1990R2377 — EN — 08.05.1999 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL REGULATION (EEC) No 2377/90
of 26 June 1990
laying down a Community procedure for the establishment of maximum residue limits of veter-
inary medicinal products in foodstuffs of animal origin
(OJ L 224, 18.8.1990, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EEC) No 675/92 of 18 March 1992 L 73 8 19.3.1992
►M2 Commission Regulation (EEC) No 762/92 of 27 March 1992 L 83 14 28.3.1992
►M3 Commission Regulation (EEC) No 3093/92 of 27 October 1992 L 311 18 28.10.1992
►M4 Commission Regulation (EEC) No 895/93 of 16 April 1993 L 93 10 17.4.1993
►M5 Council Regulation (EEC) No 2901/93 of 18 October 1993 L 264 1 23.10.1993
►M6 Commission Regulation (EC) No 3425/93 of 14 December 1993 L 312 12 15.12.1993
►M7 Commission Regulation (EC) No 3426/93 of 14 December 1993 L 312 15 15.12.1993
►M8 Commission Regulation (EC) No 955/94 of 28 April 1994 L 108 8 29.4.1994
►M9 Commission Regulation (EC) No 1430/94 of 22 June 1994 L 156 6 23.6.1994
►M10 Commission Regulation (EC) No 2701/94 of 7 November 1994 L 287 7 8.11.1994
►M11 Commission Regulation (EC) No 2703/94 of 7 November 1994 L 287 19 8.11.1994
►M12 Commission Regulation (EC) No 3059/94 of 15 December 1994 L 323 15 16.12.1994
►M13 Commission Regulation (EC) No 1102/95 of 16 May 1995 L 110 9 17.5.1995
►M14 Commission Regulation (EC) No 1441/95 of 26 June 1995 L 143 22 27.6.1995
►M15 Commission Regulation (EC) No 1442/95 of 26 June 1995 L 143 26 27.6.1995
►M16 Commission Regulation (EC) No 1798/95 of 25 July 1995 L 174 20 26.7.1995
►M17 Commission Regulation (EC) No 2796/95 of 4 December 1995 L 290 1 5.12.1995
►M18 Commission Regulation (EC) No 2804/95 of 5 December 1995 L 291 8 6.12.1995
►M19 Commission Regulation (EC) No 281/96 of 14 February 1996 L 37 9 15.2.1996
►M20 Commission Regulation (EC) No 282/96 of 14 February 1996 L 37 12 15.2.1996
►M21 Commission Regulation (EC) No 1140/96 of 25 June 1996 L 151 6 26.6.1996
►M22 Commission Regulation (EC) No 1147/96 of 25 June 1996 L 151 26 26.6.1996
►M23 Commission Regulation (EC) No 1311/96 of 8 July 1996 L 170 4 9.7.1996
►M24 Commission Regulation (EC) No 1312/96 of 8 July 1996 L 170 8 9.7.1996
►M25 Commission Regulation (EC) No 1433/96 of 23 July 1996 L 184 21 24.7.1996
►M26 Commission Regulation (EC) No 1742/96 of 6 September 1996 L 226 5 7.9.1996
►M27 Commission Regulation (EC) No 1798/96 of 17 September 1996 L 236 23 18.9.1996
►M28 Commission Regulation (EC) No 2010/96 of 21 October 1996 L 269 5 22.10.1996
►M29 Commission Regulation (EC) No 2017/96 of 22 October 1996 L 270 2 23.10.1996
►M30 Commission Regulation (EC) No 2034/96 of 24 October 1996 L 272 2 25.10.1996
1990R2377 — EN — 08.05.1999 — 002.001 — 2
►M31 Commission Regulation (EC) No 17/97 of 8 January 1997 L 5 12 9.1.1997
►M32 Commission Regulation (EC) No 211/97 of 4 February 1997 L 35 1 5.2.1997
►M33 Commission Regulation (EC) No 270/97 of 14 February 1997 L 45 8 15.2.1997
►M34 Council Regulation (EC) No 434/97 of 3 March 1997 L 67 1 7.3.1997
►M35 Commission Regulation (EC) No 716/97 of 23 April 1997 L 106 10 24.4.1997
►M36 Commission Regulation (EC) No 748/97 of 25 April 1997 L 110 21 26.4.1997
►M37 Commission Regulation (EC) No 749/97 of 25 April 1997 L 110 24 26.4.1997
►M38 Commission Regulation (EC) No 1836/97 of 24 September 1997 L 263 6 25.9.1997
►M39 Commission Regulation (EC) No 1837/97 of 24 September 1997 L 263 9 25.9.1997
►M40 Commission Regulation (EC) No 1838/97 of 24 September 1997 L 263 14 25.9.1997
►M41 Commission Regulation (EC) No 1850/97 of 25 September 1997 L 264 12 26.9.1997
►M42 Commission Regulation (EC) No 121/98 of 16 January 1998 L 11 11 17.1.1998
►M43 Commission Regulation (EC) No 426/98 of 23 February 1998 L 53 3 24.2.1998
►M44 Commission Regulation (EC) No 613/98 of 18 March 1998 L 82 14 19.3.1998
►M45 Commission Regulation (EC) No 1000/98 of 13 May 1998 L 142 18 14.5.1998
►M46 Commission Regulation (EC) No 1076/98 of 27 May 1998 L 154 14 28.5.1998
►M47 Commission Regulation (EC) No 1191/98 of 9 June 1998 L 165 6 10.6.1998
►M48 Commission Regulation (EC) No 1568/98 of 17 July 1998 L 205 1 22.7.1998
►M49 Commission Regulation (EC) No 1569/98 of 17 July 1998 L 205 7 22.7.1998
►M50 Commission Regulation (EC) No 1570/98 of 17 July 1998 L 205 10 22.7.1998
►M51 Commission Regulation (EC) No 1916/98 of 9 September 1998 L 250 8 10.9.1998
►M52 Commission Regulation (EC) No 1917/98 of 9 September 1998 L 250 13 10.9.1998
►M53 Commission Regulation (EC) No 1958/98 of 15 September 1998 L 254 7 16.9.1998
►M54 Commission Regulation (EC) No 2560/98 of 27 November 1998 L 320 28 28.11.1998
►M55 Commission Regulation (EC) No 2686/98 of 11 December 1998 L 337 20 12.12.1998
►M56 Commission Regulation (EC) No 2692/98 of 14 December 1998 L 338 5 15.12.1998
►M57 Commission Regulation (EC) No 2728/98 of 17 December 1998 L 343 8 18.12.1998
►M58 Commission Regulation (EC) No 508/1999 of 4 March 1999 L 60 16 9.3.1999
Corrected by:
►C1 Corrigendum, OJ L 222, 20.9.1995, p. 17 (1442/95)
►C2 Corrigendum, OJ L 316, 5.12.1996, p. 37 (1442/95)
►C3 Corrigendum, OJ L 76, 18.3.1997, p. 34 (1442/95)
►C4 Corrigendum, OJ L 271, 8.10.1998, p. 42 (1568/98)
▼B
COUNCIL REGULATION (EEC) No 2377/90
of 26 June 1990
laying down a Community procedure for the establishment of
maximum residue limits of veterinary medicinal products in food-
stuffs of animal origin
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas the use of veterinary medicinal products in food-producing
animals may result in the presence of residues of foodstuffs obtained
from treated animals;
Whereas as a result of scientific and technical progress it is possible to
detect the presence of residues of veterinary medicines in foodstuffs at
ever lower levels; whereas it is therefore necessary to establish
maximum residue limits for pharmacologically active substances which
are used in veterinary medicinal products in respect of all the various
foodstuffs of animal origin, including meat, fish, milk, eggs and honey;
Whereas in order to protect public health, maximum residue limits
must be established in accordance with generally recognized principles
of safety assessment, taking into account any other scientific assess-
ment of the safety of the substances concerned which may have been
undertaken by international organizations, in particular the Codex
Alimentarius or, where such substances are used for other purposes,
by other scientific committees established within the Community;
Whereas the use of veterinary medicinal products plays an important
part in agricultural production; whereas the establishment of maximum
residue levels will facilitate the marketing of foodstuffs of animal
origin;
Whereas the establishment of different maximum residue levels by
Member States may hinder the free movement of foodstuffs and of
veterinary medicinal products themselves;
Whereas it is therefore necessary to lay down a procedure for the
establishment of maximum residue levels of veterinary medicinal
products by the Community, following a single scientific assessment
of the highest possible quality;
Whereas the need for the establishment of maximum residue levels
throughout the Community is recognized in the Community rules
relating to trade in foodstuffs of animal origin;
Whereas provisions must be adopted with a view to the systematic
establishment of maximum residue levels for new substances capable
