1970L0524 — EN — 22.12.1998 — 005.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of23November1970
concerningadditivesinfeeding-stuffs
(70/524/EEC)
(OJ L 270, 14.12.1970, p. 1)
Amended by:
Official Journal
No page date
►M1 Council Directive of 28 April 1973 (73/103/EEC) L 124 17 10.5.1973
►M2 First Commission Directive of 27 July 1973 (73/264/EEC) L 253 12 10.9.1973
►M3 Second Commission Directive of 27 July 1973 (73/275/EEC) L 254 16 11.9.1973
►M4 Third Commission Directive of 13 December 1973 (74/7/EEC) L 14 21 17.1.1974
►M5 Fourth Commission Directive of 17 December 1973 (74/38/EEC) L 30 21 4.2.1974
►M6 Fifth Commission Directive of 26 February 1974 (74/180/EEC) L 94 14 4.4.1974
►M7 Sixth Commission Directive of 26 February 1974 (74/181/EEC) L 94 16 4.4.1974
►M8 Seventh Commission Directive of 26 February 1974 (74/182/EEC) L 94 18 4.4.1974
►M9 Eighth Commission Directive of 1 July 1974 (74/378/EEC) L 199 13 22.7.1974
►M10 Ninth Commission Directive of 23 July 1974 (74/421/EEC) L 221 29 12.8.1974
►M11 Tenth Commission Directive of 20 December 1974 (75/50/EEC) L 19 58 24.1.1975
►M12 Eleventh Commission Directive of 24 April 1975 (75/267/EEC) L 118 45 8.5.1975
►M13 Second Council Directive of 28 April 1975 (75/296/EEC) L 124 29 15.5.1975
►M14 Twelfth Commission Directive of 24 October 1975 (75/696/EEC) L 299 19 19.11.1975
►M15 Thirteenth Commission Directive of 15 December 1975 (76/13/EEC) L 4 21 9.1.1976
►M16 Fourteenth Commission Directive of 8 June 1976 (76/546/EEC) L 160 11 22.6.1976
►M17 Fifteenth Commission Directive of 21 June 1976 (76/603/EEC) L 198 10 23.7.1976
►M18 Sixteenth Commission Directive of 1 December 1976 (76/933/EEC) L 364 18 31.12.1976
►M19 Seventeenth Commission Directive of 16 February 1977 (77/179/EEC) L 60 15 5.3.1977
►M20 Eighteenth Commission Directive of 11 July 1977 (77/471/EEC) L 180 27 20.7.1977
►M21 Nineteenth Commission Directive of 26 July 1977 (77/512/EEC) L 207 53 13.8.1977
►M22 20th Commission Directive of 7 December 1977 (78/58/EEC) L 18 7 24.1.1978
►M23 Twenty-first Commission Directive of 23 December 1977 (78/117/
EEC)L 40 19 10.2.1978
►M24 Twenty-second Commission Directive of 30 May 1978 (78/522/EEC) L 159 43 17.6.1978
►M25 Twenty-third Commission Directive of 23 June 1978 (78/613/EEC) L 198 10 22.7.1978
►M26 Twenty-fourth Commission Directive of 28 July 1978 (78/743/EEC) L 247 25 9.9.1978
►M27 Twenty-fifth Commission Directive of 16 November 1978 (78/974/
EEC)L 330 30 25.11.1978
►M28 Twenty-sixth Commission Directive of 18 December 1978 (79/139/
EEC)L 39 11 14.2.1979
1970L0524 — EN — 22.12.1998 — 005.001 — 2
►M29 Twenty-seventh Commission Directive of 7 June 1979 (79/553/EEC) L 148 58 16.6.1979
►M30 Twenty-eighth Commission Directive of 20 July 1979 (79/697/EEC) L 207 19 15.8.1979
►M31 Twenty-ninth Commission Directive of 15 November 1979 (79/1011/
EEC)L 310 24 6.12.1979
►M32 Thirtieth Commission Directive of 9 January 1980 (80/131/EEC) L 30 21 7.2.1980
►M33 Thirty-first Commission Directive of 8 April 1980 (80/440/EEC) L 104 18 22.4.1980
►M34 Thirty-second Commission Directive of 26 June 1980 (80/618/EEC) L 171 36 4.7.1980
►M35 Thirty-third Commission Directive of 4 July 1980 (80/678/EEC) L 185 48 18.7.1980
►M36 Thirty-fourth Commission Directive of 4 September 1980 (80/884/
EEC)L 251 17 24.9.1980
►M37 Thirty-fifth Commission Directive of 25 November 1980 (80/1139/
EEC)L 336 42 13.12.1980
►M38 Thirty-sixth Commission Directive of 28 November 1980 (80/1156/
EEC)L 343 35 18.12.1980
►M39 Thirty-seventh Commission Directive of 9 April 1981 (81/332/EEC) L 131 1 18.5.1981
►M40 Thirty-eighth Commission Directive of 16 July 1981 (81/632/EEC) L 231 30 15.8.1981
►M41 Thirty-ninth Commission Directive of 15 January 1982 (82/91/EEC) L 42 16 13.2.1982
►M42 Council Directive of 30 June 1982 (82/471/EEC) L 213 8 21.7.1982
►M43 Fortieth Commission Directive of 23 June 1982 (82/474/EEC) L 213 22 21.7.1982
►M44 Forty-first Commission Directive of 19 November 1982 (82/822/EEC) L 347 16 7.12.1982
►M45 Forty-second Commission Directive of 16 May 1983 (83/266/EEC) L 147 18 6.6.1983
►M46 Forty-third Commission Directive of 28 July 1983 (83/466/EEC) L 255 28 15.9.1983
►M47 Forty-fourth Commission Directive of 29 November 1983 (83/615/
EEC)L 350 17 13.12.1983
►M48 Forty-fifth Commission Directive of 15 February 1984 (84/107/EEC) L 61 35 2.3.1984
►M49 Forty-sixth Commission Directive of 28 May 1984 (84/349/EEC) L 183 15 11.7.1984
►M50 Forty-seventh Commission Directive of 26 October 1984 (84/547/EEC) L 297 40 15.11.1984
►M51 Council Directive of 29 November 1984 (84/587/EEC) L 319 13 8.12.1984
►M52 Forty-eighth Commission Directive of 6 February 1985 (85/157/EEC) L 59 27 27.2.1985
►M53 Forty-ninth Commission Directive of 31 May 1985 (85/312/EEC) L 165 21 25.6.1985
►M54 Fiftieth Commission Directive of 24 June 1985 (85/342/EEC) L 179 35 11.7.1985
►M55 Commission Directive of 8 July 1985 (85/429/EEC) L 245 1 12.9.1985
►M56 Commission Directive of 11 November 1985 (85/520/EEC) L 323 12 4.12.1985
►M57 Council Regulation (EEC) No 3768/85 of 20 December 1985 L 362 8 31.12.1985
►M58 Second Commission Directive of 5 February 1986 (86/29/EEC) L 39 55 14.2.1986
►M59 Commission Directive of 4 June 1986 (86/300/EEC) L 189 42 11.7.1986
►M60 Commission Directive of 28 July 1986 (86/403/EEC) L 233 16 20.8.1986
►M61 Commission Directive of 27 October 1986 (86/525/EEC) L 310 19 5.11.1986
►M62 Commission Directive of 23 April 1987 (87/243/EEC) L 110 34 25.4.1987
►M63 Commission Directive of 23 April 1987 (87/244/EEC) L 110 35 25.4.1987
►M64 Council Directive of 16 June 1987 (87/316/EEC) L 160 32 20.6.1987
►M65 Council Directive of 16 June 1987 (87/317/EEC) L 160 34 20.6.1987
►M66 Commission Directive of 17 November 1987 (87/552/EEC) L 336 34 26.11.1987
►M67 Commission Directive of 8 April 1988 (88/228/EEC) L 101 30 20.4.1988
►M68 Commission Directive of 14 July 1988 (88/483/EEC) L 237 39 27.8.1988
►M69 Commission Directive of 30 November 1988 (88/616/EEC) L 343 25 13.12.1988
1970L0524 — EN — 22.12.1998 — 005.001 — 3
►M70 Commission Directive of 21 December 1988 (89/23/EEC) L 11 34 14.1.1989
►M71 Commission Directive of 27 October 1989 (89/583/CEE) L 325 33 10.11.1989
►M72 Commission Directive of 19 February 1990 (90/110/EEC) L 67 44 15.3.1990
►M73 Commission Directive of 9 April 1990 (90/206/EEC) L 106 30 26.4.1990
►M74 Commission Directive of 20 April 1990 (90/214/EEC) L 113 39 4.5.1990
►M75 Commission Directive of 20 July 1990 (90/412/EEC) L 209 25 8.8.1990
►M76 Commission Directive of 26 November 1990 (90/643/EEC) L 350 80 14.12.1990
►M77 Council Directive of 4 December 1990 (90/654/EEC) L 353 48 17.12.1990
►M78 Commission Directive of 12 April 1991 (91/248/EEC) L 124 1 18.5.1991
►M79 Commission Directive of 19 April 1991 (91/249/EEC) L 124 43 18.5.1991
►M80 Commission Directive of 10 June 1991 (91/336/EEC) L 185 31 11.7.1991
►M81 Commission Directive of 9 September 1991 (91/508/EEC) L 271 67 27.9.1991
►M82 Commission Directive of 22 November 1991 (91/620/EEC) L 334 62 5.12.1991
►M83 Commission Directive 92/64/EEC of 13 July 1992 L 221 51 6.8.1992
►M84 Commission Directive 92/99/EEC of 17 November 1992 L 350 83 1.12.1992
►M85 Commission Directive 92/113/EEC of 16 December 1992 L 16 2 25.1.1993
►M86 Commission Directive 93/27/EEC of 4 June 1993 L 179 5 22.7.1993
►M87 Commission Directive 93/55/EEC of 25 June 1993 L 206 11 18.8.1993
►M88 Commission Directive 93/107/EC of 26 November 1993 L 299 44 4.12.1993
►M89 Council Directive 93/114/EC of 14 December 1993 L 334 24 31.12.1993
►M90 Commission Directive 94/17/EC of 22 April 1994 L 105 19 26.4.1994
►M91 Commission Directive of 18 July 1994 (94/41/CE) L 209 18 12.8.1994
►M92 Commission Directive 94/50/EC of 31 October 1994 L 297 27 18.11.1994
►M93 Commission Directive 94/77/EC of 20 December 1994 L 350 113 31.12.1994
►M94 Commission Directive 95/37/EC of 18 July 1995 L 172 21 22.7.1995
►M95 Commission Directive 95/55/EC of 31 October 1995 L 263 18 4.11.1995
►M96 Council Directive 95/69/EC of 22 December 1995 L 332 15 30.12.1995
►M97 Commission Directive 96/7/EC of 21 February 1996 L 51 45 1.3.1996
►M98►M99Council Directive 96/25/EC of 29 April 1996 ◄ L 125 35 23.5.1996
►M99 amended by Directive 2000/16/EC of the European Parliament and
the Council of 10 April 2000L 105 36 3.5.2000
►M100 Council Directive 96/51/EC of 23 July 1996 L 235 39 17.9.1996
►M101 Commission Directive 96/66/EC of 14 October 1996 L 272 32 25.10.1996
►M102 Commission Directive 97/6/EC of 30 January 1997 L 35 11 5.2.1997
►M103 Commission Directive 97/72/EC of 15 December 1997 L 351 55 23.12.1997
►M104 Commission Directive 98/19/EC of 18 March 1998 L 96 39 28.3.1998
►M105 Commission Regulation (EC) No 2786/98 of 22 December 1998 L 347 25 23.12.1998
►M106 Council Directive 98/92/EC of 14 December 1998 L 346 49 22.12.1998
Amended by:
►A1 Act of Accession of Greece L 291 17 19.11.1979
►A2 Act of Accession of Spain and Portugal L 302 23 15.11.1985
►A3 Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
1970L0524 — EN — 22.12.1998 — 005.001 — 4
Corrected by:
►C1 Consolidated text of corrigenda to instruments published in Special
Editions1952-72, p. 80 (70/524/EEC)
►C2 Corrigendum, OJ L 320, 27.11.1980, p. 43 (80/678/EEC)
►C3 Corrigendum, OJ L 237, 12.8.1982, p. 46 (82/474/EEC)
►C4 Corrigendum, OJ L 83, 30.3.1990, p. 128 (90/110/EEC)
►C5 Corrigendum, OJ L 96, 12.4.1990, p. 92 (90/110/EEC)
►C6 Corrigendum, OJ L 174, 3.7.1991, p. 38 (91/249/EEC)
►C7 Corrigendum, OJ L 287, 17.10.1991, p. 44 (91/248/EEC)
►C8 Corrigendum, OJ L 44, 17.2.1994, p. 35 (93/114/EC)
►C9 Corrigendum, OJ L 115, 16.5.2000, p. 22 (96/51/EC)
▼B
COUNCILDIRECTIVE
of23November1970
concerningadditivesinfeeding-stuffs
(70/524/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles43 and 100 thereof;
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament(1);
