70/524 - - - I
COUNCIL DIRECTIVE
of 23 November 1970
concerning additives in feeding-stuffs
(70/524/EEC)
(OJ No L 270, 14. 12. 1970, p. 1.)
Amending acts
Official Journal
No page date
Council Directive of 28 April 1973 (73/103/EEC) L 124 17 10. 5. 1973First Commission Directive of 27 July 1973 (73/264/EEC) L 253 12 10. 9. 1973Second Commission Directive of 27 July 1973 (73/275/EEC) L 254 16 11. 9. 1973Third Commission Directive of 13 December 1973 (74/7/EEC) L 14 21 17. 1. 1974Fourth Commission Directive of 17 December 1973 (74/38/EEC) L 30 21 4. 2. 1974Fifth Commission Directive of 26 February 1974 (74/180/EEC) L 94 14 4. 4. 1974Sixth Commission Directive of 26 February 1974 (74/181/EEC) L 94 16 4. 4. 1974Seventh Commission Directive of 26 February 1974 (74/182/EEC) L 94 18 4. 4. 1974Eighth Commission Directive of 1 July 1974 (74/378/EEC) L 199 13 22. 7. 1974Ninth Commission Directive of 23 July 1974 (74/421/EEC) L 221 29 12. 8. 1974T enth Commission Directive of 20 December 1974 (75/50/EEC) L 19 58 24. 1. 1975Eleventh Commission Directive of 24 April 1975 (75/267/EEC) L 118 45 8. 5. 1975Second Council Directive of 28 April 1975 (75/296/EEC) L 124 29 15. 5. 1975T welfth Commission Directive of 24 October 1975 (75/696/EEC) L 299 19 19. 11. 1975Thirteenth Commission Directive of 15 December 1975 (76/13/EEC) L 4 21 9. 1. 1976Fourteenth Commission Directive of 8 June 1976 (76/546/EEC) L 160 11 22. 6. 1976Fifteenth Commission Directive of 21 June 1976 (76/603/EEC) L 198 10 23. 7. 1976Sixteenth Commission Directive of 1 December 1976 (76/933/EEC) L 364 18 31. 12. 1976Seventeenth Commission Directive of 16 February 1977 (77/179/EEC) L 60 15 5. 3. 1977Eighteenth Commission Directive of 11 July 1977 (77/471/EEC) L 180 27 20. 7. 1977Nineteenth Commission Directive of 26 July 1977 (77/512/EEC) L 207 53 13. 8. 197720th Commission Directive of 7 December 1977 (78/58/EEC) L 18 7 24. 1. 1978T wenty-first Commission Directive of 23 December 1977 (78/117/EEC) L 40 19 10. 2. 1978T wenty-second Commission Directive of 30 May 1978 (78/522/EEC) L 159 43 17. 6. 1978T wenty-third Commission Directive of 23 June 1978 (78/613/EEC) L 198 10 22. 7. 1978T wenty-fourth Commission Directive of 28 July 1978 (78/743/EEC) L 247 25 9. 9. 1978T wenty-fifth Commission Directive of 16 November 1978 (78/974/EEC) L 330 30 25. 11. 1978T wenty-sixth Commission Directive of 18 December 1978 (79/139/EEC) L 39 11 14. 2. 1979T wenty-seventh Commission Directive of 7 June 1979 (79/553/EEC) L 148 58 16. 6. 1979T wenty-eighth Commission Directive of 20 July 1979 (79/697/EEC) L 207 19 15. 8. 1979T wenty-ninth Commission Directive of 15 November 1979
(79/1011/EEC)L 310 24 6. 12. 1979
70/524 - - - I
Thirtieth Commission Directive of 9 January 1980 (80/131/EEC) L 30 21 7. 2. 1980
Thirty-first Commission Directive of 8 April 1980 (80/440/EEC) L 104 18 22. 4. 1980Thirty-second Commission Directive of 26 June 1980 (80/618/EEC) L 171 36 4. 7. 1980Thirty-third Commission Directive of 4 July 1980 (80/678/EEC) L 185 48 18. 7. 1980Thirty-fourth Commission Directive of 4 September 1980 (80/884/EEC) L 251 17 24. 9. 1980Thirty-fifth Commission Directive of 25 November 1980 (80/1139/EEC) L 336 42 13. 12. 1980Thirty-sixth Commission Directive of 28 November 1980
(80/1156/EEC)L 343 35 18. 12. 1980
Thirty-seventh Commission Directive of 9 April 1981 (81/332/EEC) L 131 1 18. 5. 1981
Thirty-eighth Commission Directive of 16 July 1981 (81/632/EEC) L 231 30 15. 8. 1981Thirty-ninth Commission Directive of 15 January 1982 (82/91/EEC) L 42 16 13. 2. 1982Council Directive of 30 June 1982 (82/471/EEC) L 213 8 21. 7. 1982Fortieth Commission Directive of 23 June 1982 (82/474/EEC) L 213 22 21. 7. 1982Forty-first Commission Directive of 19 November 1982 (82/822/EEC) L 347 16 7. 12. 1982Forty-second Commission Directive of 16 May 1983 (83/266/EEC) L 147 18 6. 6. 1983Forty-third Commission Directive of 28 July 1983 (83/466/EEC) L 255 28 15. 9. 1983Forty-fourth Commission Directive of 29 November 1983 (83/615/EEC) L 350 17 13. 12. 1983Forty-fifth Commission Directive of 15 February 1984 (84/107/EEC) L 61 35 2. 3. 1984Forty-sixth Commission Directive of 28 May 1984 (84/349/EEC) L 183 15 11. 7. 1984Forty-seventh Commission Directive of 26 October 1984 (84/547/EEC) L 297 40 15. 11. 1984Council Directive of 29 November 1984 (84/587/EEC) L 319 13 8. 12. 1984Forty-eighth Commission Directive of 6 February 1985 (85/157/EEC) L 59 27 27. 2. 1985Forty-ninth Commission Directive of 31 May 1985 (85/312/EEC) L 165 21 25. 6. 1985Fiftieth Commission Directive of 24 June 1985 (85/342/EEC) L 179 35 11. 7. 1985Commission Directive of 8 July 1985 (85/429/EEC) L 245 1 12. 9. 1985Commission Directive of 11 November 1985 (85/520/EEC) L 323 12 4. 12. 1985Council Regulation (EEC) No 3768/85 of 20 December 1985 L 362 8 31. 12. 1985Second Commission Directive of 5 February 1986 (86/29/EEC) L 39 55 14. 2. 1986Commission Directive of 4 June 1986 (86/300/EEC) L 189 42 11. 7. 1986Commission Directive of 28 July 1986 (86/403/EEC) L 233 16 20. 8. 1986Commission Directive of 27 October 1986 (86/525/EEC) L 310 19 5. 11. 1986Commission Directive of 23 April 1987 (87/243/EEC) L 110 34 25. 4. 1987Commission Directive of 23 April 1987 (87/244/EEC) L 110 35 25. 4. 1987Council Directive of 16 June 1987 (87/316/EEC) L 160 32 20. 6. 1987Council Directive of 16 June 1987 (87/317/EEC) L 160 34 20. 6. 1987Commission Directive of 17 November 1987 (87/552/EEC) L 336 34 26. 11. 1987Commission Directive of 8 April 1988 (88/228/EEC) L 101 30 20. 4. 1988Commission Directive of 14 July 1988 (88/483/EEC) L 237 39 27. 8. 1988Commission Directive of 30 November 1988 (88/616/EEC) L 343 25 13. 12. 1988Commission Directive of 21 December 1988 (89/23/EEC) L 11 34 14. 1. 1989Commission Directive of 19 February 1990 (90/110/EEC) L 67 44 15. 3. 1990Commission Directive of 9 April 1990 (90/206/EEC) L 106 30 26. 4. 1990Commission Directive of 20 April 1990 (90/214/EEC) L 113 39 4. 5. 1990Commission Directive of 20 July 1990 (90/412/EEC) L 209 25 8. 8. 1990
70/524 - - - I
Commission Directive of 26 November 1990 (90/643/EEC) L 350 80 14. 12. 1990
Council Directive of 4 December 1990 (90/654/EEC) L 353 48 17. 12. 1990Commission Directive of 12 April 1991 (91/248/EEC) L 124 1 18. 5. 1991Commission Directive of 19 April 1991 (91/249/EEC) L 124 43 18. 5. 1991Commission Directive of 10 June 1991 (91/336/EEC) L 185 31 11. 7. 1991Commission Directive of 9 September 1991 (91/508/EEC) L 271 67 27. 9. 1991Commission Directive of 22 November 1991 (91/620/EEC) L 334 62 5. 12. 1991Commission Directive 92/64/EEC of 13 July 1992 L 221 51 6. 8. 1992Commission Directive 92/99/EEC of 17 November 1992 L 350 83 1. 12. 1992Commission Directive 92/113/EEC of 16 December 1992 L 16 2 25. 1. 1993Commission Directive 93/27/EEC of 4 June 1993 L 179 5 22. 7. 1993Commission Directive 93/55/EEC of 25 June 1993 L 206 11 18. 8. 1993Commission Directive 93/107/EC of 26 November 1993 L 299 44 4. 12. 1993Council Directive 93/114/EC of 14 December 1993 L 334 24 31. 12. 1993Commission Directive 94/17/EC of 22 April 1994 L 105 19 26. 4. 1994Commission Directive 94/50/EC of 31 October 1994 L 297 27 18. 11. 1994
70/524 - - - I
4Article 1
This Directive shall apply to additives in feedingstuffs.
Article 2
For the purposes of this Directive the following definitions
shall apply:
(a) Additives: substances, or preparations containing sub-
stances, other than premixtures referred to in (h)
which, when incorporated in feedingstuffs, are likely
to affect their characteristics or livestock production;
(b) Feedingstuffs: products of vegetable or animal origin
in their natural state, fresh or preserved, and products
derived from the industrial processing thereof, and or-
ganic or inorganic substances, used singly or in mix-
tures, whether or not containing additives, for oral
animal feeding;
(c) Daily ration: the average total quantity of feeding-
stuffs, calculated on a moisture content of 12 %, re-quired daily by an animal of a given species, age cat-
egory and yield, to satisfy all its needs;
(d) Complete feedingstuffs: mixtures of feedingstuffs which,
by reason of their composition, are sufficient for a
daily ration;
(e) Supplementary feedingstuffs: mixtures of feedingstuffs
which have a high content of certain substances and
which, by reason of their composition, are sufficient
for a daily ration only if they are used in combination
with other feedingstuffs;
(f) Straight feedingstuffs: the various vegetable or animal
products in their natural state, fresh or preserved, and
products derived from the industrial processing there-
of, as well as the various organic or inorganic sub-
stances, whether or not containing additives, intended
a ss u c hf o ro r a la n i m a lf e e d i n g ;
(g) Compound feedingstuffs: mixtures of products of veg-
etable or animal origin in their natural state, fresh or
preserved, or products derived from the industrial
processing thereof, or organic or inorganic substances,
whether or not containing additives, for oral animal
feeding in the form of complete feedingstuffs or sup-
plementary feedingstuffs;
(h) Premixtures: mixtures of additives or mixtures of one
or more additives with substances used as carriers, in-
tended for the manufacture of feedingstuffs;
(i) Animals: animals belonging to species normally nour-
ished and kept or consumed by man;84/587/EEC
70/524 - - - I
5(j) Pet animals: animals belonging to species normally
nourished and kept, but not consumed, by man, ex-
cept animals bred for fur.
Article 3
1. Member States shall provide that, as regards feeding-
stuffs, only those additives listed in Annex I which comply
with this Directive may be marketed and that they may be
incorporated in feedingstuffs only subject to the require-
ments set out in that Annex. These additives may not be
used in any other way for the purposes of animal feeding.
2. Member States shall, in particular, ensure that addi-
tives may be incorporated in straight feedingstuffs only as
long as their use is expressly provided for in Annex I or
Annex II.
Article 4
1. By way of derogation from Article 3 (1), Member
States may authorize the marketing and use, within theirown territory, of:
(a) additives listed in Annex II, provided that they com-
ply with the provisions laid down for them by this
Directive;
(b) additives belonging to groups other than those listed
in Annex I or Annex II, provided that tests have
shown that the conditions set out in Article 7 (2) (A)
are satisfied. This derogation shall not apply to sub-
stances having a hormonal or anti-hormonal effect.
2. Member States shall forward:
— before 3 January 1985 the list of groups and additives
authorized under paragraph 1 (b) to the other
Member States and to the Commission,
— before 3 December 1985 the documents justifying
these authorizations with reference to the conditions
set out in Article 7 (2) (A).
Article 5
Before 3 December 1988 the national authorizations
granted pursuant to Article 4 (1) (b) shall be decided on
in accordance with the procedure laid down in Article 23.
Article 6
1. The maximum and minimum contents listed in
Annex I and Annex II shall refer to complete feedingstuffs
with a moisture content of 12 % in so far as no special
provisions are set forth in the said Annexes.84/587/EEC
70/524 - - - I
6If the substance permitted as an additive also exists in the
natural state in certain ingredients of the feedingstuff, the
amount of additive to be incorporated is calculated so that
the total of the elements added and the elements present
naturally does not exceed the maximum content provided
for in Annexes I and II.
