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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for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (repealed)

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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for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (repealed)

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 1U.K.

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 2U.K.

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 3U.K.

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 4U.K.

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 5U.K.

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.

[F1Article 6 U.K.

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 U.K.

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.]

[F2Article 8 U.K.

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.]

Article 9U.K.

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.[F1The 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.

[F2Article 10 U.K.

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.]

Article 11U.K.

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.

[F1Article 12 U.K.

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 [X1Annexes I and III.] ]

Article 13U.K.

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 14U.K.

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.

[F3However, 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 :

  • [F1until 1 January 1998 in the case of pyrazolinones (including pyrazolidinediones and phenylbutazones), nitroimidazoles and arsalinic acid, and]

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

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

Article 15U.K.

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 16U.K.

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.

[F4ANNEX I U.K. LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

1. Anti-infectious agents U.K.

1.1. Chemotheurapeutics U.K.

1.1.1. Sulfonamides U.K.
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 U.K.
a

[F5For porcine and poultry species this MRL relates to skin and fat in natural proportions .

b

For fin fish this MRL relates to muscle and skin in natural proportions .]

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
[F6Trimethoprim Trimethoprim All food producing species except equidae 50 μg/kg Fat a Not for use in animals from which eggs are produced for human consumption
50 μg/kg Muscle  b
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]

1.2. Antibiotics U.K.

1.2.1. Penicillins U.K.
a

[F7For intramammary use only.]

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
[F8Nafcillin Nafcillin All ruminants a 300 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk]
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
[F9 Porcine 50 μg/kg Muscle
50 μg/kg Fat
50 μg/kg Liver
50 μg/kg Kidney ]
[F10Phenoxymethylpenicillin Phenoxymethylpenicillin Porcine 25 μg/kg Muscle
25 μg/kg Liver
25 μg/kg Kidney ]
1.2.2. Cephalosporins U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F11Cefacetrile Cefacetrile Bovine 125 μg/kg Milk For intramammary use only]
[F12Cefalexin Cefalexin Bovine 200 μg/kg Muscle
200 μg/kg Fat
200 μg/kg Liver
1 000  μg/kg Kidney
100 μg/kg Milk ]
[F13Cefalonium Cefalonium Bovine 20 μg/kg Milk ]
[F14Cefapirin Sum of cephapirin and desacetylcephapirin Bovine 50 μg/kg Muscle
50 μg/kg Fat
100 μg/kg Kidney
60 μg/kg Milk ]
Cefazolin Cefazolin Bovine, ovine, caprine 50 μg/kg Milk
[F15Cefoperazone Cefoperazone Bovine 50 μg/kg Milk ]
Cefquinome Cefquinome Bovine 50 μg/kg Muscle
50 μg/kg Fat
100 μg/kg Liver
200 μg/kg Kidney
20 μg/kg Milk
[F16 Porcine 50 μg/kg Muscle
50 μg/kg Skin + fat
100 μg/kg Liver
200 μg/kg Kidney ]
[F17 Equidae 50 μg/kg Muscle
50 μg/kg Fat
100 μg/kg Liver
200 μg/kg Kidney ]
[F18Ceftiofur Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur Bovine 1 000 μg/kg Muscle
2 000 μg/kg Fat
2 000 μg/kg Liver
6 000 μg/kg Kidney
100 μg/kg [F19Milk]
Porcine 1 000 μg/kg Muscle
2 000 μg/kg Fat
2 000 μg/kg Liver
6 000 μg/kg Kidney ]

Textual Amendments

1.2.3. Quinolones U.K.
a

[F5For fin fish this MRL relates to muscle and skin in natural proportions .

b

For porcine species this MRL relates to skin and fat in natural proportions .]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F6Danofloxacin Danofloxacin [X2All food producing species except bovine, ovine, caprine, porcine and poultry] 100 μg/kg Muscle b
50 μg/kg Fat a
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 b
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 b
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 a
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 a
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 ]
[F20Marbofloxacin 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 ]
[F21Oxolinic 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 ]
Sarafloxacin Sarafloxacin Chicken 10 μg/kg Skin and fat
100 μg/kg Liver
Salmonidae 30 μg/kg Muscle and skin in natural proportions
1.2.4. Macrolides U.K.
a

[F5For fin fish this MRL relates to a muscle and skin in natural proportions .

b

For procine species this MRL relates to skin and fat in natural proportions .

c

For porcine and poultry species this MRL relates to skin and fat in natural proportions .

