Legislator Case Law & Legislation
sl_437.74 MT

FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

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Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

FEEDINGSTUFFS INTENDED FOR

PARTICULAR NUTRITIONAL PURPOSES

SUBSIDIARY LEGISLATION 437.74

FEEDINGSTUFFS INTENDED FOR

PARTICULAR NUTITIONAL PURPOSES

RULES *

21st June, 2005

LEGAL NOTICE 231 of 2005.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

(1) The title of these rules is the Feedingstuffs intended for

Particular Nutritional Purposes Rules.

(2) These rules concern feedingstuffs intended for particular

nutritional purposes.

(3) Feedingstuffs intended for particular nutritional purposes

may be marketed only if -

(a) they fulfil the conditions referred to in rule 3,

(b) they are labelled in accordance with the provisions laid

down in rule 5,

(c) their intended uses are included in the list drawn up

pursuant to rule 6 and they fulfil the other provisions

laid down in that list.

(4) The Veterinary Services shall ensure that the provisions

under "General provisions" of Part A of the Schedule are complied

with.

(5) The scope of these rules is to implement the rules found

under European Union Council Directive 93/74/EEC as amended

by European Union Council Directive 96/25/EC, European Union

Directive 2000/16/EC, European Union Council Directive 1999/29/

EC, European Union Council Regulation (EC) No 806/2003. Annex

A and B to European Commission Directive 94/39/EC, establishing

a list of intended uses of animal feedingstuffs for particular

nutritional purposes are hereby included in the Schedule.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

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(s) used must be in Regulation (EC) No 1831/2003 of the European

Parliament and of the Council corresponding to the specified essential characteristic.

3. Where the source(s) of ingredients or of analytical constituents is (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 in Regulation (EC) No 1831/2003 of the

European Parliament and of the Council, the total quantity of the substance naturally

present and the amount added as an additive.

5. The declarations required in column 4 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.

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

concerning analytical constituents and additives must be quantitative.

7. 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.

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

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

9. 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 of Animal Feedingstuffs for Particular Nutritional Purposes

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

S u p p o r t o f R e n a l - Low level of D o g s a n d -

Protein source(s) Initially up Indicate on the

Function in case of p h o s p h o r u s a n d Cats

to 6 months p a c k a g e ,

-

Calcium

(2)

c h ro n ic a n d re n al restricted level of

container or

insufficiency

protein but of

-

Phosphorus

label: "It is

high quality

recommended

-

Potassium

that

a

- Sodium

veterinarian’s

opinion be

- Content

of

sought before

essential fatty acids

extending the

period of use"

Indicate in the

instructions for

u s e : " Wa t e r

should

be

available at all

times."

D i s s o l u t i o n o f - Urine

Dogs

- Protein source(s) 5 t o

1 2 Indicate in the

struvite stones (4)

acidifying

weeks

instructions for

- Calcium

properties, low

u s e : " Wa t e r

level

of

- Phosphorus

should

be

magnesium, and

available at all

- Sodium

restricted level of

times."

protein but of

- Magnesium

Indicate on the

high quality

- Potassium

package,

container or

- Chlorides

label: "It is

- Sulphur

recommended

that

a

- Urine acidifying

veterinarian’s

substances

opinion be

sought before

use."

- Urine

Cats

- Calcium

acidifying

- Phosphorus

properties and

low level of

- Sodium

magnesium

- Magnesium

- Potassium

- Chlorides

- Sulphur

- Total taurine

- Urine acidifying

substances

Reduction

o f Urine acidifying D o g s a n d - Calcium

Up to

6 Indicate on the

struvite

s t o n e p r o p e r t i e s a n d cats

months

package,

- Phosphorus

recurrence (4)

moderate level of

container or

magnesium

- Sodium

label: "It is

recommended

- Magnesium

that

a

- Potassium

veterinarian’s

opinion be

-

Chlorides

sought before

-

Sulphur

use."

- Urine acidifying

substances

Recommen-

Essential

Species or

Labelling

ded length

Other

Particular

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

Reduction of urate L o w l e v e l o f D o g s a n d Protein source(s)

U p t o 6 Indicate on the

stones formation

purines, low level cats

months but p a c k a g e ,

of protein but of

lifetime use c o n t a i n e r o r

high quality

in cases of label: "It i s

irreversible recommended

disturbance t h a t

a

of uric acid veterinarian’s

metabolism o p i n i o n b e

sought before

use."

