CELEX: 
Language: en
Date: 2019-07-05
Title: COMMISSION REGULATION (EU) …/… establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               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. 
            
            
               (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 were to be reviewed. 
            
            
               (4)Articles 11 to 17 of Regulation (EC) No 767/2009 established new principles and rules for the placing on the market of feed, including labelling. As a consequence, several entries in the list of intended uses of feed intended for particular nutritional purposes contained in Part B of Annex I to Directive 2008/38/EC became outdated, partially because of poor and overly general descriptions in the column "Essential nutritional characteristics". For such entries, it has been very difficult for the control authorities to verify compliance with the provisions of Regulation (EC) No 767/2009, including whether the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose. 
            
            
               (5)In accordance with Article 10 of Regulation (EC) No 767/2009, the Commission received a number of applications to amend and change the conditions of several 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 deleted.
            
            
               (6)As regards other intended uses of feed intended for particular nutritional purposes in Part B of Annex I to Directive 2008/38/EC, amendments were necessary for the essential nutritional characteristics and the labelling declarations to adapt them to the scientific and technological developments and to improve the enforceability of the provisions. 
            
            
               (7)Furthermore, the Commission received, in accordance with Article 10 of Regulation (EC) No 767/2009 applications to add the particular nutritional purposes ‘support of energy metabolism and of the muscle function in the case of rhabdomyolosis’ and ‘support in stressful situations, which will lead to the reduction of associated behaviour’ to the list of intended uses of feed intended for particular nutritional purposes. 
            
            
               (8)The Commission made all applications, including the dossiers, available to the Member States. 
            
            
               (9)Following the assessment of the dossiers included in those applications, the Standing Committee on Plants, Animals, Food and Feed (‘the Committee’) acknowledged that the specific composition of the feed concerned fulfils the respective particular intended nutritional purpose and that it has no adverse effects on animal health, human health, the environment or animal welfare.
            
            
               (10)Based on the above considerations, the list of intended uses should be reviewed.
            
            
               (11)Since safety reasons do not require the immediate application of the new general provisions and the list for the intended uses of feed intended 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.
            
            
               (13)In order to enable Member States to make the necessary adjustments, an adequate period should be allowed before this Regulation becomes applicable.
            
            
               (14)The measures provided for in this Regulation are in accordance with the opinion of the Committee,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Feed intended for particular nutritional purposes within the meaning of Regulation (EC) No 767/2009 shall be marketed only if: 
            
            
               –the general provisions for feed intended for particular nutritional purposes of Part A of the Annex to this Regulation are complied with, and
            
            
               –its intended use is included in Part B of the Annex 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 be placed on the market, provided that an application for the respective intended use has been submitted to the Commission in accordance with Article 10 of Regulation (EC) No 767/2009 before [12 months after the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication].
            
            
               Article 3
            
            
               Feed intended for particular nutritional purposes which has been labelled before [24 months after the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication] in accordance with the rules applicable before [the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication] 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 [3 months after the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication].
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
            
         
         
            
               
                     The President 
               
               
                     …
               
            
         
         
      
    ---documentbreak--- 
      
         
         
            
               ANNEX
            
            
               PART A
            
            
               General provisions for feed for particular nutritional purposes
            
            
               1.Where there is more than one group of essential nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same particular nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the particular nutritional purpose defined in column 1 of Part B. For each option the corresponding labelling declarations are given in column 4 of Part B.
            
            
               2.Where an essential nutritional characteristic mentioned in column 2 of Part B is quantitatively indicated, the provisions of Article 17(2) of Regulation (EC) No 767/2009 and the permitted tolerances as established in Annex IV to that Regulation shall apply. If that Annex does not establish a tolerance for the respective labelling particular, a technical deviation of +/- 15 % shall be permitted.
            
            
               3.Where a feed additive is mentioned in column 2 or column 4 of Part B, the authorisation provisions for feed additive(s) in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council are applicable and their use shall comply with the specified essential nutritional characteristic.
            
            
               4.Where the declaration of a substance, also authorised as a feed additive, is required in column 4 of Part B and is accompanied by the expression ‘total’, the total content of the substance shall be labelled under the heading “analytical constituents”.
            
            
               5.The declarations to be given in accordance with column 4 of Part B concerning feed materials and feed additives shall be quantitative, except if the labelling declarations refer to, without prejudice to Article 17(2) of Regulation (EC) No 767/2009, as “source”. 
            
            
               6.The recommended period of use indicated in column 5 of Part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods of use, within the fixed limits.
            
            
               7.Where a feed intended for particular nutritional purposes is intended to meet more than one particular nutritional purpose, it shall comply with each respective entry in Part B. 
            
            
               8.In the case of complementary feed intended for particular nutritional purposes, guidance on the balance of the daily ration must be provided in the instructions for proper use. 
            
            
               9.When a feed intended for particular nutritional purposes is with an appropriate mode of use intended for individual oral administration via a bolus, this shall be established in the column "other provisions" of the respective feed. Such feed shall exclusively contain, including a potential coating, feed materials and feed additives, unless detailed otherwise in the respective entry. It is recommended that feed intended for individual oral administration is administered by a veterinarian or any other competent person.
            
            
               10.When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration with retarding release of the compounds, the labelling of such feed shall, if applicable, mention for each feed additive for which a maximum content in complete feed is fixed the maximum period of continuous release of the bolus and the daily release rate. The feed business operator which is placing a bolus on the market shall have the proof that the daily available feed additive level in the digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (retarding release effect). Such proof should be based on a peer reviewed methodology or in-house analysis. 
            
            
               11.In case of intended uses for which in column 2 a concentration of certain feed additives higher than 100 times the relevant fixed maximum content in complete feed is allowed for complementary feed, the concentration of those feed additives shall not be higher than 500 times the relevant fixed maximum content in complete feed, except if the feed is intended for individual oral administration as referred to in point 10. The incorporation of such complementary feed into the animal`s diet shall ensure that the uptake of the animal complies with the fixed maximum content in complete feed. 
            
            
               PART B
            
            
               List of intended uses
            
            
                     
                  
                  
                     
                        Particular nutritional purpose
                     
                  
                  
                     
                        Essential nutritional characteristics(GP1)
                     
                  
                  
                     
                        Species or category of animal
                     
                  
                  
                     
                        Labelling declarations(GP2)
                     
                  
                  
                     
                        Recommended length of time
                     
                  
                  
                     
                        Other provisions
                     
                  
               
                     
                        Number
                     
                  
                  
                     
                        1
                     
                  
                  
                     
                        2
                     
                  
                  
                     
                        3
                     
                  
                  
                     
                        4
                     
                  
                  
                     
                        5
                     
                  
                  
                     
                        6
                     
                  
               
                     
                        10
                     
                  
                  
                     
                        Support of renal function in case of chronic renal insufficiency (1)
                     
                  
                  
                     
                        High quality proteins and phosphorus ≤ 5 g/kg complete feed with a moisture content of 12 %(2) and crude protein ≤ 220 g/kg complete feed with a moisture content of 12 %(2)
                     
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        — Protein source(s)
                     
                     
                         — Calcium 
                     
                     
                        — Phosphorus 
                     
                     
                        — Potassium
                     
                     
                        — Sodium
                     
                     
                        — Essential fatty acids (if added)
                     
                  
                  
                     
                        Initially up to 6 months (3)
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Recommended digestibility of proteins: minimum 85 %. 
                     
