S.I. No. 59/1996 - European Communities (Feedingstuffs Intended For Particular Nutritional Purposes) Regulations, 1996.

S.I. No. 59 of 1996.

EUROPEAN COMMUNITIES (FEEDINGSTUFFS INTENDED FOR PARTICULAR NUTRITIONAL PURPOSES) REGULATIONS, 1996.

I, Ivan Yates, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive 93/74/EEC of 13 September, 1993¹, Commission Directive 94/39/EC of 25 July 1994², Commission Directive 95/9/EC of 7 April, 1995³ and Commission Directive 95/10/EC of 7 April, 1995⁴ hereby make the following Regulations:

¹ O.J. No. L 237, 22. 9. 1993, p. 23

² O.J. No. L 207, 10. 8. 1994, p. 20

³ O.J. No. L 91, 22. 4. 1995, p. 35

⁴ O.J. No. L 91, 22.4.1995, p. 39

1. These Regulations may be cited as the European Communities (Feedingstuffs intended for Particular Nutritional Purposes) Regulations, 1996.

2. (1) In these Regulations—

"authorised officer" means a person appointed under Regulation 13 to be an authorised officer;

"the Directive" means Council Directive 93/74/EEC of 13 September, 1993, as amended by Commission Directive 94/39/EC of 25 July, 1994, Commission Directive 95/9/EC of 7 April, 1995 and Commission Directive 95/10/EC of 7 April, 1995;

"the Directive of 1979" has the meaning assigned to it by the European Communities (Marketing of Feedingstuffs) Regulations, 1992 ( S.I. No. 143 of 1992 );

"the Minister" means the Minister for Agriculture, Food and Forestry;

"particular nutritional purpose" means the purpose of satisfying the specific nutritional needs of certain pets or productive livestock whose process of assimilation, absorption or metabolism could be temporarily impaired or is temporarily or irreversibly impaired and are therefore able to derive benefit from ingestion of feedingstuffs appropriate to their condition;

"the Regulations of 1978" means the European Communities (Feedingstuffs) (Methods of Analysis) Regulations, 1978 to 1994;

"the Regulations of 1984" means the European Communities (Marketing of Feedingstuffs) Regulations, 1984 to 1994

"the Regulations of 1992" means the European Communities (Marketing of Feedingstuffs)(Amendment) Regulations, 1992 ( S.I. No. 143 of 1992 );

(2) A word or expression that is used in these Regulations and is also used in the Directive has the meaning that it has in the Directive unless the contrary intention appears.

3. These Regulations apply to feedingstuffs intended for particular nutritional purposes.

4. (1) A person shall not market feedingstuffs intended for particular nutritional purposes unless the feedingstuffs—

( a ) fulfil the conditions referred to in Regulation 5 of these Regulations,

(b) are labelled in accordance with Regulation 7 of these Regulations,

(2) A person shall not market a feedingstuff to which these Regulations apply unless the particular nutritional purpose of the feedingstuff is specified in Column 1 of Part B of the Schedule to these Regulations and the feedingstuff fulfils the other provisions laid down in the said Schedule in respect of the particular nutritional purpose.

5. No person shall market feedingstuffs to which these Regulations apply unless the nature or composition of the feedingstuffs are such that they are appropriate for their intended nutritional purpose.

6. These Regulations shall apply without prejudice to:

(a) the European Communities (Marketing of Feedingstuffs) Regulations, 1984 to 1994;

(b) the European Communities (Additives in Feedingstuffs) Regulations, 1989 to 1995;

(c) the European Communities (Feedingstuffs) (Tolerances of Undesirable Substances and Products) Regulations, 1989 to 1995;

(d) the European Communities (Protein Feedingstuffs) Regulations, 1986 to 1994;

7. (1) Without prejudice to the Regulations of 1984, no person shall market a feedingstuff to which these Regulations apply unless the additional indications referred to in paragraph (2) of this Regulation appear in the space provided for that purpose on the packaging, on the container or on the label of the feedingstuff and any other indications appearing in the said space comply with the provisions of paragraph 4 of this Regulation.

(2) The following are the additional indications referred to in paragraph (1) of this Regulation:

(a) the qualifying expression 'dietetic' together with the description of the feedingstuff;

(b) the precise use, i.e. the particular nutritional purpose;

(d) the declarations prescribed in column 4 of Part B of the Schedule to these Regulations concerning the particular nutritional purpose;

(e) the recommended length of time for use of the feedingstuff;

(f) the indications specified in Column 6 of Part B of the Schedule to these Regulations concerning the particular nutritional purpose;

(g) the indication "It is recomended that a specialist's opinion be sought before use" unless a contrary indication is specified in Column 6 of Part B of the Schedule to these Regulations in respect of the particular nutritional purpose;

(3) The indications referred to in paragraph (2) (a) to (g) shall comply with the content of the list of intended uses specified in Part B of the Schedule to these Regulations and the general provisions laid down in Part A of the said Schedule.

(4) Indications other than those referred to in paragraph 2 may not be given in the space provided for that purpose unless such indications are explicitly permitted in the Schedule to these Regulations in respect of the particular nutritional purpose for which the feedingstuff is intended.

8. Without prejudice to Regulation 10(b) (inserted by Regulation 8 of the Regulations of 1992) of the Regulations of 1984, the labelling of feedingstuffs to which these Regulations apply may make reference to a specific pathological condition in so far as that condition corresponds to the nutritional purpose laid down in Column 1 of Part B of the Schedule to these Regulations.

9. The provisions of Regulation 9A(4) (inserted by Regulation 7 of the Regulations of 1992) of the Regulations of 1984 shall also apply to feedingstuffs to which these Regulations apply and intended for animals other than pets.

10. The labelling of the feedingstuffs to which these Regulations apply may also highlight the presence or the low level of one or more analytical constituents which are essential for the description of the feedingstuff. In such cases, the minimum or maximum level of the analytical constituents, expressed as a percentage by weight of the feedingstuff, shall be clearly indicated in the list of declared analytical constituents.

11. (1) The qualifying expression 'dietetic' shall be reserved solely for feedingstuffs to which these Regulations apply.

(2) Qualifying expressions other than 'dietetic' shall be prohibited in the labelling and presentation of feedingstuffs to which these Regulations apply.

12. Notwithstanding the provisions of Regulation 9A(5) (inserted by Regulation 7 of the Regulations of 1992) of the Regulations of 1984, the declaration of ingredients may be made in the form of categories grouping several ingredients, even where the declaration of certain ingredients by their specific name is required to justify the nutritional characteristics of the feedingstuff.

13. (1) The Minister may appoint persons to be authorised officers for the purposes of these Regulations.

(2) Every person who is appointed to be an authorised officer shall be furnished with a certificate of appointment and when exercising a power under these Regulations shall, if requested by any person affected by the exercise of that power, produce that certificate and a means of identification.

14. (1) Where a person has on his premises any feedingstuff to which these Regulations apply which he has purchased and which he proposes to use in the course of his farming operations, he may apply to the Minister to have a sample thereof taken for analysis.

(2) An application under this Regulation shall be—

(a) made within the period of thirty days beginning on the date on which the feedingstuff to which the application relates was delivered to the applicant, and

(b) accompanied by a fee which shall be calculated by reference to the rates specified in Part D of the Schedule to these Regulations.

(3) Where an application is made under this Regulation, an authorised person shall, subject to paragraph (4) of this Regulation—

(a) take and deal with a sample of the relevant feedingstuff according to the methods described in the Annex to Commission Directive No. 76/371/EEC of 1 March, 1976,¹

¹ O.J. No. L 102, 15. 4. 1976, p. 1

and

(b) give or cause to be given, or sent by registered post or by such other method as for the time being stands approved of for the purposes of this paragraph by the Minister, to the State Chemist and to the person whose name or trade name has been given pursuant to paragraph (g) of Article 5 (1) of the Directive of 1979 (as amended by Council Directive 90/44/EEC)² one of the final samples prepared pursuant to the requirements of subparagraph (a) of this paragraph.

