Feedingstuffs Intended for Particular Nutritional Purposes Rules, 2005 (L.N. 231 of 2005)

B 3644 Title and scope. Definitions. L.N. 231 of 2005 VETERINARY SERVICES ACT, 2001 (CAP. 437) Feedingstuffs Intended for Particular Nutritional Purposes Rules, 2005 IN exercise of the powers conferred by 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 Feedingstuffs Intended for Particular Nutritional Purposes Rules, 2005. (2) These rules concern feedingstuffs intended for paiiicular nutritional purposes. (3) Feedingstuffs intended for particular nutritional purposes may be marketed only if (a) they fulfil the conditions referred to in rule 3, (b) they are labelled in accordance with the provisions laid down in rule 5, ( c) their intended uses are included in the list drawn up pursuant to rule 6 and they fulfil the other provisions laid down in that list. ( 4) The Veterinary Services shall ensure that the provisions under "General provisions" of Part A of the Schedule are complied with. (5) The scope of these rules is to implement the rules found under European Union Council Directive 93/74/EEC as amended by European Union Council Directive 96/25/EC, European Union Directive 2000/16/EC, European Union Council Directive 1999/29/EC, European Union Council Regulation (EC) No 806/2003. Annex A and B to European Commission Directive 94/39/EC, establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes are hereby included as Schedule to these rules. 2. For the purposes of these rules, the following definitions shall apply (a) "the Commission" means the European Commission; (b) "compound feedingstuffs" means mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs; ( c) "feedingstuffs" means products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding; ( d) "feedingstuffs intended for particular nutritional purposes" means compound feedingstuffs which, by virtue of their particular composition or method of manufacture, can be clearly distinguished from both ordinary feedingstuffs and the products defined in European Union Council Directive 90/167 /EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs, and are presented as intended to meet specific nutritional requirements; (e) "particular nutritional purpose" means the purpose of satisfying the specific nutritional needs of certain pets or productive livestock whose process of assimilation, absorption or metabolism could be temporarily impaired or is temporarily or irreversibly impaired and are therefore able to derive benefit from ingestion of feedingstuff s appropriate to their condition; (f) "Veterinary Services" means the competent authority within Malta as established under article 2 of the Veterinary Services Act. 3. The nature of composition of the feedingstuffs referred to in rule 1 (2) shall such that products are appropriate for their intended particular nutritional purpose. B 3645 Nature of composition of fredingstuffs intended for particular nutritional purposes. 4. These rules shall apply, subject to the specific provisions laid Applicability of down therein, without prejudice to the legal provisions on - these rules. (a) compound feedingstuffs; (b) additives used in feedingstuffs; ( c) undesirable substances and products in animal nutrition; B 3646 Additional indications lo appear on packaging, on the container or on the label of feedings luffs. (d) certain products used in animal nutrition. (l) addition to the labelling provisions in article 5 of European Union Council Directive 79/373/EEC on the marketing of compound fecdingstuffs it is expressively required that the following additional indications appear in the space provided for the purpose on the packaging, on the container or on the label of the feedingstuffs referred to in rule 1 (2) (a) the qualifying expression "dietetic" together with the description of the feedingstuff; (b) the precise use, i.e. the particular nutritional purpose; ( c) the indication of the essential nutritional characteristics of the fecdingstuffs; ( d) the declarations prescribed in column 4 in the Schedule to these mles concerning the particular nutritional purpose; ( e) the rcco mm ended length of time for use of the feedingstuff. indications referred to in points (a) to (c) must comply with the content of the list of intended uses in the Schedule to these rules and the general provisions to be laid down in accordance with rule 6 (b). (2) Indications other than those referred to in sub-rule (1) may be supplied in the space provided for the purpose, in so far as they are covered by rule 6 (a). (3) without prejudice to article 5e of European Union Council Directive 79/373/EEC, the labelling offcedingstuffs as referred to in rule 1 (2) may make to a specific pathological condition in so as that condition corresponds to the nutritional purpose laid down in the list of uses drawn up in accordance with rule 6 (a). ( 4) the label or the directions for use of the feedingstuff s referred to in rule 1 (2) must bear the indication is recommended that a specialist's opinion be sought before use" ; It may, however, be provided in the list of intended uses in the Schedule that this declaration shall be replaced for specific dietetic feedingstuffs with a recommendation to request the prior opinion of a veterinarian. (5) the provisions of article 5c (5) of European Union Council Directive 79/373/EEC shall also apply to the fecdingstuffs referred to in mlc l (2) and intended for animals other than pets. (6) the labelling of the fecdingstuffs referred to in mlc l (2) may also highlight the presence or the low level of one or