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Document 32020R0354
Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (Text with EEA relevance)
Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (Text with EEA relevance)
Commission Regulation (EU) 2020/354 of 4 March 2020 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC (Text with EEA relevance)
C/2020/1183
IO L 67, 5.3.2020, p. 1–26
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Repeal | 32008L0038 | 25/12/2020 | |||
Implicit repeal | 32008L0082 | 25/12/2020 | |||
Implicit repeal | 32010R1070 | 25/12/2020 | |||
Implicit repeal | 32014R0005 | 25/12/2020 | |||
Implicit repeal | 32014R1123 | 25/12/2020 |
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Corrected by | 32020R0354R(01) | (ES) | |||
Corrected by | 32020R0354R(02) | (IT) | |||
Corrected by | 32020R0354R(03) | (DA) | |||
Corrected by | 32020R0354R(04) | (DE) | |||
Corrected by | 32020R0354R(05) | (ES, FR, NL, SL) |
5.3.2020 |
EN |
Official Journal of the European Union |
L 67/1 |
COMMISSION REGULATION (EU) 2020/354
of 4 March 2020
establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC
(Text with EEA relevance)
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:
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 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.
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.
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
(2) 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).
ANNEX
PART A
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. |
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 (1) 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 (2). |
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
List of intended uses
Entry number |
Particular nutritional purpose |
Essential nutritional characteristics (GP1) |
Species or category of animal |
Labelling declarations (GP2) |
Recommended length of time |
Other provisions |
||||||||||||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||||||||||||||||||||||||||||
10 |
Support of renal function in case of chronic renal insufficiency (3) |
High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 % (4) and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 % (4) |
Dogs |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate |
Adult dogs |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
High quality proteins and phosphorus ≤ 6,5 g/kg complete feed with a moisture content of 12 % (4) and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 % (4) |
Cats |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate |
Adult cats |
|
Initially up to 6 months (5) |
|
||||||||||||||||||||||||||||||||||
High density of energy with more than 8,8 MJ/kg feed with a moisture content of 12 %. Highly digestible and highly palatable sources of starch. Restricted protein level: ≤ 106 g crude protein/kg feed with a moisture content of 12 %. Level of sodium: 2 g/100 kg BW per day. High level of eicosapentaenoic acid and docosahexaenoic sum ≥ 0,2 g per kg BW0,75 per day |
Equines |
|
Initially up to six months. Long term or until resolution of the issue |
|
||||||||||||||||||||||||||||||||||
11 |
Reduction of oxalate stones formation |
Low level of calcium, low level of vitamin D, and urine alkalising properties |
Dogs and cats |
|
Up to 6 months |
Indicate on the labelling: ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
||||||||||||||||||||||||||||||||
12 |
Regulation of glucose supply (Diabetes mellitus) |
Total sugars (mono- and disaccharides) ≤ 62 g/kg complete feed with a moisture of 12 % (4) |
Dogs and cats |
|
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
13 |
Reduction of ingredient and nutrient intolerances (6) |
Selected and limited number of protein source(s) And/or hydrolysed protein source(s) And/or selected carbohydrate source(s) |
Dogs and cats |
|
3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year. |
|
||||||||||||||||||||||||||||||||
14 |
Reduction of cystine stones formation |
Urine alkalinising properties and crude protein ≤ 160 g/kg complete feed with a moisture content of 12 % (4) 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 % (4) |
Dogs |
|
Initially up to 6 month |
‘Water should be available at all times’
|
||||||||||||||||||||||||||||||||
15 |
Nutritional restoration, convalescence (7) |
Highly digestible ingredients with energy density ≥ 3 520 kcal and crude protein ≥ 250 g per kg of complete feed with a moisture level 12 % (4) |
Dogs |
|
Until restoration is achieved |
|
||||||||||||||||||||||||||||||||
Highly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12 % (4) |
Cats |
|||||||||||||||||||||||||||||||||||||
16 |
Reduction of urate stones formation |
Crude protein ≤ 130 g/kg complete feed with a moisture level of 12 % (4) Or Crude protein ≤ 220 g/kg complete feed with a moisture level of 12 % (4) and selected protein sources |
Dogs |
|
Up to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism |
|
||||||||||||||||||||||||||||||||
Crude protein ≤ 317 g/kg complete feed with a moisture content of 12 % (4) |
Cats |
|
||||||||||||||||||||||||||||||||||||
17 |
Dissolution of struvite stones (8) |
Urine undersaturating (9) properties for struvite And/or Urine acidifying properties (10) And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
5 to 12 weeks |
|
||||||||||||||||||||||||||||||||
18 |
Reduction of struvite stone recurrence (8) |
Complete feed with urine undersaturating (9) or metastabilising properties (11) for struvite And/or Diet with urine acidifying properties (10) And Magnesium ≤ 1,8 g/kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
Initially up to 6 month |
|
||||||||||||||||||||||||||||||||
19 |
Compensation for maldigestion (12) |
Highly digestible diet: Apparent digestibility of
Or
|
Dogs and cats |
|
Initially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency |
|
||||||||||||||||||||||||||||||||
20 |
Reduction of intestinal absorptive disorders |
Highly digestible diet: Apparent digestibility of
Or
And Sodium ≥ 1,8 g per kg of complete feed with a moisture level 12 % (4) And Potassium ≥ 5 g per kg of complete feed with a moisture level 12 % (4) |
Dogs and cats |
|
Up to 12 weeks |
Indicate on the labelling:
|
||||||||||||||||||||||||||||||||
21 |
Reduction of acute intestinal absorptive disorders |
Increased level of electrolytes:
And Highly digestible carbohydrates:
|
Dogs and cats |
|
1 – 7 days |
|
||||||||||||||||||||||||||||||||
22 |
Support of lipid metabolism in the case of hyperlipidaemia |
Fat (13) ≤ 110 g/kg complete feed with a moisture content of 12 % (14) |
Dogs and cats |
|
Initially up to 2 months |
|
||||||||||||||||||||||||||||||||
23 |
Support of liver function in the case of chronic liver insufficiency |
Moderate level of protein: Crude protein ≤ 279 g/kg complete feed with a moisture content of 12 % (4) for dogs Crude protein ≤ 370 g/kg complete feed with a moisture content of 12 % (4) for cats And Selected protein sources And Recommended dietary protein digestibility ≥ 85 % |
Dogs and cats |
|
Initially up to 4 months |
|
||||||||||||||||||||||||||||||||
Low level of protein but of high quality and highly digestible carbohydrates |
Equines |
|
Initially up to six months |
|
||||||||||||||||||||||||||||||||||
24 |
Support of heart function in the case of chronic cardiac insufficiency |
Restricted level of sodium: Sodium ≤ 2,6 g per kg complete feed with a moisture content of 12 % (4) |
Dogs and cats |
|
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
25 |
Reduction of excessive body weight |
Metabolizable Energy < 3060 kcal/kg complete feed with moisture content of 12 % (15) Or Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 % (15) |
Dogs |
|
Until target body weight is achieved and after if required to maintain target bodyweight |
|
||||||||||||||||||||||||||||||||
Metabolizable Energy < 3190 kcal per kg complete feed with moisture content of 12 % (15) Or Metabolizable Energy < 580 kcal per kg complete feed with moisture content of 85 % (15) |
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 % (4) |
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 % (4) |
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 % (4) |
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 % (4) 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 % (4) and docosahexaenoic acid ≥ 2,5 g per kg complete feed with a moisture content of 12 % (4) 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 % (4) |
Dogs |
Copper (total) |
Initially up to 6 months |
|
||||||||||||||||||||||||||||||||
29 |
Reduction of iodine levels in feed in case of hyperthyroidism |
Restricted level of iodine: iodine ≤ 0,26 mg per kg complete feed with a moisture content of 12 % (4) |
Cats |
Iodine (total) |
Initially up to 3 months |
|
||||||||||||||||||||||||||||||||
30 |
Support in stressful situations, which will lead to the reduction of associated behaviour |
1-3 g trypsin-hydrolysed bovine casein per kg complete feed with a moisture content of 12 % (4) |
Dogs |
Trypsin-hydrolysed bovine casein |
Initially up to 2 months |
|
||||||||||||||||||||||||||||||||
50 |
Support the preparation for oestrus and reproduction |
Or
The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals |
Names and total amounts of each added trace element and vitamin |
|
|
||||||||||||||||||||||||||||||||
|
Or
The complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Birds |
Names and total amounts of each added trace element and vitamin |
|
||||||||||||||||||||||||||||||||||
51 |
Support the regeneration of hooves, trotters and skin |
High level of zinc. The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Horses, ruminants and pigs |
|
Up to 8 weeks |
|
||||||||||||||||||||||||||||||||
52 |
Support for nutritional imbalances in dietary transition |
Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Ruminants Pigs Rabbits Poultry |
Name and total amount of the nutritional additives, if appropriate |
2 to 15 days |
|
||||||||||||||||||||||||||||||||
53 |
Support weaning |
Minimum supply via the dietetic feed of:
And/or
And/or
And/or
And/or
And/or
And/or
And/or
The complementary feed may contain selenium, zinc, copper, iodine, manganese, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals |
Name and total amount of the nutritional additives, if appropriate |
Up to 4 weeks around weaning |
|
||||||||||||||||||||||||||||||||
54 |
Support the regeneration of the skin and appendages |
And
and/or vitamin B6 and/or vitamin E and/or vitamin A and/or methionine and/or cystine and/or minimum supply of 0,4 mg biotin/kg complete feed with a moisture content of 12 % for ruminants. The complementary feed may contain zinc, copper, iodine, selenium and vitamin A in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Mammals and poultry |
Name and total amount of the nutritional additives, if appropriate |
|
|
||||||||||||||||||||||||||||||||
55 |
Stabilisation of water and electrolyte balance to support the physiological digestion |
|
Calves, pigs, lambs, kids and foals |
|
1 to 7 days |
|
||||||||||||||||||||||||||||||||
56 |
Reduction of the risk of tetany (hypomagnesaemia) |
High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium |
Ruminants |
|
3 to 10 weeks during periods of fast grass growth |
|
||||||||||||||||||||||||||||||||
57 |
Reduction of the risk of acidosis |
Low level of easily fermentable carbohydrates and high buffering capacity |
Ruminants |
|
up to 2 months (17) |
|
||||||||||||||||||||||||||||||||
58 |
Reduction of the risk of urinary calculi |
Low level of phosphorus, magnesium, and urine acidifying properties |
Ruminants |
|
Up to 6 weeks |
|
||||||||||||||||||||||||||||||||
59 |
Long-term supply of grazing animals with trace elements and/or vitamins |
High level of
And/or
The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed |
Ruminants with a functional rumen |
|
Up to 12 months |
|
||||||||||||||||||||||||||||||||
60 |
Reduction of the risk of milk fever and subclinical hypocalcaemia |
Low cations/anions ratio For the total ration:
Or |
Dairy cows |
|
From 3 weeks before calving until calving |
Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
||||||||||||||||||||||||||||||||
Zeolite (sodium aluminium silicate): 250 – 500 g/day |
|
Sodium aluminium silicate |
From 3 weeks before calving until calving |
Indicate in the instructions for proper use:
|
||||||||||||||||||||||||||||||||||
Or Supply of rumen protected feed materials rich in phytic acid (> 6 %) and having a calcium content < 0,2 %, to achieve a minimum of 28 g and a maximum of 32 g available calcium per cow per day. Or |
|
|
From 4 weeks before calving until calving |
Indicate in the instructions for proper use: ‘Stop feeding after calving’ |
||||||||||||||||||||||||||||||||||
High level of calcium in the form of highly available sources of calcium: calcium chloride and/or calcium sulfate and/or dicalcium phosphate and/or calcium carbonate and/or calcium propionate and/or calcium formate. and/or ‘any other calcium source having a similar effect’ Calcium provided by one or a combination of these sources with a minimum of 50 g per cow per day Or |
|
|
From first signs of parturition to two days Subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
Calcium pidolate in a minimum of 5,5 g per cow per day Or |
|
|
From first signs of parturition to two days subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
Waxy-leaf nightshade meal allowing a daily release of 38 – 46 μg 1,25 dihydroxycholecalciferol-glycoside per day |
|
|
From two days before calving or first signs of parturition to 10 days subsequent to parturition |
|
||||||||||||||||||||||||||||||||||
61 |
Reduction of the risk of ketosis (20) |
Or
Or
|
Dairy cows, ewes and goats |
|
Between three weeks before and six weeks after calving for dairy cows Between six weeks before and three weeks after parturition for ewes and goats |
|
||||||||||||||||||||||||||||||||
62 |
Reduction of stress reactions |
And/or
|
Pigs |
|
1 to 7 days |
Guidance shall be provided on the situation in which the use of this feed is appropriate. |
||||||||||||||||||||||||||||||||
63 |
Reduction of the risk of constipation |
Ingredients stimulating intestinal passage |
Sows |
Ingredients stimulating intestinal passage |
10 to 14 days before and 10 to 14 days after farrowing |
|
||||||||||||||||||||||||||||||||
64 |
Compensation for insufficient iron availability after birth |
High level of iron compounds authorised under the functional group ‘compounds of trace elements’ of the category ‘nutritional additives’ as referred to in Annex I to Regulation (EC) No 1831/2003. The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed. |
Suckling piglets and calves |
Iron (total) |
After birth up to 3 weeks |
The instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected. |
||||||||||||||||||||||||||||||||
65 |
Compensation for malabsorption |
Low level of saturated fatty acids and high level of fat soluble vitamins |
Poultry excluding geese and pigeons |
|
During the first 2 weeks after hatching |
|
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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 |
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Up to 12 weeks |
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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. |
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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 |
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One to three days after heavy sweating. |
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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 |
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70 |
Compensation for chronic digestive disorders of large intestine |
|
Equines |
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Long term or until resolution of the issue |
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71 |
Compensation for chronic insufficiency of small intestine function |
|
Equines |
|
Long term or until resolution of the issue |
|
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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) 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).
(GP1) For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
(GP2) These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
(3) If appropriate the manufacturer may also recommend use for temporary renal insufficiency.
(4) 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.
(5) If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
(6) In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’
(7) For cats a reference to ‘Feline hepatic lipidosis’ may be added
(8) For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome – FUS’ may be added.
(9) Undersaturating properties: urine associated with crystal and stone dissolution properties and/or properties of prevention of crystal precipitation and growth.
(10) Urine pH ≤ 6,5.
(11) Metastabilising properties: urine associated with properties of prevention of crystal precipitation.
(12) ‘exocrine pancreatic insufficiency’ may be added.
(13) 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.
(14) 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.
(15) Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
(16) FEDIAF (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
(17) In the case of feed for dairy cows: ‘maximum two months from the start of lactation’.
(18) Indicate the category of ruminants concerned.
(19) DCAD (mEq/kg dry matter) = (Na + K) – (Cl + S).
(20) The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.
(21) 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].