This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

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1 This document is meant purely as a documentation tool the institutions do not assume any liability for its contents B COMMISSION DIRECTIVE 2008/38/EC 5 March 2008 establishing a list intended uses animal feedingstuffs for particular nutritional purposes (Text with EEA relevance) (Codified version) (OJ L 062, , p.9) Amended by: Official Journal No page date M1 Commission Directive 2008/82/EC Text with EEA relevance 30 July 2008 M2 Commission Regulation (EU) No 1070/ November 2010 L L B COMMISSION DIRECTIVE 2008/38/EC 5 March 2008 establishing a list intended uses 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 13 September 1993 on feedingstuffs intended for particular nutritional purposes ( 1 ), in particular Article 6(a) there, Whereas:

2 (1) Commission Directive 94/39/EC 25 July 1994 establishing a list intended uses animal feedingstuffs for particular nutritional purposes ( 2 ) has been substantially amended several times ( 3 ). In the interests clarity rationality the said Directive should be codified. (2) Directive 93/74/EEC provides for the establishment a positive list the intended uses 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 where the special labelling requirements. (3) Certain nutritional purposes cannot be included at present in the list intended uses due to the absence Community methods control for the energy value in pet foods 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, following developments in scientific technical knowledge. (5) The measures provided for in this Directive are in accordance with the opinion the Sting Committee on the Food Chain Animal Health. (6) This Directive should be without prejudice to the obligations the Member States relating to the timelimits for transposition into national law 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 Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B Annex I to this Directive if they fulfil the other provisions laid down in that Part Annex I. Furthermore, the Member States shall ensure that the provisions under General provisions Part A 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 the Member States relating to the time-limits for transposition into national law the Directives set out in Annex II, Part B.

3 References to the repealed Directive shall be construed as references to this Directive shall be read in accordance with the correlation table in Annex III. Article 3 This Directive shall enter into force on 31 July Article 4 This Directive is addressed to the Member States. PART A General provisions ANNEX I 1. Where there is more than one group nutritional characteristics indicated in column 2 Part B, denoted by /or, for the same nutritional purpose, the manufacturer has the option to use either or both groups 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 Where a group additives is mentioned in column 2 or column 4 Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 the European Parliament the Council ( 4 ) as corresponding to the specified essential characteristic. 3. Where the source(s) ingredients or analytical constituents is (are) required in column 4 Part B, the manufacturer must make a precise declaration (e.g. specific name the ingredient(s), animal species or part the animal) allowing the evaluation conformity the feedingstuff with the corresponding essential nutritional characteristics. 4. Where the declaration a substance, also authorised as an additive, is required in column 4 Part B is accompanied by the expression total the declared content must refer to, as, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC ( 5 ), the total quantity the substance naturally present the amount added as an additive. 5. The declarations required in column 4 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 the particular nutritional purpose. 6. The declarations to be given in accordance with column 4 Part B concerning analytical constituents additives must be quantitative.

4 7. The recommended period use indicated in column 5 part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods 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 complementary feedingstuffs intended for particular nutritional purposes guidance on the balance the daily ration must be provided in the instructions for use contained on the label. PART B List intended uses lar nal Essential nutritional characteristics Species or category animals Labelling declarations Recommended length time (2) (3) (4) (5) (6) Other provisions renal Low level in case phosphorus renal restricted level ency (1) protein but high quality Protein source(s) Initially up to 6 months (2) or Reduced phosphorus Adult absorption by means incorporation Lanthanum carbonate octahydrate fatty acids (if added) Protein source(s) Initially up to 6 months (2) Lanthanum carbonate octahydrate fatty acids (if added)

5 ion stones (3) Urine acidifying properties, low level magnesium, restricted level protein but high quality Protein source(s) 5 to 12 weeks before use. Sulphur Urine acidifying substances Urine acidifying properties low level magnesium Cats Sulphur Total taurine Urine acidifying substances on ce (3) stone Urine acidifying properties moderate level magnesium Up to 6 months before use. Sulphur

6 on urate rmation on n stones Low level purines, low level protein but high quality Low level calcium, low level vitamin D, urine alkalising properties Urine acidifying substances Protein source(s) Sulphur Total vitamin D Hydroxyproline Up to 6 months but lifetime use in cases irreversible disturbance uric acid metabolism before use. Up to 6 months before use. Urine alkalising substances on n stones Low level protein, moderate level sulphur amino acids urine alkalising properties Total sulphur amino acids Initially up to 1 year Sulphur Urine alkalising substances on nt ces (4) Selected protein source(s) /or Selected carbohydrate source(s) Protein source(s) fatty acids (if added) Carbohydrate source(s) fatty acids (if added) 3 to 8 weeks: if signs intolerance disappear this feed can be used indefinitely