d

[F22 [X3Not for use in animals from which milk is produced for human consumption.] ] ]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F23Acetylisovaleryltylosin Sum of acetyl-isovaleryltylosin and 3-O-acetyltylosin Porcine 50 μg/kg Muscle
50 μg/kg Skin and fat
50 μg/kg Liver
50 μg/kg Kidney ]
[F6Erythromycin Erythromicyin A All food producing species 200 μg/kg Muscle  a
200 μg/kg Fat  b
200 μg/kg Liver
200 μg/kg Kidney
40 μg/kg Milk
150 μg/kg Eggs ]
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
[F24 Spiramycin 1 Porcine 250 μg/kg Muscle
2 000  μg/kg Liver
1 000  μg/kg Kidney ]
[F6Tilmicosin Tilmicosin All food producing species except poultry 50 μg/kg Muscle  a
50 μg/kg Fat  b
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
[F22 [X3Tulathromycin (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 d 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 ] ]
Tylosin Tylosin A All food producing species 100 μg/kg Fat  c
100 μg/kg Muscle  a
100 μg/kg Liver
100 μg/kg Kidney
50 μg/kg Milk
200 μg/kg Eggs ]
1.2.5. Florfenicol and related compounds U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F6Florfenicol Sum of florfenicol and its metabolites measured as florfenicol-amine All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish 100 μg/kg Muscle
200 μg/kg Fat
2 000  μg/kg Liver
300 μg/kg Kidney
Bovine, ovine, caprine 200 μg/kg Muscle Not for use in animals from which milk is produced for human consumption
[X43 000 μg/kg] [X4Liver]
300 μg/kg Kidney
Porcine 300 μg/kg Muscle
500 μg/kg Skin and fat
2 000  μg/kg Liver
500 μg/kg Kidney
Poultry 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption
200 μg/kg Skin and fat
2 500  μg/kg Liver
750 μg/kg Kidney
Fin fish 1 000  μg/kg Muscle and skin in natural proportions ]
Thiamphenicol Thiamphenicol Bovine 50 μg/kg Muscle
50 μg/kg Fat
50 μg/kg Liver
50 μg/kg Kidney
50 μg/kg Milk
Chicken 50 μg/kg Muscle
Not for use in animals from which eggs are produced for human consumption 50 μg/kg Skin and fat
50 μg/kg Liver
50 μg/kg Kidney
1.2.6. Tetracyclines U.K.
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 U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Rifaximin Rifaximin Bovine 60 μg/kg Milk
1.2.8. Pleuromutilines U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F12Tiamulin 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
[F20Rabbits 100 μg/kg Muscle
500 μg/kg Liver ]
[F15Turkey 100 μg/kg Muscle
100 μg/kg Skin and fat
300 μg/kg Liver ]
Tiamulin 1 000  μg/kg Eggs ]
Valnemulin Valnemulin Porcine 50 μg/kg Muscle
500 μg/kg Liver
100 μg/kg Kidney
[F181.2.9. Lincosamides U.K.
a

[F5For porcine and poultry species this MRL relates to skin and fat in natural proportions .

b

For fin fish this MRL relates to muscle and skin in natural proportions .] ]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F6Lincomycin Lincomicyn All food producing species 50 μg/kg Fat  a
100 μg/kg Muscle  b
500 μg/kg Liver
1 500  μg/kg Kidney
150 μg/kg Milk
50 μg/kg Eggs ]
[F20Pirlimycin 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 ]
[F161.2.10. Aminoglycosides U.K.
a

[F5For porcine and poultry species this MRL relates to skin and fat in natural proportions .

b

For fin fish this MRL relates to muscle and skin in natural proportions .

c

[F25Not for use in animals from which eggs are produced for human consumption.] ] ]

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
[F26Dihydrostreptomycin Dihydrostreptomycin Bovine, ovine 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 and fat
500 μg/kg Liver
1 000  μg/kg Kidney ]
[F27Gentamicin 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 ]
[F25Kanamycin Kanamycin A All food producing species except fish c 100 μg/kg Muscle
100 μg/kg Fat a
600 μg/kg Liver
2 500  μg/kg Kidney
150 μg/kg Milk ]
[F5Neomycin (including framycetin) Neomycin B All food producing species 500 μg/kg Fat  a
500 μg/kg Muscle  b
500 μg/kg Liver
5 000  μg/kg Kidney
1 500  μg/kg Milk
500 μg/kg Eggs ]
[F6Paromomycin Paromomycin All food producing species 500 μg/kg Muscle b 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 a Not for use in animals from which eggs are produced for human consumption
300 μg/kg Muscle  b
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]
[F26Streptomycin Streptomycin Bovine, ovine 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 and fat
500 μg/kg Liver
1 000  μg/kg Kidney ]
[F241.2.11. Other antibiotics U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Novobiocin Novobiocin Bovine 50 μg/kg Milk ]
[F281.2.12. Polypeptides U.K.
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
[F29 Rabbits 150 μg/kg Muscle
150 μg/kg Fat
150 μg/kg Liver
150 μg/kg Kidney ] ]
[F141.2.13. Beta-lactamase inhibitors U.K.
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 ]
[F51.2.14. Polymyxins U.K.
a

For porcine and poultry species this MRL relates to skin and fat in natural proportions .

b

For fin fish this MRL relates to muscle and skin in natural proportions .]

Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions
Colistin Colistin All food producing species 150 μg/kg Fat  a
150 μg/kg Muscle  b
150 μg/kg Liver
200 μg/kg Kidney
50 μg/kg Milk
300 μg/kg Eggs

2. Antiparasitic agents U.K.

2.1. Agents acting against endoparasites U.K.

2.1.1. Salicylanilides U.K.
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
[F28Rafoxanide 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]
2.1.2. Tatra-hydro-imidazoles (imidazolthiazoles) U.K.
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 U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F30Albendazole 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]
[F31Albendazole 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 ]
[F30Febantel 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]
Flubendazole Sum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4fluorophenyl) methanone Porcine, chicken, game birds 50 μg/kg Muscle
50 μg/kg Skin and fat
400 μg/kg Liver
300 μg/kg Kidney
[F32 Turkey 50 μg/kg Muscle
50 μg/kg Skin and fat
400 μg/kg Liver
300 μg/kg Kidney ]
Flubendazole Chicken 400 μg/kg Eggs
[F33Mebendazole 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]
[F15Netobimin Sum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazole [X5Bovine, 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]
[F30Oxfendazole 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]
Oxibendazole Oxibendazole Porcine 100 μg/kg Muscle
500 μg/kg Skin and fat
200 μg/kg Liver
100 μg/kg Kidney
[F30Thiabendazole 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]
Triclabendazole Sum of extractable residues that may be oxidised to ketotriclabendazole Bovine, ovine 100 μg/kg Muscle Not for use in animals from which milk is produced for human consumption
100 μg/kg Liver
100 μg/kg Kidney

