Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (Codified version) (Text with EEA relevance )
Modified by
  • Commission Directive 2008/82/ECof 30 July 2008amending Directive 2008/38/EC as regards feedingstuffs intended for the support of the renal function in case of chronic renal insufficiency(Text with EEA relevance), 32008L0082, July 31, 2008
  • Commission Regulation (EU) No 1070/2010of 22 November 2010amending Directive 2008/38/EC by adding to the list of intended uses as a particular nutritional purpose the support of the metabolism of the joints in the case of osteoarthritis in dogs and cats(Text with EEA relevance), 32010R1070, November 23, 2010
  • Commission Regulation (EU) No 5/2014of 6 January 2014amending Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(Text with EEA relevance), 32014R0005, January 7, 2014
  • Commission Regulation (EU) No 1123/2014of 22 October 2014amending Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(Text with EEA relevance), 32014R1123, October 23, 2014
  • Commission Regulation (EU) 2020/354of 4 March 2020establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC(Text with EEA relevance), 32020R0354, March 5, 2020
Commission Directive 2008/38/ECof 5 March 2008establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(Text with EEA relevance)(Codified version)
Article 1Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of Annex I to this Directive and if they fulfil the other provisions laid down in that Part of Annex I.Furthermore, the Member States shall ensure that the provisions under "General provisions" of Part A of Annex I are complied with.
Article 2Directive 94/39/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3This Directive shall enter into force on 31 July 2008.
Article 4This Directive is addressed to the Member States.
nullANNEX IPART AGeneral provisions1.Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by "and/or", for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4.2.Where a group of additives is mentioned in column 2 or column 4 of Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilOJ L 268, 18.10.2003, p. 29. as corresponding to the specified essential characteristic.3.Where the source(s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer 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/EECOJ L 270, 14.12.1970, p. 1., 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.10.When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration by forced feeding, the label of the feed shall, if applicable, mention the maximum period of continuously release of the bolus and the daily release rate for each additive for which a maximum content in complete feed is fixed. At the request of the competent authority the feed business operator which is placing a bolus on the market shall provide proof that the daily available additive level in the digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (slow release effect). It is recommended that feed in form of bolus is administered by a veterinarian or any other competent person.PART BList of intended uses
If appropriate the manufacturer may also recommend use for temporary renal insufficiency.If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.In the case of feedingstuffs for cats, "feline lower urinary tract disease" or "feline urological syndrome — FUS" may complete the particular nutritional purpose.In the case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace "ingredient and nutrient".The manufacturer may complete the particular nutritional purpose with the reference: "exocrine pancreatic insufficiency".The manufacturer may complete the particular nutritional purpose with a reference to "Feline hepatic lipidosis".The term "ketosis" may be replaced by "acetonaemia".The manufacturers may also recommend the use for ketosis recuperation.In the case of feedingstuffs for dairy cows.In the case of feedingstuffs for ewes.In the case of feedingstuffs for dairy cows: "maximum two months from the start of lactation".Indicate the category of ruminants concerned.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].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.
Particular nutritional purposeEssential nutritional characteristicsSpecies or category of animalsLabelling declarationsRecommended length of timeOther provisions
(1)(2)(3)(4)(5)(6)
Support of renal function in case of chronic renal insufficiencyHigh quality proteins and restricted levels ofphosphorus maximum 5 g/kg complete pet food with a moisture content of 12 % andcrude protein maximum 220 g/kg complete pet food with a moisture content of 12 %orDogsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Initially up to 6 monthsThe feed shall be placed on the market as complete feed.Recommended digestibility of proteins: minimum 85 %.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrateAdult dogsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Lanthanum carbonate octahydrateInitially up to 6 monthsIndicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
High quality proteins and restricted levels ofphosphorus maximum 6,2 g/kg complete pet food with a moisture content of 12 % andcrude protein maximum 320 g/kg complete pet food with a moisture content of 12 %orCatsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Initially up to 6 monthsThe feed shall be placed on the market as complete feed.Recommended digestibility of proteins: minimum 85 %.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrateAdult catsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Lanthanum carbonate octahydrateInitially up to 6 monthsIndicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use: "Water should be available at all times."
Dissolution of struvite stones—Urine acidifying properties, low level of magnesium, and restricted level of protein but of high qualityDogsProtein source(s)CalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substances5 to 12 weeksIndicate 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."