Reduction

of Low level of Dogs and -

Phosphorus

Up to

6 Indicate on the

oxalate

stones calcium,

l o w cats

months

package,

-

Calcium

formation

level of vitamin

container or

D, and urine

-

Sodium

label: "It is

alkalising

recommended

-

Magnesium

properties

that

a

-

Potassium

veterinarian’s

opinion be

- Chlorides

sought before

- Sulphur

use."

- Total vitamin D

- Hydroxyproline

- Urine alkalising

substances

Reduction

o f L o w l e v e l o f D o g s a n d - Total

sulphur Initially up Indicate on the

cystine

s t o n e s protein, moderate cats

amino acids

to 1 year

package,

formation

l e v e l o f sul phu r

container or

-

Sodium

amino acids, and

label: "It is

urine alkalising

- Potassium

recommended

properties

that

a

- Chlorides

veterinarian’s

- Sulphur

opinion be

sought before

- Urine alkalising

use or before

substances

extending the

period of use."

Reduction

o f - Selected

D o g s a n d - Protein source(s) 3

to

i n g r e d i e n t a n d protein source(s) cats

weeks: if

- Content

of

nutrient

and/or

essential fatty acids s i g n s

of

intolerances (5)

intolerance

- Selected

(if added)

disappear

carbohydrate

- Carbohydrate

this feed can

source(s)

source(s)

be

used

indefinitely

- Content

of

essential fatty acids

(if added)

Reduction of acute Increased level of D o g s a n d - Highly

1 to 2 weeks Indicate on the

intestinal

elec trolytes a nd cats

digestible

package,

absorptive

highly digestible

ingredients

container or

disorders

ingredients

including their

label

treatment

if

- "During

appropriate

periods of and

- Sodium

recovery from

acute

- Potassium

diarrhoea."

- Source(s)

of

- "It

is

mucilaginous

recommended

substances

(if

that

a

added)

veterinarian’s

opinion be

sought before

use."

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

Compensation for Highly digestible D o g s a n d H i g h l y d i g e s t i b l e 3 t o 1 2 Indicate on the

maldigestion (6)

i n g r e d i e n t s a n d 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

insuffi-

veterinarian’s

ciency

opinion be

sought before

use."

S u p p o r t o f h e a r t L o w l e v e l o f D o g s a n d - Sodium

Initially up Indicate on the

function in case of s o d i u m

a n d cats

to 6 months p a c k a g e ,

- Potassium

c h r o n i c ca r d ia c increased K/Na

container or

insufficiency

ratio

- Magnesium

label: "It is

recommended

that

a

veterinarian’s

opinion be

sought before

use or before

extending the

period of use."

Regulation

o f L o w l e v e l o f D o g s a n d - Carbohydrate

Initially up Indicate on the

g l u c o s e s u p p l y r a p i d g l u c o s e - cats

source(s)

to 6 months p a c k a g e ,

(Diabetes mellitus) r e l e a s i n g

container or

-

Treatment

of

carbohydrates

label: "It is

carbohydrates if

recommended

appropriate

that

a

- Starch

veterinarian’s

opinion be

- Total sugar

sought before

- Fructose

(if

use or before

added)

extending the

period of use."

- Content

of

essential fatty acids

(if added)

- Source(s)

of

short and medium

chain fatty acids (if

added)

S u p p o r t o f l i v e r - High

quality Dogs

- Protein source(s) Initially up Indicate on the

function in case of protein, moderate

of to 6 months

package,

- Content

chronic

l i v e r level of protein,

container or

essential fatty acids

insufficiency

high level of

label: "It is

essential fatty

- Highly

recommended

acids and high

digestible

that

a

level of highly

carbohydrates

veterinarian’s

digestible

including their

opinion be

carbohydrates

treatment

if

sought before

appropriate

use or before

extending the

- Sodium

period of use."

- Total copper

Indicate in the

instruction for

u s e : " Wa t e r

should

be

available at all

times"

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

- High

quality Cats

- Protein source(s) Initially up Indicate on the

protein, moderate

to 6 months p a c k a g e ,

- Content

of

level of protein,

container or

essential fatty acids

moderate level of

label: "It is

fat and high level

- Sodium

recommended

of essential fatty

that

a

- Total copper

acids

veterinarian’s

opinion be

sought before

use or before

extending the

period of use."

