Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs
Modified by
  • Council Directive of 28 April 1973 (73/103/EEC), 31973L0103, May 10, 1973
  • First Commission Directive of 27 July 1973 (73/264/EEC), 31973L0264, September 10, 1973
  • Second Commission Directive of 27 July 1973 (73/275/EEC), 31973L0275, September 11, 1973
  • Third Commission Directive of 13 December 1973 (74/7/EEC), 31974L0007, January 17, 1974
  • Fourth Commission Directive of 17 December 1973 (74/38/EEC), 31974L0038, February 4, 1974
  • Fifth Commission Directive of 26 February 1974 (74/180/EEC), 31974L0180, April 4, 1974
  • Sixth Commission Directive of 26 February 1974 (74/181/EEC), 31974L0181, April 4, 1974
  • Seventh Commission Directive of 26 February 1974 (74/182/EEC), 31974L0182, April 4, 1974
  • Eighth Commission Directive of 1 July 1974 (74/378/EEC), 31974L0378, July 22, 1974
  • Ninth Commission Directive of 23 July 1974 (74/421/EEC), 31974L0421, August 12, 1974
  • Tenth Commission Directive of 20 December 1974 (75/50/EEC), 31975L0050, January 24, 1975
  • Eleventh Commission Directive of 24 April 1975 (75/267/EEC), 31975L0267, May 8, 1975
  • Second Council Directive of 28 April 1975 (75/296/EEC), 31975L0296, May 15, 1975
  • Twelfth Commission Directive of 24 October 1975 (75/696/EEC), 31975L0696, November 19, 1975
  • Thirteenth Commission Directive of 15 December 1975 (76/13/EEC), 31976L0013, January 9, 1976
  • Fourteenth Commission Directive of 8 June 1976 (76/546/EEC), 31976L0546, June 22, 1976
  • Fifteenth Commission Directive of 21 June 1976 (76/603/EEC), 31976L0603, July 23, 1976
  • Sixteenth Commission Directive of 1 December 1976 (76/933/EEC), 31976L0933, December 31, 1976
  • Seventeenth Commission Directive of 16 February 1977 (77/179/EEC), 31977L0179, March 5, 1977
  • Eighteenth Commission Directive of 11 July 1977 (77/471/EEC), 31977L0471, July 20, 1977
  • Nineteenth Commission Directive of 26 July 1977 (77/512/EEC), 31977L0512, August 13, 1977
  • 20th Commission Directive of 7 December 1977 (78/58/EEC), 31978L0058, January 24, 1978
  • Twenty-first Commission Directive of 23 December 1977 (78/117/EEC), 31978L0117, February 10, 1978
  • Twenty-second Commission Directive of 30 May 1978 (78/522/EEC), 31978L0522, June 17, 1978
  • Twenty-third Commission Directive of 23 June 1978 (78/613/EEC), 31978L0613, July 22, 1978
  • Twenty-fourth Commission Directive of 28 July 1978 (78/743/EEC), 31978L0743, September 9, 1978
  • Twenty-fifth Commission Directive of 16 November 1978 (78/974/EEC), 31978L0974, November 25, 1978
  • Twenty-sixth Commission Directive of 18 December 1978 (79/139/EEC), 31979L0139, February 14, 1979
  • Twenty-seventh Commission Directive of 7 June 1979 (79/553/EEC), 31979L0553, June 16, 1979
  • Twenty-eighth Commission Directive of 20 July 1979 (79/697/EEC), 31979L0697, August 15, 1979
  • Actconcerning the conditions of accession of the Hellenic Republic and the adjustments to the Treaties, 11979H, November 19, 1979
  • Twenty-ninth Commission Directive of 15 November 1979 (79/1011/EEC), 31979L1011, December 6, 1979
  • Thirtieth Commission Directive of 9 January 1980 (80/131/EEC), 31980L0131, February 7, 1980
  • Thirty-first Commission Directive of 8 April 1980 (80/440/EEC), 31980L0440, April 22, 1980
  • Thirty-second Commission Directive of 26 June 1980 (80/618/EEC), 31980L0618, July 4, 1980
  • Thirty-third Commission Directive of 4 July 1980 (80/678/EEC), 31980L0678, July 18, 1980
  • Thirty-fourth Commission Directive of 4 September 1980 (80/884/EEC), 31980L0884, September 24, 1980
  • Thirty-fifth Commission Directive of 25 November 1980 (80/1139/EEC), 31980L1139, December 13, 1980
  • Thirty-sixth Commission Directive of 28 November 1980 (80/1156/EEC), 31980L1156, December 18, 1980
  • Thirty-seventh Commission Directive of 9 April 1981 (81/332/EEC), 31981L0332, May 18, 1981
  • Thirty-eighth Commission Directive of 16 July 1981 (81/632/EEC), 31981L0632, August 15, 1981
  • Thirty-ninth Commission Directive of 15 January 1982 (82/91/EEC), 31982L0091, February 13, 1982
  • Council Directive of 30 June 1982 (82/471/EEC), 31982L0471, July 21, 1982
  • Fortieth Commission Directive of 23 June 1982 (82/474/EEC), 31982L0474, July 21, 1982
  • Forty-first Commission Directive of 19 November 1982 (82/822/EEC), 31982L0822, December 7, 1982
  • Forty-second Commission Directive of 16 May 1983 (83/266/EEC), 31983L0266, June 6, 1983
  • Forty-third Commission Directive of 28 July 1983 (83/466/EEC), 31983L0466, September 15, 1983
  • Forty-fourth Commission Directive of 29 November 1983 (83/615/EEC), 31983L0615, December 13, 1983
  • Forty-fifth Commission Directive of 15 February 1984 (84/107/EEC), 31984L0107, March 2, 1984
  • Forty-sixth Commission Directive of 28 May 1984 (84/349/EEC), 31984L0349, July 11, 1984
  • Forty-seventh Commission Directive of 26 October 1984 (84/547/EEC), 31984L0547, November 15, 1984
  • Council Directive of 29 November 1984 (84/587/EEC), 31984L0587, December 8, 1984
  • Forty-eighth Commission Directive of 6 February 1985 (85/157/EEC), 31985L0157, February 27, 1985
  • Forty-ninth Commission Directive of 31 May 1985 (85/312/EEC), 31985L0312, June 25, 1985
  • Fiftieth Commission Directive of 24 June 1985 (85/342/EEC), 31985L0342, July 11, 1985
  • Commission Directive of 8 July 1985 (85/429/EEC), 31985L0429, September 12, 1985
  • Actconcerning the conditions of accession of the Kingdom of Spain and the Portuguese Republic and the adjustments to the Treaties, 11985I, November 15, 1985
  • Commission Directive of 11 November 1985 (85/520/EEC), 31985L0520, December 4, 1985
  • Council Regulation (EEC) No 3768/85 of 20 December 1985, 31985R3768, December 31, 1985
  • Second Commission Directive of 5 February 1986 (86/29/EEC), 31986L0029, February 14, 1986
  • Commission Directive of 4 June 1986 (86/300/EEC), 31986L0300, July 11, 1986
  • Commission Directive of 28 July 1986 (86/403/EEC), 31986L0403, August 20, 1986
  • Commission Directive of 27 October 1986 (86/525/EEC), 31986L0525, November 5, 1986
  • Commission Directive of 23 April 1987 (87/243/EEC), 31987L0243, April 25, 1987
  • Commission Directive of 23 April 1987 (87/244/EEC), 31987L0244, April 25, 1987
  • Council Directive of 16 June 1987 (87/316/EEC), 31987L0316, June 20, 1987
  • Council Directive of 16 June 1987 (87/317/EEC), 31987L0317, June 20, 1987
  • Commission Directive of 17 November 1987 (87/552/EEC), 31987L0552, November 26, 1987
  • Commission Directive of 8 April 1988 (88/228/EEC), 31988L0228, April 20, 1988
  • Commission Directive of 14 July 1988 (88/483/EEC), 31988L0483, August 27, 1988
  • Commission Directive of 30 November 1988 (88/616/EEC), 31988L0616, December 13, 1988
  • Commission Directive of 21 December 1988 (89/23/EEC), 31989L0023, January 14, 1989
  • Commission Directive of 27 October 1989 (89/583/CEE), 31989L0583, November 10, 1989
  • Commission Directive of 19 February 1990 (90/110/EEC), 31990L0110, March 15, 1990
  • Commission Directive of 9 April 1990 (90/206/EEC), 31990L0206, April 26, 1990
  • Commission Directive of 20 April 1990 (90/214/EEC), 31990L0214, May 4, 1990
  • Commission Directive of 20 July 1990 (90/412/EEC), 31990L0412, August 8, 1990
  • Commission Directive of 26 November 1990 (90/643/EEC), 31990L0643, December 14, 1990
  • Council Directive of 4 December 1990 (90/654/EEC), 31990L0654, December 17, 1990
  • Commission Directive of 12 April 1991 (91/248/EEC), 31991L0248, May 18, 1991
  • Commission Directive of 19 April 1991 (91/249/EEC), 31991L0249, May 18, 1991
  • Commission Directive of 10 June 1991 (91/336/EEC), 31991L0336, July 11, 1991
  • Commission Directive of 9 September 1991 (91/508/EEC), 31991L0508, September 27, 1991
  • Commission Directive of 22 November 1991 (91/620/EEC), 31991L0620, December 5, 1991
  • Commission Directive 92/64/EEC of 13 July 1992, 31992L0064, August 6, 1992
  • Commission Directive 92/99/EEC of 17 November 1992, 31992L0099, December 1, 1992
  • Commission Directive 92/113/EEC of 16 December 1992, 31992L0113, January 25, 1993
  • Commission Directive 93/27/EEC of 4 June 1993, 31993L0027, July 22, 1993
  • Commission Directive 93/55/EEC of 25 June 1993, 31993L0055, August 18, 1993
  • Commission Directive 93/107/EC of 26 November 1993, 31993L0107, December 4, 1993
  • Council Directive 93/114/EC of 14 December 1993, 31993L0114, December 31, 1993
  • Commission Directive 94/17/EC of 22 April 1994, 31994L0017, April 26, 1994
  • Commission Directive of 18 July 1994 (94/41/CE), 31994L0041, August 12, 1994
  • Actconcerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded(94/C 241/08) Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 11994N31995D0001, August 29, 1994
  • Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 31995D0001, January 1, 1995
  • Commission Directive 94/50/EC of 31 October 1994, 31994L0050, November 18, 1994
  • Commission Directive 94/77/ECof 20 December 1994amending Council Directive 70/524/EEC concerning additives in feedingstuffs, 31994L0077, December 31, 1994
  • Commission Directive 95/37/ECof 18 July 1995amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31995L0037, July 22, 1995
  • Commission Directive 95/55/ECof 31 October 1995amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31995L0055, November 4, 1995
  • Council Directive 95/69/ECof 22 December 1995laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC, 31995L0069, December 30, 1995
  • Commission Directive 96/7/ECof 21 February 1996amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31996L0007, March 1, 1996
  • Council Directive 96/25/ECof 29 April 1996on the circulation and use of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC Directive 2000/16/EC of the European Parliament and the Councilof 10 April 2000amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs and Council Directive 96/25/EC on the circulation of feed materials, 31996L002532000L0016, May 23, 1996
  • Directive 2000/16/EC of the European Parliament and the Councilof 10 April 2000amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs and Council Directive 96/25/EC on the circulation of feed materials, 32000L0016, May 3, 2000
  • Council Directive 96/51/ECof 23 July 1996amending Directive 70/524/EEC concerning additives in feedingstuffs Corrigendum to Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524/EEC concerning additives in feedingstuffs(Official Journal of the European Communities L 235 of 17 September 1996), 31996L005131996L0051R(02), September 17, 1996
  • Commission Directive 96/66/ECof 14 October 1996amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31996L0066, October 25, 1996
  • Commission Directive 97/6/ECof 30 January 1997amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31997L0006, February 5, 1997
  • Commission Directive 97/72/ECof 15 December 1997amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31997L0072, December 23, 1997
  • Commission Directive 98/19/ECof 18 March 1998amending Council Directive 70/524/EEC concerning additives in feedingstuffs(Text with EEA relevance), 31998L0019, March 28, 1998
  • Council Directive 98/92/ECof 14 December 1998amending Directive 70/524/EEC concerning additives in feedingstuffs and Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector, 31998L0092, December 22, 1998
  • Commission Regulation (EC) No 2786/98of 22 December 1998concerning the modification of the period of authorisations of additives referred to in Article 9i(1) of Council Directive 70/524/EEC, 31998R2786, December 23, 1998
  • Commission Regulation (EC) No 2788/98of 22 December 1998amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards the withdrawal of authorisation for certain growth promoters, 31998R2788, December 23, 1998
  • Council Regulation (EC) No 2821/98of 17 December 1998amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs, 31998R2821, December 29, 1998
  • Commission Regulation (EC) No 45/1999of 11 January 1999amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives belonging to the group of coccidiostats and other medicinal substances, 31999R0045, January 12, 1999
  • Council Directive 1999/20/ECof 22 March 1999amending Directives 70/524/EEC concerning additives in feedingstuffs, 82/471/EEC concerning certain products used in animal nutrition, 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector, 31999L0020, March 25, 1999
  • Directive 2001/46/EC of the European Parliament and of the Councilof 23 July 2001amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition, 32001L0046, September 1, 2001
  • Commission Regulation (EC) No 2205/2001of 14 November 2001amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives(Text with EEA relevance), 32001R2205, November 15, 2001
  • Council Regulation (EC) No 1756/2002of 23 September 2002amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of an additive and amending Commission Regulation (EC) No 2430/1999(Text with EEA relevance), 32002R1756, October 3, 2002
  • Regulation (EC) No 767/2009 of the European Parliament and of the Councilof 13 July 2009on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC(Text with EEA relevance), 32009R0767, September 1, 2009
Corrected by
  • Council Directive No 70/524/EEC of 23 November1970 concerning additives in feedingstuffs, 31970L0524R(02), January 1, 1973
  • Corrigendum to Thirty-Third Commission Directive 80/678/EEC of 4 July 1980 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31980L0678R(01), November 27, 1980
  • Corrigendum to Fortieth Commission Directive of 23 June 1982 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31982L0474R(01), August 12, 1982
  • Corrigendum to Commission Directive 90/110/EEC of 19 February 1990 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31990L0110R(01), March 30, 1990
  • Corrigendum to the corrigendum to Commission Directive 90/110/EEC of 19 February 1990 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31990L0110R(02), April 12, 1990
  • Corrigendum to Commission Directive 91/249/EEC of 19 April 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31991L0249R(02), July 3, 1991
  • Corrigendum to Commission Directive 91/248/EEC of 12 April 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs, 31991L0248R(01), October 17, 1991
  • Corrigendum to Council Directive 93/114/EC of 14 December 1993 amending Directive 70/524/EEC concerning additives in feedingstuffs, 31993L0114R(01), February 17, 1994
  • Corrigendum to Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524/EEC concerning additives in feedingstuffs, 31996L0051R(02), May 16, 2000
