
Article 1 
Feed intended for particular nutritional purposes within the meaning of Regulation (EC) No 767/2009 may be marketed only if:

— the general provisions for feed intended for particular nutritional purposes laid down in Part A of the Annex to this Regulation are complied with, and
— its intended use is included in Part B of the Annex to this Regulation and the provisions of the respective entry are complied with.
Article 2 
By way of derogation from Article 1, feed intended for particular nutritional purposes which complies with the provisions of Directive 2008/38/EC may continue to be placed on the market, provided that an application for an intended use included therein has been submitted to the  appropriate authority  in accordance with Article 10 of Regulation (EC) No 767/2009 before 25 March 2021 and until the appropriate authority decides on the respective application.
Article 3 
Feed intended for particular nutritional purposes which has been labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4 
Directive 2008/38/EC is repealed.
Article 5 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 25 December 2020.
...Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX
PART A
1. Where there is more than one group of essential nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same particular nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the particular nutritional purpose defined in column 1 of Part B. For each option the corresponding labelling declarations are given in column 4 of Part B.

2. Where an essential nutritional characteristic mentioned in column 2 of Part B is quantitatively indicated, the provisions of Article 17(2) of Regulation (EC) No 767/2009 and the permitted tolerances as established in Annex IV to that Regulation shall apply. If that Annex does not establish a tolerance for the respective labelling particular, a technical deviation of +/- 15 % shall be permitted.

3. Where a feed additive is mentioned in column 2 or column 4 of Part B, the authorisation provisions for feed additive(s) in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council are applicable and their use shall comply with the specified essential nutritional characteristic.

4. Where the declaration of a substance, also authorised as a feed additive, is required in column 4 of Part B and is accompanied by the expression ‘total’, the total content of the substance shall be labelled under the heading ‘analytical constituents’.

5. The declarations to be given in accordance with column 4 of Part B shall be quantitative without prejudice to Directive 2004/48/EC of the European Parliament and of the Council.

6. 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.

7. Where a feed intended for particular nutritional purposes is intended to meet more than one particular nutritional purpose, it shall comply with each respective entry in Part B.

8. In the case of complementary feed intended for particular nutritional purposes, guidance on the balance of the daily ration must be provided in the instructions for proper use.

9. When a feed intended for particular nutritional purposes is with an appropriate mode of use intended for individual oral administration via a bolus, this shall be established in the column ‘other provisions’ of the respective feed. Such feed shall exclusively contain, including a potential coating, feed materials and feed additives, unless detailed otherwise in the respective entry. It is recommended that feed intended for individual oral administration is administered by a veterinarian or any other competent person.

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 with retarding release, i.e. more than 24 hours, of the compounds, the labelling of such feed shall, if applicable, mention for each feed additive for which a maximum content in complete feed is fixed the maximum period of continuous release of the bolus and the daily release rate. The feed business operator which is placing a bolus on the market shall have the proof that the daily available feed 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 (retarding release effect). Such proof should be based on a peer reviewed methodology or in-house analysis.

11. In case of intended uses for which in column 2 a concentration of certain feed additives higher than 100 times the relevant fixed maximum content in complete feed is allowed for complementary feed, the concentration of those feed additives shall not be higher than 500 times the relevant fixed maximum content in complete feed, except in the case of boluses as referred to in point 10. The incorporation of such complementary feed into the animal`s diet shall ensure that the uptake of the animal complies with the fixed maximum content in complete feed.

