{
  "url": "https://openlegislation.uk/eu-regulation-2020-354/annex/part-B",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-354/annex/part-B.json",
  "legislation": "eur/2020/354",
  "legislation_title": "Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-354",
  "path": "annex/part/B",
  "kind": "part",
  "number": "B",
  "heading": "List of intended uses",
  "text": "For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.\nThese labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009\nIf appropriate the manufacturer may also recommend use for temporary renal insufficiency.\nbased on a diet with a dry matter energy density of 4000 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 4000 kcal Metabolisable Energy/kg.\nIf the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.\nIn the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’\nFor cats a reference to ‘Feline hepatic lipidosis’ may be added\nFor cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added.\nUndersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth.\nUrine pH ≤ 6,5.\nMetastabilising properties: urine associated with properties of prevention of crystal precipitation.\n‘exocrine pancreatic insufficiency’ may be added.\nThe minimum recommendations according to the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html) for all essential fatty acids shall be met in the daily ration.\nbased on a diet with a dry matter energy density of 3500 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines\n(http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 3500 kcal Metabolisable Energy/kg.\nMetabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.\nFEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.\nIn the case of feed for dairy cows: ‘maximum two months from the start of lactation’.\nIndicate the category of ruminants concerned.\nDCAD (mEq/kg dry matter) = (Na + K) – (Cl + S).\nThe term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.\nCalculated by the Strong Ion Difference method (SID-Value): SID is the difference between the sums of concentrations of the strong cations and strong anions; [SID] = [mmol Na+/l] + [mmol K+/l] + [mmol Ca++/l] + [mmol Mg++/l] – [mmol Cl-/l] – [mmol Other Strong Anions/l].\nEntry number\nParticular nutritional purpose\nEssential nutritional characteristics\nSpecies or category of animal\nLabelling declarations\nRecommended length of time\nOther provisions\n1\n2\n3\n4\n5\n6\n10\nSupport of renal function in case of chronic renal insufficiency\nHigh quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 % and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 %\nDogs\nProtein source(s)\nCalcium\nPhosphorus\nPotassium\nSodium\nEssential fatty acids (if added)\nInitially up to 6 months\n1..The feed shall be placed on the market as complete feed.\n2..Recommended digestibility of proteins: minimum 85 %.\n3..Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n4..Indicate in the instructions for proper use: ‘Water should be available at all times.’\nReduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate\nAdult dogs\nProtein source(s)\nCalcium\nPhosphorus\nPotassium\nSodium\nEssential fatty acids (if added)\nLanthanum carbonate octahydrate\nInitially up to 6 months\n1..Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n2..Indicate in the instructions for proper use: ‘Water should be available at all times.’\nHigh quality proteins and phosphorus ≤ 6,5 g/kg complete feed with a moisture content of 12 % and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 %\nCats\nProtein source(s)\nCalcium\nPhosphorus\nPotassium\nSodium\nEssential fatty acids (if added)\nInitially up to 6 months\n1..The feed shall be placed on the market as complete feed.\n2..Recommended digestibility of proteins: minimum 85 %.\n3..Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n4..Indicate in the instructions for proper use: ‘Water should be available at all times.’\nReduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate\nAdult cats\nProtein source(s)\nCalcium\nPhosphorus\nPotassium\nSodium\nEssential fatty acids (if added)\nLanthanum carbonate octahydrate\nInitially up to 6 months\n1..Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n2..Indicate in the instructions for proper use: ‘Water should be available at all times.’\nHigh density of energy with more than 8,8 MJ/kg feed with a moisture content of 12 %.\nHighly digestible and highly palatable sources of starch.\nRestricted protein level: ≤ 106 g crude protein/kg feed with a moisture content of 12 %.\nLevel of sodium: 2 g/100 kg BW per day.\nHigh level of eicosapentaenoic acid and docosahexaenoic sum ≥ 0,2 g per kg BW0,75 per day\nEquines\nProtein and energy source(s)\nCalcium\nPhosphorus\nPotassium\nMagnesium\nSodium\nSum of eicosapentaenoic acid and docosahexaenoic acid\nInitially up to six months.\nLong term or until resolution of the issue\n1..The feed shall be placed on the market as complementary feed\n2..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’\nThe complementary feed should not be used in case of hypernatraemia and hyperchloraemia.