THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC(1), and in particular Article 10(5) thereof,
Whereas:
(1) The placing on the market and use of feed is regulated by Regulation (EC) No 767/2009. In accordance with Article 9 of that Regulation, feed intended for particular nutritional purposes may only be marketed if its intended use is included in a list of intended uses established in accordance with Article 10 of the said Regulation.
(2) Commission Directive 2008/38/EC(2) established a list of intended uses of animal feedingstuffs for particular nutritional purposes.
(3) Part A of Annex I to Directive 2008/38/EC established the general provisions for feed intended for particular nutritional purposes. Considering scientific and technological developments and the labelling requirements established by Regulation (EC) No 767/2009, those general provisions are to be reviewed.
(4) Articles 11 to 17 of Regulation (EC) No 767/2009 established new principles and rules for the placing on the market of feed, including labelling. As a consequence, several entries in the list of intended uses of feed intended for particular nutritional purposes contained in Part B of Annex I to Directive 2008/38/EC became outdated, partially because of poor and overly general descriptions in the column ‘Essential nutritional characteristics’. For such entries, it has been very difficult for the control authorities to verify compliance with the provisions of Regulation (EC) No 767/2009, including whether the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose.
(5) In accordance with Article 10 of Regulation (EC) No 767/2009, the Commission received a number of applications to amend and change the conditions associated with several intended uses of feed for particular nutritional purposes, which had become outdated. Outdated entries for which no application has been submitted or for which the application was withdrawn should be removed.
(6) As regards other intended uses of feed intended for particular nutritional purposes listed in Part B of Annex I to Directive 2008/38/EC, amendments are necessary to the provisions concerning the essential nutritional characteristics and the labelling declarations in order to adapt them to the scientific and technological developments and to improve the enforceability and clarity of the provisions.
(7) Furthermore, the Commission received, in accordance with Article 10 of Regulation (EC) No 767/2009, applications to add the particular nutritional purposes ‘support of energy metabolism and of the muscle function in the case of rhabdomyolosis’ and ‘support in stressful situations, which will lead to the reduction of associated behaviour’ to the list of intended uses of feed intended for particular nutritional purposes.
(8) The Commission made all applications, including the dossiers, available to the Member States.
(9) Following the assessment of the dossiers included in those applications, the Standing Committee on Plants, Animals, Food and Feed (‘the Committee’) acknowledged that the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment or animal welfare.
(10) Based on the above considerations, the list of intended uses of feed for particular nutritional purposes should be updated.
(11) Since safety reasons do not require the immediate application of the new general provisions and of the updated list of intended uses of feed for particular nutritional purposes, it is appropriate to provide for transitional measures in order to avoid unnecessary disruption of commercial practices and to not create unnecessary administrative burden on the operators.
(12) In the interests of clarity and rationality, Directive 2008/38/EC should be repealed and replaced by a Regulation, which does not contain elements that would require transpositions by the Member States into national law. The last amendments to that Directive had already been successively brought through Regulations due to the absence of need of transposition into national law of the provisions concerned. In addition, the general requirements for the placing on the market and use of feed intended for particular nutritional purposes are provided for in Regulation (EC) No 767/2009.
(13) In order to enable Member States to make the necessary adjustments, an adequate period should be allowed before this Regulation becomes applicable.
(14) The measures provided for in this Regulation are in accordance with the opinion of the Committee,
HAS ADOPTED THIS REGULATION:
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.
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 Commission in accordance with Article 10 of Regulation (EC) No 767/2009 before 25 March 2021 and until the Commission decides on the respective application.
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.
Directive 2008/38/EC is repealed.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 March 2020.
