1990R2377 — EN — 07.02.2000 — 011.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILREGULATION(EEC)No2377/90
of26June1990
laying down a Community procedure for the establishment of maximum residue limits of veter-
inarymedicinalproductsinfoodstuffsofanimalorigin
(OJ L 224, 18.8.1990, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EEC) No 675/92 of 18 March1992 L 73 8 19.3.1992
►M2Commission Regulation (EEC) No 762/92 of 27 March1992 L 83 14 28.3.1992
►M3Commission Regulation (EEC) No 3093/92 of 27 October 1992 L 311 18 28.10.1992
►M4Commission Regulation (EEC) No 895/93 of 16 April 1993 L 93 10 17.4.1993
►M5Council Regulation (EEC) No 2901/93 of 18 October 1993 L 264 1 23.10.1993
►M6Commission Regulation (EC) No 3425/93 of 14 December 1993 L 312 12 15.12.1993
►M7Commission Regulation (EC) No 3426/93 of 14 December 1993 L 312 15 15.12.1993
►M8Commission Regulation (EC) No 955/94 of 28 April 1994 L 108 8 29.4.1994
►M9Commission Regulation (EC) No 1430/94 of 22 June 1994 L 156 6 23.6.1994
►M10Commission Regulation (EC) No 2701/94 of 7 November 1994 L 287 7 8.11.1994
►M11Commission Regulation (EC) No 2703/94 of 7 November 1994 L 287 19 8.11.1994
►M12Commission Regulation (EC) No 3059/94 of 15 December 1994 L 323 15 16.12.1994
►M13Commission Regulation (EC) No 1102/95 of 16 May 1995 L 110 9 17.5.1995
►M14Commission Regulation (EC) No 1441/95 of 26 June 1995 L 143 22 27.6.1995
►M15Commission Regulation (EC) No 1442/95 of 26 June 1995 L 143 26 27.6.1995
►M16Commission Regulation (EC) No 1798/95 of 25 July 1995 L 174 20 26.7.1995
►M17Commission Regulation (EC) No 2796/95 of 4 December 1995 L 290 1 5.12.1995
►M18Commission Regulation (EC) No 2804/95 of 5 December 1995 L 291 8 6.12.1995
►M19Commission Regulation (EC) No 281/96 of 14 February 1996 L 37 9 15.2.1996
►M20Commission Regulation (EC) No 282/96 of 14 February 1996 L 37 12 15.2.1996
►M21Commission Regulation (EC) No 1140/96 of 25 June 1996 L 151 6 26.6.1996
►M22Commission Regulation (EC) No 1147/96 of 25 June 1996 L 151 26 26.6.1996
►M23Commission Regulation (EC) No 1311/96 of 8 July 1996 L 170 4 9.7.1996
►M24Commission Regulation (EC) No 1312/96 of 8 July 1996 L 170 8 9.7.1996
►M25Commission Regulation (EC) No 1433/96 of 23 July 1996 L 184 21 24.7.1996
►M26Commission Regulation (EC) No 1742/96 of 6 September 1996 L 226 5 7.9.1996
►M27Commission Regulation (EC) No 1798/96 of 17 September 1996 L 236 23 18.9.1996
►M28Commission Regulation (EC) No 2010/96 of 21 October 1996 L 269 5 22.10.1996
►M29Commission Regulation (EC) No 2017/96 of 22 October 1996 L 270 2 23.10.1996
►M30Commission Regulation (EC) No 2034/96 of 24 October 1996 L 272 2 25.10.1996
1990R2377 — EN — 07.02.2000 — 011.001 — 2
►M31Commission Regulation (EC) No 17/97 of 8 January 1997 L 5 12 9.1.1997
►M32Commission Regulation (EC) No 211/97 of 4 February 1997 L 35 1 5.2.1997
►M33Commission Regulation (EC) No 270/97 of 14 February 1997 L 45 8 15.2.1997
►M34Council Regulation (EC) No 434/97 of 3 March1997 L 67 1 7.3.1997
►M35Commission Regulation (EC) No 716/97 of 23 April 1997 L 106 10 24.4.1997
►M36Commission Regulation (EC) No 748/97 of 25 April 1997 L 110 21 26.4.1997
►M37Commission Regulation (EC) No 749/97 of 25 April 1997 L 110 24 26.4.1997
►M38Commission Regulation (EC) No 1836/97 of 24 September 1997 L 263 6 25.9.1997
►M39Commission Regulation (EC) No 1837/97 of 24 September 1997 L 263 9 25.9.1997
►M40Commission Regulation (EC) No 1838/97 of 24 September 1997 L 263 14 25.9.1997
►M41Commission Regulation (EC) No 1850/97 of 25 September 1997 L 264 12 26.9.1997
►M42Commission Regulation (EC) No 121/98 of 16 January 1998 L 11 11 17.1.1998
►M43Commission Regulation (EC) No 426/98 of 23 February 1998 L 53 3 24.2.1998
►M44Commission Regulation (EC) No 613/98 of 18 March1998 L 82 14 19.3.1998
►M45Commission Regulation (EC) No 1000/98 of 13 May 1998 L 142 18 14.5.1998
►M46Commission Regulation (EC) No 1076/98 of 27 May 1998 L 154 14 28.5.1998
►M47Commission Regulation (EC) No 1191/98 of 9 June 1998 L 165 6 10.6.1998
►M48Commission Regulation (EC) No 1568/98 of 17 July 1998 L 205 1 22.7.1998
►M49Commission Regulation (EC) No 1569/98 of 17 July 1998 L 205 7 22.7.1998
►M50Commission Regulation (EC) No 1570/98 of 17 July 1998 L 205 10 22.7.1998
►M51Commission Regulation (EC) No 1916/98 of 9 September 1998 L 250 8 10.9.1998
►M52Commission Regulation (EC) No 1917/98 of 9 September 1998 L 250 13 10.9.1998
►M53Commission Regulation (EC) No 1958/98 of 15 September 1998 L 254 7 16.9.1998
►M54Commission Regulation (EC) No 2560/98 of 27 November 1998 L 320 28 28.11.1998
►M55Commission Regulation (EC) No 2686/98 of 11 December 1998 L 337 20 12.12.1998
►M56Commission Regulation (EC) No 2692/98 of 14 December 1998 L 338 5 15.12.1998
►M57Commission Regulation (EC) No 2728/98 of 17 December 1998 L 343 8 18.12.1998
►M58Commission Regulation (EC) No 508/1999 of 4 March1999 L 60 16 9.3.1999
►M59Commission Regulation (EC) No 804/1999 of 16 April 1999 L 102 58 17.4.1999
►M60Council Regulation (EC) No 1308/1999 of 15 June 1999 L 156 1 23.6.1999
►M61Commission Regulation (EC) No 953/1999 of 5 May 1999 L 118 23 6.5.1999
►M62Commission Regulation (EC) No 954/1999 of 5 May 1999 L 118 28 6.5.1999
►M63Commission Regulation (EC) No 997/1999 of 11 May 1999 L 122 24 12.5.1999
►M64Commission Regulation (EC) No 998/1999 of 11 May 1999 L 122 30 12.5.1999
►M65Commission Regulation (EC) No 1931/1999 of 9 September 1999 L 240 3 10.9.1999
►M66Commission Regulation (EC) No 1942/1999 of 10 September 1999 L 241 4 11.9.1999
►M67Commission Regulation (EC) No 1943/1999 of 10 September 1999 L 241 9 11.9.1999
►M68Commission Regulation (EC) No 2385/1999 of 10 November 1999 L 288 14 11.11.1999
►M69Commission Regulation (EC) No 2393/1999 of 11 November 1999 L 290 5 12.11.1999
►M70Commission Regulation (EC) No 2593/1999 of 8 December 1999 L 315 26 9.12.1999
Corrected by:
►C1Corrigendum, OJ L 222, 20.9.1995, p. 17 (1442/95)
►C2Corrigendum, OJ L 316, 5.12.1996, p. 37 (1442/95)
1990R2377 — EN — 07.02.2000 — 011.001 — 3
►C3Corrigendum, OJ L 76, 18.3.1997, p. 34 (1442/95)
►C4Corrigendum, OJ L 271, 8.10.1998, p. 42 (1568/98)
►C5Corrigendum, OJ L 9, 13.1.2000, p. 30 (1308/1999)
▼B
COUNCILREGULATION(EEC)No2377/90
of26June1990
laying down a Community procedure for the establishment of
maximum residue limits of veterinary medicinal products in food-
stuffsofanimalorigin
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (
1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas the use of veterinary medicinal products in food-producing
animals may result in the presence of residues of foodstuffs obtained
from treated animals;
Whereas as a result of scientific and technical progress it is possible to
detect the presence of residues of veterinary medicines in foodstuffs atever lower levels; whereas it is therefore necessary to establishmaximum residue limits for pharmacologically active substances which
are used in veterinary medicinal products in respect of all the various
foodstuffs of animal origin, including meat, fish, milk, eggs and honey;
Whereas in order to protect public health, maximum residue limits
must be established in accordance with generally recognized principlesof safety assessment, taking into account any other scientific assess-
ment of the safety of the substances concerned which may have been
undertaken by international organizations, in particular the CodexAlimentarius or, where such substances are used for other purposes,by other scientific committees established within the Community;
Whereas the use of veterinary medicinal products plays an important
part in agricultural production; whereas the establishment of maximum
residue levels will facilitate the marketing of foodstuffs of animalorigin;
Whereas the establishment of different maximum residue levels by
Member States may hinder the free movement of foodstuffs and of
veterinary medicinal products themselves;
Whereas it is therefore necessary to lay down a procedure for the
establishment of maximum residue levels of veterinary medicinalproducts by the Community, following a single scientific assessmentof the highest possible quality;
Whereas the need for the establishment of maximum residue levels
throughout the Community is recognized in the Community rulesrelating to trade in foodstuffs of animal origin;
Whereas provisions must be adopted with a view to the systematic
establishment of maximum residue levels for new substances capable
of pharmacological action intended for administration to food-produ-cing animals;
Whereas arrangements must also be made for the establishment of
maximum residue levels for substances which are currently used in
veterinary medicines administered to food-producing animals; whereas,
however, in view of the complexity of this matter and the large numberof substances involved, long transitional arrangements are required;
Whereas, after scientific assessment by the Committee for Veterinary
Medicinal Products, maximum residue levels must be adopted by a1990R2377 — EN — 07.02.2000 — 011.001 — 4
(1) OJ No C 61, 10. 3. 1989. p. 5.
