory particulars: B 3270 (a) the available energy value expressed in kJ and kcal, and the content of protein, carbohydrate and fat, expressed in numerical form, per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions. This information may in addition be provjded per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated; (b) the average quantity of each mineral substance and each vitamin mentioned in the Schedule present in the product, expressed in numerical form per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions. This infonnation may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated; (c) selectively the content of components of protein, carbohydrate and fat and/or of other nutrients and their components the declaration of which would be necessary for the appropriate intended use of the product, expressed in numerical form per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated; (d) information on the osmo1ality or the osmolarity of the product where appropriate; (e) information on the origin and the nature of the protein and/or protein hydrolysates contained in the product. 6.3 The 1abeJHng sha11 in addition bear the following mandatory particulars, preceded by the words 'important notice' or their equivalent: (a) a statement that the product must be used under medical supervision; (b) a statement whether the product is suitable for use as the sole source of nourishment; (c) a statement that the product is intended for a specific age group, as appropriate; (d) where appropriate a statement that the product poses a health hazard when consumed by persons who do not have the diseases, disorders or medical conditions for which the product is intended. 6.3.1 The particulars mentioned in paragraph 6.3 (a) and (d) and in paragraph 6.4 (d) shall be given in at least the Maltese or English language. 6.4 The labelling shall also include: (a) the statement 'For the dietary management of ...... " where the blank shall be filled in with the diseases. disorders or medical conditions for which the product is intended; (b) where appropriate a statement concerning adequate precautions and contra-indications; ( c) a description of the properties and/or characteristics that make the product useful in particular, as the case may be, relating to the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product; (d) where appropriate a warning that the product is nor for parenteral use. 6.5 The labelling shall bear instructions for the appropriate preparation, the use and the storage of the product after the opening of the container, as appropriate. B 3271 7 .1 When a dietary food for special medical purposes is placed Not,fl.('.ation on the market, the manufacturer or the importer shall notify the Procedure. Superintendent of Public Health by forwarding a model of the label used for the product. B 3272 SCHEDULE Essential Composition of Foods for Special Medical Purposes The specifications refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1. Products referred to in paragraph 3.2(a) intended specifically for infants will contain the vitamins and mineral substances as specified in Table 1. 2. Products referred to in paragraph 3.2(b) intended specifically for infants will contain the vitamins and mineral substances as specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 3. Maximum levels of vitamins and mineral substances present in products referred to in paragraph 3.2(c) intended specifically for infants shall not exceed those specified in Table l, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 4. Where this is not contrary to the requirements dictated by the intended use, foods for special medical purposes intended specifically for infants shall comply with the provisions relating to other nutrients applicable to infant formulae and follow-on formulae, as the case may be, laid down in the Infant Formulae and Follow-on Formulae Regulations, 1998. 