                     
                        3.Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’ 
                     
                     
                        4.Indicate in the instructions for proper use: ‘Water should be available at all times.’
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate
                     
                  
                  
                     
                        Adult dogs
                     
                  
                  
                     
                        — Protein source(s) 
                     
                     
                        — Calcium 
                     
                     
                        — Phosphorus
                     
                     
                        — Potassium 
                     
                     
                        — Sodium
                     
                     
                        —Essential fatty acids (if added) 
                     
                     
                        — Lanthanum carbonate octahydrate
                     
                  
                  
                     
                        Initially up to 6 months (3)
                     
                  
                  
                     
                        1.Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’ 
                     
                     
                        2.Indicate in the instructions for proper use: ‘Water should be available at all times.’
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        High quality proteins and phosphorus ≤ 6,5 g / kg complete feed with a moisture content of 12 %(2) and crude protein ≤ 320 g/kg complete feed with a moisture content of 12 %(2)
                     
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                        — Protein source(s)
                     
                     
                        — Calcium
                     
                     
                         — Phosphorus 
                     
                     
                        — Potassium
                     
                     
                        — Sodium
                     
                     
                        — Essential fatty acids (if added)
                     
                  
                  
                     
                        Initially up to 6 months (3)
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Recommended digestibility of proteins: minimum 85 %. 
                     
                     
                        3.Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                     
                        4.Indicate in the instructions for proper use: ‘Water should be available at all times.’
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate
                     
                  
                  
                     
                        Adult cats
                     
                  
                  
                     
                        — Protein source(s) 
                     
                     
                        — Calcium 
                     
                     
                        — Phosphorus 
                     
                     
                        — Potassium
                     
                     
                         — Sodium 
                     
                     
                        — Essential fatty acids (if added) 
                     
                     
                        — Lanthanum carbonate octahydrate
                     
                  
                  
                     
                        Initially up to 6 months (3)
                     
                  
                  
                     
                        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.’
                     
                  
               
                     
                        11
                     
                  
                  
                     
                        Reduction of oxalate stones formation
                     
                  
                  
                     
                        Low level of calcium, low level of vitamin D, and urine alkalising properties
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        — Phosphorus 
                     
                     
                        — Calcium 
                     
                     
                        — Sodium 
                     
                     
                        — Magnesium 
                     
                     
                        — Potassium
                     
                     
                         — Chlorides
                     
                     
                        — Sulphur
                     
                     
                         —Vitamin D (total) 
                     
                     
                        — Hydroxyproline
                     
                     
                        — Urine alkalising substances
                     
                  
                  
                     
                        Up to 6 months
                     
                  
                  
                     
                        Indicate on the labelling: 
                     
                     
                        ‘It is recommended that a veterinarian's opinion be sought before use.’
                     
                  
               
                     
                        12
                     
                  
                  
                     
                        Regulation of glucose supply (Diabetes mellitus)
                     
                     
                  
                  
                     
                        Total sugars (mono- and disaccharides) ≤ 60 g/kg complete feed with a moisture of 12%(2)
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        — Carbohydrate source(s)
                     
                     
                        — Treatment of carbohydrates, if appropriate
                     
                     
                        — Starch
                     
                     
                        — Total sugars
                     
                     
                        — Fructose (if added)
                     
                     
                        —essential fatty acids (if added)
                     
                     
                        — Source(s) of short and medium chain fatty acids (if added)
                     
                  
                  
                     
                        Initially up to 6 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate on the labelling:
                     
                     
                        -
                              "Low level of mono- and disaccharides"
                     
                     
                        -
                              “It is recommended that a veterinarian’s opinion be sought before use and before extending the period of use”.
                     
                  
               
                     
                        13
                     
                  
                  
                     
                        Reduction of ingredient and nutrient intolerances(4)
                     
                  
                  
                     
                        Selected and limited number of protein source(s)
                     
                     
                        And/or 
                     
                     
                        hydrolysed protein source(s)
                     
                     
                        And/or 
                     
                     
                        selected carbohydrate source(s)
                     
                     
                  
                  
                     
                        Dogs and cats
                     
                     
                  
                  
                     
                        - Protein sources including treatment, if appropriate (if added).
                     
                     
                        - Carbohydrate source(s) including treatment, if appropriate (if added).
                     
                     
                        - Essential fatty acids (if added)
                     
                     
                  
                  
                     
                        3 to 8 weeks: if signs of intolerance disappear this feed can be used initially up to one year.
                     
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.It is recommended to limit the number of main protein sources to 3.
                     
                     
                        3.To indicate on the labelling:
                     
                     
                        -Appropriate combination of the essential nutritional characteristics, as applicable
                     
                     
                        -‘It is recommended that a veterinarian's opinion be sought before use and before extending the period of use’
                     
                  
               
                     
                        14
                     
                  
                  
                     
                        Reduction of cystine stones formation
                     
                  
                  
                     
                        Urine alkalinising properties and  crude protein ≤ 160 g/kg complete feed with a moisture content of 12%(2) 
                     
                     
                        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%(2)
                     
                  
                  
                     
                        Dogs 
                     
                  
                  
                     
                        - Sulphur amino acids (total)
                     
                     
                        - Protein sources 
                     
                     
                        - Sodium 
                     
                     
                        - Potassium 
                     
                     
                        - Chlorides
                     
                     
                        - Urine alkalinizing substances (if added) 
                     
                  
                  
                     
                        Initially up to 6 month
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate in the instructions for proper use: 
                     
                     
                           “Water should be available at all times”
                     
                     
                        3.Indicate on the labelling: 
                     
                     
                        -"Urine alkalinising properties and low level of proteins" or "Low level of selected proteins", as applicable.
                     
                     
                        -“It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use”
                     
                     
                        4.For consideration of the veterinarian or nutritionist: Alkalinising properties means that the diet should be formulated to target a urinary pH ≥ 7. 
                     
                  
               
                     
                        15
                     
                  
                  
                     
                        Nutritional restoration, convalescence(5) 
                     
                     
                  
                  
                     
                        Highly digestible ingredients with 
                     
                     
                        energy density ≥ 3520 kcal and crude protein ≥250 g per kg of complete feed with a moisture level 12%(2)
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        — Highly digestible ingredient sources including their treatment, if appropriate
                     
                     
                        — Energy value
                     
                     
                  
                  
                     
                        Until restoration is achieved
                     
                  
                  
                     
                        1.Recommended apparent digestibility of Dry Matter ≥ 80% or of Organic Matter ≥ 85%.
                     
                     
                        2.In the case of feed specially presented to be given via tubing, indicate on the package, container or label: ‘Administration under veterinary supervision.’
                     
                     
                        3.The labelling may indicate the specific circumstance(s) the dietetic feed is intended for.
                     