² O.J. No. L 27, 31. 1. 1990 p. 35

(4) Where an application is made under this Regulation, an authorised person may, if he thinks fit, decline to take a sample if—

(a) he is not satisfied that the applicant has purchased the feedingstuff to which the application relates; or

(b) he is not satisfied that the applicant proposes to use such feedingstuff in the course of his farming operations; or

(c) he is not satisfied that such feedingstuff as presented for sampling is fairly representative of the feedingstuff as delivered to the applicant; or

(d) the applicant does not furnish such information relating to such feedingstuff as the authorised person may reasonably require.

(5) Where the State Chemist receives a sample taken in pursuance of an application under this Regulation, he shall in making an analysis thereof comply with any of the requirements set out in Part I of the Third Schedule to the Regulations of 1984 or in Part II of the Regulations of 1978 as apply in the particular case and send to the applicant and to the person (other than the State Chemist) referred to in paragraph (3) (b) of this Regulation a certificate, in the form set out in Part E of the Schedule to these Regulations, of the result of the analysis.

(6) Subject to paragraph (8) of this Regulation, all fees under this Regulation shall be paid into or disposed for the benefit of the Exchequer in accordance with the directions of the Minister for Finance and, accordingly, the Public Offices Fees Act, 1879, shall not apply in respect thereof.

(7) Nothing in this Regulation shall be construed as requiring the State Chemist to make a test, examination or analysis regarding the presence in or absence from a sample given or sent to him pursuant to these Regulations of any particular substance, product or other thing, if in his opinion there is not in relation to such presence or absence a method of testing, examination or analysis which is sufficiently reliable or if there is not available to the State Chemist the apparatus or other means by which such a test, examination or analysis could be made.

(8) In any case in which he considers it proper so to do (not being a case in which the applicant has received a certificate under this Regulation), the Minister may refund a fee paid in relation to an application under this Regulation.

(9) For the purpose of this Regulation a feedingstuff shall not be regarded as having been delivered to a purchaser until it arrives at the destination to which it is consigned whether the consignment is by direction of the supplier or the purchaser.

15. Every person who carries on, or is employed in connection with, the business of manufacturing, importing or marketing feedingstuffs to which these Regulations apply shall—

(a) keep records of his transactions in such feedingstuffs as will enable an authorised person to ascertain each ingredient and the quantity thereof used in every batch of feedingstuffs manufactured;

b) produce at the request of an authorised person any books, documents or records relating to such business which are in the possession or under the control of such person;

(c) permit an authorised person to inspect and take extracts from such books, documents or records and give to the person any information which he may reasonably require in relation to any entries therein;

(d) afford to an authorised person reasonable facilities for inspecting the stock of any feedingstuff which is for the time being on any premises on which such person carries on such a business;

(e) give to an authorised person any information he may reasonably require in relation to such transactions including in particular information which he may reasonably require regarding any feedingstuff which is specified by him;

(f) comply with such guidelines as may be issued by the Minister from time to time regarding the form of records to be kept.

16. (1) In addition to the powers conferred by Regulation 15 of these Regulations an authorised officer may —

(a) enter, inspect and examine any place including a vehicle where he has reasonable cause to believe that feedingstuffs to which these Regulations apply are being manufactured, stored or marketed;

(b) examine and take samples of any feedingstuff which he finds in the course of his inspection;

(c) require any person whom he has reasonable cause to believe is engaged in manufacturing, storing or marketing feedingstuffs to which these Regulations apply to provide data and information establishing the feedingstuffs conformity with these Regulations and the Directive or a reference to the publication (if available in readily accessible form) of such data.

17. Where an authorised person is satisfied that a feedingstuff which is placed on the market, or which he believes will be placed on the market, does not comply with any one or more of the requirements of these Regulations, he may require either or both of the following persons, namely, the person who appears to him to have for the time being possession or control of the feedingstuff and the person whose name or trade name has been given pursuant to paragraph (g) of Article 5(1) of the Directive of 1979 (as amended by Council Directive 90/44/EEC), to take such steps as are necessary to ensure that it does not continue to be placed on the market, or, as may be appropriate, is not placed on the market until such authorised person is satisfied that the requirement is complied with.

18. (1) In any proceedings for an offence under these Regulations, evidence of the result of any test, examination or analysis of, or of any report on, a sample taken under these Regulations may be given if, and only if, it is proved that—

(a) the sample was taken and dealt with in accordance with the methods described in the Annex to Commission Directive No. 76/371/EEC of 1 March, 1976¹

¹ O.J. No. L 102, 15. 4. 1976, p. 1

(b) before the proceedings were instituted one of the final samples prepared pursuant to the requirements of the said Annex was given or caused to be given to the defendant or sent or given to him by registered post or by such other method as stands approved of for the purposes of paragraph (b) of Regulation 14 (3) of these Regulations by the Minister, and

(c) the test, examination or analysis was carried out in accordance with such of the requirements (if any) specified in Part I of the Third Schedule to the Regulations of 1984 or in Part II of the Regulations of 1978 as applied in the particular case.

(2) In any legal proceedings, other than proceedings to which paragraph (1) of this Regulation applies, evidence, being evidence which relates to an issue regarding the accuracy of a declaration required to be made by these Regulations, of the result of any test, examination or analysis of a sample of a feedingstuff may be given if, and only if, it is proved that—

(a) the sample was taken and dealt with in accordance with the methods referred to in paragraph (1) (a) of this Regulation,

(b) before the proceedings were instituted one of the final samples prepared pursuant to the requirements of the Annex to Commission Directive No. 76/371/EEC of 1 March, 1976¹, was given or caused to be given to the defendant or sent or given to him by registered post or by any other method which is a method referred to in paragraph (1) (b) of this Regulation, and

¹ O.J. No. L 102, 15. 4. 1976, p. 1

(c) the test, examination or analysis was carried out in accordance with such of the requirements referred to in paragraph (2) (c) of this Regulation as applied in the particular case.

19. In any legal proceedings the production of a certificate in the form specified in Part D of the Schedule to these Regulations and purporting to be signed by the State Chemist shall, without proof of any signature on the certificate or that the signatory was the proper person to sign it, be sufficient evidence of the facts stated in the certificate and of the analysis to which it relates having been carried out in accordance with such of the requirements (if any) specified in Part I of the Third Schedule to the Regulations of 1984 or in Part II of the Regulations of 1978, unless the contrary is proved.

SCHEDULE

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 the European Communities (Additives in Feedingstuff) Regulations, 1989, as amended, 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 the European Communities (Additives in Feedingstuffs) Regulations, 1989, as amended, 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.

10. Where the energy value of dog and cat food intended for particular nutritional purposes must be declared persuant to Regulation 7(2)(d) of these Regulations, such value shall be calculated using the method described in Part C of the Schedule to these Regulations. This method shall be valid until 30 June 1998.