Council Directiveof 23 November 1970concerning additives in feeding-stuffs(70/524/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European ParliamentOJ No C 135, 14.12.1968, p. 20.; Having regard to the Opinion of the Economic and Social Committee; Whereas livestock production occupies a very important place in the agriculture of the European Economic Community; whereas satisfactory 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; Whereas the provisions laid down in the Member States by law, regulation 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 of the 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 and livestock 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 large quantities they have a medicinal effect; Whereas these substances must not be used in feeding-stuffs for the prime purpose of diagnosing, treating or preventing disease; whereas they 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 to feeding-stuffs as additives, since most Member States have been using them 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 be contained in feeding-stuffs and only subject to the reguirements set out 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 of the feeding-stuffs to which they are added or on livestock production; whereas they must not endanger animal or human health nor harm the consumer of livestock products; whereas, subject to the exceptions provided for, it is advisable to examine whether such additives may now be used for the treatment or prevention of disease or whether there are still serious reasons for restricting their use to medical or veterinary purposes; Whereas, because of the special situation of certain Member States, and in particular because of their different systems of animal feeding, it is necessary in certain cases to allow derogations from the above-mentioned principles to 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 or human health is being endangered; whereas Member States should not, however, be able to have recourse to that power in order to hinder the free movement of the various products; Whereas provision should be made for feeding-stuffs containing additives to be specially labelled so that the user may know the nature of the additive and be protected against fraud; whereas this provision refers particularly to supplementary feeding-stuffs containing concentrates of certain additives; Whereas Community rules should not apply to feeding-stuffs intended for export to third countries, as the latter generally apply different rules; Whereas, in order to ensure that the requirements laid down in respect of additives are satisfied during marketing, Member States must make provision 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-operation between Member Sates and the Commission within the Standing Committee 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 technically unavoidable presence of residues of the substances or their derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product. 3. Provided they are not products specially enriched with substances corresponding to additives, substances present in their natural state in feed materials which are part of the normal composition of feedingstuffs and which correspond to a substance authorized under this Directive 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 nutrition in order to: affect favourably the characteristics of feed materials or of compound feedingstuffs or of animal products; or 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 elements conducive to attaining particular nutritional objectives or to meeting the specific nutritional needs of animals at a particular time; or prevent or reduce the harmful effects caused by animal excretions or 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 additives listed in Part I of Annex C; (aaaa)Other additives: additives not subject to authorization linked to the person responsible for putting them into circulation and referred to in Part II of Annex C; (b)Feedingstuffs: products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding; (c)Daily ration: 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)Supplementary feedingstuffs: mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if they are used in combination with other feedingstuffs; (f)Feed materials: various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, 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 as carriers of premixtures, hereinafter referred to as feed materials; (g)Compound feedingstuffs: mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs; (h)Premixtures: mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture 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 any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves; (l)Person responsible for putting into circulation: the natural or legal person who has responsibility for the conformity of the additive which has been granted Community authorization and for putting it into circulation.
PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES
Article 3 Member States shall require that no additive may be put into circulation unless a Community authorization has been granted. This authorization shall be granted under a Commission regulation in accordance 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 consumer by impairing the characteristics of animal products; (c)its presence can be monitored: as an additive per se, in premixtures, in feedingstuffs or, where appropriate, in feed materials; (d)at the level permitted, treatment or prevention of animal disease is excluded; this condition shall not apply to additives belonging 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 already authorized additive, the applicant for authorization shall select a Member State to act as rapporteur during the scrutiny procedure on the dossier he has compiled in accordance with the provisions of Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutritionOJ No L 64, 7. 3. 1987, p. 19. Directive as last amended by Directive 95/11/EC (OJ No L 106, 11. 5. 1995, p. 23).. Where the applicant is established in a third country, he must have a representative in the Community. 2. The Member State acting as rapporteur shall 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, appears to meet the conditions laid 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 of submission of the applicant's dossier in the Member State acting as rapporteur, unless the latter is rejected or postponed. The Member State acting as rapporteur shall inform the applicant, the other Member States and the Commission of the reasons for rejection or postponement 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 to the Commission and the other Member States. If, on expiry of the period referred to in the first paragraph, no objection has been made, the representative of the Commission shall have a period of thirty days in 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 been complied with, a representative of the Commission shall so notify the applicant for authorization to put into circulation and the Member State acting as rapporteur; where necessary, a new application must be submitted in accordance with the above provisions. 6. The Commission shall ensure that a decision is taken, in accordance with the procedure laid down in Article 23, on the application for Community authorization within 320 days following its inclusion on the agenda for the Standing Committee for Feedingstuffs in accordance with the second subparagraph of paragraph 4. However, this time limit shall be interrupted where a request is made for additional information 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 representative of the Commission shall inform the applicant for authorization and the Member State acting as rapporteur of the reasons for the rejection or postponement of the decision.
Article 5 Amendments to Directive 87/153/EEC: which arise from developments in scientific and technical knowledge 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 groups and the nature of the Community authorization requested, by the Member State acting as rapporteur for the examination of dossiers arising from the obligations laid down in Articles 4 (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 calculation of the level of the fee referred to in paragraph 1.
Article 7 1. Member States and the Commission shall ensure that any information which, if disseminated, could affect industrial and commercial property rights is kept 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 ecotoxicological data relating to the additive, the analytical methods for monitoring the additive itself 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.
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 environment of genetically modified organismsOJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L 103, 22. 4. 1994, p. 20)., a specific environmental risk assessment similar to that laid down in the abovementioned Directive shall be carried out; for this purpose, the following documents shall be included in the dossier submitted pursuant to Article 4 of this Directive in order to ensure compliance with the principles set out in Article 3a: a copy of any written consent or consents of the competent authorities to the deliberate release into the environment of genetically modified organisms for research and development purposes pursuant 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 Annexes II and III to Directive 90/220/EEC and the environmental risk assessment resulting from this information; the results of any investigations performed for the purposes of research or development. Articles 11 to 18 of Directive 90/220/EEC shall 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/EECOJ 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). 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 in Article 4 is officially forwarded to the members of the Committee referred to in paragraph 1.
ARRANGEMENTS APPLICABLE TO AUTHORIZATIONS FOR ADDITIVES LINKED TO THE PERSON RESPONSIBLE FOR PUTTING THEM INTO CIRCULATION Authorization given for 10 years
Article 9 Additives as referred to in Article 2 (aaa) which meet the conditions laid down in Article 3a shall be authorized and included in Chapter I of the list referred to in Article 9t (b).
Provisional authorization for a maximum of four years
Article 9a 1. In the case of the additives referred to in Article 2 (aaa), provisional authorization may be given at Community level for the use of a new additive or a new use of an additive already authorized, provided that the conditions laid down in Article 3a (b), (c), (d) and (e) are met and 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 years from the date on which it takes effect.
Renewal of authorization after 10 years
Article 9b 1. Community authorization of additives referred to in Article 2 (aaa) shall be valid for 10 years from the date on which final authorization takes effect and shall be renewable for 10-year periods. In the event of renewal, the authorization holder shall send to the Commission, via the Member State acting as rapporteur, an application accompanied by a dossier complying with the provisions to be laid down for the renewal of authorizations for additives in Directive 87/153/EEC. The application and the dossier shall be sent, at least one year 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 officially forwarded by the authorization holder via the Member State acting as rapporteur to the other Member States, which shall acknowledge receipt thereof at the earliest opportunity. 2. Articles 3, 3a, 4, 7, and 7a shall apply mutatis mutandis to applications for 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 submitted for the purpose of the first authorization may not be used for the benefit of other applicants for a period of 10 years: (a)from the date on which the first authorization by means of regulation takes effect for the additives referred to in Article 9g (1), Article 9h (1) and Article 9i (1), or (b)for other additives from the data on which the first authorization by means of regulation takes effect or counting from 1 October 1999 if the latter date of taking effect is earlier,unless the applicant has agreed with the authorization holder that such data and information may be used. During this period, however, authorizations for putting into circulation may be granted to persons other than the person responsible for first putting the additive into circulation provided that the conditions in Articles 3a and 4 are met. 2. Where additional information is supplied on an additive which has been provisionally authorized under Article 9a, for the purpose of obtaining authorization of the additive under Article 3a, that information shall be considered as an integral part of the initial dossier and shall consequently cease to be protected at the same time as the information in the initial dossier. 3. On expiry of the 10-year period referred to in paragraph 1, the findings of all or part of the evaluation conducted on the basis of the scientific 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 additive which has already 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 State acting as rapporteur, to the Commission, which shall acknowledge receipt thereof as quickly as possible. A copy of the application, together with the dossier, shall be officially forwarded by the new applicant, via a Member State acting as rapporteur, to the other 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 of withdrawal of authorization at the request of the holder of that authorization. 5. The additional scientific data and information required for modification of the conditions for listing an additive or for renewal of the authorization in accordance with Article 9b (1) or any new scientific data or information provided during the period of authorization of the additive may not be used by the Commission or by a Member State for the benefit of another applicant for a period of five years from 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 conditions for listing an additive expires before the end of the period provided for in paragraph 1, the five-year period shall be extended so that both periods expire simultaneously. 6. Without prejudice to paragraph 1, an applicant for an authorization for an additive referred to in Article 2 (3) (aaa) shall, before beginning toxicological tests on vertebrates, check whether his product or its active substance has not already been authorized. If necessary, he shall find out from a Member State's competent authorities whether the product or active substance concerned is the same as that already authorized. If the product or active substance concerned has already been authorized, the applicant and the holder(s) of earlier authorizations shall take all necessary steps to reach agreement on sharing the use of information, 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 information, the Member States may take national measures to oblige the applicant and the holder(s) of previous authorizations established within their territories to share the information, in order to avoid repeating toxicological tests on vertebrates undertaken on their territory and may lay down conditions for the use of the information while ensuring a reasonable balance between the interests of the parties concerned.