of pharmacological action intended for administration to food-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 number
of substances involved, long transitional arrangements are required;
Whereas, after scientific assessment by the Committee for Veterinary
Medicinal Products, maximum residue levels must be adopted by a1990R2377 — EN — 08.05.1999 — 002.001 — 3
(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 under
Council 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 respect
of the testing of veterinary medicinal products (1), as last amended by
Directive 87/20/EEC (2); whereas an urgent procedure is also required
to ensure the swift review of any tolerance which might prove insuffi-
cient to protect public health;
Whereas medicinally induced immunological responses are usually
indistinguishable from those which arise naturally, and do not affect
consumers of food of animal origin;
Whereas the information necessary to assess the safety of residues
should be presented in accordance with the principles laid down by
Directive 81/852/EEC,
HAS ADOPTED THIS REGULATION:
Article 1
1. For the purposes of this Regulation, the following definitions
shall apply:
(a) ‘residues of veterinary medicinal products’: means all pharmacolo-
gically active substances, whether active principles, excipients or
degradation products, and their metabolites which remain in food-
stuffs obtained from animals to which the veterinary medicinal
product in question has been administered;
(b) ‘maximum residue limit’: means the maximum concentration of
residue resulting from the use of a veterinary medicinal product
(expressed in mg/kg or µg/kg on a fresh weight basis) which may
be accepted by the Community to be legally permitted or 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 into
account 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 are
available.
2. This Regulation shall not apply to active principles of biological
origin intended to produce active or passive immunity or to diagnose a
state of immunity used in immunological veterinary medicinal
products.
Article 2
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which maximum residue limits have
been established shall be contained in Annex I, which shall be adopted
in accordance with the procedure laid down in Article 8. Except as
provided for in Article 9, any amendments to Annex I shall be adopted
in accordance with the same procedure.1990R2377 — EN — 08.05.1999 — 002.001 — 4
(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 a
maximum residue limit, that substance shall be included in a list in
Annex II, which shall be adopted in accordance with the procedure
laid down in Article 8. Except as provided for in Article 9, any 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 on
the date of entry into force of this Regulation, provided that there are
no grounds for supposing that residues of the substance concerned at
the level proposed present a hazard for the health of the consumer. A
provisional maximum residue limit shall apply for a defined period of
time, which shall not exceed five years. That period may be extended
once only in exceptional cases for a period not in excess of two years if
that proves expedient for the completion of scientific studies in
progress.
In exceptional circumstances, a provisional maximum residue limit
may also be established for a pharmacologically active substance not
previously used in veterinary medicinal products on the date of entry
into force of this Regulation provided that there are no grounds for
supposing that residues of the substance concerned at the limit
proposed present a hazard for the health of the consumer.
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which provisional maximum residue
limits have been established shall be contained in Annex III, which
shall be adopted in accordance with the procedure laid down in Article
8. Except as provided for in Article 9, any amendments to Annex III
shall be adopted in accordance with the same procedure.
Article 5
Where it appears that a maximum residue limit cannot be established in
respect of a pharmacologically active substance used in veterinary
medicinal products because residues of the substances concerned, at
whatever limit, in foodstuffs of animal origin constitute a hazard to
the health of the consumer, that substance shall be included in a list
in Annex IV, which shall be adopted in accordance with the procedure
laid down in Article 8. Except as provided for in Article 9, any 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 Annex I, II, or III of a new
pharmacologically active substance which is:
— intended for use in veterinary medicinal products for administration
to food-producing animals, and
— intended to be placed on the market of one or more Member States
which have not previously authorized the use of the substance
concerned in food-producing animals,
the person responsible for marketing shall submit an application to the
Commission. The application shall contain the information and particu-
lars referred to in Annex V and shall comply with the principles laid
down in Directive 81/852/EEC.
2. After verifying within a period of 30 days that the application is
submitted in correct form, the Commission shall forthwith submit the
application for examination by the Committee for Veterinary Medicinal1990R2377 — EN — 08.05.1999 — 002.001 — 5
▼B
Products set up under Article 16 of Directive 81/851/EEC. The
Committee shall appoint one of its members to act as rapporteur and
to undertake an initial evaluation of the application.
3. Within 120 days of referral of the application to the Committee
for Veterinary Medicinal Products, and having regard to the observa-
tions formulated by the members of the Committee, the Commission
shall prepare a draft of the measures to be taken. If the information
submitted by the person responsible for marketing is insufficient to
enable such a draft to be prepared, that person will be requested to
provide the Committee with additional information for examination.
The rapporteur shall update the evaluation report to take account of
the additional information received.
4. Within 90 days of receipt of the additional information referred to
in paragraph 3, the Commission shall prepare a draft of the measures to
be taken, which shall forthwith be communicated to the Member States
and the person responsible for marketing. Within a further 60 days, the
person responsible for marketing may, at his request, provide oral or
written explanations for consideration by the Committee for Veterinary
Medicinal Products. The Commission may, at the request of the appli-
cant, extend this time limit.
5. Within a further 60 days the Commission shall submit the draft
measures to the Committee for the Adaptation to Technical Progress
of the Directives on the Removal of Technical Barriers to Trade in
the Veterinary Medicinal Products Sector, set up under Article 2b of
Directive 81/852/EEC, for the application of the procedure laid down
in Article 8.
Article 7
1. Paragraphs 2 to 6 shall apply in respect of pharmacologically
active substances which are authorized for use in veterinary medicinal
products on the date of entry into force of this Regulation.
2. After consulting the Committee on Veterinary Medicinal
Products, the Commission shall publish a timetable for the considera-
tion of these substances, including time limits for submission of the
information referred to in Annex V.
