EUROPEAN COMMUNITIES (ADDITIVES IN FEEDINGSTUFFS) REGULATIONS 1989

I, MICHAEL O'KENNEDY, Minister for Agriculture and Food, in exerciseof the powers conferred on me by section 3 of the EuropeanCommunities Act, 1972 (No. 27 of 1972), and for the purpose ofgiving effect to the Council Directive No. 70/524/EEC of 23November, 1970(1), as amended by Council Directive No. 73/103/EEC of28 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), CommissionDirective No. 85/520/EEC of 11 November, 1985(6), Commission DirectiveNo. 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 of28 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), CouncilDirective No. 87/317/EEC of 16 June, 1987(13), Commission DirectiveNo. 87/552/EEC of 17 November, 1987(14), Commission Directive No.88/228/EEC of 8 April, 1988(15), Commission Directive No. 88/483/EECof 14 July, 1988(16), Commission Directive No. 88/616/EEC of 30November, 1988(17) and Commission Directive No. 89/23/EEC of 21December, 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.

REG 1

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 intooperation on the 1st day of May, 1989.(3) Regulation 7 of these Regulations shall come into operation onthe 1st day of June, 1989.

REG 2

2. (1) In these Regulations:"additive licence" means a licence granted under Regulation 6 ofthese Regulations;"authorised officer" means a person authorised by the Minister to bean authorised officer for the purposes of these Regulations;"Council Directive" means Council Directive No. 70/524/EEC of 23November, 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), CouncilDirective 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 of11 November, 1985(6), Commission Directive No. 86/29/EEC of 5February, 1986(7), Second Commission Directive No. 86/300/EEC of 4June, 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), CouncilDirective 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/EECof 17 November, 1987(14), Commission Directive No. 88/228/EEC of 8April, 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 21December, 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 thedefinition of an additive in the Council Directive and may beclassified as an antibiotic, growth promoter, coccidiostat and othermedicinal substance;"the Minister" means the Minister for Agriculture and Food;"official methods of analysis" means a method of analysis specifiedin the European Communities (Feeding Stuffs) (Methods of Analysis)Regulations, 1978 to 1985;"State Chemist" means the head of the State Laboratory or a personauthorised in writing by him to perform the functions assigned tothe State Chemist under these Regulations.

(2) A word or expression that is used in these Regulations and isalso used in the Council Directive shall, unless the contraryintention appears, have in these Regulations the same meaning thatit has in the Council Directive.

REG 3

3. (1) A person shall not market additives for use in pre-mixturesor feedingstuffs unless—(a) the additive is mentioned in the First or Second Schedule tothese Regulations or is a medicinal additive for which an additivelicence has been granted under Regulation 6 of these Regulations,and(b) the additive complies with the conditions, if any, mentioned inrespect of the particular additive in the First or Second Scheduleto these Regulations or, in the case of a medicinal additive forwhich an additive licence has been granted, it complies with theconditions set out in that licence.(2) A person shall not incorporate an additive in a premixture orfeedingstuff, or use an additive for the purposes of animal feedingunless—(a) the additive is mentioned in the First or Second Schedule tothese Regulations or the additive is a medicinal additive for whichan additive licence has been granted, and(b) the additive is incorporated in the premixture or feedingstuffsin accordance with the provisions, if any, in respect of the saidadditive in the said Schedules or, in the case of a medicinaladditive, in accordance with the conditions set out in that additivelicence.(3) A person shall not incorporate an additive mentioned in theFirst or Second Schedule to these Regulations in a straightfeedingstuff unless such incorporation is expressly provided for incolumn (8) of either of the said Schedules in respect of thatstraight feedingstuff.(4) A person shall not market an additive specified in the SecondSchedule to these Regulations or a medicinal additive for which anadditive licence has been granted, or incorporate such an additivein a premixture or feedingstuff, or use such an additive for thepurposes of animal feeding, unless the period of authorisation, ifany, in respect of that additive specified in column (9) of thesaid Schedule or in the said additive licence, has not expired.

REG 4

4. (1) Subject to paragraph (2) of this Regulation, a person shallnot mix additives specified in the First or Second Schedule tothese Regulations or medicinal additives for which an additivelicence has been granted unless, in relation to the effects desired,there is physical and chemical compatibility between the componentsof the mixture.(2) A person shall not mix—(a) antibiotics and growth promoters together, either with substancesfrom their own group or with substances from the other group; or

(b) any coccidiostats with antibiotics and growth promoters wheresuch coccidiostats also act, for the same category of animal, as anantibiotic or a growth promoter; or(c) coccidiostats and other medicinal substances if their effects aresimilar,unless the mixture concerned is a mixture of medicinal additives forwhich an additive licence has been granted under Regulation 6(3) ofthese Regulations.(3) Where a maximum or minimum content is specified in the Firstor Second Schedule to these Regulations in respect of an additive,or, in the case of a medicinal additive, in the additive licencein respect of a feedingstuff, the maximum or minimum content shallbe construed so as to refer to complete feedingstuffs with amoisture content of 12 per cent, in so far as no special provisionis set out in the said Schedule or in the said additive licence.(4) Where a substance which is permitted as an additive exists alsoin the natural state in certain ingredients of the feedingstuff, theamount of additive to be incorporated shall be calculated so thatthe total of the elements added and the elements present naturallydoes not exceed the maximum content provided for in the First orSecond Schedule to these Regulations.(5) The Minister may exempt a person from the provisions ofRegulations 3 or 6 of these Regulations or paragraphs (1) and (2)of this Regulation for experimental or scientific purposes.

REG 5

5. (1) A person shall not market additives and premixtures otherthan 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 orcontainer which is so constructed that, if the means of fasteningthe package or container is damaged, the package or container cannotbe re-used.

REG 6

6. (1) This Regulation applies to medicinal additives.(2) A person shall not manufacture or import a substance to whichthis Regulation applies unless a licence (to be known and hereafterreferred to in these Regulations, as an "additive licence") has beengranted to him in that behalf under this Regulation and thesubstance is manufactured or imported in accordance with anyconditions in that licence.(3) The Minister may grant an additive licence in respect of eachof the following activities, namely, the manufacture or importationof any of the substances to which this Regulation applies on anapplication being made to him in that behalf by a person licencedunder Regulation 7(3) of these Regulations.(4) An additive licence shall not be granted under Paragraph (3) ofthis Regulation in respect of a substance to which this Regulationapplies 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 theCouncil Directive.(5) The Minister may revoke an additive licence granted under thisRegulation.(6) A person shall not manufacture, import or market a premixtureor compound feedingstuff containing a substance to which thisRegulation applies unless—(a) an additive licence has been granted under this Regulation inrespect of the substance,(b) the substance conforms with the provisions of such licence, and(c) the substance has been incorporated in the premixture orfeedingstuff in accordance with the conditions laid down in suchlicence.

