THE MINISTRY OF HEALTH AND
SOCIAL WELFARE
1315
Pursuant to Article 15, paragraph 2, subparagraph 17 of the Food Act (Official Gazette 46/07),
the Minister of Health and Social Welfare upon the approval of the Minister of Agriculture,
Fisheries and Rural Development hereby issues the
ORDINANCE
ON FOOD TREATED WITH IONISING RADIATION1
Article 1
This Ordinance lays down the conditions for production, processing and distribution of food
treated with ionising radiation (hereinafter: food treated with ionising radiation).
This Ordinance does not apply to food treated with ionising radiation originating from
measuring instruments or control devices under the condition that:
– it has absorbed doses less than or equal to 0.01 Gy for control devices in which neutrons are
used and 0.5 Gy in other cases, with maximum irradiation energy of 10 MeV in the case of Xrays, 14 MeV in the case of neutrons and 5 MeV in other cases,
- the food which has been treated with ionising radiation has been prepared for patients who
must consume sterile meals under medical supervision.
Article 2
The terms used in this Ordinance have the following meanings:
– “suitability of food” means the suitability of food for human consumption in accordance
with its purpose,
– “source of ionising radiation” means any device, plant or substance producing or
transmitting ionising radiation.
Article 3
Food treated with ionising radiation may be placed on the market if it complies with all
provisions of this Ordinance.
Article 4
The conditions under which food may be treated with ionising radiation are listed in Annex I
of this Ordinance and form an integral part thereof. Food treated with ionising radiation, prior
to being treated with ionising radiation must be suitable for consumption by humans.
The treating of food with ionising radiation may only be conducted from the sources of
ionising radiation listed in Annex II to this Ordinance which is printed along with this
Ordinance and forms an integral part thereof and in accordance with Article 10 of this
Ordinance.
The overall average absorbed radiation dose is calculated in accordance with Annex III which
is printed along with this Ordinance and forms an integral part thereof.
Article 5
Food which may be treated with ionising radiation and the maximum permitted overall
average radiation doses are listed in Annex IV which is printed along with this Ordinance and
forms an integral part thereof.
Article 6
To achieve the desired effect food may be repeatedly treated with ionising radiation under the
condition that the maximum permitted radiation dose is not exceeded, in accordance with the
provisions of Article 4 of this Ordinance.
The treating of food with ionising radiation may not be conducted in combination with
chemical agents which achieve the same purpose as ionising radiation.
Article 7
Food treated with ionising radiation, and intended for the end consumer and/or serving in
hospitality facilities, must have on the label the marking: “treated with ionising radiation”, in
the manner established by a special regulation on general labelling or marking of food2.
Food placed on the market in a loose state (in bulk) must contain the marking referred to in
paragraph 1 of this Article on/next to the container in which it is exhibited.
If food treated with ionising radiation is used as an ingredient of some product, the marking
referred to in paragraph 1 of this Article must be on/next to its name in the list of ingredients.
If food treated with ionising radiation is used as a food ingredient, and is sold in a loose state
(in bulk), the marking mentioned in paragraph 1 of this Article must be on/next to its name on
the list of ingredients listed next to the product name next to/on the container in which it is
presented on the market.
Ingredients treated with ionising radiation which are used as a mixture of ingredients in food,
must be labelled in accordance with the provisions of paragraph 1 of this Article, even if they
are represented with less than 25 % in the product.
Article 8
Food treated with ionising radiation, not intended for the end consumer and/or serving in
hospitality facilities, must be labelled with a marking which contains:
– “treated with ionising radiation” to mark the food treated with ionising radiation or
irradiated food ingredients treated with ionising radiation which is contained in food which
was not processed by ionising radiation;
– name and address of the facility in which the irradiation was conducted or its reference
number referred to in Article 10, paragraph 1 of this Ordinance.
Article 9
Details about treating food with ionising radiation referred to in Articles 5 and 6 of this
Ordinance must be listed in documentation which accompanies or which refers to food treated
with ionising radiation.
Article 10
The Ministry of Health and Social Welfare (hereinafter: the Ministry) issues authorisations to
legal or natural persons who can treat food with ionising radiation and allocates official
reference numbers thereto.
The Ministry shall issue the authorisation referred to in paragraph 1 of this Article if the legal
or natural person:
– has the approval from the State Office of Radiation Protection to conduct activities with a
source of ionising radiation,
– has approval from the State Office of Radiation Protection to conduct activities using
sources of ionising radiation,
– fulfils the conditions stipulated by provisions of a special regulation on conditions and
protective measures against ionising radiation to conduct activities with radioactive sources,
and conditions stipulated by the provisions of a special regulation on conditions and
protective measures against ionising radiation for conducting activities with X-ray devices,
accelerators and other electrical devices producing ionising radiation,
– determines a person who is responsible for abiding by criteria necessary for conducting the
irradiation procedure and who fulfils additional conditions in accordance with the decision of
the Ministry of Health and Social Welfare.
