According to Article 16(10) and (11) of the EU Cosmetics Regulation, the European Commission is required to draft an annual report on the use of nanomaterials in cosmetics, which is then submitted to the EU Parliament and Council. This is needed because the use of nanomaterials in cosmetic preparations may pose concerns for the consumer’s safety, due to their inherent characteristics – which, at the moment, are not well-know. A regular monitoring of the situation is aimed at ensuring that the EU law is kept up to date with the fast development of nanotechnologies.
The 2021 report was published on July 21 and addresses the following topics: the nanomaterials’ EU regulatory framework, the status of the market for cosmetics containing nanomaterials and, lastly, the proposals for revisions of the provisions concerning nanomaterials in the EU Cosmetics Regulation. In this article we are going to analyze the mentioned three elements to provide an overview of the state of the art.
The current regulatory framework for nanomaterials in cosmetics
The main provisions governing nanomaterials are set out in Article 16 of the EU Cosmetics Regulation and, in particular, it is required that the appointed EU Responsible Persons notify cosmetic products containing nanomaterials six months before their placing on the EU market. Hence, there is a special module on the Cosmetic Products Notification Portal (CPNP) called ‘Nanomaterials’, which allows this special notification.
To notify a cosmetic with a nanomaterial in the formula, it is necessary to:
- Identify the cosmetic and the nanomaterial;
- Specify the size of particles and physicochemical properties of the nanomaterial – such as morphology, surface area, aggregation or agglomeration state, solubility, and catalytic activity;
- Provide an estimate of the quantity of nanomaterial contained in the cosmetic;
- Submit the toxicological profile and safety data of the nanomaterial;
- Indicate the exposure conditions: dermal, oral and/or inhalation.
These provisions are not applicable to nanomaterials used as colorants, UV-filters, or preservatives, because these ingredients already undergo an authorization process as per Article 14 of the EU Cosmetics Regulation. Thus, cosmetics that contain raw materials in nano form used as such shall be uploaded on the CPNP following the standard notification procedure (EU Cosmetics Regulation, Article 13).
Moreover, in case the European Commission has concerns about the safety of a nanomaterial, it shall mandate the Scientific Committee on Consumer Safety (SCCS) to give its opinion on the use of such nanoparticles within six months. Before being finalized, the said opinions are subject to public consultation. Considering the SCCS’s feedback, the European Commission may amend the EU Cosmetics Regulation and include that nanomaterial in Annex II or III. According to article 16(6), an ingredient in its nano form might also be restricted, if there is insufficient information for the SCCS to assess its safety for human health. Most of the SCCS opinions issued in the last ten years are inconclusive due to the lack of data.
In addition to the mandated opinions, in October 2019 the SCCS has issued its guidance on the safety assessments of nanomaterials in cosmetics.
Furthermore, besides the annual status report, Article 16(10) establishes that the European Commission has to draft a catalogue of nanomaterials used in cosmetics and placed on the EU market that must be kept updated and made publicly available. The last version of the catalogue, with data collected until the end of 2018, was published in November 2019 and it can be found here. Compared to the first version of the catalogue, issued in 2017, in which 43 nanomaterials were listed, the newest one contains only 29 entries. The difference is due to the fact that in the first catalogue were included several not-permitted ingredients, in particular colorants.
Lastly, Article 16(11) states: “The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions” (EC, 2009).
The EU market for cosmetics containing nanomaterials
The obligation to notify cosmetics on the CPNP allows us to retrieve useful information about the products sold in the EU. The use of nanomaterials in cosmetics is increasing, but, currently, it still represents a small portion of the whole market. In fact, every day about 800 new cosmetics are notified on the CPNP, of which only 10 contain nanomaterials. In 2020, 3444 nanomaterials notifications were submitted according to Article 13, and 137 according to Article 16. Therefore, the majority of cosmetics placed on the EU market contain nano ingredients used as colorant or UV-filter.
Among nanomaterials, only Carbon Black (nano) is allowed to be used as a colorant, while in Annex VI to the EU Cosmetics Regulation (list of UV-filters allowed in cosmetic products) are included four ingredients: MBBT (nano), Titanium Dioxide (nano), Tris-biphenyl triazine (nano) and Zinc Oxide (nano). Currently, no nanoparticles can be used in cosmetic formulas as preservative.
