Notification of the Ministry of Public Health (No. 297) B.E. 2549 (2006) Re: Irradiated food

(Unofficial) Notification of the Ministry of Public Health (No. 297) B.E. 2549 (2006) Re: Irradiated food It deems appropriate to amend the notification of the Ministry of Public Health, Re: Prescribed production processes of irradiated food. By the virtue of provisions of Section 5 and 6(7) (8) and (10) of the Food Act B.E. 2522 (1979), in which contain provisions in relation to the restriction of Rights and Liberties of the Persons, in respect of which Section 29 and in conjunction with Section 35, Section 48 and Section 50 of the Constitution of the Kingdom of Thailand so permit by virtue of provisions of law: the Minister of Public Health hereby issues the notification as follows: Clause 1 The Notification of the Ministry of Public Health (No. 103) B.E. 2529 (1986), Re: Prescribed production processes of irradiated food, date 18th November B.E. 2529 (1986) shall be repealed. Clause 2 Irradiated food is prescribed food for production processes and labelling. Clause 3 This notification: “Irradiated food” means foods processed by ionizing radiation in order to achieve purpose of irradiation. “Food irradiation” means processing of food by ionizing radiation to achieve purpose of the irradiation. “Food radiation processor” means one who is granting approval for processing of food irradiation. “Dosimetry” means the measurement of the absorbed dose of radiation after irradiation. “Absorbed Dose” means the amount of energy absorbed per unit mass of irradiated food product having unit in Grey. “Technological Purpose” means radiation of food for control of foodborne pathogens, extension of durable life, delaying of maturity, reduction of parasite level, inhibition of the germination during storage, destruction and control of insect infestation or others; in this respect an irradiation of food shall have minimum absorbed dose to achieve effective radiation processing of food products and maximum absorbed dose that are safe to consumer; in a manner that maintains nutrition value of food and does not destroy structure integrity, functional properties and sensory characteristics. 2/… 2 Clause 4 Processing of food irradiation shall be carried out in accordance with the Recommended International Code of Practice for Radiation Processing of Foods (CAC/RCP 19 1979, Rev.1-2003) and also principles, procedures and provisions shall be as followed; (1) The sources of ionizing radiation shall be as followed; (a) Gamma rays from radionuclides Cobalt-60 (60 Co) or Cesium -137 (137 Cs); or (b) X-rays generated from machine sources operated at or below an energy level of 5 MeV; or (c) Electrons generated from machine sources operated at or below an energy level of 10 MeV. (2) Absorbed Dose shall be in accordance with each purposes of irradiation; in this respect absorbed dose shall not exceed the level prescribed in the Annex 1 attached with this Notification; this may be exempted if there is technical reason or necessity for approval from the Food and Drug Administration or as the Food and Drug Administration prescribed according to an approval of the Food Committee. (3) Control of process (a) Radiation treatment of foods shall be carried out in facilities licensed for this purpose by the competent authority. (b) The facilities shall be designed to meet the requirements of safety, efficacy and good hygienic practices of food processing. (c) The facilities shall be adequately staffed by competent personnel trained in its application in radiation processing. (d) Control of the process within the facility shall include the keeping of records concerning with radiation treatment of food and including quantitative dosimetry. (e) Information as in (d) shall be clear and shall be kept at least for 3 years in appropriate environment to prevent from damage or deterioration. Clause 5 Food intended for radiation process shall be prepared, processed and transported with good hygienic practice to achieve food safety purposes, raw materials and end product shall comply with applicable hygienic codes, food standards, and transportation codes. Clause 6 Foods irradiated shall not be re-irradiated except for foods with low 3/… 3 moisture content such as cereals, pulses, dehydrated foods and other such commodities, irradiated for the purpose of controlling insect reinfestation, with the cumulative maximum absorbed dose delivered to a food shall be as specified in clause 8. Clause 7 Food is not considered as having been re-irradiated when: (1) Food is prepared from materials which have been irradiated at low dose levels e.g. quarantine control, prevention of sprouting of roots and tubers; and is irradiated for other purpose; (2) The food, containing less than 5% of irradiated ingredient, is irradiated; (3) The full dose of ionizing radiation required to achieve the desired effect is applied to the food in more than one increment as part of processing for a specific technological purpose. Clause 8 Irradiated foods in clause 6 and clause 7 shall have cumulative maximum absorbed dose delivered to a food not exceed 10 kGy except when it is necessary to achieve a legitimate technological purpose, and shall not compromise consumer safety or wholesomeness of the food; in this regard, if cumulative maximum absorbed dose exceeds 10 kGy must have an approval from the Food and Drug Administration. Clause 9 Irradiation of food whether is beneficial for the protection of consumer health or not, it shall be complied with technological requirements and shall not be used as a substitute for good manufacturing practices or good agricultural practices. Clause 10 Labelling of irradiated foods shall display the following additional details, other than follows to the Notification of Ministry of Public Health, Re: Label and Notification of Ministry of Public Health for each particular food: (1) Name and location of head office of manufacturers and food radiation processor; (2) Display the words “irradiated” or other statements that convey the same meaning; (3) Specify the purpose of irradiation with the following clause “For……….” (specify the purpose of irradiation in the blank) (4) Display of irradiation symbol is optional, but when it is used, it shall be displayed as presented in Annex 2 of this Notification in close proximity to the name of the food. (5) Date, month and year of irradiation. 4/… 4 Clause 11 When an irradiated food is used as an ingredient in another food, this shall be expressed as in clause 10(2) in the list of ingredients. Clause 12 In case there is only one irradiated raw material as an ingredient in the food, it shall be expressed as clause10(2) accompanied with the name of the food. Clause 13 Packaging of irradiated foods shall be of suitable quality, acceptable hygienic condition and appropriate for this purpose and shall be in accordance with good manufacturing practices, before and after irradiation. Clause 14 Producers or importers of irradiated foods, whose Labels do not follow clause 10 and having approval from the Food and Drug Administration prior this Notification come into force, shall amend the labelling to conform to this Notification within 1 year after this Notification come into force. Clause 15 This notification shall come into force after 180 days as from the day following date of its publication in the Government Gazette. Notified on 7 t h of August 2006 signed Anutin Charnverakul (Mr. Anutin Charnverakul) Deputy Ministry of Ministry of Public Health on behalves of The Minister of Public Health (Copied from the Government Gazette Vol. 123, Special Part123 Ngor, dated 1 st September 2006) Certified true copy Varunee Saensupa (Miss Varunee Saensupa) Food and Drug Specialist level 8 Note: This English version of the notification is translated to meet the need of the non-Thai speaking people. In case of any discrepancy between the Thai original and the English translation, the former will take priority.