Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (repealed) (c. 2377)

1. Introductory Text

2. Article 1. (1) For the purposes of this Regulation, the following definitions...

3. Article 2. The list of pharmacologically active substances used in veterinary medicinal...

4. Article 3. Where, following an evaluation of a pharmacologically active substance used...

5. Article 4. A provisional maximum residue limit may be established for a...

6. Article 5. Where it appears that a maximum residue limit cannot be...

7. Article 6. (1) In order to obtain the inclusion in Annexes I,...

8. Article 7. (1) The Committee for Veterinary Medicinal Products referred to in...

9. Article 8. (1) The Commission shall be assisted by the Standing Committee...

10. Article 9. (1) Where a Member State, as a result of new...

11. Article 10. (1) The Commission shall be assisted by the Standing Committee...

12. Article 11. Any changes which are necessary to adapt Annex V to...

13. Article 12. As soon as possible after the amendment of Annexes I,...

14. Article 13. Member States may not prohibit or impede the putting into...

15. Article 14. With effect from 1 January 1997, the administration to food-producing...

16. Article 15. This Regulation shall in no way prejudice the application of...

17. Article 16. This Regulation shall enter into force on 1 January 1992....

18. Signature

19. 1. ANNEX I

       LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

       1. 1. Anti-infectious agents

          1. 1.1. Chemotheurapeutics

             1. 1.1.1. Sulfonamides

             2. 1.1.2. Diamino pyrimidine derivatives

          2. 1.2. Antibiotics

             1. 1.2.1. Penicillins

             2. 1.2.2. Cephalosporins

             3. 1.2.3. Quinolones

             4. 1.2.4. Macrolides

             5. 1.2.5. Florfenicol and related compounds

             6. 1.2.6. Tetracyclines

             7. 1.2.7. Naphtalene-ringed ansamycin

             8. 1.2.8. Pleuromutilines

             9. 1.2.9. Lincosamides

             10. 1.2.10. Aminoglycosides

             11. 1.2.11. Other antibiotics

             12. 1.2.12. Polypeptides

             13. 1.2.13. Beta-lactamase inhibitors

             14. 1.2.14. Polymyxins

       2. 2. Antiparasitic agents

          1. 2.1. Agents acting against endoparasites

             1. 2.1.1. Salicylanilides

             2. 2.1.2. Tatra-hydro-imidazoles (imidazolthiazoles)

             3. 2.1.3. Benzimidazoles and pro-benzimidazoles

             4. 2.1.4. Phenol derivatives including salicylanides

             5. 2.1.5. Benzenesulphonamides

             6. 2.1.6. Piperazine derivatives

             7. 2.1.7. Tetrahydropyrimides

          2. 2.2. Agents acting against ectoparasites

             1. 2.2.1. Organophosphates

             2. 2.2.2. Formamidines

             3. 2.2.3. Pyrethroids

             4. 2.2.4. Acyl urea derivatives

             5. 2.2.5. Pyrimidines derivatives

             6. 2.2.6. Triazine derivatives

          3. 2.3. Agents acting against endo- and ectoparasites

             1. 2.3.1. Avermectins

          4. 2.4. Agents acting against protozoa

             1. 2.4.1. Triazinetrione derivative

             2. 2.4.2. Quinazolone derivatives

             3. 2.4.3. Carbanilides

       3. 3. Agents acting on the nervous system

          1. 3.1. Agents acting on the central nervous system

             1. 3.1.1. Butyrophenone tranquillisers

          2. 3.2. Agents acting on the autonomic nervous system

             1. 3.2.1. Anti-adrenergics

             2. 3.2.2. β2 sympathomimetic agents

       4. 4. Anti-inflammatory agents

          1. 4.1. Nonsteroidal anti-inflammatory agents

             1. 4.1.1. Arylpropionic acid derivative

             2. 4.1.2. Fenamate group derivatives

             3. 4.1.3. Enolic acid derivates

             4. 4.1.4. Oxican derivatives

             5. 4.1.5. Pyrazolone derivatives

             6. 4.1.6. Phenyl acetic acid derivatives

       5. 5. Corticoides

          1. 5.1. Glucocorticoides

       6. 6. Agents acting on the reproductive system

          1. 6.1. Progestogens

    2. ANNEX II

       LIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS

       1. 1. Inorganic chemicals

       2. 2. Organic compounds

       3. 3. Substances generally recognised as safe

       4. 4. Substances used in homeopathic veterinary medicinal products

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

       6. 6. Substances of vegetable origin

       7. 7. Anti-infectious agents

    3. ANNEX III

       LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VETERINARY MEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED

       1. 1. Anti-infectious agents

          1. 1.1. Chemotheurapeutics

             1. 1.1.2. Benzenesulphonamides

          2. 1.2. Antibiotics

             1. 1.2.1. Beta-lactamase inhibitors

             2. 1.2.2. Macrolides

             3. 1.2.4. Cephalosporins

             4. 1.2.5. Aminoglycosides

             5. 1.2.6. Quinolones

             6. 1.2.9. Polymyxins

             7. 1.2.10. Penicillins

             8. 1.2.11. Florfenicol and related compounds

             9. 1.2.12. Polypeptides

             10. 1.2.13. Lincosamides

             11. 1.2.14. Pleuromutilines

       2. 2. Antiparasitic agents

          1. 2.1. Agents acting against endoparasites

             1. 2.1.1. Phenol derivatives including salicylanides

             2. 2.1.2. Benzimidazoles and pro-benzimidazoles

             3. 2.1.3. Tetrahydropyrimides

             4. 2.1.5. Piperazine derivatives

             5. 2.1.6. Salicylanilides

          2. 2.2. Agents acting against ectoparasites

             1. 2.2.1. Formamidines

             2. 2.2.2. Iminophenyl thiazolidine derivative

             3. 2.2.3. Pyretrin and pyrethroids

             4. 2.2.4. Organophosphates

             5. 2.2.5. Acyl urea derivates

             6. 2.2.6. Pyrimidines derivatives

             7. 2.2.7. Triazine derivatives

          3. 2.3. Agents acting against endo- and ectoparasites

             1. 2.3.1. Avermectins

          4. 2.4. Agents acting against protozoa

             1. 2.4.1. Carbanilides

             2. 2.4.2. Quinazolone derivatives

             3. 2.4.3. Triazinetrione derivatives

             4. 2.4.4. Other anti-protozoal agents

       3. 3. Agents acting on the nervous system

          1. 3.2. Agents acting on the autonomic nervous system

             1. 3.2.1. β 2 sympathomimetic agents

             2. 3.2.2. Anti-adrenergics

       4. 5. Anti-inflammatory agents

          1. 5.1. Nonsteroidal anti-inflammatory agents

             1. 5.1.1. Arylpropionic acid derivative

             2. 5.1.2. Enolic acid derivates

             3. 5.1.3. Pyrazolone derivatives

       5. 6. Agents acting on the reproductive system

          1. 6.1. Progestogens

       6. 7. Corticoids

          1. 7.1. Glucocorticoids

    4. ANNEX IV

       LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH NO MAXIMUM LEVELS CAN BE FIXED

       1. Pharmacologically active substance(s) Aristolochia spp. and preparations thereof Chloramphenicol Chloroform...

    5. ANNEX V

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

       1. Administrative particulars

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

          2. 2 Name of the veterinary medicinal product.

          3. 3 Qualitative and quantitative composition in terms of active principles, with...

          4. 4 Manufacturing authorization, if any.

          5. 5 Marketing authorization, if any.

          6. 6 Summary of the characteristics of the veterinary medicinal product(s) prepared...

          7. A. Safety documentation

             1. A.0. Expert report

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

                1. 1.1 International non-proprietary name (INN).

                2. 1.2 International Union of Pure and Applied Chemistry (IUPAC) name.

                3. 1.3 Chemical Abstract Service (CAS) name.

                4. 1.4 Classification:

                5. 1.5 Synonyms and abbreviations.

                6. 1.6 Structural formula.

                7. 1.7 Molecular formula.

                8. 1.8 Molecular weight.

                9. 1.9 Degree of impurity.

                10. 1.10 Qualitative and quantitative composition of impurities.

                11. 1.11 Description of physical properties:

             3. A.2. Relevant pharmacological studies

                1. 2.1 Pharmacodynamics.

                2. 2.2 Pharmacokinetics.

             4. A.3. Toxicological studies

                1. 3.1 Single dose toxicity.

                2. 3.2 Repeated dose toxicity.

                3. 3.3 Tolerance in the target species of animal.

                4. 3.4 Reproductive toxicity, including teratogenicity.

                   1. 3.4.1 Study of the effects on reproduction.

                   2. 3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.

                5. 3.5 Mutagenicity.

                6. 3.6 Carcinogenicity.

             5. A.4. Studies of other effects

                1. 4.1 Immunotoxicity.

                2. 4.2 Microbiological properties of residues.

                   1. 4.2.1 On the human gut flora;

                   2. 4.2.2 On the organisms and microorganisms used for industrial food-processing.

                3. 4.3 Observations in humans.

          8. B. Residue documentation

             1. B.0 Expert report

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

             3. B.2. Residue studies

                1. 2.1 Pharmacokinetics

                2. 2.2 Depletion of residues.

                3. 2.3 Elaboration of maximum residue limits (MRLS).

             4. B3. Routine analytical method for the detection of residues

                1. 3.1 Description of the method.

                2. 3.2 Validation of the method.

                   1. 3.2.1 specificity;

                   2. 3.2.2 accuracy, including sensitivity;

                   3. 3.2.3 precision;

                   4. 3.2.4 limit of detection;

                   5. 3.2.5 limit of quantitation;

                   6. 3.2.6 practicability and applicability under normal laboratory conditions;

                   7. 3.2.7 susceptibility to interference.