# L_2020067EN.01000101.xml

| 5.3.2020 | EN | Official Journal of the European Union | L 67/1 |
| --- | --- | --- | --- |

5.3.2020

EN

Official Journal of the European Union

L 67/1

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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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
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(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. |
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(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
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(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. |
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(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. |
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(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, |
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(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 |
| --- | --- |

—

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. |
| --- | --- |

—

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

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(1)  
  OJ L 229, 1.9.2009, p. 1.

1

(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).

2

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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. |
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1.

| 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. |
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2.

| 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. |
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3.

| 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’. |
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4.

| 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). |
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5.

| 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. |
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6.

| 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. |
| --- | --- |

7.

| 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. |
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8.

| 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. |
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9.

| 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. |
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10.

| 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. |
| --- | --- |

11.

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 | — | Protein source(s) |

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

—

Protein source(s)

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Potassium |
| --- | --- |

—

Potassium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Essential fatty acids (if added) |
| --- | --- |

—

Essential fatty acids (if added)

Initially up to 6 months (5)

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

1.

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

| 2. | Recommended digestibility of proteins: minimum 85 %. |
| --- | --- |

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.’ |
| --- | --- |

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.’ |
| --- | --- |

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) |
| --- | --- |

—

Protein source(s)

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Potassium |
| --- | --- |

—

Potassium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Essential fatty acids (if added) |
| --- | --- |

—

Essential fatty acids (if added)

| — | Lanthanum carbonate octahydrate |
| --- | --- |

—

Lanthanum carbonate octahydrate

Initially up to 6 months (5)

| 1. | Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’ |
| --- | --- |

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.’ |
| --- | --- |

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 % (4) and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 % (4)

Cats

| — | Protein source(s) |
| --- | --- |

—

Protein source(s)

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Potassium |
| --- | --- |

—

Potassium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Essential fatty acids (if added) |
| --- | --- |

—

Essential fatty acids (if added)

Initially up to 6 months (5)

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

1.

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

| 2. | Recommended digestibility of proteins: minimum 85 %. |
| --- | --- |

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.’ |
| --- | --- |

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.’ |
| --- | --- |

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) |
| --- | --- |

—

Protein source(s)

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Potassium |
| --- | --- |

—

Potassium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Essential fatty acids (if added) |
| --- | --- |

—

Essential fatty acids (if added)

| — | Lanthanum carbonate octahydrate |
| --- | --- |

—

Lanthanum carbonate octahydrate

Initially up to 6 months (5)

| 1. | Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’ |
| --- | --- |

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.’ |
| --- | --- |

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) |
| --- | --- |

—

Protein and energy source(s)

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Potassium |
| --- | --- |

—

Potassium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Sum of eicosapentaenoic acid and docosahexaenoic acid |
| --- | --- |

—

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 |
| --- | --- |

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.’ |
| --- | --- | --- |

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 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). |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- |

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 |
| --- | --- |

—

Phosphorus

| — | Calcium |
| --- | --- |

—

Calcium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Sulphur |
| --- | --- |

—

Sulphur

| — | Vitamin D (total) |
| --- | --- |

—

Vitamin D (total)

| — | Hydroxyproline |
| --- | --- |

—

Hydroxyproline

| — | Urine alkalising substances |
| --- | --- |

—

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 % (4)

Dogs and cats

| — | Carbohydrate source(s) |
| --- | --- |

—

Carbohydrate source(s)

| — | Treatment of carbohydrates, if appropriate |
| --- | --- |

—

Treatment of carbohydrates, if appropriate

| — | Starch |
| --- | --- |

—

Starch

| — | Total sugars |
| --- | --- |

—

Total sugars

| — | Fructose (if added) |
| --- | --- |

—

Fructose (if added)

| — | Essential fatty acids (if added) |
| --- | --- |

—

Essential fatty acids (if added)

| — | Source(s) of short and medium chain 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. |
| --- | --- |

1.