\nThe complementary feed should contribute to at least 10 to 20 % of the daily energy supply (approximately 0,05 to 0,1 MJ/kg BW0,75 per day).\n3..The ration should ensure an energy supply of > 0,62 MJ/kg BW0,75 per day.\n4..The ration should not exceed 50 mg calcium/kg dry matter/day.\n5..Indicate in the instructions for proper use: ‘Water should be available at all times.’\n11\nReduction of oxalate stones formation\nLow level of calcium, low level of vitamin D, and urine alkalising properties\nDogs and cats\nPhosphorus\nCalcium\nSodium\nMagnesium\nPotassium\nChlorides\nSulphur\nVitamin D (total)\nHydroxyproline\nUrine alkalising substances\nUp to 6 months\nIndicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n12\nRegulation of glucose supply (Diabetes mellitus)\nTotal sugars (mono- and disaccharides) ≤ 62 g/kg complete feed with a moisture of 12 %\nDogs and cats\nCarbohydrate source(s)\nTreatment of carbohydrates, if appropriate\nStarch\nTotal sugars\nFructose (if added)\nEssential fatty acids (if added)\nSource(s) of short and medium chain fatty acids (if added)\nInitially up to 6 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘Low level of mono- and disaccharides’\n‘It is recommended that a veterinarian’s opinion be sought before use and before extending the period of use.’\n13\nReduction of ingredient and nutrient intolerances\nSelected and limited number of protein source(s)\nAnd/or\nhydrolysed protein source(s)\nAnd/or\nselected carbohydrate source(s)\nDogs and cats\nProtein sources including treatment, if appropriate (if added).\nCarbohydrate source(s) including treatment, if appropriate (if added).\nEssential fatty acids (if added)\n3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year.\n1..The feed shall be placed on the market as complete feed.\n2..It is recommended to limit the number of main protein sources to 3.\n3..To indicate on the labelling:\nAppropriate combination of the essential nutritional characteristics, as applicable\n‘It is recommended that a veterinarian’s opinion be sought before use and before extending the period of use.’\n14\nReduction of cystine stones formation\nUrine alkalinising properties and crude protein ≤ 160 g/kg complete feed with a moisture content of 12 %\nOr\nProteins selected for a limited cystine and cysteine content (e.g. casein, pea protein, soy protein) and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 %\nDogs\nSulphur amino acids (total)\nProtein sources\nSodium\nPotassium\nChlorides\nUrine alkalinizing substances (if added)\nInitially up to 6 month\n1..The feed shall be placed on the market as complete feed.\n2..Indicate in the instructions for proper use:\n‘Water should be available at all times’\n3..Indicate on the labelling:\n‘Urine alkalinising properties and low level of proteins’ or ‘Low level of selected proteins’, as applicable.\n‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’\n4..For consideration of the veterinarian or nutritionist: Alkalinising properties means that the diet should be formulated to target a urinary pH ≥ 7.\n15\nNutritional restoration, convalescence\nHighly digestible ingredients with\nenergy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 %\nDogs\nHighly digestible ingredient sources including their treatment, if appropriate\nEnergy value\nUntil restoration is achieved\n1..Recommended apparent digestibility of Dry Matter ≥ 80 % or of Organic Matter ≥ 85 %.\n2..In the case of feed specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision.’\n3..The labelling may indicate the specific circumstance(s) the dietetic feed is intended for.\n4..Indicate on the labelling:\n‘High energy density, high concentrations of essential nutrients and highly digestible ingredients’\nHighly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12 %\nCats\n16\nReduction of urate stones formation\nCrude protein ≤ 130 g/kg complete feed with a moisture level of 12 %\nOr\nCrude protein ≤ 220 g/kg complete feed with a moisture level of 12 % and selected protein sources\nDogs\nProtein source(s)\nUp to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism\n1..The feed shall be placed on the market as complete feed.\n2..Protein quality and level of purines should be taken into account when selecting the protein source. Examples of selected protein sources of high quality with low level of purines include eggs, casein, soy proteins, and maize gluten.\n3..Indicate in the instructions for proper use: ‘Water should be available at all times’.\n4..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n‘Low level of protein’ or ‘Restricted level of protein and selected protein sources’, as appropriate.\nCrude protein ≤ 317 g/kg complete feed with a moisture content of 12 %\nCats\n1..The feed shall be placed on the market as complete feed.\n2..Protein quality and level of purines should be taken into account when selecting the protein source. Examples of selected protein sources of high quality with low level of purines include eggs, casein, soy proteins, and maize gluten.\n3..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n‘Restricted level of protein’\n4..Indicate in the instructions for proper use: ‘Water should be available at all times’.