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.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate


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.


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.


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


  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.


medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »