1990R2377 — EN — 20.01.2008 — 056.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:





Corrected by:









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COUNCIL REGULATION (EEC) No 2377/90

of 26 June 1990

laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin







THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, 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 at ever lower levels; whereas it is therefore necessary to establish maximum 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 principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organizations, in particular the Codex Alimentarius 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 animal origin; 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 medicinal products by the Community, following a single scientific assessment of the highest possible quality; Whereas the need for the establishment of maximum residue levels throughout the Community is recognized in the Community rules relating 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-producing 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 number of 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 a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products ( 4 ), as last amended by Directive 87/20/EEC ( 5 ); whereas an urgent procedure is also required to ensure the swift review of any tolerance which might prove insufficient 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 by Directive 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 pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the veterinary medicinal product 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 recognized 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 into account other relevant public health risks as well as food technology 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 with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.

2. This Regulation shall not apply to active principles of biological origin intended to produce active or passive immunity or to diagnose a state 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 have been established shall be contained in Annex I, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex I shall be adopted in accordance with the same procedure.

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 a maximum residue limit, that substance shall be included in a list in Annex II, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex II shall be adopted in accordance with the same procedure.

Article 4

A provisional maximum residue limit may be established for a pharmacologically active substance used in veterinary medicinal products on the date of entry into force of this Regulation, provided that there are no 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 of time, which shall not exceed five years. That period may be extended once only in exceptional cases for a period not in excess of two years if that 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 not previously used in veterinary medicinal products on the date of entry into 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 residue limits have been established shall be contained in Annex III, which shall 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 to the health of the consumer, that substance shall be included in a list in Annex IV, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex IV shall be adopted in accordance with the same procedure.

The administration of the substances listed in Annex IV to food-producing animals shall be prohibited throughout the Community.

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Article 6

1. In order to obtain the inclusion in Annexes I, II or III of a pharmacologically active substance which is intended for use in veterinary medicinal products for administration to food-producing animals, an application to establish a maximum residue limit shall be submitted to the European Agency for the Evaluation of Medicinal Products set up by Council Regulation (EEC) No 2309/93 ( 6 ), 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 principles laid down in Directive 81/852/EEC.

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 ‘the Committee’) 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 delivered within a period of 120 days following the reception of a valid application.

If the information submitted by the applicant is not sufficient to enable such an opinion to be prepared, the Committee may ask the applicant to supply additional information within a specific time limit. The deadline for the opinion shall then be deferred until the additional information 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 notice to the Agency that he wishes to appeal. In that case he shall forward the 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 should be revised and the reasons for the conclusion reached on the appeal shall 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 and to the applicant. The opinion shall be accompanied by a report describing 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 in Article 8. The Committee referred to in Article 8 shall adapt its rules of procedure in order to take account of the tasks conferred on it by this Regulation.

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Article 8

1. The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC ( 7 ) shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Standing Committee shall adopt its Rules of Procedure.

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Article 9

1. Where a Member State, as a result of new information or a reassessment 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 to be taken, that Member State may temporarily suspend the operation of the provision concerned in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures, attaching a statement of the reasons therefor.

2. ►M64 The 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 deliver its opinion forthwith and take appropriate measures; the person responsible for marketing may be requested to provide the Committee with oral 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 Council within 15 days of such notification. The Council, acting by a qualified majority, may take a different decision within 30 days of the date on which 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 difficulties referred to in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 10 with a view to adopting those amendments; the Member State which has taken measures under paragraph 1 may maintain them until the Council or the Commission has taken a decision in accordance with the abovementioned procedure.

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Article 10

1. The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

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Article 11

Any changes which are necessary to adapt Annex V to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 2c of Directive 81/852/EEC.

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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 any proprietary data shall be respected. The Agency shall provide the competent authorities and the Commission with appropriate methods for identifying pharmacologically active substances for which the MRL's have been determined in ►C5 Annexes I and III. ◄

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Article 13

Member States may not prohibit or impede the putting into circulation within their territories of foodstuffs of animal origin originating in other Member States on the grounds that they contain residues of veterinary 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

With effect from 1 January 1997, the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II or III shall be prohibited within the Community, except in the case of clinical trials accepted by the competent authorities following notification or authorization in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health.

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However, the date referred to in the previous subparagraph shall be deferred for substances the use of which was authorized on the date of entry into force of this Regulation and in respect of which documented 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:

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— until 1 January 1998 in the case of pyrazolinones (including pyrazolidinediones and phenylbutazones), nitroimidazoles and arsalinic acid, and

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— until 1 January 2000 in the case of other substances.

The Agency shall publish a list of these substances before 7 June 1997.

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Article 15

This Regulation shall in no way prejudice the application of Community 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 medicinal products.

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.

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ANNEX I

LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

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 group Parent drug All food-producing species 100 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 ▼M96 Trimethoprim Trimethoprim All food producing species except equidae 50 μg/kg Fat (1) Not for use in animals from which eggs are produced for human consumption 50 μg/kg Muscle (2) 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk Equidae 100 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 100 μg/kg Kidney ▼M58 (1) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. (2) For fin fish this MRL relates to ‘muscle and skin in natural proportions’. 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 species 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 4 μg/kg Milk Ampicillin Ampicillin All food-producing species 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 4 μg/kg Milk Benzylpenicillin Benzylpenicillin All food-producing species 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 4 μg/kg Milk Cloxacillin Cloxacillin All food-producing species 300 μg/kg Muscle 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 30 μg/kg Milk Dicloxacillin Dicloxacillin All food-producing species 300 μg/kg Muscle 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 30 μg/kg Milk ▼M111 Nafcillin Nafcillin All ruminants (1) 300 μg/kg Muscle 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 30 μg/kg Milk ▼M58 Oxacillin Oxacillin All food-producing species 300 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 ▼M72 Porcine 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney ▼M120 All mammalian-food producing species 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 4 μg/kg Milk ▼M74 Phenoxymethylpenicillin Phenoxymethylpenicillin Porcine 25 μg/kg Muscle 25 μg/kg Liver 25 μg/kg Kidney ▼M121 Poultry (2) 25 μg/kg Muscle 25 μg/kg Skin + fat 25 μg/kg Liver 25 μg/kg Kidney ▼M58 (1) For intramammary use only. (2) Not for use in animals from which eggs are produced for human consumption. 1.2.2. Cephalosporins



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M91 Cefacetrile Cefacetrile Bovine 125 μg/kg Milk For intramammary use only ▼M71 Cefalexin Cefalexin Bovine 200 μg/kg Muscle 200 μg/kg Fat 200 μg/kg Liver 1 000 μg/kg Kidney 100 μg/kg Milk ▼M100 Cefalonium Cefalonium Bovine 20 μg/kg Milk ▼M87 Cefapirin Sum of cephapirin and desacetylcephapirin Bovine 50 μg/kg Muscle 50 μg/kg Fat 100 μg/kg Kidney 60 μg/kg Milk ▼M58 Cefazolin Cefazolin Bovine, ovine, caprine 50 μg/kg Milk ▼M83 Cefoperazone Cefoperazone Bovine 50 μg/kg Milk ▼M58 Cefquinome Cefquinome Bovine 50 μg/kg Muscle 50 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney 20 μg/kg Milk ▼M65 Porcine 50 μg/kg Muscle 50 μg/kg Skin + fat 100 μg/kg Liver 200 μg/kg Kidney ▼M109 Equidae 50 μg/kg Muscle 50 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney ▼M128 Ceftiofur Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur All mammalian food-producing species 1 000 μg/kg Muscle 2 000 μg/kg Fat (1) 2 000 μg/kg Liver 6 000 μg/kg Kidney 100 μg/kg Milk ▼M58 (1) For porcine species this MRL relates to ‘skin and fat in natural proportions’. 1.2.3. Quinolones



