What type of study is this?

This is a Systematic Review study.

September 12, 2025

Comparing Regulatory Framework for Nutraceuticals Between India and The European Union

Key Points

India's nutraceutical regulations are largely governed by the Food Safety and Standards Act of 2006, emphasizing specific pathways.
The European Union employs a comprehensive regulatory framework including the General Food Law Regulation 178/2002 and various directives.
This systematic review analyzes registration and labeling requirements alongside complexities in both regulatory environments.
The study highlights the challenges posed by differing regulatory approaches for nutraceutical product approval across regions.

Abstract

This systematic review paper analyzes the regulatory pathways of the Indian and European Union (EU) nutraceuticals to compare frameworks in these two regions. The regulatory framework of India is dominated by the Food Safety and Standards Act of 2006, with health supplements, nutraceuticals, and functional foods having their specific regulations in the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purposes, Functional Food, and Novel Food) Regulations of 2016. In contrast, the EU’s approach is managed by many comprehensive regulations, such as the General Food Law Regulation 178/2002, the Food Supplements Directive 2002/46, and specific regulations on fortified foods, nutrition claims, and novel foods. This study emphasizes key regulations in both regions, particularly focusing on the respective legal requirements regarding registration, product approval, and labeling, and discusses registration procedures in India and the procedural complexities of nutraceuticals within the EU framework.

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