ARRANGEMENTS APPLICABLE TO AUTHORIZATION OF OTHER ADDITIVES Authorization without a time limit
Article 9d 1. Additives as referred to in Article 2 (aaaa) which meet the conditions laid down in Article 3a shall be authorized and included in Chapter III of the list referred to in Article 9t (b). 2. Additives as referred 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).
Provisional authorization for a maximum of four or five years
Article 9e 1. In the case of the additives referred to in Article 2 (aaaa), provisional authorization may be given at Community level for the use of a new additive or a new use of an additive already authorized, provided that the conditions laid down in Article 3a (b), (c), (d) and (e) are met and it is reasonable to assume that the condition laid down in Article 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 years from the date on which it takes effect. 3. Additives as referred to in Article 2 (aaa), included in Annex II before 1 April 1998, may continue to be the subject of national provisional authorizations; they shall be included in Chapter IV of the list referred to in Article 9t (b). The period of provisional authorization of these additives may not exceed five years taking account of the period of 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.
Additives included in Annex I before 1 January 1988
Article 9g 1. Additives as referred to in Article 2 (aaaa) included in Annex I before 1 January 1988 shall be provisionally authorized as from 1 April 1998 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 additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was granted 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, provisional authorization of the additives shall be withdrawn through the adoption of a Regulation and they shall be deleted from the list in Chapter 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 monographs and identification notes are not in accordance with the date in the dossier on the basis of which the original authorization was given. 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, the dossier referred to in Article 4 with a view to re-evaluation. Where he fails to do so, the authorization of the additive in question shall be withdrawn 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 no later than three years after the dossier is submitted. In accordance with the procedure laid down in Article 23, authorizations of the additives referred 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, or (b)shall be replaced by authorizations linked to the person responsible for putting them into circulation for a period of 10 years through the 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.
Additives included in Annex I after 31 December 1987
Article 9h 1. Additives as referred to in Article 2 (aaa) included in Annex I after 31 December 1987 shall be authorized provisionally as from 1 April 1998 and transferred to Chapter II of Annex B with a view to their authorization for a period of 10 years as additives linked to a person responsible for putting them into circulation in accordance with paragraphs 2 and 3. 2. The additives referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization 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, provisional 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 established that the monographs or the identification notes are not in accordance with the data in the dossier on the basis of which the original authorization was given, 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 years through the adoption of a regulation taking effect no later than 1 October 1999 and included in Chapter I of the list referred to in Article 9t (b). 4. The provisions of Article 9b (3) shall apply mutatis mutandis.
Additives included in Annex II before 1 April 1998
Article 9i 1. Additives as referred to in Article 2 (aaa) included in Annex II before 1 April 1998 may continue to be the subject of national provisional authorizations; they shall be authorized and transferred to Chapter III of Annex B with a view to their authorization as additives linked to a person responsible for putting them into circulation; the period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above. 2. The additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization; such applications, accompanied by the monographs and identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization 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, provisional 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 the documents prescribed in paragraph 2 are not submitted within the time allowed or if, after scrutiny of the documents, it is established that the monographs and identification notes are not in accordance with the data in the dossier on the basis of which the original authorization was given, or (b)shall be replaced by provisional authorizations as referred to in paragraph 1 linked to the person responsible for putting them into circulation through the adoption of a regulation taking effect no later than 1 October 1999 and the additives shall be included in Chapter 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 Applications for authorization to put into circulation submitted between 1 April 1998 and 30 September 1999 in respect of which the Commission has not yet given a ruling at that date shall be examined in accordance with Articles 3, 3a, 7, 7a, 9, 9a, 9b, 9c, 9d, 9e, 9n and 9o, as appropriate.
DISTRIBUTION AND USE OF ADDITIVES
Article 9k 1. Member States shall ensure that in the field of animal nutrition only additives authorized in accordance with this Directive may be put into circulation and that they may be used only if incorporated in feedingstuffs under the conditions set out in the authorization regulation. 2. Notwithstanding paragraph 1, additives belonging to groups other than "antibiotics", "coccidiostats and other medicinal substances", and growth promoters may be used if administered by a method other than incorporation in feedingstuffs, on condition that that method is provided 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 is expressly provided for in the authorization regulation.
REGISTRATION
Article 9l 1. Where additives as referred 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 Community registration number. 2. Authorized additives as referred to in Article 2 (aaaa) shall be given a Community registration number.
WITHDRAWAL OF ADDITIVES
Article 9m A regulation shall be adopted to withdraw the authorization of an additive: at the request of the person responsible for putting the additive into circulation, if the additive is one of those referred to in Article 2 (aaa), if any of the conditions for the authorization of the additive referred to in Article 3a are no longer met, if a standard sample of the additive is not supplied to the official authorities which have requested it or if an additive put into circulation 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 authorities which have requested it, if the person responsible for putting the additive into circulation does not 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 conditions laid 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 States shall ensure that applicants present a monograph for additives as referred to in Article 2 (aaa). 2. During the authorization procedure for additives as referred to in Article 2 (aaa), the Standing Committee for Feedingstuffs shall give an opinion, 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 authorities of the Member States shall have recourse to the monograph: (a)to determine whether an additive for which authorization to put into circulation has been requested constitutes an innovation or should be considered as a copy; (b)to ascertain whether the additive put into circulation actually corresponds to the additive described in the dossier on the basis of which the Community authorization was granted. 5. Subsequent amendments to be made to monographs on account of developments in scientific and technical knowledge shall be submitted to the Standing Committee for Feedingstuffs for its opinion in accordance with the procedure laid down in Article 23.
Article 9o 1. In accordance with Directive 87/153/EEC, Member States shall ensure that the applicant presents an identification note summarizing the characteristics and properties of the additive. In the case of the additives referred to in Article 2 (aaa), or should Article 9n (3) be applied, the identification note shall contain a summary of the most important characteristics and properties given in the monograph referred 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 developments in scientific and technical knowledge. 3. In order to facilitate identification of the additives referred to in paragraph 1 during official checks, the identification note provided for in that paragraph shall be published in the Official Journal of the European Communities.
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 monograph referred to in Article 9n together with a reference sample of the active substance shall be made available, upon request, to the national inspection 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 be provided. 3. Detailed rules concerning the provision and maintenance of standard samples shall be adopted in accordance with the procedure laid down 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 incorporated shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the authorization regulation. 2. The mixing of additives shall be permitted in premixtures and feedingstuffs only where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired. 3. Unless the mixture concerned is the subject of a specific authorization as an additive, Member States shall require that: (a)antibiotics and growth promoters may not be mixed together, either with substances from their own group or with substances from the other group; (b)coccidiostats and other medicinal substances may not be mixed with antibiotics and growth promoters where coccidiostats also act, for the same category of animal, as an antibiotic or as a growth promoter; (c)coccidiostats and other medicinal substances may not be mixed together if their effects are similar. 4. Mixing antibiotics, growth promoters, coccidiostats and other medicinal substances with micro-organisms shall be prohibited unless such a mixture is authorized by the regulation authorizing the micro-organisms. 5. By way of derogation from Article 3 and paragraphs 2 and 3 of this Article, Member States may authorize, but only for practical tests conducted for scientific purposes and for non-commercial ends, the use as additives of products which are not authorized at Community level or the use of additives under conditions other than those laid down in the authorization regulation, provided that: the tests are carried out in accordance with the principles and conditions to be laid down in Directive 87/153/EEC, and an adequate official inspection has been performed.
AMENDMENTS TO THE ANNEXES
Article 9r Amendments to be made to the Annexes shall be adopted in accordance 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 additives referred to in Article 2 (aaa) into circulation forward to the Commission as quickly as possible the name or corporate name and the address or registered office of the producers to whom they have granted the right to manufacture the additive and, if the producers are established 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 as referred to in Article 9s, the names of the producers to whom they have granted the right to manufacture the additives and their representatives in the Community if such producers are established in 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 10 years, Chapter II: list of additives linked to a person responsible for putting them into circulation and authorized on a provisional basis for no longer than four years or five years in the case of additives which have been the subject of provisional authorization 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 of additives which have been the subject of provisional authorization before 1 April 1998.
PACKAGING
Article 10 Member States shall require that additives and premixtures may be marketed only in closed packages or closed containers. Member States shall require that packages or containers must be closed in such a way that the fastener is damaged on opening and cannot be re-used.
SAFEGUARD AND MEASURES
Article 11 1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives authorized or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision. 2. The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures. 3. Should the Commission consider that amendments to the Directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.
ADDITIVE LEVELS IN COMPLEMENTARY FEEDINGSTUFFS
Article 12 1. Member States shall require that supplementary feedingstuffs, diluted as specified, may not contain levels of the additives named in this Directive which exceed those fixed for complete feedingstuffs. 2. Member States may require that the levels of antibiotics, coccidiostats and other medicinal substances, growth promoters, D vitamins and antioxidants in supplementary feedingstuffs may exceed the maximum 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 antibiotics, D vitamins or growth promoters does not exceed five times the fixed maximum level; (b)supplementary feedingstuffs which are intended for certain species of animal and which a Member State is permitted to authorize to be made available within its territory to all users because of special feeding systems, provided that their level does not exceed: for antibiotics and growth promoters, 1000 mg/kg and, provided that the use of these substances is permitted, 2000 mg/kg in the case of cattle for fattening; for antioxidants, coccidiostats and other medicinal substances, five times the fixed maximum level; for D vitamins, 200000 IU/kg. Member States shall prescribe that if, in the manufacture of supplementary feedingstuffs, recourse is had to the possibility referred to in (a), the possibility referred to in (b) may not be made use of at the same time. 3. Where paragraph 2 is invoked, Member States shall require that the feedingstuff has one or more compositional characteristics (as regards, for example, proteins or minerals) which in practice ensure that the level of additives fixed for complete feedingstuffs is not exceeded and that the feedingstuff is not used for other species of animal.
