Article 4

Member States shall take the necessary measures to ensure that, for the purposes of applying Article 4 (1) of Directive 89/662/EEC and Article 4 (1) (a) of Directive 90/425/EEC, the products of animal origin referred to in F1 X1Annex I and the second and third indents of Article 3 of this Directive may, without prejudice to the particular provisions to be adopted in implementation of Articles 10 (3) and 11, be the subject of trade only if they satisfy the following requirements:

1. 1..

   they must meet the requirements of Article 5 and the specific requirements laid down in Annex I as regards animal health aspectsF2 and Annex II as regards public health aspects ,

2. 2..

   they must come from establishments which:

   1. (a)

      undertake, in the light of the specific requirements laid down in Annex I for the products the establishment produces, to:

      • comply with the specific production requirements set out in this Directive,

      • establish and implement methods of monitoring and checking the critical points on the basis of the processes used,

      • depending on the products, take samples for analysis in a laboratory recognized by the competent authority for the purpose of checking compliance with the standards established by this Directive,

      • keep a record, whether written or otherwise recorded, of the information obtained pursuant to the preceding indents for presentation to the competent authority. The results of the various checks and tests in particular shall be kept for at least two years,

      • guarantee the administration of marking and labelling,

      • should the result of the laboratory examination or any other information available to them reveal the existence of a serious animal health or public health hazard, inform the competent authority,

      • consign, for purposes of trade, only products accompanied by a commercial document indicating the nature of the product, the name and, where appropriate, the veterinary approval number of the establishment of production;

   2. (b)

      they are under supervision by the competent authority to ensure that the operator or manager of the establishment complies with the requirements of this Directive;

   3. (c)

      they were registered by the competent authority on the basis of assurances from the establishment guaranteeing compliance with the requirements of this Directive.