The adoption of this regulation is expected in the fourth quarter of 2023. This article will shed light on the impending changes and their implications for beauty brands and consumers.
Important highlights from the draft Regulation:
- The draft Regulation has set restrictions on the concentration of Vitamin A compounds (including Retinol, Retinyl Acetate, Retinyl Palmitate) in cosmetic products. In body lotions, the limit is now 0.05%, while in other leave-on and rinse-off products, it is set at 0.3% (in retinol equivalent).
- Kojic Acid is now only permitted at 1% in face and hand products.
- Genistein and Daidzein, which were previously not subject to any regulations, will now be restricted to concentrations of 0.007% and 0.02%, respectively.
- The UV filter 4-Methylbenzylidene Camphor, currently authorised up to 4%, is banned.
- The use of Alpha-Arbutin is now limited to a maximum concentration of 2% in face creams and 0.5% in body lotions, while Arbutin can only be used up to 7% in face creams.
- The maximum concentration of Triclocarban is now set at 0.2% in all cosmetic products, except for mouthwashes. Triclosan is limited to 0.3% in toothpastes, hand soaps, body soaps/shower gels, deodorants (excluding sprays), facial powders, blemish correctors, and nail products used to clean fingernails and toenails before applying artificial nail systems. Both Triclocarban and Triclosan are prohibited in toothpastes for children under 6 years old.
- Products must comply with the new rules within 9 to 24 months, depending on the case.
Retinol and Vitamin A Compounds
One of the key components of this draft regulation focuses on Retinol and other Vitamin A derivatives, including Retinyl Acetate and Retinyl Palmitate. Contrary to rumors of an outright ban, the regulation primarily proposes usage restrictions rather than a complete prohibition. The restrictions will vary depending on the type of product, with body lotions allowed to contain 0.05% Retinol Equivalent (RE), while other leave-on and rinse-off products can contain up to 0.3% RE. Additionally, products containing these ingredients must include the following mandatory label:
“Contains Vitamin A-related compounds, which contribute to your daily intake of Vitamin A.”
This regulation aims to address the potential health risks associated with excessive exposure to Vitamin A through cosmetic products.
Kojic Acid, Genistein and Daidzein
Kojic Acid, a popular skin-lightening agent, and Genistein and Daidzein, used as skin conditioners and antioxidants, will have certain restrictions imposed. However, they will not be completely prohibited. The draft regulation sets specific limits on these ingredients, allowing Genistein to be used in cosmetic products up to 0.007% and Daidzein up to 0.02%. Kojic Acid will be permitted in face and hand products at a concentration of up to 1%, but it will not be included in other products.
The draft regulation takes a cautious approach towards 4-Mthylbenzylidene Camphor, a commonly used UV filter in cosmetic products. It emphasises that this substance should no longer be authorised for use in cosmetic products due to potential health risks. As a result, it will be completely prohibited in cosmetic products and included in Annex II of the Regulation.
- DSM-firmenich, which previously included this ingredient in their portfolio, made the proactive decision to remove it long ago due to environmental concerns, even before the potential risks to humans became more evident. They offer various alternatives for this recently banned UV filter, such as Parsol® EHT and Parsol® Shield. Using their innovative sunscreen optimizer™ tool, they provide a range of sun filter combinations with indicated levels based on your desired SPF protection, cost considerations, and ecological impact. This proprietary tool was developed internally to assist in selecting the right ingredients.
- Ingredients supplier Symrise used to offer 4MBC as an oil soluble UVB filter. They now recommend using Neo Heliopan® EHT as an alternative that is even more effective in the UVB range. Neo Heliopan® BMT can be an alternative as well that delivers additional UVA absorbance, and Neo Heliopan® Hydro USP can also be used to achieve your SPF, but it is water soluble and thus more suitable to make lighter formulations.
Alpha-Arbutin and Arbutin
The draft Regulation imposes limitations on the usage of Alpha-Arbutin and Arbutin, which are commonly employed as agents for skin lightening and conditioning. The European Commission intends to distinguish between facial and body products, permitting the inclusion of Arbutin in face creams at concentrations of up to 7%, Alpha-Arbutin at concentrations of up to 2% in face creams, and 0.5% in body lotions. In order to minimise health risks, the levels of Hydroquinone in formulations containing Alpha-Arbutin should be kept as low as possible and should not exceed trace amounts that are unavoidable.
Triclocarban and Triclosan
The use of Triclosan and Triclocarban as preservatives in cosmetic products has been carefully evaluated by the draft regulation. In order to ensure consumer safety, new restrictions have been imposed on these substances. Triclocarban will be permitted in all cosmetic products, except mouthwash, at concentrations up to 0.2%. Similarly, Triclosan will have a limit of 0.3% in specific products, including toothpaste, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders, blemish concealers, and nail products for cleaning fingernails and toenails. However, any other uses of Triclosan will be prohibited.
What does this mean for you as a beauty brand?
For beauty brands, the upcoming EU regulation will bring significant changes to the skin care industry, impacting the use of various key ingredients. It's crucial for you to take a proactive approach in assessing your product formulations to ensure compliance with the new restrictions. By acting early, you not only demonstrate a commitment to safety but also ensure that you'll be prepared to meet the deadlines specified in the Regulation (see below).
As consumers, this Regulation represents a positive step towards enhanced safety and transparency in skin care products. With stricter limitations on certain ingredients, it's important to stay informed about the products you use and make choices that align with your preferences and promote skin health.
In this ever-changing world of beauty, it's crucial for the industry to adapt, prioritise consumer safety, and push the boundaries of skin care innovation to meet regulations and exceed customer expectations. Need help finding alternative ingredients for your formulations? Look no further than Covalo.com! With a database of over 80k ingredients, you'll find the perfect ingredient for your products with just a few clicks.
Transition periods will be granted to allow the industry to adapt to the new requirements:
1. For 4-Methylbenzylidene Camphor
- 12 months for the placing compliant product on the market (Q4 2024)
- 24 months for removing non-compliant product from the market (Q4 2025)
2. For Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin:
- 9 months for the placing compliant product on the market (Q3 2024)
- 18 months for removing non-compliant product from the market (Q2 2025)
3. For Retinol, Retinyl Acetate and Retinyl Palmitate:
- 18 months for the placing compliant product on the market (Q2 2025)
- 36 months for removing non-compliant product from the market (Q4 2026)
4. For Triclosan and Triclocarban:
- 8 months for the placing compliant product on the market (Q3 2024)
- 17 months for removing non-compliant product from the market (Q2 2025)
- Draft Regulation part 1
- Draft Regulation part 2
- Cosmeservice, "Future restrictions on Retinl, Kojic Acid, Triclosan and 4-Methylbenzylidene Camphor". Available online. Accessed 23 October 2023.
- Cosmeticobs, "Notification from the European Commission: ban on a UV filter, restrictions on several endocrine disruptors". Available online. Accessed 23 October 2023.