The persons responsible for marketing the veterinary medicinal
products concerned shall ensure that all relevant information is
submitted to the Commission in accordance with the requirements of
Annex V and in conformity with the principles laid down in Directive
81/852/EEC before expiry of the relevant time limits. The competent
authorities of the Member States shall bring any other relevant infor-
mation to the attention of the Commission.
3. After verifying within 30 days that the information is submitted in
correct form, the Commission shall forthwith submit the information
for examination to the Committee for Veterinary Medicinal Products,
which shall deliver its opinion within a renewable period of 120 days.
That Committee shall appoint one of its members to act as rapporteur
and to undertake an evaluation of the information.
4. Having regard to the observations formulated by the members of
the Committee for Veterinary Medicinal Products, the Commission
shall prepare, within a maximum period of 30 days, a draft of the
measures to be taken. If the information submitted by the person
responsible for marketing is insufficient to enable such a draft to be
prepared, that person will be requested to provide additional informa-
tion, within a specified period, for examination by the Committee.
The rapporteur shall update the evaluation report to take account of
the additional information received.
5. The draft of the measures to be taken shall be communicated
forthwith by the Commission to the Member States and those persons
responsible for marketing who have submitted information to the
Commission before expiry of the time limit established in accordance
with paragraph 2. These persons may, at their request, provide oral or1990R2377 — EN — 08.05.1999 — 002.001 — 6
▼B
written explanations to the Committee for Veterinary Medicinal
Products.
6. The Commission shall forthwith submit the draft measures to the
Committee for Adaptation to Technical Progress of the Directives on
Veterinary Medicinal Products for the application of the procedure
laid down in Article 8.
Article 8
1. Where the procedure laid down in this Article is to be followed,
the chairman shall, without delay, refer the matter to the Committee for
Adaptation to Technical Progress of the Directives on Veterinary
Medicinal Products either on his own initiative or at the request of a
representative of a Member State.
2. The representative of the Commission shall submit a draft of the
measures to be adopted to the Committee for Adaptation to Technical
Progress. The 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 of the Member
States being weighted as provided for in Article 148 (2) of the Treaty.
The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged where they
are in accordance with the opinion of the Committee.
(b) Where the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is adopted, the
Commission shall without delay propose to the 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 be
adopted by the Commission, unless the Council has voted
against 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 to
be taken, that Member State may temporarily suspend the operation of
the provision concerned in its own territory. In that case, it shall imme-
diately notify the other Member States and the Commission of the
measures, attaching a statement of the reasons therefor.
2. The Commission shall as soon as possible examine the grounds
given by the Member State concerned and, after consulting the
Member States within the Committee for Veterinary Medicinal
Products, it shall then deliver its opinion forthwith and take appropriate
measures; the person responsible for marketing may be requested to
provide the Committee with oral or written explanations. The Commis-
sion shall immediately notify the Council and the Member States of
any measures taken. Any Member State may refer the Commission's
measures to the Council within 15 days of such notification. The
Council, acting by a qualified majority, may take a different decision
within 30 days of the date on which the matter was referred to it.
3. If the Commission considers that it is necessary to amend the
provision of Annex I to IV concerned in order to resolve the 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 a
view to adopting those amendments; the Member State which has taken
measures under paragraph 1 may maintain them until the Council or
the Commission has taken a decision in accordance with the above-
mentioned procedure.1990R2377 — EN — 08.05.1999 — 002.001 — 7
▼B
Article 10
1. Where the procedure laid down in this Article is to be followed,
the chairman shall, without delay, refer the matter to the Committee for
Adaptation to Technical Progress of the Directives on Veterinary
Medicinal Products either on his own initiative or at the request of a
representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be adopted. The 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 of the Member States being weighted as provided
for in Article 148 (2) of the Treaty. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged, where
they are in accordance with the opinion of the Committee.
(b) Where the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is adopted, the
Commission shall without delay propose to the Council the
measures to be adopted. The Council shall act by a qualified
majority.
(c) If within 15 days of the proposals being submitted to it, the
Council has not acted, the proposed measures shall be adopted
by the Commission.
Article 11
Any changes which are necessary to adapt Annex V to take account of
scientific and technical progress shall be adopted in accordance with
the procedure laid down in Article 2c of Directive 81/852/EEC.
Article 12
As soon as possible after the amendment of Annexes I, II, III or IV, the
Commission shall publish a summary of the assessment of the safety of
the substances concerned by the Committee for Veterinary Medicinal
Products. The confidential nature of any proprietary data shall be
respected.
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 the
maximum residue limit provided for in Annex I or III, or if the
substance concerned is listed in Annex II.
Article 14
With effect from 1 January 1997, the administration to food-producing
animals of veterinary medicinal products containing pharmacologically
active substances which are not mentioned in Annexes I, II or III shall
be prohibited within the Community, except in the case of clinical
trials accepted by the competent authorities following notification or
authorization in accordance with the legislation in force and which do
not cause foodstuffs obtained from livestock participating in such trials
to contain residues which constitute a hazard to human health.
However, the date referred to in the previous subparagraph shall be
deferred for substances the use of which was authorized on the date
of entry into force of this Regulation and in respect of which docu-
mented applications for the establishment of maximum residue limits
have been lodged with the Commission or with the European Agency
for the Evaluation of Medicinal Products before 1 January 1996:
— until 1 January 1998 in the case of products derived from pyraso-
lidon, nitroimidazoles, arsanilic acid and phenylbutazone, and
— until 1 January 2000 in the case of other substances.1990R2377 — EN — 08.05.1999 — 002.001 — 8
▼M34
▼M34
The Agency shall publish a list of these substances before 7 June 1997.
Article 15
This Regulation shall in no way prejudice the application of Commu-
nity legislation prohibiting the use in livestock farming of certain
substances having a hormonal action.
Nothing in this Regulation shall prejudice the measures taken by
Member States to prevent the unauthorized use of veterinary medicinal
products.
