title: Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (Codified version) (Text with EEA relevance )

text:
               6.3.2008

               EN

               Official Journal of the European Union

               L 62/9

      COMMISSION DIRECTIVE 2008/38/EC
   of 5 March 2008
   establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes
   (Text with EEA relevance)
   (Codified version)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (1), and in particular Article 6(a) thereof,
   Whereas:

               (1)

               Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Directive 93/74/EEC provides for the establishment of a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes. That list must indicate the precise use, that is to say, the particular nutritional purpose, the essential nutritional characteristics, the labelling declarations and where appropriate the special labelling requirements.

               (3)

               Certain nutritional purposes cannot be included at present in the list of intended uses due to the absence of Community methods of control for the energy value in pet foods and for dietary fibre in feedingstuffs. This list must be completed as soon as these methods have been adopted.

               (4)

               The established list may be modified, where appropriate, following developments in scientific and technical knowledge.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

               (6)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of Annex I to this Directive and if they fulfil the other provisions laid down in that Part of Annex I.
   Furthermore, the Member States shall ensure that the provisions under ‘General provisions’ of Part A of Annex I are complied with.
   Article 2
   Directive 94/39/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
   Article 3
   This Directive shall enter into force on 31 July 2008.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 5 March 2008.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 237, 22.9.1993, p. 23. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

      (2)  OJ L 207, 10.8.1994, p. 20. Directive as last amended by Directive 2008/4/EC (OJ L 6, 10.1.2008, p. 4).

      (3)  See Annex II, part A.

      ANNEX I
      PART A
      General provisions

                  1.

                  Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4.

                  2.

                  Where a group of additives is mentioned in column 2 or column 4 of Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the Council (1) as corresponding to the specified essential characteristic.

                  3.

                  Where the source(s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient(s), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics.

                  4.

                  Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression ‘total’ the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC (2), the total quantity of the substance naturally present and the amount added as an additive.

                  5.

                  The declarations required in column 4 of Part B with the reference ‘if added’ are compulsory where the ingredient or the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose.

                  6.

                  The declarations to be given in accordance with column 4 of Part B concerning analytical constituents and additives must be quantitative.

                  7.

                  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.

                  8.

                  Where a feedingstuff is intended to meet more than one particular nutritional purpose, it must comply with the corresponding entries in Part B.

                  9.

                  In the case of complementary feedingstuffs intended for particular nutritional purposes guidance on the balance of the daily ration must be provided in the instructions for use contained on the label.

            PART B
      List of intended uses

                  Particular nutritional purpose

                  Essential nutritional characteristics

                  Species or category of animals

                  Labelling declarations

                  Recommended length of time

                  Other provisions

                  (1)

                  (2)

                  (3)

                  (4)

                  (5)

                  (6)

                  Support of renal function in the case of chronic renal insufficiency (3)

                  Low level of phosphorus and restricted level of protein but of high quality

                  Dogs and cats

                              —

                              Protein source(s)

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Potassium

                              —

                              Sodium

                              —

                              Content of essential fatty acids (if added)

                  Initially up to 6 months (4)

                  Indicate on the package, container or label:

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

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

                  Dissolution of struvite stones (5)

                              —

                              Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality

                  Dogs

                              —

                              Protein source(s)

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Urine acidifying substances

                  5 to 12 weeks

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

                  Indicate on the package, container or label:

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

                              —

                              Urine acidifying properties and low level of magnesium

                  Cats

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Total taurine

                              —

                              Urine acidifying substances

                  Reduction of struvite stone recurrence (5)

                  Urine acidifying properties and moderate level of magnesium

                  Dogs and cats

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Urine acidifying substances

                  Up to 6 months

                  Indicate on the package, container or label:

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

                  Reduction of urate stones formation

                  Low level of purines, low level of protein but of high quality

                  Dogs and cats

                  Protein source(s)

                  Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism

                  Indicate on the package, container or label:

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

                  Reduction of oxalate stones formation

                  Low level of calcium, low level of vitamin D, and urine alkalising properties

                  Dogs and cats

                              —

                              Phosphorus

                              —

                              Calcium

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Total vitamin D

                              —

                              Hydroxyproline

                              —

                              Urine alkalising substances

                  Up to 6 months

                  Indicate on the package, container or label:

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

                  Reduction of cystine stones formation

                  Low level of protein, moderate level of sulphur amino acids and urine alkalising properties

                  Dogs and cats

                              —

                              Total sulphur amino acids

                              —

                              Sodium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Urine alkalising substances

                  Initially up to 1 year

                  Indicate on the package, container or label:

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

                  Reduction of ingredient and nutrient intolerances (6)

                              —

                              Selected protein source(s)

                  Dogs and cats

                              —

                              Protein source(s)

                              —

                              Content of essential fatty acids (if added)

                  3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely

                  and/or

                              —

                              Selected carbohydrate source(s)

                              —

                              Carbohydrate source(s)

                              —

                              Content of essential fatty acids (if added)

                  Reduction of acute intestinal absorptive disorders

                  Increased level of electrolytes and highly digestible ingredients

                  Dogs and cats

                              —

                              Highly digestible ingredients including their treatment if appropriate

                              —

                              Sodium

                              —

                              Potassium

                              —

                              Source(s) of mucilaginous substances (if added)

                  1 to 2 weeks

                  Indicate on the package, container or label:

                                 —

                                 ‘During periods of and recovery from acute diarrhoea.’