REG 7

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

produced additive, premixture or feedingstuff.

REG 8

8. (1) A person shall not deliver medicinal additives tomanufacturers of premixtures or, subject to paragraph (2) of thisRegulation, manufacturers of compound feedingstuffs unless the saidmanufacturer is licensed under Regulation 7(3) of these Regulations.(2) A person shall not deliver medicinal additives to manufacturersof compound feedingstuffs unless the medicinal additives are in theform of premixture which comply with the requirements of Regulation9 of these Regulations.

REG 9

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

REG 10

10. (1) Subject to paragraph (2) of this Regulation, a person shallnot—(a) manufacture a supplementary feedingstuff for a species orcategory of animal unless the level of additives therein equals oris less than the permitted level of additives specified in theFirst or Second Schedule to these Regulations or, in the case of amedicinal additive, in the additive licence for a completefeedingstuff for that species or category of animal, or(b) feed a supplementary feedingstuff to a species or category ofanimal unless the level of additives therein equals or is less thanthe permitted level of additives specified in the First or SecondSchedule to these Regulations or, in the case of a medicinaladditive, in the additive licence for a complete feedingstuff forthat category of animal.(2) Where a supplementary feedingstuff is such that were it mixedwith other feedingstuffs prior to feeding, or fed as such inconjunction with other feedingstuffs, in accordance with instructionsissued by its manufacturer and printed on, or on a label attachedto, its packaging or, in case the supplementary feedingstuff isdelivered in bulk, on documents accompanying the feedingstuff, theresulting feedingstuff or the daily ration as appropriate wouldcomply with the requirements of Paragraph (1) of this Regulation,then the said requirements shall, as regards the supplementaryfeedingstuff, be regarded as having been complied with: provided thesupplementary feedingstuff has one or more characteristics (forexample, a feed or mineral block or the content of crude proteinor minerals) which in practice ensure that the level of additivesfixed for a complete feedingstuff for that species or category ofanimal is not exceeded and that the feedingstuff is not used for

other species of animals.

REG 11

11. (1) A person shall not market any of the additives specifiedin the First or Second Schedule to these Regulations or, in thecase of a medicinal additive, in the additive licence, unless theparticulars (which shall be clearly visible, readily legible andindelible) set out in paragraph (2) of this Regulation are set outon the package or container in which they are packed or on alabel 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 thisRegulation are set out on the package or container in which theadditives are packed or on a label attached thereto.(2) The particulars referred to in paragraph (1) of this Regulationto be displayed in respect of all additives shall be—(a) the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations or, in the case ofmedicinal additives, in accordance with the additive licence;(b) the name or business name and the address or registered placeof business of the person responsible for the particulars specifiedin this paragraph and paragraph (3) of this Regulation; and(c) the net weight and, in the case or liquid additives, eitherthe net volume or the net weight.(3) The particulars referred to in paragraph (1) of this Regulationsshall be in respect of—(a) antibiotics, growth promoters, coccidiostats and other medicinalsubstances:(i) the name or business name and the address or registered placeof business of the manufacturer if he is not responsible for theparticulars on the label,(ii) the active substance level,(iii) the expiry date of the guarantee or storage life from thedate of manufacture,(iv) batch reference number,(v) date of manufacture,(vi) the indication "to be used exclusively by manufacturers ofpremixtures for compound feedingstuffs".(vii) directions for use, and(viii) where appropriate, a safety recommendation regarding use inthe case of additives which are the subject of special provisionsin the additive licence;(b) vitamin E: the alpha-tocopherol level and expiry date of theguarantee of that level or storage life from the date ofmanufacture;(c) vitamins (other than vitamin E), provitamins and substanceshaving a similar effect: the active substance level and expiry dateof the guarantee of that level or storage life from the date ofmanufacture;(d) trace elements, colourants including pigments, preserving agentsand other additives: the active substance level; and(e) the additives referred to in sub-paragraphs (b), (c) and (d) ofthis paragraph: the indication: "to be used exclusively in the

manufacture of feedingstuffs".

REG 12

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

REG 13

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

REG 14

14. (1) A person shall not market premixtures unless the particulars(which shall be clearly visible, readily legible and indelible)specified in paragraphs (2) and (3) of this Regulation are given onthe package or container in which the premixtures are packed or ona label affixed thereto.(2) The particulars referred to in paragraph (1) of this Regulationin respect of premixtures shall be—( a ) the description "premixture";( b ) the indication "to be used exclusively in the manufacture offeedingstuffs", except for the premixtures referred to in paragraph(3) (a), of this Regulation;( c ) directions for use, and any safety recommendations regardingthe use of the premixtures;( d ) the animal species or category of animal for which thepremixture is intended;( e ) the name or business name and the address or registeredplace of business of the person responsible for the particularsreferred to in this paragraph and paragraph (3) of this Regulation;and( f ) the net weight and, in the case of liquids either the netvolume 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 othermedicinal substances:

(i) the name or business name and the address or registered placeof business of the manufacturer if he is not responsible for thedetails on the label,(ii) the specific name of the additive being the name used in theadditive licence,(iii) the active substance level,(iv) the expiry date of the guarantee of that level or storagelife from the date of manufacture, and(v) the indication "to be used exclusively by manufacturers ofcompound feedingstuffs";( b ) substances having antioxidant effects:(i) the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations, and(ii) the active substance level: provided that a maximum level isfixed for complete feedingstuffs in the First or Second Schedule tothese Regulations;( c ) colourants, including pigments:(i) the specific name of the additive, if any, being the name usedin the First or Second Schedule to these Regulations and if noname is given the common chemical name of the additive, and(ii) the active substance level: provided that a maximum level isfixed for complete feedingstuffs in the First or Second Schedule tothese Regulations;( d ) vitamin E:(i) the specific name of the additive, if any, being the name usedin the First or Second Schedule to these Regulations and if noname 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 storagelife from the date of manufacture;( e ) vitamins (other than vitamin E), provitamins and substanceshaving a similar effect:(i) the specific name of the additive, if any, being the name usedin the First or Second Schedule to these Regulations or the commonchemical name of the additive where no such name is given in thesaid Schedules.(ii) the active substance level, and(iii) the expiry date of the guarantee of that level of storagelife from the date of manufacture;( f ) trace elements:(i) the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations, and(ii) the level of the various elements in so far as a maximumlevel is fixed for complete feedingstuffs in the said Schedules;( g ) preserving agents:(i) the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations, and(ii) the active substance level, provided that a maximum level isfixed for complete feedingstuffs in the said Schedules;( h ) other additives belonging to the groups referred to inparagraphs (b) to (g) of this Regulation for which no maximum levelis laid down for complete feedingstuffs in the First or SecondSchedule to these Regulations, and additives belonging to othergroups 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 thereis no name, the common chemical name of the additive, and(ii) the active substance level: provided that these additives fulfila function in the feedingstuff as such and the amounts present canbe determined by official methods of analysis or, failing this, byvalid scientific methods.