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M96 Danofloxacin Danofloxacin ►C8 All food producing species except bovine, ovine, caprine, porcine and poultry ◄ 100 μg/kg Muscle (2) 50 μg/kg Fat (1) 200 μg/kg Liver 200 μg/kg Kidney Bovine, ovine, caprine 200 μg/kg Muscle 100 μg/kg Fat 400 μg/kg Liver 400 μg/kg Kidney 30 μg/kg Milk Poultry 200 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 100 μg/kg Skin and fat 400 μg/kg Liver 400 μg/kg Kidney Difloxacin Difloxacin All food producing species except bovine, ovine, caprine and poultry 300 μg/kg Muscle (2) 100 μg/kg Fat 800 μg/kg Liver 600 μg/kg Kidney Bovine, ovine, caprine 400 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 100 μg/kg Fat 1 400 μg/kg Liver 800 μg/kg Kidney Porcine 400 μg/kg Muscle 100 μg/kg Skin and fat 800 μg/kg Liver 800 μg/kg Kidney Poultry 300 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 400 μg/kg Skin and fat 1 900 μg/kg Liver 600 μg/kg Kidney Enrofloxacin Sum of enrofloxacin and ciprofloxacin All food producing species except bovine, ovine, caprine, porcine, rabbits and poultry 100 μg/kg Muscle (2) 100 μg/kg Fat 200 μg/kg Liver 200 μg/kg Kidney Bovine, ovine, caprine 100 μg/kg Muscle 100 μg/kg Fat 300 μg/kg Liver 200 μg/kg Kidney 100 μg/kg Milk Porcine, rabbits 100 μg/kg Muscle 100 μg/kg Fat (1) 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 consumption 100 μg/kg Skin and fat 200 μg/kg Liver 300 μg/kg Kidney Flumequine Flumequine All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish 200 μg/kg Muscle 250 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney Bovine, porcine, ovine, caprine 200 μg/kg Muscle 300 μg/kg Fat (1) 500 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Milk Poultry 400 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 250 μg/kg Skin and fat 800 μg/kg Liver 1 000 μg/kg Kidney Fin fish 600 μg/kg Muscle and skin in natural proportion ▼M77 Marbofloxacin Marbofloxacin Bovine 150 μg/kg Muscle 50 μg/kg Fat 150 μg/kg Liver 150 μg/kg Kidney 75 μg/kg Milk Porcine 150 μg/kg Muscle 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney ▼M103 Oxolinic acid Oxolinic acid Porcine 100 μg/kg Muscle 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney Chicken 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney Fin fish 100 μg/kg Muscle and skin in natural proportions ▼M122 All food-producing species (3) 100 μg/kg Muscle (1) 50 μg/kg Fat (4) 150 μg/kg Liver 150 μg/kg Kidney ▼M58 Sarafloxacin Sarafloxacin Chicken 10 μg/kg Skin and fat 100 μg/kg Liver Salmonidae 30 μg/kg Muscle and skin in natural proportions (1) For fin fish this MRL relates to ‘muscle and skin in natural proportions’. (2) For porcine species this MRL relates to ‘skin and fat in natural proportions’. (3) Not for use in animals from which milk or eggs are produced for human consumption; MRLs for fat, liver and kidney do not apply to fin fish. (4) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. 1.2.4. Macrolides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M137 ————— ▼M96 Erythromycin Erythromicyin A All food producing species 200 μg/kg Muscle (1) 200 μg/kg Fat (2) 200 μg/kg Liver 200 μg/kg Kidney 40 μg/kg Milk 150 μg/kg Eggs ▼M58 Spiramycin Sum of spiramycin and neospiramycin Bovine 200 μg/kg Muscle 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 200 μg/kg Milk Chicken 200 μg/kg Muscle 300 μg/kg Skin and fat 400 μg/kg Liver ▼M70 Spiramycin 1 Porcine 250 μg/kg Muscle 2 000 μg/kg Liver 1 000 μg/kg Kidney ▼M96 Tilmicosin Tilmicosin All food producing species except poultry 50 μg/kg Muscle (1) 50 μg/kg Fat (2) 1 000 μg/kg Liver 1 000 μg/kg Kidney 50 μg/kg Milk Poultry 75 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 75 μg/kg Sin and fat 1 000 μg/kg Liver 250 μg/kg Kidney ▼C11 Tulathromycin (2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R)-2-ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopy-ranosyl]oxy]-1-oxa-6-azacyclopent-decan-15-one expressed as tulathromycin equivalents Bovine (4) 100 μg/kg Fat 3 000 μg/kg Liver 3 000 μg/kg Kidney Porcine 100 μg/kg Skin + fat 3 000 μg/kg Liver 3 000 μg/kg Kidney ▼M96 Tylosin Tylosin A All food producing species 100 μg/kg Fat (3) 100 μg/kg Muscle (1) 100 μg/kg Liver 100 μg/kg Kidney 50 μg/kg Milk 200 μg/kg Eggs ▼M137 Tylvalosin Sum of tylvalosin and 3-O-acetyltylosin Porcine 50 μg/kg Muscle 50 μg/kg Fat (2) 50 μg/kg Liver 50 μg/kg Kidney Poultry (6) 50 μg/kg Fat (7) 50 μg/kg Liver (1) For fin fish this MRL relates to a ‘muscle and skin in natural proportions’. (2) For porcine species this MRL relates to ‘skin and fat in natural proportions’. (3) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. (4) Not for use in animals from which milk is produced for human consumption. (5) Not for use in animals from which milk is produced for human consumption. (6) Not for use in animals from which eggs are produced for human consumption. (7) For poultry species, this MRL relates to “skin and fat in natural proportions”. 1.2.5. Florfenicol and related compounds