                                 —

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

                  Compensation for maldigestion (7)

                  Highly digestible ingredients and low level of fat

                  Dogs and cats

                  Highly digestible ingredients including their treatment if appropriate

                  3 to 12 weeks, but lifetime in the case of chronic pancreatic insufficiency

                  Indicate on the package, container or label:

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

                  Support of heart function in the case of chronic cardiac insufficiency

                  Low level of sodium and increased K/Na ratio

                  Dogs and cats

                              —

                              Sodium

                              —

                              Potassium

                              —

                              Magnesium

                  Initially up to 6 months

                  Indicate on the package, container or label:

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

                  Regulation of glucose supply (Diabetes mellitus)

                  Low level of rapid glucose-releasing carbohydrates

                  Dogs and cats

                              —

                              Carbohydrate source(s)

                              —

                              Treatment of carbohydrates if appropriate

                              —

                              Starch

                              —

                              Total sugar

                              —

                              Fructose (if added)

                              —

                              Content of essential fatty acids (if added)

                              —

                              Source(s) of short and medium chain fatty acids (if added)

                  Initially up to 6 months

                  Indicate on the package, container or label:

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

                  Support of liver function in the case of chronic liver insufficiency

                              —

                              High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates

                  Dogs

                              —

                              Protein source(s)

                              —

                              Content of essential fatty acids

                              —

                              Highly digestible carbohydrates including their treatment if appropriate

                              —

                              Sodium

                              —

                              Total copper

                  Initially up to 6 months

                  Indicate on the package, container or label:

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

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

                              —

                              High quality protein, moderate level of protein and high level of essential fatty acids

                  Cats

                              —

                              Protein source(s)

                              —

                              Content of essential fatty acids

                              —

                              Sodium

                              —

                              Total copper

                  Initially up to 6 months

                  Indicate on the package, container or label:

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

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

                  Regulation of lipid metabolism in the case of hyperlipidaemia

                  Low level of fat and high level of essential fatty acids

                  Dogs and cats

                              —

                              Content of essential fatty acids

                              —

                              Content of n-3 fatty acids (if added)

                  Initially up to 2 months

                  Indicate on the package, container or label:

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

                  Reduction of copper in the liver

                  Low level of copper

                  Dogs

                  Total copper

                  Initially up to 6 months

                  Indicate on the package, container or label:

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

                  Reduction of excessive body weight

                  Low energy density

                  Dogs and cats

                  Energy value

                  Until target body weight is achieved

                  In the instructions for use an appropriate daily intake must be recommended.

                  Nutritional restoration, convalescence (8)

                  High energy density, high concentrations of essential nutrients and highly digestible ingredients

                  Dogs and cats

                              —

                              Highly digestible ingredients, including their treatment if appropriate

                              —

                              Energy value

                              —

                              Content of n-3 and n-6 fatty acids (if added)

                  Until restoration is achieved

                  In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:

                     ‘Administration under veterinary supervision.’

                  Support of skin function in the case of dermatosis and excessive loss of hair

                  High level of essential fatty acids

                  Dogs and cats

                  Content of essential fatty acids

                  Up to 2 months

                  Indicate on the package, container or label:

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

                  Reduction of the risk of milk fever

                              —

                              Low level of calcium

                  Dairy cows

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Magnesium

                  1 to 4 weeks before calving

                  Indicate in the instructions for use:

                     ‘Stop feeding after calving’

                  and/or

                              —

                              Low cations/anions ratio

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Sodium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                  1 to 4 weeks before calving

                  Indicate in the instructions for use:

                     ‘Stop feeding after calving’

                  or

                              —

                              High level of zeolite (synthetic sodium aluminium silicate)

                  Content of synthetic sodium aluminium silicate

                  The 2 weeks before calving

                  Indicate in the instructions for use:

                                 —

                                 ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’

                                 —

                                 ‘Stop feeding after calving’

                  or

                              —

                              High level of calcium in the form of highly available calcium salts

                  Total calcium content, sources and respective quantity of calcium

                  Star at first signs of parturition to two days subsequent to parturition

                  Indicate on the package, container or label:

                              —

                              The instruction of use i.e. the number of applications and the time before and after calving.

                              —

                              The text ‘It is recommended that a nutritional expert's opinion be sought before use’

                  Reduction of the risk of ketosis (9)
                      (10)

                  Ingredients providing glucogenic energy sources

                  Dairy cows and ewes

                              —

                              Ingredients providing glucogenic energy sources

                              —

                              Propan-1,2-diol (if added as a glucose precursor)

                              —

                              Glycerol (if added as a glucose precursor)

                  3 to 6 weeks after calving (11)

                  Last 6 weeks before and the first 3 weeks after lambing (12)

                  Reduction of the risk of tetany (hypomagnesaemia)

                  High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium

                  Ruminants

                              —

                              Starch

                              —

                              Total sugars

                              —

                              Magnesium

                              —

                              Sodium

                              —

                              Potassium

                  3 to 10 weeks during periods of fast grass growth

                  In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily available energy sources.
                  In the case of feedingstuffs for ovines indicate on the package, container or label:

                     ‘Especially for lactating ewes.’