REG 15

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

REG 16

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

REG 17

17. (1) A person shall not market feedingstuffs incorporatingmedicinal additives unless the particulars (which shall be clearlyvisable and readily legible and indelible) set out in paragraph (2)of this Regulation are given on the package, the container or alabel affixed thereto.(2) The particulars referred to in paragraph (1) of this Regulationare(i) the specific name of the additive being the name used in theadditive licence,(ii) the active substance level,(iii) the expiry date of the guarantee of that level or storagelife from the date of manufacture and(iv) particulars concerning the proper use of the feedingstuff ifthere are any specified in the additive licence.

REG 18

18. (1) A person shall not market feedingstuffs incorporatingsubstances having antioxidant effects unless the particulars (whichshall be clearly visible and readily legible and indelible) set outin paragraph (2) of this Regulation in the case of pet foods, andin paragraph (3) of this Regulation in the case of feedingstuffsother than pet foods, are given on the package, container or alabel affixed thereto.(2) The particulars referred to in paragraph (1) of this Regulationare the words "With antioxidant" followed by the specific name ofthe additive being the name used in the First or Second Scheduleto these Regulations.(3) The particulars referred to in paragraph (1) of this Regulationare the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations.

REG 19

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

REG 20

20. (1) A person shall not market feedingstuffs incorporating vitaminA, vitamin D, vitamin E or copper unless the particulars (whichshall be clearly visible and readily legible and indelible) set outin 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 Regulationare the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations, and(i) in the case of vitamins A and D, the active substance leveland the expiry date of the guarantee of that level or storage lifefrom the date of manufacture,(ii) in the case of vitamin E, the alpha-tocopherol level and theexpiry date of the guarantee of that level or storage life fromthe date of manufacture, and

(iii) in the case of copper, the level expressed as Cu.

REG 21

21. (1) A person shall not market feedingstuffs incorporatingpreserving agents unless the particulars (which shall be clearlyvisible 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 petfoods, are given on the package, container or on a label affixedthereto.(2) The particulars referred to in paragraph (1) of this Regulationare the words "preservative" or "preserved with" followed by thespecific name of the additive being the name used in the First orSecond Schedule to these Regulations.(3) The particulars referred to in paragraph (1) of this Regulationare the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations.

REG 22

22. (1) Without prejudice to the generality of Regulation 20 ofthese Regulations, in the case of feedingstuffs incorporating traceelements (other than copper) and vitamins (other than vitamins A, Dand E), provitamins and additives having a similar effects, theparticulars (which shall be clearly visible and readily legible andindelible) set out in paragraph (2) of this Regulation in the caseof trace elements (other than copper) and the particulars set outin paragraph (3) of this Regulation in respect of vitamins (otherthan vitamins A, D and E) provitamins and substances having asimilar chemical effect, may be given on the package, container oron a label affixed thereto: provided the amounts of those additivescan be determined by official methods of analysis or by validscientific methods.(2) The particulars referred to in paragraph (1) of this Regulationare the specific name of the additive being the name used in theFirst or Second Schedule to these Regulations and the level of thevarious elements.(3) The particulars referred to in paragraph (1) of this Regulationare the specific name of the additive, if any, being the name usedin the First or Second Schedule to these Regulations or the commonchemical name if there is no name used in either of the saidSchedules, the active substance level and the expiry date of theguarantee of that level or storage life from the date ofmanufacture.

REG 23

23. (1) The information required or allowed to be printed underRegulations 17, 18, 19, 20, 21, or 22 of these Regulations shallbe printed close to the particulars which have to appear on thepackage, 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 theamount of additive incorporated in the feedingstuff.(3) Nothing in Regulations 17, 18, 19, 20, 21 or 22 of theseRegulations shall prohibit the printing on any package, container orlabel affixed thereto of the EEC number or trade name of anadditive.

REG 24

24. (1) Where feedingstuffs are distributed by road tankers orsimilar vehicles or in bulk the details provided for in Regulations17, 18, 19, 20, 21 or 22 shall be given in a documentaccompanying the feedingstuffs.(2) Where small quantities of feedingstuffs that are intended forthe end-user are involved, it shall be sufficient for the detailsprovided for in Regulations 17, 18, 19, 20, 21 or 22 of theseRegulations to be conveyed to the purchaser by a special notice.

REG 25

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

REG 26

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

REG 27

27. (1) Without prejudice to the provisions of the EuropeanCommunities (Marketing of Feedingstuffs) Regulations, 1984 (S.I. No.200 of 1984) and Regulation 10 of these Regulations, a person shallnot place on the market supplementary feedingstuffs which containadditives in excess of the maximum levels fixed for completefeedingstuffs unless the directions for use state, according to thespecies and age of the animal, the maximum quantity in grams orkilogramms of supplementary feedingstuff to be given to each animal

each day and this information shall comply with the provisions ofthe First or Second Schedule to these Regulations or, in the caseof medicinal additives, the additive licence.(2) This Regulation shall not apply to products delivered tomanufacturers of compound feedingstuffs or to their suppliers.(3) The declaration referred to in paragraph (1) of this Regulationshall be so formulated that, when it is correctly followed, theproportion of additives does not exceed the maximum level fixed forcomplete feedingstuffs.

REG 28

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

REG 29

29. (1) The Minister may appoint persons to be authorised officersfor the purposes of these Regulations and may revoke any suchappointment.(2) An authorised officer shall be furnished with a warrant ofappointment and when visiting any premises to which these Regulationsapply shall, if so required, produce the warrant to the occupier orany other person holding a responsible position of management at thepremises.

REG 30

30. An authorised officer may at all reasonable times enter—( a ) any premises in which he has reasonable grounds forbelieving that there are additives, premixtures or feedingstuffs,( b ) any railway wagon, vehicle, ship, vessel or aircraft inwhich he has reasonable grounds for believing that additives,premixtures or feedingstuffs are either being transported or kept forthe 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 orfeedingstuffs which he finds in the course of his inspection,as he may consider appropriate for the purpose of these Regulationsand the Council Directive.