\n17\nDissolution of struvite stones\nUrine undersaturating properties for struvite\nAnd/or\nUrine acidifying properties\nAnd\nMagnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %\nDogs and cats\nPhosphorus\nCalcium\nSodium\nMagnesium\nPotassium\nChloride\nSulfur\n5 to 12 weeks\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n‘Urine undersaturating properties for struvite and/or Urine acidifying properties.’\n3..Indicate in the instructions for proper use: ‘Water should be available at all times.’\n4..Declaration of conformity supporting undersaturating and/or acidifying properties of the diet shall be made available to the relevant competent authorities upon request.\n18\nReduction of struvite stone recurrence\nComplete feed with urine undersaturating or metastabilising properties for struvite\nAnd/or\nDiet with urine acidifying properties\nAnd\nMagnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %\nDogs and cats\nPhosphorus\nCalcium\nSodium\nMagnesium\nPotassium\nChloride\nSulfur\nInitially up to 6 month\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n‘Urine undersaturating or metastabilising properties for struvite and/or Urine acidifying properties’\n3..Indicate in the instructions for proper use: ‘Water should be available at all times.’\n4..Declaration of conformity supporting undersaturating or metastabilising and/or acidifying properties of the diet shall be made available to the relevant competent authorities upon request.\n19\nCompensation for maldigestion\nHighly digestible diet:\nApparent digestibility of\nlow-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %):\nCrude protein ≥ 85 %\nCrude fat ≥ 90 %\nOr\nfibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %):\nCrude protein ≥ 80 %\nCrude fat ≥ 80 %\nDogs and cats\nHighly digestible ingredient sources including their treatment, if appropriate\nInitially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘Highly digestible feed’\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n20\nReduction of intestinal absorptive disorders\nHighly digestible diet:\nApparent digestibility of\nlow-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %):\nCrude protein ≥ 85 %\nCrude fat ≥ 90 %\nOr\nfibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %):\nCrude protein ≥ 80 %\nCrude fat ≥ 80 %\nAnd\nSodium ≥ 1,8 g per kg of complete feed with a moisture level 12 %\nAnd\nPotassium ≥ 5 g per kg of complete feed with a moisture level 12 %\nDogs and cats\nHighly digestible ingredient sources including their treatment, if appropriate\nSodium\nPotassium\nUp to 12 weeks\nIndicate on the labelling:\n‘Highly digestible feed with increased sodium and potassium’\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n21\nReduction of acute intestinal absorptive disorders\nIncreased level of electrolytes:\nSodium ≥ 1,8 %\nPotassium ≥ 0,6 %\nAnd\nHighly digestible carbohydrates:\n≥ 32 %\nDogs and cats\nSodium\nPotassium\nCarbohydrate source(s)\n1 – 7 days\n1..The feed shall be placed on the market as complementary feed.\n2..Indicate on the labelling:\n‘During periods of and recovery from acute diarrhoea’\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n3..In case of solid feed, the recommended range of electrolytes should be calculated on the basis of a normal daily voluntary intake of water.\n22\nSupport of lipid metabolism in the case of hyperlipidaemia\nFat ≤ 110 g/kg complete feed with a moisture content of 12 %\nDogs and cats\nCrude fat\nInitially up to 2 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’\n‘Low level of fat’\n23\nSupport of liver function in the case of chronic liver insufficiency\nModerate level of protein:\nCrude protein ≤ 279 g/kg complete feed with a moisture content of 12 % for dogs\nCrude protein ≤ 370 g/kg complete feed with a moisture content of 12 % for cats\nAnd\nSelected protein sources\nAnd\nRecommended dietary protein digestibility ≥ 85 %\nDogs and cats\nProtein source(s)\nCopper (total)\nSodium\nInitially up to 4 months\n1..The feed shall be placed on the market as complete feed.\n2..Examples of selected protein sources based on high digestibility: dairy proteins (whey, casein, milk, cottage cheese), other animal based proteins (egg, poultry) and vegetable proteins (soy).\n3..Indicate in the instructions for proper use: ‘Water should be available at all times.’\n4..Indicate on the labelling:\n‘Moderate level of protein, selected and highly digestible’\n‘It is recommended that a veterinarian’s opinion be sought before use.’\nLow level of protein but of high quality and highly digestible carbohydrates\nEquines\nProtein and fibre sources\nHighly digestible carbohydrates including their treatment, if appropriate\nMethionine\nCholine\nContent of n-3 fatty acids (if added)\nInitially up to six months\n1..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’\n2..Guidance should be provided on the manner in which the feed should be fed including many small meals per day.