                  Reduction of the risk of acidosis

                  Low level of easily fermentable carbohydrates and high buffering capacity

                  Ruminants

                              —

                              Starch

                              —

                              Total sugars

                  Maximum 2 months (13)

                  In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily fermentable carbohydrate sources.
                  In the case of feedingstuffs for dairy cows indicate on the package, container or label:

                     ‘Especially for high yielding cows.’

                  In the case of feedingstuffs for ruminants for fattening indicate on the package, container or label:

                     ‘Especially for intensively fed.’ (14)

                  Stabilisation of water and electrolyte balance

                  Predominantly electrolytes and easily absorbable carbohydrates

                  Calves
                  Piglets
                  Lambs
                  Kids
                  Foals

                              —

                              Carbohydrate source(s)

                              —

                              Sodium

                              —

                              Potassium

                              —

                              Chlorides

                  1 to 7 days (1 to 3 days if fed exclusively)

                  Indicate on the package, container or label:

                                 —

                                 ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’

                                 —

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

                  Reduction of the risk of urinary calculi

                  Low level of phosphorus, magnesium, and urine acidifying properties

                  Ruminants

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Sulphur

                              —

                              Urine acidifying substances

                  Up to 6 weeks

                  Indicate on the package, container or label:

                     ‘Especially for intensively fed young animals.’

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

                  Reduction of stress reactions

                              —

                              High level magnesium

                  Pigs

                              —

                              Magnesium

                  1 to 7 days

                  Guidance shall be provided on the situation in which the use of this feed is appropriate.

                  and/or

                              —

                              Highly digestible ingredients

                              —

                              Highly digestible ingredients including their treatment if appropriate

                              —

                              Content of n-3 fatty acids (if added)

                  Stabilisation of physiological digestion

                              —

                              Low buffering capacity, and highly digestible ingredients

                  Piglets

                              —

                              Highly digestible ingredients including their treatment if appropriate

                              —

                              Buffering capacity

                              —

                              Source(s) of astringent substances (if added)

                              —

                              Source(s) of mucilaginous substances (if added)

                  2 to 4 weeks

                  Indicate on the package, container or label:

                     ‘In case of risk of, during periods of, or recovery from, digestive disturbance.’

                              —

                              Highly digestible ingredients

                  Pigs

                              —

                              Highly digestible ingredients including their treatment if appropriate

                              —

                              Source(s) of astringent substances (if added)

                              —

                              Source(s) of mucilaginous substances (if added)

                  Reduction of the risk of constipation

                  Ingredients stimulating intestinal passage

                  Sows

                  Ingredients stimulating intestinal passage

                  10 to 14 days before and 10 to 14 days after farrowing

                  Reduction of the risk of fatty liver syndrome

                  Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids

                  Laying hens

                              —

                              Energy value (calculated according to EC method)

                              —

                              Percentage of metabolisable energy from lipids

                              —

                              Content of poly-unsaturated fatty acids

                  Up to 12 weeks

                  Compensation for malabsorption

                  Low level of saturated fatty acids and high level of fat soluble vitamins

                  Poultry excluding geese and pigeons

                              —

                              Percentage of saturated fatty acids in relation to total fatty acids

                              —

                              Total vitamin A

                              —

                              Total vitamin D

                              —

                              Total vitamin E

                              —

                              Total vitamin K

                  During the first 2 weeks after hatching

                  Compensation for chronic insufficiency of small intestine function

                  Highly precaecally digestible carbohydrates proteins and fats

                  Equines (15)

                              —

                              Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate

                  Initially up to six months

                  Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which it should be fed including many small meals per day.
                  Indicate on the package, container or label:

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

                  Compensation for chronic digestive disorders of large intestine

                  Highly digestible fibre

                  Equines

                              —

                              Fibre source(s)

                              —

                              Content of n-3 fatty acids (if added)

                  Initially up to six months

                  Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which the feed should be fed.
                  Indicate on the package, container or label:

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

                  Reduction of stress reactions

                  Highly digestible ingredients

                  Equines

                              —

                              Magnesium

                              —

                              Highly digestible ingredients including their treatment if appropriate

                              —

                              Content of n-3 fatty acids (if added)

                  Two to four weeks

                  Guidance shall be provided on the precise situations in which the use of the feed is appropriate.

                  Compensation of electrolyte loss in the cases of heavy sweating

                  Predominantly electrolytes and easily absorbable carbohydrates

                  Equines

                              —

                              Calcium

                              —

                              Sodium

                              —

                              Magnesium

                              —

                              Potassium

                              —

                              Chlorides

                              —

                              Glucose

                  One to three days

                  Guidance shall be provided on the situations in which the use of the feed is appropriate.
                  When the feed corresponds to a significant part of the daily ration, guidance should be provided to prevent the risk of abrupt changes in the nature of the feed.
                  Indicate on the instructions for use:

                     ‘Water should be available at all times.’

                  Nutritional restoration, convalescence

                  High concentration of essential nutrients and highly digestible ingredients

                  Equines

                              —

                              Highly digestible ingredients, including their treatment if appropriate

                              —

                              Content of n-3 and n-6 fatty acids (if added)

                  Until restoration is achieved

                  Guidance shall be provided on the situations in which the use of the feed is appropriate.
                  In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:

                     ‘Administration under veterinary supervision.’

