CELEX: 
Language: en
Date: 2020-03-04 00:00:00
Title: COMMISSION REGULATION (EU) …/… establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC

EUROPEAN
                              COMMISSION
                                                        Brussels, 4.3.2020
                                                        C(2020) 1183 final
                           COMMISSION REGULATION (EU) …/…
                                            of 4.3.2020
   establishing a list of intended uses of feed intended for particular nutritional purposes
                               and repealing Directive 2008/38/EC
                                    (Text with EEA relevance)
EN                                                                                           EN
 ---pagebreak---                                COMMISSION REGULATION (EU) …/…
                                                      of 4.3.2020
     establishing a list of intended uses of feed intended for particular nutritional purposes
                                     and repealing Directive 2008/38/EC
                                            (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 767/2009 of the European Parliament and of the
   Council of 13 July 2009 on the placing on the market and use of feed, amending European
   Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive
   79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC,
   83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC1,
   and in particular Article 10(5) thereof,
   Whereas:
   (1)    The placing on the market and use of feed is regulated by Regulation (EC) No
          767/2009. In accordance with Article 9 of that Regulation, feed intended for particular
          nutritional purposes may only be marketed if its intended use is included in a list of
          intended uses established in accordance with Article 10 of the said Regulation.
   (2)    Commission Directive 2008/38/EC2 established a list of intended uses of animal
          feedingstuffs for particular nutritional purposes.
   (3)    Part A of Annex I to Directive 2008/38/EC established the general provisions for feed
          intended for particular nutritional purposes. Considering scientific and technological
          developments and the labelling requirements established by Regulation (EC) No
          767/2009, those general provisions are to be reviewed.
   (4)    Articles 11 to 17 of Regulation (EC) No 767/2009 established new principles and rules
          for the placing on the market of feed, including labelling. As a consequence, several
          entries in the list of intended uses of feed intended for particular nutritional purposes
          contained in Part B of Annex I to Directive 2008/38/EC became outdated, partially
          because of poor and overly general descriptions in the column "Essential nutritional
          characteristics". For such entries, it has been very difficult for the control authorities to
          verify compliance with the provisions of Regulation (EC) No 767/2009, including
          whether the specific composition of the feed concerned fulfils the respective particular
          intended nutritional purpose.
   (5)    In accordance with Article 10 of Regulation (EC) No 767/2009, the Commission
          received a number of applications to amend and change the conditions associated with
          several intended uses of feed for particular nutritional purposes, which had become
   1
           OJ L 229, 1.9.2009, p. 1.
   2
           Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal
           feedingstuffs for particular nutritional purposes (OJ L 62, 6.3.2008, p. 9).
EN                                                          1                                             EN
 ---pagebreak---           outdated. Outdated entries for which no application has been submitted or for which
          the application was withdrawn should be removed.
   (6)    As regards other intended uses of feed intended for particular nutritional purposes
          listed in Part B of Annex I to Directive 2008/38/EC, amendments are necessary to the
          provisions concerning the essential nutritional characteristics and the labelling
          declarations in order to adapt them to the scientific and technological developments
          and to improve the enforceability and clarity of the provisions.
   (7)    Furthermore, the Commission received, in accordance with Article 10 of Regulation
          (EC) No 767/2009, applications to add the particular nutritional purposes ‘support of
          energy metabolism and of the muscle function in the case of rhabdomyolosis’ and
          ‘support in stressful situations, which will lead to the reduction of associated
          behaviour’ to the list of intended uses of feed intended for particular nutritional
          purposes.
   (8)    The Commission made all applications, including the dossiers, available to the
          Member States.
   (9)    Following the assessment of the dossiers included in those applications, the Standing
          Committee on Plants, Animals, Food and Feed (‘the Committee’) acknowledged that
          the specific composition of the feed concerned fulfils the respective particular intended
          nutritional purpose and that it has no adverse effects on animal health, human health,
          the environment or animal welfare.
   (10)   Based on the above considerations, the list of intended uses of feed for particular
          nutritional purposes should be updated.
   (11)   Since safety reasons do not require the immediate application of the new general
          provisions and of the updated list of intended uses of feed for particular nutritional
          purposes, it is appropriate to provide for transitional measures in order to avoid
          unnecessary disruption of commercial practices and to not create unnecessary
          administrative burden on the operators.
   (12)   In the interests of clarity and rationality, Directive 2008/38/EC should be repealed and
          replaced by a Regulation, which does not contain elements that would require
          transpositions by the Member States into national law. The last amendments to that
          Directive had already been successively brought through Regulations due to the
          absence of need of transposition into national law of the provisions concerned. In
          addition, the general requirements for the placing on the market and use of feed
          intended for particular nutritional purposes are provided for in Regulation (EC) No
          767/2009.
   (13)   In order to enable Member States to make the necessary adjustments, an adequate
          period should be allowed before this Regulation becomes applicable.
   (14)   The measures provided for in this Regulation are in accordance with the opinion of the
          Committee,
   HAS ADOPTED THIS REGULATION:
                                                Article 1
   Feed intended for particular nutritional purposes within the meaning of Regulation (EC) No
   767/2009 may be marketed only if:
EN                                                  2                                               EN
 ---pagebreak---    –         the general provisions for feed intended for particular nutritional purposes laid down
             in Part A of the Annex to this Regulation are complied with, and
   –         its intended use is included in Part B of the Annex to this Regulation and the
             provisions of the respective entry are complied with.
                                                Article 2
   By way of derogation from Article 1, feed intended for particular nutritional purposes which
   complies with the provisions of Directive 2008/38/EC may continue to be placed on the
   market, provided that an application for an intended use included therein has been submitted
   to the Commission in accordance with Article 10 of Regulation (EC) No 767/2009 before [12
   months after the date of entry into force of this Regulation – Date to be inserted by the Service
   responsible for the publication], and until the Commission decides on the respective
   application.
                                                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 [9 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, 4.3.2020
                                                  For the Commission
                                                  The President
                                                  Ursula VON DER LEYEN
EN                                                  3                                                EN
 ---documentbreak---                               EUROPEAN
                              COMMISSION
                                                      Brussels, 4.3.2020
                                                      C(2020) 1183 final
                                                      ANNEX
                                             ANNEX
                                              to the
                           COMMISSION REGULATION (EU) …/...
   establishing a list of intended uses of feed intended for particular nutritional purposes
                               and repealing Directive 2008/38/EC
EN                                                                                           EN
 ---pagebreak---                                                      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 shall be
         quantitative without prejudice to Directive 2004/48/EC1.
   6.    The recommended period of use indicated in column 5 of Part B indicates a range
         within which the nutritional purpose should normally be achieved. Manufacturers
         can refer to more precise periods of use, within the fixed limits.
   7.    Where a feed intended for particular nutritional purposes is intended to meet more
         than one particular nutritional purpose, it shall comply with each respective entry in
         Part B.
   8.    In the case of complementary feed intended for particular nutritional purposes,
         guidance on the balance of the daily ration must be provided in the instructions for
         proper use.