(2) OJ No C 96, 17. 4. 1990, p. 273.
(3) OJ No C 201, 17. 8. 1989, p. 1.
▼B
rapid procedure which ensures close cooperation between the Commis-
sion and the Member States through the Committee set up underCouncil Directive 81/852/EEC of 28 September 1981 on the approxi-
mation of the laws of the Member States relating to analytical,
pharmaco-toxicological and clinical standards and protocols in respectof the testing of veterinary medicinal products (
1), as last amended by
Directive 87/20/EEC (2); whereas an urgent procedure is also required
to ensure the swift review of any tolerance which might prove insuffi-
cient to protect public health;
Whereas medicinally induced immunological responses are usually
indistinguishable from those which arise naturally, and do not affect
consumers of food of animal origin;
Whereas the information necessary to assess the safety of residues
should be presented in accordance with the principles laid down byDirective 81/852/EEC,
HAS ADOPTED THIS REGULATION:
Article 1
1. For the purposes of this Regulation, the following definitions
shall apply:
(a) ‘residues of veterinary medicinal products’: means all pharmacolo-
gically active substances, whether active principles, excipients or
degradation products, and their metabolites which remain in food-
stuffs obtained from animals to which the veterinary medicinalproduct in question has been administered;
(b) ‘maximum residue limit’: means the maximum concentration of
residue resulting from the use of a veterinary medicinal product
(expressed in mg/kg or µg/kg on a fresh weight basis) which may
be accepted by the Community to be legally permitted or recog-nized as acceptable in or on a food.
It is based on the type and amount of residue considered to be
without any toxicological hazard for human health as expressed
by the acceptable daily intake (ADI), or on the basis of a temporary
ADI that utilizes an additional safety factor. It also takes intoaccount other relevant public health risks as well as food tech-nology aspects.
When establishing a maximum residue limit (MRL), consideration
is also given to residues that occur in food of plant origin and/or
come from the environment. Furthermore, the MRL may be
reduced to be consistent withgood practices in th e use of veter-inary drugs and to the extent that practical analytical methods areavailable.
2. This Regulation shall not apply to active principles of biological
origin intended to produce active or passive immunity or to diagnose astate of immunity used in immunological veterinary medicinal
products.
Article 2
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which maximum residue limits havebeen established shall be contained in Annex I, which shall be adopted
in accordance withth e procedure laid down in Article 8. Except as
provided for in Article 9, any amendments to Annex I shall be adoptedin accordance withth e same procedure.1990R2377 — EN — 07.02.2000 — 011.001 — 5
(1) OJ No L 317, 6. 11. 1981, p. 16.
(2) OJ No L 15, 17. 1. 1987, p. 34.
▼B
Article 3
Where, following an evaluation of a pharmacologically active
substance used in veterinary medicinal products, it appears that it is
not necessary for the protection of public health to establish amaximum residue limit, that substance shall be included in a list inAnnex II, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, any amend-ments to Annex II shall be adopted in accordance with the same
procedure.
Article 4
A provisional maximum residue limit may be established for a pharma-
cologically active substance used in veterinary medicinal products onthe date of entry into force of this Regulation, provided that there areno grounds for supposing that residues of the substance concerned at
the level proposed present a hazard for the health of the consumer. A
provisional maximum residue limit shall apply for a defined period oftime, which shall not exceed five years. That period may be extendedonce only in exceptional cases for a period not in excess of two years ifthat proves expedient for the completion of scientific studies in
progress.
In exceptional circumstances, a provisional maximum residue limit
may also be established for a pharmacologically active substance notpreviously used in veterinary medicinal products on the date of entryinto force of this Regulation provided that there are no grounds for
supposing that residues of the substance concerned at the limit
proposed present a hazard for the health of the consumer.
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which provisional maximum residuelimits have been established shall be contained in Annex III, whichshall be adopted in accordance with the procedure laid down in Article
8. Except as provided for in Article 9, any amendments to Annex III
shall be adopted in accordance with the same procedure.
Article 5
Where it appears that a maximum residue limit cannot be established in
respect of a pharmacologically active substance used in veterinary
medicinal products because residues of the substances concerned, at
whatever limit, in foodstuffs of animal origin constitute a hazard tothe health of the consumer, that substance shall be included in a listin Annex IV, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, any amend-ments to Annex IV shall be adopted in accordance with the same
procedure.
The administration of the substances listed in Annex IV to food-produ-
cing animals shall be prohibited throughout the Community.
Article 6
1. In order to obtain the inclusion in Annexes I, II or III of a phar-
macologically active substance which is intended for use in veterinarymedicinal products for administration to food-producing animals, anapplication to establisha maximum residue limit sh all be submitted tothe European Agency for the Evaluation of Medicinal Products set up
by Council Regulation (EEC) No 2309/93 (
1), hereinafter referred to as
‘the Agency’.
This application shall contain the information and particulars referred
to in Annex V of this Regulation and shall conform with the principleslaid down in Directive 81/852/EEC.1990R2377 — EN — 07.02.2000 — 011.001 — 6
(1) OJ L 214, 24.8.1993, p. 1▼M60
▼M60
2. The application shall also be accompanied by the fee payable to
the Agency.
Article 7
1. The Committee for Veterinary Medicinal Products referred to in
Article 27 of Regulation (EC) No 2309/93 (hereinafter ‘theCommittee’) shall be responsible for formulating the Agency's opinion
on the classification of substances referred to in Annexes I, II, III or IV
to this Regulation.
2. Articles 52 and 53 of Regulation (EEC) No 2309/93 shall be
applicable for the purposes of this Regulation.
3. The Agency shall ensure that the Committee's opinion is deliv-
ered within a period of 120 days following the reception of a validapplication.
If the information submitted by the applicant is not sufficient to enable
such an opinion to be prepared, the Committee may ask the applicantto supply additional information within a specific time limit. The dead-line for the opinion shall then be deferred until the additionalinformation has been received.
4. The Agency shall forward the opinion to the applicant. Within 15
days of receipt of the opinion, the applicant may provide written noticeto the Agency that he wishes to appeal. In that case he shall forwardthe detailed grounds for his appeal to the Agency within 60 days of
receipt of the opinion. Within 60 days of the receipt of the grounds
for appeal, the Committee shall consider whether its opinion shouldbe revised and the reasons for the conclusion reached on the appealshall be annexed to the report referred to in paragraph 5.
5. The Agency shall forward the definitive opinion of the
Committee within 30 days of its adoption both to the Commission andto the applicant. The opinion shall be accompanied by a reportdescribing the safety evaluation of the substance by the Committee,which shall give the grounds for its conclusions.
6. The Commission shall prepare draft measures taking account of
Community legislation and shall start the procedure provided for inArticle 8. The Committee referred to in Article 8 shall adapt its rulesof procedure in order to take account of the tasks conferred on it bythis Regulation.
Article 8
1. Where the procedure laid down in this Article is to be followed,
the Chairman shall, without delay, refer the matter to the Standing
Committee on Veterinary Medicinal Products, hereinafter referred toas ‘the Standing Committee’, either on his own initiative or at therequest of a Member State.
2. The representative of the Commission shall submit a draft of the
measures to be adopted to the ►
M60Standing Committee ◄for
Adaptation to Technical Progress. The ►M60Standing Committee ◄
shall deliver its opinion on the draft within a time limit set by thechairman, having regard to the urgency of the matter. It shall act by aqualified majority, the votes of the Member States being weighted asprovided for in Article 148 (2) of the Treaty. The chairman shall notvote.
3. (a) The Commission shall adopt the measures envisaged where they
are in accordance with the opinion of the ►
M60Standing
Committee ◄.
(b) Where the measures envisaged are not in accordance with the
opinion of the ►M60Standing Committee ◄, or if no opinion
is adopted, the Commission shall without delay propose to the1990R2377 — EN — 07.02.2000 — 011.001 — 7
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▼M60
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Council the measures to be adopted. The Council shall act by a
qualified majority.
(c) If, after a period of three months of the proposal being referred
to it, the Council has not acted, the proposed measures shall beadopted by the Commission, unless the Council has votedagainst them by a simple majority.
Article 9
1. Where a Member State, as a result of new information or a reas-
sessment of existing information, considers that the urgent amendment
of a provision contained in Annexes I to IV is necessary in order to
protect human or animal health, and therefore requires swift action tobe taken, that Member State may temporarily suspend the operation ofthe provision concerned in its own territory. In that case, it shall imme-diately notify the other Member States and the Commission of themeasures, attaching a statement of the reasons therefor.
2.►
M60The Commission shall as soon as possible examine the
grounds given by the Member State concerned and, after consulting
the Committee for Veterinary Medicinal Products, it shall then deliverits opinion forthwith and take appropriate measures; the person respon-sible for marketing may be requested to provide the Committee withoral or written explanations ◄. The Commission shall immediately
notify the Council and the Member States of any measures taken. Any
Member State may refer the Commission's measures to the Councilwithin 15 days of such notification. The Council, acting by a qualifiedmajority, may take a different decision within 30 days of the date onwhich the matter was referred to it.
3. If the Commission considers that it is necessary to amend the
provision of Annex I to IV concerned in order to resolve the difficul-
ties referred to in paragraph 1 and to ensure the protection of human
health, it shall initiate the procedure laid down in Article 10 with aview to adopting those amendments; the Member State which has takenmeasures under paragraph 1 may maintain them until the Council orthe Commission has taken a decision in accordance with the above-
mentioned procedure.
Article 10
1. Where the procedure laid down in this Article is to be followed,
the chairman shall, without delay, refer the matter to the
►
M60Standing Committee ◄either on his own initiative or at the
request of a representative of a Member State.
2. The representative of the Commission shall submit to the
►M60Standing Committee ◄a draft of the measures to be adopted.
The►M60Standing Committee ◄shall deliver its opinion on the
draft within a time limit set by the chairman, having regard to the
urgency of the matter. It shall act by a qualified majority, the votes ofthe Member States being weighted as provided for in Article 148 (2) ofthe Treaty. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged, where
they are in accordance with the opinion of the
►
M60Standing Committee ◄.
(b) Where the measures envisaged are not in accordance with the
opinion of the ►M60Standing Committee ◄, or if no opinion
is adopted, the Commission shall without delay propose to theCouncil the measures to be adopted. The Council shall act by a
qualified majority.
