European Communities (Additives in Feedingstuffs) Regulations 1989

EUROPEAN COMMUNITIES (ADDITIVES IN FEEDINGSTUFFS) REGULATIONS 1989

I, MICHAEL O'KENNEDY, Minister for Agriculture and Food, 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 the Council Directive No. 70/524/EEC of 23 November, 1970(1), as amended by Council Directive No. 73/103/EEC of 28 April, 1973(2), Council Directive No. 75/296/EEC of 28 April. 1975(3), Council Directive No. 84/587/EEC of 29 November, 1984(4), Commission Directive No. 85/429/EEC of 8 July, 1985(5), Commission Directive No. 85/520/EEC of 11 November, 1985(6), Commission Directive No. 86/29/EEC of 5 February, 1986(7), Second Commission Directive No. 86/300/EEC of 4 June, 1986(8), Commission Directive No. 86/403/EEC of 28 July, 1986(9), Commission Directive No. 86/525/EEC of 27 October, 1986(10), Council Directive No. 87/153/EEC of 16 February, 1987(11), Council Directive No. 87/316/EEC of 16 June, 1987(12), Council Directive No. 87/317/EEC of 16 June, 1987(13), Commission Directive No. 87/552/EEC of 17 November, 1987(14), Commission Directive No. 88/228/EEC of 8 April, 1988(15), Commission Directive No. 88/483/EEC of 14 July, 1988(16), Commission Directive No. 88/616/EEC of 30 November, 1988(17) and Commission Directive No. 89/23/EEC of 21 December, 1988(18), hereby make the following Regulations: (1)O.J. No. L270, 14.12.1970, p1. (2)O.J. No. L124, 10.5.1973, p17. (3)O.J. No. L124, 15.5.1975, p29. (4)O.J. No. L319, 8.12.1984, p13. (5)O.J. No. L245, 12.9.1985, p1. (6)O.J. No. L323, 4.12.1985, p12. (7)O.J. No. L39, 14.2.1986, p55. (8)O.J. No. L189, 11.7.1986, p42. (9)O.J. No. L233, 20.8.1986, p16. (10)O.J. No. L310, 5.11.1986, p19. (11)O.J. No. L64, 7.3.1987, p19. (12)O.J. No. L160, 20.6.1987, p32. (13)O.J. No. L160, 20.6.1987, p34. (14)O.J. No. L336, 26.11.1987, p34. (15)O.J. No. L101, 20.4.1988, p30. (16)O.J. No. L237, 27.8.1988, p39. (17)O.J. No. L343, 23.12.1988, p25. (18)O.J. No. L11, 14.1.1989, p34.

1. (1) These Regulations may be cited as the European Communities (Additives in Feedingstuffs) Regulations, 1989. (2) These Regulations other than Regulation 7 shall come into operation on the 1st day of May, 1989. (3) Regulation 7 of these Regulations shall come into operation on the 1st day of June, 1989. REG 2

2. (1) In these Regulations: "additive licence" means a licence granted under Regulation 6 of these Regulations; "authorised officer" means a person authorised by the Minister to be an authorised officer for the purposes of these Regulations; "Council Directive" means Council Directive No. 70/524/EEC of 23 November, 1970(1) as amended by— (1)O.J. No. L270, 14.12.1970, p1. Council Directive No. 73/103/EEC of 28 April, 1973(2), Council Directive No. 75/296/EEC of 28 April, 1975(3), Council Directive No. 84/587/EEC of 29 November, 1984(4), Commission Directive No. 85/429/EEC of 8 July, 1985(5), Commission Directive No. 85/520/EEC of 11 November, 1985(6), Commission Directive No. 86/29/EEC of 5 February, 1986(7), Second Commission Directive No. 86/300/EEC of 4 June, 1986(8), Commission Directive No. 86/403/EEC of 28 July, 1986(9), Commission Directive No. 86/525/EEC of 27 October, 1986(10), Council Directive No. 87/153/EEC of 16 February, 1987(11), Council Directive No. 87/316/EEC of 16 June, 1987(12), Council Directive No. 87/317/EEC of 16 June, 1987(13), Commission Directive No. 87/552/EEC of 17 November, 1987(14), Commission Directive No. 88/228/EEC of 8 April, 1988(15), Commission Directive No. 88/483/ECC of 14 July, 1988(16), Commission Directive No. 88/616/EEC of 30 (2)O.J. No. L124, 10.5.1973, p17. (3)O.J. No. L124, 15.5.1975, p29. (4)O.J. No. L319, 8.12.1984, p13. (5)O.J. No. L245, 12.9.1985, p1. (6)O.J. No. L323, 4.12.1985, p12. (7)O.J. No. L39, 14.2.1986, p55. (8)O.J. No. L189, 11.7.1986, p42. (9)O.J. No. L233, 20.8.1986, p16. (10)O.J. No. L310, 5.11.1986, p19. (11)O.J. No. L64, 7.3.1987, p19. (12)O.J. No. L160, 20.6.1987, p32. (13)O.J. No. L160, 20.6.1987, p34. (14)O.J. No. L336, 26.11.1987, p34. (15)O.J. No. L101, 20.4.1988, p30. (16)O.J. No. L237, 27.8.1988, p39. November, 1988(17) and Commission Directive No. 89/23/EEC of 21 December, 1988(18). (17)O.J. No. L343, 23.12.1988, p25. (18)O.J. No. L11, 14.1.1989, p34. "medicinal additive" means any substance which complies with the definition of an additive in the Council Directive and may be classified as an antibiotic, growth promoter, coccidiostat and other medicinal substance; "the Minister" means the Minister for Agriculture and Food; "official methods of analysis" means a method of analysis specified in the European Communities (Feeding Stuffs) (Methods of Analysis) Regulations, 1978 to 1985; "State Chemist" means the head of the State Laboratory or a person authorised in writing by him to perform the functions assigned to the State Chemist under these Regulations. (2) A word or expression that is used in these Regulations and is also used in the Council Directive shall, unless the contrary intention appears, have in these Regulations the same meaning that it has in the Council Directive.

3. (1) A person shall not market additives for use in pre-mixtures or feedingstuffs unless— (a) the additive is mentioned in the First or Second Schedule to these Regulations or is a medicinal additive for which an additive licence has been granted under Regulation 6 of these Regulations, and (b) the additive complies with the conditions, if any, mentioned in respect of the particular additive in the First or Second Schedule to these Regulations or, in the case of a medicinal additive for which an additive licence has been granted, it complies with the conditions set out in that licence. (2) A person shall not incorporate an additive in a premixture or feedingstuff, or use an additive for the purposes of animal feeding unless— (a) the additive is mentioned in the First or Second Schedule to these Regulations or the additive is a medicinal additive for which an additive licence has been granted, and (b) the additive is incorporated in the premixture or feedingstuffs in accordance with the provisions, if any, in respect of the said additive in the said Schedules or, in the case of a medicinal additive, in accordance with the conditions set out in that additive licence. (3) A person shall not incorporate an additive mentioned in the First or Second Schedule to these Regulations in a straight feedingstuff unless such incorporation is expressly provided for in column (8) of either of the said Schedules in respect of that straight feedingstuff. (4) A person shall not market an additive specified in the Second Schedule to these Regulations or a medicinal additive for which an additive licence has been granted, or incorporate such an additive in a premixture or feedingstuff, or use such an additive for the purposes of animal feeding, unless the period of authorisation, if any, in respect of that additive specified in column (9) of the said Schedule or in the said additive licence, has not expired.