RULES FOR THE DISTRIBUTION AND INCORPORATION IN FEEDINGSTUFFS OF ADDITIVES AND PREMIXTURES
Article 13 1. Member States shall require that certain additives covered by this Directive, premixtures prepared from those additives with a view to their being incorporated in compound feedingstuffs and compound feedingstuffs containing those premixtures may be put into circulation or used only by the establishments or intermediaries which meet the conditions laid down, as appropriate, in Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sectorOJ No L 332, 30. 12. 1995, p. 15.. 2. Member States shall require that: (a)additives referred to in Part A of Annex A may be supplied only by approved establishments: (i)to intermediaries or establishments which manufacture premixtures and which have been approved in accordance with the provisions 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 establishments which manufacture compound feedingstuffs with a view to putting them into circulation or for the exclusive requirements of their holding and which have been approved in accordance 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 premixtures and 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: intermediaries which have been approved in accordance with the provisions laid down in Article 3 of the above Directive, or establishments which manufacture compound feedingstuffs with a view to putting them into circulation or for the exclusive requirements of their holding and which have been registered in accordance with the provisions laid down in Article 7 (2) (c) or (d) respectively of the said Directive or, as appropriate, approved in accordance with the provisions laid down in Article 2 (2) (c) or (e) of this Directive. 3. Member States shall require that additives referred to in Annex A (a) and (B) may be incorporated in compound feedingstuffs only if they have been prepared beforehand in the form of premixtures containing a carrier substance by establishments which meet the conditions laid down in Article 2 (2) (b) of Directive 95/69/EC. Such premixtures may be incorporated in compound feedingstuffs only in a proportion of at least 0,2 % by weight. By way of derogation from the first subparagraph, Member States may allow premixtures to be incorporated in compound feedingstuffs in a proportion as low as 0,05 % by weight, provided that the quantitative and 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 homogeneous distribution of premixtures and observing the additive levels set for 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: "Manufacturers of compound feedingstuffs authorized to use a minimum proportion of 0,05 % by weight of premixtures". 4. By way of derogation from paragraph 2, Member States shall require that: (a)additives referred to in Annex A (B) may be supplied to approved intermediaries or registered establishments which manufacture compound feedingstuffs for pets and fulfil the conditions laid down, as appropriate, in Article 3(1) or Article 7(2)(c) or (d) of Directive 95/65/EC; (b)additives referred 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 direct addition to feedingstuffs, and the manufacturer of compound feedingstuffs is approved in accordance with Article 2 (2) (c) of the above Directive for the additives referred to in Annex A (A) or is registered in accordance with Article 7 (2) (c) of the above Directive for the additives referred to in Annex A (B), and it has been checked on the spot that the manufacturer is in possession of the appropriate technology defined in Chapter I (3) (b) or Chapter II (c) of the Annex to the above Directive in order to add the preparation in question directly to the compound feedingstuff.Such manufacturers shall appear on the national list under a special heading as follows: "Manufacturers of compound feedingstuffs referred to in point (b) authorized to add antibiotics, cocciodiostats and other medicinal substances, and growth promoters directly to compound feedingstuffs" or "Manufacturers of compound feedingstuffs authorized to add copper, selenium and vitamins A and D directly to compound feedingstuffs". 5. By way of derogation from Article 7 of Directive 95/69/EC and paragraphs 1 and 2 of this Article, Finland and, as regards that part of its territory situated to the north of latitude 60°, Sweden shall be authorized, in view of the special feeding conditions on their farms, to allow premixtures of vitamins, provitamins and chemically well-defined substances having similar effect to be supplied to stock farmers for direct addition to feed materials of 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 of fodder used, and special measures are taken by Finland and Sweden to monitor use of such premixtures. 6. Paragraphs 1 to 3 shall apply without prejudice to Article 4(2) and Article 9(2) of Directive 95/69/EC.
LABELLING OF ADDITIVES
Article 14 1. Member States shall require that authorized additives may be put into circulation for use in feedingstuffs only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: A.for all additives, with the exception of enzymes and micro-organisms: (a)the specific name given to the additive upon authorization, the EC registration number of the additive and, in the case of an additive 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 referred to in this paragraph; (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 establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment or the intermediary pursuant to Article 10 of the above Directive. B.In addition, with regard to: (a)antibiotics, growth promoters, coccidiostats and other medicinal substances: the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars in the label, the active-substance level, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where appropriate, a safety recommendation regarding use in the case of additives 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 manufacture; (c)vitamins, other than vitamin E, provitamins and substances having a similar effect: the active-substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture; (d)trace elements, colourants including pigments, preserving agents and other additives, with the exception of those belonging to the enzyme and micro-organism groups: the active-substance level. C.For additives belonging to the groups: (a)of enzymes: the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorization given, the International Union of Biochemistry identification number, units of activityUnits of activity expressed in micromoles of product released per minute, per gram of enzyme preparation. (units of activity per gram or units of activity per millilitre), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible 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 the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended 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 accordance 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 authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate indication of special significant characteristics due to the manufacturing 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 name and the address or registered place of business of the person responsible 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 the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where applicable, safety recommendations as provided 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 an indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling 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 required by 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 the particulars on the label, the directions for use and, where appropriate, a safety recommendation regarding use. 3. Member States shall 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 States shall require that premixtures may be marketed only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: A.For all premixtures: (a)the description "premixture"; (b)directions for use, and any safety recommendations regarding the use of the premixtures; (c)the animal species or category of animals for which the premixture is intended; (d)the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph; (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 establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment or the intermediary pursuant to Article 10 of the above Directive. B.In addition, for the premixtures incorporating the additives listed below: (a)antibiotics, growth promoters, coccidiostats and other medicinal substances: the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the details on the label, specific name given to the additive upon authorization, active substance level and expiry date of the guarantee of that level, or storage life from the 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 is fixed for complete feedingstuffs on authorization of the additive; (c)colourants, including pigments: specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (d)vitamin E: specific name given to the additive upon authorization, alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture; (e)vitamins other than vitamin E, provitamins and substances having a similar effect: specific name given to the additive upon 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 authorization, and level of the various elements insofar as a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (g)preserving agents: specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs upon authorization of the additive; (h)enzymes: the specific name of the active component(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 (activity units per g or activity units per ml), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of 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, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, indication 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 accordance 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's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee of the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive; (j)other additives belonging to the groups referred to in (b) or (i) for which no maximum level is laid down and additives belonging to other groups authorized: specific name given to the 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 official methods of analysis or, failing this, by valid scientific methods. 2. Member States shall require that: (a)the specific name of additives may be accompanied by the tradename; (b)the name of the producer of the additives referred 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's EC registration number. 3. Where, pursuant to paragraph 1, the expiry date of the guarantee or storage life from the date of manufacture of several additives belonging to the same group or different groups has to be stated, Member States shall require that a single date of guarantee or a single reference to the storage life may be indicated for all the additives, namely the deadline which will be reached first. 4. Member States shall require that information other than that required or authorized pursuant to paragraphs 1 to 3 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars.
Article 16 1. Member States shall require that feedingstuffs incorporating the additives belonging to the groups listed below may be put into circulation only if the following particulars, which must be clearly visible, readily legible and indelible and must place responsibility on the producer, packer, importer, seller or distributor established within the Community, are given on the package, the container or a label affixed thereto: (a)for 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 the guarantee of that level or storage life from the date of manufacture, the approval number assigned to the establishment in accordance with 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 the additive 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 authorization, the alpha-tocopherol level and the expiry date of the guarantee of that level or storage life from the date of manufacture; (e)for vitamins A and D: the specific 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 authorization 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 (activity units per kilogram or activity unit per litre), the EC registration number of the additive, the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive; (i)for micro-organisms: the identification of the strain(s) in accordance with the authorization given, the file number of the strain(s), the number of colony-forming units (CFU/kg), the EC registration number of the additive, the expiry date of the guarantee or the storage life from the date of manufacture and, where applicable, indication of any particular significant characteristic due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive. 2. In addition to the particulars provided for by paragraph 1, particulars concerning the proper use of the feedingstuffs may be laid down in the authorization of the additive in accordance with the procedure provided 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 vitamins A, D and E, provitamins and additives having a similar effect may be indicated if the amounts of these substances can be determined by official methods of analysis or, failing this, by valid scientific methods of analysis. In such cases the following details shall be given: (a)for trace elements other than copper: the specific name of the additive in accordance with the authorization given and level of the various elements; (b)for vitamins other than vitamins A, D and E, provitamins and substances having a similar chemical effect: the specific name of the additive in accordance with the authorization given, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture; 4. Member States shall require that: (a)the details provided for in paragraphs 1 to 3 shall be printed close to the particulars which have to appear on the package, container or the label affixed thereto in accordance with Community rules on feedingstuffs; (b)where a level or a quantity is stated pursuant to paragraphs 1 to 3, such statement shall refer to the amount of additive incorporated in the feedingstuff; (c)the details of additives may be accompanied by the EC registration number of the additive or the trade name where those particulars are 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 additives belonging 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 indicated for all the additives, namely the deadline which will be reached first. 6. In the case of feedingstuffs distributed by road tankers or similar vehicles or in bulk, the details provided for in paragraphs 1 to 3 shall be 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 a suitable notice. 7. Member States shall require that, in the case of pet foods containing colourants, preservatives or substances having antioxidant effects and put up in packages having a net weight of not more than 10 kilograms, it shall be sufficient for the package to bear the words "coloured with", or "preserved with", or the words "with antioxidant" as appropriate, followed by the words "EC additives", provided that: (a)the package, container or label bears a reference number by means of which the feedingstuff may be identified, and (b)the manufacturer gives, on request, the specific name, or names, of the additive or additives used. 8. Any reference to additives other than in the form provided for in this Directive shall be prohibited.
Article 16a Articles 14 to 16 referring to the approval and registration numbers provided for in Directive 95/69/EC shall apply from 1 April 2001.
Article 17 1. Without prejudice to the provisions of Directive 79/373/EECOJ No L 86, 6. 4. 1979, p. 30., Member States shall require that supplementary feedingstuffs which contain additives in excess of the maximum levels fixed for complete feedingstuffs may be placed on the market only if the directions for use state, according to the species and age of the animal, the maximum quantity in grams or kilograms of supplementary feedingstuff to be given per animal per day. This information must be in accordance with the 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 is correctly followed, the proportion of additives does not exceed the maximum level fixed for complete feedingstuffs.
Article 18 Where feedingstuffs are marketed in other Member States the details referred to in Articles 14 to 17 shall be given in at least one of the official languages of the country of destination.
Article 19 Member States shall ensure that additives, premixtures and feedingstuffs which conform to this Directive are subject only to the marketing restrictions provided for in this 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 additives used and to verify that the other conditions laid down in this Directive are satisfied. To this end, they shall require in particular that undertakings which intend to manufacture additives or to put them on the market must first inform the competent authorities thereof. 2. Under the procedure provided for in Article 23, margins of tolerance may be fixed, to be allowed where there is a discrepancy between the result of the official check and the stated content of the additive in the compound feedingstuff.
MONITORING OF UNDESIRABLE INTERACTIONS
Article 21a Where there is found to be unforeseen undesirable interaction between additives referred to in Article 2 (aaa) and other additives or veterinary medicines, Member States shall require that the person responsible for putting the additive into circulation, or his representative within the Community where additives originate in third countries, gathers all the relevant information and forwards it to the competent authorities.
EXPORTS TO THIRD COUNTRIES
Article 22 This Directive shall not apply to additives, premixtures and feedingstuffs which are shown, at least by an appropriate indication, to be for export to third countries.
IMPLEMENTATION POWERS OF THE COMMISSION
Article 23 1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay be (SIC! by) the chairman, either on his own initiative or at the request of a Member State, to the Standing Committee for Feedingstuffs, hereinafter called "the Committee". 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty 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 States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the 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 has not adopted any measures within three months of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.
Article 24 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee without delay by the chairman, either on his own initiative or at the request of a Member State. 2. The 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 by the majority laid down in Article 148 (2) of the Treaty 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 States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the 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 has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.
FINAL PROVISIONS
Article 25 A decision on the transfer of antibiotics, coccidiostats and other medicinal substances, together with preparations based on these products, to Directive 81/851/EEC and to future rules on medicinal feedingstuffs shall be adopted by the Council acting unanimously on a proposal from the Commission once the degree of harmonization with regard to the free movement of products in the sector of veterinary medicinal products and medicated feedingstuffs has reached a level comparable to that obtaining with regard to additives.
Article 26 Member States shall, within two years following notification thereof, bring into force the laws, regulations, or administrative provisions necessary to comply with this Directive. They shall forthwith inform the 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 or prohibition of the use of the additives listed above, and by 31 December 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 of the Community; derogate, until 31 December 1991, from the labelling provisions in Articles 14, 15 and 16 for the additives, additive pre-mixtures and compound feedingstuffs to which additives have been added, produced in the territory in question.