—Urine acidifying properties and low level of magnesiumCatsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurTotal taurineUrine acidifying substances
Reduction of struvite stone recurrenceUrine acidifying properties and moderate level of magnesiumDogs and catsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substancesUp to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of urate stones formationLow level of purines, low level of protein but of high qualityDogs and catsProtein source(s)Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolismIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of oxalate stones formationLow level of calcium, low level of vitamin D, and urine alkalising propertiesDogs and catsPhosphorusCalciumSodiumMagnesiumPotassiumChloridesSulphurTotal vitamin DHydroxyprolineUrine alkalising substancesUp to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of cystine stones formationLow level of protein, moderate level of sulphur amino acids and urine alkalising propertiesDogs and catsTotal sulphur amino acidsSodiumPotassiumChloridesSulphurUrine alkalising substancesInitially up to 1 yearIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use or before extending the period of use."
Reduction of ingredient and nutrient intolerances—Selected protein source(s)Dogs and catsProtein source(s)Content of essential fatty acids (if added)3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely
and/or
—Selected carbohydrate source(s)Carbohydrate source(s)Content of essential fatty acids (if added)
Reduction of acute intestinal absorptive disordersIncreased level of electrolytes and highly digestible ingredientsDogs and catsHighly digestible ingredients including their treatment if appropriateSodiumPotassiumSource(s) of mucilaginous substances (if added)1 to 2 weeksIndicate 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."
Compensation for maldigestionHighly digestible ingredients and low level of fatDogs and catsHighly digestible ingredients including their treatment if appropriate3 to 12 weeks, but lifetime in the case of chronic pancreatic insufficiencyIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Support of heart function in the case of chronic cardiac insufficiencyLevel of sodium restricted to be lower than 2,6 g/kg complete pet food with a moisture content of 12 %Dogs and catsMagnesiumPotassiumSodiumInitially up to 6 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Regulation of glucose supply (Diabetes mellitus)Low level of rapid glucose-releasing carbohydratesDogs and catsCarbohydrate source(s)Treatment of carbohydrates if appropriateStarchTotal sugarFructose (if added)Content of essential fatty acids (if added)Source(s) of short and medium chain fatty acids (if added)Initially up to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use or before extending the period of use."
Support of liver function in the case of chronic liver insufficiency—High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydratesDogsProtein source(s)Content of essential fatty acidsHighly digestible carbohydrates including their treatment if appropriateSodiumTotal copperInitially up to 6 monthsIndicate 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."
—High quality protein, moderate level of protein and high level of essential fatty acidsCatsProtein source(s)Content of essential fatty acidsSodiumTotal copperInitially up to 6 monthsIndicate 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 the case of hyperlipidaemiaLow level of fat and high level of essential fatty acidsDogs and catsContent of essential fatty acidsContent of n-3 fatty acids (if added)Initially up to 2 monthsIndicate 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 iodine levels in feed in case of hyperthyroidismRestricted level of iodine: maximum 0,26 mg/kg complete pet food with a moisture content of 12 %CatsTotal iodineInitially up to 3 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Reduction of copper in the liverRestricted level of copper: maximum 8,8 mg/kg complete pet food with a moisture content of 12 %DogsTotal copperInitially up to 6 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Reduction of excessive body weightLow energy densityDogs and catsEnergy valueUntil target body weight is achievedIn the instructions for use an appropriate daily intake must be recommended.
Nutritional restoration, convalescenceHigh energy density, high concentrations of essential nutrients and highly digestible ingredientsDogs and catsHighly digestible ingredients, including their treatment if appropriateEnergy valueContent of n-3 and n-6 fatty acids (if added)Until restoration is achievedIn the case of feed specially presented to be given via tubing, indicate on the labelling: "Administration under veterinary supervision."
The complementary feed may contain Enterococcus faecium DSM 10663/NCIMB 10415 in a concentration higher than 100 times the relevant fixed maximum content in complete feed.DogsEnterococcus faecium DSM 10663/NCIMB 10415 including added amount10 to 15 daysThe instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser//micro-organism for complete feed is respected.Indicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Support of skin function in the case of dermatosis and excessive loss of hairHigh level of essential fatty acidsDogs and catsContent of essential fatty acidsUp to 2 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Support of the metabolism of joints in the case of osteoarthritisDogs:Minimum dry matter content of total omega-3 fatty acids 3,3 % and of eicosapentaenoic acid (EPA) 0,38 %.Adequate level of vitamin E.Cats:Minimum dry matter content of total omega-3 fatty acids 1,2 % and of docosahexaenoic acid (DHA) 0,28 %.Increased levels of methionine and manganese.Adequate level of vitamin E.Dogs and catsDogs:Total omega-3 fatty acidsTotal EPATotal vitamin ECats:Total omega-3 fatty acidsTotal DHATotal methionineTotal manganeseTotal vitamin EInitially up to 3 monthsIt is recommended that a veterinary surgeon’s opinion be sought before use or before extending the period of use.
