Decree No. 133 / 2004 Coll.
Decree on the conditions for irradiation of food and raw materials, on the maximum permitted dose of radiation and on the method of labelling of radiation on packaging
Valid
Order
Effective from 26.03.2004
Text versions:
26.03.2004
133
DECLARATION
of 12 March 2004
on the conditions for irradiation of foodstuffs and raw materials, on the maximum permitted dose of radiation and on the method of labelling of radiation on the packaging
According to Article 19 (1) (c) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 146 / 2002 Coll., Act No. 306 / 2000 Coll. and Act No. 274 / 2003 Coll., ("the Act ') for the implementation of Section 4 (1) of the Act:
Subject matter
(1) This Decree lays down, in accordance with European Community law, the conditions for the use of ultraviolet rays and ionising radiation for the treatment of foodstuffs and raw materials, the highest overall average permitted doses of radiation to which individual types of food and raw materials may be exposed and the method of labelling irradiated food and raw materials on packaging.
(2) The decree does not apply to:
(a) the exposure caused by diagnostic or measuring instruments used to control foodstuffs, if the absorbed dose is not more than 0,01 Gy2) for inspection facilities using neutrons, and 0,5 Gy in other cases, using a maximum radiation energy of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 MeV in other cases; or
(b) treatment by irradiation of food for consumers receiving sterilised diet under medical supervision.
(3) The requirements for sources of ionising radiations.3)
Definition of terms
For the purposes of this decree:
(a) ultraviolet radiation of 250-270 nm wavelength and 400 J / m2 surface density, with at least 85% radiation power having to be emitted at 253,7 nm wavelength or 200-400 nm wavelength radiation and 400 J / m2 surface density (for polychromatic central-pressure lamps);
(b) ionising radiation consisting of particles charged, uncharged or both, capable of being directly or indirectly ionised.
Conditions of irradiation of food by ultraviolet rays
Ultraviolet rays can be used for treatment
(a) water intended for the production of packed infant water and bottled drinking water, unless the essential ingredients which confer its characteristics are changed;
(b) water used as raw material for the manufacture of foodstuffs.
Conditions of exposure to food and food ingredients by ionising radiation
(1) Only food and raw materials listed in Annex No 1 may be irradiated up to the maximum total average absorbed dose. At the time of exposure, the food and the raw material shall comply with the health requirements of the food, except for the indicator for which the exposure is carried out. The method of calculating the total average absorbed dose of radiation is set out in Annex 2.
(2) Food and raw materials can only be irradiated by ionising radiation if:
(a) there is sufficient technological need for this, such as the cases referred to in paragraph 3;
(b) there is no health risk to consumers and the exposure is carried out under the conditions laid down in this Decree;
(c) it is favourable to consumers;
(d) the exposure is not used to replace sanitary and health measures or good manufacturing and agricultural practice.
(3) Under the conditions laid down in paragraph 2, ionising radiation may only be used for:
(a) the destruction of pathogenic organisms, thereby reducing the risk of food-borne disease;
(b) restrictions on food spoils by slowing down or stopping breakdown processes by destroying organisms contributing to such breakdown processes;
(c) reduction of losses resulting from premature maturation, stamping or germination; or
(d) the destruction of harmful organisms contained in plant products and plants.
(4) The maximum total average absorbed dose of ionising radiation may be administered in single or multiple doses up to the level set out in Annex 1.
(5) The treatment of food and raw materials by ionising radiation must not be used in combination with a chemical treatment having the same purpose.5)
(1) Only the sources referred to in Article 2 (a) may be used for the treatment of food and raw materials by ultraviolet rays.
(2) Only the following types of ionising radiation may be used to treat foodstuffs and raw materials with ionising radiation:
(a) gamma radiation of radionuclides 60Co or 137Cs;
(b) X-ray radiation not exceeding 5 MeV; or
(c) accelerated electrons with an energy not exceeding 10 MeV.
(3) The dose of ionising radiation must be limited to the minimum necessary, which is appropriate to the indicator for which the food or raw material is treated with radiation, as set out in Annex 1.