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

| 2. | Indicate on the labelling:






  — | ‘Low level of mono- and disaccharides’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

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

13

Reduction of ingredient and nutrient intolerances (6)

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). |
| --- | --- |

—

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

| — | Carbohydrate source(s) including treatment, if appropriate (if added). |
| --- | --- |

—

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

| — | Essential fatty acids (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. |
| --- | --- |

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. |
| --- | --- |

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 |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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 % (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

| — | Sulphur amino acids (total) |
| --- | --- |

—

Sulphur amino acids (total)

| — | Protein sources |
| --- | --- |

—

Protein sources

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Urine alkalinizing substances (if added) |
| --- | --- |

—

Urine alkalinizing substances (if added)

Initially up to 6 month

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

1.

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

| 2. | Indicate in the instructions for proper use: |
| --- | --- |

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. |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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. |
| --- | --- |

4.

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

15

Nutritional restoration, convalescence (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

| — | Highly digestible ingredient sources including their treatment, if appropriate |
| --- | --- |

—

Highly digestible ingredient sources including their treatment, if appropriate

| — | Energy value |
| --- | --- |

—

Energy value

Until restoration is achieved

| 1. | Recommended apparent digestibility of Dry Matter ≥ 80 % or of Organic Matter ≥ 85 %. |
| --- | --- |

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.’ |
| --- | --- |

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. |
| --- | --- |

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’ |
| --- | --- |

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 % (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

| — | Protein source(s) |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- |

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.’ |
| --- | --- | --- |

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. |
| --- | --- |

—

‘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 % (4)

Cats

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- | --- |

3.

Indicate on the labelling:

—

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

| — | ‘Restricted level of protein’ |
| --- | --- |

—

‘Restricted level of protein’

| 4. | Indicate in the instructions for proper use: ‘Water should be available at all times’. |
| --- | --- |

4.

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

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

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Calcium |
| --- | --- |

—

Calcium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chloride |
| --- | --- |

—

Chloride

| — | Sulfur |
| --- | --- |

—

Sulfur

5 to 12 weeks

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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.’ |
| --- | --- |

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. |
| --- | --- |

4.

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

18

Reduction of struvite stone recurrence (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

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Calcium |
| --- | --- |

—

Calcium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chloride |
| --- | --- |

—

Chloride

| — | Sulfur |
| --- | --- |

—

Sulfur

Initially up to 6 month

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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’ |
| --- | --- |

—

‘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.’ |
| --- | --- |

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. |
| --- | --- |

4.

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

19

Compensation for maldigestion (12)

Highly digestible diet:

Apparent digestibility of

| — | low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 % (4)):
  Crude protein ≥ 85 %
  Crude fat ≥ 90 % |
| --- | --- |

—

low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 % (4)):

Crude protein ≥ 85 %

Crude fat ≥ 90 %

Or

| — | fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 % (4)):
  Crude protein ≥ 80 %
  Crude fat ≥ 80 % |
| --- | --- |

—

fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 % (4)):

Crude protein ≥ 80 %

Crude fat ≥ 80 %

Dogs and cats

| — | Highly digestible ingredient sources including their treatment, if appropriate |
| --- | --- |

—

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. |
| --- | --- |

1.

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

| 2. | Indicate on the labelling:






  — | ‘Highly digestible feed’ |
| --- | --- | --- |

2.

Indicate on the labelling:

—

‘Highly digestible feed’

| — | ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
| --- | --- |

—

‘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 % (4)):
  Crude protein ≥ 85 %
  Crude fat ≥ 90 % |
| --- | --- |

—

low-fibre feed (crude fibre ≤ 44 g per kg of complete feed with a moisture level 12 % (4)):

Crude protein ≥ 85 %

Crude fat ≥ 90 %

Or

| — | fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 % (4)):
  Crude protein ≥ 80 %
  Crude fat ≥ 80 % |
| --- | --- |

—

fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 % (4)):

Crude protein ≥ 80 %

Crude fat ≥ 80 %

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

| — | Highly digestible ingredient sources including their treatment, if appropriate |
| --- | --- |

