1990R2377 — EN — 18.06.2001 — 021.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILREGULATION(EEC)No2377/90
of26June1990
laying down a Community procedure for the establishment of maximum residue limits of veter-
inarymedicinalproductsinfoodstuffsofanimalorigin
(OJ L 224, 18.8.1990, p. 1)
Amended by:
Official Journal
No page date
►M1CommissionRegulation(EEC) No 675/92 of 18 March 1992 L 73 8 19.3.1992
►M2CommissionRegulation(EEC) No 762/92 of 27 March 1992 L 83 14 28.3.1992
►M3CommissionRegulation(EEC) No 3093/92 of 27 October 1992 L 311 18 28.10.1992
►M4CommissionRegulation(EEC) No 895/93 of 16 April 1993 L 93 10 17.4.1993
►M5Council Regulation (EEC) No 2901/93 of 18 October 1993 L 264 1 23.10.1993
►M6CommissionRegulation(EC) No 3425/93 of 14 December 1993 L 312 12 15.12.1993
►M7CommissionRegulation(EC) No 3426/93 of 14 December 1993 L 312 15 15.12.1993
►M8CommissionRegulation(EC) No 955/94 of 28 April 1994 L 108 8 29.4.1994
►M9CommissionRegulation(EC) No 1430/94 of 22 Jun e 1994 L 156 6 23.6.1994
►M10CommissionRegulation(EC) No 2701/94 of 7 November 1994 L 287 7 8.11.1994
►M11CommissionRegulation(EC) No 2703/94 of 7 November 1994 L 287 19 8.11.1994
►M12CommissionRegulation(EC) No 3059/94 of 15 December 1994 L 323 15 16.12.1994
►M13CommissionRegulation(EC) No 1102/95 of 16 May 1995 L 110 9 17.5.1995
►M14CommissionRegulation(EC) No 1441/95 of 26 Jun e 1995 L 143 22 27.6.1995
►M15CommissionRegulation(EC) No 1442/95 of 26 Jun e 1995 L 143 26 27.6.1995
►M16CommissionRegulation(EC) No 1798/95 of 25 July 1995 L 174 20 26.7.1995
►M17CommissionRegulation(EC) No 2796/95 of 4 December 1995 L 290 1 5.12.1995
►M18CommissionRegulation(EC) No 2804/95 of 5 December 1995 L 291 8 6.12.1995
►M19CommissionRegulation(EC) No 281/96 of 14 February 1996 L 37 9 15.2.1996
►M20CommissionRegulation(EC) No 282/96 of 14 February 1996 L 37 12 15.2.1996
►M21CommissionRegulation(EC) No 1140/96 of 25 Jun e 1996 L 151 6 26.6.1996
►M22CommissionRegulation(EC) No 1147/96 of 25 Jun e 1996 L 151 26 26.6.1996
►M23CommissionRegulation(EC) No 1311/96 of 8 July 1996 L 170 4 9.7.1996
►M24CommissionRegulation(EC) No 1312/96 of 8 July 1996 L 170 8 9.7.1996
►M25CommissionRegulation(EC) No 1433/96 of 23 July 1996 L 184 21 24.7.1996
►M26CommissionRegulation(EC) No 1742/96 of 6 September 1996 L 226 5 7.9.1996
►M27CommissionRegulation(EC) No 1798/96 of 17 September 1996 L 236 23 18.9.1996
►M28CommissionRegulation(EC) No 2010/96 of 21 October 1996 L 269 5 22.10.1996
►M29CommissionRegulation(EC) No 2017/96 of 22 October 1996 L 270 2 23.10.1996
►M30CommissionRegulation(EC) No 2034/96 of 24 October 1996 L 272 2 25.10.1996
1990R2377 — EN — 18.06.2001 — 021.001 — 2
►M31CommissionRegulation(EC) No 17/97 of 8 Jan uary 1997 L 5 12 9.1.1997
►M32CommissionRegulation(EC) No 211/97 of 4 February 1997 L 35 1 5.2.1997
►M33CommissionRegulation(EC) No 270/97 of 14 February 1997 L 45 8 15.2.1997
►M34Council Regulation (EC) No 434/97 of 3 March 1997 L 67 1 7.3.1997
►M35CommissionRegulation(EC) No 716/97 of 23 April 1997 L 106 10 24.4.1997
►M36CommissionRegulation(EC) No 748/97 of 25 April 1997 L 110 21 26.4.1997
►M37CommissionRegulation(EC) No 749/97 of 25 April 1997 L 110 24 26.4.1997
►M38CommissionRegulation(EC) No 1836/97 of 24 September 1997 L 263 6 25.9.1997
►M39CommissionRegulation(EC) No 1837/97 of 24 September 1997 L 263 9 25.9.1997
►M40CommissionRegulation(EC) No 1838/97 of 24 September 1997 L 263 14 25.9.1997
►M41CommissionRegulation(EC) No 1850/97 of 25 September 1997 L 264 12 26.9.1997
►M42CommissionRegulation(EC) No 121/98 of 16 Jan uary 1998 L 11 11 17.1.1998
►M43CommissionRegulation(EC) No 426/98 of 23 February 1998 L 53 3 24.2.1998
►M44CommissionRegulation(EC) No 613/98 of 18 March 1998 L 82 14 19.3.1998
►M45CommissionRegulation(EC) No 1000/98 of 13 May 1998 L 142 18 14.5.1998
►M46CommissionRegulation(EC) No 1076/98 of 27 May 1998 L 154 14 28.5.1998
►M47CommissionRegulation(EC) No 1191/98 of 9 Jun e 1998 L 165 6 10.6.1998
►M48CommissionRegulation(EC) No 1568/98 of 17 July 1998 L 205 1 22.7.1998
►M49CommissionRegulation(EC) No 1569/98 of 17 July 1998 L 205 7 22.7.1998
►M50CommissionRegulation(EC) No 1570/98 of 17 July 1998 L 205 10 22.7.1998
►M51CommissionRegulation(EC) No 1916/98 of 9 September 1998 L 250 8 10.9.1998
►M52CommissionRegulation(EC) No 1917/98 of 9 September 1998 L 250 13 10.9.1998
►M53CommissionRegulation(EC) No 1958/98 of 15 September 1998 L 254 7 16.9.1998
►M54CommissionRegulation(EC) No 2560/98 of 27 November 1998 L 320 28 28.11.1998
►M55CommissionRegulation(EC) No 2686/98 of 11 December 1998 L 337 20 12.12.1998
►M56CommissionRegulation(EC) No 2692/98 of 14 December 1998 L 338 5 15.12.1998
►M57CommissionRegulation(EC) No 2728/98 of 17 December 1998 L 343 8 18.12.1998
►M58CommissionRegulation(EC) No 508/1999 of 4 March 1999 L 60 16 9.3.1999
►M59CommissionRegulation(EC) No 804/1999 of 16 April 1999 L 102 58 17.4.1999
►M60CommissionRegulation(EC) No 953/1999 of 5 May 1999 L 118 23 6.5.1999
►M61CommissionRegulation(EC) No 954/1999 of 5 May 1999 L 118 28 6.5.1999
►M62CommissionRegulation(EC) No 997/1999 of 11 May 1999 L 122 24 12.5.1999
►M63CommissionRegulation(EC) No 998/1999 of 11 May 1999 L 122 30 12.5.1999
►M64Council Regulation (EC) No 1308/1999 of 15 June 1999 L 156 1 23.6.1999
►M65CommissionRegulation(EC) No 1931/1999 of 9 September 1999 L 240 3 10.9.1999
►M66CommissionRegulation(EC) No 1942/1999 of 10 September 1999 L 241 4 11.9.1999
►M67CommissionRegulation(EC) No 1943/1999 of 10 September 1999 L 241 9 11.9.1999
►M68CommissionRegulation(EC) No 2385/1999 of 10 November 1999 L 288 14 11.11.1999
►M69CommissionRegulation(EC) No 2393/1999 of 11 November 1999 L 290 5 12.11.1999
►M70CommissionRegulation(EC) No 2593/1999 of 8 December 1999 L 315 26 9.12.1999
►M71CommissionRegulation(EC) No 2728/1999 of 20 December 1999 L 328 23 22.12.1999
►M72CommissionRegulation(EC) No 2757/1999 of 22 December 1999 L 331 45 23.12.1999
►M73CommissionRegulation(EC) No 2758/1999 of 22 December 1999 L 331 49 23.12.1999
►M74CommissionRegulation(EC) No 1286/2000 of 19 Jun e 2000 L 145 15 20.6.2000
1990R2377 — EN — 18.06.2001 — 021.001 — 3
►M75CommissionRegulation(EC) No 1295/2000 of 20 Jun e 2000 L 146 11 21.6.2000
►M76CommissionRegulation(EC) No 1960/2000 of 15 September 2000 L 234 5 16.9.2000
►M77CommissionRegulation(EC) No 2338/2000 of 20 October 2000 L 269 21 21.10.2000
►M78CommissionRegulation(EC) No 2391/2000 of 27 October 2000 L 276 5 28.10.2000
►M79CommissionRegulation(EC) No 2535/2000 of 17 November 2000 L 291 9 18.11.2000
►M80CommissionRegulation(EC) No 2908/2000 of 29 December 2000 L 336 72 30.12.2000
►M81CommissionRegulation(EC) No 749/2001 of 18 April 2001 L 109 32 19.4.2001
►M82CommissionRegulation(EC) No 750/2001 of 18 April 2001 L 109 35 19.4.2001
Corrected by:
►C1Corrigendum, OJ L 222, 20.9.1995, p. 17 (1442/95)
►C2Corrigendum, OJ L 316, 5.12.1996, p. 37 (1442/95)
►C3Corrigendum, OJ L 76, 18.3.1997, p. 34 (1442/95)
►C4Corrigendum, OJ L 271, 8.10.1998, p. 42 (1568/98)
►C5Corrigendum, OJ L 9, 13.1.2000, p. 30 (1308/1999)
▼B
COUNCILREGULATION(EEC)No2377/90
of26June1990
laying down a Community procedure for the establishment of
maximum residue limits of veterinary medicinal products in food-
stuffsofanimalorigin
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (
1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas the use of veterinary medicinal products in food-producing
animals may result in the presence of residues of foodstuffs obtained
from treated animals;
Whereas as a result of scientific and technical progress it is possible to
detect the presence of residues of veterinary medicines in foodstuffs atever lower levels; whereas it is therefore necessary to establishmaximum residue limits for pharmacologically active substances which
are used in veterinary medicinal products in respect of all the various
foodstuffs of animal origin, including meat, fish, milk, eggs and honey;
Whereas inorder to protect public health, maximum residue limits
must be established in accordance with generally recognized principlesof safety assessment, taking into account any other scientific assess-
ment of the safety of the substances concerned which may have been
undertaken by international organizations, in particular the CodexAlimentarius or, where such substances are used for other purposes,by other scientific committees established within the Community;
Whereas the use of veterinary medicinal products plays an important
part in agricultural production; whereas the establishment of maximum
residue levels will facilitate the marketing of foodstuffs of animalorigin;
Whereas the establishment of different maximum residue levels by
Member States may hinder the free movement of foodstuffs and of
veterinary medicinal products themselves;
Whereas it is therefore necessary to lay down a procedure for the
establishment of maximum residue levels of veterinary medicinalproducts by the Community, following a single scientific assessmentof the highest possible quality;
Whereas the need for the establishment of maximum residue levels
throughout the Community is recognized in the Community rulesrelating to trade in foodstuffs of animal origin;
Whereas provisions must be adopted with a view to the systematic
establishment of maximum residue levels for new substances capable
of pharmacological action intended for administration to food-produ-cing animals;
Whereas arrangements must also be made for the establishment of
maximum residue levels for substances which are currently used in
veterinary medicines administered to food-producing animals; whereas,
however, in view of the complexity of this matter and the large numberof substances involved, long transitional arrangements are required;
Whereas, after scientific assessment by the Committee for Veterinary
Medicinal Products, maximum residue levels must be adopted by a1990R2377 — EN — 18.06.2001 — 021.001 — 4
(1) OJ No C 61, 10. 3. 1989. p. 5.
(2) OJ No C 96, 17. 4. 1990, p. 273.
(3) OJ No C 201, 17. 8. 1989, p. 1.
▼B
rapid procedure which ensures close cooperation between the Commis-
sion and the Member States through the Committee set up underCouncil Directive 81/852/EEC of 28 September 1981 on the approxi-
mation of the laws of the Member States relating to analytical,
pharmaco-toxicological and clinical standards and protocols in respectof the testing of veterinary medicinal products (
1), as last amended by
Directive 87/20/EEC (2); whereas anurgen t procedure is also required
to ensure the swift review of any tolerance which might prove insuffi-
cient to protect public health;
Whereas medicinally induced immunological responses are usually
indistinguishable from those which arise naturally, and do not affect
consumers of food of animal origin;
Whereas the information necessary to assess the safety of residues
should be presented in accordance with the principles laid down byDirective 81/852/EEC,
HAS ADOPTED THIS REGULATION:
Article 1
1. For the purposes of this Regulation, the following definitions
shall apply:
(a) ‘residues of veterinary medicinal products’: means all pharmacolo-
gically active substances, whether active principles, excipients or
degradationproducts, an d their metabolites which remaininfood-
stuffs obtained from animals to which the veterinary medicinalproduct inquestionhas beenadmin istered;
(b) ‘maximum residue limit’: means the maximum concentration of
residue resulting from the use of a veterinary medicinal product
(expressed inmg/kg or µg/kg ona fresh weight basis) which may
be accepted by the Community to be legally permitted or recog-nized as acceptable in or on a food.
It is based on the type and amount of residue considered to be
without any toxicological hazard for human health as expressed
by the acceptable daily intake (ADI), or on the basis of a temporary
ADI that utilizes an additional safety factor. It also takes intoaccount other relevant public health risks as well as food tech-nology aspects.
When establishing a maximum residue limit (MRL), consideration
is also given to residues that occur in food of plant origin and/or
come from the environment. Furthermore, the MRL may be
reduced to be consistent with good practices in the use of veter-inary drugs and to the extent that practical analytical methods areavailable.
2. This Regulation shall not apply to active principles of biological
origin intended to produce active or passive immunity or to diagnose astate of immunity used in immunological veterinary medicinal
products.
Article 2
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which maximum residue limits havebeen established shall be contained in Annex I, which shall be adopted
inaccordan ce with the procedure laid downinArticle 8. Except as
provided for in Article 9, any amendments to Annex I shall be adoptedinaccordan ce with the same procedure.1990R2377 — EN — 18.06.2001 — 021.001 — 5
(1) OJ No L 317, 6. 11. 1981, p. 16.
(2) OJ No L 15, 17. 1. 1987, p. 34.
▼B
Article 3
Where, following an evaluation of a pharmacologically active
substance used in veterinary medicinal products, it appears that it is
not necessary for the protection of public health to establish amaximum residue limit, that substance shall be included in a list inAnnex II, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, any amend-ments to Annex II shall be adopted in accordance with the same
procedure.
Article 4
A provisional maximum residue limit may be established for a pharma-
cologically active substance used in veterinary medicinal products onthe date of entry into force of this Regulation, provided that there areno grounds for supposing that residues of the substance concerned at
the level proposed present a hazard for the health of the consumer. A
provisional maximum residue limit shall apply for a defined period oftime, which shall not exceed five years. That period may be extendedonce only in exceptional cases for a period not in excess of two years ifthat proves expedient for the completion of scientific studies in
progress.
In exceptional circumstances, a provisional maximum residue limit
may also be established for a pharmacologically active substance notpreviously used in veterinary medicinal products on the date of entryinto force of this Regulation provided that there are no grounds for
supposing that residues of the substance concerned at the limit
proposed present a hazard for the health of the consumer.
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which provisional maximum residuelimits have been established shall be contained in Annex III, whichshall be adopted inaccordan ce with the procedure laid downinArticle
8. Except as provided for in Article 9, any amendments to Annex III
shall be adopted inaccordan ce with the same procedure.
Article 5
Where it appears that a maximum residue limit cannot be established in
respect of a pharmacologically active substance used in veterinary
medicinal products because residues of the substances concerned, at
whatever limit, in foodstuffs of animal origin constitute a hazard tothe health of the consumer, that substance shall be included in a listin Annex IV, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, any amend-ments to Annex IV shall be adopted in accordance with the same
procedure.
The administration of the substances listed in Annex IV to food-produ-
cing animals shall be prohibited throughout the Community.
Article 6
1. In order to obtain the inclusion in Annexes I, II or III of a phar-
macologically active substance which is intended for use in veterinarymedicinal products for administration to food-producing animals, anapplicationto establish a maximum residue limit shall be submitted tothe European Agency for the Evaluation of Medicinal Products set up
by Council Regulation (EEC) No 2309/93 (
1), hereinafter referred to as
‘the Agency’.
This application shall contain the information and particulars referred
to in Annex V of this Regulation and shall conform with the principleslaid downinDirective 81/852/EEC.1990R2377 — EN — 18.06.2001 — 021.001 — 6
(1) OJ L 214, 24.8.1993, p. 1▼M64
▼M64
2. The applicationshall also be accompan ied by the fee payable to
the Agency.
Article 7
1. The Committee for Veterinary Medicinal Products referred to in
Article 27 of Regulation(EC) No 2309/93 (herein after ‘theCommittee’) shall be responsible for formulating the Agency's opinion
on the classification of substances referred to in Annexes I, II, III or IV
to this Regulation.
2. Articles 52 and 53 of Regulation (EEC) No 2309/93 shall be
applicable for the purposes of this Regulation.
3. The Agency shall ensure that the Committee's opinion is deliv-
ered withina period of 120 days followin g the receptionof a validapplication.
If the information submitted by the applicant is not sufficient to enable
such an opinion to be prepared, the Committee may ask the applicantto supply additional information within a specific time limit. The dead-line for the opinion shall then be deferred until the additionalinformation has been received.
4. The Agency shall forward the opinion to the applicant. Within 15
days of receipt of the opinion, the applicant may provide written noticeto the Agency that he wishes to appeal. In that case he shall forwardthe detailed grounds for his appeal to the Agency within 60 days of
receipt of the opinion. Within 60 days of the receipt of the grounds
for appeal, the Committee shall consider whether its opinion shouldbe revised and the reasons for the conclusion reached on the appealshall be annexed to the report referred to in paragraph 5.
5. The Agency shall forward the definitive opinion of the
Committee within30 days of its adoptionboth to the Commissionan dto the applicant. The opinion shall be accompanied by a reportdescribing the safety evaluation of the substance by the Committee,which shall give the grounds for its conclusions.
6. The Commission shall prepare draft measures taking account of
Community legislation and shall start the procedure provided for inArticle 8. The Committee referred to inArticle 8 shall adapt its rulesof procedure in order to take account of the tasks conferred on it bythis Regulation.
Article 8
1. Where the procedure laid downinthis Article is to be followed,
the Chairman shall, without delay, refer the matter to the Standing
Committee on Veterinary Medicinal Products, hereinafter referred toas ‘the Standing Committee’, either on his own initiative or at therequest of a Member State.
2. The representative of the Commission shall submit a draft of the
measures to be adopted to the ►
M64Standing Committee ◄for
Adaptationto Techn ical Progress. The ►M64Standing Committee ◄
shall deliver its opinion on the draft within a time limit set by thechairman, having regard to the urgency of the matter. It shall act by aqualified majority, the votes of the Member States being weighted asprovided for inArticle 148 (2) of the Treaty. The chairmanshall n otvote.
3. (a) The Commissionshall adopt the measures en visaged where they
are in accordance with the opinion of the ►
M64Standing
Committee ◄.
(b) Where the measures envisaged are not in accordance with the
opinion of the ►M64Standing Committee ◄, or if no opinion
is adopted, the Commissionshall without delay propose to the1990R2377 — EN — 18.06.2001 — 021.001 — 7
▼B
▼M64
▼B
▼B
Council the measures to be adopted. The Council shall act by a
qualified majority.
(c) If, after a period of three months of the proposal being referred
to it, the Council has not acted, the proposed measures shall beadopted by the Commission, unless the Council has votedagainst them by a simple majority.
Article 9
1. Where a Member State, as a result of new information or a reas-
sessment of existing information, considers that the urgent amendment
of a provision contained in Annexes I to IV is necessary in order to
protect human or animal health, and therefore requires swift action tobe taken, that Member State may temporarily suspend the operation ofthe provision concerned in its own territory. In that case, it shall imme-diately notify the other Member States and the Commission of themeasures, attaching a statement of the reasons therefor.
2.►
M64The Commissionshall as soonas possible examin e the
grounds given by the Member State concerned and, after consulting
the Committee for Veterinary Medicinal Products, it shall then deliverits opinion forthwith and take appropriate measures; the person respon-sible for marketing may be requested to provide the Committee withoral or written explanations ◄. The Commissionshall immediately
notify the Council and the Member States of any measures taken. Any
Member State may refer the Commission's measures to the Councilwithin 15 days of such notification. The Council, acting by a qualifiedmajority, may take a different decision within 30 days of the date onwhich the matter was referred to it.
3. If the Commission considers that it is necessary to amend the
provision of Annex I to IV concerned in order to resolve the difficul-
ties referred to in paragraph 1 and to ensure the protection of human
health, it shall initiate the procedure laid down in Article 10 with aview to adopting those amendments; the Member State which has takenmeasures under paragraph 1 may maintain them until the Council orthe Commissionhas takena decisioninaccordan ce with the above-
mentioned procedure.
Article 10
1. Where the procedure laid downinthis Article is to be followed,
the chairmanshall, without delay, refer the matter to the
►
M64Standing Committee ◄either onhis ownin itiative or at the
request of a representative of a Member State.
2. The representative of the Commission shall submit to the
►M64Standing Committee ◄a draft of the measures to be adopted.
The►M64Standing Committee ◄shall deliver its opinion on the
draft within a time limit set by the chairman, having regard to the
urgency of the matter. It shall act by a qualified majority, the votes ofthe Member States being weighted as provided for in Article 148 (2) ofthe Treaty. The chairmanshall n ot vote.
3. (a) The Commissionshall adopt the measures en visaged, where
they are in accordance with the opinion of the
►
M64Standing Committee ◄.
(b) Where the measures envisaged are not in accordance with the
opinion of the ►M64Standing Committee ◄, or if no opinion
is adopted, the Commissionshall without delay propose to theCouncil the measures to be adopted. The Council shall act by a
qualified majority.
(c) If within15 days of the proposals bein g submitted to it, the
Council has not acted, the proposed measures shall be adoptedby the Commission.1990R2377 — EN — 18.06.2001 — 021.001 — 8
▼B
Article 11
Any changes which are necessary to adapt Annex V to take account of
scientific and technical progress shall be adopted in accordance withthe procedure laid downinArticle 2c of Directive 81/852/EEC.
Article 12
As soon as possible after the amendment of Annexes I, II, III or IV, the
Commissionshall publish a summary of the assessmen t of the safety of
the substances concerned that have been examined by the Committee
for Veterinary Medicinal Products. The confidential nature of anyproprietary data shall be respected. The Agency shall provide thecompetent authorities and the Commission with appropriate methodsfor identifying pharmacologically active substances for which theMRL's have beendetermin ed in ►
C5Annexes I and III. ◄
Article 13
Member States may not prohibit or impede the putting into circulation
within their territories of foodstuffs of animal origin originating in
other Member States on the grounds that they contain residues of veter-
inary medicinal 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-producing
animals of veterinary medicinal products containing pharmacologicallyactive substances which are not mentioned in Annexes I, II or III shallbe prohibited within the Community, except in the case of clinicaltrials accepted by the competent authorities following notification or
authorization in accordance with the legislation in force and which do
not cause foodstuffs obtained from livestock participating in such trialsto contain residues which constitute a hazard to human health.
However, the date referred to inthe previous subparagraph shall be
deferred for substances the use of which was authorized on the dateof entry into force of this Regulation and in respect of which docu-
mented applications for the establishment of maximum residue limits
have beenlodged with the Commissionor with the EuropeanAgen cyfor the Evaluation of Medicinal Products before 1 January 1996:
— until 1 January 1998 in the case of pyrazolinones (including pyra-
zolidinediones and phenylbutazones), nitroimidazoles and arsalinic
acid, and
— until 1 January 2000 in the case of other substances.
The Agency shall publish a list of these substances before 7 June 1997.
Article 15
This Regulationshall inn o way prejudice the applicationof Commu-
nity legislation prohibiting the use in livestock farming of certain
substances having a hormonal action.
Nothing in this Regulation shall prejudice the measures taken by
Member States to prevent the unauthorized use of veterinary medicinal
products.
Article 16
This Regulation shall enter into force on 1 January 1992.1990R2377 — EN — 18.06.2001 — 021.001 — 9
▼M64
▼B
▼M34
▼M64
▼M34
▼B
▼B
This Regulation shall be binding in its entirety and directly applicable
inall Member States.1990R2377 — EN — 18.06.2001 — 021.001 — 10
ANNEX I
LISTOFPHARMACOLOGICALLYACTIVESUBSTANCESFORWHICHMAXIMUMRESIDUELIMITSHAVEBEENFIXED
1. Anti-infectious agents
1.1. Chemotheurapeutics
1.1.1. Sulfonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
All substances belonging to the
sulfonamide groupParent drug All food-producing
species100 µg/kg Muscle The combined total residues of all substances
within the sulfonamide group should not
exceed 100 µg/kg
100 µg/kg Fat
100 µg/kg Liver
100 µg/kg Kidney
Bovine, ovine, caprine 100 µg/kg Milk
1.1.2. Diamino pyrimidine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Baquiloprim Baquiloprim Bovine 10 µg/kg Fat
300 µg/kg Liver
150 µg/kg Kidney
30 µg/kg Milk
Porcine 40 µg/kg Skin and fat
50 µg/kg Liver
50 µg/kg Kidney
Trimethoprim Trimethoprim Bovine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
50 µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 11
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Porcine 50 µg/kg Muscle
50 µg/kg Skinan d fat
50 µg/kg Liver
50 µg/kg Kidney
Equidae 100 µg/kg Muscle
100 µg/kg Fat
100 µg/kg Liver
100 µg/kg Kidney
Poultry 50 µg/kg Muscle
Not for use inan imals
from which eggs are
produced for human
consumption50 µg/kg Skinan d fat
50 µg/kg Liver
50 µg/kg Kidney
Finfish 50 µg/kg Muscle an d skinin
natural proportions▼M581990R2377 — EN — 18.06.2001 — 021.001 — 12
1.2. Antibiotics
1.2.1. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
AmoxicyllinAmoxicyllin All food-producin g
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
AmpicillinAmpicillin All food-producin g
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
Benzylpenicillin Benzylpenicillin All food-producing
species50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
CloxacillinCloxacillin All food-producin g
species300 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
DicloxacillinDicloxacillin All food-producin g
species300 µg/kg Muscle
300 µg/kg Fat▼M581990R2377 — EN — 18.06.2001 — 021.001 — 13
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
OxacillinOxacillin All food-producin g
species300 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver
300 µg/kg Kidney
30 µg/kg Milk
Penethamate Benzylpenicillin Bovine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
Porcine 50 µg/kg Muscle
50µg/kg Fat
50µg/kg Liver
50µg/kg Kidney
Phenoxymethylpenicillin Phenoxymethylpenicillin Porcine 25 µg/kg Muscle
25µg/kg Liver
25µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 14▼M72
▼M74
1.2.2. Cephalosporins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
CefalexinCefalexin Bovin e 200 µg/kg Muscle
200µg/kg Fat
200µg/kg Liver
1 000 µg/kg Kidney
100µg/kg Milk
Cefazolin Cefazolin Bovine, ovine, caprine 50 µg/kg Milk
Cefquinome Cefquinome Bovine 50 µg/kg Muscle
50 µg/kg Fat
100 µg/kg Liver200 µg/kg Kidney
20 µg/kg Milk
Porcine 50 µg/kg Muscle
50µg/kg Skin+ fat
100µg/kg Liver
200µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 15▼M71
▼M58
▼M65
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Ceftiofur Sum of all residues
retaining the betalactam
structure expressed as
desfuroylceftiofurBovine 1 000 µg/kg Muscle
2 000 µg/kg Fat
2 000 µg/kg Liver
6 000 µg/kg Kidney
100µg/kg Milk, not for intramam-
mary use
Porcine 1 000 µg/kg Muscle
2 000 µg/kg Fat
2 000 µg/kg Liver
6 000 µg/kg Kidney
1.2.3. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Danofloxacin Danofloxacin Bovine 200 µg/kg Muscle
100µg/kg Fat
400µg/kg Liver
400µg/kg Kidney
30µg/kg Milk
Porcine 100 µg/kg Muscle
50µg/kg Skinan d fat
200µg/kg Liver
200µg/kg Kidney
DifloxacinDifloxacin Chicken , turkey 300 µg/kg Muscle
400 µg/kg Skinan d fat
1 900 µg/kg Liver▼M651990R2377 — EN — 18.06.2001 — 021.001 — 16▼M59
▼M58
▼M63
▼M66
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
600 µg/kg Kidney
Bovine 400 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption
100µg/kg Fat
1 400 µg/kg Liver
800µg/kg Kidney
Porcine 400 µg/kg Muscle
100µg/kg Skinan d fat
800µg/kg Liver
800µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinBovine 100 µg/kg Muscle
100 µg/kg Fat
300 µg/kg Liver200 µg/kg Kidney100 µg/kg Milk
Rabbits 100 µg/kg Muscle
100 µg/kg Fat
200 µg/kg Liver300 µg/kg Kidney
Porcine 100 µg/kg Muscle
100 µg/kg Skinan d fat
200 µg/kg Liver300 µg/kg Kidney
Poultry 100 µg/kg Muscle
Not for use inan imals
from which eggs areproduced for humanconsumption100 µg/kg Skinan d fat
200 µg/kg Liver▼M581990R2377 — EN — 18.06.2001 — 021.001 — 17▼M80
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
300 µg/kg Kidney
Ovine 100 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption
100µg/kg Fat
300µg/kg Liver
200µg/kg Kidney
Flumequine Flumequine Bovine, ovine
Not for use inan imals
from which milk isproduced for humanconsumption200µg/kg Muscle
300µg/kg Fat
500µg/kg Liver
1 500 µg/kg Kidney
Porcine 200 µg/kg Muscle
300µg/kg Skinan d fat
500µg/kg Liver
1 500 µg/kg Kidney
Chicken
Not for use inan imals
from which eggs areproduced for humanconsumption400µg/kg Muscle
250µg/kg Skinan d fat
800µg/kg Liver
1 000 µg/kg Kidney
Salmonidae 600 µg/kg Muscle and skin in
natural proportions
Bovine
Turkey50µg/kg Milk
400µg/kg Muscle
250µg/kg Skinan d fat
800µg/kg Liver
1 000 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 18▼M70
▼M71
▼M77
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
MarbofloxacinMarbofloxacin Bovin e 150 µg/kg Muscle
50µg/kg Fat
150µg/kg Liver
150µg/kg Kidney
75µg/kg Milk
Porcine 150 µg/kg Muscle
50µg/kg Skinan d fat
150µg/kg Liver
150µg/kg Kidney
SarafloxacinSarafloxacin Chicken10 µg/kg Skin an d fat
100 µg/kg Liver
Salmonidae 30 µg/kg Muscle and skin in
natural proportions▼M771990R2377 — EN — 18.06.2001 — 021.001 — 19▼M58
1.2.4. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
ErythromycinErythromycin A Chiken200 µg/kg Muscle
200µg/kg Skinan d fat
200µg/kg Liver
200µg/kg Kidney
150µg/kg Eggs
Bovine 200 µg/kg Muscle
200µg/kg Fat
200µg/kg Liver
200µg/kg Kidney
40µg/kg Milk
Ovine 200 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption200µg/kg Fat
200µg/kg Liver
200µg/kg Kidney
Porcine 200 µg/kg Muscle
200µg/kg Skinan d fat
200µg/kg Liver
200µg/kg Kidney
SpiramycinSum of spiramycin an d
neospiramycinBovine 200 µg/kg Muscle
300 µg/kg Fat
300 µg/kg Liver300 µg/kg Kidney200 µg/kg Milk
Chicken200 µg/kg Muscle
300 µg/kg Skinan d fat▼M581990R2377 — EN — 18.06.2001 — 021.001 — 20▼M77
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
400 µg/kg Liver
Spiramycin1 Porcin e 250 µg/kg Muscle
2 000 µg/kg Liver
1 000 µg/kg Kidney
Tilmicosin Tilmicosin Bovine, ovine, porcine 50 µg/kg Muscle
50 µg/kg Fat
1 000 µg/kg Liver1 000 µg/kg Kidney
Bovine 50 µg/kg Milk
Ovine 50 µg/kg Milk
Chicken75 µg/kg Muscle Not for use in an imals from which eggs are
produced for humancon sumption
75 µg/kg Skinan d fat
1 000 µg/kg Liver
250 µg/kg Kidney
Rabbits 50 µg/kg Muscle
50µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
TylosinTylosin A Bovin e 100 µg/kg Muscle
100 µg/kg Fat100 µg/kg Liver100 µg/kg Kidney
50 µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 21▼M70
▼M58
▼M78
▼M58
▼M77
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Porcine 100 µg/kg Muscle
100 µg/kg Skinan d fat
100 µg/kg Liver
100 µg/kg Kidney
Poultry 100 µg/kg Muscle
100µg/kg Skinan d fat
100µg/kg Liver
100µg/kg Kidney
200µg/kg Eggs
Not for use inhen s
producing eggs for
humancon sumption100 µg/kg Skinan d fat
100 µg/kg Liver
100 µg/kg Kidney
1.2.5. Florfenicol and related compounds
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Florfenicol Sum of florfenicol and
its metabolites measured
as florfenicol-amineBovine 200 µg/kg Muscle
3 000 µg/kg Liver
300 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 22▼M76
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Porcine 300 µg/kg Muscle
500µg/kg Skinan d fat
2 000 µg/kg Liver
500µg/kg Kidney
Chicken100 µg/kg Muscle Not for use inan imals from which eggs are
produced for humancon sumption
200µg/kg Skinan d fat
2 500 µg/kg Liver
750µg/kg Kidney
Thiamphenicol Thiamphenicol Bovine 50 µg/kg Muscle
50 µg/kg Fat50 µg/kg Liver
50 µg/kg Kidney
50 µg/kg Milk
Chicken50 µg/kg Muscle
Not for use inan imals
from which eggs are
produced for human
consumption50 µg/kg Skinan d fat
50 µg/kg Liver
50 µg/kg Kidney
1.2.6. Tetracyclines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chlortetracycline Sum of parent drug and
its 4- epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver▼M581990R2377 — EN — 18.06.2001 — 021.001 — 23▼M66
▼M68
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
600 µg/kg Kidney
100 µg/kg Milk200 µg/kg Eggs
Doxycycline Doxycycline Bovine 100 µg/kg Muscle
Not for use inan imals
from which milk is
produced for humanconsumption300 µg/kg Liver
600 µg/kg Kidney
Porcine 100 µg/kg Muscle
300 µg/kg Skinan d fat300 µg/kg Liver600 µg/kg Kidney
Poultry 100 µg/kg MuscleNot for use inan imals
from which eggs are
produced for human
consumption300 µg/kg Skinan d fat
300 µg/kg Liver
600 µg/kg Kidney
Oxytetracycline Sum of parent drug and
its 4-epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver
600 µg/kg Kidney100 µg/kg Milk200 µg/kg Eggs
Tetracycline Sum of parent drug and
its 4-epimerAll food-producing
species100 µg/kg Muscle
300 µg/kg Liver
600 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 24
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
100 µg/kg Milk
200 µg/kg Eggs
1.2.7. Naphtalene-ringed ansamycin
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
RifaximinRifaximin Bovin e 60 µg/kg Milk
1.2.8. Pleuromutilines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
TiamulinSum of metabolites that
may be hydrolysed to 8-
a-hydroxymutilinPorcine 100 µg/kg Muscle
500µg/kg Liver
Chicken100 µg/kg Muscle
100µg/kg Skinan d fat
1 000 µg/kg Liver
Rabbits 100 µg/kg Muscle
500µg/kg Liver
Tiamulin1 000 µg/kg Eggs
Valnemulin Valnemulin Porcine 50 µg/kg Muscle
500 µg/kg Liver
100 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 25▼M71
▼M77
▼M71
▼M58
1.2.9. Lincosamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Lincomycin Lincomycin Bovine 100 µg/kg Muscle
50µg/kg Fat
500µg/kg Liver
1 500 µg/kg Kidney
150µg/kg Milk
PirlimycinPirlimycin Bovin e 100 µg/kg Muscle
100µg/kg Fat
1 000 µg/kg Liver
400µg/kg Kidney
100µg/kg Milk
1.2.10. Aminoglycosides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
ApramycinApramycin Bovin e 1 000 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption1 000 µg/kg Fat
10000 µg/kg Liver
20000 µg/kg Kidney▼M591990R2377 — EN — 18.06.2001 — 021.001 — 26▼M77
▼M65
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
ParomomycinParomomycin Bovin e 500 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption1 500 µg/kg Liver
1 500 µg/kg Kidney
Porcine, rabbits 500 µg/kg Muscle
1 500 µg/kg Liver
1 500 µg/kg Kidney
Chicken500 µg/kg Muscle Not for use inan imals from which eggs are
produced for humancon sumption1 500 µg/kg Liver
1 500 µg/kg Kidney
Spectinomycin Spectinomycin Bovine 300 µg/kg Muscle
500µg/kg Fat
1 000 µg/kg Liver
5 000 µg/kg Kidney
200µg/kg Milk
Porcine, chicken 300 µg/kg Muscle
500µg/kg Skinan d fat
1 000 µg/kg Liver
5 000 µg/kg Kidney
1.2.11. Other antibiotics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
NovobiocinNovobiocin Bovin e 50 µg/kg Milk▼M651990R2377 — EN — 18.06.2001 — 021.001 — 27▼M77
▼M76
▼M70
2. Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Salicylanilides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Closantel Closantel Bovine 1 000 µg/kg Muscle
3 000 µg/kg Fat
1 000 µg/kg Liver
3 000 µg/kg Kidney
Ovine 1 500 µg/kg Muscle
2 000 µg/kg Fat
1 500 µg/kg Liver
5 000 µg/kg Kidney
2.1.2. Tatra-hydro-imidazoles (imidazolthiazoles)
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Levamisole Levamisole Bovine, ovine, porcine,
poultry10 µg/kg Muscle
10 µg/kg Fat
100 µg/kg Liver
10 µg/kg Kidney
2.1.3. Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole Sum of albendazole
sulphoxide, albendazole
sulphone, and albenda-
zole 2-amino sulphone,
expressed as albendazoleBovine, ovine 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver▼M581990R2377 — EN — 18.06.2001 — 021.001 — 28
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
500 µg/kg Kidney
100 µg/kg Milk
Albendazole oxide Sum of albendazole
oxide, albendazole
sulphone and albenda-
zole 2-aminosulphone,
expressed as albendazoleBovine, ovine 100 µg/kg Muscle
100µg/kg Fat
1 000 µg/kg Liver
500µg/kg Kidney
100µg/kg Milk
Febantel Sum of extractable resi-
dues which may be
oxidised to oxfendazoleBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equidae50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Fenbendazole Sum of extractable resi-
dues which may be
oxidised to oxfendazole
sulphoneBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equide50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Flubendazole Sum of flubendazole and
(2-amino 1H-benzimi-
dazol-5-yl) (4fluoro-
phenyl) methanonePorcine, chicken, game
birds50 µg/kg Muscle
50 µg/kg Skinan d fat▼M581990R2377 — EN — 18.06.2001 — 021.001 — 29▼M69
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
