FSSAI Proposes Restrictions on Sucrose and Fructose in Infant Nutrition Products: Regulatory Implications for Manufacturers

Introduction

Infant nutrition products are subject to stringent regulatory controls because their nutritional composition plays a critical role in supporting growth and development during early life. The selection of carbohydrate sources, formulation design, ingredient quality and compliance with age-specific nutritional requirements are therefore important considerations for manufacturers.

In October 2026, the Food Safety and Standards Authority of India (FSSAI) published the draft Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2026, proposing to prohibit the addition of sucrose and fructose in products intended for infants up to six months of age.

The proposal seeks to strengthen the existing framework under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, with a greater emphasis on age-appropriate formulations and minimising unnecessary exposure to added sugars during early infancy.

For infant formula manufacturers, ingredient suppliers, contract manufacturers, quality assurance teams and food testing laboratories, this development highlights the importance of reviewing carbohydrate sources, formulation specifications, analytical verification and regulatory documentation.

Regulatory status: This is a draft amendment open to stakeholder consultation. The proposed restriction should not be described as a final enforceable requirement unless and until FSSAI finalises and notifies the amendment.

What Does the Proposed FSSAI Amendment State?

The draft notification, dated 15 October 2026 and published in the Gazette of India on 16 October 2026, proposes to amend Regulation 3, sub-regulation 6 of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.

The proposed provision states that:

“sucrose and fructose shall not be added in the products intended for infants up to the age of 6 months”

The proposal specifically concerns the addition of these two sugars to products intended for infants up to six months of age.

The existing framework provides nutritional composition requirements for different categories of infant nutrition products. It identifies lactose and glucose polymers as preferred carbohydrate sources, while allowing sucrose and/or fructose to be added when required as a carbohydrate source, subject to the prescribed conditions and limits.

The draft proposes a more specific restriction for products intended for the youngest age group.

Key elements of the proposal

Regulatory element	Details
Regulatory authority	Food Safety and Standards Authority of India (FSSAI)
Draft amendment	Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2026
Parent regulation	Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020
Substances covered	Sucrose and fructose
Proposed restriction	Prohibition on adding sucrose and fructose
Product age group	Products intended for infants up to six months of age
Regulatory status	Draft amendment under stakeholder consultation
Consultation period	60 days from the date on which copies of the relevant Official Gazette are made available to the public

The proposed wording addresses the addition of sucrose and fructose. It should not automatically be interpreted as a requirement for every carbohydrate or every sugar-related analytical parameter to be absent from the finished product. The precise scope and interpretation must follow the final notified provision and applicable product requirements.

Understanding Sucrose and Fructose in Infant Nutrition

Sucrose and fructose are sugars that can contribute to the carbohydrate content of a food product. Their functional properties may influence formulation, sweetness, carbohydrate composition and other product characteristics.

Sucrose

Sucrose is a disaccharide composed of glucose and fructose. In food formulation, it is commonly used as a sweetening ingredient and a source of carbohydrates.

In products where sucrose is added as an ingredient, its presence can be assessed through formulation records, ingredient specifications and suitable analytical testing.

Fructose

Fructose is a monosaccharide naturally present in some foods and can also be used as an ingredient in food formulations.

For infant nutrition products, its relevance depends on the product category, intended age group, source and function within the formulation, and the applicable regulatory requirements.

Why distinguish added sugars from total sugars?

The distinction is important for regulatory interpretation and analytical planning.

A restriction on adding specific ingredients is not automatically equivalent to a requirement that the finished product contain zero detectable amounts of those compounds under every possible circumstance. Analytical results may be influenced by the ingredient composition, raw materials, manufacturing process, sample preparation and method capability.

Manufacturers should therefore maintain evidence of ingredient selection and formulation controls alongside finished-product test results. Any interpretation of incidental presence, carry-over or naturally occurring constituents should be based on the applicable legal text rather than assumed from the draft wording alone.

Why Is FSSAI Proposing This Restriction?

The stated objective is to strengthen nutritional safeguards during the first six months of life and encourage formulations aligned with the nutritional requirements of young infants.

This stage is particularly important for growth and development. Public health recommendations support exclusive breastfeeding during the first six months of life, where feasible and appropriate. For products intended for infants who require them, composition must be carefully controlled to meet the applicable nutritional and safety standards.

