New Delhi, May 2025 – The Food Safety and Standards Authority of India (FSSAI) has notified the World Trade Organisation (WTO) of draft amendments to the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011, with the notification issued on April 7, 2025. These revisions, open for stakeholder comments until June 6, 2025, introduce significant updates to food safety testing protocols, with far-reaching implications for the dairy industry. The amendments aim to enhance the efficiency, accuracy, and global alignment of laboratory testing, addressing gaps in the existing framework and accommodating the evolving needs of India’s food sector.
Key Amendments and Changes from the 2011 Regulations
The proposed amendments introduce several critical updates to the 2011 regulations, focusing on test reporting, analysis methods, and timelines. Below is a detailed comparison of the new provisions against the earlier framework, highlighting their relevance to dairy products like milk, cheese, butter, and yoghurt:
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Revised Test Reporting Protocols (Regulation 2.3.1, Clause 2)
- New Provision: After testing, the certificate from the Referral Food Laboratory (signed by the Director) or the report from the Food Analyst must be provided immediately to the sender in a prescribed format under the Food Safety and Standards (FSS) Rules, 2011.
- Previous Rule: The 2011 regulations required a certificate or report but did not explicitly mandate immediate delivery or reference the FSS Rules, 2011, for the format.
- Impact for Dairy: This change ensures faster communication of test results for dairy products, reducing delays in regulatory compliance and market access. For instance, processors of perishable dairy items like fresh milk or yoghurt will benefit from streamlined reporting, minimising spoilage risks during testing.
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Flexible Sample Quantities for Unspecified Products (Regulation 2.3.1, Clause 4)
- New Provision: For food products not listed in the regulations, sample quantities will follow guidelines issued periodically by FSSAI.
- Previous Rule: The earlier proviso allowed flexibility but lacked clarity on how quantities for unlisted products would be determined, often leading to ad-hoc decisions.
- Impact for Dairy: This is particularly relevant for innovative or niche dairy products, such as plant-based dairy alternatives or speciality cheeses, which may not have been covered in the 2011 regulations. Clear guidelines will reduce ambiguity and ensure consistent sampling for testing.
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Adoption of International Analysis Methods (New Regulation 2.5)
- New Provision: Laboratories must use FSSAI’s manuals for analysis, but if a method for a specific parameter is unavailable, they can adopt validated methods from internationally recognized bodies like AOAC, ISO, Codex Alimentarius, or others.
- Previous Rule: The 2011 regulations did not explicitly allow the use of international methods, relying solely on FSSAI manuals, which could be limiting for complex or new food products.
- Impact for Dairy: This change aligns India’s testing protocols with global standards, facilitating the analysis of sophisticated dairy products like fortified milk powders or probiotic yoghurts. It also supports exporters by ensuring compliance with international trade requirements, enhancing India’s dairy export potential.
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Defined Timelines for Analysis (New Regulation 2.6)
- New Provisions:
- Regulatory Samples: Food Analysts must issue reports within 14 days of receiving a sample. If delays occur, the analyst must inform the Designated Officer and Commissioner of Food Safety, specifying reasons and additional time needed.
- Appeal Samples: Referral laboratories must issue reports within 14 days, with similar provisions for delays.
- Import Samples: Notified or referral laboratories must provide reports within five days of sample receipt, as per FSS (Import) Regulations, 2017. Delays must be justified in writing to the Authorised Officer.
- Previous Rule: The 2011 regulations did not specify timelines for issuing reports, leading to inconsistent turnaround times and potential bottlenecks in trade and compliance.
- Impact on Dairy: The five-day timeline for import samples is a game-changer for dairy imports, such as cheese or butter. It ensures swift clearance at ports and reduces spoilage risks. The 14-day timeline for regulatory samples provides predictability for domestic dairy producers, aiding supply chain planning.
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Removal of FORM A and FORM B
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- New Provision: The amendments omit FORM A and FORM B from the regulations.
- Previous Rule: These forms were used for reporting test results, but their format and utility were outdated.
- Impact for Dairy: The shift to formats prescribed under FSS Rules, 2011, modernises reporting, potentially integrating digital or standardised templates. This could simplify compliance for dairy businesses, especially small-scale processors.
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Periodic Updates to Sample Requirements (Regulation 2.3.1, Table)
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- New Provision: FSSAI will intermittently update the table listing food products and their sample quantities to include previously unlisted items.
- Previous Rule: The 2011 regulations had a static table, which struggled to keep pace with new food products entering the market.
- Impact for Dairy: This ensures that emerging dairy products, such as high-protein milk or lactose-free variants, are covered under the regulations, providing clarity for testing requirements.
Implications for the Dairy Industry
India’s dairy sector, one of the largest globally, stands to benefit significantly from these amendments. The faster turnaround times for import and regulatory testing will reduce delays, ensuring that perishable dairy products reach markets promptly. The adoption of international analysis methods aligns India’s testing standards with global benchmarks, boosting the competitiveness of Indian dairy exports, which reached $550 million in 2024, according to USDA estimates. Small and medium-sized dairy enterprises, which often face compliance challenges, will benefit from clearer guidelines on sample quantities and modernised reporting.
However, the tightened timelines may pressure laboratories to upgrade infrastructure and staffing, potentially increasing testing costs. Dairy businesses should prepare for these changes by engaging with FSSAI during the comment period to ensure the regulations address industry-specific needs, such as specialised testing for fermented dairy products or infant formula.
Draft FSS_Laboratory and Sampling Analysis_Amendment Regulations_2025.pdf
