LegalizeCouncil Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
- 1.The competent authority of a Member State shall designate only laboratories for diagnostic services pursuant to Article 57 that fulfil the following requirements. They must: (a)undertake to notify, without delay, the competent authority whenever a laboratory is aware of a suspicion of any of the diseases referred to in Annex IV; (b)undertake to participate in comparative tests (ring-tests) of diagnostic procedures arranged by the national reference laboratory; (c)operate and be assessed and accredited in accordance with the following European Standards account being taken of the criteria for different testing methods laid down in this Directive: (i)EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; (ii)EN 45002 on ‘General criteria for the assessment of testing laboratories’; (iii)EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for operation and recognition’.
- 2.The accreditation and assessment of testing laboratories referred to in paragraph 1(c) may relate to individual tests or groups of tests.
- 3.The Member States may designate laboratories which do not comply with the requirements referred to in point 1(c)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided that the laboratory operates under quality assurance in line with the guidelines in ISO 9001.
- 4.The competent authority shall cancel the designation where the conditions referred to in this Annex are no longer fulfilled.
ANNEX VII
CRITERIA AND REQUIREMENTS FOR CONTINGENCY PLANS
Member States shall ensure that contingency plans meet at least the following requirements:
- 1.Provision must be made to ensure the legal powers needed to implement contingency plans and put into effect a rapid and successful eradication campaign;
- 2.Provision must be made to ensure access to emergency funds, budgetary means and financial resources in order to cover all aspects of the fight against exotic diseases listed in Part II of Annex IV;
- 3.A chain of command must be established to guarantee a rapid and effective decision-making process for dealing with exotic diseases listed in Annex IV or emerging diseases. A central decision-making unit must be in charge of the overall direction of control strategies;
- 4.Detailed plans must be available for Member States to be prepared for the immediate establishment of local disease control centres in the event of an outbreak of exotic diseases listed in Part II of Annex IV or emerging diseases and to implement disease control and environment protection measures at a local level;
- 5.Member States must ensure cooperation between the competent authorities and competent environmental authorities and bodies in order to ensure that actions on veterinary and environmental safety issues are properly coordinated;
- 6.Provision must be made for adequate resources to ensure a rapid and effective campaign, including personnel, equipment and laboratory capacity;
- 7.An up-to-date operations manual must be available, with a detailed, comprehensive and practical description of all the actions, procedures, instructions and control measures to be employed in handling exotic diseases listed in Part II of Annex IV or emerging diseases;
- 8.Detailed plans must be available for emergency vaccination, where appropriate;
- 9.Staff must be regularly involved in training in clinical signs, epidemiological enquiry and control of epizootic diseases, in real-time alert exercises, and in training in communication skills to provide ongoing disease awareness campaigns for authorities, farmers and veterinarians;
- 10.Contingency plans must be prepared that take into account the resources needed to control a large number of outbreaks occurring within a short period of time;
- 11.Without prejudice to the veterinary requirements laid down in Regulation (EC) No 1774/2002, contingency plans must be prepared to ensure that, in the event of an outbreak of diseases, any mass disposal of aquatic animal carcases and aquatic animal waste is done without endangering animal and human health, using processes or methods which prevent damage to the environment and in particular: (i)with minimum risk to soil, air, surface and groundwater, and to plants and animals; (ii)with minimum nuisance caused by noise or odours; (iii)with minimum adverse effects on the nature or places of special interest;
- 12.Such plans must include the identification of appropriate sites and undertakings for the treatment or disposal of animal carcasses and animal waste in the event of an outbreak in accordance with Regulation (EC) No 1774/2002.
ANNEX VIII
CORRELATION TABLE
| This Directive | Repealed Directives | Repealed Directives | Repealed Directives |
|---|---|---|---|
| 91/67/EEC | 93/53/EEC | 95/70/EC | |
| Article 1(1)(a) | Article 1, first subparagraph | — | — |
| Article 1(1)(b) | — | — | — |
| Article 1(1)(c) | — | Article 1 | Article 1 |
| Article 1(2) | — | Article 20(2) | Article 12(2) |
| Article 2(1) | — | — | — |
| Article 2(2) | — | — | — |
| Article 2(3) | Article 1, second subparagraph | — | — |
| Article 3 | Article 2 | Article 2 | Article 2 |
| Article 4 | — | — | — |
| Article 5 | — | — | — |
| Article 6 | — | — | — |
| Article 7 | — | — | — |
| Article 8(1) | — | Article 3(2) | Article 3(2) |
| Article 8(2) | — | — | — |
| Article 8(3) | — | — | — |
| Article 8(4) | — | — | — |
| Article 9 | — | — | — |
| Article 10 | — | — | Article 4 |
| Article 11 | — | — | — |
| Article 12 | — | — | — |
| Article 13(1) | Article 4, first paragraph | — | — |
| Article 13(2) | Article 4, second paragraph | — | — |
| Article 14(1)(a) | Article 7(1), Article 8(1) | — | — |
| Article 14(1)(b) | — | — | — |
| Article 14(2) | Article 16(1) | — | — |
| Article 14(3) | Article 16(1), | — | — |
| Article 14(4) | — | — | — |
| Article 15(1) | Article 3(1)(a) and (2) | — | — |
| Article 15(2) | — | — | — |
| Article 15(3) | Article 3(1)(b) and (2) | — | — |
| Article 15(4) | — | — | — |
| Article 16(1) | Article 7(1)(a), first sentence Article 7(1)(b) Article 8(1)(a) Article 8(1)(b) | — | — |
| Article 16(2) | — | — | — |
| Article 17 | — | — | — |
| Article 18(1) | Article 9 | — | — |
| Article 18(2) | — | — | — |
| Article 19(1) | — | — | — |
| Article 19(2) | Article 9(2) | — | — |
| Article 20 | Article 14(3) | — | — |
| Article 21 | — | — | — |
| Article 22 | Article 19(1) | — | — |
| Article 23(1) | — | — | — |
| Article 23(2) | Article 22 | — | — |
| Article 23(3) | Article 19(2) | — | — |
| Article 23(4) | Article 19(3) | — | — |
| Article 23(5) | — | — | — |
| Article 24 | Article 21 | — | — |
| Article 25(a) | Article 20 | — | — |
| Article 25(b) | — | — | — |
| Article 25(c) | — | — | — |
| Article 25(d) | Article 21(2) | — | — |
| Article 25(e) | — | — | — |
| Article 26 | — | Article 4 | Article 5(1) |
| Article 27 | — | — | Article 5(5) |
| Article 28(a) | — | Article 5(1) Article 10(1)(a) | Article 5(2)(a) |
| Article 28(b) | — | Article 5(2)(b) Article 10(1)(c) | Article 5(2)(b) |
| Article 29(1) | — | Article 5 (2)(h) Article 6(a), seventh indent Article 8(1) Article 9(1), first sentence Article 10(1)b | Article 4(1), third subparagraph, third indent Article 5(4), first and fourth subparagraph |
| Article 29(2) | — | Article 5(2)(i) | Article 5(4), second and fourth subparagraph |
| Article 29(3) | — | Article 6(b) Article 6(d) Article 8(2) Article 8(3) Article 9(2) | — |
| Article 29(4) | — | Article 5(2)(i), second indent | — |
| Article 30 | — | Article 5(4) | Article 5(3) |
| Article 31 | — | — | — |
| Article 32 | — | Article 5(2), Article 6 | Article 4(1), third subparagraph, second indent, Article 5(2)(b), Article 5(4), third and fourth subparagraph |
| Article 33(1) | Article 3(3) | Article 6(a) fourth indent | — |
| Article 33(2) | — | Article 6(a), fourth indent | — |
| Article 33(3) | — | — | — |
| Article 33(4) | — | — | — |
| Article 34(1) | — | Article 5(2)(c) Article 6(a), first and third indent | — |
| Article 34(2) | — | Article 6(a), fourth indent | — |
| Article 35 | — | Article 6(a), second, fifth and sixth indent | — |
| Article 36 | — | — | — |
| Article 37(a) | — | — | — |
| Article 37(b) | — | — | Article 5(3) |
| Article 38(1) | — | Article 9(1), second sentence | — |
| Article 38(2) | — | Article 9(3) | — |
| Article 38(3) | — | — | — |
| Article 39(a) | — | Article 10(1)(c) | Article 4(1), third paragraph, first indent |
| Article 39(b) | — | — | — |
| Article 39(c) | — | Article 10(1)(c) | — |
| Article 39(d) | — | — | — |
| Article 40 | — | Article 7 | — |
| Article 41 | — | — | — |
| Article 42 | — | — | — |
| Article 43 | — | — | — |
| Article 44(1) | Article 10 | Article 10(2) | — |
| Article 44(2) | Article 10 | Article 10(2) | — |
| Article 45 | Article 10(1) | — | — |
| Article 46 | — | — | — |
| Article 47 | — | Article 6(a), first indent Article 15 | — |
| Article 48(1) | — | Article 14(1) | — |
| Article 48(2) | — | Article 14(1) | — |
| Article 48(3) | — | — | — |
| Article 48(4) | — | — | — |
| Article 49(1) | Article 5(1) | — | — |
| Article 49(2) | — | — | — |
| Article 49(3) | Article 15 | — | — |
| Article 50(1) | Article 5(1) Article 6(1) | — | — |
| Article 50(2) | — | — | — |
| Article 50(3) | Article 5(1) | — | — |
| Article 50(4) | Article 15 | — | — |
| Article 51(1) | — | — | — |
| Article 51(2) | Article 5(2) | — | — |
| Article 52 | — | — | — |
| Article 53(1) | — | — | — |
| Article 53(2) | — | — | — |
| Article 53(3) | — | Article 9(1), second sentence | — |
| Article 54(1) | — | — | — |
| Article 54(2) | — | Article 6(d) Article 8(3) | — |
| Article 54(3) | — | — | — |
| Article 55(1) | — | Article 13(1) | Article 7(1) |
| Article 55(2) | — | Article 13(2) | Article 7(2) |
| Article 55(3) | — | — | — |
| Article 56(1) | — | Article 12(1) Article 12(4) | Article 6(2) Article 6(3) |
| Article 56(2) | — | — | — |
| Article 56(3) | — | Article 12(6) | Article 6(5) |
| Article 56(4) | — | — | — |
| Article 56(5) | — | Article 12(1) Article 12(3) | Article 6(2) |
| Article 57(a) | — | Article 11(2) | — |
| Article 57(b) | — | Article 11(1) | Article 6(1) |
| Article 57(c) | — | — | — |
| Article 58(1) | Article 17 | Article 16 | Article 8 |
| Article 58(2) | Article 22 | — | — |
| Article 58(3) | Article 17 | — | — |
| Article 59 | — | — | — |
| Article 60 | — | — | — |
| Article 61(1) | — | — | — |
| Article 61(2) | Article 25 | Article 18 | Article 9 |
| Article 61(3) | Article 9(3) Article 17(2) | Article 18a | Article 4(2) Article 5(4), fourth subparagraph Article 8(4) |
| Article 62 | Article 26 Article 27 | Article 19 | Article 10 |
| Article 63 | — | — | — |
| Article 64 | — | — | — |
| Article 65 | Article 29 | Article 20 | Article 12 |
| Article 66 | — | — | Article 13 |
| Article 67 | Article 30 | Article 21 | Article 14 |
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