4. (1) Subject to paragraph (2) of this Regulation, a person shall not mix additives specified in the First or Second Schedule to these Regulations or medicinal additives for which an additive licence has been granted unless, in relation to the effects desired, there is physical and chemical compatibility between the components of the mixture. (2) A person shall not mix— (a) antibiotics and growth promoters together, either with substances from their own group or with substances from the other group; or (b) any coccidiostats with antibiotics and growth promoters where such coccidiostats also act, for the same category of animal, as an antibiotic or a growth promoter; or (c) coccidiostats and other medicinal substances if their effects are similar, unless the mixture concerned is a mixture of medicinal additives for which an additive licence has been granted under Regulation 6(3) of these Regulations. (3) Where a maximum or minimum content is specified in the First or Second Schedule to these Regulations in respect of an additive, or, in the case of a medicinal additive, in the additive licence in respect of a feedingstuff, the maximum or minimum content shall be construed so as to refer to complete feedingstuffs with a moisture content of 12 per cent, in so far as no special provision is set out in the said Schedule or in the said additive licence. (4) Where a substance which is permitted as an additive exists also in the natural state in certain ingredients of the feedingstuff, the amount of additive to be incorporated shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum content provided for in the First or Second Schedule to these Regulations. (5) The Minister may exempt a person from the provisions of Regulations 3 or 6 of these Regulations or paragraphs (1) and (2) of this Regulation for experimental or scientific purposes.

5. (1) A person shall not market additives and premixtures other than in closed packages or closed containers. (2) A package or container used for the purposes of paragraph (1) of this Regulation shall have a means of fasterning the package or container which is so constructed that, if the means of fastening the package or container is damaged, the package or container cannot be re-used.

6. (1) This Regulation applies to medicinal additives. (2) A person shall not manufacture or import a substance to which this Regulation applies unless a licence (to be known and hereafter referred to in these Regulations, as an "additive licence") has been granted to him in that behalf under this Regulation and the substance is manufactured or imported in accordance with any conditions in that licence. (3) The Minister may grant an additive licence in respect of each of the following activities, namely, the manufacture or importation of any of the substances to which this Regulation applies on an application being made to him in that behalf by a person licenced under Regulation 7(3) of these Regulations. (4) An additive licence shall not be granted under Paragraph (3) of this Regulation in respect of a substance to which this Regulation applies unless— (a) the substance is authorised in the Annexes to the Council Directive, and (b) any terms of the licence comply with the provisions of the Council Directive. (5) The Minister may revoke an additive licence granted under this Regulation. (6) A person shall not manufacture, import or market a premixture or compound feedingstuff containing a substance to which this Regulation applies unless— (a) an additive licence has been granted under this Regulation in respect of the substance, (b) the substance conforms with the provisions of such licence, and (c) the substance has been incorporated in the premixture or feedingstuff in accordance with the conditions laid down in such licence.

7. (1) A person shall not manufacture, import or market— (a) medicinal additives, (b) premixture containing medicinal additives with a view to those premixtures being incorporated in compound feedingstuffs, or (c) compound feedingstuffs containing medicinal additives, unless— (i) the conditions specified in the Third Schedule to these Regulations have been satisfied, and (ii) the medicinal additives and the said premixtures and feedingstuffs have been put on the market by— (I) in the case of medicinal additives and premixtures imported into the State or manufactured or marketed in the State, a person licensed in that behalf by the Minister under paragraph (3) of this Regulation, or (II) in the case of feedingstuffs imported into the State or manufactured in the State, a person licensed in that behalf by the Minister under paragraph (3) of this Regulation, and (III) in the case of medicinal additives, premixtures and feedingstuffs manufactured outside the State but in a Member State of the European Economic Community, a manufacturer who satisfies the requirements of the Third Schedule to these Regulations and who has a representative in the State, or (IV) in the case of medicinal additives, premixtures and feedingstuffs manufactured outside the European Community, a representative of the manufacturer who satisfies the requirement of the Third Schedule to these Regulations. (2) Where a person desires to be licensed under this Regulation he shall apply to the Minister for a licence in that behalf. (3) The Minister may grant a licence under this Regulation if he is satisfied that the conditions set out in the Third Schedule to these Regulations have been satisfied. (4) The Minister may revoke a licence under this Regulation. (5) No person shall market a medicinal additive produced outside the Member States of the European Economic Community or a premixture or feedingstuff containing such additives unless he can satisfy the Minister that the requirements of the Third Schedule to these Regulations have been satisfied by the manufacturer of the said produced additive, premixture or feedingstuff.

8. (1) A person shall not deliver medicinal additives to manufacturers of premixtures or, subject to paragraph (2) of this Regulation, manufacturers of compound feedingstuffs unless the said manufacturer is licensed under Regulation 7(3) of these Regulations. (2) A person shall not deliver medicinal additives to manufacturers of compound feedingstuffs unless the medicinal additives are in the form of premixture which comply with the requirements of Regulation 9 of these Regulations.

9. A person shall not incorporate a medicinal additive in a compound feedingstuff unless the medicinal additive has been prepared in advance in the form of a premixture including a carrier and such premixture has been incorporated in the compound feedingstuff only in a proportion of at least 0.2 per cent by weight.

REG 10

10. (1) Subject to paragraph (2) of this Regulation, a person shall not— (a) manufacture a supplementary feedingstuff for a species or category of animal unless the level of additives therein equals or is less than the permitted level of additives specified in the First or Second Schedule to these Regulations or, in the case of a medicinal additive, in the additive licence for a complete feedingstuff for that species or category of animal, or (b) feed a supplementary feedingstuff to a species or category of animal unless the level of additives therein equals or is less than the permitted level of additives specified in the First or Second Schedule to these Regulations or, in the case of a medicinal additive, in the additive licence for a complete feedingstuff for that category of animal. (2) Where a supplementary feedingstuff is such that were it mixed with other feedingstuffs prior to feeding, or fed as such in conjunction with other feedingstuffs, in accordance with instructions issued by its manufacturer and printed on, or on a label attached to, its packaging or, in case the supplementary feedingstuff is delivered in bulk, on documents accompanying the feedingstuff, the resulting feedingstuff or the daily ration as appropriate would comply with the requirements of Paragraph (1) of this Regulation, then the said requirements shall, as regards the supplementary feedingstuff, be regarded as having been complied with: provided the supplementary feedingstuff has one or more characteristics (for example, a feed or mineral block or the content of crude protein or minerals) which in practice ensure that the level of additives fixed for a complete feedingstuff for that species or category of animal is not exceeded and that the feedingstuff is not used for other species of animals.

REG 11

11. (1) A person shall not market any of the additives specified in the First or Second Schedule to these Regulations or, in the case of a medicinal additive, in the additive licence, unless the particulars (which shall be clearly visible, readily legible and indelible) set out in paragraph (2) of this Regulation are set out on the package or container in which they are packed or on a label attached thereto and, in addition to the said particulars, provided the relevant particulars (which shall be clearly visible, readily legible and indelible) set out in paragraph (3) of this Regulation are set out on the package or container in which the additives are packed or on a label attached thereto. (2) The particulars referred to in paragraph (1) of this Regulation to be displayed in respect of all additives shall be— (a) the specific name of the additive being the name used in the First or Second Schedule to these Regulations or, in the case of medicinal additives, in accordance with the additive licence; (b) the name or business name and the address or registered place of business of the person responsible for the particulars specified in this paragraph and paragraph (3) of this Regulation; and (c) the net weight and, in the case or liquid additives, either the net volume or the net weight. (3) The particulars referred to in paragraph (1) of this Regulations shall be in respect of— (a) antibiotics, growth promoters, coccidiostats and other medicinal substances: (i) the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, (ii) the active substance level, (iii) the expiry date of the guarantee or storage life from the date of manufacture, (iv) batch reference number, (v) date of manufacture, (vi) the indication "to be used exclusively by manufacturers of premixtures for compound feedingstuffs". (vii) directions for use, and (viii) where appropriate, a safety recommendation regarding use in the case of additives which are the subject of special provisions in the additive licence; (b) vitamin E: the alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture; (c) vitamins (other than vitamin E), provitamins and substances having a similar effect: the active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture; (d) trace elements, colourants including pigments, preserving agents and other additives: the active substance level; and (e) the additives referred to in sub-paragraphs (b), (c) and (d) of this paragraph: the indication: "to be used exclusively in the manufacture of feedingstuffs".

REG 12

12. Without prejudice to the generality of Regulation 11 of these Regulations, the specific name of the additive may be accompanied by— ( a ) the trade name and EEC number of the additive, or ( b ) the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the directions for use and, where appropriate, a safety recommendation regarding use in these cases where the last three indications are not required under paragraph (3) of Regulation 11 of these Regulations.

REG 13

13. Notwithstanding Regulations 11 and 12 of these Regulations, information other than that required or authorised pursuant to the said Regulations may appear on packages, containers or labels, provided it is clearly separated from the particulars required by Regulation 11 or permitted under Regulation 12 of these Regulations.

REG 14

14. (1) A person shall not market premixtures unless the particulars (which shall be clearly visible, readily legible and indelible) specified in paragraphs (2) and (3) of this Regulation are given on the package or container in which the premixtures are packed or on a label affixed thereto. (2) The particulars referred to in paragraph (1) of this Regulation in respect of premixtures shall be— ( a ) the description "premixture"; ( b ) the indication "to be used exclusively in the manufacture of feedingstuffs", except for the premixtures referred to in paragraph (3) (a), of this Regulation; ( c ) directions for use, and any safety recommendations regarding the use of the premixtures; ( d ) the animal species or category of animal for which the premixture is intended; ( e ) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph and paragraph (3) of this Regulation; and ( f ) the net weight and, in the case of liquids either the net volume or net weight. (3) The particulars referred to in paragraph (1) of this Regulation, in addition to those specified in Paragraph (2) of this Regulation, shall be, in respect of premixtures containing— ( a ) antibiotics, growth promoters, coccidiostats and other medicinal substances: (i) the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the details on the label, (ii) the specific name of the additive being the name used in the additive licence, (iii) the active substance level, (iv) the expiry date of the guarantee of that level or storage life from the date of manufacture, and (v) the indication "to be used exclusively by manufacturers of compound feedingstuffs"; ( b ) substances having antioxidant effects: (i) the specific name of the additive being the name used in the First or Second Schedule to these Regulations, and (ii) the active substance level: provided that a maximum level is fixed for complete feedingstuffs in the First or Second Schedule to these Regulations; ( c ) colourants, including pigments: (i) the specific name of the additive, if any, being the name used in the First or Second Schedule to these Regulations and if no name is given the common chemical name of the additive, and (ii) the active substance level: provided that a maximum level is fixed for complete feedingstuffs in the First or Second Schedule to these Regulations; ( d ) vitamin E: (i) the specific name of the additive, if any, being the name used in the First or Second Schedule to these Regulations and if no name is given the common chemical name of the additive, (ii) the alpha-tocopherol level, and (iii) the expiry date of the guarantee of that level or storage life from the date of manufacture; ( e ) vitamins (other than vitamin E), provitamins and substances having a similar effect: (i) the specific name of the additive, if any, being the name used in the First or Second Schedule to these Regulations or the common chemical name of the additive where no such name is given in the said Schedules. (ii) the active substance level, and (iii) the expiry date of the guarantee of that level of storage life from the date of manufacture; ( f ) trace elements: (i) the specific name of the additive being the name used in the First or Second Schedule to these Regulations, and (ii) the level of the various elements in so far as a maximum level is fixed for complete feedingstuffs in the said Schedules; ( g ) preserving agents: (i) the specific name of the additive being the name used in the First or Second Schedule to these Regulations, and (ii) the active substance level, provided that a maximum level is fixed for complete feedingstuffs in the said Schedules; ( h ) other additives belonging to the groups referred to in paragraphs (b) to (g) of this Regulation for which no maximum level is laid down for complete feedingstuffs in the First or Second Schedule to these Regulations, and additives belonging to other groups provided for in the said Schedules; (i) the specific name of the additive, if any, being the name used in the First or Second Schedule to these Regulations or, if there is no name, the common chemical name of the additive, and (ii) the active substance level: provided that these additives fulfil a function in the feedingstuff as such and the amounts present can be determined by official methods of analysis or, failing this, by valid scientific methods.

REG 15

15. Without prejudice to the generality of Regulation 14 of these Regulations, the following information may be indicated on the package, the container or the label of premixtures, namely, ( a ) the specific name of the additive listed in the First or Second Schedule to these Regulations (or, in the case of a medicinal additive, in the additive licence) may be accompanied by the trade name and the EEC number, ( b ) the name of the producer of the additives referred to in Regulation 11 (3) (a), or ( c ) any information other than that required under Regulation 14 or permitted under paragraphs (a) and (b) of this Regulation on the label of any container or package in which premixtures are supplied; provided that such information is clearly separated from the information required under Regulation 14 or permitted under paragraph (a) and (b)of this Regulation.

REG 16

16. Where, pursuant to Regulations 3, 14, 17, 20 or 22 of these Regulations, the expiry date of the guarantee or storage life from the date of manufacture of several additives belonging to the same group or different groups has to be stated or may be stated under the provisions of these Regulations, a single date or guarantee or a single reference to the storage life may be indicated; provided, however, the date mentioned shall be that which is the earliest of each of these dates.

REG 17

17. (1) A person shall not market feedingstuffs incorporating medicinal additives unless the particulars (which shall be clearly visable and readily legible and indelible) set out in paragraph (2) of this Regulation are given on the package, the container or a label affixed thereto. (2) The particulars referred to in paragraph (1) of this Regulation are (i) the specific name of the additive being the name used in the additive licence, (ii) the active substance level, (iii) the expiry date of the guarantee of that level or storage life from the date of manufacture and (iv) particulars concerning the proper use of the feedingstuff if there are any specified in the additive licence. REG 18

18. (1) A person shall not market feedingstuffs incorporating substances having antioxidant effects unless the particulars (which shall be clearly visible and readily legible and indelible) set out in paragraph (2) of this Regulation in the case of pet foods, and in paragraph (3) of this Regulation in the case of feedingstuffs other than pet foods, are given on the package, container or a label affixed thereto. (2) The particulars referred to in paragraph (1) of this Regulation are the words "With antioxidant" followed by the specific name of the additive being the name used in the First or Second Schedule to these Regulations. (3) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive being the name used in the First or Second Schedule to these Regulations.