   9.    When a feed intended for particular nutritional purposes is with an appropriate mode
         of use intended for individual oral administration via a bolus, this shall be established
         in the column "other provisions" of the respective feed. Such feed shall exclusively
         contain, including a potential coating, feed materials and feed additives, unless
         detailed otherwise in the respective entry. It is recommended that feed intended for
         individual oral administration is administered by a veterinarian or any other
         competent person.
   10.   When a feed intended for particular nutritional purposes is placed on the market in
         the form of a bolus, being a feed material or complementary feed intended for
         individual oral administration with retarding release, i.e. more than 24 hours, of the
         compounds, the labelling of such feed shall, if applicable, mention for each feed
   1
       Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of
       intellectual property rights (OJ L 157, 30.4.2004, p. 45).
EN                                                        1                                                      EN
 ---pagebreak---        additive for which a maximum content in complete feed is fixed the maximum period
       of continuous release of the bolus and the daily release rate. The feed business
       operator which is placing a bolus on the market shall have the proof that the daily
       available feed additive level in the digestive tract will not exceed, if applicable, the
       maximum content of the additive established per kg complete feed during the whole
       feeding period (retarding release effect). Such proof should be based on a peer
       reviewed methodology or in-house analysis.
   11. In case of intended uses for which in column 2 a concentration of certain feed
       additives higher than 100 times the relevant fixed maximum content in complete feed
       is allowed for complementary feed, the concentration of those feed additives shall
       not be higher than 500 times the relevant fixed maximum content in complete feed,
       except in the case of boluses as referred to in point 10. The incorporation of such
       complementary feed into the animal`s diet shall ensure that the uptake of the animal
       complies with the fixed maximum content in complete feed.
EN                                           2                                                  EN
 ---pagebreak---                                                                                  PART B
                                                                           List of intended uses
             Particular                                              Species or
   Entry                              Essential nutritional                              Labelling         Recommended
             nutritional                                            category of                                                                  Other provisions
   num-                                characteristics(GP1)                         declarations(GP2)      length of time
              purpose                                                 animal
    ber
                  1                             2                        3                  4                      5                                     6
    10   Support of renal    High quality proteins and phosphorus   Dogs           Protein source(s)     Initially up to 6 1. The feed shall be placed on the market as complete
         function in case of ≤ 5 g/kg complete feed with a moisture                Calcium               months (3)           feed.
         chronic renal       content of 12 %(2) and crude protein ≤
                                                                                   Phosphorus                              2. Recommended digestibility of proteins: minimum 85
         insufficiency (1)   220 g/kg complete feed with a                                                                     %.
                             moisture content of 12 %(2)                           Potassium
                                                                                   Sodium                                  3. Indicate on the labelling: ‘It is recommended that
                                                                                                                               advice from a veterinarian be sought before use and
                                                                                   Essential fatty acids                      before extending the period of use.’
                                                                                    (if added)
                                                                                                                            4. Indicate in the instructions for proper use: ‘Water
                                                                                                                               should be available at all times.’
                             Reduced phosphorus absorption by       Adult dogs     Protein source(s)     Initially up to 6 1. Indicate on the labelling: ‘It is recommended that
                             means of incorporation of Lanthanum                   Calcium               months (3)           advice from a veterinarian be sought before use and
                             carbonate octahydrate                                                                             before extending the period of use.’
                                                                                   Phosphorus
                                                                                                                            2. Indicate in the instructions for proper use: ‘Water
                                                                                   Potassium
                                                                                                                               should be available at all times.’
                                                                                   Sodium
                                                                                   Essential fatty acids
                                                                                    (if added)
                                                                                   Lanthanum
                                                                                    carbonate
                                                                                    octahydrate
                             High quality proteins and phosphorus ≤ Cats           Protein source(s)     Initially up to 6 1. The feed shall be placed on the market as complete
                             6,5 g / kg complete feed with a                       Calcium               months (3)           feed.
                             moisture content of 12 %(2) and crude
                                                                                   Phosphorus                              2. Recommended digestibility of proteins: minimum 85
                             protein ≤ 320 g/kg complete feed with                                                             %.
                             a moisture content of 12 %(2)                         Potassium
                                                                                   Sodium                                  3. Indicate on the labelling: ‘It is recommended that
                                                                                                                               advice from a veterinarian be sought before use and
                                                                                   Essential fatty acids                      before extending the period of use.’
                                                                                    (if added)
                                                                                                                            4. Indicate in the instructions for proper use: ‘Water
                                                                                                                               should be available at all times.’
EN                                                                                     3                                                                                           EN
 ---pagebreak---                       Reduced phosphorus absorption by       Adult cats  Protein source(s)     Initially up to 6 1. Indicate on the labelling: ‘It is recommended that
                      means of incorporation of Lanthanum                Calcium               months (3)             advice from a veterinarian be sought before use and
                      carbonate octahydrate                                                                            before extending the period of use.’
                                                                         Phosphorus
                                                                                                                  2. Indicate in the instructions for proper use: ‘Water
                                                                         Potassium
                                                                                                                       should be available at all times.’
                                                                         Sodium
                                                                         Essential fatty acids
                                                                          (if added)
                                                                         Lanthanum
                                                                          carbonate
                                                                          octahydrate
                     High density of energy with more than   Equines     Protein and energy    Initially up to   1. The feed shall be placed on the market as
                     8,8 MJ/kg feed with a moisture content               source(s)             six months.            complementary feed
                     of 12%.                                             Calcium               Long term or      2. Indicate on the labelling:
                     Highly digestible and highly palatable              Phosphorus            until resolution            ‘It is recommended that a veterinarian's opinion
                     sources of starch.                                                         of the issue
                                                                         Potassium                                          be sought before use or before extending the
                     Restricted protein level: ≤ 106 g crude             Magnesium                                          period of use.’
                     protein / kg feed with a moisture                                                                  
                     content of 12%.                                     Sodium                                             The complementary feed should not be used in
                                                                                                                             case of hypernatraemia and hyperchloraemia.
                     Level of sodium: 2 g / 100 kg BW per                Sum of
                                                                          eicosapentaenoic                                  The complementary feed should contribute to at
                     day.
                                                                          acid and                                           least 10 to 20% of the daily energy supply
                     High level of eicosapentaenoic acid and              docosahexaenoic                                    (approximately 0.05 to 0.1 MJ/kg BW0.75 per
                     docosahexaenoic sum ≥ 0.2 g per kg                   acid                                               day).
                     BW0.75 per day
                                                                                                                  3. The ration should ensure an energy supply of > 0.62
                                                                                                                       MJ/kg BW0.75 per day.
                                                                                                                  4. The ration should not exceed 50 mg calcium/kg dry
                                                                                                                       matter/day.
                                                                                                                  5. Indicate in the instructions for proper use: ‘Water
                                                                                                                       should be available at all times.’
   11 Reduction of    Low level of calcium, low level of      Dogs and   Phosphorus            Up to 6 months    Indicate on the labelling:
      oxalate stones  vitamin D, and urine alkalising         cats       Calcium                                 ‘It is recommended that a veterinarian's opinion be sought
      formation       properties                                                                                  before use.’
