The NABL 127 document, known as the "Procedure for Integrated Assessment & Additional Requirements of Regulatory Body(ies) For Testing Laboratories," lays out the guidelines for testing laboratories aiming for recognition or approval from various regulatory bodies in India, like IOPEPC, Tea Board, EIC, APEDA, and FSSAI.

Recent Expansion: Update and Inclusion of New Regulatory Bodies in NABL 127 Document

Integrated assessment now includes Spices Board and SHEFEXIL, reflecting an expansion in coverage and underscoring the significance of compliance and quality standards for associated testing laboratories. The following details pertain specifically to technical aspects.

 

Regulatory requirements from FSSAI- Update

1. Labs need to use sampling and analysis methods specified by FSSAI, with validation criteria in line with FSSAI guidelines mentioned in the manuals as specified by the Food Safety and Standards Authority of India from time to time (as applicable).
2. Testing activities (scope of lab) must adhere to the Food Safety and Standards Regulations, incorporating applicable amendments, within the defined scope for specific parameters.
3. Labs should submit monthly reports of their testing activities following the format outlined in clause 6.8.
4. Regularly upload test reports on FSSAI's online platform and update profiles, including details on manpower, equipment, test parameters, accreditation, proficiency testing, and analysis capacity.
5. Labs must participate in Proficiency Testing or Inter-Laboratory Test Comparison programs to demonstrate technical competence, organized nationally or internationally in collaboration with FSSAI.
6. Equipment and machinery should align with their least count and range, adhering to relevant Food Safety and Standards Regulations and amendments.
7. FSSAI Recognition Categories:  

Labs seeking FSSAI recognition should fall into one of the following categories:

Category A:   Labs in this category should have the full capability to test all safety and quality parameters for the specified category or sub-category. Their competence is evaluated against the standards outlined in relevant Food Product Standards Regulations and any amendments made over time.

Category B:   Laboratories falling into this category need to demonstrate adequate capability and competence for testing the majority of quality safety parameters (like contaminants, hazards, or toxins) within the applied category. However, they may lack the ability to test certain remaining parameters or analytes. For instance, if a lab can test pesticides, heavy metals, and antibiotics but not toxins, it may still receive recognition for the parameters it can effectively assess.

Category C, laboratories possess the capability and expertise to perform qualitative/quantitative analysis of safety and quality parameters using rapid kits or screening kits. However, unlike Category A and B, labs in Category C will not receive formal recognition and notification according to Section 43 of the FSS Act, 2006. Instead, they are enlisted solely for specific purposes, indicating that their recognition is limited to the tasks they can perform with rapid or screening kits.

Additionally, it's noted that mobile testing facilities should be considered alongside the mentioned categories, depending on their applicability to site facilities. This implies that mobile labs, equipped for on-the-go testing, can be relevant in certain situations, aligning with the specified categories as appropriate for their operational context.

Requirements of Spice Board

1. Laboratories seeking approval of Spice Board must establish and uphold a laboratory management system in compliance with ISO/IEC 17025, ensuring competence in testing and calibration. They should demonstrate sufficient capability and expertise in testing food safety and quality parameters, aligning with the specifications of Spices Board and the requirements of importing countries. Approval for Spices Board's scope is granted based on the laboratory's international competence, meeting standards and notifications for Spices and Spice Products. Specifically, for certifying products bound for export to the European Union, testing must adhere to the regulations and guidelines outlined by the European Commission.
2. Testing within the approved scope must adhere to the validation methods specified by the importing countries requirements.
3. The approved laboratory is not allowed to modify the Quality Management System, crucial for approval, and its compliance with the Scheme. Any changes affecting adherence to the Scheme must receive prior approval from the Spices Board.
4. The approved laboratory must adhere to the following guidelines when testing samples provided by the Spices Board:
5. Every sample must be accompanied by a test request specifying the parameter, specification, and purpose; without this information, the sample will not be accepted for testing.
6. When accepting samples, the laboratory must ensure that the seal is intact, and the necessary details, including the sample code, name of the spice matrix, and parameters to be tested, are provided in the official letter received with the sample.
7. The laboratory is required to conduct tests following the conditions outlined in the pertinent standard method approved by the Spices Board. This method should have been adequately validated to ensure its suitability for the intended purpose. 

8. The testing should be performed using properly calibrated equipment and valid certified reference materials and/or internal standards.The laboratory is obligated to retain the leftover sample for a minimum of three months under specified storage conditions before disposal. For samples tested for biological parameters, retention duration will be determined by the laboratory's policy aligned with the Spices Board or importing country's requirements. The laboratory must maintain records of disposal and present them upon request.The laboratory shall submit the test reports via online software to the concerned Regional Labs of Spices Board, immediately after completion of the tests.

9. The laboratory shall submit the test reports via online software to the concerned Regional Labs of Spices Board, immediately after completion of the tests.

Requirements of Shellac & Forest Products Export Promotion Council (SHEFEXIL)

1. Before seeking approval from SHEFEXIL and accreditation from NABL, laboratories must adhere to the following requirements: Ensuring the availability of necessary high precision equipment like GC-MS/MS, HPLC-MS/MS, and other essential laboratory facilities to conduct testing within the specified scope. This includes having appropriate backup, supporting equipment, and accessories to meet the prescribed turnaround time.
2. Shefexil-approved laboratories are designated to handle SHEFEXIL Scheduled Products. The assessment process will comprehensively cover areas relevant to the laboratory's approved scope. Evaluation entails verifying test facilities, accommodation, and the environment, examining documents and records, including matrix-specific, in-house, internationally accepted method validation documents related to the applied scope. The assessment also considers the competence of laboratory personnel in conducting analyses and testing, their performance in witness tests, and documented evidence of participation in proficiency testing programs.
3. Sampling and testing must be exclusively conducted by a laboratory approved by SHEFEXIL. For the reporting format, please refer to Annexure 2 under SHEFEXIL.
4. The laboratory is required to adhere to the sampling procedure outlined in Commission (EU) Directive 2002/63/EC or any subsequent amendments or substitutions. Reference to this directive must be included in the test report.
5. The laboratory must uphold proper sampling records, which should be retrievable during the laboratory assessment.
6. During sampling, the laboratory is required to draw three samples: one for laboratory testing, another to be provided to the shipper, and a control sample to be retained by the lab. The control sample may be requested during any investigation in response to concerns. The laboratory should preserve the control sample for a period of six months under suitable environmental conditions.
7. When necessary, the approved laboratory must draw samples exclusively using its trained, authorized, and approved samplers. These approved samplers must possess a minimum qualification of graduation, accompanied by relevant sampling experience and training.
8. Testing within the recognized scope must adhere to the analytical methods of validation specified by the importing countries requirements. 

Note: It is recommended to follow the NABL 127 document for any amendments periodically. For the latest information, please refer to the NABL document available at the following link: 

https://nabl-india.org/nabl/index.php?c=publicaccredationdoc&m=index&docType=both&Itemid=199