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WatchNanos - Supervision of nanos in cosmetics

Regulation of nanos in cosmetics

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Regulation of nanos in cosmetics

By AVICENN Team – Last Modified November 2022

Nanomaterials in cosmetics: definition and labeling obligation

A definition without a minimum threshold…

The definition of the term “nanomaterial” retained by the Cosmetics Regulations (2009) is as follows:
“an insoluble or bio-persistent material, intentionally made and characterized by one or more external dimensions, or internal structure, on a scale of 1 to 100 nm”.

She's different of the definition recommendation of the European Commission in 2011 and, contrary to the latter, does not include a minimum threshold of 50%.

A tolerance of 10% is nevertheless applied by the French control authorities, in order to cover measurement uncertainties and possible environmental contamination.1See Information note for the application of the definition of nanomaterials in the context of Regulation (EC) No 1223/2009 on cosmetic products, DGCCRF & ANSM, July 5, 2021.

… which could evolve soon

En 2022, the revision of the Cosmetics Regulation was launched. The Commission has expressed the wish that the recommendation for the definition of the term "nanomaterial", revised in 2022, be transposed in the future revised Cosmetics Regulation, without having more information at this stage on the possible adaptations that could be made to this transposition.

NB: In 2012, the European Bureau of Consumers' Unions (BEUC) had proposed various changes to the definition of nanomaterials aimed at better protecting consumers from the potential dangers posed by nanomaterials in cosmetics2See the report “Nano-materials in cosmetic products: definition needs to effectively protect consumers”, BEUC, August 2012.

The [nano] labeling of cosmetics has been mandatory since 2013…

2009 in the Cosmetics Regulations made mandatory, from July 2013, the reporting of the presence of “nanomaterials” (as defined above) in the list of cosmetic ingredients (article 19).
The labeling rule provides for the term nano to be indicated in square brackets after the name of the ingredient concerned. For example in the case of TiO2: Titanium dioxide [nano].

Note: the [nano] labeling obligation applies to aggregates or agglomerates3Pascal Courtellemont (LVMH Research) affirmed in October 2009 that nano titanium dioxide agglomerates “when put into cosmetic matrices. (…) We go from sizes of around tens of nanometers to 150 nanometers, then to agglomerates of 1 or 3 microns” ; source : Verbatim of the Orleans meeting, CNDP nano, October 27, 2009, if they are composed of primary particles having at least one dimension less than 100 nm, as well as particles with little or no “soluble” properties: silicas are no exception4See Opinion on solubility of Synthetic Amorphous Silica (SAS), Scientific Committee on Consumer Safety (SCCS), June 20-21, 2019 (corrigendum of December 6, 2019).

… is insufficiently applied by the cosmetics sector

Although the mention [nano] may have appeared on certain cosmetics as early as 2014, tests carried out by associations and the French public authorities (DGCCRF) have shown that many brands have been very slow to comply with labeling requirement5The "Collective of organic solar", for example, complied in 2022 only. See for example the Biarritz Laboratories press releaseJanuary 2022… and that others still haven't gotten to it!

Each year, these tests highlight the presence of nanoparticles (not always authorized) in cosmetics, without mentioning [nano] on the packaging.

