SCHEDULE 1METHOD OF MEASUREMENT OF IRRADIATION

Regulation 3(2)(e) and (3) and Schedule2 Part 1 paragraphs 1(g) and 2(l)

(This Schedule sets out (with a correction7 in paragraph 1(5)) the provisions of Annex III to Directive 1999/2/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation8 as amended)

Dosimetry: overall average absorbed doseI11

1

It can be assumed for the purpose of the determination of the wholesomeness of foodstuffs treated with an overall average dose of 10kGy or less that all radiation chemical effects in that particular dose range are proportional to that dose.

2

The overall average dose, D¯math, is defined by the following integral over the total volume of the goods:
D¯=1M∫p(x,y,z) d(x,y,z) dVmath

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.

3

The overall average absorbed dose can be determined directly for homogeneous products or for bulk goods of homogeneous 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.

4

If the shape of the dose distribution curve throughout the product 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.

5

In some cases, the mean value of the average values of the minimum dose (D¯math min) and maximum dose (D¯math max) will be a good estimate of the overall average dose: i.e., in these cases:
overall average dose ≈D¯max⁡+D¯min⁡2mathThe ratio of D¯max⁡D¯min⁡ should not exceed 3math

ProceduresI22

1

Before routine irradiation of a given category of foodstuffs 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

Measurements must be repeated whenever the product, its geometry or the irradiation conditions are changed.

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.

4

Routine dose measurements must be carried out on each batch and at regular intervals during production.

5

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.

6

Dose measurements should be carried out by using recognised dosimetry systems, and the measurements should be traceable to primary standards.

7

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.

SCHEDULE 2LICENCES

Regulations 4(2), 5(2)(b) and (3)(a), 6(1)(b) and7(a)(i) and (ii)(aa)

Part 1Grant of Licences

Application for licenceI111

A person seeking a licence to irradiate food (“the applicant”) shall apply by sending to the Agency an application in writing containing—

a

the applicant’s name;

b

the applicant’s address;

c

the address of the facility at which the applicant proposes to irradiate food;

d

details of any licence or registration under any other legislation which enables the applicant to use ionising radiation at the facility in circumstances where, but for that licence or registration, that use would be unlawful;

e

a description of each food which the applicant proposes to irradiate which is sufficient to show that it falls within a permitted category of food;

f

in respect of each food described pursuant to sub-paragraph (e)—

i

the purpose for which the applicant proposes to irradiate the food and how that would benefit consumers;

ii

the method by which the applicant will ensure that the food is in a suitably wholesome state before irradiation;

iii

the overall average dose, maximum dose and minimum dose of ionising radiation which the applicant proposes to apply to the food;

iv

the method (including instrumentation and frequency) by which the applicant proposes to measure any dose of ionising radiation and the dosimetry standard which the applicant proposes to use to calibrate the dose meters used to measure it;

v

whether or not the applicant proposes to irradiate that description of food in packaging in contact with the food and, if so, the packaging which the applicant proposes to use; and

vi

whether or not the applicant proposes to apply temperature control to the food while irradiating it and, if so, the temperature at which the applicant proposes to keep the food during the application of temperature control;

g

in respect of each food described under sub-paragraph (e), particulars demonstrating that the irradiation will be in conformity with Schedule 1 and the Joint FAO/WHO Codex Alimentarius Commission Recommended International Code of Practice for the operation of irradiation facilities used for the treatment of foods (in this Part of this Schedule referred to as “the Code of Practice”), reference FAO/WHO/CAC, vol XV, edition 19;

h

a plan of the layout of the facility, details of its design and construction and a statement of the practices which the applicant proposes to apply, including—

i

the proposed method of irradiating food;

ii

the type of radiation to be used;

iii

the proposed methods of business control and organisation, including the minimum qualifications (whether they are formal or are derived from skill, training or experience) of persons who will be involved in applying the practices;

i

the identity and qualifications of the person who has been designated to be responsible for compliance with the conditions necessary for application of the practices referred to in sub-paragraph (h) and that person’s position within the applicant’s management structure;

j

the date from which the applicant wishes the licence to run; and

k

any other particulars which the applicant wishes the Agency to consider in deciding whether to grant the licence.

Consideration of the application

I122

The Agency may grant a licence where it is satisfied that—

a

the facility specified in the application satisfies the requirements of the Code of Practice;

b

each food described in the application falls within a permitted category;

c

there is a reasonable technological need;

d

the irradiation would present no health hazard and would be carried out under the conditions described in the application;

e

the irradiation would be of benefit to the consumer;

f

the irradiation would not be used as a substitute for hygiene and health practices or for good manufacturing or agricultural practice;

g

the purposes of irradiation are only—

i

to reduce the incidence of food-borne disease by destroying pathogenic organisms;

ii

to reduce spoilage of foodstuffs by retarding or arresting decay processes and destroying spoilage organisms;

iii

to reduce loss of foodstuffs by premature ripening, germination or sprouting; or

iv

to rid foodstuffs of organisms harmful to plants or plant products;

h

where the purposes of irradiation include reducing the incidence of food-borne disease by destroying pathogenic organisms, the applicant will use microbiological criteria in deciding whether to irradiate food;

i

there is no significant risk that the applicant may irradiate food which for microbiological reasons cannot comply with food safety requirements, or cannot comply without being irradiated;

j

every method specified under paragraph 1(f)(ii) is adequate to enable the applicant to ensure that the food is in a suitably wholesome state before irradiation;

k

the overall average dose specified under paragraph 1(f)(iii) in relation to each description of food is consistent with each purpose specified in respect of that description of food under paragraph 1(f)(i);

l

the method and standard specified under paragraph 1(f)(iv)—

i

comply with Schedule 1; and

ii

eliminate any significant risk that the overall average dose, measured by that method, will deviate significantly from the overall average dose as defined under paragraph 1 of Schedule 1;

m

the factors specified under paragraph 1(f) eliminate any significant risk that food, irradiated in any packaging specified under paragraph 1(f)(v), and at any temperature specified under paragraph 1(f)(vi), will fail to comply with food safety requirements; and

n

the practices and qualifications specified in the statement under paragraph 1(h) are adequate for ensuring that the requirements of these Regulations and any conditions of the licence will not be breached.

I133

Where the Agency believes that—

a

it ought to take account of the practical operation of the facility before it finally determines the application; and

b

it would not prejudice safety if food was irradiated at the facility for the time being,

it may grant a licence for a period, or further period, not exceeding 6 months in total to enable it to take such account.

Refusal of applicationI144

1

Where the Agency refuses to grant a licence, it shall give to the applicant a statement in writing of its reasons for doing so and shall invite the applicant to make representations to it in writing within 28 days after the statement is sent.

2

After considering any such representations, the Agency—

a

may if satisfied as to the matters specified in paragraph 2 grant a licence; or

b

shall give to the applicant a statement in writing of its reasons for continuing to refuse a licence.

DurationI155

1

Subject to sub-paragraph (2), a licence shall continue in effect unless cancelled or suspended in accordance with the provisions of Part 5 or surrendered by the licensee to the Agency.

2

A licence under paragraph 3 shall continue in effect until—

a

the expiration of the period for which it was granted; or

b

the refusal by the Agency of a licence on its final determination of the application,

unless cancelled or suspended in accordance with the provisions of Part 5 or surrendered by the licensee to the Agency.

Part 2Contents of Licence

Contents of licenceI161

Every licence shall contain—

a

the name of the licensee;

b

the address of the licensed facility;

c

a licence number;

d

a description of each food to which the licence applies;

e

the date from which the licence is to run; and

f

in the case of a licence under Part 1 paragraph 3, the date of its expiry,

and may contain conditions.

Part 3Requirements and prohibitions to be observed by a licensee

I171

1

A licensee shall only irradiate food—

a

to which the licence applies; and

b

at the licensed facility.

2

A licensee shall 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 by the licensee as a bailee—

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 been irradiated.

I182

Every licensee shall keep—

a

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.

I193

1

A licensee shall not irradiate food in combination with any chemical treatment having the same purpose as irradiating it.

2

Subject to sub-paragraph (3), a licensee shall 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 shall 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.

I204

Every licensee shall 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 1(2)(b).

I215

A licensee shall not irradiate food save 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 10MeV.

I36

A licensee shall not irradiate food save by proper irradiation.

I47

Every licensee shall maintain such controls as shall at all times ensure that irradiation is consistent with the method of measurement specified under paragraph 1(f)(iv) of Part 1.

I58

Every licensee shall 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;

ii

either the speed at which the batch travels through the facility and the route which the batch travels while passing through it or the time which the batch spends in the radiation zone;

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.

I69

1

Every licensee shall 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 4;

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 the licensee has applied temperature control while irradiating it, 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 shall 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 to be recorded by sub-paragraph (1)(h).

I710

Every licensee shall keep for 5 years the information required to be recorded by paragraphs 8 and 9(1), even if the licensee ceases meanwhile to be licensed.

I811

Every 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.

Part 4Variation of Licence

I221

1

Subject to paragraph 2, the Agency may at the request or with the consent of the licensee vary any condition of the licence.

I232

1

Subject to sub-paragraph (2), the Agency shall not agree a variation which permits any act or omission a proposal for which would, had it been made in the application for a licence, have caused the Agency to refuse to grant a licence under paragraph 2 of Part 1.

2

For the purposes of sub-paragraph (1) the Agency, in considering whether to vary a licence, shall treat all scientific knowledge which it has at that time as if it had had it at the time it granted the licence.

Part 5Cancellation and Suspension of Licence

I241

If the Agency considers that circumstances exist which, had it foreseen them (and possessed the same scientific knowledge it does now) at the time, it would have refused under paragraph 2 of Part 1 to grant the licence, it may give notice to the licensee —

a

explaining why it would have refused to grant the licence; and

b

informing the licensee that, unless the licensee persuades it in writing not to do so within a period of 28 days after the sending of the notice, or such longer period as it may allow, it will cancel the licence.

I252

If by the expiration of the 28 day period or of any longer period allowed under paragraph 1(b) the Agency is not persuaded to the contrary, it shall give notice in writing to the licensee that the licence is cancelled from a date specified in the notice and shall state in the notice why it is not so persuaded; but if so persuaded it shall notify the licensee accordingly.

I263

If cancelled, the licence shall cease to have effect on the date specified in the notice.

I274

1

If the Agency considers that unless the licence is suspended there will or may be a risk of injury to health it may give notice in writing to the licensee suspending the licence from a date specified in the notice and, subject to sub-paragraphs (2) and (3), the licence shall have no effect for the purpose of these Regulations during that period.

2

Subject to sub-paragraph (3), where notice is given suspending the licence—

a

the suspension shall cease to have effect at the expiration of three days after notice of the suspension has been given unless notice has in the meantime been given to the licensee under paragraph 1; but

b

if notice has in the meantime been given to the licensee under paragraph 1, the suspension shall continue until either—

i

the Agency is persuaded not to cancel the licence; or

ii

the licence terminates.

3

The Agency may, if it considers that in the absence of suspension there will not be a risk of injury to health, by further notice in writing to the licensee withdraw the notice suspending the licence.

Part 6Other Provisions Concerning Licence

I281

The Agency shall publish in the Belfast Gazette notice of—

a

each licence granted;

b

each suspension of a licence;

c

each cancellation of a licence; and

d

each agreed variation of the terms of a licence.

I292

Any notice so published shall specify—

a

the name of the licensee or former licensee;

b

the licensed or formerly licensed facility; and

c

their licence number,

and shall state in outline the effect of the matter to which it relates.

I303

Save as provided by Article 42 of the Order (continuance on death), a licence is not transferable.

I9SCHEDULE 3LIST OF APPROVED FACILITIES IN MEMBER STATES

Regulations 3(1) and 5(1)(b)(i)

Annotations:
Commencement Information
I9

Sch. 3 in operation at 31.7.2009, see reg. 1

Official reference number

Name and address

2110/91/0004

IR-01-CZ

IBA Mediris SA

Zoning Industriel

B-6220 Fleurus

Belgium

Artim spol. S.r.o.