Editorial Information

Textual Amendments

[F342.1.4. Phenol derivatives including salicylanides U.K.
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
[F30Oxyclozanide Oxyclozanide All ruminants 20  μg/kg Muscle
20  μg/kg Fat
500  μg/kg Liver
100  μg/kg Kidney
10  μg/kg Milk] ]
[F352.1.5. Benzenesulphonamides U.K.
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 ]
[F272.1.6. Piperazine derivatives U.K.
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 ]
[F362.1.7. Tetrahydropyrimides U.K.
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 ]

2.2. Agents acting against ectoparasites U.K.

2.2.1. Organophosphates U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F28Coumafos Coumafos Bees 100 μg/kg Honey ]
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
[F15Phoxim 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]
2.2.2. Formamidines U.K.
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
[F31 Bees (honey) 200 μg/kg Honey ]
[F37 Caprine 200  μg/kg Fat
100  μg/kg Liver
200  μg/kg Kidney
10  μg/kg Milk ]
2.2.3. Pyrethroids U.K.
a

[F13Further provisions in Commission Directive 98/82/EC are to be observed ( OJ L 290, 29.10.1998, p. 25 ).]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F15 [X5Cyhalothrin 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] ]
[F38 [F30Deltamethrin Deltamethrin All ruminants 10  μg/kg Muscle
50  μg/kg Fat
10  μg/kg Liver
10  μg/kg Kidney
20  μg/kg Milk]
[F11Fin fish 10 μg/kg Muscle and skin in natural proportions] ]
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
[F39 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 ]
[F13Permethrin 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 a ]
[F40Cypermethrin Cypermethrin (sum of isomers) Salmonidae 50 μg/kg Muscle and skin in natural proportions ]
[F30All ruminants 20  μg/kg Muscle
200  μg/kg Fat
20  μg/kg Liver
20  μg/kg Kidney
20  μg/kg Milk a ]
[F41Alphacypermethrin 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] a
[F162.2.4. Acyl urea derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F24Diflubenzuron Diflubenzuron Salmonidae 1 000  μg/kg Muscle and skin in natural proportions ]
Teflubenzuron Teflubenzuron Salmonidae 500 μg/kg Muscle and skin in natural proportions ]
[F422.2.5. Pyrimidines derivatives U.K.
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
[F43150 μg/kg] Fat
400 μg/kg Liver
400 μg/kg Kidney]
[F282.2.6. Triazine derivatives U.K.
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 U.K.

2.3.1. Avermectins U.K.
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
[F27 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 ]
Doramectin Doramectin Bovine 10 μg/kg Muscle Not for use in bovine from which milk is produced for human consumption
150 μg/kg Fat
100 μg/kg Liver
30 μg/kg Kidney
Porcine, ovine 20 μg/kg Muscle Not for use in ovine from which milk is produced for human consumption
100 μg/kg Fat
50 μg/kg Liver
30 μg/kg Kidney
[F28 Deer, including reindeer 20 μg/kg Muscle
100 μg/kg Fat
50 μg/kg Liver
30 μg/kg Kidney ]
[F44Emamectin Emamectin B1a Fin fish 100 μg/kg Muscle and skin in natural proportions ]
Eprinomectin Eprinomectin B1a Bovine [F4550 μg/kg] Muscle
[F45250 μg/kg] Fat
[F451 500  μg/kg] Liver
[F45300 μg/kg] Kidney
[F4520 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
Moxidectin Moxidectin Bovine, ovine 50 μg/kg Muscle
500 μg/kg Fat
100 μg/kg Liver
50 μg/kg Kidney
[F14 Bovine 40 μg/kg Milk ]
[F35 Equidae 50 μg/kg Muscle
500 μg/kg Fat
100 μg/kg Liver
50 μg/kg Kidney ]

2.4. Agents acting against protozoa U.K.

2.4.1. Triazinetrione derivative U.K.
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
[F46 Porcine 100 μg/kg Muscle
150 μg/kg Skin and fat
500 μg/kg Liver
250 μg/kg Kidney ]
[F462.4.2. Quinazolone derivatives U.K.
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]
[F112.4.3. Carbanilides U.K.
a

[F17Not for use in ovine from which milk is produced for human consumption.] ]

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
[F17Ovine a 300 μg/kg Muscle
50 μg/kg Fat
2 000  μg/kg Liver
1 500  μg/kg Kidney ]

3. Agents acting on the nervous system U.K.

3.1. Agents acting on the central nervous system U.K.

3.1.1. Butyrophenone tranquillisers U.K.
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 U.K.

3.2.1. Anti-adrenergics U.K.
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
[F9 Bovine 5 μg/kg Muscle
5 μg/kg Fat
15 μg/kg Liver
15 μg/kg Kidney
1 μg/kg Milk ]
[F393.2.2. β2 sympathomimetic agents U.K.
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 U.K.

4.1. Nonsteroidal anti-inflammatory agents U.K.

4.1.1. Arylpropionic acid derivative U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F16Carprofen 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 ]
Vedaprofen Vedaprofen Equidae 50 μg/kg Muscle
20 μg/kg Fat
100 μg/kg Liver
1 000  μg/kg Kidney
4.1.2. Fenamate group derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F12Flunixin 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
[F46Equidae 10 μg/kg Muscle
20 μg/kg Fat
100 μg/kg Liver
200 μg/kg Kidney ] ]
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
[F264.1.3. Enolic acid derivates U.K.
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 ]
[F314.1.4. Oxican derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine [F4720 μg/kg] Muscle
[F4765 μg/kg] Liver
[F4765 μg/kg] Kidney
[F1215 μg/kg] [F12Milk]
[F48Porcine 20 μg/kg Muscle
65 μg/kg Liver
65 μg/kg Kidney ] ]
[F414.1.5. Pyrazolone derivatives U.K.
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 ]
[F254.1.6. Phenyl acetic acid derivatives U.K.
a

Not for use in animals from which milk is produced for human consumption.]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diclofenac Diclofenac Bovine a 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

5. Corticoides U.K.

5.1. Glucocorticoides U.K.

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F24Betamethasone 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 ]
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
[F37 Caprine 0,75  μg/kg Muscle
2  μg/kg Liver
0,75  μg/kg Kidney
0,3  μg/kg Milk]
[F23Methylprednisolone 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]
[F49Prednisolone Prednisolone Bovine 4 μg/kg Muscle
4 μg/kg Fat
10 μg/kg Liver
10 μg/kg Kidney
6 μg/kg Milk ]

[F506. Agents acting on the reproductive system U.K.