2. The mixing of additives named in this Directive shall
be permitted in premixtures and feedingstuffs only where,
in relation to the effects desired, there is physical and
chemical compatibility between the components of the mix-
ture.
3. Unless the mixture concerned is set out in Annex I or
Annex II, Member States shall require that:
(a) antibiotics and growth promoters may not be mixed
together, either with substances from their own group
or with substances from the other group;
(b) coccidiostats may not be mixed with antibiotics and
growth promoters where coccidiostats also act, for the
same category of animal, as an antibiotic or as a
growth promoter;
(c) coccidiostats and other medicial (SIC! medical) sub-
stances may not be mixed together if their effects are
similar.
4. Member States may, for experimental or scientific
purposes, provide for derogations from the provisions of
Article 3 or of paragraphs 2 or 3 of this Article on condi-
tion that there is adequate official supervision.
Article 7
1. Amendments to be made to Annexes on account of
the growth of scientific and technical knowledge shall be
adopted in accordance with the procedure laid down in Ar-
ticle 23.
A codified version of the Annexes shall be adopted at reg-
ular intervals in accordance with the same procedure, the
aim being to incorporate the successive amendments made
pursuant to this paragraph.
2. When amendments are made to Annex I or Annex II,
the following principles shall be applied:
A. An additive shall be included in Annex I only if:
(a) it has a favourable effect on the characteristics of
those feedingstuffs or on livestock production
when incorporated in such feedingstuffs;
(b) at the level permitted in feedingstuffs, it does
not adversely affect human or animal health or
the environment, nor harm the consumer by al-
tering the characteristics of livestock products;
(c) its presence in feedingstuffs can be controlled;84/587/EEC
70/524 - - - I
7(d) at the level permitted in feedingstuffs, treatment
or prevention of animal disease is excluded; this
condition does not apply to substances of the
kind listed in Annex I (D);
(e) for serious reasons concerning human or animal
health its use must not be restricted to medical
or veterinary purposes.
B. An additive shall be deleted from Annex I if any of
the conditions listed under A is no longer satisfied.
However, such an additive may be inserted in
Annex II for a specified period, if as a minimum the
conditions of subparagraph A (b) and (e) are always
satisfied.
C. A new additive or a new usage attributed to an addi-
tive may be inserted in Annex II only if the condi-
tions stipulated under subparagraph A (b), (c) and (e)are satisfied and it can be assumed, taking into ac-
count available results, that the other conditions stipu-
lated under subparagraph A are also satisfied.
T h el e n g t ho ft i m ef o rw h i c han e wa d d i t i v eo rn e w
use is authorized must not exceed five years, from its
being entered in that Annex.
Article 7a
If an additive contains or consists of genetically modified
organisms within the meaning of Article 2 (1) and (2) of
Council Directive 90/220/EEC of 23 April 1990 on the de-
liberate release into the environment of genetically modi-
fied organisms(1), a specific environmental risk assessment
similar to that laid down in the abovementioned Directive
shall be carried out for this purpose, the following docu-
ments to be included in the dossier submitted pursuant to
Article 9 of this Directive in order to ensure compliance
with the principles set out in Article 7 (2) of this Direc-
tive:
— a copy of any written consent or consents of the com-
petent authorities to the deliberate release of geneti-
cally modified organisms for research and develop-
ment purposes pursuant to Article 6 (4) of Directive
90/220/EEC and the result of the release(s) with re-
spect to the risk in each case to human health and
the environment;
— the complete technical dossier supplying the informa-
tion requested in Annexes I and II to Directive
90/220/EEC and the environmental risk assessment
resulting from this information; the results of any in-vestigations performed for the purposes of research or
development.
(1)OJ No L 117, 8. 5. 1990, p. 15.84/587/EEC
93/114/EC
70/524 - - - I
8Article 8
1. When an additive belonging to the groups of “anti-
biotics”, “coccidiostats”; and “other medicinal substances”
or “growth promoters”; is added to Annex I or Annex II, a
monograph indicating the identification process or the cri-
teria for the identification and characterization of the addi-
tive, particularly its composition and degree of purity and
its physico-chemical and biological properties, shall be
drawn up by means of a Directive, taking account of scien-
tific and technical knowledge, in accordance with the pro-
cedure laid down in Article 23.
2. By 31 December 1988 at the latest, monographs shall
also be drawn up for such additives belonging to the
groups referred to in paragraph as are added to Annex I
or Annex II before the date on which this Directive is
adopted.
3. In accordance with paragraph 1, monographs may
also be drawn up for additives belonging to groups other
than those referred to in that paragraph.
4. The amendments to be made thereafter to the mono-
graphs as a result of developments in scientific or technical
knowledge shall be adopted in accordance with the pro-
cedure laid down in Article 23.
Article 9
1. For the purposes of checking whether the additives
comply with the principles defined in Article 7 (2),
Member States shall ensure that a dossier complying with
paragraph 2 below is officially forwarded to the Member
States and to the Commission.
2. The Council, acting on a proposal from the Commis-
sion, shall adopt, by means of a Directive, the guidelines
for preparing the dossiers referred to in paragraph 1, so
that these guidelines can be applied by 3 December 1986.
The amendments to be made thereafter to the guidelines
as a result of developments in scientific or technical knowl-
edge shall be adopted in accordance with the procedure
laid down in Article 23.
3. At the reasoned request of the applicant, Member
States and the Commission shall ensure that any informa-
tion which, if disseminated, could affect industrial or com-
mercial property rights is kept confidential.
Industrial and commercial secrecy shall not apply to:
— the denomination and composition of the additive,
— the physico-chemical and biological characteristics of
the additive,
— the interpretation of the pharmacological, toxicologi-
cal and ecotoxicological data,84/587/EEC
70/524 - - - I
9— the analytical methods for monitoring the additive in
the feedingstuffs.
Article 10
Member States shall require that additives and premixtures
m a yb em a r k e t e do n l yi nc l o s e dp a c k a g e so rc l o s e dc o n -
tainers. Member States shall require that packages or con-
tainers must be closed in such a way that the fastener is
damaged on opening and cannot be re-used.
Article 11
1. Where a Member State, as a result of new informa-
tion or of a reassessment of existing information made
since the provisions in question were adopted, has detailed
grounds for establishing that the use of one of the addi-
tives listed in Annex I or its use in conditions which may
be specified constitutes a danger to animal or human
health or the environment although it complies with the
provisions of this Directive, that Member State may tem-porarily suspend or restrict application of the provisions in
question in its territory. It shall immediately inform the
other Member States and the Commission thereof, giving
reasons for its decision.
2. The Commission shall, as soon as possible, examine
the grounds cited by the Member State concerned and
consult the Member States within the Standing Committee
for Feedingstuffs; it shall then deliver its opinion without
delay and take the appropriate measures.
3. Should the Commission consider that amendments to
the Directive are necessary in order to mitigate the diffi-
culties mentioned in paragraph 1 and to ensure the protec-
tion of human or animal health or the environment, it
shall initiate the procedure laid down in Article 24 with a
view to adopting these amendments; the Member State
which has adopted safeguard measures may in that event
retain them until the amendments enter into force.
Article 12
1. Member States shall require that supplementary feed-
ingstuffs, diluted as specified, may not contain levels of the
additives named in this Directive which exceed those fixed
for complete feedingstuffs.
2. Member States may require that the levels of anti-
biotics, coccidiostats and other medicinal substances,
growth promoters, D vitamins and antioxidants in supple-
mentary feedingstuffs may exceed the maximum levels
fixed for complete feedingstuffs in the case of:84/587/EEC
70/524 - - - I
10(a) supplementary feedingstuffs which a Member State
has authorized to be made available to all users, pro-
vided that their level of antibiotics, D vitamins or
growth promoters does not exceed five times the fixed
maximum level;
(b) supplementary feedingstuffs which are intended for
certain species of animal and which a Member State
is permitted to authorize to be made available within
its territory to all users because of special feeding sys-
tems, provided that their level does not exceed:
— for antibiotics and growth promoters, 1 000 mg/
kg and, provided that the use of these substances
is permitted, 2 000 mg/kg in the case of cattle for
fattening;
— for antioxidants, coccidiostats and other medici-
nal substances, five times the fixed maximum
level;
— for D vitamins, 200 000 IU/kg.
Member States shall prescribe that if, in the manufacture
of supplementary feedingstuffs, recourse is had to the
possibility referred to in (a), the possibility referred to in
(b) may not be made use of at the same time.
3. Where paragraph 2 is invoked, Member States shall
require that the feedingstuff has one or more composi-
tional characteristics (as regards, for example, proteins or
minerals) which in practice ensure that the level of addi-
tives fixed for complete feedingstuffs is not exceeded and
that the feedingstuff is not used for other species of ani-
mal.
Article 13
1. Member States shall require that antibiotics, cocci-
diostats and other medicinal substances and the growth
promoters listed in Annex I or Annex II, premixtures pre-
pared from these additives with a view to being incorpo-
r a t e di nc o m p o u n df e e d i n g s t u f f sa n dc o m p o u n df e e d i n g -
stuffs containing these premixtures may only be put on the
market under the conditions referred to in Annex III and,
in particular, only if they have been produced by manufac-
turers found by at least one Member State to have fulfilled
the minimum conditions laid down in Annex III.
Moreover, in the case of additives, premixtures or com-
pound feedingstuffs referred to in the first subparagraph
produced in third countries with a view to being marketed
in the Community, Member States shall stipulate that
manufacturers have a representative established within the
Community who fulfils the conditions laid down for him inAnnex III.84/587/EEC
70/524 - - - I
11They shall require that the name of the representative es-
tablished within the Community appears opposite the
name of the manufacturer on the list referred to in para-
graph 3.
2. Member States shall require that the additives re-
ferred to in paragraph 1 may be delivered at the final
stage of marketing:
— only to manufacturers of premixtures, and
— in the form of premixtures, only to manufacturers of
compound feedingstuffs
who fulfil the minimum conditions set out in Annex III.
3. Each Member State shall publish annually and, at the
latest by 30 November each year, the list of manufacturers
of additives, premixtures and compound feedingstuffs who
have, to the satisfaction of the Member State concerned,
complied with the requirements listed in Annex III.
It shall forward such list to the other Member States and
to the Commission before 31 December each year.
Any amendments made to these lists after 30 November
shall be forwarded separately to the other Member States
and to the Commission.
4. Member States shall require that the additives re-
ferred to in paragraph 1 may be incorporated in compound
feedingstuffs only if they have been prepared in advance in
the form of premixtures including a carrier. These premix-
tures may be incorporated in the compound feedingstuffs
only in a proportion of at least 0,2 % by weight. However,
Member States may permit premixtures to be incorporated
in compound feedingstuffs in a lower proportion down to
0,05 %.
5. Member States may make paragraphs 1 and 2 appli-
cable to carotenoids and xanthophylls and to trace el-
ements and vitamins.
Article 14
1. Member States shall require that additives listed in
Annex I or Annex II may be marketed for use in feeding-
stuffs only if the following particulars, which must be clear-
ly visible, readily legible and indelible and must place re-
sponsibility on the producer, packer, importer, seller or
distributor established within the Community, are given on
the package, the container or a label affixed thereto:
A. for all additives with the exception of enzymes and
micro-organisms:
(a) the specific name of the additive, in accordance
with Annexes I or II;84/587/EEC
93/114/EC
84/587/EEC
70/524 - - - I
12(b) the name or business name and the address or
registered place of business of the person re-
sponsible for the particulars referred to in this
paragraph;
(c) the net weight and, in the case of liquid addi-
tives, either the net volume or the net weight;
B. in addition, for:
(a) antibiotics, growth promoters, coccidiostats and
other medicinal substances: the name or business
name and the address or registered place of
business of the manufacturer, if he is not respon-
sible for the particulars on the label, the active
substance level, expiry date of the guarantee or
storage life from the date of manufacture, batch
reference number and date of manufacture, the
indication: “to be used exclusively by manufac-
turers of premixtures for compound feeding-stuffs”, together with the directions for use and,
where appropriate, a safety recommendation re-
garding use in the case of additives which are the
subject of special provisions in the “other provi-
sions” column of the Annexes;
(b) vitamin E: 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: active sub-
stance level and expiry date of the guarantee of
that level or storage life from the date of manu-
facture;
(d) trace elements, colorants including pigments, pre-
servatives and other additives with the exception
of those belonging to the groups of enzymes and
micro-organisms: active substance level;
(e) with respect to the additives referred to in (b),
(c) and (d), the indication: “to be used exclusive-
ly in the manufacture of feedingstuffs”;84/587/EEC
93/114/EC
84/587/EEC
70/524 - - - I
13C. for additives belonging to the groups:
(a) of enzymes: the specific name of the active com-
ponents (SIC! component) (s) according to its
(their) enzymatic activity(ies) in accordance with
Annex I or II, the indentification number accord-
ing to the International Union of Biochemistry,
the activity units(2)(activity units per g or activ-
ity units per ml), 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 the name or business
name and the address or registered place of
business of the manufacturer if he is not respon-
sible for the particulars on the label, the expiry
date of the guarantee or the storage life from
the date of manufacture, the batch reference
number and the date of manufacture, the words‘to be used exclusively in the manufacture of
feedingstuffs’, the directions for use and, where
appropriate, the safety recommendation where
the column entitled ‘Other provisions’, in Annex
I or II contains special provisions concerning the
additives, the net weight and for liquid additives
either the net volume or the net weight and,
where applicable, indication of any particular sig-
nificant characteristics due to the manufacturing
process, in accordance with the provisions con-
cerning labelling in the column entitled ‘Other
provisions’ in Annex I or II;
(b) of micro-organisms: the identification of the
strain(s) in accordance with Annex I or II, the
file number of the strain(s), the number of col-
ony-forming units (CFU/g), the name or business
name and address or registered place of business
of the person responsible for the particulars re-
ferred to in this paragraph, the name or business
name and address or registered place of business
of the manufacturer if he is not responsible for
the particulars on the label, the expiry date of
the guarantee or the storage life from the date
of manufacture, the batch reference number and
the date of manufacture, the words ‘to be used
exclusively in the manufacture of feedingstuffs’,
the directions for use and, where appropriate, a
safety recommendation where the column en-
titled ‘Other provisions’ in Annex I or II containsspecial provisions concerning the additives, the
net weight and for liquid additives either the net
volume or the net weight and where applicable,
indication of any particular significant character-
istics due to the manufacturing process, in ac-
cordance with the provisions concerning labelling
in the column entitled ‘Other provisions’ in
Annex I or II
(2)Activity units expressed as μmole of product released per
minute per gram of enzymatic preparation.93/114/EC
70/524 - - - I
142. Member States shall require that the specific name of
the additive may be accompanied:
(a) by the trade name and the EEC number;
(b) by 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 those cases where
the last three indications are not required under para-
graph 1 B (a).
3. Where Article 13 (5) is applied, Member States may
require that the indication “to be used exclusively by
manufacturers of premixtures” be mentioned.
4. Member States shall require that information other
than that required or authorized pursuant to paragraphs 1,
2 and 3 may appear on packages, containers or labels, pro-
vided that they are clearly separated from the abovemen-tioned marking particulars.
Article 15
1. Member States shall require that premixtures may be
marketed only if the following particulars, which must be
clearly visible, readily legible and indelible and must place
responsibility on the producer, packer, importer, seller or
distributor established within the Community, are given on
the package, the container or a label affixed thereto:
A. for all premixtures:
(a) the description “premixture”;
(b) the indication “to be used exclusively in the
manufacture of feedingstuffs”, except for the pre-
mixtures referred to in B (a), directions for use,
and any safety recommendations regarding the
use of the premixtures;
(c) the animal species or category of animals for
which the premixture is intended;
(d) the name or business name and the address or
registered place of business of the person re-
sponsible for the particulars referred to in this
paragraph;
(e) the net weight and, in the case of liquids, either
t h ev o l u m eo rn e tw e i g h t ;
B. in addition, for the premixtures incorporating the
additives listed below:84/587/EEC
70/524 - - - I
15(a) antibiotics, growth promoters, coccidiostats and
other medicinal substances; the name or business
name and the address or registered place of
business of the manufacturer if he is not respon-
s i b l ef o rt h ed e t a i l so nt h el a b e l ,s p e c i f i cn a m e
of the additive in accordance with Annexes I
or II, active substance level and expiry date of
the guarantee of that level, or storage life from
the date of manufacture and the indication to be
used exclusively by manufacturers of compound
feedingstuffs;
(b) substances having antioxidant effects: specific
name of the additive in accordance with Annexes
I or II, and active substance level, provided that
a maximum level is fixed for complete feeding-
stuffs in Annexes I or II;
(c) colorants, including pigments: specific name of
the additive in accordance with Annexes I or II,
and active substance level, provided that a maxi-
mum level is fixed for complete feedingstuffs in
Annexes I or II;
(d) vitamin E: specific name of the additive in ac-
cordance with Annexes I or II, alphatocopherol
level and expiry date of the guarantee of that
level or storage life from the date of manufac-
ture;
(e) vitamins other than vitamin E, provitamins and
substances having a similar effect: specific name
of the additive in accordance with Annexes I or
II, active substance level and expiry date of the
guarantee of that level or storage life from the
date of manufacture;
(f) trace elements: specific name of the additive in
accordance with Annexes I or II, and level of the
various elements in so far as a maximum level is
fixed for complete feedingstuffs in Annexes I or
II;
(g) preserving agents: specific name of the additive
in accordance with Annexes I or II, and active
substance level, provided that a maximum level is
fixed for complete feedingstuffs in Annexes I or
II;84/587/EEC
70/524 - - - I
16(h) enzymes: the specific name of the active compo-
nent(s) according to its (their) enzymatic activ-
ity(ies) in accordance with Annex I or II, the
identification number according to the Interna-
tional Union of Biochemistry, the activity units
(activity units per g or activity units per ml), the
expiry date of the guarantee or the storage life
from the date of manufacture, the name or busi-
ness name and the address or registered place of
business of the manufacturer if he is not respon-
sible for the particulars on the label and, where
applicable, indication of any particular significant
characteristics due to the manufacturing process,
in accordance with the provisions concerning la-
belling in the column entitled ‘Other provisions’
in Annex I or II;
(i) micro-organisms: the identification of the
strain(s) in accordance with Annex I or II, the
file number of the strain(s), the number of col-
ony-forming units (CFU/g), the expiry date of
the guarantee of the storage life from the date of
m a n u f a c t u r e ,t h en a m eo rb u s i n e s sn a m ea n dt h e
address or registered place of business of the
manufacturer if he is not responsible for the par-
ticulars on the label and, where applicable, in-
dication of any particular significant characteris-
tics due to the manufacturing process, in
accordance with the provisions concerning label-
ling in the column entitled ‘Other provisions’ in
Annex I or II;
(j) other additives belonging to the groups referred
t oi n( b )t o( i )f o rw h i c hn om a x i m u ml e v e li s
laid down and additives belonging to other
groups provided for in Annex I or II: specific
name of the additive in accordance with Annex I
or II and active substance level, provided that
these additives fulfil a function in the feeding-
stuff as such and the amounts present can be de-
termined by official methods of analysis or, fail-
ing this, by valid scientific methods;
2. Member States shall require that:
(a) the specific name of additives authorized pursuant to
Article 4 (1) (b) must be indicated on the package,
the container or the label of premixtures. They may
require that the active substance level of such addi-
tives must also be indicated;
(b) the specific name of additives may be accompanied by
the trade name;
(c) the name of the producer of the additives referred to
in paragraph l B (a) may be indicated in the labelling
of premixtures. However, they may stipulate that this
indication shall be compulsory;93/114/EC
84/587/EEC
70/524 - - - I
17(d) the specific name of the additives listed in Annex I
may be accompanied by the EEC number.
3. Where, pursuant to paragraph 1, the expiry date of
the guarantee or storage life from the date of manufacture
of several additives belonging to the same group or differ-
ent groups has to be stated, Member States shall require
that a single date of guarantee or a single reference to the
storage life may be indicated for all the additives, namely
t h ed e a d l i n ew h i c hw i l lb er e a c h e df i r s t .
4. Member States shall require that information other
than that required or authorized pursuant to paragraphs 1
to 3 may appear on packages, containers or labels, pro-
vided that they are clearly separated from the abovemen-
tioned marking particulars.
Article 16
1. Member States shall require that feedingstuffs incor-
porating the additives belonging to the groups listed belowmay be marketed only if the following particulars, which
must be clearly visible, readily legible and indelible and
must place responsibility on the producer, packer, im-
porter, seller or distributor established within the Com-
munity, are given on the package, the container or a label
affixed thereto:
(a) for antibiotics, coccidiostats and other medicinal sub-
stances and growth promoters: specific name of the
additive in accordance with Annexes I or II, active
substance level and expiry date of the guarantee of
that level or storage life from the date of manufac-
ture;
(b) for substances having antioxidant effects:
— in the case of pet foods: use of the words “with
antioxidant” followed by the specific name of the
additive in accordance with Annexes I or II,
— in the case of compound feedingstuffs other than
pet foods: specific name of the additive in ac-
cordance with Annexes I or II;
(c) for colorants, including pigments provided that these
are used for the coloration of feedingstuffs or animal
products:
— in the case of pet foods: use of the words “color-
ant” or “coloured with” followed by the specific
name of the additive in accordance with Annexes
I or II,84/587/EEC
70/524 - - - I
18— in the case of compound feedingstuffs other than
pet foods: specific name of the additive in ac-
cordance with Annexes I or II;
(d) for vitamin E: specific name of the additive in accord-
ance with Annexes I or II, alphatocopherol level and
the expiry date of the guarantee of that level or stor-
a g el i f ef r o mt h ed a t eo fm a n u f a c t u r e ;
(e) for vitamins A and D: specific name of the additive,
in accordance with Annexes I or II, active substance
level and expiry date of the guarantee of that level or
storage life from the date of manufacture;
(f) for copper: specific name of the additive in accord-
ance with Annexes I or II, and the level expressed in
Cu;
(g) for preserving agents:
— in the case of pet foods: use of the words “pre-
servative” or “preserved with” followed by thespecific name of the additive in accordance with
Annexes I or II,
— in the case of compound feedingstuffs other than
pet foods: specific name of the additive in ac-
cordance with Annexes I or II.
(h) for enzymes: the specific name of the active constitu-
ent(s) according to its (their) enzymatic activity(ies) in
accordance with Annex I or II, the identification
number according to the International Union of Bio-
chemistry, the activity units (activity units per kg or
activity unit per l), the expiry date of the guarantee or
the storage life from the date of manufacture and,
where applicable, indication of any particular char-
acteristic due to the manufacturing process, in accord-
ance with the provisions concerning labelling in the
column entitled ‘Other provisions’ in Annex I or II;
(i) for micro-organisms: the identification of the strain(s)
in accordance with Annex I or II, the file number of
the strain(s), the number of colony-forming units
(CFU/kg), the expiry date of the guarantee or the
storage life from the date of manufacture and, where
applicable, indication of any particular significant
characteristic due to the manufacturing process, in ac-
cordance with the provisions concerning labelling in
the column entitled ‘Other provisions’ in Annex I or
II;
2. In addition to the particulars provided for by para-graph 1, particulars concerning the proper use of the feed-
ingstuffs may be laid down in Annexes I and II in accord-ance with the procedure provided for in Article 23.84/587/EEC
93/114/EC
84/587/EEC
70/524 - - - I
19Member States shall require that these indications must
appear on the package or the container or on a label af-
fixed thereto.
3. The presence of trace elements other than copper and
of vitamins other than vitamins A, D and E, provitamins
and additives having a similar effect may be indicated if
the amounts of these substances can be determined by
official methods of analysis or, failing this, by valid scien-
tific methods of analysis. In such cases the following details
shall be given:
(a) for trace elements other than copper: the specific
name of the additive in accordance with Annexes I or
II, and level of the various elements;
(b) for vitamins other than vitamins A, D and E, provita-
mins and substances having a similar chemical effect:
the specific name of the additive in accordance with
Annexes I or II, active substance level and expiry dateof the guarantee of that level or storage life from the
date of manufacture.
4. Member States shall require that the specific names
of additives permitted under Article 4 (1) (b) must be
specified on the package, container or label of the feeding-
stuffs. They may require that the active substance level
must also be specified.
5. Member States shall require that:
(a) the details provided for in paragraphs 1 to 4 shall be
printed close to the particulars which have to appear
on the package, container or the label affixed thereto
in accordance with Community rules on feedingstuffs;
(b) where a level or a quantity is stated pursuant to para-
graphs 1 to 4, such statement shall refer to the
amount of additive incorporated in the feedingstuff;
(c) the details of additives referred to in paragraphs 1 to
4 may be accompanied by the EEC number or the
trade name.
6. Where, pursuant to paragraph 1, the expiry date of
the guarantee or storage life from the date of manufacture
of several additives belonging to the same group or differ-
ent groups has to be stated, Member States shall require
that a single date of guarantee or a single reference to the
storage life from the date of manufacture may be indicated
for all the additives, namely the deadline which will be re-
ached first.
7. In the case of feedingstuffs distributed by road
tankers or similar vehicles or in bulk, the details provided
for in paragraphs 1 to 4 shall be given in the accompany-ing document.84/587/EEC
70/524 - - - I
20Where small quantities intended for the end-user are in-
volved, it shall be sufficient for such details to be conveyed
to the purchaser by a suitable notice.
8. By way of derogation from paragraph 1 (b), (c) and
(g) and until ... (two years after the notification of this
Directive) Member States may give permission for the in-
dication of the specific name of substances having antioxi-
dant effects, colorants and preservatives to be replaced by
an indication of the name of the group of additives con-
cerned accompanied by the word “authorized”.
9. Member States shall require that, in the case of pet
foods containing colorants, preservatives or substances hav-
ing antioxidant effects and put up in packages having a net
weight of not more than 10 kilograms, it shall be sufficient
for the package to bear the words “coloured with”, or
“preserved with”, or the words “with antioxidant” as ap-
propriate, followed by the words “EEC additives”, pro-vided that:
(a) the package, container or label bears a reference
number by means of which the feedingstuff may be
identified, and
(b) the manufacturer gives, on request, the specific name,
or names, of the additive or additives used.
10. Any reference to additives other than in the form
provided for in this Directive shall be prohibited.
