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On May 26^th, 2021, the COMMISSION REGULATION (EU) 2021/850 was published, amending Annexes II, III, IV and VI of the “cosmetic regulation” (1223/2009). The changes concern the conditions of use of titanium dioxide and salicylic acid, as well as the extension of Annex II by new prohibited substances. The entire Regulation can be found at the link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0850&from=EN

And you can read about the details of the changes in the post below 🙂

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TiO₂ – the story continues…

The aforementioned SCCS opinion has been reflected in cosmetic legislation, thus – in changes to Regulation 1223/2009. So, what are the changes regarding the use of titanium dioxide in cosmetics?

• Firstly, apart from Annex IV (colourant) and VI (UV filter), titanium dioxide is also included now in the Annex III (the list of substances which cosmetic products must not contain except subject to the restrictions laid down) in the entry 321. Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm can be used in the following products:

a) Face products in loose powder form – at a maximum concentration of 25%, only in the pigmentary form;

b) Hair aerosol spray products – at a maximum concentration of 1.4% for general consumers and 1.1% for professional use, only in pigmentary form;

c) Other products – not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.

• Secondly, the conditions of TiO₂ use as a colourant have changed (Annex IV). In addition to the purity requirements of this raw material, the following entry has been added to the position 143: “titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No [321]”.
• Finally, there is a change to Annex VI (list of UV filters allowed for use in cosmetic products), which also includes TiO₂, in entry 27. It has been also added here that titanium dioxide in powder form containing at least 1% of particles with an aerodynamic diameter ≤ 10 μm must be used in accordance with Annex III.

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Salicylic acid

Salicylic acid is another substance from the disgraceful CMR 2 category, which I wrote about here:https://www.cosmeticscare.eu/en/new-year-new-changes/

The latest changes for salicylic acid use have been implemented in Annex III, entry 98. Next to rinse-off hair products (a) and other products except: body lotions, eye shadows, mascaras, eyeliners, lipsticks, roll-on deodorants (b), the possibility of using this acid was added in the mentioned (c):

The maximum concentration of salicylic acid in “category c)” cosmetics is 0.5%. Other conditions of use, including non-use in products for children under 3 years of age, in cosmetics with inhalation exposure and in the oral cavity, remain the same. It is worth noting that the maximum permitted concentrations of salicylic acid indicated in this annex cover all applications of this substance in a ready product. In other words, the total concentration of salicylic acid in the cosmetic (e.g. as a preservative and keratolytic substance) should be taken into account.

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New CMR substances

To sum up, the new changes in the cosmetic law concern: changes in the conditions of use of titanium dioxide and salicylic acid, as well as new prohibited substances for use in cosmetics. I know from certain sources that these are not the only changes this year. So, I encourage you to check the blog, because we will keep our finger on the pulse 🙂

Changes are underway for manufacturers of nail polishes, hair dyes and sunscreens. Recently, on the 12^th 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 🙂

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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 3^rd 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

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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 3^rd of September 2021, hair and eyelash dye products containing these compounds shall not be placed on the Union market. Afterwards, from 3^rd 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 315: Dimethylpiperazinium Aminopyrazolopyridine HCl with conditions of use, including maximum allowed concentration = 2%,
• new entry 316: Methylimidazoliumpropyl 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 318: Acid Orange 7 with conditions of use, incl. maximum allowed concentration = 0.5%,
• new entry 319: Tetrabromophenol Blue with conditions of use, incl. maximum allowed concentration = 0.2%,
• new entry 320: Indigofera 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 3^rd of June 2021. From 3^rd 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

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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 – 32^nd 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 🙂

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 8^th. 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:
  • Position 27: Titanium dioxide; the maximum concentration in ready for use preparation is 25.0%;
  • Position 27a: Titanium dioxide (nano); the maximum concentration in ready for use preparation is also 25.0%. In addition, there are numerous other conditions for the use of nano-titanium dioxide, which can be read here: https://www.cosmeticscare.eu/en/titanium-dioxide-climbazole-and-a-new-preservative-changes-in-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 4^th, 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