more analytical constituents which arc essential for the description of the fecdingstuff. In such cases, the minimum or maximum level of the analytical constituents expressed as percentage weight of the fecdingstuff must be clearly indicated in the list of declared analytical constituents. (7) the qualifying expression "dietetic" shall be reserved solely for feedingstuffs as referred to in rule 1 (2). Qualifying expressions other than "dictitic" shall be prohibited in the labelling and presentation of these fecdingstuffs. (8) Notwithstanding the provisions of article 5c (3) of European Union Council Directive 79/373/EEC, the declaration offccd materials may be made in the form of categories grouping several feed materials, even where the declaration of certain feed materials by their specific name is required to justify the nutritional characteristics of the fecdingstuff. B 3647 6. Pursuant to the procedure laid down in aiiiclc 9 to European List of intended Union Council Directive 93/74/EEC - ~ 1 ;:~i~~sluffs inlended for . , . . . particular nutritional ( a) a hst of rntcndcd uses shall be established rn accordance pmposes. with the Schedule. That list shall contain (i) the indications referred to in rule 5(1) (b), (c), (d) and (c), and (ii) where appropriate, the indications referred to in mlc 5 (2) and rule 5 (4), second subparagraph; (b) general provisions regarding the application of the indications referred to in paragraph (a) hereof, including applicable tolerances, may be established; ( c) the measures adopted in accordance with paragraphs (a) and (b) hereof may be modified, following developments m scientific and technical knowledge. B 3648 Marketing restrictions. Prescribed conditions that represent a hazard. Official inspection of feedingstuffs. 7. In Malta, feedingstuffs as referred to in mle 1 (2) are not, for reasons concerning the provisions of these rules, subject to marketing restrictions other than those provided for in these m1cs. 8. (1) Where it is established that the use of a feedingstuff as referred to in mle 1 (2) or its use in the prescribed conditions presents a hazard for animal or human health or for the environment, the Veterinary Services shall immediately inform the relevant European Union Commission, giving the reasons for its decision. (2) Appropriate measures shall be implemented as soon as possible according to decisions adopted by the European Commission. 9. To allow effective official inspection of feedingstuffs as referred to in mle 1 (2), the following specific provisions shall apply (a) the Veterinary shall make a11 necessary arrangements for official inspection during manufacture or marketing, at least by sampling, in order to ensure compliance with the requirements of these rules; and (b) appropriate, the Veterinary Services shall be empowered to require the person responsible for placing the product on the market to produce data and information establishing the feedingstuff' s conformity with these rules. If such data have been published in readily accessible form, a reference to the publication shall suffice. SCHEDULE PART A General provisions B 3649 1. Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by "and/or", for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4. 2. Where a group of additives is mentioned in column 2 or column 4 of Part B the additive (s) used must be in Regulation (EC) No 1831/2003 of the European Parliament and of the Council corresponding to the specified essential characteristic. 3. Where the source (s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient ( s ), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics. 4. Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression "total" the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from in Regulation (EC) No 1831/2003 of the European Parliament and of the Council, the total quantity of the substance naturally present and the amount added as an additive. 5. The declarations required in column 4 with the reference "if added" are compulsory where the ingredient or the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose. 6. The declarations to be given in accordance with column 4 of Part B concerning analytical constituents and additives must be quantitative. 7. The recommended period of use indicated in column 5 of part B indicates a 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. PARTB List of Intended Uses of Animal Feedingstuffs for Particular Nutritional Purposes Particular nutritional Essential nutritional Species or Labelling declarations Recommende purpose characteristics category of d length of animals time for use 1 2 3 4 5 Support of Renal - Low level of phosphorus Dogs and - Protein source(s) Initially up to Function in case of and restricted level of protein Cats - Calcium 6 months C2l chronic and renal but of high quality - Phosphorus insufficiency - Potassium Sodium Content of essential fatty acids Dissolution of struvite - Urine acidifying properties, Dogs - Protein source(s) 5 to 12 weeks stones C4l low level of magnesium, and - Calcium restricted level of protein but - Phosphorus of high quality - Sodium Magnesium Potassium Chlorides Sulphur Urine acidifying substances Urine acidifying properties Cats - Calcium and low level of magnesium - Phosphorus Sodium Magnesium Potassium Chlorides Sulphur Total ta urine Urine acidifying substances Other provisions 6 Indicate on the package, container or label: "It is recommended that a veterinarian's opinion be sought 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." t;d w °' Vi 0 1 2 3 