—

Highly digestible ingredient sources including their treatment, if appropriate

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

Potassium

Up to 12 weeks

Indicate on the labelling:

| — | ‘Highly digestible feed with increased sodium and potassium’ |
| --- | --- |

—

‘Highly digestible feed with increased sodium and potassium’

| — | ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
| --- | --- |

—

‘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 % |
| --- | --- |

—

Sodium ≥ 1,8 %

| — | Potassium ≥ 0,6 % |
| --- | --- |

—

Potassium ≥ 0,6 %

And

Highly digestible carbohydrates:

| — | ≥ 32 % |
| --- | --- |

—

≥ 32 %

Dogs and cats

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Carbohydrate source(s) |
| --- | --- |

—

Carbohydrate source(s)

1 – 7 days

| 1. | The feed shall be placed on the market as complementary feed. |
| --- | --- |

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’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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. |
| --- | --- |

3.

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

22

Support of lipid metabolism in the case of hyperlipidaemia

Fat (13) ≤ 110 g/kg complete feed with a moisture content of 12 % (14)

Dogs and cats

| — | Crude fat |
| --- | --- |

—

Crude fat

Initially up to 2 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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’ |
| --- | --- |

—

‘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 % (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

| — | Protein source(s) |
| --- | --- |

—

Protein source(s)

| — | Copper (total) |
| --- | --- |

—

Copper (total)

| — | Sodium |
| --- | --- |

—

Sodium

Initially up to 4 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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). |
| --- | --- |

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.’ |
| --- | --- |

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’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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 |
| --- | --- |

—

Protein and fibre sources

| — | Highly digestible carbohydrates including their treatment, if appropriate |
| --- | --- |

—

Highly digestible carbohydrates including their treatment, if appropriate

| — | Methionine |
| --- | --- |

—

Methionine

| — | Choline |
| --- | --- |

—

Choline

| — | Content of n-3 fatty acids (if added) |
| --- | --- |

—

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.’ |
| --- | --- | --- |

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. |
| --- | --- |

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 % (4)

Dogs and cats

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Sodium |
| --- | --- |

—

Sodium

Initially up to 6 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- |

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 % (15)

Or

Metabolizable Energy < 560 kcal/kg complete feed with moisture content of 85 % (15)

Dogs

| — | Energy value |
| --- | --- |

—

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. |
| --- | --- |

1.

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

| 2. | To ensure that minimum requirements are met, the nutrient levels of a diet for reduction of excessive bodyweight should be increased accordingly to compensate for the restricted daily energy intake (16) |
| --- | --- |

2.

To ensure that minimum requirements are met, the nutrient levels of a diet for reduction of excessive bodyweight should be increased accordingly to compensate for the restricted daily energy intake (16)

| 3. | Indicate on the labelling:






  — | ‘It is recommended that a veterinarian’s opinion be sought before use.’ |
| --- | --- | --- |

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 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.’ |
| --- | --- |

—

‘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 % (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

| — | Linoleic acid |
| --- | --- |

—

Linoleic acid

| — | Sum of eicosapentaenoic acid and docosahexaenoic 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.’ |
| --- | --- |

—

‘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)’ |
| --- | --- |

—

‘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 % (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

| — | Omega-3 fatty acids (total) |
| --- | --- |

—

Omega-3 fatty acids (total)

| — | Eicosapentaenoic acid (total) |
| --- | --- |

—

Eicosapentaenoic acid (total)

| — | Vitamin E (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.’ |
| --- | --- |

—

‘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 % (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

| — | Omega-3 fatty acids (total) |
| --- | --- |

—

Omega-3 fatty acids (total)

| — | Docosahexaenoic acid (total) |
| --- | --- |

—

Docosahexaenoic acid (total)

| — | Methionine (total) |
| --- | --- |

—

Methionine (total)

| — | Manganese (total) |
| --- | --- |

—

Manganese (total)

| — | Vitamin E (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 % (4)

Dogs

Copper (total)

