IRRADIATION OF FOODS [ S.L.231.45 1
SUBSIDIARY LEGISLATION 231.45
IRRADIATION OF FOODS REGULATIONS
16th April, 2001
LEGAL NOTICE 61 of 2001.
Title .
Regulations.
Scope.
marketing and importation of foods and food ingredients,
hereinafter called “foodstuffs”, treated with ionising radiation.
2.2 These regulations shall not apply to:
( a ) foodstuffs exposed to ionising radiation generated by
measuring or inspection devices, provided that the
dose absorbed is not greater than 0.01 Gy for
inspection devices which utilise neutrons and 0.5 Gy
in other cases,at a maximum radiation energy level of
10 MeV in the case of X-rays, 14 MeV in the case of
neutrons and  5  MeV in other cases;
( b ) the irradiation of foodstuffs which are prepared for
patients requiring sterile diets under medical
supervision.
Prohibition of 
marketing.
3.1 Irradiated foodstuffs can be placed on the market only if
they comply with the provisions of these regulations.
Conditions to be 
fulfilled.
4.1 The conditions to be fulfilled for authorisation of the
treatment of foodstuffs with ionising radiation are set out in the
First Schedule. At the time of treatment such foodstuffs must be in
a suitably wholesome state.
4.2 Irradiation may be carried out only be means of the sources
listed in the Second Schedule and in accordance with the
requirements of the Code of Practice referred to in regulation 7.2.
The overall average absorbed dose shall be calculated in
accordance with the Third Schedule.
4.3 The maximum radiation dose for foodstuffs may be given
in partial doses; however, the maximum radiation dose must not be
exceeded.
4.4  Irradiation treatment may not be used in combination with
any chemical treatment having the same purpose as that treatment.
Foodstuffs which 
may be irradiated.
5.1 The foodstuffs that may be treated with ionising radiation
and the maximum overall average dose that may be imparted are
listed in the Fourth Schedule. Only the foodstuffs listed therein
may be treated with ionising radiation.
Labelling of 
irradiated food.
6.1 The labelling of foodstuffs treated with ionising radiation
shall be governed by the following provisions:
6.1.1 in the case of products intended for the ultimate
consumer and mass caterers:
2 [ S.L.231.45 IRRADIATION OF FOODS
S.L.231.27
( a ) if the products are sold as items, the words
“irradiated” or “treated with ionising radiation”
shall appear on the label as provided for in the
Labelling, Presentation and Advertising of
Foodstuffs Regulations. In the case of products
sold in bulk, these words shall appear together
with the name of the product on a display or
notice above or beside the container in which the
products are placed;
( b ) if an irradiated product is used as an ingredient,
the same words shall accompany its designation
in the list of ingredients. In the case of products
sold in bulk, these words shall appear together
with the name of the product on a display or
notice above or beside the container in which the
products are placed;
( c ) by way of derogation from the Labelling and
Presentation of Foodstuffs Regulations, the
same words shall be required in order to indicate
the irradiated ingredients used in compound
ingredients in foodstuffs, even if these constitute
less than 25% of the finished product;
6.1.2 in the case of products not intended for the ultimate
consumer and mass caterers:
( a ) the words provided for in regulation 6.1.1 shall
be used to indicate treatment of both the foods
and the ingredients contained in a non-irradiated
foodstuff;
( b ) either the identity and address of the facility
which carried out the irradiation or its reference
number as provided for in these regulations shall
be indicated;
6.1.3 the indication of treatment shall in all cases be given
on the documents which accompany or refer to
irradiated foodstuffs.
Approval of 
irradiation 
facilities.
7.1 The Superintendent of Public Health shall be responsible
for: 
- prior approval of all irradiation facilities in Malta,
- the allocation of an official reference number for
approved irradiation facilities,
- official control and inspection,
- withdrawal or modification of approval.
7.2 Approval shall be granted only if the facility:
- meets the requirements of the Joint FAO/WHO Codex
Alimentarius Commission Recommended International
Code of Practice for the operation of irradiation
facilities used for the treatment of foods (reference
FAO/WHO/CAC, vol. XV edition 1), and any
supplementary requirements which may be adopted
with the procedure laid down in accordance with the
IRRADIATION OF FOODS [ S.L.231.45 3
procedure laid down in Article 12 of Directive 1999/2/
EC of the European Parliament and of the Council,
- designates a person responsible for compliance with
all the conditions necessary for application of the
process.
7.3 The Superintendent of Public Health shall keep a detailed
record for each approved irradiation facility, containing:
- the name, addreess and reference number of the
facility, a copy of the text of the approval document
and of any decision suspending or withdrawing
approval;
- the results of checks carried out at the product
marketing stage. The methods used to detect treatment
with ionising radiation shall comply with paragraphs 1
and 2 of the Annex to Directive 85/591/EEC *  and are
to be standardised or validated by 1 January, 2003 at
the latest.
7.4 Approved irradiation facilities must, for each source of
ionising radiation used, keep a record showing for each batch of
foodstuffs treated:
( a ) the nature and quantity of foodstuffs irradiated;
( b ) the batch number;
( c ) the person ordering the irradiation treatment;
( d ) the recipient of the treated foodstuffs;
( e ) the date of irradiation;
( f ) the packaging materials used during treatment;
( g ) the data for control of the irradiation process as
provided for in the Third Schedule, the dosimetric
checks carried out and the results obtained, with
details in particular of the limits, lower and upper, of
the dose absorbed and the type of ionising radiation;
( h ) reference to the initial dose validation measurements.
7.5 The records referred to in regulation 7.3 must be kept for a
period of five years.
Importation of 
irradiated food.
8.1 A foodstuff treated with ionising radiation may not be
imported from a country outside the European Community unless
it:
- complies with the conditions which apply to those
foodstuffs,
- is accompanied by documents showing the name and
address of the facility which carried out the irradiation
and providing the information referred to in regulation
7.3,
- was treated in an irradiation facility approved by the
European Community and appearing on the list
*OJ L372, 31.12.1985, p.50
4 [ S.L.231.45 IRRADIATION OF FOODS
published in the Official Journal of the European
Communities pursuant to Article 9 of Directive 1999/
2/EC.
Packaging 
materials.
9.1 Materials used for packaging foodstuffs to be irradiated
must be suitable for the purpose.
FIRST SCHEDULE
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.
SECOND SCHEDULE
Sources of Ionising Radiation
1. Foodstuffs may be treated only by the following sources of
ionising radiation:
( a ) gamma rays from radionuclides  60 Co or  137 Cs;
( 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.
IRRADIATION OF FOODS [ S.L.231.45 5
THIRD SCHEDULE
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,  D , is defined by the following
integral over the total volume of the goods:
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 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 the 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 given an estimate of the overall average dose.
In some cases, the mean value of the average values of the
minimum dose ( D  min) and maximum dose  D  max) will be a good
estimate of the overall dose: that is, in these cases,
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
1
MD = fp(x,y,z)d(x,y,z)dV
overall average dose = D  max +  D  min2
The ratio of D  max should not exceed 3.D  min
6 [ S.L.231.45 IRRADIATION OF FOODS
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 cases 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 and energy level,
electron current and scanner width of the facility.
FOURTH SCHEDULE
Foodstuffs authorised for Irradiation Treatment
and Maximum Radiation Doses
Category of foodstuff Maximum overall average absorbed radiation dose (kGy)
Dried aromatic herbs, spices and 
vegetable seasonings 10
