France

Presentation

This oder is related in particular to decree no. 73-138 of February 12, 1973 implementing the law of August 1, 1905 on fraud and falsification with regard to processes and products used for cleaning materials and objects intended to come into contact with foodstuffs, products and beverages for human and animal consumption.

This order, issued after consultation with the Conseil supérieur d'hygiène publique de France, the Académie nationale de médecine and the Commission interministérielle des radio-éléments artificiels, applies to ionizing radiation:

  • gamma radiation emitted by cobalt 60 or cesium 137;
  • accelerated electrons with energy less than or equal to 10 MeV;
  • X-rays with energy less than or equal to 5 MeV.

This order entails reciprocal administrative obligations for the supplier of materials or objects intended to receive ionizing treatment as mentioned above, and for the customer (food industry), who must verify the supplier's operations. In particular, the supplier must apply for authorization for ionizing treatment

  • migration tests carried out on the material or object after treatment. In the event that a specific migration limit for certain substances entering into the composition of the material or object has been set, this must be verified after treatment;
  • search for possible degradation products that may result from the chemical structure of these materials and objects and the adjuvants they contain.

This order also includes administrative obligations for the company in charge of processing the materials or objects.

This order is modified by the order of June 23, 2006.

Amendments

The order of June 23, 2006 concerns the treatment by ionizing radiation of materials and objects brought or intended to be brought into contact with foodstuffs. It revises the order of August 12, 1986. The changes are as follows:

  • repeal of article 3, which concerned materials or objects intended to be treated with doses less than or equal to 10 kGy;
  • deletion of the reference to article 3 in articles 4, 5 and 7.

Application guidelines

This notice cancels and replaces the recommendations of May 31, 2001 concerning the assessment of health risks of ionizing radiation treatment of plastic materials intended for contact with foodstuffs. It describes the information to be contained in an application to authorize the use of ionizing radiation-treated plastic materials intended for contact with foodstuffs.