(c) If within 15 days of the proposals being submitted to it, the
Council has not acted, the proposed measures shall be adoptedby the Commission.1990R2377 — EN — 07.02.2000 — 011.001 — 8
▼B
Article 11
Any changes which are necessary to adapt Annex V to take account of
scientific and technical progress shall be adopted in accordance withthe procedure laid down in Article 2c of Directive 81/852/EEC.
Article 12
As soon as possible after the amendment of Annexes I, II, III or IV, the
Commission shall publish a summary of the assessment of the safety of
the substances concerned that have been examined by the Committee
for Veterinary Medicinal Products. The confidential nature of anyproprietary data shall be respected. The Agency shall provide thecompetent authorities and the Commission with appropriate methodsfor identifying pharmacologically active substances for which the
MRL's have been determined in ►
C5Annexes I and III. ◄
Article 13
Member States may not prohibit or impede the putting into circulation
within their territories of foodstuffs of animal origin originating inother Member States on the grounds that they contain residues of veter-inary medicinal products if the quantity of residue does not exceed the
maximum residue limit provided for in Annex I or III, or if the
substance concerned is listed in Annex II.
Article 14
Witheffect from 1 January 1997, th e administration to food-producing
animals of veterinary medicinal products containing pharmacologicallyactive substances which are not mentioned in Annexes I, II or III shallbe prohibited within the Community, except in the case of clinicaltrials accepted by the competent authorities following notification orauthorization in accordance with the legislation in force and which do
not cause foodstuffs obtained from livestock participating in suchtrials
to contain residues which constitute a hazard to human health.
However, the date referred to in the previous subparagraph shall be
deferred for substances the use of which was authorized on the dateof entry into force of this Regulation and in respect of which docu-mented applications for the establishment of maximum residue limits
have been lodged with the Commission or with the European Agency
for the Evaluation of Medicinal Products before 1 January 1996:
— until 1 January 1998 in the case of pyrazolinones (including pyra-
zolidinediones and phenylbutazones), nitroimidazoles and arsalinic
acid, and
— until 1 January 2000 in the case of other substances.
The Agency shall publish a list of these substances before 7 June 1997.
Article 15
This Regulation shall in no way prejudice the application of Commu-
nity legislation prohibiting the use in livestock farming of certain
substances having a hormonal action.
Nothing in this Regulation shall prejudice the measures taken by
Member States to prevent the unauthorized use of veterinary medicinalproducts.1990R2377 — EN — 07.02.2000 — 011.001 — 9
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▼M34
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▼M34
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Article 16
This Regulation shall enter into force on 1 January 1992.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.1990R2377 — EN — 07.02.2000 — 011.001 — 10
ANNEX I
LISTOFPHARMACOLOGICALLYACTIVESUBSTANCESFORWHICHMAXIMUMRESIDUELIMITSHAVEBEENFIXED
1. Anti-infectious agents
1.1. Chemotheurapeutics
1.1.1. Sulfonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
All substances belonging to the
sulfonamide groupParent drug All food-producing
species100 µg/kg Muscle The combined total residues of all substances
within the sulfonamide group should not
exceed 100 µg/kg
100 µg/kg Fat
100 µg/kg Liver
100 µg/kg Kidney
Bovine, ovine, caprine 100 µg/kg Milk
1.1.2. Diamino pyrimidine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Baquiloprim Baquiloprim Bovine 10 µg/kg Fat
300 µg/kg Liver
150 µg/kg Kidney
30 µg/kg Milk
Porcine 40 µg/kg Skin and fat
50 µg/kg Liver
50 µg/kg Kidney
Trimethoprim Trimethoprim Bovine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
50 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 11
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Porcine 50 µg/kg Muscle
50 µg/kg Skin and fat
50 µg/kg Liver
50 µg/kg Kidney
Equidae 100 µg/kg Muscle
100 µg/kg Fat
100 µg/kg Liver
100 µg/kg Kidney
Poultry 50 µg/kg Muscle
Not for use in animals
from which eggs are
produced for human
consumption50 µg/kg Skin and fat
50 µg/kg Liver
50 µg/kg Kidney
Fin fish50 µg/kg Muscle and skin in
natural proportions▼M581990R2377 — EN — 07.02.2000 — 011.001 — 12
1.2. Antibiotics
1.2.1. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amoxicyllin Amoxicyllin All food-producing
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
Ampicillin Ampicillin All food-producing
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
Benzylpenicillin Benzylpenicillin All food-producing
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
Cloxacillin Cloxacillin All food-producing
species300 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
Dicloxacillin Dicloxacillin All food-producing
species300 µg/kg Muscle
300 µg/kg Fat▼M581990R2377 — EN — 07.02.2000 — 011.001 — 13
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
Oxacillin Oxacillin All food-producing
species300 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
Penethamate Benzylpenicillin Bovine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
1.2.2. Cephalosporins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefazolin Cefazolin Bovine, ovine, caprine 50 µg/kg Milk
Cefquinome Cefquinome Bovine 50 µg/kg Muscle
50 µg/kg Fat
100 µg/kg Liver
200 µg/kg Kidney
20 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 14
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Porcine 50 µg/kg Muscle
50µg/kg Skin + fat
100µg/kg Liver
200µg/kg Kidney
Ceftiofur Sum of all residues
retaining the betalactam
structure expressed as
desfuroylceftiofurBovine 1 000 µg/kg Muscle
2 000 µg/kg Fat
2 000 µg/kg Liver
6 000 µg/kg Kidney
100µg/kg Milk, not for intramam-
mary use
Porcine 1 000 µg/kg Muscle
2 000 µg/kg Fat
2 000 µg/kg Liver
6 000 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 15▼M65
▼M59
1.2.3. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Danofloxacin Danofloxacin Bovine 200 µg/kg Muscle
100µg/kg Fat
400µg/kg Liver
400µg/kg Kidney
30µg/kg Milk
Porcine 100 µg/kg Muscle
50µg/kg Skin and fat
200µg/kg Liver
200µg/kg Kidney
Difloxacin Difloxacin Chicken, turkey 300 µg/kg Muscle
400 µg/kg Skin and fat
1 900 µg/kg Liver
600 µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinBovine 100 µg/kg Muscle
100 µg/kg Fat
300 µg/kg Liver
200 µg/kg Kidney100 µg/kg Milk
Rabbits 100 µg/kg Muscle
100 µg/kg Fat200 µg/kg Liver300 µg/kg Kidney
Porcine 100 µg/kg Muscle▼M581990R2377 — EN — 07.02.2000 — 011.001 — 16▼M64
▼M66
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
100 µg/kg Skin and fat
200 µg/kg Liver
300 µg/kg Kidney
Poultry 100 µg/kg Muscle
Not for use in animals
from which eggs are
produced for human
consumption100 µg/kg Skin and fat
200 µg/kg Liver
300 µg/kg Kidney
Ovine 100 µg/kg Muscle Not for use in animals from which milk is
produced for human consumption
100µg/kg Fat
300µg/kg Liver
200µg/kg Kidney
Sarafloxacin Sarafloxacin Chicken 10 µg/kg Skin and fat
100 µg/kg Liver
Salmonidae 30 µg/kg Muscle and skin in
natural proportions
1.2.4. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Spiramycin Sum of spiramycin and
neospiramycinBovine 200 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
200 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 17▼M70
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chicken 200 µg/kg Muscle
300 µg/kg Skin and fat400 µg/kg Liver
Spiramycin 1 Porcine 250 µg/kg Muscle
2 000 µg/kg Liver
1 000 µg/kg Kidney
Tilmicosin Tilmicosin Bovine, ovine, porcine 50 µg/kg Muscle
50 µg/kg Fat
1 000 µg/kg Liver1 000 µg/kg Kidney
Ovine 50 µg/kg MilkChicken 75 µg/kg Muscle Not for use in animals from which eggs are
produced for human consumption
75 µg/kg Skin and fat
1 000 µg/kg Liver
250 µg/kg Kidney
Tylosin Tylosin A Bovine 100 µg/kg Muscle
100 µg/kg Fat100 µg/kg Liver100 µg/kg Kidney
50 µg/kg Milk
Porcine 100 µg/kg Muscle
100 µg/kg Skin and fat100 µg/kg Liver100 µg/kg Kidney
Poultry 100 µg/kg Muscle▼M581990R2377 — EN — 07.02.2000 — 011.001 — 18▼M70
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Not for use in hens
producing eggs for
human consumption100 µg/kg Skin and fat
100 µg/kg Liver
100 µg/kg Kidney
1.2.5. Florfenicol and related compounds
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Florfenicol Sum of florfenicol and
its metabolites measured
as florfenicol-amineBovine 200 µg/kg Muscle
3 000 µg/kg Liver
300 µg/kg Kidney
Porcine 300 µg/kg Muscle
500µg/kg Skin and fat
2 000 µg/kg Liver
500µg/kg Kidney
Chicken 100 µg/kg Muscle Not for use in animals from which eggs are
produced for human consumption
200µg/kg Skin and fat
2 500 µg/kg Liver
750µg/kg Kidney
Thiamphenicol Thiamphenicol Bovine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
50 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 19▼M66
▼M68
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chicken 50 µg/kg Muscle
Not for use in animals
from which eggs are
produced for human
consumption50 µg/kg Skin and fat
50 µg/kg Liver
50 µg/kg Kidney
1.2.6. Tetracyclines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chlortetracycline Sum of parent drug and
its 4- epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver
600 µg/kg Kidney
100 µg/kg Milk
200 µg/kg Eggs
Doxycycline Doxycycline Bovine 100 µg/kg Muscle
Not for use in animals
from which milk is
produced for human
consumption300 µg/kg Liver
600 µg/kg Kidney
Porcine 100 µg/kg Muscle
300 µg/kg Skin and fat
300 µg/kg Liver
600 µg/kg Kidney
Poultry 100 µg/kg Muscle
Not for use in animals
from which eggs are
produced for human
consumption300 µg/kg Skin and fat▼M581990R2377 — EN — 07.02.2000 — 011.001 — 20
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
300 µg/kg Liver
600 µg/kg Kidney
Oxytetracycline Sum of parent drug and
its 4-epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver
600 µg/kg Kidney
100 µg/kg Milk
200 µg/kg Eggs
Tetracycline Sum of parent drug and
its 4-epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver
600 µg/kg Kidney
100 µg/kg Milk
200 µg/kg Eggs
1.2.7. Naphtalene-ringed ansamycin
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Rifaximin Rifaximin Bovine 60 µg/kg Milk
1.2.8. Pleuromutilines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Valnemulin Valnemulin Porcine 50 µg/kg Muscle
500 µg/kg Liver
100 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 21
1.2.9. Lincosamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Lincomycin Lincomycin Bovine 100 µg/kg Muscle
50µg/kg Fat
500µg/kg Liver
1 500 µg/kg Kidney
150µg/kg Milk
1.2.10. Aminoglycosides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Apramycin Apramycin Bovine 1 000 µg/kg Muscle Not for use in animals from which milk is
