Annex

Annexes II, III and IV to Directive 2009/158/EC are amended as follows:

1. 1..

   Annex II is amended as follows:

   1. (a)

      Chapter II is amended as follows:

      1. (i)

         in Section A, point 2(e) is replaced by the following:

         1. (e)

            ‘Eggs must be:

            1. (i)

               collected at frequent intervals, at least daily and as soon as possible after laying;

            2. (ii)

               cleaned and disinfected as soon as possible, unless disinfection takes place at a hatchery in the same Member State;

            3. (iii)

               placed either in new or in clean and disinfected packaging material.’;

      2. (ii)

         in Section B, in point 2(e), the first indent is replaced by the following:

         • ‘eggs, between the time of their arrival at the hatchery and the incubation process or at the time of their dispatch for trade within the Union or export to a third country, unless they have been previously disinfected at the breeding establishment of origin,’;

   2. (b)

      Chapters III and IV are replaced by the following:

      ‘CHAPTER III

      DISEASE SURVEILLANCE PROGRAMME

      Without prejudice to health measures and to Articles 16 and 17, disease surveillance programmes must, as a minimum, comprise surveillance of the infections and species listed in Sections A to D.

      A.

      Salmonella Pullorum^f1, Salmonella Gallinarum^f2 and Salmonella arizonae ^f3 infections

      1.

      Species concerned

      1. (a)

         Salmonella Pullorum and Salmonella Gallinarum: fowls, turkeys, guinea fowls, quails, pheasants, partridges and ducks.

      2. (b)

         Salmonella arizonae: turkeys.

      2.

      Disease surveillance programme

      1. (a)

         Serological and/or bacteriological tests must be used to determine whether an infection is present^f4.

      2. (b)

         Samples for testing must be taken, as appropriate, from blood, embryos that fail to hatch (namely embryos dead-in-shell), second grade chicks, meconium, post mortem tissues, especially liver, spleen, ovary/oviduct and ileo-caecal junction^f5.

      3. (c)

         Direct enrichment in Selenite-cysteine broth for faecal/meconium and intestinal samples is to be used. Non-selective pre-enrichment followed by selective enrichment in soya based Rappaport-Vassiliadis (RVS) broth or Müller-Kauffmann Tetrathionate-novobiocin broth (MKTTn) may be used for samples (such as embryos dead-in-shell) where competing flora is expected to be minimal^f6,^f7.

      4. (d)

         When blood samples are taken from a flock for serological testing for Salmonella Pullorum and Salmonella Gallinarum or Salmonella arizonae, the prevalence of infection in the Member State concerned and its past incidence in the establishment must be allowed for in determining the number of samples to be taken. However, a statistically valid number of samples for serological and/or bacteriological testing to detect infection must always be taken.

      5. (e)

         Flocks must be inspected during each laying period at the best time for detecting the disease in question.

      6. (f)

         Samples for bacteriological testing must not be taken from poultry or eggs that have been treated with antimicrobial medicinal products during the 2 to 3 weeks prior to testing.

      7. (g)

         Detection techniques must be capable of differentiating serological responses to Salmonella Pullorum and Salmonella Gallinarum infection from serological responses due to the use of Salmonella Enteritidis vaccine, where this vaccine is used^f8. Such vaccination must therefore not be used if serological monitoring is to be used. If vaccination has been used, bacteriological testing must be used, but the confirmation method used must be capable of differentiating live vaccinal strains from field strains.

      B.

      Mycoplasma gallisepticum and Mycoplasma meleagridis infections

      1.

      Species concerned

      1. (a)

         Mycoplasma gallisepticum: fowls and turkeys.

      2. (b)

         Mycoplasma meleagridis: turkeys.

      2.

      Disease surveillance programme

      1. (a)

         The presence of infection must be tested by validated serological and/or bacteriological and/or molecular tests. The presence of air sacculitis lesions in day-old chicks and turkey poults suggests that a Mycoplasma infection is present and must be investigated.

      2. (b)

         Samples for testing for the presence of Mycoplasma infection must be taken, as appropriate, from blood, day-old chicks and turkey poults, sperm, or swabs taken from the trachea, the choanae, cloaca or air sacs and in particular for the detection of Mycoplasma meleagridis samples must be taken from oviduct and penis of turkeys.

      3. (c)

         Tests for detecting Mycoplasma gallisepticum or Mycoplasma meleagridis must be performed on a representative sample in order to allow continuous surveillance of the infection during rearing and laying, namely just before the start of laying and every 3 months thereafter.

      C.

      Results and measures to be taken

      If there are no reactors, the test must be deemed to be negative. Otherwise, the flock must be deemed to be suspect and the measures set out in Chapter IV must be applied to it.

      D.

      In the case of holdings which consist of two or more separate production units, the competent veterinary authority may derogate from the measures set out in point 3(b) of Chapter IV required for restoring of approval as regards healthy production units on a holding where the infection is present provided that the authorised veterinarian has confirmed that the structure and size of those production units and the operations carried out there are such that the production units provide completely separate facilities for housing, keeping and feeding, so that the disease in question cannot spread from one production unit to another.

      CHAPTER IV

      CRITERIA FOR SUSPENDING OR WITHDRAWING APPROVAL OF AN ESTABLISHMENT

      1.

      Approval granted to an establishment must be suspended:

      1. (a)

         when the conditions laid down in Chapter II are no longer met;

      2. (b)

         until an investigation appropriate to the disease has been completed,

         if:

         • an outbreak of avian influenza or Newcastle disease is suspected at the establishment,

         • the establishment has received poultry or hatching eggs from an establishment with a suspected or confirmed outbreak of avian influenza or Newcastle disease,

         • contact liable to transmit the infection has occurred between the establishment and the site of an outbreak of avian influenza or Newcastle disease;

      3. (c)

         until such time as new tests are performed, if the results of surveillance carried out in accordance with the conditions laid down in Chapters II and III for infection by Salmonella Pullorum, Salmonella Gallinarum, Salmonella arizonae, Mycoplasma gallisepticum or Mycoplasma meleagridis give cause to suspect an outbreak;

      4. (d)

         until completion of the appropriate measures required by the official veterinarian, if the establishment is found not to conform with the requirements of point 1(a), (b) and (c) of Chapter I.

      2.

      Approval must be withdrawn if:

      1. (a)

         an outbreak of avian influenza or Newcastle disease is confirmed on the establishment;

      2. (b)

         a second test of an appropriate type confirms an outbreak of infection by Salmonella Pullorum, Salmonella Gallinarum, Salmonella arizonae, Mycoplasma gallisepticum or Mycoplasma meleagridis;

      3. (c)

         after a second notice served by the official veterinarian on the person responsible for the establishment, action to bring the establishment into line with the requirements of point 1(a), (b) and (c) of Chapter I, has not been taken.

      3.

      Conditions for restoring approval if:

      1. (a)

         approval has been withdrawn because of an outbreak of avian influenza or Newcastle disease, it may be restored 21 days after cleansing and disinfection if sanitary slaughter has been carried out;

      2. (b)

         approval has been withdrawn because of an outbreak caused by:

         • Salmonella Pullorum and Salmonella Gallinarum, or Salmonella arizonae, it may be restored after negative results have been recorded in two tests performed with an interval of at least 21 days on the establishment following sanitary slaughter of the infected flock and after disinfection for which the effectiveness has been verified by suitable tests on dried surfaces,

         • Mycoplasma gallisepticum or Mycoplasma meleagridis, it may be restored either after negative results have been recorded in two tests performed on the entire flock with an interval of at least 60 days or after negative results have been recorded in two tests performed with an interval of at least 21 days on the establishment after disinfection following sanitary slaughter of the entire infected flock.’;

2. 2..

   Annex III is amended as follows:

   1. (a)

      point 1 is replaced by the following:

      ‘1.

      Vaccines used for vaccinating poultry or flocks producing hatching eggs must have a marketing authorisation issued by the competent authority of any Member State.’;

   2. (b)

      the following point 3 is added:

      ‘3.

      In relation to vaccination against any Salmonella serotype the following conditions shall be met:

      1. (a)

         Salmonella vaccination programmes must not interfere with serological detection in the context of field investigation, or result in false-positive tests;

      2. (b)

         live Salmonella vaccines must not be used in the framework of national control programmes:

         1. (i)

            in breeding or productive poultry during their reproductive or laying stage unless the safety of their use has been demonstrated and they are authorised for such purpose in accordance with Directive 2001/82/EC of the European Parliament and of the Council^f9;

         2. (ii)

            where the manufacturer does not provide an appropriate method to distinguish bacteriologically wild-type strains of Salmonella from vaccine strains.’.

3. 3..

   Annex IV is replaced by the following:

   ANNEX IV

   VETERINARY CERTIFICATES FOR TRADE WITHIN THE UNION

   (Models 1 to 6)

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   MODEL 3

   

   

   

   MODEL 4

   

   

   

   MODEL 5

   

   

   

   MODEL 6