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 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 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 🙂