                                                                         Sodium
                                                                         Magnesium
                                                                         Potassium
                                                                         Chlorides
                                                                         Sulphur
EN                                                                           4                                                                                                EN
 ---pagebreak---                                                                         Vitamin D (total)
                                                                        Hydroxyproline
                                                                        Urine alkalising
                                                                         substances
   12 Regulation of    Total sugars (mono- and                Dogs and  Carbohydrate          Initially up to 6  1. The feed shall be placed on the market as complete
      glucose supply   disaccharides) ≤ 62 g/kg complete feed cats       source(s)             months                 feed.
      (Diabetes        with a moisture of 12%(2)                        Treatment of                             2. Indicate on the labelling:
      mellitus)                                                          carbohydrates, if                                  ‘Low level of mono- and disaccharides’
                                                                         appropriate
                                                                                                                            ‘It is recommended that a veterinarian’s opinion
                                                                        Starch                                              be sought before use and before extending the
                                                                        Total sugars                                        period of use.’
                                                                        Fructose (if added)
                                                                        Essential fatty acids
                                                                         (if added)
                                                                        Source(s) of short
                                                                         and medium chain
                                                                         fatty acids (if
                                                                         added)
   13 Reduction of     Selected and limited number of protein Dogs and  Protein sources        3 to 8 weeks: if 1. The feed shall be placed on the market as complete feed.
      ingredient and   source(s)                              cats       including treatment,   signs of         2. It is recommended to limit the number of main protein
      nutrient         And/or                                            if appropriate (if     intolerance         sources to 3.
      intolerances(4)                                                    added).                disappear this
                       hydrolysed protein source(s)                                                              3. To indicate on the labelling:
                                                                        Carbohydrate           feed can be
                       And/or                                            source(s) including    used initially           Appropriate combination of the essential
                       selected carbohydrate source(s)                   treatment, if          up to one year.              nutritional characteristics, as applicable
                                                                         appropriate (if                                 ‘It is recommended that a veterinarian's opinion
                                                                         added).                                             be sought before use and before extending the
                                                                        Essential fatty acids                               period of use.’
                                                                         (if added)
   14 Reduction of    Urine alkalinising properties and crude Dogs      Sulphur         amino Initially up to 6  1. The feed shall be placed on the market as complete
      cystine stones  protein ≤ 160 g/kg complete feed with a            acids (total)         month                  feed.
      formation       moisture content of 12%(2)                        Protein sources                          2. Indicate in the instructions for proper use:
                      Or                                                Sodium                                       “Water should be available at all times”
                      Proteins selected for a limited cystine           Potassium                                3. Indicate on the labelling:
                      and cysteine content (e.g. casein, pea            Chlorides                                          ‘Urine alkalinising properties and low level of
                      protein, soy protein) and crude protein           Urine alkalinizing                                  proteins’ or ‘Low level of selected proteins’, as
EN                                                                          5                                                                                                  EN
 ---pagebreak---                        ≤ 220 g/kg complete feed with a                substances (if                                 applicable.
                       moisture content of 12%(2)                     added)                                        ‘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       Highly digestible ingredients with     Dogs  Highly digestible  Until restoration 1. Recommended apparent digestibility of Dry Matter ≥
      restoration,
                        energy density ≥ 3520 kcal and crude          ingredient sources is achieved          80% or of Organic Matter ≥ 85%.
      convalescence(5)                                                including their                      2. In the case of feed specially presented to be given via
                        protein ≥ 250 g per kg of complete
                        feed with a moisture level 12%(2)             treatment, if                           tubing, indicate on the package, container or label:
                                                                      appropriate                             ‘Administration under veterinary supervision.’
                        Highly digestible ingredients with     Cats  Energy value                         3. The labelling may indicate the specific circumstance(s)
                        energy density ≥ 3520 kcal and crude                                                  the dietetic feed is intended for.
                        protein ≥ 270 g per kg of complete
                                                                                                           4. Indicate on the labelling:
                        feed with a moisture level 12%(2)
                                                                                                              “High energy density, high concentrations of essential
                                                                                                              nutrients and highly digestible ingredients”
   16 Reduction of      Crude protein ≤ 130 g / kg complete   Dogs   Protein source(s)  Up to 6 months,
                                                                                                           1. The feed shall be placed on the market as complete
      urate stones      feed with a moisture level of 12%(2)                             but lifetime use
                                                                                                              feed.
      formation        Or                                                                in case of
                                                                                         irreversible      2. Protein quality and level of purines should be taken into
                        Crude protein ≤ 220 g / kg complete                              disturbance of       account when selecting the protein source. Examples of
                        feed with a moisture level of 12%(2)                             uric acid            selected protein sources of high quality with low level
                        and selected protein sources                                     metabolism           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    Cats                                         1. The feed shall be placed on the market as complete
                       feed with a moisture content of 12%(2)                                                 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
EN                                                                      6                                                                                               EN
 ---pagebreak---                                                                                                              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     Urine undersaturating(7) properties for  Dogs and  Phosphorus 5 to 12 weeks     1. The feed shall be placed on the market as complete
      struvite stones(6)                                                                                     feed.
                         struvite                                 cats      Calcium
                         And/or                                             Sodium                       2. Indicate on the labelling:
                         Urine acidifying properties (8)                    Magnesium                          ‘It is recommended that advice from a
                                                                                                                   veterinarian be sought before use and before
                         And                                                Potassium                             extending the period of use.’
                         Magnesium ≤ 1.8 g/kg complete feed                 Chloride                           ‘Urine undersaturating properties for struvite
                         with a moisture content of 12%(2)                  Sulfur                                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       Complete feed with urine                 Dogs and  Phosphorus Initially up to 6 1. The feed shall be placed on the market as complete
      struvite stone     undersaturating(7) or metastabilising                                               feed.
                                                                  cats      Calcium    month
      recurrence(6)      properties(9) for struvite                                                       2. Indicate on the labelling:
                                                                            Sodium
                         And/or                                             Magnesium                          ‘It is recommended that advice from a
                         Diet with urine acidifying properties(8)                                                  veterinarian be sought before use and before
                                                                            Potassium                             extending the period of use.’
                         And                                                Chloride                           ‘Urine undersaturating or metastabilising
                         Magnesium ≤ 1.8 g/kg complete feed                 Sulfur                                properties for struvite and/or Urine acidifying
                         with a moisture content of 12%(2)
                                                                                                                   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.
EN                                                                            7                                                                                      EN
 ---pagebreak---    19 Compensation for  Highly digestible diet:                  Dogs and  Highly digestible  Initially up to 1. The feed shall be placed on the market as complete
      maldigestion(10)                                           cats       ingredient sources 12 weeks and       feed.
                        Apparent digestibility of
                                                                            including their    lifetime in the 2. Indicate on the labelling:
                        - low-fibre feed (crude fibre ≤ 44 g per            treatment, if      case of chronic
                          kg of complete feed with a moisture                                                        ‘Highly digestible feed’
                                                                            appropriate        pancreatic
                          level 12 %(2)):                                                      insufficiency         ‘It is recommended that a veterinarian’s opinion
                                                                                                                         be sought before use.’