Article 27 This Directive is addressed to the Member States.
null ANNEX I
According to the method of analysis of the British Pharmacopeia (Veterinary 1985) Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-4, Springer Verlag 1984. A.Antibiotics B.Antioxidants C.Aromatic and appetizing substances D.Coccidiostas and other medicinal substances E.Emulsiflers, stabilizers, thickeners and gelling agents F.Colouring matters including pigments G.Preservatives
EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions
mg/kg of complete feedingstuff mg/kg of complete feedingstuff
E 700 Bacitracin zinc C66H103O16N17SZn (polypeptide containing 12 to 20 % zinc) Laying hens 15 100
Turkeys 4 weeks 5 50
26 weeks 5 20
Other poultry, excluding ducks, geese, pigeons 4 weeks 5 50
16 weeks 5 20
Calves, lambs, kids 16 weeks 5 50
6 months 5 20
6 months 5 80 Milks replacers only
Piglets 4 months 5 50
3 months 5 80 Milks replacers only
Pigs 6 months 5 20
Animals bred for fur excluding rabbits 5 20
E 710 Spiramycin I C43H74O14N2II C45H76O15N2III C46H78O15N2(makrolide) base Turkeys 26 weeks 5 20
Other poultry excluding ducks, geese, laying hens, pigeons 16 weeks 5 20
Calves, lambs, kids 16 weeks 5 50
6 months 5 20
6 months 5 80 Milks replacers only
Piglets 4 months 5 50
3 months 3 80 Milks replacers only
Pigs 6 months 5 20
Animals bred for fur excluding rabbits 5 20
E 711 Virginiamycin I C28H35O7N3II C43H49O10N7 Turkeys 26 weeks 5 20
Other poultry excluding ducks, geese, laying hens, pigeons 16 weeks 5 20
Piglets 4 months 5 50
Pigs 6 months 5 20
Calves 16 weeks 5 50
6 months 5 20
6 months 5 80 Milks replacers only
Laying hens 20 20
Cattle for fattening 15 40 Indicate in the instructions for use: "The quantity of virginiamycin in the daily ration must not exceed 140 mg for 100 kg of bodyweight and 6 mg for each additional 10 kg of bodyweight"
E 712 Flavophospholipol C70H124O40N6P Laying hens 2 5
Turkeys 26 weeks 1 20
Other poultry excluding ducks, geese, pigeons 16 weeks 1 20
Piglets 3 months 10 25 Milks replacers only
Pigs 6 months 1 20
Animals bred for fur excluding rabbits 2 4
Calves 6 months 6 16
6 months 8 16 Milks replacers only
Cattle for fattening 2 10 Indicate in the instructions for use: "The quantity of flavophospholipol in the daily ration must not exceed 40 mg for 100 kg of bodyweight and 1,5 mg for each additional 10 kg of bodyweight"
Rabbits 2 4
E 713 Tylosin phosphate Macrolide product of Streptomyces frodiae Piglets 4 months 10 40 The minimum and maximum contents are expressed as tylosing base
Composition of antibiotic factors: a)Tylosin C46H77NO17: min. 80 % b)Desmycosin C39H65NO14 c)Macrocin C45H75NO17 d)Relomycin C46H79NO17a) + b) + c) + d): min. 95 % Pigs 6 months 5 20
E 714 Monensin-sodium C36H61O11Na (sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis) Cattle for fattening 10 40 Indicate in the instructions for use: "The quantity of monensin sodium in the daily ration must not exceed 140 mg for 100 kg of bodyweight and 6 mg for each additional 10 kg of bodyweight.Dangerous for equines" This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated
E 715 Avoporcin C53H6O30N6Cl3 (glycopeptide) Chickens for fattening 7,5 15
Turkeys for fattening 16 weeks 10 20
Piglets 4 months 10 40
Pigs 6 months 5 20
Calves 6 months 15 40
Cattle for fattening 15 30 Indicate in the instructions for use: "The quantity of avoparcin in the daily ration must not exceed 103 mg for 100 kg of bodyweight and 4,3 mg for each additional 10 kg of bodyweight"
Lambs from the beginning of rumination with the exception of posturegrazed lambs 16 weeks 10 20
E 716 Salinomycin sodium C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus)Elaiophylin content: less than 42 mg per kg of Salinomycin sodium17-epi-20-desoxy-salinomycin content: less than 40 mg per kg of Salinomycin sodium Piglets 4 months 30 60 Indicate in the instructions for use "Dangerous for equines"; "This feedingstuff contains on ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated."
Pigs 6 months 15 30
E 717 Avilamycin C57-62H82-90Cl1-2O31-32 (Mixture of oligosaccharides of the orthosomycin group produced by Strepomyces viridochromogenes) Piglets 4 months 20 40
Pigs 6 months 10 20
Chickens for fattening 2,5 10
E 300 L-ascorbic acid C6H8O6 All species or categories of animals All feedingstuffs
E 301 Sodium L-ascorbate C6H7O6Na
E 302 Calcium L-ascorbate C12H14O12Ca.2H2O
E 303 5,6-Diacetyl-L-ascorbic acid C10H12O8
E 304 6-Palmityl-L-ascorbic acid C22H38O7
E 306 Tocopherol-rich extracts of natural origin
E 307 Synthetic alphatocopherol C29H50O2
E 308 Synthetic gammatocopherol C28H48O2
E 309 Synthetic deltatocopherol C27H46O2
E 310 Propyl gallate C10H12O5 100:aloneortogether
E 311 Octyl gallate C15H22O5
E 312 Dodecyl gallate C19H30O5
E 320 Butylated hydroxyanisole(BHA) C11H16O2 150:aloneortogether
E 321 Butylated hydroxytoluene(BHT) C15H24O
E 324 Ethoxyquin C14H19ON
1. All natural products and corresponding synthetic products All species or categories of animals
2. Artificial substances:
E 954(i) Saccharin C7H5NO3S Piglets 4 months 150
E 954(ii) Calcium saccharin C7H3NCaO3S Piglets 4 months 150
E 954(iii) sodium saccharin C7H4NNaO3S Piglets 4 months 150
E 959 Neohesperidine dihydrochalcone C28H36O15 Piglets 4 months 35
Dogs 35
Calves 30
Ovines 30
E 750 Amprolium 1-[(4-amino-2-propylpyrimidin-5-yl) methyl]-2-methyl-pyridinium chloride hydrochloride Poultry 62,5 125 Use prohibited from laying age onwards and at least 3 days before slaughter respectively
E 751 Amprolium/ethopabate (mixture of 25 parts of (a) amprolium and 1,6 parts of (b) ethopabate) a) 1-[4-amino-2-propylpyrimidin-5-yl) methyl]-2-methylpyridinium chloride hydrochloride Chickens, turkeys and guinea-fowl 66,5 133 Use prohibited from laying age onwards and at least 3 days before slaughter respectively
b) Methyl-4-acetamido-2-ethoxybenzoate
E 752 Dinitolmide(DOT) 3,5-dinitro-2-toluamide Poultry 62,5 125 Use prohibited from laying age onwards and at least 3 days before slaughter respectively
E 754 Dimetridazole 1,2-dimethyl-5-nitroimidazole Turkeys 100 200 Use prohibited from laying age onwards and at least 6 days before slaughter respectively
Guinea-fowl 125 150 Use prohibited from laying age onwards and at least 6 days before slaughter respectively
E 755 Meticlorpindol 3,5-dichloro-2,6-dimethylpyridin-4-ol Chickens for fattening, guinea-fowl 125 125 Use prohibited from laying age onwards and at least 6 days before slaughter respectively
Rabbits 125 200 Use prohibited at least 5 days before slaughter
E 756 Decoquinate 3-ethoxycarbonyl-4-hydroxy-6-decyloxy-7-ethoxyquinoline Chickens for fattening 20 40 Use prohibited at least 3 days before slaughter
E 757 Monensin-sodium C36H61O11Na (sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis) Chickens for fattening 100 125 Use prohibited at least 3 days before slaughter Indicate in the instructions for use: "Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated"
Chickens reared for laying 16 weeks 100 120 Indicate in the instructions for use "Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated"
Turkeys 16 weeks 90 100 Use prohibited at least 3 days before slaughter Indicate in the instructions for use: "Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated"
E 758 Robenidine 1,3-bis[(4-chlorobenzylidene)-amino]-guanidine hydrochloride Chickens for fattening, turkeys 30 36 Use prohibited at least 5 days before slaughter
Rabbits for fattening 50 66 Use prohibited at least 5 days before slaughter
Rabbits for breeding purposes 50 66 Use prohibited at least five days before slaughter
E 759 Ronidazole (1-methyl-5-nitroimidazol-2-yl)methylcarbamate Turkeys 60 90 Use prohibited from laying age onwards and least 6 days before slaughter respectively
E 760 Ipronidazole 1-methyl-2-isopropyl-5-nitroimidazole Turkeys 50 85 Use prohibited from laying age onwards and at least 6 days before slaughter respectively
E 761 Meticlorpindol/methylbenzoquate: (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate) a) 3,5-dichloro-2,6-dimethyl-pyridin-4-ol Chickens for fattening 110 110 Use prohibited at least 5 days before slaughter
b) 7-benzyloxy-6-butyl-3-methoxycarbonyl-4-quinolone Chickens reared for laying 16 weeks 110 110
Turkeys 12 weeks 110 110 Use prohibited at least 5 days before slaughter
E 762 Arprinocid 9-(2-chloro-6-fluorobenzyl) adenine Chickens for fattening 60 60 Use prohibited at least 5 days before slaughter
Chickens reared for laying 16 weeks 60 60
E 763 Lasalocid sodium C34H53O8Na (sodium salt of polyether monocarboxylic acid produced by Streptomyces lasaliensis) Chickens for fattening 75 125 Use prohibited at least 5 days before slaughter. Indicate in the instructions for use: "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra indicated"
Chickens reared for laying 16 weeks 75 125
Turkeys 12 weeks 90 125 Use prohibited at least five days before slaughterIndicate in the instructions for use: "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances can be contra-indicated"
E 764 Halofuginone dl-trans-7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidyl) acetonyl]-quinazolin-4-(3H)-one hydrobromide Chickens for fattening 2 3 Use prohibited at least 5 days before slaughter
Turkeys 12 weeks 2 3 Use prohibited at least 5 days before slaughter
E 765 Narasin C43H72O11 (polyether of monocarboxylic acid produced by Streptomyces aureofaciens) Chickens for fattening 60 70 Use prohibited at least 5 days before slaughter Indicate in the instructions for use:"Dangerous for equines.This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra-indicated"
E 766 Salinomycin sodium C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus)Elaiophylin content: less than 42 mg per kg of Salinomycin sodium17-epi-20-desoxy-salinomycin content: less than 40 mg per kg of Salinomycin sodium Chickens for fattening 50 70 Use prohibited at least 5 days before slaughter Indicate in the instructions for use:"Dangerous for equines.This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated."