produced for human consumption1 000 µg/kg Fat
10000 µg/kg Liver
20000 µg/kg Kidney
1.2.11. Other antibiotics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Novobiocin Novobiocin Bovine 50 µg/kg Milk
2. Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Salicylanilides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Closantel Closantel Bovine 1 000 µg/kg Muscle
3 000 µg/kg Fat▼M591990R2377 — EN — 07.02.2000 — 011.001 — 22▼M65
▼M70
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1 000 µg/kg Liver
3 000 µg/kg Kidney
Ovine 1 500 µg/kg Muscle
2 000 µg/kg Fat
1 500 µg/kg Liver
5 000 µg/kg Kidney
2.1.2. Tatra-hydro-imidazoles (imidazolthiazoles)
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Levamisole Levamisole Bovine, ovine, porcine,
poultry10 µg/kg Muscle
10 µg/kg Fat
100 µg/kg Liver
10 µg/kg Kidney
2.1.3. Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole Sum of albendazole
sulphoxide, albendazole
sulphone, and albenda-
zole 2-amino sulphone,
expressed as albendazoleBovine, ovine 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney
100 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 23
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole oxide Sum of albendazole
oxide, albendazole
sulphone and albenda-
zole 2-aminosulphone,
expressed as albendazoleBovine, ovine 100 µg/kg Muscle
100µg/kg Fat
1 000 µg/kg Liver
500µg/kg Kidney
100µg/kg Milk
Febantel Sum of extractable resi-
dues which may be
oxidised to oxfendazoleBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equidae50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Fenbendazole Sum of extractable resi-
dues which may be
oxidised to oxfendazole
sulphoneBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equide50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Flubendazole Sum of flubendazole and
(2-amino 1H-benzimi-
dazol-5-yl) (4fluoro-
phenyl) methanonePorcine, chicken, game
birds50 µg/kg Muscle
50 µg/kg Skin and fat
400 µg/kg Liver
300 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 24▼M69
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Turkey 50 µg/kg Muscle
50µg/kg Skin and fat
400µg/kg Liver
300µg/kg Kidney
Flubendazole Chicken 400 µg/kg Eggs
Oxfendazole Sum of extractable resi-
dues which may be
oxidised to oxfendazole
sulphoneBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equidae50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Oxibendazole Oxibendazole Porcine 100 µg/kg Muscle
500 µg/kg Skin and fat200 µg/kg Liver
100 µg/kg Kidney
Thiabendazole Sum of thiabendazole
and 5-hydroxythiabenda-
zoleBovine 100 µg/kg Muscle
100 µg/kg Fat
100 µg/kg Liver100 µg/kg Kidney100 µg/kg Milk
Triclabendazole Sum of extractable resi-
dues that may be
oxidised to ketotriclaben-
dazoleBovine, ovine 100 µg/kg Muscle Not for use in animals from which milk is
produced for human consumption▼M581990R2377 — EN — 07.02.2000 — 011.001 — 25▼M68
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
100 µg/kg Liver
100 µg/kg Kidney
2.1.4. Phenol derivatives including salicylanides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Nitroxinil Nitroxinil Bovine, ovine 400 µg/kg Muscle
200µg/kg Fat
20µg/kg Liver
400µg/kg Kidney
2.1.5. Benzenesulphonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clorsulon Clorsulon Bovine 35 µg/kg Muscle
100µg/kg Liver
200µg/kg Kidney
2.2. Agents acting against ectoparasites
2.2.1. Organophosphates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diazinon Diazinon Bovine, ovine, caprine 20 µg/kg Milk
Bovine, porcine, ovine,
caprine20 µg/kg Muscle
700 µg/kg Fat
20 µg/kg Liver▼M581990R2377 — EN — 07.02.2000 — 011.001 — 26▼M63
▼M66
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
20 µg/kg Kidney
2.2.2. Formamidines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all
metabolites containing
the 2,4-DMA moiety,
expressed as amitrazBovine 200 µg/kg Fat
200 µg/kg Liver
200 µg/kg Kidney
10 µg/kg Milk
Ovine 400 µg/kg Fat
100 µg/kg Liver
200 µg/kg Kidney
10 µg/kg Milk
Porcine 400 µg/kg Skin and fat
200 µg/kg Liver
200 µg/kg Kidney
Bees (honey) 200 µg/kg Honey
2.2.3. Pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Flumethrin Flumethrin (sum of
trans-Z isomers)Bovine 10 µg/kg Muscle
150 µg/kg Fat
20 µg/kg Liver
10 µg/kg Kidney
30 µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 27
▼M69
▼M58
2.2.4. Acyl urea derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg Muscle and skin in
natural proportions
Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg Muscle and skin in
natural proportions
2.3. Agents acting against endo- and ectoparasites
2.3.1. Avermectins
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Abamectin Avermectin B1a Bovine 10 µg/kg Fat
20 µg/kg Liver
Doramectin Doramectin Bovine 10 µg/kg Muscle Not for use in bovine from which milk is
produced for human consumption
150 µg/kg Fat
100 µg/kg Liver
30 µg/kg Kidney
Porcine, ovine 20 µg/kg Muscle Not for use in ovine from which milk is
produced for human consumption
100 µg/kg Fat
50 µg/kg Liver
30 µg/kg Kidney▼M651990R2377 — EN — 07.02.2000 — 011.001 — 28▼M70
▼M65
▼M58
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Emamectin Emamectin B1a Salmonidae 100 µg/kg Muscle and skin in
natural proportions
Eprinomectin Eprinomectin B1a Bovine ►M67
50µg/kg
◄Muscle
►M67
250µg/kg
◄Fat
►M67
1 500 µg/kg
◄Liver
►M67
300µg/kg
◄Kidney
►M67
20µg/kg
◄Milk
Ivermectin 22, 23-Dihydro-aver-
mectin B1aBovine 40 µg/kg Fat
100 µg/kg Liver
Porcine, ovine, equidae 20 µg/kg Fat
15 µg/kg Liver
Deer, including reindeer 20 µg/kg Muscle
100 µg/kg Fat
50 µg/kg Liver20 µg/kg Kidney
Moxidectin Moxidectin Bovine, ovine 50 µg/kg Muscle
500 µg/kg Fat100 µg/kg Liver
50 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 29▼M65
▼M58
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Equidae 50 µg/kg Muscle
500µg/kg Fat
100µg/kg Liver
50µg/kg Kidney
2.4. Agents acting against protozoa
2.4.1. Triazinetrione derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Chicken 100 µg/kg Muscle Not for use in animals from which eggs are
produced for human consumption
200 µg/kg Skin and fat
600 µg/kg Liver
400 µg/kg Kidney
Turkey 100 µg/kg Muscle
200 µg/kg Skin and fat
600 µg/kg Liver
400 µg/kg Kidney
3. Agents acting on the nervous system
3.1. Agents acting on the central nervous system3.1.1. Butyrophenone tranquillisers
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azaperone Sum of azaperone and
azaperolPorcine 100 µg/kg Muscle
100 µg/kg Skin and fat
100 µg/kg Liver
100 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 30▼M66
▼M58
3.2. Agents acting on the autonomic nervous system
3.2.1. Anti-adrenergics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Porcine 5 µg/kg Muscle
5 µg/kg Skin and fat
25 µg/kg Liver
25 µg/kg Kidney
4. Anti-inflammatory agents
4.1. Nonsteroidal anti-inflammatory agents4.1.1. Arylpropionic acid derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carprofen Carprofen Bovine
Not for use in animals
from which milk is
produced for human
consumption500µg/kg Muscle
1 000 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
Equidae 500 µg/kg Muscle
1 000 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
Vedaprofen Vedaprofen Equidae 50 µg/kg Muscle
20 µg/kg Fat
100 µg/kg Liver
1 000 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 31▼M65
▼M58
4.1.2. Fenamate group derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Tolfenamic acid Tolfenamic acid Bovine 50 µg/kg Muscle
400 µg/kg Liver
100 µg/kg Kidney
50 µg/kg Milk
Porcine 50 µg/kg Muscle
400 µg/kg Liver
100 µg/kg Kidney
4.1.4. Oxican derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine 25 µg/kg Muscle
60µg/kg Liver
35µg/kg Kidney
5. Corticoides
5.1. Glucocorticoides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Betamethasone Betamethasone Bovine 0,75 µg/kg Muscle
2,0µg/kg Liver
0,75 µg/kg Kidney
0,3µg/kg Milk
Porcine 0,75 µg/kg Muscle
2,0µg/kg Liver
0,75 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 32▼M69
▼M58
▼M70
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dexamethasone Dexamethasone Bovine 0,3 µg/kg Milk
Bovine, porcine, equidae 0,75 µg/kg Muscle
2 µg/kg Liver
0,75 µg/kg Kidney▼M701990R2377 — EN — 07.02.2000 — 011.001 — 33▼M58
ANNEX II
LISTOFSUBSTANCESNOTSUBJECTTOMAXIMUMRESIDUELIMITS
1. Inorganic chemicals
Pharmacologically active substance(s) Animal species Other provisions
Aluminium distearate All food-producing species
Aluminium hydroxide acetate All food-producing speciesAluminium phosphate All food-producing species
Aluminium tristearate All food-producing species
Ammonium chloride All food-producing species
Bismuthsubcarbonate All food-producing species For oral use only
Bismuthsubgallate All food-producing species For oral use onlyBismuthsubnitrate All food-producing species For oral use only
Bismuthsubsalicylate All food-producing species For oral use only
Boric acid and borates All food-producing species
Bromide, potassium salt All food producing speciesBromide, sodium salt All mammalian food-producing species For topical use only▼M581990R2377 — EN — 07.02.2000 — 011.001 — 34
▼M65
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Calcium acetate
Calcium benzoate
Calcium carbonate
Calcium chloride
Calcium gluconate
Calcium hydroxide
Calcium hypophosphite
Calcium malate
Calcium oxide
Calcium phosphate
Calcium polyphosphates
Calcium propionate
Calcium silicate
Calcium stearate
Calcium sulphateAll food-producing species
Calcium glucoheptonate All food-producing species
Calcium glucono glucoheptonate All food-producing species
Calcium gluconolactate All food-producing species
Calcium glutamate All food-producing speciesCobalt carbonate All food-producing speciesCobalt dichloride All food-producing species
Cobalt gluconate All food-producing species
Cobalt oxide All food-producing speciesCobalt sulphate All food-producing speciesCobalt trioxide All food-producing species
Copper chloride All food-producing species
Copper gluconate All food-producing speciesCopper heptanoate All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 35
Pharmacologically active substance(s) Animal species Other provisions
Copper methionate All food-producing species
Copper oxide All food-producing species
Copper sulphate All food-producing species
Dicopper oxide All food-producing species
Hydrochloric acid All food-producing species For use as excipient
Hydrogen peroxide All food-producing species
Iodine and iodine inorganic compounds including:
— Sodium and potassium-iodide
— Sodium and potassium-iodate— Iodophors including polyvinylpyrrolidone-iodineAll food-producing species
Iron dichloride All food-producing species
Iron sulphate All food-producing species
Magnesium
Magnesium sulphate
Magnesium hydroxide
Magnesium stearate
Magnesium glutamate
Magnesium orotate
Magnesium aluminium silicate
Magnesium oxide
Magnesium carbonate
Magnesium phosphate
Magnesium glycerophosphate
Magnesium aspartate
Magnesium citrate
Magnesium acetate
Magnesium trisilicateAll food-producing species
Nickel gluconate All food-producing species
Nickel sulphate All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 36
Pharmacologically active substance(s) Animal species Other provisions
Potassium DL-aspartate All food-producing species
Potassium glucuronate All food-producing speciesPotassium glycerophosphate All food-producing species
Potassium nitrate All food-producing species
Potassium selenate All food-producing speciesSodium chlorite Bovine For topical use onlySodium dichloroisocyanurate Bovine, ovine, caprine For topical use only
Sodium glycerophosphate All food producing speciesSodium hypophosphite All food-producing species
Sodium selenate All food-producing speciesSodium selenite All food-producing species
Sulphur Bovine, porcine, ovine, caprine, equidae
Zinc acetate
Zinc chloride
Zinc gluconate
Zinc oleate
Zinc stearateAll food-producing species
2. Organic compounds
Pharmacologically active substance(s) Animal species Other provisions
17β-Oestradiol All mammalian food-producing species For therapeutic and zootechnical uses only
2-Aminoethanol All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 37▼M63
▼M58
Pharmacologically active substance(s) Animal species Other provisions
2-Aminoethyl dihydrogenphosphate All food-producing species
2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw8-Hydroxyquinoline All mammalian food-producing species For topical use in newborn animals only
Acetyl cysteine All food-producing species
Alfacalcidol Bovine For parturient cows onlyAlfaprostol Rabbits
Bovine, porcine, equidae
Bacitracin Bovine For intramammary use in lactating cows only and for all tissues except
milk
Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0,05 % only
Benzocaine All food-producing species For use as local anaesthetic onlyBenzylalcohol All food-producing species For use as excipientBetaine All food-producing species
Bronopol Salmonidae For use only on farmed fertilised eggs
Brotizolam Bovine For therapeutic uses onlyBuserelin All food-producing speciesButorphanol tartrate Equidae For intravenous administration onlyButyl 4-hydroxybenzoate All food-producing species
Butylscopolaminium bromide All food-producing species
Caffeine All food-producing speciesCarbetocin All mammalian food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 38
Pharmacologically active substance(s) Animal species Other provisions
Cefazolin Bovine
Ovine, caprineFor intramammary use, except if the udder may be used as food for
human consumption
Cetostearyl alcohol All food-producing species
Cetrimide All food-producing species
Chlorhexidine All food-producing species For topical use only
Chlorocresol All food-producing species
Clazuril Pigeon
Cloprostenol Bovine, porcine, equidae
Coco alkyl dimethyl betaines All food-producing species For use as excipient
Corticotropin All food-producing species
D-Phe 6 -luteinising-hormone releasing hormone All food-producing species
Dembrexine Equidae
Denaverine hydrochloride Bovine
Detomidine Bovine, equidae For therapeutic uses only
Diclazuril Ovine For oral use in lambs only
Diethyl phtalate All food-producing species
Diethylene glycol monoethyl ether Bovine, porcine
Dimanganese trioxide All food-producing species For oral use only
Dimethyl phtalate All food-producing species
Dinoprost All mammalian food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 39
Pharmacologically active substance(s) Animal species Other provisions
Dinoprost tromethamine All mammalian food-producing species
Diprophylline All food-producing species
Etamiphylline camsylate All food-producing speciesEthanol All food-producing species For use as excipient
Ethyl lactate All food-producing species
Etiproston tromethamine Bovine, porcine
Fertirelin acetate Bovine
Flumethrin Bees (honey)
Folic acid All food-producing species
Glycerol formal All food-producing species
Gonadotrophin releasing hormone All food-producing species
Heptaminol All food-producing species
Hesperidin Equidae
Hesperidin methyl chalcone Equidae
Hexetidine Equidae For topical use only
Human chorion gonadotrophin All food-producing species
Human menopausal urinary gonadotrophin Bovine
Hydrocortisone All food-producing species For topical use only
Iodine organic compounds
— IodoformAll food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 40
Pharmacologically active substance(s) Animal species Other provisions
Isobutane All food-producing species
Isoflurane Equidae For use as anaesthetic onlyIsoxsuprine Bovine, equidae For therapeutic use only in accordance with Council Directive 96/22/
EEC (OJ L 125, 23.5.1996, p. 3)
Ketamine All food-producing speciesKetanserin tartrate Equidae
Ketoprofen Bovine, porcine, equidae
L-tartaric acid and its mono- and di-basic salt of sodium, potassium
and calciumAll food-producing species For use as excipient
Lactic acid All food-producing species
Lecirelin Bovine, equidae, rabbitsLobeline All food-producing speciesLuprostiol All mammalian species
Malic acid All food-producing species For use as excipient
Manganese carbonate All food-producing species For oral use onlyManganese chloride All food-producing species For oral use onlyManganese gluconate All food-producing species For oral use onlyManganese glycerophosphate All food-producing species For oral use only
Manganese oxide All food-producing species For oral use only
Manganese pidolate All food-producing species For oral use onlyManganese ribonucleate All food-producing species For oral use only▼M581990R2377 — EN — 07.02.2000 — 011.001 — 41
Pharmacologically active substance(s) Animal species Other provisions
Manganese sulphate All food-producing species For oral use only
Mecillinam Bovine For intrauterine use onlyMedroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes only
Melatonin Ovine, caprine
Menadione All food-producing speciesMenbutone Bovine, ovine, caprine, porcine, equidaeMenthol All food-producing species
Methyl nicotinate Bovine, equidae For topical use only
Mineral hydrocarbons, low to high viscosity including microcristalline
waxes, approximately C10-C60; aliphatic, branched aliphatic and
alicyclic compoundsAll food-producing species Excludes aromatic and unsaturated compounds
N-butane All food-producing species
N-butanol All food-producing species For use as excipient
Natamycin Bovine, equidae For topical use only
Neostigmine All food-producing speciesNicoboxil Equidae For topical use onlyNonivamide Equidae For topical use onlyOleyloleate All food-producing species For topical use only
Oxytocin All mammalian food-producing species
Pancreatin All mammalian food-producing species For topical use onlyPapain All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 42
Pharmacologically active substance(s) Animal species Other provisions
Papaverine Bovine Newborn calves only
Peracetic acid All food-producing speciesPhenol All food-producing speciesPhloroglucinol All food-producing speciesPhytomenadione All food-producing speciesPolicresulen All food-producing species For topical use onlyPolyethylene glycol 15 hydroxystearate All food-producing species For use as excipient
Polyethylene glycol 7 glyceryl cocoate All food-producing species For topical use only
Polyethylene glycol stearates with 8-40 oxyethylene units All food-producing species For use as excipientPolysulphated glycosaminoglycan EquidaePraziquantel Ovine
EquidaeFor use in non-lactating sheep only
Pregnant mare serum gonadotrophin All food-producing species
Prethcamide (crotethamide and cropropamide) All mammalian food-producing speciesProcaine All food-producing speciesPropane All food-producing speciesPropylene glycol All food-producing speciesQuatresin All food-producing species For use as preservative only at concentrations of up to 0,5 %R-Cloprostenol Bovine, porcine, equidae▼M581990R2377 — EN — 07.02.2000 — 011.001 — 43
Pharmacologically active substance(s) Animal species Other provisions
Rifaximin All mammalian food-producing species
BovineFor topical use only
For intramammary use, except if the udder may be used as food for
human consumption
Romifidine Equidae For therapeutic uses only
Sodium 2-methyl-2-phenoxy-propanoate Bovine, porcine, caprine, equidaeSodium benzyl 4-hydroxybenzoate All food-producing species
Sodium butyl 4-hydroxybenzoate All food-producing species
Sodium cetostearyl sulphate All food-producing species For topical use only
Somatosalm Salmon
Tanninum All food-producing species
Tau fluvalinate
Terpin hydrate Bovine, porcine, ovine, caprine
Tetracaine All food-producing species For use as anaesthetic only
Theobromine All food-producing species
Theophylline All food-producing species
Thiomersal All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %
Thymol All food-producing species
Timerfonate All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %
Trimethylphloroglucinol All food-producing species
Vitamin D All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 44
Pharmacologically active substance(s) Animal species Other provisions
Wool alcohols All food-producing species For topical use only
1-Methyl-2-pyrrolidone Equidae
Cefacetrile Bovine For intramammary use only and for all tissues except milk
Enilconazole Bovine, equidae For topical use onlyEtamsylate All food producing species
Strychnine Bovine For oral use only at dose to 0,1 mg/kg bw
Parconazole Guinea fowl
Biotin All food producing species
Bromhexine Bovine
Not for use in animals from which milk is
produced for human consumption
Porcine
Poultry
Not for use in animals from which eggs are
produced for human consumption
Mercaptamine hydrochloride All mammalian food-producing species
Praziquantel Ovine
Pyrantel embonate EquidaeVitamin B1 All food-producing species
Vitamin B12 All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 45▼M59
▼M61
▼M63
Pharmacologically active substance(s) Animal species Other provisions
Vitamin B2 All food-producing species
Vitamin B3 All food-producing speciesVitamin B5 All food-producing species
Vitamin B6 All food-producing species
Vitamin E All food-producing species
Tiaprost Bovine, ovine, porcine, equidae
Apramycin Porcine, rabbits
Ovine
Not for use in animals from which milk is
produced for human consumption
Chicken
Not for use in animals from which eggs are
produced for human consumptionFor oral use only
Azamethiphos Salmonidae
Doxapram All mammalian food producing speciesPiperonyl butoxide Bovine, ovine, caprine, equidae For topical use onlySulfogaiacol All food producing species
Vetrabutine hydrochloride Porcine
Fenpipramide hydrochloride Equidae For intravenous use only
Hydrochlorothiazide Bovine
Levomethadone Equidae For intravenous use onlyTricaine mesilate Fin fishFor water borne use only▼M631990R2377 — EN — 07.02.2000 — 011.001 — 46▼M64
▼M65
▼M66
Pharmacologically active substance(s) Animal species Other provisions
Trichlormethiazide All mammalian food producing species Not for use in animals from which milk is produced for human
consumption
Vincamine Bovine For use in newborn animals only
Atropine All food producing species
