B COUNCIL REGULATION (EEC) No 2377/90 of 26 June 1990

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

►B COUNCIL REGULATION (EEC) No 2377/90

of 26 June 1990

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

(OJ L 224, 18.8.1990, p. 1)

Amended by:

Official Journal

No page date

►M1 Commission Regulation (EEC) No 675/92 of 18 March 1992 L 73 8 19.3.1992

►M2 Commission Regulation (EEC) No 762/92 of 27 March 1992 L 83 14 28.3.1992

►M3 Commission Regulation (EEC) No 3093/92 of 27 October 1992 L 311 18 28.10.1992

►M4 Commission Regulation (EEC) No 895/93 of 16 April 1993 L 93 10 17.4.1993

►M5 Council Regulation (EEC) No 2901/93 of 18 October 1993 L 264 1 23.10.1993

►M6 Commission Regulation (EC) No 3425/93 of 14 December 1993 L 312 12 15.12.1993


►M8 Commission Regulation (EC) No 955/94 of 28 April 1994 L 108 8 29.4.1994

►M9 Commission Regulation (EC) No 1430/94 of 22 June 1994 L 156 6 23.6.1994

►M10 Commission Regulation (EC) No 2701/94 of 7 November 1994 L 287 7 8.11.1994



►M13 Commission Regulation (EC) No 1102/95 of 16 May 1995 L 110 9 17.5.1995



►M16 Commission Regulation (EC) No 1798/95 of 25 July 1995 L 174 20 26.7.1995



►M19 Commission Regulation (EC) No 281/96 of 14 February 1996 L 37 9 15.2.1996







►M26 Commission Regulation (EC) No 1742/96 of 6 September 1996 L 226 5 7.9.1996


►M28 Commission Regulation (EC) No 2010/96 of 21 October 1996 L 269 5 22.10.1996



►M31 Commission Regulation (EC) No 17/97 of 8 January 1997 L 5 12 9.1.1997



1990R2377— EN— 16.08.2008 — 058.002— 1

►M34 Council Regulation (EC) No 434/97 of 3 March 1997 L 67 1 7.3.1997










►M44 Commission Regulation (EC) No 613/98 of 18 March 1998 L 82 14 19.3.1998




















►M64 Council Regulation (EC) No 1308/1999 of 15 June 1999 L 156 1 23.6.1999





















1990R2377— EN— 16.08.2008 — 058.002— 2




►M88 Commission Regulation (EC) No 1680/2001 of 22 August 2001 L 227 33 23.8.2001




►M92 Council Regulation (EC) No 2584/2001 of 19 December 2001 L 345 7 29.12.2001












►M104 Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003










►M114 Commission Regulation (EC) No 1851/2004 of25 October 2004 L 323 6 26.10.2004






















1990R2377— EN— 16.08.2008 — 058.002— 3






Corrected by:

►C1 Corrigendum, OJ L 222, 20.9.1995, p. 17 (1442/95)














1990R2377— EN— 16.08.2008 — 058.002— 4

COUNCIL REGULATION (EEC) No 2377/90

of 26 June 1990

laying down a Community procedure for the establishment ofmaximum residue limits of veterinary medicinal products in

foodstuffs of animal origin

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas the use of veterinary medicinal products in food-producinganimals may result in the presence of residues of foodstuffs obtainedfrom treated animals;

Whereas as a result of scientific and technical progress it is possible todetect the presence of residues of veterinary medicines in foodstuffs atever lower levels; whereas it is therefore necessary to establishmaximum residue limits for pharmacologically active substanceswhich are used in veterinary medicinal products in respect of all thevarious foodstuffs of animal origin, including meat, fish, milk, eggs andhoney;

Whereas in order to protect public health, maximum residue limits mustbe established in accordance with generally recognized principles ofsafety assessment, taking into account any other scientific assessmentof the safety of the substances concerned which may have beenundertaken by international organizations, in particular the CodexAlimentarius or, where such substances are used for other purposes,by other scientific committees established within the Community;

Whereas the use of veterinary medicinal products plays an importantpart in agricultural production; whereas the establishment of maximumresidue levels will facilitate the marketing of foodstuffs of animal origin;

Whereas the establishment of different maximum residue levels byMember States may hinder the free movement of foodstuffs and ofveterinary medicinal products themselves;

Whereas it is therefore necessary to lay down a procedure for theestablishment of maximum residue levels of veterinary medicinalproducts by the Community, following a single scientific assessmentof the highest possible quality;

Whereas the need for the establishment of maximum residue levelsthroughout the Community is recognized in the Community rulesrelating to trade in foodstuffs of animal origin;

Whereas provisions must be adopted with a view to the systematicestablishment of maximum residue levels for new substances capableof pharmacological action intended for administration to food-producinganimals;

Whereas arrangements must also be made for the establishment ofmaximum residue levels for substances which are currently used in

▼B

1990R2377— EN— 16.08.2008 — 058.002— 5

(1) OJ No C 61, 10. 3. 1989. p. 5.(2) OJ No C 96, 17. 4. 1990, p. 273.(3) OJ No C 201, 17. 8. 1989, p. 1.

veterinary medicines administered to food-producing animals; whereas,however, in view of the complexity of this matter and the large numberof substances involved, long transitional arrangements are required;

Whereas, after scientific assessment by the Committee for VeterinaryMedicinal Products, maximum residue levels must be adopted by arapid procedure which ensures close cooperation between theCommission and the Member States through the Committee set upunder Council Directive 81/852/EEC of 28 September 1981 on theapproximation of the laws of the Member States relating to analytical,pharmaco-toxicological and clinical standards and protocols in respectof the testing of veterinary medicinal products (1), as last amended byDirective 87/20/EEC (2); whereas an urgent procedure is also required toensure the swift review of any tolerance which might prove insufficientto protect public health;

Whereas medicinally induced immunological responses are usuallyindistinguishable from those which arise naturally, and do not affectconsumers of food of animal origin;

Whereas the information necessary to assess the safety of residuesshould be presented in accordance with the principles laid down byDirective 81/852/EEC,

HAS ADOPTED THIS REGULATION:

Article 1

1. For the purposes of this Regulation, the following definitions shallapply:

(a) ‘residues of veterinary medicinal products’: means all pharmacolo-gically active substances, whether active principles, excipients ordegradation products, and their metabolites which remain in food-stuffs obtained from animals to which the veterinary medicinalproduct in question has been administered;

(b) ‘maximum residue limit’: means the maximum concentration ofresidue resulting from the use of a veterinary medicinal product(expressed in mg/kg or μg/kg on a fresh weight basis) which maybe accepted by the Community to be legally permitted orrecognized as acceptable in or on a food.

It is based on the type and amount of residue considered to bewithout any toxicological hazard for human health as expressedby the acceptable daily intake (ADI), or on the basis of atemporary ADI that utilizes an additional safety factor. It alsotakes into account other relevant public health risks as well asfood technology aspects.

When establishing a maximum residue limit (MRL), considerationis also given to residues that occur in food of plant origin and/orcome from the environment. Furthermore, the MRL may be reducedto be consistent with good practices in the use of veterinary drugsand to the extent that practical analytical methods are available.

2. This Regulation shall not apply to active principles of biologicalorigin intended to produce active or passive immunity or to diagnose astate of immunity used in immunological veterinary medicinal products.

Article 2

The list of pharmacologically active substances used in veterinarymedicinal products in respect of which maximum residue limits have

▼B

1990R2377— EN— 16.08.2008 — 058.002— 6

(1) OJ No L 317, 6. 11. 1981, p. 16.(2) OJ No L 15, 17. 1. 1987, p. 34.

been established shall be contained in Annex I, which shall be adoptedin accordance with the procedure laid down in Article 8. Except asprovided for in Article 9, any amendments to Annex I shall beadopted in accordance with the same procedure.

Article 3

Where, following an evaluation of a pharmacologically active substanceused in veterinary medicinal products, it appears that it is not necessaryfor the protection of public health to establish a maximum residue limit,that substance shall be included in a list in Annex II, which shall beadopted in accordance with the procedure laid down in Article 8. Exceptas provided for in Article 9, any amendments to Annex II shall beadopted in accordance with the same procedure.

Article 4

A provisional maximum residue limit may be established for a pharma-cologically active substance used in veterinary medicinal products onthe date of entry into force of this Regulation, provided that there are nogrounds for supposing that residues of the substance concerned at thelevel proposed present a hazard for the health of the consumer. Aprovisional maximum residue limit shall apply for a defined period oftime, which shall not exceed five years. That period may be extendedonce only in exceptional cases for a period not in excess of two years ifthat proves expedient for the completion of scientific studies inprogress.

In exceptional circumstances, a provisional maximum residue limit mayalso be established for a pharmacologically active substance notpreviously used in veterinary medicinal products on the date of entryinto force of this Regulation provided that there are no grounds forsupposing that residues of the substance concerned at the limitproposed present a hazard for the health of the consumer.

The list of pharmacologically active substances used in veterinarymedicinal products in respect of which provisional maximum residuelimits have been established shall be contained in Annex III, which shallbe adopted in accordance with the procedure laid down in Article 8.Except as provided for in Article 9, any amendments to Annex III shallbe adopted in accordance with the same procedure.

Article 5

Where it appears that a maximum residue limit cannot be established inrespect of a pharmacologically active substance used in veterinarymedicinal products because residues of the substances concerned, atwhatever limit, in foodstuffs of animal origin constitute a hazard tothe health of the consumer, that substance shall be included in a listin Annex IV, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, anyamendments to Annex IV shall be adopted in accordance with thesame procedure.

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

▼M64

Article 6

1. In order to obtain the inclusion in Annexes I, II or III of a phar-macologically active substance which is intended for use in veterinarymedicinal products for administration to food-producing animals, anapplication to establish a maximum residue limit shall be submitted to

▼B

1990R2377— EN— 16.08.2008 — 058.002— 7

the European Agency for the Evaluation of Medicinal Products set upby Council Regulation (EEC) No 2309/93 (1), hereinafter referred to as‘the Agency’.

This application shall contain the information and particulars referred toin Annex V of this Regulation and shall conform with the principleslaid down in Directive 81/852/EEC.

2. The application shall also be accompanied by the fee payable tothe Agency.

Article 7

1. The Committee for Veterinary Medicinal Products referred to inArticle 27 of Regulation (EC) No 2309/93 (hereinafter ‘the Committee’)shall be responsible for formulating the Agency's opinion on the classi-fication of substances referred to in Annexes I, II, III or IV to thisRegulation.

2. Articles 52 and 53 of Regulation (EEC) No 2309/93 shall beapplicable for the purposes of this Regulation.

3. The Agency shall ensure that the Committee's opinion is deliveredwithin a period of 120 days following the reception of a valid appli-cation.

If the information submitted by the applicant is not sufficient to enablesuch an opinion to be prepared, the Committee may ask the applicant tosupply additional information within a specific time limit. The deadlinefor the opinion shall then be deferred until the additional informationhas been received.

4. The Agency shall forward the opinion to the applicant. Within 15days of receipt of the opinion, the applicant may provide written noticeto the Agency that he wishes to appeal. In that case he shall forward thedetailed grounds for his appeal to the Agency within 60 days of receiptof the opinion. Within 60 days of the receipt of the grounds for appeal,the Committee shall consider whether its opinion should be revised andthe reasons for the conclusion reached on the appeal shall be annexed tothe report referred to in paragraph 5.

5. The Agency shall forward the definitive opinion of the Committeewithin 30 days of its adoption both to the Commission and to theapplicant. The opinion shall be accompanied by a report describingthe safety evaluation of the substance by the Committee, which shallgive the grounds for its conclusions.

6. The Commission shall prepare draft measures taking account ofCommunity legislation and shall start the procedure provided for inArticle 8. The Committee referred to in Article 8 shall adapt its rulesof procedure in order to take account of the tasks conferred on it by thisRegulation.

▼M104

Article 8

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

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

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

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

▼M64

1990R2377— EN— 16.08.2008 — 058.002— 8

(1) OJ L 214, 24.8.1993, p. 1(2) OJ L 184, 17.7.1999, p. 23.

Article 9

1. Where a Member State, as a result of new information or a reas-sessment of existing information, considers that the urgent amendmentof a provision contained in Annexes I to IV is necessary in order toprotect human or animal health, and therefore requires swift action to betaken, that Member State may temporarily suspend the operation of theprovision concerned in its own territory. In that case, it shall imme-diately notify the other Member States and the Commission of themeasures, attaching a statement of the reasons therefor.

2. ►M64 The Commission shall as soon as possible examine thegrounds given by the Member State concerned and, after consulting theCommittee for Veterinary Medicinal Products, it shall then deliver itsopinion forthwith and take appropriate measures; the person responsiblefor marketing may be requested to provide the Committee with oral orwritten explanations ◄. The Commission shall immediately notify theCouncil and the Member States of any measures taken. Any MemberState may refer the Commission's measures to the Council within 15days of such notification. The Council, acting by a qualified majority,may take a different decision within 30 days of the date on which thematter was referred to it.

3. If the Commission considers that it is necessary to amend theprovision of Annex I to IV concerned in order to resolve the difficultiesreferred 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 toadopting those amendments; the Member State which has takenmeasures under paragraph 1 may maintain them until the Council orthe Commission has taken a decision in accordance with the above-mentioned procedure.

▼M104

Article 10

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

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

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

▼B

Article 11

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

▼M64

Article 12

As soon as possible after the amendment of Annexes I, II, III or IV, theCommission shall publish a summary of the assessment of the safety ofthe substances concerned that have been examined by the Committeefor Veterinary Medicinal Products. The confidential nature of anyproprietary data shall be respected. The Agency shall provide thecompetent authorities and the Commission with appropriate methodsfor identifying pharmacologically active substances for which theMRL's have been determined in ►C7 Annexes I and III. ◄

▼B

1990R2377— EN— 16.08.2008 — 058.002— 9

Article 13

Member States may not prohibit or impede the putting into circulationwithin their territories of foodstuffs of animal origin originating in otherMember States on the grounds that they contain residues of veterinarymedicinal products if the quantity of residue does not exceed themaximum residue limit provided for in Annex I or III, or if thesubstance concerned is listed in Annex II.

Article 14

With effect from 1 January 1997, the administration to food-producinganimals of veterinary medicinal products containing pharmacologicallyactive substances which are not mentioned in Annexes I, II or III shallbe prohibited within the Community, except in the case of clinical trialsaccepted by the competent authorities following notification or author-ization in accordance with the legislation in force and which do notcause foodstuffs obtained from livestock participating in such trials tocontain residues which constitute a hazard to human health.

▼M34However, the date referred to in the previous subparagraph shall bedeferred for substances the use of which was authorized on the dateof entry into force of this Regulation and in respect of which docu-mented applications for the establishment of maximum residue limitshave been lodged with the Commission or with the European Agencyfor the Evaluation of Medicinal Products before 1 January 1996:

▼M64— until 1 January 1998 in the case of pyrazolinones (including pyra-

zolidinediones and phenylbutazones), nitroimidazoles and arsalinicacid, and

▼M34— until 1 January 2000 in the case of other substances.

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

▼B

Article 15

This Regulation shall in no way prejudice the application of Communitylegislation prohibiting the use in livestock farming of certain substanceshaving a hormonal action.

Nothing in this Regulation shall prejudice the measures taken byMember States to prevent the unauthorized use of veterinarymedicinal products.

Article 16

This Regulation shall enter into force on 1 January 1992.

This Regulation shall be binding in its entirety and directly applicable inall Member States.

▼B

1990R2377— EN — 16.08.2008 — 058.002— 10

1990R2377— EN— 16.08.2008 — 058.002 — 11

ANNEX

I

LIST

OF

PHARMACOLOGIC

ALLY

ACTIV

ESUBSTANCESFOR

WHIC

HMAXIM

UM

RESID

UE

LIM

ITSHAVE

BEEN

FIX

ED

1.Anti-infectious

agents

1.1.

Chemotheurapeutics

1.1.1.

Sulfonamides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

All

substances

belong

ing

tothe

sulfo-

namidegroup

Parentdrug

All

food

-produ

cing

species

100μg

/kg

Muscle

The

combined

totalresidu

esof

all

substances

with

inthe

sulfon

amide

grou

pshou

ldno

texceed

100μg

/kg

100μg

/kg

Fat

100μg

/kg

Liver

100μg

/kg

Kidney

Bov

ine,

ovine,

caprine

100μg

/kg

Milk

1.1.2.

Diaminopy

rimidinederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Baquiloprim

Baquiloprim

Bov

ine

10μg

/kg

Fat

300μg

/kg

Liver

150μg

/kg

Kidney

30μg

/kg

Milk

Porcine

40μg

/kg

Skinandfat

50μg

/kg

Liver

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 12

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

50μg

/kg

Kidney

▼M96

Trimetho

prim

Trimetho

prim

All

food

prod

ucing

speciesexcept

equidae

50μg

/kg

Fat(1)

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

50μg

/kg

Muscle

(2)

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Milk

Equ

idae

100μg

/kg

Muscle

100μg

/kg

Fat

100μg

/kg

Liver

100μg

/kg

Kidney

(1)For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(2)For

finfish

this

MRL

relatesto

‘muscleandskin

innaturalprop

ortio

ns’.

