August 05, 2021 – The presence of nanomaterials in cosmetics is rapidly increasing, due the development of nanotechnology. Nanoparticles offer several advantages – such as higher stability, long-lasting effects and a better absorption of ingredients through the skin. At present, the most common use of nanomaterials in cosmetics is as UV filters in sunscreen products.
However, the use of nanomaterials in cosmetics may pose some concerns for human safety because of their inherent characteristics. As a matter of, the physio-chemical properties of a nanomaterial may vary from the bulk version of the same ingredient, due to the different size and features. At the moment, the available studies do not provide sufficient information on the risks associated with these elements. In light of this, the EU competent authorities have set out a special regulatory framework for nanomaterials in cosmetics. In particular:
- Cosmetic products containing nanomaterials must be notified to the CPNP 6 months before being placed on the EU market (EU Cosmetics Regulation article 16(3));
- Nanoscale ingredients must be labelled by adding ‘nano’ among brackets after the name of the ingredient (e.g., Titanium Dioxide (nano));
- Whenever the EU Commission has concerns regarding the safety of a nanomaterial, the Scientific Committee on Consumer Safety (SCCS) should be mandated to perform a safety assessment (EU Cosmetics Regulation article 16(4)) according to the latest SCCS Guidance on the Safety Assessment of nanomaterials in cosmetics published in 2019.
Additionally, the European Union Observatory for Nanomaterials announced in 2020 that all companies that manufacture, use, or import nanomaterials need to register through REACH to provide consumers with adequate information on the supply chain of these substances.
Nano UV filters
At present, there are 4 nanomaterials allowed to be used in cosmetic formulations as UV filters (Annex VI to the EU Cosmetics Regulation):
- Titanium Dioxide;
- Zinc Oxide;
- Tris-Biphenyl Triazine.
According to the Catalogue of nanomaterials in cosmetic products placed on the market published by the European Commission and updated on November 21, 2019, the above-mentioned nanomaterials were used as UV filters in sun protection products, before and after sun products, self-tanning products and many more.
Titanium Dioxide and Zinc Oxide nano forms (mineral active ingredients) are particularly popular among cosmetics’ manufacturers because, compared to their bulk version, they have higher UVA and UVB absorption capabilities and they are transparent – ensuring better dispersibility and visual clarity on skin – which are features appreciated by the consumers.
Besides the benefits, however, these nano ingredients raise some concerns for human health – in particular regarding the possible skin penetration and inhalation. Considering this, the European Commission asked the SCCS to evaluate the safety of these nanomaterials.
The SCCS has already scrutinized this substance at different occasions and published the following opinions on nano Titanium Dioxide:
- SCCS/1583/17 final opinion on Titanium Dioxide (nano form) as UV-filter in sprays;
- SCCS/1580/16 final opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic;
- SCCS/1516/13 final opinion on Titanium Dioxide (nano form).
According to the available data, the SCCS concluded that nano Titanium Dioxide at a concentration up to 25% as UV filter in sunscreens does not pose any risk for human safety. However, the has noted that there is a gap in knowledge about the possibility of penetration into damaged skin, or during repeated and long-term applications of the product.
Moreover, the SCCS confirmed the safety of nano Titanium Dioxide coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone and Simethicone.
The additional requirements that nano Titanium Dioxide has to meet in order to be used as UV filter in cosmetic products are available here (Annex VI to the EU Cosmetics Regulation, entry 27a).
Conversely, due to the carcinogenic properties of Titanium Dioxide when inhaled – it has been classified as CMR substance of category 2 – its nanoparticles should not be used as UV filter in cosmetics that could lead to exposure of the consumer’s lungs via inhalation – such as spray sunscreen.
In the opinion SCCS/1489/12 of September 18, 2012, and in the addendum dated July 23, 2013, the SCCS concluded that nano Zinc Oxide used as a UV filter is safe up to a concentration of 25% in the finished product, as there is no evidence of alarming penetration of nanoparticles through the skin. In fact, the amount of solubilized zinc that may be absorbed through the body is insignificant compared to the zinc quantity already present in our organism. Therefore, no risks for the consumers’ safety have been identified.
On the other hand, the SCCS is of the opinion that nano Zinc Oxide should not be used in spray products because of the serious side effects that the exposure to these nanoparticles can cause to the lungs.
The additional requirements that nano Zinc Oxide must meet in order to be used as UV filter in cosmetics’ formulations are available here (Annex VI to the EU Cosmetics Regulation, entry 30a).
Finally, Bisoctrizole (MBBT) and Tris-Biphenyl Triazine are listed in Annex VI to the EU Cosmetics Regulation in entries 23a and 29: their use as nano UV filter is safe up to a concentration of 10% in the finished product. They cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation and no additional label requirements are foreseen.
Nanomaterials are a hot topic within the EU Cosmetics industry: make sure to be always updated with the latest news by following COSlaw – your favorite source of regulatory information on cosmetics!
- EC. (2019). Guidance on the safety assessment of nanomaterials in cosmetics. Retrieved on 01/07/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_233.pdf
- EC. (2019). Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Retrieved on 01/07/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20190813&from=EN
- EC. (2018). SCCS Opinion on Titanium Dioxide (nano form) as UV-Filter in sprays. Retrieved on 01/07/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_206.pdf
- (2018). SCCS Opinion on Titanium Dioxide (nano form) coated with Acetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic. Retrieved on 01/07/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_202.pdf
- EC. (2014). SCCS Addendum to the Opinion SCCS/1489/12 on Zinc oxide (nano form). Retrieved on 01/07/2021 from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_137.pdf
- EC. (2013). SCCS Opinion on Titanium Dioxide (nano form). Colipa n. S75. Retrieved on 01/07/2021 from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf
- EC. (2012). SCCS Opinion on Zinc oxide (nano form). Colipa S76. Retrieved on 01/07/2021 from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_103.pdf