Reduction of the risk of milk fever—Low level of calciumDairy cowsCalciumPhosphorusMagnesium1 to 4 weeks before calvingIndicate in the instructions for use:"Stop feeding after calving"
and/or
—Low cations/anions ratioCalciumPhosphorusSodiumPotassiumChloridesSulphur1 to 4 weeks before calvingIndicate in the instructions for use:"Stop feeding after calving"
or
—High level of zeolite (synthetic sodium aluminium silicate)Content of synthetic sodium aluminium silicateThe 2 weeks before calvingIndicate in the instructions for use:"The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.""Stop feeding after calving"
or
—High level of calcium in the form of highly available calcium saltsTotal calcium content, sources and respective quantity of calciumStar at first signs of parturition to two days subsequent to parturitionIndicate 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"
Reduction of the risk of ketosisIngredients providing glucogenic energy sourcesDairy cows and ewesIngredients providing glucogenic energy sourcesPropan-1,2-diol (if added as a glucose precursor)Glycerol (if added as a glucose precursor)3 to 6 weeks after calvingLast 6 weeks before and the first 3 weeks after lambing
Reduction of the risk of tetany (hypomagnesaemia)High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassiumRuminantsStarchTotal sugarsMagnesiumSodiumPotassium3 to 10 weeks during periods of fast grass growthIn 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 the case of feedingstuffs for ovines indicate on the package, container or label:"Especially for lactating ewes."
Reduction of the risk of acidosisLow level of easily fermentable carbohydrates and high buffering capacityRuminantsStarchTotal sugarsMaximum 2 monthsIn 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 the case of feedingstuffs for dairy cows indicate on the 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."
----------------------
Long-term supply of grazing animals with trace elements and/or vitaminsHigh level ofTrace elementsand/orvitamins, provitamins and chemically well-defined substances having similar effects.The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Ruminants with a functional rumenNames and total amounts of each added trace element, vitamin, provitamin and chemically well-defined substance having similar effects.Daily release rate for each trace element and/or vitamin if a bolus is used;Maximum period of continuously release of the trace element or vitamin if a bolus is used.Up to 12 monthsApplication 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.Indicate on the labelling of the feed:"—Simultaneous supplementation of additives with a maximum content from other sources to those incorporated in a bolus, if applicable, shall be avoided.—Before using, it is recommended to have advice from a veterinarian or nutritionist concerning:(1)the balance of trace elements in the daily ration;(2)the trace elements status of the herd—The bolus contains x % inert iron in order to increase its density, if applicable."
Compensation for insufficient iron availability after birthHigh 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.The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Suckling piglets and calvesTotal iron contentAfter birth up to 3 weeksThe instructions for use for the feed shall ensure that the legal maximum contents of iron for complete feed are respected.
Support the regeneration of hooves, trotters and skinHigh level of zinc.The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Horses, ruminants and pigsTotal amount ofzincmethionineUp to 8 weeksThe instructions of use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected.
Support the preparation for oestrus and reproductionHigh level of selenium anda minimum content of vitamin E per kg complete feed with a moisture content of 12 % for pigs of 53 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 1100 mgorHigh level(s) of vitamins Aand/or vitamin D and/or aminimum content of beta- carotene of 300 mg per animal and day.The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.MammalsNames and total amounts of each added trace element and vitamin.Cows: 2 weeks before the end of gestation until the next gestation is confirmed.Sows: 7 days before until 3 days after parturition and 7 days before until 3 days mating.Other female mammals: from the last part of gestation until the next gestation is confirmed.Males: during periods of reproductive activity.The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.Indicate on the labelling of the feed:"Guidance on the situations in which the use of the feed is appropriate."
High level(s) of vitamin A and/or vitamin DorHigh level(s) of selenium and/or zinc and/or a minimum content of vitamin E of 44 mg/kg complete feed with a moisture content of 12 %.The 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.BirdsNames and total amounts of each added trace element and vitamin.For females: during oestrusFor males: during periods of reproductive activity
Stabilisation of water and electrolyte balance to support the physiological digestionPredominantly electrolytes: sodium, potassium and chloridesBuffering capacity: minimum 60 mmol per litre potion ready prepared for feedingEasily digestible carbohydratesCalves, pigs, lambs, kids and foalsSodiumPotassiumChloridesCarbohydrate source(s)Bicarbonates and/or citrates (if added)1 to 7 daysRecommended range of electrolytes per litre potion ready prepared for feeding:Sodium: 1,7 g – 3,5 gPotassium: 0,4 g – 2,0 gChlorides: 1 g – 2,8 gIndicate on the labelling:(1)"In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea)."(2)"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:(1)The recommended intake of the ready stirred potion and of milk, if appropriate.(2)In case of bicarbonates and/or citrates are above 40 mmol per litre potion ready prepared for feeding: "Simultaneous feeding of milk should be avoided in animals with abomasum"
Reduction of the risk of urinary calculiLow level of phosphorus, magnesium, and urine acidifying propertiesRuminantsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substancesUp to 6 weeksIndicate 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 magnesiumPigs—Magnesium1 to 7 daysGuidance shall be provided on the situation in which the use of this feed is appropriate.
and/or
—Highly digestible ingredientsHighly digestible ingredients including their treatment if appropriateContent of n-3 fatty acids (if added)
Stabilisation of physiological digestionLow buffering capacity, and highly digestible ingredientsPigletsHighly digestible ingredients including their treatment if appropriateBuffering capacitySource(s) of astringent substances (if added)Source(s) of mucilaginous substances (if added)2 to 4 weeksIndicate on the labelling:"In case of risk of, during periods of, or recovery from, digestive disturbance."
Highly digestible ingredientsPigsHighly digestible ingredients including their treatment if appropriateSource(s) of astringent substances (if added)Source(s) of mucilaginous substances (if added)
Feed additives of the functional group "Gut flora stabiliser" of the category "zootechnical additives" 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".The complementary feed may contain feed additives of the functional group of "gut flora stabilisers/micro-organisms" in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Animal species for which the gut flora stabiliser/micro-organism is authorisedName and added amount of the gut flora stabiliser/micro-organismUp to 4 weeksIndicate on the labelling of the feed:(1)"In case of risk of, during periods of, or recovery from digestive disturbance".(2)If applicable: "The feed contains a gut flora stabiliser/micro-organism in a concentration above 100 times the authorised maximum content in complete feed".The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser/micro-organism for complete feed is respected.
Reduction of the risk of constipationIngredients stimulating intestinal passageSowsIngredients stimulating intestinal passage10 to 14 days before and 10 to 14 days after farrowing
Reduction of the risk of fatty liver syndromeLow energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acidsLaying hensEnergy value (calculated according to EC method)Percentage of metabolisable energy from lipidsContent of poly-unsaturated fatty acidsUp to 12 weeks
Compensation for malabsorptionLow level of saturated fatty acids and high level of fat soluble vitaminsPoultry excluding geese and pigeonsPercentage of saturated fatty acids in relation to total fatty acidsTotal vitamin ATotal vitamin DTotal vitamin ETotal vitamin KDuring the first 2 weeks after hatching
Compensation for chronic insufficiency of small intestine functionHighly precaecally digestible carbohydrates proteins and fatsEquines—Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriateInitially up to six monthsGuidance 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."
Compensation for chronic digestive disorders of large intestineHighly digestible fibreEquinesFibre source(s)Content of n-3 fatty acids (if added)Initially up to six monthsGuidance 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 reactionsHighly digestible ingredientsEquinesMagnesiumHighly digestible ingredients including their treatment if appropriateContent of n-3 fatty acids (if added)Two to four weeksGuidance shall be provided on the precise situations in which the use of the feed is appropriate.
Compensation of electrolyte loss in the cases of heavy sweatingPredominantly electrolytes and easily absorbable carbohydratesEquinesCalciumSodiumMagnesiumPotassiumChloridesGlucoseOne to three daysGuidance 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."
Support the preparation for and recovery from sport effortHigh level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %.The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed.EquidaeTotal amount ofvitamin Eselenium.Up to 8 weeks before sport effort – Up to 4 weeks after sport effortThe instructions for use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected.
Nutritional restoration, convalescenceHigh concentration of essential nutrients and highly digestible ingredientsEquinesHighly digestible ingredients, including their treatment if appropriateContent of n-3 and n-6 fatty acids (if added)Until restoration is achievedGuidance shall be provided on the situations in which the use of the feed is appropriate.In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:"Administration under veterinary supervision."
Support of liver function in the case of chronic liver insufficiencyLow level of protein but of high quality and highly digestible carbohydratesEquinesProtein and fibre sourcesHighly digestible carbohydrates including their treatment if appropriateMethionineCholineContent of n-3 fatty acids (if added)Initially up to six monthsGuidance 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 the case of chronic renal insufficiencyLow level of protein but of high quality and low level of phosphorusEquinesProtein source(s)CalciumPhosphorusPotassiumMagnesiumSodiumInitially up to six monthsIndicate 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."
ANNEX IIPART A
Repealed Directive with list of its successive amendments(referred to in Article 2)
Commission Directive 94/39/EC(OJ L 207, 10.8.1994, p. 20)
Commission Directive 95/9/EC(OJ L 91, 22.4.1995, p. 35)
Commission Directive 2002/1/EC(OJ L 5, 9.1.2002, p. 8)
Commission Directive 2008/4/EC(OJ L 6, 10.1.2008, p. 4)
PART B
List of time-limits for transposition into national law(referred to in Article 2)
DirectiveTime-limit for transposition
94/39/EC30 June 1995
95/9/EC30 June 1995
2002/1/EC20 November 2002
2008/4/EC30 July 2008
ANNEX III
Correlation table
Directive 94/39/ECThis Directive
Article 1Article 1
Article 2—
—Article 2
Article 3Article 3
—Article 4
AnnexAnnex I
—Annex II
—Annex III
Article 1Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of Annex I to this Directive and if they fulfil the other provisions laid down in that Part of Annex I.Furthermore, the Member States shall ensure that the provisions under "General provisions" of Part A of Annex I are complied with.
