L.S. 437.53(R) Regoli dwar Lista ta’ Użu Maħsub għall-Materjal tal-Għalf għall-Annimali għal Skopijiet Nutrittivi Partikolari Imħassrin bl-Avviż Lega

(1)The title of these rules is the List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes Rules. Title and scope.

(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. 2.

(1)Unless otherwise established in these rules, the definitions provided in the Veterinary Services Act shall apply. Definitions. Cap. 437.

(2)For the purpose of these rules and unless the context otherwise requires: "authorised provider" means a person authorised by the Authority to manufacture animal products for particular nutritional purposes by making use of sources of ingredients or other similar constituents of the product or by making use of additives to such product in terms of the Schedule or who provides final consumers with nutritive products produced by animals; "competent authority" means the Veterinary Services within Malta as provided under article 2 of the Veterinary Services Act; Cap. 437. "final consumer" means the person who acquires nutritive products produced by animals for her own use; "general benefits” means all those benefits that the consumer acquires from those particular nutritive products produced by animals; "milk fever" means a hypocalcaemic paresis (disorder of nerve and muscle function) at parturition, caused by sudden and large demand of calcium from blood due to the onset of lactation. 3.

(1)These rules shall apply for the reduction and prevention of the risk of milk fever so as to safeguard animal health, human health and the environment as well as for the *These rules have been repealed by Legal Notice 36 of 2025. Applicability. 1 2 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES measures provided in these rules regarding the food producing chain and animal health: Provided that the competent authority shall consider the marginal risk as one which cannot be completely excluded: Provided further that the competent authority shall ensure that the individual risk is balanced with the general benefits of the administration and considers such balance as necessary.

(2)The competent authority shall take all the appropriate and necessary measures to reduce the risk presented to the consumer together with any additional risk to the environment in accordance with the provisions established in the Schedule.

(3)These measures shall include the direct confiscation of the product, the suspension of activities carried out by the authorised provider when such activities are presenting a risk to the final consumer and to the environment, and the application of fines.

(4)The competent authority shall also ensure that there is conformity with the dispositions mentioned under "General Dispositions" of Part A of the Schedule. Marketing of feedingstuffs intended for particular nutritional purposes. 4. Feedingstuffs intended for particular nutritional purposes within the meaning of European Union Council Directive 93/74/ EEC shall be marketed in Malta only if their intended uses are included in the Schedule and if they fulfill the other provisions laid down in the Schedule. LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES [ S.L.437.53 3 SCHEDULE (Regulations 3 and 4) PART A General provisions 1. Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4. 2. Where a group of additives is mentioned in column 2 or column 4 of Part B the additive or additives used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the Council as corresponding to the specified essential characteristic. 3. Where the source or sources of ingredients or of analytical constituents are required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient(s), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics. 4. Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression ‘total’ the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC, the total quantity of the substance naturally present and the amount added as an additive. 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. 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. 4 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES PART B List of intended uses Particular nutritional purpose Essential nutritional characteristics Species or Labelling category of declarations animals Support of renal function in case of chronic renal insufficiency 1 Low level of Dogs and phosphorus and cats restricted level of protein but of high quality Recommen- Other ded length of provisions time for use - Protein source(