REG 19

19. (1) A person shall not market feedingstuffs incorporating colourants, including pigments (being pigments used for the colouration of feedingstuffs or animal products) unless the particulars (which shall be clearly visible and readily legible and indelible) set out in paragraph (2) of this Regulation in the case of pet foods, and set out in paragraph (3) of this Regulation in the case of feedingstuffs other than pet foods, are given on the package, container or a label affixed thereto. (2) The particulars referred to in paragraph (1) of this Regulation are the words "colourant" or "coloured with" followed by the specific name of the additive being the name used in the First or Second Schedule to these Regulations. (3) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive being the name used in the First or Second Schedule to these Regulations.

REG 20

20. (1) A person shall not market feedingstuffs incorporating vitamin A, vitamin D, vitamin E or copper unless the particulars (which shall be clearly visible and readily legible and indelible) set out in paragraph (2) of this Regulation are given on the package, container or a label attached thereto. (2) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive being the name used in the First or Second Schedule to these Regulations, and (i) in the case of vitamins A and D, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture, (ii) in the case of vitamin E, the alpha-tocopherol level and the expiry date of the guarantee of that level or storage life from the date of manufacture, and (iii) in the case of copper, the level expressed as Cu.

REG 21

21. (1) A person shall not market feedingstuffs incorporating preserving agents unless the particulars (which shall be clearly visible and readily legible and indelible) set out in paragraph (2) of this Regulation in the case of pet foods, and in paragraph (3) of this Regulation in the case of feedingstuffs other than pet foods, are given on the package, container or on a label affixed thereto. (2) The particulars referred to in paragraph (1) of this Regulation are the words "preservative" or "preserved with" followed by the specific name of the additive being the name used in the First or Second Schedule to these Regulations. (3) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive being the name used in the First or Second Schedule to these Regulations.

REG 22

22. (1) Without prejudice to the generality of Regulation 20 of these Regulations, in the case of feedingstuffs incorporating trace elements (other than copper) and vitamins (other than vitamins A, D and E), provitamins and additives having a similar effects, the particulars (which shall be clearly visible and readily legible and indelible) set out in paragraph (2) of this Regulation in the case of trace elements (other than copper) and the particulars set out in paragraph (3) of this Regulation in respect of vitamins (other than vitamins A, D and E) provitamins and substances having a similar chemical effect, may be given on the package, container or on a label affixed thereto: provided the amounts of those additives can be determined by official methods of analysis or by valid scientific methods. (2) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive being the name used in the First or Second Schedule to these Regulations and the level of the various elements. (3) The particulars referred to in paragraph (1) of this Regulation are the specific name of the additive, if any, being the name used in the First or Second Schedule to these Regulations or the common chemical name if there is no name used in either of the said Schedules, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture.

REG 23

23. (1) The information required or allowed to be printed under Regulations 17, 18, 19, 20, 21, or 22 of these Regulations shall be printed close to the particulars which have to appear on the package, container or label affixed thereto in accordance with law. (2) Where a level or quantity is stated pursuant to Regulations 17, 20 or 22 of these Regulations such statement shall refer to the amount of additive incorporated in the feedingstuff. (3) Nothing in Regulations 17, 18, 19, 20, 21 or 22 of these Regulations shall prohibit the printing on any package, container or label affixed thereto of the EEC number or trade name of an additive.

REG 24

24. (1) Where feedingstuffs are distributed by road tankers or similar vehicles or in bulk the details provided for in Regulations 17, 18, 19, 20, 21 or 22 shall be given in a document accompanying the feedingstuffs. (2) Where small quantities of feedingstuffs that are intended for the end-user are involved, it shall be sufficient for the details provided for in Regulations 17, 18, 19, 20, 21 or 22 of these Regulations to be conveyed to the purchaser by a special notice.

REG 25

25. (1) Without prejudice to the generality of Regulations 18, 19 and 21, in the case of pet foods containing colourants, preservatives or substances having antioxidant effects and put up in packages having a net weight of not more than 10 kilograms, the particulars to be shown on the package under these Regulations may be replaced by the words "coloured with" or "preserved with" or "with antioxidant" as appropriate followed by the words "EEC additives" provided that: ( a ) the package, container or label bears a reference number by means of which the feedingstuff may be identified, and ( b ) the manufacturer gives, on request, the specific name, or names of the additive or additives used.

REG 26

26. A person shall not refer to additives on the packaging, labelling of or other documents in connection with additives, premixtures of feedingstuffs other than in the form provided for in these Regulations.

REG 27

27. (1) Without prejudice to the provisions of the European Communities (Marketing of Feedingstuffs) Regulations, 1984 (S.I. No. 200 of 1984) and Regulation 10 of these Regulations, a person shall not place on the market supplementary feedingstuffs which contain additives in excess of the maximum levels fixed for complete feedingstuffs unless the directions for use state, according to the species and age of the animal, the maximum quantity in grams or kilogramms of supplementary feedingstuff to be given to each animal each day and this information shall comply with the provisions of the First or Second Schedule to these Regulations or, in the case of medicinal additives, the additive licence. (2) This Regulation shall not apply to products delivered to manufacturers of compound feedingstuffs or to their suppliers. (3) The declaration referred to in paragraph (1) of this Regulation shall be so formulated that, when it is correctly followed, the proportion of additives does not exceed the maximum level fixed for complete feedingstuffs.

REG 28

28. Every person concerned shall comply with the provisions of Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition(1). (1) O.J. No. L64, 7.3.1987, p19.

REG 29

29. (1) The Minister may appoint persons to be authorised officers for the purposes of these Regulations and may revoke any such appointment. (2) An authorised officer shall be furnished with a warrant of appointment and when visiting any premises to which these Regulations apply shall, if so required, produce the warrant to the occupier or any other person holding a responsible position of management at the premises.

REG 30

30. An authorised officer may at all reasonable times enter— ( a ) any premises in which he has reasonable grounds for believing that there are additives, premixtures or feedingstuffs, ( b ) any railway wagon, vehicle, ship, vessel or aircraft in which he has reasonable grounds for believing that additives, premixtures or feedingstuffs are either being transported or kept for the purposes of such transport, and there or at any other place— (i) make such examinations, tests or inspections, and (ii) take such reasonable samples of any additives, premixtures or feedingstuffs which he finds in the course of his inspection, as he may consider appropriate for the purpose of these Regulations and the Council Directive.

REG 31

31. (1) Where a person has on his premises any additive, premixture or feedingstuff 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 additive, premixture or 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 Fourth Schedule to these Regulations. (3) Where an application is made under this Regulation, an authorised officer shall, subject to paragraph (4) of this Regulation— ( a ) take and deal with a sample of the relevant additive, premixture or feedingstuff according to the methods described in the Annex to Commission Directive 76/371/EEC(1), and (1) O.J. No. L102, 15.4.1976, p1. ( b ) give or cause to be given, or send 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 appears on the label of the additive, premixture or feedingstuff or, in the case of an imported additive, premixture or feedingstuff, the importer, samples prepared pursuant to the requirements of subparagraph (a) of this paragraph. (4) Where an application is made under this Regulation, an authorised officer may, if he thinks fit, decline to take a sample if— ( a ) he is not satisfied that the applicant has purchased the additive, premixture or feedingstuff to which the application relates, or ( b ) he is not satisfied that the applicant proposes to use the additive, premixture or feedingstuff in the course of his farming operations, or ( c ) he is not satisfied that the additive, premixture or feedingstuff as presented for sampling is fairly representative of the additive, premixture or feedingstuff as delivered to the applicant, or ( d ) the applicant does not furnish such information relating to such additive, premixture or feedingstuff as the authorised officer 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 such official methods of analysis 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 the European Communities (Feeding Stuffs) (Methods of Analysis (Amendment) and Methods of Sampling) Regulations, 1980 (S.I. No. 14 of 1980), 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 of for the benefit of the Exchequer in accordance with the directions of the Minister for Finance. (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.