Article 2Directive 94/39/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3This Directive shall enter into force on 31 July 2008.
Article 4This Directive is addressed to the Member States.
nullANNEX IPART AGeneral provisions1.Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by "and/or", for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4.2.Where a group of additives is mentioned in column 2 or column 4 of Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilOJ L 268, 18.10.2003, p. 29. as corresponding to the specified essential characteristic.3.Where the source(s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer 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/EECOJ L 270, 14.12.1970, p. 1., 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.10.When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration by forced feeding, the label of the feed shall, if applicable, mention the maximum period of continuously release of the bolus and the daily release rate for each additive for which a maximum content in complete feed is fixed. At the request of the competent authority the feed business operator which is placing a bolus on the market shall provide proof that the daily available additive level in the digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (slow release effect). It is recommended that feed in form of bolus is administered by a veterinarian or any other competent person.PART BList of intended uses
If appropriate the manufacturer may also recommend use for temporary renal insufficiency.If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.In the case of feedingstuffs for cats, "feline lower urinary tract disease" or "feline urological syndrome — FUS" may complete the particular nutritional purpose.In the case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace "ingredient and nutrient".The manufacturer may complete the particular nutritional purpose with the reference: "exocrine pancreatic insufficiency".The manufacturer may complete the particular nutritional purpose with a reference to "Feline hepatic lipidosis".The term "ketosis" may be replaced by "acetonaemia".The manufacturers may also recommend the use for ketosis recuperation.In the case of feedingstuffs for dairy cows.In the case of feedingstuffs for ewes.In the case of feedingstuffs for dairy cows: "maximum two months from the start of lactation".Indicate the category of ruminants concerned.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].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.
Particular nutritional purposeEssential nutritional characteristicsSpecies or category of animalsLabelling declarationsRecommended length of timeOther provisions
(1)(2)(3)(4)(5)(6)
Support of renal function in case of chronic renal insufficiencyHigh quality proteins and restricted levels ofphosphorus maximum 5 g/kg complete pet food with a moisture content of 12 % andcrude protein maximum 220 g/kg complete pet food with a moisture content of 12 %orDogsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Initially up to 6 monthsThe feed shall be placed on the market as complete feed.Recommended digestibility of proteins: minimum 85 %.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrateAdult dogsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Lanthanum carbonate octahydrateInitially up to 6 monthsIndicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
High quality proteins and restricted levels ofphosphorus maximum 6,2 g/kg complete pet food with a moisture content of 12 % andcrude protein maximum 320 g/kg complete pet food with a moisture content of 12 %orCatsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Initially up to 6 monthsThe feed shall be placed on the market as complete feed.Recommended digestibility of proteins: minimum 85 %.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:"Water should be available at all times."
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrateAdult catsProtein source(s)CalciumPhosphorusPotassiumSodiumContent of essential fatty acids (if added)Lanthanum carbonate octahydrateInitially up to 6 monthsIndicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use: "Water should be available at all times."
Dissolution of struvite stones—Urine acidifying properties, low level of magnesium, and restricted level of protein but of high qualityDogsProtein source(s)CalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substances5 to 12 weeksIndicate 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."
—Urine acidifying properties and low level of magnesiumCatsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurTotal taurineUrine acidifying substances
Reduction of struvite stone recurrenceUrine acidifying properties and moderate level of magnesiumDogs and catsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substancesUp to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of urate stones formationLow level of purines, low level of protein but of high qualityDogs and catsProtein source(s)Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolismIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of oxalate stones formationLow level of calcium, low level of vitamin D, and urine alkalising propertiesDogs and catsPhosphorusCalciumSodiumMagnesiumPotassiumChloridesSulphurTotal vitamin DHydroxyprolineUrine alkalising substancesUp to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Reduction of cystine stones formationLow level of protein, moderate level of sulphur amino acids and urine alkalising propertiesDogs and catsTotal sulphur amino acidsSodiumPotassiumChloridesSulphurUrine alkalising substancesInitially up to 1 yearIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use or before extending the period of use."
Reduction of ingredient and nutrient intolerances—Selected protein source(s)Dogs and catsProtein source(s)Content of essential fatty acids (if added)3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely
and/or
—Selected carbohydrate source(s)Carbohydrate source(s)Content of essential fatty acids (if added)
Reduction of acute intestinal absorptive disordersIncreased level of electrolytes and highly digestible ingredientsDogs and catsHighly digestible ingredients including their treatment if appropriateSodiumPotassiumSource(s) of mucilaginous substances (if added)1 to 2 weeksIndicate 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."