Initially up to 6 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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 % (4)

Cats

Iodine (total)

Initially up to 3 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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 % (4)

Dogs

Trypsin-hydrolysed bovine casein

Initially up to 2 months

| 1. | The feed shall be placed on the market as complete feed. |
| --- | --- |

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.’ |
| --- | --- | --- |

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 |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

Other female mammals: from the last part of gestation until the next gestation is confirmed.

| — | Males: during periods of reproductive activity. |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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 |
| --- | --- |

—

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 %. |
| --- | --- |

—

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 females: during oestrus

| — | For males: during periods of reproductive activity |
| --- | --- |

—

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) |
| --- | --- |

—

Zinc (total)

| — | Methionine (total) |
| --- | --- |

—

Methionine (total)

| — | Biotin (if added) |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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 |
| --- | --- |

—

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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 |
| --- | --- |

—

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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 % |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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 % |
| --- | --- |

—

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 |
| --- | --- |

—

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 |
| --- | --- |

—

Up to 8 weeks

| — | Complementary feed for ruminants containing biotin: Up to 6 months |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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 |
| --- | --- |

—

Predominantly electrolytes: sodium, potassium and chlorides

| — | Buffering capacity (21) in case of liquid feed: minimum 60 mmol per litre potion ready prepared for feeding |
| --- | --- |

—

Buffering capacity (21) in case of liquid feed: minimum 60 mmol per litre potion ready prepared for feeding

| — | Easily digestible carbohydrates |
| --- | --- |

—

Easily digestible carbohydrates

Calves, pigs, lambs, kids and foals

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Carbohydrate source(s) |
| --- | --- |

—

Carbohydrate source(s)

| — | Bicarbonates and/or citrates (if added) |
| --- | --- |

—

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 |
| --- | --- |

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. |
| --- | --- |

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).’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

‘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. |
| --- | --- | --- |

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’ |
| --- | --- |

—

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 |
| --- | --- |

—

Starch

| — | Sugars (total) |
| --- | --- |

—

Sugars (total)

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- |

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 |
| --- | --- |

—

Starch

| — | Sugars (total) |
| --- | --- |

—

Sugars (total)

up to 2 months (17)

| 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. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- |

3.

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

| 4. | In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed (18).’ |
| --- | --- |

4.

In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed (18).’

58

Reduction of the risk of urinary calculi

Low level of phosphorus, magnesium, and urine acidifying properties

Ruminants

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Sodium |
| --- | --- |

—

Sodium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Sulphur |
| --- | --- |

—

Sulphur

| — | Urine acidifying substances |
| --- | --- |

—

Urine acidifying substances

Up to 6 weeks

| 1. | Indicate on the labelling: ‘Especially for intensively fed young animals.’ |
| --- | --- |

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.’ |
| --- | --- |

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 |
| --- | --- |

—

Trace elements

And/or

| — | Vitamins, provitamins and chemically well-defined substances having similar effects. |
| --- | --- |

—

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 |
| --- | --- |

—

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 |
| --- | --- |

—

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 |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- | --- |

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; |
| --- | --- | --- |

—

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’ |
| --- | --- |

(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 |
| --- | --- |

—

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

| — | Objective: 0 < DCAD (19) (mEq/kg dry matter) < 100 |
| --- | --- |

—

Objective: 0 < DCAD (19) (mEq/kg dry matter) < 100

Or

Dairy cows

| — | Calcium |
| --- | --- |

—

Calcium

| — | Phosphorus |
| --- | --- |

—

Phosphorus

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Sodium |
| --- | --- |

—

Sodium

| — | Potassium |
| --- | --- |

—

Potassium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Sulphur |
| --- | --- |

—

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 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. |
| --- | --- |