                  Support of liver function in the case of chronic liver insufficiency

                  Low level of protein but of high quality and highly digestible carbohydrates

                  Equines

                              —

                              Protein and fibre sources

                              —

                              Highly digestible carbohydrates including their treatment if appropriate

                              —

                              Methionine

                              —

                              Choline

                              —

                              Content of n-3 fatty acids (if added)

                  Initially up to six months

                  Guidance should be provided on the manner in which the feed should be fed including many small meals per day.
                  Indicate on the package, container or label:

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

                  Support of renal function in the case of chronic renal insufficiency

                  Low level of protein but of high quality and low level of phosphorus

                  Equines

                              —

                              Protein source(s)

                              —

                              Calcium

                              —

                              Phosphorus

                              —

                              Potassium

                              —

                              Magnesium

                              —

                              Sodium

                  Initially up to six months

                  Indicate on the package, container or label:

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

                  Indicate in the instructions for use:

                     ‘Water should be available at all times.’

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  OJ L 270, 14.12.1970, p. 1.

         (3)  If appropriate the manufacturer may also recommend use of temporary renal insufficiency.

         (4)  If the feedingstuff is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.

         (5)  In the case of feedingstuffs for cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome — FUS’ may complete the particular nutritional purpose.

         (6)  In the case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace ‘ingredient and nutrient’.

         (7)  The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine pancreatic insufficiency’.

         (8)  In the case of feedingstuffs for cats, the manufacturer may complete the particular nutritional purpose with a reference to ‘Feline hepatic lipidosis’.

         (9)  The term ‘ketosis’ may be replaced by ‘acetonaemia’.

         (10)  The manufacturers may also recommend the use for ketosis recuperation.

         (11)  In the case of feedingstuffs for dairy cows.

         (12)  In the case of feedingstuffs for ewes.

         (13)  In the case of feedingstuffs for dairy cows: ‘maximum two months from the start of lactation’.

         (14)  Indicate the category of ruminants concerned.

         (15)  In the case of feedingstuffs specially prepared to meet the specific conditions of very old animals (easily ingestible ingredients) a reference to ‘old animals’ shall complete the indication of the species or category of animals.

      ANNEX II
      PART A
      Repealed Directive with list of its successive amendments
      (referred to in Article 2)

                  Commission Directive 94/39/EC

                  (OJ L 207, 10.8.1994, p. 20)

                  Commission Directive 95/9/EC

                  (OJ L 91, 22.4.1995, p. 35)

                  Commission Directive 2002/1/EC

                  (OJ L 5, 9.1.2002, p. 8)

                  Commission Directive 2008/4/EC

                  (OJ L 6, 10.1.2008, p. 4)

            PART B
      List of time-limits for transposition into national law
      (referred to in Article 2)

                  Directive

                  Time-limit for transposition

                  94/39/EC

                  30 June 1995

                  95/9/EC

                  30 June 1995

                  2002/1/EC

                  20 November 2002

                  2008/4/EC

                  30 July 2008

      ANNEX III
      Correlation table

                  Directive 94/39/EC

                  This Directive

                  Article 1

                  Article 1

                  Article 2

                  —

                  —

                  Article 2

                  Article 3

                  Article 3

                  —

                  Article 4

                  Annex

                  Annex I

                  —

                  Annex II

                  —

                  Annex III


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First Council Directive 77/780/EEC of 12 December 1977 on the coordination of the laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions

Official Journal L 322 , 17/12/1977 P. 0030 - 0037 Greek special edition: Chapter 06 Volume 2 P. 0003  Spanish special edition: Chapter 06 Volume 2 P. 0021  Portuguese special edition Chapter 06 Volume 2 P. 0021  Finnish special edition: Chapter 6 Volume 1 P. 0210  Swedish special edition: Chapter 6 Volume 1 P. 0210

