LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES RULES *

LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS

FOR PARTICULAR NUTRITIONAL PURPOSES

SUBSIDIARY LEGISLATION 437.53

LIST OF INTENDED USES OF ANIMAL

FEEDINGSTUFFS FOR PARTICULAR

NUTRITIONAL PURPOSES RULES *

13th February, 2009

LEGAL NOTICE 49 of 2009.

(1) The title of these rules is the List of Intended Uses of

Animal Feedingstuffs for Particular Nutritional Purposes Rules.

(2) The scope of these rules is to transpose Directive 2008/38/

EC establishing a list of intended uses of animal feedingstuffs for

particular nutritional purposes, as amended by Directive 2008/82/

EC as regards feedingstuffs intended for the support of the renal

function in case of chronic renal insufficiency, and codifying

Directive 94/39/EC establishing a list of intended uses of animal

feedingstuffs for particular nutritional purposes, as last amended by

Directive 2008/4/EC as regards feedingstuffs intended for the

reduction of the risk of milk fever, and subsequently repealing

Directive 94/39/EC.

(Regulations 3 and 4)

PART A

General provisions

1. Where there is more than one group of nutritional characteristics indicated

in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the

manufacturer has the option to use either or both groups of essential characteristics,

in order to achieve the nutritional purpose defined in column 1. For each option the

corresponding labelling declarations are given opposite in column 4.

2. Where a group of additives is mentioned in column 2 or column 4 of Part B

the additive or additives used must be authorised in Regulation (EC) No 1831/2003

of the European Parliament and of the Council as corresponding to the specified

essential characteristic.

3. Where the source or sources of ingredients or of analytical constituents are

required in column 4 of Part B, the manufacturer must make a precise declaration

(e.g. specific name of the ingredient(s), animal species or part of the animal)

allowing the evaluation of conformity of the feedingstuff with the corresponding

essential nutritional characteristics.

4. Where the declaration of a substance, also authorised as an additive, is

required in column 4 of Part B and is accompanied by the expression ‘total’ the

declared content must refer to, as appropriate, the quantity naturally present where

none is added or, by derogation from Council Directive 70/524/EEC, the total

quantity of the substance naturally present and the amount added as an additive.

(1) Unless otherwise established in these rules, the

definitions provided in the Veterinary Services Act shall apply.

(2) For the purpose of these rules and unless the context

otherwise requires

"authorised provider" means a person authorised by the

Authority to manufacture animal products for particular nutritional

purposes by making use of sources of ingredients or other similar

constituents of the product or by making use of additives to such

product in terms of the Schedule or who provides final consumers

with nutritive products produced by animals;

"competent authority" means the Veterinary Services within

Malta as provided under article 2 of the Veterinary Services Act;

"final consumer" means the person who acquires nutritive

products produced by animals for her own use;

"general benefits” means all those benefits that the consumer

acquires from those particular nutritive products produced by

animals;

"milk fever" means a hypocalcaemic paresis (disorder of nerve

and muscle function) at parturition, caused by sudden and large

demand of calcium from blood due to the onset of lactation.

(1) These rules shall apply for the reduction and

prevention of the risk of milk fever so as to safeguard animal

health, human health and the environment as well as for the

*These rules have been repealed by Legal Notice 36 of 2025.

LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS

FOR PARTICULAR NUTRITIONAL PURPOSES

measures provided in these rules regarding the food producing

chain and animal health

Provided that the competent authority shall consider the

marginal risk as one which cannot be completely excluded

Provided further that the competent authority shall ensure

that the individual risk is balanced with the general benefits of the

administration and considers such balance as necessary.

(2) The competent authority shall take all the appropriate and

necessary measures to reduce the risk presented to the consumer

together with any additional risk to the environment in accordance

with the provisions established in the Schedule.

(3) These measures shall include the direct confiscation of the

product, the suspension of activities carried out by the authorised

provider when such activities are presenting a risk to the final

consumer and to the environment, and the application of fines.

