Nutrition and Health Claims: How to Validate Them Under Sri Lanka Food (Labelling and Advertising) Regulations 2026

Regulatory compliance guide for food manufacturers, importers and brand owners

Based on the Food (Labelling and Advertising) Regulations, 2026 (Gazette Extraordinary No. 2494/47)

Introduction

Nutrition and health claims are increasingly used to communicate the nutritional value and potential health benefits of foods. Such claims can assist consumers in making informed food choices when they are accurate, truthful and supported by scientific evidence.

However, nutrition and health claims may also mislead consumers if they are exaggerated, incomplete or not adequately substantiated. Recognizing this risk, the Food (Labelling and Advertising) Regulations 2026 establish specific conditions governing the use of nutrient content claims, nutrient comparative claims and health claims in food labels and advertisements. Health claims and nutrient function claims additionally require prior written approval from the Chief Food Authority before use.

This guide provides a practical framework for food manufacturers, importers, brand owners, advertising agencies and regulatory affairs professionals to assess whether proposed claims comply with Sri Lankan regulatory requirements before they are used in commercial communications.

Why Compliance Matters

Food claims influence consumer purchasing decisions and may affect public health perceptions. Manufacturers and advertisers are therefore responsible for ensuring that all claims are:

• Scientifically substantiated;
• Consistent with the product composition;
• Compliant with regulatory requirements; and
• Not false, misleading or deceptive.

Importance of Claim Validation

Marketing teams often wish to highlight nutritional benefits such as: High Fibre, Source of Protein, Low Fat, No Added Sugar, High in Vitamin C.

However, under Sri Lankan law, a claim can only be made when the food complies with the prescribed regulatory conditions and supporting evidence is available. False, misleading or unsubstantiated claims are prohibited.

A nutrition or health claim should therefore be reviewed before it appears on:

• Product labels
• Packaging
• Advertisements
• Company websites
• Social media promotions
• Point-of-sale materials

Understanding the Difference

Nutrition Claims

A nutrition claim states, suggests, or implies that a food possesses particular nutritional properties relating to: energy, protein, fat, carbohydrates, dietary fibre, vitamins and minerals.

Examples: Source of Protein, High Fibre, Low Fat, Sugar Free, No Added Sugar.

These claims must comply with the conditions prescribed in Schedule VI.

Health Claims

Health claims include the following:

• Nutrient function claims – a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body. For example: “Calcium aids in the development of strong bones and teeth. Food X is a source of/high in calcium.”
• Other function claims – claims concerning specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet, on normal functions or biological activities of the body. Such claims relate to a positive contribution to health, to the improvement of a function, or to modifying or preserving health. For example: “Substance A (naming the effect of substance A on improving or modifying a physiological function or biological activity associated with health). Food Y contains X grams of substance A.”

In short, a health claim states, suggests or implies a relationship between a food or one of its constituents and health.

Examples:

• Calcium contributes to the development of strong bones and teeth.
• Dietary fibre helps maintain normal bowel function.

How to Validate the Message Against the Product and the Law

Build the review around each specific claim. Review its wording, the product’s composition and the materials where it will appear. A separate file for each message shows which data support it and what is still unresolved.

Five-Step Validation Process

1. Collect the full message and classify it
2. Identify the applicable regulatory conditions
3. Verify nutrient composition and data justification
4. Check mandatory accompanying statements
5. Complete documentation and maintain ongoing compliance

Step 1: Collect the Full Message and Classify It

The initial phase of the validation framework requires a comprehensive inventory of all customer-facing representations associated with the food product. Food business operators must audit every medium through which a product claim may be explicitly or implicitly communicated.

a) Scope of media and materials to audit

The verification process applies across all physical packaging and marketing assets, including:

• Product packaging, primary and secondary container labelling, and physical artwork.
• Print, broadcast, and digital advertisements across traditional and social media channels.
• Website product descriptions, promotional graphics, and pictorial representations.

b) Regulatory classification of claims

Once collected, each representation must be evaluated against the definitions established under the Sri Lanka Food (Labelling and Advertising) Regulations 2026 to determine whether it constitutes:

• A nutrition claim: any representation stating, suggesting, or implying that a food possesses particular nutritional properties (e.g., energy value or nutrient content).
• A nutrient comparative claim: a claim comparing the nutrient levels or energy value of two or more foods (e.g., “reduced fat” or “increased protein”).
• A health or nutrient function claim: any representation stating or implying a relationship between a food (or one of its constituents) and health, including nutrient function claims describing physiological roles in growth and development.

Step 2: Identify the Applicable Regulatory Conditions

Once a proposed claim has been classified, the Food Business Operator (FBO) must cross-reference the claim against the specific statutory schedules and condition parameters prescribed under the Sri Lanka Food (Labelling and Advertising) Regulations 2026. Every claim category, whether quantitative, comparative, or functional, is governed by explicit nutritional thresholds and authorization procedures.

i) Mapping claims to prescribed statutory schedules

Proposed claims must be evaluated against their corresponding regulatory schedules to establish the exact quantitative conditions required for compliance:

ii) Non-standardized and unlisted claims

Step 3: Verification of Nutrient Composition and Data Justification

To substantiate any nutrition or quantitative nutrient content claim under the Sri Lanka Food (Labelling and Advertising) Regulations 2026, the FBO must establish that all declared nutrient values are backed by robust, reliable, and verifiable technical evidence.

A claim cannot be maintained solely on theoretical assumptions without documented proof of accuracy across the product’s entire commercial lifespan. All declared nutrient values must be supported by reliable, verifiable evidence demonstrating that the product consistently meets claimed levels throughout its shelf life.

1. Approved evidentiary sources

Nutrient content must be established through one or more of the following:

• Accredited laboratory reports: test certificates from an ISO/IEC 17025 accredited laboratory or a government-recognized analyst using validated test methods (e.g., AOAC).
• Supplier specifications: technical data sheets and Certificates of Analysis (CoA) for raw ingredients.
• Formulation calculations: recipe calculations based on verified ingredient data, accounting for processing losses, thermal degradation, moisture changes, and shelf-life decay.
• Recognized databases: analysis using validated food composition databases (e.g., ASEAN, USDA, FAO/INFOODS) or scientifically recognized nutrition software appropriate for the food matrix.

2. Compliance and verification criteria

• Batch consistency and audit trail: FBOs must maintain quality assurance records proving that production variations do not compromise claimed nutrient levels. Full supporting calculations, conversion factors, and assumptions must be archived for inspection by Authorized Officers under the Food Act.
• Basis of calculation: values must be calculated based on the food as sold or the food as prepared (where clear, step-by-step preparation instructions are prominently labelled).

3. Technical criteria for analytical and calculation methods

When compiling the technical justification for a claim, FBOs must adhere to strict analytical and calculation protocols:

• Analytical testing accuracy: physical laboratory testing must use validated standard test methods (such as AOAC International standards) on composite samples representative of actual market batches.

Justification: manufacturers should retain documentary evidence demonstrating that the declared fibre level consistently meets or exceeds the applicable criterion, accounting for normal production variability.

Step 4: Check Mandatory Accompanying Statements

Accuracy, justification and rationale

In addition to meeting the compositional requirements applicable to a claim, manufacturers shall ensure that all mandatory accompanying statements, disclosures, qualifying conditions, and explanatory information are accurate, clear, and not misleading.

The manufacturer shall maintain sufficient evidence to justify the use of such statements, including product formulations, ingredient specifications, analytical reports, scientific evidence, comparative assessments, approved claim dossiers, and other relevant supporting records, as applicable.

Manufacturers and importers should retain all records used to substantiate accompanying statements and shall make such records available to the competent authority upon request for verification of compliance.

