Following a vote by member states in the EU Commission Working Group on Cosmetics in October last year, zinc oxide in both its nano and non-nano forms has now been added officially to the list of UV filters allowed for use in cosmetic products. Being known for decades for its beneficial properties as skin protectant and its antimicrobial activity, zinc oxide is one of only two UV filters approved for UVA1 protection in sun care applications in the US.
According to Regulation (EU) 2016/621 of 21 April 2016, amending Annex VI to the Cosmetics Regulation , both the nano and non-nano forms will be authorized for use at a maximum concentration of 25%, except in applications that may lead to exposure of the consumer’s lungs by inhalation. Therefore, the use in an aerosol sunspray would not be allowed as part of the formulation could be unwittingly inspired.
Furthermore, only the nano forms meeting the criteria mentioned in the annex of the regulation - including particle size, morphology, purity and solubility - are allowed.
This modification to the Cosmetics Regulation is effective on May 11, 2016.
Ingredients suppliers applaud
Suppliers of these substances applaud the move, which will widen formulation options for products aimed at filtering UV rays.
“The formal approval of new options to achieve effective UVA and UVB protection is a major milestone for formulators of UV protection products. Having a wider choice of globally approved filters enables brands to meet consumer needs more easily,” said Helene Hine, Marketing Manager at Croda. The company offers a range of zinc oxide dispersions under their Solaveil Clarus brand, Solaveil CZ-100 and Solaveil CZ-300.
“UV radiation is responsible for various physiological effects in the skin. These include sunburn, premature appearance of wrinkles and - with frequent intensive exposure - an increased risk of skin cancer. Each approval of a UV filter offers new options and a wider choice for formulators of sun care products to provide vital protection for the skin against these harmful effects of UV radiation,” also said Dirk Mampe, BASF’s Head of Business Management for Personal Care Specialties in Europe.
BASF offers zinc oxide - with and without coating - under its Z-Cote brand.
Two more UV filters ready for EU approval
The EU may soon approve other nano UV filters. In February 2016, titanium dioxide has received a positive vote by the EU Commission Working Group on Cosmetics. The official entry of the nano UV filter into Annex VI of the EU Cosmetics Regulation is expected for the second half of 2016.
Methylene Bis-Benzotriazolyl Tetramethylbutyl-phenol (MBBT) is still on the voting list. In 2015, the Scientific Committee for Consumer Safety (SCCS) published a positive scientific opinion on MBBT in nano form. Its official entry into Annex VI is anticipated for 2017.
Both titanium dioxide and MBBT were already approved as UV filters and have been used in sunscreens for years. However, a new approval as “nano“ was required due to the new EU Cosmetics Regulation.