▼M58

1.2.

Antibiotics

1.2.1.

Penicillins

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Amox

icyllin

Amox

icyllin

All

food

-produ

cing

species

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 13

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Ampicillin

Ampicillin

All

food

-produ

cing

species

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

Benzylpenicillin

Benzylpenicillin

All

food

-produ

cing

species

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

Cloxacillin

Cloxacillin

All

food

-produ

cing

species

300μg

/kg

Muscle

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

30μg

/kg

Milk

Dicloxacillin

Dicloxacillin

All

food

-produ

cing

species

300μg

/kg

Muscle

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

30μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 14

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Nafcillin

Nafcillin

Allruminants(1)

300μg

/kg

Muscle

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

30μg

/kg

Milk

▼M58

Oxacillin

Oxacillin

All

food

-produ

cing

species

300μg

/kg

Muscle

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

30μg

/kg

Milk

Penethamate

Benzylpenicillin

Bov

ine

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

▼M72

Porcine

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

▼M120

All

mam

malian-food

prod

ucingspecies

50μg

/kg

Muscle

50μg

/kg

Fat

▼M111

1990R2377— EN — 16.08.2008 — 058.002— 15

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

▼M74

Phenoxymethylpenicillin

Phenoxymethylpeni-

cillin

Porcine

25μg

/kg

Muscle

25μg

/kg

Liver

25μg

/kg

Kidney

▼M121

Pou

ltry(2)

25μg

/kg

Muscle

25μg

/kg

Skin+fat

25μg

/kg

Liver

25μg

/kg

Kidney

▼M111

(1)For

intram

ammaryuseon

ly.

►M12

1(2)Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

◄

▼M58

1.2.2.

Cephalosporins

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M91

Cefacetrile

Cefacetrile

Bov

ine

125μg

/kg

Milk

For

intram

ammaryuseon

ly

▼M71

Cefalexin

Cefalexin

Bov

ine

200μg

/kg

Muscle

200μg

/kg

Fat

200μg

/kg

Liver

▼M120

1990R2377— EN — 16.08.2008 — 058.002— 16

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

100

0μg

/kg

Kidney

100μg

/kg

Milk

▼M100

Cefalon

ium

Cefalon

ium

Bov

ine

20μg

/kg

Milk

▼M87

Cefapirin

Sum

ofceph

apirin

and

desacetylcephapirin

Bov

ine

50μg

/kg

Muscle

50μg

/kg

Fat

100μg

/kg

Kidney

60μg

/kg

Milk

▼M58

Cefazolin

Cefazolin

Bov

ine,

ovine,

caprine

50μg

/kg

Milk

▼M83

Cefop

erazon

eCefop

erazon

eBov

ine

50μg

/kg

Milk

▼M58

Cefqu

inom

eCefqu

inom

eBov

ine

50μg

/kg

Muscle

50μg

/kg

Fat

100μg

/kg

Liver

200μg

/kg

Kidney

20μg

/kg

Milk

▼M65

Porcine

50μg

/kg

Muscle

50μg

/kg

Skin+fat

100μg

/kg

Liver

200μg

/kg

Kidney

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 17

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M109

Equ

idae

50μg

/kg

Muscle

50μg

/kg

Fat

100μg

/kg

Liver

200μg

/kg

Kidney

▼M128

Ceftio

fur

Sum

ofall

residu

esretainingthebetalactam

structure

expressed

asdesfuroy

lceftio

fur

All

mam

malian

food-

prod

ucingspecies

100

0μg

/kg

Muscle

200

0μg

/kg

Fat(1)

200

0μg

/kg

Liver

600

0μg

/kg

Kidney

100μg

/kg

Milk

(1)For

porcinespeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

▼M58

1.2.3.

Quino

lones

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M96

Danofloxacin

Danofloxacin

►C11

All

food

prod

ucing

species

except

bovine,

ovine,

caprine,

porcine

and

poultry◄

100μg

/kg

Muscle(2)

50μg

/kg

Fat(1)

200μg

/kg

Liver

200μg

/kg

Kidney

▼M65

1990R2377— EN — 16.08.2008 — 058.002— 18

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Bov

ine,

ovine,

caprine

200μg

/kg

Muscle

100μg

/kg

Fat

400μg

/kg

Liver

400μg

/kg

Kidney

30μg

/kg

Milk

Pou

ltry

200μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

100μg

/kg

Skinandfat

400μg

/kg

Liver

400μg

/kg

Kidney

Difloxacin

Difloxacin

All

food

prod

ucing

speciesexcept

bovine,

ovine,

caprine

and

poultry

300μg

/kg

Muscle(2)

100μg

/kg

Fat

800μg

/kg

Liver

600μg

/kg

Kidney

Bov

ine,

ovine,

caprine

400μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

100μg

/kg

Fat

140

0μg

/kg

Liver

800μg

/kg

Kidney

Porcine

400μg

/kg

Muscle

100μg

/kg

Skinandfat

800μg

/kg

Liver

800μg

/kg

Kidney

Pou

ltry

300μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

400μg

/kg

Skinandfat

190

0μg

/kg

Liver

600μg

/kg

Kidney

Enrofloxacin

Sum

ofenroflox

acin

andciprofloxacin

All

food

prod

ucing

speciesexcept

bovine,

ovine,

caprine,

porcine,

rabb

itsand

poultry

100μg

/kg

Muscle(2)

100μg

/kg

Fat

200μg

/kg

Liver

200μg

/kg

Kidney

▼M96

1990R2377— EN — 16.08.2008 — 058.002— 19

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Bov

ine,

ovine,

caprine

100μg

/kg

Muscle

100μg

/kg

Fat

300μg

/kg

Liver

200μg

/kg

Kidney

100μg

/kg

Milk

Porcine,rabb

its10

0μg

/kg

Muscle

100μg

/kg

Fat(1)

200μg

/kg

Liver

300μg

/kg

Kidney

Pou

ltry

100μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

100μg

/kg

Skinandfat

200μg

/kg

Liver

300μg

/kg

Kidney

Flumequine

Flumequine

All

food

prod

ucing

speciesexcept

bovine,

ovine,

caprine,

porcine,

poultry

and

finfish

200μg

/kg

Muscle

250μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

Bov

ine,

porcine,

ovine,

caprine

200μg

/kg

Muscle

300μg

/kg

Fat(1)

500μg

/kg

Liver

150

0μg

/kg

Kidney

50μg

/kg

Milk

Pou

ltry

400μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

250μg

/kg

Skinandfat

800μg

/kg

Liver

100

0μg

/kg

Kidney

Fin

fish

600μg

/kg

Muscle

and

skin

innaturalprop

ortio

n

▼M96

1990R2377— EN — 16.08.2008 — 058.002— 20

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M77

Marbo

flox

acin

Marbo

flox

acin

Bov

ine

150μg

/kg

Muscle

50μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

75μg

/kg

Milk

Porcine

150μg

/kg

Muscle

50μg

/kg

Skinandfat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M103

Oxo

linic

acid

Oxo

linic

acid

Porcine

100μg

/kg

Muscle

50μg

/kg

Skinandfat

150μg

/kg

Liver

150μg

/kg

Kidney

Chicken

100μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

50μg

/kg

Skinandfat

150μg

/kg

Liver

150μg

/kg

Kidney

Fin

fish

100μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M122

All

food

-produ

cing

species(3)

100μg

/kg

Muscle(1)

50μg

/kg

Fat(4)

150μg

/kg

Liver

150μg

/kg

Kidney

▼M96

1990R2377— EN — 16.08.2008 — 058.002— 21

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Sarafloxacin

Sarafloxacin

Chicken

10μg

/kg

Skinandfat

100μg

/kg

Liver

Salmonidae

30μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M96

(1)For

finfish

this

MRL

relatesto

‘muscleandskin

innaturalprop

ortio

ns’.

(2)For

porcinespeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

►M12

2(3)Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

forhu

man

consum

ption;

MRLsforfat,liv

erandkidn

eydo

notapplyto

finfish.

(4)For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.◄

▼M58

1.2.4.

Macrolid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M137

____

____

__

▼M96

Erythromycin

ErythromicyinA

All

food

prod

ucing

species

200μg

/kg

Muscle

(1)

200μg

/kg

Fat

(2)

200μg

/kg

Liver

200μg

/kg

Kidney

40μg

/kg

Milk

150μg

/kg

Egg

s

▼M122

1990R2377— EN — 16.08.2008 — 058.002— 22

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Spiramycin

Sum

ofspiram

ycin

and

neospiramycin

Bov

ine

200μg

/kg

Muscle

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

200μg

/kg

Milk

Chicken

200μg

/kg

Muscle

300μg

/kg

Skinandfat

400μg

/kg

Liver

▼M70

Spiramycin

1Porcine

250μg

/kg

Muscle

200

0μg

/kg

Liver

100

0μg

/kg

Kidney

▼M96

1990R2377— EN — 16.08.2008 — 058.002— 23

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M96

Tilm

icosin

Tilm

icosin

All

food

prod

ucing

speciesexcept

poultry

50μg

/kg

Muscle

(1)

50μg

/kg

Fat

(2)

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

50μg

/kg

Milk

Pou

ltry

75μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

75μg

/kg

Sin

andfat

100

0μg

/kg

Liver

250μg

/kg

Kidney

▼M112

▼C14

Tulathrom

ycin

(2R,3S,4R,5R,8R,10-

R,11R

,12S

,13

S,14R

)-2-ethy

l-3,4,10

,13-tetra-

hydrox

y-3,5,8,10

,12,14

-hexamethy

l-11

-[[3,4,6-

trideoxy

-3-(dimethy

-lamino)-ß-D

-xylo-

hexo

py-ranosyl]oxy

]-1-

oxa-6-azacyclopent-

decan-15

-one

expressed

astulathromycin

equivalents

Bov

ine(4)

100μg

/kg

Fat

300

0μg

/kg

Liver

300

0μg

/kg

Kidney

Porcine

100μg

/kg

Skin+fat

300

0μg

/kg

Liver

300

0μg

/kg

Kidney

▼M70

1990R2377— EN — 16.08.2008 — 058.002— 24

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M96

Tylosin

Tylosin

AAll

food

prod

ucing

species

100μg

/kg

Fat

(3)

100μg

/kg

Muscle

(1)

100μg

/kg

Liver

100μg

/kg

Kidney

50μg

/kg

Milk

200μg

/kg

Egg

s

▼M137

Tylva

losin

Sum

oftylvalosin

and

3-O-acetylty

losin

Porcine

50μg

/kg

Muscle

50μg

/kg

Fat(18 )

50μg

/kg

Liver

50μg

/kg

Kidney

Pou

ltry(6)

50μg

/kg

Fat(7)

50μg

/kg

Liver

▼M96

(1)For

finfish

this

MRL

relatesto

a‘m

uscleandskin

innaturalprop

ortio

ns’.

(2)For

porcinespeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(3)For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

►M11

2►C14

(4)N

otforusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

◄◄

►M12

3(5)

Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

◄►M13

7(6)

Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

(7)For

poultryspecies,

this

MRL

relatesto

“skinandfatin

naturalprop

ortio

ns”.◄

▼C14

1990R2377— EN — 16.08.2008 — 058.002— 25

1.2.5.Florfenicol

andrelatedcompo

unds

Pharm

acolog

ically

activ

eSub

stance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Thiamphenicol

Thiam

phenicol

Allfood

prod

ucingspecies(1)

50μg

/kg

Muscle(2)

50μg

/kg

Fat(3)

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Milk

(1)

Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption,

MRLsforfat,liv

erandkidn

eydo

notapplyto

finfish.

(2)

For

finfish

musclerelatesto

‘muscleandskin

innaturalprop

ortio

ns’.

(3)

For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

▼M58

1.2.6.Tetracyclines

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chlortetracyclin

eSum

ofparent

drug

and

its4-

epim

erAll

food

-produ

cing

species

100μg

/kg

Muscle

300μg

/kg

Liver

600μg

/kg

Kidney

100μg

/kg

Milk

200μg

/kg

Egg

s

Dox

ycyclin

eDox

ycyclin

eBov

ine

100μg

/kg

Muscle

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

300μg

/kg

Liver

600μg

/kg

Kidney

Porcine

100μg

/kg

Muscle

300μg

/kg

Skinandfat

300μg

/kg

Liver

600μg

/kg

Kidney

▼M131

1990R2377— EN — 16.08.2008 — 058.002— 26

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Pou

ltry

100μg

/kg

Muscle

Not

forusein

anim

als

from

which

eggs

are

prod

uced

for

human

consum

ption

300μg

/kg

Skinandfat

300μg

/kg

Liver

600μg

/kg

Kidney

Oxy

tetracyclin

eSum

ofparent

drug

and

its4-epim

erAll

food

-produ

cing

species

100μg

/kg

Muscle

300μg

/kg

Liver

600μg

/kg

Kidney

100μg

/kg

Milk

200μg

/kg

Egg

s

Tetracycline

Sum

ofparent

drug

and

its4-epim

erAll

food

-produ

cing

species

100μg

/kg

Muscle

300μg

/kg

Liver

600μg

/kg

Kidney

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 27

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

100μg

/kg

Milk

200μg

/kg

Egg

s

1.2.7.Naphtalene-ring

edansamycin

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Rifaxim

inRifaxim

inBovine

60μg

/kg

Milk

1.2.8.Pleurom

utilines

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M71

Tiamulin

Sum

ofmetabolitesthat

may

behy

drolysed

to8-a-hy

drox

ymutilin

Porcine

100μg

/kg

Muscle

500μg

/kg

Liver

Chicken

100μg

/kg

Muscle

100μg

/kg

Skinandfat

100

0μg

/kg

Liver

▼M77

Rabbits

100μg

/kg

Muscle

500μg

/kg

Liver

▼M83

Turkey

100μg

/kg

Muscle

100μg

/kg

Skinandfat

300μg

/kg

Liver

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 28

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M71

Tiamulin

100

0μg

/kg

Egg

s

▼M58

Valnemulin

Valnemulin

Porcine

50μg

/kg

Muscle

500μg

/kg

Liver

100μg

/kg

Kidney

▼M59

1.2.9.Lincosamides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M96

Lincomycin

Lincomicyn

All

food

prod

ucing

species

50μg

/kg

Fat

(1)

100μg

/kg

Muscle

(2)

500μg

/kg

Liver

150

0μg

/kg

Kidney

150μg

/kg

Milk

50μg

/kg

Egg

s

▼M77

Pirlim

ycin

Pirlim

ycin

Bov

ine

100μg

/kg

Muscle

100μg

/kg

Fat

100

0μg

/kg

Liver

400μg

/kg

Kidney

▼M83

1990R2377— EN — 16.08.2008 — 058.002— 29

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

100μg

/kg

Milk

Porcine

100μg

/kg

Muscle

50μg

/kg

Skinandfat

500μg

/kg

Liver

150

0μg

/kg

Kidney

Chicken

100μg

/kg

Muscle

50μg

/kg

Skinandfat

500μg

/kg

Liver

150

0μg

/kg

Kidney

50μg

/kg

Egg

s

▼M96

(1)For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(2)For

finfish

this

MRL

relatesto

‘muscleandskin

innaturalprop

ortio

ns’.

▼M65

1.2.10

.Aminog

lycosides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Apram

ycin

Apram

ycin

Bov

ine

100

0μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

100

0μg

/kg

Fat

1000

0μg

/kg

Liver

2000

0μg

/kg

Kidney

▼M77

1990R2377— EN — 16.08.2008 — 058.002— 30

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M134

Dihyd

rostreptom

ycin

Dihyd

rostreptom

ycin

Allruminants

500μg

/kg

Muscle

500μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

200μg

/kg

Milk

Porcine

500μg

/kg

Muscle

500μg

/kg

Skin+fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

Rabbits

500μg

/kg

Muscle

500μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

▼M94

Gentamicin

Sum

ofgentam

icin

C1,

gentam

icin

C1a,

gentam

icin

C2and

gentam

icin

C2a

Bov

ine

50μg

/kg

Muscle

50μg

/kg

Fat

200μg

/kg

Liver

750μg

/kg

Kidney

100μg

/kg

Milk

▼M65

1990R2377— EN — 16.08.2008 — 058.002— 31

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Porcine

50μg

/kg

Muscle

50μg

/kg

Skinandfat

200μg

/kg

Liver

750μg

/kg

Kidney

▼M110

Kanam

ycin

Kanam

ycin

AAll

food

prod

ucing

speciesexcept

fish

(3)

100μg

/kg

Muscle

100μg

/kg

Fat(1)

600μg

/kg

Liver

250

0μg

/kg

Kidney

150μg

/kg

Milk

▼M96

Neomycin

(including

fram

ycetin)

Neomycin

BAll

food

prod

ucing

species

500μg

/kg

Fat

(1)

500μg

/kg

Muscle

(2)

500μg

/kg

Liver

500

0μg

/kg

Kidney

150

0μg

/kg

Milk

500μg

/kg

Egg

s

Parom

omycin

Parom

omycin

All

food

prod

ucing

species

500μg

/kg

Muscle(2)

Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

forhu

man

consum

ption

150

0μg

/kg

Liver

150

0μg

/kg

Kidney

▼M94

1990R2377— EN — 16.08.2008 — 058.002— 32

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Spectinom

ycin

Spectinom

ycin

All

food

producing

speciesexcept

ovine

500μg

/kg

Fat(1)

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

300μg

/kg

Muscle

(2)

100

0μg

/kg

Liver

500

0μg

/kg

Kidney

200μg

/kg

Milk

Ovine

300μg

/kg

Muscle

500μg

/kg

Fat

200

0μg

/kg

Liver

500

0μg

/kg

Kidney

200μg

/kg

Milk

▼M134

Streptomycin

Streptomycin

Allruminants

500μg

/kg

Muscle

500μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

200μg

/kg

Milk

Porcine

500μg

/kg

Muscle

500μg

/kg

Skin+fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

Rabbits

500μg

/kg

Muscle

500μg

/kg

Fat

500μg

/kg

Liver

▼M96

1990R2377— EN — 16.08.2008 — 058.002— 33

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

100

0μg

/kg

Kidney

▼M96

(1)

For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(2)

For

finfish

this

MRL

relatesto

‘muscleandskin

innaturalprop

ortio

ns’.

