FSSAI advisory · 18 Aug 2025
फ़ाइल संख्या: QA-11013/1/2025-QA-FSSAI भारतीय खाद्य सुरक्षा एवं मानक प्राधिकरण (खाद्य सुरक्षा एवं मानक अधिनियम, 2006 के अंतर्गत स्थापित एक वैधानिक प्राधिकरण) (गुणवत्ता आश्वासन प्रभागग) FDA भवन, कोटला रोड, नई दिल्ली – 110002 दिनांक: 18th अगगस्त, 2025 सूचना / Notice Subject: Notice inviting comments from Original Equipme…
Official record
Open source pageफ़ाइल संख्या: QA-11013/1/2025-QA-FSSAI
भारतीय खाद्य सुरक्षा एवं मानक प्राधिकरण
(खाद्य सुरक्षा एवं मानक अधिनियम, 2006 के अंतर्गत स्थापित एक वैधानिक प्राधिकरण)
(गुणवत्ता आश्वासन प्रभाग)
FDA भवन, कोटला रोड, नई दिल्ली – 110002
दिनांक: 18^th अगस्त, 2025
सूचना / Notice
Subject: Notice inviting comments from Original Equipment Manufacturers (OEMs)/ suppliers of High End Equipment (HEEs) – GC-MS/MS, LC-MS/MS, ICP-MS & ICP-OES on respective technical specifications – reg.
FSSAI is in process of finalizing the technical specifications of High End Equipment (HEEs) – GC-MS/MS, LC-MS/MS, ICP-MS & ICP-OES.
In this regard, FSSAI is inviting comments along with proper justification, from Original Equipment Manufacturers (OEMs)/ suppliers of GC-MS/MS, LC-MS/MS, ICP-MS & ICP-OES on respective technical specifications, in the prescribed formats placed at Annexure-I, Annexure-II, Annexure-III & Annexure-IV respectively.
Further, for convenience of the OEMs/ suppliers, the soft copy of the above-mentioned annexures has been made accessible through following links:
i. Annexure-I (GC-MS/MS):
https://docs.google.com/spreadsheets/d/1W3maByl08drcU6VBg7VEyk8cDv53yh66rJL_nKS5k2k/edit?usp=sharing
ii. Annexure-II (LC-MS/MS):
https://docs.google.com/spreadsheets/d/1qPDzzlYhxiAWQ9MA_cmctLg0-m2UY1hB7BfzWp6tXjM/edit?usp=sharing
iii. Annexure-III (ICP-MS):
https://docs.google.com/spreadsheets/d/1Zx2GT0DAm18EPaxwezGCJxncs1KNB4fkoYCaH9yW8xk/edit?usp=sharing
iv. Annexure-IV (ICP-OES):
https://docs.google.com/spreadsheets/d/13T-R9nWP7DKAiRSslHtK8kBYf_Cu4SLsxCDT0yq4lr4/edit?usp=sharing
The equipment-wise comments with its justification in the prescribed format need to be submitted in editable soft copy, only through email on following email IDs, positively by 25^th August, 2025:
To: abhinay.shashank@fssai.gov.in
CC: advisor.qa@fssai.gov.in; balasubramanian.74@fssai.gov.in
Further, it is advised that prior to submission of comments on email, OEMs/ suppliers should fill their details in the Google Form: https://forms.gle/wKCjCUa5PAWDHgPM7
It is pertinent to state that in case both the OEM and the supplier (of the same OEM) for a particular equipment submit their respective comments, only the comments submitted by OEM will be taken into consideration.
Further, this is to inform that mere submission of comments does not guarantee its incorporation in the technical specifications and FSSAI is not bound to accept all the comments submitted.
(अभिनय शशांक)
सहायक निदेशक (तकनीकी)
ईमेल: abhinay.shashank@fssai.gov.in
Copy To -
Annexure-I
| Sl. No. | SPECIFICATION | REQUIREMENT | Comments | Justification |
|---|---|---|---|---|
| 1 | GC-MS/MS system | (i) A bench top compact high sensitive GC-MSMS system to detected contaminants upto 10 ng/ml or below in Water, Food and Agricultural products such as Organo-chlorine pesticides, Organo-phosphorous pesticides, Synthetic Pyrethriods, PCBs, and VOCs with user friendly software to meet the requirements of FSSAI. | ||
| 2 | Gas Chromatograph | (i) Temp range: Ambient + 5°C to 450°C (ii) Column Oven can accommodate two columns with a maximum temperature range of up to 450 °C with a set point resolution of 0.1 ° C. | ||
| (iii) Fast oven cooling 450°C to 50°C in less than 5 minutes | ||||
| (iv) It should support 20 Oven ramps & maximum temperature ramp rates of 120° C/min. | ||||
| (v) Intelligent features like EMF, etc. should be built into the system | ||||
| (vi) The vendors should provide a readymade method if available. | ||||
| (i) Independently temperature-controlled injection ports. (ii) Split / Splitless injector for capillary Columns with Septum Purge functions (iii) Must be able to install at least 2 independently temperature controlled injector units simultaneously | ||||
| 3 | Inlet: 2 Nos | (iv) Inlet 1: PTV or Equivalent Inlet | ||
| (a) An Inlet providing the flexibility of a standard Split/ Splitless inlet, along with a programmable temperature vaporizer (PTV) capability/ Equivalent, enabling large- volume injections should be provided. It should be equipped with EPC with a pressure range of 0.1 to 100 psi. | ||||
| (b) The same inlet should also support cool injections for an improved signal response. | ||||
| (c) Temperature programming of up to 5 ramps or more at up to 800 °C/min or higher with fully EPC /equivalent. | ||||
| (d) Split ratio of 7500:1 or more. | ||||
| (e) Fast cooling facility for PTV preferably with Air | ||||
| (f) Following injection modes should be made available: a. Hot or cold split/ Splitless b. Pulsed split/ Splitless | ||||
| (v) Inlet 2: Split Splitless Inlet | ||||
| (a) An Inlet providing ability of a standard split/Split less inlet. It should be equipped with EPC with a pressure range of 0.1 to 100 psi. | ||||
| (b) Maximum temperature of 400 °C. | ||||
| (c) It should have a He Gas saver module or equivalent to reduce gas consumption without compromising performance. | ||||
| (d) Split ratio of 7500:1 or more. (e) Must have electronic septum purge flow control or equivalent technology to eliminate carry-over | ||||
| 4 | Gas flow control | (i) Should be able to run in constant flow, ramped flow, constant pressure and ramped pressure modes. | ||
| (ii) Pressure set points minimum increments: 0.005 psi in all ranges. | ||||
| (iii) Electronic pneumatic control for auto pressure regulation for split / Splitless operation, septum purge. | ||||
| 5 | Back flush Technology | (i) Automated back flush is required and should be configurable with inlet and column, for removal of high boiling interferences to ensure column life. | ||
| 6 | Auto Sampler/Auto Injector | (i) The auto sampler control (method, sequences, etc.) must be possible with in the Chromatographic Data system in use, without any external software needs. | ||
| (ii) Liquid sample injection via special micro syringe | ||||
| (iii) Number of samples capacity: 100 or better holding capacity 1.5/2 ml | ||||
| (iv) Cross-Contamination Free Pre- and Post-injection syringe rinsing with single or combined solvents | ||||
| (v) Sample vials: Glass construction, 1.5ml vials, set of 1000 vials to be provided. | ||||
| (vi) Rinse solvent vial: Glass construction, screw top, PTFE-coated septum | ||||
| (vii) Injection volume linearity: ±0.5 % or better | ||||
| (viii) Peak Area Repeatability ≤ 1% RSD | ||||
| 7 | Tandem Mass Spectrometer | (i) High performance tandem mass spectrometer with heated inert ion source and off axis channel electron multiplier detector/Photomultiplier detector capable of analyzing all the parameters given in other requirements | ||
| 8 | Vacuum System | (i) High efficiency low noise vacuum system suitable for mass spectrometer | ||
| 9 | Mass Range | (i) 10 to 1000 m/z or better | ||
| 10 | Interface | (i) Direct interface to capillary column and transfer line temp up to 350°C or better | ||
| 11 | Ionization | (i) Should provide high efficiency EI ionization source or equivalent. | ||
| 12 | EI MRM IDL (Instrument Detection Limit) | (i) m/z 272 - 222 IDL for 1 fg OFN ≤ 0.4 fg or better (Proof of Statement must be provided) | ||
| 13 | Maximum MRM speed | (i) 800 MRM transitions per second or higher | ||
| 14 | Mass Stability | (i) ±0.1 amu / 48hours | ||
| 15 | Scan Speed | (i) 20,000 u/sec or higher | ||
| 16 | Mass resolution | (i) 0.7 amu, Minimum (width at half height) or better | ||
| 17 | Dwell Time | (i) ≤1 m sec | ||
| 18 | Ionization Voltage | (i) 70 eV or better | ||
| 19 | Ionization Current | (i) At least up to 250µA or better | ||
| 20 | Mode of operation of MS/MS | (i) Should be able to do Scan, SIM, MRM/SRM, Parent ion scan, Product ion Scan, Neutral loss scan-time segment based. | ||
| 21 | Dynamic range | (i) 6th order of magnitude or better | ||
| 22 | Columns | (i) Low bleed suitable Capillary column for Pesticide residue analysis (30 m x 0.25 mm x 0.25 µm) - 5 Nos. (ii) Wax column (30 m × 0.25 mm, 0.25 μm film thickness) for ethylene oxide analysis – 05 nos. | ||
| 23 | Quantitation Software | (i) The complete system should be supplied with a computer and a heavy duty branded duplex laser printer with original software with a license to control GC-MS/MS and other accessories data handling software and integrated with it. | ||
| (ii) Should have the capability to run the mass spectrometer in all the modes specified. | ||||
| (iii) Data acquisition, integration, calibration, quantification and QC calculations must be automated. | ||||
| (iv) Manual and Auto tune options should be provided. | ||||
| (v) Automatic MRM/SRM method Development | ||||
| (vi) Library searching facility with latest series of NIST Library. | ||||
| (vii) Pesticides / environmental pollutants MRM Database for atleast 5000 ion transitions, covering applicable FSSAI Parameters. | ||||
| (viii) 21 CFR part 11 & food safety compliance. | ||||
| 24 | Workstation & Accessories: | (i) A Workstation should be provided for controlling the mass spectrometer, GC and auto- sampler including headspace with data acquisition & for data processing and analysis with minimum following specification: (a) Suitable High-End factory-fitted Compatible Computer workstation should come along with the System. (b) Suitable branded PC with LED monitor 32’’ or better with Black & White Laser Printer | ||
| (c) Memory / RAM/ Hard Disk/ Processor - compatible with the system to ensure smooth operation without lag. | ||||
| (d) External Hard disk: 10 TB or better (Provided Additionally with the System) | ||||
| (e) Operating system: Latest Windows configuration, 64 - bit or better. | ||||
| (f) Wireless USB Adapter for Wi-Fi connectivity | ||||
| (g) All hardware and software including drivers, monitor, device interfaces cards/network must be preinstalled and preconfigured on the computer provided. | ||||
| (h) Original licensed software CD of Operating system and MS office 365 licensed (MS-WORD, MS- EXCEL, MS-POWERPOINT). | ||||
| (i) Should be complete with all necessary accessories with comprehensive warranty of minimum 5 years of all the electronic components as well as wear and tear consumables (PC, Hard Drive, Black & White Laser Printer of reputed brand, etc.) | ||||
| 25 | Gas Generator, Gas Cylinders, Gas Regulators, Gas tubings, Manifold and Gas purification systems | (i) Pre requisite for MS: (a) Suitable gas cylinders required for operating the equipment including Helium, Argon, Nitrogen of UHP grade - 02 Nos (with requisite certificate) with all accessories such as dual pressure SS regulator, gas purification panel unit /Inline filters such as Oxygen trap, Moisture trap, etc. Cylinder cage or Bracket should be supplied and commissioned. The gas lining panel work should be done by the supplier for the connection of the instrument. | ||
| (b) All the items, regulator, gas purification panel unit, cylinder cage or Bracket etc should be covered under five years’ comprehensive warranty with at least one Preventive maintenance along with PM kit each year. Gas purification filters of the above gas should be refilled or replaced every year or whenever required, whichever is earlier during the warranty period. | ||||
| 26 | Uninterrupted Power Supply(UPS) system | (i) True online UPS system of 10 KVA capacity or above better suitable with power factor correction and harmonic. Three phase 440V/240V for the smooth running of GC-MS-MS with battery back-up of minimum 2 hr with 80 % load capacity with comprehensive warranty of minimum 5 years inclusive of SMF or latest. The electrical work of the UPS system should be done by the supplier for the connection of the instrument. | ||
| (ii) All the UPS system batteries should be replaced by brand new batteries with warranty certificate two months before completion of warranty period of GC-MSMS and the performance of UPS system should be verified. Satisfactory performance certificate of UPS should submit to the laboratory by the GC-MSMS supplier and UPS supplier together. | ||||
| (iii) The maintenance of UPS system and batteries is responsibility of GC-MS-MS supplier. Any malfunction of GC-MS-MS due to UPS system and its batteries failure, the supplier of GC-MS- MS has to take whole responsibility and rectify the same during warranty period. | ||||
| 27 | Instrument and Software Qualification/ Performance Verification IPV (IQ,OQ,PQ) | (i) The instrument must be “Qualified” along with the Software. Necessary reagents & accessories along with Documents must be provided. During installation and qualification, Instrument should perform as per submitted specification in presence of user. | ||
| (ii) IQ/OQ/PQ to be performed as per OEM protocol, should be done free of cost with necessary traceable standards along with necessary performance kit standard solutions | ||||
| (iii) Documents, Kits & standards etc. as required being supply along with the instrument | ||||
| (iv) To be done free of cost with traceable calibration standards for the first 5 years’ warranty period (at installation & at every maintenance visit of each year) along with PM kits. | ||||
| (v) OQ/IPV should be done free of cost with supply of PM Kits, Tuning solution, setup solution, calibration standards etc. and calibration standards at least once in a year during warranty period. | ||||
| (vi)Documents, PM Kits & calibration standards etc. to be supply along with instrument at every PM visit free of cost during warranty period. | ||||
| (vii) Satisfactory performance certificate should submit to the laboratory after calibration of GC-MSMS before one month of warranty period expired with supply and fixation of PM kits of GC and MS system. | ||||
| 28 | Warranty | (i) Minimum 5 years from the date of completion of IQ, OQ and PQ of GC-MS/MS to the satisfaction of lab and UPS system with batteries and all accessories. | ||
| (ii) Tune solution: Tuning and performance solution to cover the Warranty period | ||||
| (iii) Setup solution: Detector and Mass calibration Solution to cover the warranty period | ||||
| (iv) The date of warranty period for GC-MSMS including Headspace, UPS system with batteries, PC, Printer, Gas cylinders with its accessories and all associated supply of GC-MSMS, which will start from the date completion of IQ, OQ and PQ of GC-MSMS. | ||||
| (v) It should cover hardware, software as well as wear and tear consumables (except column and sample preparation), Up-gradation of software to the latest version (if applicable), prompt service (within 24-48 hours on-call), training and application support during the period. | ||||
| (vi) In case of breakdown of the system, the servicing to be done immediately by the supplier during the warranty period and maximum down time period is 24-48 hrs, if it’s not attended the warranty will extend accordingly. | ||||
| 29 | After sales service/ Post warranty | (i) Should have a good after sales service/technical support capable of reaching at short notice the places where GC-MS/MS is proposed to be installed. Visits and unlimited breakdown calls by service/application support, engineers should attend within 72 hrs without fail for GC-MS/MS System, including Computer, Printer and UPS sytem. | ||
| (ii) Troubleshooting training (Instrumentation/Application) as and when required free of cost | ||||
| (iii) The vendor should also assure supply of spares, accessories, consumables and service for at least 10 years. | ||||
| (iv) AMC Price for GC-MS/MS to be quoted separately. Terms and conditions for the AMC after the warranty period has to be specified. | ||||
| (v) AMC price quoted by the vendor will be considered for finalizing the L1. However it needs to be submitted separately. | ||||
| (i) Demonstration and Training on system to our Lab personal at site to be incorporated, responsibility of the supplier for training of the lab personnel at supplier site/installation site | ||||
| 30 | Demonstration and Training of personnel | (ii) Basic training for a period of not less than two weeks after installation of the equipment to technical personnel and further for method development whenever required during warranty and AMC period should be provided free of cost. | ||
| (iii) A general entry-level training-cum-workshop and advanced-level training-cum-workshop must be arranged at the user’s site by the vendor on experimental and data analysis part, with no extra cost involved. | ||||
| (iv) Trouble shooting training along with Application support for developing validating at least one polar parameter or selected by the lab. | ||||
| (v) The instrument supplier shall validate three methods: (a) 100 pesticides in two food commodities (as preferred by the laboratory) as per SANTE/11312/2021 (or latest) regulation | ||||
| (b) Demonstration of Ethylene oxide analysis (including its reaction product 2-chloroethylene) in various food commodities as per SANTE/11312/2021 (or latest) regulation with and without headspace. | ||||
| (i) The following accessories, but not limited to, should be supplied along with instrument: (a) PM kit for GC, Auto Sampler and MASS sufficient for trouble free operation during warranty period should be provided along with instrument. (b) Standard Tool kit should be provided for Instrument maintenance | ||||
| (c) Auto sampler vials with caps: 2000 Nos each (Amber & Transparent) | ||||
| (d) Injector port Septa- 200 Nos (e) Suitable glass inserts for 2 ml vials-1000 nos. | ||||
| (f) Injector port liners – 20 liners for each type of injectors and based on application of Pesticide residues, PCB etc. |