10

Dogs

• Protein source(s)

• Calcium

• Phosphorus

• Potassium

• Sodium

• Essential fatty acids (if added)

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Recommended digestibility of proteins: minimum 85 %.

3. 3.

   Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

4. 4.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate

Adult dogs

• Protein source(s)

• Calcium

• Phosphorus

• Potassium

• Sodium

• Essential fatty acids (if added)

• Lanthanum carbonate octahydrate

Initially up to 6 months9

1. 1.

   Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

2. 2.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

High quality proteins and phosphorus ≤ 6,5 g/kg complete feed with a moisture content of 12 %8 and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 %8

Cats

• Protein source(s)

• Calcium

• Phosphorus

• Potassium

• Sodium

• Essential fatty acids (if added)

Initially up to 6 months9

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Recommended digestibility of proteins: minimum 85 %.

3. 3.

   Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

4. 4.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate

Adult cats

• Protein source(s)

• Calcium

• Phosphorus

• Potassium

• Sodium

• Essential fatty acids (if added)

• Lanthanum carbonate octahydrate

Initially up to 6 months9

1. 1.

   Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

2. 2.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

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 BW^0,75 per day

Equines

• Protein and energy source(s)

• Calcium

• Phosphorus

• Potassium

• Magnesium

• Sodium

• Sum of eicosapentaenoic acid and docosahexaenoic acid

Initially up to six months.

Long term or until resolution of the issue

1. 1.

   The feed shall be placed on the market as complementary feed

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’

   • The complementary feed should not be used in case of hypernatraemia and hyperchloraemia.

   • The complementary feed should contribute to at least 10 to 20 % of the daily energy supply (approximately 0,05 to 0,1 MJ/kg BW^0,75 per day).

3. 3.

   The ration should ensure an energy supply of > 0,62 MJ/kg BW^0,75 per day.

4. 4.

   The ration should not exceed 50 mg calcium/kg dry matter/day.

5. 5.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

11

Reduction of oxalate stones formation

Low level of calcium, low level of vitamin D, and urine alkalising properties

Dogs and cats

• Phosphorus

• Calcium

• Sodium

• Magnesium

• Potassium

• Chlorides

• Sulphur

• Vitamin D (total)

• Hydroxyproline

• Urine alkalising substances

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 %8

Dogs and cats

• Carbohydrate source(s)

• Treatment of carbohydrates, if appropriate

• Starch

• Total sugars

• Fructose (if added)

• Essential fatty acids (if added)

• Source(s) of short and medium chain fatty acids (if added)

Initially up to 6 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘Low level of mono- and disaccharides’

   • ‘It is recommended that a veterinarian’s opinion be sought before use and before extending the period of use.’

13

Selected and limited number of protein source(s)

And/or

hydrolysed protein source(s)

And/or

selected carbohydrate source(s)

Dogs and cats

• Protein sources including treatment, if appropriate (if added).

• Carbohydrate source(s) including treatment, if appropriate (if added).

• Essential fatty acids (if added)

3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year.

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   It is recommended to limit the number of main protein sources to 3.

3. 3.

   To indicate on the labelling:

   • Appropriate combination of the essential nutritional characteristics, as applicable

   • ‘It is recommended that a veterinarian’s opinion be sought before use and before extending the period of use.’

14

Reduction of cystine stones formation

Urine alkalinising properties and crude protein ≤ 160 g/kg complete feed with a moisture content of 12 %8

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 %8

Dogs

• Sulphur amino acids (total)

• Protein sources

• Sodium

• Potassium

• Chlorides

• Urine alkalinizing substances (if added)

Initially up to 6 month

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate in the instructions for proper use:

‘Water should be available at all times’

1. 3.

   Indicate on the labelling:

   • ‘Urine alkalinising properties and low level of proteins’ or ‘Low level of selected proteins’, as applicable.

   • ‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’

2. 4.

   For consideration of the veterinarian or nutritionist: Alkalinising properties means that the diet should be formulated to target a urinary pH ≥ 7.

15

Highly digestible ingredients with

energy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 %8

Dogs

• Highly digestible ingredient sources including their treatment, if appropriate

• Energy value

Until restoration is achieved

1. 1.