PART B

List of intended uses

Particular nutritional purpose	Essential nutritional characteristics	Species or category of animals	Labelling declarations	Recommended length of time for use	Other provisions
1	2	3	4	5	6
Support of renal function in case of chronic renal insufficiency⁽¹⁾	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⁽²⁾	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^(³)	- Urine acidifying properties and 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^(³)	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 alkalizing properties	Dogs and cats	- Phosphorus - Calcium - Sodium - Magnesium - Potassium - Chlorides - Sulphur - Total vitamin D - Hydroxyproline - Urine alkalizing 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 alkalizing properties	Dogs and cats	- Total sulphur amino acids - Sodium - Potassium - Chlorides - Sulphur - Urine alkalizing 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⁽⁴⁾	- Selected protein source(s) and/or - Selected carbohydrate source(s)	Dogs and cats	- Protein source(s) - Content of essential fatty acids (if added) - Carbohydrate source(s) - Content of essential fatty acids (if added)	3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely
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 acutediarrhoea'. - 'It is recommended that a veterinarian's opinion be sought before use'.
Compensation for maldigestion⁽⁵⁾	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 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 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 case of chronic liver insufficiency	- High quality protein, moderate level of protein, low level of fat, 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'.
	- High quality protein, moderate level of protein, moderate level of fat and high level of essential fatty acids	Cats	— Protein sources(s) — Content of essential fatty acids — Sodium — Total copper
Regulation of lipid metabolism in 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 (calculated according to EC method)	Until target body weight is achieved	In the instructions for use an appropriate daily intake must be recommended
Nutritional restoration, convalescence⁽⁶⁾	High energy density, high concentrations of essential nutrients and highly digestable ingredients	Dogs and cats	— Highly digestible ingredients, including their treatment if appropriate — Energy value (calculated according to EC method) — 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 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 — Postassium — Chlorides — Sulphur
Reduction of the risk of ketosis⁽⁷⁾⁽⁸⁾	Ingredients providing glucogenic energy sources	Dairy cows and ewes	— Ingredients providing glucogenic energy sources — Propane-1,2-diol (if added as a glucose precursor) — Glycerol (if added as a glucose precursor)	3 to 6 weeks after calving⁽⁹⁾ Last 6 weeks before and the first 3 weeks after lambing⁽¹⁰⁾
Reduction of the risk of tetany (hypomag- nesaemia)	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 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⁽¹¹⁾	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 case of feedingstuffs for dairy cows indicate on the package, container or label: 'Especially for high yielding cows'. In case of feedingstuffs for ruminants for fattening indicate on the package, container or label: 'Especially for intensively fed __'⁽¹²⁾
Stabilization 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 calcull	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)
Stabilization 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 metabolizable energy from lipids with high level of polyunsaturated fatty acids	Laying hens	— Energy value (calculated according to EEC method) — Percentage of metabolizable energy from lipids — Content of polyunsaturated 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⁽¹³⁾	Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate	Initially up to 6 months	Guidance shall 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 6 months	Guidance shall 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)	2 to 4 weeks	Guidance shall be provided on the precise situations in which the use of the feed is appropriate.
Compensation of electrolyte loss in cases of heavy sweating	Predominantly electrolytes and easily absorbable carbohydrates	Equines	— Calcium — Sodium — Magnesium — Potassium — Chlorides — Glucose	1 to 3 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 digestable 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 case of chronic liver insufficiency	Low level of protein but of high quality and highly digestible carbohydrates	Equines	— Pritein and fibre sources — Highly digestible carbohydrates including their treatment if appropriate — Methionine — Choline — Content of n-3 fatty acids (if added)	Initially up to 6 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 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 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'
(1) If appropriate the manufacturer may also recommend use for temporary renal insufficiency. ⁽²⁾If the feedingstuff is recommended for temporary renal insufficiency, the recommended period for use shall be two to four weeks. (3) In case of feedingstuffs for cats, 'feline lower urinary tract disease' or 'feline urological syndrome - F.U.S.' may complete the particular nutritional purpose. (4) In the case of feedingstuffs for a particular intolerance, reference to the specific intolerance can replace 'ingredient and nutrient'. (5) The manufacturer may complete the particular nutritional purpose with the reference: 'exocrine pancreatic insufficiency'. (6) In the case of feedingstuffs for cats, the manufacturer may complete the particular nutritional purpose with a reference to 'Feline hepatic lipidosis' (7) The term 'ketosis' may be replaced by 'acetonaemia'. (8) The manufacturer may also recommend the use for ketosis recuperation. (9) In the case of feedingstuffs for dairy cows. (10) In the case of feedingstuffs for ewes. (11) In the case of feedingstuffs for dairy cows: 'maximum two months from the start of lactation'. (12) Indicate the category of ruminants concerned. (13) 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

