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Decision of 2 April 1992 on Warenwetdecision Tirradiated
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of the Secretary of State for Welfare, Health and Culture of 13 August 1991, VVP/L-691449, made in accordance with our Minister for Economic Affairs and the Secretary of State for Agriculture, Nature Management and Fisheries;
Whereas, from the point of view of public health, the treatment of eating and drinking water and other movable cases with ionising radiations can be considered to be safe at a dose of 10 kGy;
Whereas, however, it must be regarded as undesirable that eating and drinking products would be subject to such treatment without demonstrable necessity;
Whereas, moreover, it is necessary to avoid the use of original raw materials which, after treatment with ionising radiations, are still in conformity with the preparation of food and drink-drinking products. brought with the applicable requirements;
Whereas the General Decree (Warenwet) ( Stb. 1981, 621) and the Commodity code Labelling of foodstuffs ( Stb. 1992, 14) must be supplemented by specific rules on the information to final consumers concerning the indication of any treatment with ionising radiation of eating and drinking products and their ingredients;
Whereas, in addition, food and drink-drinking goods must be informed of possible treatment of raw materials with ionising radiations;
Having regard to the Article 1, fifth paragraph , 4, first paragraph, 5, first paragraph, parts a, 1 °, and b, fourth and sixth member , 6, part d , 8, part c , 9 , 12 and 16 of the Warenwet (Stb. 1988, No 360) and Article II, first paragraph, of the 1988 Warenwet Act (Stb. 358), jo Article 14 of the Warenwet (Stb. 1935, 793);
Opinion of the Advisory Committee on Warenwet (Opinion of 12 July 1985, No 13516/115);
Having regard to the opinion of the Health Council (Opinion of 28 April 1983, No U 2802 /LG/AR);
The Council of State heard (opinion delivered on 29 October 1991, No W13.91.0426);
Having regard to the further report of the Secretary of State for Welfare, Health and Culture of 20 March 1992, VVP/L-692641, expressed in accordance with our Minister for Economic Affairs and the Secretary of State for Agriculture, Nature Management and Fisheries;
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. ionising radiations: which is the same in the Nuclear energy law ( Stb. 1963, 82);
b. installation: an undertaking to which, by virtue of the Nuclear energy law a licence has been granted for the holding and use of radioactive substances, or for the use of an ionising radii of apparatus capable of carrying out the treatment of products with ionising radiations;
c. irradiated goods: those which have been treated with ionising radiations;
d. Raw materials: raw materials intended for the preparation of food-and drinking-products.
This Decision shall not apply to food and drink products and raw materials exposed to ionising radiation generated by measuring or checking instruments, provided that the absorbed dose does not exceed 0,01 Gy for control instruments. which use neutrons, and 0,5 Gy in other cases, at an energy level of up to 10 MeV in the case of X-ray radiation, 14 MeV in the case of neutrons and 5 MeV in other cases.
1 It shall be prohibited to treat eating or drinking products and raw materials with ionising radiation other than in accordance with the rules laid down in this Decision.
2 It shall be prohibited for use in the treatment of drinking or drinking materials and raw materials which do not comply with the conditions laid down in this Decision.
It shall be prohibited to trade in eating and drinking products other than in accordance with the provisions of this Decision as regards the use of particulars.
4 It was prohibited to carry out irradiated goods within the territory of the Netherlands other than in accordance with the rules laid down in this Decision.
1 For the treatment of these products with ionising samples only the following sources may be used:
a. gamma-rays of radionuclides 60 Co or 137 Cs;
b. X-rays generated by machining sources, having an energy level of not more than 5 Mev;
c. electrons generated by machining sources, having an energy level of not more than 10 Mev.
2 The treatment of products with ionising radiations may take place only in an installation as referred to in Article 1 (b) (b) , for which a recognition for the possibility of carrying out that treatment has been granted by Our Minister.
3 Without prejudice to paragraph 4, as regards treatment with ionising radiation of food and drink products and raw materials, the approval provided for in paragraph 2 shall be granted if the installation complies with the conditions of the International Code of Practice for the Operation of Irradiation Facilities Used for the Treatment of Foods (FAO/WHO CAC/Vol. XV, Ed.1.CAC/RCP 10-1979 (Rev. 1) of the Codex Alimentarius, and a person shall be designated to ensure compliance with all the requirements necessary for this process.
4 Our Minister may lay down further requirements regarding the conditions for granting a recognition as referred to in the second paragraph.
Applications for recognition as referred to in the second paragraph shall be submitted to our Minister. In each case, part of the application must be a copy of the application Article 29 or 34 of the Nuclear Energy Act authorisation granted.