   Recommended apparent digestibility of Dry Matter ≥ 80 % or of Organic Matter ≥ 85 %.

2. 2.

   In the case of feed specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision.’

3. 3.

   The labelling may indicate the specific circumstance(s) the dietetic feed is intended for.

4. 4.

   Indicate on the labelling:

   ‘High energy density, high concentrations of essential nutrients and highly digestible ingredients’

Highly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12 %8

Cats

16

Reduction of urate stones formation

Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 %8

Or

Crude protein ≤ 220 g/kg complete feed with a moisture level of 12 %8 and selected protein sources

Dogs

• Protein source(s)

Up to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   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.

3. 3.

   Indicate in the instructions for proper use: ‘Water should be available at all times’.

4. 4.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

   • ‘Low level of protein’ or ‘Restricted level of protein and selected protein sources’, as appropriate.

Crude protein ≤ 317 g/kg complete feed with a moisture content of 12 %8

Cats

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   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.

3. 3.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

   • ‘Restricted level of protein’

4. 4.

   Indicate in the instructions for proper use: ‘Water should be available at all times’.

17

And/or

And

Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %8

Dogs and cats

• Phosphorus

• Calcium

• Sodium

• Magnesium

• Potassium

• Chloride

• Sulfur

5 to 12 weeks

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

   • ‘Urine undersaturating properties for struvite and/or Urine acidifying properties.’

3. 3.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

4. 4.

   Declaration of conformity supporting undersaturating and/or acidifying properties of the diet shall be made available to the relevant competent authorities upon request.

18

Reduction of struvite stone recurrence12

And/or

Diet with urine acidifying properties14

And

Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %8

Dogs and cats

• Phosphorus

• Calcium

• Sodium

• Magnesium

• Potassium

• Chloride

• Sulfur

Initially up to 6 month

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

   • ‘Urine undersaturating or metastabilising properties for struvite and/or Urine acidifying properties’

3. 3.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

4. 4.

   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.

19

Highly digestible diet:

Apparent digestibility of

• low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %8):

  Crude protein ≥ 85 %

  Crude fat ≥ 90 %

Or

• fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %8):

  Crude protein ≥ 80 %

  Crude fat ≥ 80 %

Dogs and cats

• Highly digestible ingredient sources including their treatment, if appropriate

Initially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘Highly digestible feed’

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

20

Reduction of intestinal absorptive disorders

Highly digestible diet:

Apparent digestibility of

• low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %8):

  Crude protein ≥ 85 %

  Crude fat ≥ 90 %

Or

• fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %8):

  Crude protein ≥ 80 %

  Crude fat ≥ 80 %

And

Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 %8

And

Potassium ≥ 5 g per kg of complete feed with a moisture level 12 %8

Dogs and cats

• Highly digestible ingredient sources including their treatment, if appropriate

• Sodium

• Potassium

Up to 12 weeks

Indicate on the labelling:

• ‘Highly digestible feed with increased sodium and potassium’

• ‘It is recommended that a veterinarian’s opinion be sought before use.’

21

Reduction of acute intestinal absorptive disorders

Increased level of electrolytes:

• Sodium ≥ 1,8 %

• Potassium ≥ 0,6 %

And

Highly digestible carbohydrates:

• ≥ 32 %

Dogs and cats

• Sodium

• Potassium

• Carbohydrate source(s)

1 – 7 days

1. 1.

   The feed shall be placed on the market as complementary feed.

2. 2.

   Indicate on the labelling:

   • ‘During periods of and recovery from acute diarrhoea’

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

3. 3.

   In case of solid feed, the recommended range of electrolytes should be calculated on the basis of a normal daily voluntary intake of water.

22

Support of lipid metabolism in the case of hyperlipidaemia

Dogs and cats

• Crude fat

Initially up to 2 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’

   • ‘Low level of fat’

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 %8 for dogs

Crude protein ≤ 370 g/kg complete feed with a moisture content of 12 %8 for cats

And

Selected protein sources

And

Recommended dietary protein digestibility ≥ 85 %

Dogs and cats

• Protein source(s)

• Copper (total)

• Sodium

Initially up to 4 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   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).

