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UV filters and formaldehyde donors

Summer is in full swing, so the perfect time to write about UV filters 🙂 We are awaiting changes in the cosmetic law regarding the use of two UV filters: Benzophenone-3 and Octocrylene. That’s not all, because the new regulations will also apply to substances that release formaldehyde. More details can be found below.


Benzophenone-3 and Octocrylene

Caution, manufacturers of sunscreen cosmetics: the conditions of using the above-mentioned UV filters are changing. On July 7th, the Commission Regulation (EU) 2022/1176 appeared, introducing changes to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products with regard to the use of Benzophenone-3 and Octocrylene in cosmetic products. What’s going on and where do these changes come from?

It all started with concerns about the potential endocrine disrupting properties that Benzophenone-3 and Octocrylene could potentially induce. Both Benzophenone-3 and Octocrylene are included in the Annex VI (list of permitted UV filters) of the Regulation 1223/2009, in positions 4 and 10, respectively. The maximum permitted concentration of Benzophenone-3 in cosmetics was 6% so far, and 10% for Octocrylene.

Meanwhile, the Scientific Committee on Consumer Safety (SCCS) concluded in its opinion SCCS/1625/20 that Benzophenone-3 is not safe for consumers when used as a UV filter at the current maximum concentration of 6% in sunscreen products. This assessment applies to cosmetics in the form of a body cream as well as a sunscreen propellant spray or pump spray. However, the safety of using this UV filter has been confirmed up to the maximum concentration:

  • 6% in face creams, hand creams and lipsticks (where due to the smaller application area the exposure is lower),
  • 0.5% in cosmetic products to protect the formulation of the cosmetic,
  • 2.2% in body creams and in propellant sprays and in pump sprays, if there is no additional use of Benzophenone-3 at a concentration of 0.5% in the same formulation in order to protect the composition of the cosmetic.

The SCCS further concluded that when Benzophenone-3 is also used at a concentration of 0.5% in the same formulation, the level of this UV filter should not exceed 1.7% in body creams and in propellant sprays and in pump sprays.

Therefore, the use of Benzophenone-3 will be limited to the maximum concentrations proposed by the SCCS. According to the new requirements, Benzophenone-3 can be used taking into account the following maximum concentrations:

  • 6% – in face, hand and lip products, excluding propellant and pump spray products (IMPORTANT! If 0.5% Benzophenone-3 is used to protect the product formulation, the levels used as a UV filter must not exceed 5.5% – we just subtract 0.5% from the initial concentration of 6%);
  • 2.2% – in body care products, including propellant and pump spray products (IMPORTANT! If 0.5% Benzophenone-3 is used to protect the formulation of the product, the levels used as a UV filter must not exceed 1,7%);
  • 0.5% – in other products.

With regard to Octocrylene, SCCS issued an opinion SCCS/1627/21 confirming the safety of using this UV filter up to a maximum concentration of 10% in cosmetic products when used individually. However, for products such as a sunscreen propellant spray, Octocrylene can be considered safe up to a concentration of 9% – considering the use together with a face cream, hand cream or lipstick containing 10% of this substance.

Thus, the modification of Octocrylene conditions of use is to add a new category of cosmetics to the entry 10, Annex VI. Namely, propellant spray products were included, where the maximum allowed concentration of Octocrylene will be 9%. The use of this filter in other types of products will remain unchanged, where the max. concentration of 10% will continue apply.

With regard to the transitional periods to this regulation, we have time until: January 28th, 2023 – for placing cosmetics on the market, and until July 28th, 2023 for making them available on the market.

To learn about the new regulation, please visit the link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1176&qid=1657880385749&from=en

I would also like to refer you to the SCCS opinions: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_247.pdf

https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdf


Formaldehyde donors

One more change awaits us, related to formaldehyde donors, i.e. substances capable of releasing formaldehyde. The preamble of the Annex V to the Regulation 1223/2009 on cosmetic products will change here.

According to the new Commission Regulation (EU) 2022/1181 of 8 July 2022, the aforementioned preamble, point 2 is replaced by the following: „All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning <releases formaldehyde> where the total concentration of formaldehyde released in the finished product exceeds 0,001% (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.”.

What has changed compared to the previous preamble? The version in force so far included the requirement to apply the warning “releases formaldehyde” for 0.05% of the released formaldehyde, so this concentration has been significantly reduced. In scientific opinion No. SCCS/1632/21, the SCCS Committee concluded that the current threshold of 0.05% (500 ppm) does not sufficiently protect consumers allergic to formaldehyde. In order to protect the vast majority of these users, the current threshold for the labeling requirement has therefore been lowered to 0.001% (10 ppm).