PART C

Method of calculating the energy value of dog and cat food intended for particular nutritional purposes

1. Method of calculating and expressing energy value

The energy value of dog and cat food intended for particular nutritional purposes must be calculated using the formula set out below, on the basis of the percentages of certain analytical constituents of the food; this value is expressed in megajoules (MJ) of metabolizable energy (ME) per kilogram of compound feedingstuff, thus:

(a) dog and cat food with the exception of cat food with a moisture content exceeding 14%:

MJ/kg of ME = 0,1464 x % crude protein + 0,3556 x % crude oils and fats + 0,1464 x % nitrogen-free extract

(b) cat food with a moisture content exceeding 14%:

MJ/kg of ME = (0,1632 x % crude protein + 0,3222 x % crude oils and fats + 0,1255 x % nitrogen-free extract) - 0,2092

where the percentage of nitrogen-free extract is calculated by taking the difference between 100 and the percentage of moisture, crude ash, crude protein, crude oils and fats and crude fibre.

2. Tolerances applicable to the declared value

If the official inspection provided for in Regulation 14 of the Regulations of 1984 or Regulation 14 of these Regulations reveals a discrepancy between the result of the inspection and the declared energy value (increased or reduced energy value of the feedingstuff), a tolerance of 15% shall be applied.

3. Expression of result

After application of the above formula, the result obtained must be given to one decimal place.

4. Sampling and analysis methods

Sampling of the compound feed and determination of the content of the analytical constituents indicated in the method of calculation must be performed in accordance with, respectively, Community sampling methods and analysis methods for the official control of feedingstuffs.

Part D

Fee in respect of analysis

(Regulation 14(2)(b))

The fee payable in respect of an analysis of a feedingstuff to which these Regulations apply shall be calculated at the rate of £10.00 per hour.

PART E

(Regulation 16)

CERTIFICATE OF RESULT OF ANALYSIS

	Laboratory Ref. No.___________________
Sample of ________________________	Marked_____________________________
received by the State Chemist on_____________________________________________
from__________________________________________________________________
taken at the premises of ____________________________________________________
	___________________________________

Method of analysis used where two or more methods are applicable

This is to certify that the above-mentioned sample, which was duly fastened and sealed, has been analysed under the direction of the State Chemist and that the result of the analysis is as follows:—–

________________	________________	________________	________________
________________	________________	________________	________________
________________	________________	________________	________________
________________	________________	________________	________________
________________	________________	________________	________________
________________	________________	________________	________________

This certificate is given under the European Communities (Feedingstuffs Intended for Particular Nutritional Purposes) Regulations, 1996.

Date__________________		Signed_________________________________________
				State Chemist.

GIVEN under my Official Seal, this 5th day of March, 1996

IVAN YATES

Minister for Agriculture, Food and Forestry.

EXPLANATORY NOTE

These Regulations which give effect to Council Directive 93/74/EEC, Commission Directive 94/39/EC, Commission Directive 95/9/EC and Commission Directive 95/10/EC concerns feedingstuffs intended for particular nutritional purposes. These feedingstuffs are essentially dietetic feedingstuffs intended for animals whose process of assimilation, absorption or metabolism could be temporarily or irreversibly impaired.

The Regulations sets out requirements concerning the composition and marketing of the products concerned. Special requirements are also set out regarding the labelling of the products so as to distinguish them from both ordinary feedingstuffs and medicated feedingstuffs.

The Regulations also contain a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes indicating the precise use, essential nutritional characteristics, compulsory or optional declarations and special labelling requirements.