Are the arguments put forward by the cosmetics industry admissible?
  • Some manufacturers invoke the fact that any grinding process has the effect of producing small particles, including a part of nanoparticle size which should therefore not be considered as "intentionally" nano and would thus escape the labeling obligation. This interpretation, which suits them, does not comply with either the regulatory texts or the spirit of the law, which was written in order to allow better information and protection of the consumer. The French authorities nevertheless considered that a threshold of 10% made it possible to provide some flexibility (see above).
  • Some brands have not seen fit to comply with the law, on the grounds that the latter would have to change – which is not admissible either from a regulatory point of view… or from a ethical view. In 2022, the revision of the cosmetics regulation is just beginning and could be an opportunity to review this definition, articulated – or not – to the recommendation for the definition of the term "nanomaterial" (under review). But the duration and outcome of these processes are highly uncertain.
  • Many blame their suppliers6See in particular:
    -“If some (suppliers) do not have the capacity or the will to characterize their ingredients, the information will be truncated. Marie-Laure Gratadour Valcarcel, responsible for the approval of raw materials at Pierre Fabre, a manufacturer of cosmetics, food supplements and medicines, testified to this. If suppliers with strong backs (…) are able to transmit elements of information on their materials, suppliers of materials (…) have much more difficulty in producing data or transmitting them”. Source : Minutes from the NanoRESP Forum of the 19 June 2018
    – “In the Avène lip balm “the additives/ingredients are entirely in nanometric form without the consumer having any information of their presence” , is indignant the association UFC Que Choisir. “Our Cold cream lip stick does not contain any nanomaterials within the meaning of European cosmetics regulations, as evidenced by the certificates issued to us by our raw material suppliers”, says Avene. " Source : Nanoparticles: development by Avène laboratories, Le Moniteur des pharmacies, January 24, 2018
    , which did not send them information on the nanometric nature of their ingredients, or worse, sent them certificates ensuring, wrongly, that they were NOT nanometric; but brands must ensure control of the supply of ingredients and raw materials and more control of their finished products, with controls based on appropriate methods and tools, coupled with solid expertise.
  • Other arguments put forward testify to a casual attitude (or bad faith) that is out of phase with the seriousness and responsibility that consumers have the right to expect from brands, at a time when " corporate social responsibility (CSR): "there are less than 50% nanoparticles in my substance, I don't have to label it" : false, the definition of the Cosmetics Regulation does not include a threshold; "but then, almost everything would have to be labeled nano, so it doesn't make sense!" » : wrong again...

In the end, the brands that have played the watch and the wait-and-see card since 2013, by not respecting the [nano] labeling obligation, have thus illegally "won" at least ten years not to label , during which the European Commission turned a blind eye!

Admittedly, some very regrettable non-compliance issues have to do with the fact that the regulations are somewhat confusing. In addition to the definition problems mentioned above, there is the complexity of the authorization process which can lead to the relatively grotesque situation where a substance may not (yet) be "prohibited"... without however being expressly "authorized" (cf. . lower). Still, even when they are not formally “prohibited”, these substances must be labeled [nano]!

And if all suppliers do not necessarily specify the nanometric dimension of the ingredients they sell to brands7“The problem of the presence or absence of nanoparticles in a product can become even more complex as soon as the manufacturing chain of a product integrates ingredients from different suppliers. If some of them do not have the ability or the will to characterize their ingredients, the information will be truncated. Marie-Laure Gratadour Valcarcel, responsible for the approval of raw materials at Pierre Fabre, a manufacturer of cosmetics, food supplements and medicines, testified to this. If suppliers with strong backs (…) are able to transmit elements of information on their materials, suppliers of materials (…) have much more difficulty in producing data or transmitting them”. Source : Minutes of the NanoRESP forum of June 19, 2018 or present erroneous "nano-free" certificates (because they are based on inappropriate measurements carried out with analysis methods that are unsuitable for measuring particles smaller than 100 nm for example!), brands are responsible for the products they put on the market and must check the information of their suppliers: if the documentary analyzes of the "product sheets" are necessary, additional laboratory checks are a more reliable guarantee - on condition that they are carried out with appropriate methods and tools, coupled with solid expertise.

The DGCCRF for its part is therefore continuing its checks and has already obtained product withdrawals or compliance (see below).

And fortunately, some brands or federations have taken the nano issue seriously. Cosmed, for example, an association of SMEs in the cosmetics sector, has thus produced documents for its members (and also made available to the public) by deploying a real educational effort, remarkable for the quality and rigor of its information.8See Nano or not Nano? (video), Cosmed, May 2022 and NANOMATERIALS: Cosmed disentangles fact from fiction, (press release), Cosmed, February 2021.

Placing nanos on the market: prior authorizations & declarations

For professionals, there is an obligation to notification of all the nano ingredients used, in particular on the “Cosmetic Products Notification Portal” (CPNP) of the European Commission.

The 6 nanomaterials authorized in cosmetics (under conditions)

* The almost systematic use of titanium dioxide for applications where the anti-UV function is not strictly necessary is controversial, particularly in anti-wrinkle creams: "In a purely aesthetic care cream such as an anti-wrinkle product, the presence of UV filters with a proven risk, or even only suspected of toxicity, is not acceptable" indicated 60 million consumers in 201816See " Anti-wrinkle creams: unwelcome UV filters », 60 Million consumers, October 25, 2018.