REG 32

32. Every person who carries on, or is employed in connection with, the placing on the market of additives, premixtures of feedingstuffs shall— ( a ) Keep records of his transactions in such additives, premixtures of feedingstuffs; and, in the case of medicinal additives or premixtures and feedingstuffs containing medicinal additives, such records shall include the information required by the Third Schedule to these Regulations; ( b ) produce at the request of an authorised officer 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 officer to inspect and take extracts from such books, documents or records and give to the officer any information which he may reasonably require in relation to any entries therein; ( d ) afford to an authorised officer reasonable facilities for inspecting the stock of any additives, premixtures of feedingstuffs which is for the time being on any premises on which such person carried on such a business; and ( e ) give to an authorised officer any information he may reasonably require in relation to such transactions including in particular information which he may reasonably require regarding any additive, premixture of feedingstuff which is specified by him.

REG 33

33. Where an authorised officer is satisfied that an additive, premixture or 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 additive, premixture or feedingstuff, and the person whose name or trade name appears on the label of the additive, premixture or feedingstuff 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 officer is satisfied that the requirement is complied with.

REG 34

34. (1) Where a sample of an additive, premixture or feedingstuff is taken pursuant to these Regulations by an authorised officer and is found on official examination not to comply with a requirement of these Regulations, the Minister may require that the additive, premixture or feedingstuff shall be destroyed or otherwise disposed of in such manner as the Minister shall determine. (2) In case the Minister makes a requirement under this Regulation the following provision shall apply: ( a ) he shall inform in writing of the requirement the person who is in possession or control of the additive, premixture of feedingstuff to which the requirement relates; ( b ) where such person is so informed pending the disposal of such additive, premixture or feedingstuff in accordance with the requirement, the additive, premixture or feedingstuff shall be moved only with the consent of an authorised officer; and ( c ) the person in such possession or control shall dispose of the additive, premixture or feedingstuff or cause or permit it to be disposed of, only in accordance with the requirement.

REG 35

35. Where a sample of an additive, premixture or feedingstuff is taken pursuant to these Regulations by an authorised officer, a person shall not move the additive, premixture or feedingstuff, as the case may be, during the period of seven working days immediately following the day on which the sample is taken, without the consent of an authorised officer and, where a consent under this Regulation is given, a person shall not move the additive, premixture or feedingstuff concerned other than in accordance with the terms and conditions of the consent.

REG 36

36. (1) Where in any proceedings for an offence in which a contravention of these Regulations is alleged the defendant claims that the additive claims that the additive, premixture or feedingstuff to which the alleged offence relates was exempted from these Regulations by reason of Regulations 4(5) and 40 of these Regulations, the onus of proving that such additive, premixture or feedingstuff was so exempted shall be on the defendant. (2) 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 76/371/EEC(1), (1) O.J. No. L102, 15.4.1976, p1. ( 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 and to the State Chemist or sent or given to them by registered post or by such other method as stands approved of for the purposes of paragraph (b) of Regulation 31(3) of these Regulations by the Minister, and ( c ) the test, examination or analysis was carried out in accordance with such official methods of analysis as applied in the particular case. (3) In any legal proceedings, other than proceedings to which paragraph (2) 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 of analysis of a sample of an additive, premixture or 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 (2) (a) of this Regulation, ( b ) before the proceedings were instituted one of the final samples prepared pursuant to the requirements of paragraph (2) (a) of this Regulation was given or caused to be given to the party to the proceedings against whom it is sought to adduce such evidence, or sent or given to him by registered post or by such other method which is a method referred to in paragraph (2) (b) of this Regulation, and ( c ) the test, examination or analysis was carried out in accordance with such official methods of analysis as applied in the particular case.

REG 37

37. In any legal proceedings the production of a certificate in the form specified in 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 the official methods of analysis as applied in the particular case.

REG 38

38. (1) The Minister shall direct an authorised officer, from time to time, to take random samples of additives, premixtures and feedingstuffs to establish the identity of additives and to vertify that the conditions laid down in these Regulations are satisfied. (2) A person intending to manufacture additives (other than medicinal additives) or place them on the market shall inform the Minister of his intention in writing to manufacture additives or place additives on the market. REG 39

39. A person shall not pack or export additives, premixtures or feedingstuffs for use in other Member States unless the details referred to in Regulations 11 to 27 of these Regulations are given in at least one of the official languages of the country of destination.

REG 40

40. These Regulations shall not apply to additives, premixtures and feedingstuffs for export to countries which are not Member States of the European Economic Community.

REG 41

41. A person shall not fraudulently— ( a ) tamper with any additive, premixture or feedingstuff, so as to procure that any sample of it taken under these Regulations does not correctly represent the additive, premixture or feedingstuff, or ( b ) tamper or interfere with any sample taken under these Regulations.

REG 42

42. (1) Any person who— ( a ) contravenes Regulation 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15(c), 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 32, 35, 38(2), 39 or 41, ( b ) obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by Regulation 30 of these Regulations, ( c ) fails to comply with a provision of a licence granted under Regulations 6 or 7 of these Regulations, or ( d ) fails to comply with a requirement of an authorised officer pursuant to Regulation 33 of these Regulations, or with a requirement of the Minister pursuant to Regulation 34 of these Regulations shall be guilty of an offence. (2) Any person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,000, or, at the discretion of the Court, to imprisonment for a term not exceeding 12 months. (3) An offence under these Regulations may be prosecuted by the Minister. REG 43

