French Public Health Code
In forceAs stated in article R. 234-4 of the French Rural and Maritime Fishing Code, which reads as follows:
"I. - Foodstuffs derived from an animal that has undergone a clinical trial on veterinary medicinal products mentioned in V of article L. 234-2 may only be placed on the market if this trial has not been opposed by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail under the conditions set out in article R. 5141-8 of the Code de la santé publique and has been conducted in accordance with the declared protocol.
II. - Before the clinical trial begins, the investigator, or each investigator in the case of a trial taking place at several sites, sends the prefect of the département where the trial is to take place a declaration containing the following information:
a) The surname, first name and address of the investigator ;
b) The identity of the trial sponsor;
c) The name and purpose of the trial;
d) Duration of the experiments;
e) The farm, the number of animals involved and their identification where identification is compulsory;
f) The withdrawal period(s) to be observed depending on the foodstuffs likely to be released for consumption.
III. - Where the clinical trial concerns a medicinal product containing a pharmacologically active substance covered by Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, the animal tested may not be taken to the slaughterhouse or the animal products obtained from it introduced into the human food supply unless the withdrawal period declared to the Director of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail and the Prefect has elapsed. This withdrawal time must :
a) Be at least that set by the order provided for in the last paragraph of Article L. 5143-4 of the Public Health Code, possibly increased by an additional safety period taking into account the nature of the substance tested ;
or
b) Be set in such a way that the maximum residue limit is not exceeded in foodstuffs when such a maximum residue limit has been set pursuant to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 mentioned above;
If the animals have to be slaughtered before the end of the withdrawal period, it is the responsibility of the investigator in charge of conducting the trial to ensure that the foodstuffs are destroyed in the establishments mentioned in Article L. 226-9 of this Code. However, if a maximum residue limit has been set for the substance which was the subject of the trial, the foodstuffs may be placed on the market provided that the investigator ensures, by carrying out the residue analyses described by the trial sponsor in the information provided under 5° of article R. 5141-6 of the Public Health Code, that none of these foodstuffs is likely to contain residues of pharmacologically active substances at a level in excess of the maximum residue limit.
IV. - When the foodstuffs are presented to the slaughterhouse or supplied to the processors, the investigator issues an accompanying document containing the declaration of the trial to the prefecture, together with proof that the withdrawal period has been complied with or a copy of the results of the analyses referred to in III.