►M11

0(3)

Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

◄

▼M70

1.2.11

.Other

antib

iotics

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Nov

obiocin

Nov

obiocin

Bov

ine

50μg

/kg

Milk

▼M86

1.2.12

.Polyp

eptid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Bacitracin

Sum

ofbacitracin

A,

bacitracin

B,andbaci-

tracin

C

Bov

ine

100μg

/kg

Milk

▼M101

Rabbits

150μg

/kg

Muscle

150μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M134

1990R2377— EN — 16.08.2008 — 058.002— 34

1.2.13

.Beta-lactam

aseinhibitors

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clavu

lanicacid

Clavu

lanicacid

Bov

ine

100μg

/kg

Muscle

100μg

/kg

Fat

200μg

/kg

Liver

400μg

/kg

Kidney

200μg

/kg

Milk

Porcine

100μg

/kg

Muscle

100μg

/kg

Skinandfat

200μg

/kg

Liver

400μg

/kg

Kidney

▼M96

1.2.14

.Polym

yxins

Pharm

acolog

ically

activ

esubstance

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Colistin

Colistin

All

food

prod

ucing

species

150μg

/kg

Fat

(1)

150μg

/kg

Muscle

(2)

150μg

/kg

Liver

200μg

/kg

Kidney

50μg

/kg

Milk

300μg

/kg

Egg

s

(1)

For

porcineandpo

ultryspeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(2)

For

finfish

this

MRL

relatesto

‘muscleandskin

innaturalprop

ortio

ns’.

▼M87

1990R2377— EN — 16.08.2008 — 058.002— 35

1.2.15

.Ortho

somycins

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Avilamycin

Dichloroisoeverninic

acid

Porcine

50μg

/kg

Muscle

100μg

/kg

Fat(1)

300μg

/kg

Liver

200μg

/kg

Kidney

Rabbit

50μg

/kg

Muscle

100μg

/kg

Fat

300μg

/kg

Liver

200μg

/kg

Kidney

Pou

ltry(2)

50μg

/kg

Muscle

100μg

/kg

Fat(1)

300μg

/kg

Liver

200μg

/kg

Kidney

(1)

For

porcineandpo

ultryspecies,

this

MRL

relatesto

skin

andfatin

naturalprop

ortio

ns.

(2)

Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

▼M137

1.2.16

.Ion

opho

res

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Mon

ensin

Mon

ensinA

Bov

ine

2μg

/kg

Muscle

10μg

/kg

Fat

30μg

/kg

Liver

2μg

/kg

Kidney

2μg

/kg

Milk

▼M135

1990R2377— EN — 16.08.2008 — 058.002— 36

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Lasalocid

Lasalocid

APou

ltry

20μg

/kg

Muscle

100μg

/kg

Fat(1)

100μg

/kg

Liver

50μg

/kg

Kidney

150μg

/kg

Egg

s

(1)

For

poultryspecies,

this

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

▼M137

1990R2377— EN — 16.08.2008 — 058.002— 37

2.Antiparasiticagents

2.1.

Agentsactin

gagainstendo

parasites

2.1.1.

Salicylanilides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Closantel

Closantel

Bov

ine

100

0μg

/kg

Muscle

300

0μg

/kg

Fat

100

0μg

/kg

Liver

300

0μg

/kg

Kidney

Ovine

150

0μg

/kg

Muscle

200

0μg

/kg

Fat

150

0μg

/kg

Liver

500

0μg

/kg

Kidney

▼M86

Rafox

anide

Rafox

anide

Bov

ine

30μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

30μg

/kg

Fat

10μg

/kg

Liver

40μg

/kg

Kidney

Ovine

100μg

/kg

Muscle

250μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 38

2.1.2.

Tatra-hyd

ro-imidazoles

(imidazolthiazoles)

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Levam

isole

Levam

isole

Bov

ine,

ovine,

porcine,

poultry

10μg

/kg

Muscle

10μg

/kg

Fat

100μg

/kg

Liver

10μg

/kg

Kidney

2.1.3.

Benzimidazoles

andpro-benzim

idazoles

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M113

Albendazole

Sum

ofalbend

azole

sulpho

xide,albend

azole

sulpho

ne,

and

alben-

dazole

2-am

ino

sulpho

ne,expressed

asalbend

azole

Allruminants

100μg

/kg

Muscle

100μg

/kg

Fat

100

0μg

/kg

Liver

500μg

/kg

Kidney

100μg

/kg

Milk

▼M69

Albendazole

oxide

Sum

ofalbend

azole

oxide,

albend

azole

sulpho

neand

alben-

dazole

2-am

ino-

sulpho

ne,expressed

asalbend

azole

Bov

ine,

ovine

100μg

/kg

Muscle

100μg

/kg

Fat

100

0μg

/kg

Liver

500μg

/kg

Kidney

100μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 39

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M113

Febantel

Sum

ofextractable

residu

eswhich

may

beox

idised

toox

fend

azole

sulpho

ne

Allruminants

50μg

/kg

Muscle

50μg

/kg

Fat

500μg

/kg

Liver

50μg

/kg

Kidney

10μg

/kg

Milk

Fenbend

azole

Sum

ofextractable

residu

eswhich

may

beox

idised

toox

fend

azole

sulpho

ne

Allruminants

50μg

/kg

Muscle

50μg

/kg

Fat

500μg

/kg

Liver

50μg

/kg

Kidney

10μg

/kg

Milk

▼M127

Flubendazole

Sum

offlubendazole

and(2-amino1H

-benzi-

midazol-5-yl)

(4fluo

ro-

phenyl)methano

ne

Pou

ltry,

porcine

50μg

/kg

Muscle

50μg

/kg

Skin+fat

400μg

/kg

Liver

300μg

/kg

Kidney

Flubend

azole

Flubend

azole

Pou

ltry

400μg

/kg

Egg

s

▼M88

Mebendazole

Sum

ofmebendazole

methy

l(5-(1-hy

drox

y,1-ph

enyl)

methy

l-1H

-benzim

idazol-2-yl)

carbam

ate

and

(2-

amino-1H

-benzi-

midazol-5-yl)

phenyl-

methano

ne,

expressed

asmebendazole

equivalents

Ovine,caprine,

equidae

60μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

60μg

/kg

Fat

400μg

/kg

Liver

60μg

/kg

Kidney

▼M69

1990R2377— EN — 16.08.2008 — 058.002— 40

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M83

Netob

imin

Sum

ofalbend

azole

oxide,

albend

azole

sulpho

neand

alben-

dazole

2-am

ino-

sulpho

ne,expressed

asalbend

azole

►C8

Bov

ine,

ovine◄

100μg

/kg

Muscle

For

oral

useon

ly

100μg

/kg

Fat

100

0μg

/kg

Liver

500μg

/kg

Kidney

100μg

/kg

Milk

▼M113

Oxfendazole

Sum

ofextractable

residu

eswhich

may

beox

idised

toox

fend

azole

sulpho

ne

Allruminants

50μg

/kg

Muscle

50μg

/kg

Fat

500μg

/kg

Liver

50μg

/kg

Kidney

10μg

/kg

Milk

▼M58

Oxibend

azole

Oxibend

azole

Porcine

100μg

/kg

Muscle

500μg

/kg

Skinandfat

200μg

/kg

Liver

100μg

/kg

Kidney

▼M113

Thiabendazole

Sum

ofthiabendazole

and

5-hy

drox

ythiaben-

dazole

Caprine

100μg

/kg

Muscle

100μg

/kg

Fat

100μg

/kg

Liver

100μg

/kg

Kidney

100μg

/kg

Milk

▼M88

1990R2377— EN — 16.08.2008 — 058.002— 41

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Triclabendazole

Sum

ofextractable

residu

esthat

may

beox

idised

toketotricla-

bend

azole

Allruminants(1)

225μg

/kg

Muscle

100μg

/kg

Fat

250μg

/kg

Liver

150μg

/kg

Kidney

▼M130

(1)Not

forusein

anim

alsprod

ucingmilk

forhu

man

consum

ption.

▼M62

2.1.4.

Pheno

lderivativ

esinclud

ingsalicylanides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Nitrox

inil

Nitrox

inil

Bov

ine,

ovine

400μg

/kg

Muscle

200μg

/kg

Fat

20μg

/kg

Liver

400μg

/kg

Kidney

▼M113

Oxy

clozanide

Oxy

clozanide

Allruminants

20μg

/kg

Muscle

20μg

/kg

Fat

500μg

/kg

Liver

100μg

/kg

Kidney

▼M113

1990R2377— EN — 16.08.2008 — 058.002— 42

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

10μg

/kg

Milk

▼M66

2.1.5.

Benzenesulpho

namides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clorsulon

Clorsulon

Bov

ine

35μg

/kg

Muscle

100μg

/kg

Liver

200μg

/kg

Kidney

▼M94

2.1.6.

Piperazinederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Piperazine

Piperazine

Porcine

400μg

/kg

Muscle

800μg

/kg

Skind

andfat

200

0μg

/kg

Liver

100

0μg

/kg

Kidney

Chicken

200

0μg

/kg

Egg

s

▼M114

2.1.7.

Tetrahydropyrim

ides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Morantel

Sum

ofresidu

eswhich

may

behy

drolysed

toN-m

ethy

l-1,3-

prop

ane-

diam

ine

and

expressed

asmorantelequivalents

Bov

ine,

ovine

100μg

/kg

Muscle

100μg

/kg

Fat

800μg

/kg

Liver

200μg

/kg

Kidney

50μg

/kg

Milk

▼M113

1990R2377— EN — 16.08.2008 — 058.002— 43

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M122

Allruminants

100μg

/kg

Muscle

100μg

/kg

Fat

800μg

/kg

Liver

200μg

/kg

Kidney

50μg

/kg

Milk

▼M58

2.2.

Agentsactin

gagainstectoparasites

2.2.1.

Organophosphates

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M86

Cou

mafos

Cou

mafos

Bees

100μg

/kg

Hon

ey

▼M58

Diazino

nDiazino

nBov

ine,

ovine,

caprine

20μg

/kg

Milk

Bov

ine,

porcine,

ovine,

caprine

20μg

/kg

Muscle

700μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M83

Pho

xim

Pho

xim

Ovine

50μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

400μg

/kg

Fat

50μg

/kg

Kidney

▼M114

1990R2377— EN — 16.08.2008 — 058.002— 44

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Porcine

20μg

/kg

Muscle

700μg

/kg

Skinandfat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M121

Chicken

25μg

/kg

Muscle

550μg

/kg

Skin+fat

50μg

/kg

Liver

30μg

/kg

Kidney

60μg

/kg

Egg

s

▼M58

2.2.2.

Formam

idines

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Amitraz

Sum

ofam

itraz

andall

metabolites

containing

the

2,4-DMA

moiety,

expressedas

amitraz

Bov

ine

200μg

/kg

Fat

200μg

/kg

Liver

200μg

/kg

Kidney

10μg

/kg

Milk

▼M83

1990R2377— EN — 16.08.2008 — 058.002— 45

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Ovine

400μg

/kg

Fat

100μg

/kg

Liver

200μg

/kg

Kidney

10μg

/kg

Milk

Porcine

400μg

/kg

Skinandfat

200μg

/kg

Liver

200μg

/kg

Kidney

▼M69

Bees(hon

ey)

200μg

/kg

Hon

ey

▼M113

Caprine

200μg

/kg

Fat

100μg

/kg

Liver

200μg

/kg

Kidney

10μg

/kg

Milk

▼M58

2.2.3.

Pyrethroids

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M83

▼C8

Cyh

alothrin

Cyh

alothrin

(sum

ofisom

ers)

Bov

ine

500μg

/kg

Fat

Further

prov

isions

inCou

ncil

Directiv

e94

/29/EC

are

tobe

observed

50μg

/kg

Kidney

50μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 46

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼C9

Cyfluthrin

Cyfluthrin

(sum

ofisom

ers)

Bov

ine,

caprine

50μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

20μg

/kg

Milk

Further

prov

isions

inCou

ncil

Directiv

e94

/29/EC

are

tobe

observed

▼M113

Deltamethrin

Deltamethrin

Allruminants

10μg

/kg

Muscle

50μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

20μg

/kg

Milk

▼M91

Fin

fish

10μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M131

Fenvalerate

Fenvalerate

(sum

ofRR,SS,RS

and

SR

isom

ers)

Bov

ine

25μg

/kg

Muscle

250μg

/kg

Fat

25μg

/kg

Liver

25μg

/kg

Kidney

40μg

/kg

Milk

▼M58

Flumethrin

Flumethrin

(sum

oftrans-Z

isom

ers)

Bov

ine

10μg

/kg

Muscle

150μg

/kg

Fat

20μg

/kg

Liver

10μg

/kg

Kidney

▼C8

1990R2377— EN — 16.08.2008 — 058.002— 47

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

30μg

/kg

Milk

▼M78

Ovine

10μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

150μg

/kg

Fat

20μg

/kg

Liver

10μg

/kg

Kidney

▼M100

Permethrin

Permethrin

(sum

ofisom

ers)

Bov

ine

50μg

/kg

Muscle

500μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Milk

(*)

▼M105

Cyp

ermethrin

Cyp

ermethrin

(sum

ofisom

ers)

Salmonidae

50μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M113

Allruminants

20μg

/kg

Muscle

200μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 48

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

20μg

/kg

Milk

(*)

Alphacyperm

ethrin

Cyp

ermethrin

(sum

ofisom

ers)

Bov

ine,

ovine

20μg

/kg

Muscle

200μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

20μg

/kg

Milk

(*)

▼M100

(*)F

urther

prov

isions

inCom

mission

Directiv

e98

/82/EC

areto

beob

served

(OJL

290,

29.10.19

98,p.

25).

▼M65

2.2.4.

Acylurea

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M70

Diflubenzuron

Diflubenzuron

Salmonidae

1000μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M129

Fluazuron

Fluazuron

Bov

ine(1)

200μg

/kg

Muscle

700

0μg

/kg

Fat

500μg

/kg

Liver

500μg

/kg

Kidney

▼M65

Teflubenzuron

Teflubenzuron

Salmonidae

500μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M129

(1)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M113

1990R2377— EN — 16.08.2008 — 058.002— 49

2.2.5.

Pyrim

idines

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Dicyclanil

Sum

ofdicyclanil

and

2,4,

6-triamino-py

ri-

midine-5-carbon

itrile

Ovine

200μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

►M78

150μg

/kg

◄Fat

400μg

/kg

Liver

400μg

/kg

Kidney

▼M86

2.2.6.

Triazinederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Cyrom

azine

Cyrom

azine

Ovine

300μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

▼M58

2.3.

Agentsactin

gagainstendo

-andectoparasites

2.3.1.

Averm

ectin

s

Phram

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Abamectin

Averm

ectin

B1a

Bov

ine

10μg

/kg

Fat

▼M76

1990R2377— EN — 16.08.2008 — 058.002— 50

Phram

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

20μg

/kg

Liver

▼M94

Ovine

20μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

50μg

/kg

Fat

25μg

/kg

Liver

20μg

/kg

Kidney

▼M132

Doram

ectin

Doram

ectin

All

mam

malian

food

prod

ucingspecies(1)

40μg

/kg

Muscle

150μg

/kg

Fat

100μg

/kg

Liver

60μg

/kg

Kidney

▼M106

Emam

ectin

Emam

ectin

B1a

Fin

fish

100μg

/kg

Muscle

and

skin

innaturalprop

ortio

ns

▼M58

Eprinom

ectin

Eprinom

ectin

B1a

Bov

ine

►M67

50μg

/kg

◄Muscle

►M67

250μg

/kg

◄Fat

►M67

150

0μg

/kg◄

Liver

►M67

300μg

/kg

◄Kidney

►M67

20μg

/kg

◄Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 51

Phram

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Ivermectin

22,

23-D

ihyd

ro-aver-

mectin

B1a

Bov

ine

40μg

/kg

Fat

100μg

/kg

Liver

Porcine,ov

ine,

equidae

20μg

/kg

Fat

15μg

/kg

Liver

Deer,

includ

ing

reindeer

20μg

/kg

Muscle

100μg

/kg

Fat

50μg

/kg

Liver

20μg

/kg

Kidney

▼M119

All

mam

malian

food-

prod

ucingspecies(1)

100μg

/kg

Fat

100μg

/kg

Liver

30μg

/kg

Kidney

▼M58

Mox

idectin

Mox

idectin

Bov

ine,

ovine

50μg

/kg

Muscle

500μg

/kg

Fat

100μg

/kg

Liver

50μg

/kg

Kidney

▼M87

Bov

ine

40μg

/kg

Milk

▼M66

Equ

idae

50μg

/kg

Muscle

500μg

/kg

Fat

100μg

/kg

Liver

50μg

/kg

Kidney

▼M117

Ovine

40μg

/kg

Milk

▼M119

(1)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 52

2.4.

