FSSAI has issued an order dated 9 September, 2021 related to the inclusion of ‘Radiation Processing of Food’ as new Kind of Businesses (KoBs) in the FoSCoS Portal for Licensing of Food Businesses.
In its order, FSSAI has drawn attention to the proviso of clause 2.1.2 (5) under the Food Safety and Standards (Licensing and Registration) Regulations 2011, where it is stated that no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article of food which has been subjected to the treatment of irradiation, except under a license obtained from the Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations 1996. Standards for Radiation of Processing of Food are mentioned in clause 2.13 under Food Safety and Standards (Food Products Standards and Food Additives) Regulations 2011.
To facilitate the licensing of Food Business Operators (FBOs) involved in radiation processing of foods, the FSSAI has decided to include “Radiation Processing of Foods” as new Kind of Business in FoSCoS portal with the following criteria
- KoB Name: Radiation Processing of Food
- KoB Definition: Radiation processing of food or food irradiation is a physical process in which food commodities, bulk or pre-packaged are exposed to controlled doses of energy of ionizing radiation such as gamma rays or X-rays to achieve different technological objectives”
- Eligibility – only Central License
- Fee – Rs.7500/- (as per Annexure 3 of the Food Safety and Standards (licensing and Registration of Food Businesses) Regulation 2011
- Documentation required for License – (Given in Annexure below)
- Annual Return – As per the existing regulations for Manufacturers/ Processors
Documentation Required for License of “Radiation Processing of Foods” KoB
All Documents mentioned in List B1: List of Documents for Manufacturers / Processors
(Here FSSAI has asked to refer to its previous order dated 19 March 2021 on the subject Revised list of Kind of Businesses wise document required to be submitted along with application for FSSAI License)
Additional Documents Required (to be added to list B2 of the said order)
- License obtained from the Department of Atomic Energy under Atomic Energy (Radiation Processing of Food and Allied Products) Rules, 2012
- List of Food Products along with ‘Class category/Allied Product category’, Purpose’ and Dose/Dose range’ as per clause 2.13 of FSS (Food Products Standards & Food Additives).
- Self-declaration to comply with the conditions for approval, operation, license and process control prescribed under the Atomic Energy (Radiation Processing of Food and Allied Products) Rules, 2012
Additional Records to be inspected during Inspection or any time after grant of License
- Certificate of irradiation indicating the dose of irradiation and purpose of irradiation provided by the facility
Given Below is the List of Documents Required as per FSSAI order dated 19, March 2021
B1: List of Documents for Manufacturers / Processors Sr. No. 1 to 10 — applicable for all Manufacturing/Processing KoBs
- List of Directors/Partners/Proprietor/Executive Members of Society/Trust with full address and contact details with nomination of authorized signatory*
- Photo I.D and address proof issued by Government authority of Proprietor/ Partner/ Director(s)/ Authorised Signatory.
- Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill, etc.)
- Partnership Deed/Self Declaration for Proprietorship/Memorandum & Articles of Association towards the constitution of the firm/ Copy of certificate obtained under Coop Act – 1861/Multi State Coop Act – 2002 in case of Co-operatives.
- Form IX: Nomination of Person as per Clause 2.5 of FSS Rules, 2008 (Not applicable in case of Proprietor) *
- Blueprint/layout plan of the processing unit showing the dimensions in metres/square metres and operation-wise area allocation *
- Production unit photographs
- Name and List of Equipment and Machinery along with the number, installed capacity and horse power used*
- Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food from a recognized/ public health laboratory to confirm the potability indicating the name of authorized representative of Lab who collected the sample and date of collecting sample. (Not applicable if water is not being used as ingredient)
- Recall Plan*
For additional information on order 19 March, 2021 please refer to the following URL https://foodsafetyhelpline.com/fssai-revised-list-of-kind-of-business-wise-documents-required-with-application-for-fssai-license/