Cefoperazone Bovine For intramammary use in lactating cows only and for all tissues except
milk
2-aminoethanol glucuronate All food-producing species
Betaine glucuronate All food-producing speciesBituminosulfonates, ammonium and sodium salts All mammalian food-producing species For topical use only
Not for use in animals from which milk is produced for human
consumption
Chlorphenamine All mammalian food-producing species
Humic acids and their sodium salts All food-producing species For oral use onlyParacetamol Porcine For oral use onlyTosylchloramide sodium Fin fish For water-borne use only
1-methyl-2-pyrrolidone All food-producing species
Ergometrine maleate All mammalian food-producing species For use in parturient animals only
Jecoris oleum All food-producing species For topical use only
Mepivacaine Equidae For intra-articular and epidural use as local anaesthetic onlyNovobiocin Bovine For intrammary use only and for all tissues except milkPiperazine dihydrochloride Chicken For all tissues except eggs▼M661990R2377 — EN — 07.02.2000 — 011.001 — 47▼M67
▼M69
▼M70
Pharmacologically active substance(s) Animal species Other provisions
Polyoxyl castor oil with30 to 40 oxyeth ylene units All food-producing species For use as excipient
Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units All food-producing species For use as excipientXylazine hydrochloride Bovine, equidae Not for use in animals from which milk is produced for human
consumptiom
3. Substances generally recognised as safe
Pharmacologically active substance(s) Animal species Other provisions
Absinthium extract All food-producing species
Acetylmethionine All food-producing speciesAluminium hydroxide All food-producing species
Aluminium monostearate All food-producing species
Ammonium sulfate All food-producing speciesBenzoyl benzoate All food-producing speciesBenzyl p-hydroxybenzoate All food-producing species
Calcium borogluconate All food-producing species
Calcium citrate All food-producing speciesCamphor All food-producing species External use onlyCardamon extract All food-producing species
Diethyl sebacate All food-producing species
Dimethicone All food-producing speciesDimethyl acetamide All food-producing species▼M701990R2377 — EN — 07.02.2000 — 011.001 — 48▼M58
Pharmacologically active substance(s) Animal species Other provisions
Dimethyl sulphoxide All food-producing species
Epinephrine All food-producing species
Ethyl oleate All food-producing speciesEthylenediaminetetraacetic acid and salts All food-producing species
Eucalyptol All food-producing species
Follicle stimulating hormone (natural FSH from all species and their
synthetic analogues)All food-producing species
Formaldehyde All food-producing species
Formic acid All food-producing speciesGlutaraldehyde All food-producing speciesGuaiacol All food-producing species
Heparin and its salts All food-producing species
Human chorionic gonadotropin (natural HCG and its synthetic analo-
gues)All food-producing species
Iron ammonium citrate All food-producing species
Iron dextran All food-producing speciesIron glucoheptonate All food-producing speciesIsopropanol All food-producing species
Lanolin All food-producing species
Luteinising hormone (natural LH from all species and their synthetic
analogues)All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 49
Pharmacologically active substance(s) Animal species Other provisions
Magnesium chloride All food-producing species
Magnesium gluconate All food-producing speciesMagnesium hypophosphite All food-producing species
Mannitol All food-producing species
Methylbenzoate All food-producing speciesMonothioglycerol All food-producing speciesMontanide All food-producing species
Myglyol All food-producing species
Orgotein All food-producing speciesPoloxalene All food-producing speciesPoloxamer All food-producing species
Polyethylene glycols (molecular weight ranging from 200 to 10000) All food-producing species
Polysorbate 80 All food-producing speciesSerotonin All food-producing speciesSodium chloride All food-producing speciesSodium cromoglycate All food-producing species
Sodium dioctylsulphosuccinate All food-producing species
Sodium formaldehydesulphoxylate All food-producing speciesSodium lauryl sulphate All food-producing speciesSodium pyrosulphite All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 50
Pharmacologically active substance(s) Animal species Other provisions
Sodium stearate All food-producing species
Sodium thiosulphate All food-producing species
TragacanthAll food-producing species
Urea All food-producing species
Zinc oxide All food-producing species
Zinc sulphate All food-producing species
Adenosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Alanine All food producing species
Arginine All food producing species
Asparagine All food producing species
Aspartic acid All food producing species
Carnitine All food producing species
Choline All food producing species
Chymotrypsin All food producing species
Citrulline All food producing species
Cysteine All food producing species
Cytidine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Glutamic acid All food producing species
Glutamine All food producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 51▼M65
Pharmacologically active substance(s) Animal species Other provisions
Glycine All food producing species
Guanosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Histidine All food producing species
Hyaluronic acid All food producing species
Inosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Inositol All food producing speciesIsoleucine All food producing species
Leucine All food producing species
Lysine All food producing speciesMethionine All food producing speciesOrnithine All food producing species
Orotic acid All food producing species
Pepsin All food producing speciesPhenylalanine All food producing speciesProline All food producing speciesSerine All food producing species
Thioctic acid All food producing species
Threonine All food producing speciesThymidine All food producing speciesTrypsin All food producing species▼M651990R2377 — EN — 07.02.2000 — 011.001 — 52
Pharmacologically active substance(s) Animal species Other provisions
Tryptophan All food producing species
Tyrosine All food producing speciesUridine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Valine All food producing species
4. Substances used in homeopathic veterinary medicinal products
Pharmacologically active substance(s) Animal species Other provisions
All substances used in homeopathic veterinary medicinal products
provided that their concentration in the product does not exceed one
part per ten thousandAll food-producing species
Adonis vernalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Acqua levici All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias only
Atropa belladonna All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Convallaria majalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only
Apocynum cannabinum All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
For oral use only▼M651990R2377 — EN — 07.02.2000 — 011.001 — 53▼M58
▼M64
▼M66
Pharmacologically active substance(s) Animal species Other provisions
Harunga madagascariensis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Selenicereus grandiflorus All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Thuja occidentalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Virola sebifera All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only
Ruta graveolens All food-producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only.
Not for use in animals from which milk is produced for human
consumption
5. Substances used as food additives in foodstuffs for human consumption
Pharmacologically active substance(s) Animal species Other provisions
Substances withan E number All food-producing species Only substances approved as additives in foodstuffs for h uman
consumption, withth e exception of preservatives listed in part C of
Annex III to European Parliament and Council Directive 95/2/EC (OJ
L 61, 18.3.1995, p. 1).
6. Substances of vegetable origin
Pharmacologically active substance(s) Animal species Other provisions
Angelicae radix aetheroleum All food-producing species
Anisi aetheroleum All food-producing species▼M661990R2377 — EN — 07.02.2000 — 011.001 — 54▼M68
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Balsamum peruvianum All food-producing species For topical use only
Calendulae flos All food-producing species For topical use only
Capsici fructus acer All food-producing species
Carvi aetheroleum All food-producing species
Caryophylli aetheroleum All food-producing species
Centellae asiaticaer extractum All food producing species For topical use only
Chrysanthemi cinerariifolii flos All food-producing species For topical use only
Cimicifugae racemosae rhizoma All food-producing species Not for use in animals from which milk is produced for human
consumptiom
Cinnamomi cassiae aetheroleum All food-producing species
Cinnamomi ceylanici aetheroleum All food-producing species
Citri aetheroleum All food-producing species
Citronellae aetheroleum All food-producing species
Coriandri aetheroleum All food-producing species
Echinacea purpurea All food-producing species For topical use only
Eucalypti aetheroleum All food-producing species
Foeniculi aetheroleum All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 55▼M70
▼M68
▼M58
▼M59
▼M58
▼M70
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Hamamelis virginiana All food-producing species For topical use only
Hippocastani semen All food-producing species For topical use only
Hyperici oleum All food-producing species For topical use only
Juniperi fructus All food-producing species
Lauri folii aetheroleum All food-producing species
Lauri fructus All food-producing species
Lespedeza capitata All food-producing species
Lini oleum All food-producing species
Majoranae herba All food-producing species
Matricariae flos All food-producing species
Medicago sativa extractum All food-producing species For topical use only
Melissae aetheroleum All food producing species
Melissae folium All food-producing species
Menthae piperitae aetheroleum All food-producing species
Millefolii herba All food-producing species
Myristicae aetheroleum All food-producing species For use in newborn animals only
Oxidation products of Terebinthinae oleum Bovine, porcine, ovine, caprine▼M581990R2377 — EN — 07.02.2000 — 011.001 — 56▼M68
▼M58
▼M68
▼M58
▼M59
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Pyrethrum extract All food-producing species For topical use only
Quercuscortex All food-producing species
Quillaia saponins All food-producing species
Ricini oleum All food-producing species For use as excipient
Rosmarini aetheroleum All food-producing species
Rosmarini folium All food-producing species
Ruscus aculeatus All food-producing species For topical use only
Salviae folium All food-producing species
Sambuci flos All food-producing species
