IRRADIATION OF FOODS REGULATIONS

SUBSIDIARY LEGISLATION 449.26

IRRADIATION OF FOODS REGULATIONS

16th April, 2001

LEGAL NOTICE 61 of 2001.

1 The title of these regulations is the Irradiation of Foods

Regulations.

Conditions for authorising Food Irradiation

1. Food irradiation may be authorised only if

-

there is a reasonable technological need,

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it presents no health hazard and is carried out under

the conditions proposed,

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it is of benefit to the consumer,

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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.

1 These regulations shall apply to the manufacture,

m ar k e t i n g a n d i m p o r t a t i o n o f f o o d s a n d f o o d i n g r e d i e n t s ,

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.

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.

1 Irradiated foodstuffs can be placed on the market only if

they comply with the provisions of these regulations.

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

D =

fp(x,y,z)d(x,y,z)dV

M

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,

D max + D min

overall average dose =

D max

The ratio of

should not exceed 3.

D min

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 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.

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

l i s t e d i n t h e S e c o n d S c h e d u l e a n d i n a cc o r d a n c e w i t h t h e

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 authorised for Irradiation Treatment

and Maximum Radiation Doses

Maximum overall average

Category of foodstuff

absorbed radiation dose (kGy)

Dried aromatic herbs, spices and

vegetable seasonings

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.

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

IRRADIATION OF FOODS

(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.

The Superintendent of Public Health shall be responsible

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prior approval of all irradiation facilities in Malta,

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the allocation of an official reference number for

approved irradiation facilities,

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official control and inspection,

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withdrawal or modification of approval.

Approval shall be granted only if the facility

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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

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.

3 The Superintendent of Public Health shall keep a detailed

record for each approved irradiation facility, containing

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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.

1 A foodstuff treated with ionising radiation may not be

imported from a country outside the European Community unless

it

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complies with the conditions which apply to those

foodstuffs,

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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,

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was treated in an irradiation facility approved by the

*OJ L372, 31.12.1985, p.50

European Community and appearing on the list

published in the Official Journal of the European

Communities pursuant to Article 9 of Directive 1999/

2/EC.

1 Materials used for packaging foodstuffs to be irradiated

must be suitable for the purpose.