At the end of June 2022, the European Commission required the Scientific Committee for Consumer Safety (SCCS) to reassess the safety of TiO2 in cosmetics, in view of its genotoxicity when exposed by inhalation and by the oral route. Among the types of cosmetics mentioned: lip balms, lipsticks, toothpastes, powders, hair sprays. The CSSC has nine months to issue its opinion, which should therefore be finalized in March 2023.

The 12 nanomaterials soon to be banned in cosmetics

In February 2022, following health concerns identified by the Scientific Committee on Consumer Safety (SCCS), the European Commission published a draft regulation to prohibit the use in cosmetics of five groups of twelve nanomaterials in total:

  • styrene acrylate copolymer, sodium styrene acrylate copolymer,
  • copper, colloidal copper,
  • hydroxyapatite,
  • gold, colloidal gold, gold thioethylaminohyaluronic acid, colloidal gold acetylheptapeptide-9,
  • platinum, colloidal platinum and colloidal platinum acetyltetrapeptide-17.

NB: The project was subject to comments by April 12, 2022. It amends Annex II of the Cosmetics Regulation (which lists the substances prohibited in cosmetic products) to add these twelve nanomaterials in the name of the protection of human health. The text provides that a “reasonable time” be granted to manufacturers to make the necessary adjustments in terms of product formulation and labeling. Another deadline should be defined for the withdrawal of cosmetics that do not comply with the new requirements and which have been placed on the market before the entry into force of the latter. The length of these periods should be determined taking into account the concerns of the SCCS and the potential risk to human health associated with the specific nanomaterials, as well as the number of cosmetic products concerned.

Two types of authorization

The Cosmetics Regulation provides two types of permissions, depending on whether the nanomaterials are used or not as colorants, UV filters and preservatives or not:

Source: DGCCRF, 2018

The express authorization 

An "express" authorization has been put in place for substances used as dyes, UV filters or preservatives and listed (a posteriori) in the annexes of the Regulation17As of July 11, 2013, the date of entry into force of the regulations, the CSSC had not given all its opinions on the main nano-ingredients used in cosmetics in response to the cosmetics industry, which wanted them to be included in the annexes of the Cosmetics Regulations to be able to use them without prior declaration.
But then he caught up. See below.

Notification before placing on the market

For substances with another function, a prior Declaration (six months before they are placed on the market) must be made by the marketer to the European Commission18See article 16 of regulation (EC) n°1226/2009. The latter may request the opinion of the Scientific Committee for Consumer Safety (CSSC).

Opinions issued by the CSSC / SCCS on nano substances

NB: At the end of October 2019, the European Scientific Committee for Consumer Safety (SCCS) adopted the document “ Guidance on the Safety Assessment of Nanomaterials in Cosmetics » which integrates recent developments in the field of research on the safety of nanomaterials in order to help manufacturers and assessors in their work of characterization and evaluation of the health risks associated with nanomaterials used in the cosmetics field.

(Not forgetting the French declaration in r-nano)

In France, "substances in the nanoparticle state" used in cosmetics are subject, like other nanomaterials, toobligation to declare to the R-nano register.
The statement in R-nano does not exempt manufacturers from the European notification obligation on the CPNP, and vice versa.

In the r-nano register, the category of products "cosmetics, personal care products" (PC 39) was the second most declared category with 616 declarations in 2017. But, in the current state of the register, products that contain these nano substances cannot be identified, hence the need to make improvements to the French declaration procedure.

Some cosmetics manufacturers complain of the "administrative burden" linked to the fact that the statements in R-nano and in the CPNP are not based on the same definitions of the term “nanomaterial” and that their suppliers do not send them the necessary data correctly and/or very late.
Nevertheless, brands are responsible for ensuring the quality of their raw materials and always have the possibility of having them tested, using appropriate methods and tools.

What controls by the authorities? 

In France

The DGCCRF26See in particular:
- Control of the presence of nanoparticles in food products and cosmetics by the DGCCRF, DGCCRF, January 2018
Nanomaterials in cosmetic products: the DGCCRF takes stock, DGCCRF, February 22, 2021
Composition of cosmetics: the requirement for clear consumer information, DGCCRF, October 15, 2019
and the ANSM27– See Review of inspections of cosmetic products at the ANSM, ANSM, Parfums & Cosmétiques Congress, November 4, 2020: the ANSM presented the results of the tests it had carried out in 2019 on 12 toothpastes from different brands, supplementing the analyzes carried out by the DGCCRF on 5 other toothpastes. Unfortunately, these results have not been made public outside the congresses reserved for cosmetic brands and the ANSM has never responded to AVICENN's requests for clarification. verify the application by companies of the provisions of the Cosmetics Regulation concerning nanos on French territory.

Since 2017, the DGCCRF has carried out checks which have confirmed the failures of the [nano] labeling as well as the presence of unauthorized nanomaterials (iron oxide and nano titanium dioxide used as dyes for example). Since 2020, the DGCCRF has issued injunctions to bring labeling back into compliance and obtained the voluntary withdrawal of around ten products by companies (mainly make-up).

Focus on the use of nanomaterials in UV filters by the French authorities from 2018

La “roadmap” from the 2016 environmental conference had planned to accelerate supervising the use of nanomaterials in the UV filters of cosmetic products as part of the application of European regulation, and in particular the entry into force at national level of measures concerning the employment of titanium dioxide in nano form« . The Ministry of Health and DGCCRF are the key players in this “action”.

After initial tests on cosmetics other than sunscreen products in 2016-2017, DGCCRF looked, from 2018, more specifically at nanoparticles of titanium dioxide (TiO2) and zinc oxide (ZnO) in sun protection products, in order to verify compliance with theEuropean labeling obligation for nanomaterials in cosmetics, in force since 2013.

It highlighted numerous non-conformities: the absence of [nano] mention in products containing titanium dioxide or zinc oxide in nanoparticle form.

Elsewhere in Europe?

It seems that France is the only country in the European Union where these controls are carried out by the public authorities. When will there be similar checks in the other Member States?

The DGCCRF has communicated on its approach and its results to the European Commission since February 2018. Other countries could benefit from this feedback to also carry out checks on their territory.

France's lead in this area is probably explained by the tests carried out by the associations which have led to tests and work to raise the awareness of companies by the DGCCRF for several years, as well as by the compulsory declaration via the r-nano register that French companies (and those abroad selling their products in France) have integrated into their practices: France is the country which comes very far ahead of the number of notifications of nanomaterials in the Cosmetic Products Notification Portal (CPNP ), with nearly 16 notifications (i.e. ~500% of European notifications!), almost four times more than Italy and Germany, which arrive in 44e and 3rd positions, according to a European Commission report published in 202128See Report on the use of nanomaterials in cosmetic products and the revision of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials, European Commission, July 2021.

This is an additional element which pleads in favor of a european register of nanomaterials.


See the chapter “Sunscreens Containing Nanomaterials” in the English document: Sunscreen Drug Products for Over-the-Counter Human Use – A Proposed Rule by the Food and Drug Administration, FDA, February 2019

A question, a remark ? This sheet produced by AVICENN is intended to be supplemented and updated. Please feel free to contribute.

The next nano appointments

“Nano and Health” dialogue committee (ANSES, Maisons-Alfort)
Dialogue Committee
  • 14th meeting of the “nano and health” dialogue committee
  • Organizer: ANSES
  • Website :
Nanomaterials, how to identify them more efficiently? (LNE, Paris)
  • Technical Day
  • Organizer: National Metrology and Testing Laboratory (LNE)
  • On the agenda: identification of nanomaterials, recent technological innovations in terms of particle size characterization, areas for progress to be considered 
  • Upcoming program
  • Website :…
NanoSafe conference 2023 (CEA, Grenoble)
  • 8th International Conference on Health Issues for a Responsible Approach to Nanomaterials
  • June 5-9, 2023
  • Organizer: Commissariat for Atomic Energy and Alternative Energies (CEA)
  • Website :…  

This listing was originally created in February 2019

Notes & references

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