S.I. No. 49/1989 - European Communities (Additives in Feedingstuffs) Regulations, 1989.

S.I. No. 49 of 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.

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

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

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.

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.

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

(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".

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,

( 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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,

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

( 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,

( 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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,

( b ) tamper or interfere with any sample taken under these Regulations.

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.

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

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 content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff			Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)		(8)
	A. Antioxidants			All species or categories of animals						All feedingstuffs
E300	L-Ascorbic acid	C₆H₈O₆			—	—	—
E301	Sodium L-ascorbate	C₆H₇O₆Na			—	—	—
E302	Calcium L-ascorbate	(C₆H₇O₆)₂Ca. 2H₂O			—	—	—
E303	5, 6-Diacetyl-L-ascorbic acid	C₁₀H₁₂O₈			—	—	—
E304	6-Palmitoyl-L-ascorbic acid	C₂₂H₃₈O₇
E306	Tocopherol-rich extracts of natural origin	—			—	—	—
E307	Synthetic alpha-tocopherol	C₂₉H₅₀O₂			—	—	—
E308	Synthetic gamma-tocopherol	C₂₈H₄₈O₂			—	—	—
E309	Synthetic delta-tocopherol	C₂₇H₄₆O₂			—	—	—
E310	Propyl gallate	C₁₀H₁₂O₅			—	—		100: alone or together
E311	Octyl gallate	C₁₅H₂₂O₅			—	—		100: alone or together
E312	Dodecyl gallate	C₁₉H₃₀O₅			—	—
E320	Butylated hydroxyanisole (BHA)	C₁₁H₁₆O₂			—	—
E321	Butylated hydroytoluene (BHT)	C₁₅H₂₄O			—	—
E324	Ethoxyquin	C₁₄H₁₉NO	—	—

							Minimum content	Maximum content
EEC No.	Additive		Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)		(3)		(4)	(5)	(6)	(7)	(8)
	B. Aromatic substances and appetising substances
	1.	All natural products and corresponding synthetic products	—		All species or categories of animals	—	—	—
	2.	Artificial substances:
	Saccharin		C₇H₅NO₃S		Piglets	4 Months	—	150
	Calcium saccharin		C₇H₃NCaO₃S		Piglets	4 Months	—	150
	Sodium saccharin		C₇H₄NNaO₃S		Piglets	4 Months	—	150
	C. Emulsifiers, stabilisers, thickeners and gelling agents
E322	Lecithins		—		All species or categories of animals	—	—	—
E400	Alginic acid		—			—	—
E401	Sodium alginate		—			—	—	—
E402	Potassium alginate		—	—	—	—
E403	Ammonium alginate		—		All species or categories of animals with the exception of aquarium fish	—	—	—
E404	Calcium alginate		—			—	—	—
E405	Propane-1, 2-diol alginate (Propylene glycol alginate)		—		All species or categories of animals	—	—	—

					Minimum content	Maximum content
EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	mg/kg of complete feedingstuff			Other provisions
(1)	(2)	(3)	(4)	(5)	(6)	(7)		(8)
E406	Agar	—		—	—	—			All feedingstuffs
E407	Carrageenan	—		—	—	—
E408	Furcellaran		—	—	—
E410	Locust bean gum (Carob gum)	—		—	—	—
E411	Tamarind seed flour	—		—	—	—
E412	Guar gum	—		—	—	—
E413	Tragacanth	—		—	—	—
E414	Acacia (Gum arabic)	—		—	—	—
E415	Xanthan gum	—	All species or categories of animals	—	—	—
E420	Sorbitol	—		—	—	—
E421	Mannitol	—		—	—	—
E422	Glycerol	—		—	—	—
E432	Polyoxyethylene(20)-sorbitan monolaurate	—		—	—		5000 alone or with the other poly-sorbates
E433	Polyoxyethylene(20)-sorbitan monooleate	—		—	—
E434	Polyoxyethylene (20)-sorbitan momopalmitate	—		—	—
E435	Polyoxyethylene(20)-sorbitan monostearate	—		—	—
E436	Polyoxyethylene(20)-sorbitan tristearate	—		—	—
E440	Pectins	—	—	—	—

						Minimum content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)	(8)
E450 b(i)	Pentasodium triphosphate	—		Dogs, cats	—	—	5,000		All feedingstuffs
E460	Microcrystalline cellulose	—		All species or categories of animals	—	—	—
E461	Methylcellulose	—			—	—	—
E462	Ethylcellulose	—			—	—	—
E463	Hydroxypropylcellulose	—			—	—	—
E464	Hydroxypropylmethylcellulose	—			—	—	—
E465	Ethylmethylcellulose	—			—	—	—
E466	Carboxymethylcellulose (sodium salt of carboxymethyl ether of cellulose)	—			—	—	—
E470	Sodium, potassium and calcium salts of edible fatty acids, alone or in mixtures, derived either from edible fats or from distilled edible fatty acids	—			—	—	—
E471	Mono- and diglycerides of fatty acids	—			—	—	—
E472	Mono-and diglycerides of edible fatty acids esterified with the following acids:
	(a) acetic	—			—	—	—
	(b) lactic	—			—	—	—
	(c) citric	—			—	—	—
	(d) tartaric	—			—	—	—
	(e) Mono-and diacetyltartaric	—	—	—	—

						Minimum content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)	(8)
E473	Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)	—		All species or categories of animals	—	—	—
E474	Sucroglycerides (mixture of esters of saccharose and mono-aand diglycerides of edible fatty acids)	—			—	—	—
E475	Polyglycerol esters of non-polymerised edible fatty acids	—			—	—	—
E477	Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters	—			—	—	—
E480	Stearoyl-2-lactylic acid	—			—	—	—
E481	Sodium stearoyl-2-lactylate	—			—	—	—
E482	Calcium stearoyl-2-lactylate	—			—	—	—
E483	Stearyl tartrate	—			—	—	—
E484	Glyceryl polyethyleneglycol ricinoleate	—			—	—	—
E485	Dextrans	—	—	—	—
E487	Polyethyleneglycol ester of fatty acids from soya oil	—		Calves	—	—	6000	Milk replacers only
E488	Polyoxyethylated glyceride of tallow fatty acids	—		Calves	—	—	5000	Milk replacers only

							Minimum content			Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age		mg/kg of complete feedingstuff				Other provisions
(1)	(2)	(3)		(4)	(5)		(6)			(7)	(8)
E489	Ether of polyglycerol and of alcohols obtained by the reduction of oleic and palmitic acids	—		Calves	—		—			5000	Milk replacers only
E490	Propane-1,2-diol	—		Dairy cows Cattle for fattening, calves, lambs, kids, pigs, poultry		—		—		12000
				—	—		36000
E491	Sorbitan monostearate	—		All species or categories of animals		—	—			—
E492	Sorbitan tristearate	—				—	—			—
E493	Sorbitan monolaurate	—				—	—			—
E494	Sorbitan monooleate	—			—		—			—
E495	Sorbitan monopalmitate	—			—		—			—
E496	Polyethylene glycol 6000	—			—		—			300
E497	Polyoxpropylene-polyoxethylene polymers (M.W. 6800-9000)	—	—		—			50
E498	Partial polyglycerol esters of polycondensed fatty acids of castor oil	—		Dogs	—		—			—		All feedingstuffs
	D. Colouring matters including pigments
	1. Carotenoids and xan-thophylls:
E160c	Capsanthin	C₄₀H₅₆O₃			—		—			80 (alone or with the other carotenoids and xanthopylls)		—
E160e	beta-Apo-8'-carotenal	C₃₀H₄₀O			—		—					—
E160f	Ethyl ester of beta-apo-8'-carotenoic acid	C₃₂H₄₄O₂		Poultry	—		—
E161b	Lutein	C₄₀H₅₆O₂			—		—					—
E161c	Cryptoxanthin	C₄₀H₅₆O			—		—					—
E161e	Violaxanthin	C₄₀H₅₆O₄			—		—		—

