Cosmetic Regulations: India, EU, US, Practical 2025 Guide

If you're formulating or selling cosmetics across markets, you're operating under three very different regulatory frameworks, each with distinct requirements for safety, labelling, and prohibited substances.

This guide covers the practical differences between India's CDSCO framework, the EU Cosmetics Regulation (EC) No 1223/2009, and the US MoCRA (Modernization of Cosmetics Regulation Act).

India, CDSCO & the Drugs and Cosmetics Act

India's primary cosmetics law is the Drugs and Cosmetics Act, 1940 (being replaced in 2025–26). The Central Drugs Standard Control Organisation (CDSCO) oversees licensing and enforcement.

• Prohibited substances list: IS 4707 Part 2 (updated September 2025)
• Imported cosmetics require import license under D&C Rules, Schedule Q
• No pre-market approval required for most cosmetics
• INCI nomenclature technically required but enforcement has been inconsistent
• BIS certification being piloted and expected mandatory by end of 2026

EU, Regulation (EC) No 1223/2009

The EU has the most comprehensive cosmetics regulatory framework globally. All cosmetics must have a Product Information File (PIF), a Cosmetic Product Safety Report (CPSR) signed by a qualified assessor, and be notified on the CPNP portal before sale.

• 1,328 substances prohibited (Annex II)
• Restricted substances list (Annex III) with concentration limits
• Mandatory CPSR by a qualified safety assessor
• CPNP portal notification required pre-market
• Claims substantiation required and auditable
• Nanomaterial notification required

US, MoCRA (2022, enforced 2024–25)

The Modernization of Cosmetics Regulation Act of 2022 was the first major update to US cosmetics law since 1938. Full FDA enforcement began in 2024.

• Facility registration and product listing now mandatory (FDA)
• Safety substantiation required and must be on file
• Adverse event reporting requirements
• Fragrance allergen disclosure coming into effect
• Talc and PFAS testing requirements for some categories

The global direction is clear: more documentation, more transparency, more liability. Building a compliance system now is cheaper than retrofitting it later.