Accuracy, justification and rationale for sugar-related claims

For claims relating to sugar content, including “Low Sugar”, “Sugar Free”, and “No Added Sugar”, the manufacturer shall possess adequate evidence demonstrating compliance with the applicable criteria. Supporting evidence may include:

• Laboratory analyses of total sugars and other relevant carbohydrates;
• Product formulations and ingredient specifications;
• Supplier declarations regarding the absence of added sugars and sweetening ingredients;
• Production records and quality control documentation;
• Scientific or technical justification where required.

The selected method of substantiation should be appropriate to the nature of the claim and sufficient to demonstrate compliance under normal manufacturing conditions.

Compliance assessment

The manufacturer shall be able to demonstrate that the product continuously meets the applicable claim criteria throughout its shelf life, taking into account normal manufacturing variability and analytical uncertainty. Supporting documentation shall be made available to the competent authority upon request.

No Added Sugar

“No Added Sugar” is frequently misunderstood. A “No Added Sugar” claim does not necessarily mean the food is low in sugar or sugar-free. The product may contain naturally occurring sugars derived from its ingredients. Consumers should therefore be able to distinguish between the absence of added sugars and the total sugar content of the product.

The food shall not contain:

• Added monosaccharides
• Added disaccharides
• Any ingredient used for sweetening purposes

Health claims

Health claims must:

• Be scientifically substantiated
• Be supported by peer-reviewed evidence
• Obtain prior approval from the Chief Food Authority
• Include information on the physiological role or accepted diet-health relationship

Step 5: Complete Documentation and Ongoing Compliance Maintenance

FBOs must compile and maintain a dedicated, centralized Claim Substantiation File prior to placing any product on the market. This compliance dossier serves as the official audit trail for Authorized Officers under the Food Act and must contain:

• The exact proposed claim wording and visual representations.
• Complete product formulations and ingredient specifications.
• Comprehensive nutrition calculations and raw data sheets.
• Accredited laboratory test reports and Certificates of Analysis (CoA).
• Citations of applicable statutory schedules under Sri Lanka Food Regulations.
• Written prior approval records and registration certificates issued by the Chief Food Authority (where required).
• Version-controlled label artwork proofs and packaging change logs.

a) Continuous reassessment protocol

A claim substantiation file is a living document. FBOs are required to formally reassess and revalidate product claims whenever there is:

• A change in the product formulation;
• Substitution or sourcing of raw ingredients;
• Alteration of the declared serving size; or
• Modification of the manufacturing process that could impact nutrient retention or product identity.

b) Critical regulatory risk and high-risk compliance errors

To prevent enforcement actions under the Sri Lanka Food (Labelling and Advertising) Regulations 2026, regulatory compliance managers must audit labels against the following common high-risk pitfalls:

• Unauthorized health and function claims: under Regulation 13(6) and Regulation 14, making health claims or nutrient function claims without obtaining prior written approval from the Chief Food Authority constitutes a strict regulatory offence.
• Restricted use of “Natural”: the term “Natural” may only be applied to foods that are unmixed, unadulterated, free from all food additives, and derived exclusively from biological rather than synthetic sources. Permitted processing is strictly limited to basic physical methods such as chilling, pasteurization, filtration, freezing, or drying.
• Restricted use of “Pure”: a food product shall not be labelled or advertised as “Pure” unless it fully satisfies the specific standards of identity prescribed under the applicable Food Regulations and contains no additions, extractions, or foreign substances.
• Mandatory qualifying statements on vegetable oils: declaring “Cholesterol-Free” on edible vegetable oils requires a mandatory contextual disclosure. Whenever a cholesterol-free claim is made on a vegetable oil, the label must prominently carry an accompanying statement clarifying that all edible vegetable oils are naturally cholesterol-free, preventing deceptive single-brand marketing.