5. Products referred to in paragraph 3 .2( a), other than those specifically intended for infants will contain the vitamins and mineral substances as specified in Table 2. 6. Products referred to in paragraph 3.2(b) other than those specifically intended for infants will contain the vitamins and mineral substances as specified in Table 2 without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 7. Maximum levels of vitamins and mineral substances present in products referred to in paragraph 3.2(c) other than those intended specifically for infants shall not exceed those specified in Table 2, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. B 3273 TABLE 1 Values for vitamins, mineral and trace elements in nutritionally complete foods intended for use by infants Vitamins: Per 100 kJ Per 100 kcaJ Minimum Maximum Minimum Maximum Vitamin A (µ2 RE) 14 43 60 180 Vitamin D (µg) 0.25 0.75 1 3 Vitamin K (µg) 1 5 4 20 Vitamin C (mg) 1.9 6 8 25 Thiamin (mg:) 0.01 0.075 0.04 0.3 Riboflavin (mg) 0.014 0.1 0.06 0.45 Vitamin B6 (mg) 0.009 0.075 0.035 0.3 Niacin (me NE) 0.2 0.75 0.8 3 Folic acid (µg) 1 6 4 25 Vitamin B12 (µg) 0.025 0.12 0.1 0.5 Pantothenic acid (mg) 0.07 0.5 0,3 2 Biotin <ue) 0.4 5 1.5 20 Vitamin E (mg a.-TE) 0.5/g polyun- 0.75 05/g polyun- 3 saturated fatty saturated fatty acids acids expressed as expressed as linoleic acid Jinoleic acid but in no case but in no case less than 0.1 less than 0.1 mg per 100 mg per 100 available kJ available kcal B 3274 Minerals: Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Sodium (mg) 5 14 20 60 Chloride (mg) 12 29 50 125 Potassium (mg) 15 35 60 145 Calcium (mg) 12 60 50 250 Phosphorus (mg)' 6 22 25 90 Magnesium (mg) 1.2 3.6 5 15 lron (mg) 0.12 0.5 0.5 2 Zinc (mg) 0.12 0.6 0.5 2.4 Copper (JJJ?.) 4.8 29 20 120 Iodine (J.12) 1.2 8.4 5 35 Selenium (µg) 0.25 0.7 1 3 Manganese (mg) 0.012 0.05 0.05 0.2 Chromium (µg) - 2.5 - 10 Molybdenum {u2) - 2.5 - 10 Fluoride (mg) - 0.05 - 0.2 1 The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0. B 3275 TABLE2 Values for vitamins, minerals and trace elements in nutritionally complete foods other than those intended for use by infants Vitamins: Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (µg RE) 8.4 43 3S 180 Vitamin D (µg) 0.12 Q,65/0,75l 0.5 25/3l Vitamfo K ( ug) 0.85 5 35 20 Vitamin C (mg) 0.54 5.25 2.25 22 Thiamin (mg) 0.015 0.12 0.06 OS Riboflavin (mg) 0.02 0.12 0.08 0.5 Vitamin B6 (mg) 0.02 0.12 0.08 0.5 Niacin (mg NE) 0.22 0.75 0.9 3 Folic acid (µg) 2.5 12.5 10 50 Vitamin B12 (u2) 0.017 0.17 0.07 0.7 Pantothenic acid (m2) 0.035 0.35 0.15 1.5 Biotin (µg) 0.18 1.8 0.75 15 Vitamin E (mg a-TE) 0.5/g polyun- 0.75 05/g polyun- 3 saturated fatty saturated fatty acids acids expressed as expressed as linoleic acid linoleic acid but in no case but in no case less than 0.1 less than 0.1 mg per 100 mg per 100 available kJ available kcal 2 For product~ intended fur children of 1 to 10 years of age. B 3276 Minerals: Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Sodium (mg) 7.2 42 30 175 Chloride (mg) 7.2 42 30 175 Potassium (mg) 19 70 80 295 Calcium (mg) 8.4/Jil 42/602 35/502 175/250~ Phosphorus (mg)5 7.2 ~ 19 30 80 ~~nesium Cm~l 1.8 6 7.5 25 Iron (mg) 0.12 0.5 0.5 2.0 --Zinc (mg) 0.12 0.36 0.5 1.5 Copper (µg) 15 125 60 500 ~Iodine (µg) 1.55 8.4 6.5 35 I Selenium (µg) 0.6 2.5 2.5 10 ~Manganese (mg) 0.012 0.12 0.05 0.5 Chromium (1-tg) 0.3 3.6 1.25 15 Molybdenum (µg) 0.72 4.3 3.5 18 Fluoride (mg) - 0.05 - 0.2 J The calcium/phosphorus ratio shall not be less than 1.2 nor grealer than 2.0. Ippubblikat mid-Dipartiment la' 1-Informazzjoni- 3, Pjazza Kastilja- Publfahecl by rite Deptmment of information - 3, Casri/le Place Milbugh fl-lstamperija lal-Gvern - Printed at the Government Printing Press Preu 18c - Price 18c