Pharmacologically active Substance(s) Marker residue Animal species MRLs Target tissues Thiamphenicol Thiamphenicol All food producing species (1) 50 μg/kg Muscle (2) 50 μg/kg Fat (3) 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk (1) Not for use in animals from which eggs are produced for human consumption, MRLs for fat, liver and kidney do not apply to fin fish. (2) For fin fish muscle relates to ‘muscle and skin in natural proportions’. (3) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. 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- epimer All food-producing species 100 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 consumption 300 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 consumption 300 μg/kg Skin and fat 300 μg/kg Liver 600 μg/kg Kidney Oxytetracycline Sum of parent drug and its 4-epimer All food-producing species 100 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-epimer All food-producing species 100 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 ▼M71 Tiamulin Sum of metabolites that may be hydrolysed to 8-a-hydroxymutilin Porcine 100 μg/kg Muscle 500 μg/kg Liver Chicken 100 μg/kg Muscle 100 μg/kg Skin and fat 1 000 μg/kg Liver ▼M77 Rabbits 100 μg/kg Muscle 500 μg/kg Liver ▼M83 Turkey 100 μg/kg Muscle 100 μg/kg Skin and fat 300 μg/kg Liver ▼M71 Tiamulin 1 000 μg/kg Eggs ▼M58 Valnemulin Valnemulin Porcine 50 μg/kg Muscle 500 μg/kg Liver 100 μg/kg Kidney 1.2.9. Lincosamides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M96 Lincomycin Lincomicyn All food producing species 50 μg/kg Fat (1) 100 μg/kg Muscle (2) 500 μg/kg Liver 1 500 μg/kg Kidney 150 μg/kg Milk 50 μg/kg Eggs ▼M77 Pirlimycin Pirlimycin Bovine 100 μg/kg Muscle 100 μg/kg Fat 1 000 μg/kg Liver 400 μg/kg Kidney 100 μg/kg Milk Porcine 100 μg/kg Muscle 50 μg/kg Skin and fat 500 μg/kg Liver 1 500 μg/kg Kidney Chicken 100 μg/kg Muscle 50 μg/kg Skin and fat 500 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Eggs (1) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. (2) For fin fish this MRL relates to ‘muscle and skin in natural proportions’. 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 consumption 1 000 μg/kg Fat 10 000 μg/kg Liver 20 000 μg/kg Kidney ▼M134 Dihydrostreptomycin Dihydrostreptomycin All ruminants 500 μg/kg Muscle 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney 200 μg/kg Milk Porcine 500 μg/kg Muscle 500 μg/kg Skin + fat 500 μg/kg Liver 1 000 μg/kg Kidney Rabbits 500 μg/kg Muscle 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney ▼M95 Gentamicin Sum of gentamicin C1, gentamicin C1a, gentamicin C2 and gentamicin C2a Bovine 50 μg/kg Muscle 50 μg/kg Fat 200 μg/kg Liver 750 μg/kg Kidney 100 μg/kg Milk Porcine 50 μg/kg Muscle 50 μg/kg Skin and fat 200 μg/kg Liver 750 μg/kg Kidney ▼M110 Kanamycin Kanamycin A All food producing species except fish (3) 100 μg/kg Muscle 100 μg/kg Fat (1) 600 μg/kg Liver 2 500 μg/kg Kidney 150 μg/kg Milk ▼M96 Neomycin (including framycetin) Neomycin B All food producing species 500 μg/kg Fat (1) 500 μg/kg Muscle (2) 500 μg/kg Liver 5 000 μg/kg Kidney 1 500 μg/kg Milk 500 μg/kg Eggs ▼M96 Paromomycin Paromomycin All food producing species 500 μg/kg Muscle (2) Not for use in animals from which milk or eggs are produced for human consumption 1 500 μg/kg Liver 1 500 μg/kg Kidney Spectinomycin Spectinomycin All food producing species except ovine 500 μg/kg Fat (1) Not for use in animals from which eggs are produced for human consumption 300 μg/kg Muscle (2) 1 000 μg/kg Liver 5 000 μg/kg Kidney 200 μg/kg Milk Ovine 300 μg/kg Muscle 500 μg/kg Fat 2 000 μg/kg Liver 5 000 μg/kg Kidney 200 μg/kg Milk ▼M134 Streptomycin Streptomycin All ruminants 500 μg/kg Muscle 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney 200 μg/kg Milk Porcine 500 μg/kg Muscle 500 μg/kg Skin + fat 500 μg/kg Liver 1 000 μg/kg Kidney Rabbits 500 μg/kg Muscle 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney (1) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. (2) For fin fish this MRL relates to ‘muscle and skin in natural proportions’. (3) Not for use in animals from which eggs are produced for human consumption. 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 1.2.12. Polypeptides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Bacitracin Sum of bacitracin A, bacitracin B, and bacitracin C Bovine 100 μg/kg Milk ▼M101 Rabbits 150 μg/kg Muscle 150 μg/kg Fat 150 μg/kg Liver 150 μg/kg Kidney 1.2.13. Beta-lactamase inhibitors



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Clavulanic acid Clavulanic acid Bovine 100 μg/kg Muscle 100 μg/kg Fat 200 μg/kg Liver 400 μg/kg Kidney 200 μg/kg Milk Porcine 100 μg/kg Muscle 100 μg/kg Skin and fat 200 μg/kg Liver 400 μg/kg Kidney 1.2.14. Polymyxins



Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Colistin Colistin All food producing species 150 μg/kg Fat (1) 150 μg/kg Muscle (2) 150 μg/kg Liver 200 μg/kg Kidney 50 μg/kg Milk 300 μg/kg Eggs (1) For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’. (2) For fin fish this MRL relates to ‘muscle and skin in natural proportions’. 1.2.15. Orthosomycins



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Avilamycin Dichloroisoeverninic acid Porcine 50 μg/kg Muscle 100 μg/kg Fat (1) 300 μg/kg Liver 200 μg/kg Kidney Rabbit 50 μg/kg Muscle 100 μg/kg Fat 300 μg/kg Liver 200 μg/kg Kidney Poultry (2) 50 μg/kg Muscle 100 μg/kg Fat (1) 300 μg/kg Liver 200 μg/kg Kidney (1) For porcine and poultry species, this MRL relates to skin and fat in natural proportions. (2) Not for use in animals from which eggs are produced for human consumption. 1.2.16. Ionophores



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Monensin Monensin A Bovine 2 μg/kg Muscle 10 μg/kg Fat 30 μg/kg Liver 2 μg/kg Kidney 2 μg/kg Milk Lasalocid Lasalocid A Poultry 20 μg/kg Muscle 100 μg/kg Fat (1) 100 μg/kg Liver 50 μg/kg Kidney 150 μg/kg Eggs (1) For poultry species, this MRL relates to ‘skin and fat in natural proportions’.

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 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 ▼M86 Rafoxanide Rafoxanide Bovine 30 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 30 μg/kg Fat 10 μg/kg Liver 40 μg/kg Kidney Ovine 100 μg/kg Muscle 250 μg/kg Fat 150 μg/kg Liver 150 μg/kg Kidney ▼M58 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, poultry 10 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 ▼M113 Albendazole Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole All ruminants 100 μg/kg Muscle 100 μg/kg Fat 1 000 μg/kg Liver 500 μg/kg Kidney 100 μg/kg Milk ▼M69 Albendazole oxide Sum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazole Bovine, ovine 100 μg/kg Muscle 100 μg/kg Fat 1 000 μg/kg Liver 500 μg/kg Kidney 100 μg/kg Milk ▼M113 Febantel Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 μg/kg Muscle 50 μg/kg Fat 500 μg/kg Liver 50 μg/kg Kidney 10 μg/kg Milk Fenbendazole Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 μg/kg Muscle 50 μg/kg Fat 500 μg/kg Liver 50 μg/kg Kidney 10 μg/kg Milk ▼M127 Flubendazole Sum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4fluorophenyl) methanone Poultry, porcine 50 μg/kg Muscle 50 μg/kg Skin + fat 400 μg/kg Liver 300 μg/kg Kidney Flubendazole Flubendazole Poultry 400 μg/kg Eggs ▼M88 Mebendazole Sum of mebendazole methyl (5-(1-hydroxy, 1-phenyl) methyl-1H-benzimidazol-2-yl) carbamate and (2-amino-1H-benzimidazol-5-yl) phenylmethanone, expressed as mebendazole equivalents Ovine, caprine, equidae 60 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 60 μg/kg Fat 400 μg/kg Liver 60 μg/kg Kidney ▼M83 Netobimin Sum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazole ►C6 Bovine, ovine ◄ 100 μg/kg Muscle For oral use only 100 μg/kg Fat 1 000 μg/kg Liver 500 μg/kg Kidney 100 μg/kg Milk ▼M113 Oxfendazole Sum of extractable residues which may be oxidised to oxfendazole sulphone All ruminants 50 μg/kg Muscle 50 μg/kg Fat 500 μg/kg Liver 50 μg/kg Kidney 10 μg/kg Milk ▼M58 Oxibendazole Oxibendazole Porcine 100 μg/kg Muscle 500 μg/kg Skin and fat 200 μg/kg Liver 100 μg/kg Kidney ▼M113 Thiabendazole Sum of thiabendazole and 5-hydroxythiabendazole Caprine 100 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 100 μg/kg Kidney 100 μg/kg Milk ▼M130 Triclabendazole Sum of extractable residues that may be oxidised to ketotriclabendazole All ruminants (1) 225 μg/kg Muscle 100 μg/kg Fat 250 μg/kg Liver 150 μg/kg Kidney (1) Not for use in animals producing milk for human consumption. 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 200 μg/kg Fat 20 μg/kg Liver 400 μg/kg Kidney ▼M113 Oxyclozanide Oxyclozanide All ruminants 20 μg/kg Muscle 20 μg/kg Fat 500 μg/kg Liver 100 μg/kg Kidney 10 μg/kg Milk 2.1.5. Benzenesulphonamides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Clorsulon Clorsulon Bovine 35 μg/kg Muscle 100 μg/kg Liver 200 μg/kg Kidney 2.1.6. Piperazine derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Piperazine Piperazine Porcine 400 μg/kg Muscle 800 μg/kg Skind and fat 2 000 μg/kg Liver 1 000 μg/kg Kidney Chicken 2 000 μg/kg Eggs 2.1.7. 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- propanediamine and expressed as morantel equivalents Bovine, ovine 100 μg/kg Muscle 100 μg/kg Fat 800 μg/kg Liver 200 μg/kg Kidney 50 μg/kg Milk ▼M122 All ruminants 100 μg/kg Muscle 100 μg/kg Fat 800 μg/kg Liver 200 μg/kg Kidney 50 μg/kg Milk 2.2. Agents acting against ectoparasites 2.2.1. Organophosphates



