How to Register Whitening Products for Import in the US, EU, and UK

Why Import Registration Matters More Than Ever for Whitening Product Buyers

Three years ago, a dental distributor in Florida reportedly lost a $340,000 shipment of whitening gels to a customs hold. The product sat in a bonded warehouse for eleven weeks. The reason? Their overseas manufacturer had listed hydrogen peroxide concentration at 16% on the formulation sheet, but the labels made no mention of the drug facts panel that FDA requires for products classified as drugs. The shipment crossed from cosmetic into unapproved new drug territory without anyone at the import desk catching it.

That type of case is not unusual. In practice, the single most expensive mistake B2B buyers make is treating registration as paperwork to handle after sourcing. It is not. Registration architecture determines whether your product clears customs, whether your liability insurance covers you, and whether your clinic or retail channel can legally sell what you have already paid for.

Here is the thing: the US, EU, and UK have all tightened their frameworks in recent years. The US Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022 as part of the Consolidated Appropriations Act of 2023, now mandates facility registration and product listing for cosmetics. The EU continues to enforce Regulation (EC) No 1223/2009, which sets hydrogen peroxide thresholds with national-level penalties that vary by member state. Post-Brexit Great Britain operates a parallel but divergent system with its own Responsible Person requirement and Submit Cosmetic Product Notification (SCPN) portal. For buyers sourcing from third-party manufacturers—especially in Asia—the gap between factory documentation and market-ready compliance has widened, not narrowed.

This guide walks through the registration, notification, and ingredient compliance steps for each market. We cover the hydrogen peroxide thresholds that determine whether your product is a cosmetic or something far more regulated, the device classification rules that trap LED whitening systems, and why peroxide-free formulas are not the compliance shortcut many buyers assume.

US Market: FDA Classification, OTC Drug Monograph Rules, and Cosmetic Notification Under MoCRA

The US does not have a pre-market approval system for most cosmetics. This confuses buyers constantly. Your whitening gel or strip can enter the country without FDA sign-off—until it cannot. The dividing line is claims and ingredients, not product format.

Cosmetic pathway under MoCRA. MoCRA requires cosmetic facilities to register with FDA and cosmetic products to be listed. FDA began accepting facility registrations and product listings through its dedicated portal, with initial compliance timelines phased in during 2023 and 2024. The facility registration belongs to the manufacturer or brand owner; if you are the importer of record, you need to verify it exists and is current. Product listing includes fragrance and flavor ingredients to the extent manufacturers are aware of them—a transparency requirement that has exposed formulation gaps in many overseas suppliers. Under MoCRA, FDA has authority to suspend facility registration if products present a reasonable probability of serious adverse health consequences, which means your supply chain can be severed at the facility level, not just the shipment level.

But here is where buyers get trapped. If your whitening product contains hydrogen peroxide and makes any claim beyond general cosmetic language—claims like “bleaches,” “whitens teeth,” or references to specific shade changes—it may meet FDA’s definition of a drug. The relevant OTC drug monograph framework for oral care antiseptic products has historically addressed hydrogen peroxide at specific concentrations. If your product falls within a monograph’s conditions, it may be considered generally recognized as safe and effective (GRASE) and would not require a new drug application. Outside those conditions—wrong concentration, unapproved combination, novel delivery system—you may be in unapproved new drug territory, and import becomes exponentially more complex.

In practice, many professional whitening gels at concentrations such as 16%, 25%, or 35% hydrogen peroxide are sold through dental professional channels. The regulatory status of these products can be ambiguous, and FDA’s enforcement posture has varied over time. For B2B buyers, the actionable step is clear: demand your manufacturer specify whether the formulation conforms to an applicable OTC monograph or is intended strictly for professional use, and get that classification in writing. Your customs broker needs this documentation. Your liability insurer will ask for it. Your dental clinic customers, if they are using these products in-office, need to understand their own regulatory exposure.