If the legal person authorised to treat food with ionising radiation no longer fulfils the
conditions referred to in paragraph 1 of this Article, the Ministry shall withdraw the issued
authorisation.
The list of legal and natural persons for whom, pursuant to official inspection, it is established
that they fulfil the conditions stipulated by this Ordinance shall be published in the Official
Gazette.
Article 11
Official inspection of legal and natural persons authorised to treat food with ionising radiation
is conducted by sanitary inspectors of the Ministry.
Article 12
The Ministry shall forward to the competent authority for the health safety, hygiene and
quality of food:
– the names, addresses and official reference numbers of legal or natural persons authorised
for treating food with ionising radiation referred to in Article 10, paragraph 1 of this
Ordinance,
– issued authorisation for treating food with ionising radiation, as well as all decisions to
temporarily withdraw or revoke the authorisation.
The Ministry shall annually forward to the competent authority for the health safety, hygiene
and quality of food:
– the results of official inspections conducted of legal or natural persons authorised to treat
food with ionising radiation, especially details about the types and quantities of products
treated with ionising radiation, as well as the applied radiation doses,
– the results of official inspections of food treated with ionising radiation in retail stores
which are conducted by sanitary inspectors of the Ministry.
The competent body for the health safety, hygiene and quality of food shall notify the
European Commission about the details referred to in paragraphs 1 and 2 of this Article.
Article 13
The methods which apply to proving whether food has been treated with ionising radiation
must be standardised and validated.
Article 14
Legal or natural persons authorised for treating food with ionising radiation must keep records
in accordance with a special regulation for each source of ionising radiation used and records
for each product batch treated with ionising radiation, about:
a) type and quantity of food treated with ionising radiation,
b) batch number,
c) orderer of the food treated with ionising radiation,
d) recipient of food treated with ionising radiation,
e) date of treatment with ionising radiation,
f) packaging in which the food was contained while being treated with ionising radiation,
g) details for control of the procedure of treatment of food with ionising radiation as
envisaged in Annex III to this Ordinance, results of conducted dosimetric measurements,
especially about the minimum and maximum absorbed radiation dose, as well as the type of
ionising radiation used,
h) initial validation of the radiation dose.
The documentation referred to in paragraph 1 of this Article must be kept for five years from
the date of treating food with ionising radiation.
Article 15
Food subjected to ionising radiation may be imported into the Republic of Croatia under the
condition that:
– it has complied with the provisions of this Ordinance,
– the accompanying documentation contains the name and address of the legal or natural
person who conducted the treatment of food with ionising radiation, as well as the details
referred to in Article 14 of this Ordinance,
– it was treated with ionising radiation by a legal person or natural person with authorisation
for treating food with ionising radiation.
If the food referred to in paragraph 1 of this Article is being imported into the Republic of
Croatia from a country which is not an EU Member State, it may not be imported if the
treatment of food with ionising radiation was not conducted in the facilities listed in Annex V
which is printed along with this Ordinance and forms an integral part thereof.
The name of the facility referred to in paragraph 2 of this Article must be listed in the
importing documentation.
Article 16
Materials used for packaging food which is subjected to ionising radiation must be safe
healthwise and suitable for this purpose and must comply with the provisions of a special
regulation on objects which come into direct contact with food.
Article 17
Legal or natural persons authorised to treat food with ionising radiation pursuant to legislation
in force up to the date of entry into force of this Ordinance, must co-ordinate their activity
with the provisions of this Ordinance at the latest by 31 December 2009.
Article 18
On the date of entry into force of this Ordinance, the Ordinance on the conditions for
conserving foodstuffs and objects of general use using ionising radiation (Official Gazette
46/94) shall cease to have effect.
Article 19
This Ordinance shall enter into force on the eighth day after the day of its publication in the
Official Gazette, except for the provisions of Article 12, Article 15, paragraphs 2 and 3, and
Annex V to this Ordinance which shall enter into force on the date of accession of the
Republic of Croatia to the European Union.
Class: 011-02/08-04/10
Reg. No.: 534-07-08-2
Zagreb, 27 March 2008
The Minister
Darko Milinović, m.p.
_____
1
The Ordinance adopts the provisions 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 concerning foods and food ingredients
treated with ionizing radiation and Directive 1999/3/EC of the European Parliament and of the Council of 22
February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising
radiation
2
Special legislation adopting the provisions of Directive 2000/13/EC of the European Parliament and of the
Council on the approximation of the laws of the Member States relating to the labelling, presentation and
advertising of foodstuffs.
ANNEX I
CONDITIONS FOR AUTHORISING FOOD IRRADIATION
Food irradiation may be authorised only if:
– there is a reasonable technological need,
– it presents no health hazard and is carried out in accordance with the provisions of this
Ordinance,
– it is of benefit to the consumer,
– it is not used as a a substitute for hygiene and health practices or for good manufacturing or
agricultural practice.
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
Food may be treated only by the following sources of ionising radiation:
1. gamma rays from radionuclides 60Co and 137Cs,
2. X-rays generated from machine sources operated at or below a nominal energy (maximum
quantum energy) level of 5 MeV,
3. electrons generated from machine sources operated at or below a nominal energy
(maximum quantum energy) 10 MeV.
ANNEX III
DOSIMETRY
1. OVERALL AVERAGE ABSORBED DOSES
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, D, is defined by the following integral through the overall volume
of goods:
D = 1/M ∫ p(x,y,z) d(x,y,z) dV
where:
M = the total mass of the treated sample
p = the local density at the point (x, y, z)
d = the local absorbed dose at the point (x, y, z)
dV = dx dy dz, the infinitesimal volume element which in real cases is represented by the
volume fractions.
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 in random throughout the volume of 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 products 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 (Dmin) and maximum dose (Dmax) will be a good estimate of the overall
dose, i.e. in these cases the: overall average dose ≈ (Dmax + Dmin)/2
The ratio of Dmax/Dmin should not exceed 3.
2. PROCEDURES
Before routine irradiation of a given category of foodstuff begins at a radiation facility, the
locations of the minimum and maximum does 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.
2.1. Measurements must be repeated whenever the product, its geometry or the irradiation
conditions are changed.
2.2. 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 should be quantitatively linked to the maximum and minimum dose. The
reference position should be located in at a convenient point in or on a product where dose
variations are low.
2.3. Routine dose measurements must be carried out on each batch and at regular intervals
during production.
2.4. 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.
2.5. Dose measurements should be carried out by using recognised dosimetry systems, and the
measurements should be traceable to primary standards.
2.6. 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.
ANNEX IV
FOODSTUFFS AUTHORISED FOR IRRADIATION TREATMENT AND
MAXIMUM RADIATION DOSES
Category of foodstuff
Dried aromatic herbs, spices
and vegetable seasonings
Maximum overall average
absorbed radiation dose (kGy)
10
Tea plants
3
Dried vegetables and fruit
1
Gum arabic
3
Powdered eggs, frozen eggs
and egg products
3
ANNEX V
LIST OF FACILITIES IN WHICH IT IS PERMITTED TO TREAT FOOD
IMPORTED FROM COUNTRIES WHICH ARE NOT EU MEMBER STATES
WITH IONISING RADIATION
1. HEPRO Cape (Pty) Ltd
6 Ferrule Avenue
Montague Gardens
Milnerton 7441
Western Cape
Republic of South Africa
Tel: (27-21) 551 24 40
Fax: (27-21) 551 17 66
2. Gammaster South Africa (Pty) Ltd
PO Box 3219
5 Waterpas Street
IsandoExtensio n 3
Kempton Park 1620
Johannesburg
Republic of South Africa
Tel: (27-11) 974 88 51
Fax: (27-11) 974 89 86
3. Gamwave (Pty) Ltd
PO Box 26406
IsipingoBeach
Durban 4115
Kwazulu-Natal
Republic of South Africa
Tel: (27-31) 902 88 90
Fax: (27-31) 912 17 04
4. GAMMA-PAK AS
Yünsa Yolu N: 4 OSB
Cerkezköy/TEKIRDAG
TR-59500
Turkey
Tel. (90-282) 726 57 90
Fax (90-282) 726 51 78
5. STUDER AGG WERK HARD
Hogenweidstrasse 2
Däniken
CH-4658
Switzerland
Tel. (41-062) 288 90 60
Fax (41-062) 288 90 70
6. THAI IRRADIATION CENTER
Thailand Institute of Nuclear Tehnology (Public Organisation)
37 Moo 3, TECHNOPOLIS
Klong 5, Klong Luang
Pathumthani 12120
Thailand
Tel. (662) 577 4167 to 71
Fax (662) 577 1945
7. ISOTRON (THAILAND) LTD
Bangpakong Industrial Park (Amata Nakorn)
700/465 Moo 7, Tambon Donhuaroh,
Amphur Muang,
Chonburi 20000
Thailand
Tel. (66) (0) 38458431 to 4
Fax (66) (0) 38458435