NANOMATERIALS EU LEGAL FRAMEWORK
Nanomaterials consist of very small particles that cannot be observed by the human eye and can be present in nature or may be manufactured and added to consumer products in order to provide specific properties. The very small size of these materials provides special physical and chemical properties (e.g., color change when compared to non-nano form), but it can also influence the hazard properties of a specific nanomaterial. This means that some nanomaterials may have potential intrinsic hazards that are not observed in their non-nano form.
According to the European Regulation (EC) No 1223/2009 on cosmetic products (‘Cosmetics Regulation), nanomaterial means “an insoluble or biopersistent and intentionally manufactured material whit one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. However, this definition may suffer adjustments in time by the Commission, according to the constant technical and scientific developments in the field of nanotechnologies.
Cosmetic products containing nanomaterials must follow specific regulatory provisions. For every cosmetic product that contains nanomaterials, a high level of protections of human health shall be ensure. So, when notifying a cosmetic product, the presence substances in the nano form needs to be identified. The cosmetics containing nanomaterials must be notified by the Responsible Person (by electronic means) six months before being placed on the market (except for colorants, UV-filters and preservatives included in the Annexes of the Regulation). See previous post for more information.
NANOMATERIALS IN SUNSCREENS
Bisoctrizole, Titanium Dioxide, Tris-Biphenyl Triazine and Zinc Oxide are the 4 nano ingredients allowed in cosmetic products as UV filters in the European Union (EU) that are included in Annex VI of the European Cosmetic Regulation. They are used as UV filters in sun protection products, before and after sun products, self-tanning products and others.
The mineral active ingredients Titanium Dioxide and Zinc Oxide are the most commonly used. This happens because these ingredients in their nano forms have higher UVA and UVB absorption capabilities (when compared to non-nano form) and are transparent, which ensures better dispersibility and visual clarity on skin.
As for other nano-ingredients, these nanomaterials also raise some concerns for human health, particularly in terms of possible skin penetration and inhalation. According to EU Cosmetic Regulation, when there are any concerns regarding the safety of a nanomaterial, the European Commission shall request the Scientific Committee on Consumer Safety (SCCS) to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions.
NANO INGREDIENTS ALLOWED AS UV FILTERS
Conditions for the use of the approved nano UV filters are specified in each corresponding entry of Annex VI of the EU Cosmetics Regulation:
- Bisoctrizole (INCI name: Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano)) – VI/23a
- Titanium Dioxide (nano) – VI/27a
- Tris-Biphenyl Triazine – VI/29
- Zinc Oxide – VI/30
The SCCS has issued several opinions on Titanium Dioxide in its nano form. The Committee concluded that nano Titanium Dioxide up to a concentration of 25% in sunscreens does not pose any risk for human safety, if applied on healthy, intact or sunburnt skin.
Titanium Dioxide is classified as a CMR (carcinogenic, mutagenic or toxic for reproduction) substance of category 2, when inhaled. In his 2020 opinion, the SCCS concluded that the use of this ingredient (up to a maximum concentration of 25%) in typical hair styling aerosol spray product is not safe for either general consumers or hairdressers. This conclusion is applicable to the use of nano Titanium Dioxide in a cosmetic product that may give rise to consumer exposure by the inhalation route (aerosol, spray and powder form products). Moreover, this ingredient was considered safe (up to 25%) when used in loose powder in typical face make-up application for general consumer. Up to a maximum concentration of 1.4% for general consumers and 1.1% for hairdressers, the use of pigmentary Titanium Dioxide was considered safe in typical hair styling aerosol spray products by the SCCS.
With respect to Zinc Oxide, the SCCS did not identify any risk for the safety of consumers and concluded that its nano form, when used as a UV filter, is safe up to a concentration of 25% in finished product. There was no evidence of alarming penetration of nanoparticles through the skin. Nevertheless, this ingredient should not used in spray products, due to side effects that can outcome of inhalation exposure.
Both Bisoctrizole (MBBT) and Tris-Biphenyl Triazine in their nano-forms can be used safely as UV filters up to a maximum concentration of 10% in cosmetic products. As applicable to other nano UV filters allowed in the EU, Bisoctrizole (MBBT) and Tris-Biphenyl Triazine can not be used in applications that may lead to exposure of the end user’s lungs by inhalation.
If you wish to get more information regarding nanoparticles in cosmetics and its safe use, feel free to contact us at info@criticalcatalyst.com.
References:
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
- Scientific Committee on Consumer Safety (SCCS). Scientific Advice on the safety of nanomaterials in cosmetics. (SCCS/1618/20). Corrigendum of 8 March 2021.
- Scientific Committee on Consumer Safety (SCCS). Opinion on Titanium Dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation. (SCCS/1617/20). 2020.
- Scientific Committee on Consumer Safety (SCCS). Opinion on Zinc Oxide (nano form). COLIPA S 76. (SCCS/1489/12). 2012.
- Scientific Committee on Consumer Safety (SCCS). Opinion on 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (nano form). Submission III. COLIPA nº S79. (SCCS/1546/15). 2015.
- Scientific Committee on Consumer Safety (SCCS). Opinion on 1,3,5-Triazine, 2,4,6-tris[1,1’-biphenyl]-4-yl. (SCCS/1429/11). 2011.