3. 3.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

4. 4.

   Indicate on the labelling:

   • ‘Moderate level of protein, selected and highly digestible’

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

Low level of protein but of high quality and highly digestible carbohydrates

Equines

• Protein and fibre sources

• Highly digestible carbohydrates including their treatment, if appropriate

• Methionine

• Choline

• Content of n-3 fatty acids (if added)

Initially up to six months

1. 1.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’

2. 2.

   Guidance should be provided on the manner in which the feed should be fed including many small meals per day.

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 %8

Dogs and cats

• Magnesium

• Potassium

• Sodium

Initially up to 6 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

25

Reduction of excessive body weight

Or

Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 %19

Dogs

• Energy value

Until target body weight is achieved and after if required to maintain target bodyweight

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.
   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 intake20
3. 3.

   Indicate on the labelling:

   • ‘It is recommended that a veterinarian’s opinion be sought before use.’

   • ‘For cats, a transition period when starting the diet is advised.’

   • ‘For an efficient weight loss or ideal weight maintenance, the recommended daily energy intake should not be exceeded.’

Metabolizable Energy < 3190 kcal per kg complete feed with moisture content of 12 %19

Or

Metabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 %19

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 %8

Dogs and cats

• Linoleic acid

• Sum of eicosapentaenoic acid and docosahexaenoic acid

Initially up to 2 months

Indicate on the labelling:

• ‘It is recommended that a veterinarian’s opinion be sought before use.’

• ‘High level of linoleic acid (LA) and of sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)’

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 %8

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 %8

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 %8

And

Adequate levels of vitamin E

Dogs

• Omega-3 fatty acids (total)

• Eicosapentaenoic acid (total)

• Vitamin E (total)

Initially up to 3 months

Indicate on the labelling:

• ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

Total omega-3 fatty acids ≥ 10,6 g per kg complete feed with a moisture content of 12 %8 and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 %8

And

Increased levels of methionine and manganese

Adequate levels of vitamin E.

Cats

• Omega-3 fatty acids (total)

• Docosahexaenoic acid (total)

• Methionine (total)

• Manganese (total)

• Vitamin E (total)

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 %8

Dogs

Copper (total)

Initially up to 6 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

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 %8

Cats

Iodine (total)

Initially up to 3 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

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 %8

Dogs

Trypsin-hydrolysed bovine casein

Initially up to 2 months

1. 1.

   The feed shall be placed on the market as complete feed.

2. 2.

   Indicate on the labelling:

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

50

Support the preparation for oestrus and reproduction

• High 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

Or

• High level(s) of vitamins A and/or vitamin D and/or a minimum 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.

Mammals

Names 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.

1. 1.

   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.

2. 2.

   The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.

3. 3.

   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 D

Or

• High 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 %.

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

• For females: during oestrus

• For males: during periods of reproductive activity

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

• Zinc (total)

• Methionine (total)

• Biotin (if added)

Up to 8 weeks

1. 1.

   The instructions for proper use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected.

2. 2.

   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.

52

Support for nutritional imbalances in dietary transition

Minimum supply via the dietetic feed of:

• Selenium: 0,1 mg/kg complete feed with a moisture content of 12 %

And/or

• Zinc: 15 mg/kg complete feed with a moisture content of 12 %

And/or

• Copper: 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

And/or

• Vitamin A: 2000 IU/kg complete feed with a moisture content of 12 %

And/or

• Vitamin D: 400 IU/kg complete feed with a moisture content of 12 %

And/or

• Vitamin 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 %

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

1. 1.

   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.

2. 2.

   The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.

3. 3.

   Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.

53

Support weaning

Minimum supply via the dietetic feed of:

• Selenium: 0,1 mg/kg complete feed with a moisture content of 12 %

And/or

• Zinc: 15 mg/kg complete feed with a moisture content of 12 %

And/or

• Copper: 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

And/or

• Iodine: 0,2 mg/kg complete feed with a moisture content of 12 %

And/or

• Manganese: 20 mg/kg complete feed with a moisture content of 12 %

And/or

• Vitamin A: 1500 IU/kg complete feed with a moisture content of 12 %

And/or

• Vitamin D: 400 IU/kg complete feed with a moisture content of 12 %

And/or

• Vitamin 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.

