List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes Rules, 2009 (L.N. 49 of 2009)

B 649 L.N. 49 of 2009 VETERINARY SERVICES ACT (CAP. 437) List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes Rules, 2009 IN exercise of the powers conferred under the article 26 of the Veterinary Services Act, the Minister for Resources and Rural Affairs, has made the following rules: 1. (1) The title of these rules is the List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes Rules, 2009. (2) The scope of these rules is to transpose Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes, as amended by Directive 2008/82/EC as regards feedingstuffs intended for the support of the renal function in case of chronic renal insufficiency, and codifying Directive 94/39/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes, as last amended by Directive 2008/4/EC as regards feedingstuffs intended for the reduction of the risk of milk fever, and subsequently repealing Directive 94/39/EC. 2. (1) Unless otherwise established in these rules, the definitions provided in the Veterinary Services Act shall apply. (2) For the purpose of these rules and unless the context otherwise requires: “authorised provider” means a person authorised by the Authority to manufacture animal products for particular nutritional purposes by making use of sources of ingredients or other similar constituents of the product or by making use of additives to such product in terms of the Schedule to these rules or who provides final consumers with nutritive products produced by animals; “competent authority” means the Veterinary Services Definitions. Title, scope and commencement. B 650 within Malta as provided under article 2 of the Veterinary Services Act; “general benefits” means all those benefits that the consumer acquires from those particular nutritive products produced by animals; “milk fever” means a hypocalcaemic paresis (disorder of nerve and muscle function) at parturition, caused by sudden and large demand of calcium from blood due to the onset of lactation; “final consumer” means the person who acquires nutritive products produced by animals for her own use. 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 measures provided in these rules regarding the food producing chain and animal health: Provided that the competent authority shall consider the marginal risk as one which cannot be completely excluded: Provided further that the competent authority shall ensure that the individual risk is balanced with the general benefits of the administration and considers such balance as necessary. (2) The competent authority shall take all the appropriate and necessary measures to reduce the risk presented to the consumer together with any additional risk to the environment in accordance with the provisions established in the Schedule to these rules. (3) These measures shall include the direct confiscation of the product, the suspension of activities carried out by the authorised provider when such activities are presenting a risk to the final consumer and to the environment, and the application of fines. (4) The competent Authority shall also ensure that there is conformity with the dispositions mentioned under “General Dispositions” of Part A of the Schedule to these regulations. 4. Feedingstuffs intended for particular nutritional purposes within the meaning of European Union Council Directive Applicability. Marketing of feedingstuffs intended for particular nutritional purposes. B 651 93/74/EEC shall be marketed in Malta only if their intended uses are included in the Schedule to these rules and if they fulfill the other provisions laid down in the Schedule. 5. The List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes rules, 2005 are hereby being revoked. Revokes L.N. 70 of 2005. B 652 SCHEDULE PART A General Provisions 1. Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4. 2. Where a group of additives is mentioned in column 2 or column 4 of Part B the additive or additives used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the Council as corresponding to the specified essential characteristic. 3. Where the source or sources of ingredients or of analytical constituents are required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient(s), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics. 4. Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression ‘total’ the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC (2), the total quantity of the substance naturally present and the amount added as an additive. 5. The declarations required in column 4 of Part B with the reference ‘if added’ are compulsory where the ingredient or the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose. 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 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. B 653 PART B [Regulation 3(2)] List of Intended Uses Particular Nutritional Purpose Essential Nutritional Characteristic s Species or Category of Animals Labelling Declarations Recommended Length of Time Other Provisions Support of renal function in the case of chronic renal insufficiency1 Low level of phosphorus ad restricted level of protein but of high quality or Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate Dogs and cats Adult cats Protein source(s) Calcium Phosphorus Potassium Sodium Contents of essential fatty acids (if added) Protein source(s) Calcium Phosphorus Potassium Sodium Lanthanum carbonate octahydrate Contents of essential fatty acids (if added) Initially up to 6 months2 Initially up to 6 months2 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 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’. Dissolution of struvite stones3 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 Cats 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 5 to 12 weeks Indicate in the instructions for use: ‘Water should be available at all time’. Indicate on the package, container or label: ‘It is recommended that a veterinarian’s opinion be sought before use’. B 654 Reduction of struvite stone recurrence3 Urine acidifying properties and moderate level of magnesium Dogs and cats Calcium Phosphorus Sodium Magnesium Potassium Chlorides Sulphur Urine acidifying 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 urate stones formation Low level of prines, low level of protein but of high quality Dogs and cats Protein source(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’. B 655 Reduction of ingredient and nutrient intolerences4 Selected protein source(s) and/or Selected carbohydrate source(s) Dogs and cats Protein source(s) Content of essential fatty acids (if added) Carbohydrate source(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 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(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’. Compensation for maldigestion5 Highly digestible ingredients and low level of fat Dogs and cats Highly digestible ingredients including their treatment if appropriate 3 to 12 weeks but lifetime in case of chronic pancreatic insufficiency Indicate on the package, container or label: ‘It is recommended that a 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 glucose releasing carbohydrates Dogs and cats Carbohydrate source(s) Treatment of carbohydrate 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) 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’. B 656 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. High quality protein, moderate level of protein and high level of essential fatty acids Dogs 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 Initially up to 6 months 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’. 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 in the instructions for use: ‘Water should be available at all times.’ Regulation of lipid metabolism in case of hyperlipidaema Low level of fat and high level of essential fatty acids Dogs and cats Content of essential fatty acids Content of n-3 fatty acids (if added) Initially up to 2 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 copper in the liver Low level of 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 body weight is achieved In the instructions for use an appropriate daily intake must be recommended B 657 Nutritional restoration, convalescence6 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 restoration is achieved 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 skin function in case of dermatosis and excessive loss of hair High level of essential fatty acids Dogs and cats Content of essential fatty acids Up to 2 months Indicate on the package, container or label: ‘It is recommended that a veterinarian’s opinion be sought before use’. Reduction of the risk of milk fever Low level of calcium and/or Low cations/anions ratio or High level of zeolite (synthetic sodium aluminium silicate) or High level of calcium in the form of highly available calcium salts Dairy cows Calcium Phosphorus Magnesium Calcium Phosphorus Sodium Potassium Chlorides Sulphur Content of synthetic sodium aluminium silicate Total calcium content, sources and respective quantity of calcium 1 to 4 weeks before calving 1 to 4 weeks before calving The 2 weeks before calving Start at first signs of parturition to two days subsequent to parturition Indicate in the instructions for use: ‘Stop feeding after calving’ Indicate in the instructions for use: ‘Stop feeding after calving’ Indicate in the instructions for use: ‘The amount of feed shall be restricted to ensure that a daily intake of 500g sodium aluminium-silcate per animal is not exceeded.’ ‘Stop feeding after calving’ Indicate on the package, container or label: The 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’. B 658 Reduction of the risk of ketosis7 8 Ingredients providing gluco-genic energy sources Dairy cows and ewes Ingredients providing glucogenic energy sources Propane-1,2-diol (if added as a glucose precursor) Glycerol (if added as a glucose precursor) 3 to 6 weeks after calving9 Last 6 weeks before and the first 3 weeks after lambing10 Reduction of the risk of tetany (hypomagnesae mia) High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium Ruminants Starch Total sugars Magnesium Sodium Potassium 3 to 10 weeks during periods of fast grass growth 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 package, container or label: ‘Especially for lactating ewes’. Reduction of the risk of acidosis Low level of easily fermentable carbohydrates and highly buffering capacity Ruminants 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 package, container or label: ‘Especially for high yielding cows’. In the case of feedingstuffs for ruminants for fattening indicate on the package, container or label: ‘Especially for intensively fed’.12 B 659 Stabilization of water and electrolyte balance Predominately electrolytes and easily absorbable carbohydrates Calves Piglets Lambs Kids Foals Carbohydrate source(s) Sodium Potassium Chlorides 1 to 7 days (1 to 3 days if fed exclusively) Indicate on the package, container or label: ‘In the case of risk of, during periods of, or recovery from digestive disturbance (diarrhea)’. ‘It it recommended that a veterinarian’s opinion be sought before use’. Reduction of the risk of urinary calculi Low level of phosphorus, magnesium and urine acidifying properties Ruminants Calcium Phosphorus Sodium Magnesium Potassium Chlorides Sulphur Urine acidifying substances Up to 6 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.’ Reduction of stress reactions High level of magnesiu m and/or Highly digestible ingredien ts Pigs Magnesium Highly digestible ingredients including their treatment if appropriate Content of n-3 fatty acids if added 1 to 7 days Guidance shall be provided on the situation in which the use of this feed is appropriate. Stabilization of physiological digestion Low buffering capacity, and highly digestible ingredients Highly digestible ingredients Piglets Pigs 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 2 to 4 weeks Indicate on the package, container or label: ‘In case of risk of, during periods of, or recovery from, digestive disturbance.’ B 660 (if added) Reduction of the risk of constipation Ingredients stimulating intestinal passage Sows Ingredients stimulating intestinal passage 10 to 14 days before and 10 to 14 days after farrowing. Reduction of the risk of fatty liver syndrome Low energy and high proportion of metabolisable energy from lipids with high level of poly unsaturated fatty acids. Laying hens Energy value (calculated according to EEC method) Percentage of metabolisable energy form lipids Content of the polyunsaturated fatty acids Up to 12 weeks Compensation for mal absorption Low level of saturated fatty acids and high level of fatty 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 Highly precaecally digestible carbohydrates, protein and fats. Equines13 Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate. 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 veterinarian’s opinion be sought before use or before extending the period of use’. B 661 Compensation for chronic digestive disorders of large intestine Highly digestible fibre Equines Fibre source(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 Guidance shall be provided on the precise situation in which the use of the feed is appropriate. Compensation of electrolyte loss in cases of heavy sweating Predominantly electrolyte and easily absorbable carbohydrates Equines Calcium Sodium Magnesium Potassium Chlorides Glucose One to three day Guidance shall be provided on the situations in which the use of the food 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’ Nutritional restoration, convalescence High concentration of essential nutrients and highly digestible ingredients Equines Highly digestible ingredients including their treatment if appropriate Contents of n-3 and n-6 fatty acids (if added) Until restoration is achieved 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 packages, container or label: ‘Administration under veterinary supervision’ B 662 (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’. (5) The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine pancretic 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 of ketosis recuperation. (9) In the case of feedingstuffs for dairy cows. (10) In the case of feedingstuffs for ewes. (11) In the case of feedingstuffs for dairy cows: ‘maximum two months from the start of lactation’. (12) Indicate the category of ruminants concerned. (13) In the case of feedingstuffs specially prepared to meet the specific conditions of very old animals (easily ingestible ingredients) a reference to old animals shall complete the indication of the species or category of animals. Nutritional restoration, convalescence High concentration of essential nutrients and highly digestible ingredients Equines Highly digestible ingredients including their treatment if appropriate Contents of n-3 and n-6 fatty acids (if added) Until restoration is achieved 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 packages, container or label: ‘Administration under veterinary supervision’ Support of liver function in case of chronic liver insufficiency Low level of protein but of high quality and highly digestible carbohydrates Equines Protein and fibre sources Highly digestible carbohydrates including their treatment if appropriate Methionine Choline Content of n-3 fatty acids (if added) 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’. Support of renal function in case of chronic renal insufficiency Low level of protein but of high quality and low level of phosphorus Equines Protein source(s) Calcium Phosphorus Potassium Magnesium Sodium 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 on the instructions for use: ‘Water should be available at all times’ Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press Prezz#Price €1.30