7 on acute l absorptive s Increased level electrolytes highly digestible ingredients Highly digestible ingredients including their treatment if 1 to 2 weeks During periods recovery from acute dia n use. sation for Highly digestible stion (5) ingredients low level fat heart Low level sodium in the case increased K/Na nic cardiac ratio ency ion Low level rapid supply glucose-releasing s mellitus) carbohydrates Source(s) mucilaginous substances (if added) Highly digestible ingredients including their treatment if Carbohydrate source(s) Treatment carbohydrates if 3 to 12 weeks, but lifetime in the case chronic pancreatic insufficiency Initially up to 6 months Initially up to 6 months before use. liver in the case onic liver ency High quality protein, moderate level protein, high level essential fatty acids high level highly digestible carbohydrates Starch Total sugar Fructose (if added) fatty acids (if added) Source(s) short medium chain fatty acids (if added) Protein source(s) fatty acids Highly digestible carbohydrates including their treatment if Initially up to 6 months

8 ion lipid ism in the idaemia on n the liver on e body nal on, scence (6) High quality protein, moderate level protein high level essential fatty acids Low level fat high level essential fatty acids Cats Total copper Protein source(s) fatty acids Total copper fatty acids Content n-3 fatty acids (if added) Initially up to 6 months Initially up to 2 months Low level copper Total copper Initially up to 6 months Low energy density High energy density, high concentrations essential nutrients highly digestible ingredients It is recommended that a veterinarian s opinio Energy value Until target In the instructions for use an daily body weight is recommended. achieved Highly digestible Until ingredients, including restoration their treatment if achieved Energy value is In the case feedingstuffs specially presented to be giv indicate on the package, container or label: Administration under veterinary supervision. skin High level in the case essential fatty acids atosis e loss Content n-3 n-6 fatty acids (if added) Content essential fatty acids Up to 2 months before use. the ism the case hritis : Minimum dry matter content total omega-3 fatty acids 3,3 % eicosapentaenoic acid (EPA) 0,38 %. : Cats: Total omega-3 fatty acids Total EPA Total vitamin E Initially up to 3 months It is recommended that a veterinary surgeon s opinion use or before extending the period use. Adequate level

9 vitamin E. Cats: Minimum dry matter content total omega-3 fatty acids 1,2 % docosahexaenoic acid (DHA) 0,28 %. Total omega-3 fatty acids Total DHA Total methionine Total manganese Total vitamin E Increased levels methionine manganese. Adequate level vitamin E. on the ilk fever Low level calcium Dairy cows 1 to 4 weeks before calving Stop feeding after calving /or Low cations/anions ratio 1 to 4 weeks before calving Stop feeding after calving or High level zeolite (synthetic sodium aluminium silicate) or High level calcium in the form highly available calcium salts Sulphur Content synthetic sodium aluminium silicate Total calcium content, sources respective quantity calcium The 2 weeks before calving Star at first signs parturition to two days subsequent to The amount feed shall be restricted to en intake 500 g sodium aluminium-silicate pe exceeded. Stop feeding after calving The instruction use i.e. the number app time before after calving.

10 on the etosis (7) (8) Ingredients providing glucogenic energy sources Dairy cows ewes on the High level Ruminants tetany magnesium, easily agnesaemia) available carbohydrates, moderate level protein low level potassium on the cidosis Low level easily Ruminants fermentable carbohydrates high buffering capacity Ingredients providing glucogenic energy sources Propan-1,2-diol (if added as a glucose precursor) Glycerol (if added as a glucose precursor) Starch Total sugars Starch Total sugars parturition 3 to 6 weeks after calving (9) Last 6 weeks before the first 3 weeks after lambing (10) 3 to 10 weeks during periods fast grass growth Maximum 2 months (11) The text It is recommended that a nutritional e sought before use In the instructions for use guidance shall be provided on the daily ration, with regard to the inclusion fibre energy sources. In the case feedingstuffs for ovines indicate on the pa or label: Especially for lactating ewes. In the instructions for use guidance shall be provided on the daily ration, with regard to the inclusion fibre fermentable carbohydrate sources. In the case feedingstuffs for dairy cows indicate on th container or label: Especially for high yielding cows. In the case feedingstuffs for ruminants for fattening i package, container or label: tion te balance Predominantly Calves electrolytes easily absorbable Piglets carbohydrates Lambs Kids Foals on the Low level Ruminants f urinary phosphorus, magnesium, urine acidifying properties Carbohydrate source(s) Especially for intensively fed. (12) 1 to 7 days (1 to 3 days if fed exclusively) In case risk, during periods, or recove disturbance (diarrhoea). Up to 6 weeks n use. Especially for intensively fed young animals.

