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The Food Irradiation (Scotland) Regulations 2009

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PART 3Requirements and prohibitions to be observed by a licensee

7.—(1) A licensee must only irradiate food—

(a)to which the licence applies; and

(b)at the licensed facility.

(2) A licensee must not irradiate any food received from another person unless the following particulars are attached to or accompany the food when it is received—

(a)a description of the food and the name and address of its consignor;

(b)a reference by which the food, or any batch, lot or consignment of food of the same description within which food falls, can be identified;

(c)if the food is received from its owner for the purposes of irradiation—

(i)the name and address of its owner; and

(ii)the reason why its owner wants it to be irradiated; and

(d)a statement as to whether the food or any part of it has previously been irradiated.

8.  A licensee must keep—

(a)all food which awaits irradiation at the licensed facility, on a part of the facility, which is separated by a wall or barrier from any part of the facility where food which has been irradiated is kept; and

(b)all food which is either awaiting irradiation or has been irradiated, on parts of the facility, which are separated by a wall or barrier from any part of the facility on which other food is kept in the course of the business.

9.—(1) A licensee must not irradiate food in combination with any chemical treatment having the same purpose as irradiating it.

(2) Subject to sub-paragraph (3), a licensee must not irradiate food which, or any part of which, has previously been irradiated.

(3) The removal of food from, and its return to, the facility where irradiation takes place does not constitute a breach of sub‑paragraph (2) where they form part of a continuous process required by the design and construction of that facility.

10.  A licensee must number each batch of food irradiated by the licensee and, where any of the food has been received from another person, do so in such a way that the number can be linked to the reference specified in paragraph 7(2)(b).

11.  A licensee must only irradiate food with—

(a)gamma rays from the radionuclide 60Co;

(b)gamma rays from the radionuclide 137Cs;

(c)X-rays generated from machine sources operated at or below an energy level of 5 MeV; or

(d)electrons generated from machine sources operated at or below an energy level of 10 MeV.

12.  A licensee must only irradiate food by proper irradiation.

13.  A licensee must maintain such controls as are necessary to at all times ensure that irradiation is consistent with the method of measurement specified under paragraph 1(f)(iv) of Part 1.

14.  A licensee must record, in relation to each batch of food irradiated by the licensee, the following information—

(a)in the case of a radionuclide facility—

(i)in relation to each source configuration of ionising radiation available for use in the facility, such information as to its position as shows whether and, if so, when the batch of food was exposed to it; and

(ii)either—

(aa)the speed at which the batch travels through the facility and the route which the batch travels while passing through it; or

(bb)the time which the batch spends in the radiation zone; and

(b)in the case of a machine source—

(i)its energy level;

(ii)its electron current;

(iii)its scanner width;

(iv)the characteristics of its beam;

(v)unless it has a scattering device, the frequency with which its beam scans the batch; and

(vi)the speed at which the batch travels through the facility.

15.—(1) A licensee must record for each batch of food irradiated by the licensee—

(a)the nature and quantity of food in the batch;

(b)the number given to it under paragraph 10;

(c)the name and address of each consignor and consignee of food within the batch;

(d)the date on which the batch was irradiated;

(e)any microbiological information relating to food within the batch;

(f)the type of packaging in contact with the food in the batch during irradiation;

(g)where temperature control has been applied while irradiating the food, the temperature of the food in the batch immediately before irradiation;

(h)the maximum, minimum and overall average dose of ionising radiation applied to the batch;

(i)the type of ionising radiation used;

(j)the data used for control of the irradiation including—

(i)the positioning of dose meters within the batch and the doses of ionising radiation recorded by them;

(ii)previous tests used for the purpose of validating that positioning; and

(iii)the method (including instrumentation and frequency) used for measuring the doses of ionising radiation applied during the irradiation, and in the previous tests, and the dosimetry standard used to calibrate the meters used to measure them.

(2) A licensee must not consign food irradiated by the licensee to another person unless it is accompanied by—

(a)the licensee’s name;

(b)the licensee’s licence number;

(c)the information specified in sub-paragraph (1)(a) to (d); and

(d)the overall average dose required by sub‑paragraph (1)(h).

16.  A licensee must keep the information required by paragraphs 14 and 15(1) to be recorded for 5 years, even if the licensee ceases meanwhile to be licensed.

17.  A licensee shall send to the Agency by the last day of February each year a return in writing in respect of the previous calendar year containing—

(a)the licensee’s name;

(b)the licensee’s licence number;

(c)the year to which the return relates;

(d)a description of each food which the licensee has irradiated during the year; and

(e)the quantity, by volume or weight, of each such food.

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