FIRST COUNCIL DIRECTIVE  of 12 December 1977  on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of credit institutions  (77/780/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas, pursuant to the Treaty, any discriminatory treatment with regard to establishment and to the provision of services, based either on nationality or on the fact that an undertaking is not established in the Member States where the services are provided, is prohibited from the end of the transitional period;  Whereas, in order to make it easier to take up and pursue the business of credit institutions, it is necessary to eliminate the most obstructive differences between the laws of the Member States as regards the rules to which these institutions are subject;  Whereas, however, given the extent of these differences, the conditions required for a common market for credit institutions cannot be created by means of a single Directive ; whereas it is therefore necessary to proceed by successive stages ; whereas the result of this process should be to provide for overall supervision of a credit institution operating in several Member States by the competent authorities in the Member State where it has its head office, in consultation, as appropriate, with the competent authorities of the other Member States concerned;  Whereas measures to coordinate credit institutions must, both in order to protect savings and to create equal conditions of competition between these institutions, apply to all of them ; whereas due regard must be had, where applicable, to the objective differences in their statutes and their proper aims as laid down by national laws;  Whereas the scope of those measures should therefore be as broad as possible, covering all institutions whose business is to receive repayable funds from the public whether in the form of deposits or in other forms such as the continuing issue of bonds and other comparable securities and to grant credits for their own account ; whereas exceptions must be provided for in the case of certain credit institutions to which this Directive cannot apply;  Whereas the provisions of this Directive shall not prejudice the application of national laws which provide for special supplementary authorizations permitting credit institutions to carry on specific activities or undertake specific kinds of operations;  Whereas the same system of supervision cannot always be applied to all types of credit institution ; whereas provision should therefore be made for application of this Directive to be deferred in the case of certain groups or types of credit institutions to which its immediate application might cause technical problems ; whereas more specific provisions for such institutions may prove necessary in the future ; whereas these specific provisions should nonetheless be based on a number of common principles;  Whereas the eventual aim is to introduce uniform authorization requirements throughout the Community for comparable types of credit institution ; whereas at the initial stage it is necessary, however, to specify only certain minimum requirements to be imposed by all Member States;  Whereas this aim can be achieved only if the particularly wide discretionary powers which certain supervisory authorities have for authorizing credit establishments are progressively reduced ; whereas the requirement that a programme of operations must be produced should therefore be seen merely as a factor enabling the competent authorities to decide on the basis of more precise information using objective criteria;  (1)OJ No C 128, 9.6.1975, p. 25. (2)OJ No C 263, 17.11.1975, p. 25.    Whereas the purpose of coordination is to achieve a system whereby credit institutions having their head office in one of the Member States are exempt from any national authorization requirement when setting up branches in other Member States;  Whereas a measure of flexibility may nonetheless be possible in the initial stage as regards the requirements on the legal form of credit institutions and the protection of banking names;  Whereas equivalent financial requirements for credit institutions will be necessary to ensure similar safeguards for savers and fair conditions of competition between comparable groups of credit institutions ; whereas, pending further coordination, appropriate structural ratios should be formulated that will make it possible within the framework of cooperation between national authorities to observe, in accordance with standard methods, the position of comparable types of credit institutions ; whereas this procedure should help to bring about the gradual approximation of the systems of coefficients established and applied by the Member States ; whereas it is necessary, however, to make a distinction between coefficients intended to ensure the sound management of credit institutions and those established for the purposes of economic and monetary policy ; whereas, for the purpose of formulating structural ratios and of more general cooperation between supervisory authorities, standardization of the layout of credit institutions' accounts will have to begin as soon as possible;  Whereas the rules governing branches of credit institutions having their head office outside the Community should be analogous in all Member States ; whereas it is important at the present time to provide that such rules may not be more favourable than those for branches of institutions from another Member State ; whereas it should be specified that the Community may conclude agreements with third countries providing for the application of rules which accord such branches the same treatment throughout its territory, account being taken of the principle of reciprocity;  Whereas the examination of problems connected with matters covered by Council Directives on the business of credit institutions requires cooperation between the competent authorities and the Commission within an Advisory Committee, particularly when conducted with a view to closer coordination;  Whereas the establishment of an Advisory Committee of the competent authorities of the Member States does not rule out other forms of cooperation between authorities which supervise the taking up and pursuit of the business of credit institutions and, in particular, cooperation within the Contact Committee set up between the banking supervisory authorities,  HAS ADOPTED THIS DIRECTIVE:    TITLE I Definitions and scope  Article 1 For the purposes of this Directive:    - "credit institution" means an undertaking whose business is to receive deposits or other repayable funds from the public and to grant credits for its own account,       - "authorization" means an instrument issued in any form by the authorities by which the right to carry on the business of a credit institution is granted,       - "branch" means a place of business which forms a legally dependent part of a credit institution and which conducts directly all or some of the operations inherent in the business of credit institutions ; any number of branches set up in the same Member State by a credit institution having its head office in another Member State shall be regarded as a single branch, without prejudice to Article 4 (1),       - "own funds" means the credit institution's own capital, including items which may be treated as capital under national rules.          Article 2 1. This Directive shall apply to the taking up and pursuit of the business of credit institutions.  