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Food Industry, FSSAI and Good Manufacturing Practices - A Detailed and Critical Analysis in context with Additives and synthetic food colours!

YAGAY andSUN
Urgent reform needed in India's food additive rules: align FSSAI standards with global risks, phase out harmful synthetic colours The article examines India's regulatory framework for food additives and synthetic colours, focusing on FSSAI rules and Good Manufacturing Practices (GMP). It highlights permitted synthetic dyes and prescribed limits, mandatory labelling, enforcement weaknesses, and health risks such as allergies and behavioural effects. Key gaps include allowance of some internationally restricted colours, weak surveillance, under-resourced testing, and widespread non-compliance in informal sectors. Recommendations include updating standards to align with global risk assessments, phasing out high-risk dyes, strengthening laboratory networks and random sampling, incentivizing natural alternatives, and promoting industry adoption of GMP and digital traceability. (AI Summary)

Here's a detailed and critical analysis of the Food Industry, FSSAI, and Good Manufacturing Practices (GMP)—with a particular focus on food additives and synthetic food colours in the Indian context:

I. Introduction

The Indian food industry is among the largest globally, with vast diversity, rapid growth, and a significant impact on public health and the economy. As this sector grows, concerns regarding food safety, especially the use of food additives and synthetic food colours, have intensified.

To address these concerns, the Food Safety and Standards Authority of India (FSSAI) plays a regulatory role, while Good Manufacturing Practices (GMP) serve as a benchmark for ensuring hygiene, safety, and quality during food production and processing.

II. The Role of FSSAI in Food Safety

1. What is FSSAI?

  • The FSSAI is an autonomous body under the Ministry of Health & Family Welfare, Government of India.
  • Established under the Food Safety and Standards Act, 2006, it consolidates various food-related laws and standards.

2. Key Functions

  • Regulation of food safety standards
  • Licensing and registration of food businesses
  • Surveillance and monitoring
  • Issuing guidelines on additives, labelling, packaging, and hygiene

3. Additives and Synthetic Colours Regulation

  • FSSAI regulates the permissible types, quantities, and uses of food additives, including synthetic colours, under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
  • Only additives approved by Codex Alimentarius, JECFA (FAO/WHO), or validated by scientific risk assessment are allowed.

III. Food Additives and Synthetic Food Colours

1. What Are Food Additives?

Substances added to food to:

  • Enhance taste, appearance, shelf-life
  • Preserve texture, freshness, or nutritional value

Types include:

  • Preservatives
  • Emulsifiers
  • Stabilizers
  • Artificial sweeteners
  • Colouring agents

2. Synthetic Food Colours

These are man-made, petroleum-based chemical dyes used to enhance appearance.
Common examples:

  • Tartrazine (E102) – Yellow
  • Sunset Yellow (E110) – Orange
  • Brilliant Blue (E133)
  • Allura Red (E129)

3. Health Concerns

  • Hyperactivity in children (e.g., ADHD)
  • Allergic reactions
  • Carcinogenic risks (some banned internationally)
  • Cumulative toxicity from regular consumption

IV. FSSAI Regulations on Synthetic Colours

Permitted Colours in India

FSSAI permits only eight synthetic colours, such as:

  1. Tartrazine
  2. Sunset Yellow FCF
  3. Carmoisine
  4. Ponceau 4R
  5. Brilliant Blue FCF
  6. Indigo Carmine
  7. Fast Green FCF
  8. Erythrosine

Permissible Limits

  • Typically 100 ppm (parts per million) in solid foods
  • 200 ppm in beverages
  • Mandatory labelling if synthetic colours are added

Ban and Enforcement

  • Certain colours banned in the EU or US are still permitted in India (e.g., Erythrosine).
  • Enforcement is a challenge due to:
    • Weak surveillance
    • Lack of awareness
    • Corruption or non-compliance in small-scale and unorganised sectors

V. Good Manufacturing Practices (GMP) and Additive Use

1. What is GMP?

A system ensuring that products are:

  • Consistently produced and controlled
  • Meet quality standards
  • Minimizing risks of contamination or errors

In India, GMP for food industries is regulated by:

  • FSSAI's Schedule 4 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011

2. GMP Relevance to Additives

  • Ensures appropriate dosing and mixing of additives
  • Prevents cross-contamination
  • Maintains hygienic processing and storage
  • Ensures traceability and record-keeping

3. Challenges in Implementation

  • In small or informal sectors, GMP compliance is low
  • Inadequate training and lack of automation
  • Limited audits and inspections by authorities
  • Pressure to cut costs leads to use of non-permitted dyes and additives

VI. Critical Analysis

1. Regulatory Gaps

  • FSSAI allows certain synthetic colours banned elsewhere
  • Lack of consumer education about risks of synthetic additives
  • Infrequent updates to regulatory lists compared to global benchmarks

2. Industry Practices

  • Use of non-permitted synthetic dyes (e.g., Rhodamine B, Malachite Green) especially in street foods, sweets, and unorganised sectors
  • Lack of transparency and testing
  • GMP protocols often bypassed for profitability

3. Enforcement and Surveillance Issues

  • Food inspectors often under-resourced
  • Random sampling is rare in rural and semi-urban markets
  • Testing labs are either inadequate or under-equipped

4. Global Comparison

Country

Permitted Colours

Labelling Required

Banned Colours

India

8

Yes

Few (limited)

EU

~7 (stricter)

Yes + warning labels

Tartrazine restricted

USA

9 (FDA approved)

Yes

Sudan dyes banned

VII. Recommendations and Way Forward

For Regulators (FSSAI):

  • Update standards in sync with global safety data
  • Phase out risky synthetic colours (e.g., Erythrosine)
  • Strengthen lab network and random sampling
  • Promote natural colour alternatives through subsidies/incentives

For Industry:

  • Adopt voluntary GMP audits
  • Shift to natural or nature-identical additives
  • Use digital traceability systems to track ingredients

For Consumers:

  • Read labels carefully
  • Prefer brands with certified quality standards (e.g., FSSAI + ISO)
  • Demand transparency and report suspicious products

VIII. Conclusion

While FSSAI and GMP guidelines offer a robust framework, the reality of unsafe additive use and non-compliance persists—especially regarding synthetic food colours. A holistic approach combining strict regulation, industry accountability, and consumer awareness is essential for improving food safety in India.

The move towards clean-label products and natural ingredients isn't just a global trend—it's a public health necessity.

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