                          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 %
   20 Reduction of      Highly digestible diet:                  Dogs and  Highly digestible  Up to 12 weeks  Indicate on the labelling:
      intestinal                                                 cats       ingredient sources
      absorptive        Apparent digestibility of                                                                       ‘Highly digestible feed with increased sodium
                                                                            including their                              and potassium’
      disorders         - low-fibre feed (crude fibre ≤ 44 g per            treatment, if
                          kg of complete feed with a moisture               appropriate                                 ‘It is recommended that a veterinarian’s opinion
                          level 12 %(2)):                                                                                be sought before use.’
                                                                           Sodium
                          Crude protein ≥ 85 %                             Potassium
                          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)
EN                                                                            8                                                                                          EN
 ---pagebreak---    21 Reduction of      Increased level of electrolytes:         Dogs and  Sodium            1 - 7 days        1. The feed shall be placed on the market as
      acute intestinal             Sodium ≥ 1.8 %                                                                  complementary feed.
                             -                                   cats      Potassium
      absorptive                                                                                                2. Indicate on the labelling:
      disorders              -     Potassium ≥ 0,6 %                       Carbohydrate
                                                                            source(s)                                 ‘During periods of and recovery from acute
                        And
                                                                                                                          diarrhoea’
                        Highly digestible carbohydrates:                                                              ‘It is recommended that a veterinarian’s opinion
                             -     ≥ 32 %                                                                                 be sought before use.’
                                                                                                                3. In case of solid feed, the recommended range of
                                                                                                                   electrolytes should be calculated on the basis of a
                                                                                                                   normal daily voluntary intake of water.
   22 Support of lipid  Fat(11) ≤ 110 g / kg complete feed with  Dogs and  Crude fat         Initially up to 2 1. The feed shall be placed on the market as complete
      metabolism in the a moisture content of 12%(12)            cats                         months               feed.
      case of                                                                                                   2. Indicate on the labelling:
      hyperlipidaemia
                                                                                                                      ‘It is recommended that a veterinarian’s opinion
                                                                                                                          be sought before use or before extending the
                                                                                                                          period of use.’
                                                                                                                      ‘Low level of fat’
   23 Support of liver   Moderate level of protein:              Dogs and  Protein source(s) Initially up to 4 1. The feed shall be placed on the market as complete
      function in the                                                                                              feed.
                         Crude protein ≤ 279 g / kg complete     cats      Copper (total)    months
      case of chronic
      liver              feed with a moisture content of 12%(2)            Sodium                              2. Examples of selected protein sources based on high
      insufficiency      for dogs                                                                                  digestibility: dairy proteins (whey, casein, milk, cottage
                         Crude protein ≤ 370 g / kg complete                                                       cheese), other animal based proteins (egg, poultry) and
                         feed with a moisture content of 12%(2)                                                    vegetable proteins (soy).
                         for cats                                                                               3. Indicate in the instructions for proper use: 'Water
                         And                                                                                       should be available at all times.'
                         Selected protein sources                                                               4. Indicate on the labelling:
                         And                                                                                             ‘Moderate level of protein, selected and highly
                         Recommended dietary protein                                                                      digestible’
                         digestibility ≥ 85%                                                                             ‘It is recommended that a veterinarian’s opinion
                                                                                                                          be sought before use.’
                        Low level of protein but of high quality Equines   Protein and fibre Initially up to   1. Indicate on the labelling:
                        and highly digestible carbohydrates                 sources           six months              ‘It is recommended that a veterinarian's opinion
                                                                           Highly digestible                             be sought before use or before extending the
                                                                            carbohydrates                                 period of use.’
                                                                            including their                     2. Guidance should be provided on the manner in which
                                                                            treatment, if                          the feed should be fed including many small meals per
EN                                                                            9                                                                                              EN
 ---pagebreak---                                                                            appropriate                               day.
                                                                          Methionine
                                                                          Choline
                                                                          Content of n-3 fatty
                                                                           acids (if added)
   24  Support of heart  Restricted level of sodium:            Dogs and  Magnesium            Initially up to 6 1. The feed shall be placed on the market as complete
       function in the   Sodium ≤ 2.6 g per kg complete feed    cats      Potassium            months               feed.
       case of chronic   with a moisture content of 12 %(2)                                                       2. Indicate on the labelling: ‘It is recommended that
                                                                          Sodium
       cardiac                                                                                                       advice from a veterinarian be sought before use and
       insufficiency                                                                                                 before extending the period of use.’
   25  Reduction of     Metabolizable Energy < 3060 kcal /kg    Dogs      Energy value         Until target      1. The feed shall be placed on the market as complete
       excessive body   complete feed with moisture content of                                  body weight is       feed.
       weight           12%(13)                                                                 achieved and      2. To ensure that minimum requirements are met, the
                                                                                                after if required    nutrient levels of a diet for reduction of excessive
                        Or                                                                      to maintain          bodyweight should be increased accordingly to
                        Metabolizable Energy < 560 kcal /kg
                                                                                                target               compensate for the restricted daily energy intake(14)
                                                                                                bodyweight        3. Indicate on the labelling:
                        complete feed with moisture content of
                        85%(13)                                                                                         ‘It is recommended that a veterinarian’s opinion
                                                                                                                            be sought before use.’
                        Metabolizable Energy < 3190 kcal per    Cats                                                    ‘For cats, a transition period when starting the
                        kg complete feed with moisture content                                                              diet is advised.’
                        of 12%(13)                                                                                      ‘For an efficient weight loss or ideal weight
                        Or                                                                                                  maintenance, the recommended daily energy
                                                                                                                            intake should not be exceeded.’
                        Metabolizable Energy < 580 kcal per kg
                        complete feed with moisture content of
                        85%(13)
   26 Support of skin    Linoleic acid  12.3 g per kg and sum  Dogs and  Linoleic acid        Initially up to 2 Indicate on the labelling:
      function in the    of eicosapentaenoic acid and           cats      Sum of               months                  ‘It is recommended that a veterinarian's opinion
      case of            docosahexaenoic acid  2.9 g per kg of            eicosapentaenoic                                 be sought before use.’
      dermatosis and
      excessive loss of
                         complete feed with a moisture content             acid and                                     ‘High level of linoleic acid (LA) and of sum of
                         of 12%(2)                                         docosahexaenoic                                  eicosapentaenoic acid (EPA) and
      hair
                                                                           acid                                             docosahexaenoic acid (DHA)’
                         Linoleic acid  18.5 g per kg and sum  Dogs
                         of eicosapentaenoic acid and
                         docosahexaenoic acid  0.39 g per kg
                         of complete feed with a moisture
                         content of 12%(2)
EN                                                                          10                                                                                             EN
 ---pagebreak---                          Linoleic acid  18.5 g per kg and sum  Cats
                         of eicosapentaenoic acid and
                         docosahexaenoic acid  0.09 g per kg
                         of complete feed with a moisture
                         content of 12%(2)
   27 Support of the     Total omega-3 fatty acids ≥ 29 g per   Dogs  Omega-3 fatty      Initially up to 3 Indicate on the labelling:
      metabolism of      kg and eicosapentaenoic acid ≥ 3.3 g          acids (total)      months                  ‘It is recommended that advice from a
      joints in the case per kg complete feed with a moisture         Eicosapentaenoic                               veterinarian be sought before use and before
      of osteoarthritis  content of 12 %(2)                            acid (total)                                   extending the period of use.’