Article 16
This Regulation shall enter into force on 1 January 1992.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.1990R2377 — EN — 08.05.1999 — 002.001 — 9
▼B
ANNEX I
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED
1. Anti-infectious agents1.1. Chemotheurapeutics1.1.1. Sulfonamides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
All substances belonging to thesulfonamide groupParent drug All food-producing
species100 µg/kg Muscle The combined total residues of all substances
within the sulfonamide group should notexceed 100 µg/kg
100 µg/kg Fat100 µg/kg Liver100 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 Liver150 µg/kg Kidney
30 µg/kg Milk
Porcine 40 µg/kg Skin and fat
50 µg/kg Liver50 µg/kg Kidney
Trimethoprim Trimethoprim Bovine 50 µg/kg Muscle
50 µg/kg Fat50 µg/kg Liver▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 10
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
50 µg/kg Kidney50 µg/kg Milk
Porcine 50 µg/kg Muscle
50 µg/kg Skin and fat50 µg/kg Liver50 µg/kg Kidney
Equidae 100 µg/kg Muscle
100 µg/kg Fat100 µg/kg Liver100 µg/kg Kidney
Poultry 50 µg/kg MuscleNot for use in animalsfrom which eggs areproduced for humanconsumption50 µg/kg Skin and fat 50 µg/kg Liver50 µg/kg Kidney
Fin fish 50 µg/kg Muscle and skin in
natural proportions
1.2. Antibiotics1.2.1. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amoxicyllin Amoxicyllin All food-producing
species50 µg/kg Muscle 50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 11
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Ampicillin Ampicillin All food-producing
species50 µg/kg Muscle 50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
Benzylpenicillin Benzylpenicillin All food-producing
species50 µg/kg Muscle 50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
Cloxacillin Cloxacillin All food-producing
species300 µg/kg Muscle 300 µg/kg Fat300 µg/kg Liver300 µg/kg Kidney
30 µg/kg Milk
Dicloxacillin Dicloxacillin All food-producing
species300 µg/kg Muscle 300 µg/kg Fat300 µg/kg Liver300 µg/kg Kidney
30 µg/kg Milk
Oxacillin Oxacillin All food-producing
species300 µg/kg Muscle 300 µg/kg Fat300 µg/kg Liver300 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 12
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
30 µg/kg Milk
Penethamate Benzylpenicillin Bovine 50 µg/kg Muscle
50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
1.2.2. Cephalosporins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cefazolin Cefazolin Bovine, ovine, caprine 50 µg/kg Milk Cefquinome Cefquinome Bovine 50 µg/kg Muscle
50 µg/kg Fat
100 µg/kg Liver200 µg/kg Kidney
20 µg/kg Milk
1.2.3. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Danofloxacin Danofloxacin Bovine 200 µg/kg Muscle
Not for use in animalsfrom which milk isproduced for humanconsumption100 µg/kg Fat 400 µg/kg Liver400 µg/kg Kidney
Chicken 200 µg/kg Muscle▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 13
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Not for use in animalsfrom which eggs areproduced for humanconsumption100 µg/kg Skin and fat 400 µg/kg Liver400 µg/kg Kidney
Difloxacin Difloxacin Chicken, turkey 300 µg/kg Muscle
400 µg/kg Skin and fat
1 900 µg/kg Liver
600 µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinBovine 100 µg/kg Muscle
100 µg/kg Fat300 µg/kg Liver200 µg/kg Kidney100 µg/kg Milk
Rabbits 100 µg/kg Muscle
100 µg/kg Fat200 µg/kg Liver300 µg/kg Kidney
Porcine 100 µg/kg Muscle
100 µg/kg Skin and fat200 µg/kg Liver300 µg/kg Kidney
Poultry 100 µg/kg MuscleNot for use in animalsfrom which eggs areproduced for humanconsumption100 µg/kg Skin and fat 200 µg/kg Liver▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 14
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
300 µg/kg Kidney
Sarafloxacin Sarafloxacin Chicken 10 µg/kg Skin and fat
100 µg/kg Liver
Salmonidae 30 µg/kg Muscle and skin in
natural proportions
1.2.4. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Spiramycin Sum of spiramycin and
neospiramycinBovine 200 µg/kg Muscle
300 µg/kg Fat300 µg/kg Liver300 µg/kg Kidney200 µg/kg Milk
Chicken 200 µg/kg Muscle
300 µg/kg Skin and fat400 µg/kg Liver
Tilmicosin Tilmicosin Bovine, ovine, porcine 50 µg/kg Muscle
50 µg/kg Fat
1 000 µg/kg Liver1 000 µg/kg Kidney
Ovine 50 µg/kg MilkChicken 75 µg/kg Muscle Not for use in animals from which eggs are
produced for human consumption
75 µg/kg Skin and fat
1 000 µg/kg Liver
250 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 15
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Tylosin Tylosin A Bovine 100 µg/kg Muscle
100 µg/kg Fat100 µg/kg Liver100 µg/kg Kidney
50 µg/kg Milk
Porcine 100 µg/kg Muscle
100 µg/kg Skin and fat100 µg/kg Liver100 µg/kg Kidney
Poultry 100 µg/kg MuscleNot for use in hensproducing eggs forhuman consumption100 µg/kg Skin and fat 100 µg/kg Liver100 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 asflorfenicol-amineBovine 200 µg/kg Muscle
3 000 µg/kg Liver
300 µg/kg Kidney
Thiamphenicol Thiamphenicol Bovine 50 µg/kg Muscle
50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney50 µg/kg Milk▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 16
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Chicken 50 µg/kg MuscleNot for use in animalsfrom which eggs areproduced for humanconsumption50 µg/kg Skin and fat 50 µg/kg Liver50 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-producingspecies100 µg/kg Muscle 300 µg/kg Liver600 µg/kg Kidney100 µg/kg Milk200 µg/kg Eggs
Doxycycline Doxycycline Bovine 100 µg/kg Muscle
Not for use in animalsfrom which milk isproduced for humanconsumption300 µg/kg Liver 600 µg/kg Kidney
Porcine 100 µg/kg Muscle
300 µg/kg Skin and fat300 µg/kg Liver600 µg/kg Kidney
Poultry 100 µg/kg Muscle▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 17
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Not for use in animalsfrom which eggs areproduced for humanconsumption300 µg/kg Skin and fat 300 µg/kg Liver600 µg/kg Kidney
Oxytetracycline Sum of parent drug and
its 4-epimerAll food-producingspecies100 µg/kg Muscle 300 µg/kg Liver600 µg/kg Kidney100 µg/kg Milk200 µg/kg Eggs
Tetracycline Sum of parent drug and
its 4-epimerAll food-producingspecies100 µg/kg Muscle 300 µg/kg Liver600 µg/kg Kidney100 µg/kg Milk200 µg/kg Eggs
1.2.7. Naphtalene-ringed ansamycin
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Rifaximin Rifaximin Bovine 60 µg/kg Milk
1.2.8. Pleuromutilines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Valnemulin Valnemulin Porcine 50 µg/kg Muscle
500 µg/kg Liver▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 18
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
100 µg/kg Kidney
2. Antiparasitic agents2.1. Agents acting against endoparasites2.1.1. 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 Fat1 000 µg/kg Liver3 000 µg/kg Kidney
Ovine 1 500 µg/kg Muscle
2 000 µg/kg Fat1 500 µg/kg Liver5 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▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 19
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, albendazolesulphone, and albenda-zole 2-amino sulphone,expressed as albendazoleBovine, ovine 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney100 µg/kg Milk
Febantel Sum of extractable resi-
dues which may beoxidised 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 beoxidised to oxfendazolesulphoneBovine, 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, gamebirds50 µg/kg Muscle 50 µg/kg Skin and fat▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 20
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
400 µg/kg Liver300 µg/kg Kidney
Flubendazole Chicken 400 µg/kg Eggs
Oxfendazole Sum of extractable resi-
dues which may beoxidised to oxfendazolesulphoneBovine, ovine 10 µg/kg Milk Bovine, ovine, porcine,equidae50 µg/kg Muscle 50 µg/kg Fat
500 µg/kg Liver
50 µg/kg Kidney
Oxibendazole Oxibendazole Porcine 100 µg/kg Muscle
500 µg/kg Skin and fat200 µg/kg Liver100 µg/kg Kidney
Thiabendazole Sum of thiabendazole
and 5-hydroxythiabenda-zoleBovine 100 µg/kg Muscle
100 µg/kg Fat100 µg/kg Liver100 µg/kg Kidney100 µg/kg Milk
Triclabendazole Sum of extractable resi-
dues that may beoxidised to ketotriclaben-dazoleBovine, ovine 100 µg/kg Muscle Not for use in animals from which milk is
produced for human consumption
100 µg/kg Liver100 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 21
2.2. Agents acting against ectoparasites2.2.1. Organophosphates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Diazinon Diazinon Bovine, ovine, caprine 20 µg/kg Milk
Bovine, porcine, ovine,caprine20 µg/kg Muscle
700 µg/kg Fat
20 µg/kg Liver20 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 containingthe 2,4-DMA moiety,expressed as amitrazBovine 200 µg/kg Fat
200 µg/kg Liver200 µg/kg Kidney
10 µg/kg Milk
Ovine 400 µg/kg Fat
100 µg/kg Liver200 µg/kg Kidney
10 µg/kg Milk
Porcine 400 µg/kg Skin and fat
200 µg/kg Liver200 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 22
2.2.3. Pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Flumethrin Flumethrin (sum of trans-
Z isomers)Bovine 10 µg/kg Muscle
150 µg/kg Fat
20 µg/kg Liver10 µg/kg Kidney30 µg/kg Milk
2.3. Agents acting against endo- and ectoparasites2.3.1. Avermectins
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Abamectin Avermectin B1a Bovine 10 µg/kg Fat
20 µg/kg Liver
Doramectin Doramectin Bovine 10 µg/kg Muscle Not for use in bovine from which milk is
produced for human consumption
150 µg/kg Fat100 µg/kg Liver
30 µg/kg Kidney
Porcine, ovine 20 µg/kg Muscle Not for use in ovine from which milk is
produced for human consumption
100 µg/kg Fat
50 µg/kg Liver30 µg/kg Kidney
Eprinomectin Eprinomectin B1a Bovine 30 µg/kg Muscle
30 µg/kg Fat
600 µg/kg Liver100 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 23
Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
30 µg/kg Milk
Ivermectin 22, 23-Dihydro-aver-
mectin B1aBovine 40 µg/kg Fat
100 µg/kg Liver
Porcine, ovine, equidae 20 µg/kg Fat
15 µg/kg Liver
Deer, including reindeer 20 µg/kg Muscle
100 µg/kg Fat
50 µg/kg Liver20 µg/kg Kidney
Moxidectin Moxidectin Bovine, ovine 50 µg/kg Muscle
500 µg/kg Fat100 µg/kg Liver
50 µg/kg Kidney
2.4. Agents acting against protozoa2.4.1. Triazinetrione derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Toltrazuril Toltrazuril sulfone Chicken 100 µg/kg Muscle Not for use in animals from which eggs are
produced for human consumption
200 µg/kg Skin and fat600 µg/kg Liver400 µg/kg Kidney
Turkey 100 µg/kg Muscle
200 µg/kg Skin and fat600 µg/kg Liver400 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 24
3. Agents acting on the nervous system3.1. Agents acting on the central nervous system3.1.1. Butyrophenone tranquillisers
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Azaperone Sum of azaperone and
azaperolPorcine 100 µg/kg Muscle
100 µg/kg Skin and fat100 µg/kg Liver100 µg/kg Kidney
3.2. Agents acting on the autonomic nervous system3.2.1. Anti-adrenergics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Carazolol Carazolol Porcine 5 µg/kg Muscle
5 µg/kg Skin and fat
25 µg/kg Liver25 µg/kg Kidney
4. Anti-inflammatory agents4.1. Nonsteroidal anti-inflammatory agents4.1.1. Arylpropionic acid derivative
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Vedaprofen Vedaprofen Equidae 50 µg/kg Muscle
20 µg/kg Fat
100 µg/kg Liver▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 25
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1 000 µg/kg Kidney
4.1.2. Fenamate group derivatives
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Tolfenamic acid Tolfenamic acid Bovine 50 µg/kg Muscle
400 µg/kg Liver100 µg/kg Kidney
50 µg/kg Milk
Porcine 50 µg/kg Muscle
400 µg/kg Liver100 µg/kg Kidney
5. Corticoides5.1. Glucocorticoides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dexamethasone Dexamethasone Bovine 0,3 µg/kg Milk
Bovine, porcine, equidae 0,75 µg/kg Muscle
2 µg/kg Liver
0,75 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 26
ANNEX II
LIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS
1. Inorganic chemicals
Pharmacologically active substance(s) Animal species Other provisions
Aluminium distearate All food-producing species
Aluminium hydroxide acetate All food-producing species
Aluminium phosphate All food-producing species
Aluminium tristearate All food-producing species
Ammonium chloride All food-producing species
Bismuth subcarbonate All food-producing species For oral use only
Bismuth subgallate All food-producing species For oral use only
Bismuth subnitrate All food-producing species For oral use only
Bismuth subsalicylate All food-producing species For oral use only
Boric acid and borates All food-producing species
Bromide, sodium salt All mammalian food-producing species For topical use only▼M581990R2377 — EN — 08.05.1999 — 002.001 — 27
Pharmacologically active substance(s) Animal species Other provisions
Calcium acetateCalcium benzoateCalcium carbonateCalcium chlorideCalcium gluconateCalcium hydroxideCalcium hypophosphiteCalcium malateCalcium oxideCalcium phosphateCalcium polyphosphatesCalcium propionateCalcium silicateCalcium stearateCalcium 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
Cobalt carbonate All food-producing species
Cobalt dichloride All food-producing species
Cobalt gluconate All food-producing species
Cobalt oxide All food-producing species
Cobalt sulphate All food-producing species
Cobalt trioxide All food-producing species
Copper chloride All food-producing species
Copper gluconate All food-producing species
Copper heptanoate All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 28
Pharmacologically active substance(s) Animal species Other provisions
Copper methionate All food-producing species
Copper oxide All food-producing species
Copper sulphate All food-producing species
Dicopper oxide All food-producing species
Hydrochloric acid All food-producing species For use as excipient
Hydrogen peroxide All food-producing species
Iodine and iodine inorganic compounds including:— Sodium and potassium-iodide— Sodium and potassium-iodate— Iodophors including polyvinylpyrrolidone-iodineAll food-producing species
Iron dichloride All food-producing species
Iron sulphate All food-producing species
MagnesiumMagnesium sulphateMagnesium hydroxideMagnesium stearateMagnesium glutamateMagnesium orotateMagnesium aluminium silicateMagnesium oxideMagnesium carbonateMagnesium phosphateMagnesium glycerophosphateMagnesium aspartateMagnesium citrateMagnesium acetateMagnesium trisilicateAll food-producing species
Nickel gluconate All food-producing species
Nickel sulphate All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 29
Pharmacologically active substance(s) Animal species Other provisions
Potassium DL-aspartate All food-producing species
Potassium glucuronate All food-producing species
Potassium glycerophosphate All food-producing species
Potassium nitrate All food-producing species
Potassium selenate All food-producing species
Sodium chlorite Bovine For topical use only
Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only
Sodium hypophosphite All food-producing species
Sodium selenate All food-producing species
Sodium selenite All food-producing species
Sulphur Bovine, porcine, ovine, caprine, equidae
Zinc acetateZinc chlorideZinc gluconateZinc oleateZinc stearateAll food-producing species
2. Organic compounds
Pharmacologically active substance(s) Animal species Other provisions
17β-Oestradiol All mammalian food-producing species For therapeutic and zootechnical uses only
