admin

The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion no. SCCS/1455/11 that there are no safety concerns for the use of M-N-MA up to 0.2% in rinse-off products. However, it was noted that M-N-MA is phototoxic. Therefore, the SCCS Committee concluded that the risks associated with the use of this substance in sunscreen products or cosmetics (including fragrances) applied to body surfaces exposed to light cannot be excluded. Since M-N-MA is a secondary amine, it is susceptible to nitrosation. Hence, the SCCS emphasized that Methyl-N-methylanthranilate should not be used in combination with nitrosating agents and that the nitrosamine content should be less than 50 μg/kg.

In another scientific opinion no. SCCS/1616/20 of 16 October 2020, the SCCS Committee concluded that M-N-MA should not be used in sunscreen products and cosmetics exposed to natural or artificial UV radiation. However, with regard to other cosmetics, the use of M-N-MA was found to be safe at a concentration of up to 0.1% for rinse-off products and up to 0.2% for leave-on products.

Lilial is one of the 26 fragrance allergens that is known under the names Butylphenyl Methylpropional, p-BMHCA, 2-(4-tert-butylbenzyl) propionaldehyde or Lily Aldehyde. It is an organic chemical compound from the group of aromatic aldehydes. It is characterized by a floral scent, reminiscent of cyclamen or lily of the valley. Until now, it has been one of the most popular allergens and has been found in many synthetic fragrances.

However, lilial has been shown to be toxic to reproduction. According to the CLP Regulation, it is classified as a CMR substance: Repr. 2, H361 – Suspected of damaging fertility or the unborn child. This compound was assessed by the SCCS Committee, which concluded that Butylphenyl Methylpropional cannot be considered as safe: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_213.pdf

In connection with the above, Butylphenyl Methylpropional, under the Regulation 2021/1902, was included in the Annex II, i.e. on the list of substances banned in cosmetic products (new entry – 1666). Therefore, the entry 83 was deleted from the Annex III – the list of substances restricted by the Regulation 1223/2009, where lilial has been previously found. The ban of placing and making products with lilial available on the market will apply from March 1^st, 2022.

Zinc Pyrithione is currently listed in entry 8 of Annex V to Regulation 1223/2009 as a preservative allowed in rinse-off hair products in a concentration not exceeding 1% and in other rinse-off products that are not oral hygiene products at a concentration of up to 0.5%. In addition, this compound appears in entry 101 of Annex III as a restricted substance: permitted only when used for purposes other than as a preservative – in leave-on hair products at a concentration of max. 0.1%.

The substance is currently classified as CMR category 1B (toxic for reproduction). In the opinion No. SCCS / 1614/19 of March 2020, the SCCS concluded that Zinc Pyrithione can be considered safe when used as an anti-dandruff ingredient in rinse-off hair products at a maximum concentration of 1%: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_236.pdf

However, the above SCCS opinion has not demonstrated that there are no suitable alternative anti-dandruff substances for use in rinse-off hair products. As a result, Zinc Pyrithione will disappear both from the list of restricted substances (Annex III) and from the list of preservatives allowed in cosmetic products (Annex V). Instead, it will be included in the list of prohibited substances and will be listed as entry 1670 in Annex II.

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 26^th, 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 – 322. 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