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Importing Cosmetics From China: FDA, EU CPNP, UK SCPN Compliance

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Cosmetics from China became significantly harder to import legally in 2024-2025. The US implemented MoCRA (Modernization of Cosmetics Regulation Act) requiring facility registration, product listing, and adverse event reporting. The EU and UK each require pre-market product notification via CPNP and SCPN. None of this is optional — and Chinese factories rarely volunteer compliance, leaving the importer of record (you) liable.

I’m not a regulatory consultant. This is a structural overview for importers planning a cosmetic launch; you’ll need a compliance consultant before commercial sale. But here’s the framework.

What counts as a “cosmetic”

The definition is broader than most people think. In all three jurisdictions, cosmetics include:

  • Skincare (moisturizer, serum, cleanser, sunscreen — but sunscreen is OTC drug in US)
  • Makeup (foundation, lipstick, mascara, eye shadow)
  • Hair care (shampoo, conditioner, dye)
  • Nail products
  • Fragrance (perfume, cologne, scented body sprays)
  • Personal hygiene (deodorant — antiperspirant is OTC drug in US)
  • Toothpaste (in EU/UK; US treats toothpaste with fluoride as OTC drug)

Borderline categories sometimes regulated as drugs (not cosmetics): anti-aging products with active drug claims, acne treatments, hair growth products, sunscreen (US), antiperspirant (US). Drug status triggers a much heavier regulatory regime — for first-time importers, stick to clear cosmetic categories.

US: MoCRA (Modernization of Cosmetics Regulation Act)

MoCRA passed in late 2022 and took effect through 2023-2024. As of 2025, key requirements for imported cosmetics:

Facility registration

Every facility that manufactures or processes cosmetics for sale in the US must register with FDA. For imported products, the Chinese manufacturing facility must be registered. The importer (you) typically files on behalf of the manufacturer.

  • Cost: free (FDA online filing)
  • Renewal: every 2 years
  • Database: FDA’s Cosmetic Direct portal

Product listing

Every cosmetic product distributed in the US must be listed with FDA, including:

  • Brand name and product name
  • Ingredient list per INCI nomenclature
  • Manufacturing facility
  • Responsible person (you, as importer)

Cost: free filing; allow 2-4 weeks for FDA processing.

Responsible person

Each cosmetic must have a US-based Responsible Person (RP) — a US company or person whose name and contact appears on the product label. This is the entity FDA contacts for adverse event reports and safety information.

For non-US brands, you can be the RP if you have a US business address. Otherwise, use a US-based agent service. Cost: $300-1,500/year per brand.

Safety substantiation

You must hold safety data supporting that the product is safe under labeled use. This typically means:

  • Toxicological assessment by a qualified expert
  • Ingredient compatibility data
  • Stability and preservative efficacy data

Cost: $500-3,000 per product for a third-party safety assessment.

Adverse event reporting

Serious adverse events (hospitalization, disfigurement, death) related to cosmetic use must be reported to FDA within 15 business days. You need a system for capturing customer complaints and triaging them.

Labeling

US cosmetic labels require:

  • Identity of the product
  • Net quantity (weight or volume)
  • Name and address of distributor or manufacturer
  • Ingredient declaration per INCI
  • Warnings (e.g. “External use only”)
  • Any allergen disclosures per FDA

Mislabeling is one of the most common reasons Amazon pulls cosmetic listings.

EU: CPNP (Cosmetic Products Notification Portal)

Every cosmetic product placed on the EU market must be notified through CPNP before going on sale.

Responsible person

EU requires a Responsible Person based in the EU — a person or legal entity established in the EU who ensures compliance. Non-EU brands must contract an EU RP.

Cost: €600-2,000/year per brand for a typical EU RP service.

Product Information File (PIF)

The Responsible Person must hold a Product Information File for each product, containing:

  • Qualitative and quantitative composition
  • Physico-chemical and microbiological specifications
  • Method of manufacture (GMP)
  • Safety assessment by a qualified safety assessor
  • Description of intended use
  • Existing data on undesirable effects

The Cosmetic Product Safety Report (CPSR) is the most expensive component — a qualified safety assessor reviews ingredients and produces a formal assessment.

Cost: €400-2,500 per product for a CPSR. Required for every product variant (different shade of lipstick = different CPSR).

CPNP notification

Once the PIF is complete, the Responsible Person notifies the product via CPNP. The notification includes formulation, packaging, intended use, undesirable effects.

Cost: free filing; the cost is in producing the supporting PIF and CPSR.

Ingredient restrictions

The EU Cosmetics Regulation (EC) 1223/2009 has long annexes of:

  • Annex II: prohibited substances (1,300+)
  • Annex III: restricted substances with use conditions
  • Annex IV: allowed colorants
  • Annex V: allowed preservatives
  • Annex VI: allowed UV filters

A Chinese factory formulation may contain ingredients that are common in China but prohibited or restricted in the EU. Verify the full INCI ingredient list against current annexes before commissioning production.

UK: SCPN (Submit Cosmetic Product Notifications)

Post-Brexit, the UK has its own portal: SCPN. Substantively similar to EU CPNP but requires separate notification.

  • UK Responsible Person: UK-based entity required (non-UK brands contract a UK RP service)
  • Cosmetic Product Safety Report: same requirement as EU
  • Product notification: via SCPN before sale

Costs and structure parallel the EU process.

One file, two notifications: if launching in both EU and UK, the same PIF works for both — but separate notifications via CPNP (EU) and SCPN (UK) are needed.

What this means for the cost of launching a cosmetic SKU

Realistic budget for a single cosmetic SKU launched in US + EU + UK:

ItemCost
US RP service$500-1,500/year
EU RP service€600-2,000/year
UK RP service£500-1,800/year
Safety assessment (US)$500-3,000
CPSR (EU/UK, shared)€400-2,500
Stability + microbiological testing$400-1,500
Allergen and preservative testing$300-1,000
Compliance consultant (first product)$1,500-5,000
Total launch compliance budget$5,000-15,000 per SKU

Add $3,000-8,000 per year ongoing for RP services and any required surveillance testing.

This is why cosmetic launches don’t make economic sense below $30-50k annual SKU revenue. Many small Etsy/Shopify cosmetic brands operate technically illegally because they can’t or won’t pay these costs — and increasingly face Amazon, Shopify, or marketplace enforcement.

What to ask a Chinese cosmetic factory

Before placing your first PO:

  1. Full INCI ingredient list for every product variant. Verify against EU Annex II/III/V before commitment.
  2. GMP (Good Manufacturing Practice) certification. ISO 22716 is the international cosmetic GMP standard. Verify the certificate is current with the issuing body.
  3. Microbiological challenge test results. Demonstrates preservative system efficacy.
  4. Stability test data. Typically 3-6 month accelerated stability + ongoing real-time stability.
  5. Country compliance history. Has the factory shipped to US (post-MoCRA) and EU buyers before? If yes, they can supply formulation tweaks for compliance.

Many Chinese cosmetic OEMs are accustomed to producing for the domestic Chinese market (NMPA-regulated, different ingredient norms than EU). Don’t assume their stock formulations are EU-compliant — many use ingredients that fail EU restriction lists.

Realistic categories for first-time cosmetic importers

If you’re new to cosmetic importing, lower-risk product categories:

  • Solid bar soaps: simple formulation, fewer preservatives, easier compliance
  • Face oils and body oils: minimal preservative requirements
  • Bath salts: very simple regulatory profile
  • Simple lip balms (non-claim): low-risk if no medicinal or SPF claims

Higher-risk categories to avoid until you have compliance infrastructure:

  • Sunscreens (US: OTC drug — much higher regulatory burden)
  • Anti-aging serums with active claims (drug status risk)
  • Color cosmetics with many shade variants (each shade is a separate compliance file)
  • Acne products (drug status risk)
  • Hair dyes (heavily restricted ingredients)

Resources

China Market Guide

We've been sourcing products from China since 2018 — from 1688 factories in Guangzhou to the Yiwu wholesale market. Everything on this site is based on real buying experience, not secondhand research.