Overall, only 1,5% of the cosmetics notified on the CPNP contain nanomaterials, of which 96% are related to nano ingredients used as colorants or UV filters. The most common nanoparticles are Titanium Dioxide (nano), Silica Dimethyl Silylate, Silane, dichlorodimethyl-, reaction products with silica, Carbon Black (nano) and Silica. On the other hand, product categories in which the use of nanomaterials is the most prevalent are sun protection, nail varnish, oxidative hair care, foundation and lip care products.
Review of the provisions concerning nanomaterials
Following the Article 16(11) of the EU Cosmetics Regulation, the European Commission reviewed the current provisions concerning nanomaterials to assess whether the applicable regulatory framework needs improvements due to the development of nanotechnologies.
The four elements taken into account are:
- The definition of nanomaterial;
- The notification of nanomaterials;
- The scientific assessment of nanomaterials;
- The labelling of cosmetic products containing nanomaterials.
Definition of nanomaterial
In article 2(1) of the EU Cosmetics Regulation, a nanomaterial is defined as “an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm” (EC, 2009). However, in October 2011, the European Commission adopted a recommendation on the definition of a nanomaterial, in which it is described as “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm” (EC, 2011).
The latter definition was applied in the REACH Regulation and this difference can create discrepancies: a material might be classified as a nanomaterial according to the REACH Regulation, but not under the EU Cosmetics Regulation.
Moreover, in the EU Chemicals Strategy for Sustainability published in October 2020, is highlighted the necessity to adopt a new horizontal definition of nanomaterial by 2021 (as) to ensure its application across all sectors. In conclusion, it is likely that Article 2(1) of the EU Cosmetics Regulation will be amended according to the definition that will soon be introduced. In light of this, the European Commission has launched a stakeholder consultation, which closed on July 30.
Notification and safety assessment of nanomaterials
As for the notification of nanomaterials, in February 2020 the European Commission requested the SCCS to determine whether certain nanomaterials included in the 2019 catalogue could cause specific concerns in order to create a priority list for risk assessments. The scientific advice was published in March 2021.
Furthermore, the six months period after the notification according to Article 16 in which a cosmetic product cannot be marketed can create problems to economic operators that have to plan their business activities. Therefore, the duration of the process should be reconsidered in light of the experience acquired in the last decade. The European Commission is open to consider extending the ex ante authorisation process foreseen in Article 14 of the EU Cosmetics Regulation for colorants, preservatives and UV-filters also to nanomaterials.
Lastly, as for the labelling of cosmetic products containing nanomaterials, raw materials in nano form have to be shown in the ingredients list with their name followed by the word ‘nano’ in brackets. It is worth noting that cosmetic products are the only consumer goods for which it is required to specify on the label the presence of nanomaterials. According to a survey conducted for the European Union Observatory for Nanomaterials in November 2020, the majority of consumers considers important to be informed on the presence of nanometerials in the products they buy.
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- EC. (2021). Report from the Commission to the European Parliament and the Council on the use of nanomaterials in cosmetics and on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials. Retrieved on 23/08 from https://data.consilium.europa.eu/doc/document/ST-11068-2021-INIT/en/pdf
- EC. (2021). Scientific Committee on Consumer Safety SCCS Scientific Advice on the safety of nanomaterials in cosmetics. Retrieved on 23/08/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_239.pdf
- EC. (2020). Request for a scientific advice on the safety of nanomaterials in cosmetics. Retrieved on 23/08/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs2016_q_044.pdf
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- EC. (2019). SCCS Guidance on the Safety Assessment of nanomaterials in cosmetics. Retrieved on 23/08/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_233.pdf
- EC. (2019). Catalogue of nanomaterials in cosmetic products placed on the market – Version 2. Retrieved on 23/08/2021 from https://ec.europa.eu/docsroom/documents/38284
- EC. (2011). Commission Recommendation of 18 October 2011 on the definition of nanomaterial. Retrieved on 23/08/2021 from https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:en:PDF
- EC. (2009). Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Retrieved on 23/08/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20190813&from=EN