Indicate in the

instruction for

u s e : " Wa t e r

should

be

available at all

times"

Regulation of lipid Low level of fat D o g s a n d - Content

of Initially up Indicate on the

metabolism in case and high level of cats

essential fatty acids to 2 months p a c k a g e ,

of hyperlipidaemia e s s e n t i a l f a t t y

container or

- Content of n-3

acids

label: "It is

fatty acids (if

recommended

added)

that

a

veterinarian’s

opinion be

sought before

use or before

extending the

period of use."

Reduction

of Low level

o f Dogs

Total copper

Initially up Indicate on the

copper in the liver copper

to 6 months p a c k a g e ,

container or

label: "It is

recommended

that

a

veterinarian’s

opinion be

sought before

use or before

extending the

period of use."

Reduction

o f - Low

energy D o g s a n d - Energy

value Until target I n

the

e x c e s s i v e b o d y density

cats

(calculated

body weight instructions for

weight

a c c o r d i n g t o E C is achieved u s e

an

method)

appropriate

daily intake

must

be

recommended

Nutritional

- High

energy D o g s a n d - Highly

Until

In the case of

restoration,

d e n s i t y, h i g h l y cats

digestible

r e s t o r a t i o n f e e d i n g s t u ff s

convalescence

concentrations of

ingredients,

is achieved s p e c i a l l y

essential nutrients

including their

presented to be

and

highly

treatment

if

given

via

digestible

appropriate

tubing,

ingredients

indicate on the

- Energy

value

package,

(calculated

container or

according to EC

label

method)

"Administra-

- Content of n-3

tion

under

and n-6 fatty acids

veterinary

(if added)

supervision"

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

reference to "Feline hepatic lipidosis".

Recommen-

Essential

Species or

Labelling

ded length

Other

Particular

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

R e d u c t i o n o f t h e - Low level of Dairy cows - Calcium

1 to 4 weeks Indicate in the

risk of milk fever

calcium and/or

before

instructions for

- Phosphorus

calving

use

"Stop

- Magnesium

feeding after

calving."

- Low cations/

- Calcium

anions ratio

- Phosphorus

- Sodium

- Potassium

- Chlorides

- Sulphur

Reduction of the Ingredients

Dairy cows - ingredients

3 to 6 weeks

risk of ketosis (7) (8) p r o v i d i n g

and ewes

providing

after calving

(9)

glucogenic energy

glucogenic energy

. Last 6

sources

sources

weeks

before and

- Propane-1,2-diol

(if added as a the first 3

weeks after

glucose precursor) lambing (10)

- Glycerol

(if

added as a glucose

precursor)

R e d u c t i o n o f t h e H i g h l e v e l o f Ruminants

- Starch

3 to 10 In

the

risk of tetany magnesium,

weeks

instructions for

- Total sugars

(hypomagnesaemia) e a s i l y a v a i l a b l e

during

use guidance

carbohydrates,

- Magnesium

periods of shall

be

moderate level of

fast grass provided on

- Sodium

protein and low

growth

the balance of

level of potassium

- Potassium

the

daily

ration, with

regard to the

inclusion of

fibre

and

easily

available

energy

sources.

In case of

f e e d i n g s t u ff s

for

ovines

indicate on the

package,

container or

label

"Especially for

lactating

ewes."

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

R e d u c t i o n o f t h e L o w l e v e l o f Ruminants

- Starch

Maximum 2 I n

the

months (11) instructions for

risk of acidosis

easily

- Total sugars

fermentable

use guidance

carbohydrates and

shall

be

high buffering

provided on

capacity

the balance of

the

daily

ration, with

regard to the

inclusion of

fibre

and

easily

fermentable

carbohydrate

sources.

In case of

f e e d i n g s t u ff s

for dairy cows

indicate on the

package,

container or

label

"Especially for

high yielding

cows."

In case of

f e e d i n g s t u ff s

for ruminants

for fattening

indicate on the

package,

container or

label

"Especially for

intensively

fed..." (12)

S t a b i l i s a t i o n o f P r e d o m i n a n t l y Calves

- Carbohydrate

1 t o 7 d a y s Indicate on the

water

a n d elec trolytes a nd

source(s)

(1 to 3 days p a c k a g e ,

Piglets

electrolyte balance easily absorbable

if

fed container or

- Sodium

carbohydrates

Lambs

exclusively) label: "In case

- Potassium

of risk of,

Kids

during periods

-

Chlorides

Foals

of, or recovery

from digestive

disturbance

(d iarrh oea). -

It

is

recommended

that

a

veterinarian’s

opinion be

sought before

use."