(4) The competent authority shall also ensure that there is

conformity with the dispositions mentioned under "General

Dispositions" of Part A of the Schedule.

Feedingstuffs intended for particular nutritional purposes

within the meaning of European Union Council Directive 93/74/

EEC shall be marketed in Malta only if their intended uses are

included in the Schedule and if they fulfill the other provisions laid

down in the Schedule.

The declarations required in column 4 of Part B with the reference ‘if added’

are compulsory where the ingredient or the additive has been incorporated or

increased specifically to enable the achievement of the particular nutritional

purpose.

The declarations to be given in accordance with column 4 of Part B

concerning analytical constituents and additives must be quantitative.

The recommended period of use indicated in column 5 of Part B indicates a

r a n g e w i t h i n wh i c h th e n u tr i t i o n a l p u r p o s e s h o u l d n o r m a l l y b e ac h i ev e d.

Manufacturers can refer to more precise periods of use, within the fixed limits.

Where a feedingstuff is intended to meet more than one particular nutritional

purpose, it must comply with the corresponding entries in Part B.

In the case of complementary feedingstuffs intended for particular

nutritional purposes guidance on the balance of the daily ration must be provided in

the instructions for use contained on the label.

PART B

List of intended uses

Particular

Essential

Species or Labelling

Recommen- Other

nutritional

nutritional

category of declarations

ded length of provisions

purpose

characteristics

animals

time for use

Support of renal

Low level of

Dogs and

- Protein source(s) Initially up

Indicate on the

to 6 months 2

function in case of

phosphorus and

cats

- Calcium

package,

chronic renal

restricted level of

- Phosphorus

container or

insufficiency 1

protein but of high

- Potassium

label: ‘It is

quality

- Sodium

recommended

- Contents of

that a

essential fatty acids

veterinarian's

(if added)

opinion be

sought before

use or before

extending the

period of use’.

Indicate in the

instructions for

use: ‘Water

should be

available at all

times.’

or

Reduced

Adult cats

- Protein source(s) Initially up

Indicate on the

to 6 months 2

phosphorus

- Calcium

package,

absorption by

- Phosphorus

container or

means of

- Potassium

label: ‘It is

incorporation of

- Sodium

recommended

Lanthanum

- Lanthanum

that a

carbonate

carbonate

veterinarian's

octahydrate

octahydrate

opinion be

- Contents of

sought before

essential fatty acids

use’.

(if added)

Indicate in the

instructions for

use: ‘Water

should be

available at all

times.’

Dissolution of

-

Urine

Dogs

- Protein source(s) 5 to 12

Indicate in the

struvite stones 3

acidifying

- Calcium

weeks

instructions for

properties,

- Phosphorus

use: ‘Water

low level of

- Sodium

should be

magnesium,

- Potassium

available at all

and restricted

- Chlorides

times.’

level of

- Sulphur

Indicate on the

protein but of

- Urine acidifying

package,

high quality

substances

container or

-

Urine

Cats

- Calcium

label: ‘It is

acidifying

- Phosphorus

recommended

properties and

- Sodium

that a

low level of

- Magnesium

veterinarian's

magnesium

- Potassium

opinion be

- Chlorides

sought before

- Sulphur

use’.

- Total taurine

- Urine acidifying

substances

Reduction of

Urine acidifying

Dogs and

- Calcium

Up to 6

Indicate on the

struvite stone

properties and

cats

- Phosphorus

months

package,

recurrence 3

moderate level of

- Sodium

container or

magnesium

- Magnesium

label: ‘It is

- Potassium

recommended

- Chlorides

that a

- Sulphur

veterinarian's

- Urine acidifying

opinion be

substances

sought before

use’.

Reduction of urate Low level of

Dogs and

Protein source(s)

Up to 6

Indicate on the

stones formation prines, low level of cats

months but

package,

protein but of high

lifetime use

container or

quality

in cases of

label: ‘It is

irreversible

recommended

disturbance

that a

of uric acid

veterinarian's

metabolism

opinion be

sought before

use’.

Reduction of

Low level of

Dogs and

- Phosphorus

Up to 6

Indicate on the

oxalate stones

calcium, low level

cats

- Calcium

months

package,

formation

of Vitamin D and

- Sodium

container or

urine alkalizing

- Magnesium

label: ‘It is

properties

- Potassium

recommended

- Chlorides

that a

- Sulphur

veterinarian's

- Total Vitamin D

opinion be

- Hydroxyproline

sought before

- Urine alkalizing

use’.

substances

Reduction of

Low level of

Dogs and

- Total sulphur

Initially up

Indicate on the

cystine stones

protein, moderate

cats

amino acids

to 1 year

package,

formation

level of sulphur

- Sodium

container or

amino acids and

- Potassium

label: ‘It is

urine alkalizing

- Chlorides

recommended

properties

- Sulphur

that a

- Urine alkalizing

veterinarian's

substances

opinion be

sought before

use or before

extending the

period of use’.

Reduction of

- Selected protein Dogs and

- Protein

3 to 8 weeks

ingredient and

source(s)

cats

source(s)

if signs of

nutrient

- Content of

intolerance

intolerences 4

essential fatty acids

disappear

and/or

(if added)

this feed can

be used

indefinitely

- Selected

- Carbohydrate

carbohydrate

source(s)

source(s)

- Content of

essential fatty acids

(if added)

Reduction of

Increased level of

Dogs and

- Highly

1 to 2 weeks Indicate on the

acute intestinal

electrolytes and

cats

digestible

package,

absorptive

highly digestible

ingredients

container or

disorders

ingredients

including their

label

treatment if

- ‘During

appropriate

periods of

- Sodium

and recovery

- Potassium

from acute

- Source(s) of

diarrhea.’

mucilaginous

- ‘It is

substances (if

recommen-

added)

ded that a

veterinarian's

opinion be

sought before

use’.

Compensation for Highly digestible

Dogs and

Highly digestible

3 to 12

Indicate on the

maldigestion 5

ingredients and

cats

ingredients

weeks but

package,

low level of fat

including their

lifetime in

container or

treatment if

case of

label: ‘It is

appropriate

chronic

recommended

pancreatic

that a

insufficiency veterinarian's

opinion be

sought before

use’.

Support of heart

Low level of

Dogs and

- Sodium

Initially up

Indicate on the

function in case of

sodium and

cats

- Potassium

to 6 months

package,

chronic cardiac

increased K/Na

- Magnesium

container or

insufficiency

ratio

label: ‘It is

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use’.

Regulation of

Low level of rapid Dogs and

- Carbohydrate

Initially up

Indicate on the

glucose supply

glucose-releasing cats

source(s)

to 6 months

package,

(Diabetis

carbohydrates

- Treatment of

container or

carbohydrates if

label: ‘It is

mellitus)

appropriate

recommended

- Starch

that a

- Total sugar

veterinarian's

- Fructose (if

opinion be

added)

sought before

- Content of

use or before

essential fatty acids

extending the

(if added)

period of use’.

- Source(s) of

short and medium

chain fatty acids (if

added)

Support of liver

High quality

Dogs

- Protein

Initially up

Indicate on the

function in case of

protein, moderate

source(s)

to 6 months

package,

chronic liver

level of protein,

- Content of

container or

insufficiency

high level of

essential fatty acids

label: ‘It is

essential fatty

- Highly

recommended

acids and high

digestible

that a

level of highly

carbohydrates

veterinarian's

digestive

including their

opinion be

carbohydrates

treatment if

sought before

appropriate

use or before

- Sodium

extending the

- Total copper

period of use’.

Indicate in the

instructions for

use

‘Water should

be available at

all times.’

High quality

Cats

- Protein

Initially up

Indicate on the

protein, moderate

source(s)

to 6 months

package,

level of protein and

- Content of

container or

high level of

essential fatty acids

label: ‘It is

essential fatty

- Sodium

recommended

acids

- Total copper

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use’.