REG 31

31. (1) Where a person has on his premises any additive, premixtureor feedingstuff which he has purchased and which he proposes to usein the course of his farming operations, he may apply to theMinister 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 dateon which the additive, premixture or feedingstuff to which theapplication relates was delivered to the applicant, and( b ) accompanied by a fee which shall be calculated by referenceto the Fourth Schedule to these Regulations.(3) Where an application is made under this Regulation, anauthorised officer shall, subject to paragraph (4) of thisRegulation—( a ) take and deal with a sample of the relevant additive,premixture or feedingstuff according to the methods described in theAnnex 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 orby such other method as for the time being stands approved of forthe purposes of this paragraph by the Minister, to the StateChemist and to the person whose name or trade name appears on thelabel of the additive, premixture or feedingstuff or, in the caseof an imported additive, premixture or feedingstuff, the importer,samples prepared pursuant to the requirements of subparagraph (a) ofthis paragraph.(4) Where an application is made under this Regulation, anauthorised officer may, if he thinks fit, decline to take a sampleif—( a ) he is not satisfied that the applicant has purchased theadditive, premixture or feedingstuff to which the application relates,or( b ) he is not satisfied that the applicant proposes to use theadditive, premixture or feedingstuff in the course of his farmingoperations,or( c ) he is not satisfied that the additive, premixture orfeedingstuff as presented for sampling is fairly representative ofthe additive, premixture or feedingstuff as delivered to theapplicant,or( d ) the applicant does not furnish such information relating tosuch additive, premixture or feedingstuff as the authorised officermay reasonably require.(5) Where the State Chemist receives a sample taken in pursuance ofan application under this Regulation, he shall, in making ananalysis thereof, comply with such official methods of analysis asapply in the particular case and send to the applicant and to theperson (other than the State Chemist) referred to in paragraph(3)(b) of this Regulation a certificate, in the form set out inthe European Communities (Feeding Stuffs) (Methods of Analysis(Amendment) and Methods of Sampling) Regulations, 1980 (S.I. No. 14of 1980), of the result of the analysis.(6) Subject to paragraph (8) of this Regulation, all fees underthis Regulation shall be paid into or disposed of for the benefitof the Exchequer in accordance with the directions of the Ministerfor Finance.(7) Nothing in this Regulation shall be construed as requiring theState Chemist to make a test, examination or analysis regarding thepresence in or absence from a sample given or sent to him pursuantto these Regulations of any particular substance, product or other

thing, if in his opinion there is not in relation to such presenceor absence a method of testing, examination or analysis which issufficiently reliable or if there is not available to the StateChemist 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 (notbeing a case in which the applicant has received a certificateunder this Regulation), the Minister may refund a fee paid inrelation to an application under this Regulation.(9) For the purpose of this Regulation a feedingstuff shall not beregarded as having been delivered to a purchaser until it arrivesat the destination to which it is consigned whether the consignmentis by direction of the supplier or the purchaser.

REG 32

32. Every person who carries on, or is employed in connection with,the placing on the market of additives, premixtures of feedingstuffsshall—( a ) Keep records of his transactions in such additives,premixtures of feedingstuffs; and, in the case of medicinal additivesor premixtures and feedingstuffs containing medicinal additives, suchrecords shall include the information required by the Third Scheduleto these Regulations;( b ) produce at the request of an authorised officer any books,documents or records relating to such business which are in thepossession or under the control of such person;( c ) permit an authorised officer to inspect and take extractsfrom such books, documents or records and give to the officer anyinformation which he may reasonably require in relation to anyentries therein;( d ) afford to an authorised officer reasonable facilities forinspecting the stock of any additives, premixtures of feedingstuffswhich is for the time being on any premises on which such personcarried on such a business;and( e ) give to an authorised officer any information he mayreasonably require in relation to such transactions including inparticular information which he may reasonably require regarding anyadditive, premixture of feedingstuff which is specified by him.

REG 33

33. Where an authorised officer is satisfied that an additive,premixture or feedingstuff which is placed on the market, or whichhe believes will be placed on the market, does not comply with anyone or more of the requirements of these Regulations, he mayrequire either or both of the following persons, namely, the personwho appears to him to have, for the time being, possession orcontrol of the additive, premixture or feedingstuff, and the personwhose name or trade name appears on the label of the additive,premixture or feedingstuff to take such steps as are necessary toensure that it does not continue to be placed on the market, or

as may be appropriate, is not placed on the market until suchauthorised officer is satisfied that the requirement is compliedwith.

REG 34

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

REG 35

35. Where a sample of an additive, premixture or feedingstuff istaken pursuant to these Regulations by an authorised officer, aperson shall not move the additive, premixture or feedingstuff, asthe case may be, during the period of seven working daysimmediately following the day on which the sample is taken, withoutthe consent of an authorised officer and, where a consent underthis Regulation is given, a person shall not move the additive,premixture or feedingstuff concerned other than in accordance withthe terms and conditions of the consent.

REG 36

36. (1) Where in any proceedings for an offence in which acontravention of these Regulations is alleged the defendant claimsthat the additive claims that the additive, premixture orfeedingstuff to which the alleged offence relates was exempted fromthese Regulations by reason of Regulations 4(5) and 40 of theseRegulations, the onus of proving that such additive, premixture orfeedingstuff 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, orof any report on, a sample taken under these Regulations may begiven if, and only if, it is proved that—( a ) the sample was taken and dealt with in accordance with themethods 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 finalsamples prepared pursuant to the requirements of the said Annex wasgiven or caused to be given to the defendant and to the StateChemist or sent or given to them by registered post or by suchother 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 inaccordance with such official methods of analysis as applied in theparticular case.(3) In any legal proceedings, other than proceedings to whichparagraph (2) of this Regulation applies, evidence, being evidencewhich relates to an issue regarding the accuracy of a declarationrequired to be made by these Regulations, of the result of anytest, examination of analysis of a sample of an additive, premixtureor feedingstuff may be given if, and only if, it is proved that—( a ) the sample was taken and dealt with in accordance with themethods referred to in paragraph (2) (a) of this Regulation,( b ) before the proceedings were instituted one of the finalsamples prepared pursuant to the requirements of paragraph (2) (a)of this Regulation was given or caused to be given to the partyto the proceedings against whom it is sought to adduce suchevidence, or sent or given to him by registered post or by suchother method which is a method referred to in paragraph (2) (b) ofthis Regulation, and( c ) the test, examination or analysis was carried out inaccordance with such official methods of analysis as applied in theparticular case.

REG 37

37. In any legal proceedings the production of a certificate in theform specified in these Regulations and purporting to be signed bythe State Chemist shall, without proof of any signature on thecertificate or that the signatory was the proper person to sign it,be sufficient evidence of the facts stated in the certificate andof the analysis to which it relates having been carried out inaccordance with such of the requirements (if any) specified in theofficial methods of analysis as applied in the particular case.

REG 38

38. (1) The Minister shall direct an authorised officer, from timeto time, to take random samples of additives, premixtures andfeedingstuffs to establish the identity of additives and to vertifythat the conditions laid down in these Regulations are satisfied.(2) A person intending to manufacture additives (other than medicinaladditives) or place them on the market shall inform the Minister ofhis intention in writing to manufacture additives or place additiveson the market.

REG 39

39. A person shall not pack or export additives, premixtures orfeedingstuffs for use in other Member States unless the detailsreferred to in Regulations 11 to 27 of these Regulations are givenin at least one of the official languages of the country ofdestination.

REG 40

40. These Regulations shall not apply to additives, premixtures andfeedingstuffs for export to countries which are not Member States ofthe European Economic Community.

REG 41

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

REG 42

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

REG 43

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

REG 44

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

FIRST SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)A. AntioxidantsAllspecies or categories of animalsAll feedingstuffsE300L-AscorbicacidC6H8O6———E301Sodium L-ascorbateC6H7O6Na———E302CalciumL-ascorbate(C6H7O6)2Ca. 2H2O———E3035, 6-Diacetyl-L-ascorbicacidC10H12O8———E3046-Palmitoyl-L-ascorbic acidC22H38O7E306Tocopherol-richextracts of natural origin————E307Syntheticalpha-tocopherolC29H50O2———E308Syntheticgamma-tocopherolC28H48O2———E309Syntheticdelta-tocopherolC27H46O2———E310Propyl gallateC10H12O5——100: alone ortogetherE311Octyl gallateC15H22O5——E312DodecylgallateC19H30O5——E320Butylated hydroxyanisole (BHA)C11H16O2——150: alone ortogetherE321Butylated hydroytoluene (BHT)C15H24O——E324EthoxyquinC14H19NO——Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)B. Aromatic substancesand appetising substances1.All natural products and correspondingsynthetic products—All species or categories of animals————2.Artificialsubstances:SaccharinC7H5NO3SPiglets4 Months—150CalciumsaccharinC7H3NCaO3SPiglets4 Months—150Sodium saccharinC7H4NNaO3SPiglets4Months—150—C. Emulsifiers, stabilisers, thickeners and gellingagentsE322Lecithins—All species or categories of animals———E400Alginicacid———All feedingstuffsE401Sodium alginate————E402Potassiumalginate————E403Ammonium alginate—All species or categories of animalswith the exception of aquarium fish———E404Calciumalginate————E405Propane-1, 2-diol alginate (Propylene glycolalginate)—All species or categories of animals———Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E406Agar————AllfeedingstuffsE407Carrageenan————E408Furcellaran———E410Locust bean gum(Carob gum)————E411Tamarind seed flour————E412Guargum————E413Tragacanth————E414Acacia (Gum arabic)————E415Xanthan gum—Allspecies or categories of

animals———E420Sorbitol————E421Mannitol————E422Glycerol————E432Polyoxyethylene(20)-sorbitanmonolaurate———5000 alone or with the other poly-sorbatesMilk ReplacersonlyE433Polyoxyethylene(20)-sorbitan monooleate———E434Polyoxyethylene(20)-sorbitan momopalmitate———E435Polyoxyethylene(20)-sorbitanmonostearate———E436Polyoxyethylene(20)-sorbitantristearate———E440Pectins————All feedingstuffsMinimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E450 b(i)Pentasodiumtriphosphate—Dogs, cats——5,000All feedingstuffsE460Microcrystallinecellulose—All species or categories ofanimals———E461Methylcellulose————E462Ethylcellulose————E463Hydroxypropylcellulose————E464Hydroxypropylmethylcellulose————E465Ethylmethylcellulose————E466Carboxymethylcellulose(sodium salt of carboxymethyl ether of cellulose)————E470Sodium,potassium and calcium salts of edible fatty acids, alone or inmixtures, derived either from edible fats or from distilled ediblefatty acids————E471Mono- and diglycerides of fatty acids————E472Mono-anddiglycerides of edible fatty acids esterified with the followingacids:(a) acetic————(b) lactic————(c) citric————(d) tartaric————(e)Mono-and diacetyltartaric————Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E473Sucrose esters offatty acids (esters of saccharose and edible fatty acids)—All speciesor categories of animals———All feedingstuffsE474Sucroglycerides (mixtureof esters of saccharose and mono-aand diglycerides of edible fattyacids)————E475Polyglycerol esters of non-polymerised edible fattyacids————E477Mono-esters of propane-1,2-diol (propyleneglycol) and ediblefatty acids, alone or in mixtures withdiesters————E480Stearoyl-2-lactylic acid————E481Sodiumstearoyl-2-lactylate————E482Calcium stearoyl-2-lactylate————E483Stearyltartrate————E484Glyceryl polyethyleneglycolricinoleate————E485Dextrans————E487Polyethyleneglycol ester of fatty acidsfrom soya oil—Calves——6000Milk replacers onlyE488Polyoxyethylatedglyceride of tallow fatty acids—Calves——5000Milk replacers onlyMinimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E489Ether ofpolyglycerol and of alcohols obtained by the reduction of oleic andpalmitic acids—Calves——5000Milk replacers onlyE490Propane-1,2-diol—Dairycows Cattle for fattening, calves, lambs, kids, pigs,poultry——12000——36000E491Sorbitan monostearate—All species or categoriesof animals———E492Sorbitan tristearate————E493Sorbitanmonolaurate————E494Sorbitan monooleate————E495Sorbitanmonopalmitate————E496Polyethylene glycol6000———300E497Polyoxpropylene-polyoxethylene polymers (M.W.6800-9000)———50E498Partial polyglycerol esters of polycondensed fattyacids of castor oil—Dogs———All feedingstuffsD. Colouring mattersincluding pigments1. Carotenoids andxan-thophylls:E160cCapsanthinC40H56O3——80 (alone or with the othercarotenoids and xanthopylls)—E160ebeta-Apo-8'-carotenalC30H40O———E160fEthylester of beta-apo-8'-carotenoic

