The Food Irradiation Regulations (Northern Ireland) 2009

Made: 29th June 2009

Coming into operation: 31st July 2009

As required by Article 9 of Regulation EC No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[^f00003] there has been open and transparent public consultation during the preparation of these Regulations.

Citation and commencement

1

These Regulations may be cited as the Food Irradiation Regulations (Northern Ireland) 2009 and come into operation on 31st July 2009.

Scope

2

These Regulations do not apply to—

• (a) irradiation by measuring or inspection devices at a maximum level of—

• (i) 10MeV in the case of X-rays;

• (ii) 14MeV in the case of neutrons; or

• (iii) 5MeV in other cases,

where the dose of ionising radiation absorbed does not exceed 0.01Gy in the case of inspection devices which utilise neutrons and 0.5 Gy in other cases; or

• (b) irradiation of food prepared under medical supervision for patients requiring sterile diets.

Interpretation

3

• (1) In these Regulations—

• “the Agency” means the Food Standards Agency;

• “approval” includes a licence;

• “import” means to introduce from another member State or from a country outside the European Union;

• “ionising radiation” means any gamma rays, X rays or corpuscular radiations which are capable of producing ions either directly or indirectly;

• “irradiated” means treated by ionising radiation;

• “licence” save in regulation 7(a)(ii)(bb) means a licence granted by the Agency in accordance with Schedule 2 to a person and a facility to irradiate food;

• “member State” means a member State of the European Union;

• “official reference number” in relation to a facility in a member State means the reference number allocated by the member State in connection with its approval as an irradiation facility (being the number shown for it in the list in Schedule 3);

• “sell” includes possess, offer, expose and advertise for sale;

• “the Order” means the Food Safety (Northern Ireland) Order 1991.

• (2) For the purposes of these Regulations—

• (a) “properly irradiated food” means food which—

• (i) was either irradiated alone or as part of a batch of food in which each item was food which fell within the same permitted category of food; and

• (ii) has not been over-irradiated;

• (b) food falls within a permitted category of food when (excluding the weight of any added water) no less than 98 per cent of it by weight falls within that category, and “item”, in relation to a batch of food, means each item within that batch intended to be capable of being sold individually;

• (c) the permitted categories of food are—

• (i) fruit;

• (ii) vegetables;

• (iii) cereals;

• (iv) bulbs and tubers;

• (v) dried aromatic herbs, spices and vegetable seasonings;

• (vi) fish and shellfish; and

• (vii) poultry;

• (d) in the permitted categories of food—

• (i) “fruit” includes fungi, tomatoes and rhubarb;

• (ii) “vegetables” excludes fruit, cereals, bulbs and tubers and dried aromatic herbs, spices and vegetable seasonings but includes pulses;

• (iii) “bulbs and tubers” means potatoes, yams, onions, shallots and garlic;

• (iv) “fish and shellfish” includes eels, crustaceans and molluscs; and

• (v) “poultry” means domestic fowls, geese, ducks, guinea fowls, pigeons, quails and turkeys;

• (e) food has been over-irradiated either when the overall average dose of ionising radiation absorbed by it, measured in accordance with Schedule 1, exceeds, in the case of—

• (i) fruit, 2 kGy;

• (ii) vegetables, 1 kGy;

• (iii) cereals, 1 kGy;

• (iv) bulbs and tubers, 0.2 kGy;

• (v) dried aromatic herbs, spices and vegetable seasonings, 10 kGy;

• (vi) fish and shellfish, 3 kGy; or

• (vii) poultry, 7 kGy,

or in the circumstances described in paragraph (3).

• (3) The circumstances are that the maximum dose of ionising radiation absorbed by the food, or by any food in the same batch, measured in accordance with Schedule 1, is—

• (a) more than three times the minimum dose absorbed by it; or

• (b) more than 1.5 times the overall average dose specified for the food in paragraph (2)(e).

Prohibition on treatment without a licence

4

• (1) A person shall not in the preparation of any foodirradiate it or any part of it unless—

• (a) that person has been licensed;

• (b) it is in a suitably wholesome state; and

• (c) it is irradiated in accordance with these Regulations and any conditions of the licence.

• (2) Schedule 2 shall have effect in relation to licences.

Restrictions on importation

5

• (1) A person shall not import into Northern Ireland for the purpose of sale any irradiated food unless—

• (a) it falls within a permitted category of food;

• (b) it has been irradiated in one of the facilities listed in the Table in—

• (i) Schedule 3, being in each case a facility in a member State approved for the irradiation of foods and food ingredients by the member State concerned; or

• (ii) Schedule 4, being in each case a facility in a country outside the European Union and approved by the European Union;

• (c) it is properly irradiated food; and

• (d) the requirements of paragraph (2) or (3) are complied with.

• (2) Where the food was irradiated in another member State, it must be accompanied by documents containing—

• (a) either the name and address of the facility which carried out the irradiation, or its official reference number; and

• (b) the information specified in paragraph 9(1)(a) to (d) and (2)(d) of Part 3 of Schedule 2.

• (3) Where the food was irradiated outside the European Community—

• (a) it is accompanied by documents containing the name and address of the facility in which it was irradiated and the information specified in paragraph 9(1) of Part 3 of Schedule 2; and

• (b) in the case of food other than dried aromatic herbs, spices or vegetable seasonings—

• (i) it was irradiated by a person approved, under a reference by which the approval can be identified, by a competent authority in the country in which it was irradiated;

• (ii) the approval requires the method of measurement specified in Schedule 1 relating to food to which the approval relates; and

• (iii) the operation of the legislation in force in that country relating to the irradiation of food protects human health to an extent not less than human health is protected by the operation of these Regulations; and

• (c) it complies with the conditions which apply to the food.

