Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.

Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.

Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:

1. (i)

   before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;

2. (ii)

   the products which are to undergo treatment are clearly identified;

3. (iii)

   the products undergo treatment enabling the animal health problem concerned to be eliminated, and

4. (iv)

   the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.

The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).

The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).

Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:

• provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or

• a derogation has been granted under Article 4(3).

Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.

Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.

Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.

Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.

If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.

The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).