The proposal also reflects broader public health considerations concerning early exposure to added sugars and dietary risk factors associated with long-term health outcomes.

The regulatory objective is not simply to reduce sweetness. It is to encourage age-appropriate product formulation while preserving the nutritional adequacy and functional performance required of products intended for this sensitive population.

Sampling: A Critical Part of Compliance

Pesticide residue results are only as representative as the sample tested. Residues can vary between individual fruits, field lots, production sites, harvest dates and batches.

A robust sampling programme should consider:

Lot identification: Clearly identify the consignment, commodity, origin, production lot and relevant traceability details.
Representative sampling: Use a suitable sampling procedure for the commodity and intended compliance assessment.
Sample handling: Prevent contamination during collection, packaging, storage and transport.
Sample preparation: Ensure that the laboratory prepares the sample according to the applicable commodity-specific method and residue definition.
Documentation: Maintain traceability between the tested sample, analytical report, supplier and export consignment.

A laboratory result from one batch should not automatically be treated as proof that all other batches from the same supplier or growing region will comply.

Practical Steps to Prepare for the 5 November 2026 Implementation Date

Food exporters and manufacturers can take the following actions to prepare for the revised MRLs.

Review pesticide use and supplier information

Identify whether the six substances are used in relevant crops, ingredients or supply chains. Obtain current pesticide-use records and supplier declarations where appropriate.

Map commodities to applicable MRLs

Create a product-specific matrix linking each exported commodity to the relevant pesticide, residue definition, MRL and analytical requirement.

Update residue-monitoring plans

Review existing testing frequency and analyte lists. Include additional testing or targeted verification where the risk assessment indicates a need.

Confirm laboratory method suitability

Check that the selected method can quantify the relevant residues at sufficiently low levels and covers any required metabolites or residue sums.

Review consignments around the effective date

Confirm the applicable legal requirements for consignments moving through the supply chain around 5 November 2026. Do not assume that the date of production, testing or dispatch alone determines which provisions apply

Investigate non-compliant results

Where results exceed an applicable limit, assess sample identity, analytical validity, the relevant legal residue definition and the applicable decision rules. Investigate the source and implement corrective action before making further compliance decisions.

Maintain traceability and records

Retain test reports, sampling records, pesticide-use information, supplier documents and corrective-action records to support internal review and customer or regulatory enquiries.

Potential Implications for Infant Formula Manufacturers

If finalised in its proposed form, the amendment could require manufacturers to review products intended for infants up to six months of age where sucrose or fructose is currently added.

Ingredient and formulation review

Manufacturers should identify whether sucrose or fructose is intentionally added to any relevant product, including through premixes, compound ingredients, flavour systems or other formulation components.

The review should cover:

Master formulation records and approved recipes.
Ingredient specifications and supplier declarations.
Premixes and compound ingredients.
Manufacturing instructions and weighing records.
Product development and reformulation documentation.
Controls for ingredient substitution and formulation changes.

The purpose is to establish whether the targeted sugars are deliberately introduced at any point in the formulation process.

Carbohydrate-source evaluation

Removing a carbohydrate ingredient may affect more than the declared composition. Changes can influence processability, powder characteristics, ingredient interactions, product stability and other relevant product attributes.

Any reformulation must remain consistent with the applicable nutritional composition requirements. Manufacturers should not replace sucrose or fructose with another ingredient without assessing its regulatory acceptability, nutritional suitability and functional performance.

Lactose and glucose polymers are identified as preferred carbohydrate sources under the existing framework. Their suitability for a specific product must still be assessed against the applicable category-specific requirements.

Supplier and contract-manufacturing controls

Ingredient suppliers and contract manufacturers may need updated specifications, purchasing requirements and declarations to support compliance.

Manufacturers should ensure that ingredient changes are communicated across procurement, product development, manufacturing, quality control and regulatory affairs. Version-controlled formulation documents can help prevent outdated recipes from being used in production.

Product verification and release controls

Finished-product testing can support verification of formulation controls, but a laboratory result alone may not establish whether a substance was intentionally added.

Manufacturers should combine analytical evidence with ingredient traceability, batch records, supplier information and process controls when assessing compliance.

Analytical Testing for Sucrose and Fructose

Analytical testing can help manufacturers establish a baseline for existing products, verify reformulated products and investigate unexpected sugar profiles. The method should be selected according to the product matrix, target analytes, expected concentrations and intended decision.