In this case, the transition periods for adapting to the new changes are much longer: July 31, 2024 – for placing on the market and July 31, 2026 – for making the products available on the market.

You can find the link to the regulation at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1181&from=PL

And the SCCS opinion is here: https://health.ec.europa.eu/system/files/2021-05/sccs_o_254_0.pdf


To sum up, significant changes in the cosmetic law are awaiting us. The first ine concerns the new conditions of use of two UV filters: Benzophenone-3 and Octocrylene. Additional categories of cosmetics in which these filters can be used are listed, along with new maximum allowable concentrations. Another change is the lowering of the threshold for the concentration of formaldehyde released from its donors from 500 to 10 ppm in the preamble to Annex V. This is related to the requirement to display the warning “releases formaldehyde” on the labels of cosmetics where the concentration of formaldehyde released from its donors exceeds the mentioned 10 ppm.

New conditions of use of Methyl-N-methylanthranilate

The Commission Regulation (EU) 2022/135 of 31 January 2022 was published in the Official Journal of the European Union, changing the conditions of use of Methyl-N-methylanthranilate in cosmetic products. What is this substance and what are the new regulations? I invite you to read the new post 🙂


Methyl-N-methylanthranilate

Methyl-N-methylanthranilate (M-N-MA) is a methyl ester resulting from the condensation of the carboxy group of N-methylanthranilic acid with methanol. In cosmetics, it acts as a fragrance. It is used in fine fragrances, shampoos, soaps and many other types of cosmetics. Until now, M-N-MA has not been subject to any restrictions of use under the Regulation (EC) No 1223/2009.

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.

In the light of the above opinions of the SCCS, the Regulation 1223/2009 was amended. The substance Methyl-N-methylanthranilate was included in Annex III (the list of substances with restrictions of use). From now, M-N-MA takes the position 323 in the mentioned appendix. This component can only be used in:

  1. Leave-on products – at a maximum concentration of 0.1%,
  2. Rinse-off products – at a maximum concentration of 0.2%.

Other conditions of use M-N-MA in the above products are:

  • Do not use with nitrosating agents,
  • Maximum nitrosamine content: 50 μg/kg,
  • Keep in nitrite-free containers.

In addition, when used in leave-on cosmetics, M-N-MA should not be used in sunscreen productsa and products marketed for exposure to natural or artificial UV light.

The transitional periods provided in the regulation are as follows: August 21, 2022 – for placing cosmetics on the market, and November 21, 2022 – for making them available on the market.


You can find the new regulation at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0135&from=EN

The opinions of the SCCS can be found at the following links: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_075.pdf

https://ec.europa.eu/health/system/files/2021-11/sccs_o_242.pdf

Lilial and zinc pyrithione banned

It is finally here! The long-announced and awaited regulation prohibiting the use in cosmetic products, incl. lilial (INCI: Butylphenyl Methylpropional) and zinc pyrithione (INCI: Zinc Pyrithione). Therefore, Comission Regulation (EU) 2021/1902 of 29 October 2021 amends Annexes II, III and V to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council with regard to the use of certain CMR substances – classified as carcinogenic, mutagenic or toxic to reproduction, in cosmetics.


Lilial

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 1st, 2022.


Zinc pyrithione

Another substance that so far has been widely used in the cosmetics industry and has been classified to the CMR category is zinc pyrithione. It has been a popular anti-dandruff ingredient used in hair shampoos, regulating sebum production, antibacterial and anti-itching.

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.


Other prohibited substances and changes

In addition to the above-mentioned key substances for the cosmetics industry, Regulation 2021/1902 also includes a number of other compounds in Annex II, such as: Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), 2-methoxyethyl acrylate, dichlorodioctylstannane and bis(α,α-dimethylbenzyl) peroxide. Therefore, new entries will be added to the list of banned substances – from 1658 to 1680.

What else is introduced by this Regulation?

  • In entry 24 in Annex III, the zinc pyrithione has been renumbered. It was: “Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8)“. Now it is: “Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (Annex II, entry X)“.
  • In entry 51 of Annex V, new conditions for the use of Sodium Hydroxymethylglycinate have been added: “Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w”.

The entire new regulation will come into force on 1st March 2022.

You can read the content of this legal act at the link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1902&from=EN

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