43. The Public Offices Fees Act, 1879 (1879, C.58), shall not apply in respect of fees under these Regulations.

REG 44

44. The European Communities (Feeding Stuffs) (Additives) Regulations, 1974 to 1987, are hereby repealed.

FIRST SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)A. AntioxidantsAll species or categories of animalsAll feedingstuffsE300L-Ascorbic acidC6H8O6———E301Sodium L-ascorbateC6H7O6Na———E302Calcium L-ascorbate(C6H7O6)2Ca. 2H2O———E3035, 6-Diacetyl-L-ascorbic acidC10H12O8———E3046-Palmitoyl-L-ascorbic acidC22H38O7E306Tocopherol-rich extracts of natural origin————E307Synthetic alpha-tocopherolC29H50O2———E308Synthetic gamma-tocopherolC28H48O2———E309Synthetic delta-tocopherolC27H46O2———E310Propyl gallateC10H12O5——100: alone or togetherE311Octyl gallateC15H22O5——E312Dodecyl gallateC19H30O5——E320Butylated hydroxyanisole (BHA)C11H16O2——150: alone or togetherE321Butylated hydroytoluene (BHT)C15H24O——E324EthoxyquinC14H19NO—— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)B. Aromatic substances and appetising substances1.All natural products and corresponding synthetic products—All species or categories of animals————2.Artificial substances:SaccharinC7H5NO3SPiglets4 Months—150Calcium saccharinC7H3NCaO3SPiglets4 Months—150Sodium saccharinC7H4NNaO3SPiglets4 Months—150—C. Emulsifiers, stabilisers, thickeners and gelling agentsE322Lecithins—All species or categories of animals———E400Alginic acid———All feedingstuffsE401Sodium alginate————E402Potassium alginate————E403Ammonium alginate—All species or categories of animals with the exception of aquarium fish———E404Calcium alginate————E405Propane-1, 2-diol alginate (Propylene glycol alginate)—All species or categories of animals——— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E406Agar————All feedingstuffsE407Carrageenan————E408Furcellaran———E410Locust bean gum (Carob gum)————E411Tamarind seed flour————E412Guar gum————E413Tragacanth————E414Acacia (Gum arabic)————E415Xanthan gum—All species or categories of animals———E420Sorbitol————E421Mannitol————E422Glycerol———— E432Polyoxyethylene(20)-sorbitan monolaurate———5000 alone or with the other poly-sorbatesMilk Replacers onlyE433Polyoxyethylene(20)-sorbitan monooleate———E434Polyoxyethylene (20)-sorbitan momopalmitate———E435Polyoxyethylene(20)-sorbitan monostearate———E436Polyoxyethylene(20)-sorbitan tristearate———E440Pectins————All feedingstuffs Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E450 b(i)Pentasodium triphosphate—Dogs, cats——5,000All feedingstuffsE460Microcrystalline cellulose—All species or categories of animals———E461Methylcellulose————E462Ethylcellulose———— E463Hydroxypropylcellulose————E464Hydroxypropylmethylcellulose———— E465Ethylmethylcellulose————E466Carboxymethylcellulose (sodium salt of carboxymethyl ether of cellulose)————E470Sodium, potassium and calcium salts of edible fatty acids, alone or in mixtures, derived either from edible fats or from distilled edible fatty acids————E471Mono- and diglycerides of fatty acids————E472Mono-and diglycerides of edible fatty acids esterified with the following acids:(a) acetic————(b) lactic————(c) citric————(d) tartaric————(e) Mono-and diacetyltartaric———— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E473Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)—All species or categories of animals———All feedingstuffsE474Sucroglycerides (mixture of esters of saccharose and mono-aand diglycerides of edible fatty acids)————E475Polyglycerol esters of non-polymerised edible fatty acids————E477Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters————E480Stearoyl-2-lactylic acid————E481Sodium stearoyl-2-lactylate————E482Calcium stearoyl-2-lactylate————E483Stearyl tartrate————E484Glyceryl polyethyleneglycol ricinoleate————E485Dextrans————E487Polyethyleneglycol ester of fatty acids from soya oil—Calves——6000Milk replacers onlyE488Polyoxyethylated glyceride of tallow fatty acids—Calves——5000Milk replacers only Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E489Ether of polyglycerol and of alcohols obtained by the reduction of oleic and palmitic acids—Calves——5000Milk replacers onlyE490Propane-1,2-diol—Dairy cows Cattle for fattening, calves, lambs, kids, pigs, poultry——12000——36000E491Sorbitan monostearate—All species or categories of animals———E492Sorbitan tristearate————E493Sorbitan monolaurate————E494Sorbitan monooleate————E495Sorbitan monopalmitate————E496Polyethylene glycol 6000———300E497Polyoxpropylene-polyoxethylene polymers (M.W. 6800-9000)———50E498Partial polyglycerol esters of polycondensed fatty acids of castor oil—Dogs———All feedingstuffsD. Colouring matters including pigments1. Carotenoids and xan-thophylls:E160cCapsanthinC40H56O3——80 (alone or with the other carotenoids and xanthopylls)—E160ebeta-Apo-8'-carotenalC30H40O———E160fEthyl ester of beta-apo-8'-carotenoic acidC32H44O2Poultry——E161bLuteinC40H56O2———E161cCryptoxanthinC40H56O——— E161eViolaxanthinC40H56O4——— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E161gCanthaxanthinC40H52O2(a) Poultry———(b) Dogs, cats————(c) Salmon, trout——80Use permitted from the age of 6 months onwardsE161hZeaxanthinC40H56O2Poultry——E161iCitranaxanthinC33H44OLaying hens——80 (alone or with the other carotenoids and xanthophylls)E1312.1 Patent Blue VCalcium salt of the disulphonic acid of m-hydroxytetraethyldiamino triphenylcarbinol anhydride(a) All species or categories of animals with the exception of dogs and cats———Permitted in animal feedingstuffs only in products processed from: (i) waste products of foodstuffs, (ii) denatured cereals or manioc flour, or (iii) other base substances denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture(b) Dogs and cats———— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E1422.2 Acid brilliant green BS (Lissamine Green)Sodium salt of 4,4'-bis (dimenthylamino) diphenylmethylene-2-naphtol-3, 6-disulphonic acid(a) All species or categories of animals with the exception of dogs and cats———Permitted in animal feedingstuffs only in products processed from: (i) waste products of foodstuffs, (ii) denatured cereals or manioc flour, or (iii) other base substance denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture(b) Dogs and cats————3. All colouring agents authorized for colouring foodstuffs by the Health (Colouring Agents in Food) Regulations, 1973, as amended, other than those already covered by 2.1 and 2.2—(a) All species or categories of animals with the exception of dogs and cats———Permitted in animal feedingstuffs only in products processed from: (i) waste products of foodstuffs, or (ii) other base substances, with the exception of cereal and manioc flour, denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture(b) Dogs and cats———— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E. PreservativesE200Sorbic acidC6H8O2All species or categories of animals———All feedingstuffsE201Sodium sorbateC6H7O2Na———E202Potassium sorbateC6H7O2K———E203Calcium sorbateC12H14O4Ca———E214Ethyl 4-hydroxybenzoateC9H10O3NaPets———E215Sodium ethyl 4-hydroxybenzoateC9H9O3Na———E216Propyl 4-hydroxybenzoateC10H12O3———E217Sodium propyl 4-hydroxybenzoateC10H12O3Na———E218Methyl 4-hydroxybenzoateC8H8O3———E219Sodium methyl 4-hydroxybenzoateC8H7O3Na———E222Sodium bisulphiteNaHSO3Dogs, cats— —Separately or together: 500 expressed as SO2All feedingstuffs except unprocessed meat and fishE223Sodium metabisulphiteNa2S2O5— —E236Formic AcidCH2O2— ——All feedingstuffsE237Sodium formateCHO2NaAll species or categories of animals— ——E238Calcium formateC2H2O4Ca— —— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E240FormaldehydeCH2OPigs6 months——Skimmed milk only: maximum content: 600 mg/kgAll species and categories of animals———For silage onlyE250Sodium nitriteNaNO2Dogs, cats——100Canned feedingstuffs onlyE260Acetic acidC2H4O2All species or categories of animals———All feedingstuffsE261Potassium acetateC2H3O2K———E262Sodium diacetateC4H7O4Na———E263Calcium acetateC4H6O4Ca———E270Lactic acidC3H6O3———E280Propionic acidC3H6O2———E281Sodium propionateC3H5O2Na———E282Calcium proprionateC6H10O4Ca———E283Potassium propionateC3H5O2K———E284Ammonium propionateC3H9O2N———E295Ammonium formateCH5O2N—E296DL-Malic acidC4H6O5———E297Fumaric acidC4H4O4———E325Sodium lactateC3H5O3Na——— Minimum contentMaximum contentEEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E326Potassium lactateC3H5O3KAll species or categories of animals———E327Calcium lactateC6H10O6Ca———E330Citric acidC6H8O7———All feedingstuffsE331Sodium citrates————E332Potassium citrates————E333Calcium citrates————E334L-Tartaric