Reduction of struvite Urine acidifying properties Dogs and stone recurrence C4) and moderate level of cats magnesmm Reduction of urate Low level of purines, low Dogs and stones formation level of protein but of high cats quality Reduction of oxalate Low level of calcium, low Dogs and stones formation level of vitamin D, and urine cats alkalising properties Reduction of cystine Low level of protein, Dogs and stones formation moderate level of sulphur cats amino acids, and urine alkalising properties Reduction of - Selected protein source(s) Dogs and ingredient and nutrient and/or cats intolerances C5l - Selected carbohydrate source(s) 4 Calcium Phosphorus Sodium Magnesium Potassium Chlorides Sulphur Urine acidifying substances Protein source(s) Phosphorus Calcium Sodium Magnesium Potassium Chlorides Sulphur Total vitamin D Hydroxyproline Urine alkalising substances Total sulphur amino acids Sodium Potassium Chlorides Sulphur Urine alkalising substances Protein source(s) Content of essential fatty acids (if added) Carbohydrate source(s) Content of essential fatty acids (if added) 5 Upto 6 months Upto 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism Upto 6 months Initially up to 1 year 3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely 6 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." t;d w °' Vi I--" 1 2 3 Reduction of acute Increased level of electrolytes Dogs and intestinal absorptive and highly digestible cats disorders ingredients Compensation for Highly digestible ingredients Dogs and maldigestion (6) and low level of fat cats Support of heart Low level of sodium and Dogs and function in case of increased K/Na ratio cats chronic cardiac insufficiency Regulation of glucose Low level of rapid Dogs and supply (Diabetes glucosereleasing cats mellitus) carbohydrates 4 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 Potassium 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) 5 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 6 Indicate on the package, container or label: "During periods of and recovery from acute diarrhoea." "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." 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." t;d w °' Vi N 1 2 3 Support of liver - High quality protein, Dogs function in case of moderate level of protein, chronic liver high level of essential fatty insufficiency acids and high level of highly digestible carbohydrates High quality protein, Cats moderate level of protein, moderate level of fat and high level of essential fatty acids Regulation of lipid Low level of fat and high Dogs and metabolism in case of level of essential fatty acids cats hyperlipidaemia Reduction of copper in Low level of copper Dogs the liver Reduction of excessive - Low energy density Dogs and body weight cats 4 5 Protein source(s) Initially up to Content of essential fatty acids 6 months Highly digestible carbohydrates including their treatment if appropriate Sodium Total copper Protein source(s) Initially up to Content of essential fatty acids 6 months Sodium Total copper Content of essential fatty acids Initially up to Content of n-3 fatty acids (if added) 2 months Total copper Initially up to 6 months Energy value ( calculated according to EC Until target method) body weight is achieved 6 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 instruction 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 instruction 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 opinion be sought before use or before extending the period of use." In the instructions for use an appropriate daily intake must be recommended t;d w °' Vi w 1 2 3 4 5 6 Nutritional restoration, - High energy density, highly Dogs and - Highly digestible ingredients, including their Until In the case of feedingstuffs convalescence concentrations of essential cats treatment if appropriate restoration is specially presented to be given nutrients and highly - Energy value ( calculated according to EC achieved via tubing, indicate on the digestible ingredients method) package, container or label Content of n-3 and n-6 fatty acids (if added) "Administration under veterinary supervision" In case of feedingstuffs for cats, the manufacturer may complete the particular nutritional purpose with a reference to "Feline hepatic lipidosis" .' Reduction of the risk - Low level of calcium and/or Dairy cows - Calcium 1 to 4 weeks Indicate in the instructions for of milk fever - Phosphorus before calving use: Magnesium "Stop feeding after calving." Low cations/anions ratio - Calcium Phosphorus Sodium Potassium Chlorides Sulphur Reduction of the risk Ingredients providing Dairy cows - Ingredients providing glucogenic energy 3 to 6 weeks of ketosis C7l cs) glucogenic energy sources and ewes sources after calving Propane- I ,2-diol (if added as a glucose C9l Last 6 precursor) weeks before Glycerol (if added as a glucose precursor) and the first 3 weeks after lambing (lo) Reduction of the risk High level of magnesium, Ruminants - Starch 3 to 10 weeks In the instructions for use oftetany easily available - Total sugars during periods guidance shall be provided on (hypomagnesaemia) carbohydrates, moderate level - Magnesium of fast grass the balance of the daily ration, of protein and low level of - Sodium growth with regard to the inclusion of potassium - Potassium fibre and easily available energy sources. In case of feedingstuffs for ovines indicate on the package, container or label: "Especially for lactating ewes." t;d w °' Vi +' 1 2 3 4 Reduction of the risk Low level of easily Ruminants - Starch of