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? 😉

New Year – new changes

The beginning of the New Year is a time of summaries, resolutions and changes, including those in cosmetic regulations. What changes in the cosmetics law will 2020 bring us? You can find it out from the below post 🙂

  • Salicylic Acid as hot potato topic

On November 27th, 2019Commission Regulation (EU) No. 2019/1966 introducing amendments to the Regulation 1223/2009 appeared. These changes largely concern the conditions of Salicylic Acid use in cosmetics.

Salicylic Acid, 2-hydroxybenzoic acid, belongs to the group of β-hydroxy acids (BHA) and occurs in the nature, including in willow bark and chamomile flowers. It is widely used in cosmetics as a preservative, keratolytic, anti-dandruff, masking, skin and hair conditioning agent.

Salicylic Acid is included both in the list of substances which cosmetic products must not contain except subject to the restrictions laid down (Annex III of the Regulation 1223/2009 – position 98) and on the list of allowed preservatives (Annex V, position 3, Salicylic Acid and its salts).

Classification of Salicylic Acid as a CMR (carcinogenic, mutagenic or toxic for reproduction) substance category 2, in accordance with the Regulation No. 1272/2008/EC (CLP), forced changes regarding the conditions of use of this substance in cosmetics. Category 2 CMRs are substances that are suspected to be carcinogenic to humans. Should therefore Salicylic Acid be on the list of banned substances in cosmetics (Annex II)? Not completely. Salicylic Acid meets the conditions described in the Article 15 of the Regulation 1223/2009, i.e.:

  • it was assessed by the Scientific Committee on Consumer Safety (SCCS),
  • SCCS found Salicylic Acid safe for use in cosmetic products.

Therefore, the SCCS Committee supported the safety of Salicylic Acid in its opinion no. SCCS/1601/18. The safety of the acid has been confirmed in applications other than as a preservative while maintaining the existing restrictions and concentrations, i.e. in rinse-off hair products at a maximum concentration = 3.0% and in other products at a concentration not exceeding 2.0%, except for body lotions, eye shadows, mascaras, eyeliners, lipsticks and roll-on deodorants. The SCCS opinion does not apply to oral products or spray products that may lead to exposure through inhalation. In addition, the SCCS Committee concluded that Salicylic Acid is irritating to the eyes and may potentially cause serious eye damage.

Considering the above properties of Salicylic Acid and the SCCS opinion, new restrictions of the acid use have been introduced, described in the Annex III, position 98 (uses other than as a preservative). Therefore, Salicylic Acid cannot be used in the following products:

  • body lotions, eye shadows, mascaras, eyeliners, lipsticks and roll-on deodorants,
  • ANY products for children under 3 years old (until now the use of acid in shampoos for children under 3 years of age has been allowed),
  • products that may lead to exposure of the user’s lungs via inhalation (e.g. spray cosmetics),
  • oral care cosmetics.

Changes have also been made to the Annex V (position 3 – use of Salicylic Acid as a preservative). Here also the current maximum concentration (0.5% as acid) and conditions of use have been maintained, however, new restrictions, similar to those from the Annex III, have been added:

  • not to be used in products for children under 3 years of age (in any products, the use of acid in shampoos for children under 3 years of age has been allowed so far),
  • not to be used in oral products,
  • not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. 

The above changes regarding Salicylic Acid will come into force on May 1st, 2020.

In the opinion SCCS/1601/18 it was also noted that studies are currently underway on the potential for endocrine disrupting of Salicylic Acid. The results of these studies may be significant for further restrictions on the use of Salicylic Acid in cosmetics. So, the time will tell us how the further history of Salicylic Acid in the cosmetics industry will unfold…

  • New prohibited substances

Changes will also take place in the Annex II (list of prohibited substances in cosmetic products). Here, due to the aforementioned CLP Regulation, compounds classified as CMR must be included in the list of prohibited substances. Annex II will therefore be extended by another 30 compounds and will already contain 1641 items. New banned substances will include: Phosmet, Potassium permanganatePropiconazole, Tetramethrin, 1-Vinylimidazole, Phenol, dodecyl-, branched, Acetochlor, Glass microfibres of representative compositionDicyclohexyl phthalate and tert-Butyl hydroperoxide.

Some of these substances are already prohibited from December 18th, 2019, while others will be banned from May 1st, 2020.

As it can be seen, there is a tendency to systematically include subsequent CMR substances in the list of prohibited substances of the Regulation 1223/2009. Due to the classification of Salicylic Acid as a CMR substance, it was necessary to collect data from new studies, waiting for the opinion of SCCS, and then implement further restrictions under the conditions of use of this compound in cosmetics. We already know about such significant changes in the cosmetics law at the very beginning of the new year 2020. I wonder what will be the next ones and what this year will bring for the cosmetics sector 🙂

Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1966&from=EN

Link to the website with SCCS opinions concerning Salicylic Acid: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf

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