\n24\nSupport of heart function in the case of chronic cardiac insufficiency\nRestricted level of sodium:\nSodium ≤ 2,6 g per kg complete feed with a moisture content of 12 %\nDogs and cats\nMagnesium\nPotassium\nSodium\nInitially up to 6 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n25\nReduction of excessive body weight\nMetabolizable Energy < 3060 kcal/kg complete feed with moisture content of 12 %\nOr\nMetabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 %\nDogs\nEnergy value\nUntil target body weight is achieved and after if required to maintain target bodyweight\n1..The feed shall be placed on the market as complete feed.\n2..To ensure that minimum requirements are met, the nutrient levels of a diet for reduction of excessive bodyweight should be increased accordingly to compensate for the restricted daily energy intake\n3..Indicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n‘For cats, a transition period when starting the diet is advised.’\n‘For an efficient weight loss or ideal weight maintenance, the recommended daily energy intake should not be exceeded.’\nMetabolizable Energy < 3190 kcal per kg complete feed with moisture content of 12 %\nOr\nMetabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 %\nCats\n26\nSupport of skin function in the case of dermatosis and excessive loss of hair\nLinoleic acid ≥ 12,3 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 2,9 g per kg of complete feed with a moisture content of 12 %\nDogs and cats\nLinoleic acid\nSum of eicosapentaenoic acid and docosahexaenoic acid\nInitially up to 2 months\nIndicate on the labelling:\n‘It is recommended that a veterinarian’s opinion be sought before use.’\n‘High level of linoleic acid (LA) and of sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)’\nLinoleic acid ≥ 18,5 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 0,39 g per kg of complete feed with a moisture content of 12 %\nDogs\nLinoleic acid ≥ 18,5 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 0,09 g per kg of complete feed with a moisture content of 12 %\nCats\n27\nSupport of the metabolism of joints in the case of osteoarthritis\nTotal omega-3 fatty acids ≥ 29 g per kg and eicosapentaenoic acid ≥ 3,3 g per kg complete feed with a moisture content of 12 %\nAnd\nAdequate levels of vitamin E\nDogs\nOmega-3 fatty acids (total)\nEicosapentaenoic acid (total)\nVitamin E (total)\nInitially up to 3 months\nIndicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\nTotal omega-3 fatty acids ≥ 10,6 g per kg complete feed with a moisture content of 12 % and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 %\nAnd\nIncreased levels of methionine and manganese\nAdequate levels of vitamin E.\nCats\nOmega-3 fatty acids (total)\nDocosahexaenoic acid (total)\nMethionine (total)\nManganese (total)\nVitamin E (total)\n28\nReduction of copper in the liver\nRestricted level of copper: copper ≤ 8,8 mg per kg complete feed with a moisture content of 12 %\nDogs\nCopper (total)\nInitially up to 6 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n29\nReduction of iodine levels in feed in case of hyperthyroidism\nRestricted level of iodine: iodine ≤ 0,26 mg per kg complete feed with a moisture content of 12 %\nCats\nIodine (total)\nInitially up to 3 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n30\nSupport in stressful situations, which will lead to the reduction of associated behaviour\n1-3 g trypsin-hydrolysed bovine casein per kg complete feed with a moisture content of 12 %\nDogs\nTrypsin-hydrolysed bovine casein\nInitially up to 2 months\n1..The feed shall be placed on the market as complete feed.\n2..Indicate on the labelling:\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n50\nSupport the preparation for oestrus and reproduction\nHigh level of selenium and a minimum content of vitamin E per kg complete feed with a moisture content of 12 % for pigs of 50 mg, rabbits of 35 mg, for dogs, cats, mink of 88 mg; a minimum content of vitamin E per animal and day for ovines of 100 mg, cattle of 300 mg, horses of 1 100 mg\nOr\nHigh level(s) of vitamins A and/or vitamin D and/or a minimum content of beta- carotene of 300 mg per animal and day.\nThe complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nMammals\nNames and total amounts of each added trace element and vitamin\nCows: 2 weeks before the end of gestation until the next gestation is confirmed.\nSows: 7 days before until 3 days after parturition and 7 days before until 3 days mating.\nOther female mammals: from the last part of gestation until the next gestation is confirmed.\nMales: during periods of reproductive activity.\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.\n3..Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.\nHigh level(s) of vitamin A and/or vitamin D\nOr\nHigh level(s) of selenium and/or zinc and/or a minimum content of vitamin E of 40 mg/kg complete feed with a moisture content of 12 %.\nThe complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nBirds\nNames and total amounts of each added trace element and vitamin\nFor females: during oestrus\nFor males: during periods of reproductive activity\n51\nSupport the regeneration of hooves, trotters and skin\nHigh level of zinc.