Indicate in the

instructions for

use: ‘Water

should be

available at all

times.’

Regulation of

Low level of fat

Dogs and

- Content of

Initially up

Indicate on the

lipid metabolism

and high level of

cats

essential fatty acids to 2 months

package,

in case of

essential fatty

- Content of n-3

container or

hyperlipidaemia

acids

fatty acids (if

label: ‘It is

added)

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use’.

Reduction of

Low level of

Dogs

Total copper

Initially up

Indicate on the

copper in the liver copper

to 6 months

package,

container or

label: ‘It is

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use’.

Reduction of

Low energy

Dogs and

Energy value

Until target In the

excessive body

density

cats

body weight instructions for

weight

is achieved use an

appropriate

daily intake

must be

recommended

Nutritional

High energy

Dogs and

Highly

Until

In the case of

restoration,

density, high

cats

digestible

restoration is feedingstuffs

convalescence 6

concentrations of

ingredients,

achieved

specially

essential nutrients

including their

presented to be

and highly

treatment if

given via

digestible

appropriate

tubing, indicate

ingredients

- Energy value

on the package,

- Content of n-3

container or

and n-6 fatty acids

label

(if added)

‘Administra-

tion under

veterinary

supervision’

Support of skin

High level of

Dogs and

Content of

Up to 2

Indicate on the

function in case of essential fatty

cats

essential fatty acids months

package,

dermatosis and

acids

container or

excessive loss of

label: ‘It is

hair

recommended

that a

veterinarian's

opinion be

sought before

use’.

Reduction of the - Low level of

Dairy cows - Calcium

1 to 4 weeks Indicate in the

risk of milk fever calcium and/or

- Phosphorus

before

instructions for

- Magnesium

calving

use: ‘Stop

feeding after

calving’.

and/or

- Low cations/

-

Calcium

1 to 4 weeks Indicate in the

anions ratio

-

Phosphorus

before

instructions for

-

Sodium

calving

use: ‘Stop

-

Potassium

feeding after

-

Chlorides

calving’.

-

Sulphur

or

- High level of

Content of

The 2 weeks Indicate in the

zeolite (synthetic

synthetic sodium

before

instructions for

sodium aluminium

aluminium silicate

calving

use

silicate)

- ‘The amount

of feed shall be

restricted to

ensure that a

daily intake of

500g sodium

aluminium-

silcate per

animal is not

exceeded.’

- ‘Stop feeding

after calving’

or

- High level of

Total calcium

Start at first Indicate on the

calcium in the form

content, sources

signs of

package,

of highly available

and respective

parturition to container or

calcium salts

quantity of calcium two days

label

subsequent

- The

to parturition instruction of

use, i.e. the

number of

applications

and the time

before and after

calving.

- The text ‘It is

recommended

that a

nutritional

expert’s

opinion be

sought before

use’.

Reduction of the

Ingredients

Dairy cows - Ingredients

3 to 6 weeks

risk of ketosis 7 8

proving glucogenic and ewes

providing

after

calving 9

energy sources

glucogenic energy

sources

- Propane-1,2-

Last 6 weeks

diol (if added as a

before and

glucose precursor)

the first 3

- Glycerol (if

weeks after

lambing 10

added as a glucose

precursor)

Reduction of the

High level of

Ruminants

-

Starch

3 to 10

In

the

risk of tetany

magnesium, easily

-

Total sugars

weeks during instructions for

(hypomagne-

available

-

Magnesium

periods of

use guidance

saemia)

carbohydrates,

-

Sodium

fast grass

shall

be

moderate level of

-

Potassium

growth

provided on the

protein and low

balance of the

level of potassium

daily ration,

with regard to

the inclusion of

fibre and easily

available

energy sources.

In case of

feedingstuffs

for ovines

indicate on the

package,

container or

label

‘Especially for

lactating ewes.’

