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Regulation 3.4 and Appendix C to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011: processing aids, their conditions of use and the permitted enzymes, including GMM enzymes

A processing aid may be used only where Appendix C expressly permits it, for the food and up to the residue level the table prints, with "GMP" meaning residues kept as low as...

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Last updated: October 2026Verified against: Government sources

A processing aid is used during manufacture and should leave only an unavoidable residue. Regulation 3.4 sets the definitions and conditions for processing aids, and Appendix C holds the tables that say which processing aids may be used, for which foods, and up to what residue level. The tables include 51 enzyme rows derived from genetically modified microorganisms. The First Amendment Regulations, 2025, in force from 1 February 2026, changed Appendix C, part II. Enzyme makers, bakers, brewers, oil refiners and dairy processors can start with food product approval.

This article reads the text as amended up to 10 July 2025 (FSSAI chapter compendium consolidated to amendment 83 of 21 October 2024, and the First Amendment Regulations, 2025 of 10 July 2025, in force 1 February 2026). Later notifications should be checked on fssai.gov.in. A compendium is a reference consolidation; the Gazette text prevails.

Regulation 3.4.1: definitions and conditions of use

ClauseSubject
(1)processing aids listed are recognised as suitable if they have an ADI or are found safe on other criteria and their use is technologically justified
(2), (3)the foods or procedures and the conditions of use are defined by the Regulations
(4)unless expressly permitted, processing aids shall not be used in food processing
(5)definition: any substance or material, not including apparatus or utensils, not consumed as a food ingredient by itself, intentionally used in processing to fulfil a technological purpose, which may leave unintended but unavoidable residues or derivatives
(6), (7)Acceptable Daily Intake; maximum permitted level
(8)residual level: the level remaining in food after processing, in mg/kg, with values at the detection limit reported as "Not more than"
(9)EC number: the Enzyme Commission number for the principal enzyme activity
(10)justification: the use performs a technological function, and residues should not perform a technological function in the final product
(11)GMP: lowest achievable quantity, residues reduced as far as reasonably achievable, handled like a food ingredient
(12)specifications: food grade quality, with Codex-type purity criteria where no standard is specified; safety to be demonstrated by the supplier or user
(13)labelling under the packaging and labelling regulations, with a vegetarian or non-vegetarian declaration irrespective of residue level

The wording parallels regulation 3.1 for additives; see our article on the general conditions for food additives for the difference. The Act's side is in our post on section 19 of the FSS Act.

Appendix C, part I: the 12 categories

Part I defines twelve categories: antifoaming agents, catalysts, clarifying and filtration agents, lubricants, release and antistick agents, microbial control agents and nutrients, solvents for extraction and processing, bleaching, washing, peeling and denuding agents, flocculating agents, contact freezing and cooling agents, desiccating agents, enzymes, and generally permitted processing aids.

Appendix C, part II: the tables

Part II says that the processing aids in Tables 1 to 12 may be used in manufacturing the foods named in the table, provided the final food contains not more than the residue level the table specifies.

TableCategoryA few entries as printed
1Antifoaming agentspolydimethylsiloxane (INS 900a), residual level 10; sorbitan monolaurate (INS 493), 1
2Catalystsnickel in hardened oil 0.8 and in hydrogenated vegetable oil 1.5
3Clarifying agents and filtration aidsacid clays of montmorillonite for juices, nectars, syrups, oils and wine, GMP
4Lubricants, release and antistick agentslisted substances and foods
5Microbial control agents, nutrients and adjunctsdimethyl dicarbonate (INS 242), non-detectable, with usage maximums of 200 mg/kg for wine and 250 mg/kg for fruit and vegetable juices
6Solvents for extraction and processinglisted solvents and residual levels
7Bleaching, washing, denuding and peeling agentschlorine, 1 (as available chlorine) for fruits, vegetables, flours and starches
8Flocculating agentsacids and sour whey for paneer and chhana, GMP
9Contact freezing and cooling agentsliquid nitrogen (INS 941) for ice cream, GMP
10Desiccating agentscorn starch for icing sugar, GMP
11Enzymeseach enzyme in EC number order, with its permitted sources, GMP
11AEnzymes from genetically modified microorganisms (GMM)enzyme, production organism, donor organism, function, indicative food uses, residual level
12Generally permitted processing aidsactivated carbon, argon, biotin and others, with the function and product category

What Appendix C part II changed from 1 February 2026

The First Amendment Regulations, 2025 made these changes:

  • Table 7, serial number 8 (hydrogen peroxide): the entry in column (4) for fruits and vegetables, flours and starches was substituted with "5 (as hydrogen peroxide)".
  • Table 11, enzymes: a source organism was added to the entries at serial numbers 5 (lipase triacylglycerol), 6, 26, 35 and 42, namely Aspergillus oryzae against serial numbers 5 and 6, Bacillus licheniformis against 26, Rhizomucor miehei and Cryphonectria parasitica against 35, and Aspergillus niger (variety Awamori) against 42.
  • Table 11A, GMM enzymes: six rows (serial numbers 46 to 51) were inserted after serial number 45: phospholipase A2, lysophospholipase, lipase triacylglycerol, glucose oxidase, serine endopeptidase (protease) and chymosin, each with a production organism (Trichoderma reesei, or Aspergillus niger var. Awamori for chymosin), a donor organism or source, a function, indicative food uses (oils and fats processing, egg products, bakery and pasta products, fish and meat processing, paneer and cheese) and a residual level of GMP. A note marks each of these enzyme preparations as having to meet criteria: lead not more than 5 mg/kg, Salmonella absent in 25 g, total coliforms not more than 30 per g, Escherichia coli absent in 25 g, and DNA and antibiotic activity absent in preparations from microbial sources.

These entries were inserted or substituted by the First Amendment Regulations, 2025, in force 1 February 2026. For genetically modified organisms and the approval process see our post on GM food regulations and the approval process.

How to use the tables

  1. Find the category. Decide whether the substance is a catalyst, solvent, enzyme or another category.
  2. Find the table row. Match the substance and the food to a row; a substance that appears only for another food is not permitted for yours.
  3. Check the residue level. The final food must contain not more than the printed residue level; "GMP" means as low as reasonably achievable under GMP.
  4. Label. Declare the vegetarian or non-vegetarian status.

Appendix C's partner for additives is Appendix A; see our articles on the food category system and on flavourings, oligofructose, trehalose and plant sterols, the preceding provision.

A practical example

Golden Press, an oil refiner, plans to degum oil with phospholipase A2 from a GMM source. Under Table 11A, serial number 46 (in force from 1 February 2026) lists phospholipase A2 from Trichoderma reesei with a donor organism of Aspergillus nishimurae for use in degumming oils and fats and in egg yolk processing, with a residual level of GMP. The enzyme supplier's certificate must also show lead not more than 5 mg/kg, Salmonella absent in 25 g and the other listed criteria, and the oil label carries the vegetarian declaration.

Need help with processing aids and enzymes?

Our team can match a process step to the right table row and check a supplier's certificate and label. Start with food product approval. Appendix A and B are covered in the next articles of this series, beginning with the food category system.

Key takeaways

  • Processing aids are permitted only where Appendix C expressly lists them, with a residue level.
  • The labelling declaration of vegetarian or non-vegetarian status applies irrespective of residue level.
  • Appendix C has 12 tables, including 11 for enzymes and 11A for GMM enzymes.
  • From 1 February 2026 Table 7, Table 11 and Table 11A were changed.
  • All enzyme preparations in the new rows must meet the lead, Salmonella, coliform, E. coli, DNA and antibiotic criteria.

Read next

Disclaimer: Based on the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 as consolidated in FSSAI's chapter-wise compendium (to amendment 83 of 21 October 2024) and the First Amendment Regulations, 2025, as consulted on fssai.gov.in on 2-3 October 2026. Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.

Quick recapKey facts & short answers

Key Facts About Processing Aids

  • Applies in: All states across India, under the relevant central law.
  • Mode: Mostly online via the official government portal.
  • Typical timeline: Ranges from a few days to a few weeks depending on the case.
  • Non-compliance: May attract penalties, interest or late fees.
  • Expert help: TaxClue completes the entire process end to end for you.

What is a processing aid?

A substance or material, other than apparatus or utensils, not consumed as a food ingredient by itself, used intentionally in processing for a technological purpose, which may leave unintended but unavoidable residues.

Where is a list of permitted enzymes?

In Table 11 and, for genetically modified microorganisms, Table 11A of Appendix C.

Renew before expiry — a lapsed licence turns an ordinary sale into an offence.

— TaxClue Product Compliance Desk

Processing Aids: a key compliance topic in Indian tax and corporate law that businesses and individuals must understand to remain compliant.

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Disclaimer: This article is for general informational purposes only and does not constitute professional tax, legal or financial advice. Laws, rates and due dates change and can vary by individual case — always verify with the relevant government source (e.g. mca.gov.in, incometax.gov.in) or consult a qualified professional before acting. TaxClue accepts no liability for decisions taken based on this content.

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Questions, answered

Short, direct answers to the 6 questions readers ask most on this topic.

A substance or material, other than apparatus or utensils, not consumed as a food ingredient by itself, used intentionally in processing for a technological purpose, which may leave unintended but unavoidable residues.

In Table 11 and, for genetically modified microorganisms, Table 11A of Appendix C.

Hydrogen peroxide's entry was substituted with "5 (as hydrogen peroxide)".

The residue is kept as low as reasonably achievable under good manufacturing practice, with no numerical ceiling in the table.

A declaration of vegetarian or non-vegetarian, irrespective of residue level.

Not unless expressly permitted in the Regulations.