1 The corresponding Article 3 approved installation shall keep records for each ionising radiation source used and for each batch of treated or drinking products or raw materials, with the following information:
a. Nature and quantity of irradiated food or drinking materials or raw materials;
b the number of the lot;
(c) the name of the person who ordered the treatment;
(d) the name of the person for whom the irradiated goods were intended;
e. the date of irradiation,
f. The packaging material used during irradiation;
g. the data relating to the monitoring of the irradiation process as set out in the Annex, the radiation measurements carried out, and the results obtained, giving details of the upper and lower limit of the absorbed dose and the type of ionising radiation; and
h. indication of the preliminary validation measurements.
2 Our Minister may lay down detailed rules relating to the provisions of the first paragraph.
3 The data referred to in paragraph 1 must be kept by the installation manager for at least five years.
1 Food and drinking goods and raw materials are at the time of treatment with ionising radiations in a proper state of hygiene.
2 The treatment of eating or drinking goods and raw materials with ionising radiations:
a. technologically provided in an acceptable need;
b. does not pose a danger to public health and is carried out in accordance with the relevant conditions;
c. is useful to the consumer; and
d. is not applied to replace poor hygiene and health practices or due to proper production and farming processes.
3 Food and drinking products and raw materials shall only be treated with ionising radiations in order to:
a. To reduce the risk of food-borne diseases, by destruction of germs;
b. To reduce spoilage of eating or drinking goods or raw materials, by slowing down or stopping rotting processes and destroying perishable organisms;
(c) the loss of eating or drinking products or raw materials resulting from premature maturing, germination or leanery; or
d. Eating or drinking products or raw materials to be rid of organisms harmful to the crops and derived from them.
1 The following food or drinking products and raw materials may be used or treated with ionising radiations. They may only be treated with an absorbed dose of radiation, which shall not exceed, on average, the value as indicated for the relevant value.
Eating or drinking products, or drinking materials
Average absorbed radiation dose
Dried fruit
1 kGy;
| Pulses |
1 kGy; |
| Dehydrated vegetables |
10 kGy; |
| Cereal flakes |
1 kGy; |
| Dried aromatic herbs, spices and vegetable herbs |
10 kGy; |
| Shrimps |
3 kGy; |
| Poultry meat |
7 kGy; |
| Frogs ' parts |
5 kGy; |
| The thickener: gum arabic (E 414) |
10 kGy; |
| Frozen meals (for patients who require sterile nutrition on medical prescription) |
75 kGy; |
| Egg products |
6 kGy. |
2 The total dose required for a specific technical function may be divided into more than one treatment in relation to the goods referred to in paragraph 1. The largest radiation dose absorbed must not exceed 150% of the value determined for the respective where the radiation dose is to be used.
3 Food and drinking products and raw materials may be treated with ionising radiation only once and up to the level of the estimated average absorbed radiation dose. The treatment should not be combined with a chemical process that has the same purpose as the said treatment.
The second sentence of Article 1, third paragraph, of the Warenwet ( Stb. 1988, in so far as concerns the supply of food and drink products and raw materials to enable them to be brought into line with the provisions of that law by means of a treatment with ionizing radiation, is not of a kind used as a means of dealing with the application to food and drink products and raw materials which are not in accordance with Article 18 of that law.
1 Food and drinking products which are manifestly intended for the ultimate consumer before being subjected to ionising radiation must be present in the packaging containing the goods to which the final consumer is concerned. delivered.
2 Continuous eating and drinking products which appear to be intended for the final consumer as such may only be marketed in packaging.
3 Material to be used for the packaging of eating or drinking goods and raw materials to be irradiated is suitable for this purpose.
1 Continuous eating and drinking water and raw materials may only be brought within Dutch territory if the following requirements are fulfilled:
a. the treatment must have taken place in an installation
-which, if it is established in another Member State of the European Union, has been recognised by the relevant authority in the relevant Member State;
-which, if it is established in a third country, is included in the list drawn up by the Commission of the European Communities, as provided for in Article 9 (2) (a), of the Directive No 1999 /2/EC of the European Parliament and of the Council of the European Union of 22 February 1999 on the approximation of the laws of the Member States relating to the treatment of food with ionising radiation (PbEG L 66);
b. Each consignment must bear the name and address of the installation where the irradiation has been carried out.
2 Our Minister may specify what is meant by recognition as referred to in the first paragraph. To the extent that a measure has been adopted pursuant to the Treaty establishing the European Economic Community, such measures shall be adopted for the purpose of implementing that measure.
3 Without prejudice to the first and second paragraphs, irradiated food and drinking materials and raw materials may be imported only if the following conditions are fulfilled:
a. must be met Article 6, first paragraph and
b. Each consignment must contain the data specified in Annex II. Article 4, first paragraph , have been mentioned.