					Minimum content		Maximum content
EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	mg/kg of complete feedingstuff			Other provisions
(1)	(2)	(3)	(4)	(5)	(6)		(7)	(8)
E161g	Canthaxanthin	C₄₀H₅₂O₂	(a) Poultry	—	—			—
			(b) Dogs, cats	—	—		—	—
			(c) Salmon, trout	—	—		80	Use permitted from the age of 6 months onwards
E161h	Zeaxanthin	C₄₀H₅₆O₂	Poultry	—	—
E161i	Citranaxanthin	C₃₃H₄₄O	Laying hens	—	—	80 (alone or with the other carotenoids and xanthophylls)
E131	2.1 Patent Blue V	Calcium 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 content	Maximum content
EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)	(4)	(5)	(6)	(7)	(8)
E142	2.2 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 content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)	(8)
	E. Preservatives
E200	Sorbic acid	C₆H₈O₂		All species or categories of animals	—	—	—		All feedingstuffs
E201	Sodium sorbate	C₆H₇O₂Na			—	—	—
E202	Potassium sorbate	C₆H₇O₂K			—	—	—
E203	Calcium sorbate	C₁₂H₁₄O₄Ca	—	—		—
E214	Ethyl 4-hydroxybenzoate	C₉H₁₀O_3Na		Pets	—	—	—
E215	Sodium ethyl 4-hydroxybenzoate	C₉H₉O₃Na			—	—	—
E216	Propyl 4-hydroxybenzoate	C₁₀H₁₂O₃			—	—	—
E217	Sodium propyl 4-hydroxybenzoate	C₁₀H₁₂O₃Na			—	—	—
E218	Methyl 4-hydroxybenzoate	C₈H₈O₃			—	—	—
E219	Sodium methyl 4-hydroxybenzoate	C₈H₇O₃Na	—	—		—
E222	Sodium bisulphite	NaHSO₃		Dogs, cats	—	—	Separately or together: 500 expressed as SO₂
E223	Sodium metabisulphite	Na₂S₂O₅	—	—
E236	Formic Acid	CH₂O₂			—	—
E237	Sodium formate	CHO₂Na		All species or categories of animals	—	—	—
E238	Calcium formate	C2H2O4Ca	—	—		—

						Minimum content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)	(8)
E240	Formaldehyde	CH₂O		Pigs	6 months	—	—	Skimmed milk only: maximum content: 600 mg/kg
				All species and categories of animals	—	—	—	For silage only
E250	Sodium nitrite	NaNO₂		Dogs, cats	—	—	100	Canned feedingstuffs only
E260	Acetic acid	C₂H₄O₂		All species or categories of animals	—	—	—		All feedingstuffs
E261	Potassium acetate	C₂H₃O₂K			—	—	—
E262	Sodium diacetate	C₄H₇O₄Na			—	—	—
E263	Calcium acetate	C₄H₆O₄Ca			—	—	—
E270	Lactic acid	C₃H₆O₃			—	—	—
E280	Propionic acid	C₃H₆O₂			—	—	—
E281	Sodium propionate	C₃H₅O₂Na			—	—	—
E282	Calcium proprionate	C₆H₁₀O₄Ca			—	—	—
E283	Potassium propionate	C₃H₅O₂K			—	—	—
E284	Ammonium propionate	C₃H₉O₂N			—	—	—
E295	Ammonium formate	CH₅O₂N			—
E296	DL-Malic acid	C₄H₆O₅			—	—	—
E297	Fumaric acid	C₄H₄O₄			—	—	—
E325	Sodium lactate	C₃H₅O₃Na	—	—	—

						Minimum content	Maximum content
EEC No.	Additive	Chemical formula, description		Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions
(1)	(2)	(3)		(4)	(5)	(6)	(7)	(8)
E326	Potassium lactate	C₃H₅O₃K		All species or categories of animals	—	—	—
E327	Calcium lactate	C₆H₁₀O₆Ca				—	—
E330	Citric acid	C₆H₈O₇			—	—	—
E331	Sodium citrates	—			—	—	—
E332	Potassium citrates	—			—	—	—
E333	Calcium citrates	—			—	—	—
E334	L-Tartaric acid	C₄H₆O₆			—	—	—
E335	Sodium L-tartrates	—			—	—	—
E336	Potassium L-tartrates	—			—	—	—
E337	Potassium sodium L-tartrate	C₄H₆O₆KNa.4H₂O			—	—	—
E338	Orthophosphoric acid	H₃PO₄	—	—	—
E490	Propane-1,2-diol	C₃H₈O₂		Dogs	—	—	53000
				Cats	—	—	75000
E507	Hydrochoric acid	HC₁		All species or categories of animals	—	—	—
E513	Sulphuric acid	H₂SO₄		All species or categories of animals	—	—	—

EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	Maximum content iu/kg of complete feedingstuff or of the daily ration	Other provisions
	F. Vitamins, provitamins and chemically well defined substances having a similar effect
E672	1. Vitamin A	—	Chickens for fattening	—	20,000		All feedingstuffs
			Other species or categories of animals	—	—
	2. Vitamin D	—	Pigs	—	2,000	—
E670 Vitamin D₂
			Piglets	—	10,000	Milk replacers only
			Bovines	—	4,000
			Ovines	—	4,000
			Calves	—	10,000	Milk replacers only
			Equines	—	4,000	—
			Other species or categories of animals with the exception of poultry	—	2,000	—

EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	Maximum content iu/kg of complete feedingstuff or of the daily ration	Other provisions
E671	Vitamin D₃	—	Pigs	—	2,000	—	Simultaneous use of vitamin D₃ prohibited
			Piglets	—	10,000	Milk replacers only
			Bovines	—	4,000
			Ovines	—	4,000
			Calves	—	10,000	Milk replacers only
			Equines	—	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.	Element	Additive	Chemical formula	Maximum content of the element in mg/kg of the complete feedingstuff		Other provisions
	1 Trace elements			1 250 (total)		—
E1	Iron-Fe					—
		Ferrous carbonate	FeCO₃			—
		Ferrous chloride, tetrahydrate	FeCl₂. 4H₂ O			—
		Ferric chloride, hxahydrate	FeCl₃. 6H₂ O			—
		Ferrous citrate, hexahydrate	Fe₃ (C₆ H₅ O₇) ₂.₆H₂O			—
		Ferrous fumarate	FeC₄ H₂O₄			—
		Ferrous lactate, trihydrate	Fe(C₃H₅O₃)₂.3H₂O			—
		Ferric oxide	Fe₂O₃
		Ferrous sulphate monohydrate	FeSO₄.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 No	Element	Additive	Chemical formula	Maximum content of the element in mg/kg of the complete feedingstuff		Other provisions
		Ferrous sulphate, heptahydrate	FeSO₄.7H₂O			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.	Element	Additive	Chemical formula	Maximum content of the element in mg/kg of the complete feedingstuff		Other provisions
E2	Iodine — 1	Calcium iodate, hexahydrate	Ca(IO₃)₂.6H₂O	40 (total)		—
		Calcium iodate, anhydrous	Ca(IO₃)₂			—
		Sodium iodide	Nal			—
		Potassium iodide	Kl			—
E3	Cobalt-Co			10 (total)
		Cobaltous acetate, tetrahydrate	Co(CH₃COO)₂.4H₂O			—
		Basic cobaltous carbonate	2CoCO₃.3Co(OH)₂.H₂O			—
		Cobaltous chloride, hexahydrate	CoCL₂.6H₂O			—
		Cobaltous sulphate, heptahydrate	CoSO₄.7H₂O			—
		Cobaltous sulphate, monohydrate	CoSO₄.H₂O			—
		Cobaltous nitrate, hexahydrate	Co(NO₃)₂.6H₂O			—
E4	Copper-Cu	Cupric acetate, monohydrate	Cu(CH₃COO)_2.H₂O		Pigs for fattening	—
		Basic cupric carbonate, monohydrate	CuCo₃.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 methionate	Cu(C₃H₁₀NO₂S)₂			—
		Cupric oxide	CuO			—
		Cupric sulphate, pentahydrate CuSO₄.5H₂O
					— up to 16 weeks: 175 (total)
				— from 17th week up to slaughter: 35 (total)