2. It shall not apply to:    - the central banks of Member States,       - post office giro institutions,       - in Belgium, the communal savings banks ("caisses d'épargne communales - gemeentelijke spaarkassen"), the "Institut de Réescompte et de Garantie - Herdiscontering- en Waarborginstituut", the "Société nationale d'Investissement - Nationale Investeringsmaatschappij", the regional development companies ("sociétés de développement régional - gewestelijke ontwikkelingsmaatschappijen"), the "Société nationale du Logement - Nationale Maatschappij voor de Huisvesting" and its authorized companies and the "Société nationale terrienne - Nationale Landmaatschappij" and its authorized companies,        - in Denmark, the "Dansk Eksportfinansieringsfond" and "Danmarks Skibskreditfond",       - in Germany, the "Kreditanstalt für Wiederaufbau", undertakings which are recognized under the "Wohnungsgemeinnützigkeitsgesetz" (non-profit housing law) as bodies of state housing policy and are not mainly engaged in banking transactions and undertakings recognized under that law as non-profit housing undertakings,       - in France, the "Caisse des Dépôts et Consignations", the "Crédit Foncier" and the "Crédit National",       - in Ireland, credit unions,       - in Italy, the "Cassa Depositi e Prestiti",       - in the Netherlands, the "NV Export-Financieringsmaatschappij", the "Netherlandse Financieringsmaatschappij voor Ontwikkelingslanden NV", the "Nederlandse Investeringsbank voor Ontwikkelingslanden NV", the "Nationale Investeringsbank NV", the "NV Bank van Nederlandse Gemeenten", the "Nederlandse Waterschapsbank NV", the "Financieringsmaatschappij Industrieel Garantiefonds Amsterdam NV", the "Financieringsmaatschappij Industrieel Garantiefonds' s-Gravenhage NV", the "NV Noordelijke Ontwikkelings Maatschappij", the "NV Industriebank Limburgs Instituut voor ontwikkeling en financiering" and the "Overijsselse Ontwikkelingsmaatschappij NV",       - in the United Kingdom, the National Savings Bank, the Commonwealth Development Finance Company Ltd, the Agricultural Mortgage Corporation Ltd, the Scottish Agricultural Securities Corporation Ltd, the Crown Agents for overseas governments and administrations, credit unions, and municipal banks.         3. The Council, acting on a proposal from the Commission, which, for this purpose, shall consult the Committee referred to in Article 11 (hereinafter referred to as "the Advisory Committee") shall decide on any amendments to the list in paragraph 2.  4.    (a) Credit institutions existing in the same Member State at the time of the notification of this Directive and permanently affiliated at that time to a central body which supervises them and which is established in that same Member State, may be exempted from the requirements listed in the first, second and third indents of the first subparagraph of Article 3 (2), the second subparagraph of Article 3 (2), Article 3 (4) and Article 6, if, no later than the date when the national authorities take the measures necessary to translate this Directive into national law, that law provides that:      - the commitments of the central body and affiliated institutions are joint and several liabilities or the commitments of its affiliated institutions are entirely guaranteed by the central body,           - the solvency and liquidity of the central body and of all the affiliated institutions are monitored as a whole on the basis of consolidated accounts,           - the management of the central body is empowered to issue instructions to the management of the affiliated institutions.                  (b) Credit institutions operating locally which are affiliated, subsequent to notification of this Directive, to a central body within the meaning of subparagraph (a) may benefit from the conditions laid down in subparagraph (a) if they constitute normal additions to the network belonging to that central body.       (c) In the case of credit institutions other than those which are set up in areas newly reclaimed from the sea or have resulted from scission or mergers of existing institutions dependent or answerable to the central body, the Council, acting on a proposal from the Commission, which shall, for this purpose, consult the Advisory Committee, may lay down additional rules for the application of subparagraph (b) including the repeal of exemptions provided for in subparagraph (a), where it is of the opinion that the affiliation of new institutions benefiting from the arrangements laid down in subparagraph (b) might have an adverse effect on competition. The Council shall decide by a qualified majority.        5. Member States may defer in whole or in part the application of this Directive to certain types or groups of credit institutions where such immediate application would cause technical problems which cannot be overcome in the short-term. The problems may result either from the fact that these institutions are subject to supervision by an authority different from that normally responsible for the supervision of banks, or from the fact that they are subject to a special system of supervision. In any event, such deferment cannot be justified by the public law statutes, by the smallness of size or by the limited scope of activity of the particular institutions concerned.  Deferment can apply only to groups or types of institutions already existing at the time of notification of this Directive.  6. Pursuant to paragraph 5, a Member State may decide to defer application of this Directive for a maximum period of five years from the notification thereof and, after consulting the Advisory Committee may extend deferment once only for a maximum period of three years.   The Member State shall inform the Commission of its decision and the reasons therefor not later than six months following the notification of this Directive. It shall also notify the Commission of any extension or repeal of this decision. The Commission shall publish any decision regarding deferment in the Official Journal of the European Communities.  Not later than seven years following the notification of this Directive, the Commission shall, after consulting the Advisory Committee, submit a report to the Council on the situation regarding deferment. Where appropriate, the Commission shall submit to the Council, not later than six months following the submission of its report, proposals for either the inclusion of the institutions in question in the list in paragraph 2 or for the authorization of a further extension of deferment. The Council shall act on these proposals not later than six months after their submission.   TITLE II Credit institutions having their head office in a Member State and their branches in other Member States  Article 3 1. Member States shall require credit institutions subject to this Directive to obtain authorization before commencing their activities. They shall lay down the requirements for such authorization subject to paragraphs 2, 3 and 4 and notify them to both the Commission and the Advisory Committee.  2. Without prejudice to other conditions of general application laid down by national laws, the competent authorities shall grant authorization only when the following conditions are complied with:    - the credit institution must possess separate own funds,       - the credit institution must possess adequate minimum own funds,       - there shall be at least two persons who effectively direct the business of the credit institution.         Moreover, the authorities concerned shall not grant authorization if the persons referred to in the third indent of the first subparagraph are not of sufficiently good repute or lack sufficient experience to perform such duties.  3.    (a) The provisions referred to in paragraphs 1 and 2 may not require the application for authorization to be examined in terms of the economic needs of the market.       (b) Where the laws, regulations or administrative provisions of a Member State provide, at the time of notification of the present Directive, that the economic needs of the market shall be a condition of authorization and where technical or structural difficulties in its banking system do not allow it to give up the criterion within the period laid down in Article 14 (1), the State in question may continue to apply the criterion for a period of seven years from notification.  It shall notify its decision and the reasons therefor to the Commission within six months of notification.       (c) Within six years of the notification of this Directive the Commission shall submit to the Council, after consulting the Advisory Committee, a report on the application of the criterion of economic need. If appropriate, the Commission shall submit to the Council proposals to terminate the application of that criterion. The period referred to in subparagraph (b) shall be extended for one further period of five years, unless, in the meantime, the Council, acting unanimously on proposals from the Commission, adopts a Decision to terminate the application of that criterion.       (d) The criterion of economic need shall be applied only on the basis of general predetermined criteria, published and notified to both the Commission and the Advisory Committee and aimed at promoting:      - security of savings,           - higher productivity in the banking system           - greater uniformity of competition between the various banking networks,           - a broader range of banking services in relation to population and economic activity.             Specification of the above objectives shall be determined within the Advisory Committee, which shall begin its work as from its initial meetings.        4. Member States shall also require applications for authorization to be accompanied by a programme of operations setting out inter alia the types of business envisaged and the structural organization of the institution.  5. The Advisory Committee shall examine the content given by the competent authorities to requirements listed in paragraph 2, any other requirements which the Member States apply and the information which must be included in the programme of operations, and shall, where appropriate, make suggestions to the Commission with a view to a more detailed coordination.   6. Reasons shall be given whenever an authorization is refused and the applicant shall be notified thereof within six months of receipt of the application or, should the latter be incomplete, within six months of the applicant's sending the information required for the decision. A decision shall, in any case, be taken within 12 months of the receipt of the application.  7. Every authorization shall be notified to the Commission. Each credit institution shall be entered in a list which the Commission shall publish in the Official Journal of the European Communities and shall keep up to date.   Article 4 1. Member States may make the commencement of business in their territory by branches of credit institutions covered by this Directive which have their head office in another Member State subject to authorization according to the law and procedure applicable to credit institutions established on their territory.  2. However, authorization may not be refused to a branch of a credit institution on the sole ground that it is established in another Member State in a legal form which is not allowed in the case of a credit institution carrying out similar activities in the host country. This provision shall not apply, however, to credit institutions which possess no separate own funds.  3. The competent authorities shall inform the Commission of any authorizations which they grant to the branches referred to in paragraph 1.  4. This Article shall not affect the rules applied by Member States to branches set up on their territory by credit institutions which have their head office there. Notwithstanding the second part of the third indent of Article 1, the laws of Member States requiring a separate authorization for each branch of a credit institution having its head office in their territory shall apply equally to the branches of credit institutions the head offices of which are in other Member States.   Article 5 For the purpose of exercising their activities, credit institutions to which this Directive applies may, notwithstanding any provisions concerning the use of the words "bank", "saving bank" or other banking names which may exist in the host Member State, use throughout the territory of the Community the same name as they use in the Member States in which their head office is situated. In the event of there being any danger of confusion, the host Member State may, for the purposes of clarification, require that the name be accompanied by certain explanatory particulars.   Article 6 1. Pending subsequent coordination, the competent authorities shall, for the purposes of observation and, if necessary, in addition to such coefficients as may be applied by them, establish ratios between the various assets and/or liabilities of credit institutions with a view to monitoring their solvency and liquidity and the other measures which may serve to ensure that savings are protected.  To this end, the Advisory Committee shall decide on the content of the various factors of the observation ratios referred to in the first subparagraph and lay down the method to be applied in calculating them.  Where appropriate, the Advisory Committee shall be guided by technical consultations between the supervisory authorities of the categories of institutions concerned.  2. The observation ratios established in pursuance of paragraph 1 shall be calculated at least every six months.  3. The Advisory Committee shall examine the results of analyses carried out by the supervisory authorities referred to in the third subparagraph of paragraph 1 on the basis of the calculations referred to in paragraph 2.  4. The Advisory Committee may make suggestions to the Commission with a view to coordinating the coefficients applicable in the Member States.   Article 7 1. The competent authorities of the Member States concerned shall collaborate closely in order to supervise the activities of credit institutions operating, in particular by having established branches there, in one or more Member States other than that in which their head offices are situated. They shall supply one another with all information concerning the management and ownership of such credit institutions that is likely to facilitate their supervision and the examination of the conditions for their authorization and all information likely to facilitate the monitoring of their liquidity and solvency.  2. The competent authorities may also, for the purposes and within the meaning of Article 6, lay  down ratios applicable to the branches referred to in this Article by reference to the factors laid down in Article 6.  3. The Advisory Committee shall take account of the adjustments necessitated by the specific situation of the branches in relation to national regulations.   Article 8 1. The competent authorities may withdraw the authorization issued to a credit institution subject to this Directive or to a branch authorized under Article 4 only where such an institution or branch:    (a) does not make use of the authorization within 12 months, expressly renounces the authorization or has ceased to engage in business for more than six months, if the Member State concerned has made no provision for the authorization to lapse in such cases;       (b) has obtained the authorization through false statements or any other irregular means;       (c) no longer fulfils the conditions under which authorization was granted, with the exception of those in respect of own funds;       (d) no longer possesses sufficient own funds or can no longer be relied upon to fulfil its obligations towards its creditors, and in particular no longer provides security for the assets entrusted to it;       (e) falls within one of the other cases where national law provides for withdrawal of authorization.         2. In addition, the authorization issued to a branch under Article 4 shall be withdrawn if the competent authority of the country in which the credit institution which established the branch has its head office has withdrawn authorization from that institution.  3. Member States which grant the authorizations referred to in Articles 3 (1) and 4 (1) only if, economically, the market situation requires it may not invoke the disappearance of such a need as grounds for withdrawing such authorizations.  