Agentsactin

gagainstprotozoa

2.4.1.

Triazinetrionederivativ

e

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Toltrazuril

Toltrazurilsulfon

eChicken

100μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

for

human

consum

ption

200μg

/kg

Skinandfat

600μg

/kg

Liver

400μg

/kg

Kidney

Turkey

100μg

/kg

Muscle

200μg

/kg

Skinandfat

600μg

/kg

Liver

400μg

/kg

Kidney

▼M80

Porcine

100μg

/kg

Muscle

150μg

/kg

Skinandfat

500μg

/kg

Liver

250μg

/kg

Kidney

▼M126

All

mam

malian

food

prod

ucingspecies(1)

100μg

/kg

Muscle

150μg

/kg

Fat(2)

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 53

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

500μg

/kg

Liver

250μg

/kg

Kidney

Pou

ltry(3)

100μg

/kg

Muscle

200μg

/kg

Skin+fat

600μg

/kg

Liver

400μg

/kg

Kidney

(1)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

(2)For

porcinespeciesthis

MRL

relatesto

‘skinandfatin

naturalprop

ortio

ns’.

(3)Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

▼M80

2.4.2.

Quinazolone

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Halofug

inon

eHalofug

inon

eBov

ine

10μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

25μg

/kg

Fat

30μg

/kg

Liver

30μg

/kg

Kidney

▼M91

2.4.3.

Carbanilid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Imidocarb

Imidocarb

Bov

ine

300μg

/kg

Muscle

50μg

/kg

Fat

▼M126

1990R2377— EN — 16.08.2008 — 058.002— 54

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

200

0μg

/kg

Liver

150

0μg

/kg

Kidney

50μg

/kg

Milk

▼M109

Ovine

(1)

300μg

/kg

Muscle

50μg

/kg

Fat

200

0μg

/kg

Liver

150

0μg

/kg

Kidney

(1)Not

forusein

ovinefrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M118

2.4.4.

Iono

phores

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M137

____

____

__

▼M91

1990R2377— EN — 16.08.2008 — 058.002— 55

3.Agentsactin

gon

thenervou

ssystem

3.1.

Agentsactin

gon

thecentralnervou

ssystem

3.1.1.

Butyrophenone

tranquillisers

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Azaperone

Sum

ofazaperon

eand

azaperol

Porcine

100μg

/kg

Muscle

100μg

/kg

Skinandfat

100μg

/kg

Liver

100μg

/kg

Kidney

3.2.

Agentsactin

gon

theautono

mic

nervou

ssystem

3.2.1.

Anti-adrenergics

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Carazolol

Carazolol

Porcine

5μg

/kg

Muscle

5μg

/kg

Skinandfat

25μg

/kg

Liver

25μg

/kg

Kidney

▼M72

Bov

ine

5μg

/kg

Muscle

5μg

/kg

Fat

15μg

/kg

Liver

15μg

/kg

Kidney

1μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 56

3.2.2.

β2sympathom

imetic

agents

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clenb

uterol

hydrochloride

Clenb

uterol

Bov

ine

0,1μg

/kg

Muscle

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

0,05

μg/kg

Milk

Equ

idae

0,1μg

/kg

Muscle

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

▼M58

4.Anti-inflam

matoryagents

4.1.

Non

steroidalanti-inflam

matoryagents

4.1.1.

Arylpropion

icacid

derivativ

e

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M65

Carprofen

Carprofen

Bov

ine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

500μg

/kg

Muscle

100

0μg

/kg

Fat

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

Equ

idae

500μg

/kg

Muscle

100

0μg

/kg

Fat

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

▼M78

1990R2377— EN — 16.08.2008 — 058.002— 57

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Vedaprofen

Vedaprofen

Equ

idae

50μg

/kg

Muscle

20μg

/kg

Fat

100μg

/kg

Liver

100

0μg

/kg

Kidney

▼M119

Carprofen

Sum

ofcarprofen

and

carprofen

glucuron

ide

conjug

ate

Bov

ine,

equidae

500μg

/kg

Muscle

100

0μg

/kg

Fat

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

▼M58

4.1.2.

Fenam

ategrou

pderivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M71

Flunixin

Flunixin

Bov

ine

20μg

/kg

Muscle

30μg

/kg

Fat

300μg

/kg

Liver

100μg

/kg

Kidney

5-Hyd

roxy

flun

ixin

40μg

/kg

Milk

Flunixin

Porcine

50μg

/kg

Muscle

10μg

/kg

Skinandfat

200μg

/kg

Liver

30μg

/kg

Kidney

▼M65

1990R2377— EN — 16.08.2008 — 058.002— 58

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M80

Equ

idae

10μg

/kg

Muscle

20μg

/kg

Fat

100μg

/kg

Liver

200μg

/kg

Kidney

▼M58

Tolfenamic

acid

Tolfenamic

acid

Bov

ine

50μg

/kg

Muscle

400μg

/kg

Liver

100μg

/kg

Kidney

50μg

/kg

Milk

Porcine

50μg

/kg

Muscle

400μg

/kg

Liver

100μg

/kg

Kidney

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 59

4.1.3.

Eno

licacid

derivates

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Melox

icam

Melox

icam

Equ

idae

20μg

/kg

Muscle

65μg

/kg

Liver

65μg

/kg

Kidney

▼M69

4.1.4.

Oxicanderivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M131

Melox

icam

Melox

icam

Porcine,equidae,

rabb

it20

μg/kg

Muscle

65μg

/kg

Liver

65μg

/kg

Kidney

Bov

ine,

caprine

20μg

/kg

Muscle

65μg

/kg

Liver

65μg

/kg

Kidney

15μg

/kg

Milk

▼M97

1990R2377— EN — 16.08.2008 — 058.002— 60

4.1.5.

Pyrazolon

ederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Metam

izole

4-Methy

laminoan-

tipyrin

Bov

ine

100μg

/kg

Muscle

100μg

/kg

Fat

100μg

/kg

Liver

100μg

/kg

Kidney

50μg

/kg

Milk

Porcine

100μg

/kg

Muscle

100μg

/kg

Skinandfat

100μg

/kg

Liver

100μg

/kg

Kidney

Equ

idae

100μg

/kg

Muscle

100μg

/kg

Fat

100μg

/kg

Liver

100μg

/kg

Kidney

▼M110

4.1.6.

Phenylacetic

acid

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Diclofenac

Diclofenac

Bov

ine(1)

5μg

/kg

Muscle

1μg

/kg

Fat

5μg

/kg

Liver

10μg

/kg

Kidney

Porcine

5μg

/kg

Muscle

1μg

/kg

Skin+fat

5μg

/kg

Liver

10μg

/kg

Kidney

(1)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M108

1990R2377— EN — 16.08.2008 — 058.002— 61

4.1.7.

Sulph

onated

feny

llacton

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Firocox

ibFirocox

ibEqu

idae

10μg

/kg

Muscle

15μg

/kg

Fat

60μg

/kg

Liver

10μg

/kg

Kidney

▼M58

5.Corticoides

5.1.

Glucocorticoides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M70

Betam

ethasone

Betam

ethasone

Bov

ine

0,75

μg/kg

Muscle

2,0μg

/kg

Liver

0,75

μg/kg

Kidney

0,3μg

/kg

Milk

Porcine

0,75

μg/kg

Muscle

2,0μg

/kg

Liver

0,75

μg/kg

Kidney

▼M58

Dexam

ethasone

Dexam

ethasone

Bovine

0,3μg

/kg

Milk

Bov

ine,

porcine,

equidae

0,75

μg/kg

Muscle

2μg

/kg

Liver

0,75

μg/kg

Kidney

Caprine

0,75

μg/kg

Muscle

2μg

/kg

Liver

0,75

μg/kg

Kidney

0,3μg

/kg

Milk

▼M136

1990R2377— EN — 16.08.2008 — 058.002— 62

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M93

Methylprednisolone

Methylprednisolone

Bovine

10μg

/kg

Muscle

Not

forusein

anim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

10μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

▼M79

Predn

isolon

ePredn

isolon

eBov

ine

4μg

/kg

Muscle

4μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

6μg

/kg

Milk

▼M92

6.Agentsactin

gon

thereprod

uctiv

esystem

6.1.

Progestog

ens

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chlormadinone

Chlormadinone

Bovine

4μg

/kg

Fat

For

zootechn

ical

useon

ly

2μg

/kg

Liver

2,5μg

/kg

Milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 63

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Flugeston

eacetate

Flugetone

acetate

Ovine

1μg

/kg

Milk

For

intravaginal

useforzootechn

ical

purposes

only

▼M103

Caprine

1μg

/kg

Milk

For

intra-vaginal

use

for

zootechn

ical

purposes

only

▼M124

Ovine,caprine

0,5μg

/kg

Muscle

For

therapeutic

and

zootechn

ical

purposes

only

0,5μg

/kg

Fat

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

▼M116

Altrenog

est(

1 )Altrenog

est

Porcine

1μg

/kg

Skinandfat

0,4μg

/kg

Liver

Equ

idae

1μg

/kg

Fat

0,9μg

/kg

Liver

▼M121

Norgestom

et(2)

Norgestom

etBov

ine

0,2μg

/kg

Muscle

0,2μg

/kg

Fat

0,2μg

/kg

Liver

0,2μg

/kg

Kidney

0,12

μg/kg

Milk

▼M116

(1)Onlyforzootechn

ical

useandin

accordance

with

theprov

isions

ofDirectiv

e96

/22/EC.

►M12

1(2)

For

therapeutic

andzootechn

ical

purposes

only.◄

▼M92

1990R2377— EN — 16.08.2008 — 058.002— 64

ANNEX

II

LIST

OF

SUBSTANCESNOT

SUBJE

CT

TO

MAXIM

UM

RESID

UE

LIM

ITS

1.Inorganicchem

icals

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Aluminium

distearate

Allfood-produ

cing

species

Aluminium

hydrox

ideacetate

Allfood-produ

cing

species

Aluminium

phosph

ate

Allfood-produ

cing

species

▼M99

Aluminium

salicylate,

basic

Bov

ine

For

oral

useon

ly;Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption

▼M58

Aluminium

tristearate

Allfood-produ

cing

species

Ammon

ium

chloride

Allfood-produ

cing

species

▼M72

Barium

selenate

Bov

ine,

ovine

▼M58

Bismuthsubcarbo

nate

Allfood-produ

cing

species

For

oral

useon

ly

Bismuthsubg

allate

Allfood-produ

cing

species

For

oral

useon

ly

Bismuthsubn

itrate

Allfood-produ

cing

species

For

oral

useon

ly

Bismuthsubsalicylate

Allfood-produ

cing

species

For

oral

useon

ly

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 65

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Boric

acid

andbo

rates

Allfood-produ

cing

species

▼M65

Bromide,

potassium

salt

Allfood

prod

ucingspecies

▼M58

Bromide,

sodium

salt

Allmam

malianfood

-produ

cing

species

For

topicaluseon

ly

Calcium

acetate

Calcium

benzoate

Calcium

carbon

ate

Calcium

chloride

Calcium

gluconate

Calcium

hydrox

ide

Calcium

hypo

phosphite

Calcium

malate

Calcium

oxide

Calcium

phosph

ate

Calcium

polyph

osph

ates

Calcium

propionate

Calcium

silicate

Calcium

stearate

Calcium

sulphate

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 66

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Calcium

glucoheptonate

Allfood-producing

species

Calcium

glucon

oglucoh

eptonate

Allfood-produ

cing

species

Calcium

gluconolactate

Allfood-producing

species

Calcium

glutam

ate

Allfood-produ

cing

species

▼M80

Calcium

glycerophosphate

Allfood

producingspecies

▼M58

Cob

altcarbon

ate

Allfood-produ

cing

species

Cob

altdichloride

Allfood-produ

cing

species

Cob

altglucon

ate

Allfood-produ

cing

species

Cob

altox

ide

Allfood-produ

cing

species

Cob

altsulphate

Allfood-produ

cing

species

Cob

alttrioxide

Allfood-produ

cing

species

Cop

perchloride

Allfood-produ

cing

species

Cop

perglucon

ate

Allfood-produ

cing

species

Cop

perheptanoate

Allfood-produ

cing

species

Cop

permethion

ate

Allfood-produ

cing

species

Cop

perox

ide

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 67

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Cop

persulphate

Allfood-produ

cing

species

Dicop

perox

ide

Allfood-produ

cing

species

Hyd

rochloricacid

Allfood-produ

cing

species

For

useas

excipient

Hydrogenperoxide

Allfood-producing

species

Iodine

andiodine

inorganiccompo

unds

includ

ing:

—Sod

ium

andpo

tassium-iod

ide

—Sod

ium

andpo

tassium-iod

ate

—Iodophorsincludingpolyvinylpyrrolid

one-iodine

Allfood-produ

cing

species

Iron

dichloride

Allfood-produ

cing

species

Iron

sulphate

Allfood-produ

cing

species

Magnesium

Magnesium

sulphate

Magnesium

hydrox

ide

Magnesium

stearate

Magnesium

glutam

ate

Magnesium

orotate

Magnesium

alum

inium

silicate

Magnesium

oxide

Magnesium

carbon

ate

Magnesium

phosph

ate

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 68

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Magnesium

glycerop

hosphate

Magnesium

aspartate

Magnesium

citrate

Magnesium

acetate

Magnesium

trisilicate

Nickelglucon

ate

Allfood-produ

cing

species

Nickelsulphate

Allfood-produ

cing

species

Potassium

DL-aspartate

Allfood-producing

species

Potassium

glucuron

ate

Allfood-produ

cing

species

Potassium

glycerop

hosphate

Allfood-produ

cing

species

Potassium

nitrate

Allfood-produ

cing

species

Potassium

selenate

Allfood-produ

cing

species

Sod

ium

chlorite

Bov

ine

For

topicaluseon

ly

Sod

ium

dichloroisocyanu

rate

Bov

ine,

ovine,

caprine

For

topicaluseon

ly

▼M62

Sod

ium

glycerop

hosphate

Allfood

prod

ucingspecies

▼M58

Sod

ium

hypo

phosph

iteAllfood-produ

cing

species

▼M129

Sod

ium

nitrite

Bov

ine

For

topicaluseon

ly

▼M77

Sod

ium

prop

ionate

Allfood

prod

ucingspecies

▼M58

Sod

ium

selenate

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 69

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Sod

ium

selenite

Allfood-produ

cing

species

Sulph

ur►M10

1Allfood

prod

ucingspecies◄

Zincacetate

Zincchloride

Zincglucon

ate

Zincoleate

Zincstearate

Allfood-produ

cing

species

2.Organic

compo

unds Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

17β-Oestradiol

Allmam

malianfood

-produ

cing

species

For

therapeutic

andzootechn

ical

uses

only

2-Aminoethanol

Allfood-produ

cing

species

2-Aminoethyl

dihy

drog

enphosph

ate

Allfood-produ

cing

species

2-Pyrrolid

one

Allfood-produ

cing

species

Atparenteral

dosesup

to40

mg/kg

bw

8-Hyd

roxy

quinoline

Allmam

malianfood

-produ

cing

species

For

topicalusein

newbo

rnanim

alson

ly

Acetylcysteine

Allfood-produ

cing

species

Alfacalcido

lBov

ine

For

parturient

cowson

ly

Alfaprostol

Rabbits

Bov

ine,

porcine,

equidae

Bacitracin

Bov

ine

For

intram

ammaryusein

lactatingcowson

lyandforalltissues

except

milk

Benzalkon

ium

chloride

Allfood-produ

cing

species

For

useas

anexcipientat

concentrations

upto

0,05

%on

ly

Benzocaine

Allfood-produ

cing

species

For

useas

localanaesthetic

only

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 70

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Benzylalcoh

olAllfood-produ

cing

species

For

useas

excipient

Betaine

Allfood-produ

cing

species

Brono

pol

Salmon

idae

For

useon

lyon

farm

edfertilisedeggs

Brotizolam

Bov

ine

For

therapeutic

uses

only

Buserelin

Allfood-produ

cing

species

Butorph

anol

tartrate

Equ

idae

For

intravenou

sadministrationon

ly

Butyl

4-hy

drox

ybenzoate

Allfood-produ

cing

species

Butylscop

olam

inium

brom

ide

Allfood-produ

cing

species

Caffeine

Allfood-produ

cing

species

Carbetocin

Allmam

malianfood

-produ

cing

species

Cefazolin

Bov

ine

Ovine,caprine

For

intram

ammaryuse,

except

iftheud

dermay

beused

asfood

for

human

consum

ption

Cetostearyl

alcoho

lAllfood-produ

cing

species

Cetrimide

Allfood-produ

cing

species

Chlorhexidine

Allfood-produ

cing

species

For

topicaluseon

ly

Chlorocresol

Allfood-produ

cing

species

Clazuril

Pigeon

Cloprosteno

lBov

ine,

porcine,

equidae

Cocoalky

ldimethy

lbetaines

Allfood-produ

cing

species

For

useas

excipient

Corticotropin

Allfood-produ

cing

species

D-Phe

6-luteinising

-hormon

ereleasingho

rmon

eAllfood-produ

cing

species

Dem

brexine

Equ

idae

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 71

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Denaverinehy

drochloride

Bov

ine

Detom

idine

Bov

ine,

equidae

For

therapeutic

uses

only

▼M112

Diclazuril

Allruminants(1)

Porcine

(1)

▼M58

Diethyl

phtalate

Allfood-produ

cing

species

Diethyleneglycol

mon

oethyl

ether

Bov

ine,

porcine

Dim

anganese

trioxide

Allfood-produ

cing

species

For

oral

useon

ly

Dim

ethy

lph

talate

Allfood-produ

cing

species

Dinop

rost

Allmam

malianfood

-produ

cing

species

Dinop

rost

trom

ethamine

Allmam

malianfood

-produ

cing

species

Diproph

yllin

eAllfood-produ

cing

species

Etamiphy

lline

camsylate

Allfood-produ

cing

species

Ethanol

Allfood-produ

cing

species

For

useas

excipient

Ethyl

lactate

Allfood-produ

cing

species

Etip

roston

trom

ethamine

Bovine,

porcine

Fertirelin

acetate

Bov

ine

Flumethrin

Bees(hon

ey)

Folic

acid

Allfood-produ

cing

species

Glycerolform

alAllfood-produ

cing

species

Gon

adotroph

inreleasingho

rmon

eAllfood-produ

cing

species

Heptaminol

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 72

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Hesperidin

Equ

idae

Hesperidinmethy

lchalcone

Equ

idae

Hexetidine

Equ

idae

For

topicaluseon

ly

Hum

anchoriongo

nado

trop

hin

Allfood-produ

cing

species

Hum

anmenop

ausalurinarygo

nado

trop

hin

Bov

ine

Hyd

rocortison

eAllfood-produ

cing

species

For

topicaluseon

ly

Iodine

organiccompo

unds

—Iodo

form

Allfood-produ

cing

species

Isob

utane

Allfood-produ

cing

species

Isoflurane

Equ

idae

For

useas

anaesthetic

only

Isox

suprine

Bov

ine,

equidae

For

therapeutic

useon

lyin

accordance

with

Cou

ncilDirectiv

e96

/22

/EEC

(OJL

125,

23.5.199

6,p.

3)

Ketam

ine

Allfood-produ

cing

species

Ketanserintartrate

Equ

idae

Ketop

rofen

Bov

ine,

porcine,

equidae

L-tartaricacid

andits

mon

o-anddi-basic

saltof

sodium

,po

tassium

andcalcium

Allfood-produ

cing

species

For

useas

excipient

Lactic

acid

Allfood-produ

cing

species

Lecirelin

Bov

ine,

equidae,

rabb

its

Lob

eline

Allfood-produ

cing

species

Luprostiol

Allmam

malianspecies

Malic

acid

Allfood-produ

cing

species

For

useas

excipient

Manganese

carbon

ate

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

chloride

Allfood-produ

cing

species

For

oral

useon

ly

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 73

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Manganese

glucon

ate

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

glycerop

hosphate

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

oxide

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

pido

late

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

ribo

nucleate

Allfood-produ

cing

species

For

oral

useon

ly

Manganese

sulphate

Allfood-produ

cing

species

For

oral

useon

ly

Mecillinam

Bov

ine

For

intrauterine

useon

ly

Medroxyprogesterone

acetate

Ovine

For

intravaginal

useforzootechnical

purposes

only

Melaton

inOvine,caprine

Menadione

Allfood-produ

cing

species

Menbu

tone

Bov

ine,

ovine,

caprine,

porcine,

equidae

Menthol

Allfood-produ

cing

species

Methy

lnicotin

ate

Bov

ine,

equidae

For

topicaluseon

ly

Mineral

hydrocarbo

ns,low

tohigh

viscosity

includ

ingmicrocris-

talline

waxes,

approxim

ately

C10-C60;

aliphatic,

branched

aliphatic

andalicyclic

compo

unds

Allfood-producing

species

Excludesarom

atic

andunsaturatedcompounds

N-butane

Allfood-produ

cing

species

N-butanol

Allfood-produ

cing

species

For

useas

excipient

Natam

ycin

Bov

ine,

equidae

For

topicaluseon

ly

Neostigmine

Allfood-produ

cing

species

Nicob

oxil

Equ

idae

For

topicaluseon

ly

Non

ivam

ide

Equ

idae

For

topicaluseon

ly

Oleyloleate

Allfood-produ

cing

species

For

topicaluseon

ly

Oxy

tocin

Allmam

malianfood

-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 74

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Pancreatin

Allmam

malianfood

-produ

cing

species

For

topicaluseon

ly

Papain

Allfood-produ

cing

species

Papaverine

Bov

ine

New

born

calves

only

Peracetic

acid

Allfood-produ

cing

species

Pheno

lAllfood-produ

cing

species

Phlorog

lucino

lAllfood-produ

cing

species

Phy

tomenadione

Allfood-produ

cing

species

Policresulen

Allfood-produ

cing

species

For

topicaluseon

ly

Polyethyleneglycol

15hy

drox

ystearate

Allfood-produ

cing

species

For

useas

excipient

Polyethyleneglycol

7glyceryl

cocoate

Allfood-produ

cing

species

For

topicaluseon

ly

Polyethyleneglycol

stearateswith

8-40

oxyethyleneun

itsAllfood-produ

cing

species

For

useas

excipient

Polysulph

ated

glycosam

inog

lycan

Equ

idae

Praziqu

antel

Ovine

Equ

idae

For

usein

non-lactatingsheepon

ly

Pregn

antmareserum

gonado

trop

hin

Allfood-produ

cing

species

Prethcamide(crotetham

ideandcrop

ropamide)

Allmam

malianfood

-produ

cing

species

Procaine

Allfood-produ

cing

species

Propane

Allfood-produ

cing

species

Propy

lene

glycol

Allfood-produ

cing

species

Quatresin

Allfood-produ

cing

species

For

useas

preservativ

eon

lyat

concentrations

ofup

to0,5%

R-Cloprosteno

lBov

ine,

porcine,

equidae

Rifaxim

inAllmam

malianfood

-produ

cing

species

Bov

ine

For

topicaluseon

lyFor

intram

ammaryuse,

except

iftheud

dermay

beused

asfood

for

human

consum

ption

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 75

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Rom

ifidine

Equ

idae

For

therapeutic

uses

only

Sod

ium

2-methy

l-2-ph

enox

y-prop

anoate

Bov

ine,

porcine,

caprine,

equidae

Sod

ium

benzyl

4-hydrox

ybenzoate

Allfood-produ

cing

species

Sodium

butyl4-hydroxybenzoate

Allfood-producing

species

Sod

ium

cetostearylsulphate

Allfood-produ

cing

species

For

topicaluseon

ly

Som

atosalm

Salmon

Tanninu

mAllfood-produ

cing

species

Tau

fluv

alinate

Terpinhy

drate

Bov

ine,

porcine,

ovine,

caprine

Tetracaine

Allfood-produ

cing

species

For

useas

anaesthetic

only

Theob

romine

Allfood-produ

cing

species

Theop

hylline

Allfood-produ

cing

species

Thiom

ersal

Allfood-produ

cing

species

For

useon

lyas

preservativ

esin

multid

osevaccines

ataconcen-

trationno

texceeding0,02

%

Thy

mol

Allfood-produ

cing

species

Tim

erfonate

Allfood-produ

cing

species

For

useon

lyas

preservativ

esin

multid

osevaccines

ataconcen-

trationno

texceeding0,02

%

Trimethy

lphlorog

lucino

lAllfood-produ

cing

species

Vitamin

DAllfood-produ

cing

species

Woo

lalcoho

lsAllfood-produ

cing

species

For

topicaluseon

ly

▼M59

1-Methy

l-2-py

rrolidon

eEqu

idae

Cefacetrile

Bov

ine

For

intram

ammaryuseon

lyandforalltissues

except

milk

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 76

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Enilcon

azole

Bov

ine,

equidae

For

topicaluseon

ly

Etamsylate

Allfood

prod

ucingspecies

Strychn

ine

Bov

ine

For

oral

useon

lyat

dose

to0,1mg/kg

bw

▼M60

Parconazole

Guineafowl

▼M62

Biotin

Allfood

prod

ucingspecies

Bromhexine

Bov

ine

Not

foruse

inanim

als

from

which

milk

isprod

uced

forhu

man

consum

ption

Porcine

Pou

ltry

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

forhu

man

consum

ption

Mercaptam

inehydrochloride

Allmam

malianfood-producing

species

Praziqu

antel

Ovine

Pyrantelem

bonate

Equ

idae

Vitamin

B1

Allfood-produ

cing

species

Vitamin

B12

Allfood-produ

cing

species

Vitamin

B2

Allfood-produ

cing

species

Vitamin

B3

Allfood-produ

cing

species

Vitamin

B5

Allfood-produ

cing

species

Vitamin

B6

Allfood-produ

cing

species

▼M59

1990R2377— EN — 16.08.2008 — 058.002— 77

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Vitamin

EAllfood-produ

cing

species

▼M63

Tiaprost

Bov

ine,

ovine,

porcine,

equidae

▼M65

Apram

ycin

Porcine,rabb

its

Ovine

Not

foruse

inanim

als

from

which

milk

isprod

uced

forhu

man

consum

ption

Chicken

Not

forusein

anim

alsfrom

which

eggs

are

prod

uced

forhu

man

consum

ption

For

oral

useon

ly

Azamethiph

osSalmon

idae

Dox

apram

Allmam

malianfood

prod

ucingspecies

Piperon

ylbu

toxide

Bov

ine,

ovine,

caprine,

equidae

For

topicaluseon

ly

Sulfogaiacol

Allfood

prod

ucingspecies

Vetrabu

tinehy

drochloride

Porcine

▼M66

Fenpipram

idehy

drochloride

Equ

idae

For

intravenou

suseon

ly

Hyd

rochlorothiazide

Bov

ine

Levom

ethado

neEqu

idae

For

intravenou

suseon

ly

Tricainemesilate

Fin

fish

For

water

borneuseon

ly

Trichlorm

ethiazide

Allmam

malianfood

prod

ucingspecies

Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption

▼M62

1990R2377— EN — 16.08.2008 — 058.002— 78

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Vincamine

Bov

ine

For

usein

newbo

rnanim

alson

ly

▼M67

Atrop

ine

Allfood

prod

ucingspecies

Cefop

erazon

eBov

ine

For

intram

ammaryusein

lactatingcowson

lyandforalltissues

except

milk

▼M69

2-am

inoethanol

glucuron

ate

Allfood-produ

cing

species

Betaine

glucuron

ate

Allfood-produ

cing

species

▼M118

Bitu

minosulfonates,

ammon

ium

andsodium

salts

Allmam

malianfood

prod

ucingspecies

For

topicaluseon

ly

▼M69

Chlorph

enam

ine

Allmam

malianfood

-produ

cing

species

Hum

icacidsandtheirsodium

salts

Allfood-produ

cing

species

For

oral

useon

ly

Paracetam

olPorcine

For

oral

useon

ly

Tosylchloramidesodium

Fin

fish

For

water-borne

useon

ly

▼M88

Bov

ine

For

topicaluseon

ly

▼M125

Equ

idae

For

topicaluseon

ly

▼M70

1-methy

l-2-py

rrolidon

eAllfood-produ

cing

species

Ergom

etrine

maleate

Allmam

malianfood

-produ

cing

species

For

usein

parturient

anim

alson

ly

Jecorisoleum

Allfood-produ

cing

species

For

topicaluseon

ly

▼M66

1990R2377— EN — 16.08.2008 — 058.002— 79

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Mepivacaine

Equ

idae

For

intra-articular

andepidural

useas

localanaesthetic

only

Nov

obiocin

Bov

ine

For

intram

maryuseon

lyandforalltissues

except

milk

Piperazinedihydrochloride

Chicken

For

alltissues

except

eggs

Polyo

xylcastor

oilwith

30to

40ox

yethyleneun

itsAllfood-produ

cing

species

For

useas

excipient

Polyo

xylhy

drog

enated

castor

oilwith

40to

60ox

yethyleneun

itsAllfood-produ

cing

species

For

useas

excipient

Xylazinehy

drochloride

Bov

ine,

equidae

Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ptiom

▼M71

Butafosfan

Bov

ine

►M78

For

intravenou

suseon

ly◄

Cefalon

ium

Bov

ine

For

intram

ammaryuseandeyetreatm

enton

ly,andforalltissues

except

milk

Furosem

ide

Bov

ine,

equidae

For

intravenou

sadministrationon

ly

Lidocaine

Equ

idae

For

local-region

alanaesthesiaon

ly

▼M72

3,5-Diio

do-L-thy

rosine

Allmam

malianfood

-produ

cing

species

Levothy

roxine

Allmam

malianfood

-produ

cing

species

▼M74

Aluminium

salicylate,

basic

All

food

prod

ucing

species

except

fish

For

topicaluseon

ly

Bismuthsubn

itrate

Bov

ine

For

intram

ammaryuseon

ly

Calcium

aspartate

Allfood

producingspecies

Methy

lsalicylate

Allfood

prod

ucingspeciesexcept

fish

For

topicaluseon

ly

▼M70

1990R2377— EN — 16.08.2008 — 058.002— 80

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Salicylic

acid

Allfood

prod

ucingspeciesexcept

fish

For

topicaluseon

ly

▼M115

Sod

ium

salicylate

Bov

ine,

porcine(2)

▼M74

Zincaspartate

Allfood

prod

ucingspecies

▼M75

Toldimfos

Allfood

prod

ucingspecies

▼M77

Decoq

uinate

Bov

ine,

ovine

For

oral

use

only.Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption

Sod

ium

boroform

iate

Allfood

prod

ucingspecies

▼M81

Thiam

ylal

Allmam

malianfood

prod

ucingspecies

For

intravenou

sadministrationon

ly

Thiop

entalsodium

Allfood-produ

cing

species

For

intravenou

sadministrationon

ly

▼M105

Acetylsalicylic

acid

Allfood

prod

ucingspeciesexcept

fish

Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

for

human

consum

ption

Acetylsalicylic

acid

DL-lysine

Allfood

prod

ucingspeciesexcept

fish

Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

for

human

consum

ption

Carbasalate

calcium

Allfood

prod

ucingspeciesexcept

fish

Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

for

human

consum

ption

▼M74

1990R2377— EN — 16.08.2008 — 058.002— 81

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Sod

ium

acetylsalicylate

Allfood

prod

ucingspeciesexcept

fish

Not

forusein

anim

alsfrom

which

milk

oreggs

areprod

uced

for

human

consum

ption

▼M83

Linearalkylbenzene

sulpho

nic

acidswith

alky

lchain

leng

ths

rang

ing

from

C9to

C13,containing

less

than

2,5

%of

chains

long

erthan

C13

Bov

ine

For

topicaluseon

ly

▼M117

Ovine

(4)

▼M86

Amprolium

Pou

ltry

For

oral

useon

ly

Tilu

dron

icacid,disodium

salt

Equ

idae

For

intravenou

suseon

ly

▼M89

Sorbitantrioleate

Allfood-produ

cing

species

▼M90

Vitamin

AAllfood

prod

ucingspecies

▼M91

Ammon

ium

lauryl

sulphate

Allfood-produ

cing

species

Brono

pol

Fin

fish

Calcium

pantothenate

Allfood-producing

species

▼M94

Allantoin

Allfood

prod

ucingspecies

For

topicaluseon

ly

Benzocaine

Salmon

idae

▼M95

Dexpantheno

lAllfood

prod

ucingspecies

▼M105

1990R2377— EN — 16.08.2008 — 058.002— 82

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M97

Azagly-nafarelin

Salmon

idae

Not

foruse

infish

from

which

eggs

are

prod

uced

forhu

man

consum

ption

Deslorelin

acetate

Equ

idae

▼M98

Hyd

roxy

ethy

lsalicylate

Allfood

prod

ucingspeciesexcept

fish

For

topicaluseon

ly

Xylazinehydrochloride

Bovine,

equidae

▼M99

Omeprazole

Equ

idae

For

oral

useon

ly

▼M100

Trichlorm

ethiazide

Allmam

malianfood

prod

ucingspecies

▼M107

Progesteron

e(*)

Bov

ine,

ovine,

caprine,

Equ

idae

(fem

ale)

▼M116

Beclomethasone

dipropionate

Equidae

(3)

Cloprosteno

lCaprine

R-cloprosteno

lCaprine

Sorbitansesquioleate

Allfood

prod

ucingspecies

▼M126

Diethyleneglycol

mon

oethyl

ether

Allruminants

andpo

rcine

▼M129

Peforelin

Porcine

▼M94

1990R2377— EN — 16.08.2008 — 058.002— 83

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M138

Dinop

roston

eAllmam

malianspecies

▼M107

(*)O

nlyforintravaginal

therapeutic

orzootechn

ical

useandin

accordance

with

theprov

isions

ofDirectiv

e96

/22/EC.

