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VeilleNanos - Regulating nanos in cosmetics

Regulating nanos in cosmetics

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Regulating nanos in cosmetics

By the AVICENN team – Last modification March 2024

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 manufactured and characterized by one or more external dimensions, or internal structure, on a scale of 1 to 100 nm” .

It is different from the European Commission’s 2011 definition recommendation and, unlike 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 contamination1Cf. Information note for the application of the definition of nanomaterials in the framework of Regulation (EC) No. 1223/2009 on cosmetic products, DGCCRF & ANSM, 5 July 2021.

… which could evolve soon

In 2022, the European Commission expressed the will that its new recommendation on the definition of the term “nanomaterial” be transposed in the future revised Cosmetics Regulation – without giving more information, at this stage, on the possible adaptations that could be made.

NB: In 2012, the European Consumers’ Organisation (BEUC) proposed various changes to the definition of nanomaterials to better protect consumers from the potential hazards 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 mandatory since 2013…

In 2009, the Cosmetics Regulation made it mandatory, as of July 2013, to report the presence of “nanomaterials” (as defined above) in the list of ingredients of cosmetics (Article 19).
The labeling rule requires that the term nano be indicated in square brackets after the name of the ingredient concerned. For example, in the case of TiO2: Titanium dioxide [nano].

Please note: the labeling requirement [nano] applies to aggregates or agglomerates3Pascal Courtellemont (LVMH Research) stated in October 2009 that nano titanium dioxide agglomerates “when it is put into cosmetic matrices. (…) We go from sizes around tens of nanometers to 150 nanometers, then to agglomerates at 1 or 3 microns”; source: Verbatim of the Orléans meeting, CNDP nano, October 27, 2009 if they are composed of primary particles with at least one dimension smaller than 100 nm, as well as to particles with little or no “solubility”: silicas are no exception4Cf. Opinion on solubility of Synthetic Amorphous Silica (SAS), Scientific Committee on Consumer Safety (SCCS), June 20-21, 2019 (December 6, 2019 corrigendum).

… is insufficiently applied by the cosmetics industry

Although the mention [nano] appeared on some cosmetics as early as 2014, tests conducted by associations and the French public authorities (DGCCRF) have shown that many brands have been very slow to comply with the labeling obligation5The “Organic Solar Collective”, for example, complied only in 2022. See for example the press release from Biarritz Laboratories, January 2022… and others haven’t even started yet.

These tests highlight every year the presence of nanoparticles (not always authorized) in cosmetics, with no [nano] mention on the packaging.

Are the justifications put forward by the cosmetics industry acceptable?
  • Some manufacturers argue that any grinding process produces small particles, some of which are nanoparticles, which should not be considered as “intentional” nano and would therefore escape the labeling obligation. This interpretation, which obviously suits them, does not comply with the regulatory texts, nor with the spirit of the law, that was written to allow better information and protection of consumers. The French authorities nevertheless considered that a 10% threshold provided some flexibility (see above).
  • Some brands have not seen fit to comply with the law, on the grounds that the law will be changed – which is not acceptable from a regulatory point of view… nor from an ethical point of view. In 2022, the revision of the cosmetics regulation is just starting and could be the opportunity to review the term definition, aligned – or not – with the recommendation on the definition of the term “nanomaterial” (under revision). However, these processes take time abd the outcome is highly uncertain.
  • Many blame their suppliers6See in particular:
    “If some (suppliers) don’t have the ability or willingness to characterize their ingredients, the information will be truncated. Marie-Laure Gratadour Valcarcel, head of raw material approval at Pierre Fabre, a manufacturer of cosmetics, food supplements and medicines, testified to this. If suppliers with strong backbones (…) are able to transmit information on their materials, suppliers of materials (…) have much more difficulty in producing data or transmitting them”.. Source : NanoRESP Forum Proceedings, June 19, 2018.
    – In the lip balm Avene “the additives / ingredients are entirely in nanometric form without the consumer having the information of their presence , indignant association UFC Que Choisir. “Our Cold cream lip stick does not contain any nanomaterial as defined by European cosmetics regulations, as attested by the certificates issued to us by our raw material suppliers,” says Avene.” Source: Nanoparticles: clarification from Avène laboratories, Le Moniteur des pharmacies, 24 January 2018
    , for not providing them with information on the nanometric nature of their ingredients, or worse, providing them with certificates that falsely state that the ingredients were NOT nanometric. Nevertheless, brands must control all ingredients and raw materials coming into their finished products, with controls based on adequate methods and tools, coupled with a solid expertise on the subject.
  • Other arguments put forward demonstrate a casual attitude (or even bad faith) that is far removed from the seriousness and responsibility that consumers have a right to expect from brands, particularly at a time when “corporate social responsibility” (CSR) is being touted: “there are less than 50% nanoparticles in my substance, I don’t have to label it” – wrong, the definition of the Cosmetic Regulation does not include a threshold; “but then you’d have to label almost everything nano, so it doesn’t make sense!”- wrong again…

In the end, the brands that have had a wait-and-see attitude since 2013 by not complying with the [nano] labeling obligation have illegally “gained” at least a decade of not labeling, during which the European Commission has turned a blind eye.

It has to be said that some of the non-compliance issues relate to the fact that the regulations are somewhat confusing. In addition to the problems of definition mentioned above, the complexity of the authorization process can lead to the rather bizarre situation where a substance may not (yet) be “prohibited” without being expressly “authorized” (see below). However, even when they are not formally “prohibited”, these substances must still be labeled [nano].

Even if all suppliers do not always specify the nanometric size of the ingredients they sell to brands7“The problem of the presence or absence of nanoparticles in a product can become even more complex once the manufacturing chain of a product integrates ingredients from different suppliers. If some of them do not have the capacity or the will to characterize their ingredients, the information will be truncated. Marie-Laure Gratadour Valcarcel, in charge of raw material approval at Pierre Fabre, a manufacturer of cosmetics, food supplements and medicines, testified to this. If suppliers with strong backbones (…) are able to transmit information on their materials, suppliers of materials (…) have much more difficulty in producing data or transmitting them”.. Source : NanoRESP Forum Proceedings, June 19, 2018. or deliver erroneous “nano-free” certificates (because they are based on inadequate measurements performed with analysis methods that are not suitable for measuring particles smaller than 100 nm, for example), brands are still responsible for the products they put on the market. They must check the information provided by their suppliers: while analysis of the “product sheets” is necessary, additional laboratory controls offer a more reliable guarantee – provided they are carried out with adequate methods and tools, coupled with a solid expertise on the subject.

The DGCCRF continues its controls and has already obtained withdrawals or compliance of products (see below).

On the positive side, some brands or federations have taken the nano issue seriously. Cosmed, for example, an association of SMEs in the cosmetics industry, has produced didactic documents for its members (which are also available to the public), that are remarkable for the quality and thoroughness of their content8See Nano or not Nano? (video), Cosmed, May 2022 and NANOMATERIAUX: Cosmed untangles the real from the fake, (press release), Cosmed, February 2021.

Placing nanos on the market: required authorizations & prior declarations

For professionals, there is an obligation to notify all nano-ingredients used 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. 60 Millions de consommateurs indicated in 2018: “In a skin care cream with a purely aesthetic aim such as an anti-wrinkle, the presence of UV filters with a proven risk, or even only suspected of toxicity, is not acceptable”16Cf. ” Anti-wrinkle creams: unwelcome UV filters,” 60 Millions de consommateurs, October 25, 2018.

At the end of June 2022, the European Commission asked the Scientific Committee on Consumer Safety (SCCS) to re-evaluate the safety of TiO2 in cosmetics, with regard to its genotoxicity in case of inhalation and oral exposure. Lip balms, lipsticks, toothpastes, powders and hair sprays were among the types of cosmetics mentioned. The SCCS had nine months to issue its opinion, which should have been finalized in March 2023.

The 12 nanomaterials banned in cosmetics

In March 2024, following health concerns identified by the Scientific Committee on Consumer Safety (SCCS), the European Commission published a regulation to ban the use of five groups totaling twelve nanomaterials in cosmetics:

  • styrene/acrylates copolymer, sodium styrene/ acrylates copolymer,
  • copper, colloidal copper,
  • colloidal silver,
  • gold, colloidal gold, gold thioethylamino hyaluronic acid, and acetyl heptapeptide-9 colloidal gold,
  • platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum

In order to protect human health, these twelve nanomaterials will be included in Annex II of the Cosmetics Regulation, which lists the substances prohibited in cosmetic products.

Cosmetics containing thess substances will no longer be :

  • be placed on the European Union market by manufacturers or importers as of February 1, 2025
  • be made available by distributors, wholesalers or retailers from November 1, 2025.

Restricted nano hydroxyapatite in toothpastes and mouthwashes

The same regulation restricts the hydroxyapatite nanomaterial (HAP) by adding it to Annex III of the Cosmetics Regulation, which lists substances which cosmetic products must not contain except subject to the restriction laid down. In this case, nano PAH can only be used in toothpastes in concentrations of less than 10%, and in mouthwashes in concentrations of less than 0.465%. It should not be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed:

  • [composed of] rod-shaped particles of which at least 95,8 % (in particle number) have an aspect ratio less than 3, and the remaining 4,2 % have an aspect ratio not exceeding 4,9,
  • particles are not coated or surface modified.

The same deadlines apply here: cosmetics containing this substance and not complying with these restrictions may no longer be placed on the EU market from February 1, 2025, nor made available from November 1, 2025.

According to the regulation, the length of these periods has been determined considering the SCCS concerns and the potential risk to human health associated to the nanomaterials concerned, as well as the number of cosmetic products concerned.

Two types of authorizations

The Cosmetics Regulation provides for two types of authorizations, depending on whether or not nanomaterials are used as colorants, UV filters or preservatives.

Express authorization

An “express” authorization has been put in place for substances used as colorants, UV filters or preservatives and included (a posteriori) in the annexes of the Regulation17As of July 11, 2013, the date of entry into force of the regulation, the SCCS had not issued 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 Regulation so that they could be used without prior declaration.
But it subsequently caught up. See below.
.

Pre-market notification

For substances with another function, a prior declaration must be made to the European Commission by the requesting entity six months before they are placed on the market18Cf. article 16 of regulation (CE) n°1226/2009. The Commission may request the opinion of the Scientific Committee for Consumer Safety (SCCS).

Opinions issued by the SCCS on nanosubstances

NB: At the end of October 2019, the European Scientific Committee on Consumer Safety (SCCS) adopted a document, revised in 2023, “Guidance on the Safety Assessment of Nanomaterials in Cosmetics“. It incorporates recent developments in nanomaterial safety research to help manufacturers and assessors in their work to characterize and assess the health risks associated with nanomaterials used in cosmetics.

(Without forgetting the French declaration in r-nano)

In France, “nanoparticulate substances” like other nanomaterials used in cosmetics are subject, to a mandatory declaration in the R-nano register.
The declaration in R-nano does not exempt manufacturers from the European notification obligation on CPNP, and vice versa.

In the r-nano register, the product category “cosmetics, personal care products” (PC 39) was the second most reported category with 616 reports in 2017. However, as the register currently stands, products containing these nano substances cannot be identified, hence there is a need for improvements to the French declaration procedure.

Some cosmetics manufacturers complain about the “administrative burden” related to the fact that the declarations in R-nano and CPNP are not based on the same definitions of “nanomaterial ” and that their suppliers do not provide them with the necessary accurate data and/or the data are provided late.
Nevertheless, brands have the responsibility to ensure the quality of their raw materials and always have the possibility to have them tested, using the appropriate methods and tools.

What controls do the authorities do?

In France

The DGCCRF27See 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, 22 February 2021
Composition of cosmetics: the requirement of clear information for consumers, DGCCRF, October 15, 2019
and the ANSM28– Cf. Assessment of cosmetic products inspections at ANSM, ANSM, Perfumes & Cosmetics Congress, November 4, 2020: ANSM presented the results of tests it had conducted in 2019 on 12 toothpastes of different brands, complementing the analyses conducted by the DGCCRF on 5 other toothpastes. Unfortunately, these results have not been made public outside the conferences 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 distributed in France.

Since 2017, the DGCCRF has conducted controls that have confirmed the failures of the [nano] labeling as well as the presence of unauthorized nanomaterials (iron oxide and nano titanium dioxide used as colorants for example). Since 2020, the DGCCRF has issued injunctions to bring labelling back into compliance and has obtained the voluntary withdrawal of a dozen products by companies (mainly make-up).

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

The “roadmap” from the 2016 environmental conference planned to accelerate the regulations on the use of nanomaterials in the UV filters of cosmetic products as part of the application of the European regulationand in particular, the coming into force at the national level of the measures concerning the use of titanium dioxide in nano form. The Ministry of Health and the DGCCRF were the key owners of this “action”.

Starting in 2018, after initial tests on cosmetics other than sunscreen products in 2016-2017, the DGCCRF has been looking more specifically at nanoparticles of titanium dioxide (TiO2) and zinc oxide (ZnO) in sunscreen products, in order to verify compliance with the European obligation to label nanomaterials in cosmeticsin effect since 2013.

It highlighted many non-conformities concerning the absence of mention [nano] in products containing titanium dioxide or zinc oxide in nanoparticulate form.

Elsewhere in Europe?

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

The DGCCRF has been communicating its approach and results to the European Commission since February 2018. Other countries could benefit from this feedback to carry out controls on their territory as well.

The fact that France is ahead in this area is probably due to the tests conducted by associations. As a result, the DGCCRF has been testing and raising companies’ awareness for several years now. This is also helped by the mandatory declaration via the register r-nano that French companies (and those from abroad selling their products in France) have integrated into their practices. France is the country that comes first in terms of the number of notifications of nanomaterials in the Cosmetics Notification Portal (CPNP), with nearly 16,500 notifications (i.e. ~44% of European notifications), nearly four times more than Italy and Germany, which come in at number 2nd and 3rd positions respectively, according to a European Commission report published in 202129Cf. Report on the use of nanomaterials in cosmetic products and the revision of Regulation (EC) No. 1223/2009 on cosmetic products with regard to nanomaterials, European Commission, July 2021.

This is another element that supports the need for a European register of nanomaterials.

In the United States

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

Any questions or comments? This information sheet compiled by AVICENN is intended to be completed and updated. Please feel free to contribute.

Upcoming Nano Agenda

6
Juin
2024
Managing the risks associated with nanomaterials (CEA, Grenoble)
Grenoble
Training
  • Awareness-raising aimed at personnel in contact with nanomaterials during research, formulation, production, maintenance, cleaning, upkeep, etc., as well as safety coordinators or engineers, facility managers, heads of laboratories where nanoparticles are handled.
  • Organizers: INSTN Grenoble (CEA)
  • On the agenda: potential impact on health; metrology and protection; control of potential risks associated with nanomaterials; consideration of societal aspects.
  • Website: https://instn.cea.fr/formation/maitrise-des-risques-lies-aux-nanomateriaux-sensibilisation
6
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2024
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Maisons-Alfort
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10
Juin
2024
Nanoparticles NPC-24 (ETH, Zurich)
Zurich
Conference
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  • From June 10 to June 14, 2024
  • Website: https://npc24.scg.ch

This sheet was originally created in February 2019


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