Recommen-

Essential

Species or

Labelling

ded length

Other

Particular

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

R e d u c t i o n o f t h e L o w l e v e l o f Ruminants

- Calcium

Up to

6 Indicate on the

risk of urinary phosphorus,

weeks

package,

- Phosphorus

calcull

magnesium, and

container or

urine acidifying

- Sodium

label

properties

"Especially for

- Magnesium

intensively fed

- Potassium

young

animals"

- Chlorides

Indicate in the

- Sulphur

instructions for

- Urine acidifying

u s e : " Wa t e r

substances

should

be

available at all

times."

Reduction of stress - High

level Pigs

- Magnesium

1 to 7 days

Guidance shall

reactions

magnesium and/

be provided on

- Highly

or

the situation in

digestible

which the use

- Highly

ingredients

of this feed is

digestible

including their

appropriate.

ingredients

treatment

if

appropriate

- Content of n-3

fatty acids (if

added)

S t a b i l i s a t i o n o f - Low buffering Piglets

- Highly

2 to 4 weeks Indicate on the

physiological

c a p a c i t y, a n d

digestible

package,

digestion

highly digestible

ingredients

container or

ingredients

including their

label: "In case

treatment

if

of risk of,

appropriate

during periods

of, or recovery

- Buffering

from, digestive

capacity

disturbance."

- Source(s)

of

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

risk of constipation s t i m u l a t i n g

stimulating

days before

intestinal passage

intestinal passage

and 10 to 14

days after

farrowing

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

R e d u c t i o n o f t h e Low energy and Laying hens - Energy

value U p t o

risk o f fatty live r high proportion of

(calculated

weeks

syndrome

metabolizable

according to EEC

energy

from

method)

lipids with h igh

- Percentage

of

level

of

metabolisable

polyunsaturated

energy from lipids

fatty acids

- Content

of

polyunsaturated

fatty acids

Compensation for L o w l e v e l o f P o u l t r y

- Percentage

of D u r i n g t h e

malabsorption

s a t u r a t e d f a t t y e x c l u d i n g saturated fatty acids first 2 weeks

a c i d s a n d h i g h g e e s e a n d in relation to total a f t e r

l e v e l o f f a t pigeons

fatty acids

hatching

soluble vitamins

- Total vitamin A

- Total vitamin D

- Total vitamin E

- Total vitamin K

Equines (2)

- Source(s)

of Initially up G u i d a n c e

Compensation for - Highly

chronic

precaecally

highly digestible t o

six should

be

insufficiency of digestible

c a r b o h y d r a t e s , months

provided on

small intestine carbohydrates,

proteins and f ats,

the situations

function

proteins and fats

including their

in which the

treatment

if

use of the feed

appropriate

is 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"

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

Compensation for - Highly

Equines

- Fibre source(s)

Initially up G u i d a n c e

c h r o n i c d i g e s t i v e digestible fibre

- Content of n-3 t o

six should

be

disorders of large

months

provided on

fatty acids (if

intestine

the situations

added)

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 stress - Highly

Equines

- Magnesium

Two to four Guidance shall

reactions

digestible

weeks

be provided on

- Highly

ingredients

the precise

digestible

situations in

ingredients

which the use

including their

o f th e f eed is

treatment

if

appropriate

appropriate

- Content of n-3

fatty acids (if

added)

C o m p e n s a t i o n o f P r e d o m i n a n t l y Equines

- Calcium

One to three Guidance shall

electrolyte loss in ele ctr oly te s an d

days

be provided on

- Sodium

c a s e s o f h e a v y easily absorbable

the situations

sweating

carbohydrates

- Magnesium

in which the

use of the feed

- Potassium

is appropriate

- Chlorides

When the feed

- Glucose

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

u s e : " Wa t e r

should

be

available at all

times"

Recommen-

Essential

Species or

Particular

Labelling

ded length

Other

nutritional

category of

nutritional purpose

declarations

of time for

provisions

characteristics

animals

use

Nutritional

- High

Equines

- Highly

Until

Guidance shall

restoration,

concentration of

digestible

r e s t o r a t i o n be provided on

convalescence

essential nutrients

ingredients,

is achieved the situations

and

highly

including their

in which the

digestible

treatment

if

use of the feed

ingredients

appropriate

is appropriate

- Content of n-3

In the case of

and n-6 fatty acids

f e e d i n g s t u ff s

(if added)

specially

presented to be

given

via

tubing,

indicate on the

package,

container or

label

"Administra-

tion

under

veterinary

supervision"

S u p p o r t o f l i v e r L o w l e v e l o f Equines

- Protein and fibre Initially tip G u i d a n c e

function in case of p r o t e i n b u t o f

sources

to

six should

be

chronic

l i v e r high quality and

months

provided on

- Highly

insufficiency

highly digestible

the manner in

digestible

carbohydrates

which the feed

carbohydrates

should be fed

including their

including

treatment

if

many small

appropriate

meals per day

- Methionine

Indicate on the

- Choline

package,

container or

- Content of n-3

label: "It is

fatty acids (if

recommended

added)

that

a

veterinarian’s

opinion be

sought before

use or before

extending the

period of use"

S u p p o r t o f r e n a l L o w l e v e l o f Equines

- Protein source(s) Initially up Indicate on the

function in case of p r o t e i n b u t o f

to

six package,

- Calcium

chronic

r e n a l high quality and

months

container or

insufficiency

low level of

- Phosphorus

label: "It is

phosphorus

recommended

- Potassium

that

a

- Magnesium

veterinarian’s

opinion be

- Sodium

sought before

use or before

extending the

period of use."

Indicate in the

instructions for

u s e : " Wa t e r

should

be

available at all

times."

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.

(2)

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

(3)

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

use shall be two to four weeks.

(4) In case of feedingstuffs for cats, "feline lower urinary tract disease" or "feline urological syndrome

- F.U.S." may complete the particular nutritional purpose.

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

"ingredient and nutrient".

(6)

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

pancreatic insufficiency".

(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.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

For the purposes of these rules, the following definitions

shall apply -

(a) "the Commission" means the European Commission;

(b) "compound feedingstuffs" means mixtures of feed

materials, whether or not containing additives, which

are intended for oral animal feeding as complete or

complementary feedingstuffs;

(c) "feedingstuffs" means products of vegetable or animal

origin in their natural state, fresh or preserved, and

products derived from the industrial processing

thereof, and organic or inorganic substances, used

singly or in mixtures, whether or not containing

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

FEEDINGSTUFFS INTENDED FOR

PARTICULAR NUTRITIONAL PURPOSES

additives, for oral animal feeding;

(d) "feedingstuffs intended for particular nutritional

purposes" means compound feedingstuffs which, by

virtue of their particular composition or method of

manufacture, can be clearly distinguished from both

ordinary feedingstuffs and the products defined in

European Union Council Directive 90/167/EEC laying

down the conditions governing the preparation,

placing on the market and use of medicated

feedingstuffs, and are presented as intended to meet

specific nutritional requirements;

(e) "particular nutritional purpose" means the purpose of

satisfying the specific nutritional needs of certain pets

or productive livestock whose process of assimilation,

absorption or metabolism could be temporarily

impaired or is temporarily or irreversibly impaired and

are therefore able to derive benefit from ingestion of

feedingstuffs appropriate to their condition;

(f)

"Veterinary Services" means the competent authority

within Malta as established under article 2 of the

Veterinary Services Act.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

The nature of composition of the feedingstuffs referred to

in rule 1(2) shall be such that the products are appropriate for their

intended particular nutritional purpose.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

These rules shall apply, subject to the specific provisions

laid down therein, without prejudice to the legal provisions on -

(a) compound feedingstuffs;

(b) additives used in feedingstuffs;

(c) undesirable

substances

and

products

in

animal

nutrition;

(d) certain products used in animal nutrition.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

(1) In addition to the labelling provisions in Article 5 of

European Union Council Directive 79/373/EEC on the marketing

of compound feedingstuffs it is expressively required that the

following additional indications appear in the space provided for

the purpose on the packaging, on the container or on the label of the

feedingstuffs referred to in rule 1(2) -

(a) the qualifying expression "dietetic" together with the

description of the feedingstuff;

(b) the precise use, i.e. the particular nutritional purpose;

(c) the

indication

of

the

essential

nutritional

characteristics of the feedingstuffs;

(d) the declarations prescribed in column 4 in the

Schedule concerning the particular nutritional

purpose;

FEEDINGSTUFFS INTENDED FOR

PARTICULAR NUTRITIONAL PURPOSES

(e) the recommended length of time for use of the

feedingstuff.