                         And                                          Vitamin E (total)
                         Adequate levels of vitamin E
                         Total omega-3 fatty acids ≥10.6 g per  Cats  Omega-3 fatty
                         kg complete feed with a moisture              acids (total)
                         content of 12 %(2) and                       Docosahexaenoic
                         docosahexaenoic acid ≥ 2.5 g per kg           acid (total)
                         complete feed with a moisture content
                                                                      Methionine (total)
                         of 12 %(2)
                                                                      Manganese (total)
                         And
                                                                      Vitamin E (total)
                         Increased levels of methionine and
                         manganese
                         Adequate levels of vitamin E.
   28 Reduction of       Restricted level of copper: copper ≤   Dogs  Copper (total)      Initially up to 6 1. The feed shall be placed on the market as complete
      copper in the      8.8 mg per kg complete feed with a                               months               feed.
      liver              moisture content of 12 %(2)                                                        2. Indicate on the labelling:
                                                                                                                  ‘It is recommended that advice from a
                                                                                                                      veterinarian be sought before use and before
                                                                                                                      extending the period of use.’
   29 Reduction of       Restricted level of iodine: iodine ≤   Cats Iodine (total)       Initially up to 3 1. The feed shall be placed on the market as complete
      iodine levels in   0.26 mg per kg complete feed with a                              months               feed.
      feed in case of    moisture content of 12 %(2)                                                        2. Indicate on the labelling:
      hyperthyroidism                                                                                             ‘It is recommended that advice from a
                                                                                                                      veterinarian be sought before use and before
                                                                                                                      extending the period of use.’
   30 Support in         1-3 g trypsin-hydrolysed bovine casein Dogs  Trypsin-hydrolysed  Initially up to 2 1. The feed shall be placed on the market as complete
      stressful          per kg complete feed with a moisture         bovine casein       months               feed.
      situations, which  content of 12%(2)                                                                  2. Indicate on the labelling:
EN                                                                      11                                                                                         EN
 ---pagebreak---       will lead to the                                                                                              ‘It is recommended that advice from a
      reduction of                                                                                                   veterinarian be sought before use and before
      associated                                                                                                     extending the period of use.’
      behaviour
   50 Support the       High level of selenium and a         Mammals Names and total      Cows: 2        1. Application in the form of bolus is allowed. A bolus
      preparation for     minimum content of vitamin E per            amounts of each       weeks             may contain up to 20 % iron in an inert, non-
      oestrus and         kg complete feed with a moisture            added trace element   before the        bioavailable form, in order to increase its density.
      reproduction        content of 12 % for pigs of 50 mg,          and vitamin           end of         2. The instructions for proper use for the feed shall ensure
                          rabbits of 35 mg, for dogs, cats,                                 gestation         that the respective legal maximum contents for
                          mink of 88 mg; a minimum content                                  until the next    complete feed are respected.
                          of vitamin E per animal and day for                               gestation is   3. Indicate on the labelling of the feed guidance on the
                          ovines of 100 mg, cattle of 300 mg,                               confirmed.        situations in which the use of the feed is appropriate.
                          horses of 1 100 mg                                               Sows: 7 days
                        Or                                                                  before until
                        High level(s) of vitamins A and/or                                 3 days after
                          vitamin D and/or a minimum                                        parturition
                          content of beta- carotene of 300 mg                               and 7 days
                          per animal and day.                                               before until
                                                                                            3 days
                        The complementary feed may contain                                  mating.
                        selenium, vitamin A and D in a
                        concentration higher than 100 times                                Other female
                        the relevant fixed maximum content in                               mammals:
                        complete feed.                                                      from the last
                                                                                            part of
                                                                                            gestation
                                                                                            until the next
                                                                                            gestation is
                                                                                            confirmed.
                                                                                           Males:
                                                                                            during
                                                                                            periods of
                                                                                            reproductive
                                                                                            activity.
                        High level(s) of vitamin A and/or    Birds   Names and total      For females:
                          vitamin D                                   amounts of each       during
                        Or                                            added trace element   oestrus
                        High level(s) of selenium and/or
                                                                      and vitamin          For males:
                          zinc and/or a minimum content of                                  during
                          vitamin E of 40 mg/kg complete                                    periods of
                          feed with a moisture content of 12                                reproductive
EN                                                                      12                                                                                             EN
 ---pagebreak---                              %.                                                                        activity
                          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.
   51 Support the         High level of zinc.                     Horses,    Zinc (total)         Up to 8 weeks 1. The instructions for proper use for the feed shall ensure
      regeneration of                                                                                               that the legal maximum contents of zinc for complete
                          The complementary feed may contain      ruminants  Methionine (total)
      hooves, trotters                                            and pigs                                          feed are respected.
      and skin            zinc in a concentration higher than 100            Biotin (if added)
                          times the relevant fixed maximum                                                       2. Application in the form of bolus is allowed for
                          content in complete feed.                                                                 ruminants. A bolus may contain up to 20 % iron in an
                                                                                                                    inert, non-bioavailable form, in order to increase its
                                                                                                                    density.
   52 Support for        Minimum supply via the dietetic feed     Ruminants Name and total         2 to 15 days  1. Application in the form of bolus is allowed for
      nutritional        of:                                      Pigs      amount of the                           ruminants and pigs. A bolus may contain up to 20 %
      imbalances in                                                         nutritional additives,                  iron in an inert, non-bioavailable form, in order to
                          Selenium: 0.1 mg/kg complete feed      Rabbits
      dietary transition                                                    if appropriate                          increase its density.
                             with a moisture content of 12%
                                                                  Poultry                                        2. The instructions for proper use for the feed shall ensure
                         And/or
                                                                                                                    that the respective legal maximum contents for
                          Zinc: 15 mg/kg complete feed with                                                        complete feed are respected.
                             a moisture content of 12%                                                           3. Indicate on the labelling of the feed guidance on the
                         And/or                                                                                     situations in which the use of the feed is appropriate.
                          Copper: 2 mg/kg complete feed with
                             a moisture content of 12% for sheep
                             and 5 mg/kg complete feed with a
                             moisture content of 12% for other
                             species
                         And/or
                          Vitamin A: 2000 IU/kg complete
                             feed with a moisture content of 12%
                         And/or
                          Vitamin D: 400 IU/kg complete
                             feed with a moisture content of 12%
                         And/or
                          Vitamin E: 35 mg/kg complete feed
                             with a moisture content of 12% for
                             poultry, 10 mg/kg complete feed
                             with a moisture content of 12% for
                             ruminants, 40 mg/kg complete feed
EN                                                                              13                                                                                           EN
 ---pagebreak---                           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.
