Article 1Subject matter and scope
1.For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish:
(a)the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit);
(b)the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation (reference point for action).
2.This Regulation shall not apply:
(a)to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;
(b)to substances falling within the scope of Regulation (EEC) No 315/93.
3.This Regulation shall apply without prejudice to Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by Directive 96/22/EC.