Food Irradiation (England) (Amendment) Regulations 2010 (S.I. No. 2312 of 2010)

S T A T U T O R Y I N S T R U M E N T S 2010 No. 2312 FOOD, ENGLAND The Food Irradiation (England) (Amendment) Regulations 2010 Made - - - - 19th September 2010 Laid before Parliament 23rd September 2010 Coming into force - - 20th October 2010 The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 16(1) and (3), 17(1), 18(1)(c), 19(1)(b), 26 and 48(1) of, and paragraphs 1 and 4(b) of Schedule 1 to, the Food Safety Act 1990(a) and now vested in him(b). In accordance with section 48(4A) of that Act, he has 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(c) there has been open and transparent public consultation during the preparation and evaluation of these Regulations. Title and commencement 1. These Regulations may be cited as the Food Irradiation (England) (Amendment) Regulations 2010 and come into force on 20th October 2010. (a) 1990 c.16; section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990. Sections 17, 19 and 48 were amended by paragraphs 12, 14 and 21 respectively of Schedule 5 to the Food Standards Act 1999 (1999 c.28), “the 1999 Act”. Section 48 was also amended by S.I. 2004/2990. Section 26(3) was amended by Schedule 6 to the 1999 Act. Section 53(2) was amended by paragraph 19 of Schedule 16 to the Deregulation and Contracting Out Act 1994 (1994 c.40), Schedule 6 to the 1999 Act, S.I. 2004/2990 and S.I. 2004/3279. (b) Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the 1999 Act. Functions of “the Ministers” so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the 1999 Act, and thereafter transferred to the Welsh Ministers by paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (2006 c.32). Those functions so far as exercisable in relation to Scotland were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c.46) as read with section 40(2) of the 1999 Act. (c) OJ No. L31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny – Part Four (OJ No. L188, 18.7.2009, p.14). 2 Amendment of the Food Irradiation (England) Regulations 2009 2. The Food Irradiation (England) Regulations 2009(a) are amended in accordance with regulations 3 to 5. 3. In Schedule 2 (licences) for sub-paragraph (1)(b) of paragraph 9 of Part 3 (requirements and prohibitions to be observed by a licensee) there is substituted the following sub-paragraph— “(b) its batch number;”. 4. For Schedule 3 (list of approved facilities in member States) there is substituted the Schedule set out in Schedule 1. 5. For Schedule 4 (list of facilities in a country outside the European Community) there is substituted the Schedule set out in Schedule 2. Signed by authority of the Secretary of State for Health. Anne Milton Parliamentary Under-Secretary of State, 19th September 2010 Department of Health (a) S.I. 2009/1584. 3 SCHEDULE 1 Regulation 4 SCHEDULE SUBSTITUTED FOR SCHEDULE 3 TO THE FOOD IRRADIATION (ENGLAND) REGULATIONS 2009 “SCHEDULE 3 Regulations 3(1) and 5(1)(b)(i) LIST OF APPROVED FACILITIES IN MEMBER STATES Official reference number Name and address 2110/91/0004 Sterigenics SA Zoning Industriel B-6220 Fleurus Belgium 01/23.05.2008 BULGAMMA SOPHARMA Ltd Iliensko Shosse Str.16 Sofia Bulgaria IR-02-CZ BIOSTER a.s. Tejny 621 664- 71 Veverska Bityska 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 BSG 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 4 Official reference number Name and address 500001/CU Ionmed Esterilización, SA Santiago Rusiñol 12. Madrid Antigua Cntra Madrid-Valencia KM 83.7. Tarancón Cuenca Spain 5.00002/B ARAGOGAMMA S.A. Salvador Mundi 11, bajo. 08017 Barcelona Carretera Granoolers a Cardedeu km 3,5. 08520 Les Franqueses dêsVallés Barcelona Spain 13055 F Isotron France SAS 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 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 5 Official reference number Name and address GZB/VVB-991393 Ede Isotron Nederland BV Morsestraat 3 6716AH Ede Netherlands GZB/VVB-991393 Etten-Leur Isotron Nederland BV Soevereinsestraat 2 4879NN 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 RG016/2008 Multipurpose Irradiation Facility IRASM Technological Irradiations Department Horia Hulubei National Institute for Research and Development of Physics and Nuclear Engineering Atomistilor Street No. 407 PO Box MG-6 Magurele. Ilfov County Romania EW/04 Isotron Limited Moray Road Elgin Industrial Estate Swindon Wilts SN2 8XS United Kingdom.” 6 SCHEDULE 2 Regulation 5 SCHEDULE SUBSTITUTED FOR SCHEDULE 4 TO THE FOOD IRRADIATION (ENGLAND) REGULATIONS 2009 “SCHEDULE 4 Regulation 5(1)(b)(ii) LIST OF FACILITIES IN COUNTRIES OUTSIDE THE EUROPEAN UNION 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 0SB Cerkezköy/TEKIRDAG TR-59500 Turkey EU-AIF 06-2004 Studer Agg Werk Hard Hogenweidstrasse 2 Däniken CH-4658 Switzerland 7 Official reference number Name and address EU-AIF 07-2006 Thai Irradiation Centre 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 EU-AIF 09-2010 Board of Radiation and Isotope Technology Department of Atomic Energy BRIT/BARC Vashi Complex Sector 20, Vashi Navi Mumbai – 400 705 (Maharashtra) India EU-AIF 10-2010 Board of Radiation and Isotope Technology ISOMED Bhabha Atomic Research Centre South Site Gate, Refinery Road Next to TATA Power Station, Trombay Mumbai – 400 085 (Maharashtra) India EU-AIF 11-2010 Microtrol Sterilisation Services Pvt. Ltd Plot No. 14 Bommasandra- Jigani Link Road Industrial Area KIADB, Off Hosur Road Hennagarra Post Bengalooru – 562 106 (Karnataka) India.” EXPLANATORY NOTE (This note is not part of the Regulations) 1. These Regulations amend the Food Irradiation (England) Regulations 2009 (S.I. 2009/1584). 2. These Regulations give effect to the provisions of— (a) Commission Decision 2010/172/EU amending Decision 2002/840/EC as regards the list of approved facilities in third countries for the irradiation of foods (OJ No. L75, 23.3.2010, p.33); and (b) undated Commission list of approved facilities for the treatment of foods and food ingredients with ionising radiation in the member States(a) replacing Commission list of such facilities of 3 September 2004. 3. These Regulations amend the Food Irradiation (England) Regulations 2009 by— (a) substituting for sub-paragraph (1)(b) of paragraph 9 of Part 3 (requirements and prohibitions to be observed by a licensee) of Schedule 2 (licences) a revised sub paragraph (1)(b) (regulation 3); (b) substituting for Schedule 3 (list of approved facilities in member States) a revised Schedule 3 containing a modified list of approved facilities in member States (regulation 4); and (c) substituting for Schedule 4 (list of facilities in a country outside the European Community) a revised Schedule 4 adding three new facilities to the list of the approved facilities in countries outside the European Union (regulation 5). 4. A full impact assessment has not been produced for this instrument as no impact on the public or voluntary sectors is foreseen. (a) Published on the Commission website via http://ec.europa.eu/food/food/biosafety/irradiation/comm legisl en.htm. A hard copy may be obtained from the European Commission, Directorate General for Health and Consumers, B-1049 Brussels, Belgium. Crown copyright 2010 Printed and published in the UK by The Stationery Office Limited under the authority and superintendence of Carol Tullo, Controller of Her Majesty’s Stationery Office and Queen’s Printer of Acts of Parliament. £5.75 E7968 9/2010 107968T 19585