EEC No.	Element	Additive	Chemical formula		Maximum content of the element in mg/kg of the complete feedingstuff	Other 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.	Element	Additive	Chemical formula		Maximum content of the element in mg/kg of the complete feedingstuff	Other provisions
		Cupric sulphate, monohydrate	CuSO₄.H₂O		Pigs for fattening:	Denatured skimmed-milk powder
		Cupric sulphate, pentahydrate	CuSO₄.5H₂O			and compound feedingstuffs
					— In Member States where	manufactured 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.	Element	Additive	Chemical formula	Maximum content of the element in mg/kg of the complete feedingstuff	Other provisions
				Breeding pigs: 35 (total)
				Ovines: 15 (total)
			Other species or categories of animals with the exception of calves: 35 (total)
E5	Manganese — Mn		250 (total)
		Manganous carbonate	MnCO₃
		Manganous chloride, tetrahydrate	MnCl₂.4H₂O
		Manganous hydrogen phosphate, trihydrate	MnHPO₄.3H₂O
		Manganous oxide	MnO
		Manganic oxide	Mn₂O₃
		Manganous sulphate, tetrahydrate	MnSO₄.H₂O
		Manganous sulphate, monohydrate	MnSO₄.H₂O
E6	Zinc — Zn			250 (total)
		Zinc lactate, trihydrate	Zn(C₃H₅O₃)₂.3H₂O
		Zinc acetate, dihydrate	Zn(CH₃COO)₂.2H₂O
		Zinc carbonate	ZnCO₃
		Zinc chloride, monohydrate	ZnCl₂.H₂O
		Zinc oxide	ZnO
		Zinc sulphate, heptahydrate	ZnSO₄.7H₂O
		Zinc sulphate, monohydrate	ZnSO₄.H₂O
E7	Molybdenum — Mo			2,5 (total)
		Ammonium molybdate	(NH₄)₄Mo₇O₂₄.4H₂O
		Sodium molybdate	Na₂MoO₄.2H₂o
E8	Selenium — Se			0,5 (total)
		Sodium selenite	Na₂SeO₃
		Sodium selenate	Na₂SeO₄

EEC No.	Additive	Chemical formula, description	Species or category of animal	Maximum age	Minimum content		Maximum content	Other provisions
					mg/kg of complete feedingstuff
(1)	(2)	(3)	(4)	(5)	(6)	(7)		(8)
	H. Binders, anti-caking agents and coagulants
E330	Citric acid	C₆H₈O₇	All species or categories of animals	—	—	—			All feedingstuffs.
									Compliance with porvisions of Regulation 21
E470	Sodium, potassium	C₁₈H₃₅O₂Na,		—	—	—			All feedingstuffs
	and calcium	C₁₈H₃₅O₂K and		—	—	—
	stearates	C₃₆H₇₀O₄Ca		—	—	—
E516	Calcium sulphate dihydrate	CaSO₄.2H₂O		—	—	30 000
E551a	Silicic acid, precipitated and dried			—	—	—

E551b	Colloidal silica	—		—	—	—
E551c	Kieselgur (diatomaceous earth, purified)	—		—	—	—
E552	Calcium silicate, synthetic	—		—	—	—
E554	Sodium, aluminosilicate, synthetic	—		—	—	—
E558	Bentonite/montmorillonite	—		—	—	20 000		All 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 animals				Monensin
								sodium,
								Narasin,
								Ipronidazole
								Lasalocid sodium,
								Avoparcin,
								Flavophospholipol
								, Salinomycin
								sodium,
								Ronidazole,
								Virginiamycin,
								Nicarbazin and
								Robenidine

						Indication on the label of the specific name of the additive.
E559	Kaolinitic clays, free of asbestos	Naturally occurring mixtures of minerals containing at least 65% complex hydrated aluminium silicates whose main constituent is Kaolinite		—	—	—
E560	Natural mixtures of steatite and chlorite	Natural mixtures of steatite and chlorite free of asbestos. Minimum purity of the mixture: 85%	All species	—	—	—
E561	Vermiculite	Natural silicate of magnesium, aluminium and iron, expanded by heating, free of asbestos. Maximum fluorine content: 0.3%	or categories of animals	—	—	—			All feedingstuffs
E565	Lignosulphonates	—		—	—	—