\nThe complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nHorses, ruminants and pigs\nZinc (total)\nMethionine (total)\nBiotin (if added)\nUp to 8 weeks\n1..The instructions for proper use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected.\n2..Application in the form of bolus is allowed for ruminants. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n52\nSupport for nutritional imbalances in dietary transition\nMinimum supply via the dietetic feed of:\nSelenium: 0,1 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nZinc: 15 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nCopper: 2 mg/kg complete feed with a moisture content of 12 % for sheep and 5 mg/kg complete feed with a moisture content of 12 % for other species\nAnd/or\nVitamin A: 2000 IU/kg complete feed with a moisture content of 12 %\nAnd/or\nVitamin D: 400 IU/kg complete feed with a moisture content of 12 %\nAnd/or\nVitamin E: 35 mg/kg complete feed with a moisture content of 12 % for poultry, 10 mg/kg complete feed with a moisture content of 12 % for ruminants, 40 mg/kg complete feed with a moisture content of 12 % for rabbits and 20 mg/kg complete feed for pigs with a moisture content of 12 %\nThe complementary feed may contain selenium, zinc, copper, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nRuminants\nPigs\nRabbits\nPoultry\nName and total amount of the nutritional additives, if appropriate\n2 to 15 days\n1..Application in the form of bolus is allowed for ruminants and pigs. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.\n3..Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.\n53\nSupport weaning\nMinimum supply via the dietetic feed of:\nSelenium: 0,1 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nZinc: 15 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nCopper: 2 mg/kg complete feed with a moisture content of 12 % for sheep and 5 mg/kg complete feed with a moisture content of 12 % for other species\nAnd/or\nIodine: 0,2 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nManganese: 20 mg/kg complete feed with a moisture content of 12 %\nAnd/or\nVitamin A: 1500 IU/kg complete feed with a moisture content of 12 %\nAnd/or\nVitamin D: 400 IU/kg complete feed with a moisture content of 12 %\nAnd/or\nVitamin E: 100 mg/kg complete feed with a moisture content of 12 % for calves and 50 mg/kg complete feed with a moisture content of 12 % for lambs, kids and piglets.\nThe complementary feed may contain selenium, zinc, copper, iodine, manganese, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nMammals\nName and total amount of the nutritional additives, if appropriate\nUp to 4 weeks around weaning\n1..The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.\n2..Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.\n54\nSupport the regeneration of the skin and appendages\nMinimum supply of zinc compounds via dietetic feed corresponding to 20 mg/kg complete feed with a moisture content of 12 %\nAnd\nHigh level of copper and/or iodine and/or selenium\nand/or\nvitamin B6 and/or vitamin E and/or vitamin A\nand/or\nmethionine and/or cystine and/or\nminimum supply of 0,4 mg biotin/kg complete feed with a moisture content of 12 % for ruminants.\nThe complementary feed may contain zinc, copper, iodine, selenium and vitamin A in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nMammals and poultry\nName and total amount of the nutritional additives, if appropriate\nUp to 8 weeks\nComplementary feed for ruminants containing biotin: Up to 6 months\n1..The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.\n2..Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.\n55\nStabilisation of water and electrolyte balance to support the physiological digestion\nPredominantly electrolytes: sodium, potassium and chlorides\nBuffering capacity in case of liquid feed: minimum 60 mmol per litre potion ready prepared for feeding\nEasily digestible carbohydrates\nCalves, pigs, lambs, kids and foals\nSodium\nPotassium\nChlorides\nCarbohydrate source(s)\nBicarbonates and/or citrates (if added)\n1 to 7 days\n1..Recommended range of electrolytes per litre potion ready prepared for feeding:\nSodium: 1.7 g – 3.5 g\nPotassium: 0.4 g – 2 g\nChlorides: 1 g – 2.8 g\n2..In case of solid feed, the recommended range of electrolytes should be calculated on the basis of a normal daily voluntary intake of water.\n3..Indicate on the labelling:\n‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’\n‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’\n4..Indicate in the instructions for proper use:\nThe recommended intake of the ready stirred potion and of milk, if appropriate.\nIn case of bicarbonates and/or citrates are above 40 mmol per litre potion ready prepared for feeding of ruminants: ‘Simultaneous feeding of milk should be avoided in animals with abomasum’\n56\nReduction of the risk of tetany (hypomagnesaemia)\nHigh level of magnesium, easily\navailable carbohydrates,\nmoderate level of protein and\nlow level of potassium\nRuminants\nStarch\nSugars (total)\nMagnesium\nSodium\nPotassium\n3 to 10 weeks during periods of fast grass growth\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..In the instructions for proper use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily available energy sources.\n3..In the case of feed for ovines indicate on the labelling: ‘Especially for lactating ewes.’\n57\nReduction of the risk of acidosis\nLow level of easily fermentable carbohydrates and high buffering capacity\nRuminants\nStarch\nSugars (total)\nup to 2 months\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..In the instructions for proper use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily fermentable carbohydrate sources.\n3..In the case of feed for dairy cows indicate on the labelling: ‘Especially for high yielding cows.’\n4..In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed.’\n58\nReduction of the risk of urinary calculi\nLow level of phosphorus, magnesium, and urine acidifying properties\nRuminants\nCalcium\nPhosphorus\nSodium\nMagnesium\nPotassium\nChlorides\nSulphur\nUrine acidifying substances\nUp to 6 weeks\n1..Indicate on the labelling: ‘Especially for intensively fed young animals.’\n2..Indicate in the instructions for proper use: ‘Water should be available at all times.’\n59\nLong-term supply of grazing animals with trace elements and/or vitamins\nHigh level of\nTrace elements\nAnd/or\nVitamins, provitamins and chemically well-defined substances having similar effects.\nThe complementary feed may\ncontain feed additives in a\nconcentration higher than 100\ntimes the relevant fixed\nmaximum content in complete\nfeed\nRuminants\nwith a\nfunctional\nrumen\nNames and total amounts of each added trace element, vitamin, provitamin and chemically well-defined substance having similar effects\nDaily release rate for each trace element and/or vitamin if a bolus is used\nMaximum period of continuously release of the trace element or vitamin if a bolus is used\nUp to 12 months\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..Indicate on the labelling of the feed:\n‘Simultaneous supplementation of additives with a maximum content from other sources to those incorporated in a bolus, if applicable, shall be avoided.\nBefore using, it is recommended to have advice from a veterinarian or nutritionist concerning:\n(a)the balance of trace elements in the daily ration;\n(b)the trace elements status of the herd’\n60\nReduction of the risk of milk fever and subclinical hypocalcaemia\nLow cations/anions ratio\nFor the total ration:\nMinimum acidification via feed for particular nutritional purpose: 100 mEq/kg dry matter\nObjective: range from -200 mEq/kg dry matter DCAD to < 100 mEq/kg dry matter DCAD\nOr\nDairy cows\nCalcium\nPhosphorus\nMagnesium\nSodium\nPotassium\nChlorides\nSulphur\nFrom 3 weeks before calving until calving\nIndicate in the instructions for proper use:\n‘Stop feeding after calving’\nZeolite (sodium aluminium silicate): 250 – 500 g/day\nSodium aluminium silicate\nFrom 3 weeks before calving until calving\nIndicate in the instructions for proper use:\n‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’\nThe duration of use shall be restricted to a maximum of 2 weeks.\n‘Stop feeding after calving’\nOr\nSupply of rumen protected feed materials rich in phytic acid (> 6 %) and having a calcium content < 0,2 %, to achieve a minimum of 28 g and a maximum of 32 g available calcium per cow per day.\nOr\nCalcium\nFrom 4 weeks before calving until calving\nIndicate in the instructions for proper use:\n‘Stop feeding after calving’\nHigh level of calcium in the form of highly available sources of calcium: calcium chloride and/or calcium sulfate and/or dicalcium phosphate and/or calcium carbonate and/or calcium propionate and/or calcium formate. and/or ‘any other calcium source having a similar effect’\nCalcium provided by one or a combination of these sources with a minimum of 50 g per cow per day\nOr\nCalcium\nCalcium sources\nFrom first signs of parturition to two days\nSubsequent to parturition\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..Indicate in the instructions for proper use the number of applications and the time before and after calving.\n3..Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.\nCalcium pidolate in a minimum of 5,5 g per cow per day\nOr\nCalcium\nCalcium pidolate\nFrom first signs of parturition to two days subsequent to parturition\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.\nWaxy-leaf nightshade meal allowing a daily release of 38 – 46 μg 1,25 dihydroxycholecalciferol-glycoside per day\nWaxy-leaf nightshade meal\nContent of 1,25 dihydroxycholecalciferol-glycoside\nCrude fibre\nMagnesium\nCrude fat\nStarch\nVitamin D3 (total) as cholecalciferol\nFrom two days before calving or first signs of parturition to 10 days subsequent to parturition\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.\n61\nReduction of the risk of ketosis\nMinimum supply of propane-1,2-diol or propylene glycol:\n250 g/day for dairy cows\n50 g/day for ewes or goats\nOr\nMinimum supply of propionates (calcium or sodium salts):\n110 g/day for dairy cows\n22 g/day for ewes or goats\nOr\nMinimum combined supply of propane-1,2-diol and propionates (sodium or calcium salts), as long as:\nThe combination of propane-1,2-diol and propionates for dairy cows is such that propionates 0,44 x propane-1,2 diol > 110 g/day\nThe combination of propane-1,2-diol and propionates for ewes or goats is such that propionates 0,44 x propane-1,2 diol > 22 g/day\nDairy cows, ewes and goats\nPropane-1,2-diol, if added\nPropionates in the form of sodium or calcium salts, if added\nBetween three weeks before and six weeks after calving for dairy cows\nBetween six weeks before and three weeks after parturition for ewes and goats\n1..Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.\n2..Indicate on the labelling: ‘During the supply of calcium or sodium propionates at the end of gestation, an evaluation of the mineral equilibrium in association with the risk of hypocalcaemie after parturition is necessary.’\n62\nReduction of stress reactions\nHigh level magnesium\nAnd/or\nHighly digestible ingredients\nPigs\nMagnesium\nHighly digestible ingredients including their treatment if appropriate\nContent of n-3 fatty acids (if added)\n1 to 7 days\nGuidance shall be provided on the situation in which the use of this feed is appropriate.\n63\nReduction of the risk of constipation\nIngredients stimulating intestinal passage\nSows\nIngredients stimulating intestinal passage\n10 to 14 days before and 10 to 14 days after farrowing\n64\nCompensation for insufficient iron availability after birth\nHigh level of iron compounds authorised under the functional group ‘compounds of trace elements’ of the category ‘nutritional additives’ as referred to in Annex I to Regulation (EC) No 1831/2003.\nThe complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nSuckling piglets and calves\nIron (total)\nAfter birth up to 3 weeks\nThe instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected.\n65\nCompensation for malabsorption\nLow level of saturated fatty acids and high level of fat soluble vitamins\nPoultry excluding geese and pigeons\nPercentage of saturated fatty acids in relation to total fatty acids\nVitamin A (total)\nVitamin D (total)\nVitamin E (total)\nVitamin K (total)\nDuring the first 2 weeks after hatching\n66\nReduction of the risk of fatty liver syndrome\nLow energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids\nLaying hens\nEnergy value (calculated according to EC method)\nPercentage of metabolisable energy from lipids\nContent of poly-unsaturated fatty acids\nUp to 12 weeks\n67\nSupport the preparation for and recovery from sport effort\nHigh level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %.\nThe complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed.\nEquidae\nVitamin E (total)\nSelenium (total)\nUp to 8 weeks before sport effort – Up to 4 weeks after sport effort\nThe instructions for proper use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected.\n68\nCompensation of electrolyte loss in the cases of heavy sweating\nMust contain sodium chloride and should contain potassium chloride.\nLow levels of Magnesium, Calcium and Phosphorus\nThe inclusion of other electrolyte salts is optional.\nEquines\nSodium\nChlorides\nPotassium\nCalcium\nMagnesium\nPhosphorus\nOne to three days after heavy sweating.\n1..Guidance shall be provided on the situations in which the use of the feed is appropriate.\n2..The instructions for proper use must give administration guidelines based on the duration and intensity of exercise performed relevant to the formulation and presentation of the feed.\n3..Indicate on the labelling:\n‘Water should be available at all times.’\nIn the case of the administration of electrolytes not mixed with water (e.g. in feed or in syringe format): ‘Water must be available for at least 20 minutes or preferably for 1 hour post administration.’\n4..Furthermore guidance must be given to monitor subsequent drinking, if insufficient water intake is observed veterinary advice should be sought.\n5..Guidance may optionally be given regarding the quantity of water (in litres) to be provided alongside in feed or syringed electrolytes.\n69\nSupport of energy metabolism and of the muscle function in the case of rhabdomyolosis\nStarch and sugar not more than 20 % of available energy.\nCrude fat more than 20 % of available energy\nMinimum of 350 IU Vitamin E/kg complete feed with a moisture content of 12 %\nEquines\nStarch\nSugar\nCrude fat\nVitamin E (total)\nInitially for a minimum of 3 months\n1..Guidance shall be provided on the situations in which the use of this feed is appropriate.\n2..The instructions for proper use shall contain guidance on the balance of the daily ration and the appropriate daily intake.\n3..Indicate on the labelling: ‘It is recommended that a veterinarian’s opinion be sought before use.’\n70\nCompensation for chronic digestive disorders of large intestine\nStarch content to provide < 1 g/kg BW/meal (< 0,5 g/kg BW/meal, if diarrhoea present)\nCereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve small intestinal starch digestion\nAdditional supply of water soluble vitamins and adequate minerals/electrolytes levels\nAdditional supply of oil if no diarrhoea\nEquines\nStarch\nCrude fat\nLong term or until resolution of the issue\n1..Guidance shall be provided\non the precise situations in which the use of the feed is appropriate, in particular whether the product is for use in animals with concurrent diarrhoea or not.