Sinapis nigrae semen All food-producing species
Strychni semen Bovine, ovine, caprine For oral use only at doses up to the equivalent of 0,1 mg strychnine/kg
bw
Terebinthinae aetheroleum rectificatum All food-producing species For topical use only
Terebinthinae laricina All food-producing species For topical use only
Thymi aetheroleum All food-producing species
Tiliae flos All food-producing species
Urticae herba All food-producing species▼M581990R2377 — EN — 07.02.2000 — 011.001 — 57▼M68
▼M58
▼M68
▼M58
ANNEX III
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCESUSED IN VETERINARYMEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE
BEENFIXED
1. Anti-infectious agents
1.1. Chemotheurapeutics
1.1.2. Benzenesulphonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clorsulon Clorsulon Bovine 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
150 µg/kg Liver
400 µg/kg Kidney
1.2. Antibiotics
1.2.1. Beta-lactamase inhibitors
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clavulanic acid Clavulanic acid Bovine, ovine 200 µg/kg Milk ►M67Provisional MRLs expire on 1 July
2001◄
Bovine, ovine, porcine 200 µg/kg Muscle
200 µg/kg Fat
200 µg/kg Liver
200 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 58
1.2.2. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Erythromycin MRLs apply to all
microbiological active
residues expressed as
erythromycin equivalentBovine, ovine 40 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,
poultry400 µg/kg Muscle
400 µg/kg Fat
400 µg/kg Liver
400 µg/kg Kidney
Poultry 200 µg/kg Eggs
Josamycin Josamycin Chicken 200 µg/kg Muscle Provisional MRLs expire on 1 July 2000
200 µg/kg Fat
200 µg/kg Liver400 µg/kg Kidney
200 µg/kg Eggs
Sum of the microbiologi-
cally active metabolites,
expressed as josamycinPorcine 200 µg/kg Muscle Provisional MRLs expire on 1.7.2002
200µg/kg Skin and fat
200µg/kg Liver
400µg/kg Kidney
Tilmicosin Tilmicosin Bovine 40 µg/kg Milk Provisional MRLs expire on 1.1.2001
1.2.4. Cephalosporins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefacetrile Cefacetrile Bovine 125 µg/kg Milk Provisional MRLs expire on 1.1.2001
For intrammamary use only▼M581990R2377 — EN — 07.02.2000 — 011.001 — 59
▼M61
▼M70
▼M59
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefoperazone Cefoperazone Bovine 50 µg/kg Milk Provisional MRLs expire on 1 January 2001
Cefquinome Cefquinome Porcine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2000
50µg/kg Skin + fat
100µg/kg Liver
200µg/kg Kidney
Cephapirin Sum of cephapirin and
desacetylcephapirinBovine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
50µg/kg Liver
100µg/kg Kidney
10µg/kg Milk
1.2.5. Aminoglycosides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Aminosidine Aminosidine Bovine, porcine, rabbits,
chicken500 µg/kg Muscle Provisional MRLs expire on 1 July 2000
1 500 µg/kg Liver
1 500 µg/kg Kidney
Apramycin Apramycin Bovine 1 000 µg/kg Muscle Provisional MRLs expire on 1 July 1999
For use in non-lactating
cattle only1 000 µg/kg Fat
10000 µg/kg Liver
20000 µg/kg Kidney
Porcine 1 000 µg/kg Muscle
1 000 µg/kg Skin and fat
1 000 µg/kg Liver▼M591990R2377 — EN — 07.02.2000 — 011.001 — 60▼M67
▼M62
▼M59
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
5 000 µg/kg Kidney
Dihydrostreptomycin Dihydrostreptomycin Bovine, ovine 200 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,
poultry500 µg/kg Muscle
500 µg/kg Fat
500 µg/kg Liver
1 000 µg/kg Kidney
Gentamicin Gentamicin Bovine 100 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, porcine 100 µg/kg Muscle
100 µg/kg Fat
200 µg/kg Liver
1 000 µg/kg Kidney
Kanamycin Kanamycin Rabbits 100 µg/kg Muscle Provisional MRLs expire on 1.1.2002
100µg/kg Fat
600µg/kg Liver
2 500 µg/kg Kidney
Bovine, ovine 100 µg/kg Muscle
100µg/kg Fat
600µg/kg Liver
2 500 µg/kg Kidney
150µg/kg Milk
Porcine, chicken 100 µg/kg Muscle
100µg/kg Skin + fat
600µg/kg Liver
2 500 µg/kg Kidney
Neomycin (including framycetin) Neomycin Bovine, ovine, caprine 500 µg/kg Milk Provisional MRLs expire on 1 June 2000▼M581990R2377 — EN — 07.02.2000 — 011.001 — 61▼M65
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Bovine, ovine, caprine,
porcine, chicken, turkey,
duck500 µg/kg Muscle
500 µg/kg Fat
500 µg/kg Liver
5 000 µg/kg Kidney
Chicken 500 µg/kg Eggs
Spectinomycin Spectinomycin Bovine 200 µg/kg Milk Provisional MRLs expire on 1 July 2000
Bovine, porcine, poultry 300 µg/kg Muscle
500 µg/kg Fat
2 000 µg/kg Liver
5 000 µg/kg Kidney
Streptomycin Streptomycin Bovine, ovine 200 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,
poultry500 µg/kg Muscle
500 µg/kg Fat
500 µg/kg Liver
1 000 µg/kg Kidney
1.2.6. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Danofloxacin Danofloxacin Porcine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2000
50µg/kg Skin and fat
200µg/kg Liver
200µg/kg Kidney
Decoquinate Decoquinate Bovine, ovine 500 µg/kg Muscle Provisional MRLs expire on 1 July 2000▼M581990R2377 — EN — 07.02.2000 — 011.001 — 62
▼M61
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
500 µg/kg Fat
500 µg/kg Liver500 µg/kg Kidney
Difloxacin Difloxacin Bovine
Not for use in animals
from which milk is
produced for human
consumption400µg/kg Muscle Provisional MRLs expire on 1.1.2001
100µg/kg Fat
1 400 µg/kg Liver
800µg/kg Kidney
Porcine 400 µg/kg Muscle
100µg/kg Skin and fat
800µg/kg Liver
800µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinOvine 100 µg/kg Muscle Provisional MRLs expire on 1 July 1999
100 µg/kg Fat
300 µg/kg Liver
200 µg/kg Kidney
Flumequine Flumequine Bovine, ovine, porcine,
chicken50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
50 µg/kg Fat or skin and fat
100 µg/kg Liver
300 µg/kg Kidney
Salmonidae 150 µg/kg Muscle and skin
Marbofloxacin Marbofloxacin Bovine 150 µg/kg Muscle Provisional MRLs expire on 1 July 2000
50 µg/kg Fat
150 µg/kg Liver150 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 63▼M63
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
75 µg/kg Milk
Porcine 150 µg/kg Muscle
50 µg/kg Skin and fat
150 µg/kg Liver
150 µg/kg Kidney
Oxolinic acid Oxolinic acid Bovine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
150µg/kg Liver
150µg/kg Kidney
Porcine 100 µg/kg Muscle
50µg/kg Skin + fat
150µg/kg Liver
150µg/kg Kidney
Chicken 100 µg/kg Muscle
50µg/kg Skin + fat
150µg/kg Liver
150µg/kg Kidney
50µg/kg Eggs
Fin fish300 µg/kg Muscle and skin in
natural proportions
1.2.9. Polymyxins
Phamarcologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Colistin Colistin Bovine, ovine 50 µg/kg Milk Provisional MRLs expire on 1 July 2000
Bovine, ovine, porcine,
chicken, rabbits150 µg/kg Muscle
150 µg/kg Fat▼M581990R2377 — EN — 07.02.2000 — 011.001 — 64▼M59
▼M58
Phamarcologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
150 µg/kg Liver
200 µg/kg Kidney
Chicken 300 µg/kg Eggs
1.2.10. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Nafcillin Nafcillin Bovine 300 µg/kg Muscle Provisional MRLs expire on 1.1.2001
300µg/kg Fat
300µg/kg Liver
300µg/kg Kidney
30µg/kg Milk
Penethamate Benzylpenicillin Ovine 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
Porcine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
1.2.11. Florfenicol and related compounds
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Florfenicol Sum of florfenicol and
its metabolites measured
as florfenicol-amineFish1 000 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 July 2001▼M581990R2377 — EN — 07.02.2000 — 011.001 — 65▼M59
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Thiamphenicol Thiamphenicol Ovine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
50µg/kg Liver
50µg/kg Kidney
Porcine 50 µg/kg Muscle
50µg/kg Skin + fat
50µg/kg Liver
50µg/kg Kidney
Fin fish50 µg/kg Muscle and skin in
natural proportions
1.2.12. Polypeptides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Bacitracin Bacitracin Bovine 150 µg/kg Milk Provisional MRLs expire on 1.7.2001▼M581990R2377 — EN — 07.02.2000 — 011.001 — 66▼M59
▼M61
1.2.13. Lincosamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Lincomycin Lincomycin Ovine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
500µg/kg Liver
1 500 µg/kg Kidney
150µg/kg Milk
Porcine 100 µg/kg Muscle
50µg/kg Skin + fat
500µg/kg Liver
1 500 µg/kg Kidney
Chicken 100 µg/kg Muscle
50µg/kg Skin + fat
500µg/kg Liver
1 500 µg/kg Kidney
50µg/kg Eggs
Pirlimycin Pirlimycin Bovine 100 µg/kg Muscle Provisional MRLs expire on 1.7.2000
100µg/kg Fat
1 000 µg/kg Liver
400µg/kg Kidney
100µg/kg Milk▼M591990R2377 — EN — 07.02.2000 — 011.001 — 67
▼M61
2. Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Phenol derivatives including salicylanides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Oxyclozanide Oxyclozanide Bovine 20 µg/kg Muscle Provisional MRLs expire on 1.7.2000
20µg/kg Fat
500µg/kg Liver
100µg/kg Kidney
10µg/kg Milk
Ovine 20 µg/kg Muscle
20µg/kg Fat
500µg/kg Liver
100µg/kg Kidney
2.1.2. Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole sulphoxide Sum of albendazole,
albendazole sulphoxide,
albendazole sulphone,
and albendazole 2-amino
sulphone, expressed as
albendazoleBovine, ovine 100 µg/kg Milk Provisional MRLs expire on 1 January 2000
Bovine, ovine, pheasant 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 68▼M63
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Netobimin Sum of netobimin and
albendazole and metabo-
lites of albendazole
measured as 2-amino-
benzimidazole sulphoneBovine, ovine, caprine 100 µg/kg Muscle Provisional MRLs expire on 31 July 1999
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney
100 µg/kg Milk
2.1.3. Tetrahydropyrimides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Morantel Sum of residues which
may be hydrolysed to N-
Methyl-1,3-propanedia-
mine and expressed as
morantel equivalentsBovine, ovine 100 µg/kg Muscle Provisional MRLs expire on 1.7.2001
100µg/kg Fat
800µg/kg Liver
200µg/kg Kidney
100µg/kg Milk
Porcine 100 µg/kg Muscle
100µg/kg Skin and fat
800µg/kg Liver
200µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 69▼M63
2.1.5. Piperazine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Piperazine Piperazine Porcine 400 µg/kg Muscle Provisional MRLs expire on 1.7.2001
800µg/kg Skin and fat
2 000 µg/kg Liver
1 000 µg/kg Kidney
Chicken 2 000 µg/kg Eggs
2.2. Agents acting against ectoparasites
2.2.1. Formamidines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all
metabolites containing
the 2,4-DMA moeity,
expressed as amitrazBees 200 µg/kg Honey Provisional MRLs expire on 1 July 1999
2.2.2. Iminophenyl thiazolidine derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cymiazole Cymiazole Bees 1 000 µg/kg Honey ►M65Provisional MRLs expire on
1.7.2001 ◄▼M701990R2377 — EN — 07.02.2000 — 011.001 — 70▼M58
2.2.3. Pyretrin and pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyfluthrin Cyfluthrin Bovine 10 µg/kg Muscle Provisional MRLs expire on 1 January 2001
50 µg/kg Fat10 µg/kg Liver
10 µg/kg Kidney
20 µg/kg Milk
Further provisions in
Council Directive 94/29/
EC are to be observed
(OJ L 189, 23.7.1994, p.