Reduction of the

Low level of easily Ruminants

- Starch

Maximum 2

In

the

months 11

risk of acidosis

fermentable

- Total sugars

instructions for

carbohydrates and

use guidance

highly buffering

shall

be

capacity

provided on the

balance of the

daily ration,

with regard to

the inclusion of

fibre and easily

fermentable

carbohydrate

sources.

In case of

feedingstuffs

for dairy cows

indicate on the

package,

container or

label

‘Especially for

high yielding

cows.’

In case of

feedingstuffs

for ruminants

for fattening

indicate on the

package,

container or

label

‘Especially for

intensively fed

.........’ 12

Stabilization of

Predominantly

Calves

- Carbohydrate

1 to 7 days

Indicate on the

water and

electrolytes and

Piglets

source(s)

(1 to 3 days

package,

electrolyte

easily absorbable

Lambs

- Sodium

if fed

container or

balance

carbohydrates

Kids

- Potassium

exclusively)

label

Foals

- Chlorides

- ‘In case of

risk of,

during

periods of, or

recovery

from

digestive

disturbance

(diarrhea)’

- ‘It is

recommen-

ded that a

veterinarian's

opinion be

sought before

use’.

Reduction of the

Low level of

Ruminants

- Calcium

Up to 6

Indicate on the

risk of urinary

phosphorus,

- Phosphorus

weeks

package,

calculi

magnesium and

- Sodium

container or

urine acidifying

- Magnesium

label

properties

- Potassium

‘Especially for

- Chlorides

intensively fed

- Sulphur

young

- Urine acidifying

animals.’

substances

Indicate in the

instructions for

use

‘Water should

be available at

all times’.

Reduction of

- High level

Pigs

Magnesium

1 to 7 days

Guidance shall

stress reactions

magnesium

be provided on

the situation in

and/or

which the use

- Highly

- Highly

of this feed is

digestible

digestible

appropriate.

ingredients

ingredients

including their

treatment if

appropriate

- Content of n-3

fatty acids if added

Stabilization of

- Low buffering

Piglets

- Highly

2 to 4 weeks Indicate on the

physiological

capacity, and

digestible

package,

digestion

highly digestible

ingredients

container or

ingredients

including their

label: ‘In case

treatment if

of risk of,

appropriate

during periods

- Buffering

of, or recovery

capacity

from, digestive

- Source(s) of

disturbance.’

astringent

substances (if

added)

- Source(s) of

mucilaginous

substances (if

added)

- Highly

Pigs

- Highly

digestible

digestible

ingredients

ingredients

including their

treatment if

appropriate

- Source(s) of

astringent

substances (if

added)

- Source(s) of

mucilaginous

substances (if

added)

Reduction of the

Ingredients

Sows

Ingredients

10 to 14 days

risk of

stimulating

stimulating

before and

constipation

intestinal passage

intestinal passage

10 to 14 days

after

farrowing

Reduction of the

Low energy and

Laying hens - Energy value

Up to 12

risk of fatty liver

high proportion of

(calculated

weeks

syndrome

metabolizable

according to EEC

energy from lipids

method)

with high level of

- Percentage of

polyunsaturated

metabolizable

fatty acids

energy from lipids

- Content of

polyunsaturated

fatty acids

Compensation for Low level of

Poultry

- Percentage of

During the

malabsorption

saturated fatty

excluding

saturated fatty

first 2 weeks

acids and high

geese and

acids in relation to

after

level of fat soluble

pigeons

total fatty acids

hatching

vitamins

- Total vitamin A

- Total vitamin D

- Total vitamin E

- Total vitamin K

Equines 13

Compensation for

- Highly

Source(s) of highly Initially up

Guidance

chronic

precaecally

digestible

to six

should

be

insufficiency of

digestible

carbohydrates,

months

provided on the

small intestine

carbohydrates,

proteins and fats,

situations in

function

proteins and fats

including their

which the use

treatment if

of the feed is

appropriate

appropriate and

the manner in

which it should

be

fed

including many

small meals per

day

Indicate on the

package,

container or

label: ‘It is

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use.’