Radiová 1

102 27 Prague

Czech Republic

SN 01

Gamma-Service

Produktbestrahlung GmbH

Juri-Gagarin Strasse 15

D-01454 Radeberg

Germany

BY FS 01/2001

Isotron Deutschland GmbH

Kesselbodenstrasse 7

D-85391 Allershausen

Germany

NRW-GM 01 and NRW-GM 02

BGS Beta-Gamma-Service GmbH & Co.KG

Fritz-Kotz-Str.16

D-51674 Wiehl

Germany

D-BW-X-01

Beta-Gamma-Service GmbH & Co. KG

John-Deere-Strasse 3

D-76646 Bruchsal

Germany

500001/CU

Ionmed Esterilización, SA

Santiago Rusiñol 12 Madrid

Antigua Ctra Madrid-Valencia Km 83,7,

Tarancón

Cuenca

Spain

5.00002/B

ARAGOGAMMA S.A.

Salvador Mundi 11, bajo.

08017 Barcelona

Carretera Granollers a Carcadedu km 3,5.

08520 Les Franqueses del Vallés

Barcelona

Spain

13055 F

Gammaster Provence SA

Rue Jean Queillau

Marché des Arnavaux

F-13014 Marseille Cedex 14

France

01 142 F

Ionisos SA

Zone Industrielle les Chartinières

F-01120 Dagneux

France

72 264 F

Ionisos SA

Zone Industrielle de l’Aubrée

F-72300 Sablé-sur-Sarthe

France

85 182 F

Ionisos SA

ZI Montifaud

F-85700 Pouzauges

France

10 093 F

Ionisos SA

Zone Industrielle

F-10500 Chaumesnil

France

91471 F

Ionisos SA

Domaine de Corbeville

F-91400 Orsay

France

56 015 F

Radient Ouest

Le Flachec

F-56230 Berric

France

EU-AIF-04-2002

AGROSTER Besugárzó Részvénytársaság

Budapest X

Jászberényi út 5

H-1106

Hungary

RAD 1/04 IT

GAMMARAD ITALIA SPA

Via Marzabotto,4

Minerbio (BO)

Italy

GZB/VVB-991503 and GZB/VVB-991393

Gammaster BV

Morsestraat 3

Ede

Netherlands

GZB/VVB-991503 and GZB/VVB-991393

Gammaster BV

Soevereinsestraat 2

Etten-Leur

Netherlands

GIS-HZ-4434-W.-3/MR/03

Institute of Nuclear Chemistry and Technology

16 Dorodna Str.

03-195 Warsaw

Poland

GIS-HZ-4434-W.-2/MR/03

Institute of Applied Radiation Chemistry

Technical University of Lodz

15 Wróblewskiego Str.

39-590 Lodz

Poland

EW/04

Isotron plc

Moray Road

Elgin Industrial Estate

Swindon

Wilts SN2 6DU

United Kingdom

I10SCHEDULE 4LIST OF FACILITIES IN A COUNTRY OUTSIDE THE EUROPEAN COMMUNITY

Regulation 5(1)(b)(ii)

Annotations:
Commencement Information
I10

Sch. 4 in operation at 31.7.2009, see reg. 1

Official reference number

Name and address

EU-AIF 01-2002

HEPRO Cape (Pty) Ltd

6 Ferrule Avenue

Montague Gardens

Milnerton 7441

Western Cape

Republic of South Africa

EU-AIF 02-2002

Gammaster South Africa (Pty) Ltd

PO Box 3219

5 Waterpas Street

Isando Extension 3

Kempton Park 1620

Johannesburg

Republic of South Africa

EU-AIF 03-2002

Gamwave (Pty) Ltd

PO Box 26406

Isipingo Beach

Durban 4115

Kwazulu-Natal

Republic of South Africa

EU-AIF 05-2004

Gamma-Pak AS

Yünsa Yolu N: 4 OSB

Cerkezköy/TEKIRDAG

TR-59500

Turkey

EU-AIF 06-2004

Studer Agg Werk Hard

Hogenweidstrasse 2

Däniken

CH-4658

Switzerland

EU-AIF 07-2006

Thai Irradiation Center

Thailand Institute of Nuclear Technology (Public Organisation)

37 Moo 3, TECHNOPOLIS

Klong 5, Klong Luang

Pathumthani 12120

Thailand

EU-AIF 08-2006

Isotron (Thailand) Ltd

Bangpakong Industrial Park (Amata Nakorn)

700/465 Moo 7, Tambon Donhuaroh,

Amphur Muang,

Chonburi 20000

Thailand