Compensation for maldigestionHighly digestible ingredients and low level of fatDogs and catsHighly digestible ingredients including their treatment if appropriate3 to 12 weeks, but lifetime in the case of chronic pancreatic insufficiencyIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Support of heart function in the case of chronic cardiac insufficiencyLevel of sodium restricted to be lower than 2,6 g/kg complete pet food with a moisture content of 12 %Dogs and catsMagnesiumPotassiumSodiumInitially up to 6 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Regulation of glucose supply (Diabetes mellitus)Low level of rapid glucose-releasing carbohydratesDogs and catsCarbohydrate source(s)Treatment of carbohydrates if appropriateStarchTotal sugarFructose (if added)Content of essential fatty acids (if added)Source(s) of short and medium chain fatty acids (if added)Initially up to 6 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use or before extending the period of use."
Support of liver function in the case of chronic liver insufficiency—High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydratesDogsProtein source(s)Content of essential fatty acidsHighly digestible carbohydrates including their treatment if appropriateSodiumTotal copperInitially up to 6 monthsIndicate 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."
—High quality protein, moderate level of protein and high level of essential fatty acidsCatsProtein source(s)Content of essential fatty acidsSodiumTotal copperInitially up to 6 monthsIndicate 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 the case of hyperlipidaemiaLow level of fat and high level of essential fatty acidsDogs and catsContent of essential fatty acidsContent of n-3 fatty acids (if added)Initially up to 2 monthsIndicate 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 iodine levels in feed in case of hyperthyroidismRestricted level of iodine: maximum 0,26 mg/kg complete pet food with a moisture content of 12 %CatsTotal iodineInitially up to 3 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Reduction of copper in the liverRestricted level of copper: maximum 8,8 mg/kg complete pet food with a moisture content of 12 %DogsTotal copperInitially up to 6 monthsThe feed shall be placed on the market as complete feed.Indicate on the labelling:"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Reduction of excessive body weightLow energy densityDogs and catsEnergy valueUntil target body weight is achievedIn the instructions for use an appropriate daily intake must be recommended.
Nutritional restoration, convalescenceHigh energy density, high concentrations of essential nutrients and highly digestible ingredientsDogs and catsHighly digestible ingredients, including their treatment if appropriateEnergy valueContent of n-3 and n-6 fatty acids (if added)Until restoration is achievedIn the case of feed specially presented to be given via tubing, indicate on the labelling: "Administration under veterinary supervision."
The complementary feed may contain Enterococcus faecium DSM 10663/NCIMB 10415 in a concentration higher than 100 times the relevant fixed maximum content in complete feed.DogsEnterococcus faecium DSM 10663/NCIMB 10415 including added amount10 to 15 daysThe instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser//micro-organism for complete feed is respected.Indicate on the labelling: "It is recommended that advice from a veterinarian be sought before use and before extending the period of use."
Support of skin function in the case of dermatosis and excessive loss of hairHigh level of essential fatty acidsDogs and catsContent of essential fatty acidsUp to 2 monthsIndicate on the package, container or label:"It is recommended that a veterinarian's opinion be sought before use."
Support of the metabolism of joints in the case of osteoarthritisDogs:Minimum dry matter content of total omega-3 fatty acids 3,3 % and of eicosapentaenoic acid (EPA) 0,38 %.Adequate level of vitamin E.Cats:Minimum dry matter content of total omega-3 fatty acids 1,2 % and of docosahexaenoic acid (DHA) 0,28 %.Increased levels of methionine and manganese.Adequate level of vitamin E.Dogs and catsDogs:Total omega-3 fatty acidsTotal EPATotal vitamin ECats:Total omega-3 fatty acidsTotal DHATotal methionineTotal manganeseTotal vitamin EInitially up to 3 monthsIt is recommended that a veterinary surgeon’s opinion be sought before use or before extending the period of use.
Reduction of the risk of milk fever—Low level of calciumDairy cowsCalciumPhosphorusMagnesium1 to 4 weeks before calvingIndicate in the instructions for use:"Stop feeding after calving"
and/or
—Low cations/anions ratioCalciumPhosphorusSodiumPotassiumChloridesSulphur1 to 4 weeks before calvingIndicate in the instructions for use:"Stop feeding after calving"
or
—High level of zeolite (synthetic sodium aluminium silicate)Content of synthetic sodium aluminium silicateThe 2 weeks before calvingIndicate in the instructions for use:"The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.""Stop feeding after calving"
or
—High level of calcium in the form of highly available calcium saltsTotal calcium content, sources and respective quantity of calciumStar at first signs of parturition to two days subsequent to parturitionIndicate 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"
Reduction of the risk of ketosisIngredients providing glucogenic energy sourcesDairy cows and ewesIngredients providing glucogenic energy sourcesPropan-1,2-diol (if added as a glucose precursor)Glycerol (if added as a glucose precursor)3 to 6 weeks after calvingLast 6 weeks before and the first 3 weeks after lambing
Reduction of the risk of tetany (hypomagnesaemia)High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassiumRuminantsStarchTotal sugarsMagnesiumSodiumPotassium3 to 10 weeks during periods of fast grass growthIn 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 the case of feedingstuffs for ovines indicate on the package, container or label:"Especially for lactating ewes."