E 768 Nicarbazin Equimolecular complex of 1,3-bis (4-nitrophenyl) urea and 4,6-di methyl pyrimidin-2-ol Chickens for fattening 4 weeks 100 125 Use prohibited at least 9 days before slaughter
E 769 Nifursol 3,5-dinitro-N1-(5-nitrofurfurylidene) salicylohydrazide Turkeys 50 75 Use prohibited at least 5 days before slaughter
Minimum purity: 98 % on an anhydrous basis. Particular features of the three authorized preparations of the three authorized preparations: maximum nifursol content: 14,6 %, 44 % or 50 % minimum stability: 24 months carrier for the three preparations: maize starch and, respectively, 12 %, 33 % or 34 % of soya bean oil Maximum amount of dust emitted during handling, as determined by the Stauber Heubach method: 0,1μg nifursol
E 770 Maduramicin ammonium C47H83O17N (ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis) Chickens for fattening 5 5 Indicate in the instructions for use "—Use prohibited at least five days before slaughter Dangerous for Equidae""This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra-indicated"
E 771 Diclazuril (+)-4-chlorphenyl (2,6-dichloro-4-(2,3.4,5-tetrohydro-3,5-dioxo-1,2,4-triazin-2-yl-phenyl) acetonitrile Chickens for fattening 1 1 Use prohibited at least five days before slaughter
E 772 Narasin/Nicarbazin(mixture of (a)narasin and (b)nicarbazin in a 1/1 ratio (a)C43H72O11 (polyether monocarboxylic acid produced by Streptomyces aureofaciens), in granular form (b)Equimolecular complex of 1,3 bis (4-nitrophenyl) urea and 4,6-dimethyl pyrimidin-2-ol, in granular form Chickens for fattening 80 100 Use prohibited at least five days before slaughter.Indicate in the instructions for use: "Dangerous for equines" "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra-indicated"
E 322 Lecithins All species or categories of animals All feedingstuffs
E 400 Alginic acid
E 401 Sodium alginate
E 402 Potassium alginate
E 403 Ammonium alginate All species or categories of animals with the exception of aquarium fish
E 404 Calcium alginate All species or categories of animals
E 405 Propane-1,2-diol alginate (Propyleneglycol alginate)
E 406 Agar
E 407 Carrageenan
E 408 Furcelleran
E 410 Locust bean gum (Carob gum)
E 411 Tamarind seed flour
E 412 Guar gum
E 413 Tragacanth
E 414 Acacia (Gum arabic)
E 415 Xanthan gum
E 418 Gellan gum Polytetrasaccharide containing glucose, glucuronic acid and rhamnose (2:1:1) produced by Pseudomonas elodea (ATCC 31466) Dogs, cats Only canned feedingstuffs
E 420 Sorbitol All species or categories of animals All feedingstuffs
E 421 Mannitol
E 422 Glycerol
E 432 Polyoxyethylene (20)-sorbitan monolaurate 5000(aloneorwiththeotherpolysorbates) Milks replacers only
E 433 Polyoxyethylene (20)-sorbitan Monooleate
E 434 Polyoxyethylene (20)-sorbitan monopalmitate
E 435 Plyoxyethylene (20)-sorbitan monostearate
E 436 Polyoxyethylene (20)-sorbitan tristearate
E 440 Pectins All species or categories of animals All feedingstuffs
E 450 b(i) Pentasodium triphosphate Dogs, cats 5000
E 460 Microcrystalline cellulose All species or categories of animals
E 460 (ii) Cellulose powder
E 461 Methylcellulose All species or categories of animals All feedingstuffs
E 462 Ethylcellulose
E 463 Hydroxypropylcellulose
E 464 Hydroxypropylmethylcellulose
E 465 Ethylmethylcellulose
E 466 Carboxymethylcellulose (sodium salt of carboxymethyl ether of cellulose)
E 470 Sodium, potassium and calcium salts of edible fatty acid, alone or in mixtures, derived either from edible fats or from distilled edible fatty acids
E 471 Mono- and diglycerides of fatty acids
E 472 Mono- and diglycerides of edible fatty acids esterified with the following acids
a) acetic
b) lactic
c) citric
d) tartaric
e) mono- and diacetyltartaric
E 473 Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)
E 474 Sucroglycerides (mixture of esters of saccharose and mono- and diglycerides of edible fatty acids)
E 475 Polyglycerol esters of non-polymerized edible fatty acids
E 477 Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters
E 480 Stearoyl-2-lactylic acid
E 481 Sodium stearoyl-2-lactylate
E 482 Calcium stearoyl-2-lactylate
E 483 Stearyl tartrate
E 484 Glyceryl polyethylene-glycol ricinoleate
E 486 Dextrans
E 487 Ployethyleneglycol ester of fatty acids from soya oil Calves 6000
E 488 Polyoxyethylated glyceride of tallow fatty acids Calves 5000 Milks replacers only
E 489 Ether of polyglycerol and of alcohols obtained by the reduction of oleic and palmitic acids Calves 5000
E 490 Propane-1,2-diol Dairy cows 12000 All feedingstuffs
Cattle for fattening, calves, lambs, kids, pigs, poultry 36000
E 491 Sorbitan monostearate All species or categories of animals
E 492 Sorbitan tristearate
E 493 Sorbitan monolaurate
E 494 Sorbitan monooleate
E 495 Sorbitan monopalmitate
E 496 Polyethyleneglycol 6000 300
E 497 Polyoxypropylene-polyoxyethylene polymers (M. W.6800-9000) 50
E 498 Partial polyglycerol esters of polycondensed fatty acids of castor oil Dogs
E 499 Cassia gum Dogs and cats 17600 Canned feedingstuffs only
1. Carotenoids and xanthophylls:
E 160c Copsanthin C40H56O3 Poultry 80(aloneorwiththeothercarotenoidsandxanthophylls
E 160e Beta-apo-8′-carotenal C30H40O
E 160f Ethyl ester of beta-apo-8′-carotenoico acid C32H44O2
E 161b Lutein C40H56O2
E 161c Cryptoxanthin C40H56O
E 161g Canthoxanthin C40H52O2 (a) Poultry
(b) Salmon, trout 80 Use permitted from the age of six months onwards.The mixture of canthaxanthin with astaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff
c) Dogs, cats and ornamental fish
E 161h Zeaxanthin C40H56O2 Poultry 80(aloneorwiththeothercarotenoidsandxanthophylls)
E 161i Citranaxanthin C33H44O Laying hens
E 161j Astaxanthin C40H52O4 a) Salmons, trout 100 Use only permitted from the age of six months onwards.The mixture of astaxanthin with contaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff
b) Ornamental fish
2. Other colourants:
E 102 Tartrazine C16H9N4O9S2Na3 Ornamental fish
E 110 Sunset yellow FCF C16H10N2O7S2Na2
E 124 Ponceau 4 R C20H11N2O10S3Na3
E 127 Erythrosine C20H6I4O5Na2H2O
E 131 Patent Blue V Calcium salt of the disulphonic acid of m- hydroxytetraethyldiamino triphenylcarbinol anhydride a) All species or categories of animals with the exception of dogs and cats Permitted in animal feedingstuffs only in products processed from: i)waste products of feedingstuffs; ii)denatured cereals or manioc flour; or iii)other base substances denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture
b) Dogs and cats
E 132 Indigotine C16H8N2O8S2Na2 Ornamental fish
E 141 Chlorophyll copper complex Ornamental fish
E 142 Acid brilliant green BS (Lissamine green) Sodium salt of 4,4′-bis (dimethylamino) diphenylmethylene-2-naphtol-3,6-disulphonic acid a) All species or categories of animals with the exception of dogs, cats and ornamental fish Permitted in animals feedingstuffs only in products processed from: i)waste products of foodstuffs: ii)denatured cereals or manioc flour; or iii)other base substances denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture
b) Dogs, cats and ornamental fish
E 153 Carton black C Ornamental fish
E 160 B Bixin C25H30O4
E 172 Iron oxide, red Fe2O3
3. Colouring agents authorized for colouring foodstuffs by Community rules, other than Patent blue V and Acid brilliant green BS a) All species or categories of animals with the exception of dogs and cats Permitted in animal feedingstuffs only in products processed from: i)waste products of foodstuffs; or ii)other base substances, with the exception of cereals and manioc flour, denatured by means of these agents of coloured during technical preparation to ensure the necessary identification during manufacture
b) Dogs and cats
E 200 Sorbic acid C6H8O2 All species or categories of animals All feedingstuffs
E 201 Sodium sorbate C6H7O2Na
E 202 Potassium sorbate C6H7O2K
E 203 Calcium sorbate C12H14O4Ca
E 214 Ethyl 4-hydroxybenzoate C9H10O3 Pets
E 215 Sodium ethyl 4-hydroxybenzoate C9H9O3Na
E 216 Propyl 4-hydroxybenzoate C10H12O3
E 217 Sodium propyl 4-hydroxybenzoate C10H11O3Na
E 218 Methyl 4-hydroxybenzoate C8H8O3
E 219 Sodium methyl 4-hydroxybenzoate C8H7O3Na
E 222 Sodium bisulphite NaHSO3 Dogs, cats aloneortogether:500expressedasSO2 All feedingstuffs except unprocessed meat and fish
E 223 Sodium metabislphite Na2S2O5
E 236 Formic acid CH2O2 All species or categories of animals All feedingstuffs
E 237 Sodium formate CHO2Na
E 238 Calcium formate C2H2O4Ca
E 240 Formaldehyde CH2O Pigs 6 months Skimmed milk only: maximum content: 600 mg/kg
All species or categories of animals For silage only
E 250 Sodium nitrate NaNO2 Dogs, cats 100 Canned feedingstuffs only
E 260 Acetic acid C2H4O2 All species or categories of animals All feedingstuffs
E 261 Potassium acetate C2H3O2K
E 262 Sodium diacetate C4H7O4Na
E 263 Calcium acetate C4H6O4Ca
E 270 Lactic acid C3H6O3
E 280 Propionic acid C3H6O2
E 281 Sodium propionate C3H5O2Na
E 282 Calcium propionate C6H10O4Ca
E 283 Potassium propionate C3H5O2K
E 284 Ammonium propionate C3H9O2N
E 285 Methylpropionic acid C4H8O2 Ruminants, at the beginning of rumination 1000 4000
E 295 Ammonium formate CH5O2N All species or categories of animals All feedingstuffs
E 296 DL-malic acid C4H6O5
E 297 Fumaric acid C4H4O4
E 325 Sodium lactate C3H5O3Na
E 326 Potassium lactate C3H5O3K
E 327 Calcium lactate C6H10O6Ca
E 330 Citric acid C6H8O7
E 331 Sodium citrates
E 332 Potassium citrates
E 333 Calcium citrates
E 334 L-Tartaric acid C4H6O6
E 335 Sodium L-tartrates
E 336 Potassium L-tartrates
E 337 Potassium sodium L-tartrate C4H4O6KNa.4H2O
E 338 Orthophosphoric acid H3PO4
E 490 Propane-1,2-diol C3H8O2 Dogs 53000
E 507 Hydrochloric acid HCl All species or categories of animals For silage only
E 513 Sulphuric acid H2SO4
H.Vitamins, provitamins and chemically well defined substances having a similar effect
EEC No Additive Chemical formula, description Species or category of animal Maximum age Maximum content iu/kg of complete feedingstuff or of the daily ration Other provisions
E 672 1. Vitamin A Chickens for fattening 13500 All feedingstuffs except feedingstuffs for young animals
Ducks for fattening 13500
Turkeys for fattening 13500
Lambs for fattening 13500
Pigs for fattening 13500
Bovines for fattening 13500
Calves for fattening 25000 Only milk replacers
Other species or categories of animals All feedingstuffs
2. Vitamin D
E 670 Vitamin D2 Pigs 2000 Simultaneous use of vitamin D3, prohibited
Piglets 10000 Milk replacers only
Bovines 4000
Ovines 4000
Calves 10000 Milk replacers only
Equines 4000
Other species or categories of animals with the exception of poultry and fish 2000
E 671 1. Vitamin D3 Pigs 2000 Simultaneous use of vitamin D2 prohibited
Piglets 10000 Milk replacers only
Bovines 4000
Ovines 4000
Calves 10000 Milk replacers only
Equines 4000
Chickens for fattening 5000
Turkeys 5000
Other Poultry 3000
Fish 3000
Other species or categories of animals 2000
3. All substances in the group except vitamins A and D All species or categories of animals All feedingstuffs
I.Trace elements
EEC No Element Additive Chemical formula Maximum content of the element in mg/kg of the complete feedingstuff Other provisions
E 1 Iron — Fe 1250 (total)
Ferrous carbonate FeCO3
Ferrous chloride, tetrahydrate FeCl2.4H2O
Ferric chloride, hexahydrate FeCl3.6H2O
Ferrous citrate, hexahydrate Fe3(C6H5O7)2.6H2O
Ferrous fumarate FeC4H2O4
Ferrous lactate, trihydrate Fe(C3H5O3)2.3H2O
Ferric oxide Fe2O3
Ferrous sulphate, monohydrate FeSO4H2O Permitted: i)in denatured skimmed milk and in compound feedingstuffs manufactured from denatured skimmed-milk powder: subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed-milk powder ii)in compound feedingstuffs other than those listed under (i)
Ferrous sulphate, heptahydrate FeSO4.7H2O Permitted: i)in denatured skimmed milk and in compound feedingstuffs manufactured from denatured skimmed milk powder: subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed milk powder ii)in compound feedingstuffs other than those listed under (i)
