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


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.

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