Reduction of the risk of acidosisLow level of easily fermentable carbohydrates and high buffering capacityRuminantsStarchTotal sugarsMaximum 2 monthsIn 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 the case of feedingstuffs for dairy cows indicate on the 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."
----------------------
Long-term supply of grazing animals with trace elements and/or vitaminsHigh level ofTrace elementsand/orvitamins, provitamins and chemically well-defined substances having similar effects.The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Ruminants with a functional rumenNames and total amounts of each added trace element, vitamin, provitamin and chemically well-defined substance having similar effects.Daily release rate for each trace element and/or vitamin if a bolus is used;Maximum period of continuously release of the trace element or vitamin if a bolus is used.Up to 12 monthsApplication 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.Indicate on the labelling of the feed:"—Simultaneous supplementation of additives with a maximum content from other sources to those incorporated in a bolus, if applicable, shall be avoided.—Before using, it is recommended to have advice from a veterinarian or nutritionist concerning:(1)the balance of trace elements in the daily ration;(2)the trace elements status of the herd—The bolus contains x % inert iron in order to increase its density, if applicable."
Compensation for insufficient iron availability after birthHigh 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.The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Suckling piglets and calvesTotal iron contentAfter birth up to 3 weeksThe instructions for use for the feed shall ensure that the legal maximum contents of iron for complete feed are respected.
Support the regeneration of hooves, trotters and skinHigh level of zinc.The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Horses, ruminants and pigsTotal amount ofzincmethionineUp to 8 weeksThe instructions of use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected.
Support the preparation for oestrus and reproductionHigh level of selenium anda minimum content of vitamin E per kg complete feed with a moisture content of 12 % for pigs of 53 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 1100 mgorHigh level(s) of vitamins Aand/or vitamin D and/or aminimum content of beta- carotene of 300 mg per animal and day.The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.MammalsNames and total amounts of each added trace element and vitamin.Cows: 2 weeks before the end of gestation until the next gestation is confirmed.Sows: 7 days before until 3 days after parturition and 7 days before until 3 days mating.Other female mammals: from the last part of gestation until the next gestation is confirmed.Males: during periods of reproductive activity.The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.Indicate on the labelling of the feed:"Guidance on the situations in which the use of the feed is appropriate."
High level(s) of vitamin A and/or vitamin DorHigh level(s) of selenium and/or zinc and/or a minimum content of vitamin E of 44 mg/kg complete feed with a moisture content of 12 %.The 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.BirdsNames and total amounts of each added trace element and vitamin.For females: during oestrusFor males: during periods of reproductive activity
Stabilisation of water and electrolyte balance to support the physiological digestionPredominantly electrolytes: sodium, potassium and chloridesBuffering capacity: minimum 60 mmol per litre potion ready prepared for feedingEasily digestible carbohydratesCalves, pigs, lambs, kids and foalsSodiumPotassiumChloridesCarbohydrate source(s)Bicarbonates and/or citrates (if added)1 to 7 daysRecommended range of electrolytes per litre potion ready prepared for feeding:Sodium: 1,7 g – 3,5 gPotassium: 0,4 g – 2,0 gChlorides: 1 g – 2,8 gIndicate on the labelling:(1)"In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea)."(2)"It is recommended that advice from a veterinarian be sought before use and before extending the period of use."Indicate in the instructions for use:(1)The recommended intake of the ready stirred potion and of milk, if appropriate.(2)In case of bicarbonates and/or citrates are above 40 mmol per litre potion ready prepared for feeding: "Simultaneous feeding of milk should be avoided in animals with abomasum"
Reduction of the risk of urinary calculiLow level of phosphorus, magnesium, and urine acidifying propertiesRuminantsCalciumPhosphorusSodiumMagnesiumPotassiumChloridesSulphurUrine acidifying substancesUp to 6 weeksIndicate 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 magnesiumPigs—Magnesium1 to 7 daysGuidance shall be provided on the situation in which the use of this feed is appropriate.
and/or
—Highly digestible ingredientsHighly digestible ingredients including their treatment if appropriateContent of n-3 fatty acids (if added)
Stabilisation of physiological digestionLow buffering capacity, and highly digestible ingredientsPigletsHighly digestible ingredients including their treatment if appropriateBuffering capacitySource(s) of astringent substances (if added)Source(s) of mucilaginous substances (if added)2 to 4 weeksIndicate on the labelling:"In case of risk of, during periods of, or recovery from, digestive disturbance."