E599	Perlite	Natural silicate of sodium and aluminium, expanded by heating, free of asbestos	—	—	—
	I. Acidity regulators
E170	Calcium carbonate			—	—	—		—
296	DL-and L-Malic acid			—	—	—		—
—	Ammonium dihydrogen			—	—	—
	orthophosphate
—	di Ammonium hydrogen			—	—	—		—
	orthophosphate
E339(i)	Sodium dihydrogen orthophosphate			—	—	—		—
E339(ii)	di Sodium hydrogen orthophosphate			—	—	—		—
E339 (iii)	tri Sodium orthophosphate		Dogs, Cats	—	—	—		—
E340(i)	Potassium dihydrogen			—	—	—		—
	orthophosphate
E340(ii)	di Potassium hydrogen			—	—	—		—
	orthophosphate
E340(iii)	tri Potassium orthophosphate			—	—	—		—
E341(i)	Calcium tetrahydrogen			—	—	—		—
	diorthophosphate
E341(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 diphosphate
E450 (a) (iii)	tetra Sodium diphospate
E450 (a) (iv)	tetra Potassium diphosphate
E 450 (b) (i)	penta Sodium triphosphate
E450 (b) (ii)	penta Potassium triphosphate
500 (i)	Sodium carbonate
500 (ii)	Sodium hydrogen carbonate		Dogs, cats
500 (iii)	Sodium sesquicarbonate
501 (ii)	Potassium hydrogen carbonate
503 (i)	Ammonium carbonate
503 (ii)	Ammonium Hydrogen carbonate
507	Hydrochloric acid
510	Ammonium chloride
513	Sulphuric acid
524	Sodium hydroxide
529	Calcium oxide
540	di Calcium diphosphate

SECOND SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

					Minimum content	Maximum content
No	Additive	Chemical formula, description	Species or category of animal	Maximum age	mg/kg of complete feedingstuff		Other provisions	Period of authorisation
(1)	(2)	(3)	(4)	(5)	(6)	(7)	(9)
	C. Emulsifiers, stabilizers, thickeners and gelling agents
29	Polyoxyethylene(20)sorbitan trioleate		All species or categories of animals			5000 (alone or with the polysorbates)	All feedingstuffs	30.11.89
	D. Colouring matters including pigments
5	Astaxanthin	C₄₀H₅₂O₄	Salmon, trout			100 (alone or together with canthaxanthin)	use permitted from the age of 6 months onwards	30.11.89
	E. Preservatives
20	Methylproprionic acid	C₄H₈O₂	All species or categories of animals with the exception of laying hens		1 000	4 000		30.11.89
	I. Acidity Regulators
E 170	Calcium carbonate			—	—	—	—	30.11.89
296	DL-and L-Malic acid							30.11.89
	Ammonium dihydrogen orthophosphate							30.11.89
	di Ammonium hydrogen orthophosphate							30.11.89
E 339 (i)	Sodium dihydrogen orthophosphate							30.11.89
E 339(ii)	di Sodium hydrogen orthophosphate		All pets with the exception of cats and dogs					30.11.89
339 (iii)	tri Sodium orthophosphate							30.11.89
E 340 (i)	Potassium dihydrogen orthophosphate							30.11.89
E 340 (ii)	di Potassium hydrogen orthophosphate							30.11.89
E 341 (i)	Calcium tetrahydrogen diorthophosphate							30.11.89
E 341 (ii)	Calcium hydrogen orthophosphate							30.11.89
350 (i)	Sodium malate (salt of DL or L-Malic acid)						30.11.89
E 450(a)(i)	di Sodium dihydrogen diphosphate		—	—	—		30.11.89
E 450 a (iii)	tetra Sodium diphosphate							30.11.89
E 450 (a) (iv)	tetra Potassium diphosphate							30.11.89
E 450 (b) (i)	penta Sodium triphosphate							30.11.89
E 450 (b) (ii)	penta Potassium triphosphate							30.11.89
500 (i)	Sodium carbonate							30.11.89
500 (ii)	Sodium hydrogen carbonate		All pets with the exception of cats and dogs					30.11.89
500 (iii)	Sodium sesquicarbonate							30.11.89
501 (ii)	Potassium hydrogen carbonate							30.11.89
503 (i)	Ammonium carbonate							30.11.89
503 (ii)	Ammonium hydrogen carbonate							30.11.89
507	Hydrocloric acid							30.11.89
510	Ammonium chloride							30.11.89
513	Sulphuric acid							30.11.89
524	Sodium hydroxide							30.11.89
529	Calcium oxide							30.11.89
540	di Calcium diphosphate						30.11.89

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.