4. Before withdrawal from a branch of an authorization granted under Article 4, the competent authority of the Member State in which its head office is situated shall be consulted. Where immediate action is called for, notification may take the place of such consultation. The same procedure shall be followed, by analogy, in cases of withdrawal of authorization from a credit institution which has branches in other Member States.  5. Reasons must be given for any withdrawal of authorization and those concerned informed thereof ; such withdrawal shall be notified to the Commission.   TITLE III Branches of credit institutions having their head offices outside the Community  Article 9 1. Member States shall not apply to branches of credit institutions having their head office outside the Community, when commencing or carrying on their business, provisions which result in more favourable treatment than that accorded to branches of credit institutions having their head office in the Community.  2. The competent authorities shall notify the Commission and the Advisory Committee of all authorizations for branches granted to credit institutions having their head office outside the Community.  3. Without prejudice to paragraph 1, the Community may, through agreements concluded in accordance with the Treaty with one or more third countries, agree to apply provisions which, on the basis of the principle of reciprocity, accord to branches of a credit institution having its head office outside the Community identical treatment throughout the territory of the Community.   TITLE IV General and transitional provisions  Article 10 1. Credit institutions subject to this Directive, which took up their business in accordance with the provisions of the Member States in which they have their head offices before the entry into force of the provisions implementing this Directive shall be deemed to be authorized. They shall be subject to the provisions of this Directive concerning the carrying on of the business of credit institutions and to the requirements set out in the first and third indents of the first subparagraph and in the second subparagraph of Article 3 (2).  Member States may allow credit institutions which at the time of notification of this Directive do not comply with the requirement laid down in the third indent of the first subparagraph of Article 3 (2), no more than five years in which to do so.  Member States may decide that undertakings which do not fulfil the requirements set out in the first indent of the first subparagraph of Article 3 (2) and   which are in existence at the time this Directive enters into force may continue to carry on their business. They may exempt such undertakings from complying with the requirement contained in the third indent of the first subparagraph of Article 3 (2).  2. All the credit institutions referred to in paragraph 1 shall be given in the list referred to in Article 3 (7).  3. If a credit institution deemed to be authorized under paragraph 1 has not undergone any authorization procedure prior to commencing business, a prohibition on the carrying on of its business shall take the place of withdrawal of authorization.  Subject to the first subparagraph, Article 8 shall apply by analogy.  4. By way of derogation from paragraph 1, credit institutions established in a Member State without having undergone an authorization procedure in that Member State prior to commencing business may be required to obtain authorization from the competent authorities of the Member State concerned in accordance with the provisions implementing this Directive. Such institutions may be required to comply with the requirement in the second indent of Article 3 (2) and with such other conditions of general application as may be laid down by the Member State concerned.   Article 11 1. An "Advisory Committee of the Competent Authorities of the Member States of the European Economic Community" shall be set up alongside the Commission.  2. The tasks of the Advisory Committee shall be to assist the Commission in ensuring the proper implementation of both this Directive and Council Directive 73/183/EEC of 28 June 1973 on the abolition of restrictions on freedom of establishment and freedom to provide services in respect of self-employed activities of banks and other financial institutions (1) in so far as it relates to credit institutions. Further it shall carry out the other tasks prescribed by this Directive and shall assist the Commission in the preparation of new proposals to the Council concerning further coordination in the sphere of credit institutions.  3. The Advisory Committee shall not concern itself with concrete problems relating to individual credit institutions.  4. The Advisory Committee shall be composed of not more than three representatives from each Member State and from the Commission. These representatives may be accompanied by advisers from time and subject to the prior agreement of the Committee. The Committee may also invite qualified persons and experts to participate in its meetings. The secretariat shall be provided by the Commission.  5. The first meeting of the Advisory Committee shall be convened by the Commission under the chairmanship of one of its representatives. The Advisory Committee shall then adopt its rules of procedure and shall elect a chairman from among the representatives of Member States. Thereafter it shall meet at regular intervals and whenever the situation demands. The Commission may ask the Committee to hold an emergency meeting if it considers that the situation so requires.  6. The Advisory Committee's discussions and the outcome thereof shall be confidential except when the Committee decides otherwise.   Article 12 1. Member States shall ensure that all persons now or in the past employed by the competent authorities are bound by the obligation of professional secrecy. This means that any confidential information which they may receive in the course of their duties may not be divulged to any person or authority except by virtue of provisions laid down by law.  2. Paragraph 1 shall not, however, preclude communications between the competent authorities of the various Member States, as provided for in this Directive. Information thus exchanged shall be covered by the obligation of professional secrecy applying to the persons now or in the past employed by the competent authorities receiving the information.  3. Without prejudice to cases covered by criminal law, the authorities receiving such information shall use it only to examine the conditions for the taking up and pursuit of the business of credit institutions, to facilitate monitoring of the liquidity and solvency of these institutions or when the decisions of the competent authority are the subject of an administrative appeal or in court proceedings initiated pursuant to Article 13.   Article 13 Member States shall ensure that decisions taken in respect of a credit institution in pursuance of laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. The same shall apply  (1)OJ No L 194, 16.7.1973, p. 1.   where no decision is taken within six months of its submission in respect of an application for authorization which contains all the information required under the provisions in force.   TITLE V Final provisions  Article 14 1. Member States shall bring into force the measures necessary to comply with this Directive within 24 months of its notification and shall forthwith inform the Commission thereof.  2. As from the notification of this Directive, Member States shall communicate to the Commission the texts of the main laws, regulations and administrative provisions which they adopt in the field covered by this Directive.   Article 15 This Directive is addressed to the Member States.     Done at Brussels, 12 December 1977.  For the Council  The President  A. HUMBLET