ANNEX ISupplementary provisions
CONDITIONS FOR AUTHORISING FOOD IRRADIATION 1. Food irradiation may be authorised only if: - there is a reasonable technological need, - it presents no health hazard and is carried out under the conditions proposed, - it is of benefit to the consumer, - it is not used as a substitute for hygiene and health practices or for good manufacturing or agricultural practice. 2. Food irradiation may be used only for the following purposes: - to reduce the incidence of food-borne disease by destroying pathogenic organisms, - to reduce spoilage of foodstuffs by retarding or arresting decay processes and destroying spoilage organisms, - to reduce loss of foodstuffs by premature ripening, germination or sprouting, - to rid foodstuffs of organisms harmful to plant or plant products. ANNEX II SOURCES OF IONISING RADIATION Foodstuffs may be treated only by the following sources of ionising radiation: (a) gamma rays from radionuclides 60Co or 137Cs; (b) X-rays generated from machine sources operated at or below a nominal energy (maximum quantum energy) level of 5 MeV; (c) electrons generated from machine sources operated at or below a nominal energy (maximum quantum energy) level of 10 MeV. ANNEX III 1. DOSIMETRY Overall average absorbed dose It can be assumed for the purpose of the determination of the wholesomeness of foodstuffs treated with an overall average dose of 10 kGy or less that all radiation chemical effects in that particular dose range are proportional to the dose. The overall average dose, >START OF GRAPHIC> FD>END OF GRAPHIC> , is defined by the following integral over the total volume of the goods: >START OF GRAPHIC> FD>END OF GRAPHIC> = >NUM>1 >DEN>M ∫ p (x,y,z) d (x,y,z) dV where >TABLE> The overall average absorbed dose can be determined directly for homogenous products or for bulk goods of homogenous apparent density by distributing an adequate number of dosimeters strategically and at random throughout the volume of the goods. From the dose distribution determined in this manner an average can be calculated which is the overall average absorbed dose. If the shape of the dose distribution curve through the product is well determined, the positions of minimum and maximum dose are known. Measurements of the distribution of dose in these two positions in a series of samples of the product can be used to give an estimate of the overall average dose. In some cases, the mean value of the average values of the minimum dose (>START OF GRAPHIC> FD>END OF GRAPHIC> min) and maximum dose (>START OF GRAPHIC> FD>END OF GRAPHIC> max) will be a good estimate of the overall dose: i.e., in these cases: overall average dose ≈ >NUM"START OF GRAPHIC> FD>END OF GRAPHIC> max + >START OF GRAPHIC> FD>END OF GRAPHIC> min >DEN>2 The ratio of >NUM"START OF GRAPHIC> FD>END OF GRAPHIC> max >DEN"START OF GRAPHIC> FD>END OF GRAPHIC> min should not exceed 3. 2. PROCEDURES 2.1. Before routine irradiation of a given category of foodstuff begins at a radiation facility, the locations of the minimum and maximum doses are determined by making dose measurements throughout the product volume. These validation measurements must be carried out a suitable number of times (e.g. 3-5) in order to make allowance for variations in product density or geometry. 2.2. Measurements must be repeated whenever the product, its geometry or the irradiation conditions are changed. 2.3. During the process, routine dose measurements are carried out in order to ensure that the dose limits are not exceeded. Measurements should be carried out by placing dosimeters at the positions of the maximum or minimum dose, or at a reference position. The dose at the reference position must be quantitatively linked to the maximum and minimum dose. The reference position should be located at a convenient point in or on the product, where dose variations are low. 2.4. Routine dose measurements must be carried out on each batch and at regular intervals during production. 2.5. In cases where flowing, non-packaged goods are irradiated, the locations of the minimum and maximum doses cannot be determined. In such a case it is preferable to use random dosimeter sampling to ascertain the values of these dose extremes. 2.6. Dose measurements should be carried out by using recognised dosimetry systems, and the measurements should be traceable to primary standards. 2.7. During irradiation, certain facility parameters must be controlled and continuously recorded. For radionuclide facilities the parameters include product transport speed or time spent in the radiation zone and positive indication for correct position of the source. For accelerator facilities, the parameters include product transport speed and energy level, electron current and scanner width of the facility. STATEMENT BY THE COMMISSION Recital 17 The Commission stresses that, once the new decision on the reform of the committee procedure has been adopted, it will propose to the legislator that the provisions governing committees in all previous acts should be adjusted to bring them into line with the new 'committee procedure` decision. The Commission undertakes to apply in full any interinstitutional agreement deriving from this new decision. STATEMENT BY THE COUNCIL AND THE COMMISSION Article 7(3) third indent With the objective of ensuring that such methods exist for all products, the Commission and the Member States will encourage the further development of standardised or validated methods of analysis, which aim to verify whether foodstuffs have been treated by ionising radiation. The Commission confirms that the annual report referred to in Article 7(4) will include information on such developments. It will include in its annual report for the year 2001 a review of the application of these provisions to determine whether any problems have arisen with the use of validated or standardised methods. The Commission will, where appropriate and in accordance with the decision-making procedures defined in the Treaties or in this Directive, take steps to deal with these problems and those that are likely to arise. This information shall also be made available to the European Parliament.