                     
                        4.Indicate on the labelling: 
                     
                     
                           “High energy density, high concentrations of essential nutrients and highly digestible ingredients”
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Highly digestible ingredients with energy density ≥ 3520 kcal and crude protein ≥ 270 g per kg of complete feed with a moisture level 12%(2)
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        16
                     
                  
                  
                     
                        Reduction of urate stones formation
                     
                     
                  
                  
                     
                        -Crude protein ≤ 130 g / kg complete feed with a moisture level of 12%(2)
                     
                     
                        Or
                     
                     
                        -Crude protein ≤ 220 g / kg complete feed with a moisture level of 12%(2) and selected protein sources
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        Protein source(s)
                     
                  
                  
                     
                        Up to 6 months, but lifetime use in case of irreversible disturbance of uric acid metabolism
                     
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Protein quality and level of purines should be taken into account when selecting the protein source. Examples of selected protein sources of high quality with low level of purines include eggs, casein, soy proteins, and maize gluten.
                     
                     
                        3.Indicate in the instructions for proper use: “Water should be available at all times”.
                     
                     
                        4.Indicate on the labelling: 
                     
                     
                        -“It is recommended that a veterinarian’s opinion be sought before use”.
                     
                     
                        -“Low level of protein” or “Restricted level of protein and selected protein sources”, as appropriate.
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Crude protein ≤ 317 g / kg complete feed with a moisture content of 12%(2)
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Protein quality and level of purines should be taken into account when selecting the protein source. Examples of selected protein sources of high quality with low level of purines include eggs, casein, soy proteins, and maize gluten.
                     
                     
                        3.Indicate on the labelling: 
                     
                     
                        ·“It is recommended that a veterinarian’s opinion be sought before use”
                     
                     
                        ·"Restricted level of protein"
                     
                     
                        4.Indicate in the instructions for proper use: “Water should be available at all times”.
                     
                  
               
                     
                        17
                     
                  
                  
                     
                        Dissolution of struvite stones(6)
                     
                  
                  
                     
                        Complete feed with urine undersaturating(7) properties for struvite
                     
                     
                        And/or
                     
                     
                        Urine acidifying properties (compliance criteria: urine pH ≤ 6.5) (8)
                     
                  
                  
                     
                        Dogs and cats 
                     
                  
                  
                     
                        - Phosphorus
                     
                     
                        - Calcium
                     
                     
                        - Sodium
                     
                     
                        - Magnesium
                     
                     
                        - Potassium
                     
                     
                        - Chloride
                     
                     
                        - Sulfur
                     
                     
                        - Urine acidifying substances, if appropriate
                     
                  
                  
                     
                        5 to 12 weeks
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate on the labelling: 
                     
                     
                        -“It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” 
                     
                     
                        -“Urine undersaturating properties for struvite and/or 
                           Urine acidifying properties”
                     
                     
                        3.Indicate in the instructions for proper use: “Water should be available at all times.”
                     
                     
                        4.Declaration of conformity supporting undersaturating and/or acidifying properties of the diet shall be made available to the relevant competent authorities upon request.
                     
                  
               
                     
                        18
                     
                  
                  
                     
                        Reduction of struvite stone recurrence(6)
                     
                  
                  
                     
                        Complete feed with urine undersaturating(7) or metastabilising properties(9)  for struvite
                     
                     
                        And/or
                     
                     
                        Urine acidifying properties (compliance criteria: urine pH ≤ 6.5) (8)
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        - Phosphorus
                     
                     
                        - Calcium
                     
                     
                        - Sodium
                     
                     
                        - Magnesium
                     
                     
                        - Potassium
                     
                     
                        - Chloride
                     
                     
                        - Sulfur
                     
                     
                        - urine acidifying substances, if appropriate
                     
                  
                  
                     
                        Initially up to 6 month
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate on the labelling: 
                     
                     
                        -“It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” 
                     
                     
                        -“Urine undersaturating or metastabilising properties for struvite and/or Urine acidifying properties”
                     
                     
                        3.Indicate in the instructions for proper use: “Water should be available at all times.”
                     
                     
                        4.Declaration of conformity supporting undersaturating or metastabilising and/or acidifying properties of the diet shall be made available to the relevant competent authorities upon request. 
                     
                  
               
                     
                        19
                     
                  
                  
                     
                        Compensation for maldigestion(10)
                     
                  
                  
                     
                        Highly digestible diet:
                     
                     
                        Apparent digestibility of
                     
                     
                        -low-fibre feed (crude fibre ≤ 45 g per kg of complete feed with a moisture level 12 %(2)):
                     
                     
                        Crude protein  ≥ 85 %
                     
                     
                        Crude fat  ≥ 90 %
                     
                     
                        Or
                     
                     
                        -fibre-enhanced feed (crude fibre > 45 g per kg of complete feed with a moisture level 12 %(2)):
                     
                     
                        Crude protein  ≥ 80 %
                     
                     
                        Crude fat  ≥ 80 %
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        Highly digestible ingredient sources including their treatment, if appropriate
                     
                  
                  
                     
                        Initially up to 12 weeks and lifetime in the case of chronic pancreatic insufficiency
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate on the labelling: 
                     
                     
                        -“Highly digestible feed”
                     
                     
                        -"It is recommended that a veterinarian’s opinion be sought before use".
                     
                     
                     
                     
                  
               
                     
                        20
                     
                  
                  
                     
                        Reduction of intestinal absorptive disorders 
                     
                     
                  
                  
                     
                        Highly digestible diet:
                     
                     
                        Apparent digestibility of
                     
                     
                        -low-fibre feed (crude fibre ≤ 45 g per kg of complete feed with a moisture level 12 %(2)):
                     
                     
                        Crude protein  ≥ 85 %
                     
                     
                        Crude fat  ≥ 90 %
                     
                     
                        Or
                     
                     
                        -fibre-enhanced feed (crude fibre > 44 g per kg of complete feed with a moisture level 12 %(2)):
                     
                     
                        Crude protein  ≥ 80 %
                     
                     
                        Crude fat  ≥ 80 %
                     
                     
                        And
                     
                     
                        Sodium  ≥ 1.8 g per kg of complete feed with a moisture level 12%(2)
                     
                     
                        And
                     
                     
                        Potassium  ≥ 5 g per kg of complete feed with a moisture level 12%(2)
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        - Highly digestible ingredient sources including their treatment, if appropriate
                     
                     
                        - Sodium
                     
                     
                        - Potassium
                     
                  
                  
                     
                        Up to 12 weeks
                     
                  
                  
                     
                        1.Indicate on the labelling: 
                     
                     
                        -“Highly digestible feed with increased sodium and potassium”
                     
                     
                        -"It is recommended that a veterinarian’s opinion be sought before use".
                     