67)
Alphacypermethrin Cypermethrin (sum of
isomers)Bovine, ovine 20 µg/kg Muscle Provisional MRLs expire on 1.1.2002
200µg/kg Fat
20µg/kg Liver
20µg/kg Kidney
20µg/kg Milk
Further provisions in
Council Directive 93/57/
EC (OJ L 211,
23.8.1992, p. 1) are to be
observed
Chicken 50 µg/kg Muscle
50µg/kg Skin + fat
50µg/kg Liver
50µg/kg Kidney
50µg/kg Eggs▼M581990R2377 — EN — 07.02.2000 — 011.001 — 71▼M62
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cypermethrin Cypermethrin (sum of
isomers)Bovine, ovine, caprine 20 µg/kg Muscle Provisional MRLs expire on 1.1.2002
200µg/kg Fat
20µg/kg Liver
20µg/kg Kidney
20µg/kg Milk
Further provisions in
Council Directive 93/57/
EC (OJ L 211,
23.8.1992, p. 1) are to be
observed
Porcine 20 µg/kg Muscle
200µg/kg Skin + fat
20µg/kg Liver
20µg/kg Kidney
Chicken 50 µg/kg Muscle
50µg/kg Skin + fat
50µg/kg Liver
50µg/kg Kidney
50µg/kg Eggs
Salmonidae 50 µg/kg Muscle and skin in
natural proportions
Deltamethrin Deltamethrin Bovine 10 µg/kg Muscle Provisional MRLs expire on 1 July 2001
50µg/kg Fat
10µg/kg Liver
10µg/kg Kidney
20µg/kg Milk
Ovine
Not for use in animals
from which milk is
produced for human
consumption10µg/kg Muscle
50µg/kg Fat
10µg/kg Liver
10µg/kg Kidney▼M621990R2377 — EN — 07.02.2000 — 011.001 — 72
▼M66
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chicken 10 µg/kg Muscle
50µg/kg Skin + fat
10µg/kg Liver
10µg/kg Kidney
50µg/kg Eggs
2.2.4. Organophosphates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azamethiphos Azamethiphos Salmonidae 100 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 June 1999
Coumafos Coumafos Bees 100 µg/kg Honey Provisional MRLs expire on 1.7.2001
Phoxim Phoxim Porcine 20 µg/kg Muscle Provisional MRLs expire on 1 January 2001
700µg/kg Skin and fat
20µg/kg Liver
20µg/kg Kidney
2.2.5. Acyl urea derivates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 July 1999
Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1.7.2000▼M661990R2377 — EN — 07.02.2000 — 011.001 — 73▼M58
▼M65
▼M68
▼M58
▼M63
2.2.6. Pyrimidines derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dicyclanil Sum of dicyclanil and
2,4,6-triamino-pyrimi-
dine-5-carbonitrileOvine 200 µg/kg Muscle Provisional MRLs expire on 1 July 2000;
Not for use in animals from which milk is
produced for human consumption50µg/kg Fat
400µg/kg Liver
400µg/kg Kidney
2.2.7. Triazine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyromazine Cyromazine Ovine 300 µg/kg Muscle Provisional MRLs expire on 1.7.2001
Not for use in animals from which milk is
produced for human consumption300µg/kg Fat
300µg/kg Liver
300µg/kg Kidney
2.3. Agents acting against endo- and ectoparasites
2.3.1. Avermectins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Moxidectin Moxidectin Equidae 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
500 µg/kg Fat
100 µg/kg Liver
50 µg/kg Kidney▼M691990R2377 — EN — 07.02.2000 — 011.001 — 74▼M70
▼M58
2.4. Agents acting against protozoa
2.4.1. Carbanilides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Imidocarb Imidocarb Bovine, ovine 300 µg/kg Muscle Provisonal MRLs expire on 1.1.2002
50µg/kg Fat
2 000 µg/kg Liver
1 500 µg/kg Kidney
50µg/kg Milk
2.4.2. Quinazolone derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Halofuginone Halofuginone Bovine 10 µg/kg Muscle Provisional MRL's expire on 1.1.2001
25µg/kg Fat
30µg/kg Liver
30µg/kg Kidney
2.4.3. Triazinetrione derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Porcine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
150µg/kg Skin and fat
500µg/kg Liver
250µg/kg Kidney▼M611990R2377 — EN — 07.02.2000 — 011.001 — 75▼M63
▼M70
3. Agents acting on the nervous system
3.2. Agents acting on the autonomic nervous system
3.2.1. β2sympathomimetic agents
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clenbuterol hydrochloride Clenbuterol Bovine 0,1 µg/kg Muscle Provisional MRLs expire on 1 July 2000
Indication: solely for
tocolysis in parturient
cows0,5 µg/kg Liver
0,5 µg/kg Kidney
0,05 µg/kg Milk
Equidae 0,1 µg/kg Muscle
Indications: tocolysis and
the treatment of respira-
tory ailments0,5 µg/kg Liver
0,5 µg/kg Kidney
3.2.2. Anti-adrenergics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Bovine 5 µg/kg Muscle Provisional MRLs expire on 1.1.2000
5µg/kg Fat
15µg/kg Liver
15µg/kg Kidney
1µg/kg Milk▼M581990R2377 — EN — 07.02.2000 — 011.001 — 76▼M61
5. Anti-inflammatory agents
5.1. Nonsteroidal anti-inflammatory agents
5.1.1. Arylpropionic acid derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carprofen Carprofen Bovine 500 µg/kg Muscle Provisional MRLs expire on 1 January 2000
500 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
Equidae 50 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
5.1.2. Enolic acid derivates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine 25 µg/kg Muscle Provisional MRLs expire on 1 January 2000
60 µg/kg Liver
35 µg/kg Kidney▼M581990R2377 — EN — 07.02.2000 — 011.001 — 77
▼M58
ANNEX IV
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR
WHICHNOMAXIMUMLEVELSCANBEFIXED
Pharmacologically active substance(s)
Aristolochia spp. and preparations thereof
Chloramphenicol
Chloroform
ChlorpromazineColchicineDapsoneDimetridazole
Metronidazole
Nitrofurans (including furazolidone)Ronidazole1990R2377 — EN — 07.02.2000 — 011.001 — 78
▼M2
ANNEX V
Information and particulars to be included in an application for the estab-
lishment of a maximum residue limit for a pharmacologically active
substanceusedinveterinary medicinalproducts
Administrative particulars
1 Name or corporate name and permanent address of the applicant.
2 Name of the veterinary medicinal product.3 Qualitative and quantitative composition in terms of active principles, with
mention of the international non-proprietary name recommended by the
World HealthOrganization, wh ere suchname exists.
4 Manufacturing authorization, if any.
5 Marketing authorization, if any.6 Summary of the characteristics of the veterinary medicinal product(s)
prepared in accordance withArticle 5a of Directive 81/851/EEC.
A.Safety documentation
A.0. Expert report
A.1. Precise identification of the substance concerned by the application
1.1 International non-proprietary name (INN).1.2 International Union of Pure and Applied Chemistry (IUPAC) name.
1.3 Chemical Abstract Service (CAS) name.
1.4 Classification:
— therapeutic;
— pharmacological.
1.5 Synonyms and abbreviations.
1.6 Structural formula.
1.7 Molecular formula.1.8 Molecular weight.
1.9 Degree of impurity.
1.10 Qualitative and quantitative composition of impurities.1.11 Description of physical properties:
— melting point;
— boiling point;— vapour pressure;
— solubility in water and organic solvents, expressed in grams per
litre, withindication of temperature;
— density;— refractive index, rotation, etc.
A.2. Relevant pharmacological studies
2.1 Pharmacodynamics.2.2 Pharmacokinetics.
A.3. Toxicological studies
3.1 Single dose toxicity.3.2 Repeated dose toxicity.
3.3 Tolerance in the target species of animal.
3.4 Reproductive toxicity, including teratogenicity.3.4.1 Study of the effects on reproduction.
3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.
3.5 Mutagenicity.3.6 Carcinogenicity.1990R2377 — EN — 07.02.2000 — 011.001 — 79
▼M2
A.4. Studies of other effects
4.1 Immunotoxicity.
4.2 Microbiological properties of residues.4.2.1 On the human gut flora;
4.2.2 On the organisms and microorganisms used for industrial food-
processing.
4.3 Observations in humans.
B.Residue documentation
B.0 Expert reportB.1. Precise identification of the substance concerned by the application
The substance concerned should be identified in accordance with point
A.1. However, where the application relates to one or more veterinary
medicinal products, the product itself should be identified in detail,
including:
— qualitative and quantitative composition;
— purity;— identification of the manufacturer's batch used in the studies; relation-
ship to the final product;
— specific activity and radio-purity of labelled substances;— position of labelled atoms on the molecule.
B.2. Residue studies
2.1 Pharmacokinetics
(absorption, distribution, biotransformation, excretion).
2.2 Depletion of residues.2.3 Elaboration of maximum residue limits (MRLS).
B3. Routine analytical method for the detection of residues
3.1 Description of the method.3.2 Validation of the method.
3.2.1 specificity;
3.2.2 accuracy, including sensitivity;3.2.3 precision;
3.2.4 limit of detection;
3.2.5 limit of quantitation;3.2.6 practicability and applicability under normal laboratory conditions;
3.2.7 susceptibility to interference.1990R2377 — EN — 07.02.2000 — 011.001 — 80