COMMISSION DIRECTIVE 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes

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

Whereas 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; whereas this list must be completed as soon as these methods have been adopted;

Whereas the established list may be modified, where appropriate, following developments in scientific and technical knowledge;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Council Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of the Annex to this Directive and if they fulfil the other provisions laid down in that Part of the Annex.

Furthermore, the Member States shall ensure that the provisions under 'General provisions' of Part A of the Annex are complied with.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall immediately inform the Commission thereof.

When Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 3

This Directive shall enter into force 20 days after its publication in the Official Journal of the European Communities.

Done at Brussels, 25 July 1994.

For the Commission

René STEICHEN

Member of the Commission

(1) OJ No L 237, 22. 9. 1993, p. 23.

ANNEX

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 authorized in Council Directive 70/524/EEC (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 authorized 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 Directive 70/524/EEC, the total quantity of the substance naturally present and the amount added as an additive.

5. The declarations required in column 4 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 "" ID="1">Support of renal function in case of chronic renal insufficiency (2)> ID="2">Low level of phosphorus and restricted level of protein but of high quality> ID="3">Dogs and cats> ID="4">- Protein source(s)> ID="5">Initially up to 6 months (3)> ID="6">Indicate on the package, container or label:"> ID="4">- Calcium> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="4">- Phosphorus> ID="6">Indicate in the instructions for use:"> ID="4">- Potassium> ID="6">'Water should be available at all times.'"> ID="4">- Sodium"> ID="4">- Content of essential fatty acids (if added)"> ID="1">Dissolution of struvite stones (4)> ID="2">- Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality> ID="3">Dogs> ID="4">- Protein source(s)> ID="5">5 to 12 weeks> ID="6">Indicate in the instructions for use:"> ID="4">- Calcium> ID="6">'Water should be available at all times.'"> ID="4">- Phosphorus> ID="6">Indicate on the package, container or label:"> ID="4">- Sodium> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="4">- Magnesium"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Urine acidifying substances"> ID="2">- Urine acidifying properties and low level of magnesium> ID="3">Cats> ID="4">- Calcium

"> ID="4">- Phosphorus"> ID="4">- Sodium"> ID="4">- Magnesium"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Total taurine"> ID="4">- Urine acidifying substances"> ID="1">Reduction of struvite stone recurrence (4)> ID="2">Urine acidifying properties and moderate level of magnesium> ID="3">Dogs and cats> ID="4">- Calcium> ID="5">Up to 6 months> ID="6">Indicate on the package, container or label:"> ID="4">- Phosphorus> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="4">- Sodium"> ID="4">- Magnesium"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Urine acidifying substances"> ID="1">Reduction of urate stones formation> ID="2">Low level of purines, low level of protein but of high quality> ID="3">Dogs and cats> ID="4">Protein source(s)> ID="5">Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="1">Reduction of oxalate stones formation> ID="2">Low level of calcium, low level of vitamin D, and urine alkalizing properties> ID="3">Dogs and cats> ID="4">- Phosphorus> ID="5">Up to 6 months> ID="6">Indicate on the package, container or label:"> ID="4">- Calcium> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="4">- Sodium"> ID="4">- Magnesium"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Total vitamin D"> ID="4">- Hydroxyproline"> ID="4">- Urine alkalizing substances"> ID="1">Reduction of cystine stones formation> ID="2">Low level of protein, moderate level of sulphur amino acids, and urine alkalizing properties> ID="3">Dogs and cats> ID="4">- Total sulphur amino acids> ID="5">Initially