acidC32H44O2Poultry——E161bLuteinC40H56O2———E161cCryptoxanthinC40H56O———E161eViolaxanthinC40H56O4———Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOtherprovisions(1)(2)(3)(4)(5)(6)(7)(8)E161gCanthaxanthinC40H52O2(a) Poultry———(b)Dogs, cats————(c) Salmon, trout——80Use permitted from the age of 6monthsonwardsE161hZeaxanthinC40H56O2Poultry——E161iCitranaxanthinC33H44OLayinghens——80 (alone or with the other carotenoids and xanthophylls)E1312.1Patent Blue VCalcium salt of the disulphonic acid ofm-hydroxytetraethyldiamino triphenylcarbinol anhydride(a) All species orcategories of animals with the exception of dogs and cats———Permittedin animal feedingstuffs only in products processed from: (i) wasteproducts of foodstuffs, (ii) denatured cereals or manioc flour, or(iii) other base substances denatured by means of these agents orcoloured during technical preparation to ensure the necessaryidentification during manufacture(b) Dogs and cats————Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E1422.2 Acid brilliantgreen BS (Lissamine Green)Sodium salt of 4,4'-bis (dimenthylamino)diphenylmethylene-2-naphtol-3, 6-disulphonic acid(a) All species orcategories of animals with the exception of dogs and cats———Permittedin animal feedingstuffs only in products processed from: (i) wasteproducts of foodstuffs, (ii) denatured cereals or manioc flour, or(iii) other base substance denatured by means of these agents orcoloured during technical preparation to ensure the necessaryidentification during manufacture(b) Dogs and cats————3. All colouringagents authorized for colouring foodstuffs by the Health (ColouringAgents in Food) Regulations, 1973, as amended, other than thosealready covered by 2.1 and 2.2—(a) All species or categories ofanimals with the exception of dogs and cats———Permitted in animalfeedingstuffs only in products processed from: (i) waste products offoodstuffs, or (ii) other base substances, with the exception ofcereal and manioc flour, denatured by means of these agents orcoloured during technical preparation to ensure the necessaryidentification during manufacture(b) Dogs and cats————Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E.PreservativesE200Sorbic acidC6H8O2All species or categories ofanimals———All feedingstuffsE201Sodium sorbateC6H7O2Na———E202PotassiumsorbateC6H7O2K———E203Calcium sorbateC12H14O4Ca———E214Ethyl4-hydroxybenzoateC9H10O3NaPets———E215Sodium ethyl4-hydroxybenzoateC9H9O3Na———E216Propyl 4-hydroxybenzoateC10H12O3———E217Sodiumpropyl 4-hydroxybenzoateC10H12O3Na———E218Methyl4-hydroxybenzoateC8H8O3———E219Sodium methyl4-hydroxybenzoateC8H7O3Na———E222Sodium bisulphiteNaHSO3Dogs, cats——Separately or together: 500 expressed as SO2All feedingstuffs exceptunprocessed meat and fishE223Sodium metabisulphiteNa2S2O5— —E236FormicAcidCH2O2— ——All feedingstuffsE237Sodium formateCHO2NaAll species orcategories of animals— ——E238Calcium formateC2H2O4Ca— ——Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of complete

feedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E240FormaldehydeCH2OPigs6months——Skimmed milk only: maximum content: 600 mg/kgAll species andcategories of animals———For silage onlyE250Sodium nitriteNaNO2Dogs,cats——100Canned feedingstuffs onlyE260Acetic acidC2H4O2All species orcategories of animals———All feedingstuffsE261PotassiumacetateC2H3O2K———E262Sodium diacetateC4H7O4Na———E263CalciumacetateC4H6O4Ca———E270Lactic acidC3H6O3———E280PropionicacidC3H6O2———E281Sodium propionateC3H5O2Na———E282CalciumproprionateC6H10O4Ca———E283Potassium propionateC3H5O2K———E284AmmoniumpropionateC3H9O2N———E295Ammonium formateCH5O2N—E296DL-MalicacidC4H6O5———E297Fumaric acidC4H4O4———E325Sodium lactateC3H5O3Na———Minimum contentMaximum contentEEC No.AdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisions(1)(2)(3)(4)(5)(6)(7)(8)E326PotassiumlactateC3H5O3KAll species or categories of animals———E327CalciumlactateC6H10O6Ca———E330Citric acidC6H8O7———All feedingstuffsE331Sodiumcitrates————E332Potassium citrates————E333Calcium citrates————E334L-TartaricacidC4H6O6———E335Sodium L-tartrates————E336PotassiumL-tartrates————E337Potassium sodiumL-tartrateC4H6O6KNa.4H2O———E338OrthophosphoricacidH3PO4———E490Propane-1,2-diolC3H8O2Dogs——53000Cats——75000E507HydrochoricacidHC1All species or categories of animals———For silageonlyE513Sulphuric acidH2SO4All species or categories of animals———Forsilage onlyEEC No.AdditiveChemical formula, descriptionSpecies or category ofanimalMaximum ageMaximum content iu/kg of complete feedingstuff or ofthe daily rationOther provisionsF. Vitamins, provitamins and chemicallywell defined substances having a similar effectE6721. VitaminA—Chickens for fattening—20,000All feedingstuffsOther species orcategories of animals——2. Vitamin D—Pigs—2,000—Simultaneous use ofvitamin D3 prohibitedE670 Vitamin D2Piglets —10,000Milk replacersonlyBovines—4,000Ovines—4,000Calves—10,000Milk replacersonlyEquines—4,000—Other species or categories of animals with theexception of poultry—2,000—EEC No.AdditiveChemical formula, descriptionSpecies or category ofanimalMaximum ageMaximum content iu/kg of complete feedingstuff or ofthe daily rationOther provisionsE671Vitamin D3—Pigs—2,000—Simultaneoususe of vitamin D3 prohibitedPiglets—10,000Milk replacersonlyBovines—4,000Ovines —4,000Calves—10,000Milk replacersonlyEquines—4,000—Chickens for fattening —5,000—Turkeys—5,000—Otherpoultry —3,000—Other species or categories of animals—2,000—3. Allsubstances in the group except vitamins A and D—All species orcategories of animals——All feedingstuffsEEC No.ElementAdditiveChemical formulaMaximum content of the element inmg/kg of the complete feedingstuffOther provisions1 Trace elements 1250 (total)—E1Iron-Fe—Ferrous carbonateFeCO3—Ferrous chloride,tetrahydrate FeCl2. 4H2 O—Ferric chloride, hxahydrateFeCl3. 6H2O—Ferrous citrate, hexahydrateFe3 (C6 H5 O7 ) 2 .6H2O—FerrousfumarateFeC4 H2O4 —Ferrous lactate, trihydrateFe(C3H5O3)2.3H2O—FerricoxideFe2O3Ferrous sulphate monohydrateFeSO4.H2O Permitted only fordenaturing— in skimmed-milk powder and— in compound feedingstuffsmanufacture from denatured skimmed-milk powder Subject to the relevantprovisions of Commission Regulations(EEC) No 368/77 and (EEC) No443/77 Declaration of the amount of iron added, expressed as theelement, on the label or package or container of denatured

