1990R2377 — EN — 18.05.1992 — 001.001 — 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
▼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 — 18.05.1992 — 001.001 — 2
(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 — 18.05.1992 — 001.001 — 3
(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 on
the date of entry into force of this Regulation, provided that there are
no grounds for supposing that residues of the substance concerned atthe level proposed present a hazard for the health of the consumer. Aprovisional maximum residue limit shall apply for a defined period oftime, which shall not exceed five years. That period may be extendedonce only in exceptional cases for a period not in excess of two years 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 forsupposing that residues of the substance concerned at the limitproposed present a hazard for the health of the consumer.
The list of pharmacologically active substances used in veterinary
medicinal products in respect of which provisional maximum residue
limits have been established shall be contained in Annex III, whichshall be adopted inaccordan ce with the procedure laid downinArticle8. Except as provided for in Article 9, any amendments to Annex IIIshall 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 veterinarymedicinal products because residues of the substances concerned, atwhatever 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 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 sameprocedure.
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
downinDirective 81/852/EEC.
2. After verifying within a period of 30 days that the application is
submitted incorrect form, the Commissionshall forthwith submit theapplication for examination by the Committee for Veterinary Medicinal1990R2377 — EN — 18.05.1992 — 001.001 — 4
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Products set up under Article 16 of Directive 81/851/EEC. The
Committee shall appoint one of its members to act as rapporteur andto undertake an initial evaluation of the application.
3. Within120 days of referral of the applicationto 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 informationsubmitted by the person responsible for marketing is insufficient toenable such a draft to be prepared, that person will be requested toprovide the Committee with additional information for examination.The rapporteur shall update the evaluationreport to take accoun t of
the additional information received.
4. Within 90 days of receipt of the additional information referred to
inparagraph 3, the Commissionshall 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, theperson responsible for marketing may, at his request, provide oral orwritten explanations for consideration by the Committee for VeterinaryMedicinal Products. The Commission may, at the request of the appli-cant, extend this time limit.
5. Withina further 60 days the Commissionshall submit the draft
measures to the Committee for the Adaptationto Techn ical Progress
of the Directives onthe Removal of Techn ical Barriers to Trade in
the Veterinary Medicinal Products Sector, set up under Article 2b ofDirective 81/852/EEC, for the applicationof the procedure laid downinArticle 8.
Article 7
1. Paragraphs 2 to 6 shall apply inrespect 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 Commissionshall publish a timetable for the con sidera-
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 Commissioninaccordan ce with the requiremen ts ofAnnex V and in conformity with the principles laid down in Directive81/852/EEC before expiry of the relevant time limits. The competentauthorities 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 Commissionshall forthwith submit the in formationfor 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 rapporteurand 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 Commissionshall prepare, withina maximum period of 30 days, a draft of themeasures to be taken. If the information submitted by the personresponsible 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 evaluationreport to take accoun t ofthe additional information received.
5. The draft of the measures to be takenshall be commun icated
forthwith by the Commission to the Member States and those personsresponsible for marketing who have submitted information to theCommissionbefore expiry of the time limit established inaccordan cewith paragraph 2. These persons may, at their request, provide oral or1990R2377 — EN — 18.05.1992 — 001.001 — 5
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written explanations to the Committee for Veterinary Medicinal
Products.
6. The Commissionshall forthwith submit the draft measures to the
Committee for Adaptationto Techn ical Progress of the Directives onVeterinary Medicinal Products for the application of the procedure
laid downinArticle 8.
Article 8
1. Where the procedure laid downinthis Article is to be followed,
the chairmanshall, without delay, refer the matter to the Committee forAdaptation to Technical Progress of the Directives on VeterinaryMedicinal Products either on his own initiative or at the request of arepresentative of a Member State.
