3 stories – HEMA, hair dyes and a new UV filter

Changes are underway for manufacturers of nail polishes, hair dyes and sunscreens. Recently, on the 12th of November, 3 regulations of the European Commission have appeared, changing the relevant annexes to the Regulation 1223/2009. What are these changes and what are the results of them? I invite you to the reading 🙂

First story – HEMA

HEMA (2-Hydroxyethyl Methacrylate) and Di-HEMA Trimethylhexyl Dicarbamate are substances from the group of acrylates, well-known to nail polish manufacturers. They are commonly used in hybrid nail polishes to create a coating and to model nails. They act on the principle of polymerization caused by the curing process of UV radiation.

So far, these substances have not been banned or restricted in the Regulation 1223/2009. However, they have been found to cause a sensitizing effect, which may pose a potential risk to the consumer. The SCCS Committee issued an opinion no. SCCS/1592/17, in which it informed that both HEMA (in a maximum concentration up to 35%) and Di-HEMA Trimethylhexyl Dicarbamate (up to 99%) pose a low risk of sensitization in light-cured artificial nail modelling systems. The safety condition is the use of these raw materials only within the nail plate and avoiding contact with adjacent skin. In other words, it is very important to apply the nail polish precisely to the nail plate. The allergenic effect may appear as a result of contact of the lacquer with the skin.

Therefore, the European Commission Regulation 2020/1682 introduces new regulations and includes HEMA and Di-HEMA Trimethylhexyl Dicarbamate to the Annex III (the list of substances which cosmetic products must not contain except subject to the restrictions laid down) of the Regulation 1223/2009. HEMA will take the entry 313 and Di-HEMA Trimethylhexyl Dicarbamate will take the entry 314 in the Annex III. The restrictions that will apply to these substances are as follows:

  • type of products where may be used: only nail products,
  • the substances can only be used in products for professional use,
  • product labels will need to include warnings:
    • for professional use only,
    • can cause an allergic reaction.

Cosmetics companies have time until 3rd of June 2021 to adapt to the new changes. From that date, it will not be possible to place on the Union market products that do not comply with the requirements described above.

The content of the Regulation can be found at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1682&from=EN

The SCCS opinion can be found here: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_214.pdf

Second story – hair dyes

Subsequent changes concern hair dye substances, which will take place under the EC Regulation 2020/1683. The SCCS Committee assessed the safety of specific hair dye substances with potential health risks.

Therefore, 3 substances will be included in the Annex II, and hence will be banned in hair and eyelash dye products. These substances are:

  •  1,2,4-trihydroxybenzene (will take the entry 1642),
  • 4-amino-3-hydroxytoluene (entry 1643),
  • 2 -[(4-amino-2-nitrophenyl)-amino]-benzoic acid (entry 1644).

From 3rd of September 2021, hair and eyelash dye products containing these compounds shall not be placed on the Union market. Afterwards, from 3rd of June 2022 – there will be a ban on making them available on the market.

In addition, for 6 other hair dye substances there will be limited maximum concentrations as well as other conditions of use. Therefore, Annex III will include, inter alia, the following changes:

  • for the substances 2-Methoxymethyl-p-Phenylenediamine and 2-Methoxymethyl-p-Phenylenediamine Sulfate (entry 292), the conditions of use in products intended for colouring eyelashes have been added,
  • new entry 315Dimethylpiperazinium Aminopyrazolopyridine HCl with conditions of use, including maximum allowed concentration = 2%,
  • new entry 316Methylimidazoliumpropyl p-phenylenediamine HCl with conditions of use, incl. maximum allowed concentration = 2%,
  • new entry 317: HC Orange No. 6 together with the conditions of use, incl. maximum allowed concentration = 0.5%,
  • new entry 318Acid Orange 7 with conditions of use, incl. maximum allowed concentration = 0.5%,
  • new entry 319Tetrabromophenol Blue with conditions of use, incl. maximum allowed concentration = 0.2%,
  • new entry 320Indigofera Tinctoria Leaf, Indigofera Tinctoria Leaf Powder, Indigofera Tinctoria Leaf Extract and Indigofera Tinctoria Extract with conditions of use, incl. maximum allowed concentration = 25%.

Changes regarding the maximum concentrations used of these substances will apply from 3rd of June 2021. From 3rd of December 2021, it will be necessary to place appropriate warnings on packaging labels.

The full text of the regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1683&from=EN

And a corrigendum to the regulation with the renumbering of the substances: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1683R(01)&from=EN

Third story – a new UV filter

And last but not least – we have a new UV filter! Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate, because we are talking about it, has been assessed by the SCCS Committee as a safe UV-protective substance at a maximum concentration of 3%. In the opinion SCCS/1605/19 it was noted that this compound is a secondary amine and therefore is prone to nitrosation and the formation of nitrosamines. Hence, it should not be used in combination with nitrosating agents. Due to the lack of data, the toxicity of the ingredient after inhalation exposure has not been assessed, and therefore its safety in cosmetics causing exposure by inhalation has not been confirmed.

So far, there have been 31 substances listed in the Annex VI (the list of allowed UV filters). Now, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate will join to this list, in accordance with the Regulation 2020/1684, in the next – 32nd position. The conditions for this filter use are as follows:

  • maximum allowed concentration = 3%,
  • not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation,
  • do not use with nitrosating agents – maximum nitrosamine content: 50 μg/kg,
  • keep in nitrite-free containers.

Link to the SCCS opinion: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_227.pdf

Link to the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1684&from=EN

In conclusion, new amendments have been made to annexes II, III and VI of the cosmetics regulation. The new regulations apply to substances used in nail polishes, hair dyes and cosmetics with UV filters. I hope you like it and provided information will be valuable 🙂

Titanium dioxide – new SCCS opinion

Here is it! The new opinion of the Scientific Committee on Consumer Safety – SCCS No. SCCS/1617/20 concerning the safety of titanium dioxide was released on October 8th. The current opinions of the SCCS concerned mainly titanium dioxide as a UV filter in its nano-form (opinion no. SCCS/1516/13 of 2013 and opinion no. SCCS/1583/17 of 2018). Earlier, in 2000, there appeared an opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) with the number SCCNFP/0005/98. It confirmed the safety of using titanium dioxide as a UV filter at a maximum concentration of 25%. In contrast, the latest SCCS publication for the first time focuses on pigmented TiO2 materials. The current classification of titanium dioxide as Carc. 2 (suspected of causing cancer by inhalation) has caused quite a confusion in the cosmetics industry. Does the latest SCCS opinion dispel these concerns?

Let’s start with the versatile use of titanium dioxide in cosmetics. This raw material is a naturally occurring inorganic compound obtained from ilmenite, rutile and anatase. It is commonly used in cosmetics as a white pigment (so-called titanium white), an opacifier and a physical UV filter. For decades, TiO2 has been mainly used in makeup, sunbathing, hair, skin and oral care cosmetics. Taking into account the current legal status, titanium dioxide is included in:

  • Annex IV (list of colorants allowed in cosmetic products) of the Regulation 1223/2009 – Titanium dioxide (entry 143, CI marking: 77891). Conditions of use: purity criteria must be as set out in Commission Directive 95/45/EC (E 171),
  • Annex VI (list of UV filters allowed for use in cosmetic products) of the Regulation 1223/2009:

Except from cosmetic applications, this substance is also widely used in pharmacy and as a food colourant.

As various scientific and regulatory bodies have considered titanium dioxide as a potential human carcinogen after inhalation exposure, this has led to many challenges and discussions in the cosmetics industry. Following the recommendation of the RAC (The European Risk Assessment Committee), on October 4th, 2019, the European Commission adopted the classification of titanium dioxide as Carc. 2 (suspected of causing cancer, by inhalation; in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm). It should be remembered that this classification is based only on the inhalation route of exposure, and that no carcinogenic effects were found for oral and dermal exposure. In addition, carcinogenicity has been shown in animals (rats) but has not been confirmed by epidemiological studies in humans.

Therefore, the SCCS Committee took a closer look at the safety of using titanium dioxide in cosmetic products with inhalation exposure. So, what are the conclusions of the latest SCCS/1617/20 opinion?

  • The SCCS concluded that the use of pigmentary TiO2 in a conventional hair styling aerosol spray is safe up to a maximum concentration of 1.4% for general consumers and up to 1.1% for professional users – in this case: hairdressers;
  • The safety assessment showed that the use of titanium white in loose powders (in a typical face makeup application) is safe for the general consumer up to a maximum concentration of 25%.

These conclusions only apply to pigmentary TiO2 in products that may give rise to consumer exposure by the inhalation route (i.e. aerosol, spray and powder cosmetics). Moreover, the conclusions of the SCCS were drawn from a very selected group of cosmetic products based on only one type of TiO2 material (pigmentary, anatase, surface-treated). So what about the other uses of TiO2 pigmentary materials in other similar cosmetics? The SCCS is of the opinion that pigmentary titanium dioxide can also be considered safe in similar products. A prerequisite, of course, is that margins of safety are properly calculated as described in this SCCS Opinion. This margin of safety should be > 25 for both general and professional users (hairdressers) for cumulative use of different products.

In summary, the latest SCCS opinion provides information on the maximum and safe limit of titanium white concentrations in such products as: hair styling sprays and face powders. The focus was on this type of cosmetics due to inhalation exposure, which may lead to a potential carcinogenic risk of titanium dioxide. It seems that at the moment we can be calm about the use of titanium white in products that do not cause exposure to this substance by inhalation, e.g. nail polishes or eye shadows. Nevertheless, the cosmetics industry is likely to grapple with the bad reputation of titanium dioxide and the attribution of carcinogenic properties to, for example, solid products that do not pose such a risk. Will the cosmetics industry be forced to look for alternative “substitutes” for titanium dioxide? Time will tell…

I encourage you to read the full SCCS opinion at the link: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_238.pdf

New SCCS opinion regarding the safety of aluminium compounds

On April 2nd the final opinion of the Scientific Committee on Consumer Safety (SCCS / 1613/19) regarding the safety of aluminium compounds in cosmetics appeared. These substances have recently raised a lot of controversy and they are not well received by consumers quite often. The main reason may be that aluminium in high doses is a systemic toxic substance. There are also known some studies on the neurotoxic effect of aluminium, or the correlation with its use and breast cancer. Therefore, the SCCS Committee was asked to review data and issue an opinion on the safety of aluminium-based substances.

Aluminium is the most abundant metal in the earth’s crust, where it occurs, among others, in the form of silicates and aluminosilicates. Small amounts of this element can be also found in water. Aluminium-containing ingredients are widely used in the cosmetics industry in a variety of product categories. These include antiperspirants, deodorants, lipsticks and toothpastes – and they have been recognized by SCCS as the main sources of exposure to aluminium through cosmetic products. There are over 50 compounds containing aluminium on the cosmetics market. The most common aluminium compound in cosmetics is Aluminum Chlorohydrate, which is used in antiperspirants as an antiperspirant agent. Other popular aluminium salts used in this type of products include: Aluminum Chloride, Aluminum Zirconium Tetrachlorohydrex Gly or Aluminum Citrate. On the other hand, in lipsticks there are commonly used colloidal dyes obtained by reacting alumina with organic pigments. Afterwards, toothpastes may contain insoluble aluminium minerals as mild abrasives and rheology modifiers. In addition, aluminium is a part of many other raw materials widely used in cosmetics, e.g. cosmetic clays (Kaolin) contain hydrated Aluminium Silicate and Mica consists of Potassium Aluminium Silicate.

Many of aluminium compounds are regulated by the cosmetic Regulation 1223/2009. For example, in the Annex III (the list of substances which cosmetic products must not contain except subject to the restrictions laid down) we can find, among others: Aluminum Fluoride (position 34), Aluminium Zirconium Chloride Hydroxide Complexes and Aluminium Zirconium Chloride Hydroxide Glycine Complexes (position 50), as well as many colloidal aluminium dyes (so-called Aluminum Lakes, positions: 189, 190, 192). These substances can be used in cosmetics with certain restrictions on their maximum concentrations, type of products or other conditions of use. The list of permitted colourants, so the Annex IV, also contains a lot of aluminium compounds. There is both aluminium itself as a white colourant (CI 77000, position 117) and its compounds, e.g. white Aluminium Hydroxide Sulphate (CI 77002, position 118), Natural Hydrated Aluminium Silicate (CI 77004, position 119) and Aluminum Stearate (position 150), red Aluminum Silicate Coloured with Ferric Oxide (CI 77015, position 121), or green Cobalt Aluminum Oxide (CI 77346, position 131). It is worth adding that some aluminium dyes (Aluminum Lakes) were included in the list of banned substances – Annex II (Pigment Red 90: 1 Aluminum lake – position 1334, Pigment Red 172 Aluminum – position 1337) as substances in hair dye products.

Let’s return to the SCCS opinion 😉 The Committee believes that systemic exposure to aluminium via daily use of cosmetic products does not significantly increase the body burden to this element compared to other sources of exposure. In fact, the exposure of the population to aluminium is significantly higher via the digestive tract (drinking water, food). In addition, available research results show that aluminium compounds have a favourable toxicological profile. The acute oral toxicity of aluminium salts (bromide, nitrate, chloride and sulphate) is defined as moderate to low. Evidence from epidemiological studies does not confirm the carcinogenic effect of aluminium. Causal relationship of aluminium with neurodegenerative disorders such as Alzheimer’s disease has also not been proven. What is more, aluminium compounds have been widely used in cosmetics for many years without damaging the skin. These substances generally have no irritating or allergenic effect. Of course, there are people who are extremely sensitive to the topical use of these substances, but considering how widespread their use is, SCCS considers it to be a rare phenomenon. In addition, aluminium compounds are poorly absorbed by the gastrointestinal tract in animals and humans, and they are also characterized by very low bioavailability and dermal absorption (only 0.00052% – according to the SCCS assumption). Therefore, all described studies results support aluminium as a safe cosmetic raw material.

To sum up, SCCS confirmed the safety of using aluminium compounds in antiperspirants, as well as other types of cosmetics, such as lipsticks and toothpastes. According to SCCS, aluminium compounds are safe ingredients in cosmetics up to the following maximum concentrations (calculated as aluminium): 10.60% – in spray deodorants or spray antiperspirants, 6.25% – in non-spray deodorants and non-spray antiperspirants, 2.65% – in toothpastes, 0.77% – in lipsticks. You can read the full SCCS opinion at the following link: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_235.pdf

So how will it be? Have you become convinced of aluminium compounds as cosmetic ingredients or will you still avoid them? 😉

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