   53 Support weaning Minimum supply via the dietetic feed    Mammals Name and total         Up to 4 weeks  1. The instructions for proper use for the feed shall ensure
                      of:                                             amount of the          around weaning    that the respective legal maximum contents for
                                                                      nutritional additives,                   complete feed are respected.
                       Selenium: 0.1 mg/kg complete feed
                          with a moisture content of 12%              if appropriate                        2. Indicate on the labelling of the feed guidance on the
                                                                                                               situations in which the use of the feed is appropriate.
                      And/or
                       Zinc: 15 mg/kg complete feed with
                          a moisture content of 12%
                      And/or
                       Copper: 2 mg/kg complete feed with
                          a moisture content of 12% for sheep
                          and 5 mg/kg complete feed with a
                          moisture content of 12% for other
                          species
                      And/or
                       Iodine: 0.2 mg/kg complete feed
                          with a moisture content of 12%
                      And/or
                       Manganese: 20 mg/kg complete
                          feed with a moisture content of 12%
                      And/or
                       Vitamin A: 1500 IU/kg complete
                          feed with a moisture content of 12%
                      And/or
                       Vitamin D: 400 IU/kg complete
                          feed with a moisture content of 12%
                      And/or
                       Vitamin E: 100 mg/kg complete
EN                                                                        14                                                                                             EN
 ---pagebreak---                            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.
   54 Support the      — Minimum supply of zinc compounds       Mammals      Name and total           Up to 8         1. The instructions for proper use for the feed shall ensure
      regeneration of     via dietetic feed corresponding to 20 and poultry  amount of the               weeks            that the respective legal maximum contents for
      the skin and        mg/kg complete feed with a                         nutritional additives,   Complement         complete feed are respected.
      appendages          moisture content of 12%                                                        ary feed for  2. Indicate on the labelling of the feed guidance on the
                                                                             if appropriate
                       And                                                                               ruminants        situations in which the use of the feed is appropriate.
                        — High level of                                                                  containing
                                                                                                         biotin: Up to
                          copper and/or iodine and/or                                                    6 months
                          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.
   55 Stabilisation of  Predominantly electrolytes: sodium,    Calves,         Sodium              1 to 7 days       1. Recommended range of electrolytes per litre potion
      water and            potassium and chlorides              pigs, lambs,    Potassium                                ready prepared for feeding:
      electrolyte       Buffering capacity(19) in case of      kids and        Chlorides                                 Sodium: 1.7 g – 3.5 g
      balance to           liquid feed: minimum 60 mmol per                                                                Potassium: 0.4 g – 2 g
      support the
                                                                foals           Carbohydrate
                           litre potion ready prepared for                                                                 Chlorides: 1 g – 2.8 g
      physiological                                                              source(s)
                           feeding
      digestion                                                               Bicarbonates                            2. In case of solid feed, the recommended range of
                        Easily digestible carbohydrates                                                                  electrolytes should be calculated on the basis of a
                                                                                 and/or citrates (if
EN                                                                               15                                                                                                EN
 ---pagebreak---                                                                        added)                            normal daily voluntary intake of water.
                                                                                                      3. Indicate on the labelling:
                                                                                                            ‘In case of risk of, during periods of, or recovery
                                                                                                                from digestive disturbance (diarrhoea).’
                                                                                                            ‘It is recommended that advice from a
                                                                                                                veterinarian be sought before use and before
                                                                                                                extending the period of use.’
                                                                                                      4. Indicate in the instructions for proper use:
                                                                                                            The recommended intake of the ready stirred
                                                                                                                potion and of milk, if appropriate.
                                                                                                            In case of bicarbonates and/or citrates are above
                                                                                                                40 mmol per litre potion ready prepared for
                                                                                                                feeding of ruminants: ‘Simultaneous feeding of
                                                                                                                milk should be avoided in animals with
                                                                                                                abomasum’
   56 Reduction of the High level of magnesium, easily     Ruminants  Starch         3 to 10 weeks   1. Application in the form of bolus is allowed. A bolus
                       available carbohydrates,                                       during periods     may contain up to 20 % iron in an inert, non-
      risk of tetany                                                  Sugars (total)
      (hypomagnesaem   moderate level of protein and                                  of fast grass      bioavailable form, in order to increase its density.
                       low level of potassium                         Magnesium      growth
      ia)                                                                                             2. In the instructions for proper use guidance shall be
                                                                      Sodium                            provided on the balance of the daily ration, with regard
                                                                      Potassium                         to the inclusion of fibre and easily available energy
                                                                                                         sources.
                                                                                                      3. In the case of feed for ovines indicate on the labelling:
                                                                                                         ‘Especially for lactating ewes.’
   57 Reduction of the Low level of easily fermentable     Ruminants  Starch         up      to    2 1. Application in the form of bolus is allowed. A bolus
                       carbohydrates and high buffering                                  months(15)      may contain up to 20 % iron in an inert, non-
      risk of acidosis                                                Sugars (total)
                       capacity                                                                          bioavailable form, in order to increase its density.
                                                                                                      2. In the instructions for proper use guidance shall be
                                                                                                         provided on the balance of the daily ration, with regard
                                                                                                         to the inclusion of fibre and easily fermentable
                                                                                                         carbohydrate sources.
                                                                                                      3. In the case of feed for dairy cows indicate on the
                                                                                                         labelling: ‘Especially for high yielding cows.’
                                                                                                      4. In the case of feed for ruminants for fattening indicate
                                                                                                                                                          (16)
                                                                                                         on the labelling: ‘Especially for intensively fed .’
   58 Reduction of the Low level of phosphorus, magnesium, Ruminants  Calcium        Up to 6 weeks   1. Indicate on the labelling: ‘Especially for intensively fed
      risk of urinary  and urine acidifying properties
                                                                      Phosphorus                        young animals.’
      calculi
                                                                      Sodium                         2. Indicate in the instructions for proper use: ‘Water
EN                                                                     16                                                                                          EN
 ---pagebreak---                                                                             Magnesium                                should be available at all times.’
                                                                            Potassium
                                                                            Chlorides
                                                                            Sulphur
                                                                            Urine acidifying
                                                                             substances
   59 Long-term supply   High level of                          Ruminants    Names and total      Up to 12        1. Application in the form of bolus is allowed. A bolus
      of grazing          Trace elements                       with a       amounts of each          months          may contain up to 20 % iron in an inert, non-
      animals with                                              functional   added           trace                    bioavailable form, in order to increase its density.
                         And/or
      trace elements                                            rumen        element, vitamin,                     2. Indicate on the labelling of the feed:
                          Vitamins, provitamins and
      and/or vitamins                                                        provitamin        and                       ‘Simultaneous supplementation of additives with
                            chemically well-defined substances
                            having similar effects.                          chemically well-                                 a maximum content from other sources to those
                                                                             defined substance                                incorporated in a bolus, if applicable, shall be
                                                                             having        similar                            avoided.
                         The complementary feed may                          effects
                         contain feed additives in a                                                                     Before using, it is recommended to have advice
                         concentration higher than 100                      Daily release rate                               from a veterinarian or nutritionist concerning:
                         times the relevant fixed                            for each trace
                         maximum content in complete                         element        and/or                              (a) the balance of trace elements in the daily
                         feed                                                vitamin if a bolus                                 ration;
                                                                             is used
                                                                                                                                (b) the trace elements status of the herd’
                                                                            Maximum period
                                                                             of     continuously
                                                                             release of the trace
                                                                             element or vitamin
                                                                             if a bolus is used
   60 Reduction of the   Low cations/anions ratio               Dairy cows  Calcium               From 3 weeks    Indicate in the instructions for proper use:
                         For the total ration:                                                     before calving ‘Stop feeding after calving’
      risk of milk fever                                                    Phosphorus
      and subclinical    - Minimum acidification via feed for                                      until calving
                            particular nutritional purpose: 100             Magnesium
      hypocalcaemia
                            mEq/kg dry matter                               Sodium
                         - Objective:                                       Potassium
                            0 < DCAD(17) (mEq/kg dry matter) <
                                                                            Chlorides
                            100
                                                                            Sulphur
                         Or
EN                                                                           17                                                                                                EN
 ---pagebreak---    Zeolite (sodium aluminium silicate):     Sodium aluminium     From 3 weeks        Indicate in the instructions for proper use:
      250 - 500 g / day                       silicate           before calving
                                                                                           ‘The amount of feed shall be restricted to ensure
                                                                 until calving
                                                                                                that a daily intake of 500 g sodium aluminium-
                                                                                                silicate per animal is not exceeded.’
                                                                                           The duration of use shall be restricted to a
                                                                                                maximum of 2 weeks.
                                                                                           ‘Stop feeding after calving’
   Or
   Supply of rumen protected feed            Calcium            From 4 weeks
                                                                            1.       Indicate in the instructions for proper use:
   materials rich in phytic acid (> 6%) and                      before calving
                                                                                  2. ‘Stop feeding after calving’
   having a calcium content < 0.2%, to                           until calving
   achieve a minimum of 28 g and a
   maximum of 32 g available calcium per
   cow per day.
   Or
   High level of calcium in the form of      Calcium            From first signs    1. Application in the form of bolus is allowed. A bolus
   highly available sources of calcium:                          of parturition to      may contain up to 20 % iron in an inert, non-
                                             Calcium sources
   calcium chloride and/or calcium sulfate                       two days               bioavailable form, in order to increase its density.
   and/or dicalcium phosphate and/or                             Subsequent to       2. Indicate in the instructions for proper use the number of
   calcium carbonate and/or calcium                              parturition            applications and the time before and after calving.
   propionate and/or calcium formate.
   and/or “any other calcium source                                                  3. Indicate on the labelling: ‘It is recommended that a
                                                                                        nutritional expert's opinion be sought before use’.
   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 pidolate in a minimum of 5.5g     Calcium            From first signs    1. Application in the form of bolus is allowed. A bolus
   per cow per day                                               of parturition to      may contain up to 20 % iron in an inert, non-
                                             Calcium pidolate
                                                                 two days               bioavailable form, in order to increase its density.
                                                                 subsequent to       2. Indicate on the labelling: ‘It is recommended that a
                                                                 parturition            nutritional expert's opinion be sought before use’.
   Or
   Waxy-leaf nightshade meal allowing a      Waxy-leaf          From two days       1. Application in the form of bolus is allowed. A bolus
   daily release of 38 - 46 µg 1,25            nightshade meal   before calving         may contain up to 20 % iron in an inert, non-
   dihydroxycholecalciferol-glycoside per                        or first signs of      bioavailable form, in order to increase its density.
                                             Content of 1,25
   day                                                           parturition     to  2. Indicate on the labelling: ‘It is recommended that a
                                               dihydroxycholecal
                                                                 ten           days     nutritional expert's opinion be sought before use’.
                                               ciferol-glycoside
                                                                 subsequent to
EN                                             18                                                                                                EN
 ---pagebreak---                                                                              Crude fibre           parturition
                                                                             Magnesium
                                                                             Crude fat
                                                                             Starch
                                                                             Vitamin D3 (total)
                                                                              as cholecalciferol
   61 Reduction of the     Minimum supply of propane-1,2-      Dairy cows,  Propane-1,2-diol,     Between three     1. Application in the form of bolus is allowed. A bolus
      risk of ketosis(18)    diol or propylene glycol:          ewes and      if added              weeks before         may contain up to 20 % iron in an inert, non-
                              250 g/day for dairy cows          goats        Propionates in the    and six weeks        bioavailable form, in order to increase its density.
                                                                              form of sodium or     after calving for 2. Indicate on the labelling: 'During the supply of calcium
                              50 g/day for ewes or goats
                                                                              calcium salts, if                          or sodium propionates at the end of gestation, an
                          Or                                                                        dairy cows
                                                                              added                                      evaluation of the mineral equilibrium in association
                           Minimum supply of propionates                                           Between six          with the risk of hypocalcaemie after parturition is
                             (calcium or sodium salts) :                                            weeks before         necessary.'
                              110 g/day for dairy cows                                              and three weeks
                              22 g/day for ewes or goats                                            after parturition
                          Or                                                                        for ewes and
                                                                                                    goats
                           Minimum combined supply of
                             propane-1,2-diol and propionates
                             (sodium or calcium salts), as long
                             as:
                             — The combination of propane-
                                  1,2-diol and propionates for
                                  dairy cows is such that
                                  propionates + 0.44 x propane-
                                  1,2 diol > 110 g/day
                             — The combination of propane-
                                  1,2-diol and propionates for
                                  ewes or goats is such that
                                  propionates + 0.44 x propane-
                                  1,2 diol > 22 g/day
   62 Reduction of         High level magnesium                Pigs         Magnesium             1 to 7 days       Guidance shall be provided on the situation in which the
      stress reactions    And/or                                             Highly digestible                       use of this feed is appropriate.
                           Highly digestible ingredients                     ingredients
                                                                              including      their
                                                                              treatment          if
                                                                              appropriate
                                                                             Content of n-3
EN                                                                            19                                                                                                 EN
 ---pagebreak---                                                                                   fatty acids       (if
                                                                                  added)
   63 Reduction of the    Ingredients stimulating intestinal      Sows        Ingredients               10 to 14 days
      risk of             passage                                             stimulating intestinal    before and 10 to
      constipation                                                            passage                   14 days after
                                                                                                        farrowing
   64 Compensation for    High level of iron compounds            Suckling    Iron (total)              After birth up to The instructions for proper use shall ensure that the legal
      insufficient iron   authorised under the functional group   piglets and                           3 weeks           maximum contents of iron for complete feed are respected.
      availability after  "compounds of trace elements" of the    calves
      birth               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.