6.1. Progestogens U.K.

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
[F21Caprine 1 μg/kg Milk For intra-vaginal use for zootechnical purposes only] ] ]

[F4ANNEX II U.K. LIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS

1. Inorganic chemicals U.K.

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
[F51Aluminium salicylate, basic Bovine For oral use only; Not for use in animals from which milk is produced for human consumption]
Aluminium tristearate All food-producing species
Ammonium chloride All food-producing species
[F9Barium selenate Bovine, ovine ]
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
[F16Bromide, potassium salt All food producing species ]
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
[F46Calcium glycerophosphate All food producing species ]
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
[F34Sodium glycerophosphate All food producing species ]
Sodium hypophosphite All food-producing species
[F20Sodium propionate All food producing species ]
Sodium selenate All food-producing species
Sodium selenite All food-producing species
Sulphur [F52All food producing species]

Zinc acetate

Zinc chloride

Zinc gluconate

Zinc oleate

Zinc stearate

All food-producing species

2. Organic compounds U.K.

a

[F53Only for intravaginal therapeutic or zootechnical use and in accordance with the provisions of Directive 96/22/EC.

b

[F22For oral use only.]

c

[F54For oral use; not for use in animals from which milk is produced for human consumption.] ]

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
[F55Diclazuril

All ruminants b

Porcine b

]
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
[F181-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]
[F56Parconazole Guinea fowl ]
[F34Biotin 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 ]
[F57Tiaprost Bovine, ovine, porcine, equidae ]
[F16Apramycin

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 ]
[F35Fenpipramide 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]
[F58Atropine All food producing species
Cefoperazone Bovine For intramammary use in lactating cows only and for all tissues except milk]
[F312-aminoethanol glucuronate All food-producing species
Betaine glucuronate All food-producing species
Bituminosulfonates, ammonium and sodium salts All mammalian food-producing species

For topical use only

Not for use in animals from which milk is produced for human consumption

Chlorphenamine All mammalian food-producing species
Humic acids and their sodium salts All food-producing species For oral use only
Paracetamol Porcine For oral use only
Tosylchloramide sodium Fin fish For water-borne use only]
[F33 Bovine For topical use only]
[F241-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]
[F12Butafosfan Bovine [F43For 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]
[F93,5-Diiodo-L-thyrosine All mammalian food-producing species
Levothyroxine All mammalian food-producing species ]
[F10Aluminium 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
[F59Sodium salicylate Bovine, porcine c ]
Zinc aspartate All food producing species ]
[F60Toldimfos All food producing species ]
[F20Decoquinate 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 ]
[F61Thiamylal All mammalian food producing species For intravenous administration only
Thiopental sodium All food-producing species For intravenous administration only]
[F62Acetylsalicylic 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]
[F15Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C 9 to C 13 , containing less than 2,5 % of chains longer than C 13 Bovine For topical use only]
[F28Amprolium Poultry For oral use only
Tiludronic acid, disodium salt Equidae For intravenous use only]
[F38Sorbitan trioleate All food-producing species ]
[F63Vitamin A All food producing species ]
[F11Ammonium lauryl sulphate All food-producing species
Bronopol Fin fish
Calcium pantothenate All food-producing species ]
[F27Allantoin All food producing species For topical use only
Benzocaine Salmonidae ]
[F64Dexpanthenol All food producing species ]
[F26Azagly-nafarelin Salmonidae Not for use in fish from which eggs are produced for human consumption
Deslorelin acetate Equidae ]
[F65Hydroxyethylsalicylate All food producing species except fish For topical use only
Xylazine hydrochloride Bovine, equidae ]
[F51Omeprazole Equidae For oral use only]
[F13Trichlormethiazide All mammalian food producing species ]
[F53Progesterone a Bovine, ovine, caprine, Equidae (female) ]

Textual Amendments

3. Substances generally recognised as safe U.K.

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
[F16Adenosine 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 ]

4. Substances used in homeopathic veterinary medicinal products U.K.

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
[F57Adonis 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]
[F35Apocynum 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]
[F32Ruta 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]

[F12Aesculus 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]
[F9Phytolacca 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]

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

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 U.K.