Highly digestible ingredientsPigsHighly digestible ingredients including their treatment if appropriateSource(s) of astringent substances (if added)Source(s) of mucilaginous substances (if added)
Feed additives of the functional group "Gut flora stabiliser" of the category "zootechnical additives" 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".The complementary feed may contain feed additives of the functional group of "gut flora stabilisers/micro-organisms" in a concentration higher than 100 times the relevant fixed maximum content in complete feed.Animal species for which the gut flora stabiliser/micro-organism is authorisedName and added amount of the gut flora stabiliser/micro-organismUp to 4 weeksIndicate on the labelling of the feed:(1)"In case of risk of, during periods of, or recovery from digestive disturbance".(2)If applicable: "The feed contains a gut flora stabiliser/micro-organism in a concentration above 100 times the authorised maximum content in complete feed".The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser/micro-organism for complete feed is respected.
Reduction of the risk of constipationIngredients stimulating intestinal passageSowsIngredients stimulating intestinal passage10 to 14 days before and 10 to 14 days after farrowing
Reduction of the risk of fatty liver syndromeLow energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acidsLaying hensEnergy value (calculated according to EC method)Percentage of metabolisable energy from lipidsContent of poly-unsaturated fatty acidsUp to 12 weeks
Compensation for malabsorptionLow level of saturated fatty acids and high level of fat soluble vitaminsPoultry excluding geese and pigeonsPercentage of saturated fatty acids in relation to total fatty acidsTotal vitamin ATotal vitamin DTotal vitamin ETotal vitamin KDuring the first 2 weeks after hatching
Compensation for chronic insufficiency of small intestine functionHighly precaecally digestible carbohydrates proteins and fatsEquines—Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriateInitially up to six monthsGuidance 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."
Compensation for chronic digestive disorders of large intestineHighly digestible fibreEquinesFibre source(s)Content of n-3 fatty acids (if added)Initially up to six monthsGuidance 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 reactionsHighly digestible ingredientsEquinesMagnesiumHighly digestible ingredients including their treatment if appropriateContent of n-3 fatty acids (if added)Two to four weeksGuidance shall be provided on the precise situations in which the use of the feed is appropriate.
Compensation of electrolyte loss in the cases of heavy sweatingPredominantly electrolytes and easily absorbable carbohydratesEquinesCalciumSodiumMagnesiumPotassiumChloridesGlucoseOne to three daysGuidance 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."
Support the preparation for and recovery from sport effortHigh level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %.The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed.EquidaeTotal amount ofvitamin Eselenium.Up to 8 weeks before sport effort – Up to 4 weeks after sport effortThe instructions for use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected.
Nutritional restoration, convalescenceHigh concentration of essential nutrients and highly digestible ingredientsEquinesHighly digestible ingredients, including their treatment if appropriateContent of n-3 and n-6 fatty acids (if added)Until restoration is achievedGuidance shall be provided on the situations in which the use of the feed is appropriate.In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:"Administration under veterinary supervision."
Support of liver function in the case of chronic liver insufficiencyLow level of protein but of high quality and highly digestible carbohydratesEquinesProtein and fibre sourcesHighly digestible carbohydrates including their treatment if appropriateMethionineCholineContent of n-3 fatty acids (if added)Initially up to six monthsGuidance 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 the case of chronic renal insufficiencyLow level of protein but of high quality and low level of phosphorusEquinesProtein source(s)CalciumPhosphorusPotassiumMagnesiumSodiumInitially up to six monthsIndicate 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."
ANNEX IIPART A
Repealed Directive with list of its successive amendments(referred to in Article 2)
Commission Directive 94/39/EC(OJ L 207, 10.8.1994, p. 20)
Commission Directive 95/9/EC(OJ L 91, 22.4.1995, p. 35)
Commission Directive 2002/1/EC(OJ L 5, 9.1.2002, p. 8)
Commission Directive 2008/4/EC(OJ L 6, 10.1.2008, p. 4)
PART B
List of time-limits for transposition into national law(referred to in Article 2)
DirectiveTime-limit for transposition
94/39/EC30 June 1995
95/9/EC30 June 1995
2002/1/EC20 November 2002
2008/4/EC30 July 2008
ANNEX III
Correlation table
Directive 94/39/ECThis Directive
Article 1Article 1
Article 2—
—Article 2
Article 3Article 3
—Article 4
AnnexAnnex I
—Annex II
—Annex III