Nutritional Purposes Rules, 2009

L.N. 49 of 2009

VETERINARY SERVICES ACT

(CAP. 437)

List of Intended Uses of Animal Feedingstuffs for Particular

Nutritional Purposes Rules, 2009

IN exercise of the powers conferred under the article 26 of

the Veterinary Services Act, the Minister for Resources and Rural

Affairs, has made the following rules:-

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

of Animal Feedingstuffs for Particular Nutritional Purposes Rules,

2009. (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.

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 (2), the total quantity of

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

5. 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.

(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 to these

rules 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;

“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;

“final consumer” means the person who acquires nutritive

products produced by animals for her own use.

(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 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 to these rules.

(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 to these regulations.

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 to these rules and if they fulfill the other

provisions laid down in the Schedule.

The List of Intended Uses of Animal Feedingstuffs

2005. for Particular Nutritional Purposes rules, 2005 are hereby being

revoked.

B

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

range within which the nutritional purpose should normally be achieved. 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.

B

PART B

[Regulation 3(2)]

List of Intended Uses

Particular

Essential

Species or

Labelling Declarations

Recommended

Other Provisions

Nutritional

Nutritional

Category

Length of Time

Purpose

Characteristic

of Animals

s

Support of

Low level of

Dogs and

-

Protein source(s)

Initially up to 6

Indicate on the package,

renal function

phosphorus ad

cats

-

Calcium

months 2

container or label: ‘It is

in the case of

restricted

-

Phosphorus

recommended that a

chronic renal

level of

-

Potassium

veterinarian’s opinion

insufficiency 1

protein but of

-

Sodium

be sought before use or

high quality

-

Contents of essential

before extending the

fatty acids (if added)

period of use’.

Indicate in the

instructions for use

‘Water should be

or

available at all times’.

Adult cats

-

Protein source(s)

Initially up to 6

Indicate on the package,

Reduced

-

Calcium

months 2

container or label: ‘It is

phosphorus

-

Phosphorus

recommended that a

absorption by

-

Potassium

veterinarian’s opinion

means of

-

Sodium

be sought before use or

incorporation

-

Lanthanum

before extending the

of Lanthanum

carbonate

period of use’.

carbonate

octahydrate

octahydrate

- Contents of essential

Indicate in the

fatty acids (if added)

instructions for use

‘Water should be

available at all times’.

Dissolution of

- Urine

Dogs

-

Protein source(s)

5 to 12 weeks

Indicate in the

struvite stones 3

acidifying

-

Calcium

instructions for use

properties,

-

Phosphorus

low level of

-

Sodium

‘Water should be

magnesium,

-

Magnesium

available at all time’.

and

-

Potassium

restricted

-

Chlorides

Indicate on the package,

level of

-

Sulphur

container or label

protein but

-

Urine acidifying

of high

substances

‘It is recommended that

quality

a veterinarian’s opinion

be sought before use’.

Cats

-

Calcium

-

Phosphorus

- Urine

-

Sodium

acidifying

-

Magnesium

properties

-

Potassium

and low

-

Chlorides

level of

-

Sulphur

magnesium

-

Total taurine

-

Urine acidifying

substances

Reduction of

Urine

Dogs and

-

Calcium

Up to 6 months

Indicate on the package,

struvite stone

acidifying

cats

-

Phosphorus

container or label

recurrence 3

properties and

-

Sodium

moderate

-

Magnesium

‘It is recommended that

level of

-

Potassium

a veterinarian’s opinion

magnesium

-

Chlorides

be sought before use’.

-

Sulphur

-

Urine acidifying

substances

Reduction of

Low level of

Dogs and

Protein source(s)

Up to 6 months

Indicate on the package,

urate stones

prines, low

cats

but lifetime use

container or label

formation

level of

in cases of

protein but of

irreversible

‘It is recommended that

high quality

disturbance of

a veterinarian’s opinion

uric acid

be sought before use’.

metabolism

Reduction of

Low level of

Dogs and

-

Phosphorus

Up to 6 months

Indicate on the package,

oxalate stones

calcium, low

cats

-

Calcium

container or label

formation

level of

-

Sodium

vitamin D and

-

Magnesium

‘It is recommended that

urine

-

Potassium

a veterinarian’s opinion

alkalizing

-

Chlorides

be sought before use’.

properties

-

Sulphur

-

Total vitamin D

-

Hydroxyproline

-

Urine alkalizing

substances

Reduction of

Low level of

Dogs and

- Total sulphur amino

Initially up to 1

Indicate on the package,

cystine stones

protein,

cats

acids

year

container or label

formation

moderate

- Sodium

level of

- Potassium

‘It is recommended that

sulphur amino

- Chlorides

a veterinarian’s opinion

acids and

- Sulphur

be sought before use or

urine

- Urine alkalizing

before extending the

alkalizing

substances

period of use’.

