In early April 2024, Regulation (EU) 2024/996 was published, amending Cosmetic Regulation (EC) 1223/2009, specifically the following annexes:
- Annex II (substances prohibited in cosmetic products)
- Annex III (substances that cosmetic products cannot contain except under established restrictions)
- Annex V (preservatives permitted in cosmetic products)
- Annex VI (list of ultraviolet filters permitted in cosmetic products)
The affected substances include vitamin A and its derivatives, Arbutin, and Alpha-arbutin, as well as certain substances of concern due to their potential endocrine-disrupting properties, such as Triclosan, Kojic Acid, or 4-Methylbenzylidene Camphor (4-MBC), among others.
In today’s article, we will explore the reasons behind these changes, case by case, as well as the transitional periods to comply with this regulation.
Why have these changes occurred?
The impact of this regulation on cosmetics is undeniable: product reformulation, concentration adjustments, search for alternatives, updating of product safety dossiers (PIFs), new registrations…
But the most important thing is to understand that they arise to fulfil the basic premise of Cosmetic Regulation (EC) 1223/2009: to ensure consumer safety.
Therefore, after evaluating various studies, the Commission has decided to include ingredients that were not previously regulated, further restrict the concentrations of others, or even prohibit their use.
Let’s now examine, case by case, the substances involved in this regulatory change.
What happens with retinol in cosmetics?
Vitamin A, better known as Retinol, is widely used in beauty products for its anti-ageing properties.
If we go back to October 6, 2016, the Scientific Committee on Consumer Safety (SCCS) determined that the use of vitamin A and its derivatives was safe. However, the main issue is that the maximum daily intake limit could be exceeded, considering consumers’ overall exposure to this vitamin.
In October 2022, after reevaluating their safety and that of their derivatives, namely, retinol, retinyl palmitate, and retinyl acetate, the following safe limits were established (expressed in retinol equivalents or RE):
– 0.05% in body lotions (leave on)
– 0.3% in other products that remain on the skin (leave on) and in rinse-off products.
While it is true that the contribution of vitamin A from cosmetics is tiny, it is estimated that 5% of the population is exposed to it through other means, such as food or dietary supplements.
Therefore, due to this possibility, the SCCS considered that there was a potential risk to human health. Hence, in addition to the limitation, the following warning phrase must be included: “This product contains vitamin A. Consider your daily intake before using it” in all cosmetics containing retinol, retinyl palmitate, and retinyl acetate.
Arbutin and alpha-arbutin, are now regulated substances!
Yes, these skin whitening and conditioning agents were not included in any of the annexes of Regulation 1223/2009. However, the SCCS decided to reevaluate them because hydroquinone is released during their use.
Recall that hydroquinone is prohibited in cosmetics (annex II, entry 1339), except for use in artificial nail systems, where it is limited to 0.02% (annex III, entry 14).
In May and March 2015, their respective evaluations were published, and in both cases, they were considered safe as long as the concentration restrictions were met.
The problem was that their combined use was not evaluated at that time, nor with other hydroquinone releasers.
On January 31, 2023, the SCCS concluded that it was necessary to include both substances in annex III. Despite the combined exposure of both being considered safe and the levels of hydroquinone should not exceed “unavoidable traces,” the following restrictions have been decided:
– Alpha-arbutin: maximum of 2% in facial creams and 0.5% in body creams.
– Arbutin: maximum of 7% in facial creams.
And what about substances with potential endocrine-disrupting properties?
In 2019, the Commission launched a public data call due to concerns about certain substances for their possible endocrine-disrupting properties. Among them:
- 4-Methylbenzylidene Camphor
- Genistein
- Daidzein
- Kojic Acid
- Triclosan
- Triclocarban
Subsequently, the SCCS evaluated them and proposed to limit or prohibit their use in cosmetics. Below, we show what they determined for each of these substances:
4-Methylbenzylidene Camphor (4-MBC)
4-MBC was listed in Annex VI (entry 18) as a permitted UV filter in cosmetics, at a maximum concentration of 4%. Its use as a UV absorber and light stabilizer was also allowed.
In April 2022, after evaluating the available information, it was determined that there was sufficient evidence that this filter could act as an endocrine disruptor. Since a safe maximum concentration cannot be determined, the SCCS has decided to prohibit its use in cosmetic products. For this reason, it is added to Annex II and removed from Annex VI.
The antioxidants Genistein and Daidzein are limited
These antioxidants are isoflavones used in formulations of leave-on cosmetic products. Until now, they were substances not regulated by Regulation 1223/2009.
In September 2022, the SCCS evaluated the available data on their potential endocrine-disrupting properties and concluded that their use was safe in cosmetic products as long as the following concentrations were not exceeded:
- Genistein at a maximum of 0.007%.
- Daidzein at a maximum of 0.02%.
