The Food Irradiation (Wales) Regulations 2009

Made: 6 July 2009

Laid before the National Assembly for Wales: 7 July 2009

Coming into force: 31 July2009

The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16(1) and (3), 17(1), 18(1)(c), 19(1)(b), 6 and 48(1) of, and paragraphs 1 and 4(b) of Schedule 1 to, the Food Safety Act 1990 which are now vested in them.

In accordance with section 48(4A) of that Act, they have had regard to relevant advice given by the Food Standards Agency.

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 there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

Title, commencement and application

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• (1) The title of these Regulations is the Food Irradiation (Wales) Regulations 2009, and they come into force on 31 July 2009.

• (2) These Regulations apply in relation to Wales.

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

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• (1) In these Regulations—

• “the Act”(“y Ddeddf”) means the Food Safety Act 1990;

• “the Agency” (“yr Asiantaeth”) means the Food Standards Agency;

• “approval” (“cymeradwyaeth”) includes a licence;

• “approved” (“a gymeradwywyd”, “wedi'i gymeradwyo”, “wedi'u cymeradwyo”) includes “licensed” (“trwyddedig”, “wedi'i drwyddedu”);

• “import” (“mewnforio”) means to introduce from outside the United Kingdom;

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

• “irradiated” (“a arbelydrir”, “a arbelydrwyd”, “arbelydrwyd”, “cael ei arbelydru”, “wedi'i arbelydru”) means treated by ionising radiation, and similar expressions must be construed accordingly;

• “licence” (“trwydded”) 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 and “licensed” (“ei drwyddedu”, “trwyddedig”, “wedi'i drwyddedu”) and “licensee” (“trwyddedai”) must be construed accordingly;

• “official reference number” (“Rhif cyfeirnod swyddogol”) in relation to a facility in a Member State means the number shown for it in the list in Schedule 3 ;

• “sell” (“gwerthu”) includes possess, offer, expose and advertise for sale, and “sale” (“gwerthu”) must be construed accordingly.

• (2) For the purposes of these Regulations—

• (a) “properly irradiated food” (“bwyd a arbelydrwyd yn briodol”) 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,

and “proper irradiation” (“arbelydru priodol”) must be construed accordingly;

• (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” (“eitem”), 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” (“ffrwythau”) includes but is not limited to fungi, tomatoes and rhubarb;

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

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

• (iv) “fish and shellfish” (“pysgod a physgod cregyn”) includes but is not limited to eels, crustaceans and molluscs; and

• (v) “poultry” (“dofednod”) 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 where one of the circumstances described in paragraph (3) applies.

• (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

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• (1) No person may in the preparation of any food irradiate 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 has effect in relation to licences.

Restrictions on importation

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• (1) No person may import any irradiated food into Wales for the purpose of sale 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 Schedule 3 or Schedule 4;

• (c) it is properly irradiated food; and

• (d) where it was irradiated in a Member State, it is accompanied by documents containing—

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

• (ii) the information specified in paragraph 9(1)(a) to (d) and ( )(d) of Part 3 of Schedule ; or

• (e) where it was irradiated outside the European Union—

• (i) it is accompanied by documents—

• (aa) showing the name and address of the facility in which the food was irradiated; and

• (bb) containing the information specified in paragraph 9(1) of Part 3 of Schedule 2;

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

• (aa) 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;

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

• (cc) 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

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

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

• (3) In paragraph (1)(e)(iii) the expression “the conditions which apply to the food” is to be construed in accordance with the expression “the conditions which apply to the 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 .

Restriction on storage or transport

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• (1) No person may store or transport any irradiated food for the purpose of sale 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 Wales, it is accompanied by the documents, or copies of the documents, required in relation to it by regulation 5(1)(d) or (e)(i); 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

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No person may sell food which or any part of which has been irradiated unless—

• (a) either—

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

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

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• (1) No person may import into Wales, 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 where the irradiation was carried out, or its official reference number.

• (2) In this regulation—

• (a) “catering establishment” (“sefydliad arlwyo”) means a restaurant, canteen, café, 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” (“defnyddiwr olaf”) 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

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

• (2) The Agency and each food authority within its area must 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 food authority must enforce within its area 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 must give 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 or fails to comply with 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 Act 1990

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

• (a) section 2 (extended meaning of “sale” etc.);

• (b) section 3 (presumption that food is intended for human consumption);

• (c) section 20 (offences due to fault of other person);

• (d) section 21 (defence of due diligence), with the modification that subsections (2) to (4) are to apply in relation to an offence of contravening regulation 4,5,6,7,or 8 of these Regulations as they apply in relation to an offence under section 14 or 15;

• (e) section 30(8) (which relates to documentary evidence);

• (f) section 33(1) (obstruction etc. of officers);

• (g) section 35(1) (punishment of offences), in so far as it relates to offences under section 33(1) as applied by sub-paragraph (f);

• (h) section 36 (offences by bodies corporate);

• (i) section 36A (offences by Scottish partnerships) ;

• (j) section 44 (protection of officers acting in good faith);

• (k) section 58(1) (which relates to territorial waters).

• (2) Section 9 (inspection and seizure of suspected food) of the Act applies 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) Section 34 (which relates to time limits for the beginning of prosecutions) of the Act applies in relation to offences under these Regulations as it applies to offences punishable under section 35(2) of the Act.

Revocation of existing Regulations

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• (1) In so far as they apply in relation to Wales, the Food (Control of Irradiation) Regulations 1990 are revoked.

• (2) Regulations 2 to 16 of the Food Irradiation Provisions (Wales) Regulations 2001 are revoked.

SCHEDULE 1 — METHOD OF MEASUREMENT OF IRRADIATION

(Mae'r Atodlen hon yn gosod (gyda chywiriad[^f00008] ym mharagraff 1(5)) ddarpariaethau Atodiad III i Gyfarwyddeb 1999/2/EC Senedd Ewrop a'r Cyngor ar gyd-ddynesu cyfreithiau'r Aelod-wladwriaethau ynghylch bwydydd a chynhwysion bwydydd sydd wedi'u trin ag ymbelydredd ïoneiddio[^f00009])

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,

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

• [image omitted]

• whereM = the total mass of the treated samplep = 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:

• [image omitted]

• [image omitted]

Procedures

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• (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.