Selling whitening pens into the EU can feel a bit like walking a tightrope. One incorrect peroxide level can shift a product meant for consumers may fall into the dental-supervision category instead. But what is it that the rules say?
The Council Directive 2011/84/EU has established a distinct division of tooth whitening and bleaching products in accordance to their concentration of hydrogen peroxide or the amount of hydrogen peroxide they emit. This guide explains the numbers, what they mean for OTC pens versus dentist supply, and how to plan product combinations without stepping outside the rules.
The Directive is built on a practical safety idea: stronger whitening carries higher misuse risk, so it needs professional oversight. It also stresses proper labelling for products above 0.1%, including stating the exact hydrogen peroxide concentration on the label.
Here are the thresholds buyers should remember:
Products containing or releasing 0.1% hydrogen peroxide or less are generally the “freely available” consumer tier. In plain terms: this is the level that can sit on a retail shelf or be sold online to the public, depending on local enforcement and how the product is presented.
Tooth whitening or bleaching products that contain or release more than 0.1% and up to 6% hydrogen peroxide are not meant to be made directly available to consumers as a general retail item.
They are restricted to use under a dental professional’s supervision, with conditions around examination, appropriate use, and how the first application is handled. Many professional summaries also note that these products should not be used on under-18s.
For B2B buyers, the rule affects three things straight away:
● Channel: Is this pen for Amazon/DTC/retail, or for dental distribution?
● Claims: OTC language must stay realistic and compliance-friendly. Avoid anything that implies “clinical” results.
● Packaging and labelling: Above 0.1%, the concentration needs to be clearly indicated, and the supply route needs to match the restrictions.
A useful way to explain it internally is:
● OTC pens focus on maintenance, surface stain care, and gradual brightening.
● Dentist-supplied products can sit in a stronger band, but they come with professional control and patient screening.
These are the “easy mistakes” that can backfire:
● Labelling a product as “professional strength” when it’s sold OTC
● Selling >0.1% products direct-to-consumer without the correct professional route
● Missing, unclear, or inconsistent peroxide concentration labelling
● Suggesting treatment-like outcomes without the proper dental context
Buyers often ask, “If OTC peroxide is limited, how do we still give users a good experience?” The answer is: plan a routine, not a one-hit wonder.
Here are sensible combinations brands use:
● OTC pen + whitening toothpaste to support daily stain control
● OTC pen + sensitivity toothpaste to help users stay consistent
● Professional whitening (dentist-supplied) + OTC pen for maintenance between treatments
● OTC pen + stain-control habits (coffee timing, rinsing after meals, good brushing)
The key is guidance. Encourage spacing, sensible frequency, and realistic expectations. Nobody wants a customer using everything at once and then leaving a one-star review, do they?
When you’re selling into Europe, the peroxide percentage is only one part of the job. The bigger challenge is building a product plan that stays compliant and still keeps customers happy. That means thinking about format choice (OTC maintenance vs. dentist-supplied strength), clear labelling, and a routine that supports results without risky overuse.
This is where Onuge fits in for B2B buyers. Through our OEM/ODM service, Onuge supports brands that want to develop whitening products for different channels such as consumer-maintenance pens alongside other whitening formats so your range can match the EU’s OTC vs professional split.
And when you’re ready to scale a compliant SKU, Onuge’s stated production capacity includes 15K whitening pens per day which helps brands keep supply steady across retail, DTC, or distributor demand.
The headline is simple: EU peroxide limits for whitening pens separate low-strength consumer products (≤0.1%) from stronger whitening products (0.1–6%) that must be under dental supervision and in appropriate conditions. If you align your formula, claims, and channel with that split, you protect your brand and your buyers.
And if you build a smart routine through product pairing, you can still deliver strong customer satisfaction without crossing a legal line. Need an EU-ready whitening pen plan that matches the 0.1% vs 6% rules? Contact us to discuss compliant OEM/ODM options with Onuge.