Ferrous chelate of amino acids hydrate Fe.(×)1-3nH2O (where × equals an anion of any amino acids derived from hydrolyzed soya protein) molecular weight not exceeding 1500
E 2 Iodine-I Calcium iodate hexahydrate Ca(IO3)2.6H2O Equines: 4 (total)Fish: 20 (total)Other species or categories of animal: 10 (total)
Calcium iodate, anhydrous Ca(IO3)2
Sodium iodide NaI
Potassium iodide KI
E 3 Cobalt — Co
Cobaltous acetate, tetrahydrate Co(CH3COO)2.4H2O 10 (total)
Basic cobaltous carbonate, monohydrate 2CoCO3.3Co(OH)2.H2O
Colbaltous chloride, hexahydrate CoCl2.6H2O
Cobaltous sulphate, heptahydrate CoSO4.7H2O
Cobaltous sulphate, monohydrate CoSO4.H2O
Cobaltous nitrate, hexahydrate Co(NO3)2.6H2O
E 4 Copper — Cu Cupric acetate, monohydrate Cu(CH3COO)2.H2O Pigs for fattening: in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land: up to 16 weeks: 175 (total) from 17th week up to slaughter: 35 (total) In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land: up to 16 weeks: 175 (total) from 17th week up to six months: 100 (total) over six months up to slaughter: 35 (total)Breedings pigs: 35 (total)Calves: milk replacers: 30 (total) other complete feedingstuffs: 50 (total)Ovines: 15 (total)Other species or categories of animals: 35 (total)
Basic cupric carbonate, monohydrate CuCO3.Cu(OH)2.H2O
Cupric chloride, dihydrate CuCl2.2H2O
Cupric methionate Cu(C5H10NO2S)2
Cupric oxide CuO
Cupric sulphate, pentahydrate CuSO4.5H2O
Cupric sulphate, monohydrate CuSO4.H2O Pigs for fattening: In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land: up to 16 weeks: 175 (total) from 17th week up to slaughter: 35 (total) In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land: up to 16 weeks: 175 (total) from 17th week up to six months: 100 (total) over six months up to slaughter: 35 (total)Breeding pigs: 35 (total)Ovines: 15 (total)Other species or categories of animals with the exception of calves: 35 (total) Denatured skimmed milk powder and compound feedingstuffs manufactured from denatured skimmed milk powder: Subject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 Declaration of the amount of copper added, expressed as the element on the label or package or the container of denatured skimmed milk powder
Cupric sulphate, pentahydrate CuSO4.5H2O
E 5 Manganese — Mn 250 (total)
Manganous carbonate MnCO3
Manganous chloride, tetrahydrate MnCl2.4H2O
Manganous hydrogen phosphate, trihydrate MnHPO4.3H2O
Manganous oxide MnO
Manganic oxide Mn2O3
Manganous sulphate, tetrahydrate MnSO4.4H2O
Manganous sulphate, monohydrate MnSO4.H2O
E 6 Zinc — Zn 250 (total)
Zinc lactate, trihydrate Zn(C3H5O3)2.3H2O
Zinc acetate, dihydrate Zn(CH3.COO)2.2H2O
Zinc carbonate ZnCO3
Zinc chloride, monohydrate ZnCl2.H2O
Zinc oxide ZnO Maximum content of lead: 600 mg/kg
Zinc sulphate, heptahydrate ZnSO4.7H2O
Zinc sulphate, monohydrate ZnSO4.H2O
E 7 Molybdenum — Mo 2,5 (total)
Ammonium molybdate (NH4)6Mo7O24.4H2
Sodium molybdate Na2MoO4.2H2
E 8 Selenium — Se 0,5 (total)
Sodium selenite Na2SeO3
Sodium selenate Na2SeO4
Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-524, Springer Verlag 1984. Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-4, Springer Verlag 1984. Milk replacers only.J.Growth promoters L.Binders, anti-caking agents and coagulants M.Acidity regulators
EEC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions
mg/kg of complete feedingstuff mg/kg of complete feedingstuff
E 850 Carbadox Methyl-3-(2-quinoxalinylmethylene) carbazateN1, N4-dioxide Piglets 4 months 20 50 Use prohibited at least 4 weeks before slaughter
Minimum purity: 96 %Characteristics of the authorized preparations: carbadox content: 5 or 10 % minimum stability: 24 months propionic acid: 0,5 % soya bean oil: 7 % soya bean mill run: up to 100 % Maximum amount of dust emitted during handlings as determined by the Stauber Heubach method: 0,1 μg carbadoxIndication on the label of the additives, premixtures and feedingstuffs of safety instructions and warnings designed to protect the health of operatives and in particular to avoid any exposure to the additive, especially by touch or inhalation
E 851 Olaquindox 2-[N-2′-(hydroxyethyl) carbamoyl]-3-methylquinoxaline-N1,N4-dioxyde Piglets 4 months 15 50 Use prohibited at least four weeks before slaughter
4 months 50 100
Minimum purity: 98 %Characteristics of the authorized preparation: olaquindox content: 10 % minimum stability: 24 months medium: calcium carbonate containing 1,5 % of glyceril polyethyleneglycol ricinoleate Maximum amount of dust emitted during handling as determined by the Stauber Heubach method: 0,1 μg olaquindox.Indication on the label of the additives, premixtures and feedingstuffs of safety instructions and warnings designed to protect the health of operatives and in particular to avoid any exposure to the additive, especially by touch or inhalation with the mention "Warning: Risk of photoallergy for people so predisposed"
E 330 Citric acid C6H8O7 All species or categories of animals All feedingstuffs. Compliance with the provisions of Article 16 (1) (g)
E 470 Sodium, potassium and calcium stearates C18H35O2Na,C18H35O2K andC36H70O4Ca All feedingstuffs
E 516 Calcium sulphate, dihydrate CaSO4.2H2O 30000
E 551a Silicic acid, precipitated and dried
E 551b Colloidal silica
E 551c Kieselgur (diatamaceous earth, purified)
E 552 Calcium silicate, synthetic
E 562 Sepiolite Hydrated magnesium silicate of sedimentary origin, containing at least 60 % sepiolite and a maximum of 30 % montmorillonite. Asbestos free 20000
E 554 Sodium aluminosilicate, synthetic
E 558 Bentonite/montmorillonite 20000 All feedingstuffs.Mixing with additives from the groups of "antibiotics", ‘growth promoters, coccidiostats and other medicinal substances is prohibited except in the case of:tylosin phosphate, monensin sodium, narasin, ipronidazole, lasalocid sodium, avoparcin, flavophospholipol, salinamycin sodium, ronidazole, virginiamycin, nicarbazin, robenidine, maduramicin ammonium Indication on the label of the specific name of the additive.
E 559 Kaolinitics clays, free of asbestos Naturally occuring mixtures of minerals containing at least 65 % complex hydrated aluminium silicates whose main constituent is kaolinite All feedingstuffs
E 560 Natural mixtures of steatite and chlorite Natural mixtures of steatite and chlorite, free of asbestos: minimum purity of the mixture: 85 %
E 561 Vermiculite Natural silicate of magnesium, aluminium and iron, expanded by heating, free of asbestosMaximum fluorine content: 0,3 %
E 563 Sepiolitic clay Hydrated magnesium silicate of sedimentary origin, containing at least 40 % sepiolite and 25 % illite. Asbestos free. 20000
E 565 Lignosulphonates
E 598 Synthetic calcium aluminates Mixture of calcium aluminates containing between 35 and 51 % of AI2O3 Poultry, rabbits and Pigs 20000
Maximum molybdenum content of 20mg/kg
E 599 Perlite Natural silicate of sodium and aluminium, expanded by heating, free of asbestos All species or categories of animals
E 170 Calcium carbonate Dogs, cats
296 DL- and L-malic acid
Ammonium dihydrogen orthophosphate
di Ammonium hydrogen orthophosphate
E 339(i) Sodium dihydrogen orthophosphate
E 339(ii) di Sodium hydrogen orthophosphate
E 339(iii) tri Sodium orthophosphate
E 340(i) Potassium dihydrogen orthophosphate
E 340(ii) di Potassium hydrogen orthophosphate
E 340(iii) tri Potassium orthophosphate
E 341(i) Calcium tetrahydrogen diorthophosphate
E 341(ii) Calcium hydrogen orthophosphate
E 350(i) Sodium malate (salt of DL- or L-Malic acid)
E 450a(i) di Sodium dihydrogen diphosphate
E 450a(iii) tetra Sodium diphosphate
E 450a(iv) tetra Potassium diphosphate
E 450b(i) penta Sodium triphosphate
E 450b(ii) penta Potassium triphosphate
500(i) Sodium carbonate
500(ii) Sodium hydrogen carbonate
500(iii) Sodium sesquicarbonate
501(ii) Potassium hydrogen carbonate
503(i) Ammonium carbonate
503 (ii) Ammonium hydrogen carbonate
507 Hydrochloric acid
510 Ammonium chloride
513 Sulphuric acid
524 Sodium hydroxide
E 525 Potassium hydroxide Dogs and cats
E 526 Calcium hydroxide Dogs and cats
529 Calcium oxide Dogs, cats
540 di Calcium diphosphate
ANNEX II
A.Antibiotics D.Coccidiostats and other medicinal substances F.Colouring matters including pigments G.Preservatives L.Binders, anti-caking agents and coagulants N.Enzymes O.Micro-organisms
No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Period of authorization
mg/kg of complete feedingstuff mg/kg of complete feedingstuff
22 Avoparcin C53H6O30N6Cl3 (Glycopeptide) Lambs from the beginning of rumination with the exception of pasture-grazed lambs 16 weeks 10 20 7. 4. 1993
Dairy cattle 4 10 Indicate in the instruction for use: "The quantity of avoparcin in the daily ration must must not exceed 100 mg and, for reasons of efficacy, must not be less than 50 mg" 8. 4. 1995
27 Salinomycin sodium C42H69O11Na (Sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus) Piglets 4 months 30 60 Indicate in the instructions for use: "Dangerous for equines" 30. 11. 1992
Pigs 6 months 15 30 30. 11. 1992
28 Avilamycin C57-62H82-90Cl1-2O31-32 (Mixtures of oligosaccharides of the orthosomycin group produced by Streptomyces viridochromogenes Piglets 4 months 20 40 30. 3. 1993
Pigs 6 months 10 20 30. 3. 1993
Chickens for fattening 2,5 10 19. 7. 1995
29 Efrotamycin C59H88N2O20 Piglets Four months 4 8 18. 4. 1996
Pigs Six months 4 6 18. 4. 1996
30 Virginiamycin I C28H35O7N3II C43H49O10N7 Sows 20 40 30. 11. 1996
31 Bacitracin zinc C66H103O16N17SZn (Polypeptide containing 12 to 20 % zinc) Chickens for fattening 5 50 30. 11. 1996
Pigs 6 months 5 50 30. 11. 1996
32 Ardacin C81 — 83H80 — 84Na2N8O30Cl4 (Glycopeptide)Na salt of 10 component complex:Factor A: 16-36 %Factor B: 15-30 %Components C+C1: 20-50 %Component C2: 5-14 %Component D: 0-5 %HP-4: 0-10 %produced by Kibdelosporangium aridum (ATCC 39323).Ardacin content in the authorized preparation: 25 % Chickens for fattening 3 7 30. 11. 1996
B.Antioxidants
16 Meticlorpindol/methyl-benzoquate: (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate) a)3,5-Dichloro-2,6-dimethyl-4-pyridinol b)7-benzyloxy-6-butyl-3-methoxycarbonyl-4-quinolone Rabbits 220 220 Use prohibited at least 5 days before slaughter 30. 11. 1992
20 Lasalocid sodium C34H53O8Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces lasaliensis) Turkeys 12 weeks 90 125 Use prohibited at least 5 days before slaughter Indicate in the instructions for use: "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra indicated" 30. 11. 1992
21 Maduramicin ammonium C47H83O17N (ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis) Chickens for fattening 5 5 Indicate in the instructions for use: Use prohibited at least 7 days before slaughter Dangerous for equines. "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra indicated"Mixture of maduramicin ammonium with bentonite montmorillonite is allowed 30. 3. 1993
22 Robenidine 1,3-bis[(4-chlorobenzylidene)-amino] guanidine hydrochloride Rabbits for breeding purposes 50 66 Use prohibited at least 5 days before slaughter 30. 3. 1994
23 Narasin/Nicarbazin (mixture of (a) narasin and (b) nicarbazin in a 1/1 ratio) (a)C43H72O11 (polyether of monocarboxylic acid produced by Streptomyces aureofaciens). (b)Equimolecular complex of 1,3-bis (4-nitrophenyl)-urea and 4,6-dimethylpyrimidin-2-ol. In granular form Chickens for fattening 80 100 Use prohibited at least 7 days before slaughterIndicate in the instructions for use: Dangerous for equinesThis feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated 30. 11. 1995
24 Diclazuril (+)-4-chlorphenyl [2,6-dichloro-4-(2,3,4,5-tetrophydro-3,5-dioxo-1,2,4-triazin-2-yl) phenyl] acetonitrile Chickens for fattening 1 1 Use prohibited at least 5 days before slaughter 30. 11. 1994
25 Halofuginone di-trans-7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidyl) acetonyl] quinazolin-4(3H)-one hydrobromide Chickens reared for laying 16 weeks 3 3 30. 11. 1996
