Nutritional Purposes Rules, 2005 (ln_2005_70) | MT

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Preamble — Nutritional Purposes Rules, 2005 Open official source

L.N. 70 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

List of Intended Uses of Animal Feedingstuffs for Particular

Nutritional Purposes Rules, 2005

IN exercise of the powers conferred under the article 26 of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment has made the following rules>–

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 1 — Nutritional Purposes Rules, 2005 Open official source

(1) The title of these rules is the List of Intended Uses of Title and scope.

Animal Feedingstuffs for Particular Nutritional Purposes Rules, 2005.

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

under European Union Commission Directive 94#39#EEC establishing

a list of intended uses of animal feedingstuffs for particular nutritional

purposes.

For the purpose of these rules>

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Schedule — Nutritional Purposes Rules, 2005 Open official source

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

authorized in European Union Council Directive 70/524/EEC as 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 mu st 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.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 2 — Nutritional Purposes Rules, 2005 Open official source

Definitions.

“the competent authority” means the Veterinary Services

within Malta as provided under article 2 of the Veterinary Services

Act<

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 3 — Nutritional Purposes Rules, 2005 Open official source

(1) Feedingstuffs intended for particular nutritional purposes Marketing of

feedingstuffs

within the meaning of European Union Council Directive 93#74#EEC intended for

shall be marketed in Malta only if their intended uses are included in particular nutritional

purposes.

Part B of the Schedule to these rules and if they fulfil the other provisions

laid down in that Part of the Schedule.

(2) The competent authority shall ensure that the provisions

under the ‘General provisions’ of Part A of the Schedule are complied

with.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 4 — Nutritional Purposes Rules, 2005 Open official source

Where the declaration of a substance, also authorized 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 European Union Directive 70/524/EEC,the total quantity of

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

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 5 — Nutritional Purposes Rules, 2005 Open official source

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.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 6 — Nutritional Purposes Rules, 2005 Open official source

The declarations to be given in accordance with column 4 of Part B concerning analytical constituents and

additives must be quantitative.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 7 — Nutritional Purposes Rules, 2005 Open official source

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.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 8 — Nutritional Purposes Rules, 2005 Open official source

Where a feedingstuff is intended to meet more than one particular nutritional purpose, it must comply with

the corresponding entries in Part B.

Malta Government Gazette — Legal Notice 2005 70 — Nutritional Purposes Rules, 2005

Reg. 9 — Nutritional Purposes Rules, 2005 Open official source

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.

‘Water should be available at all times.’

‘It is recommended that a veterinarian's

opinion be sought before use or before

Indicate on the package, container or

Indicate in the instructions for use

opinion be sought before use’.

extending the period of use’.

Other provisions

label

length of time for

Initially up to 6

Recommended

5 to 12 weeks

months 2

use

Urine acidifying substances

Contents of essential fatty

List of intended uses

Labelling declarations

Protein source(s)

acids (if added)

PART B

Total taurine

Magnesium

Phosphorus

Potassium

Chlorides

Calcium

Sodium

Sulphur

-

category of

Species or

Dogs and

animals

Dogs

Cats

cats

Low level of phosphorus and

properties, low level

restricted level of protein but

level of magnesium

of magnesium, and

protein but of high

properties and low

restricted level of

Urine acidifying

Essential nutritional

quality

of high quality

characteristics

-

Dissolution of struvite

Particular nutritional

function in case of

Support of renal

insufficiency 1

chronic renal

purpose

stones 3

‘It is recommended that a veterinarian's

opinion be sought before use or before

Indicate on the package, container or

opinion be sought before use’.

extending the period of use’.

label

Up to 6 months but

disturbance of uric

acid metabolism

Up to 6 months

Initially up to 1

lifetime use in

irreversible

cases of

year

Urine acidifying substances

Urine alkalizing substances

Total sulphur amino acids

Total Vitamin D

Hydroxyproline

Protein source(s)

Magnesium

Phosphorus

Potassium

Chlorides

Calcium

Sodium

Sulphur

-

Dogs and

cats

level of Vitamin D and urine

Urine acidifying properties

level of protein but of high

Low level of calcium, low

Low level of purines, low

moderate level of sulphur

amino acids and urine

and moderate level of

Low level of protein,

alkalizing properties

magnesium

quality

Reduction of struvite

Reduction of oxalate

Reduction of cystine

Reduction of urate

stone recurrence 3

stones formation

‘During periods of and recovery

veterinarian's opinion be sought

‘It is recommended that a veterinarian's

opinion be sought before use or before

Indicate on the package, container or

‘It is recommended that a

opinion be sought before use’.

from acute diarrhea.’

extending the period of use’.

-

before use’.

label

-

signs of intolerance

disappear this feed

chronic pancreatic

lifetime in case of

3 to 12 weeks but

3 to 8 weeks: if

Initially up to 6

insufficiency

1 to 2 weeks

can be used

indefinitely

months

- Treatment of carbohydrates

- Source(s) of mucilaginous

ingredients including their

Highly digestible ingredients

medium chain fatty acids

- Content of essential fatty

including their treatment if

- Carbohydrate source(s)

- Content of essential fatty

treatment if appropriate

- Source(s) of short and

- Carbohydrate source(s)

substances (if added)

- Fructose (if added)

- Highly digestible

acids (if added)

- Protein source(s)

if appropriate

- Magnesium

- Total sugar

- Potassium

(if added)

appropriate

- Sodium

- Starch

Dogs and

cats

Increased level of electrolytes

Highly digestible ingredients

Low level of rapid glucose

Selected protein

Low level of sodium and

releasing carbohydrates

carbohydrate

and highly digestible

increased K/Na ratio

and low level of fat

source(s)

Selected

ingredients

-

ingredient and nutrient

Regulation of glucose

intestinal absorptive

Reduction of acute

function in case of

Compensation for

supply (Diabetis

Support of heart

chronic cardiac

maldigestion 5

intolerences 4

insufficiency

Reduction of

disorders

mellitus)

In the instructions for use an appropriate

‘Water should be available at all times.’

‘It is recommended that a veterinarian's

opinion be sought before use or before

Indicate on the package, container or

daily intake must be recommended

Indicate in the instructions for use

extending the period of use’.

label

weight is achieved

Until target body

Initially up to 6

Initially up to 2

Initially up to 6

months

- Content of n-3 fatty acids

- Content of essential fatty

carbohydrates including

according to EC method)

Energy value (calculated

- Highly digestible

- Protein source(s)

their treatment if

- Total copper

appropriate

(if added)

Total copper

- Sodium

acids

Dogs and

Dogs

Cats

cats

moderate level of protein and

level of essential fatty acids

high level of essential fatty

moderate level of protein,

Low level of fat and high

acids and high level of

High quality protein,

Low level of copper

Low energy density

highly digestive

carbohydrates

acids

Reduction of excessive

Reduction of copper in

metabolism in case of

Regulation of lipid

function in case of

hyperlipidaemia

Support of liver

insufficiency

chronic liver

body weight

the liver

presented to be given via tubing, indicate

‘It is recommended that a veterinarian's

Indicate on the package, container or

In the case of feedingstuffs specially

Indicate in the instructions for use

on the package, container or label

‘Administration under veterinary

opinion be sought before use’.

‘Stop feeding after calving’.

supervision’

label

1 to 4 weeks before

before and the first

Until restoration is

3 to 6 weeks after

Up to 2 months

3 weeks after

Last 6 weeks

lambing 10

achieved

calving 9

calving

Content of essential fatty acids

Ingredients providing

Glycerol (if added as

ingredients, including their

a glucose precursor)

according to EC method)

Propane-1,2-diol(if

- Energy value (calculated

added as a glucose

glucogenic energy

treatment if appropriate

- Content of n-3 and n-6

fatty acids (if added)

Magnesium

Phosphorus

- Highly digestible

Potassium

precursor)

Chlorides

Calcium

Sodium

Sulphur

sources

-

Dairy cows

Dogs and

and ewes

cats

High level of essential fatty

Ingredients proving gluco-

- Low cations/anions ratio

concentrations of essential

High energy density, high

- Low level of calcium

genic energy sources

nutrients and highly

ingredients

and/or

digestible

acids

Nutritional restoration,

excessive loss of hair

Reduction of the risk

of dermatosis and

function in case

Support of skin

convalescence 6

of milk fever

of ketosis 7 8

‘In case of risk of, during periods

fibre and easily fermentable carbohydrate

fibre and easily available energy sources.

veterinarian's opinion be sought

In case of feedingstuffs for ruminants for

In the instructions for use guidance shall

be provided on the balance of the daily

of, or recovery from digestive

In case of feedingstuffs for dairy cows

ration, with regard to the inclusion of

Indicate on the package, container or

indicate on the package, container or

‘Especially for intensively fed …’ 12

‘Especially for high yielding cows.’

‘It is recommended that a

In case of feedingstuffs for ovines

fattening indicate on the package,

disturbance (diarrhea)’

‘Especially for lactating ewes.’

before use’.

container or label

sources.

label

-

1 to 7 days (1 to 3

during periods of

fast grass growth

3 to 10 weeks

exclusively)

Maximum 2

days if fed

months 11

Carbohydrate

Total sugars

Magnesium

Potassium

Chlorides

source(s)

Sodium

Starch

-

Ruminants

Calves

Piglets

Lambs

Foals

Kids

carbohydrates, moderate level

and highly buffering capacity

Predominantly electrolytes

fermentable carbohydrates

of protein and low level of

High level of magnesium,

and easily absorbable

Low level of easily

easily available

carbohydrates

potassium

and electrolyte balance

Stabilization of water

Reduction of the risk

(hypomagnesaemia)

of acidosis

of tetany

‘Water should be available at all times’.

situation in which the use of this feed is

In case of risk of, during periods of, or

recovery from, digestive disturbance.’