• (4) This regulation applies to food which has (as well as food which has not) become an ingredient of other food.

• (5) In paragraph (3)(c) the expression “the conditions which apply to the food” is to be construed in accordance with the expression “the conditions which apply to those foodstuffs” in Article 9(1) of 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[^f00004] as amended.

Restriction on storage or transport

6

• (1) A person shall not store or transport for the purpose of sale any irradiated food unless—

• (a) that person has been licensed in relation to the food; or

• (b) that person has not been licensed in relation to the food and—

• (i) where the food has been imported into Northern Ireland, it is accompanied by the documents, or copies of the documents, required in relation to it by regulation 5(2) or 5(3)(a); or

• (ii) where the irradiation took place in the United Kingdom, it is accompanied by documents containing a statement that the food has been irradiated and a document or copy containing the information specified in paragraph 9(1)(a) to (d) and (2) of Part 3 of Schedule 2.

• (2) This regulation applies to food which has (as well as food which has not) become an ingredient of other food.

Restriction on sale

7

A person shall not sell food which, or any part of which, has been irradiated unless—

• (a) either—

• (i) the irradiation took place in Northern Ireland and regulation 4 and Schedule 2 and any conditions of the licence were complied with; or

• (ii) the irradiation took place in England, Scotland or Wales and

• (aa) provisions having effect there, corresponding to regulation 4 and Schedule 2; and

• (bb) any conditions of a licence to irradiate food issued there,

were complied with; or

• (iii) the food was imported into Northern Ireland and regulation 5 was complied with; and

• (b) where it was stored or transported, regulation 6 was complied with.

Documentation for food not ready for a final sale

8

• (1) A person shall not import into Northern Ireland, store or transport for the purpose of sale or sell irradiated food, or food containing an irradiated ingredient, which is not ready for delivery to the ultimate consumer or catering establishments unless the documents which accompany the food—

• (a) apply the word “irradiated” or the words “treated with ionising radiation” to the food or the ingredient, as the case may be; and

• (b) include either the name and address of the facility which carried out the irradiation, or its official reference number.

• (2) In this regulation—

• (a) “catering establishment” means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation;

• (b) “ultimate consumer” means any person who buys otherwise than—

• (i) for the purpose of resale;

• (ii) for the purposes of a catering establishment; or

• (iii) for the purposes of a manufacturing business.

Enforcement

9

• (1) The Agency shall enforce the provisions of these Regulations in so far as they fall to be observed by a licensee.

• (2) The Agency or each district council within its district shall each enforce the provisions of regulation 4 in so far as they fall to be observed by any person other than a licensee.

• (3) Each district council shall enforce within its district the provisions of these Regulations save in so far as they fall to be enforced under paragraph (1) or (2).

• (4) Each authority concerned in the administration of these Regulations shall give to each other authority so concerned such assistance and information as that other authority may reasonably require for the purposes of its duties under these Regulations.

Offences and penalties

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• (1) Any person who contravenes any of the provisions of these Regulations or, for the purposes of these Regulations, makes any false statement or uses any document containing a false statement either recklessly or knowing it to be false, is guilty of an offence and is liable—

• (a) on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or both; and

• (b) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both.

• (2) Any licensee who contravenes or fails to comply with any condition of the licence is guilty of an offence and is liable—

• (a) on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or both; and

• (b) on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both.

Application of various provisions of the Food Safety (Northern Ireland) Order 1991

11

• (1) The following provisions of the Order shall apply for the purposes of these Regulations with the modification that any reference in them to the Order shall be construed as a reference to these Regulations—

• (a) Articles 2(4) (extended meaning of sale) and 3 (application of food offered as prizes etc.);

• (b) Article 2(6) (which relates to territorial waters);

• (c) Article 4 (presumptions that food intended for human consumption);

• (d) Article 19 (offences due to fault of another person);

• (e) Article 20 (defence of due diligence), with the modification that paragraphs (2) to (4) shall apply in relation to an offence of contravening regulation 4, 5, 6, 7 or 8 as they apply in relation to an offence under Article 13 or 14;

• (f) Article 30(8) (which relates to documentary evidence);

• (g) Article 34(1) (obstruction etc. of officers);

• (h) Article 36(1) (punishment of offences), in so far as it relates to offences under Article 34(1) as applied by sub-paragraph (g);

• (2) Article 8 of the Order (inspection and seizure of suspected food) shall apply for the purposes of these Regulations as if food which it was an offence to sell under them were food which failed to comply with food safety requirements.

• (3) Article 35 of the Order (which relates to time limits for the beginning of prosecutions) shall apply in relation to offences under these Regulations as it applies to offences punishable under Article 36(2) of the Order.

Revocation of existing Regulations

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• (1) The Food (Control of Irradiation) Regulations (Northern Ireland) 1992[^f00005] are revoked.

• (2) Regulations 2 to 12 of the Food Irradiation Provisions Regulations (Northern Ireland) 2000[^f00006] are revoked.

SCHEDULE 1 — METHOD OF MEASUREMENT OF IRRADIATION

(This Schedule sets out (with a correction[^f00007]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[^f00008]as amended)

Dosimetry: overall average absorbed dose

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, $D ¯$, is defined by the following integral over the total volume of the goods:

$$D ¯ = 1 M ∫ p(x,y,z) d(x,y,z) dV$ 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 ($D ¯$ min) and maximum dose ($D ¯$ max) will be a good estimate of the overall average dose: i.e., in these cases:

$overall average dose ≈ D ¯ max⁡+ D ¯ min⁡ 2$

$The ratio of D ¯ max⁡ D ¯ min⁡ should not exceed 3$

Procedures

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.

SCHEDULE 2 — LICENCES

Part 1 — Grant of Licences

Application for licence

1