Consequences of Non-Compliance

Failure to comply with the requirements governing nutrition and health claims may result in regulatory action under the Food Act and its regulations. Potential consequences include:

Regulatory Enforcement

Food authorities may determine that a claim is false, misleading, deceptive, or otherwise non-compliant where it does not satisfy the requirements of the Food (Labelling and Advertising) Regulations 2026 or where a required approval has not been obtained. Regulations 13 and 14 prohibit false or misleading claims and unauthorized health claims.

In addition, Section 32A(3) of the Food Amendment Act No. 20 of 1991 provides that:

This means that where a nutrition claim, health claim, nutrient function claim, or any other food-related representation is found to be false, misleading, deceptive or otherwise contrary to the law, the Chief Food Authority may prohibit the continued use of such labelling or advertising after affording due process to the responsible party.

This enforcement action may require the withdrawal, amendment, or discontinuation of non-compliant labels, promotional materials, advertisements, digital content or other marketing communications relating to the food product.

Product Detention or Market Withdrawal

Food products bearing non-compliant labels or advertisements may be subject to enforcement action requiring correction, relabelling, withdrawal from the market, or other measures deemed necessary by the competent authority.

Advertisement Restrictions

Health claims and nutrient function claims cannot be used in advertisements without prior written approval from the Chief Food Authority. Publication or dissemination of such claims may therefore be restricted until regulatory requirements are satisfied.

Reputational Impact

Incorrect nutrition or health claims can undermine consumer confidence, damage brand reputation and lead to complaints from consumers, competitors or regulatory authorities.

Financial Losses

Non-compliant claims may result in:

• Label redesign costs;
• Product recall or relabelling expenses;
• Delays in product launch;
• Withdrawal of marketing materials; and
• Additional compliance assessments.

Recommended Industry Practice

Before approving any nutrition or health claim, food business operators must establish and maintain a comprehensive claim substantiation file prior to commercial launch.

The dossier must contain the exact proposed claim wording alongside the complete product formulation, detailed nutrition calculations, and accredited analytical test reports. Where applicable, it must also include supporting scientific references, comparative product data, and all formal regulatory approvals received from the Chief Food Authority.

This documentation should be systematically reviewed and updated whenever there is a change to the product formulation, declared serving size, raw material ingredient specifications, or manufacturing process.

Quick Regulatory Compliance Checklist

Before giving final clearance for any label proof or advertising campaign, verify that all of the following requirements are fulfilled:

• Claim classification: claim type correctly identified (nutrition, comparative, or health claim).
• Nutrition panel: mandatory Nutrition Information Panel (NIP) completed and consistent with declared claims.
• Compositional thresholds: nutrient levels independently verified against Schedule VI conditions.
• Comparative basis: comparative claim calculations and reference product baseline documented.
• Mandatory statements: accompanying disclosures, warnings, and qualifying statements included (e.g., “Naturally occurring sugars present”).
• Evidentiary dossier: complete supporting analytical and scientific evidence archived in the substantiation file.
• Statutory approval: formal prior approval obtained from the Chief Food Authority (for health claims).
• Media assets: commercial advertisements, promotional materials, and digital media copy reviewed.
• Packaging proofs: physical label artwork, typography, font sizes, and layout verified.
• Document archival: version-controlled compliance dossier logged and filed for regulatory audit.

Conclusion

Nutrition and health claims are powerful tools for communicating the characteristics and benefits of food products. Their value, however, depends on their accuracy, scientific validity and regulatory compliance.

Food business operators should ensure that every claim is properly classified, supported by reliable evidence, assessed against the applicable regulatory criteria and, where required, approved by the Chief Food Authority before use. Compliance should not be viewed as a one-time activity but as an ongoing process that includes periodic review whenever the product, formulation, manufacturing process or marketing communication changes.

By adopting a structured validation process and maintaining appropriate documentation, manufacturers and advertisers can improve regulatory compliance, facilitate enforcement verification, reduce business risk and enhance consumer confidence in food information and advertising.