MBBT (nano) is now approved for use in cosmetic products

The European Commission has amended Annex VI of the Cosmetics Regulation in June this year in what concerns the entry of the nano-sized UV filter called Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT).

This increased use of nanoscale materials in cosmetics and its appeal to the cosmetics and personal care industries is based on the fact that, as a difference to the large-scale particles, these nanoparticles obtain newer properties, including colour, solubility, transparency and chemical reactivity. Their main advantage is that they do not inflict cutaneous adverse health effects while providing extensive UV-protection.

As this may come as news to some manufacturers or consumers, the regulatory struggle of MBBT started back in 2000 when it was actually approved. However, a recast of the EU Cosmetic Regulation established the requirement of an additional approval for products in nano form, making MBBT take a step back. What clarified the issue was the Opinion of the SCCS (Scientific Committee for Consumer Safety) published in 2015 clarifying its safety.

Thus now, as clearly stated in the second and forth recital of the Commission Regulation (EU) 2018/885, the use of MBBT (nano) is safe, being allowed up to a concentration of 10% w/w, apart from when the applications may lead to the exposure of the end user’s lungs by inhalation.

Should you wish to have more information, Obelis remains at your disposition. With 30 years of regulatory experience, it will be our pleasure to help and advise you on regulatory updates for the EU market, SCCS opinions and cosmetic ingredients in the EU. If you would like to know more on cosmetics products regulatory compliance, please contact us.

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