Article 17
1. Without prejudice to the provisions of Directive
79/373/EEC
(3), Member States shall require that supple-
mentary feedingstuffs which contain additives in excess of
the maximum levels fixed for complete feedingstuffs may
be placed on the market only if the directions for use
state, according to the species and age of the animal, the
maximum quantity in grams or kilograms of supplementary
feedingstuff to be given per animal per day.
This information must be in accordance with the provisions
of Annexes I or II.
This provision shall not apply to products delivered to
manufacturers of compound feedingstuffs or to their
suppliers.
2. The declaration referred to in paragraph 1 shall be so
formulated that, when it is correctly followed, the propor-
tion of additives does not exceed the maximum level fixed
for complete feedingstuffs.
Article 18
Where feedingstuffs are marketed in other Member States
the details referred to in Articles 14 to 17 shall be given inat least one of the official languages of the country of des-
tination.
(3)OJ No L 86, 6. 4. 1979, p. 30.84/587/EEC
70/524 - - - I
21Article 19
Member States shall ensure that additives, premixtures and
feedingstuffs which conform to this Directive are subject
only to the marketing restrictions provided for in this Di-
rective.
Article 20
Member States shall ensure that livestock products are not
subject to any marketing restriction as a result of the ap-
plication of this Directive.
Article 21
1. Member States shall in particular take all necessary
measures to ensure that additives, premixtures and feeding-
stuffs put on the market are officially checked, at least by
random sampling, in respect of the identity of the additives
used and to verify that the other conditions laid down in
this Directive are satisfied.
T o this end, they shall require in particular that undertak-
ings which intend to manufacture additives or to put them
on the market must first inform the competent authorities
thereof.
2. Under the procedure provided for in Article 23, mar-
gins of tolerance may be fixed, to be allowed where there
is a discrepancy between the result of the official check
and the stated content of the additive in the compound
feedingstuff.
Article 22
This Directive shall not apply to additives, premixtures and
feedingstuffs which are shown, at least by an appropriate
indication, to be for export to third countries.
Article 23
1. Where the procedure laid down in this Article is to
be followed, matters shall be referred without delay be
(SIC! by) the chairman, either on his own initiative or at
the request of a Member State, to the Standing Committee
for Feedingstuffs, hereinafter called “the Committee”.
2. The votes of the Member States within the Commit-
tee shall be weighted as provided for in Article 148 (2) of
the T reaty. The chairman shall not vote.
3. The representative of the Commission shall submit a
draft of the measures to be adopted. The Committee shall
d e l i v e ri t so p i n i o no ns u c hm e a s u r e sw i t h i nat i m el i m i ts e t
by the chairman according to the urgency of the matters.
Opinions shall be delivered by a majority of fifty-four
votes.
4. The Commission shall adopt the measures and imple-
ment them forthwith where they are in accordance withthe opinion of the Committee. Where they are not in ac-
cordance with the opinion of the Committee, or if no opin-
ion is delivered, the Commission shall without delay pro-
pose to the Council the measures to be adopted. The
Council shall adopt the measures by a qualified majority.84/587/EEC
3768/85
70/524 - - - I
22If the Council has not adopted any measures within three
months of the proposal being submitted to it, the Commis-
sion shall adopt the proposed measures and implement
them forthwith, except where the Council has voted by a
simple majority against such measures.
Article 24
1. Where the procedure laid down in this Article is to
be followed, matters shall be referred to the Committee
without delay by the chairman, either on his own initiative
or at the request of a Member State.
2. The votes of the Member States within the Commit-
tee shall be weighted as provided for in Article 148 (2) of
the T reaty. The chairman shall not vote.
3. The representative of the Commission shall submit a
draft of the measures to be adopted. The Committee shall
d e l i v e ri t so p i n i o no ns u c hm e a s u r e sw i t h i nt w od a y s .
Opinions shall be delivered by a majority of 54 votes.
4. The Commission shall adopt the measures and imple-
ment them forthwith where they are in accordance with
the opinion of the Committee. Where they are not in ac-
cordance with the opinion of the Committee, or if no opin-
ion is delivered, the Commission shall without delay pro-
pose to the Council the measures to be adopted. The
Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15
days of the proposal being submitted to it, the Commission
shall adopt the proposed measures and implement them
forthwith, except where the Council has voted by a simple
majority against such measures.
Article 25
A decision on the transfer of antibiotics, coccidiostats and
other medicinal substances, together with preparations
based on these products, to Directive 81/851/EEC and to
future rules on medicinal feedingstuffs shall be adopted by
the Council acting unanimously on a proposal from the
Commission once the degree of harmonization with regard
to the free movement of products in the sector of veterin-
ary medicinal products and medicated feedingstuffs has re-
ached a level comparable to that obtaining with regard to
additives.
Article 26
Member States shall, within two years following notifica-
tion thereof, bring into force the laws, regulations, or ad-
ministrative provisions necessary to comply with this Direc-
tive. They shall forthwith inform the Commission thereof.84/587/EEC
3768/85
70/524/EEC
70/524 - - - I
23However, in the case of the territory of the former Ger-
man Democratic Republic, the Federal Republic of Ger-
many may:
— maintain the provisions applicable prior to unification
under which the use of the following additives in
feedingstuffs is authorized:
—O l a q u i n d o x ,
— Nourseothricine,
— Ergambur.
This derogation shall expire on the date of the
Decision to be taken, in accordance with Article
7, on the authorization or prohibition of the use
of the additives listed above, and by 31 De-
cember 1992 at the latest. The Federal Republic
of Germany shall ensure that those additives and
any feedingstuffs into which they are incorpo-
rated are not dispatched to other parts of theCommunity;
— derogate, until 31 December 1991, from the labelling
provisions in Articles 14, 15 and 16 for the additives,
additive pre-mixtures and compound feedingstuffs to
which additives have been added, produced in the
territory in question.
Article 27
This Directive is addressed to the Member States.90/654/EEC
84/587/EEC
70/524/EEC
70/524 - - - I
24ANNEX I
91/248/EEC
EEC No AdditiveChemical formula, descrip-
tionSpecies or categor yof
animalMaximum
ageMini-
mum
contentMaxi-
mum
content Other
provisionsEECNo Additivetion animal age
mg/kg of complete
feedingstuffprovisions
A. Antibiotics
E 700 Bacitracin zinc C66H103O16N17SZn (po-
lypeptide containing 12to 20 % zinc)Laying hens — 15 100 —
Tu r k e y s 4 weeks
26 weeks55 5020 ——
Other poultry, excludingducks, geese, pigeons 4 weeks
16 weeks55 5020 ——
C a l v e s ,l a m b s ,k i d s 16 weeks 5 50 —
6m o n t h s 5 20 —
6m o n t h s 5 80 Milks replacers only
Piglets 4m o n t h s 5 50 —
3m o n t h s 5 80 Milks replacers only
Pigs 6m o n t h s 5 20 —
Animals bred for fur ex-
cluding rabbits— 5 20 —
E 710 SpiramycinIC43H74O14N2Tu r k e y s 26 weeks 5 20 —4374142
II C 45H76O15N2 base
III C 46H78O15N2
(makrolide)Other poultry excludingducks, geese, laying hens,pigeons 16 weeks 5 20
—
70/524 - - - I
2591/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
C a l v e s ,l a m b s ,k i d s 16 weeks 5 50 —
6m o n t h s 5 20 —
6m o n t h s 5 80 Milks replacers only
Piglets 4m o n t h s 5 50 —
3m o n t h s 3 80 Milks replacers only
Pigs 6m o n t h s 5 20 —
Animals bred for fur
excluding rabbits— 5 20 —
E 711 Virginiamycin IC28H35O7N3
II C 43H49O10N7Tu r k e y s 26 weeks 5 20 —
Other poultryexcluding ducks, geese,laying hens, pigeons 16 weeks 5 20 —
Piglets 4m o n t h s 5 50 —
Pigs 6m o n t h s 5 20 —
Calves 16 weeks 5 50 —
6m o n t h s 5 20 —
6m o n t h s 5 80 Milks replacers only
70/524 - - - I
2691/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Laying hens — 20 20 —
Cattle for fattening — 15 40 Indicate in the instruc-
tions for use:
‘The quantity of virgi-
niamycin in the daily
ration must not ex-
ceed 140 mg for
100 kg of bodyweightand 6 mg for each ad-
ditional 10 kg of bo-
dyweight’
E 712 Flavophospholi-
polC70H124O40N6P Laying hens — 2 5 —
Tu r k e y s 26 weeks 1 20 —
Other poultry excludingducks, geese, pigeons 16 weeks 1 20 —
Piglets 3m o n t h s 10 25 Milks replacers only
Pigs 6m o n t h s 1 20 —
Animals bred for fur ex-cluding rabbits — 2 4 —
Calves 6m o n t h s 6 16 —
6m o n t h s 8 16 Milks replacers only
70/524 - - - I
2791/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Cattle for fattening — 2 10 Indicate in the instruc-
tions for use:
‘The quantity of fla-
vophospholipol in the
daily ration must not
exceed 40 mg for
100 kg of bodyweightand 1,5 mg for each
additional 10 kg of
bodyweight’
Rabbits 2 4 —
E 713 T ylosin phosphate Macrolide product ofStreptomyces frodiae Piglets 4m o n t h s 10 40 The minimum and
maximum contents are
expressed as tylosing
base94/17/EEC
Composition of antibioticfactors
(1):Pigs 6m o n t h s 5 20 —
a) T ylosin
C46H77NO17:
min. 80 %
b) Desmycosin
C39H65NO14
c) Macrocin
C45H75NO17
d) Relomycin
C46H79NO17
a )+b )+c )+d ) :m i n .
95 %
(1)According to the method of analysis of the British Pharmacopeia (Veterinary 1985)
70/524 - - - I
2891/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 714 Monensin-sodium C36H61O11Na (sodium
salt of polyether mono-carboxylic acid produced
by Streptomyces cinna-
monensis )Cattle for fattening — 10 40 Indicate in the instruc-
tions for use:
‘The quantity of mo-
nensin sodium in the
daily ration must not
exceed 140 mg for
100 kg of bodyweightand 6 mg for each ad-
ditional 10 kg of bo-
dyweight.
Dangerous for equi-
nes’This
feedingstuff
contains an ionopho-
re: simultaneous use
with certain medicinal
substances (e.g. tia-
mulin) can be contra
indicated91/508/EEC
E 715 Avoporcin C53H6O30N6Cl3(glyco-
peptide)Chickens for fattening — 7,5 15 —
T urkeys for fattening 16 weeks 10 20 —
Piglets 4m o n t h s 10 40 —
Pigs 6m o n t h s 5 20 —
Calves 6m o n t h s 15 40 —
70/524 - - - I
2991/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Cattle for fattening — 15 30 Indicate in the instruc-
tions for use:
‘The quantity of avo-
parcin in the daily ra-
tion must not exceed
103 mg for 100 kg of
bodyweight and 4,3mg for each additio-
nal 10 kg of body-
weight’
Lambs from the beginningof rumination with the ex-ception of posturegrazed
lambs
16 weeks 10 20 —93/27/EEC
E 716 Salinomycin so-
diumC42H69O11Na (sodium
salt of a polyether mono-carboxylic acid produced
byStreptomyces albus )Piglets
Pigs4m o n t h s6m o n t h s 3015 6030 Indicate in the ins-
tructions for use— ‘Dangerous for
equines’;
— ‘This feeding-
stuff contains
on ionophore:simultaneous
use with certain
medicinalsub91/508/EEC
medicinalsub-
stances (e.g.
tiamulin) can becontra indica-
ted.’
70/524 - - - I
3091/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 717 Avilamycin C57-62H82-90Cl1-2O31-32
(Mixture of oligosaccha-
rides of the orthosomycin
group produced by Stre-
pomyces viridochromoge-
nes)Piglets
Pigs4m o n t h s6m o n t h s 2010 4020 —
—92/64/EEC
70/524 - - - I
3191/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
B. Antioxidants
E 300 L-ascorbic acid C6H8O6 — — —
E 301 Sodium L-ascor-
bateC6H7O6Na — — —
E 302 Calcium L-ascor-
bateC12H14O12Ca·2H2O — — —
E 303 5,6-Diacetyl-L-as-
corbic acidC10H12O8 — — —
E 304 6-Palmityl-L-as-
corbic acidC22H38O7 — — —
E 306 T ocopherol-rich
extracts of natu-ral origin—
All species or catego-ri
esofanimals— — —
Allfeedingstu ffs
E 307 Synthetic alpha-
tocopherolC29H50O2riesofanimals
— — —Allfeedingstuffs
E 308 Synthetic gamma-
tocopherolC28H48O2 — — —
E 309 Synthetic delta-
tocopherolC27H46O2 — — —
E 310 Propyl gallate C10H12O5 — —100:alone
E 311 Octyl gallate C15H22O5 — —alone
or
toge-
ther
E 312 Dodecyl gallate C19H30O5 — —ther
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 320 Butylated hydro-
xyanisole(BHA)C11H16O2
All i t— —
150:
alone
E 321 Butylated hydro-
xytoluene(BHT)C15H24OAll species or catego-ries of animals— —or
toge-
therAll feedingstuffs
E 324 Ethoxyquin C14H19ON — —
70/524 - - - I
3391/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
C. Aromatic and ap-
petizing substan-ces
1.All natural pro-
ducts and corres-ponding synthetic
products— All species or categories
of animals— — — —
2.Artificial substan-
ces:
E 954(i) Saccharin C7H5NO3S Piglets 4m o n t h s — 150 —
E 954(ii) Calcium saccharin C7H3NCaO 3S Piglets 4m o n t h s — 150 —
E 954( iii) sodium saccharin C7H4NNaO 3S Piglets 4m o n t h s — 150 —
E 959 Neohesperidine
dihydrochalconeC28H36O15 Piglets 4m o n t h s — 35 — 91/508/EEC
Dogs — — 35 —
Calves — — 30 — 93/27/EEC
Ovines — — 30 —
70/524 - - - I
3491/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
D. Coccidiostas and
other medicinalsubstances
E 750 Amprolium 1-[(4-amino-2-propylpyri-midin-5-yl) methyl]-2-me-thyl-pyridinium chloride
hydrochloridePoultry — 62,5 125 Use prohibited from
laying age onwards andat least 3 days before
slaughter respectively
E 751 Amprolium/etho-
pabate (mixtureof 25 parts of (a)
amprolium and
1,6 parts of (b)
ethopabate)a) 1-[4-amino-2-propyl-
pyrimidin-5-yl) me-thyl]-2-methylpyridi-
nium chloride hydro-
chloride Chickens, turkeys andguinea-fowl— 66,5 133
Use prohibited fromlaying age onwardsand at least 3 days
before slaughter res-
ilp )
b) Methyl-4-acetami-
do-2-ethoxybenzoateg
pectively
E 752 Dinitolmide
(DOT)3,5-dinitro-2-toluamide Poultry — 62,5 125 Use prohibited fromlaying age onwards andat least 3 days before
slaughter respectively
E 754 Dimetridazole 1,2-dimethyl-5-nitroimi-
dazoleTu r k e y s — 100 200 Use prohibited fromlaying age onwards andat least 6 days before
slaughter respectively
Guinea-fowl — 125 150 Use prohibited from
laying age onwards andat least 6 days before
slaughter respectively
E 755 Meticlorpindol 3,5-dichloro-2,6-dimethyl-
pyridin-4-olChickens for fattening,guinea-fowl — 125 125 Use prohibited fromlaying age onwards andat least 6 days before
slaughter respectively
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Rabbits — 125 200 Use prohibited at least
5 days before slaughter
E 756 Decoquinate 3-ethoxycarbonyl-4-hy-droxy-6-decy-loxy-7-ethoxyquinoline Chickens for fattening — 20 40 Use prohibited at least3 days before slaughter
E 757 Monensin-sodium C36H61O11Na (sodium
salt of polyether mono-carboxylic acid produced
by Streptomyces cinna-
monensis )Chickens for fattening — 100 125 Use prohibited at least
3 days before slaughterIndicate in the instruc-
tions for use: ‘Dange-
rous for equines’
‘This
feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra indicated’91/508/EEC
Chickens reared for
laying16 weeks 100 120 Indicate in the instruc-tions for use ‘Dange-rous for equines’
‘This
feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra indicated’91/508/EEC
70/524 - - - I
3691/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Tu r k e y s 16 weeks 90 100 Use prohibited at least
3 days before slaughterIndicate in the instruc-
tions for use: ‘Dange-
rous for equines’
‘This
feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra indicated’91/508/EEC
E 758 Robenidine 1,3-bis[(4-chlorobenzyli-
dene)-amino]-guanidinehydrochlorideChickens for fattening,turkeys — 30 36 Use prohibited at least5 days before slaughter
Rabbits for fattening — 50 66 Use prohibited at least5 days before slaughter
Rabbits for breeding pur-poses — 50 66 Use prohibited at leastfive days before slaugh-ter 93/27/EEC
E 759 Ronidazole (1-methyl-5-nitroimida-zol-2-yl)methylcarbamate Tu r k e y s — 60 90 Use prohibited fromlaying age onwards andleast 6 days before
slaughter respectively91/248/EEC
E 760 Ipronidazole 1-methyl-2-isopropyl-5-ni-
troimidazoleTu r k e y s — 50 85 Use prohibited fromlaying age onwards andat least 6 days before
slaughter respectively
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 761 Meticlorpindol/
methylbenzoqua-te: (mixture of
100 parts of (a)
meticlorpindol
and 8,35 parts of
(b) methylbenzo-quate)a) 3,5-dichloro-2,6-di-
methyl-pyridin-4-olChickens for fattening — 110 110 Use prohibited at least5 days before slaughter
b) 7-benzyloxy-6-bu-
tyl-3-methoxycarbo-nyl-4-quinoloneChickens reared forlaying 16 weeks 110 110 —
Tu r k e y s 12 weeks 110 110 Use prohibited at least5 days before slaughter
E 762 Arprinocid 9-(2-chloro-6-fluoroben-zyl) adenine Chickens for fattening — 60 60 Use prohibited at least5 days before slaughter
Chickens reared forlaying 16 weeks 60 60 —
E 763 Lasalocid sodium C34H53O8Na (sodium
salt of polyether mono-carboxylic acid produced
by Streptomyces lasalien-
sis)Chickens for fattening — 75 125 Use prohibited at least5 days before slaughter.Indicate in the
instruc-
tions for use:
“This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances can be contra
indicated”91/508/EEC
Chickens reared for laying 16 weeks 75 125
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Tu r k e y s 12 weeks 90 125 Use prohibited at least
five days before slaugh-ter
Indicate in the instruc-
tions for use:
‘This feedingstuff
contains an ionophore;simultaneous use with
certain medicinal sub-
stances can be contra-
indicated’92/64/EEC
E 764 Halofuginone dl-trans-7-bromo-6-chlo-
ro-3-[3-(3-hydroxy-2-pipe-ridyl) acetonyl]-quinazo-
lin-4-(3H)-one hydrobro-
mideChickens for fattening — 2 3 Use prohibited at least5 days before slaughter 91/248/EEC
Tu r k e y s 12 weeks 2 3 Use prohibited at least5 days before slaughter
E 765 Narasin C43H72O11(polyether of
monocarboxylic acid pro-duced by Streptomyces
aureofaciens)Chickens for fattening — 60 70 Use prohibited at least
5 days before slaughterIndicate in the instruc-
tions for use: ‘Dange-
rous for equines.
This
feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra-indicated’91/508/EEC
70/524 - - - I
3991/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 766 Salinomycin so-
diumC42H69O11Na (sodium
salt of polyether of mo-nocarboxylic acid produ-
ced by Streptomyces al-
bus)Chickens for fattening — 50 70 Use prohibited at least
5 days before slaughterIndicate in the instruc-
tions for use: ‘Dange-
rous for equines.
This
feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra indica-
ted.’91/508/EEC
E 768 Nicarbazin Equimolecular complex
of 1,3-bis (4-nitrophenyl)urea and 4,6-di methyl
pyrimidin-2-olChickens for fattening 4 weeks 100 125 Use prohibited at least
9 days before slaughter
E 769 Nifursol 3,5-dinitro-N1-(5-nitrofur-
furylidene) salicylohydra-zideTu r k e y s — 50 75 Use prohibited at least5 days before slaughter
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
Minimum purit y:9 8%
on an anhydrous basis.Particular features of the
three authorized prepara-
tions of the three autho-
rized preparations:
— maximum nifursolMaximum amount of
dust emitted duringhandling, as determined
by the Stauber Heu-
bach method
(1):0 , 1 ←g
nifursol
maximum nifursol
content: 14,6 %,
44 % or 50 %
— minimum stability: 24
months mont hs
— carrier for the three
preparations: maize
starchand,respecti- starchand,respecti-
v e l y ,1 2 % ,3 3 %o r
34 % of soya bean
oil
E 770 Maduramicin am-
moniumC47H83O17N (ammonium
salt of a polyether mono-carboxylic acid produced
by Actinomadura yu-
maensis )Chickens for fattening — 5 5 Indicate in the instruc-
tions for use
‘— Use prohibited at
least five days befo-
re slaughter
— Dangerous for
Equidae’92/64/EEC
(1)Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-4, Springer V erlag 1984.
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
‘This feedingstuff
contains an ionophore;simultaneous use with
certain medicinal sub-
stances (e.g. tiamulin)
can be contra-indicated’92/64/EEC
E 771 Diclazuril (+)-4-chlorphenyl
(2,6-dichlo-ro-4-(2,3.4,5-tetrohy-
dro-3,5-dioxo-1,2,4-tria-
zin-2-yl-phenyl) acetoni-
trileChickens for fattening — 1 1 Use prohibited at least
five days before slaugh-ter93/107/EEC
70/524 - - - I
4291/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E. Emulsiflers, sta-
bilizers, thicke-
ners and gelling
agents
E 322 Lecithins — — — —
E 400 Alginic acid —
All species or catego-
riesofanimals— — —
E 401 Sodium alginate —ries ofanimals
— — —
E 402 Potassium algina-
te— — — —
E 403 Ammonium algi-
nate— All species or categoriesof animals with the ex-ception of aquarium fish — — —
E 404 Calcium alginate — — — —
All feedingstuffs
E 405 Propane-1,2-diol
alginate (Propyl-eneglycol algina-
te)— — — —
E 406 Agar —
All i t— — —
E 407 Carrageenan —All species or catego-
ries of animals— — —
— — —
E 408 Furcelleran — — — —
E 410 Locust bean gum
(Carob gum)— — — —
E 411 T amarind seed
flour— — — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 412 Guar gum — — — —
E 413 T ragacanth —
All species or catego-— — —
E 414 Acacia (Gum ara-
bic)—p g
ries of animals— — —All feedingstuffs
E 415 Xanthan gum — — — —
E 418 Gellan gum Polytetrasaccharidecontaining glucose, glucu-ronic acid and rhamnose
(2:1:1) produced by
Pseudomonas elodea
(ATCC 31466)Dogs, cats — — — Only canned feeding-
stuffs94/17/EC
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 420 Sorbitol — — — —
E 421 Mannitol — — — — All feedingstuffs
E 422 Glycerol — — — —
E 432 Polyoxyethylene
(20)-sorbitan mo-nolaurate— — —
E 433 Polyoxyethylene
(20)-sorbitan Mo-nooleate—
All species or catego-ries of animals— —
5 000
(alone
or with
the
E 434 Polyoxyethylene
(20)-sorbitan mo-nopalmitate— — —the
other
poly-
sorba-
tes)Milks replacers only
E 435 Plyoxyethylene
(20)-sorbitan mo-nostearate— — —tes)
E 436 Polyoxyethylene
(20)-sorbitan tris-tearate— — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 440 Pectins — All species or categories
of animals— — —
E 450 b(i) Pentasodium tri-
phosphate— Dogs, cats — — 5 000
All feedingstuffs
E 460 Microcrystalline
cellulose— All species or categoriesof animals — — —
E 460 (ii) Cellulose powder — — — — 93/27/EEC
E 461 Methylcellulose — — — — 91/248/EEC
E 462 Ethylcellulose — — — —
E 463 Hydroxypropyl-
cellulose—
All species or catego-ries o
fanimals— — —
All feedingstuffs
E 464 Hydroxypropyl-
methylcellulose—riesofanimals
— — —
E 465 Ethylmethylcellu-
lose— — — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 466 Carboxymethyl-
cellulose (sodiumsalt of carboxy-
methyl ether of
cellulose)— — — —
E 470 Sodium, potas-
sium and calciumsalts of edible fat-
ty acid, alone or
in mixtures, deri-
ved either from
edible fats orfrom distilled edi-
ble fatty acids— — — —
E 471 Mono- and digly-
cerides of fattyacids—
All species or catego-ries of animals— — —
All feedingstuffs
E 472 Mono- and digly-
cerides of ediblefatty acids esteri-
fied with the fol-
lowing acids
a) acetic — — — —
b) lactic — — — —
c) citric — — — —
d) tartaric — — — —
e) mono- and
diacetyltartaric— — — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 473 Sucrose esters of
fatty acids (estersof saccharose and
edible fatty acids)— — — —
E 474 Sucroglycerides
(mixture of estersof saccharose and
mono- and digly-
cerides of edible
fatty acids)— — — —
E 475 Polyglycerol es-
ters of non-poly-merized edible
fatty acids—
All species or catego-
ries of animals— — —
All feedingstuffs
E 477 Mono-esters of
propane-1,2-diol(propyleneglycol)
and edible fatty
acids, alone or in
mixtures with
diesters— — — —
E 480 Stearoyl-2-lactylic
acid— — — —
E 481 Sodium stea-
royl-2-lactylate— — — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 482 Calcium stea-
royl-2-lactylate— — — —
E 483 Stearyl tartrate — — — —
E 484 Glyceryl poly-
ethylene-glycol ri-cinoleate—All species or catego-ries of animals— — — All feedingstuffs
E 486 Dextrans — — — —
E 487 Ployethylenegly-
col ester of fattyacids from soya
oil— Calves — — 6 000
E 488 Polyoxyethylated
glyceride of tal-low fatty acids— Calves — — 5 000
Milks replacers only
E 489 Ether of polygly-
cerol and of alco-hols obtained by
the reduction of
oleic and palmitic
acids— Calves — — 5 000
70/524 - - - I
4991/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 490 Propane-1,2-diol — Dairy cows — — 12 000
Cattle for fattening, cal-
ves, lambs, kids, pigs,poultry— — 36 000
E 491 Sorbitan mono-
stearate— — — —
E 492 Sorbitan tristeara-
te— — — —
E 493 Sorbitan mono-
laurate— — — —
E 494 Sorbitan mono-
oleate—All species or catego-ries of animals— — —
All feedingstuffs
E 495 Sorbitan mono-
palmitate— — — —
E 496 Polyethylenegly-
col 6000— — — 300
E 497 Polyoxypropylene-
polyoxyethylenepolymers (M.
W .6800-9000)— — — 50
E 498 Partial polyglyce-
rol esters of poly-condensed fatty
acids of castor oil— Dogs — — —
E 499 Cassia gum — Dogs and cats — — 17 600 Canned feedingstuffs
only93/55/EEC
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
F. C o l o u r i n g m a t -
ters includingpigments94/17/EC
1. Carotenoids and
xanthophylls:
E 160c Copsanthin C40H56O3 — —
80—
E 160e Beta-apo-8 〈-caro-
tenalC30H40O — —80
(aloneor with
the—
E 160f Ethyl ester of
beta-apo-8 〈-caro-
tenoico acidC32H44O2
Poultry— —the
other
carote-
noidsand
xan-—
E 161b Lutein C40H56O2 — —xan-
tho-
phylls—
E 161c Cryptoxanthin C40H56O — —py
—
E 161g Canthoxanthin C40H52O2 (a) Poultry — — —
(b) Salmon, trout — — 80 Use permitted from the
age of six months on-wards.
The mixture of can-
thaxanthin with astaxan-
thin is allowed provided
that the total concen-tration of the mixture
does not exceed 100
mg/kg in the complete
feedingstuff
c) Dogs, cats and orna-
mental fish— — —
70/524 - - - I
5191/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 161h Zeaxanthin C40H56O2 Poultry — — 80
(aloneor
with
the
other
caro-te-
noids— 94/17/EC
E 161i Citranaxanthin C33H44O Laying hens — —andxan-
tho-phylls)
—
E 161j Astaxanthin C40H52O4 a) Salmons, trout — — 100 Use only permittedfrom the age of sixmonths onwards.
The mixture of astaxan-
thin with contaxanthin
is allowed provided that
the total concentrationof the mixture does not
exceed 100 mg/kg in
t h ec o m p l e t ef e e d i n g -
stuff
b) Ornamental fish — — — —
70/524 - - - I
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EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
2. Other colourants: 94/17/EC
E 102 T artrazine C16H9N4O9S2Na3
E 110Sunset yellow
FCFC16H10N2O7S2Na2Ornamental fish — — — —
E 124 Ponceau 4 R C20H11N2O10S3Na3
E 127 Erythrosine C20H6I4O5Na2H2O
E 131 Patent Blue V Calcium salt of the disul-phonic acid of m- hy-droxytetraethyldiamino
triphenylcarbinol anhy-
dridea) All species or cate-
gories of animalswith the exception of
dogs and cats— — — Permitted in animal
feedingstuffs only inproducts processed
from:
i) waste products of
feedingstuffs;
ii) denatured cereals
or manioc flour; or
iii) other base substan-
ces denatured by
means of these
agents or colouredduring technical
preparation to en-
sure the necessaryidentification du-
ring manufacture
b) Dogs and cats — — — —
70/524 - - - I
5391/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 132 Indigotine C16H8N2O8S2Na2 Ornamental fish — — — — 94/17/EC
E 141 Chlorophyll cop-
per complex— Ornamental fish — — — —
E 142 Acid brilliant
green BS (Lissa-mine green)Sodium salt of 4,4’-bis(dimethylamino) diphe-nylmethylene-2-naph-
tol-3,6-disulphonic acida) All species or cate-
gories of animalswith the exception of
dogs, cats and orna-
mental fish— — — Permitted in animalsfeedingstuffs only inproducts processed
from:
i) waste products of
foodstuffs:
ii) denatured cereals
or manioc flour; or
iii) other base substan-
ces denatured by
means of these
agents or colouredduring technical
preparation to en-
sure the necessaryidentification du-
ring manufacture
b) Dogs, cats and orna-
mental fish— — — —
E 153 Carton black C — — —
E 160 B Bixin C25H30O4 Ornamental fish — — —
E 172 Iron oxide, red Fe2O3 — — —
70/524 - - - I
5491/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
3. Colouring agents
authorized for co-louring foodstuffs
by Community
rules, other than
Patent blue V
a n dA c i db r i l l i a n tgreen BS— a) All species or cate-
gories of animalswith the exception of
dogs and cats— — — Permitted in animal
feedingstuffs only inproducts processed
from:
i) waste products of
foodstuffs;
or
ii) other base substan-
ces, with the excep-
tion of cereals and
manioc flour, dena-
tured by means ofthese agents of co-
loured during tech-
nical preparation toensure the necessa-
ry identification du-
ring manufacture94/17/EC
b) Dogs and cats — — — —
70/524 - - - I
5591/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
G. Preservatives
E 200 Sorbic acid C6H8O2 — — —
E 201 Sodium sorbate C6H7O2Na
All species or catego-
ries o fanimals— — —
E 202 Potassium sorbate C6H7O2Kriesofanimals
— — —
E 203 Calcium sorbate C12H14O4Ca — — —
E 214 Ethyl 4-hydroxy-
benzoateC9H10O3 — — —
All feedingstuffs
E 215 Sodium ethyl
4-hydroxybenzoa-teC9H9O3Na — — —
E 216 Propyl 4-hydroxy-
benzoateC10H12O3
Pets— — —
E 217 Sodium propyl
4-hydroxybenzoa-teC10H11O3NaPets
— — —
E 218 Methyl 4-hydro-
xybenzoateC8H8O3 — — —
E 219 Sodium methyl
4-hydroxybenzoa-teC8H7O3Na — — —
70/524 - - - I
5691/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 222 Sodium bisulphite NaHSO 3 — — alone
ortoge-
ther:
500All feedingstuffs ex-
cept unprocessed
E 223 Sodium metabisl-
phiteNa2S2O5Dogs, cats— —ex-pres-sed
as
SO
2cept unprocesse d
meat and fish
E 236 Formic acid CH2O2
Allspeciesorcatego— — —
E 237 Sodium formate CHO 2NaAllspecies or catego-
ries of animals — — — All feedingstuffs
E 238 Calcium formate C2H2O4Ca — — —
E 240 Formaldehyde CH2O Pigs 6m o n t h s — — Skimmed milk only:maximum content: 600mg/kg
All species or categoriesof animals
E 250 Sodium nitrate NaNO 2 Dogs, cats — — 100 Canned feedingstuffsonly
E 260 Acetic acid C2H4O2 — — —
E 261 Potassium acetate C2H3O2K All species or catego-ries of animals — — —
Allfeedingstuffs
E 262 Sodium diacetate C4H7O4Na — — —Allfeedingstuffs
E 263 Calcium acetate C4H6O4Ca — — —
70/524 - - - I
5791/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 270 Lactic acid C3H6O3 — — —
E 280 Propionic acid C3H6O2 — — —
E 281 Sodium propiona-
teC3H5O2Na
Allspeciesorcatego-— — —
E 282 Calcium propio-
nateC6H10O4CaAllspeciesorcatego-
ries of animals — — — All feedingstuffs
E 283 Potassium propio-
nateC3H5O2K — — —
E 284 Ammonium pro-
pionateC3H9O2N — — —
E 285 Methylpropionic
acidC4H8O2 Ruminants, at the begin-ning of rumination — 1 000 4 000 — 92/113/EEC
E 295 Ammonium for-
mateCH5O2N — — — 91/248/EEC
E 296 DL-malic acid C4H6O5 — — —
E 297 Fumaric acid C4H4O4All species or catego-
ifil— — —
E 325 Sodium lactate C3H5O3Nap g
ries o fanimals— — — All feedingstuffs
E 326 Potassium lactate C3H5O3K — — —
E 327 Calcium lactate C6H10O6Ca — — —
E 330 Citric acid C6H8O7 — — —
70/524 - - - I
5891/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or category of
animalChemical formula, descrip-
tionAdditive
E 331 Sodium citrates — — — —
E 332 Potassium citrates — — — —
E 333 Calcium citrates — — — —
E 334 L-T artaric acid C4H6O6 — — —
E 335 Sodium L-tartra-
tes— All species or catego-ries of animals — — —
All feedingstuffs
E 336 Potassium L-tar-
trates— — — —
E 337 Potassium sodium
L-tartrateC4H4O6KNa ·4H2O — — —
E 338 Orthophosphoric
acidH3PO4 — — —
E 490 Propane-1,2-diol C3H8O2 Dogs — — 53 000
91/336/EEC
--- d e l e t e d
E 507 Hydrochloric acid HClAll species or catego-
riesofanimals— — —
For silage only
E 513 Sulphuric acid H2SO4riesofanimals
— — —g y
70/524 - - - I
5991/248/EEC
EEC No AdditiveChemical formula,
descriptionSpecies or category
of animalMaximum
ageMaximum content
iu/kg of completefeedingstuff or of
the daily rationOther provisions
H. Vitamins, provi-
tamins and che-mically well defi-
ned substances
having a similar
effect
E 672 1. Vitamin A — Chickens for fattening — 13 500 91/249/EEC
Ducks for fattening — 13 500
T urkeys for fattening — 13 500 All feedingstuffs except
feedingstuffsforyoung
Lambs for fattening — 13 500feedingstuffsforyoung
animals
Pigs for fattening — 13 500
Bovines for fattening — 13 500
Calves — 25 000 Only milk replacers
Other species or catego-ries of animals — — All feedingstuffs
70/524 - - - I
6091/248/EEC
EEC No Other provisionsMaximum content
iu/kg of completefeedingstuff or of
the daily rationMaximum
ageSpecies or category
of animalChemical formula,
descriptionAdditive
2.Vitamin D
E 670 Vitamin D 2 — Pigs — 2 000 —
Piglets — 10 000 Milk repla-
cers only
Bovines — 4 000 —
Simulta
Ovines — 4 000 —Simulta-
neoususe of
Calves — 10 000 Milk repla-cers onlyvitaminD
3,pro-
hibited
Equines — 4 000 —
Other species or catego-
ries of animals with the
exception of poultry and
fish— 2 000 — 91/508/EEC
70/524 - - - I
6191/248/EEC
EEC No Other provisionsMaximum content
iu/kg of completefeedingstuff or of
the daily rationMaximum
ageSpecies or category
of animalChemical formula,
descriptionAdditive
E 671 1. Vitamin D 3 — Pigs — 2 000 —
Piglets — 10 000 Milk repla-
cers only
Bovines — 4 000 —
Ovines — 4 000 —Simulta-
Calves — 10 000 Milk repla-cers onlyneoususe of
vitamin
Equines — 4 000 —vitamin
D2pro-
hibited
Chickens for fattening — 5 000 —hibited
Tu r k e y s — 5 000 —
Other Poultry — 3 000 —
Fish — 3000 91/508/EEC
Other species or catego-
ries of animals— 2 000 —
3. All substances in
the group exceptvitamins A and D— All species or categoriesof animals — — All feeding-stuffs
70/524 - - - I
6291/248/EEC
EEC No Element Additive Chemical formulaMaximum content of the element
in mg/kg of the complete feeding-
stuffOther provisions
I. Trace elements
E 1 Iron — Fe 1 250 (total)
Ferrous carbonate FeCO 3 —
Ferrous chloride, tetrahy-drate FeCl 2·4H2O —
Ferric chloride, hexahy-drate FeCl 3·6H2O —
Ferrous citrate, hexahy-drate Fe3(C6H5O7)2·6H2O —
Ferrous fumarate FeC 4H2O4 —
Ferrous lactate, trihydra-te Fe(C 3H5O3)2·3H2O —
Ferric oxide Fe2O3 —
Ferrous sulphate, mono-hydrate FeSO 4H2O Permitted:
i) in denatured skimmed
milk and in compound
feedingstuffs manufactu-
red from denatured
skimmed-milk powder:
— subject to the
mandatory provi-
sions of Commis-
sion R egulations
(EEC) No 368/77
and (EEC) No
443/7791/249/EEC
70/524 - - - I
6391/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
— declaration o fthe
amount of iron
added, expressed91/249/EEC
added,expressed
as the element,
on the label or
package or contai-
nerofdenatured ner o fdenature d
skimmed-milk
powder
ii)incompoundfeeding ii)in compound feeding-
stuffs other than those
listed under (i)
Ferrous sulphate, hepta-hydrate FeSO 4·7H2O Permitted:
i) in denatured skimmed
milk and in compound
feedingstuffs manufactu-
red from denatured
skimmed milk powder:
— subject to the man-
datory provisions of
Commission Regula-
tions (EEC)
Nû368/77 and
(EEC) N û443/77
— declaration of the
amount of iron ad-
ded, expressed as theelement, on the label
or package or contai-
ner of denatured
skimmed milk pow-
der
70/524 - - - I
6491/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
ii) in compound feeding-
stuffsotherthanthose stuffsotherthanthose
listed under (i)
Ferrous chelate of aminoacids hydrate Fe.(¢)1-3nH2O( w h e r e
¢equals an anion of
any amino acids derived
from hydrolyzed soya
protein) molecular
weight not exceeding
1 500— — 91/508/EEC
E2 I o d i n e—I 92/113/EEC
Calcium iodate, hexahy-drate Ca(IO 3)2·6H2O —
Calcium iodate, anhy-drous Ca(IO 3)2Equines: 4 (total)Other species or categories of
animal:40(Total)—
Sodium iodide NaIanimal:40(Total)
—
Potassium iodide KI —
E3 C o b a l t—C o 91/248/EEC
Cobaltous acetate, tetra-hydrate Co(CH 3COO) 2·4H2O 10 (total)
Basic cobaltous carbona-te, monohydrate 2CoCO 3·3Co(OH) 2·H2O
Colbaltous chloride,hexahydrate CoCl 2·6H2O
Cobaltous sulphate, hep-tahydrate CoSO 4·7H2O
Cobaltous sulphate, mo-nohydrate CoSO 4·H2O
Cobaltous nitrate, hexa-hydrate Co(NO 3)2·6H2O
70/524 - - - I
6591/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
E 4 Copper — Cu Cupric acetate, monohy-
drateCu(CH 3COO) 2·H2O Pigs forfattening:
—i n M e m b e r S t a t e s w h e r e
themeandensityofthe
B a s i cc u p r i cc a r b o n a t e ,
monohydrateCuCO 3·Cu(OH) 2·H2Othem e a n densityofthe
porcine population is equal
to or higher than 175 pigs
per100haofutilizable
Cupric chloride, dihydra-te CuCl 2·2H2Oper100haofutilizable
agricultural land:
— up to 16 weeks: 175
(total)
Cupric methionate Cu(C 5H10NO2S)2(total)
— from 17th week up to
lht35(ttl)Cupric oxide CuOslaughter: 35 (total)
—I n M e m b e r S t a t e sw h e r e
Cupric sulphate, pentahy-
drateCuSO 4·5H2Othe mean density of the
porcine population is lower
than 175 pigs per 100 ha of
tilibl iltlld utilizable agricultural land:
— up to 16 weeks: 175 p
(total)
— from 17th week u pto from17thweekupto
six months: 100 (total)
— oversixmonthsupto — oversixmonthsupto
slaughter: 35 (total)
Breedings pigs: 35 (total)
Calves:
ilk l 30( l) —milk replacers: 30 (total)
—othercompletefeeding- —othercompletefeeding-
stuffs: 50 (total)
Ovines: 15 (total)
Other species or categories of
animals: 35 (total)
70/524 - - - I
6691/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
Cupric sulphate, mono-
hydrateCuSO 4·H2O Pigs forfattening:
—I n M e m b e r S t a t e sw h e r e
the mean density of the
porcinepopulationisequal
Cupric sulphate, pentahy-drate CuSO 4·5H2Oporcine popu lationise q u a l
to or higher than 175 pigs
per 100 ha of utilizable
agricultural land:
upto16weeks:175Denatured skimmedmilk powder and com-
d fditff — up to 16 weeks: 175
(total)
— from 17th week up to
lht35(ttl)pound feedingstu ffs
manufactured from de-
natured skimmed milk
powder:slaughter: 35 (total)
—I n M e m b e r S t a t e sw h e r e
the mean density of the
i liilpowder:
— Subject to the rele-
vant provisions of
CommissionReguy
porcine population is lowerthan 175 pigs per 100 ha ofutilizable agricultural land:Comm issionRegu-
lations (EEC)
No 368/77 and
(EEC)No443/77— up to 16 weeks: 175 (to-
tal)
—from 17th week u pto(EEC)No443/77
— Declaration of the
amount of copper
addedexpressedasfrom17thweekupto
six months: 100 (total)
— over six months up to
slaughter: 35 (total)added,expresse das
the element on the
label or package or
the container o fde- slaughter:35(total) thecontainerofde
natured skimmedmilk powder
Breeding pigs: 35 (total)
Ovines: 15 (total)
Other species or categories ofanimals with the exception ofcalves: 35 (total)
70/524 - - - I
6791/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
E 5 Manganese — Mn 250 (total)
Manganous carbonate MnCO 3 —
Manganous chloride, te-
trahydrateMnCl 2·4H2O —
Manganous hydrogenphosphate, trihydrate MnHPO 4·3H2O —
Manganous oxide MnO —
Manganic oxide Mn2O3 —
Manganous sulphate, te-trahydrate MnSO 4·4H2O —
Manganous sulphate,monohydrate MnSO 4·H2O —
E6 Z i n c—Z n 250 (total)
Zinc lactate, trihydrate Zn(C 3H5O3)2·3H2O —
Zinc acetate, dihydrate Zn(CH 3·COO) 2·2H2O —
Zinc carbonate ZnCO 3 —
Zinc chloride, monohy-drate ZnCl 2·H2O —
Zinc oxide ZnO Maximum content of lead:
600mg/kg92/64/EEC
Zinc sulphate, heptahy-drate ZnSO 4·7H2O —
Zinc sulphate, monohy-drate ZnSO 4·H2O —
70/524 - - - I
6891/248/EEC
EEC No Other provisionsMaximum content of the element
in mg/kg of the complete feeding-
stuffChemical formula Additive Element
E7 M o l y b d e n u m—M o 2,5 (total)
Ammonium molybdate (NH 4)6Mo7O24·4H2O· —
Sodium molybdate Na2MoO 4·2H2O· —
E8 S e l e n i u m—S e 0,5 (total)
Sodium selenite Na2SeO 3 —
Sodium selenate Na2SeO 4 —
70/524 - - - I
6991/248/EEC
EEC No AdditiveChemical formula,
descriptionSpecies or categor y
ofanimalMaximum ageMini-
mum
contentMaxi-
mum
content Other
provisionsEECNo Additivedescription ofanimal
mg/kg of complete
feedingstuffprovisions
J. Growth promo-
ters
E 850 Carbadox Methyl-3-(2-quinoxalinyl-methylene) carbazateN
1,
N4-dioxidePiglets 4m o n t h s 20 50 Use prohibited at least4 weeks before slaugh-ter
Minimum purity: 96 %Characteristics of the au-thorized preparations:
—c a r b a d o x c o n t e n t : 5
or 10 %
— minimum stability:
24 months
— propionic acid: 0,5 %
—s o y a b e a n o i l : 7 %
—s o y a b e a n m i l l r u n :
up to 100 %Maximum amount of
dust emitted duringhandlings as deter-
mined by the Stauber
Heubach method
(1):
0,1←gc a r b a d o x
Indication on the label
of the additives, pre-
mixtures and feeding-
stuffs of safety instruc-
tions and warnings desi-
gned to protect thehealth of operatives
and in particular to
avoid any exposure tothe additive, especially
by touch or inhalation
(1)Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-524, Springer V erlag 1984.
70/524 - - - I
7091/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
E 851 Olaquindox 2-[N-2 〈-(hydroxyethyl)
carbamoyl]-3-methylqui-noxaline-N
1,N4-dioxydePiglets 4m o n t h s4m o n t h s 15
50(2)50
100(2)Use prohibited at least4 weeks before slaugh-ter
Minimum purity: 98 %Characteristics of the au-thorized preparation:
—o l a q u i n d o x c o n t e n t :
10 %
— minimum stability:
24 months
— medium: calcium
carbonate containing
1,5 % of glyceril po-
lyethyleneglycol rici-
noleateMaximum amount ofdust emitted duringhandling as determined
by the Stauber Heu-
bach method
(1):0 , 1 ←g
olaquindox
Indication on the label
of the additives, pre-
mixtures and feeding-
stuffs of safety instruc-
tions and warnings desi-
gned to protect thehealth of operatives
and in particular to
avoid any exposure tothe additive, especially
by touch or inhalation
(1)Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-4, Springer V erlag 1984.
(2)Milk replacers only.
70/524 - - - I
7191/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
L. Binders, anti-ca-
king agents andcoagulants
E 330 Citric acid C6H8O7 — — — All feedingstuffs. Com-pliance with the provi-sions of Article 16 (1)
(g)
E 470 Sodium, potas-
sium and calciumstearatesC18H35O2Na,
C18H35O2Ka n d
C36H70O4Ca— — —
E 516 Calcium sulphate,
dihydrateCaSO 4·2H2O — — 30 000
E 551a Silicic acid, preci-
pitated and dried— — — —
E 551b Colloidal silica — All species or catego-
riesofanimals— — —
E 551c Kieselgur (diata-
maceous earth,purified)—ries ofanimals
— — —
All feedingstuffs
E 552 Calcium silicate,
synthetic— — — —
E562 Sepiolite Hydrated magnesium sili-cate of sedimentary ori-gin, containing at least
60 % sepiolite and a
maximum of 30 % mont-
morillonite. Asbestos free— 20 000 94/41/EC
E 554 Sodium alumino-
silicate, synthetic— — — —
70/524 - - - I
7291/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
E 558 Bentonite/mont-
morillonite—
All species or cate-gories of animals— — 20 000 All feedingstuffs.Mixing with additivesfrom the groups of ‘anti-
biotics’, ‘growth promo-
ters, coccidiostats and
other medicinal substan-
ces is prohibited excepti nt h ec a s eo f :
tylosin phosphate, mo-
nensin sodium, narasin,
ipronidazole, lasalocid
sodium, avoparcin, fla-vophospholipol, salina-
mycin sodium, ronidazo-
le, virginiamycin, nicar-bazin, robenidine,
ma-
duramicin ammonium
Indication on the label
o ft h es p e c i f i cn a m eo f
the additive.92/64/EEC
E 559 Kaolinitics clays,
free of asbestosNaturally occuring mixtu-res of minerals containingat least 65 % complex hy-
drated aluminium silicates
whose main constituent is
kaolinite— — —
All feedingstuffs
E 560 Natural mixtures
of steatite andchloriteNatural mixtures of steatiteand chlorite, free of asbes-tos: minimum purity of the
mixture: 85 %— — —
E 561 Vermiculite Natural silicate of magne-
sium, aluminium and iron,expanded by heating, free
of asbestos
Maximum fluorine
content: 0,3 %— — —
70/524 - - - I
7391/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
E 563 Sepiolitic clay Hydrated magnesium sili-
cate of sedimentary ori-gin, containing at least
40 % sepiolite and 25 %
illite. Asbestos free.All species or catego-ries of animals— — 20 000 94/41/EEC
E 565 Lignosulphonates — — — — 91/248/EEC
E 598 Synthetic calcium
aluminatesMixture of calcium alumi-nates containing between35 and 51 % of AI
2O3
Maximum molybdenum
content of 20mg/kgPoultry, rabbits and
Pigs— — 20 000 All feedingstuffs 92/64/EEC
E 599 Perlite Natural silicate of sodiumand aluminium, expandedby heating, free of asbes-
tosAll species or catego-
ries of animals— — — 91/248/EEC
70/524 - - - I
7491/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
M. Acidity regula-
tors
E 170 Calcium carbona-
te
296 DL- and L-malic
acid
— Ammonium dihy-
drogen ortho-phosphate
— di Ammonium
hydrogen ortho-phosphate
E 339(i) Sodium dihydro-
gen orthophos-phate
Dogscats
E 339(ii) di Sodium hydro-
gen orthophos-phateDogs, ca ts — — — —
E 339( iii) tri Sodium ortho-
phosphate
E 340(i) Potassium dihy-
drogen ortho-phosphate
E 340(ii) di Potassium hy-
drogen ortho-phosphate
E 340( iii) tri Potassium or-
thophosphate
70/524 - - - I
7591/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
E 341(i) Calcium tetrahy-
drogen diortho-phosphate
E 341(ii) Calcium hydrogen
orthophosphate
E 350(i) Sodium malate
(salt of DL- orL-Malic acid)
E 450a(i) di Sodium dihy-
drogen diphos-phate
E 450a( iii) tetra Sodium di-
phosphate
E 450a(iv) tetra Potassium
diphosphateDogs, cats — — — —
E 450b(i) penta Sodium tri-
phosphate
E 450b(ii) penta Potassium
triphosphate
500(i) Sodium carbonate
500(ii) Sodium hydrogen
carbonate
500(iii) Sodium sesquicar-
bonate
501(ii) Potassium hydro-
gen carbonate
70/524 - - - I
7691/248/EEC
EEC NoOther
provisionsMaxi-
mum
contentMini-
mum
content Maximum age Species or category
of animalChemical formula,
descriptionAdditive EEC NoOther
provisions
mg/kg of complete
feedingstuffMaximum age Species or category
of animalChemical formula,
descriptionAdditive
503(i) Ammonium car-
bonate
503(ii) Ammonium hy-
drogen carbonate
507 Hydrochloric acid
Dogs, cats — — — —
510 Ammonium chlo-
rideg,
513 Sulphuric acid
524 Sodium hydroxide
E 525 Potassium hydro-
xide— Dogs and cats — — — — 94/17/EC
E 526 Calcium hydroxi-
de— Dogs and cats — — — —
529 Calcium oxide
D91/248/EEC
540 di Calcium di-
phosphateDogs, cats — — — —
70/524 - - - I
77ANNEX II
91/248/EEC
No AdditiveChemical formula, Species or cate-MaximumMinimum
contentMaximum
content
OtherprovisionsPeriod o fau-No AdditiveChemicalformula,
descriptionSpeciesorcate
gory of animalMaximum
age mg/kg of complete
feedingstuffOther prov isionsPeriodofau
thorization
A. Antibiotics
22 Avoparcin C53H6O30N6Cl3(Glyco-
peptide)Lambs fromthe beginningof rumination
with the excep-
tion of pastu-
re-grazed
lambs16 weeks 10 20 — 7. 4. 1993 92/99/EEC
Dairy cattle — 4 10 Indicate in the instruc-tion for use:
‘The quantity of
avoparcin in the
daily ration must
must not exceed
100 mg and, forreasons of efficacy,
must not be less
than 50 mg’8. 4. 1995 94/50/EC
