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

(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.

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

(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".

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.

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,

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.

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,

or

( 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

/images/si049y89p0029b.gif

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

/images/si049y89p0029c.gif

100: alone or together

E311

Octyl gallate

C15H22O5

E312

Dodecyl gallate

C19H30O5

E320

Butylated hydroxyanisole (BHA)

C11H16O2

/images/si049y89p0029d.gif

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

/images/si049y89p0030a.gif

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

/images/si049y89p0030b.gif

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

/images/si049y89p0031a.gif

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

/images/si049y89p0031c.gif

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

/images/si049y89p0032a.gif

All feedingstuffs

E460

Microcrystalline cellulose

/images/si049y89p0032b.gif

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)

/images/si049y89p0033a.gif

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

/images/si049y89p0034a.gif

12000

36000

E491

Sorbitan monostearate

/images/si049y89p0034d.gif

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

/images/si049y89p0034e.gif

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

/images/si049y89p0035.gif

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

/images/si049y89p0037a.gif

All species or categories of animals

All feedingstuffs

E201

Sodium sorbate

C6H7O2Na

E202

Potassium sorbate

C6H7O2K

E203

Calcium sorbate

C12H14O4Ca

E214

Ethyl 4-hydroxybenzoate

C9H10O3Na

/images/si049y89p0037c.gif

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

/images/si049y89p0037d.gif

Dogs, cats

  —

Separately or together: 500 expressed as SO2

E223

Sodium metabisulphite

Na2S2O5

 —

E236

Formic Acid

CH2O2

 —

E237

Sodium formate

CHO2Na

/images/si049y89p0037h.gif

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

/images/si049y89p0038a.gif

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

/images/si049y89p0039a.gif

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

/images/si049y89p0040a.gif

All feedingstuffs

Other species or categories of animals

2. Vitamin D

Pigs

2,000

/images/si049y89p0040b.gif

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

/images/si049y89p0041.gif

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

/images/si049y89p0042.gif

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

/images/si049y89p0043.gif

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

/images/si049y89p0044.gif

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

/images/si049y89p0045.gif

— 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

/images/si049y89p0046.gif

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

/images/si049y89p0047a.gif

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

/images/si049y89p0048a.gif

All species or categories of animals

All feedingstuffs.

Compliance with porvisions of Regulation 21

E470

Sodium, potassium

C18H35O2Na,

/images/si049y89p0048b.gif

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

/images/si049y89p0050a.gif

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

/images/si049y89p0051.gif

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

/images/si049y89p0052.gif

 

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

/images/si049y89p0054.gif

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

/images/si049y89p0054.gif

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.