The Food Irradiation (Wales) Regulations 2009

Regulation 3(2)(e) and (3) and Schedule 2 Part 1 paragraphs 1(g) and 2(1)

SCHEDULE 1 E+W METHOD OF MEASUREMENT OF IRRADIATION

(This Schedule sets out (with a correction M1 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 radiation M2 )

Marginal Citations

M1 The Directive omits the word “average” after “overall”.

M2 OJ No. L66, 13.3.1999, p.16.

Dosimetry: overall average absorbed dose E+W

1.—(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,

, 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.

(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 (

min) and maximum dose (

max) will be a good estimate of the overall average dose: i.e., in these cases:

• 
• 

Procedures E+W

2.—(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.

Regulations 4(2), (5)(1)(d)(ii) and (e)(i)(bb), 6(1)(b)(ii) and 7(a)(i) and (ii)(aa)

SCHEDULE 2 E+W LICENCES

PART 1 E+W Grant of Licences

Application for licence E+W

1.  A person seeking a licence to irradiate food (“ the applicant”) must 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 is to 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 1 M3 ;

(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.

Marginal Citations

M3 A copy of the Code of Practice may be obtained from the Codex Alimentarius Commission, Food and Agriculture Organisation of the United Nations, Vialle della Terme di Caracalla, 0010, Rome.

Consideration of the application E+W

2.  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) of this Part 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) of this Part 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) of this Part—

(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.

3.  Where the Agency believes that— E+W

(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 wasirradiated 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 application E+W

4.—(1) Where the Agency refuses to grant a licence, it must give to the applicant a statement in writing of its reasons for doing so and 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 of this Part grant a licence; or

(b) must give to the applicant a statement in writing of its reasons for continuing to refuse a licence.

Duration E+W

5.—(1) Subject to sub-paragraph (2), a licence continues 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 continues 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 2 E+W Contents of Licence

1.  Every licence must contain— E+W

(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 paragraph 3 of Part 1, the date of its expiry,

and may contain conditions.

PART 3 E+W Requirements and prohibitions to be observed by a licensee

1.—(1) A licensee may only irradiate food— E+W

(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 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.

2.  Every licensee must keep— E+W

(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.

3.—(1) No licensee may irradiate food in combination with any chemical treatment having the same purpose as irradiating it. E+W

(2) Subject to sub-paragraph (3), no licensee may 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.

4.  Every 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 1(2)(b) of this Part. E+W

5.  No licensee may irradiate food save with— E+W

(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.

6.  No licensee may irradiate food save by proper irradiation. E+W

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

8.  Every licensee must record, in relation to each batch of food irradiated by the licensee, the following information— E+W

(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.

9.—(1) Every licensee must record for each batch of food irradiated by the licensee— E+W

(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 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 to be recorded by sub-paragraph (1)(h).

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

11.  Every licensee must send to the Agency by the last day of February each year a return in writing in respect of the previous calendar year containing— E+W

(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 4 E+W Variation of Licence

1.  Subject to paragraph , the Agency may at therequest or with the consent of the licensee vary anycondition of the licence. E+W

2.—(1) Subject to sub-paragraph (2), the Agency must 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. E+W

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

PART 5 E+W Cancellation and suspension of Licence

1.  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— E+W

(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.

2.  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 must give notice in writing to the licensee that the licence is cancelled from a date specified in the notice and must state in the notice why it is not so persuaded; but if so persuaded it must notify the licensee accordingly. E+W

3.  If cancelled, the licence is to cease to have effect on the date specified in the notice. E+W

4.—(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 will have no effect for the purpose of these Regulations from that date. E+W

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

(a) the suspension will 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 will 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 6 E+W Other provisions concerning Licence

1.  The Agency must publish in the London Gazette notice of— E+W

(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.

2.  Any notice so published must specify— E+W

(a) the name of the licensee or former licensee;

(b) the licensed or formerly licensed facility; and

(c) their licence number,

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

3.  Save as provided by section 43 of the Act (continuance on death), a licence is not transferable. E+W

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

SCHEDULE 3 E+W LIST OF APPROVED FACILITIES IN MEMBER STATES

 

Official reference number	Name and address
2110/91/0004	IBA Mediris SA Zoning Industriel B-6220 Fleurus Belgium
IR-01-CZ	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

Regulation 5(1)(b)(ii)

SCHEDULE 4 E+W LIST OF FACILITIES IN A COUNTRY OUTSIDE THE EUROPEAN COMMUNITY

 

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 0000 Thailand