FSSAI advisory QA-11013/1/2025-QA-FSSAI · 06 May 2026
Official title
Approved technical specifications of High End Equipment (H EE) – LC/EAIRMS
Official record
Open source pageSummary
Check the official recordThe Food Safety and Standards Authority of India finalized technical specifications for High End Equipment known as Liquid Chromatography/Elemental Analyzer-Isotope Ratio Mass Spectrometry. This equipment supports food authentication, honey analysis, and adulteration detection. The specifications define requirements for mass spectrometry, software, chromatography, elemental analysis, computer systems, and power. Suppliers must provide comprehensive warranties, preventive maintenance, and training for laboratory personnel. The equipment must meet performance standards for sensitivity, linearity, and precision. Suppliers must also provide proof of performance, installation records in India, and dedicated after-sales service support. These requirements apply to the procurement and installation of LC/EA-IRMS systems to ensure compliance with food regulations.
What you must do
Key dates
Who is affected
Thresholds
If you do not comply
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)
(गगुणवत्ता आश्वासन प्रभागग)
FDA भवन, कोटला रोड, नई दिल्ली – 110002
दिनांक: 06th May, 2026
सूचना / Notice
Subject: Approved technical specifications of High End Equipment (H EE) – LC/EA-IRMS– reg.
FSSAI has finalised the technical specifications of High End Equipment (HEE) – LC/EA-IRMS.
(अभिनय शशांक)
सहायक निदेशक (तकनीकी)
ईमेल: abhinay.shashank@fssai.gov.in
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| Sl. No. | SPECIFICATION | REQUIREMENT |
|---|---|---|
| 1 | LC & EA IRMS (Instrument Details & Application) | (i) LC-IRMS system with all accessories, consumables etc. required and mentioned in the specifications for the analysis of C3 sugars, authentication of various food and Honey, identification of the source of origin along with latest software to meet Indian and global food regulation requirements. (ii) EA-IRMS system with all accessories, consumables etc. required and mentioned in the specifications for the analysis of adulteration C4 sugars, authentication of various food and Honey, organic products and nitrogen estimation along with latest software to Indian and global food regulation requirements. (iii) Data library & developed method may be provided for honey & other food matrices. |
| 2 | Mass Spectrometer | |
| 2.1 | Mass Range | 1-75 amu or better |
| 2.2 | Mass Resolution | 100 or better |
| 2.2 | Sensitivity & Linearity | (i) Sensitivity: 1200 Molecules/Ion or more with continuous flow mode. (ii) Linearity: CO2: ≤ 0.02 N2: ≤ 0.02 SO2: ≤ 0.04 |
| 2.4 | Source | (i) The instrument ion source must have suitable robust vacuum system with minimum maintenance requirement, low noise level and automatic vacuum lock. (ii) Minimum 3kv accelerating voltage for all masses from 1-75 amu or entire range (iii) Source must be self-aligning with a plug in design and should be easy to replace by user |
| 2.5 | Filament | (i) Filament should be inert to oxygen. (ii) Two additional filament shall be offered with each IRMS (LC & EA) |
| 2.6 | Collector Array | (i) The System should supplied with universal triple faraday cup collector assembly along with the collectors for Hydrogen analysis. Collector array should allow the measurement of C, N, S, O and H. (ii) The detector should last for the minimum 10 years. |
| 3 | Software | (i) The instrument control software must have a library of routine parameters which automates the measurement. (ii) The software must allow ready definition of novel inlet systems, allowing the addition of valves, traps, splits, and ovens; the software must provide complete control and automation of all interface functions during data acquisition to enable programming of novel inlet systems. (iii) Software shall support creation of user based data base/libraries. (iv) Software must contain data for corrections of measured delta values for 17O isotopomers of CO2. (v) The dilution of the sample and reference gases from should be software controlled. (vi) Free upgrades of software during the life span of the equipment. |
| 3.1 | Software & Data system for IRMS | |
| 4 | Liquid Chromatography & Interface (LC) | |
| 4.1 | LC | (i) LC should be compatible with IRMS and should be able to use independently for analysis of Sugar. (ii) LC should be compatible with IRMS and should controlled by the same operating software. |
| 4.2 | Pump | High pressure isocratic or binary pump (150 bar or better). |
| 4.3 | Auto sampler | (i) Integrated / inbuilt auto-sampler capable of handling minimum 100 samples (ii) Temperature range ambient to 40°C (Accuracy ±1 °C). (iii) Injection volume range:0.5-100μl (iv) Sample delivery precision:< 1% RSD or better |
| 4.4 | Column Oven | Temperature: ambient to 65°C or higher |
| 4.6 | Columns | Three additional carbohydrate columns for sugar analysis |
| 4.7 | Interface | Suitable interface to convert the sugars eluted form LC into CO2. The interface should ensure moisture free delivery of CO2 to the IRMS. The interface should be free from crystallization. |
| 4.8 | Gas consumption | Gas cylinders (He-2 No.), ( CO2, O2, N2,SO2-One each) along with associated parts (regulators, purification panels, tubings & plumbing etc.) |
| 5 | Elemental Analyser & Interface | |
| 5.1 | Auto sampler | (i) Auto sampler capacity should be minimum 80 sample position. (ii) The system should ensure complete removal of atmospheric gases. Zero blank auto sampler should be provided to avoid interferences of atmospheric gases. |
| 5.2 | Furnace | The system should have 2 furnaces with individual temperature control |
| 5.4 | Reactors | Reactors for carbon, nitrogen and sulphur analysis along with O, H requirement. Two additional spare reactors should be provided along with consumables/filling materials for 1000 CNS, 4000 CN and 1000 OH analysis. |
| 5.5 | Standalone operation | All necessary software and hardware should be supplied as a standard part of the EA. EA should be capable of operating as a standalone unit for CNS elemental analysis. |
| 5.6 | Precision | The trace gas should qualify the below specified precision.
a) δ13C ≤ 0.1 ‰ b) δ15N ≤ 0.15 ‰ c) δ34S ≤ 0.20 ‰ |
| 5.7 | Continuous flow interface | (i) The system should have an automatic diluter for the sample gas dilution and must be possible to dilute Sample gases by 2.5% to 100% or better.
(ii) Be expandable to minimum 3 preparation devices, to allow easy addition of future analytical capabilities.
(iii) The accessible dynamic system range should be 1: 5000 or more.
(iv) Interface must allow coupling of devices from <1 mL/min of He to >100 mL/min of He. It must be possible to choose the appropriate dilution for each analyte, so that different dilutions can be used for CO2, N2 and SO2 during a multi-isotope analysis.
(v) It must be possible to change reference gas intensity by a factor of 10 in <1 second.
(vi) Reference gas intensity must be variable over an intensity range of 2-30 V (CO2, N2) OR other equivalent unit range
(vii) The precision of gases in continuous flow mode should be as below or better:
|
| 6 | Computer system for EA & LC (Separate computer systems and other required accessories as mentioned below for EA and LC) | |
| 6.1 | Minimum configuration of processing PCs/System | Single Windows based computer systems of reputed international brands with latest processor for Acquisition and processing of results
Monitor: Minimum 42" CPU with factory certified RAM of appropriate capacity,Harddrive/SSD,Processor The system should be complete in all aspects ensuring smooth functioning of instrument operating software & the instrument. |