Having regard to the Opinion of the Economic and Social Committee;Whereaslives tock production occupiesa very important place in the
agriculture of the European Economic Community; whereas satisfac-tory results depend to a large extent on the use of appropriate good-
quality feeding-stuffs;
Whereas the existence of rules concerning feeding-stuffs is essential to
an increase in agricultural productivity;
Whereas animal feeding increasingly involves the use of additives;Whereasthe provis ionslaid down in the Member Statesby law, regu-
lation or administrative action concerning additives in feeding-stuffs,
insofar as they exist, differ as regards their basic principles; whereas
it follows that they directly affect the establishment and functioning ofthe common market and should therefore be harmonised;
Whereas, as a general rule, ‘additives’ means substances which
improve both the feeding-stuffs in which they are incorporated andlivestock production; whereas, for this reason, antibiotics should also
be regarded as additives since, when used in small quantities, they
have a physiological nutritional effect, although when used in largequantitiesthey have a medicinal effect;
Whereas these substances must not be used in feeding-stuffs for the
prime purpose of diagnosing, treating or preventing disease; whereasthey should, however be authorised for the sole purpose of improving
feeding-stuffs by preventing nutritional deficiencies;
Whereas, furthermore, certain purely medicinal substances such as
coccidiostats should, during a first stage, be regarded in relation tofeeding-stuffs as additives, since most Member States have been usingthem for collective prophylaxis, principally in poultry-farming;
whereas, however, they will be examined further if a directive on
medicinal feeding-stuffs is drawn up;
Whereas the basic principle underlying rules in this field must be that
only those additives which are named in this Directive may becontained in feeding-stuffs and only subject to the reguirements setout herein, and that such additives may not, subject to the exceptions
provided for, be used in any other way for the purposes of animal
feeding;
Whereas it is necessary, at the time when additives are authorised, to
make sure that they have a favourable effect on the characteristics ofthe feeding-stuffs to which they are added or on livestock production;
whereasthey mus t not endanger animal or human health nor harm the
consumer of livestock products; whereas, subject to the exceptionsprovided for, it is advisable to examine whether such additives maynow be used for the treatment or prevention of disease or whether thereare still serious reasons for restricting their use to medical or veterinarypurposes;1970L0524 — EN — 22.12.1998 — 005.001 — 5
(1) OJ No C 135, 14.12.1968, p. 20.
▼B
Whereas, because of the special situation of certain Member States, and
in particular because of their different systems of animal feeding, it isnecessary in certain cases to allow derogations from the above-
mentioned principlesto an extent acceptable for animal and human
health;
Whereas Member States should also retain the power to suspend the
use of certain additives or to lower their maximum levels if animal orhuman health isbeing endangered; whereasMember Statess hould not,
however, be able to have recourse to that power in order to hinder the
free movement of the variousproducts ;
Whereas provision should be made for feeding-stuffs containing addi-
tives to be specially labelled so that the user may know the nature ofthe additive and be protected against fraud; whereas this provision
refersparticularly to ►
C1supplementary ◄feeding-stuffs containing
concentratesof certain additives ;
Whereas Community rules should not apply to feeding-stuffs intended
for export to third countries, as the latter generally apply differentrules;
Whereas, in order to ensure that the requirements laid down in respect
of additives are satisfied during marketing, Member States must makeprovision for appropriate control arrangements;
Whereas feeding-stuffs satisfying these requirements must be subject
only to the marketing restrictions provided for in this Directive;
Whereas, in order to facilitate implementation of this Directive, a
procedure should be applied which establishes close co-operationbetween Member Satesand the Commis s ion within the StandingCommittee for Feeding-stuffs;
HAS ADOPTED THIS DIRECTIVE:
SCOPE
Article 1
1. This Directive shall apply to additives in feedingstuffs.2. This Directive shall not apply to processing aids used deliberately
as substances in the processing of feed materials or of feedingstuffs in
order to achieve a certain tchnological objective during treatment or
processing which may result in the unintentional but technicallyunavoidable presence of residues of the substances or their derivativesin the final product, provided that these residues do not present anyhealth risk and do not have any technological effect on the finishedproduct.
3. Provided they are not products specially enriched with substances
corresponding to additives, substances present in their natural state infeed materialswhich are part of the normal compos ition of feeding-stuffs and which correspond to a substance authorized under thisDirective shall not be regarded as additives.
DEFINITIONS
Article 2
For the purposes of this Directive the following definitions shall apply:
(a)Additives: substances or preparations used in animal nutri-
tion in order to:
— affect favourably the characteristics of feed materials or
of compound feedingstuffs or of animal products; or1970L0524 — EN — 22.12.1998 — 005.001 — 6
▼M100
▼M51
▼M100
▼M100
— satisfy the nutritional needs of animals or improve
animal production, in particular by affecting the gastro-intestinal flora or the digestibility of feedingstuffs; or
— introduce intro nutrition elementsconducive to attaining
particular nutritional objectivesor to meeting thespecific nutritional needs of animals at a particulartime; or
— prevent or reduce the harmful effectscaus ed by animal
excretionsor improve the animal environment;
(aa)Micro-organisms: micro-organisms forming colonies;
(aaa) additives subject to authorization linked to the person
responsible for putting them into circulation: the additiveslisted in Part I of Annex C;
(aaaa)Other additives: additivesnot s ubject to authorization linked
to the person responsible for putting them into circulationand referred to in Part II of Annex C;
(b)Feedingstuffs: productsof vegetable or animal origin in their
natural state, fresh or preserved, and products derived from theindustrial processing thereof, and organic or inorganic substances,
used singly or in mixtures, whether or not containing additives,
for oral animal feeding;
(c)Dailyration: the average total quantity of feedingstuffs, calculated
on a moisture content of 12 %, required daily by an animal of a
given species, age category 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)Supplementaryfeedingstuffs: mixturesof feedings tuffswhich 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)Feed materials: variousproductsof vegetable or animal origin, in
their natural state, fresh or preserved, and products derived fromthe industrial processing thereof, and organic or inorganicsubstances, whether or not containing additives, which are intended
for use in oral animal feeding either directly as such or after
processing, in the preparation of compound feedingstuffs or ascarriersof premixtures , hereinafter referred to as feed materials ;
(g)Compound feedingstuffs: mixturesof feed materials , whether or not
containing additives, which are intended for oral animal feeding ascomplete or complementary feedingstuffs;
(h)Premixtures: mixturesof additivesor mixturesof one or more
additives with substances used as carriers, intended for the manu-facture of feedingstuffs;
(i)Animals: animals belonging to species normally nourished and kept
or consumed by man;
(j)Pet animals: animals belonging to species normally nourished and
kept, but not consumed, by man, except animals bred for fur;
(k)Putting into circulation or circulation: the holding of productsfor
the purposes of sale, including offering for sale, or any other formof transfer, whether free or not, to third parties, and the sale andother forms of transfer themselves;
(l)Person responsible for putting into circulation: the natural or legal
person who has responsibility for the conformity of the additivewhich hasbeen granted Community authorization and for puttingit into circulation.1970L0524 — EN — 22.12.1998 — 005.001 — 7
▼M51
▼M100
▼M98
▼M51
▼M100
▼M100
PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES
Article 3
Member Statess hall require that no additive may be put into circula-
tion unless a Community authorization has been granted. Thisauthorization shall be granted under a Commission regulation in accor-dance with the procedure laid down in Article 4.
Article 3a
Community authorization of an additive shall be given only if:
(a) when used in animal nutrition it has one of the effects referred to in
Article 2 (a);
(b) taking account of the conditions of use, it does not adversely affect
human or animal health or the environment, nor harm the consumerby impairing the characteristics of animal products;
(c) itspres ence can be monitored:
— asan additive per s e,
— in premixtures,
— in feedingstuffs or, where appropriate, in feed materials;
(d) at the level permitted, treatment or prevention of animal disease is
excluded; thiscondition s hall not apply to additivesbelonging to
the group of coccidiostats and other medicinal substances;
(e) for serious reasons concerning human or animal health its use must
not be restricted to medical or veterinary purposes.