up to 1 year> ID="6">Indicate on the package, container or label:"> ID="4">- Sodium> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Urine alkalizing substances"> ID="1">Reduction of ingredient and nutrient intolerances (5)> ID="2">- Selected protein source(s)> ID="3">Dogs and cats> ID="4">- Protein source(s)> ID="5">3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely> ID="6">-"> ID="4">- Content of essential fatty acids (if added)"> ID="2">and/or"> ID="2">- Selected carbohydrate source(s)> ID="4">- Carbohydrate source(s)"> ID="4">- Content of essential fatty acids (if added)"> ID="1">Reduction of acute intestinal absorptive disorders> ID="2">Increased level of electrolytes and highly digestible ingredients> ID="3">Dogs and cats> ID="4">- Highly digestible ingredients including their treatment if appropriate> ID="5">1 to 2 weeks> ID="6">Indicate on the package, container or label:"> ID="4">- Sodium> ID="6">- 'During periods of and recovery from acute diarrhoea.'"> ID="4">- Potassium> ID="6">- 'It is recommended that a veterinarian's opinion be sought before use.'"> ID="4">- Source(s) of mucilaginous substances (if added)"> ID="1">Compensation for maldigestion (6)> ID="2">Highly digestible ingredients and low level of fat> ID="3">Dogs and cats> ID="4">Highly digestible ingredients including their treatment if appropriate> ID="5">3 to 12 weeks, but lifetime in case of chronic pancreatic insufficiency> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="1">Support of heart function in case of chronic cardiac insufficiency> ID="2">Low level of sodium and increased K/Na ratio> ID="3">Dogs and cats> ID="4">- Sodium> ID="5">Initially up to 6 months> ID="6">Indicate on the package, container or label:"> ID="4">- Potassium> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="4">- Magnesium"> ID="1">Regulation of glucose supply (Diabetes mellitus)> ID="2">Low level of rapid glucose-releasing carbohydrates> ID="3">Dogs and cats> ID="4">- Carbohydrate source(s)> ID="5">Initially up to 6 months> ID="6">Indicate on the package, container or label:"> ID="4">- Treatment of carbohydrates if appropriate> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="4">- Starch"> ID="4">- Total sugar"> ID="4">- Fructose (if added)"> ID="4">- Content of essential fatty acids (if added)"> ID="4">- Source(s) of short and medium chain fatty acids (if added)"> ID="1">Support of liver function in case of chronic liver insufficiency> ID="2">- High quality protein, moderate level of protein, low level of fat, high level of essential fatty acids and high level of highly digestible carbohydrates> ID="3">Dogs> ID="4">- Protein source(s)> ID="5">Initially up to 6 months> ID="6">Indicate on the package, container or label:"> ID="4">- Content of essential fatty acids> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="4">- Highly digestible carbohydrates inlcuding their treatment if appropriate"> ID="4">- Sodium"> ID="4">- Total copper"> ID="2">- High quality protein, moderate level of protein, moderate level of fat and high level of essential fatty acids> ID="3">Cats> ID="4">- Protein source(s)"> ID="4">- Content of essential fatty acids"> ID="4">- Sodium"> ID="4">- Total copper"> ID="1">Regulation of lipid metabolism in case of hyperlipidaemia> ID="2">Low level of fat and high level of essential fatty acids> ID="3">Dogs and cats> ID="4">- Content of essential fatty acids> ID="5">Initially up to 2 months> ID="6">Indicate on the package, container or label:"> ID="4">- Content of n-3 fatty acids (if added)> ID="6">'It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.'"> ID="1">Reduction of copper in the liver> ID="2">Low level of copper> ID="3">Dogs> ID="4">Total copper> ID="5">Initially up to 6 months> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a opinion be sought before use or before extending the period of use.'"> ID="1">Support of skin function in case of dermatosis and excessive loss of hair> ID="2">High level of essential fatty acids> ID="3">Dogs and cats> ID="4">Content of essential fatty acids> ID="5">Up to 2 months> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="1">Reduction of the risk of milk fever> ID="2">- Low level of calcium> ID="3">Dairy cows> ID="4">- Calcium> ID="5">1 to 4 weeks before calving> ID="6">Indicate in the instructions for use:

"> ID="4">- Phosphorus> ID="6">'Stop feeding after calving.'"> ID="4">- Magnesium"> ID="2">and/or"> ID="2">- Low cations/anions ratio> ID="4">- Calcium"> ID="4">- Phosphorus"> ID="4">- Sodium"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="1">Reduction of the risk of ketosis (7) (8)> ID="2">Ingredients providing glucogenic energy sources> ID="3">Dairy cows and ewes> ID="4">- Ingredients providing glucogenic energy sources> ID="5">3 to 6 weeks after calving (9)"> ID="4">- Propane-1,2-diol (if added as a glucose precursor)> ID="5">Last 6 weeks before and the first 3 weeks after lambing (10)"> ID="4">- Glycerol (if added as a glucose precursor)"> ID="1">Reduction of the risk of tetany (hypomagnesaemia)> ID="2">High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium> ID="3">Ruminants> ID="4">- Starch> ID="5">3 to 10 weeks during periods of fast grass growth> ID="6">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."> ID="4">- Total sugars> ID="6">In case of feedingstuffs for ovines indicate on the package, container or label: 'Especially for lactating ewes.'"> ID="4">- Magnesium"> ID="4">- Sodium"> ID="4">- Potassium"> ID="1">Reduction of the risk of acidosis> ID="2">Low level of easily fermentable carbohydrates and high buffering capacity> ID="3">Ruminants> ID="4">- Starch> ID="5">Maximum 2 months (11)> ID="6">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."> ID="4">- Total sugars> ID="6">In case of feedingstuffs for dairy cows indicate on the package, container or label: 'Especially for high yielding cows.'"> ID="6">In case of feedingstuffs for ruminants for fattening indicate on the package, container or label:"> ID="6">'Especially for intensively fed . . .' (12)"> ID="1">Stabilization of water and electrolyte balance> ID="2">Predominantly electrolytes and easily absorbable carbohydrates> ID="3">Calves> ID="4">- Carbohydrate source(s)> ID="5">1 to 7 days (1 to 3 days if fed exclusively)> ID="6">Indicate on the package, container or label:"> ID="3">Piglets> ID="4">- Sodium> ID="6">- '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.'"> ID="3">Lambs> ID="4">- Potassium"> ID="3">Kids> ID="4">- Chlorides"> ID="3">Foals"> ID="1">Reduction of the risk of urinary calcull> ID="2">Low level of phosphorus, magnesium, and urine acidifying properties> ID="3">Ruminants> ID="4">- Calcium> ID="5">Up to 6 weeks> ID="6">Indicate on the package, container or label:"> ID="4">- Phosphorus> ID="6">'Especially for intensively fed young animals.'"> ID="4">- Sodium> ID="6">Indicate in the instructions for use:"> ID="4">- Magnesium> ID="6">'Water should be available at all times.'"> ID="4">- Potassium"> ID="4">- Chlorides"> ID="4">- Sulphur"> ID="4">- Urine acidifying substances"> ID="1">Reduction of stress reactions> ID="2">- High level magnesium> ID="3">Pigs> ID="4">Magnesium> ID="5">1 to 7 days> ID="6">Guidance shall be provided on the situation in which the use of this feed is appropriate."> ID="2">and/or"> ID="2">- Highly digestible ingredients> ID="4">- Highly digestible ingredients including their treatment if appropriate"> ID="4">- Content of n-3 fatty acids (if added)"> ID="1">Stabilization of physiological digestion> ID="2">- Low buffering capacity, and highly digestible ingredients> ID="3">Piglets> ID="4">- Highly digestible ingrediets including their treatment if appropriate> ID="5">2 to 4 weeks> ID="6">Indicate on the package, container or label:"> ID="4">- Buffering capacity> ID="6">'In case of risk of, during periods of, or recovery from, digestive disturbance.'"> ID="4">- Source(s) of astringent substances (if added)"> ID="4">- Source(s) of mucilaginous substances (if added)"> ID="2">- Highly digestible ingredients> ID="3">Pigs> ID="4">- Highly digestible ingredients including their treatment if appropriate"> ID="4">- Source(s) of astringent substances (if added)"> ID="4">- Source(s) of mucilaginous substances (if added)"> ID="1">Reduction of the risk of constipation> ID="2">Ingredients stimulating intestinal passage> ID="3">Sows> ID="4">Ingredients stimulating intestinal passage> ID="5">10 to 14 days before and 10 to 14 days after farrowing> ID="6">-"> ID="1">Reduction of the risk of fatty liver syndrome> ID="2">Low energy and high proportion of metabolizable energy from lipids with high level of polyunsaturated fatty acids> ID="3">Laying hens> ID="4">- Energy value (calculated according to EEC method)> ID="5">Up to 12 weeks> ID="6">-"> ID="4">- Percentage of metabolizable energy from lipids"> ID="4">- Content of polyunsaturated fatty acids"> ID="1">Compensation for malabsorption> ID="2">Low level of saturated fatty acids and high level of fat soluble vitamins> ID="3">Poultry excluding geese and pigeons> ID="4">- Percentage of saturated fatty acids in relation to total fatty acids> ID="5">During the first 2 weeks after hatching> ID="6">-"> ID="4">- Total vitamin A"> ID="4">- Total vitamin D"> ID="4">- Total vitamin E"> ID="4">- Total vitamin K"> ID="1">Compensation for chronic digestive disorders of small intestine> ID="2">Highly digestible carbohydrates, proteins and fats> ID="3">Equines> ID="4">Highly digestible ingredients source of carbohydrates, proteins and fats, including their treatment if appropriate> ID="5">Up to 3 months> ID="6">Guidance shall be provided on the situations in which the use of this feed is appropriate."> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="1">Reduction of the risk of digestive disorders of large intestine> ID="2">High level of fibre, but highly digestible ingredients> ID="3">Equines> ID="4">Highly digestible ingredients including their treatment if appropriate> ID="5">1 to 2 weeks> ID="6">Guidance shall be provided on the situations in which the use of this feed is appropriate."> ID="6">Indicate on the package, container or label:"> ID="6">'It is recommended that a veterinarian's opinion be sought before use.'"> ID="1">Reduction of stress reactions> ID="2">Highly digestible ingredients and high level of magnesium> ID="3">Equines> ID="4">- Magnesium> ID="5">2 to 4 weeks> ID="6">Guidance shall be provided on the situations in which the use of this feed is appropriate."> ID="4">- Highly digestible ingredients including their treatment if appropriate"> ID="1">Compensation of electrolyte loss in cases of heavy sweating> ID="2">Predominantly electrolytes and easily absorbable carbohydrates> ID="3">Equines> ID="4">- Sodium> ID="5">1 to 2 days> ID="6">Indicate on the instructions for use:"> ID="4">- Potassium> ID="6">'Water should be available at all times.'"> ID="4">- Chlorides"> ID="4">- Glucose""

>

(1) OJ No L 270, 14. 12. 1970, p. 1.

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

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

(4) In case of feedingstuffs for cats, 'feline lower urinary tract disease' or 'feline urological syndrome - F.U.S.' may complete the particular nutritional purpose.

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

(6) The manufacturer may complete the particular nutritional purpose with the reference: 'exocrine pacretic insufficiency'.

(7) The term 'ketosis' may be replaced by 'acetonaemia'.

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

(9) In the case of feedingtuffs for dairy cows.

(10) In the case of feedingstuffs for ewes.

(11) In case of feedingstuffs for dairy cows: 'maximum two months from the start of lactation'.

(12) Indicate the category of ruminants concerned.