27 Salinomycin so-
diumC42H69O11Na (Sodium
salt of a polyether mono-carboxylic acid produced
byStreptomyces albus )Piglets 4m o n t h s 30 60
Indicate in the instruc-
tions for use:
‘Dangerous for
equines’30. 11. 1992 91/620/EEC
Pigs 6m o n t h s 15 30equines’
30. 11. 1992 91/620/EEC
28 Avilamycin C57-62H82-90Cl1-2O31-32
(Mixtures of oligosaccha-rides of the orthosomycin
group produced by
Streptomyces viridochro-
mogenesPiglets 4m o n t h s 20 40 — 30. 3. 1993 92/99/EEC
Pigs 6m o n t h s 10 20 — 30. 3. 1993 92/99/EEC
Chickens for
fattening— 2,5 10 — 19. 7. 1995 94/50/EC
70/524 - - - I
7891/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
91/249/EEC
29 Efrotamycin C59H88N2O20 Piglets Four
months4 8 — 30. 11. 1995 94/50/EC
Pigs Six months 4 6 — 30. 11. 1995 94/50/EC
93/27/EEC
30 Virginiamycin IC 28H35O7N3
II C 43H49O10N7Sows — 20 40 — 30. 11. 1995 94/50/EC
31 Bacitracin zinc C66H103O16N17SZn (Po-
lypeptide containing 12to 20 % zinc)Chickens forfattening — 5 50 — 30. 11. 1995 94/41/EC
Pigs 6m o n t h s 5 50 — 30. 11. 1995
B. Antioxidants 91/248/EEC
D. Coccidiostats and
other medicinalsubstances
16 Meticlorpindol/
methyl-benzoqua-te: (mixture of
100 parts of (a)
meticlorpindol
and 8,35 parts of
(b) methylbenzo-quate)a) 3,5-Dichloro-2,6-di-
methyl-4-pyridinol
b) 7-benzyloxy-6-bu-
tyl-3-methoxycarbo-
nyl-4-quinoloneRabbits — 220 220 Use prohibited at least5 days before slaughter 30. 11. 1992 91/620/EEC
70/524 - - - I
7991/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
20 Lasalocid sodium C34H53O8Na (sodium
salt of a polyether mono-carboxylic acid produced
byStreptomyces lasalien-
sis)Tu r k e y s 12 weeks 90 125 Use prohibited at least
5 days before slaughterIndicate in the
instruc-
tions for use:
“This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal sub-
stances can be contra
indicated”30. 11. 1992 91/620/EEC
91/508/EEC
21 Maduramicin
ammoniumC47H83O17N (ammonium
salt of a polyether mono-carboxylic acid produced
by Actinomadura yu-
maensis )Chickens for
fattening— 5 5 Indicate in the instruc-tions for use:
— Use prohibited at
least 7 days before
slaughter
— Dangerous for
equines. “This
fee-
dingstuff contains
an ionophore: si-
multaneous use
with certain medici-30. 3. 1993 92/99/EEC
91/508/EEC
withcertainmedici
nal substances can
be contra indica-
ted”
Mixture of madurami-
cin ammonium with
bentonite montmorillo-
nite is allowed
22 Robenidine 1,3-bis[(4-chlorobenzyli-dene)-amino] guanidinehydrochloride Rabbits forbreeding pur-poses — 50 66 Use prohibited at least5 days before slaughter 30. 3. 1994 93/107/EC
70/524 - - - I
8091/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
23 Narasin/Nicarba-
zin (mixture of(a) narasin and
(b) nicarbazin in
a 1/1 ratio)(a) C 43H72O11 (poly-
ether of monocar-boxylic acid produ-
ced by Streptomyces
aureofaciens ).
(b) Equimolecular com-
p l e x o f 1 , 3 --- b i s(4-nitrophenyl)-urea
and 4,6-dimethylpyri-
midin-2-ol.
In granular formChickens for
fattening— 80 100 Use prohibited at least7 days before slaughter
Indicate in the instruc-
tions for use:
Dangerous for
equines
This
feedingstuff
contains an iono-
phore: simulta-
neous use with cer-
tain medicinal sub-
stances (e.g. tiamu-
lin) can be contra
indicated30. 11. 1995 94/50/EC
91/508/EEC
91/508/EEC
24 Diclazuril (+)-4-chlorphenyl [2,6-di-
chloro-4-(2,3,4,5-tetro-phydro-3,5-dioxo-
1,2,4-triazin-2-yl) phenyl]
acetonitrileChickens forfattening — 1 1 Use prohibited at least5 days before slaughter 30. 11. 1994 93/107/EC
92/64/EEC
25 Halofuginone di-trans-7-bromo-6-chlo-ro-3-[3-(3-hydroxy-2-pipe-ridyl) acetonyl] quinazo-
lin-4(3H)-one hydrobro-
mideChickens rea-red for laying 16 weeks 3 3 — 30. 11. 1995 94/50/EC
70/524 - - - I
8191/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
E. Emulsifers, stabi-
lizers, thickeners
and gelling
agents91/248/EEC
F. C o l o u r i n g m a t -
ters includingpigments
1. Carotenoids and
xanthophylls93/107/EC
1 Canthaxanthin C40H52O2 Ornamentalfish — — — — 30. 11. 1994
2 Astaxanthin C40H52O4 Ornamentalfish — — — — 30. 11. 1994
2. Other colouring
matters:
1 T artrazine C16H9N4O9S2Na3
2 Sunset yellow
FCFC16H10N2O7S2Na2
Ornamental
fish— — — — 30. 11. 1994
3P o n c e a u 4 R C20H11N2O40S3Na3fish30..99
4 Erythrosine C20H6I4O5Na2.H2O
5 Indigotine C16H8N2O8S2Na2 Ornamentalfish — — — — 30. 11. 1994
6 Chlorophyll cop-
per complex— Ornamentalfish — — — — 30. 11. 1994
70/524 - - - I
8291/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
7 Acid Brillant
Green BS, (Lissa-mine Green)Sodium salt of 4,4-bis(dimethylamino) diphe-nyl-
methylene-2-
naphtol-3,6-
disulphonic acidOrnamental
fish— — — — 30. 11. 1994 93/107/CE
8C a r b o n b l a c k C
9 Bixin C25H30O4Ornamentalfish— — — — 30. 11. 1994
10 Iron oxide, red Fe2O3
94/17/EC
11 Astaxanthin-rich
Phaffia rhodozy-maConcentrated biomass ofthe yeast Phaffia rhodo-zyma (CBS 116.94) kil-
led, containing at least
2,5 g ostaxanthin per ki-
logram additiveSalmon, trout — — 100 The maximum content
is expressed as astaxan-thin.
Use only permitted
from the age of six
months onwards.
The mixture of the ad-
ditive with canthaxan-
thin is allowed provided
that the total concen-tration of astaxanthin
and canthaxanthin does
not exceed 100 mg/kgin the complete fee-
dingstuff30. 11. 1995 94/50/EC
G. Preservatives 91/248/EEC
20 Methylpropionic
acidC4H8O2 All species orcategories ofanimals with
the exception
of laying hens— 1 000 4 000 — 30. 11. 1992 91/620/EEC
70/524 - - - I
8391/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
I. Trace elements
J. Growth promo-
ters
L. Binders, anti-ca-
king agents andcoagulants
91/249/EEC
1 Synthetic calcium
aluminatesMixture of calcium alu-minates containing bet-ween 35 and 51 % of A
1203 (SIC! Al
2O3)m a x i -
mum molybdenum
content of 20 mg/kgPoultry, rab-
bits, and pigs— — 20 000 All feedingstuffs 30. 3. 1993 92/99/EEC
Dairy cows 92/64/EEC
Cattle for fat-tening calves,lambs, kids — — 8 000 All feedingstuffs 30. 11. 1995 94/50/EC
94/17/EC
2 Natrolite-phonoli-
teNatural mixture of alu-minium silicates, alkali-nes and alkaline-earth
and aluminium hydrosili-
cates, natrolite (43 % —
46,5 %) and feldsparAll animal
species and ca-tegories— — 25 000 All feedingstuffs 30. 11. 1995 94/50/EC
70/524 - - - I
8491/248/EEC
NoPeriod of au-
thorizationOther provisionsMaximum
contentMinimum
content
Maximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive NoPeriod of au-
thorizationOther provisions
mg/kg of complete
feedingstuffMaximum
ageSpecies or cate-
gory of animalChemical formula,
descriptionAdditive
M. Acidity regula-
tors
N. Enzymes 94/17/EC
1 3-phytase (EC
3.1.3.8)Preparation o f3-phytase
produced by Aspergillus
niger (CBS 114.94) ha-
vingaminimumphytasePigs (all cate-
gories of ani-mals)— — — — 30. 11. 1995 94/50/EC
vingaminimumphytase
activity of 5 000 FTU/g
for solid and liquid pre-
parationsChickens (allcategories ofanimals) — — — — 30. 11. 1995 94/50/EC
O. Micro-organisms
1 Bacillus cereus
var. toyoi (CNCM
I1012/ NCIBPreparation o fBacillus
cereus var. toyoi contai-
i ii 1010Piglets Tw o mo n t h s 109109— 30. 11. 1995 94/50/EC
y(
I-1012/ NCIB
40112)y
ning a minimum 1010
CFU/g additivefour months 0,5¢109109—
Pigs six months 0,2¢109109— 30. 11. 1995 94/50/EC
Sows — 1092¢109— 30. 11. 1995 94/50/EC
2 Bacillus licheni-
formis (DSM5749) / Bacillus
subtilis (DSM
5750) [in a 1/1
ratio]Mixture of Bacillus liche-
niformis and Bacillus
subtilis containing 3’2 ¢
109C F U / gadditive (1,6
¢109C F U / gof each
bacteria)Piglets 4m o n t h s 1,28¢1093,2¢109— 30. 11. 1995 94/41/EC
70/524 - - - I
85ANNEX III
Minimum conditions which must be fulfilled by manufac-
turers of the additives, premixtures and compound feed-
ingstuffs referred to in Article 13 and intermediaries
1. The manufacturer must possess the appropriate facili-
ties and technical equipment for the manufacture and
storage of additives, premixtures or compound feed-
ingstuffs containing those premixtures.
2. The manufacturer or his staff must possess the skills
necessary for the manufacture of additives, premix-
tures or compound feedingstuffs.
3. The manufacturer must have access to appropriate
means enabling him to ensure:
(a) in the case of additives: that they conform to the
provisions of this Directive;
(b) in the case of premixtures: the nature and level
of the different additives, and the homogeneityand stability of additives in the premixtures;
(c) in the case of compound feedingstuffs: the na-
ture and level of the additives and the homoge-
neous mixing of those additives in the compound
feedingstuff.
4. Additives intended for the manufacture of premixtures
and premixtures intended for incorporation in com-
p o u n df e e d i n g s t u f f ss h a l lb es t o r e di ns u c haw a ya s
to enable them to be easily identified and to avoid
any confusion with other additives, premixtures or
medicinal substances, medicated feedingstuffs or feed-
ingstuffs. They shall be stored in suitable places,
which can be locked and which are intended for the
storage of these products.
5. The manufacturer or, if the manufacturer is estab-
lished in a third country, his agent established in the
Community must record the following information:
(a) for additives: the nature, quantity of additives
produced and the respective dates of manufac-
ture, and the names and addresses of the
manufacturers of premixtures or intermediaries
to whom the additives have been delivered with
an indication of the nature and quantity of addi-
tive delivered;84/587/EEC
70/524 - - - I
86(b) for premixtures: the name of the manufacturers
and the suppliers, the nature and quantity of the
additives used, the date of manufacture, the
name and address of the compound feedingstuff
manufacturers or intermediaries for whom the
premixture is intended and the nature and quan-
tity of the premixture delivered;
(c) for compound feedingstuffs: the name and ad-
dress of the supplier of the premixture and of
the manufacturer if the latter is not the supplier,
the nature and quantity of the premixture and
the use to which it has been put.
6. Where the manufacturer delivers additives or premix-
tures to a person other than a manufacturer of pre-
mixtures or compound feedingstuffs, that person and
any subsequent intermediary shall be bound by the
same recording obligations laid down in paragraph 5(a) and (b).84/587/EEC
70/524 - - - I
ANNEX I
TABLE OF CORRESPONDANCE
Directive 70/524 Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 5
Article 6 Article 6
Article 7 Article 7
Article 7a Article 7a
Article 8 Article 8
Article 9 Article 9
Article 10 Article 10
Article 11 Article 11
Article 12 Article 12
Article 13 Article 13
Article 14 Article 14
Article 15 Article 15
Article 16 Article 16
Article 17 Article 17
Article 18 Article 18
Article 19 Article 19
Article 20 Article 20
Article 21 Article 21
Article 22 Article 22
Article 23 Article 23
Article 24 Article 24
Article 25 Article 25
Article 26 Article 26
Article 27 Article 27
- - - ANNEX I