Food Irradiation (Scotland) Amendment Regulations 2010 (S.S.I. No. 328 of 2010)

S C O T T I S H S T A T U T O R Y I N S T R U M E N T S 2010 No. 328 FOOD The Food Irradiation (Scotland) Amendment Regulations 2010 Made - - - - 15th September 2010 Laid before the Scottish Parliament 17th September 2010 Coming into force - - 20th October 2010 The Scottish 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), 26 and 48(1) of, and paragraphs 1 and 4(b) of Schedule 1 to, the Food Safety Act 1990(a) and all other powers enabling them to do so. In accordance with section 48(4A) of that Act, the Scottish Ministers have had regard to relevant advice given by the Food Standards Agency(b). There has been consultation 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). Citation and commencement 1. These Regulations may be cited as the Food Irradiation (Scotland) Amendment Regulations 2010 and come into force on 20th October 2010. Amendment of the Food Irradiation (Scotland) Regulations 2009 2. The Food Irradiation (Scotland) Regulations 2009(d) are amended in accordance with regulations 3 to 6. (a) 1990 c.16. Section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990; sections 16(1), 18(1), 19(1) and 48(1) were amended by paragraph 8 of Schedule 5 to the Food Standards Act 1999 (c.28) (“the 1999 Act”); section 17(1) was amended by paragraphs 8 and 12 of Schedule 5 to the 1999 Act; section 26(3) was amended by Schedule 6 to the 1999 Act and is read with section 45 of the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6); section 48(4) is disapplied in respect of these Regulations by virtue of section 48(4C) which was inserted by S.I. 2004/2990; by virtue of section 40(2) of the 1999 Act, amendments made by Schedule 5 to the 1999 Act are to be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c.46) (“the 1998 Act”). The functions of the Secretary of State, in so far as within devolved competence, were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act. In so far as not so transferred, and in so far as relating to food (including drink) including the primary production of food, relevant functions were transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2005 (S.I. 2005/849). (b) Section 48(4A) was inserted by paragraph 21 of Schedule 5 to the 1999 Act. (c) O.J. No. L 31, 1.2.2002, p.1, 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 with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny – Part Four (O.J. No. L 188, 18.7.2009, p.14). (d) S.S.I. 2009/261. 2 3. In regulation 10(1)(a) (offences and penalties) for “6 months” substitute “12 months”. 4. In Schedule 2 (licences) for paragraph 15(1)(b) (requirements and prohibitions to be observed by a licensee) substitute— “(b) its batch number;”. 5. For Schedule 3 (list of approved facilities in member States) substitute the Schedule set out in Schedule 1 to these Regulations. 6. For Schedule 4 (list of facilities in a country outside the European Community) substitute the Schedule set out in Schedule 2 to these Regulations. Application of regulation 3 7. The amendment made by regulation 3 does not apply in relation to proceedings commenced prior to 20th October 2010. SHONA ROBISON Authorised to sign by the Scottish Ministers St Andrew’s House, Edinburgh 15th September 2010 3 SCHEDULE 1 Regulation 5 REPLACEMENT SCHEDULE 3 TO THE FOOD IRRADITION (SCOTLAND) 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 4 Official reference number Name and address 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 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 5 Official reference number Name and address 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-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 6 REPLACEMENT SCHEDULE 4 TO THE FOOD IRRADIATION (SCOTLAND) 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” 9 EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations amend the Food Irradiation (Scotland) Regulations 2009 to give effect to:– (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 (O.J. No. L 75, 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. These Regulations amend the Food Irradiation (Scotland) Regulations 2009 by— (a) substituting for “6 months” in regulation 10(1)(a) (offences and penalties) the period of “12 months” so as to bring the penalty of imprisonment on summary conviction into line with section 45 of the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6) (regulation 3); (b) substituting a new paragraph 15(1)(b) in Part 3 (requirements and prohibitions to be observed by a licensee) of Schedule 2 (licences) (regulation 4); (c) 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 5); and (d) 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 6). No impact assessment has been prepared for this instrument as it has no impact on the costs of business. (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 in the UK by The Stationery Office Limited under the authority and superintendence of Carol Tullo, the Queen’s Printer for Scotland. £5.75 40. 09/10. 19593.