Article 4
1. In order to obtain the Community authorization for a substance or
a preparation as an additive or for a new use in the case of an alreadyauthorized additive, the applicant for authorization shall select aMember State to act asrapporteur during the s crutiny procedure on
the dossier he has compiled in accordance with the provisions of
Council Directive 87/153/EEC of 16 February 1987 fixing guidelinesfor the assessment of additives in animal nutrition(
1). Where the appli-
cant is established in a third country, he must have a representative inthe Community.
2. The Member State acting asrapporteur s hall check that:
(a) the dossier has been compiled in accordance with Directive 87/153/
EEC;
(b) the substance or preparation, according to the information given,
appearsto meet the conditionslaid down in Article 3a.
3. The applicant for Community authorization shall dispatch to the
Commission, via the Member State acting as rapporteur, an application
accompanied by the dossier, sending copies to the other Member
States, which shall acknowledge receipt at the earliest opportunity.That dispatch shall be affected no later than one year after the date ofsubmission of the applicant's dossier in the Member State acting asrapporteur, unless the latter is rejected or postponed. The Member State
acting asrapporteur s hall inform the applicant, the other Member
States and the Commission of the reasons for rejection or postpone-ment of the dossier.
4. Member States shall have a period of sixty days from the date on
which the dossier was dispatched to them in which to check whether
the dossier has been compiled in accordance with Directive 87/153/
EEC and, where appropriate, to submit their comments in writing tothe Commission and the other Member States.1970L0524 — EN — 22.12.1998 — 005.001 — 8
(1) OJ No L 64, 7. 3. 1987, p. 19. Directive aslas t amended by Directive 95/11/
EC (OJ No L 106, 11. 5. 1995, p. 23).
▼M100
If, on expiry of the period referred to in the first paragraph, no objec-
tion has been made, the representative of the Commission shall have aperiod of thirty daysin which to include the authorization application
on the agenda for the Standing Committee for Feedingstuffs.
5. If, after consultation of the Standing Committee for Feedingstuffs,
it is deemed that the rules on presentation of dossiers have not beencomplied with, a representative of the Commission shall so notify theapplicant for authorization to put into circulation and the Member Stateacting as rapporteur; where necessary, a new application must besubmitted in accordance with the above provisions.
6. The Commission shall ensure that a decision is taken, in accor-
dance with the procedure laid down in Article 23, on the application
for Community authorization within 320 daysfollowing itsinclus ionon the agenda for the Standing Committee for Feedingstuffs in accor-dance with the second subparagraph of paragraph 4. However, this timelimit shall be interrupted where a request is made for additional infor-mation by a Member State in the Standing Committee for
Feedingstuffs, or at the request of the Scientific Committee for Animal
Nutrition.
Where an application for Community authorization to put an additive
into circulation is rejected or the decision on it is postponed, a repre-sentative of the Commission shall inform the applicant forauthorization and the Member State acting asrapporteur of the reas onsfor the rejection or postponement of the decision.
Article 5
Amendmentsto Directive 87/153/EEC:
— which arise from developments in scientific and technical knowl-
edge and
— take account of the provisions of Article 9b (1), Article 9c (3),
Article 9o and Article 9q (5)
shall be adopted in accordance with the procedure laid down in Article
23.
Article 6
1. A fee may be charged, according to the additive groupsand the
nature of the Community authorization requested, by the Member Stateacting as rapporteur for the examination of dossiers arising from theobligationslaid down in Articles4 (2), 9b (1), 9c (3) and 9g (4). This
fee shall be paid at the time of submission of the dossier.
2. Before 1 April 1999, the Council, acting by a qualified majority
on a proposal from the Commission, shall adopt rules for the calcula-tion of the level of the fee referred to in paragraph 1.
Article 7
1. Member States and the Commission shall ensure that any infor-
mation which, if disseminated, could affect industrial and commercialproperty rightsiskept confidential.
2. Confidentiality shall not apply to:
— the name and composition of the additive,
— the physico-chemical and biological characteristics of the additive,
— the interpretation of the pharmacological, toxicological and ecotox-
icological data relating to the additive,
— the analytical methodsfor monitoring the additive its elf and the
additive in premixtures, in the feedingstuffs and, where appropriate,
in feed materials,
— the methods for testing for residues of the additive or metabolites
thereof in animal products.1970L0524 — EN — 22.12.1998 — 005.001 — 9
▼M106
▼M100
▼M100
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 deliberate release into the environ-
ment of genetically modified organisms(
1), a specific environmental
risk assessment similar to that laid down in the abovementioned Direc-tive shall be carried out; for this purpose, the following documentsshall be included in the dossier submitted pursuant to Article 4 of thisDirective in order to ensure compliance with the principles set out in
Article 3a:
— a copy of any written consent or consents of the competent autho-
ritiesto the deliberate releas e into the environment of geneticallymodified organisms for research and development purposespursuant to Article 6 (4) of Directive 90/220/EEC and the result of
the release(s) with respect to the risk in each case to human health
and the environment,
— the complete technical dossier supplying the information requested
in AnnexesII and III to Directive 90/220/EEC and the environ-mental risk assessment resulting from this information; the resultsof any investigations performed for the purposes of research ordevelopment.
Articles11 to 18 of Directive 90/220/EEC s hall not apply to additives
consisting of or containing genetically modified organisms.
Article 8
1. The Scientific Committee for Animal Nutrition established by
Commission Decision 76/791/EEC(
2) shall be responsible for assisting
the Commission, at the latter's request, on all scientific questions
relating to the use of additives in animal nutrition.
2. At the request of the Commission, the Member State acting as
rapporteur shall ensure that all or part of the dossier referred to inArticle 4 isofficially forwarded to the membersof the Committeereferred to in paragraph 1.
ARRANGEMENTS APPLICABLE TO AUTHORIZATIONS FOR ADDI-
TIVES LINKED TO THE PERSON RESPONSIBLE FOR PUTTING THEM
INTO CIRCULATION
Authorizationgivenfor10years
Article 9
Additivesasreferred to in Article 2 (aaa) which meet the conditions
laid down in Article 3a shall be authorized and included in Chapter Iof the list referred to in Article 9t (b).
Provisionalauthorizationforamaximumoffouryears
Article 9a
1. In the case of the additives referred to in Article 2 (aaa), provi-
sional authorization may be given at Community level for the use of anew additive or a new use of an additive already authorized, providedthat the conditionslaid down in Article 3a (b), (c), (d) and (e) are metand it is reasonable to assume, in view of the available results, that the
other condition laid down in Article 3a (a) is also met. These additives
shall be included in Chapter II of the list referred to in Article 9t (b).
2. Provisional authorization as referred to in paragraph 1 may not
exceed four yearsfrom the date on which it takeseffect.1970L0524 — EN — 22.12.1998 — 005.001 — 10
(1) OJ No L 117, 8. 5. 1990, p. 15. Directive aslas t amended by Directive 94/
15/EC (OJ No L 103, 22. 4. 1994, p. 20).
(2) OJ No L 279, 9. 10. 1976, p. 35. Decision as amended by Decision 86/105/
EEC (OJ No L 93, 8. 4. 1986, p. 14).
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Renewalofauthorizationafter 10years
Article 9b
1. Community authorization of additivesreferred to in Article 2
(aaa) shall be valid for 10 years from the date on which final authori-zation takeseffect and s hall be renewable for 10-year periods . In theevent of renewal, the authorization holder shall send to the Commis-
sion, via the Member State acting as rapporteur, an application
accompanied by a dossier complying with the provisions to be laiddown for the renewal of authorizationsfor additivesin Directive 87/153/EEC. The application and the dossier shall be sent, at least oneyear before the date of expiry of the authorization, to the Commission,which shall acknowledge receipt thereof at the earliest opportunity. A
copy of the renewal application, together with the dossier, shall be offi-
cially forwarded by the authorization holder via the Member Stateacting as rapporteur to the other Member States, which shall acknowl-edge receipt thereof at the earliest opportunity.
2. Articles3, 3a, 4, 7, and 7a s hall apply mutatis mutandis to appli-
cationsfor renewal.
3. Where, for reasons beyond the control of the authorization holder,
no decision may be taken on the renewal application before the expiry
date of the authorization, the period of authorization of the additive
shall be automatically extended until the Commission takes a decision.
DATA PROTECTION
Article 9c
1. In the case of the additives referred to in Article 2 (aaa), the
scientific data and other information in the initial dossier submittedfor the purpose of the first authorization may not be used for the
benefit of other applicantsfor a period of 10 years :
(a) from the date on which the first authorization by means of regula-
tion takeseffect for the additivesreferred to in Article 9g (1),Article 9h (1) and Article 9i (1), or
(b) for other additivesfrom the data on which the firs t authorization by
meansof regulation takeseffect or counting from 1 October 1999
if the latter date of taking effect isearlier,
unless the applicant has agreed with the authorization holder that such
data and information may be used.
During thisperiod, however, authorizationsfor putting into circulation
may be granted to persons other than the person responsible for firstputting the additive into circulation provided that the conditionsinArticles3a and 4 are met.
2. Where additional information iss upplied on an additive which
has been provisionally authorized under Article 9a, for the purpose ofobtaining authorization of the additive under Article 3a, that informa-tion shall be considered as an integral part of the initial dossier andshall consequently cease to be protected at the same time as the infor-
mation in the initial dossier.
3. On expiry of the 10-year period referred to in paragraph 1, the
findingsof all or part of the evaluation conducted on the bas isof thescientific data and information in the dossier which led to authorization
of the additive may be used by the Commission or by a Member State
for the benefit of another applicant for authorization to put an additivewhich hasalready been authorized into circulation.
In such a case, an application accompanied by a dossier in accordance
with the provisions to be laid down for this purpose in Directive 87/
153/EEC shall be addressed by the new applicant, via a Member Stateacting as rapporteur, to the Commission, which shall acknowledgereceipt thereof as quickly as possible. A copy of the application,together with the dossier, shall be officially forwarded by the newapplicant, via a Member State acting asrapporteur, to the other1970L0524 — EN — 22.12.1998 — 005.001 — 11
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Member States, which shall acknowledge receipt thereof at the earliest
opportunity.
The provisions of Articles 3, 3a, 4, 7 and 7a shall apply mutatis
mutandis .
4. The provisions of paragraph 3 shall also apply to the use of data
from a dossier concerning an additive which has been the subject ofwithdrawal of authorization at the request of the holder of that author-ization.
5. The additional scientific data and information required for modi-
fication of the conditionsfor lis ting an additive or for renewal of the
authorization in accordance with Article 9b (1) or any new scientificdata or information provided during the period of authorization of theadditive may not be used by the Commission or by a Member State forthe benefit of another applicant for a period of five yearsfrom the date
on which the authorization of a new use, the renewal or the submission
of new scientific data or information takes effect.