acidosis fermentable carbohydrates - Total sugars and high buffering capacity Stabilisation of water Predominantly electrolytes Calves - Carbohydrate source(s) and electrolyte balance and easily absorbable Piglets - Sodium carbohydrates Lambs - Potassium Kids - Chlorides Foals Reduction of the risk Low level of phosphorus, Ruminants - Calcium of urinary calcull magnesium, and urine - Phosphorus acidifying properties - Sodium Magnesium Potassium Chlorides Sulphur Urine acidifying substances Reduction of stress - High level magnesium Pigs - Magnesium reactions and/or - Highly digestible ingredients including their Highly digestible treatment if appropriate ingredients - Content of n-3 fatty acids (if added) 5 Maximum2 months (II) 1 to 7 days (1 to 3 days if fed exclusively) Up to 6 weeks 1 to 7 days 6 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 (diarrhoea). - It is recommended that a veterinarian's opinion be sought before use." 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. t;d w °' Vi Vi 1 2 3 Stabilisation of - Low buffering capacity, and Piglets physiological digestion highly digestible ingredients Highly digestible Pigs ingredients Reduction of the risk Ingredients stimulating Sows of constipation intestinal passage Reduction of the risk Low energy and high Laying hens of fatty liver syndrome proportion of metabolizable energy from lipids with high level of polyunsaturated fatty acids Compensation for Low level of saturated fatty Poultry malabsorption acids and high level of fat excluding soluble vitamins geese and pigeons Compensation for - Highly precaecally Equines (2J chronic insufficiency digestible carbohydrates, of small intestine proteins and fats function 4 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) Ingredients stimulating intestinal passage Energy value (calculated according to EEC method) Percentage of metabolisable 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 5 2 to 4 weeks 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 6 Indicate on the package, container or label: "In case of risk of, during periods of, or recovery from, digestive disturbance." 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" t;d w °' Vi °' 1 2 3 4 Compensation for - Highly digestible fibre Equines - Fibre source(s) chronic digestive - Content of n-3 fatty acids (if added) disorders of large intestine Reduction of stress - Highly digestible Equines - Magnesium reactions ingredients - Highly digestible ingredients including their treatment if appropriate Content of n-3 fatty acids (if added) Compensation of Predominantly electrolytes Equines - Calcium electrolyte loss in and easily absorbable - Sodium cases of heavy carbohydrates - Magnesium sweating - Potassium Chlorides Glucose Nutritional restoration, - High concentration of Equines - Highly digestible ingredients, including their convalescence essential nutrients and highly treatment if appropriate digestible ingredients - Content of n-3 and n-6 fatty acids (if added) 5 Initially up to six months Two to four weeks One to three days Until restoration is achieved 6 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" Guidance shall be provided on the precise situations in which the use of the feed is appropriate Guidance shall be provided on the 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" 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" t;d w °' Vi -J 1 2 3 4 5 6 Support of liver Low level of protein but of Equines - Protein and fibre sources Initially tip to Guidance should be provided function in case of high quality and highly - Highly digestible carbohydrates including six months on the manner in which the chronic liver digestible carbohydrates their treatment if appropriate feed should be fed including insufficiency - Methionine many small meals per day Choline Indicate on the package, Content of n-3 fatty acids (if added) 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 Low level of protein but of Equines - Protein source(s) Initially up to Indicate on the package, function in case of high quality and low level of - Calcium six months container or label: chronic renal phosphorus - Phosphorus "It is recommended that a insufficiency - Potassium veterinarian's opinion be Magnesium sought before use or before Sodium extending the period of use." Indicate in the instructions for use: "Water should be available at all times." In case of feedingstuffs specially prepared to meet the specific conditions of very old animals ( easily ingestible ingredients) a reference to "old animals" shall complete the indication of the species or category of animals." i"2J If appropriate the manufacturer may also recommend use of temporary renal insufficiency. C 3 l If the feedingstuff is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks. C 4 l In case of feedingstuffs for cats, "feline lower urinary tract disease" or "feline urological syndrome - F .U.S." may complete the particular nutritional purpose. C 5 l In case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace "ingredient and nutrient". ( 6 ) The manufacturer may complete the particular nutritional purpose with the reference: "exocrine pancreatic insufficiency". C 7 l The term "ketosis" may be replaced by "acetonaemia". cs) The manufacturers may also recommend the use for ketosis recuperation. C 9 l In the case of feedingtuffs for dairy cows. (lo) In the case of feedingstuffs for ewes. (II) In case offeedingstuffs for dairy cows: "maximum two months from the start of lactation". 0 2 l Indicate the category of ruminants concerned. t;d w °' Vi 00