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Maltese Laws |
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>–
1. (1) The title of these rules is the List of Intended Uses of
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.
2. For the purpose of these rules>
“the competent authority” means the Veterinary Services within Malta as provided under article 2 of the Veterinary Services Act<
3. (1) 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 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.
Title and scope.
Definitions.
Marketing of feedingstuffs intended for particular nutritional purposes.
B 796
SCHEDULE
PART AGeneral provisions1. 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.
4. Where the declaration o f 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.
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 re commended 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.
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.
Particular nutritional purpose | Essential nutritional characteristics | Species or category of animals | Labelling declarations | Recommended length of time for use | Other provisions |
Support of renal function in case of chronic renal insufficiency1 Dissolution of struvite stones 3 | Low level of phosphorus and restricted level of protein but of high quality - Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality - Urine acidifying properties and low level of magnesium | Dogs and cats Dogs Cats | - Protein source(s) - Calcium - Phosphorus - Potassium - Sodium - Contents of essential fatty acids (if added) - Protein source(s) - Calcium - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Urine acidifying substances - Calcium - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Total taurine - Urine acidifying substances | Initially up to 6 months2 5 to 12 weeks | 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’. Indicate in the instructions for use: ‘Water should be available at all times.’ Indicate in the instructions for use: ‘Water should be available at all times.’ Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. |
Reduction of struvite stone recurrence3 Reduction of urate stones formation Reduction of oxalate s tones formation Reduction of cystine stones formation | Urine acidifying properties and moderate level of magnesium Low level of purines, low level of protein but of high quality Low level of calcium, low level of Vitamin D and urine alkalizing properties Low level of protein, moderate level of sulphur amino acids and urine alkalizing properties | Dogs and cats Dogs and cats Dogs and cats Dogs and cats | - Calcium - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Urine acidifying substances Protein source(s) - Phosphorus - Calcium - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Total Vit amin D - Hydroxyproline - Urine alkalizing substances - Total sulphur amino acids - Sodium - Potassium - Chlorides - Sulphur - Urine alkalizing substances | Up to 6 months Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism Up to 6 months Initially up to 1 year | Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. 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 ingredient and nutrient intolerences 4 Reduction of acute intestinal absorptive disorders Compensation for maldigestion5 Support of heart function in case of chronic cardiac insufficiency Regulation of glucose supply (Diabetis mellitus) | - Selected protein source(s) - Selected carbohydrate source(s) Increased level of electrolytes and highly digestible ingredients Highly digestible ingredients and low level of fat Low level of sodium and increased K/Na ratio Low level of rapid glucose releasing carbohydrates | Dogs and cats Dogs and cats Dogs and cats Dogs and cats Dogs and cats | - Protein source(s) - Content of essential fatty acids (if added) - Carbohydrate source(s) - Content of essent ial fatty acids (if added) - Highly digestible ingredients including their treatment if appropriate - Sodium - Potassium - Source(s) of mucilaginous substances (if added) Highly digestible ingredients including their treatment if appropriate - Sodium - Potassiu m - Magnesium - Carbohydrate source(s) - Treatment of carbohydrates if appropriate - Starch - Total sugar - Fructose (if added) - Content of essential fatty acids (if added) - Source(s) of short and medium chain fatty acids (if added) | 3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely 1 to 2 weeks 3 to 12 weeks but lifetime in case of chronic pancreatic insufficiency Initially up to 6 months Initially up to 6 months | - Indicate on the package, container or label: - ‘During periods of and recovery from acute diarrhea.’ - ‘It is recommended that a veterinarian's opin ion be sought before use’. Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought befo re use or before extending the period of use’. 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’. |
Support of liver function in case of chronic liver insufficiency Regulation of lipid metabolism in case of hyperlipidaemia Reduction of copper in the liver Reduction of excessive body weight | High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestive carbohydrates High quality protein, moderate level of protein and high level of essential fatty acids Low level of fat and high level of essential fatty acids Low level of copper Low energy density | Dogs Cats Dogs and cats Dogs Dogs and cats | - Protein source(s) - Content of essential fatty acids - Highly digestible carbohydrates including their treatment if appropriate - Sodium - Total copper - Protein source(s) - Content of essential fatty acids - Sodium - Total copper - Content of essential fatty acids - Content of n -3 fatty acids (if added) Total copper Energy value (calculated according to EC method) | Initially u p to 6 months Initially up to 6 months Initially up to 2 months Initially up to 6 months Until target body weight is achieved | 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’. Indicate in the instructions for use: ‘Water should be available at all times.’ Indicate on the package, container or label: ‘It is recommended t hat 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.’ 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’. 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’. In the instructions for use an appropriate daily intake must be recommended |
Nutritional restoration, convalescence6 Support of skin function in case of dermatosis and excessive loss of hair Reduction of the risk of milk fever Reduction of the risk of ketosis 78 | High energy density, high concentrations of essential nutrients and highly digestible ingredients High level of essential fatty acids - Low level of calcium and/or - Low cations/anions ratio Ingredients proving gluco- genic energy sources | Dogs and cats Dogs and cats Dairy cows Dairy cows and ewes | - Highly digestible ingredients, including their treatment if appropriate - Energy value (calculated according to EC method) - Content of n -3 and n -6 fatty acids (if added) Content of essential fatty acids - Calcium - Phosphorus - Magnesium - Calcium - Phosphorus - Sodium - Potassium - Chlorides - Sulphur - Ingredients providing glucogenic energy sources - Propane-1,2-diol(if added as a glucose precursor) - Glycerol (if added as a glucose precursor) | Until restoration is achieved Up to 2 months 1 to 4 weeks before calving 3 to 6 weeks after calving9 Last 6 weeks before and the first 3 weeks after lambing10 | In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision’ Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Indicate in the instructions for use: ‘Stop feeding after calving’. |
Reduction of the risk of tetany (hypomagnesaemia) Reduction of the risk of acidosis Stabilization of water and electrolyte balance | High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium Low level of easily fermentable carbohydrates and highly buffering capacity Predominantly electro lytes and easily absorbable carbohydrates | Ruminants Ruminants Calves Piglets Lambs Kids Foals | - Starch - Total sugars - Magnesium - Sodium - Potassium - Starch - Total sugars - Carbohydrate source(s) - Sodium - Potassium - Chlorides | 3 to 10 weeks during periods of fast grass growth Maximum 2 months11 1 to 7 days (1 to 3 days if fed exclusively) | In the instructions for use guidance shall be provided on the balance of the 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.’ In the instructions for use guidance shall be 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 Indicate on the package, container or label: - ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhea)’ - ‘It is recommended that a veterinarian's opinion be sought before use’. |
Reduction of the risk of urinary calcull Reduction of stress reactions Stabilization of physiological digestion | Low level of phosphorus, magnesium and urine acidifying properties - High level magnesium and/or - Highly digestible ingredients - Low buffering capacity, and highly digestible ingredients - Highly digestible ingredients | Ruminants Pigs Piglets Pigs | - Calcium - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Urine acidifying substances Magnesium - Highly digestible ingredients including their treatment if appropriate - Content of n -3 fatty acids if added - Highly digestible ingredients including their treatment if appropriate - Buffering capacity - Source(s) of astringent substances (if added) - Source(s) of mucilaginous substances (if added) - Highly digestible ingredients including their treatment if appropriate - Source(s) of astringent substances (if added) - Source(s) of mucilaginous substances (if added) | Up to 6 weeks 1 to 7 days 2 to 4 weeks | Indicate on the package, container or label: ‘Especially for intensively fed young animals.’ Indicate in the instructions for use: ‘Water should be available at all times’. Guidance shall be provided on the situation in which the use of this feed is appropriate. Indicate on the package, container or label: In case of risk of, during periods of, or recovery from, digestive disturbance.’ |
Reduction of the risk of constipation Reduction of the risk of fatty liver syndrome Compensation for mal- absorption Compensation for chronic insufficiency of small intestine function Compensation for chronic insufficiency of small intestine function | Ingredients stimulating intestinal passage Low energy and high proportion of metabolizable energy from lipids with high level of polyunsaturated fatty acids Low level of saturated fatty acids and high level of fat soluble vitamins - Highly precaecally digestible carbohydrates, proteins and fats - Highly digestible fibre | Sows Laying hens Poultry excluding geese and pigeons Equines 13 Equines | Ingredients stimulating intestinal passage - Energy value (calculated according to EEC method) - Percentage of metabolizable energy from lipids - Content of polyunsaturated fatty acids - Percentage of saturated fatty acids in relation to total fatty acids - Total vitamin A - Total vitamin D - Total vitamin E - Total vitamin K Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate - Fibre source(s) - Content of n -3 fatty acids (if added) | 10 to 14 days before and 10 to 14 days after farrowing Up to 12 weeks During the first 2 weeks after hatching Initially up to six months Initially up to six months | - - - Guidance should be provided on the situations in which the use of the feed 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 veterin arian's opinion be sought before use or before extending the period of use.’ Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which the feed should be fed |
Reduction of stress reactions Compensation of electrolyte loss in cases of heavy sweating Nutritional restoration, convalescence | - Highly digestible ingredients Predominantly electrolytes and eas ily absorbable carbohydrates High concentration of essential nutrients and highly digestible ingredients | Equines Equines Equines | - Magnesium - Highly digestible ingredients including their treatment if appropriate - Content of n -3 fatty acids (if added) - Calcium - Sodium - Magnesium - Potassium - Chlorides - Glucose - Highly digestible ingredients including their treatment if appropriate - Content of n -3 and n -6 fatty acids (if added) | Two to four weeks One to three days Until restoration is achieved | 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.’ Guidance shall be provided on the precise situations in which the use of the feed is appropriate Guidance shall be provided on the sit uations in which the use of the feed is 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’ Guidance shall be provided on the situations in which the use of the feed is appropriate In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision’ |
Support of liver function in case of chronic liver insufficiency Support of renal function in case of chronic renal insufficiency | Low level of protein but of high quality and highly digestible carbohydrates Low level of protein but of high quality and lo w level of phosphorus | Equines Equines | - Protein and fibre sources - Highly digestible carbohydrates including their treatment if appropriate - Methionine - Choline - Content of n -3 fatty acids (if added) - Protein source(s) - Calcium - Phosphorus - Potassium - Magnesium - Sodium | Initially up to six months Initially up to six months | Guidance should be provided on the manner in which the feed 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’. 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.’ 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 w eeks.
(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’.
(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 particula r 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 anima ls.
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