DIETARY FOODS FOR SPECIAL MEDICAL PURPOSES REGULATIONS

SUBSIDIARY LEGISLATION 449.29

DIETARY FOODS FOR SPECIAL MEDICAL

PURPOSES REGULATIONS

1st January, 2002

LEGAL NOTICE 309 of 2001, as amended by Legal Notices 241 of 2007

and 284 of 2013.

The title of these regulations is the Dietary Foods for

Special Medical Purposes Regulations.

Amended by

L.N. 241 of 2007.

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.

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)

Vitamin D (µg)

0.25

0.75

Vitamin K (µg)

Vitamin C (mg)

1.9

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

Folic acid (µg)

Vitamin B12 (µg)

0.025

0.12

0.1

0.5

Pantothenic acid (mg)

0.07

0.5

0.3

Biotin (µg)

0.4

1.5

Vi t a m i n E ( m g  -

0.5/g

0.75

0.5/g

TE)

polyunsatura-

polyunsatura-

ted fatty

ted 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

Minerals

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Sodium (mg)

Chloride (mg)

Potassium (mg)

Calcium (mg)

Phosphorus (mg) 1

Magnesium (mg)

1.2

3.6

Iron (mg)

0.12

0.5

0.5

Zinc (mg)

0.12

0.6

0.5

2.4

Copper (µg)

4.8

Iodine (µg)

1.2

(1) 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.

(2) These regulations implement Commission Directive 1999/

21/EC on dietary foods for special medical purposes, as adapted by

Commission Directive 2006/82/EC of 23 October 2006 by reason of the

accession of Bulgaria and Romania and by Commission and by

Commission Directive 2013/26/EU by reason of the accession of

Croatia.

Added by

L.N. 241 of 2007.

Amended by

L.N. 284 of 2013.

Names under which dietary foods for special medical purposes are sold,

in all the European Community languages

- in Bulgarian

"Диетични храни за специални медицински цели"

- in Spanish

"Alimento dietético para usos médicos especiales"

- in Czech

"Dietní potravina určená pro zvláštní lékařské účely"

- in Danish

"Levnedsmiddel/Levnedsmidler til særlige medicinske formål"

- in German

"Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke

(Bilanzierte Diäten)"

- in Estonian

"Toit meditsiinilisel näidustusel kasutamiseks"

- in Greek

"Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς"

- in English

"Food(s) for special medical purposes"

- in French

"Aliment(s) diététique(s) destiné(s) a des fins médicales spéciales"

- in Croatian

"Hrana za posebne medicinske potrebe"

- in Italian

"Alimento dietetico destinato a fini medici speciali"

- in Latvian

"Diētiskā pārtika cilvēkiem ar veselības traucējumiem"

- in Lithuanian

"Specialios medicininės paskirties maisto produktai"

- in Hungarian

"Speciális – gyógyászati célra szánt – tápszer"

- in Maltese

"Ikel dijetetiku għal skopijiet mediċi speċifiċi"

- in Dutch

"Dieetvoeding voor medisch gebruik"

- in Polish

"Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego"

- in Portuguese

"Produto dietético de uso clínico"

- in Romanian

"Alimente dietetice pentru scopuri medicale speciale"

- in Slovak

"dietetická potravina na osobitné lekárske účely"

- in Slovenian

"Dietno (dietetično) živilo za posebne zdravstvene namene"

- in Finnish

"Kliininen ravintovalmiste/kliinisiä ravintovalmisteita"

- in Swedish

"Livsmedel för speciella medicinska ändamål".

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

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.

1 Dietary foods for special medical purposes may be

marketed only if they comply with the rules laid down in these

regulations.

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 First Schedule.

1 (a) The name under which dietary foods for special

medical purposes are sold shall be respectively

- in Maltese

"Ikel dijetetiku g]al skopijiet medi`i spe`ifi`i"

- in English

"Food(s) for special medical purposes"

- in Italian

"Alimento dietetico destinato a fini medici speciali".

(b) Without prejudice to paragraph (a), the list provided for in

the Second Schedule specifies the names under which dietary foods

for special medical purposes are sold in all the European

Community languages.

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 First 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

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.

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.

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

used for the product.

4

Selenium (µg)

0.25

0.7

Minerals

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Manganese (mg)

0.012

0.05

0.05

0.2

Chromium (µg)

-

2.5

-

Molybdenum (µg)

-

2.5

-

Fluoride (mg)

-

0.05

-

0.2

The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

TABLE 2

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

Vitamin D (µg)

0.12

0.65/0.75 2

0.5

2.5/3 2

Vitamin K (µg)

0.85

3.5

Vitamin C (mg)

0.54

5.25

2.25

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

Folic acid (µg)

2.5

5

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

Vi t a m i n E ( m g  -

0.5/g

0.75

0.5/g

TE)

polyunsatura-

polyunsatura-

ted fatty

ted 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

For products intended for children of 1 to 10 years of age.

Minerals

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Sodium (mg)

7.2

Chloride (mg)

7.2

Potassium (mg)

Calcium (mg)

8.4/12 2

42/60 2

35/50 2

175/250 2

Phosphorus (mg) 3

7.2

Magnesium (mg)

1.8

7.5

Iron (mg)

0.12

0.5

0.5

Zinc (mg)

0.12

0.36

0.5

1.5

Copper (µg)

Iodine (µg)

1.55

8.4

6.5

Selenium (µg)

0.6

2.5

2.5

Manganese (mg)

0.012

0.12

0.05

0.5

Chromium (µg)

0.3

3.6

1.25

Molybdenum (µg)

0.72

4.3

3.5

Fluoride (mg)

-

0.05

-

0.2

The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.