properties

Reduction of

- Selected

Dogs and

-

Protein source(s)

3 to 8 weeks: if

ingredient and

protein

cats

-

Content of

signs of

nutrient

source(s)

essential fatty

intolerance

intolerences 4

acids (if added)

disappear this

feed can be

used

and/or

-

Carbohydrate

indefinitely

source(s)

- Selected

-

Content of

carbohydrate

essential fatty

source(s)

acids (if added)

Reduction of

Increased

Dogs and

- Highly digestible

1 to 2 weeks

Indicate on the package,

acute intestinal

level of

cats

ingredients

container or label

absorptive

electrolytes

including their

disorders

and highly

treatment if

-

‘During periods of

digestible

appropriate

and recovery from

ingredients

- Sodium

acute diarrhea.’

- Potassium

- Source(s) of

-

‘It is recommended

mucilaginous

that a

substances (if

veterinarian’s

added)

opinion be sought

before use’.

Compensation

Highly

Dogs and

Highly digestible

3 to 12 weeks

Indicate on the package,

for

digestible

cats

ingredients including

but lifetime in

container or label

maldigestion 5

ingredients

their treatment if

case of chronic

and low level

appropriate

pancreatic

‘It is recommended that

of fat

insufficiency

a veterinarian’s opinion

be sought before use’.

Support of

Low level of

Dogs and

- Sodium

Initially up to 6

Indicate on the package,

heart function

sodium and

cats

- Potassium

months

container or label

in case of

increased

- Magnesium

chronic cardiac

K/Na ratio

‘It is recommended that

insufficiency

a veterinarian’s opinion

be sought before use or

before extending the

period of use’.

Regulation of

Low level of

Dogs and

- Carbohydrate

Initially up to 6

Indicate on the package,

glucose supply

rapid glucose-

cats

source(s)

months

container or label

(Diabetis

releasing

- Treatment of

mellitus)

carbohydrates

carbohydrate if

‘It is recommended that

appropriate

a veterinarian’s opinion

- Starch

be sought before use or

- Total sugar

before extending the

- Fructose (if added)

period of use’.

- Content of essential

fatty acids (if added)

- Source(s) of short

and medium chain

fatty acids (if added)

Support of liver

- High quality

Dogs

- Protein source(s)

Initially up to 6

Indicate on the package,

function in case

protein,

- Content of essential

months

container or label

of chronic liver

moderate

fatty acids

insufficiency

level of

- Highly digestible

‘It is recommended that

protein, high

carbohydrates

a veterinarian’s opinion

level of

including their

be sought before use or

essential fatty

treatment if

before extending the

acids and high

appropriate

period of use’.

level of highly

- Sodium

digestive

- Total copper

Indicate in the

carbohydrates.

instructions for use

‘Water should be

available at all times.’

Cats

- Protein source(s)

Initially up to 6

Indicate on the package,

- Content of essential

months

container or label

- High quality

fatty acids

protein,

- Sodium

‘It is recommended that

moderate

- Total copper

a veterinarian’s opinion

level of

be sought before use or

protein and

before extending the

high level of

period of use’.

essential fatty

acids

Indicate in the

instructions for use

‘Water should be

available at all times.’

Regulation of

Low level of

Dogs and

- Content of essential

Initially up to 2

Indicate on the package,

lipid

fat and high

cats

fatty acids

months

container or label

metabolism in

level of

- Content of n-3 fatty

case of

essential fatty

acids (if added)

‘It is recommended that

hyperlipidaema

acids

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 to 6

Indicate on the package,

copper in the

copper

months

container or label

liver

‘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 instructions for

excessive body

density

cats

body weight is

use an appropriate daily

weight

achieved

intake must be

recommended

Nutritional

High energy

Dogs and

-

Highly digestible

Until

In the case of

restoration,

density, high

cats

ingredients,

restoration is

feedingstuffs specially

convalescence 6

concentrations

including their

achieved

presented to be given

of essential

treatment if

via tubing, indicate on

nutrients and

appropriate

the package, container

highly

-

Energy value

or label

digestible

-

Content of n-3 and

ingredients

n-6 fatty acids (if

‘Administration under

added)

veterinary supervision’

Support of skin

High level of

Dogs and

Content of essential

Up to 2 months

Indicate on the package,

function in case

essential fatty

cats

fatty acids

container or label

of dermatosis

acids

and excessive

‘It is recommended that

loss of hair

a veterinarian’s opinion

be sought before use’.