acidC4H6O6———E335Sodium L-tartrates————E336Potassium L-tartrates————E337Potassium sodium L-tartrateC4H6O6KNa.4H2O———E338Orthophosphoric acidH3PO4———E490Propane-1,2-diolC3H8O2Dogs——53000Cats——75000E507Hydrochoric acidHC1All species or categories of animals———For silage onlyE513Sulphuric acidH2SO4All species or categories of animals———For silage only EEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMaximum content iu/kg of complete feedingstuff or of the daily rationOther provisionsF. Vitamins, provitamins and chemically well defined substances having a similar effectE6721. Vitamin A—Chickens for fattening—20,000All feedingstuffsOther species or categories of animals——2. Vitamin D—Pigs—2,000—Simultaneous use of vitamin D3 prohibitedE670 Vitamin D2Piglets —10,000Milk replacers onlyBovines—4,000Ovines—4,000Calves—10,000Milk replacers onlyEquines—4,000—Other species or categories of animals with the exception of poultry—2,000— EEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMaximum content iu/kg of complete feedingstuff or of the daily rationOther provisionsE671Vitamin D3—Pigs—2,000—Simultaneous use of vitamin D3 prohibitedPiglets—10,000Milk replacers onlyBovines—4,000Ovines —4,000Calves—10,000Milk replacers onlyEquines—4,000—Chickens for fattening —5,000—Turkeys—5,000—Other poultry —3,000—Other species or categories of animals—2,000—3. All substances in the group except vitamins A and D—All species or categories of animals——All feedingstuffs EEC No.ElementAdditiveChemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisions1 Trace elements 1 250 (total)—E1Iron-Fe—Ferrous carbonateFeCO3—Ferrous chloride, tetrahydrate FeCl2. 4H2 O—Ferric chloride, hxahydrateFeCl3. 6H2 O—Ferrous citrate, hexahydrateFe3 (C6 H5 O7 ) 2 .6H2O—Ferrous fumarateFeC4 H2O4 —Ferrous lactate, trihydrateFe(C3H5O3)2.3H2O—Ferric oxideFe2O3Ferrous sulphate monohydrateFeSO4.H2O Permitted only for denaturing— in skimmed-milk powder and— in compound feedingstuffs manufacture from denatured skimmed-milk powder Subject to the relevant provisions of Commission Regulations(EEC) No 368/77 and (EEC) No 443/77 Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk power EEC NoElementAdditiveChemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisionsFerrous sulphate, heptahydrateFeSO4.7H2O Permitted: (i) in denatured skimmed-milk powder and in compound feedingstuffs manufactured from denatured skimmed-milk powder — Subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 — Declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder (ii) in compound feedingstuffs other than those listed under (i) EEC No.ElementAdditiveChemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisionsE2Iodine — 1Calcium iodate, hexahydrateCa(IO3)2.6H2O40 (total)—Calcium iodate, anhydrousCa(IO3)2—Sodium iodideNal—Potassium iodideKl—E3Cobalt-Co10 (total)Cobaltous acetate, tetrahydrateCo(CH3COO)2.4H2O—Basic cobaltous carbonate2CoCO3.3Co(OH)2.H2O—Cobaltous chloride, hexahydrateCoCL2.6H2O—Cobaltous sulphate, heptahydrateCoSO4.7H2O—Cobaltous sulphate, monohydrateCoSO4.H2O—Cobaltous nitrate, hexahydrateCo(NO3)2.6H2O—E4Copper-CuCupric acetate, monohydrateCu(CH3COO)2.H2OPigs for fattening—Basic cupric carbonate, monohydrateCuCo3.Cu(OH)2.H2O— In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land—Cupric chloride, dihydrate CuCl22H2O—Cupric methionateCu(C3H10NO2S)2—Cupric oxideCuO —Cupric sulphate, pentahydrate CuSO4.5H2O— up to 16 weeks: 175 (total)— from 17th week up to slaughter: 35 (total) EEC No.ElementAdditive Chemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisions— In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land — up to 16 weeks: 175 (total) — from 17th week up to six months: 100 (total) — over six months up to slaughter: 35 (total)Breeding Pigs: 35(total)Calves:— milk replacers: 30 (total)— other complete feedingstuffs: 50 (total)Ovines: 15 (total)Other species or categories of animals: 35 (total) EEC No.ElementAdditiveChemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisionsCupric sulphate, monohydrateCuSO4.H2OPigs for fattening:Denatured skimmed-milk powderCupric sulphate, pentahydrateCuSO4.5H2Oand compound feedingstuffs— In Member States wheremanufactured from denatured skimmed-milk powder the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land— Subject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77— up to 16 weeks: 175 (total) — from 17th week up to slaughter: 35 (total)Declaraton of the amount of copper added expressed as the element, on the label package container of denatured skimmed milk powder— In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land — up to 16 weeks: 175 (total) — from 17th week up to six months: 100 (total) — over six months up to slaughter: 35 (total) EEC No.ElementAdditiveChemical formulaMaximum content of the element in mg/kg of the complete feedingstuffOther provisionsBreeding pigs: 35 (total)Ovines: 15 (total)Other species or categories of animals with the exception of calves: 35 (total)E5Manganese — Mn250 (total)Manganous carbonateMnCO3Manganous chloride, tetrahydrateMnCl2.4H2OManganous hydrogen phosphate, trihydrateMnHPO4.3H2OManganous oxideMnOManganic oxideMn2O3Manganous sulphate, tetrahydrateMnSO4.H2OManganous sulphate, monohydrateMnSO4.H2OE6Zinc — Zn250 (total)Zinc lactate, trihydrateZn(C3H5O3)2.3H2OZinc acetate, dihydrateZn(CH3COO)2.2H2OZinc carbonateZnCO3Zinc chloride, monohydrateZnCl2.H2OZinc oxideZnOZinc sulphate, heptahydrateZnSO4.7H2OZinc sulphate, monohydrateZnSO4.H2OE7Molybdenum — Mo2,5 (total)Ammonium molybdate(NH4)4Mo7O24.4H2OSodium molybdateNa2MoO4.2H2oE8Selenium — Se0,5 (total)Sodium seleniteNa2SeO3Sodium selenateNa2SeO4 EEC No.AdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsmg/kg of complete feedingstuff(1)(2)(3)(4)(5)(6)(7)(8)H. Binders, anti-caking agents and coagulantsE330Citric acidC6H8O7All species or categories of animals——— All feedingstuffs.Compliance with porvisions of Regulation 21E470Sodium, potassiumC18H35O2Na,———All feedingstuffsand calciumC18H35O2K and———stearatesC36H70O4Ca———E516Calcium sulphate dihydrateCaSO4.2H2O——30 000E551aSilicic acid, precipitated and dried———E551bColloidal silica————E551cKieselgur (diatomaceous earth, purified)————E552Calcium silicate, synthetic————E554Sodium, aluminosilicate, synthetic————E558Bentonite/montmorillonite———20 000All feedingstuffs. Mixing with additives from the groups of "antibiotics", "growth promoters", "coccidiostats and other medicinal substances" is prohibited except in the case of: Tylosin phosphate,All species of categories of animalsMonensinsodium,Narasin,IpronidazoleLasalocid sodium,Avoparcin,Flavophospholipol, Salinomycinsodium,Ronidazole,Virginiamycin,Nicarbazin andRobenidineIndication on the label of the specific name of the additive.E559Kaolinitic clays, free of asbestosNaturally occurring mixtures of minerals containing at least 65% complex hydrated aluminium silicates whose main constituent is Kaolinite———E560Natural mixtures of steatite and chloriteNatural mixtures of steatite and chlorite free of asbestos. Minimum purity of the mixture: 85%All species———E561VermiculiteNatural silicate of magnesium, aluminium and iron, expanded by heating, free of asbestos. Maximum fluorine content: 0.3%or categories of animals———All feedingstuffsE565Lignosulphonates————E599PerliteNatural silicate of sodium and aluminium, expanded by heating, free of asbestos———I. Acidity regulatorsE170Calcium carbonate————296DL-and L-Malic acid—————Ammonium dihydrogen———orthophosphate—di Ammonium hydrogen————orthophosphateE339(i)Sodium dihydrogen orthophosphate————E339(ii)di Sodium hydrogen orthophosphate————E339 (iii)tri Sodium orthophosphateDogs, Cats————E340(i)Potassium dihydrogen————orthophosphateE340(ii)di Potassium hydrogen————orthophosphateE340(iii)tri Potassium orthophosphate————E341(i)Calcium tetrahydrogen————diorthophosphateE341(ii)Calcium hydrogen orthophosphate————350(i)Sodium malate (salt of DL or L-Malic acid)————E 450 (a) (i)di Sodium dihydrogen diphosphate E 450 (a) (i)di Sodium dihydrogen diphosphateE 450 (a) (iii)tetra Sodium diphospate E 450 (a) (iv)tetra Potassium diphosphate E 450 (b) (i)penta Sodium triphosphate E 450 (b) (ii)penta Potassium triphosphate 500 (i)Sodium carbonate 500 (ii)Sodium hydrogen carbonateDogs, cats 500 (iii)Sodium sesquicarbonate 501 (ii)Potassium hydrogen carbonate 503 (i)Ammonium carbonate 503 (ii)Ammonium Hydrogen carbonate 507Hydrochloric acid 510Ammonium chloride 513Sulphuric acid 524Sodium hydroxide 529Calcium oxide 540di Calcium diphosphate