Pharmacologically active substance(s) Animal species Other provisions
[F66Aloe vera gel and whole leaf extract of Aloe vera All food-producing species For topical use only]
[F12Aloes, Barbados and Capae, their standardised dry extract and preparations thereof All food-producing species ]
Angelicae radix aetheroleum All food-producing species
Anisi aetheroleum All food-producing species
[F20Anisi stellati fructus , standardised extracts and preparations thereof All food producing species ]
[F12Arnica montana (arnicae flos and arnicae planta tota) All food-producing species For topical use only]
Balsamum peruvianum All food-producing species For topical use only
[F12Boldo folium All food-producing species ]
[F24Calendulae flos All food-producing species For topical use only]
[F32Capsici fructus acer All food-producing species ]
[F12Carlinae radix All food-producing species For topical use only]
Carvi aetheroleum All food-producing species
Caryophylli aetheroleum All food-producing species
[F18Centellae asiaticaer extractum All food producing species For topical use only]
Chrysanthemi cinerariifolii flos All food-producing species For topical use only
[F24Cimicifugae racemosae rhizoma All food-producing species Not for use in animals from which milk is produced for human consumptiom]
[F20Cinchonae cortex , standardised extracts and preparations thereof All food producing species ]
Cinnamomi cassiae aetheroleum All food-producing species
[F20Cinnamomi cassiae cortex , standardised extracts and preparations thereof All food producing species ]
Cinnamomi ceylanici aetheroleum All food-producing species
[F20Cinnamomi ceylanici cortex , standardised extracts and preparations thereof All food producing species ]
Citri aetheroleum All food-producing species
Citronellae aetheroleum All food-producing species
[F20Condurango cortex , standardised extracts and preparations thereof All food producing species ]
Coriandri aetheroleum All food-producing species
[F12Cupressi aetheroleum All food-producing species For topical use only]
Echinacea purpurea All food-producing species For topical use only
Eucalypti aetheroleum All food-producing species
Foeniculi aetheroleum All food-producing species
[F20Frangulae cortex , standardised extracts and preparations thereof All food producing species
Gentianae radix , standardised extracts and preparations thereof All food producing species ]
Hamamelis virginiana All food-producing species For topical use only
[F32Hippocastani semen All food-producing species For topical use only]
Hyperici oleum All food-producing species For topical use only
[F32Juniperi fructus All food-producing species
Lauri folii aetheroleum All food-producing species
Lauri fructus All food-producing species ]
[F12Lavandulae aetheroleum All food-producing species For topical use only]
Lespedeza capitata All food-producing species
Lini oleum All food-producing species
Majoranae herba All food-producing species
[F10Matricaria recutita and preparations thereof All food producing species ]
Matricariae flos All food-producing species
Medicago sativa extractum All food-producing species For topical use only
[F18Melissae aetheroleum All food producing species ]
Melissae folium All food-producing species
[F11Menthae arvensis aetheroleum All food-producing species ]
Menthae piperitae aetheroleum All food-producing species
Millefolii herba All food-producing species
Myristicae aetheroleum All food-producing species For use in newborn animals only
Oxidation products of Terebinthinae oleum Bovine, porcine, ovine, caprine
Pyrethrum extract All food-producing species For topical use only
Quercus cortex All food-producing species
Quillaia saponins All food-producing species
[F10Rhei radix , standardised extracts and preparations thereof All food producing species ]
Ricini oleum All food-producing species For use as excipient
Rosmarini aetheroleum All food-producing species
Rosmarini folium All food-producing species
[F32Ruscus aculeatus All food-producing species For topical use only]
Salviae folium All food-producing species
Sambuci flos All food-producing species
Sinapis nigrae semen All food-producing species
[F32Strychni semen Bovine, ovine, caprine For oral use only at doses up to the equivalent of 0,1 mg strychnine/kg bw]
[F12Symphyti radix All food-producing species For topical use on intact skin only]
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

[F77. Anti-infectious agents U.K.

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

[F4ANNEX III U.K. LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VETERINARY MEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

1. Anti-infectious agents U.K.

1.1. Chemotheurapeutics U.K.

1.1.2. Benzenesulphonamides U.K.
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 U.K.

1.2.1. Beta-lactamase inhibitors U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clavulanic acid Clavulanic acid Bovine, ovine 200 μg/kg Milk [F45Provisional 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 U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F10Acetylisovaleryltylosin 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]
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 [F67Provisional MRLs expire on 1.7.2002]
200 μg/kg Fat
200 μg/kg Liver
400 μg/kg Kidney
200 μg/kg Eggs
[F56 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]
[F24Tilmicosin Tilmicosin Bovine 40 μg/kg Milk Provisional MRLs expire on 1.1.2001]
[F51Tulathromycin (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]
[F181.2.4. Cephalosporins U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefacetrile Cefacetrile Bovine 125 μg/kg Milk

[F68Provisional MRLs expire on 1.1.2002]

For intrammamary use only

[F12Cefalonium Cefalonium Bovine 10 μg/kg Milk [F69Provisional MRLs expire on 1.1.2003] ]
[F58Cefoperazone Cefoperazone Bovine 50 μg/kg Milk Provisional MRLs expire on 1 January 2001]
[F70Cefquinome 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]
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 U.K.
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
[F71Dihydrostreptomycin 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]
[F16Kanamycin Kanamycin Rabbits 100 μg/kg Muscle [F72Provisional 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]
[F71Neomycin (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]
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
[F12

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]
[F71Streptomycin 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]
1.2.6. Quinolones U.K.
a

[F7Provisional MRLs expire 1 January 2006 .

b

Not for use in animals from which milk is produced for human consumption.]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F56Danofloxacin 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]
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
[F34Difloxacin 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]
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
[F18 [F8Oxolinic acid a Oxolinic acid Bovine b 100 µg/kg Muscle
50 µg/kg Fat
150 µg/kg Liver
150 µg/kg Kidney]
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]
1.2.9. Polymyxins U.K.
Phamarcologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Colistin Colistin Bovine, ovine 50 μg/kg Milk [F67Provisional 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 U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F18Nafcillin 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]
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 U.K.
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
[F18Thiamphenicol 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]
[F561.2.12. Polypeptides U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Bacitracin Bacitracin Bovine 150 μg/kg Milk Provisional MRLs expire on 1.7.2001]
[F181.2.13. Lincosamides U.K.
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
[F56Pirlimycin 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] ]
[F121.2.14. Pleuromutilines U.K.
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 U.K.