skimmed-milk powerEEC NoElementAdditiveChemical formulaMaximum content of the element inmg/kg of the complete feedingstuffOther provisionsFerrous sulphate,heptahydrateFeSO4.7H2O Permitted: (i) in denatured skimmed-milk powderand in compound feedingstuffs manufactured from denatured skimmed-milkpowder — Subject to the mandatory provisions of CommissionRegulations (EEC) No 368/77 and (EEC) No 443/77 — Declaration ofthe amount of iron added, expressed as the element, on the labelor package or container of denatured skimmed-milk powder (ii) incompound feedingstuffs other than those listed under (i)EEC No.ElementAdditiveChemical formulaMaximum content of the element inmg/kg of the complete feedingstuffOther provisionsE2Iodine — 1Calciumiodate, hexahydrateCa(IO3)2.6H2O40 (total)—Calcium iodate,anhydrousCa(IO3)2—Sodium iodideNal—Potassium iodideKl—E3Cobalt-Co10(total)Cobaltous acetate, tetrahydrateCo(CH3COO)2.4H2O—Basic cobaltouscarbonate2CoCO3.3Co(OH)2.H2O—Cobaltous chloride,hexahydrateCoCL2.6H2O—Cobaltous sulphate, heptahydrateCoSO4.7H2O—Cobaltoussulphate, monohydrateCoSO4.H2O—Cobaltous nitrate,hexahydrateCo(NO3)2.6H2O—E4Copper-CuCupric acetate,monohydrateCu(CH3COO)2.H2OPigs for fattening—Basic cupric carbonate,monohydrateCuCo3.Cu(OH)2.H2O— In Member States where the mean densityof the porcine population is equal to or higher than 175 pigs per100 ha of utilizable agricultural land—Cupric chloride, dihydrateCuCl22H2O—Cupric methionateCu(C3H10NO2S)2—Cupric oxideCuO —Cupricsulphate, pentahydrate CuSO4.5H2O— up to 16 weeks: 175 (total)— from17th week up to slaughter: 35 (total)EEC No.ElementAdditive Chemical formulaMaximum content of the elementin mg/kg of the complete feedingstuffOther provisions— In MemberStates where the mean density of the porcine population is lowerthan 175 pigs per 100 ha of utilizable agricultural land — up to16 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 completefeedingstuffs: 50 (total)Ovines: 15 (total)Other species or categoriesof animals: 35 (total)EEC No.ElementAdditiveChemical formulaMaximum content of the element inmg/kg of the complete feedingstuffOther provisionsCupric sulphate,monohydrateCuSO4.H2OPigs for fattening:Denatured skimmed-milk powderCupricsulphate, pentahydrateCuSO4.5H2Oand compound feedingstuffs— In MemberStates wheremanufactured from denatured skimmed-milk powder the meandensity of the porcine population is equal to or higher than 175pigs per 100 ha of utilizable agricultural land— Subject to therelevant provisions of Commission Regulations (EEC) No 368/77 and(EEC) No 443/77— up to 16 weeks: 175 (total) — from 17th week upto slaughter: 35 (total)Declaraton of the amount of copper addedexpressed as the element, on the label package container ofdenatured skimmed milk powder— In Member States where the meandensity of the porcine population is lower than 175 pigs per 100ha of utilizable agricultural land — up to 16 weeks: 175 (total) —from 17th week up to six months: 100 (total) — over six months upto slaughter: 35 (total)EEC No.ElementAdditiveChemical formulaMaximum content of the element inmg/kg of the complete feedingstuffOther provisionsBreeding pigs: 35(total)Ovines: 15 (total)Other species or categories of animals withthe exception of calves: 35 (total)E5Manganese — Mn250

(total)Manganous carbonateMnCO3Manganous chloride,tetrahydrateMnCl2.4H2OManganous hydrogen phosphate,trihydrateMnHPO4.3H2OManganous oxideMnOManganic oxideMn2O3Manganoussulphate, tetrahydrateMnSO4.H2OManganous sulphate,monohydrateMnSO4.H2OE6Zinc — Zn250 (total)Zinc lactate,trihydrateZn(C3H5O3)2.3H2OZinc acetate, dihydrateZn(CH3COO)2.2H2OZinccarbonateZnCO3Zinc chloride, monohydrateZnCl2.H2OZinc oxideZnOZincsulphate, heptahydrateZnSO4.7H2OZinc sulphate,monohydrateZnSO4.H2OE7Molybdenum — Mo2,5 (total)Ammoniummolybdate(NH4)4Mo7O24.4H2OSodium molybdateNa2MoO4.2H2oE8Selenium — Se0,5(total)Sodium seleniteNa2SeO3Sodium selenateNa2SeO4EEC No.AdditiveChemical formula, descriptionSpecies or category ofanimalMaximum ageMinimum contentMaximum contentOther provisionsmg/kg ofcomplete feedingstuff(1)(2)(3)(4)(5)(6)(7)(8)H. Binders, anti-cakingagents and coagulantsE330Citric acidC6H8O7All species or categories ofanimals——— All feedingstuffs.Compliance with porvisions of Regulation21E470Sodium, potassiumC18H35O2Na,———All feedingstuffsand calciumC18H35O2Kand———stearatesC36H70O4Ca———E516Calcium sulphate dihydrateCaSO4.2H2O——30000E551aSilicic acid, precipitated and dried———E551bColloidalsilica————E551cKieselgur (diatomaceous earth, purified)————E552Calciumsilicate, synthetic————E554Sodium, aluminosilicate,synthetic————E558Bentonite/montmorillonite———20 000All feedingstuffs.Mixing with additives from the groups of "antibiotics", "growthpromoters", "coccidiostats and other medicinal substances" isprohibited except in the case of: Tylosin phosphate,All species ofcategories of animalsMonensinsodium,Narasin,IpronidazoleLasalocidsodium,Avoparcin,Flavophospholipol,Salinomycinsodium,Ronidazole,Virginiamycin,Nicarbazin andRobenidineIndicationon the label of the specific name of the additive.E559Kaoliniticclays, free of asbestosNaturally occurring mixtures of mineralscontaining at least 65% complex hydrated aluminium silicates whosemain constituent is Kaolinite———E560Natural mixtures of steatite andchloriteNatural mixtures of steatite and chlorite free of asbestos.Minimum purity of the mixture: 85%All species———E561VermiculiteNaturalsilicate of magnesium, aluminium and iron, expanded by heating, freeof asbestos. Maximum fluorine content: 0.3%or categories ofanimals———All feedingstuffsE565Lignosulphonates————E599PerliteNaturalsilicate of sodium and aluminium, expanded by heating, free ofasbestos———I. Acidity regulatorsE170Calcium carbonate————296DL-and L-Malicacid—————Ammonium dihydrogen———orthophosphate—di Ammoniumhydrogen————orthophosphateE339(i)Sodium dihydrogenorthophosphate————E339(ii)di Sodium hydrogen orthophosphate————E339(iii)tri Sodium orthophosphateDogs, Cats————E340(i)Potassiumdihydrogen————orthophosphateE340(ii)di Potassiumhydrogen————orthophosphateE340(iii)tri Potassiumorthophosphate————E341(i)Calciumtetrahydrogen————diorthophosphateE341(ii)Calcium hydrogenorthophosphate————350(i)Sodium malate (salt of DL or L-Malic acid)————E450 (a) (i)di Sodium dihydrogen diphosphate E 450 (a) (i)di Sodiumdihydrogen diphosphateE 450 (a) (iii)tetra Sodium diphospate E 450(a) (iv)tetra Potassium diphosphate E 450 (b) (i)penta Sodiumtriphosphate E 450 (b) (ii)penta Potassium triphosphate 500 (i)Sodiumcarbonate 500 (ii)Sodium hydrogen carbonateDogs, cats 500 (iii)Sodiumsesquicarbonate 501 (ii)Potassium hydrogen carbonate 503 (i)Ammoniumcarbonate 503 (ii)Ammonium Hydrogen carbonate 507Hydrochloric acid