1. s)Initially up - Calcium to 6 months 2 - Phosphorus - Potassium - Sodium - Contents of essential fatty acids (if added) 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.’ or - Protein source(
2. s)Initially up to 6 months 2 - Calcium - Phosphorus - Potassium - Sodium - Lanthanum carbonate octahydrate - Contents of essential fatty acids (if added) Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Dogs Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality - Protein source(
3. s)5 to 12 weeks - Calcium - Phosphorus - Sodium - Potassium - Chlorides - Sulphur - Urine acidifying substances Indicate in the instructions for use: ‘Water should be available at all times.’ Urine Cats acidifying properties and low level of magnesium - Calcium - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Total taurine - Urine acidifying substances Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate Dissolution of struvite stones 3 - - Adult cats 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’. LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES [ S.L.437.53 5 Up to 6 - Calcium months - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Urine acidifying substances Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Reduction of urate Low level of Dogs and stones formation prines, low level of cats protein but of high quality Protein source(
4. s)Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Reduction of oxalate stones formation Low level of calcium, low level of Vitamin D and urine alkalizing properties Dogs and cats - Phosphorus - Calcium - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Total Vitamin D - Hydroxyproline - Urine alkalizing substances Up to 6 months Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Reduction of cystine stones formation Low level of protein, moderate level of sulphur amino acids and urine alkalizing properties Dogs and cats - Total sulphur amino acids - Sodium - Potassium - Chlorides - Sulphur - Urine alkalizing substances Initially up to 1 year 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 - Selected protein Dogs and cats source(
5. s)- Protein source(
6. s)- Content of essential fatty acids (if added) 3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely Reduction of struvite stone recurrence3 Urine acidifying properties and moderate level of magnesium Dogs and cats and/or - Carbohydrate source(
7. s)- Content of essential fatty acids (if added) - Selected carbohydrate source(
8. s)Reduction of acute intestinal absorptive disorders Increased level of electrolytes and highly digestible ingredients Dogs and cats - Highly digestible ingredients including their treatment if appropriate - Sodium - Potassium - Source(
9. s)of mucilaginous substances (if added) 1 to 2 weeks Indicate on the package, container or label: - ‘During periods of and recovery from acute diarrhea.’ - ‘It is recommended that a veterinarian's opinion be sought before use’. 6 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Compensation for Highly digestible maldigestion 5 ingredients and low level of fat Dogs and cats Highly digestible ingredients including their treatment if appropriate 3 to 12 Indicate on the weeks but package, lifetime in container or case of label: ‘It is chronic recommended pancreatic that a insufficiency veterinarian's opinion be sought before use’. Support of heart function in case of chronic cardiac insufficiency Low level of sodium and increased K/Na ratio Dogs and cats - Sodium - Potassium - Magnesium Initially up to 6 months 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’. Regulation of glucose supply (Diabetis mellitus) Low level of rapid Dogs and glucose-releasing cats carbohydrates Initially up - Carbohydrate to 6 months source(
10. s)- Treatment of carbohydrates if appropriate - Starch - Total sugar - Fructose (if added) - Content of essential fatty acids (if added) - Source(
11. s)of short and medium chain fatty acids (if added) 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 High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestive carbohydrates Initially up - Protein to 6 months source(
12. s)- Content of essential fatty acids - Highly digestible carbohydrates including their treatment if appropriate - Sodium - Total copper 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’. Dogs Indicate in the instructions for use: ‘Water should be available at all times.’ LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES High quality Cats protein, moderate level of protein and high level of essential fatty acids [ S.L.437.53 - Protein Initially up source(
13. s)to 6 months - Content of essential fatty acids - Sodium - Total copper 7 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.’ Regulation of lipid metabolism in case of hyperlipidaemia Low level of fat and high level of essential fatty acids Dogs and cats - Content of Initially up essential fatty acids to 2 months - Content of n-3 fatty acids (if added) 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 Low level of copper in the liver copper Dogs Total copper Initially up to 6 months 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 excessive body weight Low energy density Dogs and cats Energy value Until target In the body weight instructions for is achieved use an appropriate daily intake must be recommended Nutritional restoration, convalescence 6 High energy density, high concentrations of essential nutrients and highly digestible ingredients Dogs and cats Highly digestible ingredients, including their treatment if appropriate - Energy value - Content of n-3 and n-6 fatty acids (if added) Until In the case of restoration is feedingstuffs achieved specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision’ 8 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Support of skin High level of function in case of essential fatty dermatosis and acids excessive loss of hair Dogs and cats Content of Up to 2 essential fatty acids months Indicate on the package, container or label: ‘It is recommended that a veterinarian's opinion be sought before use’. Reduction of the - Low level of risk of milk fever calcium and/or Dairy cows - Calcium - Phosphorus - Magnesium 1 to 4 weeks Indicate in the before instructions for calving use: ‘Stop feeding after calving’. - Calcium Phosphorus Sodium Potassium Chlorides Sulphur 1 to 4 weeks Indicate in the before instructions for calving use: ‘Stop feeding after calving’. Content of synthetic sodium aluminium silicate The 2 weeks Indicate in the before instructions for calving use: - ‘The amount of feed shall be restricted to ensure that a daily intake of 500g sodium aluminiumsilcate per animal is not exceeded.’ and/or - Low cations/ anions ratio or - High level of zeolite (synthetic sodium aluminium silicate) - ‘Stop feeding after calving’ or - High level of calcium in the form of highly available calcium salts Total calcium Start at first Indicate on the content, sources signs of package, and respective parturition to container or quantity of calcium two days label: subsequent - The to parturition instruction of use, i.e. the number of applications and the time before and after calving. - The text ‘It is recommended that a nutritional expert’s opinion be sought before use’. LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Reduction of the risk of ketosis 7 8 Reduction of the risk of tetany (hypomagnesaemia) [ S.L.437.53 9 Ingredients Dairy cows - Ingredients proving glucogenic and ewes providing energy sources glucogenic energy sources - Propane-1,2diol (if added as a glucose precursor) - Glycerol (if added as a glucose precursor) 3 to 6 weeks after calving9 High level of Ruminants magnesium, easily available carbohydrates, moderate level of protein and low level of potassium 3 to 10 In the weeks during instructions for periods of use guidance fast grass shall be growth provided on the balance of the daily ration, with regard to the inclusion of fibre and easily available energy sources. - Starch Total sugars Magnesium Sodium Potassium Last 6 weeks before and the first 3 weeks after lambing 10 In case of feedingstuffs for ovines indicate on the package, container or label: ‘Especially for lactating ewes.’ Reduction of the risk of acidosis Low level of easily Ruminants fermentable carbohydrates and highly buffering capacity - Starch - Total sugars Maximum 2 months11 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 10 [ S.L.437.53 Stabilization of water and electrolyte balance Reduction of the risk of urinary calculi Reduction of stress reactions LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Predominantly electrolytes and easily absorbable carbohydrates Low level of phosphorus, magnesium and urine acidifying properties - High level magnesium Calves Piglets Lambs Kids Foals - Carbohydrate source(
14. s)- Sodium - Potassium - Chlorides Ruminants Up to 6 - Calcium weeks - Phosphorus - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Urine acidifying substances Indicate on the package, container or label: ‘Especially for intensively fed young animals.’ Magnesium Guidance shall be provided on the situation in which the use of this feed is appropriate. Pigs and/or - Highly digestible ingredients Stabilization of physiological digestion - Low buffering capacity, and highly digestible ingredients - Highly digestible ingredients including their treatment if appropriate - Content of n-3 fatty acids if added Piglets - Highly digestible ingredients including their treatment if appropriate - Buffering capacity - Source(
15. s)of astringent substances (if added) - Source(
16. s)of mucilaginous substances (if added) 1 to 7 days (1 to 3 days if fed exclusively) 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’. 1 to 7 days Indicate in the instructions for use: ‘Water should be available at all times’. 2 to 4 weeks Indicate on the package, container or label: ‘In case of risk of, during periods of, or recovery from, digestive disturbance.’ LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES [ S.L.437.53 - Highly digestible ingredients Pigs - Highly digestible ingredients including their treatment if appropriate - Source(
17. s)of astringent substances (if added) - Source(
18. s)of mucilaginous substances (if added) Reduction of the risk of constipation Ingredients stimulating intestinal passage Sows Ingredients stimulating intestinal passage Reduction of the risk of fatty liver syndrome Low energy and high proportion of metabolizable energy from lipids with high level of polyunsaturated fatty acids Laying hens - Energy value (calculated according to EEC method) - Percentage of metabolizable energy from lipids - Content of polyunsaturated fatty acids Up to 12 weeks Compensation for Low level of malabsorption saturated fatty acids and high level of fat soluble vitamins Poultry excluding geese and pigeons - Percentage of saturated fatty acids in relation to total fatty acids - Total vitamin A - Total vitamin D - Total vitamin E - Total vitamin K During the first 2 weeks after hatching Compensation for chronic insufficiency of small intestine function Equines13 Source(
19. s)of highly Initially up digestible to six carbohydrates, months proteins and fats, including their treatment if appropriate - Highly precaecally digestible carbohydrates, proteins and fats 11 10 to 14 days before and 10 to 14 days after farrowing 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 veterinarian's opinion be sought before use or before extending the period of use.’ 12 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Compensation for - Highly chronic digestive digestible fibre disorders of large intestine Equines - Fibre source(
20. s)- Content of n-3 fatty acids (if added) 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 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 reactions - Highly digestible ingredients Equines - Magnesium - Highly digestible ingredients including their treatment if appropriate - Content of n-3 fatty acids (if added) Two to four weeks Compensation of electrolyte loss in cases of heavy sweating Predominantly electrolytes and easily absorbable carbohydrates Equines - One to three Guidance shall days be provided on the situations in which the use of the feed is appropriate Calcium Sodium Magnesium Potassium Chlorides Glucose Guidance shall be provided on the precise situations 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’ LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES Nutritional restoration, convalescence Support of liver function in case of chronic liver insufficiency Support of renal function in case of chronic renal insufficiency High concentration Equines of essential nutrients and highly digestible ingredients Low level of Equines protein but of high quality and highly digestible carbohydrates Low level of Equines protein but of high quality and low level of phosphorus - Highly digestible ingredients including their treatment if appropriate - Content of n-3 and n-6 fatty acids (if added) [ S.L.437.53 13 Until Guidance shall restoration is be provided on achieved 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’ - Protein and fibre Initially up to six sources months - Highly digestible carbohydrates including their treatment if appropriate - Methionine - Choline - Content of n-3 fatty acids (if added) Guidance should be provided on the manner in which the feed should be fed including many small meals per day - Protein source(
21. s)- Calcium - Phosphorus - Potassium - Magnesium - Sodium 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.’ Initially up to six months 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 weeks.

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

(4)In case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace ‘ingredient and nutrient’. 14 [ S.L.437.53 LIST OF INTENDED USES OF ANIMAL FEEDINGSTUFFS FOR PARTICULAR NUTRITIONAL PURPOSES

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

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

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

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

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

(10)In the case of feedingstuffs for ewes.

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

(12)Indicate the category of ruminants concerned.

(13)In case of feedingstuffs specially prepared to meet the specific conditions of very old animals (easily ingestible ingredients) a reference to ‘old animals’ shall complete the indication of the species or category of animals.