2.1. Agents acting against endoparasites U.K.

[F342.1.1. Phenol derivatives including salicylanides U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Oxyclozanide Oxyclozanide Bovine 20 μg/kg Muscle [F67Provisional MRLs expire on 1.7.2002]
20 μg/kg Fat
500 μg/kg Liver
100 μg/kg Kidney
10 μg/kg Milk
Ovine 20 μg/kg Muscle
20 μg/kg Fat
500 μg/kg Liver
100 μg/kg Kidney]
2.1.2. Benzimidazoles and pro-benzimidazoles U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole sulphoxide Sum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole Bovine, ovine 100 μg/kg Milk Provisional MRLs expire on 1 January 2000
Bovine, ovine, pheasant 100 μg/kg Muscle
100 μg/kg Fat
1 000  μg/kg Liver
500 μg/kg Kidney
[F12Mebendazole Sum of mebendazole methyl (5-(1-hidroxy, 1-phenyl) methyl-1H-benzimidazol-2-yl) carbamate and (2-amino-1H-benzimidazol-5-yl) phenylmethanone, expressed as mebendazole equivalents

Ovine, caprine, equidae

Not for use in animals from which milk is produced for human consumption

60 μg/kg Muscle Provisional MRLs expire on 1.1.2002
60 μg/kg Fat
400 μg/kg Liver
60 μg/kg Kidney]
Netobimin Sum of netobimin and albendazole and metabolites of albendazole measured as 2-amino- benzimidazole sulphone Bovine, ovine, caprine 100 μg/kg Muscle Provisional MRLs expire on 31 July 1999
100 μg/kg Fat
1 000  μg/kg Liver
500 μg/kg Kidney
100 μg/kg Milk
[F342.1.3. Tetrahydropyrimides U.K.
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 [F69Provisional MRLs expire on 1.7.2003]
100 μg/kg Fat
800 μg/kg Liver
200 μg/kg Kidney
100 μg/kg Milk
Porcine 100 μg/kg Muscle
100 μg/kg Skin and fat
800 μg/kg Liver
200 μg/kg Kidney]
[F242.1.5. Piperazine derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Piperazine Piperazine Porcine 400 μg/kg Muscle [F73Provisional MRLs expire on 1.7.2003]
800 μg/kg Skin and fat
2 000  μg/kg Liver
1 000  μg/kg Kidney
Chicken 2 000  μg/kg Eggs]
[F122.1.6. Salicylanilides U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Rafoxanide Rafoxanide

Bovine

Not for use in animals from which milk is produced for human consumption

30 μg/kg Muscle Provisional MRLs expire on 1.7.2001
30 μg/kg Fat
10 μg/kg Liver
40 μg/kg Kidney

Ovine

Not for use in animals from which milk is produced for human consumption

100 μg/kg Muscle
250 μg/kg Fat
150 μg/kg Liver
150 μg/kg Kidney]

2.2. Agents acting against ectoparasites U.K.

2.2.1. Formamidines U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz Bees 200 μg/kg Honey Provisional MRLs expire on 1 July 1999
2.2.2. Iminophenyl thiazolidine derivative U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cymiazole Cymiazole Bees 1 000  μg/kg Honey [F74Provisional MRLs expire on 1.7.2001]
2.2.3. Pyretrin and pyrethroids U.K.
a

[F54Provisional MRLs expire on 1 July 2006 .]

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyfluthrin Cyfluthrin Bovine 10 μg/kg Muscle Provisional MRLs expire on 1 January 2001
50 μg/kg Fat
10 μg/kg Liver
10 μg/kg Kidney
20 μg/kg Milk
Further provisions in Council Directive 94/29/EC are to be observed ( OJ L 189, 23.7.1994, p. 67 )
[F70Alphacypermethrin Cypermethrin (sum of isomers) Bovine, ovine 20 μg/kg Muscle

[F75Provisional MRLs expire on 1.7.2003

Further provisions in Directive 93/57/EC are to be observed]

200 μg/kg Fat
20 μg/kg Liver
20 μg/kg Kidney
20 μg/kg

Milk

[F76Further provisions in Council Directive 93/57/EC ( OJ L 211, 23.8.1992, p. 1 ) are to be observed]

Chicken 50 μg/kg Muscle
50 μg/kg Skin + fat
50 μg/kg Liver
50 μg/kg Kidney
50 μg/kg Eggs
[F75Cypermethrin Cypermethrin (sum of isomers) Bovine 20 μg/kg Muscle

Provisional MRLs expire on 1.7.2003

Further provisions in Directive 93/57/EC are to be observed

200 μg/kg Fat
20 μg/kg Liver
20 μg/kg Kidney
20 μg/kg Milk
Cypermethrin (sum of isomers) Ovine 20 μg/kg Muscle

Provisional MRLs expire on 1.7.2003

Not for use in animals from which milk is produced for human consumption

200 μg/kg Fat
20 μg/kg Liver
20 μg/kg Kidney]
Porcine 20 μg/kg Muscle
200 μg/kg Skin + fat
20 μg/kg Liver
20 μg/kg Kidney
Chicken 50 μg/kg Muscle
50 μg/kg Skin + fat
50 μg/kg Liver
50 μg/kg Kidney
50 μg/kg Eggs
Salmonidae 50 μg/kg Muscle and skin in natural proportions [F23Provisional MRLs expire on 1.7.2003] ]
[F35Deltamethrin Deltamethrin Bovine 10 μg/kg Muscle Provisional MRLs expire on 1 July 2001
50 μg/kg Fat
10 μg/kg Liver
10 μg/kg Kidney
20 μg/kg Milk