One more MoCRA detail that sourcing guides often skip: serious adverse event reporting. Under MoCRA, cosmetics now require a designated responsible person to report serious adverse events to FDA within 15 business days of receiving such a report. If you are the US distributor listed as the responsible party on the product label, that obligation sits with you—not the overseas manufacturer. Negotiate this allocation clearly in your distribution agreement. Buyers who accept default manufacturer terms sometimes discover too late that adverse event liability was never properly assigned.

EU Market: CPNP Notification, Hydrogen Peroxide Thresholds, and Responsible Person Requirements

The EU operates one of the strictest cosmetic whitening frameworks globally. Regulation (EC) No 1223/2009, as amended by Commission Directive 2011/84/EU, establishes hydrogen peroxide concentration limits for tooth whitening and bleaching products. Products containing up to 0.1% hydrogen peroxide (present or released) may be sold as standard consumer cosmetics. Products containing between 0.1% and 6% hydrogen peroxide (present or released) may only be sold to dental practitioners for use by or under direct supervision of a dental practitioner, with the first cycle of use performed by the practitioner or under their direct supervision. Products above 6% hydrogen peroxide are prohibited for cosmetic use.

This threshold system means your registration pathway depends entirely on concentration and intended distribution channel. At 0.1% or below, standard Cosmetic Products Notification Portal (CPNP) notification applies. You need a Responsible Person established within the EU—this can be your own entity, a subsidiary, or a contracted regulatory services firm, but it must be a legal person within the Union. The Responsible Person maintains the Product Information File (PIF), which includes the Cosmetic Product Safety Report (CPSR), a description of the manufacturing method, evidence supporting claimed effects, and data on animal testing compliance. CPNP notification must be completed before the product is placed on the market.

Between 0.1% and 6%, CPNP notification still applies, but your labeling and distribution must restrict the product to dental professionals. Your distribution contracts must enforce this restriction. National enforcement intensity varies: certain member states, including Germany and France, maintain active market surveillance programs that purchase and test products and can prosecute unauthorized sales. EU member state authorities can—and do—remove non-compliant products from both physical and online sales channels.

For importers, the Economic Operators Registration and Identification (EORI) number is your customs prerequisite. It is separate from cosmetic compliance, but without it, your shipment does not clear. Apply through the member state where your first customs declaration will be made. If you are using a fulfillment center in the Netherlands but selling across the EU, your EORI ties to that Dutch entry point.

A sourcing pitfall specific to the EU: “equivalent releasing compounds.” Sodium perborate, carbamide peroxide, and other peroxide-releasing agents are calculated back to their hydrogen peroxide equivalent under the regulation. A manufacturer might list 10% carbamide peroxide and tell you it falls below threshold. It does not. Carbamide peroxide typically releases roughly one-third of its concentration as hydrogen peroxide, so 10% carbamide peroxide yields approximately 3.5% hydrogen peroxide equivalent. That triggers the dental professional restriction. Demand the hydrogen peroxide equivalent calculation in the CPSR. The Responsible Person will need it regardless.

UK Market: Post-Brexit SCPN Registration and How It Diverges From EU Cosmetic Regulation

Great Britain retained the substance of the EU cosmetics framework but operates its own notification portal and enforcement structure. The divergence is manageable if you plan for it; costly if you assume EU compliance covers you.

The Submit Cosmetic Product Notification (SCPN) service replaced CPNP for the Great Britain market. You cannot use your CPNP notification number in the UK. You need a UK Responsible Person—distinct from your EU Responsible Person, though the same contracted firm may offer both services if they have legal entities in both jurisdictions. The UK Responsible Person holds a GB-compliant PIF and submits notifications through SCPN.