Reduction of

- Low level of

Dairy cows

-

Calcium

1 to 4 weeks

Indicate in the

the risk of milk

calcium

-

Phosphorus

before calving

instructions for use

fever

-

Magnesium

‘Stop feeding after

calving’

and/or

Indicate in the

- Low

-

Calcium

1 to 4 weeks

instructions for use

cations/anions

-

Phosphorus

before calving

ratio

-

Sodium

‘Stop feeding after

-

Potassium

calving’

-

Chlorides

-

Sulphur

or

Indicate in the instructions

- High level of

Content of synthetic

The 2 weeks

for use

zeolite

sodium aluminium

before calving

(synthetic

silicate

- ‘The amount of feed shall

sodium

be restricted to ensure that

aluminium

a daily intake of 500g

silicate)

sodium aluminium-silcate

per animal is not

exceeded.’

- ‘Stop feeding after

calving’

or

Total calcium content,

Start at first

Indicate on the package,

- High level of

sources and respective

signs of

container or label

calcium in the

quantity of calcium

parturition to

- The instruction of use, i.e.

form of highly

two days

the number of applications

available

subsequent to

and the time before and

calcium salts

parturition

after calving.

- The text ‘It is

recommended that a

nutritional expert’s opinion

be sought before use’.

- Ingredients providing

Reduction of

Ingredients

Dairy cows

3 to 6 weeks

glucogenic energy

the risk of

providing

and ewes

after calving 9

sources

ketosis 7 8

gluco-genic

- Propane-1,2-diol (if

energy

Last 6 weeks

added as a glucose

sources

before and the

precursor)

first 3 weeks

- Glycerol (if added as a

after lambing 10

glucose precursor)

Ruminants

Reduction of

High level of

-

Starch

3 to 10 weeks

In the instructions for

the risk of

magnesium,

-

Total sugars

during periods

use guidance shall be

tetany

easily

-

Magnesium

of fast grass

provided on the balance

(hypomagnesae

available

-

Sodium

growth

of the daily ration, with

mia)

carbohydrates,

-

Potassium

regard to the inclusion

moderate

of fibre and easily

level of

available energy

protein and

sources.

low level of

potassium

In case of feedingstuffs

for ovines indicate on

package, container or

label

‘Especially for lactating

ewes’.

Ruminants

Reduction of

Low level of

-

Starch

Maximum 2

In the instructions for

the risk of

easily

-

Total Sugars

months 11

use guidance shall be

acidosis

fermentable

provided on the balance

carbohydrates

of the daily ration, with

and highly

regard to the inclusion

buffering

of fibre and easily

capacity

fermentable

carbohydrate sources.

In case of feedingstuffs

for dairy cows indicate

on package, container or

label

‘Especially for high

yielding cows’.

In the case of

feedingstuffs for

ruminants for fattening

indicate on the package,

container or label

‘Especially for

intensively fed’. 12

Calves

Stabilization of

Predominately

-

Carbohydrate

1 to 7 days (1

Indicate on the package,

Piglets

water and

electrolytes

source(s)

to 3 days if fed

container or label

Lambs

electrolyte

and easily

-

Sodium

exclusively)

Kids

balance

absorbable

-

Potassium

- ‘In the case of risk of,

Foals

carbohydrates

-

Chlorides

during periods of, or

recovery from digestive

disturbance (diarrhea)’.

- ‘It it recommended

that a veterinarian’s

opinion be sought

before use’.

Reduction of

Low level of

Ruminants

-

Calcium

Up to 6 weeks

Indicate on the package,

the risk of

phosphorus,

-

Phosphorus

container or label

urinary calculi

magnesium

-

Sodium

and urine

-

Magnesium

‘Especially for

acidifying

-

Potassium

intensively fed young

properties

-

Chlorides

animals.’

-

Sulphur

-

Urine acidifying

Indicate in the

substances

instructions for use

‘Water should be

available at all times.’

Reduction of

-

High

Pigs

- Magnesium

1 to 7 days

Guidance shall be

stress reactions

level of

provided on the

magnesiu

situation in which the

m

use of this feed is

appropriate.

and/or

- Highly digestible

-

Highly

ingredients including

digestible

their treatment if

ingredien

appropriate

ts

- Content of n-3 fatty

acids if added

- Highly digestible

Stabilization of

- Low

Piglets

2 to 4 weeks

Indicate on the package,

ingredients including their

physiological

buffering

container or label

treatment if appropriate

digestion

capacity, and

- Buffering capacity

highly

‘In case of risk of,

- Source(s) of astringent

digestible

during periods of, or

substances (if added)

ingredients

recovery from, digestive

- Source(s) of

disturbance.’

mucilaginous substances

(if added)

- Highly digestible

Pigs

ingredients including their

treatment if appropriate

- Highly

- Source(s) of astringent

digestible

substances (if added)

- Source(s) of

ingredients

mucilaginous substances

B

(if added)

Reduction of

Ingredients

Sows

Ingredients stimulating

10 to 14 days

the risk of

stimulating

intestinal passage

before and 10

constipation

intestinal

to 14 days after

passage

farrowing.

