1. Introductory Text

2. PART I GENERAL

   1. 1. Title and commencement

   2. 2. General interpretation

   3. 3. Definition of “establishment" and other related definitions

   4. 4. Definition of “intermediary" and other related definitions

   5. 5. Application of these Regulations

3. PART II APPLICATIONS FOR THE COMMUNITYAUTHORISATION OF ZOOTECHNICAL ADDITIVES

   1. 6. Transitional applications

   2. 7. Ordinary applications

   3. 8. Renewal applications

   4. 9. Fees

4. PART III APPROVAL OF ESTABLISHMENTS

   1. 10. Application for the approval of establishments

   2. 11. Approval of establishments

   3. 12. Amendment of approvals

   4. 13. Withdrawal of approvals

   5. 14. Procedure relating to the withdrawal of approvals

   6. 15. Fees

   7. 16. Publication of the national list of approved establishments

   8. 17. Interpretation of Part III

5. PART IV APPROVAL OF INTERMEDIARIES

   1. 18. Applications for the approval of intermediaries

   2. 19. Approval of intermediaries

   3. 20. Amendment of approvals

   4. 21. Withdrawal of approvals

   5. 22. Procedure relating to the withdrawal of approvals

   6. 23. Fees

   7. 24. Publication of the national list of approved intermediaries

   8. 25. Interpretation of Part IV

6. PART V CONTROL OF ZOOTECHNICAL ADDITIVES

   1. 26. Manufacture of zootechnical additives

   2. 27. Duties on persons manufacturing zootechnical additives

   3. 28. Packaging of zootechnical additives

   4. 29. Labelling of zootechnical additives

   5. 30. Wrapping, packaging and storage of zootechnical additives by intermediaries

   6. 31. Duties on intermediaries wrapping, packaging or storing zootechnical additives

   7. 32. Putting zootechnical additives into circulation

   8. 33. Duties on intermediaries putting zootechnical additives into circulation

   9. 34. Supply of zootechnical additives

   10. 35. Use of zootechnical additives for the purpose of animal feeding

   11. 36. Incorporation of zootechnical additives

   12. 37. Mixing of zootechnical additives

   13. 38. Provision of samples

   14. 39. Monitoring of undesirable interactions

   15. 40. Provision of information

7. PART VI CONTROL OF ZOOTECHNICAL PREMIXTURES

   1. 41. Manufacture of zootechnical premixtures

   2. 42. Duties on persons manufacturing zootechnical premixtures

   3. 43. Packaging of zootechnical premixtures

   4. 44. Labelling of zootechnical premixtures

   5. 45. Wrapping, packaging and storage of zootechnical premixtures by intermediaries

   6. 46. Duties on intermediaries wrapping, packaging or storing zootechnical premixtures

   7. 47. Putting zootechnical premixtures into circulation

   8. 48. Duties on intermediaries putting zootechnical premixtures into circulation

   9. 49. Supply of zootechnical premixtures

   10. 50. Use of zootechnical premixtures for the purpose of animal feeding

   11. 51. Incorporation of zootechnical premixtures

8. PART VII CONTROL OF ZOOTECHNICAL FEEDINGSTUFFS

   1. 52. Manufacture of zootechnical compound feedingstuffs

   2. 53. Duties on persons manufacturing zootechnical compound feedingstuffs

   3. 54. Production of zootechnical compound feedingstuffs

   4. 55. Duties on persons producing zootechnical compound feedingstuffs

   5. 56. Level of zootechnical additives in complete feedingstuffs

   6. 57. Level of zootechnical additives in supplementary feedingstuffs

   7. 58. Labelling of zootechnical feedingstuffs

   8. 59. Labelling of supplementary zootechnical feedingstuffs

   9. 60. Export of zootechnical feedingstuffs to E.E.A. States

   10. 61. Import of zootechnical feedingstuffs

   11. 62. Putting zootechnical compound feedingstuffs into circulation

9. PART VIII MISCELLANEOUS AND SUPPLEMENTAL PROVISIONS

   1. 63. Restrictions on toxicological tests on vertebrates

   2. 64. Confidential information relating to zootechnical additives

   3. 65. Use of Article 9c data

   4. 66. Official checks and enforcement

   5. 67. Powers of authorised persons

   6. 68. Offences

   7. 69. Punishment of offences

   8. 70. Time limit for prosecutions

   9. 71. Offences by bodies corporate and Scottish partnerships

   10. 72. Defence

   11. 73. Service of notices

   12. 74. Exclusion of application of the Medicines Act 1968

   13. 75. Revocation of product licences

10. Signature

11. 1. SCHEDULE 1

       INTERPRETATION

       1. PART I Expressions having the same meaning as in the Additives Directive

          1. animal feeding antibiotics coccidiostats and other medicinal substances compositional characteristics...

       2. PART II Expressions having the same meaning as in the Additives Directive as amended by Directive 96/51/EC

          1. Community authorisation delivered identification note incorporate last stage of circulation...

       3. PART III Expressions having the same meaning as in the Establishments Directive

          1. cease demonstrate essential condition exclusive requirements facilities holding located manufacture...

    2. SCHEDULE 2

       FEES

       1. PART I Fees payable in relation to the submission of dossiers

       2. PART II Fees payable in relation to the approval of establishments

       3. PART III Fees payable in relation to the approval of intermediaries

12. Explanatory Note