All of Makura’s mouthguards are CE and UKCA approved and certified, having been tested by independent third party organisations for EU and UK safety compliance.

CE approval is required for any personal protective equipment (PPE) like mouthguards sold within the European Economic Area (EEA). In order to acquire CE certification, mouthguards must be both impact and innocuous tested to ensure the materials are not harmful and will keep users protected while playing contact sports.

In order to acquire CE certification, mouthguards must be both impact and innocuous tested to ensure the materials are not harmful and will keep users protected while playing contact sports.

Impact and Innocuous Testing

Through independent testing, our mouthguards have achieved Level 2 and Level 3 Impact Resistance (Level 3 offering the highest level of protection for mouth-adapted mouthguards, while Level 2 is the highest for ready-made mouthguards):


Level 2 Impact Resistance


Level 2 Impact Resistance


Level 3 Impact Resistance


Level 2 Impact Resistance

As part of the CE and UKCA examination and approval process for PPE, products need to undergo chemical testing to confirm the materials used are innocuous and won’t harm users.

To see specific standards that apply to mouthguards click +

This analysis is required for any materials (plastics in particular) that come into contact with foodstuffs. To be tested, objects are immersed in an aqueous food simulant for four hours at 37oC to determine global migration. Those results are measured against distilled water under the same conditions (same length of time and temperature). In order to pass, global migration must be less than 10mg/dm22(milligrams per decimetre squared). To put it another way, this test affirms that chemicals won’t transfer from the plastic into users’ bodies in toxic quantities.

This testing is necessary for polymeric, laminates, and reinforced materials and textiles. It measures the amount of certain elements (aluminium, copper, lead, mercury, nickel, zinc, etc.) scraped off solid materials due to biting, licking, or sucking.

This determines whether certain polycyclic aromatic hydrocarbons (PAHs) are present in a given material. Products can’t be sold or supplied if any rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with skin or oral cavities contain more than 1mg/kg of any of the listed PAHs.

Though not necessary for CE approval, we can also confirm that Makura mouthguards contain neither Formamide nor BPA.

Why is CE Certification Important?

Whether you are a distributor or a mouthguard user, CE certification matters.

For distributors wanting to sell PPE like mouthguards within the EEA, it's the law that they must be CE certified. Ultimately, what CE approval does is provide harmonization. Instead of having to jump through a variety of independent national regulatory hurdles, you gain automatic access to all of the countries and markets that are part of the EEA by completing the procedure once.

Even better: choosing Makura as your mouthguard supplier means you don't have to involve yourself with the CE certification process. We've already taken all the necessary steps to ensure all of our mouthguards are fully CE certified and compliant, which means they're ready for you to take right to your customers.

If you’re an athlete using a mouthguard, the CE mark reassures you that the product you're putting in your mouth and relying on to keep you safe has been rigorously tested to ensure it meets international standards, doesn't contain materials that will harm you, and will keep you protected from contact related injuries.

Technology, Safety, Performance

These are more than just words. They’re the codes by which we work, and the pledges we make to all the athletes who put their trust in Makura mouthguards.