Where the data-protection period granted for modification of the condi-
tionsfor lis ting an additive expiresbefore the end of the periodprovided for in paragraph 1, the five-year period shall be extended sothat both periods expire simultaneously.
6. Without prejudice to paragraph 1, an applicant for an authoriza-
tion for an additive referred to in Article 2 (3) (aaa) shall, beforebeginning toxicological tests on vertebrates, check whether his productor its active substance has not already been authorized. If necessary, heshall find out from a Member State's competent authorities whether theproduct or active substance concerned is the same as that already
authorized.
If the product or active substance concerned has already been author-
ized, the applicant and the holder(s) of earlier authorizations shall takeall necessary steps to reach agreement on sharing the use of informa-tion, in order not to repeat the toxicological tests on vertebrates.
If, however, the applicant and the holder(s) of previous authorizations
for the same product do not reach agreement on sharing the informa-
tion, the Member Statesmay take national meas uresto oblige theapplicant and the holder(s) of previous authorizations establishedwithin their territoriesto s hare the information, in order to avoidrepeating toxicological tests on vertebrates undertaken on their territory
and may lay down conditionsfor the us e of the information while
ensuring a reasonable balance between the interests of the partiesconcerned.
ARRANGEMENTS APPLICABLE TO AUTHORIZATION OF OTHER
ADDITIVES
Authorizationwithoutatimelimit
Article 9d
1. Additivesasreferred to in Article 2 (aaaa) which meet the condi-
tionslaid down in Article 3a s hall be authorized and included inChapter III of the list referred to in Article 9t (b).
2. Additivesasreferred to in Article 2 (aaaa) included in Annex I
before 1 April 1998 shall be authorized and included in Chapter III of
the list referred to in Article 9t (b).
Provisionalauthorizationforamaximumoffourorfiveyears
Article 9e
1. In the case of the additives referred to in Article 2 (aaaa), provi-
sional authorization may be given at Community level for the use of anew additive or a new use of an additive already authorized, providedthat the conditionslaid down in Article 3a (b), (c), (d) and (e) are metand it is reasonable to assume that the condition laid down in Article1970L0524 — EN — 22.12.1998 — 005.001 — 12
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3a (a) is also met. These additives shall be included in Chapter IV of
the list referred to in Article 9t (b).
2. Provisional authorization as referred to in paragraph 1 may not
exceed four yearsfrom the date on which it takeseffect.
3. Additivesasreferred to in Article 2 (aaa), included in Annex II
before 1 April 1998, may continue to be the subject of national provi-
sional authorizations; they shall be included in Chapter IV of the list
referred to in Article 9t (b). The period of provisional authorization ofthese additives may not exceed five years taking account of the periodof inclusion in Annex II referred to above.
TRANSITIONAL ARRANGEMENTS APPLICABLE TO AUTHORIZATIONS
FOR ADDITIVES LINKED TO THE PERSON RESPONSIBLE FOR
PUTTING THEM INTO CIRCULATION
Article 9f
Notwithstanding Article 3, Member States shall permit the additives
listed in Annex B to be put into circulation.
AdditivesincludedinAnnexIbefore1January1988
Article 9g
1. Additivesasreferred to in Article 2 (aaaa) included in Annex I
before 1 January 1988 shall be provisionally authorized as from 1 April1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them
into circulation.
2. With a view to their re-evaluation, the additivesasreferred to in
paragraph 1 must, before 1 October 1998, be the subject of new appli-cations for authorization; such applications, accompanied by the
monographsand the identification notesprovided for in Articles9n
and 9o respectively, shall be addressed by the person responsible forthe dossier on the basis of which the former authorization was grantedor by his successor or successors, via the Member State acting asrapporteur, to the Commission, sending copies to the other MemberStates, which shall acknowledge receipt thereof.
3. In accordance with the procedure laid down in Article 23, provi-
sional authorization of the additives shall be withdrawn through theadoption of a Regulation and they shall be deleted from the list inChapter I of Annex B before 1 October 1999:
(a) if the documents prescribed in paragraph 2 are not submitted within
the time allowed or
(b) if, after scrutiny of the documents, it is established that the mono-
graphsand identification notesare not in accordance with the datein the dossier on the basis of which the original authorization wasgiven.
4. Member States shall ensure that the person responsible for putting
an additive as referred to in paragraph 1 into circulation submits, as
provided for in Article 4 and not later than 30 September 2000, thedossier referred to in Article 4 with a view to re-evaluation. Where hefails to do so, the authorization of the additive in question shall bewithdrawn through the adoption of a regulation in accordance with the
procedure laid down in Article 23 and it shall be deleted from the list
in Chapter I of Annex B.
5. The Commission shall take all necessary measures to ensure that
re-evaluation of the dossiers referred to in paragraph 4 is completed nolater than three years after the dossier is submitted.
In accordance with the procedure laid down in Article 23, authoriza-
tionsof the additivesreferred to in Article 1:
(a) shall be withdrawn and they shall be deleted from the list in
Chapter I of Annex B through the adoption of a regulation, or1970L0524 — EN — 22.12.1998 — 005.001 — 13
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(b) shall be replaced by authorizations linked to the person responsible
for putting them into circulation for a period of 10 yearsthroughthe adoption of a regulation taking effect no later than 1 October
2003 and included in Chapter I of the list referred to in Article 9t
(b).
6. The provisions of Article 9b (3) shall apply mutatis mutandis .
AdditivesincludedinAnnexIafter31December1987
Article 9h
1. Additivesasreferred to in Article 2 (aaa) included in Annex I
after 31 December 1987 shall be authorized provisionally as from 1April 1998 and transferred to Chapter II of Annex B with a view to
their authorization for a period of 10 yearsasadditiveslinked to a
person responsible for putting them into circulation in accordancewith paragraphs2 and 3.
2. The additivesreferred to in paragraph 1 mus t, before 1 October
1998, be the subject of new applications for authorization; such appli-cations, accompanied by the monographs and the identification notesprovided for in Articles 9n and 9o respectively, shall be addressed bythe person responsible for the dossier on the basis of which the formerauthorization was given or by his successor or successors, via the
Member State acting as rapporteur, to the Commission, sending copies
to the other Member States, which shall acknowledge receipt thereof.
3. In accordance with the procedure laid down in Article 23, provi-
sional authorizations of the additives referred to in paragraph 1:
(a) shall be withdrawn and they shall be deleted from the list in
Chapter II of Annex B, through the adoption of a regulation, if
the documents prescribed in paragraph 2 are not submitted within
the time allowed or if, after scrutiny of the documents, it is estab-lished that the monographs or the identification notes are not inaccordance with the data in the dossier on the basis of which theoriginal authorization wasgiven, or
(b) shall be replaced by authorizations linked to the person responsible
for putting them into circulation, which shall be given for a period
of ten yearsthrough the adoption of a regulation taking effect nolater than 1 October 1999 and included in Chapter I of the listreferred to in Article 9t (b).
4. The provisions of Article 9b (3) shall apply mutatis mutandis .
AdditivesincludedinAnnexIIbefore1April1998
Article 9i
1. Additivesasreferred to in Article 2 (aaa) included in Annex II
before 1 April 1998 may continue to be the subject of national provi-
sional authorizations; they shall be authorized and transferred to
Chapter III of Annex B with a view to their authorization asadditiveslinked to a person responsible for putting them into circulation; theperiod of provisional authorization of these additives may not exceedfive yearstaking account of the period of inclus ion in Annex II
referred to above.
2. The additivesasreferred to in paragraph 1 mus t, before 1 October
1998, be the subject of new applications for authorization; such appli-
cations, accompanied by the monographs and identification notes
provided for in Articles 9n and 9o respectively, shall be addressed bythe person responsible for the dossier on the basis of which the formerauthorization was given or by his successor or successors, via theMember State acting as rapporteur, to the Commission, sending copiesto the other Member States, which shall acknowledge receipt thereof.1970L0524 — EN — 22.12.1998 — 005.001 — 14
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3. In accordance with the procedure laid down in Article 23, provi-
sional authorizations of the additives referred to in paragraph 1:
(a) shall be withdrawn and they shall be deleted from the list in
Chapter III of Annex B through the adoption of a regulation if thedocuments prescribed in paragraph 2 are not submitted within thetime allowed or if, after scrutiny of the documents, it is establishedthat the monographsand identification notesare not in accordance
with the data in the dossier on the basis of which the original
authorization wasgiven, or
(b) shall be replaced by provisional authorizations as referred to in
paragraph 1 linked to the person responsible for putting them intocirculation through the adoption of a regulation taking effect nolater than 1 October 1999 and the additivess hall be included inChapter II of the list referred to in Article 9t (b).
4. The provisions provided for in Article 9b (3) shall apply mutatis
mtuandis .
Article 9j
Applicationsfor authorization to put into circulation s ubmitted between
1 April 1998 and 30 September 1999 in respect of which the Commis-sion has not yet given a ruling at that date shall be examined inaccordance with Articles3, 3a, 7, 7a, 9, 9a, 9b, 9c, 9d, 9e, 9n and 9o,asappropriate.
DISTRIBUTION AND USE OF ADDITIVES
Article 9k
1. Member States shall ensure that in the field of animal nutrition
only additivesauthorized in accordance with thisDirective may beput into circulation and that they may be used only if incorporated infeedingstuffs under the conditions set out in the authorization regula-tion.
2. Notwithstanding paragraph 1, additives belonging to groups other
than ‘antibiotics’, ‘coccidiostats and other medicinal substances’, andgrowth promoters may be used if administered by a method other thanincorporation in feedingstuffs, on condition that that method isprovided for in the authorization regulation.
3. Member States shall, in particular, ensure that additives are added
to feed materials and to straight feedingstuffs only where their use isexpressly provided for in the authorization regulation.
REGISTRATION
Article 9l
1. Where additivesasreferred to in Article 2 (aaa) are authorized,
the person(s) responsible for putting them into circulation shall be
given a registration number and the additive shall be given a Commu-nity registration number.
2. Authorized additivesasreferred to in Article 2 (aaaa) s hall be
given a Community registration number.
WITHDRAWAL OF ADDITIVES
Article 9m
A regulation shall be adopted to withdraw the authorization of an addi-
tive:
— at the request of the person responsible for putting the additive into
circulation, if the additive isone of thos e referred to in Article 2(aaa),
— if any of the conditionsfor the authorization of the additive referred
to in Article 3a are no longer met,1970L0524 — EN — 22.12.1998 — 005.001 — 15
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— if a standard sample of the additive is not supplied to the official
authoritieswhich have reques ted it or if an additive put into circu-lation does not correspond to the standared sample of the authorized
additive,
— if a reference sample of the active substance is not supplied to the
official authoritieswhich have reques ted it,
— if the person responsible for putting the additive into circulation
doesnot provide, within a given period of time, the information
requested by a person responsible at the Commission.
However, such additives may continue to be authorized in order to use
up stocks for a period of no longer than one year if at least the condi-
tionslaid down in Article 3a (b) and (e) continue to be met.
MONOGRAPHS AND IDENTIFICATION NOTES
Article 9n
1. In accordance with Directive 87/153/EEC, Member Statess hall
ensure that applicants present a monograph for additives as referred to
in Article 2 (aaa).
2. During the authorization procedure for additivesasreferred to in
Article 2 (aaa), the Standing Committee for Feedingstuffs shall give anopinion, if appropriate after having made the necessary amendments,
on the monograph of the additive presented in the dossier provided
for in Article 4.
The Commission shall approve the opinion given by the Standing
Committee for Feedingstuffs on the monograph and its amendments in
accordance with the procedure laid down in Article 23.
3. Monographs may also be approved for additives other than those
referred to in paragraph 1 in accordance with the procedure laid down
in paragraph 2.
4. The competent authoritiesof the Member Statess hall have
recourse to the monograph:
(a) to determine whether an additive for which authorization to put
into circulation has been requested constitutes an innovation orshould be considered as a copy;
(b) to ascertain whether the additive put into circulation actually corre-
sponds to the additive described in the dossier on the basis ofwhich the Community authorization wasgranted.
5. Subsequent amendments to be made to monographs on account of
developments in scientific and technical knowledge shall be submittedto the Standing Committee for Feedingstuffs for its opinion in accor-dance with the procedure laid down in Article 23.
Article 9o
1. In accordance with Directive 87/153/EEC, Member Statess hall
ensure that the applicant presents an identification note summarizing
the characteristics and properties of the additive. In the case of the
additivesreferred to in Article 2 (aaa), or s hould Article 9n (3) beapplied, the identification note shall contain a summary of the mostimportant characteristics and properties given in the monographreferred to in Article 9n.
2. The following shall be adopted in accordance with the procedure
laid down in Article 23:
— the identification note,
— subsequent amendments to the identification note as a result of
developmentsin s cientific and technical knowledge.
3. In order to facilitate identification of the additivesreferred to in
paragraph 1 during official checks, the identification note provided forin that paragraph shall be published in the Official Journal of the
European Communities .1970L0524 — EN — 22.12.1998 — 005.001 — 16
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STANDARD SAMPLE
Article 9p
1. For the additives referred to in Article 2 (aaa) a standard sample
having the characteristics and properties described in the monographreferred to in Article 9n together with a reference sample of the activesubstance shall be made available, upon request, to the national inspec-
tion authorities of the Member States by the person responsible for
putting them into circulation.
2. If the characteristics or properties of the additive are modified, a
new standard sample corresponding to the new monograph shall beprovided.
3. Detailed rules concerning the provision and maintenance of stan-
dard samples shall be adopted in accordance with the procedure laiddown in Article 23.
MIXTURES AND ADDITIVE LEVELS
Article 9q
1. The maximum and minimum levels set for certain additives shall
refer to complete feedingstuffs with a moisture content of 12 % insofar
as no special provisions are laid down in the authorization regulation.
If the substance permitted as an additive also exists in the natural state
in certain feed materials, the amount of additive to be incorporatedshall be calculated so that the total of the elements added and theelementspres ent naturally doesnot exceed the maximum levelprovided for in the authorization regulation.
2. The mixing of additivess hall be permitted in premixturesand
feedingstuffs only where there is physico-chemical and biological
compatibility between the componentsof the mixture in relation tothe effectsdes ired.
3. Unless the mixture concerned is the subject of a specific authori-
zation asan additive, Member Statess hall require that:
(a) antibioticsand growth promotersmay not be mixed together, either
with substances from their own group or with substances from theother group;
(b) coccidiostats and other medicinal substances may not be mixed
with antibiotics and growth promoters where coccidiostats alsoact, for the same category of animal, as an antibiotic or as a growthpromoter;
(c) coccidiostats and other medicinal substances may not be mixed
together if their effectsare s imilar.
4. Mixing antibiotics, growth promoters, coccidiostats and other
medicinal substances with micro-organisms shall be prohibited unlesssuch a mixture is authorized by the regulation authorizing the micro-organisms.
5. By way of derogation from Article 3 and paragraphs2 and 3 of
thisArticle, Member Statesmay authorize, but only for practical tes ts
conducted for scientific purposes and for non-commercial ends, the use
asadditivesof productswhich are not authorized at Community levelor the use of additives under conditions other than those laid down inthe authorization regulation, provided that:
— the tests are carried out in accordance with the principles and
conditionsto be laid down in Directive 87/153/EEC, and
— an adequate official inspection has been performed.1970L0524 — EN — 22.12.1998 — 005.001 — 17
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AMENDMENTS TO THE ANNEXES
Article 9r
Amendmentsto be made to the Annexess hall be adopted in accor-
dance with the procedure laid down in Article 23.
INFORMATION ON PRODUCERS OF ADDITIVES
Article 9s
Member State shall ensure that the persons responsible for putting the
additivesreferred to in Article 2 (aaa) into circulation forward to the
Commission as quickly as possible the name or corporate name andthe address or registered office of the producers to whom they havegranted the right to manufacture the additive and, if the producersareestablished in a third country, also the name or corporate name and the
address or registered office of their representatives in the Community.
PUBLICATION IN THE OFFICIAL JOURNAL
Article 9t
The Commission shall publish in the Official Journal of the European
Communities , ‘C’ Series, not later than 30 November each year:
(a) the list of persons responsible for putting additives into circulation
asreferred to in Article 9s , the namesof the producersto whomthey have granted the right to manufacture the additivesand theirrepresentatives in the Community if such producers are establishedin a third country;
(b) the list of authorized additives subdivided as follows:
— Chapter I: list of additives linked to a person responsible for
putting them into circulation and authorized for a period of 10years,
— Chapter II: list of additives linked to a person responsible for
putting them into circulation and authorized on a provisionalbasis for no longer than four years or five years in the case ofadditives which have been the subject of provisional authoriza-tion before 1 April 1998,
— Chapter III: list of other additives authorized for an unlimited
period,
— Chapter IV: list of other additives authorized on a provisional
basis for no longer than four years or five years in the case ofadditives which have been the subject of provisional authoriza-tion before 1 April 1998.
PACKAGING
Article 10
Member Statess hall require that additivesand premixturesmay be
marketed only in closed packages or closed containers. Member States
shall require that packages or containers must be closed in such a waythat the fastener is damaged on opening and cannot be re-used.
SAFEGUARD AND MEASURES
Article 11
1. Where a Member State, asa res ult of new information or of a
reassessment of existing information made since the provisions in ques-tion were adopted, has detailed grounds for establishing that the use ofone of the additives ►
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which may be specified constitutes a danger to animal or human healthor the environment although it complieswith the provis ionsof this1970L0524 — EN — 22.12.1998 — 005.001 — 18
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Directive, that Member State may temporarily suspend or restrict appli-
cation of the provisions in question in its territory. It shall immediatelyinform 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 deliverits opinion without delay and take the appropriate measures.
3. Should the Commission consider that amendments to the Direc-
tive are necessary in order to mitigate the difficulties mentioned inparagraph 1 and to ensure the protection of human or animal health orthe 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 untilthe amendmentsenter into force.
ADDITIVE LEVELS IN COMPLEMENTARY FEEDINGSTUFFS
Article 12
1. Member States shall require that supplementary feedingstuffs,
diluted ass pecified, may not contain levelsof the additivesnamed in
this Directive which exceed those fixed for complete feedingstuffs.
2. Member Statesmay require that the levelsof antibiotics , cocci-
diostats and other medicinal substances, growth promoters, D vitamins
and antioxidants in supplementary feedingstuffs may exceed themaximum levels fixed for complete feedingstuffs in the case of:
(a) supplementary feedingstuffs which a Member State has authorized
to be made available to all users, provided that their level of anti-biotics, D vitamins or growth promoters does not exceed five timesthe fixed maximum level;
(b) supplementary feedingstuffs which are intended for certain species
of animal and which a Member State ispermitted to authorize to bemade available within its territory to all users because of specialfeeding systems, provided that their level does not exceed:
— for antibioticsand 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 medicinal substances,
five timesthe fixed maximum level;
— for D vitamins, 200 000 IU/kg.
Member States shall prescribe that if, in the manufacture of supplemen-
tary 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 sametime.
3. Where paragraph 2 isinvoked, Member Statess hall require that
the feedingstuff has one or more compositional characteristics (as
regards, for example, proteins or minerals) which in practice ensure
that the level of additivesfixed for complete feedings tuffsisnotexceeded and that the feedingstuff is not used for other species ofanimal.
RULES FOR THE DISTRIBUTION AND INCORPORATION IN FEEDING-
STUFFS OF ADDITIVES AND PREMIXTURES
Article 13
1. Member Statess hall require that certain additivescovered by this
Directive, premixturesprepared from thos e additiveswith a view totheir being incorporated in compound feedingstuffs and compoundfeedingstuffs containing those premixtures may be put into circulation1970L0524 — EN — 22.12.1998 — 005.001 — 19
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or used only by the establishments or intermediaries which meet the
conditionslaid down, asappropriate, in Council Directive 95/69/ECof 22 December 1995 laying down the conditionsand arrangements
for approving and registering certain establishments and intermediaries
operating in the animal feed sector(
1).
2. Member Statess hall require that:
(a) additivesreferred to in Part A of Annex A may be s upplied only by
approved establishments:
(i) to intermediaries or establishments which manufacture premix-
turesand which have been approved in accordance with theprovisions laid down in Article 3 (1) or Article 2 (2) (b)respectively of Directive 95/69/EC, and
(ii) in the form of premixtures, only to intermediaries or establish-
mentswhich manufacture compound feedings tuffswith a viewto putting them into circulation or for the exclusive require-mentsof their holding and which have been approved inaccordance with the provisions laid down in Article 3 (1) or
Article 2 (2) (c) or (e) respectively of the above Directive;
(b) additives listed in Part B of Annex A may be supplied only by
approved establishments:
(i) to intermediaries or establishments which manufacture premix-
turesand which have been approved in accordance with the
provisions laid down in Article 3 (1) or Article 2 (2) (b)respectively of the above Directive, and
(ii) in the form of premixtures, only to:
— intermediarieswhich have been approved in accordance
with the provisions laid down in Article 3 of the aboveDirective, or
— establishments which manufacture compound feedingstuffs
with a view to putting them into circulation or for theexclusive requirements of their holding and which havebeen registered in accordance with the provisions laiddown in Article 7 (2) (c) or (d) respectively of the said
Directive or, asappropriate, approved in accordance with
the provisions laid down in Article 2 (2) (c) or (e) of thisDirective.
3. Member Statess hall require that additivesreferred to in Annex A
(a) and (B) may be incorporated in compound feedingstuffs only if they
have been prepared beforehand in the form of premixturescontaining acarrier substance by establishments which meet the conditions laiddown in Article 2 (2) (b) of Directive 95/69/EC. Such premixturesmay be incorporated in compound feedingstuffs only in a proportionof at least 0,2 % by weight.
By way of derogation from the first subparagraph, Member States may
allow premixturesto be incorporated in compound feedings tuffsin aproportion aslow as0,05 % by weight, provided that the quantitativeand qualitative composition of the premixture so permits and that they
have first established that the establishments satisfy the conditions set
out in Chapter I.2 (b) of the Annex, with a view to achieving homoge-neous distribution of premixtures and observing the additive levels setfor the whole feedingstuff.
These manufacturers as referred to in the second paragraph shall be
entered on the national list under a special heading as follows: ‘Manu-facturers of compound feedingstuffs authorized to use a minimumproportion of 0,05 % by weight of premixtures’.
4. By way of derogation from paragraph 2, Member Statess hall
require that:
(a) additivesreferred to in Annex A (B) may be s upplied to approved
intermediaries or registered establishments which manufacture1970L0524 — EN — 22.12.1998 — 005.001 — 20
(1) OJ No L 332, 30. 12. 1995, p. 15.
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compound feedingstuffs for pets and fulfil ►C9the conditions
laid down, asappropriate, in Article 3(1) or Article 7(2)(c) or (d)of Directive 95/65/EC; ◄
(b) additivesreferred to in Annex A (A) or (B) may be delivered at the
last stage of circulation to establishments which manufacture
compound feedingstuffs, provided that:
— the Community regulation authorizing the additive provides, in
the case of a specific preparation of the additive, for directaddition to feedingstuffs, and
— the manufacturer of compound feedingstuffs is approved in
accordance with Article 2 (2) (c) of the above Directive for
the additivesreferred to in Annex A (A) or isregis tered inaccordance with Article 7 (2) (c) of the above Directive forthe additivesreferred to in Annex A (B), and
— it hasbeen checked on the s pot that the manufacturer isin
possession of the appropriate technology defined in Chapter I
(3) (b) or Chapter II (c) of the Annex to the above Directivein order to add the preparation in question directly to thecompound feedingstuff.
Such manufacturers shall appear on the national list under a special
heading as follows: ‘Manufacturers of compound feedingstuffsreferred to in point (b) authorized to add antibiotics, cocciodiostats
and other medicinal substances, and growth promoters directly to
compound feedingstuffs’ or ‘Manufacturers of compound feeding-stuffs authorized to add copper, selenium and vitamins A and Ddirectly to compound feedingstuffs’.
5. By way of derogation from Article 7 of Directive 95/69/EC and
paragraphs1 and 2 of thisArticle, Finland and, asregardsthat part ofits territory situated to the north of latitude 60º, Sweden shall beauthorized, in view of the special feeding conditions on their farms, toallow premixturesof vitamins , provitaminsand chemically well-defined substances having similar effect to be supplied to stock farmers
for direct addition to feed materialsof vegetable origin, provided that:
— the directions for use state precisely the dosage to be complied with
according to the species or category of animals and the type offodder used, and
— special measures are taken by Finland and Sweden to monitor use
of such premixtures.
LABELLING OF ADDITIVES
Article 14
1. Member Statess hall require that authorized additivesmay be put
into circulation for use in feedingstuffs only if the following particu-lars, which must be clearly visible, readily legible and indelible andmust 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 additives, with the exception of enzymes and micro-organ-
isms:
(a) the specific name given to the additive upon authorization, the
EC registration number of the additive and, in the case of anadditive within the meaning of Article 2 (aaa), the trade name
and the registration number given to the person responsible for
putting it into circulation;
(b) the name or business name and the address or registered place
of business of the person responsible for the particulars referredto in thisparagraph;
(c) the net weight and, in the case of liquid additives, either the net
volume or the net weight;
(d) as applicable, the approval number assigned to the establish-
ment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment1970L0524 — EN — 22.12.1998 — 005.001 — 21
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or the intermediary pursuant to Article 10 of the above Direc-
tive.
B. In addition, with regard to:
(a) antibiotics, growth promoters, coccidiostats and other medicinal
substances: the name or business name and the address or regis-tered place of business of the manufacturer, if he is not
responsible for the particulars in the label, the active-substance
level, the expiry date of the guarantee or the storage life fromthe date of manufacture, the batch reference number and thedate of manufacture, the directionsfor us e and, where appro-priate, a safety recommendation regarding use in the case ofadditives which are the subject of special provisions upon
authorization;
(b) vitamin E: the alpha-tocopherol level and the expiry date of the
guarantee of that level or storage life from the date of manufac-ture;
(c) vitamins, other than vitamin E, provitamins and substances
having a similar effect: the active-substance level and theexpiry date of the guarantee of that level or storage life from
the date of manufacture;
(d) trace elements, colourants including pigments, preserving agents
and other additives, with the exception of those belonging to theenzyme and micro-organism groups: the active-substance level.
C. For additivesbelonging to the groups :
(a) of enzymes: the specific name of the active component or
componentsin accordance with their enzyme activities , inconformity with the authorization given, the International Union
of Biochemistry identification number, units of activity(
1) (units
of activity per gram or unitsof activity per millilitre), the ECregistration number of the additive, the name or business nameand the address or registered place of business of the personresponsible for the particulars on the label, 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 thelabel, the approval number assigned to the establishment or theintermediary pursuant to Article 5 of Directive 95/69/EC, theexpiry date of the guarantee or the storage life from the dateof manufacture, the batch reference number and the date of
manufacture, the directions for use specifying in particular the
recommended dose, in the form of a range if appropriate, inaccordance with the percentage(s) by weight of target feedmaterial(s) per kilogram of the whole feedingstuff in accor-dance with the requirements laid down on a case-by-case basis
in the authorization for the additive and, where applicable,
safety recommendations as provided for in the authorizationfor the additive, the net weight and, in the case of liquid addi-tives, either the net volume or the net weight, where appropriateindication of special significant characteristics due to the manu-facturing process, in accordance with the provisions concerning
labelling in the authorization for the additive;
(b) of micro-organisms: identification of the strain(s) in accordance
with the authorization granted, the file number of the strain(s),
the number of colony-forming units(CFU per gram), the EC
registration number of the additive, the name or business nameand the address or registered place of business of the personresponsible for the particulars on the label, the name or businessname and the address or registered place of business of themanufacturer, if he is not responsible for the particulars on the
label, the approval number assigned to the establishment or the
intermediary pursuant to Article 5 of Directive 95/69/EC, theexpiry date of the guarantee or the storage life from the date1970L0524 — EN — 22.12.1998 — 005.001 — 22
(1) Units of activity expressed in micromoles of product released per minute,
per gram of enzyme preparation.
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of manufacture, the batch reference number and the date of
manufacture, the directions for use and, where applicable, safetyrecommendationsasprovided for in the authorization for the
additive, the net weight and, in the case of liquid additives,
either the net volume or the net weight, where appropriate anindication of special significant characteristics due to the manu-facturing process, in accordance with the provisions concerninglabelling in the authorization of the additive.
2. Member States shall require that the specific name of the additive
may be accompanied, in cases where the indications are not requiredby virtue of paragraph 1:
(a) by the trade name;
(b) by the name or business name and the address or registered place
of business of the manufacturer, if he is not responsible for theparticularson the label, the directionsfor us e and, where appro-priate, a safety recommendation regarding use.
3. Member Statess hall require that information other than that
required or authorized pursuant to paragraphs 1 and 2 may appear on
packages, containers or labels, provided that they are clearly separated
from the abovementioned marking particulars.
Article 15
1. Member Statess hall require that premixturesmay be marketed
only if the following particulars, which must be clearly visible, readilylegible and indelible and must place responsibility on the producer,
packer, importer, seller or distributor established within the Commu-
nity, are given on the package, the container or a label affixed thereto:
A. For all premixtures:
(a) the description ‘premixture’;
(b) directions for use, and any safety recommendations regarding
the use of the premixtures;
(c) the animal species or category of animals for which the premix-
ture isintended;
(d) the name or business name and the address or registered place
of business of the person responsible for the particulars referredto in thisparagraph;
(e) the net weight and, in the case of liquids, either the volume or
net weight;
(f) as applicable, the approval number assigned to the establish-
ment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishmentor the intermediary pursuant to Article 10 of the above Direc-tive.
B. In addition, for the premixturesincorporating the additiveslis ted
below:
(a) antibiotics, growth promoters, coccidiostats and other medicinal
substances: the name or business name and the address or regis-
tered place of business of the manufacturer if he is not
responsible for the details on the label, specific name given tothe additive upon authorization, active substance level andexpiry date of the guarantee of that level, or storage life fromthe date of manufacture;
(b) substances having antioxidant effects: specific name given to
the additive upon authorization, and active substance level,provided that a maximum level isfixed for complete feeding-stuffs on authorization of the additive;
(c) colourants, including pigments: specific name given to the addi-
tive upon authorization, and active substance level, providedthat a maximum level isfixed for complete feedings tuffsuponauthorization of the additive;1970L0524 — EN — 22.12.1998 — 005.001 — 23
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(d) vitamin E: specific name given to the additive upon authoriza-
tion, alpha-tocopherol level and expiry date of the guarantee ofthat level or storage life from the date of manufacture;
(e) vitamins other than vitamin E, provitamins and substances
having a similar effect: specific name given to the additiveupon authorization, 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 given to the additive upon author-
ization, and level of the variouselementsins ofar asa maximum
level isfixed for complete feedings tuffsupon authorization ofthe additive;
(g) preserving agents: specific name given to the additive upon
authorization, and active substance level, provided that a
maximum level isfixed for complete feedings tuffsupon author-ization of the additive;
(h) enzymes: the specific name of the active component(s)
according to its(their) enzymatic activity(ies ) in accordancewith the authorization given, the identification numberaccording to the International Union of Biochemistry, theactivity units(activity unitsper g or activity unitsper ml), theadditive's EC registration number, the name or business name
and the address or registered place of business of the manufac-
turer if he is not responsible for the particulars on the label, theexpiry date of the guarantee or the storage life from the date ofmanufacture, the batch reference number and the date of manu-facture, the directions for use specifying in particular therecommended dose, in the form of a range if appropriate, in
accordance with the percentage(s) by weight of target feed
material(s) per kilogram of the whole feedingstuff in accor-dance with the requirements laid down on a case-by-case basisin the authorization for the additive and, where applicable, indi-cation of any particular significant characteristics due to the
manufacturing process, in accordance with the provisions
concerning labelling in the authorization of the additive;
(i) micro-organisms: the identification of the strain(s) in accor-
dance with the authorization given, the file number of the
strain(s) in accordance with the authorization given, the file
number of the strain(s), the number of colony-forming units(CFU/g), the additive'sEC regis tration number, the name orbusiness name and the address or registered place of businessof the manufacturer if he is not responsible for the particulars
on the label, the expiry date of the guarantee of the storage
life from the date of manufacture and, where applicable, indica-tion of any particular significant characteristics due to themanufacturing process, in accordance with the provisionsconcerning labelling in the authorization of the additive;
(j) other additivesbelonging to the groupsreferred to in (b) or (i)
for which no maximum level islaid down and additivesbelonging to other groupsauthorized: s pecific name given tothe additive upon authorization and active substance level,
provided that these additives fulfil a function in the feedingstuff
as such and the amounts present can be determined by officialmethods of analysis or, failing this, by valid scientific methods.
2. Member Statess hall require that:
(a) the specific name of additives may be accompanied by the trade-
name;
(b) the name of the producer of the additivesreferred to in paragraph 1
(B) (a) may be indicated in the labelling of premixtures. However,they may stipulate that this indication shall be compulsory;
(c) the specific name of the additives authorized may be accompanied
by the additive'sEC regis tration number.
3. Where, pursuant to paragraph 1, the expiry date of the guarantee
or storage life from the date of manufacture of several additives1970L0524 — EN — 22.12.1998 — 005.001 — 24
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belonging to the same group or different groups has to be stated,
Member States shall require that a single date of guarantee or a singlereference to the storage life may be indicated for all the additives,
namely the deadline which will be reached first.
4. Member Statess hall require that information other than that
required or authorized pursuant to paragraphs 1 to 3 may appear onpackages, containers or labels, provided that they are clearly separatedfrom the abovementioned marking particulars.
Article 16
1. Member States shall require that feedingstuffs incorporating the
additivesbelonging to the groupslis ted below may be put into circula-
tion only if the following particulars, which must be clearly visible,
readily legible and indelible and must place responsibility on theproducer, packer, importer, seller or distributor established within theCommunity, are given on the package, the container or a label affixedthereto:
(a) for antibiotics, coccidiostats and other medicinal substances and
growth promoters: the specific name given to the additive upon
authorization, the active substance level and the expiry date of theguarantee of that level or storage life from the date of manufacture,the approval number assigned to the establishment in accordancewith Article 5 of Directive 95/69/EC;
(b) for substances having antioxidant effects:
— in the case of pet foods: use of the words ‘with antioxidant’
followed by the specific name given to the additive upon
authorization,
— in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(c) for colourants, including pigments provided that these are used for
the colouration of feedingstuffs or animal products:
— in the case of pet foods: use of the words ‘colourant’ or
‘coloured with’ followed by the specific name given to theadditive upon authorization,
— in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(d) for vitamin E: the specific name given to the additive upon author-
ization, the alpha-tocopherol level and the expiry date of theguarantee of that level or storage life from the date of manufacture;
(e) for vitaminsA and D: the s pecific name given to the additive upon
authorization, the active substance level and the expiry date of the
guarantee of that level or storage life from the date of manufacture;
(f) for copper: the specific name given to the additive upon authoriza-
tion and the level expressed in Cu;
(g) for preserving agents:
— in the case of pet foods: use of the words ‘preservative’ or
‘preserved with’ followed by the specific name given to the
additive upon authorization,
— in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(h) for enzymes: the specific name of the active constituent(s)
according to its(their) enzymatic activity(ies ) in accordance with
the authorization given, the identification number according to the
International Union of Biochemistry, the activity units (activityunitsper kilogram or activity unit per litre), the EC regis trationnumber of the additive, the expiry date of the guarantee or thestorage life from the date of manufacture and, where applicable,indication of any particular significant characteristic due to the
manufacturing process, in accordance with the provisions
concerning labelling in the authorization of the additive;
(i) for micro-organisms: the identification of the strain(s) in accor-
dance with the authorization given, the file number of the1970L0524 — EN — 22.12.1998 — 005.001 — 25
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strain(s), the number of colony-forming units (CFU/kg), the EC
registration number of the additive, the expiry date of the guaranteeor the storage life from the date of manufacture and, where applic-
able, indication of any particular significant characteristic due to
the manufacturing process, in accordance with the provisionsconcerning labelling in the authorization of the additive.
2. In addition to the particularsprovided for by paragraph 1, particu-
lars concerning the proper use of the feedingstuffs may be laid down inthe authorization of the additive in accordance with the procedureprovided for in Article 23.
Member States shall require that these particulars must appear on the
package or the container or on a label affixed thereto.
3. The presence of trace elements other than copper and of vitamins
other than vitaminsA, D and E, provitaminsand additiveshaving asimilar effect may be indicated if the amounts of these substances can
be determined by official methods of analysis or, failing this, by valid
scientific methods of analysis. In such cases the following details shallbe given:
(a) for trace elementsother than copper: the s pecific name of the addi-
tive in accordance with the authorization given and level of thevariouselements ;
(b) for vitaminsother than vitaminsA, D and E, provitaminsand
substances having a similar chemical effect: the specific name of
the additive in accordance with the authorization given, the activesubstance level and the expiry date of the guarantee of that level orstorage life from the date of manufacture;
4. Member Statess hall require that:
(a) the details provided for in paragraphs 1 to 3 shall be printed close
to the particularswhich have to appear on the package, container orthe label affixed thereto in accordance with Community rulesonfeedingstuffs;
(b) where a level or a quantity is stated pursuant to paragraphs 1 to 3,
such statement shall refer to the amount of additive incorporated in
the feedingstuff;
(c) the detailsof additivesmay be accompanied by the EC regis tration
number of the additive or the trade name where those particularsare not required by virtue of paragraph 1.
5. Where, pursuant to paragraph 1, the expiry date of the guarantee
or storage life from the date of manufacture of several additivesbelonging to the same group or different 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 indi-cated for all the additives, namely the deadline which will be reachedfirst.
6. In the case of feedingstuffs distributed by road tankers or similar
vehiclesor in bulk, the detailsprovided for in paragraphs1 to 3 s hallbe given in the accompanying document.
Where small quantities intended for the end-user are involved, it shall
be sufficient for such details to be conveyed to the purchaser by asuitable notice.
7. Member States shall require that, in the case of pet foods
containing colourants, preservatives or substances having antioxidant
effectsand put up in packageshaving 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’asappropriate, followed by the words‘EC additives ’, provided that:
(a) the package, container or label bearsa 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 additivesus ed.1970L0524 — EN — 22.12.1998 — 005.001 — 26
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8. Any reference to additivesother than in the form provided for in
thisDirective s hall be prohibited.
Article 17
1. Without prejudice to the provisions of Directive 79/373/EEC(1),
Member States shall require that supplementary feedingstuffs whichcontain additivesin exces sof the maximum levelsfixed for completefeedingstuffs may be placed on the market only if the directions for usestate, 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 conditions of use
prescribed upon authorization of the additive.
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 iscorrectly followed, the proportion of additivesdoesnot
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 in at least one of the
official languagesof the country of des tination.
Article 19
Member States shall ensure that additives, premixtures and feeding-
stuffs which conform to this Directive are subject only to themarketing restrictions provided for in this Directive.
Article 20
Member States shall ensure that livestock products are not subject to
any marketing restriction as a result of the application of this Directive.
INSPECTION MEASURES
Article 21
1. Member States shall in particular take all necessary measures to
ensure that additives, premixtures and feedingstuffs put on the market
are officially checked, at least by random sampling, in respect of the
identity of the additivesus ed and to verify that the other conditionslaid down in this Directive are satisfied.
To thisend, they s hall require in particular that undertakingswhich
intend to manufacture additives or to put them on the market must firstinform the competent authoritiesthereof.
2. Under the procedure provided for in Article 23, marginsof toler-
ance may be fixed, to be allowed where there isa dis crepancy betweenthe result of the official check and the stated content of the additive inthe compound feedingstuff.1970L0524 — EN — 22.12.1998 — 005.001 — 27
(1) OJ No L 86, 6. 4. 1979, p. 30.▼M51
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MONITORING OF UNDESIRABLE INTERACTIONS
Article 21a
Where there is found to be unforeseen undesirable interaction between
additivesreferred to in Article 2 (aaa) and other additivesor veterinarymedicines, Member States shall require that the person responsible forputting the additive into circulation, or hisrepres entative within theCommunity where additivesoriginate in third countries , gathersall the
relevant information and forwardsit to the competent authorities .
EXPORTS TO THIRD COUNTRIES
Article 22
This Directive shall not apply to additives, premixtures and feeding-
stuffs which are shown, at least by an appropriate indication, to be for
export to third countries.
IMPLEMENTATION POWERS OF THE COMMISSION
Article 23
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall be referred without delay be (SIC! by) the chairman,either on hisown initiative or at the reques t of a Member State, to theStanding Committee for Feedingstuffs, hereinafter called ‘theCommittee’.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shall
deliver itsopinion on the draft within a time limit which the Chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of theTreaty in the case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives of
the Member Stateswithin the Committee s hall be weighted in themanner set out in that Article. The Chairman shall not vote.
►
A33.◄The Commission shall adopt the measures and imple-
ment them forthwith where they are in accordance with the opinion ofthe Committee. Where they are not in accordance with the opinion ofthe Committee, or if no opinion is delivered, the Commission shall
without delay propose to the Council the measures to be adopted. The
Council shall adopt the measures by a qualified majority.
If the Council hasnot adopted any meas ureswithin three monthsof the
proposal being submitted to it, the Commission shall adopt theproposed measures and implement them forthwith, except where theCouncil has voted by a simple majority against such measures.