\non meal size and forage intake.\n2..The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.\n3..Indicate on the labelling the processing used for the cereal grains.\n71\nCompensation for chronic insufficiency of small intestine function\nHighly digestible fibres\nHigh quality protein sources and lysine > 4,3 % of crude protein\nTotal sugar and starch to provide a maximum of 0,5 g/kg BW/meal\nCereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve pre-caecal digestion\nEquines\nHighly digestible feed materials including their processing, if appropriate.\nTotal sugar and starch\nProtein sources\nLong term or until resolution of the issue\n1..Guidance shall be provided on\nthe precise situations in which the use of the feed is appropriate\nmeal size and forage intake.\n2..The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.\n72\nStabilisation of the physiological digestion\nFeed additives of the functional group ‘Gut flora stabiliser’ as referred to in Annex I to Regulation (EC) No 1831/2003 or, pending the re-authorisation procedure as referred to in Article 10 of Regulation (EC) No 1831/2003, feed additives of the group ‘micro-organisms’\nAnimal species for which the gut flora stabiliser or micro-organism is authorised\nName and added amount of the gut flora stabiliser or micro- organism\nUp to 4 weeks\n1..Indicate on the labelling:\n‘In case of risk of, during periods of, or recovery from digestive disturbance’.\n2..The instructions for proper use of the feed shall ensure that the legal maximum content of the gut flora stabiliser or micro-organism for complete feed is respected.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex Pt. B Entry 60 substituted (E.) (20.12.2024) by The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024 (S.I. 2024/1101), regs. 1(1), 4 (with Pt. 5); and words in Annex Pt. B Entry 60 substituted (W.) (20.12.2024) by The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024 (S.I. 2024/1251), regs. 1(2)(c), 17(2) (with Pt. 3); and words in Annex Pt. B Entry 60 substituted (S.) (20.12.2024) by The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024 (S.S.I. 2024/330), regs. 1, 12(2) (with Pt. 4)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009"
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "If appropriate the manufacturer may also recommend use for temporary renal insufficiency."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "based on a diet with a dry matter energy density of 4000 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 4000 kcal Metabolisable Energy/kg."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’"
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "For cats a reference to ‘Feline hepatic lipidosis’ may be added"
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "Urine pH ≤ 6,5."
    },
    {
      "type": "footnote",
      "label": "f11",
      "text": "Metastabilising properties: urine associated with properties of prevention of crystal precipitation."
    },
    {
      "type": "footnote",
      "label": "f12",
      "text": "‘exocrine pancreatic insufficiency’ may be added."
    },
    {
      "type": "footnote",
      "label": "f13",
      "text": "The minimum recommendations according to the FEDIAF Nutritional Guidelines (http://www.fediaf.org/self-regulation/nutrition.html) for all essential fatty acids shall be met in the daily ration."
    },
    {
      "type": "footnote",
      "label": "f14",
      "text": "based on a diet with a dry matter energy density of 3500 kcal Metabolisable Energy/kg calculated using the equation described in the FEDIAF Nutritional Guidelines(http://www.fediaf.org/self-regulation/nutrition.html). The values shall be adapted if the energy density deviates from the 3500 kcal Metabolisable Energy/kg."
    },
    {
      "type": "footnote",
      "label": "f15",
      "text": "Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs."
    },
    {
      "type": "footnote",
      "label": "f16",
      "text": "FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs."
    },
    {
      "type": "footnote",
      "label": "f17",
      "text": "Calculated by the Strong Ion Difference method (SID-Value): SID is the difference between the sums of concentrations of the strong cations and strong anions; [SID] = [mmol Na+/l] + [mmol K+/l] + [mmol Ca++/l] + [mmol Mg++/l] – [mmol Cl-/l] – [mmol Other Strong Anions/l]."
    },
    {
      "type": "footnote",
      "label": "f18",
      "text": "In the case of feed for dairy cows: ‘maximum two months from the start of lactation’."
    },
    {
      "type": "footnote",
      "label": "f19",
      "text": "Indicate the category of ruminants concerned."
    },
    {
      "type": "footnote",
      "label": "f20",
      "text": "DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S)."
    },
    {
      "type": "footnote",
      "label": "f21",
      "text": "The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2020/354/annex/part/B",
    "retrieved_at": "2026-11-01T14:42:49.004556+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}