Compensation for - Highly

Equines

- Fibre source(s)

Initially up

Guidance

chronic digestive digestible fibre

- Content of n-3

to six

should be

disorders of large

fatty acids (if

months

provided on the

intestine

added)

situations in

which the use

of the feed is

appropriate and

the manner in

which the feed

should be fed

Indicate on the

package,

container or

label: ‘It is

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use.’

Reduction of

- Highly

Equines

- Magnesium

Two to four

Guidance shall

stress reactions

digestible

- Highly

weeks

be provided on

ingredients

digestible

the precise

ingredients

situations in

including their

which the use

treatment if

of the feed is

appropriate

appropriate

- Content of n-3

fatty acids (if

added)

Compensation of

Predominantly

Equines

-

Calcium

One to three Guidance shall

electrolyte loss in

electrolytes and

-

Sodium

days

be provided on

cases of heavy

easily absorbable

-

Magnesium

the situations in

sweating

carbohydrates

-

Potassium

which the use

-

Chlorides

of the feed is

-

Glucose

appropriate

When the feed

corresponds to

a significant

part of the daily

ration,

guidance

should

be

provided to

prevent the risk

of

abrupt

changes in the

nature of the

feed

Indicate on the

instructions for

use: ‘Water

should be

available at all

times’

Nutritional

High concentration Equines

- Highly

Until

Guidance shall

restoration,

of essential

digestible

restoration is be provided on

convalescence

nutrients and

ingredients

achieved

the situations in

highly digestible

including their

which the use

ingredients

treatment if

of the feed is

appropriate

appropriate

- Content of n-3

In the case of

and n-6 fatty acids

feedingstuffs

(if added)

specially

presented to be

given

via

tubing, indicate

on the package,

container or

label

‘Administra-

tion

under

veterinary

supervision’

Support of liver

Low level of

Equines

- Protein and fibre Initially up

Guidance

function in case of

protein but of high

sources

to six

should

be

chronic liver

quality and highly

- Highly

months

provided on the

insufficiency

digestible

digestible

manner

in

carbohydrates

carbohydrates

which the feed

including their

should be fed

treatment if

including many

appropriate

small meals per

- Methionine

day

- Choline

Indicate on the

- Content of n-3

package,

fatty acids (if

container or

added)

label

‘It is

recommended

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use’.

Support of renal

Low level of

Equines

- Protein

Initially up

Indicate on the

function in case of

protein but of high

source(s)

to six

package,

chronic renal

quality and low

- Calcium

months

container or

insufficiency

level of

- Phosphorus

label

phosphorus

- Potassium

‘It is

- Magnesium

recommended

- Sodium

that a

veterinarian's

opinion be

sought before

use or before

extending the

period of use.’

Indicate in the

instructions for

use

‘Water should

be available at

all times.’

(1)

If appropriate the manufacturer may also recommend use of temporary renal insufficiency.

(2)

If the feedingstuff is recommended for temporary renal insufficiency the recommended period for

use shall be two to four weeks.

(3)

In case of feedingstuffs for cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome -

F.US.’ may complete the particular nutritional purpose.

(4)

In case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace

‘ingredient and nutrient’.

LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS

FOR PARTICULAR NUTRITIONAL PURPOSES

(5)

The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine

pacretic insufficiency’.

(6)

In case of feedingstuffs for cats, the manufacturer may complete the particular nutritional purpose

with a reference to ‘Feline hepatic lipidosis’.

(7)

The term ‘ketosis’ may be replaced by ‘acetonaemia’.

(8)

The manufacturers may also recommend the use for ketosis recuperation.

(9)

In the case of feedingtuffs for dairy cows.

(10) In the case of feedingstuffs for ewes.

(11) In case of feedingstuffs for dairy cows: ‘maximum two months from the start of lactation’.

(12) Indicate the category of ruminants concerned.

(13) In case of feedingstuffs specially prepared to meet the specific conditions of very old animals

(easily ingestible ingredients) a reference to ‘old animals’ shall complete the indication of the

species or category of animals.