2-Aminoethanol All food-producing species
2-Aminoethyl dihydrogenphosphate All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 30
Pharmacologically active substance(s) Animal species Other provisions
2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw
8-Hydroxyquinoline All mammalian food-producing species For topical use in newborn animals only
Acetyl cysteine All food-producing species
Alfacalcidol Bovine For parturient cows only
Alfaprostol RabbitsBovine, porcine, equidae
Bacitracin Bovine For intramammary use in lactating cows only and for all tissues exceptmilk
Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0,05 % only
Benzocaine All food-producing species For use as local anaesthetic only
Benzylalcohol All food-producing species For use as excipient
Betaine All food-producing species
Bronopol Salmonidae For use only on farmed fertilised eggs
Brotizolam Bovine For therapeutic uses only
Buserelin All food-producing species
Butorphanol tartrate Equidae For intravenous administration only
Butyl 4-hydroxybenzoate All food-producing species
Butylscopolaminium bromide All food-producing species
Caffeine All food-producing species
Carbetocin All mammalian food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 31
Pharmacologically active substance(s) Animal species Other provisions
Cefazolin BovineOvine, caprineFor intramammary use, except if the udder may be used as food forhuman consumption
Cetostearyl alcohol All food-producing species
Cetrimide All food-producing species
Chlorhexidine All food-producing species For topical use only
Chlorocresol All food-producing species
Clazuril Pigeon
Cloprostenol Bovine, porcine, equidae
Coco alkyl dimethyl betaines All food-producing species For use as excipient
Corticotropin All food-producing species
D-Phe 6 -luteinising-hormone releasing hormone All food-producing species Dembrexine Equidae
Denaverine hydrochloride Bovine
Detomidine Bovine, equidae For therapeutic uses only
Diclazuril Ovine For oral use in lambs only
Diethyl phtalate All food-producing species
Diethylene glycol monoethyl ether Bovine, porcine
Dimanganese trioxide All food-producing species For oral use only
Dimethyl phtalate All food-producing species
Dinoprost All mammalian food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 32
Pharmacologically active substance(s) Animal species Other provisions
Dinoprost tromethamine All mammalian food-producing species
Diprophylline All food-producing species
Etamiphylline camsylate All food-producing species
Ethanol All food-producing species For use as excipient
Ethyl lactate All food-producing species
Etiproston tromethamine Bovine, porcine
Fertirelin acetate Bovine
Flumethrin Bees (honey)
Folic acid All food-producing species
Glycerol formal All food-producing species
Gonadotrophin releasing hormone All food-producing species
Heptaminol All food-producing species
Hesperidin Equidae
Hesperidin methyl chalcone Equidae
Hexetidine Equidae For topical use only
Human chorion gonadotrophin All food-producing species
Human menopausal urinary gonadotrophin Bovine Hydrocortisone All food-producing species For topical use only
Iodine organic compounds— IodoformAll food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 33
Pharmacologically active substance(s) Animal species Other provisions
Isobutane All food-producing species
Isoflurane Equidae For use as anaesthetic only
Isoxsuprine Bovine, equidae For therapeutic use only in accordance with Council Directive 96/22/
EEC (OJ L 125, 23.5.1996, p. 3)
Ketamine All food-producing species
Ketanserin tartrate Equidae
Ketoprofen Bovine, porcine, equidae
L-tartaric acid and its mono- and di-basic salt of sodium, potassiumand calciumAll food-producing species For use as excipient
Lactic acid All food-producing species
Lecirelin Bovine, equidae, rabbits
Lobeline All food-producing species
Luprostiol All mammalian species
Malic acid All food-producing species For use as excipient
Manganese carbonate All food-producing species For oral use only
Manganese chloride All food-producing species For oral use only
Manganese gluconate All food-producing species For oral use only
Manganese glycerophosphate All food-producing species For oral use only
Manganese oxide All food-producing species For oral use only
Manganese pidolate All food-producing species For oral use only
Manganese ribonucleate All food-producing species For oral use only▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 34
Pharmacologically active substance(s) Animal species Other provisions
Manganese sulphate All food-producing species For oral use only
Mecillinam Bovine For intrauterine use only
Medroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes only
Melatonin Ovine, caprine
Menadione All food-producing species
Menbutone Bovine, ovine, caprine, porcine, equidae
Menthol All food-producing species
Methyl nicotinate Bovine, equidae For topical use only
Mineral hydrocarbons, low to high viscosity including microcristallinewaxes, approximately C10-C60; aliphatic, branched aliphatic andalicyclic compoundsAll food-producing species Excludes aromatic and unsaturated compounds
N-butane All food-producing species
N-butanol All food-producing species For use as excipient
Natamycin Bovine, equidae For topical use only
Neostigmine All food-producing species
Nicoboxil Equidae For topical use only
Nonivamide Equidae For topical use only
Oleyloleate All food-producing species For topical use only
Oxytocin All mammalian food-producing species
Pancreatin All mammalian food-producing species For topical use only
Papain All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 35
Pharmacologically active substance(s) Animal species Other provisions
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 OvineEquidaeFor use in non-lactating sheep only
Pregnant mare serum gonadotrophin All food-producing species Prethcamide (crotethamide and cropropamide) All mammalian food-producing species Procaine All food-producing species
Propane All food-producing species
Propylene glycol All food-producing species
Quatresin All food-producing species For use as preservative only at concentrations of up to 0,5 %
R-Cloprostenol Bovine, porcine, equidae▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 36
Pharmacologically active substance(s) Animal species Other provisions
Rifaximin All mammalian food-producing speciesBovineFor topical use onlyFor intramammary use, except if the udder may be used as food forhuman consumption
Romifidine Equidae For therapeutic uses only
Sodium 2-methyl-2-phenoxy-propanoate Bovine, porcine, caprine, equidae Sodium benzyl 4-hydroxybenzoate All food-producing species
Sodium butyl 4-hydroxybenzoate All food-producing species
Sodium cetostearyl sulphate All food-producing species For topical use only
Somatosalm Salmon
Tanninum All food-producing species
Tau fluvalinate Terpin hydrate Bovine, porcine, ovine, caprine
Tetracaine All food-producing species For use as anaesthetic only
Theobromine All food-producing species
Theophylline All food-producing species
Thiomersal All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %
Thymol All food-producing species
Timerfonate All food-producing species For use only as preservatives in multidose vaccines at a concentration
not exceeding 0,02 %
Trimethylphloroglucinol All food-producing species
Vitamin D All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 37
Pharmacologically active substance(s) Animal species Other provisions
Wool alcohols All food-producing species For topical use only
3. Substances generally recognised as safe
Pharmacologically active substance(s) Animal species Other provisions