Here is where it gets complicated for buyers. Northern Ireland operates under different rules due to the Windsor Framework. Products placed on the Northern Ireland market still fall under EU cosmetics regulation, use CPNP rather than SCPN, and require an EU-based Responsible Person. If your distribution strategy includes both Great Britain and Northern Ireland—common for UK-wide dental suppliers—you need dual notification pathways. Buyers who consolidate everything under one UK Responsible Person sometimes discover their Northern Ireland listings are non-compliant.

The hydrogen peroxide thresholds for Great Britain mirror the EU framework: 0.1% for consumer products, 6% ceiling for dental professional use. Enforcement, however, is now handled by the Office for Product Safety and Standards (OPSS) and local trading standards authorities, rather than through EU-level coordination. OPSS has been active in online marketplace surveillance, identifying non-compliant listings on platforms such as Amazon UK and eBay. If your online storefront sells whitening products, confirm that your SCPN notification is traceable and current.

On the customs side, the UK import process runs through the GOV.UK step-by-step framework. You will need an EORI number starting with GB for Great Britain imports. Post-Brexit rules of origin apply to any EU-manufactured products you import into the UK—check whether your supplier’s formulation and packaging qualify for preferential tariff treatment under the UK-EU Trade and Cooperation Agreement.

LED Whitening Devices: When Your Product Crosses From Cosmetic Into Medical Device Territory

This is the category that can derail compliance budgets. A whitening kit with an LED accelerator looks like a cosmetic bundled with an accessory. Regulators may see it differently.

In the EU and UK, medical device classification depends on intended purpose and mechanism of action. If the LED device is presented as accelerating or enhancing a whitening chemical’s effect on tooth structure, it may be classified as an accessory to a medical device or, in certain configurations, as an active therapeutic device. The EU Medical Devices Regulation (EU) 2017/745 (MDR) and UK Medical Devices Regulations 2002 (as amended) would then apply. That means CE marking (EU) or UKCA marking (UK), potential notified body involvement for higher device classes, and registration timelines that differ substantially from cosmetic notification.

The US is equally complex. FDA has cleared some LED-based dental whitening devices through the 510(k) premarket notification pathway as devices intended for use in conjunction with professional whitening agents. Other LED products have been marketed without clearance, relying on positioning as general cosmetic accessories. The distinction often hinges on claims: language suggesting the device “accelerates whitening” or “activates the whitening agent” implies a therapeutic effect, while purely cosmetic language avoids that implication.

For B2B buyers, the critical specification to verify is whether your supplier holds device registration documentation or is assuming the LED component falls under a cosmetic exemption. Ask for the FDA product code and 510(k) clearance number, the EU notified body certificate, or the UKCA technical documentation. If your supplier cannot produce these, you should assume you may be importing an unregistered medical device. Your freight forwarder is unlikely to catch this. Customs may not catch it at the border. Your professional liability carrier, however, will scrutinize it—typically after a claim has been filed.

One practical approach some distributors use: source the whitening gel and LED device separately, with no bundled claims of interaction. The gel proceeds through the cosmetic or drug pathway; the LED is sold as a general cosmetic-use light with no whitening-specific claims. This separation can reduce regulatory complexity but limits marketing claims. Evaluate whether the revenue impact from restricted claims exceeds the compliance cost of pursuing full device registration.

PAP-Based and Peroxide-Free Formulas: Registration Considerations Across Markets

Phthalimidoperoxycaproic acid (PAP) and other peroxide-free whitening agents have gained popularity, driven partly by EU and UK hydrogen peroxide limits and partly by consumer preference for gentler formulations. Buyers often assume these formulas bypass regulatory scrutiny entirely. They do not; they shift it into different channels.

In the EU and UK, PAP-based products generally fall under standard cosmetic notification pathways if no medicinal claims are made. But PAP is not specifically listed in the EU cosmetics regulation’s annexes as an expressly authorized whitening agent in the way that hydrogen peroxide is addressed. Safety assessors must evaluate PAP on a case-by-case basis within the Cosmetic Product Safety Report. Some regulatory observers have noted questions around PAP’s safety profile, particularly regarding potential mucosal irritation at the concentrations used for visible whitening effect. Your Responsible Person needs toxicological data specific to your formulation’s concentration and exposure conditions—not generic PAP safety data sheets from the raw material supplier.

The US presents a different set of questions. Without hydrogen peroxide, your product likely stays on the cosmetic side, avoiding OTC drug monograph issues. But if you make explicit whitening or bleaching claims, FDA may still scrutinize whether the product’s mechanism constitutes a drug action. PAP’s mode of action—oxidative whitening through a peracid mechanism—arguably parallels peroxide’s effect on tooth color. As of this writing, FDA has not issued specific public guidance on PAP classification for tooth whitening. Conservative legal counsel generally treats PAP whitening products as cosmetics with elevated enforcement risk, often advising buyers to maintain robust adverse event tracking and documentation even when not technically required under cosmetic rules.

Other peroxide-free agents—enzyme-based systems, optical brighteners, hydroxyapatite remineralization formulas—each carry their own classification questions. Enzyme-based approaches using glucose oxidase or similar systems have been marketed as cosmetics, but their oxidative byproducts can generate small amounts of hydrogen peroxide in situ, potentially triggering the same thresholds these formulas were designed to avoid. If you are sourcing peroxide-free whitening products, request a full breakdown of reaction byproducts from your manufacturer and have your Responsible Person or regulatory counsel evaluate them against the applicable thresholds in each target market.

Practical Steps for B2B Buyers: Building a Compliant Import Strategy

Registration across three markets with divergent rules is manageable when you treat it as architecture rather than afterthought. Here is a streamlined approach based on common patterns among successful importers:

1. Lock down formulation classification before you sign a purchase order. Get the hydrogen peroxide concentration (or equivalent) in writing. Get the manufacturer’s position on whether the product is cosmetic, OTC drug, or professional-use-only. If they cannot answer clearly, find a manufacturer who can.

2. Appoint Responsible Persons early. For EU distribution, engage a Responsible Person before your first production run. For UK distribution, engage a separate UK Responsible Person. Both need access to full formulation data, toxicological assessments, and manufacturing process documentation to prepare the PIF and submit notifications. These processes take weeks to months, not days.

3. Register facilities and list products under MoCRA. If you are importing into the US, verify that your manufacturer’s facility registration is active in FDA’s system. Complete your product listing. Keep records of your responsible person designation and adverse event reporting procedures.

4. Separate cosmetic and device components. If your product line includes LED accelerators or other hardware, evaluate device classification independently. Do not assume that bundling with a cosmetic gel makes the hardware cosmetic by association.

5. Build regulatory compliance into distribution agreements. Specify which party holds adverse event reporting obligations, who maintains the PIF, and who bears the cost of reformulation if a regulatory threshold changes. These clauses are far cheaper to negotiate before shipment than to litigate after a customs hold or product recall.

6. Monitor regulatory updates continuously. MoCRA implementation is still evolving. EU member state enforcement practices shift. OPSS surveillance of online marketplaces in the UK continues to expand. A compliant product today can become non-compliant if a threshold changes or an ingredient is reclassified. Subscribe to FDA, European Commission, and OPSS update feeds, or retain a regulatory monitoring service.

References

• FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• EUR-Lex — Regulation (EC) No 1223/2009 on Cosmetic Products
• GOV.UK — Submit Cosmetic Product Notifications (SCPN)
• European Commission — Cosmetic Products Notification Portal (CPNP)
• GOV.UK — Office for Product Safety and Standards (OPSS)
• EUR-Lex — Regulation (EU) 2017/745 on Medical Devices (MDR)

Disclaimer

This article is for informational purposes only. LLRNCARE makes no representations or warranties about the completeness, accuracy, or reliability of the information. Any reliance is at your own risk.

For professional dental advice, consult a qualified dental professional.