                     
                     
                     
                     
                  
               
                     
                        21
                     
                  
                  
                     
                        Support of lipid metabolism in the case of hyperlipidaemia
                     
                  
                  
                     
                        Crude fat(11)  ≤ 110 g / kg complete feed with a moisture content of 12%(12)
                     
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        - Crude fat content 
                     
                  
                  
                     
                        Initially up to 2 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Indicate on the labelling: 
                     
                     
                        -“It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use”
                     
                     
                        -“Low level of fat”
                     
                  
               
                     
                        22
                     
                  
                  
                     
                        Support of liver function in the case of chronic liver insufficiency
                     
                  
                  
                     
                        Moderate level of protein: 
                     
                     
                        Crude protein ≤  280 g / kg complete feed with a moisture content of 12%(2) for dogs
                     
                     
                        Crude protein ≤ 370 g / kg complete feed with a moisture content of 12%(2) for cats
                     
                     
                        And
                     
                     
                        Selected protein sources 
                     
                     
                        And 
                     
                     
                        Recommended dietary protein digestibility ≥ 85%
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        -Protein source(s)
                     
                     
                        -Copper (total)
                     
                     
                        -Sodium
                     
                  
                  
                     
                        Initially up to 4 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.Examples of selected protein sources based on high digestibility: dairy proteins (whey casein, milk, cottage cheese), other animal based proteins (egg, poultry) and vegetable proteins (soy).
                     
                     
                        3.Indicate in the instructions for proper use: “Water should be available at all times”.
                     
                     
                        4.Indicate on the labelling: 
                     
                     
                        —"Moderate level of protein, selected and  highly  digestible"
                     
                     
                        —“It is recommended that a veterinarian’s opinion be sought before use”.
                     
                     
                  
               
                     
                        23
                     
                  
                  
                     
                        Support of heart function in the case of chronic cardiac insufficiency
                     
                  
                  
                     
                        Restricted level of sodium: 
                     
                     
                        Sodium ≤ 2,5 g / kg complete feed with a moisture content of 12 %(2)
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        — Magnesium
                     
                     
                        — Potassium
                     
                     
                        — Sodium
                     
                  
                  
                     
                        Initially up to 6 months
                     
                  
                  
                     
                        — The feed shall be placed on the market as complete feed.
                     
                     
                        — Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                  
               
                     
                        24
                     
                  
                  
                     
                        Support the Reduction of excessive body weight
                     
                  
                  
                     
                        Metabolizable Energy <  3060 kcal /kg complete feed with moisture content of 12%(13)
                     
                     
                        Or
                     
                     
                        Metabolizable Energy < 560 kcal /kg complete feed with moisture content of 85%(13)
                     
                  
                  
                     
                        Dogs 
                     
                     
                     
                     
                     
                     
                  
                  
                     
                        Energy value
                     
                  
                  
                     
                        Until target body weight is achieved and after if required to maintain target bodyweight
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed. 
                     
                     
                        2.To ensure that minimum requirements are met, the nutrient levels of a diet for reduction of excessive bodyweight should be increased accordingly to compensate for the restricted daily energy intake(14)
                     
                     
                        3.Indicate on the labelling:
                        - “It is recommended that a veterinarian’s opinion be sought before use”.
                           - “For cats, a transition period when starting the diet is advised.”
                           - “For an efficient weight loss or ideal weight maintenance, the recommended daily energy intake should not exceeded.”
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Metabolizable Energy < 3190 kcal  per kg complete feed with moisture content of 12%(13)
                     
                     
                        Or
                     
                     
                        Metabolizable Energy < 580 kcal  per kg complete feed with moisture content of 85%(13)
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        25 
                     
                  
                  
                     
                        Support of skin function in the case of dermatosis and excessive loss of hair
                     
                  
                  
                     
                        Linoleic acid (LA) ≥ 12 g per kg of complete feed with a moisture content of 12%(2)  and sum of eicosapentaenoic (EPA) acid and docosahexaenoic acid (DHA) ≥ 3 g per kg of complete feed with a moisture content of 12%(2)
                     
                  
                  
                     
                        Dogs and cats
                     
                  
                  
                     
                        - Linoleic acid (LA) 
                     
                     
                        - sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
                     
                  
                  
                     
                        Initially up to 2 months
                     
                  
                  
                     
                        Indicate on the labelling: 
                     
                     
                        ·‘It is recommended that a veterinarian's opinion be sought before use.’
                     
                     
                        ·“High level of linoleic acid (LA) and of sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)”
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Linoleic acid (LA) ≥ 18.5 g per kg of complete feed with a moisture content of and sum of eicosapentaenoic (EPA) acid and docosahexaenoic acid (DHA) ≥ 0.4 g per kg of complete feed with a moisture content of 12%(2)
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Linoleic acid (LA) ≥ 18.5 g/kg of complete feed with a moisture content of and sum of eicosapentaenoic (EPA) acid and docosahexaenoic acid (DHA) ≥ 0.1 g per kg of complete feed with a moisture content of 12%(2)
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                        26
                     
                  
                  
                     
                        Support of the metabolism of joints in the case of osteoarthritis
                     
                  
                  
                     
                        Total omega-3 fatty acids ≥ 30 g / kg complete feed with a moisture content of 12 %(2) and eicosapentaenoic acid (EPA) ≥ 3,0 g per kg complete feed with a moisture content of 12 %(2)
                     
                     
                        Increased levels of vitamin E
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        —Omega-3 fatty acids (total)
                     
                     
                        — Eicosapentaenoic acid EPA (total)
                     
                     
                         — Vitamin E (total)
                     
                  
                  
                     
                        Initially up to 3 months
                     
                  
                  
                     
                        1.Indicate on the labelling:
                     
                     
                        ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Total omega-3 fatty acids ≥10,5 g per kg complete feed with a moisture content of 12 %(2)  and docosahexaenoic acid (DHA) ≥ 2,5 g per kg complete feed with a moisture content of 12 %(2)
                     
                     
                        Increased levels of methionine, manganese and vitamin E.
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                        —Omega-3 fatty acids (total)
                     
                     
                        —Docosahexaenoic acid DHA (total)
                     
                     
                        — Methionine (total)
                     
                     
                        — Manganese (total)
                     
                     
                        — Vitamin E (total)
                     
                  
                  
                     
                  
                  
                     
                        2.
                     
                  
               
                     
                        27
                     
                  
                  
                     
                        Reduction of copper in the liver
                     
                  
                  
                     
                        Restricted level of copper: copper ≤ 9 mg per kg complete feed with a moisture content of 12 %(2)
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        Copper (total)
                     
                  
                  
                     
                        Initially up to 6 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed.
                     
                     
                        2.Indicate on the labelling:
                     
                     
                        ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                  
               
                     
                        28
                     
                  
                  
                     
                        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 %(2)
                     
                  
                  
                     
                        Cats
                     
                  
                  
                     
                        Iodine (total)
                     
                  
                  
                     
                        Initially up to 3 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed.
                     
                     
                        2.Indicate on the labelling: ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                  
               
                     
                        29 
                     
                  
                  
                     
                        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%(2)
                     
                  
                  
                     
                        Dogs
                     
                  
                  
                     
                        Trypsin-hydrolysed bovine casein
                     
                  
                  
                     
                        Initially up to 2 months
                     
                  
                  
                     
                        1.The feed shall be placed on the market as complete feed.
                     
                     
                        2.Indicate on the labelling:
                     
                     
                        ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                  
               
                     
                        50
                     
                  
                  
                     
                        Support the preparation for oestrus and reproduction
                     
                     
                     
                  
                  
                     
                        — High level of selenium and a minimum content of vitamin E per kg complete feed with a moisture content of 12 % for pigs of 50 mg, rabbits of 35 mg, for dogs, cats, mink of 88 mg; a minimum content of vitamin E per animal and day for ovines of 100 mg, cattle of 300 mg, horses of 1 100 mg 
                     
                     
                        Or 
                     
                     
                        — High level(s) of vitamins A and/or vitamin D and/or a minimum content of beta- carotene of 300 mg per animal and day. 
                     
