Nanotechnology in Sun Care Products
Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. Currently, there are 4 nano-ingredients approved in the European Union for use as UV filters in cosmetic products.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

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:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Scientific Committee on Consumer Safety (SCCS). Scientific Advice on the safety of nanomaterials in cosmetics. (SCCS/1618/20). Corrigendum of 8 March 2021.
  3. 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.
  4. Scientific Committee on Consumer Safety (SCCS). Opinion on Zinc Oxide (nano form). COLIPA S 76. (SCCS/1489/12). 2012.
  5. 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.
  6. 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.

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »
cosmetic products

How are Cosmetic Products Regulated in Australia?

The Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics and soaps. Cosmetic ingredients are regulated as industrial chemicals under the Industrial Chemicals Act 2019, which is administered by AICIS.

Read More »