400 µg/kg Liver
300 µg/kg Kidney
Turkey 50 µg/kg Muscle
50µg/kg Skinan d fat
400µg/kg Liver
300µg/kg Kidney
Flubendazole Chicken 400 µg/kg Eggs
Oxfendazole Sum of extractable resi-
dues which may be
oxidised to oxfendazole
sulphoneBovine, ovine 10 µg/kg Milk
Bovine, ovine, porcine,
equidae50 µg/kg Muscle
50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Oxibendazole Oxibendazole Porcine 100 µg/kg Muscle
500 µg/kg Skinan d fat200 µg/kg Liver100 µg/kg Kidney
Thiabendazole Sum of thiabendazole
and 5-hydroxythiabenda-
zoleBovine 100 µg/kg Muscle
100 µg/kg Fat
100 µg/kg Liver100 µg/kg Kidney100 µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 30▼M68
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Triclabendazole Sum of extractable resi-
dues that may be
oxidised to ketotriclaben-
dazoleBovine, ovine 100 µg/kg Muscle Not for use in animals from which milk is
produced for humancon sumption
100 µg/kg Liver
100 µg/kg Kidney
2.1.4. Phenol derivatives including salicylanides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Nitroxinil Nitroxinil Bovine, ovine 400 µg/kg Muscle
200µg/kg Fat
20µg/kg Liver
400µg/kg Kidney
2.1.5. Benzenesulphonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
ClorsulonClorsulon Bovin e 35 µg/kg Muscle
100µg/kg Liver
200µg/kg Kidney
2.2. Agents acting against ectoparasites
2.2.1. Organophosphates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diazinon Diazinon Bovine, ovine, caprine 20 µg/kg Milk
Bovine, porcine, ovine,
caprine20 µg/kg Muscle▼M581990R2377 — EN — 18.06.2001 — 021.001 — 31▼M62
▼M66
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
700 µg/kg Fat
20 µg/kg Liver
20 µg/kg Kidney
2.2.2. Formamidines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all
metabolites containing
the 2,4-DMA moiety,
expressed as amitrazBovine 200 µg/kg Fat
200 µg/kg Liver
200 µg/kg Kidney
10 µg/kg Milk
Ovine 400 µg/kg Fat
100 µg/kg Liver
200 µg/kg Kidney
10 µg/kg Milk
Porcine 400 µg/kg Skin and fat
200 µg/kg Liver
200 µg/kg Kidney
Bees (honey) 200 µg/kg Honey
2.2.3. Pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
FlumethrinFlumethrin (sum of
trans-Z isomers)Bovine 10 µg/kg Muscle
150 µg/kg Fat
20 µg/kg Liver▼M581990R2377 — EN — 18.06.2001 — 021.001 — 32
▼M69
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
10 µg/kg Kidney
30 µg/kg Milk
Ovine 10 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption
150µg/kg Fat
20µg/kg Liver
10µg/kg Kidney
2.2.4. Acyl urea derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg Muscle and skin in
natural proportions
Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg Muscle and skin in
natural proportions
2.2.5. Pyrimidines derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dicyclanil Sum of dicyclanil and 2,
4, 6-triamino-pyrimidine-
5-carbonitrileOvine 200 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption►M78
150µg/kg
◄Fat
400µg/kg Liver
400µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 33▼M78
▼M65
▼M70
▼M65
▼M76
2.3. Agents acting against endo- and ectoparasites
2.3.1. Avermectins
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
AbamectinAvermectin B1a Bovin e 10 µg/kg Fat
20 µg/kg Liver
Doramectin Doramectin Bovine 10 µg/kg Muscle Not for use in bovine from which milk is
produced for humancon sumption
150 µg/kg Fat
100 µg/kg Liver
30 µg/kg Kidney
Porcine, ovine 20 µg/kg Muscle Not for use in ovine from which milk is
produced for humancon sumption
100 µg/kg Fat
50 µg/kg Liver
30 µg/kg Kidney
EmamectinEmamectin B1a Salmon idae 100 µg/kg Muscle and skin in
natural proportions
Eprinomectin Eprinomectin B1a Bovine ►M67
50µg/kg
◄Muscle
►M67
250µg/kg
◄Fat
►M67
1 500 µg/kg
◄Liver
►M67
300µg/kg
◄Kidney
►M67
20µg/kg
◄Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 34 ▼M65
▼M58
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Ivermectin22, 23-Dihydro-aver-
mectinB1aBovine 40 µg/kg Fat
100 µg/kg Liver
Porcine, ovine, equidae 20 µg/kg Fat
15 µg/kg Liver
Deer, including reindeer 20 µg/kg Muscle
100 µg/kg Fat
50 µg/kg Liver
20 µg/kg Kidney
Moxidectin Moxidectin Bovine, ovine 50 µg/kg Muscle
500 µg/kg Fat
100 µg/kg Liver
50 µg/kg Kidney
Equidae 50 µg/kg Muscle
500µg/kg Fat
100µg/kg Liver
50µg/kg Kidney
2.4. Agents acting against protozoa
2.4.1. Triazinetrione derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Chicken 100 µg/kg Muscle Not for use in animals from which eggs are
produced for humancon sumption
200 µg/kg Skinan d fat
600 µg/kg Liver
400 µg/kg Kidney
Turkey 100 µg/kg Muscle▼M581990R2377 — EN — 18.06.2001 — 021.001 — 35▼M66
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
200 µg/kg Skinan d fat
600 µg/kg Liver
400 µg/kg Kidney
Porcine 100 µg/kg Muscle
150µg/kg Skinan d fat
500µg/kg Liver
250µg/kg Kidney
2.4.2. Quinazolone derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Halofuginone Halofuginone Bovine 10 µg/kg Muscle Not for use inan imals from which milk is
produced for humancon sumption25µg/kg Fat
30µg/kg Liver
30µg/kg Kidney
3. Agents acting on the nervous system
3.1. Agents acting on the central nervous system
3.1.1. Butyrophenone tranquillisers
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azaperone Sum of azaperone and
azaperolPorcine 100 µg/kg Muscle
100 µg/kg Skinan d fat
100 µg/kg Liver
100 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 36▼M80
▼M58
3.2. Agents acting on the autonomic nervous system
3.2.1. Anti-adrenergics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Porcine 5 µg/kg Muscle
5 µg/kg Skinan d fat
25 µg/kg Liver
25 µg/kg Kidney
Bovine 5 µg/kg Muscle
5µg/kg Fat
15µg/kg Liver
15µg/kg Kidney
1µg/kg Milk
3.2.2. β2sympathomimetic agents
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clenbuterol hydrochloride Clenbuterol Bovine 0,1 µg/kg Muscle
0,5µg/kg Liver
0,5µg/kg Kidney
0,05 µg/kg Milk
Equidae 0,1 µg/kg Muscle
0,5µg/kg Liver
0,5µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 37▼M72
▼M78
4. Anti-inflammatory agents
4.1. Nonsteroidal anti-inflammatory agents
4.1.1. Arylpropionic acid derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
CarprofenCarprofen Bovin e
Not for use inan imals
from which milk is
produced for human
consumption500µg/kg Muscle
1 000 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
Equidae 500 µg/kg Muscle
1 000 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
VedaprofenVedaprofen Equidae 50 µg/kg Muscle
20 µg/kg Fat
100 µg/kg Liver
1 000 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 38▼M65
▼M58
4.1.2. Fenamate group derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Flunixin Flunixin Bovine 20 µg/kg Muscle
30µg/kg Fat
300µg/kg Liver
100µg/kg Kidney
5-Hydroxyflunixin 40 µg/kg Milk
Flunixin Porcine 50 µg/kg Muscle
10µg/kg Skinan d fat
200µg/kg Liver
30µg/kg Kidney
Equidae 10 µg/kg Muscle
20µg/kg Fat
100µg/kg Liver
200µg/kg Kidney
Tolfenamic acid Tolfenamic acid Bovine 50 µg/kg Muscle
400 µg/kg Liver
100 µg/kg Kidney
50 µg/kg Milk
Porcine 50 µg/kg Muscle
400 µg/kg Liver
100 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 39▼M71
▼M80
▼M58
4.1.4. Oxicanderivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine ►M71
20µg/kg
◄Muscle
►M71
65µg/kg
◄Liver
►M71
65µg/kg
◄Kidney
►M71
15µg/kg
◄►M71Milk◄
5. Corticoides
5.1. Glucocorticoides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Betamethasone Betamethasone Bovine 0,75 µg/kg Muscle
2,0µg/kg Liver
0,75 µg/kg Kidney
0,3µg/kg Milk
Porcine 0,75 µg/kg Muscle
2,0µg/kg Liver
0,75 µg/kg Kidney
Dexamethasone Dexamethasone Bovine 0,3 µg/kg Milk
Bovine, porcine, equidae 0,75 µg/kg Muscle
2 µg/kg Liver
0,75 µg/kg Kidney▼M691990R2377 — EN — 18.06.2001 — 021.001 — 40▼M58
▼M70
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Prednisolone Prednisolone Bovine 4 µg/kg Muscle
4µg/kg Fat
10µg/kg Liver
10µg/kg Kidney
6µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 41▼M79
ANNEX II
LISTOFSUBSTANCESNOTSUBJECTTOMAXIMUMRESIDUELIMITS
1. Inorganic chemicals
Pharmacologically active substance(s) Animal species Other provisions
Aluminium distearate All food-producing species
Aluminium hydroxide acetate All food-producing speciesAluminium phosphate All food-producing species
Aluminium tristearate All food-producing species
Ammonium chloride All food-producing species
Barium selenate Bovine, ovine
Bismuth subcarbonate All food-producing species For oral use only
Bismuth subgallate All food-producing species For oral use onlyBismuth subnitrate All food-producing species For oral use onlyBismuth subsalicylate All food-producing species For oral use onlyBoric acid and borates All food-producing species
Bromide, potassium salt All food producing speciesBromide, sodium salt All mammalian food-producing species For topical use only▼M581990R2377 — EN — 18.06.2001 — 021.001 — 42▼M72
▼M58
▼M65
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Calcium acetate
Calcium benzoate
Calcium carbonate
Calcium chloride
Calcium gluconate
Calcium hydroxide
Calcium hypophosphite
Calcium malate
Calcium oxide
Calcium phosphate
Calcium polyphosphates
Calcium propionate
Calcium silicate
Calcium stearate
Calcium sulphateAll food-producing species
Calcium glucoheptonate All food-producing species
Calcium glucono glucoheptonate All food-producing species
Calcium gluconolactate All food-producing species
Calcium glutamate All food-producing species
Calcium glycerophosphate All food producing species
Cobalt carbonate All food-producing species
Cobalt dichloride All food-producing species
Cobalt gluconate All food-producing speciesCobalt oxide All food-producing speciesCobalt sulphate All food-producing species
Cobalt trioxide All food-producing species
Copper chloride All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 43
▼M80
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Copper gluconate All food-producing species
Copper heptanoate All food-producing species
Copper methionate All food-producing species
Copper oxide All food-producing species
Copper sulphate All food-producing species
Dicopper oxide All food-producing species
Hydrochloric acid All food-producing species For use as excipient
Hydrogenperoxide All food-producin g species
Iodine and iodine inorganic compounds including:
— Sodium and potassium-iodide
— Sodium and potassium-iodate— Iodophors including polyvinylpyrrolidone-iodineAll food-producing species
Irondichloride All food-producin g species
Ironsulphate All food-producin g species
Magnesium
Magnesium sulphate
Magnesium hydroxide
Magnesium stearate
Magnesium glutamate
Magnesium orotate
Magnesium aluminium silicate
Magnesium oxide
Magnesium carbonate
Magnesium phosphate
Magnesium glycerophosphate
Magnesium aspartate
Magnesium citrate
Magnesium acetate
Magnesium trisilicateAll food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 44
Pharmacologically active substance(s) Animal species Other provisions
Nickel gluconate All food-producing species
Nickel sulphate All food-producing speciesPotassium DL-aspartate All food-producing species
Potassium glucuronate All food-producing species
Potassium glycerophosphate All food-producing speciesPotassium nitrate All food-producing speciesPotassium selenate All food-producing species
Sodium chlorite Bovine For topical use only
Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only
Sodium glycerophosphate All food producing species
Sodium hypophosphite All food-producing species
Sodium propionate All food producing speciesSodium selenate All food-producing species
Sodium selenite All food-producing speciesSulphur Bovine, porcine, ovine, caprine, equidaeZinc acetate
Zinc chloride
Zinc gluconate
Zinc oleate
Zinc stearateAll food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 45▼M62
▼M58
▼M77
▼M58
2. Organic compounds
Pharmacologically active substance(s) Animal species Other provisions
17β-Oestradiol All mammalian food-producing species For therapeutic and zootechnical uses only
2-Aminoethanol All food-producing species
2-Aminoethyl dihydrogenphosphate All food-producing species2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw8-Hydroxyquinoline All mammalian food-producing species For topical use in newborn animals onlyAcetyl cysteine All food-producing speciesAlfacalcidol Bovine For parturient cows only
Alfaprostol Rabbits
Bovine, porcine, equidae
Bacitracin Bovine For intramammary use in lactating cows only and for all tissues except
milk
Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0,05 % onlyBenzocaine All food-producing species For use as local anaesthetic onlyBenzylalcohol All food-producing species For use as excipientBetaine All food-producing speciesBronopol Salmonidae For use only on farmed fertilised eggs
Brotizolam Bovine For therapeutic uses only
BuserelinAll food-producin g speciesButorphanol tartrate Equidae For intravenous administration onlyButyl 4-hydroxybenzoate All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 46
Pharmacologically active substance(s) Animal species Other provisions
Butylscopolaminium bromide All food-producing species
Caffeine All food-producing species
CarbetocinAll mammalian food-producin g species
CefazolinBovin e
Ovine, caprineFor intramammary use, except if the udder may be used as food for
humancon sumption
Cetostearyl alcohol All food-producing species
Cetrimide All food-producing species