                     
                        The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Mammals
                     
                  
                  
                     
                        Names and total amounts of each added trace element and vitamin
                     
                  
                  
                     
                        — Cows: 2 weeks before the end of gestation until the next gestation is confirmed.
                     
                     
                         — Sows: 7 days before until 3 days after parturition and 7 days before until 3 days mating. 
                     
                     
                        — Other female mammals: from the last part of gestation until the next gestation is confirmed. 
                     
                     
                        — Males: during periods of reproductive activity.
                     
                  
                  
                     
                        — 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.
                     
                     
                        — The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected. 
                     
                     
                        — Indicate on the labelling of the feed: ‘Guidance on the situations in which the use of the feed is appropriate.’
                     
                     
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        — High level(s) of vitamin A and/or vitamin D 
                     
                     
                        Or 
                     
                     
                        — High level(s) of selenium and/or zinc and/or a minimum content of vitamin E of 40 mg/kg complete feed with a moisture content of 12 %. 
                     
                     
                        The complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Birds
                     
                  
                  
                     
                        Names and total amounts of each added trace element and vitamin
                     
                  
                  
                     
                        — For females: during oestrus 
                     
                     
                        — For males: during periods of reproductive activity
                     
                  
                  
                     
                  
               
                     
                        51
                     
                  
                  
                     
                        Support the regeneration of hooves, trotters and skin
                     
                  
                  
                     
                        High level of zinc. 
                     
                     
                        The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Horses, ruminants and pigs
                     
                  
                  
                     
                        — zinc (total)
                     
                     
                        — methionine (total)
                     
                     
                        — biotin (if added)
                     
                     
                     
                  
                  
                     
                        Up to 8 weeks
                     
                  
                  
                     
                        — The instructions of use for the feed shall ensure that the legal maximum content of zinc for complete feed are respected.
                     
                     
                        — 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. 
                     
                  
               
                     
                        52
                     
                  
                  
                     
                        Support for nutritional imbalances in dietary transition
                     
                     
                  
                  
                     
                        Minimum supply via the dietetic feed of:
                     
                     
                        — Selenium: 0,1 mg/kg complete feed with a moisture content of 12%
                     
                     
                        and/or
                     
                     
                        — Zinc: 15 mg/kg complete feed with a moisture content of 12%
                     
                     
                         and/or
                     
                     
                        — Copper: 2 mg/kg complete feed with a moisture content of 12% for sheep and 5 mg/kg complete feed with a moisture content of 12% for other species 
                     
                     
                        and/or
                     
                     
                        — Vitamin A: 2000 UI/kg complete feed with a moisture content of 12%
                     
                     
                        and/or
                     
                     
                        — Vitamin D: 400 UI/kg complete feed with a moisture content of 12%
                     
                     
                        and/or 
                     
                     
                        — vitamin E: 35 mg/kg complete feed with a moisture content of 12% for poultry, 10 mg/kg complete feed with a moisture content of 12% for ruminants, 40 mg/kg complete feed with a moisture content of 12% for rabbits and 20 mg/kg complete feed for pigs with a moisture content of 12%
                     
                     
                        The complementary feed may contain selenium, zinc, copper, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Ruminants
                     
                     
                        Pigs
                     
                     
                        Rabbits 
                     
                     
                        Poultry
                     
                  
                  
                     
                        Name and total amount of the nutritional additives, if appropriate
                     
                  
                  
                     
                        2 to 15 days
                     
                  
                  
                     
                        — 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. 
                     
                     
                        -
                              The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
                     
                     
                        -
                              Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.’
                     
                  
               
                     
                        53 
                     
                  
                  
                     
                        Support weaning
                     
                  
                  
                     
                        Minimum supply via the dietetic feed of:
                     
                     
                        — Selenium: 0,1 mg/kg complete feed with a moisture content of 12%
                     
                     
                        And/or
                     
                     
                        — Zinc: 15 mg/kg complete feed with a moisture content of 12%
                     
                     
                        And/or
                     
                     
                        — Copper: 2 mg/kg complete feed with a moisture content of 12% for sheep and 5 mg/kg complete feed with a moisture content of 12% for other species
                     
                     
                        And/or
                     
                     
                        — Iodine: 0,2 mg/kg complete feed with a moisture content of 12%
                     
                     
                        And/or
                     
                     
                        — Manganese: 20 mg/kg complete feed with a moisture content of 12% 
                     
                     
                          And/or
                     
                     
                        — Vitamin A: 1500 UI/kg complete feed with a moisture content of 12%
                     
                     
                        And/or
                     
                     
                        — Vitamin D: 400 UI/kg complete feed with a moisture content of 12%
                     
                     
                        And/or
                     
                     
                        — Vitamin E: 100 mg/kg complete feed with a moisture content of 12% for calves and 50 mg/kg complete feed with a moisture content of 12% for lambs, kids and piglets.
                     
                     
                        The complementary feed may contain selenium, zinc, copper, iodine, manganese, vitamin A and vitamin D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Mammals
                     
                  
                  
                     
                        Name and amount of the nutritional additives, if appropriate
                     
                  
                  
                     
                        Up to 4 weeks around weaning
                     
                  
                  
                     
                        -
                              The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
                     
                     
                        -
                              Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.’
                     
                  
               
                     
                        54 
                     
                  
                  
                     
                        Support the regeneration of the  skin and appendages
                     
                  
                  
                     
                        — Minimum supply of zinc compounds via dietetic feed corresponding to 20 mg/kg complete feed with a moisture content of 12%
                     
                     
                        and
                     
                     
                        — high level of 
                           copper and/or iodine and/or selenium
                     
                     
                        and/or
                     
                     
                        vitamin B6 and/or vitamin E and/or vitamin A
                     
                     
                        and/or
                     
                     
                        methionine and/or cystine and/or
                     
                     
                        minimum supply  of 0,4 mg biotin/kg complete feed with a moisture content of 12% for ruminants.
                     
                     
                        The complementary feed may contain zinc, copper, iodine, selenium and vitamin A in
                     
                     
                        a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Mammals
                     
                     
                        Poultry
                     
                  
                  
                     
                        Name and added amount of the nutritional additives, if appropriate
                     
                  
                  
                     
                        — Up to 8 weeks
                     
                     
                        — Complementary feed for ruminants containing biotin: Up to 6 months
                     
                     
                  
                  
                     
                        -
                              The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
                     
                     
                        -
                              Indicate on the labelling of the feed guidance on the situations in which the use of the feed is appropriate.’
                     
                  
               
                     
                        55
                     
                  
                  
                     
                        Stabilisation of water and electrolyte balance to support the physiological digestion
                     
                  
                  
                     
                        —Predominantly electrolytes: sodium, potassium and chlorides 
                     
                     
                        —Buffering capacity(19) in case of liquid feed: minimum 60 mmol per litre potion ready prepared for feeding 
                     
                     
                        —Easily digestible carbohydrates
                     
                  
                  
                     
                        Calves, pigs, lambs, kids, foals, cats and dogs
                     
                  
                  
                     
                        — Sodium 
                     
                     
                     
                        — Potassium 
                     
                     
                     
                        — Chlorides 
                     
                     
                     
                        —Carbohydrate source(s) 
                     
                     
                     
                        —Bicarbonates and/or citrates (if added)
                     
                  
                  
                     
                        1 to 7 days
                     
                  
                  
                     
                        — Recommended range of electrolytes per litre potion ready prepared for feeding: 
                     
                     
                        Sodium: 1,7 g – 3,5 g
                     
                     
                        Potassium: 0,4 g – 2,0 g 
                     
                     
                        Chlorides: 1 g – 2,8 g
                     
                     
                        In case of solid feed, the recommended range of electrolytes should be calculated on the basis of a normal daily voluntary intake of water.
                     
                     
                     
                        — Indicate on the labelling: 
                     
                     
                        (1) ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’
                     
                     
                        (2) ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’
                     
                     
                     
                        — Indicate in the instructions for proper use: 
                     
                     
                        (1) The recommended intake of the ready stirred potion and of milk, if appropriate.
                     
                     
                        (2) 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 
                     
                     
                        — Total sugars
                     
                     
                        — Magnesium 
                     
                     
                        — Sodium 
                     
                     
                        — Potassium
                     
                  
                  
                     
                        3 to 10 weeks during periods of fast grass growth
                     
                  
                  
                     
                        — 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. 
                     
                     
                        — 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.
                     
                     
                        — 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 
                     
                     
                        — Total sugars
                     
                  
                  
                     
                        up to 2 months(15)
                     
                  
                  
                     
                        — 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. 
                     
                     
                     
                        — 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.
                     
                     
                        — In the case of feed for dairy cows indicate on the labelling: ‘Especially for high yielding cows.’
                     
                     
                        — In the case of feed for ruminants for fattening indicate on the labelling: ‘Especially for intensively fed(16).’
                     
                     
                  
               
                     
                        58
                     
                  
                  
                     
                        Reduction of the risk of urinary calculi
                     
                  
                  
                     
                        Low level of phosphorus, magnesium, and urine acidifying properties
                     
                  
                  
                     
                        Ruminants
                     
                  
                  
                     
                        — Calcium 
                     
                     
                        — Phosphorus
                     
                     
                         —Sodium 
                     
                     
                        — Magnesium 
                     
                     
                        — Potassium 
                     
                     
                        — Chlorides 
                     
                     
                        — Sulphur 
                     
                     
                        — Urine acidifying 
                     
                     
                        substances
                     
                  
                  
                     
                        Up to 6 weeks
                     
                  
                  
                     
                        — Indicate on the labelling: ‘Especially for intensively fed young animals.’
                     
                     
                        — Indicate in the instructions for proper use: ‘Water should be available at all times.’
                     
                  
               
                     
                        59
                     
                  
                  
                     
                        Long-term supply of grazing animals with trace elements and/or vitamins
                     
                  
                  
                     
                        High level of 
                     
                     
                        — Trace elements
                     
                     
                         and/or
                     
                     
                         — Vitamins, provitamins and chemically well-defined substances having similar effects.
                     
                     
                     
                        The complementary feed may
                     
                     
                        contain feed additives in a
                     
                     
                        concentration higher than 100
                     
                     
                        times the relevant fixed
                     
                     
                        maximum content in complete
                     
                     
                        feed.
                     
                  
                  
                     
                        Ruminants 
                     
                     
                        with a
                     
                     
                        functional 
                     
                     
                        rumen
                     
                  
                  
                     
                        — Names and total
                     
                     
                        amounts of each added 
                     
                     
                        trace element, vitamin,
                     
                     
                         provitamin and 
                     
                     
                        chemically well-
                     
                     
                        defined substance
                     
                     
                        having similar effects
                     
                     
                     
                        — Daily release rate 
                     
                     
                        for each trace element
                     
                     
                        and/or vitamin if a
                     
                     
                        bolus is used
                     
                     
                     
                         — Maximum period
                     
                     
                         of continuously
                     
                     
                         release of the trace
                     
                     
                         element or vitamin if a
                     
                     
                         bolus is used
                     
                  
                  
                     
                        Up to 12 months
                     
                  
                  
                     
                        — 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. 
                     
                     
                        — 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: 
                     
                     
                        (1) the balance of trace elements in the daily ration;
                     
                     
                        (2) 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 DM 
                     
                     
                        -
                              Objective:
                        0 < DCAD(17) (mEq/kg DM) < 100
                     
                     
                        Or
                     
                  
                  
                     
                        Dairy cows
                     
                  
                  
                     
                        —  Calcium
                     
                     
                        —  Phosphorus
                     
                     
                        —  Magnesium
                     
                     
                        — Sodium
                     
                     
                        — Potassium
                     
                     
                        — Chlorides
                     
                     
                        — Sulphur
                     
                  
                  
                     
                        From 3 weeks before calving until calving
                     
                  
                  
                     
                        Indicate in the instructions for proper use:
                     
                     
                        ‘Stop feeding after calving’
                     
                     
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Zeolite (sodium aluminium silicate): 250 - 500 g / day
                     
                     
                     
                     
                     
                     
                  
                  
                     
                  
                  
                     
                        Sodium aluminium silicate
                     
                  
                  
                     
                        From 3 weeks before calving until calving
                     
                  
                  
                     
                        Indicate in the instructions for proper use:
                     
                     
                        — ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’
                     
                     
                        — ‘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 Ca per cow per day.
                     
                     
                        Or
                     
                  
                  
                     
                  
                  
                     
                     
                        Calcium
                     
                  
                  
                     
                     
                        From 4 weeks before calving until calving
                     
                  
                  
                     
                     
                        Indicate in the instructions for proper use:
                     
                     
                        ‘Stop feeding after calving’
                     
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        High level of calcium in the form of highly available sources of calcium: calcium chloride and/or calcium sulfate and/or dicalcium phosphate and/or calcium carbonate and/or calcium propionate and/or calcium formate. and/or “any other calcium source having a similar effect”
                     
                     
                        Calcium provided by one or a combination of these sources with a minimum of 50 g per cow per day
                     
                     
                        Or
                     
                  
                  
                     
                  
                  
                     
                        —  Calcium
                     
                     
                        —  Calcium sources
                     
                  
                  
                     
                        From first signs of parturition to two days
                     
                     
                        Subsequent to parturition
                     
                  
                  
                     
                        — 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.
                     
                     
                        — Indicate in the instructions for proper use the number of    applications and the time before and after calving.
                     
                     
                        — Indicate on the labelling: ‘It is recommended that a  nutritional expert's opinion be sought before use’.
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                        Supply of calcium in the form of calcium pidolate in a minimum of  5.5g per cow per day 
                     
                     
                     
                     
                     
                     
                     
                     
                        Or
                     
                  
                  
                     
                  
                  
                     
                        —  Calcium
                     
                     
                        —  Calcium pidolate
                     
                  
                  
                     
                        From first signs of parturition to two days subsequent to parturition
                     
                  
                  
                     
                        — 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.
                     