Article 24
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall be referred to the Committee without delay by thechairman, either on hisown initiative or at the reques t of a MemberState.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shall
deliver its opinion within two days. The opinion shall be delivered bythe majority laid down in Article 148 (2) of the Treaty in the case ofdecisions which the Council is required to adopt on a proposal from theCommission. The votes of the representatives of the Member States1970L0524 — EN — 22.12.1998 — 005.001 — 28
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within the Committee shall be weighted in the manner set out in that
Article. The Chairman shall not vote.
►A33.◄The Commission shall adopt the measures and imple-
ment them forthwith where they are in accordance with the opinion ofthe Committee. Where they are not in accordance with the opinion ofthe Committee, or if no opinion is delivered, the Commission shallwithout delay propose to the Council the measures to be adopted. TheCouncil shall adopt the measures by a qualified majority.
If the Council hasnot adopted any meas ureswithin 15 daysof the
proposal being submitted to it, the Commission shall adopt the
proposed measures and implement them forthwith, except where theCouncil has voted by a simple majority against such measures.
FINAL PROVISIONS
Article 25
A decision on the transfer of antibiotics, coccidiostats and other medic-
inal substances, together with preparations based on these products, to
Directive 81/851/EEC and to future ruleson medicinal feedings tuffsshall be adopted by the Council acting unanimously on a proposalfrom the Commission once the degree of harmonization with regard tothe free movement of productsin the s ector of veterinary medicinalproductsand medicated feedings tuffshasreached a level comparable
to that obtaining with regard to additives.
Article 26
Member Statess hall, within two yearsfollowing notification thereof,
bring into force the laws, regulations, or administrative provisionsnecessary to comply with this Directive. They shall forthwith informthe Commission thereof.
However, in the case of the territory of the former German Democratic
Republic, the Federal Republic of Germany may:
— maintain the provisions applicable prior to unification under which
the use of the following additives in feedingstuffs is authorized:
— Olaquindox,
— Nourseothricine,
— Ergambur.
This derogation shall expire on the date of the Decision to be
taken, in accordance with Article 7, on the authorization orprohibition of the use of the additives listed above, and by 31December 1992 at the latest. The Federal Republic of Germany
shall ensure that those additives and any feedingstuffs into
which they are incorporated are not dispatched to other parts ofthe Community;
— derogate, until 31 December 1991, from the labelling provisions in
Articles14, 15 and 16 for the additives , additive pre-mixturesandcompound feedingstuffs to which additives have been added,produced in the territory in question.
Article 27
This Directive is addressed to the Member States.1970L0524 — EN — 22.12.1998 — 005.001 — 29
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Annex A
referred to in Article 13
PART A
— Antibiotics: all additives belonging to this group
— Coccidiostats and other medicinal substances: all additives
belonging to thisgroup
— Growth promoters: all additives belonging to this group
PART B
— Trace elements: copper and selenium
— Vitamins, provitamins and chemically well-defined substances with
similar effects: vitamins A and D.1970L0524 — EN — 22.12.1998 — 005.001 — 30
ANNEX B
CHAPTER I
Additiveslinkedtoapersonresponsibleforputtingthemintocirculation,insertedinAnnexIbefore1January1988
Registra-
tion
numberName and
registration
number of
person
responsible
for
marketing (*)AdditiveChemical
name,
descriptionSpeciesor
category of
animalMaximum
ageMinimum
contentMaximum
content
Other provi-
sionsmg/kg complete feeding-
stuff
A. Antibiotics
B. Coccidiostats and
other medicinal
substances
C. Growth promoters
(*) Authorization to be linked to the person responsible with effect from 1 October 1999.
CHAPTER II
Additiveslinkedtoapersonresponsibleforputtingthemintocirculation, insertedinAnnexIafter31December 1987
Registra-
tion
numberName and
registration
number of
person
responsible
for
marketing (*)AdditiveChemical
name,
descriptionSpeciesor
category of
animalMaximum
ageMinimum
contentMaximum
content
Other provi-
sionsmg/kg complete feeding-
stuff
A. Antibiotics
B. Coccidiostats and
other medicinal
substances▼M1001970L0524 — EN — 22.12.1998 — 005.001 — 31
Registra-
tion
numberName and
registration
number of
person
responsible
for
marketing (*)AdditiveChemical
name,
descriptionSpeciesor
category of
animalMaximum
ageMinimum
contentMaximum
content
Other provi-
sionsmg/kg complete feeding-
stuff
C. Growth promoters
(*) Authorization to be linked to the person responsible with effect from 1 October 1999.▼M1001970L0524 — EN — 22.12.1998 — 005.001 — 32
CHAPTER III
Additiveslinkedtoapersonresponsibleformarketing,insertedinAnnexIIbefore1April1998
A. Antibiotics
Regis-
tration
numberName and
registration
number of
person
responsible
for
marketing (1)Additive Chemical formula, descriptionSpeciesor category
of animalMaximum ageMinim-
um
contentMaxim-
um
content
Other provisionsDuration of
authorisation
mg/kg complete
feedingstuff
31 Bacitracin zinc C66H103O16N17SZn
(polypeptide containing 12 to
20 % zinc)Chickensfor
fattening— 5 50 — 17. 7. 1999 (2)
Pigs6 months 5 50 — 17. 7. 1999 (2)
33 Avilamycin C57.62H82.90Cl1.2O31.32(mixture of oligosaccharides of
the orthosomycin group
produced by Streptomyces viri-
dochromogenes, NRRL 2860)
Factor composition:— Avilamycin A: not less than
60 %
— Avilamycin B: not more
than 18 %
— AvilamycinsA + B: not les s
than 70 %
— Other single avilamycins:
not more than 6 %Turkeys— 5 10 — 30. 9. 1999 (
3)▼M1001970L0524 — EN — 22.12.1998 — 005.001 — 33▼M105
B. Cooccidiostats and other medicinal substances
Regis-
tration
numberName and
registration
number of
person
responsible
for
marketing (1)Additive Chemical formula, descriptionSpeciesor category
of animalMaximum ageMinim-
um
contentMaxim-
um
content
Other provisionsDuration of
authorisation
mg/kg complete
feedingstuff
26 Salinomycin
sodiumC42H69O11Na
(sodium salt of a polyether
monocarboxylic acid produced
byStreptomyces albus )
Elaiophylin content: less than
42 mg per kg of salinomycin
sodium
17-epi-20-desoxysalinomycin
content: less than 40 g per kg of
salinomycin sodiumRabbitsfor
fattening— 20 25 Use prohibited at least five days
before slaughter.
Indicate in the instructions for
use:
— ‘Dangerousfor equines ’
— ‘Thisfeedings tuff contains
an ionophore; simultaneous
use with certain medicinal
substances (e.g. tiamulin)
can be contra indicated’30. 9. 1999 (4)
Chickensreared
for laying12 weeks30 50 Indicate in the ins tructions for
use:
— ‘Dangerousfor equines ’
— ‘Thisfeedings tuff contains
an ionophore; simultaneous
use with certain medicinal
substances (e.g. tiamulin)
can be contra indicated’30. 9. 1999 (5)
27 Diclazuril (±)-4-chlorphenyl(2,6-dicloro-4-
(2,3,4,5-tetrahydro-3,5-dioxo-
1,2,4-triazin-2yl-phenyl)acetoni-
trileTurkeys 12 weeks 1 1 Use prohibited at least five days
before slaughter.30. 9. 1999 (5)
Chickensreared
for laying16 weeks1 1 — 30. 9. 1999 (3)
28 Maduramycin
ammoniumC47H83O17N
(ammonium salt of a polyether
monocarboxylic acid produced
byActinomadura yumaensis )Turkeys 16 weeks 5 5 Use prohibited at least five days
before slaughter.
Indicate in the instructions for
use:
— ‘Dangerousfor equines ’
— ‘Thisfeedings tuff contains
an ionophore; simultaneous30. 9. 1999 (5)▼M1051970L0524 — EN — 22.12.1998 — 005.001 — 34
Regis-
tration
numberName and
registration
number of
person
responsible
for
marketing (1)Additive Chemical formula, descriptionSpeciesor category
of animalMaximum ageMinim-
um
contentMaxim-
um
content
Other provisionsDuration of
authorisation
mg/kg complete
feedingstuff
use with certain medicinal
substances (e.g. tiamulin)
can be contra indicated’
C. Growth promoters
Regis-
tration
numberName and
registration
number of
person
responsible
for
marketing (1)Additive Chemical formula, descriptionSpeciesor category
of animalMaximum ageMinim-
um
contentMaxim-
um
content
Other provisionsDuration of
authorisation
mg/kg complete
feedingstuff
— ——— — — — — —
(1) Authorisation linked to the person responsible with effect from 1 October 1999.
(2) First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18).
(3) First authorisation 15 December 1997, Commission Directive 97/72/EC (OJ L 351, 23. 12. 1997, p. 55).
(4) First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3 1996, p. 45).
(5) First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32).▼M1051970L0524 — EN — 22.12.1998 — 005.001 — 35
▼M100
ANNEX C
PART I
Additives subject to authorization linked to the person responsible for putting
them into circulation referred to in Article 2 (aaa) of the Directive:
— antibiotics: all additives belonging to this group,
— coccidiostats and other medicinal substances: all additives belonging to this
group,
— growth promoters: all additives belonging to this group.
PART II
Other additivesreferred to in Article 2 (aaaa) of the Directive:
— antioxidant substances: all additives belonging to this gorup,
— flavouring and appetizing substances,— emulsifying and stabilizing agents, thickeners and gelling agents: all addi-
tivesbelonging to thisgroup,
— colourants, including pigments: all additives belonging to this group,— preservatives,— vitamins, provitamins and chemically well-defined substances having similar
effect: all additivesbelonging to thisgroup,
— trace elements: all additives belonging to this group,
— binders, anti-caking agents and coagulants: all additives belonging to this
group,
— acidity regulators: all additives belonging to this group,— enzymes: all additives belonging to this group,— micro-organisms: all additives belonging to this group.1970L0524 — EN — 22.12.1998 — 005.001 — 36
▼B
ANNEX I
TABLE OF CORRESPONDANCE
Directive 70/524 Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3Article 4 Article 4Article 5 Article 5Article 6 Article 6Article 7 Article 7Article 7a Article 7aArticle 8 Article 8Article 9 Article 9Article 10 Article 10
Article 11 Article 11
Article 12 Article 12Article 13 Article 13Article 14 Article 14Article 15 Article 15Article 16 Article 16Article 17 Article 17Article 18 Article 18Article 19 Article 19
Article 20 Article 20
Article 21 Article 21Article 22 Article 22Article 23 Article 23Article 24 Article 24Article 25 Article 25Article 26 Article 26Article 27 Article 27- ANNEX I1970L0524 — EN — 22.12.1998 — 005.001 — 37