Chlorhexidine All food-producing species For topical use only
Chlorocresol All food-producing species
Clazuril Pigeon
Cloprostenol Bovine, porcine, equidae
Coco alkyl dimethyl betaines All food-producing species For use as excipient
CorticotropinAll food-producin g species
D-Phe 6 -luteinising-hormone releasing hormone All food-producing species
Dembrexine Equidae
Denaverine hydrochloride Bovine
Detomidine Bovine, equidae For therapeutic uses only
Diclazuril Ovine For oral use in lambs only
Diethyl phtalate All food-producing species
Diethylene glycol monoethyl ether Bovine, porcine▼M581990R2377 — EN — 18.06.2001 — 021.001 — 47
Pharmacologically active substance(s) Animal species Other provisions
Dimanganese trioxide All food-producing species For oral use only
Dimethyl phtalate All food-producing speciesDinoprost All mammalian food-producing species
Dinoprost tromethamine All mammalian food-producing species
Diprophylline All food-producing speciesEtamiphylline camsylate All food-producing speciesEthanol All food-producing species For use as excipient
Ethyl lactate All food-producing species
Etiproston tromethamine Bovine, porcineFertirelinacetate Bovin eFlumethrinBees (hon ey)
Folic acid All food-producing species
Glycerol formal All food-producing speciesGonadotrophin releasing hormone All food-producing speciesHeptaminol All food-producing speciesHesperidinEquidae
Hesperidinmethyl chalcon e Equidae
Hexetidine Equidae For topical use onlyHuman chorion gonadotrophin All food-producing speciesHuman menopausal urinary gonadotrophin Bovine▼M581990R2377 — EN — 18.06.2001 — 021.001 — 48
Pharmacologically active substance(s) Animal species Other provisions
Hydrocortisone All food-producing species For topical use only
Iodine organic compounds
— IodoformAll food-producing species
Isobutane All food-producing species
Isoflurane Equidae For use as anaesthetic only
Isoxsuprine Bovine, equidae For therapeutic use only in accordance with Council Directive 96/22/
EEC (OJ L 125, 23.5.1996, p. 3)
Ketamine All food-producing species
Ketanserin tartrate EquidaeKetoprofen Bovine, porcine, equidae
L-tartaric acid and its mono- and di-basic salt of sodium, potassium
and calciumAll food-producing species For use as excipient
Lactic acid All food-producing species
LecirelinBovin e, equidae, rabbits
Lobeline All food-producing species
Luprostiol All mammalianspecies
Malic acid All food-producing species For use as excipient
Manganese carbonate All food-producing species For oral use onlyManganese chloride All food-producing species For oral use only
Manganese gluconate All food-producing species For oral use only
Manganese glycerophosphate All food-producing species For oral use only▼M581990R2377 — EN — 18.06.2001 — 021.001 — 49
Pharmacologically active substance(s) Animal species Other provisions
Manganese oxide All food-producing species For oral use only
Manganese pidolate All food-producing species For oral use onlyManganese ribonucleate All food-producing species For oral use only
Manganese sulphate All food-producing species For oral use only
Mecillinam Bovine For intrauterine use onlyMedroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes onlyMelatonin Ovine, caprine
Menadione All food-producing species
Menbutone Bovine, ovine, caprine, porcine, equidaeMenthol All food-producing speciesMethyl nicotinate Bovine, equidae For topical use only
Mineral hydrocarbons, low to high viscosity including microcristalline
waxes, approximately C10-C60; aliphatic, branched aliphatic and
alicyclic compoundsAll food-producing species Excludes aromatic and unsaturated compounds
N-butane All food-producing species
N-butanol All food-producing species For use as excipientNatamycin Bovine, equidae For topical use onlyNeostigmine All food-producing species
Nicoboxil Equidae For topical use only
Nonivamide Equidae For topical use onlyOleyloleate All food-producing species For topical use only▼M581990R2377 — EN — 18.06.2001 — 021.001 — 50
Pharmacologically active substance(s) Animal species Other provisions
OxytocinAll mammalian food-producin g species
Pancreatin All mammalian food-producing species For topical use only
PapainAll food-producin g species
Papaverine Bovine Newborn calves only
Peracetic acid All food-producing species
Phenol All food-producing species
Phloroglucinol All food-producing species
Phytomenadione All food-producing species
Policresulen All food-producing species For topical use only
Polyethylene glycol 15 hydroxystearate All food-producing species For use as excipient
Polyethylene glycol 7 glyceryl cocoate All food-producing species For topical use only
Polyethylene glycol stearates with 8-40 oxyethylene units All food-producing species For use as excipient
Polysulphated glycosaminoglycan Equidae
Praziquantel Ovine
EquidaeFor use in non-lactating sheep only
Pregnant mare serum gonadotrophin All food-producing species
Prethcamide (crotethamide and cropropamide) All mammalian food-producing species
Procaine All food-producing species
Propane All food-producing species
Propylene glycol All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 51
Pharmacologically active substance(s) Animal species Other provisions
Quatresin All food-producing species For use as preservative only at concentrations of up to 0,5 %
R-Cloprostenol Bovine, porcine, equidae
RifaximinAll mammalian food-producin g species
BovineFor topical use only
For intramammary use, except if the udder may be used as food for
humancon sumption
Romifidine Equidae For therapeutic uses only
Sodium 2-methyl-2-phenoxy-propanoate Bovine, porcine, caprine, equidae
Sodium benzyl 4-hydroxybenzoate All food-producing species
Sodium butyl 4-hydroxybenzoate All food-producing species
Sodium cetostearyl sulphate All food-producing species For topical use only
Somatosalm Salmon
Tanninum All food-producing species
Tau fluvalinate
Terpin hydrate Bovine, porcine, ovine, caprine
Tetracaine All food-producing species For use as anaesthetic only
Theobromine All food-producing species
Theophylline All food-producing species
Thiomersal All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %
Thymol All food-producing speciesTimerfonate All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %▼M581990R2377 — EN — 18.06.2001 — 021.001 — 52
Pharmacologically active substance(s) Animal species Other provisions
Trimethylphloroglucinol All food-producing species
VitaminD All food-producin g species
Wool alcohols All food-producing species For topical use only
1-Methyl-2-pyrrolidone Equidae
Cefacetrile Bovine For intramammary use only and for all tissues except milk
Enilconazole Bovine, equidae For topical use only
Etamsylate All food producing speciesStrychnine Bovine For oral use only at dose to 0,1 mg/kg bw
Parconazole Guinea fowlBiotinAll food producin g species
Bromhexine Bovine
Not for use inan imals from which milk is
produced for humancon sumption
Porcine
Poultry
Not for use inan imals from which eggs are
produced for humancon sumption
Mercaptamine hydrochloride All mammalian food-producing speciesPraziquantel Ovine
Pyrantel embonate Equidae▼M581990R2377 — EN — 18.06.2001 — 021.001 — 53▼M59
▼M60
▼M62
Pharmacologically active substance(s) Animal species Other provisions
VitaminB1 All food-producin g species
VitaminB12 All food-producin g speciesVitaminB2 All food-producin g species
VitaminB3 All food-producin g species
VitaminB5 All food-producin g speciesVitaminB6 All food-producin g speciesVitaminE All food-producin g species
Tiaprost Bovine, ovine, porcine, equidaeApramycinPorcin e, rabbits
Ovine
Not for use inan imals from which milk is
produced for humancon sumption
Chicken
Not for use inan imals from which eggs are
produced for humancon sumptionFor oral use only
Azamethiphos Salmonidae
Doxapram All mammalianfood producin g species
Piperonyl butoxide Bovine, ovine, caprine, equidae For topical use only
Sulfogaiacol All food producing speciesVetrabutine hydrochloride Porcine
Fenpipramide hydrochloride Equidae For intravenous use only
Hydrochlorothiazide Bovine▼M621990R2377 — EN — 18.06.2001 — 021.001 — 54▼M63
▼M65
▼M66
Pharmacologically active substance(s) Animal species Other provisions
Levomethadone Equidae For intravenous use only
Tricaine mesilate Fin fish For water borne use onlyTrichlormethiazide All mammalian food producing species Not for use in animals from which milk is produced for human
consumption
Vincamine Bovine For use in newborn animals only
Atropine All food producing species
Cefoperazone Bovine For intramammary use in lactating cows only and for all tissues except
milk
2-aminoethanol glucuronate All food-producing species
Betaine glucuronate All food-producing species
Bituminosulfonates, ammonium and sodium salts All mammalian food-producing species For topical use only
Not for use inan imals from which milk is produced for human
consumption
Chlorphenamine All mammalian food-producing speciesHumic acids and their sodium salts All food-producing species For oral use only
Paracetamol Porcine For oral use only
Tosylchloramide sodium Fin fish For water-borne use only
1-methyl-2-pyrrolidone All food-producing species
Ergometrine maleate All mammalian food-producing species For use in parturient animals onlyJecoris oleum All food-producing species For topical use only
Mepivacaine Equidae For intra-articular and epidural use as local anaesthetic only▼M661990R2377 — EN — 18.06.2001 — 021.001 — 55▼M67
▼M69
▼M70
Pharmacologically active substance(s) Animal species Other provisions
Novobiocin Bovine For intrammary use only and for all tissues except milk
Piperazine dihydrochloride Chicken For all tissues except eggs
Polyoxyl castor oil with 30 to 40 oxyethylene units All food-producing species For use as excipient
Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units All food-producing species For use as excipient
Xylazine hydrochloride Bovine, equidae Not for use in animals from which milk is produced for human
consumptiom
ButafosfanBovin e ►M78For intravenous use only ◄
Cefalonium Bovine For intramammary use and eye treatment only, and for all tissues
except milk
Furosemide Bovine, equidae For intravenous administration only
Lidocaine Equidae For local-regional anaesthesia only
3,5-Diiodo-L-thyrosine All mammalian food-producing species
Levothyroxine All mammalian food-producing species
Aluminium salicylate, basic All food producing species except fish For topical
use only
Bismuth subnitrate Bovine For intramammary use only▼M701990R2377 — EN — 18.06.2001 — 021.001 — 56▼M71
▼M72
▼M74
Pharmacologically active substance(s) Animal species Other provisions
Calcium aspartate All food producing species
Methyl salicylate All food producing species except fish For topical use only
Salicylic acid All food producing species except fish For topical use onlySodium salicylate All food producing species except fish For topical use onlyZinc aspartate All food producing species
Toldimfos All food producing speciesDecoquinate Bovine, ovine For oral use only. Not for use in animals from which milk is produced
for humancon sumption
Sodium boroformiate All food producing species
Thiamylal All mammalian food producing species For intravenous administration only
Thiopental sodium All food-producing species For intravenous administration only
Acetylsalicylic acid Bovine
Porcine
ChickenNot for use inan imals from which milk is produced for human
consumption
Not for use inan imals from which eggs are produced for human
consumption
Acetylsalicylic acid DL-lysine Bovine
Porcine
ChickenNot for use inan imals from which milk is produced for human
consumption
Not for use inan imals from which eggs are produced for human
consumption▼M741990R2377 — EN — 18.06.2001 — 021.001 — 57▼M75
▼M77
▼M81
▼M82
Pharmacologically active substance(s) Animal species Other provisions
Carbasalate calcium Bovine
Porcine
ChickenNot for use inan imals from which milk is produced for human
consumption
Not for use inan imals from which eggs are produced for human
consumption
Sodium acetylsalicylate Bovine
Porcine
ChickenNot for use inan imals from which milk is produced for human
consumption
Not for use inan imals from which eggs are produced for human
consumption
3. Substances generally recognised as safe
Pharmacologically active substance(s) Animal species Other provisions
Absinthium extract All food-producing species
Acetylmethionine All food-producing species
Aluminium hydroxide All food-producing speciesAluminium monostearate All food-producing speciesAmmonium sulfate All food-producing species
Benzoyl benzoate All food-producing species
Benzyl p-hydroxybenzoate All food-producing speciesCalcium borogluconate All food-producing speciesCalcium citrate All food-producing speciesCamphor All food-producing species External use only
Cardamonextract All food-producin g species
Diethyl sebacate All food-producing species▼M821990R2377 — EN — 18.06.2001 — 021.001 — 58▼M58
Pharmacologically active substance(s) Animal species Other provisions
Dimethicone All food-producing species
Dimethyl acetamide All food-producing speciesDimethyl sulphoxide All food-producing species
Epinephrine All food-producing species
Ethyl oleate All food-producing speciesEthylenediaminetetraacetic acid and salts All food-producing speciesEucalyptol All food-producing species