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

1. 1.

   The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.

2. 2.

   Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.

54

Support the regeneration of the skin and appendages

• Minimum supply of zinc compounds via dietetic feed corresponding to 20 mg/kg complete feed with a moisture content of 12 %

And

• High level of copper and/or iodine and/or selenium

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

• Up to 8 weeks

• Complementary feed for ruminants containing biotin: Up to 6 months

1. 1.

   The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.

2. 2.

   Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.

55

Stabilisation of water and electrolyte balance to support the physiological digestion

• Predominantly electrolytes: sodium, potassium and chlorides

• Buffering capacity25 in case of liquid feed: minimum 60 mmol per litre potion ready prepared for feeding

• Easily digestible carbohydrates

Calves, pigs, lambs, kids and foals

• Sodium

• Potassium

• Chlorides

• Carbohydrate source(s)

• Bicarbonates and/or citrates (if added)

1 to 7 days

1. 1.

   Recommended range of electrolytes per litre potion ready prepared for feeding:

   Sodium: 1.7 g – 3.5 g

   Potassium: 0.4 g – 2 g

   Chlorides: 1 g – 2.8 g

2. 2.

   In case of solid feed, the recommended range of electrolytes should be calculated on the basis of a normal daily voluntary intake of water.

3. 3.

   Indicate on the labelling:

   • ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’

   • ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’

4. 4.

   Indicate in the instructions for proper use:

   • The recommended intake of the ready stirred potion and of milk, if appropriate.

   • In 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’

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

• Starch

• Sugars (total)

• Magnesium

• Sodium

• Potassium

3 to 10 weeks during periods of fast grass growth

1. 1.

   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.

2. 2.

   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.

3. 3.

   In the case of feed for ovines indicate on the labelling: ‘Especially for lactating ewes.’

57

Reduction of the risk of acidosis

Low level of easily fermentable carbohydrates and high buffering capacity

Ruminants

• Starch

• Sugars (total)

1. 1.

   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.

2. 2.

   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.

3. 3.

   In the case of feed for dairy cows indicate on the labelling: ‘Especially for high yielding cows.’

4. 4.
   In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed22.’

58

Reduction of the risk of urinary calculi

Low level of phosphorus, magnesium, and urine acidifying properties

Ruminants

• Calcium

• Phosphorus

• Sodium

• Magnesium

• Potassium

• Chlorides

• Sulphur

• Urine acidifying substances

Up to 6 weeks

1. 1.

   Indicate on the labelling: ‘Especially for intensively fed young animals.’

2. 2.

   Indicate in the instructions for proper use: ‘Water should be available at all times.’

59

Long-term supply of grazing animals with trace elements and/or vitamins

High level of

• Trace elements

And/or

• Vitamins, 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

rumen

• Names 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 months

1. 1.

   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.

2. 2.

   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. (a)

        the balance of trace elements in the daily ration;

     2. (b)

        the trace elements status of the herd’

60

Reduction of the risk of milk fever and subclinical hypocalcaemia

Low cations/anions ratio

For the total ration:

• Minimum acidification via feed for particular nutritional purpose: 100 mEq/kg dry matter

• Objective: 0 < DCAD23 (mEq/kg dry matter) < 100

Or

Dairy cows

• Calcium

• Phosphorus

• Magnesium

• Sodium

• Potassium

• Chlorides

• Sulphur

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:

• ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’

• The duration of use shall be restricted to a maximum of 2 weeks.

• ‘Stop feeding after calving’

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

• Calcium

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

• Calcium

• Calcium sources

From first signs of parturition to two days

Subsequent to parturition

1. 1.

   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.

2. 2.

   Indicate in the instructions for proper use the number of applications and the time before and after calving.

3. 3.

   Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.

Calcium pidolate in a minimum of 5,5 g per cow per day

Or

• Calcium

• Calcium pidolate

From first signs of parturition to two days subsequent to parturition

1. 1.

   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.

2. 2.

   Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.

