September is the ‘back to school’ month, which for us means catching up on the latest SCCS opinions on substances used as cosmetic ingredients. In this article, we are going to summarize them so that you can stay updated on the latest news. In particular, we are going to focus on the findings concerning Methyl salicylate, Homosalate, Acid Yellow 3, and HAA299 (nano).
Methyl salicylate – CAS No. 119-36-8
At present, Methyl salicylate is not restricted under the EU Cosmetics Regulation, and it is used in cosmetics as a fragrance component and as a flavoring and soothing agent in oral hygiene products.
With the view of the classification of Methyl salicylate as a CMR substance Toxic for Reproduction Category 2 and Skin sensitizer Category 1B, on June 24-25, 2021, the SCCS issued a Preliminary Opinion on the safety of the substance in cosmetic products, indicating maximum concentration levels for various product categories. To find the limits stated in the SCCS opinion, you can consult COSlaw.eu’s Watch-out database.
Moreover, “the SCCS also notices that wintergreen oil that is used in cosmetic products may contain up to 99% methyl salicylate. Therefore, when calculating the content of methyl salicylate in a cosmetic product, any fraction coming from wintergreen oil should also be considered” (SCCS, 2021).
We can expect that the European Commission will restrict the use of Methyl salicylate according to the above-mentioned opinion.
Homosalate – CAS No. 118-56-9
Homosalate is used in cosmetic formulations as a UV filter up to a maximum concentration of 10% in the finished product – as specified in entry 3 of Annex VI to the EU Cosmetics Regulation.
Due to its potential endocrine-disrupting properties, in 2019, the European Commission included Homosalate in a list of substances that had undergone a priority safety assessment procedure. In the Final Opinion 1622/20, released on June 24-25, 2021, the SCCS concluded that the use of Homosalate as currently prescribed in the EU Cosmetics Regulation is not safe: the Scientific Committee believes that “the use of Homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 0.5%” (SCCS, 2021).
We can expect that the European Commission will modify the restrictions concerning Homosalate to align with the SCCS opinion.
Should you be interested in deepening your knowledge on endocrine disruptors in cosmetic products, you can read the latest COSlaw.eu article freely available here.
Acid Yellow 3 C054 – CAS No. 8004-92-0
Acid Yellow 3 is included in Annex IV to the EU Cosmetics Regulation, thus it is allowed to use it in non-oxidative hair coloring products as a colorant, up to a maximum on-head concentration of 0,5%. The SCCS Final Opinion 1631/21 confirmed that this use is safe for human health.
Another topic of great interest within the cosmetics industry is the use of nanomaterials: the European Union is working on the adoption of a new horizontal definition of nanomaterial, to align all sectors. At present, the definition included in the EU Cosmetics Regulation differs from the one adopted in other legislations – for example, the REACH Regulation – and this might create discrepancies.
The SCCS is currently assessing the safety of several substances in nano form. In this context, the conclusions of the Safety Committee on the following ingredients have been published in the past few months:
- Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano);
- Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano);
- HAA299 (nano).
As for the Platinum and Gold nanomaterials, in the Final Opinions 1630/21 and 1629/21, issued in June 2021, the SCCS concluded that it was not possible to carry out the related safety assessments due to the lack of essential information, therefore, further investigations on these substances are required.
In the SCCS Preliminary Opinion on HAA299 (nano) published on July 22, 2021, the SCCS declared that, due to its low dermal absorption and systemic toxicity, the use of HAA299 (nano) as a UV filter is safe up to a maximum concentration of 10% in dermally applied cosmetics. Furthermore, this limit is considered safe for HAA299 in its bulk form as well. In conclusion, we can assume that in the coming times, both HAA299 (nano) and HAA299 will be added to the list of UV filters allowed to be used in cosmetics (Annex VI to the EU Cosmetics Regulation).
The COSlaw.eu series Keep up with cosmetics news! on SCCS meetings precisely addresses the current SCCS mandates and the expected opinions – Find out the Part 1 here.
With its RP and consultancy services, Obelis can help you ensure your cosmetics are compliant with the latest novelties of the EU regulatory framework. Contact us at your earliest convenience to discover more on how we can swiftly place your products on the EU market.
- EC. (2021). SCCS Opinion on Methyl salicylate. Retrieved on 21/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_255.pdf
- EC. (2021). SCCS Opinion on Homosalate. Retrieved on 21/09/2021 from /https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_244.pdf
- EC. (2021). SCCS Opinion on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No. 305-897-5) Submission II. Retrieved on 21/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_253.pdf
- EC. (2021). SCCS Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano). Retrieved on 21/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_252.pdf
- EC. (2021). SCCS Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano). Retrieved on 21/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_251.pdf
- EC. (2021). SCCS Opinion on HAA299 (nano). Retrieved on 21/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_256.pdf