2. The representative of the Commission shall submit a draft of the
measures to be adopted to the Committee for Adaptationto Techn ical
Progress. The Committee shall deliver its opinion on the draft within a
time limit set by the chairman, having regard to the urgency of thematter. It shall act by a qualified majority, the votes of the MemberStates being weighted as provided for in Article 148 (2) of the 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 Committee.
(b) Where the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is adopted, the
Commissionshall without delay propose to the Coun cil the
measures to be adopted. The Council shall act by a qualifiedmajority.
(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 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 amendmentof a provision contained in Annexes I to IV is necessary in order toprotect human or animal health, and therefore requires swift action tobe 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 themeasures, 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 theMember States within the Committee for Veterinary MedicinalProducts, it shall then deliver its opinion forthwith and take appropriatemeasures; 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 ofany measures taken. Any Member State may refer the Commission'smeasures to the Council within 15 days of such notification. TheCouncil, acting by a qualified majority, may take a different decision
within30 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.1990R2377 — EN — 18.05.1992 — 001.001 — 6
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Article 10
1. Where the procedure laid downinthis Article is to be followed,
the chairmanshall, 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 arepresentative 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 shalldeliver 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 inArticle 148 (2) of the 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 Committee.
(b) Where the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is adopted, the
Commissionshall without delay propose to the Coun cil themeasures to be adopted. The Council shall act by a qualifiedmajority.
(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.
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 ofthe 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 inother 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 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 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 orauthorization 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.
Article 15
This Regulationshall inn o way prejudice the applicationof Commu-
nity legislation prohibiting the use in livestock farming of certainsubstances having a hormonal action.
Nothing in this Regulation shall prejudice the measures taken by
Member States to prevent the unauthorized use of veterinary medicinalproducts.1990R2377 — EN — 18.05.1992 — 001.001 — 7
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Article 16
This Regulation shall enter into force on 1 January 1992.
This Regulation shall be binding in its entirety and directly applicable
inall Member States.1990R2377 — EN — 18.05.1992 — 001.001 — 8
ANNEX I
Listofpharmacologically activesubstancesforwhichmaximumresiduelimitshavebeenfixed
1.Anti-infectious agents
1.1. Chemotherapeutics
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, liver, kidney, fat The combined total residues of all substances
within the sulfonamide group should not
excced 100 µg/kg
1.2. Antibiotics
1.2.1. Penicillins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.2.1.1.Benzylpenicillin Parent drug All food producing
species50 µg/kg Muscle, liver, kidney, fat
4 µg/kg milk
1.2.1.2. Ampicillin Parent drug All food producing
species50 µg/kg Muscle, liver, kidney, fat
4 µg/kg milk
1.2.1.3. Amoxicillin Parent drug All food producing
species50 µg/kg Muscle, liver, kidney, fat
4 µg/kg milk
1.2.1.4. Oxacillin Parent drug All food producing
species300 µg/kg Muscle, liver, kidney, fat
30 µg/kg milk
1.2.1.5. Cloxacillin Parent drug All food producing
species300 µg/kg Muscle, liver, kidney, fat
30 µg/kg milk
1.2.1.6. Dicloxacillin Parent drug All food producing
species300 µg/kg Muscle, liver, kidney, fat
30 µg/kg milk▼M11990R2377 — EN — 18.05.1992 — 001.001 — 9
2.Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Avermectins
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
2.1.1.1.Ivermectin H2B1a — metabolite Bovine, ovine, porcine,
equine15 µg/kg Liver fat The MRLs for liver and fat apply to all four
species mentioned
20 µg/kg▼M11990R2377 — EN — 18.05.1992 — 001.001 — 10
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ANNEX II
Listofsubstancesnotsubjecttomaximumresiduelevels
(List to be established inaccordan ce with the procedure laid downinArticle 8)1990R2377 — EN — 18.05.1992 — 001.001 — 11
ANNEX III
Listofpharmacologicallyactivesubstancesusedinveterinary medicinalproductsforwhichprovisionalmaximumresiduelimitshavebeenfixed
1.Anti-infectious agents
1.1. Chemotherapeutics
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 Cattle, sheep, goats 100 µg/kg milk Provisional MRL expires on 1 January 1994.
The combined total residues of all substances
within the sulfonamide group should not
exceed 100 µg/kg.
1.1.2. Diamino pyrimidine derivates
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.1.2.1.Trimethoprim Parent drug All food producing
species50 µg/kg Muscle, liver, kidney, fat
milkProvisional MRL expires on 1 January 1996
1.1.3. Nitrofurans
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
All substances belonging to the
nitrofuran groupAll residues with intact
5-nitro structureAll food producing
species5 µg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 July 1993
The combined total residues of all substances
withinthis group should n ot exceed 5 µg/kg▼M11990R2377 — EN — 18.05.1992 — 001.001 — 12
1.1.4. Nitroimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.1.4.1.Dimetridazole All residues with intact
nitroimidazole structureAll food producing
species10 µg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994
1.1.4.2. Ronidazole All residues with intact
nitroimidazole structureAll food producing
species2 µg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994
1.1.n. Other chemotherapeutics
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.1.n.1.Dapsone Parent drug All food producing
species25 µg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994
25 µg/kg milk
1.2. Antibiotics
1.2.2. Tetracyclines
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
All substances belonging to the tetra-
cycline groupParent drug All food producing
species600 µg/kg Kidney, Provisional MRLs expires on 1 January 1994.
The combined total residues of all substances
within the tetracycline group should not exceed
the limits indicated
300 µg/kg liver
200 µg/kg eggs,
100 µg/kg muscle,
100 µg/kg milk▼M11990R2377 — EN — 18.05.1992 — 001.001 — 13
1.2.3. Macrolides
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.2.3.1.Spiramycin Parent drug Bovine, porcine 300 µg/kg Liver Provisional MRLs expire on 1 July 1995
200 µg/kg kidney
50 µg/kg muscle
bovine 150 µg/kg milk The MRLs for liver, kidney and muscle apply
to both the bovine and porcine species
1.2.4. Chloramphenicol and related compounds
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
1.2.4.1.Chloramphenicol Parent drug All food producing
species10 µg/kg Muscle, liver, kidney, fat Provisional MRL expires on July 1994
2.Antiparasitic agents
2.1. Agents acting against endo-parasites
2.1.1. Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
2.1.1.1.Febantel combined residues of
oxfendazole, oxfendazole
sulfone and fenbendazoleAll food producing
species1 000 µg/kg Liver Provisional MRLs expire on 1 July 1995
2.1.1.2. Fenbendazole 10 µg/kg muscle, kidney, fat milk The MRLs cover all residues of febantel,
fenbendazole and oxfendazole
2.1.1.3. Oxfendazole 10 µg/kg▼M11990R2377 — EN — 18.05.1992 — 001.001 — 14
2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles)
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
2.1.2.1.Levamisol Parent drug All food producing
species10 µg/kg Muscle, liver, kidney, fat,
milkProvisional MRL expires on 1 January 1995
3.Agents acting on the nervous system
3.1. Agents acting on the central nervous system
3.1.1. Butyrofenone tranquillizers
Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions
3.1.1.1.Azaperone Azaperol All food producing
species100 µg/kg kidney Provisional MRLs expire on 1 January 1996
50 µg/kg liver, muscle, fat
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
3.2.1.1.Carazolol Parent drug All food producing
species30 µg/kg Liver, kidney Provisional MRLs expire on 1 July 1995
5 µg/kg muscle, fat▼M11990R2377 — EN — 18.05.1992 — 001.001 — 15
▼B
ANNEX IV
Lists of pharmacologically active substances for which no maximum levels
canbefixed
(List to be established inaccordan ce with the procedure laid downinArticle 8)1990R2377 — EN — 18.05.1992 — 001.001 — 16
▼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 — 18.05.1992 — 001.001 — 17
▼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 — 18.05.1992 — 001.001 — 18