Ovine

Not for use in animals from which milk is produced for human consumption

10 μg/kg Muscle
50 μg/kg Fat
10 μg/kg Liver
10 μg/kg Kidney
Chicken 10 μg/kg Muscle [F38Provisional MRLs expire on 1.7.2003]
50 μg/kg Skin + fat
10 μg/kg Liver
10 μg/kg Kidney
50 μg/kg Eggs
[F42 Fin fish 10 μg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1.1.2002] ]
[F59Fenvalerate a 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]
[F68Permethrin Permethrin (sum of isomers) Chicken, porcine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2003
500 μg/kg Skin and fat
50 μg/kg Liver
50 μg/kg Kidney
Bovine, caprine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2003
500 μg/kg Fat
50 μg/kg Liver
50 μg/kg Kidney
50 μg/kg Milk Further provisions in Commission Directive 98/82/EC are to be observed ( OJ L 290, 29.10.1998, p. 25 )
Chicken 50 μg/kg Eggs Provisional MRLs expire on 1.1.2003]
2.2.4. Organophosphates U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azamethiphos Azamethiphos Salmonidae 100 μg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1 June 1999
[F16Coumafos Coumafos Bees 100 μg/kg Honey Provisional MRLs expire on 1.7.2001]
[F32Phoxim Phoxim Porcine 20 μg/kg Muscle Provisional MRLs expire on 1 January 2001
700 μg/kg Skin and fat
20 μg/kg Liver
20 μg/kg Kidney
[F39Ovine 50 μg/kg Muscle Provisional MRLs expire on 1.7.2001 ; not for use in animals from which milk is produced for human consumption
400 μg/kg Fat
50 μg/kg Kidney]
[F41Chicken 50 μg/kg Muscle Provisional MRLs expire on 1.7.2005 .
550 μg/kg Skin and fat
25 μg/kg Liver
50 μg/kg Kidney
60 μg/kg Eggs] ]
[F12Propetamphos Sum of residues of propetamphos and desisopropyl-propetamphos

Ovine

Not for use in animals from which milk is produced for human consumption

90 μg/kg Fat Provisional MRLs expire on 1.1.2001
90 μg/kg Kidney]
2.2.5. Acyl urea derivates U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Teflubenzuron Teflubenzuron Salmonidae 500 μg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1 July 1999
[F34Diflubenzuron Diflubenzuron Salmonidae 1 000 μg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1.7.2000]
[F312.2.6. Pyrimidines derivatives U.K.
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

Provisional MRLs expire on 1 July 2000 ;

Not for use in animals from which milk is produced for human consumption

50 μg/kg Fat
400 μg/kg Liver
400 μg/kg Kidney]
[F242.2.7. Triazine derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyromazine Cyromazine Ovine 300 μg/kg Muscle

Provisional MRLs expire on 1.7.2001

Not for use in animals from which milk is produced for human consumption

300 μg/kg Fat
300 μg/kg Liver
300 μg/kg Kidney]

2.3. Agents acting against endo- and ectoparasites U.K.

2.3.1. Avermectins U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F12Abamectin Avermectin B1a Ovine 20 μg/kg Muscle Provisional MRLs expire on 1.1.2001
50 μg/kg Fat
25 μg/kg Liver
20 μg/kg Kidney
Doramectin Doramectin Deer, inclusing reindeer 20 μg/kg Muscle Provisional MRLs expire on 1.7.2001
100 μg/kg Fat
50 μg/kg Liver
30 μg/kg Kidney]
Moxidectin Moxidectin Equidae 50 μg/kg Muscle Provisional MRLs expire on 1 January 2000
500 μg/kg Fat
100 μg/kg Liver
50 μg/kg Kidney

[F562.4. Agents acting against protozoa U.K.

2.4.1. Carbanilides U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Imidocarb Imidocarb Bovine, ovine 300 μg/kg Muscle Provisonal MRLs expire on 1.1.2002
50 μg/kg Fat
2 000 μg/kg Liver
1 500 μg/kg Kidney
50 μg/kg Milk
[F342.4.2. Quinazolone derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Halofuginone Halofuginone Bovine 10 μg/kg Muscle Provisional MRL's expire on 1.1.2001
25 μg/kg Fat
30 μg/kg Liver
30 μg/kg Kidney]
[F242.4.3. Triazinetrione derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Porcine 100 μg/kg Muscle Provisional MRLs expire on 1.1.2001
150 μg/kg Skin and fat
500 μg/kg Liver
250 μg/kg Kidney]
[F602.4.4. Other anti-protozoal agents U.K.
Pharmacologically active substance(s) Marker residue Animal species MRL Target tissues Other provisions
Amprolium Amprolium Chicken, turkey 200 μg/kg Muscle Provisional MRLs expire on 1.1.2002
200 μg/kg Skin and fat
200 μg/kg Liver
400 μg/kg Kidney
1 000  μg/kg Eggs] ]

3. Agents acting on the nervous system U.K.

3.2. Agents acting on the autonomic nervous system U.K.

3.2.1. β 2 sympathomimetic agents U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clenbuterol hydrochloride Clenbuterol Bovine 0,1 μg/kg Muscle Provisional MRLs expire on 1 July 2000
Indication: solely for tocolysis in parturient cows 0,5 μg/kg Liver
0,5 μg/kg Kidney
0,05 μg/kg Milk
Equidae 0,1 μg/kg Muscle
Indications: tocolysis and the treatment of respiratory ailments 0,5 μg/kg Liver
0,5 μg/kg Kidney
[F563.2.2. Anti-adrenergics U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Bovine 5 μg/kg Muscle Provisional MRLs expire on 1.1.2000
5 μg/kg Fat
15 μg/kg Liver
15 μg/kg Kidney
1 μg/kg Milk]

5. Anti-inflammatory agents U.K.

5.1. Nonsteroidal anti-inflammatory agents U.K.

5.1.1. Arylpropionic acid derivative U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carprofen Carprofen Bovine 500 μg/kg Muscle Provisional MRLs expire on 1 January 2000
500 μg/kg Fat
1 000  μg/kg Liver
1 000  μg/kg Kidney
Equidae 50 μg/kg Muscle
100 μg/kg Fat
1 000  μg/kg Liver
1 000  μg/kg Kidney
5.1.2. Enolic acid derivates U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine 25 μg/kg Muscle Provisional MRLs expire on 1 January 2000
60 μg/kg Liver
35 μg/kg Kidney
[F125.1.3. Pyrazolone derivatives U.K.
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
[F69Metamizole 4-Methylaminoantipyrin Bovine, porcine, equidae 200 μg/kg Muscle

Provisional MRLs expire on 1.7.2003 .