‘Especially for intensively fed young

Indicate on the package, container or

Indicate in the instructions for use

Guidance shall be provided on the

appropriate.

animals.’

label

Up to 6 weeks

2 to 4 weeks

1 to 7 days

- Highly digestible ingredients

- Content of n-3 fatty acids if

- Source(s) of mucilaginous

including their treatment if

Urine acidifying

- Source(s) of astringent

substances (if added)

Magnesium

Phosphorus

- Buffering capacity

substances

Potassium

Chlorides

Calcium

Sodium

Sulphur

Magnesium

appropriate

added

-

Ruminants

Piglets

Pigs

magnesium and/or

Highly digestible

Low level of phosphorus,

- Low buffering capacity,

magnesium and urine

and highly digestible

acidifying properties

ingredients

High level

- Highly digestible

ingredients

-

Reduction of the risk

Reduction of stress

of urinary calcull

Stabilization of

physiological

digestion

reactions

situations in which the use of the feed is

appropriate and the manner in which the

‘It is recommended that a veterinarian's

appropriate and the manner in which it

opinion be sought before use or before

Indicate on the package, container or

Guidance should be provided on the

should be fed including many small

extending the period of use.’

-

feed should be fed

meals per day

label

During the first 2

Initially up to six

before and 10 to

Up to 12 weeks

10 to 14 days

14 days after

weeks after

farrowing

hatching

months

- Percentage of metabolizable

Source(s) of highly digestible

- Content of polyunsaturated

- Content of n-3 fatty acids

fatty acids in relation to

according to EEC method)

- Percentage of saturated

- Energy value (calculated

and fats, including their

carbohydrates, proteins

Ingredients stimulating

- Total vitamin E

- Total vitamin A

- Total vitamin D

- Total vitamin K

total fatty acids

energy from lipids

- Fibre source(s)

intestinal passage

if appropriate

(if added)

fatty acids

treatment

Laying hens

geese and

Equines 13

excluding

Equines

pigeons

Poultry

Sows

level of polyunsaturated fatty

energy from lipids with high

Low level of saturated fatty

proportion of metabolizable

acids and high level of fat

digestible carbohydrates,

- Highly digestible fibre

Ingredients stimulating

Low energy and high

- Highly precaecally

intestinal passage

soluble vitamins

proteins and fats

acids

Compensation for mal-

of fatty liver syndrome

chronic insufficiency

Reduction of the risk

Compensation for

of small intestine

of constipation

absorption

function

the risk of abrupt changes in the nature of

presented to be given via tubing, indicate

situations in which the use of the feed is

guidance should be provided to prevent

‘It is recommended that a veterinarian's

‘Water should be available at all times’

opinion be sought before use or before

Indicate on the package, container or

In the case of feedingstuffs specially

Indicate on the instructions for use

on the package, container or label

Guidance shall be provided on the

significant part of the daily ration,

‘Administration under veterinary

the use of the feed is appropriate

When the feed corresponds to a

Guidance shall be provided on

the precise situations in which

extending the period of use.’

supervision’

appropriate

the feed

label

Until restoration is

Two to four weeks

One to three days

achieved

- Highly digestible ingredients

- Content of n-3 and n-6 fatty

including their treatment if

- Content of n-3 fatty acids

including their treatment

acids (if added)

if appropriate

- Magnesium

- Potassium

appropriate

- Chlorides

- Calcium

(if added)

- Glucose

- Sodium

Equines

essential nutrients and highly

Predominantly electrolytes

High concentration of

and easily absorbable

digestible ingredients

- Highly digestible

carbohydrates

ingredients

Nutritional restoration,

Reduction of stress

electrolyte loss in

Compensation of

cases of heavy

convalescence

reactions

sweating

(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

‘Water should be available at all times.’

manner in which the feed should be fed

‘It is recommended that a veterinarian's

opinion be sought before use or before

Indicate on the package, container or

Guidance should be provided on the

including many small meals per day

Indicate in the instructions for use

(3) In case of feedingstuffs for cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome — F.US.’ may complete the particular nutritional purpose.

extending the period of use’.

extending the period of use.’

(6) In case of feedingstuffs for cats, the manufacturer may complete the particula r nutritional purpose with a reference to ‘Feline hepatic lipidosis’.

label

(2) 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 a particular intolerance reference to the specific intolerance can replace ‘ingredient and nutrient’.

Initially up to six

(5) The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine pacretic insufficiency’.

months

carbohydrates including their

- Content of n-3 fatty acids

- Protein and fibre sources

treatment if appropriate

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

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

- Highly digestible

- Protein source(s)

- Magnesium

- Phosphorus

- Methionine

- Potassium

- Calcium

(if added)

- Sodium

- Choline

(8) The manufacturers may also recommend the use for ketosis recuperation.

Equines

(7) The term ‘ketosis’ may be replaced by ‘acetonaemia’.

high quality and low level of

Low level of protein but of

the indication of the species or category of anima ls.

(12) Indicate the category of ruminants concerned.

digestible carbohydrates

high quality and highly

(9) In the case of feedingtuffs for dairy cows.

(10) In the case of feedingstuffs for ewes.

phosphorus

function in case of

Support of renal

Support of liver

chronic renal

insufficiency

chronic liver

Nutritional Purposes Rules, 2005

Table of Provisions (11)

Statutory Text (11 Articles)

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