Commission Regulation (EU) 2020/354Show full title

ANNEX U.K.

PART A U.K. General provisions for feed for particular nutritional purposes

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. U.K.

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. U.K.

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(1) are applicable and their use shall comply with the specified essential nutritional characteristic. U.K.

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’. U.K.

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(2). U.K.

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. U.K.

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. U.K.

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. U.K.

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. U.K.

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. U.K.

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. U.K.

PART B U.K. List of intended uses

a For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
b These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
c If appropriate the manufacturer may also recommend use for temporary renal insufficiency.
d 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.
e If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
f In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’
g For cats a reference to ‘Feline hepatic lipidosis’ may be added
h For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added.
i Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth.
j Urine pH ≤ 6,5.
l Metastabilising properties: urine associated with properties of prevention of crystal precipitation.
k ‘exocrine pancreatic insufficiency’ may be added.
m 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.
n 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.
o Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
p FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
q In the case of feed for dairy cows: ‘maximum two months from the start of lactation’.
r Indicate the category of ruminants concerned.
s DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S).
t The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.
u 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 characteristicsa	Species or category of animal	Labelling declarationsb	Recommended length of time	Other provisions
	1	2	3	4	5	6
10	Support of renal function in case of chronic renal insufficiencyc	High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 %d and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 %d	Dogs	Protein source(s) Calcium Phosphorus Potassium Sodium Essential fatty acids (if added)	Initially up to 6 monthse	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 monthse	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 %d and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 %d	Cats	Protein source(s) Calcium Phosphorus Potassium Sodium Essential fatty acids (if added)	Initially up to 6 monthse	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 monthse	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 %d	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 intolerancesf	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. 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 %d 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 %d	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, convalescenceg	Highly digestible ingredients with energy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 %d	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 %d	Cats
16	Reduction of urate stones formation	Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 %d Or Crude protein ≤ 220 g/kg complete feed with a moisture level of 12 %d 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 %d	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 stonesh	Urine undersaturatingi properties for struvite And/or Urine acidifying propertiesj And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %d	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 recurrenceh	Complete feed with urine undersaturatingi or metastabilising propertiesl for struvite And/or Diet with urine acidifying propertiesj And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 %d	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 maldigestionk	Highly digestible diet: Apparent digestibility of low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 %d): Crude protein ≥ 85 % Crude fat ≥ 90 % Or fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %d): 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 %d): Crude protein ≥ 85 % Crude fat ≥ 90 % Or fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %d): Crude protein ≥ 80 % Crude fat ≥ 80 % And Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 %d And Potassium ≥ 5 g per kg of complete feed with a moisture level 12 %d	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. 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	Fatm ≤ 110 g/kg complete feed with a moisture content of 12 %n	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 %d for dogs Crude protein ≤ 370 g/kg complete feed with a moisture content of 12 %d 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. 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 %d	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 %o Or Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 %o	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 intakep 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 %o Or Metabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 %o	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 %d	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 %d	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 %d	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 %d 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 %d and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 %d 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 %d	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 %d	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 %d	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 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. 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 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. 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 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. 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 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. 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 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. 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 capacityu 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, 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. 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 monthsq	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 fedr.’
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 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. 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 ratio For the total ration: Minimum acidification via feed for particular nutritional purpose: 100 mEq/kg dry matter Objective: 0 < DCADs (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. 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 day Or		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 ketosist	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. 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 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. 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 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. 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.

(1)

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

(2)

Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).