510Ammonium chloride 513Sulphuric acid 524Sodium hydroxide 529Calciumoxide 540di Calcium diphosphate

SECOND SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

Minimum contentMaximum contentNoAdditiveChemical formula,descriptionSpecies or category of animalMaximum agemg/kg of completefeedingstuffOther provisionsPeriod of authorisation(1)(2)(3)(4)(5)(6)(7)(9) C. Emulsifiers, stabilizers, thickeners andgelling agents 29Polyoxyethylene (20) sorbitan trioleate All speciesor categories of animals5000 (alone or with the polysorbates)Allfeedingstuffs30.11.89 D. Colouring matters including pigments5AstaxanthinC40H52O4Salmon, trout100 (alone or together withcanthaxanthin)use permitted from the age of 6 months onwards30.11.89E. Preservatives20Methylproprionic acidC4H8O2All species or categoriesof animals with the exception of laying hens1 0004 00030.11.89I.Acidity RegulatorsE 170Calcium carbonate————30.11.89296DL-and L-Malicacid30.11.89 Ammonium dihydrogen orthophosphate30.11.89di Ammoniumhydrogen orthophosphate30.11.89E 339 (i)Sodium dihydrogenorthophosphate30.11.89E 339(ii)di Sodium hydrogen orthophosphateAll petswith the exception of cats and dogs30.11.89 339 (iii)tri Sodiumorthophosphate30.11.89 E 340 (i)Potassium dihydrogenorthophosphate30.11.89 E 340 (ii)di Potassium hydrogenorthophosphate30.11.89 E 341 (i)Calcium tetrahydrogendiorthophosphate30.11.89 E 341 (ii)Calcium hydrogenorthophosphate30.11.89 350 (i)Sodium malate (salt of DL or L-Malicacid)30.11.89E 450(a)(i)di Sodium dihydrogen diphosphate———30.11.89E 450a (iii)tetra Sodium diphosphate30.11.89E 450 (a) (iv)tetra Potassiumdiphosphate30.11.89 E 450 (b) (i)penta Sodium triphosphate30.11.89 E450 (b) (ii)penta Potassium triphosphate30.11.89 500 (i)Sodiumcarbonate30.11.89 500 (ii)Sodium hydrogen carbonateAll pets with theexception of cats and dogs30.11.89 500 (iii)Sodiumsesquicarbonate30.11.89 501 (ii)Potassium hydrogen carbonate30.11.89 503(i)Ammonium carbonate30.11.89 503 (ii)Ammonium hydrogen carbonate30.11.89507Hydrocloric acid30.11.89 510Ammonium chloride30.11.89 513Sulphuricacid30.11.89 524Sodium hydroxide30.11.89 529Calcium oxide30.11.89 540diCalcium diphosphate30.11.89

THIRD SCHEDULE

Minimum conditions which must be fulfilled by manufacturers of theadditives, premixtures and compound feedingstuffs referred to inRegulation 7 and intermediaries trading in these substances.1. The manufacturer must possess the appropriate facilities andtechnical 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 necessaryfor the manufacture of additives, premixtures or compoundfeedingstuffs.3. The manufacturer must have access to appropriate means enablinghim 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 thedifferent additives, and the homogeneity and stability of additivesin the premixtures;( c ) in the case of compound feedingstuffs: the nature and levelof the additives and the homogeneous mixing of those additives inthe compound feedingstuff.4. Additives intended for the manufacture of premixtures andpremixtures intended for incorporation in compound feedingstuffs shallbe stored in such a way as to enable them to be easily identifiedand to avoid any confusion with other additives, premixtures ormedicinal substances, medicated feedingstuffs or feedingstuffs. Theyshall be stored in suitable places, which can be locked and whichare intended for the storage of these products.5. The manufacturer or, if the manufacturer is established in athird country, his agent established in the Community must recordthe following information:( a ) for additives: the nature, quantity of additives produced andthe respective dates of manufacture, and the names and address ofthe manufacturers of premixtures or intermediaries to whom theadditives have been delivered with an indication of the nature andquantity of additive delivered;( b ) for premixtures: the name of the manufacturers and thesuppliers, the nature and quantity of the additives used, the dateof manufacture, the name and address of the compound feedingstuffmanufacturers or intermediaries for whom the premixture is intendedand the nature and quantity of the premixture delivered;( c ) for compound feedingstuffs: the name and address of thesupplier of the premixture and of the manufacturer if the latter isnot the supplier, the nature and quantity of the premixture and theuse to which it has been put.6. Where the manufacturer delivers additives or premixtures to aperson other than a manufacturer of premixtures or compoundfeedingstuffs, that person and any subsequent intermediary shall bebound 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 orpremixtures and compound feedingstuffs containing additives shall becalculated 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 andFood.

EXPLANATORY NOTEThe Regulations which cover the marketing and use of additives infeedingstuffs consolidate existing legislation and implement additionalamendments made to Council Directive 70/524/EEC. The Regulationsrevoke the European Communities (Feedingstuffs) (Additives) Regulations, 1974 to 1987.