Absinthium extract All food-producing species
Acetylmethionine All food-producing species
Aluminium hydroxide All food-producing species
Aluminium monostearate All food-producing species
Ammonium sulfate All food-producing species
Benzoyl benzoate All food-producing species
Benzyl p-hydroxybenzoate All food-producing species
Calcium borogluconate All food-producing species
Calcium citrate All food-producing species
Camphor All food-producing species External use only
Cardamon extract All food-producing species
Diethyl sebacate All food-producing species
Dimethicone All food-producing species
Dimethyl acetamide All food-producing species
Dimethyl sulphoxide All food-producing species
Epinephrine All food-producing species▼M581990R2377 — EN — 08.05.1999 — 002.001 — 38
Pharmacologically active substance(s) Animal species Other provisions
Ethyl oleate All food-producing species
Ethylenediaminetetraacetic acid and salts All food-producing species Eucalyptol All food-producing species
Follicle stimulating hormone (natural FSH from all species and theirsynthetic analogues)All food-producing species
Formaldehyde All food-producing species
Formic acid All food-producing species
Glutaraldehyde All food-producing species
Guaiacol All food-producing species
Heparin and its salts All food-producing species
Human chorionic gonadotropin (natural HCG and its synthetic analo-gues)All food-producing species
Iron ammonium citrate All food-producing species
Iron dextran All food-producing species
Iron glucoheptonate All food-producing species
Isopropanol All food-producing species
Lanolin All food-producing species
Luteinising hormone (natural LH from all species and their syntheticanalogues)All food-producing species
Magnesium chloride All food-producing species
Magnesium gluconate All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 39
Pharmacologically active substance(s) Animal species Other provisions
Magnesium hypophosphite All food-producing species
Mannitol All food-producing species
Methylbenzoate All food-producing species
Monothioglycerol All food-producing species
Montanide All food-producing species
Myglyol All food-producing species
Orgotein All food-producing species
Poloxalene All food-producing species
Poloxamer All food-producing species
Polyethylene glycols (molecular weight ranging from 200 to 10 000) All food-producing species Polysorbate 80 All food-producing species
Serotonin All food-producing species
Sodium chloride All food-producing species
Sodium cromoglycate All food-producing species
Sodium dioctylsulphosuccinate All food-producing species
Sodium formaldehydesulphoxylate All food-producing species
Sodium lauryl sulphate All food-producing species
Sodium pyrosulphite All food-producing species
Sodium stearate All food-producing species
Sodium thiosulphate All food-producing species▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 40
Pharmacologically active substance(s) Animal species Other provisions
Tragacanth All food-producing species
Urea All food-producing species
Zinc oxide All food-producing species
Zinc sulphate 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 productsprovided that their concentration in the product does not exceed onepart per ten thousandAll food-producing species
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 ofAnnex III to European Parliament and Council Directive 95/2/EC (OJL 61, 18.3.1995, p. 1).
6. Substances of vegetable origin
Pharmacologically active substance(s) Animal species Other provisions
Angelicae radix aetheroleum All food-producing species
Anisi aetheroleum All food-producing species
Balsamum peruvianum All food-producing species For topical use only▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 41
Pharmacologically active substance(s) Animal species Other provisions
Carvi aetheroleum All food-producing species
Caryophylli aetheroleum All food-producing species
Chrysanthemi cinerariifolii flos All food-producing species For topical use only
Cinnamomi cassiae aetheroleum All food-producing species
Cinnamomi ceylanici aetheroleum All food-producing species
Citri aetheroleum All food-producing species
Citronellae aetheroleum All food-producing species
Coriandri aetheroleum All food-producing species
Echinacea purpurea All food-producing species For topical use only
Eucalypti aetheroleum All food-producing species
Foeniculi aetheroleum All food-producing species
Hamamelis virginiana All food-producing species For topical use only
Hyperici oleum 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
Matricariae flos All food-producing species
Medicago sativa extractum All food-producing species For topical use only
Melissae folium All food-producing species
Menthae piperitae aetheroleum All food-producing species▼M581990R2377 — EN — 08.05.1999 — 002.001 — 42
Pharmacologically active substance(s) Animal species Other provisions
Millefolii herba All food-producing species
Myristicae aetheroleum All food-producing species For use in newborn animals only
Oxidation products of Terebinthinae oleum Bovine, porcine, ovine, caprine
Pyrethrum extract All food-producing species For topical use only
Quercus cortex All food-producing species
Quillaia saponins All food-producing species
Ricini oleum All food-producing species For use as excipient
Rosmarini aetheroleum All food-producing species
Rosmarini folium All food-producing species
Salviae folium All food-producing species
Sambuci flos All food-producing species
Sinapis nigrae semen All food-producing species
Terebinthinae aetheroleum rectificatum All food-producing species For topical use only
Terebinthinae laricina All food-producing species For topical use only
Thymi aetheroleum All food-producing species
Tiliae flos All food-producing species
Urticae herba All food-producing species▼M581990R2377 — EN — 08.05.1999 — 002.001 — 43
ANNEX III
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VETERINARY MEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE
BEEN FIXED
1. Anti-infectious agents1.1. Chemotheurapeutics1.1.2. 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 Liver400 µg/kg Kidney
1.2. Antibiotics1.2.1. 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 Provisional MRLs expire on 1 July 1999
Bovine, ovine, porcine 200 µg/kg Muscle
200 µg/kg Fat200 µg/kg Liver200 µg/kg Kidney
1.2.2. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Erythromycin MRLs apply to all
microbiological activeresidues expressed aserythromycin equivalentBovine, ovine 40 µg/kg Milk Provisional MRLs expire on 1 June 2000▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 44
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Bovine, ovine, porcine,poultry400 µg/kg Muscle 400 µg/kg Fat400 µg/kg Liver400 µg/kg Kidney
Poultry 200 µg/kg Eggs
Josamycin Josamycin Chicken 200 µg/kg Muscle Provisional MRLs expire on 1 July 2000
200 µg/kg Fat200 µg/kg Liver400 µg/kg Kidney200 µg/kg Eggs
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 Liver1 500 µg/kg Kidney
Apramycin Apramycin Bovine 1 000 µg/kg Muscle Provisional MRLs expire on 1 July 1999
For use in non-lactatingcattle only1 000 µg/kg Fat
10 000 µg/kg Liver20 000 µg/kg Kidney
Porcine 1 000 µg/kg Muscle
1 000 µg/kg Skin and fat1 000 µg/kg Liver5 000 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 45
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Dihydrostreptomycin Dihydrostreptomycin Bovine, ovine 200 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,poultry500 µg/kg Muscle 500 µg/kg Fat500 µg/kg Liver
1 000 µg/kg Kidney
Gentamicin Gentamicin Bovine 100 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, porcine 100 µg/kg Muscle
100 µg/kg Fat200 µg/kg Liver
1 000 µg/kg Kidney