Reduction of

Low energy

Laying

-

Energy value

Up to 12 weeks

the risk of fatty

and high

hens

(calculated

liver syndrome

proportion of

according to EEC

metabolisable

method)

energy from

-

Percentage of

lipids with

metabolisable

high level of

energy form lipids

poly-

-

Content of the

unsaturated

polyunsaturated

fatty acids.

fatty acids

Compensation

Low level of

Poultry

-

Percentage of

During the first

for mal-

saturated fatty

excluding

saturated fatty

2 weeks after

absorption

acids and high

geese and

acids in relation to

hatching

level of fatty

pigeons

total fatty acids

soluble

-

Total vitamin A

vitamins

-

Total vitamin D

-

Total vitamin E

-

Total vitamin K

Equines 13

Compensation

Highly

- Source(s) of highly

Initially up to

Guidance should be

for chronic

precaecally

digestible

six months

provided on the

insufficiency of

digestible

carbohydrates, proteins

situations in which the

small intestine

carbohydrates,

and fats, including their

use of the feed is

function

protein and

treatment if appropriate.

appropriate and the

fats.

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’.

Equines

Compensation

Highly

-

Fibre source(s)

Initially up to

Guidance should be

for chronic

digestible

-

Content of n-3

six months

provided on the

digestive

fibre

fatty acids (if

situations in which the

disorders of

added)

use of the feed is

large intestine

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’.

Equines

Reduction of

Highly

-

Magnesium

Two to four

Guidance shall be

stress reactions

digestible

-

Highly digestible

weeks

provided on the precise

ingredients

ingredients

situation in which the

including their

use of the feed is

treatment if

appropriate.

appropriate

-

Content of n-3

fatty acids (if

added)

Equines

Guidance shall be provided

Compensation

Predominantly

-

Calcium

One to three

on the situations in which

of electrolyte

electrolyte

-

Sodium

day

the use of the food is

loss in cases of

and easily

-

Magnesium

appropriate.

heavy sweating

absorbable

-

Potassium

carbohydrates

-

Chlorides

When the feed corresponds

-

Glucose

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’

Equines

Guidance shall be provided

Nutritional

High

-

Highly digestible

Until

on the situations in which

restoration,

concentration

ingredients

restoration is

the use of the feed is

convalescence

of essential

including their

achieved

appropriate.

nutrients and

treatment if

highly

appropriate

In the case of feedingstuffs

digestible

specially presented to be

ingredients

-

Contents of n-3

given via tubing, indicate

and n-6 fatty acids

on the packages, container

or label

(if added)

‘Administration under

veterinary supervision’

B

Equines

Guidance shall be provided

Nutritional

High

-

Highly digestible

Until

on the situations in which

restoration,

concentration

ingredients

restoration is

the use of the feed is

convalescence

of essential

including their

achieved

appropriate.

nutrients and

treatment if

highly

appropriate

In the case of feedingstuffs

digestible

specially presented to be

ingredients

-

Contents of n-3

given via tubing, indicate

and n-6 fatty acids

on the packages, container

or label

(if added)

‘Administration under

veterinary supervision’

Equines

Support of liver

Low level of

-

Protein and fibre

Initially up to

Guidance should be

function in case

protein but of

sources

six months

provided on the manner

of chronic liver

high quality

-

Highly digestible

in which the feed should

insufficiency

and highly

carbohydrates

be fed including many

digestible

including their

small meals per day.

carbohydrates

treatment if

appropriate

Indicate on the package,

-

Methionine

container or label

-

Choline

-

Content of n-3

‘It is recommended that

fatty acids (if

a veterinarian’s opinion

added)

be sought before use or

before extending the

period of use’.

Equines

Support of

Low level of

-

Protein source(s)

Initially up to

Indicate on the package,

renal function

protein but of

-

Calcium

six months

container or label

in case of

high quality

-

Phosphorus

chronic renal

and low level

-

Potassium

‘It is recommended that

insufficiency

of phosphorus

-

Magnesium

a veterinarian’s opinion

-

Sodium

be sought before use or

before extending the

(1)

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

period of use’.

(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.

Indicate on the

(4)

In case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace ‘ingredient and nutrient’.

The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine pancretic insufficiency’. instructions for use

(5)

(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’.

‘Water should be

(8)

The manufacturers may also recommend the use of ketosis recuperation.

available at all times’

(9)

In the case of feedingstuffs for dairy cows.

(10)

In the case of feedingstuffs for ewes.

(11)

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

(12)

Indicate the category of ruminants concerned.

(13)

In the 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.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press