—

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

| — | ‘Stop feeding after calving’ |
| --- | --- |

—

‘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 |
| --- | --- |

—

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

| — | Calcium sources |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- |

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

| — | Calcium pidolate |
| --- | --- |

—

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. |
| --- | --- |

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’. |
| --- | --- |

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 |
| --- | --- |

—

Waxy-leaf nightshade meal

| — | Content of 1,25 dihydroxycholecalciferol-glycoside |
| --- | --- |

—

Content of 1,25 dihydroxycholecalciferol-glycoside

| — | Crude fibre |
| --- | --- |

—

Crude fibre

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Crude fat |
| --- | --- |

—

Crude fat

| — | Starch |
| --- | --- |

—

Starch

| — | Vitamin D3 (total) as cholecalciferol |
| --- | --- |

—

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. |
| --- | --- |

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’. |
| --- | --- |

2.

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

61

Reduction of the risk of ketosis (20)

| — | Minimum supply of propane-1,2-diol or propylene glycol:
  250 g/day for dairy cows
  50 g/day for ewes or goats |
| --- | --- |

—

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 |
| --- | --- |

—

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: |
| --- | --- |

—

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 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 |
| --- | --- |

—

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 |
| --- | --- |

—

Propane-1,2-diol, if added

| — | Propionates in the form of sodium or calcium salts, 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. |
| --- | --- |

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.’ |
| --- | --- |

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 |
| --- | --- |

—

High level magnesium

And/or

| — | Highly digestible ingredients |
| --- | --- |

—

Highly digestible ingredients

Pigs

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Highly digestible ingredients including their treatment if appropriate |
| --- | --- |

—

Highly digestible ingredients including their treatment if appropriate

| — | Content of n-3 fatty acids (if added) |
| --- | --- |

—

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 |
| --- | --- |

—

Percentage of saturated fatty acids in relation to total fatty acids

| — | Vitamin A (total) |
| --- | --- |

—

Vitamin A (total)

| — | Vitamin D (total) |
| --- | --- |

—

Vitamin D (total)

| — | Vitamin E (total) |
| --- | --- |

—

Vitamin E (total)

| — | Vitamin K (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) |
| --- | --- |

—

Energy value (calculated according to EC method)

| — | Percentage of metabolisable energy from lipids |
| --- | --- |

—

Percentage of metabolisable energy from lipids

| — | Content of poly-unsaturated fatty acids |
| --- | --- |

—

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) |
| --- | --- |

—

Vitamin E (total)

| — | Selenium (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 |
| --- | --- |

—

Sodium

| — | Chlorides |
| --- | --- |

—

Chlorides

| — | Potassium |
| --- | --- |

—

Potassium

| — | Calcium |
| --- | --- |

—

Calcium

| — | Magnesium |
| --- | --- |

—

Magnesium

| — | Phosphorus |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- | --- |

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.’ |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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 |
| --- | --- |

—

Starch

| — | Sugar |
| --- | --- |

—

Sugar

| — | Crude fat |
| --- | --- |

—

Crude fat

| — | Vitamin E (total) |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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.’ |
| --- | --- |

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) |
| --- | --- |

—

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 |
| --- | --- |

—

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 water soluble vitamins and adequate minerals/electrolytes levels

| — | Additional supply of oil if no diarrhoea |
| --- | --- |

—

Additional supply of oil if no diarrhoea

Equines

| — | Starch |
| --- | --- |

—

Starch

| — | Crude fat |
| --- | --- |

—

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. |
| --- | --- | --- |

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. |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

3.

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

71

Compensation for chronic insufficiency of small intestine function

| — | Highly digestible fibres |
| --- | --- |

—

Highly digestible fibres

| — | High quality protein sources and lysine > 4,3 % of crude protein |
| --- | --- |

—

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 |
| --- | --- |

—

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 |
| --- | --- |

—

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. |
| --- | --- |

—

Highly digestible feed materials including their processing, if appropriate.

| — | Total sugar and starch |
| --- | --- |

—

Total sugar and starch

| — | Protein sources |
| --- | --- |

—

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 |
| --- | --- | --- |

1.

Guidance shall be provided on

—

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

| — | meal size and forage intake. |
| --- | --- |

—

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. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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).

(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].

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