Complete Importer’s Guide to Gel Polish Regulations (FDA, EU, REACH)

If you’re importing gel polish, you’re not just moving boxes. You’re moving risk. One wrong label line, one restricted photoinitiator, or one missing document can turn a “hot SKU” into dead stock overnight.

This guide breaks down what actually matters for FDA (US), EU Cosmetics Regulation (EC) No 1223/2009, and REACH/CLP. I’ll keep it practical, with real import scenarios, a compliance table, and a build-ready checklist you can hand to your supplier and your logistics team.

You’ll also see how we handle this at YY DEL POLISH, a Guangzhou-based OEM/ODM manufacturer that supports private label, bulk wholesale, and cross-border sellers who need salon-tested colors and HEMA-free options for global markets.

Argument 1: Import compliance isn’t “customs clearance,” it’s “making the product compliant before it ships”

A lot of importers learn this the hard way: customs brokers don’t validate cosmetic compliance. They clear paperwork. Regulators and marketplaces care about what’s inside the bottle and what’s printed on the label.

Here’s what “pre-ship compliant” usually means in real life:

• You lock the formula version (no last-minute swaps).
• You lock the label copy (claims, warnings, ingredients, net content, responsible party).
• You lock the documentation pack (testing + safety file + traceability).

Practical scenario: A platform seller scales fast, then adds “professional salon formula” on the label. Sounds harmless. In the EU, wording can trigger “professional use” expectations for warnings and distribution controls. In the US, a claim can change how reviewers interpret safety evidence. The label becomes the trap door.

If you want fewer surprises, treat compliance like a pre-launch gate, not a post-launch patch.

Argument 2: The EU gel polish pain point isn’t the category, it’s restricted ingredients

People say “the EU banned gel polish.” That’s sloppy. The EU targets specific substances and conditions of use. In nail products, TPO has become the word that makes importers sweat, because enforcement shows up fast through distributors, salons, and marketplace checks.

Practical scenario: You import a “best seller” builder gel that works great under a strong lamp. It cures beautifully because of the photoinitiator package. Then a distributor asks, “Is it TPO-free?” If you don’t know, you’re already behind. If it isn’t, you could face a stop-sale or delisting in EU channels.

If you’re building an EU pipeline, make TPO-free options part of your core lineup, not a backup plan. For example, you can position a compliant line around HEMA-free and TPO-free SKUs like HEMA-free & TPO-free extension gel or HEMA-free & TPO-free base/top coat in bulk.

Argument 3: In the EU, importers underestimate the “Responsible Person + PIF/CPSR + CPNP notification” triad

EU compliance isn’t just “ingredients + label.” It’s a system. If you miss one part, distributors won’t touch it, and serious retailers will bounce it.

You need:

• Responsible Person (RP): the legal anchor in the EU.
• PIF (Product Information File): the compliance folder.
• CPSR (Cosmetic Product Safety Report): the core safety assessment inside the PIF.
• CPNP notification: the product notification step before placing on the market.

Practical scenario: A wholesaler ships to an EU warehouse, then tries to find an RP later. That’s backwards. You’ll lose time, and you may lose the season. EU buyers don’t want “we’re working on it.” They want the compliance pack ready for audit.

At YY DEL POLISH, we usually build the product roadmap with compliance in mind. That means pushing clients toward stable, scalable lines like OEM 56-color HEMA/TPO-free gel polish so they can run consistent batches across multiple markets without reworking every formula.

Argument 4: REACH isn’t “the cosmetics law,” but it can force SDS, hazard communication, and supply-chain proof

Gel polish is a chemical mixture. Even when you sell it as a cosmetic, REACH/CLP thinking still sneaks in through:

• distributor onboarding,
• professional salon channels,
• transport and warehousing rules,
• “What’s your SDS?” requests.

Practical scenario: A distributor wants to sell your gel polish to training academies and salon chains. Their procurement team often asks for SDS as a default vendor requirement. If you can’t produce a consistent SDS and ingredient traceability, you’ll look like a high-risk supplier, even if the product performs well.

This is where bulk formats matter too. If you sell big-volume base/top to salons, you’re automatically in a more “professional procurement” lane. Products like 1KG rubber base bulk or ultra shiny top coat (HEMA/TPO-free) tend to attract buyers who demand cleaner paperwork.

Argument 5: In the US, the path is different—labels, MoCRA registration/listing, safety substantiation, and adverse event readiness

The US doesn’t run the same “RP + PIF + CPNP” playbook. Instead, importers win by doing four things well:

• Labeling that doesn’t create regulatory headaches
• MoCRA readiness (facility registration + product listing responsibilities)
• Safety substantiation (you can show why it’s safe under intended use)
• Adverse event workflow (you can respond fast if complaints show up)

Practical scenario: A cross-border seller goes viral with a glitter gel. Returns spike because some users report irritation. Even if the product isn’t “bad,” you need a clean traceability chain: batch records, ingredient list, and a way to isolate issues without nuking your whole catalog.

For product positioning, it also helps to match compliance with customer demand. Retailers and marketplaces increasingly prefer “safer feel” lines, which is why SKUs like diamond glitter gel polish OEM/bulk or nude rubber base options do well when you pair them with clear labeling and a consistent documentation pack.

Compliance snapshot table (FDA vs EU vs REACH)

How importers actually use this (real workflows, not theory)

Cross-border eCommerce workflow (fast listing, tight risk control)

• Launch with a clean core line first (HEMA-free, TPO-free where relevant).
• Keep claims simple. Let performance speak.
• Build a “ready-to-show” compliance folder for platforms and partners.
• Use one consistent hero collection page like Gel Polish so your catalog stays organized.

Distributor workflow (they’ll test your paperwork before they test your product)

• Expect procurement to ask for: ingredients, batch traceability, and SDS-style documents.
• Offer bulk formats for salons, but only when your documentation is mature.
• Keep shade naming and INCI lists stable across batches.

Private label OEM/ODM workflow (brand owners who want scale)

• Start with a formula family you can extend: base/top, builders, nudes, effects.
• Build compliant “pillars,” then add seasonal drops.
• Plan for multi-market labels early so you don’t reprint every quarter.

That’s the sweet spot for YY DEL POLISH: we help brands and wholesalers build scalable lines, then keep the supply steady once sales kick in.

Internal links used from your Gel Polish.json list

The internal URLs used above come from your provided Gel Polish.json list.

Next step: a simple import-ready checklist you can send your supplier

If you want a clean handoff, copy this into an email or a sourcing SOP:

• Confirm target market: US / EU / both
• Lock formula version + confirm TPO status for EU plans
• Prepare label copy for: ingredients, warnings, responsible party info
• Build the documentation pack: safety substantiation + traceability + SDS-ready info for B2B
• Decide your hero SKUs (suggestion: base/top + builder + nudes + one effect line)

If you share your target countries and whether you sell mainly DTC, marketplaces, or distributors, I can adapt this into a tighter “go-to-market compliance plan” that matches your channel.