In India’s tightly regulated food sector, the use of food additives must conform to precise standards laid down under the Food Safety and Standards Act, 2006 and the subordinate regulations framed by the Food Safety and Standards Authority of India (FSSAI). One recurring question pertains to the legality of using Magnesium Carbonate as an anti-caking agent in the manufacture of pan masala, a popular composite food product consumed widely across the country.
This article examines the statutory, regulatory, and practical landscape governing the use of Magnesium Carbonate in pan masala, particularly under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 (hereinafter, “Food Additives Regulations”), as amended.
- Legal Framework: Defining Food Additives and Regulatory Oversight
1.1 Definition of a Food Additive
Under Section 3(1)(k) of the Food Safety and Standards Act, 2006 (FSS Act), a food additive is defined as:
“Any substance not normally consumed as a food by itself or used as a typical ingredient of the food… the intentional addition of which… results, or may be reasonably expected to result… in it or its by-products becoming a component of or otherwise affecting the characteristics of such food…”
The definition excludes contaminants and substances used purely for nutritional enhancement.
1.2 Statutory Prohibition Without Regulatory Approval
Section 19 of the FSS Act imposes a statutory bar on the use of any food additive in food unless expressly permitted under the Act or regulations:
“No article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of this Act and regulations made thereunder.”
The FSSAI has exclusive jurisdiction under Section 16 and Section 92 to frame regulations relating to food additives, including permissible limits, approved additives, and category-specific permissions.
- Pan Masala: Standards and Composition
Pan masala is recognized under Regulation 2.11.5 of the Food Additives Regulations as a distinct product category. The regulation defines pan masala as:
“A food generally taken as such or in conjunction with pan, and may contain betelnut, lime, catechu, cardamom, saffron, menthol, permitted natural colours and non-prohibited flavours.”
Importantly, the regulation prohibits any ingredient injurious to health and prescribes specific chemical parameters such as total ash and ash insoluble in dilute hydrochloric acid.
However, this regulation does not mention Magnesium Carbonate either as a permitted or prohibited ingredient.
- Use of Anti-Caking Agents: Historical and Evolving Norms
3.1 Under the Pre-2016 Regime
Before the Seventh Amendment to the Food Additives Regulations in 2016, Regulation 3.1.7 imposed a general prohibition on anti-caking agents unless their use was specifically permitted.
Under the earlier rules, anti-caking agents such as calcium and magnesium carbonates were permitted only in specific products like table salt, onion powder, soup powder, etc., and in defined quantities (not exceeding 2% by weight).
As pan masala was not listed as a permitted category under the pre-2016 framework, the use of Magnesium Carbonate as an anti-caking agent in pan masala was not permitted.
- Post-2016 Framework: The Seventh Amendment and New Regulatory Structure
The Food Safety and Standards (Food Products Standards and Food Additives) Seventh Amendment Regulations, 2016 overhauled the previous structure and introduced:
A comprehensive categorization of food additives,
A Good Manufacturing Practice (GMP) framework, and
Appendix A, which classifies food additives by functional class and defines usage restrictions and allowances across various food categories.
- Understanding the Current Structure: Where Magnesium Carbonate Fits
5.1 Technological Purpose
Under Regulation 3.1.1(7), the use of a food additive is justified only if it:
Provides a technological benefit (e.g., preventing clumping or sticking),
Does not mislead consumers or disguise low-quality ingredients,
Improves safety, stability, or manufacturability, and
Cannot be replaced by safer or more economical alternatives.
Magnesium Carbonate, when used as an anti-caking agent, helps prevent components of food from adhering to one another—a function that squarely falls within the definition of an additive serving a technological function.
5.2 Compliance with Good Manufacturing Practice (GMP)
Regulation 3.1.1(8) prescribes that the use of all additives must conform to GMP, which requires that:
The quantity of additive must be limited to the lowest possible level necessary for the effect,
Additives must be of food-grade quality, and
No additive should be used to mask unhygienic practices or substandard ingredients.
Thus, any use of Magnesium Carbonate must be minimal, technically necessary, and well documented.
- Appendix A: Tables of Permitted Additives and Their Application
6.1 Functional Class Definition
Appendix A of the amended regulations identifies anti-caking agents as a functional class, defined as:
“A food additive, which reduces the tendency of components of food to adhere to one another.”
This includes Magnesium Carbonate, among others.
6.2 GMP Table vs. Specific Tables (1–15)
The amended Appendix A includes three sets of tables:
Tables 1–15: These tables identify specific food categories and list permitted additives along with maximum limits.
GMP Table: A list of additives (including Magnesium Carbonate) that may be used in all food categories, subject to GMP.
Annex to GMP Table: This lists the categories of food in which GMP-based additives are not permitted.
Pan masala is not listed in the Annex to GMP Table, nor does it appear in Tables 1–15. Therefore, its additive permissions fall within the GMP Table regime.
- Final Determination: Is Magnesium Carbonate Permissible in Pan Masala?
A structured application of the amended regime yields the following conclusions:
Pan masala is not separately regulated under Tables 1–15, meaning there are no specific additive limits or prohibitions.
Magnesium Carbonate is listed in the GMP Table as an anti-caking agent allowed across all food categories except those restricted under the Annex.
Pan masala is not included in the Annex to GMP Table, which lists prohibited categories.
Accordingly, Magnesium Carbonate may be used in pan masala, provided:
It serves a legitimate anti-caking function,
Its use is technologically justified,
The quantity used is limited to the minimum necessary, and
All usage complies with GMP standards.
- Practical Considerations for Industry Stakeholders
✅ Permissibility: Magnesium Carbonate is permitted as an anti-caking agent in pan masala under the current regulatory framework.
⚠ Use With Caution: Manufacturers must ensure the use is justifiable under GMP and maintain appropriate documentation for regulatory scrutiny.
📄 Labeling & Transparency: Though not explicitly required for functional additives used in small quantities, transparent labeling may help preempt compliance issues.
🔍 Regulatory Vigilance: Stakeholders should continue to monitor updates from FSSAI, including future amendments to Appendix A, classification shifts, or category-specific notifications.
Conclusion
The permissibility of Magnesium Carbonate in pan masala reflects the maturity and complexity of India’s food regulatory regime, which now integrates functionality, safety, and proportionality under the broader umbrella of good manufacturing practices.
While earlier rules may have restricted such use due to lack of express permission, the post-2016 regulatory model offers a more adaptive and principle-based framework—provided that usage is technologically justified and responsibly executed.
Manufacturers, food safety officers, and regulatory compliance teams should remain mindful of this evolving framework and ensure scientific, traceable, and lawful use of additives in sensitive food categories like pan masala.