   65 Compensation for    Low level of saturated fatty acids and  Poultry      Percentage of           During the first
      malabsorption       high level of fat soluble vitamins      excluding       saturated fatty       2 weeks after
                                                                  geese and       acids in relation to  hatching
                                                                                  total fatty acids
                                                                  pigeons
                                                                               Vitamin A (total)
                                                                               Vitamin D (total)
                                                                               Vitamin E (total)
                                                                               Vitamin K (total)
   66 Reduction of the    Low energy and high proportion of       Laying hens  Energy value            Up to 12 weeks
      risk of fatty liver metabolisable energy from lipids with                   (calculated
      syndrome            high level of polyunsaturated fatty                     according to EC
                          acids                                                   method)
                                                                               Percentage of
                                                                                  metabolisable
                                                                                  energy from lipids
                                                                               Content of poly-
                                                                                  unsaturated fatty
                                                                                  acids
   67 Support the         High level of selenium and a minimum    Equidae      Vitamin E (total)       Up to 8 weeks     The instructions for proper use for the feed shall ensure that
      preparation for     content of 50 mg vitamin E per kg                    Selenium (total)        before sport      the legal maximum contents of selenium for complete feed
      and recovery from   complete feed with moisture content of                                        effort – Up to 4  are respected.
EN                                                                                20                                                                                                    EN
 ---pagebreak---       sport effort        12 %.                                                                weeks after
                          The complementary feed may contain                                   sport effort
                          compounds of selenium in a
                          concentration higher than 100 times the
                          relevant fixed maximum content in
                          complete feed.
   68 Compensation of     Must contain sodium chloride and         Equines  Sodium            One to three     1. Guidance shall be provided on the situations in which
      electrolyte loss in should contain potassium chloride.                Chlorides         days after heavy    the use of the feed is appropriate.
      the cases of heavy                                                                       sweating.        2. The instructions for proper use must give administration
                          Low levels of Magnesium, Calcium and              Potassium
      sweating            Phosphorus                                                                               guidelines based on the duration and intensity of
                                                                            Calcium                               exercise performed relevant to the formulation and
                          The inclusion of other electrolyte salts          Magnesium                             presentation of the feed.
                          is optional.
                                                                            Phosphorus                         3. Indicate on the labelling:
                                                                                                                      ‘Water should be available at all times.’
                                                                                                                      In the case of the administration of electrolytes
                                                                                                                          not mixed with water (e.g. in feed or in syringe
                                                                                                                          format): ‘Water must be available for at least 20
                                                                                                                          minutes or preferably for 1 hour post
                                                                                                                          administration.’
                                                                                                                4. Furthermore guidance must be given to monitor
                                                                                                                   subsequent drinking, if insufficient water intake is
                                                                                                                   observed veterinary advice should be sought.
                                                                                                                5. Guidance may optionally be given regarding the
                                                                                                                   quantity of water (in litres) to be provided alongside in
                                                                                                                   feed or syringed electrolytes.
   69 Support of energy   Starch and sugar not more than 20% of    Equines  Starch            Initially for a  1. Guidance shall be provided on the situations in which
      metabolism and      available energy.                                 Sugar             minimum of 3        the use of this feed is appropriate.
      of the muscle                                                                            months           2. The instructions for proper use shall contain guidance
                          Crude fat more than 20% of available              Crude fat
      function in the     energy                                                                                   on the balance of the daily ration and the appropriate
      case of                                                               Vitamin E (total)                     daily intake.
      rhabdomyolosis      Minimum of 350 IU Vitamin E / kg
                          complete feed with a moisture content                                                 3. Indicate on the labelling: 'It is recommended that a
                          of 12%                                                                                   veterinarian's opinion be sought before use.'
   70 Compensation for     Starch content to provide < 1 g / kg            Starch            Long term or     1. Guidance shall be provided
      chronic digestive       BW / meal (< 0,5 g / kg BW / meal,            Crude fat         until resolution       on the precise situations in which the use of the
      disorders of large      if diarrhoea present)                                            of the issue               feed is appropriate, in particular whether the
      intestine                                                    Equines
                           Cereal grains processed via a                                                                 product is for use in animals with concurrent
                              hydrothermal treatment, such as                                                             diarrhoea or not.
                              extrusion, micronisation, expansion                                                     on meal size and forage intake.
EN                                                                           21                                                                                             EN
 ---pagebreak---                                                or flaking, to improve small                                                                         2. The instructions for proper use shall refer, depending on
                                               intestinal starch digestion                                                                               the oil content, to the potential gradual use and suggest
                                            Additional supply of water soluble                                                                          a monitoring for diarrhoea.
                                               vitamins          and         adequate                                                               3. Indicate on the labelling the processing used for the
                                               minerals/electrolytes levels                                                                              cereal grains.
                                            Additional supply of oil if no
                                               diarrhoea
            71      Compensation for        Highly digestible fibres                    Equines         Highly digestible        Long term or     1. Guidance shall be provided on
                    chronic                 High quality protein sources and                               feed materials         until resolution         the precise situations in which the use of the feed
                    insufficiency of           lysine > 4.3 % of crude protein                              including their        of the issue                 is appropriate
                    small intestine                                                                         processing, if
                                            Total sugar and starch to provide a                                                                            meal size and forage intake.
                    function                                                                                appropriate.
                                               maximum of 0.5 g / kg BW / meal                                                                      2. The instructions for proper use shall refer, depending on
                                                                                                         Total sugar and
                                            Cereal grains processed via a                                                                               the oil content, to the potential gradual use and suggest
                                                                                                            starch                                       a monitoring for diarrhoea.
                                               hydrothermal treatment, such as
                                               extrusion, micronisation, expansion                       Protein sources
                                               or flaking, to improve pre-caecal
                                               digestion
            72      Stabilisation of       Feed additives of the functional group        Animal         Name and added             Up to 4 weeks    1. Indicate on the labelling:
                    the physiological      ‘Gut flora stabiliser’ as referred to in      species for    amount of the gut                              ‘In case of risk of, during periods of, or recovery from
                    digestion              Annex I to Regulation (EC) No                 which the      flora stabiliser or                            digestive disturbance’.
                                           1831/2003 or, pending the re-                 gut flora      micro- organism
                                                                                                                                                    2. The instructions for proper use of the feed shall ensure
                                           authorisation procedure as referred to in     stabiliser or
                                                                                                                                                         that the legal maximum content of the gut flora
                                           Article 10 of Regulation (EC) No 1831/        micro-
                                                                                                                                                         stabiliser or micro-organism for complete feed is
                                           2003, feed additives of the group             organism is
                                                                                                                                                         respected.
                                           ‘micro-organisms’                             authorised
  (GP1)
         For the control of the quantitative indications, the tolerances as established in Annex IV of Regulation (EC) No 767/2009 apply.
  (GP2)
         These labelling declarations apply in addition to the general labelling requirements laid down in Regulation (EC) No 767/2009
  (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 properties and/or properties of prevention of crystal precipitation and growth.
  (8)
      Urine pH < 6.5.
  (9)
      Metastabilising properties: urine associated with properties of prevention of crystal precipitation.
  (10)
       ‘exocrine pancreatic insufficiency’ may be added.
EN                                                                                                          22                                                                                                    EN
 ---pagebreak---   (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 (2019) Nutritional Guidelines for Complete and Complementary Pet Food for Cats and Dogs.
  (14)
       FEDIAF (2019) 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 dry matter) = (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].
EN                                                                                                     23                                                                                                EN