For the Commission
The President
Ursula von der Leyen
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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:
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 |
| 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 |
| Initially up to 6 months | 1. The feed shall be placed on the market as complete feed. 2. Indicate on the labelling:
|
| 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 |
| 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:
|
| 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 |
| 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:
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 |
| 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 |
| 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:
|
| 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:
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 |
| 5 to 12 weeks | 1. The feed shall be placed on the market as complete feed. 2. Indicate on the labelling:
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 |
| Initially up to 6 month | 1. The feed shall be placed on the market as complete feed. 2. Indicate on the labelling:
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
Or
| Dogs and cats |
| 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:
|
| 20 | Reduction of intestinal absorptive disorders | Highly digestible diet: Apparent digestibility of
Or
And Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 %d And Potassium ≥ 5 g per kg of complete feed with a moisture level 12 %d | Dogs and cats |
| Up to 12 weeks | Indicate on the labelling:
|
| 21 | Reduction of acute intestinal absorptive disorders | Increased level of electrolytes:
And Highly digestible carbohydrates:
| Dogs and cats |
| 1 – 7 days | 1. The feed shall be placed on the market as complementary feed. 2. Indicate on the labelling:
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 |
| Initially up to 2 months | 1. The feed shall be placed on the market as complete feed. 2. Indicate on the labelling:
|
| 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 |
| 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:
|
| Low level of protein but of high quality and highly digestible carbohydrates | Equines |
| Initially up to six months | 1. Indicate on the labelling:
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 |
| 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 |
| 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:
|
| 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 |
| Initially up to 2 months | Indicate on the labelling:
|
| Linoleic acid ≥ 18,5 g per kg and sum of eicosapentaenoic acid and docosahexaenoic acid ≥ 0,39 g per kg of complete feed with a moisture content of 12 %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 |
| Initially up to 3 months | Indicate on the labelling:
|
| Total omega-3 fatty acids ≥ 10,6 g per kg complete feed with a moisture content of 12 %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 |
| ||||
| 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:
|
| 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:
|
| 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:
|
| 50 | Support the preparation for oestrus and reproduction |
Or
The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Mammals | Names and total amounts of each added trace element and vitamin |
| 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. |
Or
The complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Birds | Names and total amounts of each added trace element and vitamin |
| |||
| 51 | Support the regeneration of hooves, trotters and skin | High level of zinc. The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Horses, ruminants and pigs |
| Up to 8 weeks | 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:
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Ruminants Pigs Rabbits Poultry | Name and total amount of the nutritional additives, if appropriate | 2 to 15 days | 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:
And/or
And/or
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, iodine, manganese, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Mammals | Name and total amount of the nutritional additives, if appropriate | Up to 4 weeks around weaning | 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 |
And
and/or vitamin B6 and/or vitamin E and/or vitamin A and/or methionine and/or cystine and/or minimum supply of 0,4 mg biotin/kg complete feed with a moisture content of 12 % for ruminants. The complementary feed may contain zinc, copper, iodine, selenium and vitamin A in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Mammals and poultry | Name and total amount of the nutritional additives, if appropriate |
| 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 |
| Calves, pigs, lambs, kids and foals |
| 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:
4. Indicate in the instructions for proper use:
|
| 56 | Reduction of the risk of tetany (hypomagnesaemia) | High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium | Ruminants |
| 3 to 10 weeks during periods of fast grass growth | 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 |
| 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 |
| 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
And/or
The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed | Ruminants with a functional rumen |
| Up to 12 months | 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:
|
| 60 | Reduction of the risk of milk fever and subclinical hypocalcaemia | Low cations/anions ratio For the total ration:
Or | Dairy cows |
| From 3 weeks before calving until calving | Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
| Zeolite (sodium aluminium silicate): 250 – 500 g/day | Sodium aluminium silicate | From 3 weeks before calving until calving | Indicate in the instructions for proper use:
| |||
| Or Supply of rumen protected feed materials rich in phytic acid (> 6 %) and having a calcium content < 0,2 %, to achieve a minimum of 28 g and a maximum of 32 g available calcium per cow per day. Or |
| From 4 weeks before calving until calving | Indicate in the instructions for proper use: ‘Stop feeding after calving’ | |||
| High level of calcium in the form of highly available sources of calcium: calcium chloride and/or calcium sulfate and/or dicalcium phosphate and/or calcium carbonate and/or calcium propionate and/or calcium formate. and/or ‘any other calcium source having a similar effect’ Calcium provided by one or a combination of these sources with a minimum of 50 g per cow per day Or |
| From first signs of parturition to two days Subsequent to parturition | 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 |
| 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 |
| 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 |
Or
Or
| Dairy cows, ewes and goats |
| Between three weeks before and six weeks after calving for dairy cows Between six weeks before and three weeks after parturition for ewes and goats | 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 |
And/or
| Pigs |
| 1 to 7 days | Guidance shall be provided on the situation in which the use of this feed is appropriate. |
| 63 | Reduction of the risk of constipation | Ingredients stimulating intestinal passage | Sows | Ingredients stimulating intestinal passage | 10 to 14 days before and 10 to 14 days after farrowing | |
| 64 | Compensation for insufficient iron availability after birth | High level of iron compounds authorised under the functional group ‘compounds of trace elements’ of the category ‘nutritional additives’ as referred to in Annex I to Regulation (EC) No 1831/2003. The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Suckling piglets and calves | Iron (total) | After birth up to 3 weeks | The instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected. |
| 65 | Compensation for malabsorption | Low level of saturated fatty acids and high level of fat soluble vitamins | Poultry excluding geese and pigeons |
| During the first 2 weeks after hatching | |
| 66 | Reduction of the risk of fatty liver syndrome | Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids | Laying hens |
| Up to 12 weeks | |
| 67 | Support the preparation for and recovery from sport effort | High level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %. The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed. | Equidae |
| Up to 8 weeks before sport effort – Up to 4 weeks after sport effort | The instructions for proper use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected. |
| 68 | Compensation of electrolyte loss in the cases of heavy sweating | Must contain sodium chloride and should contain potassium chloride. Low levels of Magnesium, Calcium and Phosphorus The inclusion of other electrolyte salts is optional. | Equines |
| One to three days after heavy sweating. | 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:
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 |
| 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 |
| Equines |
| Long term or until resolution of the issue | 1. Guidance shall be provided
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 |
| Equines |
| Long term or until resolution of the issue | 1. Guidance shall be provided on
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. |
Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (OJ L 62, 6.3.2008, p. 9).
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).
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).