Follicle stimulating hormone (natural FSH from all species and their
synthetic analogues)All food-producing species
Formaldehyde All food-producing species
Formic acid All food-producing species
Glutaraldehyde All food-producing speciesGuaiacol All food-producing speciesHeparin and its salts All food-producing speciesHuman chorionic gonadotropin (natural HCG and its synthetic analo-
gues)All food-producing species
Iron ammonium citrate All food-producing species
Irondextran All food-producin g species
Iron glucoheptonate All food-producing species
Isopropanol All food-producing speciesLanolin All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 59
Pharmacologically active substance(s) Animal species Other provisions
Luteinising hormone (natural LH from all species and their synthetic
analogues)All food-producing species
Magnesium chloride All food-producing species
Magnesium gluconate All food-producing species
Magnesium hypophosphite All food-producing species
Mannitol All food-producing species
Methylbenzoate All food-producing species
Monothioglycerol All food-producing species
Montanide All food-producing species
Myglyol All food-producing species
OrgoteinAll food-producin g species
Poloxalene All food-producing species
Poloxamer All food-producing species
Polyethylene glycols (molecular weight ranging from 200 to 10000) All food-producing species
Polysorbate 80 All food-producing species
Serotonin All food-producing species
Sodium chloride All food-producing species
Sodium cromoglycate All food-producing species
Sodium dioctylsulphosuccinate All food-producing species
Sodium formaldehydesulphoxylate All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 60
Pharmacologically active substance(s) Animal species Other provisions
Sodium lauryl sulphate All food-producing species
Sodium pyrosulphite All food-producing species
Sodium stearate All food-producing species
Sodium thiosulphate All food-producing species
Tragacanth All food-producing species
Urea All food-producing species
Zinc oxide All food-producing species
Zinc sulphate All food-producing species
Adenosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Alanine All food producing species
Arginine All food producing species
Asparagine All food producing species
Aspartic acid All food producing species
Carnitine All food producing species
Choline All food producing species
ChymotrypsinAll food producin g species
Citrulline All food producing species
Cysteine All food producing species
Cytidine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 61▼M65
Pharmacologically active substance(s) Animal species Other provisions
Glutamic acid All food producing species
Glutamine All food producing speciesGlycine All food producing species
Guanosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Histidine All food producing speciesHyaluronic acid All food producing speciesInosine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Inositol All food producing species
Isoleucine All food producing speciesLeucine All food producing speciesLysine All food producing species
Methionine All food producing species
Ornithine All food producing speciesOrotic acid All food producing speciesPepsinAll food producin g speciesPhenylalanine All food producing species
Proline All food producing species
Serine All food producing speciesThioctic acid All food producing speciesThreonine All food producing species▼M651990R2377 — EN — 18.06.2001 — 021.001 — 62
Pharmacologically active substance(s) Animal species Other provisions
Thymidine All food producing species
TrypsinAll food producin g speciesTryptophanAll food producin g species
Tyrosine All food producing species
Uridine and its 5 ′-mono-, 5 ′-di- and 5 ′-triphosphates All food producing species
Valine All food producing species
4. Substances used in homeopathic veterinary medicinal products
Pharmacologically active substance(s) Animal species Other provisions
All substances used in homeopathic veterinary medicinal products
provided that their concentration in the product does not exceed one
part per tenthousan dAll food-producing species
Adonis vernalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Acqua levici All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias only
Atropa belladonna All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only▼M651990R2377 — EN — 18.06.2001 — 021.001 — 63
▼M58
▼M63
Pharmacologically active substance(s) Animal species Other provisions
Convallaria majalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only
Apocynum cannabinum All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
For oral use only
Harunga madagascariensis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Selenicereus grandiflorus All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Thuja occidentalis All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
Virola sebifera All food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only
Ruta graveolens All food-producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only.
Not for use inan imals from which milk is produced for human
consumption
Aesculus hippocastanum All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per ten only
Agnus castus All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only▼M631990R2377 — EN — 18.06.2001 — 021.001 — 64▼M66
▼M68
▼M71
Pharmacologically active substance(s) Animal species Other provisions
Ailanthus altissima All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Allium cepa All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Arnicae radix All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding in the products not exceeding one part per ten only
Artemisia abrotanum All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Bellis perennis All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Calendula officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding in the products not exceeding one part per ten only
Camphora All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per hundred only.
Cardiospermum halicacabum All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Crataegus All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only▼M711990R2377 — EN — 18.06.2001 — 021.001 — 65
Pharmacologically active substance(s) Animal species Other provisions
Echinacea All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
For topical use only.
For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding in the products not exceeding one part per ten only
Eucalyptus globulus All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Euphrasia officinalis All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Ginkgo biloba All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per thousand only.
Ginseng All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Hamamelis virginiana All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per ten only
Harpagophytum procumbens All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Hypericum perforatum All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Lachnanthes tinctoria All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per thousand only.▼M711990R2377 — EN — 18.06.2001 — 021.001 — 66
Pharmacologically active substance(s) Animal species Other provisions
Lobaria pulmonaria All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Okoubaka aubrevillei All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Prunus laurocerasus All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations in the
products not exceeding one part per thousand only.
Serenoa repens All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Silybum marianum All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Solidago virgaurea All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Syzygium cumini All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Turnera diffusa All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Viscum album All-food producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias at concentrations corre-
sponding to the mother tincture and dilutions thereof only
Phytolacca americana All food-producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per thousand only▼M711990R2377 — EN — 18.06.2001 — 021.001 — 67
▼M72
Pharmacologically active substance(s) Animal species Other provisions
Urginea maritima All food-producing species For use in homeopathic veterinary medicinal products prepared
according to homeopathic pharmacopoeias, at concentrations in the
products not exceeding one part per hundred only
For oral use only
5. Substances used as food additives in foodstuffs for human consumption
Pharmacologically active substance(s) Animal species Other provisions
Substances with an E number All food-producing species Only substances approved as additives in foodstuffs for human
consumption, with the exception of preservatives listed in part C of
Annex III to European Parliament and Council Directive 95/2/EC (OJ
L 61, 18.3.1995, p. 1).
6. Substances of vegetable origin
Pharmacologically active substance(s) Animal species Other provisions
Aloe vera gel and whole leaf extract of Aloe vera All food-producing species For topical use only
Aloes, Barbados and Capae, their standardised dry extract and
preparations thereofAll food-producing species
Angelicae radix aetheroleum All food-producing species
Anisi aetheroleum All food-producing species
Anisi stellati fructus , standardised extracts and preparations thereof All food producing species
Arnica montana (arnicae flos and arnicae planta tota) All food-producing species For topical use only
Balsamum peruvianum All food-producing species For topical use only▼M721990R2377 — EN — 18.06.2001 — 021.001 — 68▼M58
▼M73
▼M71
▼M58
▼M77
▼M71
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Boldo folium All food-producing species
Calendulae flos All food-producing species For topical use only
Capsici fructus acer All food-producing species
Carlinae radix All food-producing species For topical use only
Carvi aetheroleum All food-producing species
Caryophylli aetheroleum All food-producing species
Centellae asiaticaer extractum All food producing species For topical use only
Chrysanthemi cinerariifolii flos All food-producing species For topical use only
Cimicifugae racemosae rhizoma All food-producing species Not for use in animals from which milk is produced for human
consumptiom
Cinchonae cortex , standardised extracts and preparations thereof All food producing species
Cinnamomi cassiae aetheroleum All food-producing species
Cinnamomi cassiae cortex , standardised extracts and preparations
thereofAll food producing species
Cinnamomi ceylanici aetheroleum All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 69▼M71
▼M70
▼M68
▼M71
▼M58
▼M59
▼M58
▼M70
▼M77
▼M58
▼M77
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Cinnamomi ceylanici cortex , standardised extracts and preparations
thereofAll food producing species
Citri aetheroleum All food-producing species
Citronellae aetheroleum All food-producing species
Condurango cortex , standardised extracts and preparations thereof All food producing species
Coriandri aetheroleum All food-producing species
Cupressi aetheroleum All food-producing species For topical use only
Echinacea purpurea All food-producing species For topical use only
Eucalypti aetheroleum All food-producing species
Foeniculi aetheroleum All food-producing species
Frangulae cortex , standardised extracts and preparations thereof All food producing species
Gentianae radix , standardised extracts and preparations thereof All food producing species
Hamamelis virginiana All food-producing species For topical use only
Hippocastani semen All food-producing species For topical use only
Hyperici oleum All food-producing species For topical use only▼M581990R2377 — EN — 18.06.2001 — 021.001 — 70▼M77
▼M58
▼M77
▼M58
▼M71
▼M58
▼M77
▼M58
▼M68
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Juniperi fructus All food-producing species
Lauri folii aetheroleum All food-producing species
Lauri fructus All food-producing species
Lavandulae aetheroleum All food-producing species For topical use only
Lespedeza capitata All food-producing species
Lini oleum All food-producing species
Majoranae herba All food-producing species
Matricaria recutita and preparations thereof All food producing species
Matricariae flos All food-producing species
Medicago sativa extractum All food-producing species For topical use only
Melissae aetheroleum All food producing species
Melissae folium All food-producing species
Menthae piperitae aetheroleum All food-producing species
Millefolii herba All food-producing species
Myristicae aetheroleum All food-producing species For use in newborn animals only
Oxidationproducts of Terebinthinae oleum Bovine, porcine, ovine, caprine
Pyrethrum extract All food-producing species For topical use only▼M581990R2377 — EN — 18.06.2001 — 021.001 — 71▼M68
▼M71
▼M58
▼M74
▼M58
▼M59
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Quercuscortex All food-producing species
Quillaia saponins All food-producing species
Rhei radix , standardised extracts and preparations thereof All food producing species