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M86 Coumafos Coumafos Bees 100 μg/kg Honey ▼M58 Diazinon Diazinon Bovine, ovine, caprine 20 μg/kg Milk Bovine, porcine, ovine, caprine 20 μg/kg Muscle 700 μg/kg Fat 20 μg/kg Liver 20 μg/kg Kidney ▼M83 Phoxim Phoxim Ovine 50 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 400 μg/kg Fat 50 μg/kg Kidney Porcine 20 μg/kg Muscle 700 μg/kg Skin and fat 20 μg/kg Liver 20 μg/kg Kidney ▼M121 Chicken 25 μg/kg Muscle 550 μg/kg Skin + fat 50 μg/kg Liver 30 μg/kg Kidney 60 μg/kg Eggs ▼M58 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 amitraz Bovine 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 ▼M69 Bees (honey) 200 μg/kg Honey ▼M113 Caprine 200 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney 10 μg/kg Milk ▼M58 2.2.3. Pyrethroids



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼C6 Cyhalothrin Cyhalothrin (sum of isomers) Bovine 500 μg/kg Fat Further provisions in Council Directive 94/29/EC are to be observed 50 μg/kg Kidney 50 μg/kg Milk Cyfluthrin Cyfluthrin (sum of isomers) Bovine 10 μg/kg Muscle 50 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney 20 μg/kg Milk ▼M113 Deltamethrin Deltamethrin All ruminants 10 μg/kg Muscle 50 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney 20 μg/kg Milk ▼M91 Fin fish 10 μg/kg Muscle and skin in natural proportions ▼M131 Fenvalerate Fenvalerate (sum of RR, SS, RS and SR isomers) Bovine 25 μg/kg Muscle 250 μg/kg Fat 25 μg/kg Liver 25 μg/kg Kidney 40 μg/kg Milk ▼M58 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 ▼M78 Ovine 10 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 150 μg/kg Fat 20 μg/kg Liver 10 μg/kg Kidney ▼M100 Permethrin Permethrin (sum of isomers) Bovine 50 μg/kg Muscle 500 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk (1) ▼M105 Cypermethrin Cypermethrin (sum of isomers) Salmonidae 50 μg/kg Muscle and skin in natural proportions ▼M113 All ruminants 20 μg/kg Muscle 200 μg/kg Fat 20 μg/kg Liver 20 μg/kg Kidney 20 μg/kg Milk (1) ▼M108 Alphacypermethrin Cypermethrin (sum of isomers) Bovine, ovine 20 μg/kg Muscle 200 μg/kg Fat 20 μg/kg Liver 20 μg/kg Kidney 20 μg/kg Milk (1) (1) Further provisions in Commission Directive 98/82/EC are to be observed (OJ L 290, 29.10.1998, p. 25). 2.2.4. Acyl urea derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M70 Diflubenzuron Diflubenzuron Salmonidae 1 000 μg/kg Muscle and skin in natural proportions ▼M129 Fluazuron Fluazuron Bovine (1) 200 μg/kg Muscle 7 000 μg/kg Fat 500 μg/kg Liver 500 μg/kg Kidney ▼M65 Teflubenzuron Teflubenzuron Salmonidae 500 μg/kg Muscle and skin in natural proportions (1) Not for use in animals from which milk is produced for human consumption. 2.2.5. Pyrimidines derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Dicyclanil Sum of dicyclanil and 2, 4, 6-triamino-pyrimidine-5-carbonitrile Ovine 200 μg/kg Muscle Not for use in animals from which milk is produced for human consumption ►M78 150 μg/kg ◄ Fat 400 μg/kg Liver 400 μg/kg Kidney 2.2.6. Triazine derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cyromazine Cyromazine Ovine 300 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 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 ▼M95 Ovine 20 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 50 μg/kg Fat 25 μg/kg Liver 20 μg/kg Kidney ▼M132 Doramectin Doramectin All mammalian food producing species (1) 40 μg/kg Muscle 150 μg/kg Fat 100 μg/kg Liver 60 μg/kg Kidney ▼M106 Emamectin Emamectin B1a Fin fish 100 μg/kg Muscle and skin in natural proportions ▼M58 Eprinomectin Eprinomectin B1a Bovine ►M67 50 μg/kg ◄ Muscle ►M67 250 μg/kg ◄ Fat ►M67 1 500 μg/kg ◄ Liver ►M67 300 μg/kg ◄ Kidney ►M67 20 μg/kg ◄ Milk Ivermectin 22, 23-Dihydro-avermectin B1a Bovine 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 Liver 20 μg/kg Kidney ▼M119 All mammalian food-producing species (1) 100 μg/kg Fat 100 μg/kg Liver 30 μg/kg Kidney ▼M58 Moxidectin Moxidectin Bovine, ovine 50 μg/kg Muscle 500 μg/kg Fat 100 μg/kg Liver 50 μg/kg Kidney ▼M87 Bovine 40 μg/kg Milk ▼M66 Equidae 50 μg/kg Muscle 500 μg/kg Fat 100 μg/kg Liver 50 μg/kg Kidney ▼M117 Ovine 40 μg/kg Milk ▼M58 (1) Not for use in animals from which milk is produced for human consumption. 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 ▼M80 Porcine 100 μg/kg Muscle 150 μg/kg Skin and fat 500 μg/kg Liver 250 μg/kg Kidney ▼M126 All mammalian food producing species (1) 100 μg/kg Muscle 150 μg/kg Fat (2) 500 μg/kg Liver 250 μg/kg Kidney Poultry (3) 100 μg/kg Muscle 200 μg/kg Skin + fat 600 μg/kg Liver 400 μg/kg Kidney (1) Not for use in animals from which milk is produced for human consumption. (2) For porcine species this MRL relates to ‘skin and fat in natural proportions’. (3) Not for use in animals from which eggs are produced for human consumption. 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 Not for use in animals from which milk is produced for human consumption 25 μg/kg Fat 30 μg/kg Liver 30 μg/kg Kidney 2.4.3. Carbanilides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Imidocarb Imidocarb Bovine 300 μg/kg Muscle 50 μg/kg Fat 2 000 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Milk ▼M109 Ovine (1) 300 μg/kg Muscle 50 μg/kg Fat 2 000 μg/kg Liver 1 500 μg/kg Kidney (1) Not for use in ovine from which milk is produced for human consumption. 2.4.4. Ionophores



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M137 —————

3. Agents acting on the nervous system 3.1. Agents acting on the central nervous system 3.1.1. Butyrophenone tranquillisers



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Azaperone Sum of azaperone and azaperol Porcine 100 μg/kg Muscle 100 μg/kg Skin and fat 100 μg/kg Liver 100 μg/kg Kidney 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 ▼M72 Bovine 5 μg/kg Muscle 5 μg/kg Fat 15 μg/kg Liver 15 μg/kg Kidney 1 μg/kg Milk 3.2.2. β2 sympathomimetic agents



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Clenbuterol hydrochloride Clenbuterol Bovine 0,1 μg/kg Muscle 0,5 μg/kg Liver 0,5 μg/kg Kidney 0,05 μg/kg Milk Equidae 0,1 μg/kg Muscle 0,5 μg/kg Liver 0,5 μg/kg Kidney