11 on stress s High level magnesium /or Highly digestible ingredients Sulphur Urine acidifying substances Pigs 1 to 7 days Guidance shall be provided on the situation in which th is. Highly digestible ingredients including their treatment if Content n-3 fatty acids (if added) tion gical n Low buffering capacity, highly digestible ingredients Piglets Highly digestible ingredients including their treatment if 2 to 4 weeks In case risk, during periods, or recove digestive disturbance. Buffering capacity Source(s) astringent substances (if added) Highly digestible ingredients Source(s) mucilaginous substances (if added) Pigs Highly digestible ingredients including their treatment if on the onstipation on the fatty liver e Source(s) astringent substances (if added) Source(s) mucilaginous substances (if added) Ingredients Sows Ingredients stimulating stimulating intestinal intestinal passage passage Low energy high proportion metabolisable energy from lipids with high level Laying hens Energy value (calculated according to EC method) Percentage 10 to 14 days before 10 to 14 days after farrowing Up to 12 weeks

12 polyunsaturated fatty acids metabolisable from lipids energy sation rption for Low level saturated fatty acids high level fat soluble vitamins Poultry excluding geese pigeons Content polyunsaturated fatty acids Percentage saturated fatty acids in relation to total fatty acids Total vitamin A Total vitamin D Total vitamin E During the first 2 weeks after hatching sation for Highly precaecally digestible ency carbohydrates intestine proteins fats Total vitamin K Equines (13) Source(s) highly digestible carbohydrates, proteins fats, including their treatment if Initially up to six months Guidance should be provided on the situations in which feed is the manner in which it should be many small meals per day. sation for Highly digestive fibre s large digestible Equines Fibre source(s) Content n-3 fatty acids (if added) Initially up to six months Guidance should be provided on the situations in which feed is the manner in which the feed sh on stress s Highly ingredients digestible Equines Highly digestible ingredients including their treatment if Two to four weeks Guidance shall be provided on the precise situations in the feed is. sation Predominantly te loss in electrolytes s heavy easily absorbable carbohydrates Equines Content n-3 fatty acids (if added) Glucose One to three days Guidance shall be provided on the situations in which th is. When the feed corresponds to a significant part the d guidance should be provided to prevent the risk abrup nature the feed. Indicate on the instructions for use:

13 nal on, scence liver in the case onic liver ency High concentration Equines Highly digestible Until essential nutrients ingredients, including restoration highly digestible their treatment if achieved ingredients Content n-3 n-6 fatty acids (if added) Low level protein Equines Protein fibre but high quality highly digestible sources carbohydrates Highly digestible carbohydrates including their treatment if Methionine Choline is Initially up to six months Guidance shall be provided on the situations in which th is. In the case feedingstuffs specially presented to be giv indicate on the package, container or label: Administration under veterinary supervision. Guidance should be provided on the manner in which th fed including many small meals per day. renal in the case onic renal ency Low level protein Equines but high quality low level phosphorus Content n-3 fatty acids (if added) Protein source(s) Initially up to six months propriate the manufacturer may also recommend use for temporary renal insufficiency. e feedingstuff is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks. e case feedingstuffs for, feline lower urinary tract disease or feline urological syndrome FUS may complete the particular nutritional purpo e case feedingstuffs for a particular intolerance reference to the specific intolerance can replace ingredient nutrient. manufacturer may complete the particular nutritional purpose with the reference: exocrine pancreatic insufficiency. e case feedingstuffs for, the manufacturer may complete the particular nutritional purpose with a reference to Feline hepatic lipidosis. term ketosis may be replaced by acetonaemia. manufacturers may also recommend the use for ketosis recuperation. e case feedingstuffs for dairy cows.

14 the case feedingstuffs for ewes. the case feedingstuffs for dairy cows: maximum two months from the start lactation. icate the category ruminants concerned. the case feedingstuffs specially prepared to meet the specific conditions very old animals (easily ingestible ingredients) a reference to old animals ation the species or category animals. PART A ANNEX II Repealed Directive with list its successive amendments (referred to in Article 2) Commission Directive 94/39/EC Commission Directive 95/9/EC Commission Directive 2002/1/EC Commission Directive 2008/4/EC (OJ L 207, , p. 20) (OJ L 91, , p. 35) (OJ L 5, , p. 8) (OJ L 6, , p. 4) PART B List time-limits for transposition into national law (referred to in Article 2) Directive Time-limit for transposition 94/39/EC 30 June /9/EC 30 June /1/EC 20 November /4/EC 30 July 2008 ANNEX III

15 Directive 94/39/EC Correlation table This Directive Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 Article 4 Annex Annex I Annex II Annex III ( 1 ) OJ L 237, , p. 23. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, , p. 1). ( 2 ) OJ L 207, , p. 20. Directive as last amended by Directive 2008/4/EC (OJ L 6, , p. 4). ( 3 ) See Annex II, part A. ( 4 ) OJ L 268, , p. 29. ( 5 ) OJ L 270, , p. 1.