Food Title, application and commencement 1 These Regulations may be cited as the Food Irradiation (England) Regulations 2009, apply in relation to England only and come into force 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 Act ” means the Food Safety Act 1990; “ the Agency ” means the Food Standards Agency; “ approval ” includes a licence; “ approved ” includes “licensed”; “ import ” means to introduce from outside the United Kingdom ; “ 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, and similar expressions shall be construed accordingly; “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 and “ licensed ” and “ licensee ” shall be construed accordingly; “ official reference number ” in relation to a facility in a member State means the number shown for it in the list in Schedule 3 ; “ sell ” includes possess, offer, expose and advertise for sale, and “ sale ” shall be construed accordingly. 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, and “ proper irradiation ” shall 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 ”, 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 No person shall 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 2 shall have effect in relation to licences. Restrictions on importation 5 1 No person shall import into England 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 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 (2)(d) of Part 3 of Schedule 2; 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 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 . Restriction on storage or transport 6 1 No person shall 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 England, 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 7 No person shall sell food which or any part of which has been irradiated unless— a either— i the irradiation took place in England and regulation 4 and Schedule 2 and any conditions of the licence were complied with; or ii the irradiation took place in Northern Ireland, 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 England 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 No person shall import into England, 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 and each food authority within its area 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 food authority shall 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 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. 5 In this regulation “ food authority ” does not include the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple). Offences and penalties 10 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 shall be guilty of an offence and shall be 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 11 1 The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in them to the Act shall be 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) shall 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 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 Section 34 (which relates to time limits for the beginning of prosecutions) of the Act shall apply in relation to offences under these Regulations as it applies to offences punishable under section 35(2) of the Act. Revocation of existing Regulations 12 1 In so far as they apply in relation to England, the Food (Control of Irradiation) Regulations 1990 are revoked. 2 Regulations 2 to 16 of the Food Irradiation Provisions (England) Regulations 2000 and the Food (Control of Irradiation) (Amendment) (England) Regulations 2002 are revoked. Signed by authority of the Secretary of State for Health. Gillian Merron Minister of State, Department of Health