4. Anti-inflammatory agents 4.1. Nonsteroidal anti-inflammatory agents 4.1.1. Arylpropionic acid derivative



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M65 Carprofen Carprofen Bovine Not for use in animals from which milk is produced for human consumption 500 μg/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 ▼M58 Vedaprofen Vedaprofen Equidae 50 μg/kg Muscle 20 μg/kg Fat 100 μg/kg Liver 1 000 μg/kg Kidney ▼M119 Carprofen Sum of carprofen and carprofen glucuronide conjugate Bovine, equidae 500 μg/kg Muscle 1 000 μg/kg Fat 1 000 μg/kg Liver 1 000 μg/kg Kidney ▼M58 4.1.2. Fenamate group derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M71 Flunixin Flunixin Bovine 20 μg/kg Muscle 30 μg/kg Fat 300 μg/kg Liver 100 μg/kg Kidney 5-Hydroxyflunixin 40 μg/kg Milk Flunixin Porcine 50 μg/kg Muscle 10 μg/kg Skin and fat 200 μg/kg Liver 30 μg/kg Kidney ▼M80 Equidae 10 μg/kg Muscle 20 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney ▼M58 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 4.1.3. Enolic acid derivates



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Meloxicam Meloxicam Equidae 20 μg/kg Muscle 65 μg/kg Liver 65 μg/kg Kidney 4.1.4. Oxican derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M131 Meloxicam Meloxicam Porcine, equidae, rabbit 20 μg/kg Muscle 65 μg/kg Liver 65 μg/kg Kidney Bovine, caprine 20 μg/kg Muscle 65 μg/kg Liver 65 μg/kg Kidney 15 μg/kg Milk 4.1.5. Pyrazolone derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Metamizole 4-Methylaminoantipyrin Bovine 100 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 100 μg/kg Kidney 50 μg/kg Milk Porcine 100 μg/kg Muscle 100 μg/kg Skin and fat 100 μg/kg Liver 100 μg/kg Kidney Equidae 100 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 100 μg/kg Kidney 4.1.6. Phenyl acetic acid derivatives



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diclofenac Diclofenac Bovine (1) 5 μg/kg Muscle 1 μg/kg Fat 5 μg/kg Liver 10 μg/kg Kidney Porcine 5 μg/kg Muscle 1 μg/kg Skin + fat 5 μg/kg Liver 10 μg/kg Kidney (1) Not for use in animals from which milk is produced for human consumption. 4.1.7. Sulphonated fenyl lactones



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Firocoxib Firocoxib Equidae 10 μg/kg Muscle 15 μg/kg Fat 60 μg/kg Liver 10 μg/kg Kidney

5. Corticoides 5.1. Glucocorticoides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M70 Betamethasone Betamethasone Bovine 0,75 μg/kg Muscle 2,0 μg/kg Liver 0,75 μg/kg Kidney 0,3 μg/kg Milk Porcine 0,75 μg/kg Muscle 2,0 μg/kg Liver 0,75 μg/kg Kidney ▼M58 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 ▼M113 Caprine 0,75 μg/kg Muscle 2 μg/kg Liver 0,75 μg/kg Kidney 0,3 μg/kg Milk ▼M93 Methylprednisolone Methylprednisolone Bovine 10 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 10 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney ▼M79 Prednisolone Prednisolone Bovine 4 μg/kg Muscle 4 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney 6 μg/kg Milk

▼M92

6. Agents acting on the reproductive system 6.1. Progestogens



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Chlormadinone Chlormadinone Bovine 4 μg/kg Fat For zootechnical use only 2 μg/kg Liver 2,5 μg/kg Milk Flugestone acetate Flugetone acetate Ovine 1 μg/kg Milk For intravaginal use for zootechnical purposes only ▼M103 Caprine 1 μg/kg Milk For intra-vaginal use for zootechnical purposes only ▼M124 Ovine, caprine 0,5 μg/kg Muscle For therapeutic and zootechnical purposes only 0,5 μg/kg Fat 0,5 μg/kg Liver 0,5 μg/kg Kidney ▼M116 Altrenogest (1) Altrenogest Porcine 1 μg/kg Skin and fat 0,4 μg/kg Liver Equidae 1 μg/kg Fat 0,9 μg/kg Liver ▼M121 Norgestomet (2) Norgestomet Bovine 0,2 μg/kg Muscle 0,2 μg/kg Fat 0,2 μg/kg Liver 0,2 μg/kg Kidney 0,12 μg/kg Milk (1) Only for zootechnical use and in accordance with the provisions of Directive 96/22/EC. (2) For therapeutic and zootechnical purposes only.