Not for use in animals from which milk is produced for human consumption

200 μg/kg Fat
200 μg/kg Liver
200 μg/kg Kidney] ]

[F506. Agents acting on the reproductive system U.K.

6.1. Progestogens U.K.

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Altrenogest Altrenogest Porcine 3 μg/kg [F77Skin and fat] [F77Provisional MRLs expire on 1.1.2005 ; for zootechnical use only]
3 μg/kg Liver
3 μg/kg Kidney
Equidae 3 μg/kg Fat
3 μg/kg Liver
3 μg/kg Kidney
[F78Flugestone acetate Flugestone acetate Ovine, caprine 0,5 μg/kg Muscle Provisional MRLs expire on 1.1.2008 ; for therapeutic or zootechnical use only
0,5 μg/kg Fat
0,5 μg/kg Liver
0,5 μg/kg Kidney
Norgestomet Norgestomet Bovine 0,5 μg/kg Muscle Provisional MRLs expire on 1.1.2008 ; for therapeutic or zootechnical use only
0,5 μg/kg Fat
0,5 μg/kg Liver
0,5 μg/kg Kidney
0,15 μg/kg Milk] ]

[F107. Corticoids U.K.

7.1. Glucocorticoids U.K.

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Methylprednisolone Methylprednisolone Bovine 10 μg/kg Muscle Provisional MRLs expire on 1.7.2001 . 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] ]

[F4ANNEX IV U.K. LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH NO MAXIMUM LEVELS CAN BE FIXED

Pharmacologically active substance(s)
Aristolochia spp. and preparations thereof
Chloramphenicol
Chloroform
Chlorpromazine
Colchicine
Dapsone
Dimetridazole
Metronidazole
Nitrofurans (including furazolidone)
Ronidazole]

[F79ANNEX V U.K. Information and particulars to be included in an application for the establishment of a maximum residue limit for a pharmacologically active substance used in veterinary medicinal products

Administrative particulars U.K.

1 Name or corporate name and permanent address of the applicant. U.K.

2 Name of the veterinary medicinal product. U.K.

3 Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name recommended by the World Health Organization, where such name exists. U.K.

4 Manufacturing authorization, if any. U.K.

5 Marketing authorization, if any. U.K.

6 Summary of the characteristics of the veterinary medicinal product(s) prepared in accordance with Article 5a of Directive 81/851/EEC. U.K.

A. Safety documentation U.K.

A.0. Expert report U.K.
A.1. Precise identification of the substance concerned by the application U.K.
1.1 International non-proprietary name (INN). U.K.
1.2 International Union of Pure and Applied Chemistry (IUPAC) name. U.K.
1.3 Chemical Abstract Service (CAS) name. U.K.
1.4 Classification: U.K.
  • therapeutic;

  • pharmacological.

1.5 Synonyms and abbreviations. U.K.
1.6 Structural formula. U.K.
1.7 Molecular formula. U.K.
1.8 Molecular weight. U.K.
1.9 Degree of impurity. U.K.
1.10 Qualitative and quantitative composition of impurities. U.K.
1.11 Description of physical properties: U.K.
  • melting point;

  • boiling point;

  • vapour pressure;

  • solubility in water and organic solvents, expressed in grams per litre, with indication of temperature;

  • density;

  • refractive index, rotation, etc.

A.2. Relevant pharmacological studies U.K.
2.1 Pharmacodynamics. U.K.
2.2 Pharmacokinetics. U.K.
A.3. Toxicological studies U.K.
3.1 Single dose toxicity. U.K.
3.2 Repeated dose toxicity. U.K.
3.3 Tolerance in the target species of animal. U.K.
3.4 Reproductive toxicity, including teratogenicity. U.K.
3.4.1 Study of the effects on reproduction. U.K.
3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity. U.K.
3.5 Mutagenicity. U.K.
3.6 Carcinogenicity. U.K.
A.4. Studies of other effects U.K.
4.1 Immunotoxicity. U.K.
4.2 Microbiological properties of residues. U.K.
4.2.1 On the human gut flora; U.K.
4.2.2 On the organisms and microorganisms used for industrial food-processing. U.K.
4.3 Observations in humans. U.K.

B. Residue documentation U.K.

B.0 Expert report U.K.
B.1. Precise identification of the substance concerned by the application U.K.

The substance concerned should be identified in accordance with point A.1. However, where the application relates to one or more veterinary medicinal products, the product itself should be identified in detail, including:

  • qualitative and quantitative composition;

  • purity;

  • identification of the manufacturer's batch used in the studies; relationship to the final product;

  • specific activity and radio-purity of labelled substances;

  • position of labelled atoms on the molecule.

B.2. Residue studies U.K.
2.1 Pharmacokinetics U.K.

(absorption, distribution, biotransformation, excretion).

2.2 Depletion of residues. U.K.
2.3 Elaboration of maximum residue limits (MRLS). U.K.
B3. Routine analytical method for the detection of residues U.K.
3.1 Description of the method. U.K.
3.2 Validation of the method. U.K.
3.2.1 specificity; U.K.
3.2.2 accuracy, including sensitivity; U.K.
3.2.3 precision; U.K.
3.2.4 limit of detection; U.K.
3.2.5 limit of quantitation; U.K.
3.2.6 practicability and applicability under normal laboratory conditions; U.K.
3.2.7 susceptibility to interference.] U.K.

Yn ôl i’r brig

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