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Deoxyarbutin ban and dihydroxyacetone regulations

Summer is in full swing, and the European Commission doesn’t laze around and introduces further changes to the cosmetic law. Thus, the Commission Regulation (EU) 2021/1099 of 5 July 2021 amending Annexes II and III to the Regulation (EC) No 1223/2009 was published. The changes concern two ingredients: Deoxyarbutin (INCI: Tetrahydropyranyloxy Phenol) and Dihydroxyacetone (INCI: Dihydroxyacetone). Details below.


Deoxyarbutin

Deoxyarbutin (INCI: Tetrahydropyranyloxy Phenol) has been used as a skin lightening agent so far, e.g. in face creams. It is a derivative of ß-arbutin, obtained by removal of hydroxyl groups from the glucose side-chain of ß-arbutin.

This compound has not been covered by the Regulation (EC) No 1223/2009 so far. However, the SCCS Scientific Committee concluded that, due to safety concerns, the use of deoxyarbutin in face creams up to 3% cannot be considered safe (opinion no. SCCS/1554/15). This is due to the fact that deoxyarbutin releases Hydroquinone. On the other hand, Hydroquinone is a prohibited substance for use in cosmetics (Annex II of the Regulation 1223/2009, item 1339), with the exception of position 14 in the Annex III (it may be used only in artificial nail products under certain conditions).

All this made Tetrahydropyranyloxy Phenol (deoxyarbutin) included in the Annex II, under entry 1657. In brief, this substance will be banned for use in cosmetic products from July 26th, 2021.

Link to the SCCS opinion: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_183.pdf


Dihydroxyacetone

Another substance that will be regulated is Dihydroxyacetone (INCI: Dihydroxyacetone). It is a well-known tanning compound with a long history of use in self-tanning products. Every sun-kissed skin lover knows it for sure 😉

So far, the use of dihydroxyacetone has also not been regulated by cosmetic law. In opinion SCCS/1612/19, the SCCS Committee considered dihydroxyacetone safe to use as a hair colouring ingredient in leave-on (non-oxidative) applications at a maximum concentration of 6.25%. In addition, the use of dihydroxyacetone (in hair dyes) described above together with the use of self-tanning lotion and face cream containing dihydroxyacetone at a maximum concentration of 10% was also considered safe.

Based on the conclusions of the SCCS, dihydroxyacetone will be added to the Annex III of the Regulation (EC) No 1223/2009 in a new position – 321. The conditions of use of dihydroxyacetone in cosmetics will be limited to those described in the SCCS opinion, i.e. it will only be used in:

– non-oxidative hair dye products, up to a maximum concentration of 6.25%;

– self-tanning products, at the maximum concentration = 10%.

The regulation provides for a 6-month transition period for the introduction and a 9-month period for making products with this component available on the market. From 26 January 2022, products containing that substance and not complying with the restrictions shall not be placed on the Union market. Afterwards, from 22 April 2022, those products cannot be made available on the market in the Union.

You can read the SCCS opinion on dihydroxyacetone at the link: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_234.pdf


As you can see, the changes in the cosmetic law are still progressing. Looking at the intensive works of the SCCS and the European Commission, it can be concluded that there will be more and more of them 😉 And finally, I encourage you to read the new regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1099&from=EN

Further fate of titanium dioxide and salicylic acid

On May 26th, 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 🙂


TiO2 – the story continues…

Recently, there have been a lot of reports about titanium dioxide. Carc. 2 classification raised a lot of concern among consumers and triggered a need for an opinion by the SCCS on the safety of this substance in cosmetics. I wrote about the entire history of TiO2 and the details of the SCCS opinion from last year on my blog – you can read the post here: https://www.cosmeticscare.eu/en/titanium-dioxide-new-sccs-opinion/

Let us recall briefly what the main conclusions of the opinion SCCS/1617/20 were:

– 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%.

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). Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μmcan 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.

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):

– body lotions,

– eye shadows,

– mascaras,

– eyeliners,

– lipsticks,

– roll-on deodorants.

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.


New CMR substances

Finally, we are left with new substances known to be carcinogenic, mutagenic or toxic to reproduction (CMR), which were included in the list of prohibited substances. Now Annex II includes, among others: cobalt, methylmercuric chloride, diisohexyl phthalate, 2-methylimidazole and dibutylbis(pentane-2,4- dionato-O,O’)tin. The full list of new banned substances can be found at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0850&from=EN

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 🙂

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 🙂

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