Annex

Part B of Annex I to Directive 2008/38/EC is amended as follows:

1. (a)

   The row of the particular nutritional purpose ‘support of heart function in the case of chronic cardiac insufficiency’ is replaced by the following:

   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   ‘Support of heart function in the case of chronic cardiac insufficiency	Level of sodium restricted to be lower than 2,6 g/kg complete pet food with a moisture content of 12 %	Dogs and cats	Magnesium Potassium Sodium	Initially up to 6 months	The feed shall be placed on the market as complete feed. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.”’

2. (b)

   The row of the particular nutritional purpose ‘support of renal function in case of chronic renal insufficiency’ is replaced by the following:

   If appropriate the manufacturer may also recommend use for temporary renal insufficiency.
   If the feed is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.’
   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   ‘Support of renal function in case of chronic renal insufficiencyf1	High quality proteins and restricted levels of phosphorus maximum 5 g/kg complete pet food with a moisture content of 12 % and crude protein maximum 220 g/kg complete pet food with a moisture content of 12 % or	Dogs	Protein source(s) Calcium Phosphorus Potassium Sodium Content of essential fatty acids (if added)	Initially up to 6 monthsf2	The feed shall be placed on the market as complete feed. Recommended digestibility of proteins: minimum 85 %. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” Indicate in the instructions for use: “Water should be available at all times.”
   	Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate	Adult dogs	Protein source(s) Calcium Phosphorus Potassium Sodium Content of essential fatty acids (if added) Lanthanum carbonate octahydrate	Initially up to 6 months	Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” Indicate in the instructions for use: “Water should be available at all times.”
   	High quality proteins and restricted levels of phosphorus maximum 6,2 g/kg complete pet food with a moisture content of 12 % and crude protein maximum 320 g/kg complete pet food with a moisture content of 12 % or	Cats	Protein source(s) Calcium Phosphorus Potassium Sodium Content of essential fatty acids (if added)	Initially up to 6 months	The feed shall be placed on the market as complete feed. Recommended digestibility of proteins: minimum 85 %. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” Indicate in the instructions for use: “Water should be available at all times.”
   	Reduced phosphorus absorption by means of incorporation of Lanthanum carbonate octahydrate	Adult cats	Protein source(s) Calcium Phosphorus Potassium Sodium Content of essential fatty acids (if added) Lanthanum carbonate octahydrate	Initially up to 6 months	Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.” Indicate in the instructions for use: “Water should be available at all times.”

3. (c)

   The row of the particular nutritional purpose ‘reduction of copper in the liver’ is replaced by the following:

   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   ‘Reduction of copper in the liver	Restricted level of copper: maximum 8,8 mg/kg complete pet food with a moisture content of 12 %	Dogs	Total copper	Initially up to 6 months	The feed shall be placed on the market as complete feed. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.”’

4. (d)

   The row of the particular nutritional purpose ‘reduction of iodine levels in feed in case of hyperthyroidism’ is replaced by the following:

   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   ‘Reduction of iodine levels in feed in case of hyperthyroidism	Restricted level of iodine: maximum 0,26 mg/kg complete pet food with a moisture content of 12 %	Cats	Total iodine	Initially up to 3 months	The feed shall be placed on the market as complete feed. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.”’

5. (e)

   The row for the particular nutritional purpose ‘stabilisation of water and electrolyte balance’ is replaced by the following:

   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]'
   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   'Stabilisation of water and electrolyte balance to support the physiological digestion	Predominantly electrolytes: sodium, potassium and chlorides Buffering capacityf3: minimum 60 mmol per litre potion ready prepared for feeding Easily digestible carbohydrates	Calves, pigs, lambs, kids and foals	Sodium Potassium Chlorides Carbohydrate source(s) Bicarbonates and/or citrates (if added)	1 to 7 days	Recommended range of electrolytes per litre potion ready prepared for feeding: Sodium: 1,7 g – 3,5 g Potassium: 0,4 g – 2,0 g Chlorides: 1 g – 2,8 g Indicate on the labelling: (1) ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’ (2) ‘It is recommended that advice from a veterinarian be sought before use and before extending the period of use.’ Indicate in the instructions for use: (1) The recommended intake of the ready stirred potion and of milk, if appropriate. (2) In case of bicarbonates and/or citrates are above 40 mmol per litre potion ready prepared for feeding: ‘Simultaneous feeding of milk should be avoided in animals with abomasum’

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6. (f)

   The row of the particular nutritional purpose ‘nutritional restoration, convalescence’, species or category of animals ‘Dogs’ is replaced by the following:

   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   	‘The complementary feed may contain Enterococcus faecium DSM 10663/NCIMB 10415 in a concentration higher than 100 times the relevant fixed maximum content in complete feed.	Dogs	Enterococcus faecium DSM 10663/NCIMB 10415 including added amount	10 to 15 days	The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser//micro-organism for complete feed is respected. Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.”’

7. (g)

   The row of the particular nutritional purpose ‘stabilisation of physiological digestion’, species or category of animals ‘Animal species for which the gut flora stabiliser is authorised’ is replaced by the following

   Particular nutritional purpose	Essential nutritional characteristics	Species or category of animal	Labelling declarations	Recommended length of time	Other provisions
   	'Feed additives of the functional group ‘Gut flora stabiliser’ of the category ‘zootechnical additives’ as referred to in Annex I to Regulation (EC) No 1831/2003 or,pending the re-authorisation procedure as referred to in Article 10 of Regulation (EC) No 1831/2003, feed additives of the group ‘micro-organisms’. The complementary feed may contain feed additives of the functional group of ‘gut flora stabilisers/micro-organisms’ in a concentration higher than 100 times the relevant fixed maximum content in complete feed.	Animal species for which the gut flora stabiliser/micro-organism is authorised	Name and added amount of the gut flora stabiliser/micro-organism	Up to 4 weeks	Indicate on the labelling of the feed: (1) ‘In case of risk of, during periods of, or recovery from digestive disturbance.’ (2) If applicable: ‘The feed contains a gut flora stabiliser/micro-organism in a concentration above 100 times the authorised maximum content in complete feed.’ The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser/micro-organism for complete feed is respected.'