The depigmenting agent Kojic Acid is limited
Also in September 2022, after analyzing various studies, the SCCS confirmed that exposure to Kojic Acid was associated with increased proliferation of thyroid cells. Although these data are limited to judge this behaviour in humans.
Nevertheless, as this depigmenting agent is often used in combination with exfoliating agents, which can weaken the skin barrier, the possibility of increased absorption is considered an additional concern.
Therefore, the SCCS considers that Kojic Acid should be limited to a maximum concentration of 1% when used as a skin-lightening or depigmenting agent.
Triclosan and Triclocarban, even more limited!
Both are permitted preservatives listed in Annex V (entry 25 and 23, respectively) of Regulation 1223/2009.
In October 2022, after examining both substances, it was concluded that there was a potential health risk due to the use of these preservatives. Both combined use in different cosmetic products and the different age groups that could be exposed were taken into account. Thus, the conditions and maximum concentrations that would ensure safe use were determined.
The SCCS decided to apply the following restrictions to these preservatives:
Triclosan:
- Maximum of 0.3% in toothpaste, soap bars, liquid soaps, shower gels, deodorants (non-aerosol), face powders, corrective creams, and nail products for cleaning the nails of hands and feet before applying artificial nail systems.
- Prohibited in mouthwashes (adults and children) and toothpaste for children under three years old.
Triclocarban:
- Maximum of 0.2% in all cosmetic products applied to the skin (adults and children).
- Prohibited in mouthwashes (adults and children) and toothpaste for children under 6 years old.
In both cases, warning phrases must be added to toothpaste intended for children.
For purposes other than inhibiting microbial growth, in products that are rinsed off, the maximum concentration of 1.5% Triclocarban is maintained (according to entry 100 of Annex III).
In summary, what are the restrictions, prohibitions, and transition periods?
So far, we have discussed the evolution and reasons why all the substances mentioned in this article have undergone regulatory changes that are mandatory to comply with.
Now, in addition to indicating the transition periods for each of them, we simplify what is mentioned in this summary table:
| Regulated Substance (INCI) | CAS | Regulatory change | Observations | Can’t entry on the market | Commercialization is forbidden |
| Retinol | 11103-57-4 / 68-26-8 | Added to Annex III:
· 0.05% max. of ER in body lotions · 0.3% max. of ER in other leave on and rinse off products |
For any cosmetic product containing the substances “Retinol”, “Retinyl Acetate” or “Retinyl Palmitate”, it is mandatory to include this warning phrase:
“This product contains vitamin A. Please take into account your daily intake before using it”. |
1/11/2025 |
1/5/2027 |
| Retinyl Palmitate | 79-81-2 | ||||
| Retinyl Acetate | 127-47-9 | ||||
| Arbutin | 497-76-7 | Added to Annex III
· 7% max. in facial creams |
The levels of the substance “Hydroquinone” will be kept as low as possible in formulations containing “Arbutin” and “Alpha-Arbutin”, and will not be higher than the unavoidable trace level |
1/02/2025 |
1/11/2025 |
| Alpha-Arbutin | 84380-01-8 | Added to Annex III
· 2% max. in facial creams · 0.5% max. in body lotions |
|||
| 4-Methylbenzylidene Camphor
|
36861-47-9 / 38102-62-4 | . Added to Annex II, prohibiting its use as a UV filter and other purposes
. It is removed from Annex VI |
1/05/2025 |
1/05/2026 |
|
| Genistein | 446-72-0 | Added to Annex III
· 0.007% max. |
1/02/2025 |
1/11/2025 |
|
| Daidzein | 486-66-8 | Added to Annex III
· 0.02% max. |
|||
| Kojic Acid | 501-30-4 | Added to Annex III
· 1% max. in facial and hand products |
|||
|
Triclosan |
3380-34-5 |
Annex V is modified
. 0.3% max. in:
|
Do not use in toothpaste for children under three years of age.
In the case of toothpaste containing the substance “Triclosan”, the following label is mandatory: “Do not use for children under three years of age”.
|
31/12/2024 |
31/10/2025 |
|
Triclocarban
|
101-20-2 |
Annex V is modified · 0.2% max. in all cosmetic products except mouthwashes. |
Purity criteria: 3,3′,4,4′- tetrachloroazobenzene ≤ 1ppm 3,3′,4,4′- tetrachloroazoxybenzene ≤ 1ppm
Do not use in toothpaste for children under six years of age. In the case of toothpaste containing the substance “Triclosan”, the following label is mandatory: “Do not use for children under six years of age” |
How can we assist you from Sigillum?
We can provide guidance on interpreting and complying with requirements stemming from Regulation (EU) 2024/996, so that your cosmetic products meet all current standards and regulations, promoting a safe and responsible cosmetics industry.
Requirements that affect formulation, cosmetic safety assessment (PIF), and registration on the European CPNP portal.
So, don’t hesitate any longer and contact us!