For the purposes of applying the third paragraph, 'importation' means the placing on free circulation of the goods under the customs procedure referred to in Article 201 of Regulation (EU) No 148/ (EU). 952/2013 of the European Parliament and of the Council of 9 October 2013 establishing the Union Customs Code (PbEU 2013, L 269), or under a customs procedure containing inward processing, temporary importation or processing outward processing operations, as referred to in Article 210 of that Regulation.
1 The description of the name and address of the plant in which the treatment with ionizing radiation is to be used must be used for the marketing of irradiated food and drinking goods and raw materials not intended for the final consumer or for an establishment. Radiation has been performed.
2 The following parts of the Food and food products shall apply mutatis mutandis to the marketing referred to in the first paragraph:
a. Article 4, first paragraph , with regard to the indication of the lot to which a foodstuff belongs; and
b. Article 6 specify the treatment of a food or an ingredient of a food, if the food or ingredient of a foodstuff is treated as an ingredient with ionising radiation.
1 In the case of examination methods which are decisive for the purpose of determining whether or not compliance with the rules laid down in or pursuant to this Decision is met, appropriate microbiological examination methods and detection methods shall be used.
2 Our Minister may lay down detailed rules on the methods referred to in paragraph 1.
1 This Decision shall enter into force from the third month following the date of issuance of the Official Journal in which it is placed. It shall not apply to goods which can be shown to have been treated with ionising radiation before that date.
2 By way of derogation from the first paragraph, the Article 10 (2) (c) and (3) (c) , 12 and 13 entry into force from the seventh month following the date referred to in that paragraph.
This decision may be cited as: Warenwetdecision has been irradiated.
Burden and order that this Decision, together with the accompanying note of explanatory note to the State Sheet will be placed and copies thereof will be sent to the Council of State.
' s-Gravenhage, 2 April 1992
Beatrix
The Secretary of State for Welfare, Health and Culture,
H. J. Simons
Published the seventh of May 1992The Minister of Justice,
E. M. H. Hirsch Ballin
The total mean absorbed dose
In determining the health of eating and drinking products and raw materials treated with an overall average dose of 10 kGy or less, all radiochemical effects within that dose range are proportional to the dose.
The total mean dose, D - , shall be equal to the following integral to the total volume of the treated foodstuffs:
D - = [ 000 p (x, y, z) d (x, y, z) dV]/M
where:
M = the total mass of the treated sample
p = local density at point (x, y, z)
d = the local absorbed dose at the point (x, y, z)
dV = dx, dy, dz, the infinitesimal volume element which is represented in reality by the volume fractions
The total mean absorbed dose may be for homogeneous or for bulk goods having a homogeneous density directly determined by a sufficient number of radiation meters planned and randomly to be distributed among the total volume of the goods. The dose distribution determined in this way can be used to calculate an average that is the total mean absorbed dose.
If the shape of the curve of the dose distribution over the commodity is well defined, the minimum and maximum doses are known. Based on measurements of the dose distributions on these two points in a series of samples of the where, an estimate may be made of the overall average dose.
In some cases, a good estimate may be made of the overall average dose by taking the mean minimum dose (D). - min) and the mean maximum dose (D - max).
The overall average dose is then (D - max + D - Min) /2
The ratio D - max/D - Not more than 3.
Before the routine irradiation of a given category of eating or drinking or raw materials begins in a irradiation installation, first the places of the minimum and maximum doses shall be determined on the whole volume of the product concerned. carrying out radiation measurements. These validation measurements are made a sufficient number of times (e.g. 3-5), to take into account varying density or geometry of a commodity.
The measurements shall be repeated when the true, geometry or conditions of irradiation have been changed.
During the process of irradiation, routine radiation measurements shall be made in order to avoid any overrun of dose limits. Measurements shall be taken with radiation meters placed at the maximum or minimum doses or at a reference point at points of maximum or minimum doses. The dose at the reference point is qualit% related to the maximum and minimum dose. The reference point is located in an easily accessible place in or on the one where the doses vary very little.
During production, radiation measurements shall be made to each batch and at appropriate intervals.
In the case of irradiation of liquid, non-packaged goods, the determination of the places of the minimum and maximum doses is not possible. It is recommended that the values of these doses should be determined using random sample measurements.
The radiation measurements shall make use of approved dosimetric systems and the measurements shall be related to baseline standards.
During the irradiation, the relevant parameters of the installation shall be checked and recorded continuously. When using radionuclides, these parameters include the transport speed of the where or the time spent in the radiation zone and an indication that confirms the correct position of the radiation source. For particle accelerators, these parameters include the transport speed of the commodity, the energy level, the electron flow, and the scanner width of the installation.