High-performance liquid chromatography (HPLC)

HPLC can be used for sugar profiling and quantification when configured with a suitable separation mechanism and detector.

Depending on the method, detectors such as refractive index (RI) or other appropriate detection systems may be used to determine sucrose, fructose and additional carbohydrates. Method suitability depends on chromatographic separation, calibration, matrix interference, recovery, precision and the required quantification capability.

High-performance anion-exchange chromatography with pulsed amperometric detection (HPAEC-PAD)

HPAEC-PAD can provide separation and detection of selected carbohydrates, including sugars, using a method suitable for the target compounds.

It may be useful when more detailed carbohydrate profiling is required. The method must be validated or verified for the specific infant nutrition matrix and intended analytical purpose.

Enzymatic methods

Enzymatic assays can provide targeted measurements of selected sugars. Their suitability depends on analyte specificity, sample composition, potential interferences and the required measurement range.

A targeted assay may be useful for routine verification where its performance characteristics meet the intended purpose, but it may not provide the same carbohydrate profile as a chromatographic method.

Method selection and validation

No single analytical technique should be assumed to be universally suitable for every infant nutrition product. Method selection should consider:

Target sugar and relevant co-eluting compounds.
Product type, including powder or liquid formulations.
Sample homogenisation and extraction efficiency.
Calibration range and analytical specificity.
Limit of detection and limit of quantification.
Recovery, precision and repeatability.
Matrix effects and potential interferences.
Quality-control samples and measurement uncertainty, where applicable.

The analytical method should be capable of distinguishing the target sugars from other components in the product. Where results are used to support a regulatory decision, the laboratory should confirm that the method is appropriate for that decision and any applicable official requirements.

Interpreting Laboratory Results Under a Restriction on Addition

The proposed provision focuses on whether sucrose and fructose are added to products intended for infants up to six months of age. This creates an important distinction between analytical measurement and assessment of manufacturing compliance.

A laboratory may quantify sucrose or fructose in a finished product, but the reported concentration alone may not establish the source of the compound or whether it was intentionally added.

For a defensible assessment, manufacturers should consider the following evidence together:

Ingredient records: Confirm whether sucrose or fructose appears in the approved formulation or in any supplied ingredient.

Supplier documentation: Review specifications, declarations and relevant compositional information for premixes and compound ingredient.

Manufacturing records: Examine weighing, dispensing, batching and cleaning records where needed to investigate possible carry-over or unintended presence.

Analytical results: Use a suitable method to quantify the relevant sugars and investigate unexpected findings.

Product and regulatory classification: Verify the intended age group and product category against the applicable infant nutrition regulations.

Regulatory interpretation: Apply the final legal wording and any relevant official clarification when determining whether a finding constitutes non-compliance.

A “not detected” result should also be interpreted in light of the method’s detection capability. It does not necessarily mean absolute chemical absence.

Quality Assurance and Documentation Requirements

A structured quality management approach can help manufacturers prepare for the proposed change while maintaining control over product safety and consistency.

Formulation and ingredient traceability

Maintain current master formulas, ingredient specifications, approved supplier details and documented change-control records. Identify any source through which sucrose or fructose could enter the formulation.

Risk assessment and gap analysis

Compare current formulations against the proposed restriction. Prioritise products intended for infants up to six months of age and identify formulations requiring further assessment.

Reformulation trials

Where changes are necessary, conduct appropriate formulation and process trials. Assess nutritional composition, manufacturing performance, stability and other product-specific quality attributes before approving a revised formulation.

Analytical verification

Develop a testing plan suited to the product and target sugars. Define the purpose of testing, method capability, sampling approach, acceptance criteria where legally or technically justified, and the response to unexpected results.

Change control and staff training

Ensure that formulation changes are reviewed and authorised by the appropriate technical and regulatory teams. Update relevant specifications, production instructions and quality-control procedures, and train personnel on the revised controls.

Regulatory monitoring

Track the consultation process and final notification. Manufacturers should avoid treating a draft requirement as final law, while also avoiding unnecessary delay in assessing the potential impact on existing formulations.

Recommended Actions for Manufacturers and Ingredient Suppliers

Before the amendment is finalised, businesses can take practical preparatory steps without assuming that the draft is already enforceable.

Map infant nutrition products by intended age group and regulatory category.
Identify sucrose and fructose in approved formulas, premixes and compound ingredients.
Review supplier declarations and ingredient specifications.
Assess technically and regulatorily suitable alternative formulation options where necessary.
Establish whether existing analytical methods can quantify the relevant sugars in each product matrix.
Review change-control, batch-traceability and product-release procedures.
Monitor the consultation outcome and assess the final notified requirements before implementation.
Submit evidence-based comments or technical suggestions through the applicable consultation process if the proposal affects product formulation or manufacturing operations.

Early assessment can help manufacturers understand the potential scale of reformulation and testing requirements while allowing decisions to be aligned with the final regulatory text.

How Eureka Supports Infant Nutrition Testing

Eureka supports food businesses with analytical testing services intended to assist quality assurance, product verification and regulatory compliance activities.

Depending on the applicable testing scope and method availability, support may include:

The appropriate testing plan depends on the product type, target analytes, analytical performance requirements and applicable testing scope. Customers should confirm method availability, sample requirements and the intended use of the results before submitting samples.

Conclusion

FSSAI’s proposed amendment to the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, represents a targeted regulatory development concerning the addition of sucrose and fructose to products intended for infants up to six months of age.

For manufacturers, the proposal highlights the importance of reviewing ingredient inputs, controlling formulation changes, evaluating carbohydrate sources and establishing suitable analytical verification. Sugar analysis can contribute useful evidence, but it should be interpreted alongside formulation records, supplier documentation and manufacturing controls.

As the proposal remains subject to consultation and finalisation, businesses should monitor the regulatory process and prepare for a structured gap assessment rather than treating the draft as a final enforceable requirement.

A coordinated approach involving regulatory affairs, product development, procurement, manufacturing and quality assurance can help infant nutrition businesses respond effectively while maintaining product quality and compliance with the applicable nutritional standards.

Frequently Asked Questions (FAQ)

1. What has FSSAI proposed regarding sucrose and fructose in infant nutrition products?

FSSAI has proposed that sucrose and fructose shall not be added to products intended for infants up to six months of age. The proposal appears in the draft Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2026.

2. Is the proposed restriction already mandatory?

The October 2026 notification is a draft amendment open to stakeholder consultation. It should not be treated as a final enforceable restriction unless and until the amendment is finalised and notified.

3. Which products are covered by the proposed restriction?

The proposed wording concerns products intended for infants up to six months of age. Manufacturers should verify the exact product category, intended age group and final legal wording before determining applicability.

4. Does the proposal mean that all sugars must be absent from infant nutrition products?

The draft specifically names sucrose and fructose in the context of their addition. It should not automatically be interpreted as a requirement for every sugar or carbohydrate to be absent. The final regulatory text and applicable nutritional composition provisions will determine the requirements.

5. Which analytical methods can be used to test sucrose and fructose?

Depending on the product matrix and method suitability, HPLC, HPAEC-PAD and selected enzymatic methods may be used. The laboratory should confirm that the method can reliably identify and quantify the target sugars for the intended purpose.

6. Can a laboratory result alone prove that sucrose or fructose was added?

Not necessarily. Analytical testing can establish the presence or concentration of a compound within the method’s capability, but it may not establish its source or whether it was intentionally added. Formulation records, supplier documentation and manufacturing records may also be necessary.

7. Why is the limit of quantification important?

The limit of quantification (LOQ) indicates the lowest concentration that can be quantified with suitable reliability under the method’s conditions. It helps determine whether a method can provide useful data at concentrations relevant to the investigation or compliance decision.

8. What should manufacturers do before the amendment is finalised?

Manufacturers can review affected formulations, check ingredient specifications, assess potential reformulation requirements, evaluate analytical methods and monitor the consultation process. Final implementation decisions should be based on the notified requirements.

9. Does the proposal apply to every product for children under 24 months?

The proposed restriction specifically refers to products intended for infants up to six months of age. It should not be automatically extended to all products for children up to 24 months; each product must be assessed against its applicable regulatory category and the final amendment.

Official References

Food Safety and Standards Authority of India — Draft Food Safety and Standards (Foods for Infant Nutrition) Amendment Regulations, 2026
Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, including applicable amendments
Food Safety and Standards Act, 2006
Food Safety and Standards Authority of India — Food Laws and Regulatory Notifications
World Health Organization — Infant and Young Child Feeding Recommendations
Codex Alimentarius — Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants