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.
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 into
operation on the 1st day of May, 1989.
(3) Regulation 7 of these Regulations shall come into operation on
the 1st day of June, 1989.
REG 2
2. (1) In these Regulations:
"additive licence" means a licence granted under Regulation 6 of
these Regulations;
"authorised officer" means a person authorised by the Minister to be
an authorised officer for the purposes of these Regulations;
"Council Directive" means Council Directive No. 70/524/EEC of 23
November, 1970(1) as amended by—
(1)O.J. No. L270, 14.12.1970, p1.
Council Directive No. 73/103/EEC of 28 April, 1973(2), Council
Directive No. 75/296/EEC of 28 April, 1975(3), Council Directive No.
84/587/EEC of 29 November, 1984(4), Commission Directive No.
85/429/EEC of 8 July, 1985(5), Commission Directive No. 85/520/EEC of
11 November, 1985(6), Commission Directive No. 86/29/EEC of 5
February, 1986(7), Second Commission Directive No. 86/300/EEC of 4
June, 1986(8), Commission Directive No. 86/403/EEC of 28 July,
1986(9), Commission Directive No. 86/525/EEC of 27 October, 1986(10),
Council Directive No. 87/153/EEC of 16 February, 1987(11), Council
Directive No. 87/316/EEC of 16 June, 1987(12), Council Directive No.
87/317/EEC of 16 June, 1987(13), Commission Directive No. 87/552/EEC
of 17 November, 1987(14), Commission Directive No. 88/228/EEC of 8
April, 1988(15), Commission Directive No. 88/483/ECC of 14 July,
1988(16), Commission Directive No. 88/616/EEC of 30
(2)O.J. No. L124, 10.5.1973, p17.
(3)O.J. No. L124, 15.5.1975, p29.
(4)O.J. No. L319, 8.12.1984, p13.
(5)O.J. No. L245, 12.9.1985, p1.
(6)O.J. No. L323, 4.12.1985, p12.
(7)O.J. No. L39, 14.2.1986, p55.
(8)O.J. No. L189, 11.7.1986, p42.
(9)O.J. No. L233, 20.8.1986, p16.
(10)O.J. No. L310, 5.11.1986, p19.
(11)O.J. No. L64, 7.3.1987, p19.
(12)O.J. No. L160, 20.6.1987, p32.
(13)O.J. No. L160, 20.6.1987, p34.
(14)O.J. No. L336, 26.11.1987, p34.
(15)O.J. No. L101, 20.4.1988, p30.
(16)O.J. No. L237, 27.8.1988, p39.
November, 1988(17) and Commission Directive No. 89/23/EEC of 21
December, 1988(18).
(17)O.J. No. L343, 23.12.1988, p25.
(18)O.J. No. L11, 14.1.1989, p34.
"medicinal additive" means any substance which complies with the
definition of an additive in the Council Directive and may be
classified as an antibiotic, growth promoter, coccidiostat and other
medicinal substance;
"the Minister" means the Minister for Agriculture and Food;
"official methods of analysis" means a method of analysis specified
in the European Communities (Feeding Stuffs) (Methods of Analysis)
Regulations, 1978 to 1985;
"State Chemist" means the head of the State Laboratory or a person
authorised in writing by him to perform the functions assigned to
the State Chemist under these Regulations.
(2) A word or expression that is used in these Regulations and is
also used in the Council Directive shall, unless the contrary
intention appears, have in these Regulations the same meaning that
it has in the Council Directive.
REG 3
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.
REG 4
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.
REG 5
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.
REG 6
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.
REG 7
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.
REG 8
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.
REG 9
9. A person shall not incorporate a medicinal additive in a
compound feedingstuff unless the medicinal additive has been prepared
in advance in the form of a premixture including a carrier and
such premixture has been incorporated in the compound feedingstuff
only in a proportion of at least 0.2 per cent by weight.
REG 10
10. (1) Subject to paragraph (2) of this Regulation, a person shall
not—
(a) manufacture a supplementary feedingstuff for a species or
category of animal unless the level of additives therein equals or
is less than the permitted level of additives specified in the
First or Second Schedule to these Regulations or, in the case of a
medicinal additive, in the additive licence for a complete
feedingstuff for that species or category of animal, or
(b) feed a supplementary feedingstuff to a species or category of
animal unless the level of additives therein equals or is less than
the permitted level of additives specified in the First or Second
Schedule to these Regulations or, in the case of a medicinal
additive, in the additive licence for a complete feedingstuff for
that category of animal.
(2) Where a supplementary feedingstuff is such that were it mixed
with other feedingstuffs prior to feeding, or fed as such in
conjunction with other feedingstuffs, in accordance with instructions
issued by its manufacturer and printed on, or on a label attached
to, its packaging or, in case the supplementary feedingstuff is
delivered in bulk, on documents accompanying the feedingstuff, the
resulting feedingstuff or the daily ration as appropriate would
comply with the requirements of Paragraph (1) of this Regulation,
then the said requirements shall, as regards the supplementary
feedingstuff, be regarded as having been complied with: provided the
supplementary feedingstuff has one or more characteristics (for
example, a feed or mineral block or the content of crude protein
or minerals) which in practice ensure that the level of additives
fixed for a complete feedingstuff for that species or category of
animal is not exceeded and that the feedingstuff is not used for
other species of animals.
REG 11
11. (1) A person shall not market any of the additives specified
in the First or Second Schedule to these Regulations or, in the
case of a medicinal additive, in the additive licence, unless the
particulars (which shall be clearly visible, readily legible and
indelible) set out in paragraph (2) of this Regulation are set out
on the package or container in which they are packed or on a
label attached thereto and, in addition to the said particulars,
provided the relevant particulars (which shall be clearly visible,
readily legible and indelible) set out in paragraph (3) of this
Regulation are set out on the package or container in which the
additives are packed or on a label attached thereto.
(2) The particulars referred to in paragraph (1) of this Regulation
to be displayed in respect of all additives shall be—
(a) the specific name of the additive being the name used in the
First or Second Schedule to these Regulations or, in the case of
medicinal additives, in accordance with the additive licence;
(b) the name or business name and the address or registered place
of business of the person responsible for the particulars specified
in this paragraph and paragraph (3) of this Regulation; and
(c) the net weight and, in the case or liquid additives, either
the net volume or the net weight.
(3) The particulars referred to in paragraph (1) of this Regulations
shall be in respect of—
(a) antibiotics, growth promoters, coccidiostats and other medicinal
substances:
(i) the name or business name and the address or registered place
of business of the manufacturer if he is not responsible for the
particulars on the label,
(ii) the active substance level,
(iii) the expiry date of the guarantee or storage life from the
date of manufacture,
(iv) batch reference number,
(v) date of manufacture,
(vi) the indication "to be used exclusively by manufacturers of
premixtures for compound feedingstuffs".
(vii) directions for use, and
(viii) where appropriate, a safety recommendation regarding use in
the case of additives which are the subject of special provisions
in the additive licence;
(b) vitamin E: the alpha-tocopherol level and expiry date of the
guarantee of that level or storage life from the date of
manufacture;
(c) vitamins (other than vitamin E), provitamins and substances
having a similar effect: the active substance level and expiry date
of the guarantee of that level or storage life from the date of
manufacture;
(d) trace elements, colourants including pigments, preserving agents
and other additives: the active substance level; and
(e) the additives referred to in sub-paragraphs (b), (c) and (d) of
this paragraph: the indication: "to be used exclusively in the
manufacture of feedingstuffs".
REG 12
12. Without prejudice to the generality of Regulation 11 of these
Regulations, the specific name of the additive may be accompanied
by—
( a ) the trade name and EEC number of the additive,
or
( b ) the name or business name and the address or registered
place of business of the manufacturer, if he is not responsible for
the particulars on the label, the directions for use and, where
appropriate, a safety recommendation regarding use in these cases
where the last three indications are not required under paragraph
(3) of Regulation 11 of these Regulations.
REG 13
13. Notwithstanding Regulations 11 and 12 of these Regulations,
information other than that required or authorised pursuant to the
said Regulations may appear on packages, containers or labels,
provided it is clearly separated from the particulars required by
Regulation 11 or permitted under Regulation 12 of these Regulations.
REG 14
14. (1) A person shall not market premixtures unless the particulars
(which shall be clearly visible, readily legible and indelible)
specified in paragraphs (2) and (3) of this Regulation are given on
the package or container in which the premixtures are packed or on
a label affixed thereto.
(2) The particulars referred to in paragraph (1) of this Regulation
in respect of premixtures shall be—
( a ) the description "premixture";
( b ) the indication "to be used exclusively in the manufacture of
feedingstuffs", except for the premixtures referred to in paragraph
(3) (a), of this Regulation;
( c ) directions for use, and any safety recommendations regarding
the use of the premixtures;
( d ) the animal species or category of animal for which the
premixture is intended;
( e ) the name or business name and the address or registered
place of business of the person responsible for the particulars
referred to in this paragraph and paragraph (3) of this Regulation;
and
( f ) the net weight and, in the case of liquids either the net
volume or net weight.
(3) The particulars referred to in paragraph (1) of this Regulation,
in addition to those specified in Paragraph (2) of this Regulation,
shall be, in respect of premixtures containing—
( a ) antibiotics, growth promoters, coccidiostats and other
medicinal substances:
(i) the name or business name and the address or registered place
of business of the manufacturer if he is not responsible for the
details on the label,
(ii) the specific name of the additive being the name used in the
additive licence,
(iii) the active substance level,
(iv) the expiry date of the guarantee of that level or storage
life from the date of manufacture, and
(v) the indication "to be used exclusively by manufacturers of
compound feedingstuffs";
( b ) substances having antioxidant effects: