DIETARY FOODS FOR SPECIAL MEDICAL PUROSES [S.L.231.48 1 
SUBSIDIARY LEGISLATION 231.48 
DIETARY FOODS FOR SPECIAL MEDICAL 
PURPOSES REGULATIONS
1st January, 2002 
Legal Notice 309 of 2001. 
Title. 1. The title of these regulations is the Dietary Foods for 
Special Medical Purposes Regulations. 
Scope and 
applicability. 
2. These regulations lay down compositional and labelling 
requirements for dietary foods for special medical purposes as 
defined in regulation 3.1 and presented as such. 
Definitions. 3.1 In these regulations, unless the context otherwise requires, 
the following definitions shall apply: 
(a) "infants" means children under the age of twelve 
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 
forrnulation 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

2 [S.L.231.48 DIETARY FOODS FOR SPECIAL MEDICAL PUROSES 
nourishment. 
3.3 The foods referred to in regulation 3.2(b) and (c) may also 
be used as a partial replacement or as a supplement to the patient’s 
diet. 
Marketing of 
dietary foods for 
special medical 
purposes. 
4.1 Dietary foods for special medical purposes may be 
marketed only if they comply with the rules laid down in these 
regulations. 
Formulation of 
dietary foods for 
special medical 
purposes. 
5.1 The formulation of dietary foods for special medical 
purposes shall be based on sound medical and nutritional 
principles. Their use, in accordance with the manufacturer’s 
instructions, shall be safe and 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. 
Labelling of 
dietary foods for 
special medical 
purposes. 
6.1 The name under which dietary foods for special medical 
purposes are sold shall be respectively: 
- in Maltese: 
"Ikel inti\ g]al skopijiet medi`i spe`jali" 
- in English: 
"Food(s) for special medical purposes" 
- in Italian: 
"Alimento dietetico destinato a fini medici speciali". 
S.L.231.27 
6.2 The labelling shall bear, in addition to the particulars 
provided for in the Labelling, Presentation and Advertising of 
Foodstuffs Regulations, the following mandatory particulars: 
(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 provided 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 
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; 
(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

DIETARY FOODS FOR SPECIAL MEDICAL PUROSES [S.L.231.48 3 
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 osmolality 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 labelling shall 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 regulation 6.3(a) and (d) and 
in regulation 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 d.ietary 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 not 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. 
Notification 
procedure. 
7.1 When a dietary food for special medical purposes is placed 
on the market, the manufacturer or the importer shall notify the 
Superintendent of Public Health by forwarding a model of the label

4 [S.L.231.48 DIETARY FOODS FOR SPECIAL MEDICAL PUROSES 
used for the product.

DIETARY FOODS FOR SPECIAL MEDICAL PUROSES [S.L.231.48 5 
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 regulation 3.2(a) intended specifically for infants 
will contain the vitamins and mineral substances as specified in Table 1. 
2. Products referred to in regulation 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 regulation 3.2(c) intended specifically for infants shall not exceed 
those specified in Table 1, 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. 
5. Products referred to in regulation 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 regulation 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 regulation 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.

6 [S.L.231.48 DIETARY FOODS FOR SPECIAL MEDICAL PUROSES 
TABLE 1 
Values for vitamins, mineral and trace elements in nutritionally complete foods 
intended for use by infants 
Vitamins: 
Per 100 kJ Per 100 kcal 
Minimum Maximum Minimum Maximum 
Vitamin A (µg 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 (mg 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 (µg) 0.4 5 1.5 20 
Vitamin E (mg - 
TE) 
0.5/g 
polyunsaturated 
fatty 
acids 
expressed as 
linoleic acid 
but in no case 
less than 0.1 
mg per 100 
available kJ 
0.75 0.5/g 
polyunsaturated 
fatty 
acids 
expressed as 
linoleic acid 
but in no case 
less than 0.1 
mg per 100 
available 
kcal 
3 
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)1 6 22 25 90 
Magnesium (mg) 1.2 3.6 5 15 
Iron (mg) 0.12 0.5 0.5 2 
Zinc (mg) 0.12 0.6 0.5 2.4 
Copper (µg) 4.8 29 20 120 
Iodine (µg) 1.2 8.4 5 35 
Selenium (µg) 0.25 0.7 1 3 
a

DIETARY FOODS FOR SPECIAL MEDICAL PUROSES [S.L.231.48 7 
TABLE 2 
Values for vitamins, minerals and trace elements in nutritionally complete foods 
other than those intended for use by infants 
Manganese (mg) 0.012 0.05 0.05 0.2 
Chromium (µg) - 2.5 - 10 
Molybdenum (µg) - 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. 
Vitamins: 
Per 100 kJ Per 100 kcal 
Minimum Maximum Minimum Maximum 
Vitamin A (µg RE) 8.4 43 35 180 
Vitamin D (µg) 0.12 0.65/0.752 0.5 2.5/32 
Vitamin K (µg) 0.85 5 3.5 20 
Vitamin C (mg) 0.54 5.25 2.25 22 
Thiamin (mg) 0.015 0.12 0.06 0.5 
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 (µg) 0.017 0.17 0.07 0.7 
Pantothenic acid (mg) 0.035 0.35 0.15 1.5 
Biotin (µg) 0.18 1.8 0.75 7.5 
Vitamin E (mg - 
TE) 
0.5/g 
polyunsaturated 
fatty 
acids 
expressed as 
linoleic acid 
but in no case 
less than 0.1 
mg per 100 
available kJ 
0.75 0.5/g 
polyunsaturated 
fatty 
acids 
expressed as 
linoleic acid 
but in no case 
less than 0.1 
mg per 100 
available 
kcal 
3 
2 For products intended for children of 1 to 10 years of age. 
Minerals: 
Per 100 kJ Per 100 kcal 
Minimum Maximum Minimum Maximum 
a

8 [S.L.231.48 DIETARY FOODS FOR SPECIAL MEDICAL PUROSES 
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) 8.4/122 42/602 35/502 175/2502 
Phosphorus (mg)3 7.2 19 30 80 
Magnesium (mg) 1.8 6 7.5 25 
Iron (mg) 0.12 0.5 0.5 2 
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 
Selenium (µg) 0.6 2.5 2.5 10 
Manganese (mg) 0.012 0.12 0.05 0.5 
Chromium (µg) 0.3 3.6 1.25 15 
Molybdenum (µg) 0.72 4.3 3.5 18 
Fluoride (mg) - 0.05 - 0.2 
3 The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