26 Salinomycin sodium C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus) Elaiophylin content: less than 42 mg per kg of Salinomycin sodium 17-epi-20-desoxy-salinomycin content: less than 40 mg per kg of Salinomycin sodium Rabbits for fattening 20 25 Use prohibited at least five days before slaughterIndicate in the instructions for use: "Dangerous for equines" "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated" 30. 11. 1996
27 Diclazuril 2,6 dichloro-alpha-(4-chlorophenyl)-4-[4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl] benzeneacetonitrile Turkeys 12 weeks 1 1 Use prohibited at least five days before slaughter 30. 11. 1996
E.Emulsifers, stabilizers, thickeners and gelling agents
1. Carotenoids and xanthophylls
1 Canthaxanthin C40H52O2 Ornamental fish 30. 11. 1994
2 Astaxanthin C40H52O4 Ornamental fish 30. 11. 1994
2. Other colouring matters:
1 Tartrazine C16H9N4O9S2Na3 Ornamental fish 30. 11. 1994
2 Sunset yellow FCF C16H10N2O7S2Na2
3 Ponceau 4 R C20H11N2O40S3Na3
4 Erythrosine C20H6I4O5Na2.H2O
5 Indigotine C16H8N2O8S2Na2 Ornamental fish 30. 11. 1994
6 Chlorophyll copper complex Ornamental fish 30. 11. 1994
7 Acid Brillant Green BS, (Lissamine Green) Sodium salt of 4,4-bis (dimethylamino) diphenyl-methylene-2-naphtol-3,6-disulphonic acid Ornamental fish 30. 11. 1994
8 Carbon black C Ornamental fish 30. 11. 1994
9 Bixin C25H30O4
10 Iron oxide, red Fe2O3
11 Astaxanthin-rich Phaffia rhodozyma Concentrated biomass of the yeast Phaffia rhodozyma (CBS 116.94) killed, containing at least 2,5 g ostaxanthin per kilogram additive Salmon, trout 100 The maximum content is expressed as astaxanthin.Use only permitted from the age of six months onwards.The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff 30. 11. 1996
20 Methylpropionic acid C4H8O2 All species or categories of animals with the exception of laying hens 1000 4000 30. 11. 1992
I.Trace elements
J.Growth promoters
1 Synthetic calcium aluminates Mixture of calcium aluminates containing between 35 and 51 % of A 1203 (SIC! Al2O3) maximum molybdenum content of 20 mg/kg Poultry, rabbits, and pigs 20000 All feedingstuffs 30. 3. 1993
Dairy cows 8000 All feedingstuffs 30. 11. 1996
Cattle for fattening calves, lambs, kids
2 Natrolite-phonolite Natural mixture of aluminium silicates, alkalines and alkaline-earth and aluminium hydrosilicates, natrolite (43 % — 46,5 %) and feldspar All animal species and categories 25000 All feedingstuffs 30. 11. 1996
M.Acidity regulators
1 3-phytase (EC 3.1.3.8) Preparation of 3-phytase produced by Aspergillus niger (CBS 114.94) having a minimum phytase activity of 5000 FTU/g for solid and liquid preparations Pigs (all categories of animals) 30. 11. 1996
Chickens (all categories of animals) 30. 11. 1996
1 Bacillus cereus var. toyoi (CNCM I-1012/ NCIB 40112) Preparation of Bacillus cereus var. toyoi containing a minimum 1010 CFU/g additive Piglets Two months 109 109 30. 11. 1996
four months 0,5×109 109
Pigs six months 0,2×109 109 30. 11. 1996
Sows 109 2×109 30. 11. 1996
2 Bacillus licheniformis (DSM 5749) / Bacillus subtilis (DSM 5750) [in a 1/1 ratio] Mixture of Bacillus licheniformis and Bacillus subtilis containing 3'2 × 109 CFU/g additive (1,6 × 109 CFU/g of each bacteria) Piglets 4 months 1,28×109 3,2×109 30. 11. 1996
3 Saccharomyces cerevisiae(NCYC Sc 47) Preparation of Saccharomyces cerevisiae containing a minimum 5 × 109 CFU/g additive Cattle for fattening 4×109 8×109 Indicate in the instructions for use: "the quantity of Saccharomyces cerevisiae in the daily ration must not exceed 2,5 × 1010 CFU for 100 kg of bodyweight; 0,5 × 1010 CFU for each additional 100 kg of bodyweight" 30. 11. 1996
4 Bacillus cereus(ATCC 14893/CIP 5832) Preparation of Bacillus cereus containing a minimum 1010 CFU/g additive Rabbits for fattening 0,5×109 2×109 30. 11. 1996
Breeding rabbits 30. 11. 1996
ANNEX III Minimum conditions which must be fulfilled by manufacturers of the additives, premixtures and compound feedingstuffs referred to in Article 13 and intermediaries 1. The manufacturer must possess the appropriate facilities and technical equipment for the manufacture and storage of additives, premixtures or compound feedingstuffs containing those premixtures. 2. The manufacturer or his staff must possess the skills necessary for the manufacture of additives, premixtures or compound feedingstuffs. 3. The manufacturer must have access to appropriate means enabling him to ensure: (a)in the case of additives: that they conform to the provisions of this Directive; (b)in the case of premixtures: the nature and level of the different additives, and the homogeneity and stability of additives in the premixtures; (c)in the case of compound feedingstuffs: the nature and level of the additives and the homogeneous mixing of those additives in the compound feedingstuff. 4. Additives intended for the manufacture of premixtures and premixtures intended for incorporation in compound feedingstuffs shall be stored in such a way as to enable them to be easily identified and to avoid any confusion with other additives, premixtures or medicinal substances, medicated feedingstuffs or feedingstuffs. They shall be stored in suitable places, which can be locked and which are intended for the storage of these products. 5. The manufacturer or, if the manufacturer is established in a third country, his agent established in the Community must record the following information: (a)for additives: the nature, quantity of additives produced and the respective dates of manufacture, and the names and addresses of the manufacturers of premixtures or intermediaries to whom the additives have been delivered with an indication of the nature and quantity of additive delivered; (b)for premixtures: the name of the manufacturers and the suppliers, the nature and quantity of the additives used, the date of manufacture, the name and address of the compound feedingstuff manufacturers or intermediaries for whom the premixture is intended and the nature and quantity of the premixture delivered; (c)for compound feedingstuffs: the name and address of the supplier of the premixture and of the manufacturer if the latter is not the supplier, the nature and quantity of the premixture and the use to which it has been put. 6. Where the manufacturer delivers additives or premixtures to a person other than a manufacturer of premixtures or compound feedingstuffs, that person and any subsequent intermediary shall be bound by the same recording obligations laid down in paragraph 5 (a) and (b). 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 this group 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. ANNEX B CHAPTER I Additives linked to a person responsible for putting them into circulation, inserted in Annex I before 1 January 1988
Authorization to be linked to the person responsible with effect from 1 October 1999.
Registration number Name and registration number of person responsible for marketing Additive Chemical name, description Species or category of animal Maximum age Minimum content Maximum content Other provisions
mg/kg complete feedingstuff mg/kg complete feedingstuff
A.Antibiotics
B.Coccidiostats and other medicinal substances
C.Growth promoters
CHAPTER II Additives linked to a person responsible for putting them into circulation, inserted in Annex I after 31 December 1987
Authorization to be linked to the person responsible with effect from 1 October 1999.
Registration number Name and registration number of person responsible for marketing Additive Chemical name, description Species or category of animal Maximum age Minimum content Maximum content Other provisions
mg/kg complete feedingstuff mg/kg complete feedingstuff
A.Antibiotics
B.Coccidiostats and other medicinal substances
C.Growth promoters
CHAPTER III Additives linked to a person responsible for marketing, inserted in Annex II before 1 April 1998 Authorisation linked to the person responsible with effect from 1 October 1999. First authorisation 18 July 1994, Commission Directive 94/41/EC (OJ L 209, 12. 8. 1994, p. 18). First authorisation 15 December 1997, Commission Directive 97/72/EC (OJ L 351, 23. 12. 1997, p. 55). First authorisation 21 February 1996, Commission Directive 96/7/EC (OJ L 51, 1. 3 1996, p. 45). First authorisation 14 October 1996, Commission Directive 96/66/EC (OJ L 272, 25. 10. 1996, p. 32).
A.Antibiotics
Registration number Name and registration number of person responsible for marketing Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Duration of authorisation
mg/kg complete feedingstuff mg/kg complete feedingstuff
31 Bacitracin zinc C66H103O16N17SZn(polypeptide containing 12 to 20 % zinc) Chickens for fattening 5 50 17. 7. 1999
Pigs 6 months 5 50 17. 7. 1999
33 Avilamycin C57.62H82.90Cl1.2O31.32(mixture of oligosaccharides of the orthosomycin group produced by Streptomyces viridochromogenes, NRRL 2860)Factor composition: Avilamycin A: not less than 60 % Avilamycin B: not more than 18 % Avilamycins A + B: not less than 70 % Other single avilamycins: not more than 6 % Turkeys 5 10 30. 9. 1999
B.Cooccidiostats and other medicinal substances
Registration number Name and registration number of person responsible for marketing Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Duration of authorisation
mg/kg complete feedingstuff mg/kg complete feedingstuff
26 Salinomycin sodium C42H69O11Na(sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus)Elaiophylin content: less than 42 mg per kg of salinomycin sodium17-epi-20-desoxysalinomycin content: less than 40 g per kg of salinomycin sodium Rabbits for fattening 20 25 Use prohibited at least five days before slaughter.Indicate in the instructions for use: "Dangerous for equines" "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated" 30. 9. 1999
Chickens reared for laying 12 weeks 30 50 Indicate in the instructions for use: "Dangerous for equines" "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated" 30. 9. 1999
27 Diclazuril (±)-4-chlorphenyl(2,6-dicloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2yl-phenyl)acetonitrile Turkeys 12 weeks 1 1 Use prohibited at least five days before slaughter. 30. 9. 1999
Chickens reared for laying 16 weeks 1 1 30. 9. 1999
28 Maduramycin ammonium C47H83O17N(ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis) Turkeys 16 weeks 5 5 Use prohibited at least five days before slaughter.Indicate in the instructions for use: "Dangerous for equines" "This feedingstuff contains an ionophore; simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra indicated" 30. 9. 1999
C.Growth promoters
Registration number Name and registration number of person responsible for marketing Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions Duration of authorisation
mg/kg complete feedingstuff mg/kg complete feedingstuff
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 additives referred 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 additives belonging to this group, colourants, including pigments: all additives belonging to this group, preservatives, vitamins, provitamins and chemically well-defined substances having similar effect: all additives belonging to this group, 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. ANNEX I TABLE OF CORRESPONDANCE
Directive 70/524 Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 5
Article 6 Article 6
Article 7 Article 7
Article 7a Article 7a
Article 8 Article 8
Article 9 Article 9
Article 10 Article 10
Article 11 Article 11
Article 12 Article 12
Article 13 Article 13
Article 14 Article 14
Article 15 Article 15
Article 16 Article 16
Article 17 Article 17
Article 18 Article 18
Article 19 Article 19
Article 20 Article 20
Article 21 Article 21
Article 22 Article 22
Article 23 Article 23
Article 24 Article 24
Article 25 Article 25
Article 26 Article 26
Article 27 Article 27
- ANNEX I