Regulation of nanos in cosmetics

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.

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)

• un colorant and only one (Annex IV): the carbon black (IC 77266)⁹Opinion on nano carbon black was published on December 12, 2013 (in response to the Request for a scientific opinion on the colorant Carbon Black, CI 77266 nano CAS n. 1333-86-4, EC no. 215-609-9) of the European Commission), revised in March 2014 and supplemented in September 2014: Scientific Opinion for clarification of the meaning of the term “sprayable applications/products” for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide, SCCS (published June 2015)
  → no other substances are permitted as colorants in nano form¹⁰See article 14 of regulation (EC) n°1226/2009 : neither titanium dioxide (TiO₂), nor the iron oxides found in many make-up products!

• five UV filters are now expressly authorized (appendix VI), but not in the form of a spray in order to avoid the potential risks caused by their inhalation:
  • dwarf zinc oxide (ZnO)¹¹THEinitial opinion on zinc oxide published in 2012 was completed April 2014 and even in september 2014 (with publication in June 2015). ⇒ In April 2016, zinc oxide nanoparticles were thus added to Annex VI of the Cosmetics Regulation, authorizing their use in cosmetics from May 2016 at a maximum concentration of 25% (except for applications likely to give rise to exposure of the users' lungs; use in a spray is therefore prohibited to avoid inhalation) (cf. Regulation (EU) 2016/621 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, European Commission, 21 April 2016). This authorization aroused the excitement of Olivier Toma, of the Committee for Sustainable Development in Health (C2DS) insofar as these particles are toxic to aquatic organisms (cf. Zinc oxide sunscreens: ecotoxicological danger!, Olivier Toma, C2DS, May 24, 2016)
  • dwarf titanium dioxide (TiO₂)*¹²The opinion on titanium dioxide nanoparticles (TiO2) was published on July 23, 2013 and revised several times, the last documents we had identified being these:
    - Scientific Opinion for clarification of the meaning of the term “sprayable applications/products” for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc Oxide, CSAS, September 2014 (published June 2015)
    - Opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic , SCCS, March 2017: (given the) “ general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, the SCCS considers that the use of the three TiO2 nanomaterials coated with either cetyl phosphate, manganese dioxide or triethoxycaprylylsilane, can be considered safe for use in cosmetic products intended for application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to exposure of the consumer's lungs to the TiO2 nanoparticles through the inhalation route (such as powders or sprayable products). »
    - Opinion on Titanium Dioxide (nano form) as UV-Filter in sprays, CSAS, January 2018: “the SCCS has concluded that the information provided is insufficient to allow assessment of the safety of the use of nano-TiO2 in spray applications that could lead to exposure of the consumer's lungs. (…) there are already sprayable products on the market containing nano forms of TiO2. Such uses need to be carefully evaluated so that the chance of harmful effects through consumer's lung exposure by inhalation is avoided” (The affected product: PARSOL® TX from DSM)
    → The nano form of titanium dioxide particles was introduced into Annex VI of the Cosmetics Regulation (the one concerning sunscreens) in July 2016 for entry into force from August 2016, at a maximum concentration of 25% (except for applications likely to result in exposure of users' lungs; use in a spray is prohibited to avoid inhalation due to the risks associated with titanium dioxide nanoparticles). see Regulation 2016/1143 of July 13, 2016, published in the Official Journal of the European Union on 14 July
  • dwarf TBPT (tris-biphenyl triazine, present in Tinosorb® A2B from BASF)¹³See European Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, 8 August 2014; see also A micronized UV filter authorized for cosmetics in the EU, Premium Beauty News, September 2014
  • dwarf MBBT (methylene bis-benzotriazolyl tetramethylbutylphenol)¹⁴Un SCCS Opinion on MBBT was published in 2013 and revised in 2015: Opinion on 2,2′-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (nano form), Submission III, SCCS, March 2015 (published June 2015). On February 28, 2018, a “draft” Regulations was validated during a meeting of the Standing Committee on Cosmetic Products. the Commission Regulation (EU) 2018/885 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products was finalized on June 20, 2018 and entered into force the following month. It authorizes the use of MBBT in the form of nanoparticles as an ultraviolet filter in cosmetic products, in accordance with CSSC specifications, at a concentration of 10% m/m, except for applications likely to give rise to exposure of the lungs of the end user by inhalation of this substance.
  • dwarf HAA299 (Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine)¹⁵See Commission Regulation (EU) 2022/2195 of 10 November 2022 amending Regulation (EC) No^o 1223/2009 of the European Parliament and of the Council as regards the use of the substances 'Butylated Hydroxytoluene', 'Acid Yellow 3', 'Homosalate' and 'HAA299' in cosmetic products and amending the said Regulation as regards the use of “Resorcinol” in cosmetics. It can be used as a nanomaterial if the median D50 particle size (50% of the number below this diameter) is ≥ 50 nm based on the numerical size distribution.
    Like the others #nanomaterials authorized in cosmetics, it cannot be used in applications that could lead to exposure of the end user's lungs by inhalation to avoid potential health risks.

* 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:

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).

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).

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 44^e 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.

U.S.

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