SECOND SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

Minimum contentMaximum contentNoAdditiveChemical formula, descriptionSpecies or category of animalMaximum agemg/kg of complete feedingstuffOther provisionsPeriod of authorisation (1)(2)(3)(4)(5)(6)(7)(9) C. Emulsifiers, stabilizers, thickeners and gelling agents 29Polyoxyethylene (20) sorbitan trioleate All species or categories of animals5000 (alone or with the polysorbates)All feedingstuffs30.11.89 D. Colouring matters including pigments 5AstaxanthinC40H52O4Salmon, trout100 (alone or together with canthaxanthin)use permitted from the age of 6 months onwards30.11.89 E. Preservatives20Methylproprionic acidC4H8O2All species or categories of animals with the exception of laying hens1 0004 00030.11.89I. Acidity RegulatorsE 170Calcium carbonate————30.11.89296DL-and L-Malic acid30.11.89 Ammonium dihydrogen orthophosphate30.11.89di Ammonium hydrogen orthophosphate30.11.89E 339 (i)Sodium dihydrogen orthophosphate30.11.89E 339(ii)di Sodium hydrogen orthophosphateAll pets with the exception of cats and dogs30.11.89 339 (iii)tri Sodium orthophosphate30.11.89 E 340 (i)Potassium dihydrogen orthophosphate30.11.89 E 340 (ii)di Potassium hydrogen orthophosphate30.11.89 E 341 (i)Calcium tetrahydrogen diorthophosphate30.11.89 E 341 (ii)Calcium hydrogen orthophosphate30.11.89 350 (i)Sodium malate (salt of DL or L-Malic acid)30.11.89E 450(a)(i)di Sodium dihydrogen diphosphate———30.11.89E 450 a (iii)tetra Sodium diphosphate30.11.89E 450 (a) (iv)tetra Potassium diphosphate30.11.89 E 450 (b) (i)penta Sodium triphosphate30.11.89 E 450 (b) (ii)penta Potassium triphosphate30.11.89 500 (i)Sodium carbonate30.11.89 500 (ii)Sodium hydrogen carbonateAll pets with the exception of cats and dogs30.11.89 500 (iii)Sodium sesquicarbonate30.11.89 501 (ii)Potassium hydrogen carbonate30.11.89 503 (i)Ammonium carbonate30.11.89 503 (ii)Ammonium hydrogen carbonate30.11.89 507Hydrocloric acid30.11.89 510Ammonium chloride30.11.89 513Sulphuric acid30.11.89 524Sodium hydroxide30.11.89 529Calcium oxide30.11.89 540di Calcium diphosphate30.11.89

THIRD SCHEDULE

Minimum conditions which must be fulfilled by manufacturers of the additives, premixtures and compound feedingstuffs referred to in Regulation 7 and intermediaries trading in these substances. 1. The manufacturer must possess the appropriate facilities and technical equipment for the manufacture and storage of additives, premixtures or compound feedingstuffs containing those premixtures. 2. The manufacturer or his staff must possess the skills necessary for the manufacture of additives, premixtures or compound feedingstuffs. 3. The manufacturer must have access to appropriate means enabling him to ensure: ( a ) in the case of additives: that they conform to the provisions of these Regulations; ( b ) in the case of premixtures: the nature and level of the different additives, and the homogeneity and stability of additives in the premixtures; ( c ) in the case of compound feedingstuffs: the nature and level of the additives and the homogeneous mixing of those additives in the compound feedingstuff. 4. Additives intended for the manufacture of premixtures and premixtures intended for incorporation in compound feedingstuffs shall be stored in such a way as to enable them to be easily identified and to avoid any confusion with other additives, premixtures or medicinal substances, medicated feedingstuffs or feedingstuffs. They shall be stored in suitable places, which can be locked and which are intended for the storage of these products. 5. The manufacturer or, if the manufacturer is established in a third country, his agent established in the Community must record the following information: ( a ) for additives: the nature, quantity of additives produced and the respective dates of manufacture, and the names and address of the manufacturers of premixtures or intermediaries to whom the additives have been delivered with an indication of the nature and quantity of additive delivered; ( b ) for premixtures: the name of the manufacturers and the suppliers, the nature and quantity of the additives used, the date of manufacture, the name and address of the compound feedingstuff manufacturers or intermediaries for whom the premixture is intended and the nature and quantity of the premixture delivered; ( c ) for compound feedingstuffs: the name and address of the supplier of the premixture and of the manufacturer if the latter is not the supplier, the nature and quantity of the premixture and the use to which it has been put. 6. Where the manufacturer delivers additives or premixtures to a person other than a manufacturer of premixtures or compound feedingstuffs, that person and any subsequent intermediary shall be bound by the same recording obligations laid down in paragraph 5 (a) and (b).

FOURTH SCHEDULE

Fee in respect of Analysis Regulation 31 (2) (b) The fee payable in respect of an analysis of additives or premixtures and compound feedingstuffs containing additives shall be calculated at the rate of 9.00 per hour.

GIVEN under my Official Seal, this 16th day of March, 1989. MICHAEL O'KENNEDY, Minister for Agriculture and Food.

EXPLANATORY NOTE The Regulations which cover the marketing and use of additives in feedingstuffs consolidate existing legislation and implement additional amendments made to Council Directive 70/524/EEC. The Regulations revoke the European Communities (Feedingstuffs) (Additives) Regulations, 1974 to 1987.