Part B List of intended uses
United Kingdom
For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply. | ||||||
These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009 | ||||||
If appropriate the manufacturer may also recommend use for temporary renal insufficiency. | ||||||
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. | ||||||
If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks. | ||||||
In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’ | ||||||
For cats a reference to ‘Feline hepatic lipidosis’ may be added | ||||||
For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added. | ||||||
Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth. | ||||||
Urine pH ≤ 6,5. | ||||||
Metastabilising properties: urine associated with properties of prevention of crystal precipitation. | ||||||
‘exocrine pancreatic insufficiency’ may be added. | ||||||
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. | ||||||
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. | ||||||
Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs. | ||||||
FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs. | ||||||
In the case of feed for dairy cows: ‘maximum two months from the start of lactation’. | ||||||
Indicate the category of ruminants concerned. | ||||||
DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S). | ||||||
The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation. | ||||||
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]. | ||||||
| Entry number | Particular nutritional purpose | Essential nutritional characteristicsf1 | Species or category of animal | Labelling declarationsf2 | Recommended length of time | Other provisions |
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | |
| 10 | Support of renal function in case of chronic renal insufficiencyf3 | High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 %f4 and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 % | Dogs |
| Initially up to 6 monthsf5 |
|
| Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate | Adult dogs |
| Initially up to 6 months |
| ||
| High 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 % | Cats |
| Initially up to 6 months |
| ||
| Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate | Adult cats |
| Initially up to 6 months |
| ||
High density of energy with more than 8,8 MJ/kg feed with a moisture content of 12 %. Highly digestible and highly palatable sources of starch. Restricted protein level: ≤ 106 g crude protein/kg feed with a moisture content of 12 %. Level of sodium: 2 g/100 kg BW per day. High level of eicosapentaenoic acid and docosahexaenoic sum ≥ 0,2 g per kg BW0,75 per day | Equines |
| Initially up to six months. Long term or until resolution of the issue |
| ||
| 11 | Reduction of oxalate stones formation | Low level of calcium, low level of vitamin D, and urine alkalising properties | Dogs and cats |
| Up to 6 months | Indicate on the labelling: ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
| 12 | Regulation of glucose supply (Diabetes mellitus) | Total sugars (mono- and disaccharides) ≤ 62 g/kg complete feed with a moisture of 12 % | Dogs and cats |
| Initially up to 6 months |
|
| 13 | Reduction of ingredient and nutrient intolerancesf6 | Selected and limited number of protein source(s) And/or hydrolysed protein source(s) And/or selected carbohydrate source(s) | Dogs and cats |
| 3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year. |
|
| 14 | Reduction of cystine stones formation | Urine alkalinising properties and crude protein ≤ 160 g/kg complete feed with a moisture content of 12 % Or Proteins 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 % | Dogs |
| Initially up to 6 month |
‘Water should be available at all times’
|
| 15 | Nutritional restoration, convalescencef7 | Highly digestible ingredients with energy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 % | Dogs |
| Until restoration is achieved |
|
| Highly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12 % | Cats | |||||
| 16 | Reduction of urate stones formation | Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 % Or Crude protein ≤ 220 g/kg complete feed with a moisture level of 12 % and selected protein sources | Dogs |
| Up to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism |
|
| Crude protein ≤ 317 g/kg complete feed with a moisture content of 12 % | Cats |
| ||||
| 17 | Dissolution of struvite stonesf8 | Urine undersaturatingf9 properties for struvite And/or Urine acidifying propertiesf10 And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % | Dogs and cats |
| 5 to 12 weeks |
|
| 18 | Reduction of struvite stone recurrence | Complete feed with urine undersaturating or metastabilising propertiesf11 for struvite And/or Diet with urine acidifying properties And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % | Dogs and cats |
| Initially up to 6 month |
|
| 19 | Compensation for maldigestionf12 | Highly digestible diet: Apparent digestibility of
Or
| Dogs and cats |
| Initially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency |
|
| 20 | Reduction of intestinal absorptive disorders | Highly digestible diet: Apparent digestibility of
Or
And Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 % And Potassium ≥ 5 g per kg of complete feed with a moisture level 12 % | Dogs and cats |
| Up to 12 weeks | Indicate on the labelling:
|
| 21 | Reduction of acute intestinal absorptive disorders | Increased level of electrolytes:
And Highly digestible carbohydrates:
| Dogs and cats |
| 1 – 7 days |
|
| 22 | Support of lipid metabolism in the case of hyperlipidaemia | Fatf13 ≤ 110 g/kg complete feed with a moisture content of 12 %f14 | Dogs and cats |
| Initially up to 2 months |
|
| 23 | Support of liver function in the case of chronic liver insufficiency | Moderate level of protein: Crude protein ≤ 279 g/kg complete feed with a moisture content of 12 % for dogs Crude protein ≤ 370 g/kg complete feed with a moisture content of 12 % for cats And Selected protein sources And Recommended dietary protein digestibility ≥ 85 % | Dogs and cats |
| Initially up to 4 months |
|
| Low level of protein but of high quality and highly digestible carbohydrates | Equines |
| Initially up to six months |
| ||
| 24 | Support of heart function in the case of chronic cardiac insufficiency | Restricted level of sodium: Sodium ≤ 2,6 g per kg complete feed with a moisture content of 12 % | Dogs and cats |
| Initially up to 6 months |
|
| 25 | Reduction of excessive body weight | Metabolizable Energy < 3060 kcal/kg complete feed with moisture content of 12 %f15 Or Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 % | Dogs |
| Until target body weight is achieved and after if required to maintain target bodyweight |
|
Metabolizable Energy < 3190 kcal per kg complete feed with moisture content of 12 % Or Metabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 % | Cats | |||||
| 26 | Support of skin function in the case of dermatosis and excessive loss of hair | Linoleic 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 % | Dogs and cats |
| Initially up to 2 months | Indicate on the labelling:
|
| Linoleic 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 % | Dogs | |||||
| Linoleic 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 % | Cats | |||||
| 27 | Support of the metabolism of joints in the case of osteoarthritis | Total omega-3 fatty acids ≥ 29 g per kg and eicosapentaenoic acid ≥ 3,3 g per kg complete feed with a moisture content of 12 % And Adequate levels of vitamin E | Dogs |
| Initially up to 3 months | Indicate on the labelling:
|
Total 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 % And Increased levels of methionine and manganese Adequate levels of vitamin E. | Cats |
| ||||
| 28 | Reduction of copper in the liver | Restricted level of copper: copper ≤ 8,8 mg per kg complete feed with a moisture content of 12 % | Dogs | Copper (total) | Initially up to 6 months |
|
| 29 | Reduction of iodine levels in feed in case of hyperthyroidism | Restricted level of iodine: iodine ≤ 0,26 mg per kg complete feed with a moisture content of 12 % | Cats | Iodine (total) | Initially up to 3 months |
|
| 30 | Support in stressful situations, which will lead to the reduction of associated behaviour | 1-3 g trypsin-hydrolysed bovine casein per kg complete feed with a moisture content of 12 % | Dogs | Trypsin-hydrolysed bovine casein | Initially up to 2 months |
|
| 50 | Support the preparation for oestrus and reproduction |
Or
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. | Mammals | Names and total amounts of each added trace element and vitamin |
|
|
Or
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. | Birds | Names and total amounts of each added trace element and vitamin |
| |||
| 51 | Support the regeneration of hooves, trotters and skin | High 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 pigs |
| Up to 8 weeks |
|
| 52 | Support for nutritional imbalances in dietary transition | Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
The 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. | Ruminants Pigs Rabbits Poultry | Name and total amount of the nutritional additives, if appropriate | 2 to 15 days |
|
| 53 | Support weaning | Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
And/or
And/or
The 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. | Mammals | Name and total amount of the nutritional additives, if appropriate | Up to 4 weeks around weaning |
|
| 54 | Support the regeneration of the skin and appendages |
And
and/or vitamin B6 and/or vitamin E and/or vitamin A and/or methionine and/or cystine and/or minimum supply of 0,4 mg biotin/kg complete feed with a moisture content of 12 % for ruminants. The 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. | Mammals and poultry | Name and total amount of the nutritional additives, if appropriate |
|
|
| 55 | Stabilisation of water and electrolyte balance to support the physiological digestion |
| Calves, pigs, lambs, kids and foals |
| 1 to 7 days |
|
| 56 | Reduction of the risk of tetany (hypomagnesaemia) | High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium | Ruminants |
| 3 to 10 weeks during periods of fast grass growth |
|
| 57 | Reduction of the risk of acidosis | Low level of easily fermentable carbohydrates and high buffering capacity | Ruminants |
| up to 2 monthsf18 |
|
| 58 | Reduction of the risk of urinary calculi | Low level of phosphorus, magnesium, and urine acidifying properties | Ruminants |
| Up to 6 weeks |
|
| 59 | Long-term supply of grazing animals with trace elements and/or vitamins | High level of
And/or
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 rumen |
| Up to 12 months |
|
| 60 | Reduction of the risk of milk fever and subclinical hypocalcaemia | Low cations/anions ratio For the total ration:
Or | Dairy cows |
| From 3 weeks before calving until calving | Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
| Zeolite (sodium aluminium silicate): 250 – 500 g/day | Sodium aluminium silicate | From 3 weeks before calving until calving | Indicate in the instructions for proper use:
| |||
Or Supply 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. Or |
| From 4 weeks before calving until calving | Indicate in the instructions for proper use: ‘Stop feeding after calving’ | |||
High 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’ Calcium provided by one or a combination of these sources with a minimum of 50 g per cow per day Or |
| From first signs of parturition to two days Subsequent to parturition |
| |||
Calcium pidolate in a minimum of 5,5 g per cow per day Or |
| From first signs of parturition to two days subsequent to parturition |
| |||
| Waxy-leaf nightshade meal allowing a daily release of 38 – 46 μg 1,25 dihydroxycholecalciferol-glycoside per day |
| From two days before calving or first signs of parturition to 10 days subsequent to parturition |
| |||
| 61 | Reduction of the risk of ketosisf21 |
Or
Or
| Dairy cows, ewes and goats |
| Between three weeks before and six weeks after calving for dairy cows Between six weeks before and three weeks after parturition for ewes and goats |
|
| 62 | Reduction of stress reactions |
And/or
| Pigs |
| 1 to 7 days | Guidance shall be provided on the situation in which the use of this feed is appropriate. |
| 63 | Reduction of the risk of constipation | Ingredients stimulating intestinal passage | Sows | Ingredients stimulating intestinal passage | 10 to 14 days before and 10 to 14 days after farrowing | |
| 64 | Compensation for insufficient iron availability after birth | High 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 calves | Iron (total) | After birth up to 3 weeks | The instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected. |
| 65 | Compensation for malabsorption | Low level of saturated fatty acids and high level of fat soluble vitamins | Poultry excluding geese and pigeons |
| During the first 2 weeks after hatching | |
| 66 | Reduction of the risk of fatty liver syndrome | Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids | Laying hens |
| Up to 12 weeks | |
| 67 | Support the preparation for and recovery from sport effort | High 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. | Equidae |
| Up to 8 weeks before sport effort – Up to 4 weeks after sport effort | The instructions for proper use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected. |
| 68 | Compensation of electrolyte loss in the cases of heavy sweating | Must contain sodium chloride and should contain potassium chloride. Low levels of Magnesium, Calcium and Phosphorus The inclusion of other electrolyte salts is optional. | Equines |
| One to three days after heavy sweating. |
|
| 69 | Support of energy metabolism and of the muscle function in the case of rhabdomyolosis | Starch and sugar not more than 20 % of available energy. Crude fat more than 20 % of available energy Minimum of 350 IU Vitamin E/kg complete feed with a moisture content of 12 % | Equines |
| Initially for a minimum of 3 months |
|
| 70 | Compensation for chronic digestive disorders of large intestine |
| Equines |
| Long term or until resolution of the issue |
|
| 71 | Compensation for chronic insufficiency of small intestine function |
| Equines |
| Long term or until resolution of the issue |
|
| 72 | Stabilisation of the physiological digestion | Feed 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’ | Animal species for which the gut flora stabiliser or micro-organism is authorised | Name and added amount of the gut flora stabiliser or micro- organism | Up to 4 weeks |
|
Annotations
Textual amendments
- F1
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)
Footnotes
- f1
For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
- f2
These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
- f3
If appropriate the manufacturer may also recommend use for temporary renal insufficiency.
- f4
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.
- f5
If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
- f6
In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’
- f7
For cats a reference to ‘Feline hepatic lipidosis’ may be added
- f8
For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added.
- f9
Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth.
- f10
Urine pH ≤ 6,5.
- f11
Metastabilising properties: urine associated with properties of prevention of crystal precipitation.
- f12
‘exocrine pancreatic insufficiency’ may be added.
- f13
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.
- f14
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.
- f15
Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
- f16
FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
- f17
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].
- f18
In the case of feed for dairy cows: ‘maximum two months from the start of lactation’.
- f19
Indicate the category of ruminants concerned.
- f20
DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S).
- f21
The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.