Packaging and labelling of food and raw materials irradiated by ionising radiation
(1) Materials used for packaging foodstuffs and raw materials intended for treatment with ionising radiation.6)
(2) Foodstuffs and raw materials treated with ionising radiation, including irradiated food ingredients and raw materials not treated with ionising radiation, intended for the final consumer and shared catering, must be labelled in accordance with the law.
(3) Foods and raw materials treated with ionising radiation which are not intended for the final consumer and for shared catering must be labelled as "treated with ionising radiation" or "treated with ionisation," even in the case of food or raw material which is an ingredient of food and raw material which is not treated with ionising radiation. This indication shall be given on the packaging next to the name of the food ingredient. At the same time, the name and address of the treatment facility or its reference number allocated at the time of approval of its operation shall be indicated on the packaging.
(4) The treatment of food and raw materials by ionising radiation shall be indicated in all documents accompanying or related to irradiated food.
Final provisions
The labelling of irradiated foodstuffs and raw materials on packaging which have been produced and put into circulation before the date of application of this Decree may be carried out in accordance with existing legislation by 30 April 2004 at the latest.
Decree No. 297 / 1997 Coll., on the conditions for irradiation of foodstuffs, on the maximum permissible dose of radiation and on the method of labelling, is hereby repealed.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Dr. Součková v. r.
Příloha č. 1
Annex No 1 to Decree No. 133 / 2004 Coll.
Species, groups and sub-groups of food and raw materials allowed to irradiate by ionising radiation and maximum permitted total absorbed doses (NPD)
| Skupina potravin | NPD v kGy* | |
|---|---|---|
| 1. | Sušené byliny, koření, kořenící přípravky | 10,0 |
| 2. | Zmrazené byliny | 10,0 |
| 3. | Brambory | 0,2 |
| 4. | Sladké brambory | 0,2 |
| 5. | Cibule, šalotka | 0,2 |
| 6. | Česnek | 0,2 |
| 7. | Luštěniny, sušená zelenina, čerstvá zelenina s výjimkou cibule, šalotky, česneku, rebarbory | 1,0 |
| 8. | Čerstvé ovoce, čerstvé houby, rebarbora | 2,0 |
| 9. | Sušené ovoce | 1,0 |
| 10. | Mlýnské obilné výrobky s výjimkou rýžové mouky, vloček a klíčků určených pro mléčné výrobky | 1,0 |
| 11. | Vločky a klíčky pro mléčné výrobky | 10,0 |
| 12. | Rýžová mouka | 4,0 |
| 13. | Arabská guma | 3,0 |
| 14. | Kuřecí maso, drůbeží maso (kur domácí, husy, kachny, perličky, holuby, křepelky, krocani) | 7,0 |
| 15. | Drůbeží droby, drůbeží separát | 5,0 |
| 16. | Mražená žabí stehýnka | 5,0 |
| 17. | Sušená živočišná krev, plasma, koaguláty | 10,0 |
| 18. | Ryby a ostatní mořští živočichové s výjimkou mražených krájených nebo dekapitovaných krevet a mražených žabích stehýnek | 3,0 |
| 19. | Mražené krájené nebo dekapitované krevety | 5,0 |
| 20. | Vaječný bílek | 3,0 |
| 21. | Kasein, kaseináty | 6,0 |
* The dose is expressed in Gray units (Gy). The fixed values apply to the maximum total average, single and cumulated (Section 4 (4) of this Decree) of the absorbed levy.
Příloha č. 2
Annex No 2 to Decree No. 133 / 2004 Coll.
Total AVERAGE ABsorbed dose
For the purposes of assessing the health of food and raw materials irradiated at a total average dose of 10 kGy or less, it can be assumed that all radiation chemical effects within this specific dose range are proportional to the dose.
The total average absorbed dose is defined by the following integral over the whole volume of the product:
D = 1M --Vpx, y, z dx, y, z dV
where M = total weight of the treated product [kg]
p = local density at point (x, y, z) [kg.m-3]
d = local dose absorbed at point (x, y, z) [J.kg-1]
dV = dx dy dz elementary volume, in real cases represented by volume fractions
For homogeneous products or for non-packaged products, the total average absorbed dose may be determined directly by placing a sufficient number of dosimeters strategically or randomly in the mass of the products. The average of the dose distribution thus determined shall be calculated as the total average absorbed dose.
If the distribution curve of the doses in the product is precisely determined, we will get the placement of the minimum and maximum doses. The distribution of doses in these two positions may be measured in a series of product samples in order to obtain the total average dose.
The total average dose is determined as the mean of the minimum dose values (Dmin) and the maximum dose (Dmax):
total average dose of, and dose of, irbesartan + Dmin2
DmaxDmin ratio < 3.
MEASURING PROCEDURES
(a) Prior to regular irradiation of a category of food in the irradiation unit, the position of the minimum and maximum doses is determined and the measurement of the dose is carried out in the total weight of the products. These validation measurements shall be made in sufficient numbers (at least three times) to take into account variations in the density or geometric parameters of the products.
(b) Measurement shall be repeated when the product, geometric parameters or irradiation conditions are changed.
(c) Routine measurements shall be made during irradiation to ensure that the limit values are not exceeded. To carry out these measurements, dosimeters shall be able to measure the minimum or maximum dose or reference level. The reference position shall be provided in an appropriate place, outside or inside the product, where only slight variation of doses occurs.
(d) Routine measurements shall be made for each consignment during irradiation at regular intervals established by the irradiation system.
(e) Where liquid unpackaged products are irradiated, the minimum and maximum dose points shall not be determined. In this case, dosimetric probes shall be used to determine maximum dose values. The measurement can only be performed by measuring instruments of the approved type and with valid verification according to Act No. 505 / 1990 Coll., on Metrology, as amended by Act No. 4 / 1993 Coll., Act No. 20 / 1993 Coll., Act No. 119 / 2000 Coll., Act No. 137 / 2002 Coll., Act No. 13 / 2002 Coll., Act No. 226 / 2003 Coll.
(f) During irradiation, the specified parameters shall be checked and recorded. Radionuclide source radiation shall be checked and registered for the speed of transport of the product or time spent in the irradiation zone and an indication confirming the correct location of the source. In the case of particle accelerator irradiation, the speed of the product's transport, energy rate, electron flow, scanning range shall be checked and registered.
1) Directive 1999 / 2 / EC of the European Parliament and of the Council 22.2.1999 on the approximation of the laws of the Member States relating to foodstuffs and food ingredients treated with ionising radiation. Directive 1999 / 3 / EC of the European Parliament and of the Council 22.2.1999 establishing a Community list of food and food ingredients treated with ionising radiation.
2) ČSN ISO 31-10 (01 1300) Quantities and units. Part 10 Nuclear reactions and ionizing radiation.
3) Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionizing Radiation (Atomic Act) and amending and supplementing certain laws, as amended by Act No. 83 / 1998 Coll., Act No. 71 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 13 / 2002 Coll., Act No. 310 / 2002 Coll. and Act No. 320 / 2002 Coll.
4) Paragraph 13 (2) of Decree No. 37 / 2001 Coll., laying down health requirements for products coming into direct contact with water and for water treatment. Decree No. 376 / 2000 Coll., laying down requirements for drinking water and the scope and frequency of its control.
5) Article 5 (2) and Article 12 of Directive 1999 / 2 / EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States relating to foodstuffs and additives in food treated with ionisation.
6) Decree No. 38 / 2001 Coll., on sanitary requirements for products intended to come into contact with food and dishes, as amended by Decree No. 186 / 2003 Coll.
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Regulation Information
| Citation | Decree No. 133 / 2004 Coll., on the conditions of irradiation of food and raw materials, on the maximum permitted dose of radiation and on the method of labelling of radiation on packaging |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.03.2004 |
|---|---|
| Effective from | 26.03.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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