The indications referred to in paragraphs (a) to (e) must comply

with the content of the list of intended uses in the Schedule and the

general provisions to be laid down in accordance with rule 6(b).

(2) Indications other than those referred to in sub-rule (1) may

be supplied in the space provided for the purpose, in so far as they

are covered by rule 6(a).

(3) Without prejudice to Article 5e of European Union Council

Directive 79/373/EEC, the labelling of feedingstuffs as referred to

in rule 1(2) may make reference to a specific pathological condition

in so far as that condition corresponds to the nutritional purpose

laid down in the list of uses drawn up in accordance with rule 6(a).

(4) The label or the directions for use of the feedingstuffs

referred to in rule 1(2) must bear the indication "It is recommended

that a specialist’s opinion be sought before use".

It may, however, be provided in the list of intended uses in

the Schedule that this declaration shall be replaced for specific

dietetic feedingstuffs with a recommendation to request the prior

opinion of a veterinarian.

(5) The provisions of Article 5c (5) of European Union Council

Directive 79/373/EEC shall also apply to the feedingstuffs referred

to in rule 1(2) and intended for animals other than pets.

(6) The labelling of the feedingstuffs referred to in rule 1(2)

may also highlight the presence or the low level of one or more

analytical constituents which are essential for the description of the

feedingstuff. In such cases, the minimum or maximum level of the

analytical constituents expressed as percentage weight of the

feedingstuff must be clearly indicated in the list of declared

analytical constituents.

(7) The qualifying expression "dietetic" shall be reserved

solely for feedingstuffs as referred to in rule 1(2). Qualifying

expressions other than "dietitic" shall be prohibited in the labelling

and presentation of these feedingstuffs.

(8) Notwithstanding the provisions of Article 5c (3) of

European Union Council Directive 79/373/EEC, the declaration of

feed materials may be made in the form of categories grouping

several feed materials, even where the declaration of certain feed

materials by their specific name is required to justify the nutritional

characteristics of the feedingstuff.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

Pursuant to the procedure laid down in Article 9 to

European Union Council Directive 93/74/EEC -

(a) a list of intended uses shall be established in

accordance with the Schedule. That list shall contain -

(i)

the indications referred to in rule 5(1)(b), (c), (d)

and (e), and

(ii) where appropriate, the indications referred to in

rule 5(2) and (4), second paragraph;

FEEDINGSTUFFS INTENDED FOR

PARTICULAR NUTRITIONAL PURPOSES

(b) general provisions regarding the application of the

indications referred to in paragraph (a), including

applicable tolerances, may be established;

(c) the measures adopted in accordance with paragraphs

(a) and (b) may be modified, following developments

in scientific and technical knowledge.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

In Malta, feedingstuffs as referred to in rule 1(2) are not,

for reasons concerning the provisions of these rules, subject to

marketing restrictions other than those provided for in these rules.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

(1) Where it is established that the use of a feedingstuff as

referred to in rule 1(2) or its use in the prescribed conditions

presents a hazard for animal or human health or for the

environment, the Veterinary Services shall immediately inform the

relevant European Union Commission, giving the reasons for its

decision.

(2) Appropriate measures shall be implemented as soon as

possible according to decisions adopted by the European

Commission.

Laws of Malta — Subsidiary Legislation 437.74 — FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTITIONAL PURPOSES RULES *

To allow effective official inspection of feedingstuffs as

referred to in rule 1(2), the following specific provisions shall

apply

(a) the Veterinary Services shall make all necessary

arrangements

for

official

inspection

during

manufacture or marketing, at least by sampling, in

order to ensure compliance with the requirements of

these rules; and

(b) where appropriate, the Veterinary Services shall be

empowered to require the person responsible for

placing the product on the market to produce data and

information establishing the feedingstuff’s conformity

with these rules. If such data have been published in

readily accessible form, a reference to the publication

shall suffice.

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