Neomycin (including framycetin) Neomycin Bovine, ovine, caprine 500 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, caprine,porcine, chicken, turkey,duck500 µg/kg Muscle 500 µg/kg Fat500 µg/kg Liver
5 000 µg/kg Kidney
Chicken 500 µg/kg Eggs
Spectinomycin Spectinomycin Bovine 200 µg/kg Milk Provisional MRLs expire on 1 July 2000
Bovine, porcine, poultry 300 µg/kg Muscle
500 µg/kg Fat
2 000 µg/kg Liver5 000 µg/kg Kidney
Streptomycin Streptomycin Bovine, ovine 200 µg/kg Milk Provisional MRLs expire on 1 June 2000
Bovine, ovine, porcine,poultry500 µg/kg Muscle 500 µg/kg Fat▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 46
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
500 µg/kg Liver
1 000 µg/kg Kidney
1.2.6. Quinolones
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Decoquinate Decoquinate Bovine, ovine 500 µg/kg Muscle Provisional MRLs expire on 1 July 2000
500 µg/kg Fat500 µg/kg Liver500 µg/kg Kidney
Enrofloxacin Sum of enrofloxacin and
ciprofloxacinOvine 100 µg/kg Muscle Provisional MRLs expire on 1 July 1999
100 µg/kg Fat300 µg/kg Liver200 µg/kg Kidney
Flumequine Flumequine Bovine, ovine, porcine,
chicken50 µg/kg Muscle Provisional MRLs expire on 1 January 2000 50 µg/kg Fat or skin and fat
100 µg/kg Liver300 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 Skin and fat▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 47
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
150 µg/kg Liver150 µg/kg Kidney
1.2.9. Polymyxins
Phamarcologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Colistin Colistin Bovine, ovine 50 µg/kg Milk Provisional MRLs expire on 1 July 2000
Bovine, ovine, porcine,chicken, rabbits150 µg/kg Muscle 150 µg/kg Fat150 µg/kg Liver200 µg/kg Kidney
Chicken 300 µg/kg Eggs
1.2.10. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Penethamate Benzylpenicillin Ovine 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney
4 µg/kg Milk
Porcine 50 µg/kg Muscle
50 µg/kg Fat50 µg/kg Liver50 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 48
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 measuredas florfenicol-amineFish 1 000 µg/kg Muscle and skin in
natural proportionsProvisional MRLs expire on 1 July 2001
2. Antiparasitic agents2.1. Agents acting against endoparasites2.1.2. 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-aminosulphone, expressed asalbendazoleBovine, ovine 100 µg/kg Milk Provisional MRLs expire on 1 January 2000 Bovine, ovine, pheasant 100 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver
500 µg/kg Kidney
Netobimin Sum of netobimin and
albendazole and metabo-lites of albendazolemeasured 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 Kidney100 µg/kg Milk▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 49
2.2. Agents acting against ectoparasites2.2.1. Formamidines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Amitraz Sum of amitraz and all
metabolites containingthe 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 Provisional MRLs expire on 1 July 1999
2.2.3. Pyretrin and pyrethroids
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Cyfluthrin Cyfluthrin Bovine 10 µg/kg Muscle Provisional MRLs expire on 1 January 2001
50 µg/kg Fat10 µg/kg Liver10 µg/kg Kidney20 µg/kg Milk
Further provisions inCouncil Directive 94/29/EC are to be observed(OJ L 189, 23.7.1994, p.67)▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 50
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
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
2.3. Agents acting against endo- and ectoparasites2.3.1. Avermectins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
Moxidectin Moxidectin Equidae 50 µg/kg Muscle Provisional MRLs expire on 1 January 2000
500 µg/kg Fat100 µg/kg Liver
50 µg/kg Kidney
3. Agents acting on the nervous system3.2. Agents acting on the autonomic nervous system3.2.1. β 2sympathomimetic 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 fortocolysis in parturientcows0,5 µg/kg Liver▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 51
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
0,5 µg/kg Kidney
0,05 µg/kg Milk
Equidae 0,1 µg/kg MuscleIndications: tocolysis andthe treatment of respira-tory ailments0,5 µg/kg Liver 0,5 µg/kg Kidney
5. Anti-inflammatory agents5.1. Nonsteroidal anti-inflammatory agents5.1.1. 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 Liver1 000 µg/kg Kidney
Equidae 50 µg/kg Muscle
100 µg/kg Fat
1 000 µg/kg Liver1 000 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 52
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 Liver35 µg/kg Kidney▼
M581990R2377 — EN — 08.05.1999 — 002.001 — 53
▼M58
ANNEX IV
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR
WHICH NO MAXIMUM LEVELS CAN BE FIXED
Pharmacologically active substance(s)
Aristolochia spp. and preparations thereof
Chloramphenicol
Chloroform
Chlorpromazine
Colchicine
Dapsone
Dimetridazole
Metronidazole
Nitrofurans (including furazolidone)
Ronidazole1990R2377 — EN — 08.05.1999 — 002.001 — 54
▼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
substance used in veterinary medicinal products
Administrative particulars
1 Name or corporate name and permanent address of the applicant.
2 Name of the veterinary medicinal product.
3 Qualitative and quantitative composition in terms of active principles, with
mention of the international non-proprietary name 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 in accordance with Article 5a of Directive 81/851/EEC.
A. Safety documentation
A.0. Expert report
A.1. Precise identification of the substance concerned by the application
1.1 International non-proprietary name (INN).
1.2 International Union of Pure and Applied Chemistry (IUPAC) name.
1.3 Chemical Abstract Service (CAS) name.
1.4 Classification:
— therapeutic;
— pharmacological.
1.5 Synonyms and abbreviations.
1.6 Structural formula.
1.7 Molecular formula.
1.8 Molecular weight.
1.9 Degree of impurity.
1.10 Qualitative and quantitative composition of impurities.
1.11 Description of physical properties:
— melting point;
— boiling point;
— vapour pressure;
— solubility in water and organic solvents, expressed in 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 on reproduction.
3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.
3.5 Mutagenicity.
3.6 Carcinogenicity.1990R2377 — EN — 08.05.1999 — 002.001 — 55
▼M2
A.4. Studies of other effects
4.1 Immunotoxicity.
4.2 Microbiological properties of residues.
4.2.1 On the human gut flora;
4.2.2 On the organisms and microorganisms used for industrial food-
processing.
4.3 Observations in humans.
B. Residue documentation
B.0 Expert report
B.1. Precise identification of the substance concerned by the application
The substance concerned should be identified in accordance with point
A.1. However, where the application relates to one or more veterinary
medicinal products, the product itself should be identified in detail,
including:
— qualitative and quantitative composition;
— purity;
— identification of the manufacturer's batch used in the studies; relation-
ship to the final product;
— specific activity and radio-purity of labelled substances;
— position of labelled atoms on the molecule.
B.2. Residue studies
2.1 Pharmacokinetics
(absorption, distribution, biotransformation, excretion).
2.2 Depletion of residues.
2.3 Elaboration of maximum residue limits (MRLS).
B3. Routine analytical method for the detection of residues
3.1 Description of the method.
3.2 Validation of the method.
3.2.1 specificity;
3.2.2 accuracy, including sensitivity;
3.2.3 precision;
3.2.4 limit of detection;
3.2.5 limit of quantitation;
3.2.6 practicability and applicability under normal laboratory conditions;
3.2.7 susceptibility to interference.1990R2377 — EN — 08.05.1999 — 002.001 — 56