Waxy-leaf nightshade meal allowing a daily release of 38 – 46 μg 1,25 dihydroxycholecalciferol-glycoside per day

• Waxy-leaf nightshade meal

• Content of 1,25 dihydroxycholecalciferol-glycoside

• Crude fibre

• Magnesium

• Crude fat

• Starch

• Vitamin D3 (total) as cholecalciferol

From two days before calving or first signs of parturition to 10 days subsequent to parturition

1. 1.

   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.

2. 2.

   Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.

61

• Minimum supply of propane-1,2-diol or propylene glycol:

  250 g/day for dairy cows

  50 g/day for ewes or goats

Or

• Minimum supply of propionates (calcium or sodium salts):

  110 g/day for dairy cows

  22 g/day for ewes or goats

Or

• Minimum combined supply of propane-1,2-diol and propionates (sodium or calcium salts), as long as:

• The 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

• The 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

Dairy cows, ewes and goats

• Propane-1,2-diol, if added

• Propionates in the form of sodium or calcium salts, if added

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

1. 1.

   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.

2. 2.

   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.’

62

Reduction of stress reactions

• High level magnesium

And/or

• Highly digestible ingredients

Pigs

• Magnesium

• Highly digestible ingredients including their treatment if appropriate

• Content of n-3 fatty acids (if added)

1 to 7 days

Guidance shall be provided on the situation in which the use of this feed is appropriate.

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

• Percentage of saturated fatty acids in relation to total fatty acids

• Vitamin A (total)

• Vitamin D (total)

• Vitamin E (total)

• Vitamin K (total)

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

• Energy value (calculated according to EC method)

• Percentage of metabolisable energy from lipids

• Content of poly-unsaturated fatty acids

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

• Vitamin E (total)

• Selenium (total)

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

• Sodium

• Chlorides

• Potassium

• Calcium

• Magnesium

• Phosphorus

One to three days after heavy sweating.

1. 1.

   Guidance shall be provided on the situations in which the use of the feed is appropriate.

2. 2.

   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.

3. 3.

   Indicate on the labelling:

   • ‘Water should be available at all times.’

   • In 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.’

4. 4.

   Furthermore guidance must be given to monitor subsequent drinking, if insufficient water intake is observed veterinary advice should be sought.

5. 5.

   Guidance may optionally be given regarding the quantity of water (in litres) to be provided alongside in feed or syringed electrolytes.

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

• Starch

• Sugar

• Crude fat

• Vitamin E (total)

Initially for a minimum of 3 months

1. 1.

   Guidance shall be provided on the situations in which the use of this feed is appropriate.

2. 2.

   The instructions for proper use shall contain guidance on the balance of the daily ration and the appropriate daily intake.

3. 3.

   Indicate on the labelling: ‘It is recommended that a veterinarian’s opinion be sought before use.’

70

Compensation for chronic digestive disorders of large intestine

• Starch content to provide < 1 g/kg BW/meal (< 0,5 g/kg BW/meal, if diarrhoea present)

• Cereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve small intestinal starch digestion

• Additional supply of water soluble vitamins and adequate minerals/electrolytes levels

• Additional supply of oil if no diarrhoea

Equines

• Starch

• Crude fat

Long term or until resolution of the issue

1. 1.

   Guidance shall be provided

   • on 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.

   • on meal size and forage intake.

2. 2.

   The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.

3. 3.

   Indicate on the labelling the processing used for the cereal grains.

71

Compensation for chronic insufficiency of small intestine function

• Highly digestible fibres

• High quality protein sources and lysine > 4,3 % of crude protein

• Total sugar and starch to provide a maximum of 0,5 g/kg BW/meal

• Cereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve pre-caecal digestion

Equines

• Highly digestible feed materials including their processing, if appropriate.

• Total sugar and starch

• Protein sources

Long term or until resolution of the issue

1. 1.

   Guidance shall be provided on

   • the precise situations in which the use of the feed is appropriate

   • meal size and forage intake.

2. 2.

   The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.

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

1. 1.

   Indicate on the labelling:

   ‘In case of risk of, during periods of, or recovery from digestive disturbance’.

2. 2.

   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.