                     
                        — 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 dihydroxycholecalciferol-glycoside per day
                     
                  
                  
                     
                  
                  
                     
                        —  Waxy-leaf nightshade meal   
                     
                     
                        —  Content of dihydroxycholecalciferol-glycoside 
                     
                     
                        —  Crude fibre 
                     
                     
                        —  Magnesium  
                     
                     
                        —  Crude fat
                     
                     
                        —  Starch 
                     
                     
                        —  Vitamin D3 (total)
                     
                  
                  
                     
                        From two days before calving or first signs of parturition to ten days subsequent to parturition
                     
                  
                  
                     
                        — 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.
                     
                     
                        — Indicate on the labelling: ‘It is recommended that a  nutritional expert's opinion be sought before use’.
                     
                  
               
                     
                        61
                     
                  
                  
                     
                        Reduction of the risk of ketosis(18)
                     
                  
                  
                     
                        — Minimum supply of Propan 1,2-diol or propylene-glycol:
                     
                     
                        250 g/day for dairy cows
                     
                     
                        50 g/day for ewes or goats
                     
                     
                        or
                     
                     
                        — minimum supply of Propionates (calcium or sodium salts) :
                     
                     
                        110 g/day for dairy cows
                     
                     
                        22 g/day for ewes or goats
                     
                     
                        or
                     
                     
                        —  Minimum combined supply of Propan 1,2-diol and Propionates (sodium or calcium salts), as long as:
                     
                     
                        —The combination of propane 1,2-diol and propionates for dairy cows is such that propionates + 0.44 x propane 1,2 diol > 110 g/day
                     
                     
                        —The combination of propane 1,2-diol and propionates for ewes or goats is such that propionates + 0.44 x propane 1,2 diol > 22 g/day
                     
                  
                  
                     
                        Dairy cows, ewes and goats
                     
                  
                  
                     
                        Propan-1,2-diol, if added (as a glucose precursor)
                     
                     
                        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
                     
                  
                  
                     
                        — 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. 
                     
                     
                        —  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 hypocalcemie after parturition is necessary".
                     
                     
                  
               
                     
                        62
                     
                  
                  
                     
                        Reduction of stress reactions
                     
                  
                  
                     
                        — High level magnesium
                     
                     
                        and/or
                     
                     
                        — Highly digestible ingredients
                     
                  
                  
                     
                        Pigs
                     
                  
                  
                     
                        — Magnesium
                     
                     
                        — Highly digestible ingredients including their treatment if appropriate
                     
                     
                        — Content of n-3 fatty acids (if added)
                     
                  
                  
                     
                        1 to 7 days
                     
                  
                  
                     
                        Guidance shall be provided on the situation in which the use of this feed is appropriate.
                     
                     
                  
               
                     
                        63
                     
                  
                  
                     
                        Reduction of the risk of constipation
                     
                  
                  
                     
                        Ingredients stimulating intestinal passage
                     
                  
                  
                     
                        Sows
                     
                  
                  
                     
                        Ingredients stimulating intestinal passage
                     
                  
                  
                     
                        10 to 14 days before and 10 to 14 days after farrowing
                     
                  
                  
                     
                  
               
                     
                        64
                     
                  
                  
                     
                        Compensation for insufficient iron availability after birth
                     
                  
                  
                     
                        High level of iron compounds authorised under the functional group "compounds of trace elements" of the category "nutritional additives" as referred to in Annex I to Regulation (EC) No 1831/2003.
                     
                     
                        The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Suckling piglets and calves
                     
                  
                  
                     
                        Iron (total)
                     
                  
                  
                     
                        After birth up to 3 weeks
                     
                  
                  
                     
                        The instructions for proper use shall ensure that the legal maximum contents of iron for complete feed are respected.
                     
                  
               
                     
                        65
                     
                  
                  
                     
                        Compensation for malabsorption
                     
                  
                  
                     
                        Low level of saturated fatty acids and high level of fat soluble vitamins
                     
                  
                  
                     
                        Poultry excluding geese and pigeons
                     
                  
                  
                     
                        — Percentage of saturated fatty acids in relation to total fatty acids 
                     
                     
                        —vitamin A (total)
                     
                     
                        —vitamin D (total)
                     
                     
                        —vitamin E (total)
                     
                     
                        — vitamin K (total)
                     
                  
                  
                     
                        During the first 2 weeks after hatching
                     
                  
                  
                     
                  
               
                     
                        66
                     
                  
                  
                     
                        Reduction of the risk of fatty liver syndrome
                     
                  
                  
                     
                        Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids
                     
                  
                  
                     
                        Laying hens
                     
                  
                  
                     
                        — Energy value (calculated according to EC method)
                     
                     
                         — Percentage of metabolisable energy from lipids 
                     
                     
                        — Content of poly-unsaturated fatty acids
                     
                  
                  
                     
                        Up to 12 weeks
                     
                  
                  
                     
                  
               
                     
                        67
                     
                  
                  
                     
                        Support the preparation for and recovery from sport effort
                     
                  
                  
                     
                        High level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %. 
                     
                     
                        The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
                     
                  
                  
                     
                        Equidae
                     
                  
                  
                     
                        — vitamin E (total)
                     
                     
                        — selenium. (total)
                     
                  
                  
                     
                        Up to 8 weeks before sport effort – Up to 4 weeks after sport effort
                     
                  
                  
                     
                        The instructions for proper use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected.
                     
                  
               
                     
                        68
                     
                  
                  
                     
                        Support of liver function in the case of liver insufficiency
                     
                  
                  
                     
                        High level of highly digestible  energy sources with moderate protein level, not exceeding a praecaecally digestible crude protein/metabolisable energy ratio of 5-7.5 g/MJ and not exceeding 50 g of fat per kg of complete feed with a moisture of 12%. 
                     
                     
                        and
                     
                     
                        High level of branched chain amino acids (BCAA) with at least 12 g BCAA per kg of complete feed with a moisture of 12% and an amino acid relation of BCAA to aromatic amino acids (Fischer ratio) above 2.3
                     
                     
                        and
                     
                     
                        High concentration of Vitamin E with at least 100 mg per kg of complete feed with a moisture of 12%.
                     
                     
                        and
                     
                     
                        High concentration of Vitamin C with at least 1 g per kg of complete feed with a moisture of 12%.
                     
                     
                        and
                     
                     
                        High concentration of Zinc with at least 50 % of the permitted maximum content of complete feed with a moisture of 12%.
                     
                     
                        and
                     
                     
                        High concentration of Selenium with at least 50 % of the permitted maximum content of complete feed with a moisture of 12%.
                     
                     
                        The complementary feed may contain zinc and/or selenium in a concentration higher than 100 times the relevant fixed maximum content.
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        — Carbohydrate, fat and protein sources. 
                     
                     
                        — Treatment of carbohydrate sources, if appropriate
                     
                     
                        — Ratio of  praecaecally digestible crude protein in g / metabolisable energy in MJ
                     
                     
                        — Amount of branched chain amino acids
                     
                     
                        — Ratio of branched chain amino acids / aromatic amino acids (Fischer ratio)
                     
                  
                  
                     
                        Initially up to six months 
                     
                  
                  
                     
                        1.Guidance should be provided on the manner in which the feed should be fed including many small meals per day.
                     
                     
                        2.Indicate on the labelling: 
                        ‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
                     
                  
               
                     
                        68
                     
                  
                  
                     
                        Support of renal function in the case of chronic renal insufficiency
                     
                  
                  
                     
                        Complementary feed contributing to at least 10 to 20% of the daily energy supply (approximately 0.05 to 0.1 MJ/kg BW075 per day).
                     
                     
                        High density of energy with more than 8,8 MJ/kg feed with a moisture content of 88%.
                     
                     
                        Highly digestible and highly palatable sources of starch.
                     
                     
                        Restricted protein level: ≤ 106 g crude protein / kg feed with a moisture content of 88%.
                     
                     
                        Level of sodium: 2 g / 100 kg BW per day.
                     
                     
                        High level of omega-3 fatty acids: EPA+DHA ≥ 0.2 g per kg BW075 per day
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        — Protein and energy source(s) 
                     
                     
                        — Calcium 
                     
                     
                        — Phosphorus 
                     
                     
                        — Potassium 
                     
                     
                        — Magnesium
                     
                     
                        — Sodium
                     
                     
                        — Omega-3 fatty acids, if added
                     
                  
                  
                     
                        Initially up to six months.
                     
                     
                        Long term or until resolution of the issue
                     
                  
                  
                     
                        — 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 ration should ensure an energy supply of > 0.62 MJ/kg BW075/day.
                     
                     
                        The ration should not exceed 50 mg calcium/kg DM/day.’ 
                     
                     
                        — Indicate in the instructions for proper use: ‘Water should be available at all times.’
                     
                  
               
                     
                        70
                     
                  
                  
                     
                        Compensation of electrolyte loss in the cases of heavy sweating
                     
                  
                  
                     
                        Must contain sodium chloride and should contain potassium chloride.
                     
                     
                        The inclusion of other electrolyte salts is optional.
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        — Sodium
                     
                     
                        — Chlorides
                     
                     
                        — Potassium
                     
                     
                        — Calcium
                     
                     
                        — Magnesium
                     
                     
                  
                  
                     
                        One to three days after heavy sweating.
                     
                  
                  
                     
                        Guidance shall be provided on the situations in which the use of the feed is appropriate.
                     
                     
                        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
                     
                     
                        Labelling must state ‘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) guidance must be given that Water must be available for at least 20 minutes or preferably for 1 hour post administration.  
                     
                     
                        Furthermore guidance must be given to: Monitor subsequent drinking, if insufficient water intake is observed veterinary advice should be sought. 
                     
                     
                        Guidance may optionally be given regarding the quantity of water (in litres) to be provided alongside in feed or syringed electrolytes.
                     
                  
               
                     
                        71 
                     
                  
                  
                     
                        Support of energy metabolism and of the muscle function in the case of rhabdomyolosis
                     
                     
                  
                  
                     
                        Starch and sugar not more than 20% of available energy.
                     
                     
                        Crude fat more than 20% of available energy 
                     
                     
                        Minimum of 350 IU Vitamin E / kg complete feed with a moisture content of 12%
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        — Starch 
                     
                     
                        — Sugar 
                     
                     
                        — Crude fat 
                     
                     
                        — Vitamin E (total)
                     
                  
                  
                     
                        Initially for a minimum of 3 months
                     
                  
                  
                     
                        Guidance shall be provided on the situations in which the use of this feed is appropriate. 
                     
                     
                        The instructions for proper use shall contain guidance on the balance of the daily ration and the appropriate daily intake.
                     
                     
                        Indicate on the labelling: "It is recommended that a veterinarian's opinion be sought before use."
                     
                  
               
                     
                        72
                     
                  
                  
                     
                        Compensation for chronic digestive disorders of large intestine 
                     
                  
                  
                     
                        — Starch content to provide < 1 g / kg BW / meal (< 0,5 g / kg BW / meal, if diarrhoea present)
                     
                     
                        — Cereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve small intestinal starch digestion 
                     
                     
                        — Additional supply of water soluble vitamins and adequate minerals/electrolytes levels 
                     
                     
                        — Additional oil if no diarrhoea
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        Starch content
                     
                     
                        Crude fat
                     
                  
                  
                     
                        Long term or until resolution of the issue
                     
                  
                  
                     
                        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.
                     
                     
                        The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.
                     
                     
                        Indicate on the labelling the processing used for the cereal grains.
                     
                     
                     
                  
               
                     
                        73
                     
                  
                  
                     
                        Compensation for chronic insufficiency of small intestine function
                     
                  
                  
                     
                        — Highly digestible fibres
                     
                     
                        — High quality protein sources and lysine > 4,3 % of crude protein
                     
                     
                        — Total sugar and starch to provide a maximum of 0,5 g / kg BW / meal   
                     
                     
                        — Cereal grains processed via a hydrothermal treatment, such as extrusion, micronisation, expansion or flaking, to improve pre-caecal digestion
                     
                  
                  
                     
                        Equines
                     
                  
                  
                     
                        — Highly digestible feed materials including their processing, if appropriate.
                     
                     
                        — Total sugar and starch
                     
                     
                        — Protein sources
                     
                  
                  
                     
                        Long term or until resolution of the issue
                     
                  
                  
                     
                        — Guidance shall be provided on
                     
                     
                        — the precise situations in which the use of the feed is appropriate
                     
                     
                        —meal size and forage intake.
                     
                     
                        — The instructions for proper use shall refer, depending on the oil content, to the potential gradual use and suggest a monitoring for diarrhoea.
                     
                     
                  
               
               (GP1) For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
            
            
               (GP1) These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
            
            
               (1) If appropriate the manufacturer may also recommend use for temporary renal insufficiency. 
            
         
         
            
               (2) 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. 
            
            
               (3) If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
            
            
               (4) In the case of feed for a particular intolerance, reference to the specific intolerance can replace ‘ingredient and nutrient’
            
            
                (5) For cats a reference to ‘Feline hepatic lipidosis’ may be added
            
            
               (6) For cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome — FUS’ may be added.
            
            
               (7) Undersaturating properties: urine associated with crystal and stone dissolution and prevention of crystal precipitation and growth.
            
            
               (8) The persons responsible for the labelling of the feed shall deliver a declaration of conformity, which refers to the proof of compliance with the essential nutritional characteristics
            
            
               (9) Metastabilising properties: urine associated with prevention of crystal precipitation.
            
            
               (10) ‘exocrine pancreatic insufficiency’ may be added.
            
            
               (11) 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.
            
            
               (12) 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.
            
            
               (13)Metabolisable Energy/kg calculated using the equation described in the FEDIAF (2018) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs
            
            
               (14) FEDIAF (2018) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs .
            
            
               (15) In the case of feed for dairy cows: ‘maximum two months from the start of lactation’.
            
            
               (16) Indicate the category of ruminants concerned.
            
            
               (17) DCAD (mEq/kg DM) = (Na + K) - (Cl + S).
            
            
               (18) The term ‘ketosis’ may be replaced by ‘acetonaemia’ and the person responsible for the labelling may also recommend the use for ketosis recuperation.
            
            
               (19) 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].