PART B

Entry number Particular nutritional purpose Essential nutritional characteristics Species or category of animal Labelling declarations Recommended length of time Other provisions
1 2 3 4 5 6
10 Support of renal function in case of chronic renal insufficiency High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 % and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 % Dogs 
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Sodium
— Essential fatty acids (if added) Initially up to 6 months 
1.. The feed shall be placed on the market as complete feed.
2.. Recommended digestibility of proteins: minimum 85 %.
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.. 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 months 
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.. 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 % and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 % Cats 
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Sodium
— Essential fatty acids (if added) Initially up to 6 months 
1.. The feed shall be placed on the market as complete feed.
2.. Recommended digestibility of proteins: minimum 85 %.
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.. 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 months 
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.. 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 BW0,75 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.. The feed shall be placed on the market as complementary feed
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 BW0,75 per day).
3.. The ration should ensure an energy supply of > 0,62 MJ/kg BW0,75 per day.
4.. The ration should not exceed 50 mg calcium/kg dry matter/day.
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 % 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.. The feed shall be placed on the market as complete feed.
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 Reduction of ingredient and nutrient intolerances Selected and limited number of protein source(s)And/orhydrolysed protein source(s)And/orselected 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.. The feed shall be placed on the market as complete feed.
2.. It is recommended to limit the number of main protein sources to 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 %OrProteins 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 
— Sulphur amino acids (total)
— Protein sources
— Sodium
— Potassium
— Chlorides
— Urine alkalinizing substances (if added) Initially up to 6 month 
1.. The feed shall be placed on the market as complete feed.
2.. Indicate in the instructions for proper use:‘Water should be available at all times’
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.’
4.. For consideration of the veterinarian or nutritionist: Alkalinising properties means that the diet should be formulated to target a urinary pH ≥ 7.
15 Nutritional restoration, convalescence Highly digestible ingredients withenergy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 % Dogs 
— Highly digestible ingredient sources including their treatment, if appropriate
— Energy value Until restoration is achieved 
1.. Recommended apparent digestibility of Dry Matter ≥ 80 % or of Organic Matter ≥ 85 %.
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.. The labelling may indicate the specific circumstance(s) the dietetic feed is intended for.
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 % Cats
16 Reduction of urate stones formation Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 %OrCrude protein ≤ 220 g/kg complete feed with a moisture level of 12 % 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.. The feed shall be placed on the market as complete feed.
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.. Indicate in the instructions for proper use: ‘Water should be available at all times’.
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 % Cats 
1.. The feed shall be placed on the market as complete feed.
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.. Indicate on the labelling:

— ‘It is recommended that a veterinarian’s opinion be sought before use.’
— ‘Restricted level of protein’
4.. Indicate in the instructions for proper use: ‘Water should be available at all times’.
17 Dissolution of struvite stones Urine undersaturating properties for struviteAnd/orUrine acidifying propertiesAndMagnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % Dogs and cats 
— Phosphorus
— Calcium
— Sodium
— Magnesium
— Potassium
— Chloride
— Sulfur 5 to 12 weeks 
1.. The feed shall be placed on the market as complete feed.
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.. Indicate in the instructions for proper use: ‘Water should be available at all times.’
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 recurrence Complete feed with urine undersaturating or metastabilising properties for struviteAnd/orDiet with urine acidifying propertiesAndMagnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % Dogs and cats 
— Phosphorus
— Calcium
— Sodium
— Magnesium
— Potassium
— Chloride
— Sulfur Initially up to 6 month 
1.. The feed shall be placed on the market as complete feed.
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.. Indicate in the instructions for proper use: ‘Water should be available at all times.’
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 Compensation for maldigestion Highly digestible diet:Apparent digestibility of
— low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %):
Crude protein ≥ 85 %
Crude fat ≥ 90 %Or
— fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %):
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.. The feed shall be placed on the market as complete feed.
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 %):
Crude protein ≥ 85 %
Crude fat ≥ 90 %Or
— fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %):
Crude protein ≥ 80 %
Crude fat ≥ 80 %AndSodium ≥ 1,8 g per kg of complete feed with a moisture level 12 %AndPotassium ≥ 5 g per kg of complete feed with a moisture level 12 % 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 %AndHighly digestible carbohydrates:
— ≥ 32 % Dogs and cats 
— Sodium
— Potassium
— Carbohydrate source(s) 1 – 7 days 
1.. The feed shall be placed on the market as complementary feed.
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.. 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 Fat ≤ 110 g/kg complete feed with a moisture content of 12 % Dogs and cats 
— Crude fat Initially up to 2 months 
1.. The feed shall be placed on the market as complete feed.
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 % for dogsCrude protein ≤ 370 g/kg complete feed with a moisture content of 12 % for catsAndSelected protein sourcesAndRecommended dietary protein digestibility ≥ 85 % Dogs and cats 
— Protein source(s)
— Copper (total)
— Sodium Initially up to 4 months 
1.. The feed shall be placed on the market as complete feed.
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.. Indicate in the instructions for proper use: ‘Water should be available at all times.’
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.. Indicate on the labelling:

— ‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
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 % Dogs and cats 
— Magnesium
— Potassium
— Sodium Initially up to 6 months 
1.. The feed shall be placed on the market as complete feed.
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 Metabolizable Energy < 3060 kcal/kg complete feed with moisture content of 12 %OrMetabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 % Dogs 
— Energy value Until target body weight is achieved and after if required to maintain target bodyweight 
1.. The feed shall be placed on the market as complete feed.
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 intake
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 %OrMetabolizable 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 
— 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 % 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 %AndAdequate 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 % and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 %AndIncreased levels of methionine and manganeseAdequate 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 % Dogs Copper (total) Initially up to 6 months 
1.. The feed shall be placed on the market as complete feed.
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 % Cats Iodine (total) Initially up to 3 months 
1.. The feed shall be placed on the market as complete feed.
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 % Dogs Trypsin-hydrolysed bovine casein Initially up to 2 months 
1.. The feed shall be placed on the market as complete feed.
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 mgOr
— 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.. 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.. The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
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 DOr
— 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.. The instructions for proper use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected.
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 speciesAnd/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. RuminantsPigsRabbitsPoultry Name and total amount of the nutritional additives, if appropriate 2 to 15 days 
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.. The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
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 speciesAnd/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.. The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
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 seleniumand/orvitamin B6 and/or vitamin E and/or vitamin Aand/ormethionine and/or cystine and/orminimum 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.. The instructions for proper use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
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 capacity 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.. 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.. 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.. 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.. 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, easilyavailable carbohydrates,moderate level of protein andlow level of potassium Ruminants 
— Starch
— Sugars (total)
— Magnesium
— Sodium
— Potassium 3 to 10 weeks during periods of fast grass growth 
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.. 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.. 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) up to 2 months 
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.. 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.. In the case of feed for dairy cows indicate on the labelling: ‘Especially for high yielding cows.’
4.. In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed.’
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.. Indicate on the labelling: ‘Especially for intensively fed young animals.’
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 elementsAnd/or
— Vitamins, provitamins and chemically well-defined substances having similar effects.The complementary feed maycontain feed additives in aconcentration higher than 100times the relevant fixedmaximum content in completefeed Ruminantswith afunctionalrumen 
— 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.. 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.. 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:
((a)) the balance of trace elements in the daily ration;
((b)) the trace elements status of the herd’
60 Reduction of the risk of milk fever and subclinical hypocalcaemia Low cations/anions ratioFor the total ration:
— Minimum acidification via feed for particular nutritional purpose: 100 mEq/kg dry matter
— Objective: range from -200 mEq/kg dry matter DCAD to < 100 mEq/kg dry matter DCADOr 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’
OrSupply 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 dayOr  
— Calcium
— Calcium sources From first signs of parturition to two daysSubsequent to parturition 
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.. Indicate in the instructions for proper use the number of applications and the time before and after calving.
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 dayOr  
— Calcium
— Calcium pidolate From first signs of parturition to two days subsequent to parturition 
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.. 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.. 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.. Indicate on the labelling: ‘It is recommended that a nutritional expert’s opinion be sought before use’.
61 Reduction of the risk of ketosis 
— Minimum supply of propane-1,2-diol or propylene glycol:
250 g/day for dairy cows
50 g/day for ewes or goatsOr
— Minimum supply of propionates (calcium or sodium salts):
110 g/day for dairy cows
22 g/day for ewes or goatsOr
— 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 cowsBetween six weeks before and three weeks after parturition for ewes and goats 
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.. 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 magnesiumAnd/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 PhosphorusThe inclusion of other electrolyte salts is optional. Equines 
— Sodium
— Chlorides
— Potassium
— Calcium
— Magnesium
— Phosphorus One to three days after heavy sweating. 
1.. Guidance shall be provided on the situations in which the use of the feed is appropriate.
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.. 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.. Furthermore guidance must be given to monitor subsequent drinking, if insufficient water intake is observed veterinary advice should be sought.
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 energyMinimum 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.. Guidance shall be provided on the situations in which the use of this feed is appropriate.
2.. The instructions for proper use shall contain guidance on the balance of the daily ration and the appropriate daily intake.
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.. 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.. The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.
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.. Guidance shall be provided on

— the precise situations in which the use of the feed is appropriate
— meal size and forage intake.
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.. Indicate on the labelling:
‘In case of risk of, during periods of, or recovery from digestive disturbance’.
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.





