▼M58









ANNEX II

LIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS

1. Inorganic chemicals



Pharmacologically active substance(s) Animal species Other provisions Aluminium distearate All food-producing species Aluminium hydroxide acetate All food-producing species Aluminium phosphate All food-producing species ▼M99 Aluminium salicylate, basic Bovine For oral use only; Not for use in animals from which milk is produced for human consumption ▼M58 Aluminium tristearate All food-producing species Ammonium chloride All food-producing species ▼M72 Barium selenate Bovine, ovine ▼M58 Bismuth subcarbonate All food-producing species For oral use only Bismuth subgallate All food-producing species For oral use only Bismuth subnitrate All food-producing species For oral use only Bismuth subsalicylate All food-producing species For oral use only Boric acid and borates All food-producing species ▼M65 Bromide, potassium salt All food producing species ▼M58 Bromide, sodium salt All mammalian food-producing species For topical use only 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 sulphate All 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 species ▼M80 Calcium glycerophosphate All food producing species ▼M58 Cobalt carbonate All food-producing species Cobalt dichloride All food-producing species Cobalt gluconate All food-producing species Cobalt oxide All food-producing species Cobalt sulphate All food-producing species Cobalt trioxide All food-producing species Copper chloride All food-producing species Copper gluconate All food-producing species Copper heptanoate All food-producing species 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-iodine All 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 trisilicate All food-producing species Nickel gluconate All food-producing species Nickel sulphate All food-producing species Potassium DL-aspartate All food-producing species Potassium glucuronate All food-producing species Potassium glycerophosphate All food-producing species Potassium nitrate All food-producing species Potassium selenate All food-producing species Sodium chlorite Bovine For topical use only Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only ▼M62 Sodium glycerophosphate All food producing species ▼M58 Sodium hypophosphite All food-producing species ▼M129 Sodium nitrite Bovine For topical use only ▼M77 Sodium propionate All food producing species ▼M58 Sodium selenate All food-producing species Sodium selenite All food-producing species Sulphur ►M101 All food producing species ◄ Zinc acetate Zinc chloride Zinc gluconate Zinc oleate Zinc stearate All 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 2-Aminoethyl dihydrogenphosphate All food-producing species 2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw 8-Hydroxyquinoline All mammalian food-producing species For topical use in newborn animals only Acetyl cysteine All food-producing species Alfacalcidol Bovine For parturient cows only Alfaprostol 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 only Benzylalcohol All food-producing species For use as excipient Betaine All food-producing species Bronopol Salmonidae For use only on farmed fertilised eggs Brotizolam Bovine For therapeutic uses only Buserelin All food-producing species Butorphanol tartrate Equidae For intravenous administration only Butyl 4-hydroxybenzoate All food-producing species Butylscopolaminium bromide All food-producing species Caffeine All food-producing species Carbetocin All mammalian food-producing species Cefazolin Bovine Ovine, caprine For 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 ▼M112 Diclazuril All ruminants (2) Porcine (2) ▼M58 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 Dinoprost tromethamine All mammalian food-producing species Diprophylline All food-producing species Etamiphylline camsylate All food-producing species Ethanol 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 — Iodoform All food-producing species Isobutane All food-producing species Isoflurane Equidae For use as anaesthetic only Isoxsuprine 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 species Ketanserin tartrate Equidae Ketoprofen Bovine, porcine, equidae L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium All food-producing species For use as excipient Lactic acid All food-producing species Lecirelin Bovine, equidae, rabbits Lobeline All food-producing species Luprostiol All mammalian species Malic acid All food-producing species For use as excipient Manganese carbonate All food-producing species For oral use only Manganese chloride All food-producing species For oral use only Manganese gluconate All food-producing species For oral use only Manganese 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 only Manganese ribonucleate All food-producing species For oral use only Manganese sulphate All food-producing species For oral use only Mecillinam Bovine For intrauterine use only Medroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes only Melatonin Ovine, caprine Menadione All food-producing species Menbutone Bovine, ovine, caprine, porcine, equidae Menthol 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 compounds All 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 species Nicoboxil Equidae For topical use only Nonivamide Equidae For topical use only Oleyloleate All food-producing species For topical use only Oxytocin All mammalian food-producing species Pancreatin All mammalian food-producing species For topical use only Papain All food-producing species Papaverine Bovine Newborn calves only Peracetic acid All food-producing species Phenol All food-producing species Phloroglucinol All food-producing species Phytomenadione All food-producing species Policresulen All food-producing species For topical use only Polyethylene 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 excipient Polysulphated glycosaminoglycan Equidae Praziquantel Ovine Equidae For use in non-lactating sheep only Pregnant mare serum gonadotrophin All food-producing species Prethcamide (crotethamide and cropropamide) All mammalian food-producing species Procaine All food-producing species Propane All food-producing species Propylene glycol All food-producing species Quatresin All food-producing species For use as preservative only at concentrations of up to 0,5 % R-Cloprostenol Bovine, porcine, equidae Rifaximin All mammalian food-producing species Bovine For 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, equidae Sodium 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 Wool alcohols All food-producing species For topical use only ▼M59 1-Methyl-2-pyrrolidone Equidae Cefacetrile Bovine For intramammary use only and for all tissues except milk Enilconazole Bovine, equidae For topical use only Etamsylate All food producing species Strychnine Bovine For oral use only at dose to 0,1 mg/kg bw ▼M60 Parconazole Guinea fowl ▼M62 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 Equidae Vitamin B1 All food-producing species Vitamin B12 All food-producing species Vitamin B2 All food-producing species Vitamin B3 All food-producing species Vitamin B5 All food-producing species Vitamin B6 All food-producing species Vitamin E All food-producing species ▼M63 Tiaprost Bovine, ovine, porcine, equidae ▼M65 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 consumption For oral use only Azamethiphos Salmonidae Doxapram All mammalian food producing species Piperonyl butoxide Bovine, ovine, caprine, equidae For topical use only Sulfogaiacol All food producing species Vetrabutine hydrochloride Porcine ▼M66 Fenpipramide hydrochloride Equidae For intravenous use only Hydrochlorothiazide Bovine Levomethadone Equidae For intravenous use only Tricaine mesilate Fin fish For water borne use only 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 ▼M67 Atropine All food producing species Cefoperazone Bovine For intramammary use in lactating cows only and for all tissues except milk ▼M69 2-aminoethanol glucuronate All food-producing species Betaine glucuronate All food-producing species ▼M118 Bituminosulfonates, ammonium and sodium salts All mammalian food producing species For topical use only ▼M69 Chlorphenamine All mammalian food-producing species Humic acids and their sodium salts All food-producing species For oral use only Paracetamol Porcine For oral use only Tosylchloramide sodium Fin fish For water-borne use only ▼M88 Bovine For topical use only ▼M125 Equidae For topical use only ▼M70 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 only Novobiocin Bovine For intrammary use only and for all tissues except milk Piperazine dihydrochloride Chicken For all tissues except eggs Polyoxyl castor oil with 30 to 40 oxyethylene 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 excipient Xylazine hydrochloride Bovine, equidae Not for use in animals from which milk is produced for human consumptiom ▼M71 Butafosfan Bovine ►M78 For intravenous use only ◄ Cefalonium Bovine For intramammary use and eye treatment only, and for all tissues except milk Furosemide Bovine, equidae For intravenous administration only Lidocaine Equidae For local-regional anaesthesia only ▼M72 3,5-Diiodo-L-thyrosine All mammalian food-producing species Levothyroxine All mammalian food-producing species ▼M74 Aluminium salicylate, basic All food producing species except fish For topical use only Bismuth subnitrate Bovine For intramammary use only Calcium aspartate All food producing species Methyl salicylate All food producing species except fish For topical use only Salicylic acid All food producing species except fish For topical use only ▼M115 Sodium salicylate Bovine, porcine (3) ▼M74 Zinc aspartate All food producing species ▼M75 Toldimfos All food producing species ▼M77 Decoquinate Bovine, ovine For oral use only. Not for use in animals from which milk is produced for human consumption Sodium boroformiate All food producing species ▼M81 Thiamylal All mammalian food producing species For intravenous administration only Thiopental sodium All food-producing species For intravenous administration only ▼M105 Acetylsalicylic acid All food producing species except fish Not for use in animals from which milk or eggs are produced for human consumption Acetylsalicylic acid DL-lysine All food producing species except fish Not for use in animals from which milk or eggs are produced for human consumption Carbasalate calcium All food producing species except fish Not for use in animals from which milk or eggs are produced for human consumption Sodium acetylsalicylate All food producing species except fish Not for use in animals from which milk or eggs are produced for human consumption ▼M83 Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13 Bovine For topical use only ▼M117 Ovine (5) ▼M86 Amprolium Poultry For oral use only Tiludronic acid, disodium salt Equidae For intravenous use only ▼M89 Sorbitan trioleate All food-producing species ▼M90 Vitamin A All food producing species ▼M91 Ammonium lauryl sulphate All food-producing species Bronopol Fin fish Calcium pantothenate All food-producing species ▼M95 Allantoin All food producing species For topical use only Benzocaine Salmonidae ▼M94 Dexpanthenol All food producing species ▼M97 Azagly-nafarelin Salmonidae Not for use in fish from which eggs are produced for human consumption Deslorelin acetate Equidae ▼M98 Hydroxyethylsalicylate All food producing species except fish For topical use only Xylazine hydrochloride Bovine, equidae ▼M99 Omeprazole Equidae For oral use only ▼M100 Trichlormethiazide All mammalian food producing species ▼M107 Progesterone (1) Bovine, ovine, caprine, Equidae (female) ▼M116 Beclomethasone dipropionate Equidae (4) Cloprostenol Caprine R-cloprostenol Caprine Sorbitan sesquioleate All food producing species ▼M126 Diethylene glycol monoethyl ether All ruminants and porcine ▼M129 Peforelin Porcine ▼M58 (1) Only for intravaginal therapeutic or zootechnical use and in accordance with the provisions of Directive 96/22/EC. (2) For oral use only. (3) For oral use; not for use in animals from which milk is produced for human consumption. (4) For inhalation use only. (5) For topical use only.

3. Substances generally recognised as safe



Pharmacologically active substance(s) Animal species Other provisions Absinthium extract All food-producing species Acetylmethionine All food-producing species Aluminium hydroxide All food-producing species Aluminium monostearate All food-producing species Ammonium sulfate All food-producing species Benzoyl benzoate All food-producing species Benzyl p-hydroxybenzoate All food-producing species Calcium borogluconate All food-producing species Calcium citrate All food-producing species Camphor All food-producing species External use only Cardamon extract All food-producing species Diethyl sebacate All food-producing species Dimethicone All food-producing species Dimethyl acetamide All food-producing species Dimethyl sulphoxide All food-producing species Epinephrine All food-producing species Ethyl oleate All food-producing species Ethylenediaminetetraacetic 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 species Glutaraldehyde All food-producing species Guaiacol All food-producing species Heparin and its salts All food-producing species Human chorionic gonadotropin (natural HCG and its synthetic analogues) All food-producing species Iron ammonium citrate All food-producing species Iron dextran All food-producing species Iron glucoheptonate All food-producing species Isopropanol All food-producing species Lanolin All food-producing species Luteinising hormone (natural LH from all species and their synthetic analogues) All food-producing species Magnesium chloride All food-producing species Magnesium gluconate All food-producing species Magnesium hypophosphite All food-producing species Mannitol All food-producing species Methylbenzoate All food-producing species Monothioglycerol All food-producing species Montanide All food-producing species Myglyol All food-producing species Orgotein All food-producing species Poloxalene All food-producing species Poloxamer All food-producing species Polyethylene glycols (molecular weight ranging from 200 to 10 000) All food-producing species Polysorbate 80 All food-producing species Serotonin All food-producing species Sodium chloride All food-producing species Sodium cromoglycate All food-producing species Sodium dioctylsulphosuccinate All food-producing species Sodium formaldehydesulphoxylate All food-producing species Sodium lauryl sulphate All food-producing species Sodium pyrosulphite All food-producing species Sodium stearate All food-producing species Sodium thiosulphate All food-producing species Tragacanth All food-producing species Urea All food-producing species Zinc oxide All food-producing species Zinc sulphate All food-producing species ▼M65 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 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 species Isoleucine All food producing species Leucine All food producing species Lysine All food producing species Methionine All food producing species Ornithine All food producing species Orotic acid All food producing species Pepsin All food producing species Phenylalanine All food producing species Proline All food producing species Serine All food producing species Thioctic acid All food producing species Threonine All food producing species Thymidine All food producing species Trypsin All food producing species Tryptophan All food producing species Tyrosine All food producing species Uridine and its 5′-mono-, 5′-di- and 5′-triphosphates All food producing species Valine All food producing species ▼M126 Polyoxyethylene sorbitan monooleate All food producing species ▼M128 Polyoxyethylene sorbitan monooleate and trioleate All food-producing species ▼M58

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 thousand All food-producing species ▼M63 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 ▼M66 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 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 ▼M68 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 ▼M71 Aesculus hippocastanum 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 ten only Agnus castus All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Ailanthus altissima All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Allium cepa All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Arnicae radix All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only Artemisia abrotanum All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Bellis perennis All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Calendula officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only Camphora 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. Cardiospermum halicacabum All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Crataegus All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Echinacea All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only For topical use only. For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only Eucalyptus globulus All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Euphrasia officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Ginkgo biloba 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. Ginseng All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Hamamelis virginiana 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 ten only Harpagophytum procumbens All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Hypericum perforatum All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Lachnanthes tinctoria 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. Lobaria pulmonaria All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Okoubaka aubrevillei All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Prunus laurocerasus 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. Serenoa repens All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Silybum marianum All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Solidago virgaurea All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Syzygium cumini All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Turnera diffusa All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only Viscum album All-food producing species For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only ▼M72 Phytolacca americana 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 Urginea maritima 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 ▼M58

5. Substances used as food additives in foodstuffs for human consumption



Pharmacologically active substance(s) Animal species Other provisions Substances with an E number All food-producing species Only substances approved as additives in foodstuffs for human consumption, with the 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 ▼M73 Aloe vera gel and whole leaf extract of Aloe vera All food-producing species For topical use only ▼M71 Aloes, Barbados and Capae, their standardised dry extract and preparations thereof All food-producing species ▼M58 Angelicae radix aetheroleum All food-producing species Anisi aetheroleum All food-producing species ▼M77 Anisi stellati fructus, standardised extracts and preparations thereof All food producing species ▼M71 Arnica montana (arnicae flos and arnicae planta tota) All food-producing species For topical use only ▼M58 Balsamum peruvianum All food-producing species For topical use only ▼M71 Boldo folium All food-producing species ▼M70 Calendulae flos All food-producing species For topical use only ▼M68 Capsici fructus acer All food-producing species ▼M71 Carlinae radix All food-producing species For topical use only ▼M58 Carvi aetheroleum All food-producing species Caryophylli aetheroleum All food-producing species ▼M59 Centellae asiaticaer extractum All food producing species For topical use only ▼M58 Chrysanthemi cinerariifolii flos All food-producing species For topical use only ▼M70 Cimicifugae racemosae rhizoma All food-producing species Not for use in animals from which milk is produced for human consumptiom ▼M77 Cinchonae cortex, standardised extracts and preparations thereof All food producing species ▼M58 Cinnamomi cassiae aetheroleum All food-producing species ▼M77 Cinnamomi cassiae cortex, standardised extracts and preparations thereof All food producing species ▼M58 Cinnamomi ceylanici aetheroleum All food-producing species ▼M77 Cinnamomi ceylanici cortex, standardised extracts and preparations thereof All food producing species ▼M58 Citri aetheroleum All food-producing species Citronellae aetheroleum All food-producing species ▼M77 Condurango cortex, standardised extracts and preparations thereof All food producing species ▼M58 Coriandri aetheroleum All food-producing species ▼M71 Cupressi aetheroleum All food-producing species For topical use only ▼M58 Echinacea purpurea All food-producing species For topical use only Eucalypti aetheroleum All food-producing species Foeniculi aetheroleum All food-producing species ▼M77 Frangulae cortex, standardised extracts and preparations thereof All food producing species Gentianae radix, standardised extracts and preparations thereof All food producing species ▼M133 Ginseng, standardised extracts and preparations thereof All food-producing species ▼M58 Hamamelis virginiana All food-producing species For topical use only ▼M68 Hippocastani semen All food-producing species For topical use only ▼M58 Hyperici oleum All food-producing species For topical use only ▼M68 Juniperi fructus All food-producing species Lauri folii aetheroleum All food-producing species Lauri fructus All food-producing species ▼M71 Lavandulae aetheroleum All food-producing species For topical use only ▼M58 Lespedeza capitata All food-producing species Lini oleum All food-producing species Majoranae herba All food-producing species ▼M74 Matricaria recutita and preparations thereof All food producing species ▼M58 Matricariae flos All food-producing species Medicago sativa extractum All food-producing species For topical use only ▼M59 Melissae aetheroleum All food producing species ▼M58 Melissae folium All food-producing species ▼M91 Menthae arvensis aetheroleum All food-producing species ▼M58 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 ▼M125 Piceae turiones recentes extractum All food producing species For oral use only ▼M58 Oxidation products of Terebinthinae oleum Bovine, porcine, ovine, caprine Pyrethrum extract All food-producing species For topical use only Quercus cortex All food-producing species Quillaia saponins All food-producing species ▼M74 Rhei radix, standardised extracts and preparations thereof All food producing species ▼M58 Ricini oleum All food-producing species For use as excipient Rosmarini aetheroleum All food-producing species Rosmarini folium All food-producing species ▼M68 Ruscus aculeatus All food-producing species For topical use only ▼M58 Salviae folium All food-producing species Sambuci flos All food-producing species Sinapis nigrae semen All food-producing species ▼M68 Strychni semen Bovine, ovine, caprine For oral use only at doses up to the equivalent of 0,1 mg strychnine/kg bw ▼M71 Symphyti radix All food-producing species For topical use on intact skin only ▼M58 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

▼M111

7. Anti-infectious agents



Pharmacologically active substance(s) Animal species Other provisions Oxalic acid Honey bees

▼M119

8. Anti-inflammatory agents



Pharmacologically active substance(s) Animal species Other provisions Carprofen Bovine (1) (1) For bovine milk only.

▼M58









ANNEX III

LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VETERINARY MEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

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 ►M67 Provisional 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 1.2.2. Macrolides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M74 Acetylisovaleryltylosin Sum of acetylisovaleryltylosin and 3-O-acetyltylosin Porcine 100 μg/kg Muscle Provisional MRLs expire on 1.7.2001 100 μg/kg Skin and fat 100 μg/kg Liver 100 μg/kg Kidney ▼M117 Acetylisovaleryltylosin (1) Sum of acetyl-isovaleryltylosin and 3-O-acetyltylosin Poultry (2) 50 μg/kg Skin and fat 50 μg/kg Liver ▼M58 Erythromycin MRLs apply to all microbiological active residues expressed as erythromycin equivalent Bovine, ovine 40 μg/kg Milk Provisional MRLs expire on 1 June 2000 Bovine, ovine, porcine, poultry 400 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 ►M77 Provisional MRLs expire on 1.7.2002 ◄ 200 μg/kg Fat 200 μg/kg Liver 400 μg/kg Kidney 200 μg/kg Eggs ▼M60 Sum of the microbiologically active metabolites, expressed as josamycin Porcine 200 μg/kg Muscle Provisional MRLs expire on 1.7.2002 200 μg/kg Skin and fat 200 μg/kg Liver 400 μg/kg Kidney ▼M70 Tilmicosin Tilmicosin Bovine 40 μg/kg Milk Provisional MRLs expire on 1.1.2001 ▼M99 Tulathromycin (2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R)-2- ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopent-decan-15-one expressed as tulathromycin equivalents Bovine 100 μg/kg Fat Provisional MRLs expire on 1 July 2004; not for use in animals from which milk is produced for human consumption 3 000 μg/kg Liver 3 000 μg/kg Kidney Porcine 100 μg/kg Skin and fat Provisional MRLs expire on 1 July 2004 3 000 μg/kg Liver 3 000 μg/kg Kidney (1) Provisional MRLs expire on 1 July 2006. (2) Not for use in animals from which eggs are produced for human consumption. 1.2.4. Cephalosporins



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cefacetrile Cefacetrile Bovine 125 μg/kg Milk ►M83 Provisional MRLs expire on 1.1.2002 ◄ For intrammamary use only ▼M71 Cefalonium Cefalonium Bovine 10 μg/kg Milk ►M85 Provisional MRLs expire on 1.1.2003 ◄ ▼M67 Cefoperazone Cefoperazone Bovine 50 μg/kg Milk Provisional MRLs expire on 1 January 2001 ▼M61 Cefquinome Cefquinome Porcine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2000 50 μg/kg Skin + fat 100 μg/kg Liver 200 μg/kg Kidney ▼M59 Cephapirin Sum of cephapirin and desacetylcephapirin Bovine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2001 50 μg/kg Fat 50 μg/kg Liver 100 μg/kg Kidney 10 μg/kg Milk 1.2.5. Aminoglycosides



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Aminosidine Aminosidine Bovine, porcine, rabbits, chicken 500 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 only 1 000 μg/kg Fat 10 000 μg/kg Liver 20 000 μg/kg Kidney Porcine 1 000 μg/kg Muscle 1 000 μg/kg Skin and fat 1 000 μg/kg Liver 5 000 μg/kg Kidney ▼M76 Dihydrostreptomycin Dihydrostreptomycin Bovine, ovine 500 μg/kg Muscle Provisional MRLs expire on 1.6.2002 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney 200 μg/kg Milk Porcine 500 μg/kg Muscle 500 μg/kg Skin and fat 500 μg/kg Liver 1 000 μg/kg Kidney Gentamicin Gentamicin Bovine 100 μg/kg Milk Provisional MRLs expire on 1.6.2002 Bovine, porcine 50 μg/kg Muscle 50 μg/kg Fat 200 μg/kg Liver 750 μg/kg Kidney ▼M65 Kanamycin Kanamycin Rabbits 100 μg/kg Muscle ►M91 Provisional MRLs expire on 1.1.2004 ◄ 100 μg/kg Fat 600 μg/kg Liver 2 500 μg/kg Kidney Bovine, ovine 100 μg/kg Muscle 100 μg/kg Fat 600 μg/kg Liver 2 500 μg/kg Kidney 150 μg/kg Milk Porcine, chicken 100 μg/kg Muscle 100 μg/kg Skin + fat 600 μg/kg Liver 2 500 μg/kg Kidney ▼M76 Neomycin (including framycetin) Neomycin B Bovine, porcine, chicken 500 μg/kg Muscle Provisional MRLs expire on 1.6.2002 500 μg/kg Fat 500 μg/kg Liver 5 000 μg/kg Kidney Bovine 500 μg/kg Milk Chicken 500 μg/kg Eggs ▼M58 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 ▼M71 Ovine Not for use in animals from which milk is produced for human consumption 300 μg/kg Muscle Provisional MRLs expire on 1.1.2002 500 μg/kg Fat 2 000 μg/kg Liver 5 000 μg/kg Kidney Chicken 200 μg/kg Eggs ▼M76 Streptomycin Streptomycin Bovine, ovine 500 μg/kg Muscle Provisional MRLs expire on 1.6.2002 500 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney 200 μg/kg Milk Porcine 500 μg/kg Muscle 500 μg/kg Skin and fat 500 μg/kg Liver 1 000 μg/kg Kidney ▼M58 1.2.6. Quinolones



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ▼M60 Danofloxacin Danofloxacin Porcine 100 μg/kg Muscle Provisional MRLs expire on 1.1.2000 50 μg/kg Skin and fat 200 μg/kg Liver 200 μg/kg Kidney ▼M58 Decoquinate Decoquinate Bovine, ovine 500 μg/kg Muscle Provisional MRLs expire on 1 July 2000 500 μg/kg Fat 500 μg/kg Liver 500 μg/kg Kidney ▼M62 Difloxacin Difloxacin Bovine Not for use in animals from which milk is produced for human consumption 400 μg/kg Muscle Provisional MRLs expire on 1.1.2001 100 μg/kg Fat 1 400 μg/kg Liver 800 μg/kg Kidney Porcine 400 μg/kg Muscle 100 μg/kg Skin and fat 800 μg/kg Liver 800 μg/kg Kidney ▼M58 Enrofloxacin Sum of enrofloxacin and ciprofloxacin Ovine 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, chicken 50 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 Liver 150 μg/kg Kidney 75 μg/kg Milk Porcine 150 μg/kg Muscle 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney ▼M111 Oxolinic acid (1) Oxolinic acid Bovine (2) 100 μg/kg Muscle 50 μg/kg Fat 150 μg/kg Liver 150 μg/kg Kidney ▼M59 Porcine 100 μg/kg Muscle 50 μg/kg Skin + fat 150 μg/kg Liver 150 μg/kg Kidney Chicken 100 μg/kg Muscle 50 μg/kg Skin + fat 150 μg/kg Liver 150 μg/kg Kidney 50 μg/kg Eggs Fin fish 300 μg/kg Muscle and skin in natural proportions ▼M58 (1) Provisional MRLs expire 1 January 2006. (2) Not for use in animals from which milk is produced for human consumption. 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 ►M77 Provisional MRLs expire on 1.7.2002 ◄ Bovine, ovine, porcine, chicken, rabbits 150 μg/kg Muscle 150 μg/kg Fat 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 ▼M59 Nafcillin Nafcillin Bovine 300 μg/kg Muscle Provisional MRLs expire on 1.1.2001 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 30 μg/kg Milk ▼M58 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-amine Fish 1 000 μg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1 July 2001 ▼M59 Thiamphenicol Thiamphenicol Ovine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2001 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney Porcine 50 μg/kg Muscle 50 μg/kg Skin + fat 50 μg/kg Liver 50 μg/kg Kidney Fin fish 50 μg/kg Muscle and skin in natural proportions ▼M121 Thiamphenicol (1) Thiamphenicol Porcine 50 μg/kg Muscle 50 μg/kg Skin + fat 50 μg/kg Liver 50 μg/kg Kidney (1) Provisional MRLs expire on 1 January 2007. 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 on1.7.2001 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 50 μg/kg Fat 500 μg/kg Liver 1 500 μg/kg Kidney 150 μg/kg Milk Porcine 100 μg/kg Muscle 50 μg/kg Skin + fat 500 μg/kg Liver 1 500 μg/kg Kidney Chicken 100 μg/kg Muscle 50 μg/kg Skin + fat 500 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Eggs ▼M60 Pirlimycin Pirlimycin Bovine 100 μg/kg Muscle Provisional MRLs expire on 1.7.2000 100 μg/kg Fat 1 000 μg/kg Liver 400 μg/kg Kidney 100 μg/kg Milk 1.2.14. Pleuromutilines



Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Tiamulin Sum of metabolites that may be hydrolysed to 8-a-hydroxymutilin Turkey 100 μg/kg Muscle Provisional MRLs expire on 1.7.2001 100 μg/kg Skin and fat 300 μg/kg Liver

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 Tar