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for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (repealed) (c. 2377)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. . . . . . . . . . ....

3. Article 2. . . . . . . . . . ....

4. Article 3. . . . . . . . . . ....

5. Article 4. . . . . . . . . . ....

6. Article 5. . . . . . . . . . ....

7. Article 6. . . . . . . . . . ....

8. Article 7. . . . . . . . . . ....

9. Article 8. . . . . . . . . . ....

10. Article 9. . . . . . . . . . ....

11. Article 10. . . . . . . . . . ....

12. Article 11. . . . . . . . . . ....

13. Article 12. . . . . . . . . . ....

14. Article 13. . . . . . . . . . ....

15. Article 14. . . . . . . . . . ....

16. Article 15. . . . . . . . . . ....

17. Article 16. . . . . . . . . . ....

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

             15. 1.2.15. Orthosomycins

             16. 1.2.16. Ionophores

       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

             8. 2.1.8. Others

          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

             4. 2.4.4. Ionophores

       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

             7. 4.1.7. Sulphonated fenyl lactones

       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

       8. 8. Anti-inflammatory 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

             6. 2.1.8. Others

          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

             5. 2.4.5. Ionophores

       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

             4. 5.1.4. Sulfonated phenyl lactones

       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. . . . . . . . . . ....

    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 . . . . . . . . . ....

          2. 2 . . . . . . . . . ....

          3. 3 . . . . . . . . . ....

          4. 4 . . . . . . . . . ....

          5. 5 . . . . . . . . . ....

          6. 6 . . . . . . . . . ....

          7. A. Safety documentation

             1. A.0. . . . . . . . . . ....

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

                1. 1.1 . . . . . . . . . ....

                2. 1.2 . . . . . . . . . ....

                3. 1.3 . . . . . . . . . ....

                4. 1.4 Classification:

                5. 1.5 . . . . . . . . . ....

                6. 1.6 . . . . . . . . . ....

                7. 1.7 . . . . . . . . . ....

                8. 1.8 . . . . . . . . . ....

                9. 1.9 . . . . . . . . . ....

                10. 1.10 . . . . . . . . . ....

                11. 1.11 Description of physical properties:

             3. A.2. Relevant pharmacological studies

                1. 2.1 . . . . . . . . . ....

                2. 2.2 . . . . . . . . . ....

             4. A.3. Toxicological studies

                1. 3.1 . . . . . . . . . ....

                2. 3.2 . . . . . . . . . ....

                3. 3.3 . . . . . . . . . ....

                4. 3.4 Reproductive toxicity, including teratogenicity.

                   1. 3.4.1 . . . . . . . . . ....

                   2. 3.4.2 . . . . . . . . . ....

                5. 3.5 . . . . . . . . . ....

                6. 3.6 . . . . . . . . . ....

             5. A.4. Studies of other effects

                1. 4.1 . . . . . . . . . ....

                2. 4.2 Microbiological properties of residues.

                   1. 4.2.1 . . . . . . . . . ....

                   2. 4.2.2 . . . . . . . . . ....

                3. 4.3 . . . . . . . . . ....

          8. B. Residue documentation

             1. B.0 . . . . . . . . . ....

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

             3. B.2. Residue studies

                1. 2.1 Pharmacokinetics

                2. 2.2 . . . . . . . . . ....

                3. 2.3 . . . . . . . . . ....

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

                1. 3.1 . . . . . . . . . ....

                2. 3.2 Validation of the method.

                   1. 3.2.1 . . . . . . . . . ....

                   2. 3.2.2 . . . . . . . . . ....

                   3. 3.2.3 . . . . . . . . . ....

                   4. 3.2.4 . . . . . . . . . ....

                   5. 3.2.5 . . . . . . . . . ....

                   6. 3.2.6 . . . . . . . . . ....

                   7. 3.2.7 . . . . . . . . . ....