Ricini oleum All food-producing species For use as excipient
Rosmarini aetheroleum All food-producing species
Rosmarini folium All food-producing species
Ruscus aculeatus All food-producing species For topical use only
Salviae folium All food-producing species
Sambuci flos All food-producing species
Sinapis nigrae semen All food-producing species
Strychni semen Bovine, ovine, caprine For oral use only at doses up to the equivalent of 0,1 mg strychnine/kg
bw
Symphyti radix All food-producing species For topical use on intact skin only
Terebinthinae aetheroleum rectificatum All food-producing species For topical use only
Terebinthinae laricina All food-producing species For topical use only
Thymi aetheroleum All food-producing species
Tiliae flos All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 72▼M74
▼M58
▼M68
▼M58
▼M68
▼M71
▼M58
Pharmacologically active substance(s) Animal species Other provisions
Urticae herba All food-producing species▼M581990R2377 — EN — 18.06.2001 — 021.001 — 73
ANNEX III
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCESUSED IN VETERINARYMEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE
BEENFIXED
1. Anti-infectious agents
1.1. Chemotheurapeutics
1.1.2. Benzenesulphonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clorsulon Clorsulon Bovine 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
150 µg/kg Liver
400 µg/kg Kidney
1.2. Antibiotics
1.2.1. Beta-lactamase inhibitors
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clavulanic acid Clavulanic acid Bovine, ovine 200 µg/kg Milk ►M67Provisional MRLs expire on 1 July
2001◄
Bovine, ovine, porcine 200 µg/kg Muscle
200 µg/kg Fat
200 µg/kg Liver
200 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 74
1.2.2. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
AcetylisovaleryltylosinSum of acetylisovaleryl-
tylosinan d 3-O-acetylty-
losinPorcine 100 µg/kg Muscle Provisional MRLs expire on 1.7.2001
100µg/kg Skinan d fat
100µg/kg Liver
100µg/kg Kidney
ErythromycinMRLs apply to all
microbiological active
residues expressed as
erythromycinequivalen tBovine, ovine 40 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,
poultry400 µg/kg Muscle
400 µg/kg Fat
400 µg/kg Liver
400 µg/kg Kidney
Poultry 200 µg/kg Eggs
JosamycinJosamycin Chicken 200 µg/kg Muscle ►M77Provisional MRLs expire on
1.7.2002 ◄
200 µg/kg Fat
200 µg/kg Liver
400 µg/kg Kidney
200 µg/kg Eggs
Sum of the microbiologi-
cally active metabolites,
expressed as josamycinPorcine 200 µg/kg Muscle Provisional MRLs expire on 1.7.2002
200µg/kg Skinan d fat
200µg/kg Liver
400µg/kg Kidney
TilmicosinTilmicosin Bovin e 40 µg/kg Milk Provisional MRLs expire on 1.1.2001▼M581990R2377 — EN — 18.06.2001 — 021.001 — 75▼M74
▼M58
▼M60
▼M70
1.2.4. Cephalosporins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefacetrile Cefacetrile Bovine 125 µg/kg Milk Provisional MRLs expire on 1.1.2001
For intrammamary use only
Cefalonium Cefalonium Bovine 10 µg/kg Milk Provisional MRLs expire on 1.7.2001
Cefoperazone Cefoperazone Bovine 50 µg/kg Milk Provisional MRLs expire on 1 January 2001
Cefquinome Cefquinome Porcine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2000
50µg/kg Skin+ fat
100µg/kg Liver
200µg/kg Kidney
CephapirinSum of cephapirin an d
desacetylcephapirinBovine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
50µg/kg Liver
100µg/kg Kidney
10µg/kg Milk
1.2.5. Aminoglycosides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Aminosidine Aminosidine Bovine, porcine, rabbits,
chicken500 µg/kg Muscle Provisional MRLs expire on 1 July 2000
1 500 µg/kg Liver
1 500 µg/kg Kidney
Apramycin Apramycin Bovine 1 000 µg/kg Muscle Provisional MRLs expire on 1 July 1999▼M591990R2377 — EN — 18.06.2001 — 021.001 — 76▼M71
▼M67
▼M61
▼M59
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
For use in non-lactating
cattle only1 000 µg/kg Fat
10000 µg/kg Liver
20000 µg/kg Kidney
Porcine 1 000 µg/kg Muscle
1 000 µg/kg Skinan d fat1 000 µg/kg Liver5 000 µg/kg Kidney
Dihydrostreptomycin Dihydrostreptomycin Bovine, ovine 500 µg/kg Muscle Provisional MRLs expire on 1.6.2002
500µg/kg Fat
500µg/kg Liver
1 000 µg/kg Kidney
200µg/kg Milk
Porcine 500 µg/kg Muscle
500µg/kg Skinan d fat
500µg/kg Liver
1 000 µg/kg Kidney
Gentamicin Gentamicin Bovine 100 µg/kg Milk Provisional MRLs expire on 1.6.2002
Bovine, porcine 50 µg/kg Muscle
50µg/kg Fat
200µg/kg Liver
750µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 77▼M76
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Kanamycin Kanamycin Rabbits 100 µg/kg Muscle Provisional MRLs expire on 1.1.2002
100µg/kg Fat
600µg/kg Liver
2 500 µg/kg Kidney
Bovine, ovine 100 µg/kg Muscle
100µg/kg Fat
600µg/kg Liver
2 500 µg/kg Kidney
150µg/kg Milk
Porcine, chicken 100 µg/kg Muscle
100µg/kg Skin+ fat
600µg/kg Liver
2 500 µg/kg Kidney
Neomycin (including framycetin) Neomycin B Bovine, porcine, chicken 500 µg/kg Muscle Provisional MRLs expire on 1.6.2002
500µg/kg Fat
500µg/kg Liver
5 000 µg/kg Kidney
Bovine 500 µg/kg Milk
Chicken500 µg/kg Eggs
Spectinomycin Spectinomycin Bovine 200 µg/kg Milk Provisional MRLs expire on 1 July 2000
Bovine, porcine, poultry 300 µg/kg Muscle
500 µg/kg Fat
2 000 µg/kg Liver5 000 µg/kg Kidney▼M761990R2377 — EN — 18.06.2001 — 021.001 — 78▼M65
▼M76
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Ovine
Not for use inan imals
from which milk is
produced for human
consumption300µg/kg Muscle Provisional MRLs expire on 1.1.2002
500µg/kg Fat
2 000 µg/kg Liver
5 000 µg/kg Kidney
Chicken200 µg/kg Eggs
Streptomycin Streptomycin Bovine, ovine 500 µg/kg Muscle Provisional MRLs expire on 1.6.2002
500µg/kg Fat
500µg/kg Liver
1 000 µg/kg Kidney
200µg/kg Milk
Porcine 500 µg/kg Muscle
500µg/kg Skinan d fat
500µg/kg Liver
1 000 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 79▼M71
▼M76
1.2.6. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Danofloxacin Danofloxacin Porcine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2000
50µg/kg Skinan d fat
200µg/kg Liver
200µg/kg Kidney
Decoquinate Decoquinate Bovine, ovine 500 µg/kg Muscle Provisional MRLs expire on 1 July 2000
500 µg/kg Fat
500 µg/kg Liver
500 µg/kg Kidney
DifloxacinDifloxacin Bovin e
Not for use inan imals
from which milk is
produced for human
consumption400µg/kg Muscle Provisional MRLs expire on 1.1.2001
100µg/kg Fat
1 400 µg/kg Liver
800µg/kg Kidney
Porcine 400 µg/kg Muscle
100µg/kg Skinan d fat
800µg/kg Liver
800µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinOvine 100 µg/kg Muscle Provisional MRLs expire on 1 July 1999
100 µg/kg Fat
300 µg/kg Liver
200 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 80▼M60
▼M58
▼M62
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Flumequine Flumequine Bovine, ovine, porcine,
chicken50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
50 µg/kg Fat or skinan d fat
100 µg/kg Liver
300 µg/kg Kidney
Salmonidae 150 µg/kg Muscle and skin
Marbofloxacin Marbofloxacin Bovine 150 µg/kg Muscle Provisional MRLs expire on 1 July 2000
50 µg/kg Fat
150 µg/kg Liver150 µg/kg Kidney
75 µg/kg Milk
Porcine 150 µg/kg Muscle
50 µg/kg Skinan d fat
150 µg/kg Liver150 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 81
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Oxolinic acid Oxolinic acid Bovine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
150µg/kg Liver
150µg/kg Kidney
Porcine 100 µg/kg Muscle
50µg/kg Skin+ fat
150µg/kg Liver
150µg/kg Kidney
Chicken100 µg/kg Muscle
50µg/kg Skin+ fat
150µg/kg Liver
150µg/kg Kidney
50µg/kg Eggs
Finfish 300 µg/kg Muscle and skin in
natural proportions
1.2.9. Polymyxins
Phamarcologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Colistin Colistin Bovine, ovine 50 µg/kg Milk ►M77Provisional MRLs expire on
1.7.2002 ◄
Bovine, ovine, porcine,
chicken, rabbits150 µg/kg Muscle
150 µg/kg Fat
150 µg/kg Liver
200 µg/kg Kidney
Chicken300 µg/kg Eggs▼M581990R2377 — EN — 18.06.2001 — 021.001 — 82▼M59
▼M58
1.2.10. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
NafcillinNafcillin Bovin e 300 µg/kg Muscle Provisional MRLs expire on 1.1.2001
300µg/kg Fat
300µg/kg Liver
300µg/kg Kidney
30µg/kg Milk
Penethamate Benzylpenicillin Ovine 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney
4 µg/kg Milk
Porcine 50 µg/kg Muscle
50 µg/kg Fat
50 µg/kg Liver
50 µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 83▼M59
▼M58
1.2.11. Florfenicol and related compounds
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Florfenicol Sum of florfenicol and
its metabolites measured
as florfenicol-amineFish 1 000 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 July 2001
Thiamphenicol Thiamphenicol Ovine 50 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
50µg/kg Liver
50µg/kg Kidney
Porcine 50 µg/kg Muscle
50µg/kg Skin+ fat
50µg/kg Liver
50µg/kg Kidney
Finfish 50 µg/kg Muscle and skin in
natural proportions
1.2.12. Polypeptides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
BacitracinBacitracin Bovin e 150 µg/kg Milk Provisional MRLs expire on 1.7.2001▼M581990R2377 — EN — 18.06.2001 — 021.001 — 84▼M59
▼M60
1.2.13. Lincosamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Lincomycin Lincomycin Ovine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
500µg/kg Liver
1 500 µg/kg Kidney
150µg/kg Milk
Porcine 100 µg/kg Muscle
50µg/kg Skin+ fat
500µg/kg Liver
1 500 µg/kg Kidney
Chicken100 µg/kg Muscle
50µg/kg Skin+ fat
500µg/kg Liver
1 500 µg/kg Kidney
50µg/kg Eggs
PirlimycinPirlimycin Bovin e 100 µg/kg Muscle Provisional MRLs expire on 1.7.2000
100µg/kg Fat
1 000 µg/kg Liver
400µg/kg Kidney
100µg/kg Milk▼M591990R2377 — EN — 18.06.2001 — 021.001 — 85
▼M60
1.2.14. Pleuromutilines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
TiamulinSum of metabolites that
may be hydrolysed to 8-
a-hydroxymutilinTurkey 100 µg/kg Muscle Provisional MRLs expire on 1.7.2001
100µg/kg Skinan d fat
300µg/kg Liver
2. Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Phenol derivatives including salicylanides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Oxyclozanide Oxyclozanide Bovine 20 µg/kg Muscle ►M77Provisional MRLs expire on
1.7.2002 ◄20µg/kg Fat
500µg/kg Liver
100µg/kg Kidney
10µg/kg Milk
Ovine 20 µg/kg Muscle
20µg/kg Fat
500µg/kg Liver
100µg/kg Kidney
2.1.2. Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Albendazole sulphoxide Sum of albendazole,
albendazole sulphoxide,
albendazole sulphone,
and albendazole 2-amino
sulphone, expressed as
albendazoleBovine, ovine 100 µg/kg Milk Provisional MRLs expire on 1 January 2000▼M711990R2377 — EN — 18.06.2001 — 021.001 — 86▼M58
▼M62
▼M58
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Bovine, ovine, pheasant 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney
Mebendazole Sum of mebendazole
methyl (5-(1-hidroxy, 1-
phenyl) methyl-1H-
benzimidazol-2-yl)
carbamate and (2-amino-
1H-benzimidazol-5-yl)
phenylmethanone,
expressed as mebenda-
zole equivalentsOvine, caprine, equidae
Not for use inan imals
from which milk is
produced for human
consumption60µg/kg Muscle Provisional MRLs expire on 1.1.2002
60µg/kg Fat
400µg/kg Liver
60µg/kg Kidney
Netobimin Sum of netobimin and
albendazole and metabo-
lites of albendazole
measured as 2-amino-
benzimidazole sulphoneBovine, ovine, caprine 100 µg/kg Muscle Provisional MRLs expire on 31 July 1999
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney
100 µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 87▼M71
▼M58
2.1.3. Tetrahydropyrimides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Morantel Sum of residues which
may be hydrolysed to N-
Methyl-1,3-propanedia-
mine and expressed as
morantel equivalentsBovine, ovine 100 µg/kg Muscle Provisional MRLs expire on 1.7.2001
100µg/kg Fat
800µg/kg Liver
200µg/kg Kidney
100µg/kg Milk
Porcine 100 µg/kg Muscle
100µg/kg Skinan d fat
800µg/kg Liver
200µg/kg Kidney
2.1.5. Piperazine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Piperazine Piperazine Porcine 400 µg/kg Muscle Provisional MRLs expire on 1.7.2001
800µg/kg Skinan d fat
2 000 µg/kg Liver
1 000 µg/kg Kidney
Chicken2 000 µg/kg Eggs▼M621990R2377 — EN — 18.06.2001 — 021.001 — 88▼M70
2.1.6. Salicylanilides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Rafoxanide Rafoxanide Bovine
Not for use inan imals
from which milk is
produced for human
consumption30µg/kg Muscle Provisional MRLs expire on 1.7.2001
30µg/kg Fat
10µg/kg Liver
40µg/kg Kidney
Ovine
Not for use inan imals
from which milk is
produced for human
consumption100µg/kg Muscle
250µg/kg Fat
150µg/kg Liver
150µg/kg Kidney
2.2. Agents acting against ectoparasites
2.2.1. Formamidines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all
metabolites containing
the 2,4-DMA moeity,
expressed as amitrazBees 200 µg/kg Honey Provisional MRLs expire on 1 July 1999
2.2.2. Iminophenyl thiazolidine derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cymiazole Cymiazole Bees 1 000 µg/kg Honey ►M65Provisional MRLs expire on
1.7.2001 ◄▼M711990R2377 — EN — 18.06.2001 — 021.001 — 89▼M58
2.2.3. Pyretrinan d pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyfluthrin Cyfluthrin Bovine 10 µg/kg Muscle Provisional MRLs expire on 1 January 2001
50 µg/kg Fat10 µg/kg Liver
10 µg/kg Kidney
20 µg/kg Milk
Further provisions in
Council Directive 94/29/
EC are to be observed
(OJ L 189, 23.7.1994, p.
67)
AlphacypermethrinCypermethrin (sum of
isomers)Bovine, ovine 20 µg/kg Muscle Provisional MRLs expire on 1.1.2002
200µg/kg Fat
20µg/kg Liver
20µg/kg Kidney
20µg/kg Milk
Further provisions in
Council Directive 93/57/
EC (OJ L 211,
23.8.1992, p. 1) are to be
observed
Chicken50 µg/kg Muscle
50µg/kg Skin+ fat
50µg/kg Liver
50µg/kg Kidney
50µg/kg Eggs▼M581990R2377 — EN — 18.06.2001 — 021.001 — 90▼M61
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
CypermethrinCypermethrin (sum of
isomers)Bovine, ovine, caprine 20 µg/kg Muscle Provisional MRLs expire on 1.1.2002
200µg/kg Fat
20µg/kg Liver
20µg/kg Kidney
20µg/kg Milk
Further provisions in
Council Directive 93/57/
EC (OJ L 211,
23.8.1992, p. 1) are to be
observed
Porcine 20 µg/kg Muscle
200µg/kg Skin+ fat
20µg/kg Liver
20µg/kg Kidney
Chicken50 µg/kg Muscle
50µg/kg Skin+ fat
50µg/kg Liver
50µg/kg Kidney
50µg/kg Eggs
Salmonidae 50 µg/kg Muscle and skin in
natural proportions▼M611990R2377 — EN — 18.06.2001 — 021.001 — 91
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
DeltamethrinDeltamethrin Bovin e 10 µg/kg Muscle Provisional MRLs expire on 1 July 2001
50µg/kg Fat
10µg/kg Liver
10µg/kg Kidney
20µg/kg Milk
Ovine
Not for use inan imals
from which milk is
produced for human
consumption10µg/kg Muscle
50µg/kg Fat
10µg/kg Liver
10µg/kg Kidney
Chicken10 µg/kg Muscle
50µg/kg Skin+ fat
10µg/kg Liver
10µg/kg Kidney
50µg/kg Eggs
Finfish 10 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1.1.2002
PermethrinPermethrin (sum of
isomers)Bovine, caprine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
500µg/kg Fat
50µg/kg Liver
50µg/kg Kidney
50µg/kg Milk
Further provisions in
CommissionDirective
98/82/EC are to be
observed (OJ L 290,
29.10.1998, p. 25.)
Porcine, chicken 100 µg/kg Muscle▼M611990R2377 — EN — 18.06.2001 — 021.001 — 92▼M66
▼M76
▼M75
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
500µg/kg Skinan d fat
50µg/kg Liver
50µg/kg Kidney
Chicken50 µg/kg Eggs
2.2.4. Organophosphates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azamethiphos Azamethiphos Salmonidae 100 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 June 1999
Coumafos Coumafos Bees 100 µg/kg Honey Provisional MRLs expire on 1.7.2001
Phoxim Phoxim Porcine 20 µg/kg Muscle Provisional MRLs expire on 1 January 2001
700µg/kg Skinan d fat
20µg/kg Liver
20µg/kg Kidney
Ovine 50 µg/kg Muscle Provisional MRLs expire on 1.7.2001; not for
use inan imals from which milk is produced
for humancon sumption400µg/kg Fat
50µg/kg Kidney
Propetamphos Sum of residues of
propetamphos and desi-
sopropyl-propetamphosOvine
Not for use inan imals
from which milk is
produced for human
consumption90µg/kg Fat Provisional MRLs expire on 1.1.2001
90µg/kg Kidney▼M751990R2377 — EN — 18.06.2001 — 021.001 — 93▼M58
▼M65
▼M68
▼M78
▼M71
2.2.5. Acyl urea derivates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 July 1999
Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1.7.2000
2.2.6. Pyrimidines derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dicyclanil Sum of dicyclanil and
2,4,6-triamino-pyrimi-
dine-5-carbonitrileOvine 200 µg/kg Muscle Provisional MRLs expire on 1 July 2000;
Not for use inan imals from which milk is
produced for humancon sumption50µg/kg Fat
400µg/kg Liver
400µg/kg Kidney
2.2.7. Triazine derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyromazine Cyromazine Ovine 300 µg/kg Muscle Provisional MRLs expire on 1.7.2001
Not for use inan imals from which milk is
produced for humancon sumption300µg/kg Fat
300µg/kg Liver
300µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 94▼M62
▼M69
▼M70
2.3. Agents acting against endo- and ectoparasites
2.3.1. Avermectins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
AbamectinAvermectin B1a Ovin e 20 µg/kg Muscle Provisional MRLs expire on 1.1.2001
50µg/kg Fat
25µg/kg Liver
20µg/kg Kidney
Doramectin Doramectin Deer, inclusing reindeer 20 µg/kg Muscle Provisional MRLs expire on 1.7.2001
100µg/kg Fat
50µg/kg Liver
30µg/kg Kidney
Moxidectin Moxidectin Equidae 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
500 µg/kg Fat
100 µg/kg Liver
50 µg/kg Kidney
2.4. Agents acting against protozoa
2.4.1. Carbanilides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Imidocarb Imidocarb Bovine, ovine 300 µg/kg Muscle Provisonal MRLs expire on 1.1.2002
50µg/kg Fat
2 000 µg/kg Liver
1 500 µg/kg Kidney
50µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 95▼M71
▼M58
▼M60
2.4.2. Quinazolone derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Halofuginone Halofuginone Bovine 10 µg/kg Muscle Provisional MRL's expire on 1.1.2001
25µg/kg Fat
30µg/kg Liver
30µg/kg Kidney
2.4.3. Triazinetrione derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Porcine 100 µg/kg Muscle Provisional MRLs expire on 1.1.2001
150µg/kg Skinan d fat
500µg/kg Liver
250µg/kg Kidney
2.4.4. Other anti-protozoal agents
Pharmacologically active substance(s) Marker residue Animal species MRL Target tissues Other provisions
Amprolium Amprolium Chicken, turkey 200 µg/kg Muscle Provisional MRLs expire on 1.1.2002
200µg/kg Skinan d fat
200µg/kg Liver
400µg/kg Kidney
1 000 µg/kg Eggs▼M621990R2377 — EN — 18.06.2001 — 021.001 — 96▼M70
▼M75
3. Agents acting on the nervous system
3.2. Agents acting on the autonomic nervous system
3.2.1. β2sympathomimetic agents
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Clenbuterol hydrochloride Clenbuterol Bovine 0,1 µg/kg Muscle Provisional MRLs expire on 1 July 2000
Indication: solely for
tocolysis inparturien t
cows0,5 µg/kg Liver
0,5 µg/kg Kidney
0,05 µg/kg Milk
Equidae 0,1 µg/kg Muscle
Indications: tocolysis and
the treatment of respira-
tory ailments0,5 µg/kg Liver
0,5 µg/kg Kidney
3.2.2. Anti-adrenergics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Bovine 5 µg/kg Muscle Provisional MRLs expire on 1.1.2000
5µg/kg Fat
15µg/kg Liver
15µg/kg Kidney
1µg/kg Milk▼M581990R2377 — EN — 18.06.2001 — 021.001 — 97▼M60
5. Anti-inflammatory agents
5.1. Nonsteroidal anti-inflammatory agents
5.1.1. Arylpropionic acid derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carprofen Carprofen Bovine 500 µg/kg Muscle Provisional MRLs expire on 1 January 2000
500 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
Equidae 50 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
1 000 µg/kg Kidney
5.1.2. Enolic acid derivates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Meloxicam Meloxicam Bovine 25 µg/kg Muscle Provisional MRLs expire on 1 January 2000
60 µg/kg Liver
35 µg/kg Kidney
5.1.3. Pyrazolone derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Metamizole 4-Methylaminoantipyrin Bovine, porcine, equidae
Not for use inan imals
from which milk is
produced for human
consumption200µg/kg Muscle Provisional MRLs expire on 1.7.2001
200µg/kg Fat
200µg/kg Liver
200µg/kg Kidney▼M581990R2377 — EN — 18.06.2001 — 021.001 — 98
▼M71
7. Corticoids
7.1. Glucocorticoids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Methylprednisolone Methylprednisolone Bovine 10 µg/kg Muscle Provisional MRLs expire on 1.7.2001. Not for
use inan imals from which milk is produced
for humancon sumption10µg/kg Fat
10µg/kg Liver
10µg/kg Kidney▼M741990R2377 — EN — 18.06.2001 — 021.001 — 99
▼M58
ANNEX IV
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR
WHICHNOMAXIMUMLEVELSCANBEFIXED
Pharmacologically active substance(s)
Aristolochia spp. and preparations thereof
Chloramphenicol
Chloroform
ChlorpromazineColchicineDapsoneDimetridazole
Metronidazole
Nitrofurans (including furazolidone)Ronidazole1990R2377 — EN — 18.06.2001 — 021.001 — 100
▼M2
ANNEX V
Information and particulars to be included in an application for the estab-
lishment of a maximum residue limit for a pharmacologically active
substanceusedinveterinary medicinalproducts
Administrative particulars
1 Name or corporate name and permanent address of the applicant.
2 Name of the veterinary medicinal product.3 Qualitative and quantitative composition in terms of active principles, with
mention of the international non-proprietary name recommended by the
World 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 inaccordan ce 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 Descriptionof physical properties:
— melting point;
— boiling point;— vapour pressure;
— solubility in water and organic solvents, expressed in grams per
litre, with indication of temperature;
— density;— refractive index, rotation, etc.
A.2. Relevant pharmacological studies
2.1 Pharmacodynamics.2.2 Pharmacokinetics.
A.3. Toxicological studies
3.1 Single dose toxicity.3.2 Repeated dose toxicity.
3.3 Tolerance in the target species of animal.
3.4 Reproductive toxicity, including teratogenicity.3.4.1 Study of the effects onreproduction .
3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.
3.5 Mutagenicity.3.6 Carcinogenicity.1990R2377 — EN — 18.06.2001 — 021.001 — 101
▼M2
A.4. Studies of other effects
4.1 Immunotoxicity.
4.2 Microbiological properties of residues.4.2.1 Onthe humangut flora;
4.2.2 On the organisms and microorganisms used for industrial food-
processing.
4.3 Observations in humans.
B.Residue documentation
B.0 Expert reportB.1. Precise identification of the substance concerned by the application
The substance concerned should be identified in accordance with point
A.1. However, where the application relates to one or more veterinary
medicinal products, the product itself should be identified in detail,
including:
— qualitative and quantitative composition;
— purity;— identification of the manufacturer's batch used in the studies; relation-
ship to the final product;
— specific activity and radio-purity of labelled substances;— positionof labelled atoms onthe molecule.
B.2. Residue studies
2.1 Pharmacokinetics
(absorption, distribution, biotransformation, excretion).
2.2 Depletionof residues.2.3 Elaborationof maximum residue limits (MRLS).
B3. Routine analytical method for the detection of residues
3.1 Descriptionof the method.3.2 Validationof the method.
3.2.1 specificity;
3.2.2 accuracy, including sensitivity;3.2.3 precision;
3.2.4 limit of detection;
3.2.5 limit of quantitation;3.2.6 practicability and applicability under normal laboratory conditions;
3.2.7 susceptibility to interference.1990R2377 — EN — 18.06.2001 — 021.001 — 102