►M11

2(1)For

oral

useon

ly.◄

►M11

5(2)For

oral

use;

notforusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

◄►M11

6(3)For

inhalatio

nuseon

ly.◄

►M11

7(4)For

topicaluseon

ly.◄

▼M129

1990R2377— EN — 16.08.2008 — 058.002— 84

3.Sub

stancesgenerally

recogn

ised

assafe

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Absinthium

extract

Allfood-produ

cing

species

Acetylm

ethion

ine

Allfood-produ

cing

species

Aluminium

hydrox

ide

Allfood-produ

cing

species

Aluminium

mon

ostearate

Allfood-produ

cing

species

Ammon

ium

sulfate

Allfood-produ

cing

species

►C6

Benzylbenzoate◄

Allfood-produ

cing

species

Benzylp-hy

drox

ybenzoate

Allfood-produ

cing

species

Calcium

boroglucon

ate

Allfood-produ

cing

species

Calcium

citrate

Allfood-produ

cing

species

Cam

phor

Allfood-produ

cing

species

Externaluseon

ly

Cardamon

extract

Allfood-produ

cing

species

Diethyl

sebacate

Allfood-produ

cing

species

Dim

ethicone

Allfood-produ

cing

species

Dim

ethylacetam

ide

Allfood-producing

species

Dim

ethy

lsulpho

xide

Allfood-produ

cing

species

Epineph

rine

Allfood-produ

cing

species

Ethyl

oleate

Allfood-produ

cing

species

Ethylenediaminetetraacetic

acid

andsalts

Allfood-produ

cing

species

Eucalyp

tol

Allfood-produ

cing

species

Follicle

stim

ulating

horm

one(natural

FSH

from

allspeciesand

theirsynthetic

analogues)

Allfood-produ

cing

species

Formaldehy

deAllfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 85

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Formic

acid

Allfood-produ

cing

species

Glutaraldehyd

eAllfood-produ

cing

species

Guaiacol

Allfood-produ

cing

species

Heparin

andits

salts

Allfood-produ

cing

species

Hum

anchorionic

gonado

trop

in(natural

HCG

and

itssynthetic

analog

ues)

Allfood-produ

cing

species

Iron

ammon

ium

citrate

Allfood-produ

cing

species

Iron

dextran

Allfood-produ

cing

species

Iron

glucoh

eptonate

Allfood-produ

cing

species

Isop

ropano

lAllfood-produ

cing

species

Lanolin

Allfood-produ

cing

species

Luteinising

horm

one

(natural

LH

from

all

species

and

their

synthetic

analogues)

Allfood-produ

cing

species

Magnesium

chloride

Allfood-produ

cing

species

Magnesium

glucon

ate

Allfood-produ

cing

species

Magnesium

hypo

phosph

iteAllfood-produ

cing

species

Mannitol

Allfood-produ

cing

species

Methy

lbenzoate

Allfood-produ

cing

species

Mon

othiog

lycerol

Allfood-produ

cing

species

Mon

tanide

Allfood-produ

cing

species

Myg

lyol

Allfood-produ

cing

species

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 86

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Orgotein

Allfood-produ

cing

species

Polox

alene

Allfood-produ

cing

species

Polox

amer

Allfood-produ

cing

species

Polyethylene

glycols

(molecular

weightranging

from

200

to10

000)

Allfood-produ

cing

species

Polysorbate

80Allfood-produ

cing

species

Seroton

inAllfood-produ

cing

species

Sod

ium

chloride

Allfood-produ

cing

species

Sod

ium

crom

oglycate

Allfood-produ

cing

species

Sod

ium

dioctylsulph

osuccinate

Allfood-produ

cing

species

Sod

ium

form

aldehy

desulpho

xylate

Allfood-produ

cing

species

Sod

ium

lauryl

sulphate

Allfood-produ

cing

species

Sod

ium

pyrosulphite

Allfood-produ

cing

species

Sod

ium

stearate

Allfood-produ

cing

species

Sod

ium

thiosulphate

Allfood-produ

cing

species

Tragacanth

Allfood-produ

cing

species

Urea

Allfood-produ

cing

species

Zincox

ide

Allfood-produ

cing

species

Zincsulphate

Allfood-produ

cing

species

▼M65

Adeno

sine

andits

5′-m

ono-,5′-di-and5′-triph

osph

ates

Allfood

prod

ucingspecies

Alanine

Allfood

prod

ucingspecies

Arginine

Allfood

prod

ucingspecies

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 87

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Asparagine

Allfood

prod

ucingspecies

Aspartic

acid

Allfood

prod

ucingspecies

Carnitin

eAllfood

prod

ucingspecies

Cho

line

Allfood

prod

ucingspecies

Chy

motrypsin

Allfood

prod

ucingspecies

Citrullin

eAllfood

prod

ucingspecies

Cysteine

Allfood

prod

ucingspecies

Cytidineandits

5′-m


osph

ates

Allfood

prod

ucingspecies

Glutamic

acid

Allfood

prod

ucingspecies

Glutamine

Allfood

prod

ucingspecies

Glycine

Allfood

prod

ucingspecies

Guano

sine

andits

5′-m


osph

ates

Allfood

prod

ucingspecies

Histid

ine

Allfood

prod

ucingspecies

Hyaluronicacid

Allfood

prod

ucingspecies

Inosineandits

5′-m


osph

ates

Allfood

prod

ucingspecies

Inosito

lAllfood

prod

ucingspecies

Isoleucine

Allfood

prod

ucingspecies

Leucine

Allfood

prod

ucingspecies

Lysine

Allfood

prod

ucingspecies

Methion

ine

Allfood

prod

ucingspecies

Ornith

ine

Allfood

prod

ucingspecies

Orotic

acid

Allfood

prod

ucingspecies

Pepsin

Allfood

prod

ucingspecies

▼M65

1990R2377— EN — 16.08.2008 — 058.002— 88

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Pheny

lalanine

Allfood

prod

ucingspecies

Prolin

eAllfood

prod

ucingspecies

Serine

Allfood

prod

ucingspecies

Thioctic

acid

Allfood

prod

ucingspecies

Threonine

Allfood

prod

ucingspecies

Thy

midine

Allfood

prod

ucingspecies

Trypsin

Allfood

prod

ucingspecies

Tryptop

han

Allfood

prod

ucingspecies

Tyrosine

Allfood

prod

ucingspecies

Uridine

andits

5′-m

ono-,5′-di-and5′-triphosphates

Allfood

producingspecies

Valine

Allfood

prod

ucingspecies

▼M126

Polyoxyethylene

sorbitanmonooleate

Allfood

producingspecies

▼M128

Polyo

xyethy

lene

sorbitanmon

ooleateandtrioleate

Allfood-produ

cing

species

▼M65

1990R2377— EN — 16.08.2008 — 058.002— 89

4.Sub

stancesused

inho

meopathic

veterinary

medicinal

prod

ucts

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Allsubstances

used

inho

meopathic

veterinary

medicinal

prod

ucts

prov

ided

that

theirconcentrationin

theprod

uctdo

esno

texceed

onepartpertenthou

sand

Allfood-produ

cing

species

▼M63

Adonisvernalis

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

ly

Acqua

levici

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiason

ly

Atrop

abellado

nna

Allfood

prod

ucingspecies

For

use

inho

meopathic

veterinary

medicinal

prod

ucts

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

ly

Con

vallariamajalis

Allfood

prod

ucingspecies

For

use

inho

meopathic

veterinary

medicinal

prod

ucts

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperthou

sand

only

▼M66

Apo

cynu

mcann

abinum

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

lyFor

oral

useon

ly

Harun

gamad

agascariensis

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

ly

Selenicereus

gran

diflo

rus

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

ly

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 90

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Thu

jaoccidentalis

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

ly

Virolasebifera

Allfood

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperthou

sand

only

▼M68

Rutagraveolens

Allfood-producing

species

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperthou

sand

only.

Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption

▼M71

Aesculushippocastanum

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartpertenon

ly

Agnus

castus

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Aila

nthu

saltissima

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Allium

cepa

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

▼M66

1990R2377— EN — 16.08.2008 — 058.002— 91

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Arnicae

radix

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

intheprod

ucts

notexceedingon

epartpertenon

ly

Artem

isia

abrotanu

mAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Bellis

perenn

isAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Calendu

laofficinalis

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

intheprod

ucts

notexceedingon

epartpertenon

ly

Cam

phora

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartperhu

ndredon

ly.

Cardiosperm

umha

licacab

umAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Crataegus

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Echinacea

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

lyFor

topicaluseon

ly.

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

intheprod

ucts

notexceedingon

epartpertenon

ly

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 92

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Eucalyptusglob

ulus

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Eup

hrasia

officinalis

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Ginkgobiloba

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartperthou

sand

only.

Ginseng

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Ham

amelis

virginiana

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartpertenon

ly

Harpa

goph

ytum

procum

bens

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Hypericum

perforatum

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Lachn

anthes

tinctoria

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartperthou

sand

only.

Lobaria

pulmonaria

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 93

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Okoub

akaau

brevillei

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Prunuslaurocerasus

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

inthe

prod

ucts

notexceedingon

epartperthou

sand

only.

Sereno

arepens

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Silybu

mmarianu

mAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Solid

agovirgau

rea

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Syzygium

cumini

All-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Turnera

diffu

saAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

Viscum

albu

mAll-food

producingspecies

For

use

inhomeopathic

veterinary

medicinal

products

prepared

accordingto

homeopathic

pharmacop

oeiasat

concentrations

corre-

spon

ding

tothemothertin

ctureanddilutio

nsthereofon

ly

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 94

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M72

Phytolaccaam

erican

aAllfood-producing

species

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperthou

sand

only

Urginea

maritima

Allfood-producing

species

For

use

inhomeopathic

veterinary

medicinal

products

prepared

according

toho

meopathic

pharmacop

oeias,

atconcentrations

intheprod

ucts

notexceedingon

epartperhu

ndredon

lyFor

oral

useon

ly

▼M58

5.Sub

stancesused

asfood

additiv

esin

food

stuffs

forhu

man

consum

ption

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Sub

stanceswith

anE

number

Allfood-produ

cing

species

Only

substances

approved

asadditiv

esin

food

stuffs

forhu

man

consum

ption,

with

theexceptionof

preservativ

eslistedin

part

Cof

Ann

exIIIto

Europ

eanParliamentandCou

ncilDirectiv

e95

/2/EC

(OJL

61,18

.3.199

5,p.

1).

6.Sub

stancesof

vegetableorigin

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M73

Aloevera

gelandwho

leleaf

extractof

Aloevera

Allfood-produ

cing

species

For

topicaluseon

ly

▼M71

Aloes,Barba

dosan

dCap

ae,theirstan

dardised

dryextractan

dpreparations

thereof

Allfood-produ

cing

species

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 95

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M58

Ang

elicae

radixaetheroleum

Allfood-produ

cing

species

Anisi

aetheroleum

Allfood-produ

cing

species

▼M77

Anisi

stellatifructus,standardised

extracts

andpreparations

thereof

Allfood

prod

ucingspecies

▼M71

Arnicamon

tana

(arnicae

flosan

darnicaeplan

tatota)

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

Balsamum

peruvian

umAllfood-produ

cing

species

For

topicaluseon

ly

▼M71

Boldo

foliu

mAllfood-produ

cing

species

▼M70

Calendu

laeflo

sAllfood-produ

cing

species

For

topicaluseon

ly

▼M68

Cap

sici

fructusacer

Allfood-produ

cing

species

▼M71

Carlin

aeradix

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

Carvi

aetheroleum

Allfood-produ

cing

species

Caryoph

ylliaetheroleum

Allfood-produ

cing

species

▼M59

Centella

easiaticaerextractum

Allfood

prod

ucingspecies

For

topicaluseon

ly

▼M58

Chrysan

them

icinerariifo

liiflo

sAllfood-produ

cing

species

For

topicaluseon

ly

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 96

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M70

Cimicifu

gaeracemosae

rhizom

aAllfood-produ

cing

species

Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ptiom

▼M77

Cinchon

aecortex,standardised

extracts

and

preparations

thereof

Allfood

producingspecies

▼M58

Cinnamom

icassiaeaetheroleum

Allfood-produ

cing

species

▼M77

Cinna

mom

icassiaecortex,standardised

extracts

andpreparations

thereof

Allfood

prod

ucingspecies

▼M58

Cinna

mom

iceylan

iciaetheroleum

Allfood-produ

cing

species

▼M77

Cinna

mom

iceylan

icicortex,standardised

extractsandpreparations

thereof

Allfood

prod

ucingspecies

▼M58

Citriaetheroleum

Allfood-produ

cing

species

Citron

ellaeaetheroleum

Allfood-produ

cing

species

▼M77

Con

durang

ocortex,standardised

extracts

andpreparations

thereof

Allfood

prod

ucingspecies

▼M58

Coriandri

aetheroleum

Allfood-produ

cing

species

▼M71

Cup

ressiaetheroleum

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

1990R2377— EN — 16.08.2008 — 058.002— 97

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M58

Echinacea

purpurea

Allfood-produ

cing

species

For

topicaluseon

ly

Eucalyptiaetheroleum

Allfood-produ

cing

species

Foeniculiaetheroleum

Allfood-produ

cing

species

▼M77

Frang

ulae

cortex,standardised

extracts

andpreparations

thereof

Allfood

producingspecies

Gentia

naeradix,

standardised

extracts

andpreparations

thereof

Allfood

prod

ucingspecies

▼M133

Ginseng

,standardised

extracts

andpreparations

thereof

Allfood-produ

cing

species

▼M58

Ham

amelis

virginiana

Allfood-produ

cing

species

For

topicaluseon

ly

▼M68

Hippo

castan

isemen

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

Hypericiol0eum

Allfood-produ

cing

species

For

topicaluseon

ly

▼M68

Juniperi

fructus

Allfood-produ

cing

species

Lauri

folii

aetheroleum

Allfood-produ

cing

species

Lau

rifructus

Allfood-produ

cing

species

▼M71

Lavan

dulaeaetheroleum

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

Lespedeza

capitata

Allfood-produ

cing

species

Linioleum

Allfood-produ

cing

species

Majoran

aeherba

Allfood-produ

cing

species

▼M74

Matricariarecutitaandpreparations

thereof

Allfood

prod

ucingspecies

▼M71

1990R2377— EN — 16.08.2008 — 058.002— 98

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

▼M58

Matricariae

flos

Allfood-produ

cing

species

Medicag

osativaextractum

Allfood-produ

cing

species

For

topicaluseon

ly

▼M59

Melissaeaetheroleum

Allfood

prod

ucingspecies

▼M58

Melissaefoliu

mAllfood-produ

cing

species

▼M91

Menthae

arvensis

aetheroleum

Allfood-produ

cing

species

▼M58

Menthae

piperitaeaetheroleum

Allfood-produ

cing

species

Millefoliiherba

Allfood-produ

cing

species

Myristicae

aetheroleum

Allfood-produ

cing

species

For

usein

newbo

rnanim

alson

ly

▼M140

Lectin

extractedfrom

redkidn

eybeansPha

seolus

vulgaris

Porcine

For

oral

useon

ly

▼M125

Piceaeturion

esrecentes

extractum

Allfood

prod

ucingspecies

For

oral

useon

ly

▼M58

Oxidatio

nprod

ucts

ofTerebinthinae

oleum

Bov

ine,

porcine,

ovine,

caprine

Pyrethrum

extract

Allfood-produ

cing

species

For

topicaluseon

ly

Quercus

cortex

Allfood-produ

cing

species

Quilla

iasapo

nins

Allfood-produ

cing

species

▼M74

Rheiradix,

standardised

extracts

andpreparations

thereof

Allfood

producingspecies

▼M58

Ricinioleum

Allfood-produ

cing

species

For

useas

excipient

Rosmariniaetheroleum

Allfood-produ

cing

species

▼M74

1990R2377— EN — 16.08.2008 — 058.002— 99

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Rosmarinifoliu

mAllfood-produ

cing

species

▼M68

Ruscusaculeatus

Allfood-produ

cing

species

For

topicaluseon

ly

▼M58

Salviaefoliu

mAllfood-produ

cing

species

Sambu

ciflo

sAllfood-produ

cing

species

Sina

pisnigrae

semen

Allfood-produ

cing

species

▼M68

Strychni

semen

Bov

ine,

ovine,

caprine

For

oral

use

only

atdo

ses

upto

the

equivalent

of0,1

mg

strychnine/kgbw

▼M71

Symph

ytiradix

Allfood-produ

cing

species

For

topicaluseon

intact

skin

only

▼M58

Terebinthinae

aetheroleum

rectificatum

Allfood-produ

cing

species

For

topicaluseon

ly

Terebinthinae

laricina

Allfood-produ

cing

species

For

topicaluseon

ly

Thymiaetheroleum

Allfood-produ

cing

species

Tiliae

flos

Allfood-produ

cing

species

Urticae

herba

Allfood-produ

cing

species

▼M1117.

Anti-infectious

agents

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Oxalic

acid

Hon

eybees

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 100

8.Anti-inflam

matoryagents

Pharm

acolog

ically

activ

esubstance(s)

Animal

species

Other

prov

isions

Carprofen

Bov

ine(1)

(1)For

bovine

milk

only.

▼M119

1990R2377— EN— 16.08.2008 — 058.002 — 101

ANNEX

III

LIST

OF

PHARMACOLOGIC

ALLY

ACTIV

ESUBSTANCES

USED

INVETERIN

ARY

MEDIC

INAL

PRODUCTS

FOR

WHIC

HPROVISIO

NAL

MAXIM

UM

RESID

UE

LIM

ITSHAVE

BEEN

FIX

ED

1.Anti-infectious

agents

1.1.

Chemotheurapeutics

1.1.2.

Benzenesulphonamides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clorsulon

Clorsulon

Bov

ine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

150μg

/kg

Liver

400μg

/kg

Kidney

1.2.

Antibiotics

1.2.1.

Beta-lactam

aseinhibitors

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clavu

lanicacid

Clavu

lanicacid

Bov

ine,

ovine

200μg

/kg

Milk

►M67

Provision

alMRLsexpire

on1July

2001

◄

Bov

ine,

ovine,

porcine

200μg

/kg

Muscle

200μg

/kg

Fat

200μg

/kg

Liver

200μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 102

1.2.2.

Macrolid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M74

Acetylisov

aleryltylosin

Sum

ofacetylisov

aler-

yltylosinand3-O-acet-

yltylosin

Porcine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01

100μg

/kg

Skinandfat

100μg

/kg

Liver

100μg

/kg

Kidney

▼M117

Acetylisov

aleryltylosin(1)

Sum

ofacetyl-isovaler-

yltylosinand3-O-acet-

yltylosin

Pou

ltry(2)

50μg

/kg

Skinandfat

50μg

/kg

Liver

▼M58

Erythromycin

MRLs

apply

toall

microbiolog

ical

activ

eresidu

esexpressed

aserythrom

ycin

equivalent

Bov

ine,

ovine

40μg

/kg

Milk

Provision

alMRLsexpire

on1

June

2000

Bov

ine,

ovine,

porcine,

poultry

400μg

/kg

Muscle

400μg

/kg

Fat

400μg

/kg

Liver

400μg

/kg

Kidney

Pou

ltry

200μg

/kg

Egg

s

Josamycin

Josamycin

Chicken

200μg

/kg

Muscle

►M77

Provision

alMRLsexpire

on1.7.20

02◄

200μg

/kg

Fat

200μg

/kg

Liver

400μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 103

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

200μg

/kg

Egg

s

▼M60

Sum

ofthemicrobiolo-

gically

activ

emeta-

bolites,

expressed

asjosamycin

Porcine

200μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

02

200μg

/kg

Skinandfat

200μg

/kg

Liver

400μg

/kg

Kidney

▼M70

Tilm

icosin

Tilm

icosin

Bov

ine

40μg

/kg

Milk

Provision

alMRLsexpire

on1.1.20

01

▼M99

Tulathrom

ycin

(2R,3S,4R,5R,8R,10-

R,11R

,12S

,13

S,14R

)-2-

ethy

l-3,4,10

,13-tetra-

hydrox

y-3,5,8,10

,12,14

-hexamethy

l-11

-[[3,4,6-

trideoxy

-3-(dimethy

-lamino)-β-D

-xylo-

hexo

pyrano

syl]ox

y]-1-

oxa-

6-azacyclopent-

decan-15

-one

expressed

astula-

thromycin

equivalents

Bov

ine

100μg

/kg

Fat

Provision

alMRLsexpire

on1

July

2004

;no

tforuse

inanim

als

from

which

milk

isproduced

forhu

man

consum

ption

300

0μg

/kg

Liver

300

0μg

/kg

Kidney

Porcine

100μg

/kg

Skinandfat

Provision

alMRLsexpire

on1

July

2004

300

0μg

/kg

Liver

300

0μg

/kg

Kidney

▼M139

Gam

ithromycin

Gam

ithromycin

Bov

ine

20μg

/kg

Fat

Provision

alMRLs

will

expire

on1July

2009

.Not

forusein

anim

alsprod

ucingmilk

forhu

man

consum

ption

200μg

/kg

Liver

100μg

/kg

Kidney

▼M117

(1)Provision

alMRLsexpire

on1July

2006

.(2)Not

forusein

anim

alsfrom

which

eggs

areprod

uced

forhu

man

consum

ption.

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 104

1.2.4.

Cephalosporins

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Cefacetrile

Cefacetrile

Bov

ine

125μg

/kg

Milk

►M83

Provision

alMRLsexpire

on1.1.20

02◄

For

intram

mam

aryuseon

ly

▼M71

Cefalon

ium

Cefalon

ium

Bov

ine

10μg

/kg

Milk

►M85

Provision

alMRLsexpire

on1.1.20

03◄

▼M67

Cefop

erazon

eCefop

erazon

eBov

ine

50μg

/kg

Milk

Provision

alMRLsexpire

on1Janu

ary

2001

▼M61

Cefqu

inom

eCefqu

inom

ePorcine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

00

50μg

/kg

Skin+fat

100μg

/kg

Liver

200μg

/kg

Kidney

▼M59

Cephapirin

Sum

ofceph

apirin

and

desacetylcephapirin

Bov

ine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

50μg

/kg

Fat

50μg

/kg

Liver

100μg

/kg

Kidney

10μg

/kg

Milk

▼M59

1990R2377— EN— 16.08.2008 — 058.002 — 105

1.2.5.

Aminoglycosides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Aminosidine

Aminosidine

Bov

ine,

porcine,

rabb

its,chicken

500μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2000

150

0μg

/kg

Liver

150

0μg

/kg

Kidney

Apram

ycin

Apram

ycin

Bov

ine

100

0μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

1999

For

use

inno

n-lactatingcattleon

ly100

0μg

/kg

Fat

1000

0μg

/kg

Liver

2000

0μg

/kg

Kidney

Porcine

100

0μg

/kg

Muscle

100

0μg

/kg

Skinandfat

100

0μg

/kg

Liver

500

0μg

/kg

Kidney

▼M76

Dihyd

rostreptom

ycin

Dihyd

rostreptom

ycin

Bov

ine,

ovine

500μg

/kg

Muscle

Provision

alMRLsexpire

on1.6.20

02

500μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

200μg

/kg

Milk

Porcine

500μg

/kg

Muscle

500μg

/kg

Skinandfat

500μg

/kg

Liver

100

0μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 106

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Gentamicin

Gentamicin

Bov

ine

100μg

/kg

Milk

Provision

alMRLsexpire

on1.6.20

02

Bov

ine,

porcine

50μg

/kg

Muscle

50μg

/kg

Fat

200μg

/kg

Liver

750μg

/kg

Kidney

▼M65

Kanam

ycin

Kanam

ycin

Rabbits

100μg

/kg

Muscle

►M91

Provision

alMRLsexpire

on1.1.20

04◄

100μg

/kg

Fat

600μg

/kg

Liver

250

0μg

/kg

Kidney

Bov

ine,

ovine

100μg

/kg

Muscle

100μg

/kg

Fat

▼M76

1990R2377— EN— 16.08.2008 — 058.002 — 107

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

600μg

/kg

Liver

250

0μg

/kg

Kidney

150μg

/kg

Milk

Porcine,chicken

100μg

/kg

Muscle

100μg

/kg

Skin+fat

600μg

/kg

Liver

250

0μg

/kg

Kidney

▼M76

Neomycin

(including

fram

ycetin)

Neomycin

BBovine,

porcine,

chicken

500μg

/kg

Muscle

Provision

alMRLsexpire

on1.6.20

02

500μg

/kg

Fat

500μg

/kg

Liver

500

0μg

/kg

Kidney

Bov

ine

500μg

/kg

Milk

Chicken

500μg

/kg

Egg

s

▼M58

Spectinom

ycin

Spectinom

ycin

Bov

ine

200μg

/kg

Milk

Provision

alMRLsexpire

on1

July

2000

Bov

ine,

porcine,

poultry

300μg

/kg

Muscle

500μg

/kg

Fat

200

0μg

/kg

Liver

500

0μg

/kg

Kidney

▼M65

1990R2377— EN— 16.08.2008 — 058.002 — 108

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M71

Ovine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

300μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

02

500μg

/kg

Fat

200

0μg

/kg

Liver

500

0μg

/kg

Kidney

Chicken

200μg

/kg

Egg

s

▼M76

Streptomycin

Streptomycin

Bov

ine,

ovine

500μg

/kg

Muscle

Provision

alMRLsexpire

on1.6.20

02

500μg

/kg

Fat

500μg

/kg

Liver

100

0μg

/kg

Kidney

200μg

/kg

Milk

Porcine

500μg

/kg

Muscle

500μg

/kg

Skinandfat

500μg

/kg

Liver

100

0μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 109

1.2.6.

Quino

lones

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M60

Danofloxacin

Danofloxacin

Porcine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

00

50μg

/kg

Skinandfat

200μg

/kg

Liver

200μg

/kg

Kidney

▼M58

Decoq

uinate

Decoq

uinate

Bov

ine,

ovine

500μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2000

500μg

/kg

Fat

500μg

/kg

Liver

500μg

/kg

Kidney

▼M62

Difloxacin

Difloxacin

Bov

ine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

400μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

100μg

/kg

Fat

140

0μg

/kg

Liver

800μg

/kg

Kidney

Porcine

400μg

/kg

Muscle

100μg

/kg

Skinandfat

800μg

/kg

Liver

800μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 110

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Enrofloxacin

Sum

ofenroflox

acin

andciprofloxacin

Ovine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

1999

100μg

/kg

Fat

300μg

/kg

Liver

200μg

/kg

Kidney

Flumequine

Flumequine

Bov

ine,

ovine,

porcine,

chicken

50μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

50μg

/kg

Fat

orskin

andfat

100μg

/kg

Liver

300μg

/kg

Kidney

Salmonidae

150μg

/kg

Muscleandskin

Marbo

flox

acin

Marbo

flox

acin

Bov

ine

150μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2000

50μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M62

1990R2377— EN — 16.08.2008 — 058.002— 111

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

75μg

/kg

Milk

Porcine

150μg

/kg

Muscle

50μg

/kg

Skinandfat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M111

Oxo

linic

acid

(1)

Oxo

linic

acid

Bov

ine(2)

100μg

/kg

Muscle

50μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M59

Porcine

100μg

/kg

Muscle

50μg

/kg

Skin+fat

150μg

/kg

Liver

150μg

/kg

Kidney

Chicken

100μg

/kg

Muscle

50μg

/kg

Skin+fat

150μg

/kg

Liver

150μg

/kg

Kidney

50μg

/kg

Egg

s

Fin

fish

300μg

/kg

Muscle

and

skin

innaturalproportio

ns

▼M111

(1)Provision

alMRLsexpire

1Janu

ary20

06.

(2)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 112

1.2.9.

Polym

yxins

Phamarcologicallyactiv

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Colistin

Colistin

Bov

ine,

ovine

50μg

/kg

Milk

►M77

Provision

alMRLsexpire

on1.7.20

02◄

Bov

ine,

ovine,

porcine,

chicken,

rabb

its15

0μg

/kg

Muscle

150μg

/kg

Fat

150μg

/kg

Liver

200μg

/kg

Kidney

Chicken

300μg

/kg

Egg

s

1.2.10.Penicillins

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M59

Nafcillin

Nafcillin

Bov

ine

300μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

30μg

/kg

Milk

▼M58

Penethamate

Benzylpenicillin

Ovine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

4μg

/kg

Milk

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 113

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Porcine

50μg

/kg

Muscle

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

1.2.11

.Florfenicol

andrelatedcompo

unds

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Florfenicol

Sum

offlorfenicoland

itsmetabolites

measured

asflor-

fenicol-am

ine

Fish

100

0μg

/kg

Muscle

and

skin

innaturalproportio

nsProvision

alMRLsexpire

on1

July

2001

▼M59

Thiam

phenicol

Thiam

phenicol

Ovine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

50μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

Porcine

50μg

/kg

Muscle

50μg

/kg

Skin+fat

50μg

/kg

Liver

50μg

/kg

Kidney

Fin

fish

50μg

/kg

Muscle

and

skin

innaturalproportio

ns

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 114

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M121

Thiam

phenicol

(1)

Thiam

phenicol

Porcine

50μg

/kg

Muscle

50μg

/kg

Skin+fat

50μg

/kg

Liver

50μg

/kg

Kidney

(1)Provision

alMRLsexpire

on1Janu

ary20

07.

▼M60

1.2.12

.Polyp

eptid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Bacitracin

Bacitracin

Bov

ine

150μg

/kg

Milk

Provision

alMRLsexpire

on1.7.20

01

▼M59

1.2.13

.Lincosamides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Lincomycin

Lincomycin

Ovine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

50μg

/kg

Fat

500μg

/kg

Liver

150

0μg

/kg

Kidney

150μg

/kg

Milk

Porcine

100μg

/kg

Muscle

50μg

/kg

Skin+fat

500μg

/kg

Liver

150

0μg

/kg

Kidney

▼M59

1990R2377— EN— 16.08.2008 — 058.002— 115

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chicken

100μg

/kg

Muscle

50μg

/kg

Skin+fat

500μg

/kg

Liver

150

0μg

/kg

Kidney

50μg

/kg

Egg

s

▼M60

Pirlim

ycin

Pirlim

ycin

Bov

ine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

00

100μg

/kg

Fat

100

0μg

/kg

Liver

400μg

/kg

Kidney

100μg

/kg

Milk

▼M59

1990R2377— EN— 16.08.2008 — 058.002— 116

1.2.14.Pleurom

utilines

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Tiamulin

Sum

ofmetabolitesthat

may

behy

drolysed

to8-a-hy

drox

ymutilin

Turkey

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01

100μg

/kg

Skinandfat

300μg

/kg

Liver

▼M58

2.Antiparasiticagents

2.1.

Agentsactin

gagainstendo

parasites

▼M62

2.1.1.

Pheno

lderivativ

esinclud

ingsalicylanides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Oxy

clozanide

Oxy

clozanide

Bov

ine

20μg

/kg

Muscle

►M77

Provision

alMRLsexpire

on1.7.20

02◄

20μg

/kg

Fat

500μg

/kg

Liver

100μg

/kg

Kidney

10μg

/kg

Milk

Ovine

20μg

/kg

Muscle

20μg

/kg

Fat

500μg

/kg

Liver

100μg

/kg

Kidney

▼M71

1990R2377— EN— 16.08.2008 — 058.002— 117

2.1.2.

Benzimidazoles

andpro-benzim

idazoles

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Albendazole

sulpho

xide

Sum

ofalbend

azole,

albend

azole

sulpho

xide,

alben-

dazole

sulpho

ne,

and

albend

azole

2-am

ino

sulpho

ne,expressed

asalbend

azole

Bov

ine,

ovine

100μg

/kg

Milk

Provision

alMRLsexpire

on1Janu

ary

2000

Bov

ine,

ovine,

pheasant

100μg

/kg

Muscle

100μg

/kg

Fat

100

0μg

/kg

Liver

500μg

/kg

Kidney

▼M71

Mebendazole

Sum

ofmebendazole

methy

l(5-(1-hidrox

y,1-ph

enyl)

methy

l-1H

-benzim

idazol-2-yl)

carbam

ate

and

(2-

amino-1H

-benzi-

midazol-5-yl)

phenyl-

methano

ne,

expressed

asmebendazole

equivalents

Ovine,caprine,

equidae

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

60μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

02

60μg

/kg

Fat

400μg

/kg

Liver

60μg

/kg

Kidney

▼M58

Netob

imin

Sum

ofnetobimin

and

albend

azole

and

meta-

bolites

ofalbendazole

measured

as2-am

ino-

benzim

idazole

sulpho

ne

Bov

ine,

ovine,

caprine

100μg

/kg

Muscle

Provision

alMRLsexpire

on31

July

1999

100μg

/kg

Fat

100

0μg

/kg

Liver

500μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 118

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

100μg

/kg

Milk

▼M62

2.1.3.

Tetrahydropyrim

ides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Morantel

Sum

ofresidu

eswhich

may

behy

drolysed

toN-M

ethy

l-1,3-prop

ane-

diam

ineand

expressed

asmorantelequivalents

Bov

ine,

ovine

100μg

/kg

Muscle

►M85

Provision

alMRLsexpire

on1.7.20

03◄

100μg

/kg

Fat

800μg

/kg

Liver

200μg

/kg

Kidney

100μg

/kg

Milk

Porcine

100μg

/kg

Muscle

100μg

/kg

Skinandfat

800μg

/kg

Liver

200μg

/kg

Kidney

▼M70

2.1.5.

Piperazinederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Piperazine

Piperazine

Porcine

400μg

/kg

Muscle

►M86

Provision

alMRLsexpire

on1.7.20

03◄

800μg

/kg

Skinandfat

200

0μg

/kg

Liver

100

0μg

/kg

Kidney

Chicken

200

0μg

/kg

Egg

s

▼M58

1990R2377— EN— 16.08.2008 — 058.002— 119

2.1.6.

Salicylanilides

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Rafox

anide

Rafox

anide

Bov

ine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

30μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01

30μg

/kg

Fat

10μg

/kg

Liver

40μg

/kg

Kidney

Ovine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

100μg

/kg

Muscle

250μg

/kg

Fat

150μg

/kg

Liver

150μg

/kg

Kidney

▼M58

2.2.

Agentsactin

gagainstectoparasites

2.2.1.

Formam

idines

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Amitraz

Sum

ofam

itraz

andall

metabolites

containing

the

2,4-DMA

moeity

,expressedas

amitraz

Bees

200μg

/kg

Hon

eyProvision

alMRLsexpire

on1

July

1999

2.2.2.

Iminophenylthiazolid

inederivativ

e

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Cym

iazole

Cym

iazole

Bees

100

0μg

/kg

Hon

ey►M65

Provision

alMRLsexpire

on1.7.20

01◄

▼M71

1990R2377— EN— 16.08.2008 — 058.002 — 120

2.2.3.

Pyretrinandpyrethroids

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Cyfluthrin

Cyfluthrin

Bov

ine

10μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2001

50μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

20μg

/kg

Milk

Further

provisions

inCou

ncilDirectiv

e94

/29/

EC

are

tobe

observed

(OJ

L18

9,23

.7.199

4,p.

67)

▼M61

Alphacyperm

ethrin

Cyp

ermethrin

(sum

ofisom

ers)

Bov

ine,

ovine

20μg

/kg

Muscle

►M95

Provision

alMRLsexpire

on1.7.20

03Further

prov

isions

inDirectiv

e93

/57/

EC

areto

beob

served

◄20

0μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

20μg

/kg

Milk

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 121

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chicken

50μg

/kg

Muscle

50μg

/kg

Skin+fat

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Egg

s

▼M95

Cyp

ermethrin

Cyp

ermethrin

(sum

ofisom

ers)

Bov

ine

20μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

03Further

prov

isions

inDirectiv

e93

/57/

EC

areto

beob

served

200μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

20μg

/kg

Milk

Cyp

ermethrin

(sum

ofisom

ers)

Ovine

20μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

03Not

foruse

inanim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

200μg

/kg

Fat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M61

Porcine

20μg

/kg

Muscle

200μg

/kg

Skin+fat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M61

1990R2377— EN— 16.08.2008 — 058.002 — 122

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chicken

50μg

/kg

Muscle

50μg

/kg

Skin+fat

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Egg

s

Salmonidae

50μg

/kg

Muscle

and

skin

innaturalproportio

ns►M93

Provision

alMRLsexpire

on1.7.20

03◄

▼M66

Deltamethrin

Deltamethrin

Bov

ine

10μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2001

50μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

20μg

/kg

Milk

Ovine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

10μg

/kg

Muscle

50μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

▼M61

1990R2377— EN— 16.08.2008 — 058.002 — 123

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Chicken

10μg

/kg

Muscle

►M89

Provision

alMRLsexpire

on1.7.20

03◄

50μg

/kg

Skin+fat

10μg

/kg

Liver

10μg

/kg

Kidney

50μg

/kg

Egg

s

▼M76

Fin

fish

10μg

/kg

Muscle

and

skin

innaturalproportio

nsProvision

alMRLsexpire

on1.1.20

02

▼M115

Fenvalerate(1)

Fenvalerate

(sum

ofRR,SS,RS

and

SR

isom

ers)

Bov

ine

25μg

/kg

Muscle

250μg

/kg

Fat

25μg

/kg

Liver

25μg

/kg

Kidney

40μg

/kg

Milk

▼M83

Permethrin

Permethrin

(sum

ofisom

ers)

Chicken,po

rcine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

03

500μg

/kg

Skinandfat

50μg

/kg

Liver

50μg

/kg

Kidney

▼M66

1990R2377— EN— 16.08.2008 — 058.002 — 124

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Bov

ine,

caprine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

03

500μg

/kg

Fat

50μg

/kg

Liver

50μg

/kg

Kidney

50μg

/kg

Milk

Further

prov

isions

inCom

mission

Directiv

e98

/82/EC

are

tobe

observed

(OJ

L29

0,29

.10.19

98,

p.25

)

Chicken

50μg

/kg

Egg

sProvision

alMRLsexpire

on1.1.20

03

▼M115

(1)Provision

alMRLsexpire

on1July

2006

.

▼M58

2.2.4.

Organophosphates

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Azamethiphos

Azamethiphos

Salmonidae

100μg

/kg

Muscle

and

skin

innaturalproportio

nsProvision

alMRLsexpire

on1

June

1999

▼M83

1990R2377— EN— 16.08.2008 — 058.002 — 125

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M65

Cou

mafos

Cou

mafos

Bees

100μg

/kg

Hon

eyProvision

alMRLsexpire

on1.7.20

01

▼M68

Pho

xim

Pho

xim

Porcine

20μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2001

700μg

/kg

Skinandfat

20μg

/kg

Liver

20μg

/kg

Kidney

▼M78

Ovine

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01;

notforuse

inanim

als

from

which

milk

isprod

uced

for

human

consum

ption

400μg

/kg

Fat

50μg

/kg

Kidney

▼M108

Chicken

50μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

05.

550μg

/kg

Skinandfat

25μg

/kg

Liver

50μg

/kg

Kidney

60μg

/kg

Egg

s

▼M71

Propetamph

osSum

ofresidu

esof

prop

etam

phos

anddesi-

soprop

yl-propetamph

os

Ovine

Not

forusein

anim

als

from

which

milk

isprod

uced

for

human

consum

ption

90μg

/kg

Fat

Provision

alMRLsexpire

on1.1.20

01

90μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 126

2.2.5.

Acylurea

derivates

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Teflubenzuron

Teflubenzuron

Salmonidae

500μg

/kg

Muscle

and

skin

innaturalproportio

nsProvision

alMRLsexpire

on1

July

1999

▼M62

Diflubenzuron

Diflubenzuron

Salmonidae

1000μg

/kg

Muscle

and

skin

innaturalproportio

nsProvision

alMRLsexpire

on1.7.20

00

▼M123

Fluazuron

(1)

Fluazuron

Bov

ine(2)

200μg

/kg

Muscle

700

0μg

/kg

Fat

500μg

/kg

Liver

500μg

/kg

Kidney

(1)Provision

alMRLsexpire

on1.1.20

07.

(2)Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M69

2.2.6.

Pyrim

idines

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Dicyclanil

Sum

ofdicyclanil

and

2,4,6-triamino-py

ri-

midine-5-carbon

itrile

Ovine

200μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2000

;Not

foruse

inanim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

50μg

/kg

Fat

400μg

/kg

Liver

400μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 127

2.2.7.

Triazinederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Cyrom

azine

Cyrom

azine

Ovine

300μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01Not

foruse

inanim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

300μg

/kg

Fat

300μg

/kg

Liver

300μg

/kg

Kidney

▼M58

2.3.

Agentsactin

gagainstendo

-andectoparasites

2.3.1.

Averm

ectin

s

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M71

Abamectin

Averm

ectin

B1a

Ovine

20μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

50μg

/kg

Fat

25μg

/kg

Liver

20μg

/kg

Kidney

Doram

ectin

Doram

ectin

Deer,

inclusing

reindeer

20μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01

100μg

/kg

Fat

50μg

/kg

Liver

30μg

/kg

Kidney

▼M70

1990R2377— EN— 16.08.2008 — 058.002 — 128

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M58

Mox

idectin

Mox

idectin

Equ

idae

50μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

500μg

/kg

Fat

100μg

/kg

Liver

50μg

/kg

Kidney

▼M60

2.4.

Agentsactin

gagainstprotozoa

2.4.1.

Carbanilid

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Imidocarb

Imidocarb

Bov

ine,

ovine

300μg

/kg

Muscle

ProvisonalMRLsexpire

on1.1.20

02

50μg

/kg

Fat

200

0μg

/kg

Liver

150

0μg

/kg

Kidney

50μg

/kg

Milk

▼M62

2.4.2.

Quinazolone

derivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Halofug

inon

eHalofug

inon

eBov

ine

10μg

/kg

Muscle

Provision

alMRL'sexpire

on1.1.20

01

25μg

/kg

Fat

30μg

/kg

Liver

▼M71

1990R2377— EN— 16.08.2008 — 058.002 — 129

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

30μg

/kg

Kidney

▼M70

2.4.3.

Triazinetrionederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Toltrazuril

Toltrazurilsulfon

ePorcine

100μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

01

150μg

/kg

Skinandfat

500μg

/kg

Liver

250μg

/kg

Kidney

▼M116

Toltrazuril(1)

Toltrazurilsulfon

eBov

ine

100μg

/kg

Muscle

150μg

/kg

Fat

500μg

/kg

Liver

250μg

/kg

Kidney

(1)Provision

alMRLsexpire

on1July

2006

.Not

forusein

anim

alsfrom

which

milk

isprod

uced

forhu

man

consum

ption.

▼M75

2.4.4.

Other

anti-protozoalagents

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRL

Targettissues

Other

prov

isions

Amprolium

Amprolium

Chicken,turkey

200μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

02

200μg

/kg

Skinandfat

200μg

/kg

Liver

400μg

/kg

Kidney

100

0μg

/kg

Egg

s

▼M62

1990R2377— EN— 16.08.2008 — 058.002 — 130

2.4.5.

Ionoph

ores

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Lasalocid

Lasalocid

APou

ltry

150μg

/kg

Egg

s(1)

(1)Provision

alMRLsexpire

on1Janu

ary20

08.

▼M58

3.Agentsactin

gon

thenervou

ssystem

3.2.

Agentsactin

gon

theautono

mic

nervou

ssystem

3.2.1.

β2sympathom

imetic

agents

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Clenb

uterol

hydrochloride

Clenb

uterol

Bov

ine

0,1μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2000

Indicatio

n:solely

for

tocolysis

inparturient

cows

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

0,05

μg/kg

Milk

Equ

idae

0,1μg

/kg

Muscle

Indicatio

ns:

tocolysis

and

the

treatm

ent

ofrespiratoryailm

ents

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

▼M127

1990R2377— EN— 16.08.2008 — 058.002 — 131

3.2.2.

Anti-adrenergics

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Carazolol

Carazolol

Bov

ine

5μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

00

5μg

/kg

Fat

15μg

/kg

Liver

15μg

/kg

Kidney

1μg

/kg

Milk

▼M58

5.Anti-inflam

matoryagents

5.1.

Nonsteroidalanti-inflam

matoryagents

5.1.1.

Arylpropionic

acid

derivativ

e

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Carprofen

Carprofen

Bov

ine

500μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

500μg

/kg

Fat

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

Equ

idae

50μg

/kg

Muscle

100μg

/kg

Fat

100

0μg

/kg

Liver

100

0μg

/kg

Kidney

▼M60

1990R2377— EN— 16.08.2008 — 058.002 — 132

5.1.2.

Eno

licacid

derivates

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Melox

icam

Melox

icam

Bov

ine

25μg

/kg

Muscle

Provision

alMRLsexpire

on1Janu

ary

2000

60μg

/kg

Liver

35μg

/kg

Kidney

▼M71

5.1.3.

Pyrazolon

ederivativ

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

▼M85

Metam

izole

4-Methy

laminoan-

tipyrin

Bov

ine,

porcine,

equidae

200μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

03.

Not

foruse

inanim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

200μg

/kg

Fat

200μg

/kg

Liver

200μg

/kg

Kidney

▼M130

5.1.4.

Sulfonatedph

enyl

lacton

es

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Firocox

ibFirocox

ibEqu

idae

10μg

/kg

Muscle

Provision

alMRLsexpire

on1

July

2007

15μg

/kg

Fat

60μg

/kg

Liver

10μg

/kg

Kidney

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 133

6.Agentsactin

gon

thereprod

uctiv

esystem

6.1.

Progestog

ens

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Altrenog

est

Altrenog

est

Porcine

3μg

/kg

►M97

Skinandfat◄

►M97

Provision

alMRLsexpire

on1.1.20

05;forzootechn

ical

useon

ly◄

3μg

/kg

Liver

3μg

/kg

Kidney

Equ

idae

3μg

/kg

Fat

3μg

/kg

Liver

3μg

/kg

Kidney

▼M102

Flugeston

eacetate

Flugeston

eacetate

Ovine,caprine

0,5μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

08;

for

therapeutic

orzootechn

ical

use

only

0,5μg

/kg

Fat

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

Norgestom

etNorgestom

etBov

ine

0,5μg

/kg

Muscle

Provision

alMRLsexpire

on1.1.20

08;

for

therapeutic

orzootechn

ical

use

only

0,5μg

/kg

Fat

0,5μg

/kg

Liver

0,5μg

/kg

Kidney

0,15

μg/kg

Milk

▼M74

7.Corticoids

7.1.

Glucocorticoids

Pharm

acolog

ically

activ

esubstance(s)

Markerresidu

eAnimal

species

MRLs

Targettissues

Other

prov

isions

Methy

lpredn

isolon

eMethy

lpredn

isolon

eBov

ine

10μg

/kg

Muscle

Provision

alMRLsexpire

on1.7.20

01.

Not

foruse

inanim

alsfrom

which

milk

isprod

uced

for

human

consum

ption

10μg

/kg

Fat

10μg

/kg

Liver

10μg

/kg

Kidney

▼M92

ANNEX IV

LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FORWHICH 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

▼M58

1990R2377— EN— 16.08.2008 — 058.002 — 134

ANNEX V

Information and particulars to be included in an application for theestablishment of a maximum residue limit for a pharmacologically active

substance used in veterinary medicinal products

Administrative particulars

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

2 Name of the veterinary medicinal product.

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

4 Manufacturing authorization, if any.

5 Marketing authorization, if any.

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

A. Safety documentation

A.0. Expert report

A.1. Precise identification of the substance concerned by the application

1.1 International non-proprietary name (INN).

1.2 International Union of Pure and Applied Chemistry (IUPAC)name.

1.3 Chemical Abstract Service (CAS) name.

1.4 Classification:

— therapeutic;

— pharmacological.

1.5 Synonyms and abbreviations.

1.6 Structural formula.

1.7 Molecular formula.

1.8 Molecular weight.

1.9 Degree of impurity.

1.10 Qualitative and quantitative composition of impurities.

1.11 Description of physical properties:

— melting point;

— boiling point;

— vapour pressure;

— solubility in water and organic solvents, expressed in gramsper litre, with indication of temperature;

— density;

— refractive index, rotation, etc.

A.2. Relevant pharmacological studies

2.1 Pharmacodynamics.

2.2 Pharmacokinetics.

A.3. Toxicological studies

3.1 Single dose toxicity.

3.2 Repeated dose toxicity.

3.3 Tolerance in the target species of animal.

3.4 Reproductive toxicity, including teratogenicity.

▼M2

1990R2377— EN— 16.08.2008 — 058.002 — 135

3.4.1 Study of the effects on reproduction.

3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.

3.5 Mutagenicity.

3.6 Carcinogenicity.

A.4. Studies of other effects

4.1 Immunotoxicity.

4.2 Microbiological properties of residues.

4.2.1 On the human gut flora;

4.2.2 On the organisms and microorganisms used for industrial food-processing.

4.3 Observations in humans.

B. Residue documentation

B.0 Expert report

B.1. Precise identification of the substance concerned by the application

The substance concerned should be identified in accordance with pointA.1. However, where the application relates to one or more veterinarymedicinal 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

2.1 Pharmacokinetics

(absorption, distribution, biotransformation, excretion).

2.2 Depletion of residues.

2.3 Elaboration of maximum residue limits (MRLS).

B3. Routine analytical method for the detection of residues

3.1 Description of the method.

3.2 Validation of the method.

3.2.1 specificity;

3.2.2 accuracy, including sensitivity;

3.2.3 precision;

3.2.4 limit of detection;

3.2.5 limit of quantitation;

3.2.6 practicability and applicability under normal laboratoryconditions;

3.2.7 susceptibility to interference.

▼M2

1990R2377— EN— 16.08.2008 — 058.002 — 136

Documents

B COUNCIL REGULATION (EEC) No 2377/90 of 26 June 1990