Nanomaterials in cosmetic products are regulated by Regulation 1223/2009. According to Article 16 of this regulation, “a high level of protection of human health shall be ensured concerning any cosmetic product that contains nanomaterials,” which is why they are subject to specific procedures.
Whenever scientific advances occur, there is a potential risk or doubt affecting consumer safety, or when data is insufficient, the Commission will amend the provisions on nanomaterials in Regulation 1223/2009.
An example is the recent amendment to the cosmetics regulation, as established on March 14, 2024, in Regulation EU 2024/858. The substances affected do not have sufficient data to determine their safety and have therefore been prohibited or restricted.
In today’s article, we will look at the evolution of nanomaterials, their current definition, and which substances are affected by the new amendment to Regulation 1223/2009, as well as the transitional compliance periods.
Here is the chronology of events
According to the commission’s report on the use of nanomaterials in cosmetic products and the review of Regulation 1223/2009, the European Cosmetic Products Notification Portal (CPNP) collected data that allowed an evaluation of how the use of nanomaterials has evolved over time.
During the period from 2013 to 2020, more than 2.5 million cosmetic products were introduced to the market, 1.5% of which contained nanomaterials.
As stipulated in Article 16 of the cosmetics regulation, the Commission published two catalogs in 2017 and 2019 on the nanomaterials marketed in Europe and notified in the CPNP.
When comparing these catalogs, discrepancies were observed, likely due to the different definitions of nanomaterials provided in Regulation 1223/2009 and Recommendation 2011/696/EU. Therefore, a new definition was necessary.
So, what is a nanomaterial?
The Commission deemed it necessary for the definition and its terms to be based on scientifically defined and internationally standardized requirements (ISO, CEN). In June 2022, a new definition was drafted, taking into account all the experience and scientific progress up to that time.
The definition of nanomaterial reflected in the new recommendation 2022/C 229/01 is as follows:
“A natural, incidental or manufactured material containing solid particles which are present individually or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number size distribution meet at least one of the following conditions:
1 – One or more external dimensions of the particle are in the size range 1 nm to 100 nm;
2 – The particle has an elongated shape (rod, fiber, or tube) and two of its external dimensions are less than 1 nm, while the other dimension is greater than 100 nm;
The particle has a plate-like shape, and one of its external dimensions is less than 1 nm, while the other dimensions are greater than 100 nm.”
What regulatory changes have been introduced with the new EU Regulation 2024/858?
In January 2021, the Scientific Committee on Consumer Safety (SCCS) compiled a priority list of nanomaterials for which specific concerns could be identified or justified in their opinions. For those that were inconclusive, it was evaluated whether a potential risk could be identified. All of this was outlined in the scientific advice document on the safety of nanomaterials in cosmetics, SCCS/1618/20.
Thus, between March and June 2021, the SCCS concluded that there was insufficient data to assess the safety and health risks to humans arising from the use of the following nanomaterials in cosmetic products:
- Styrene/Acrylates copolymer and Sodium Styrene/Acrylates copolymer (CAS 9010-92-8)
- Colloidal Silver (CAS 7440-22-4)
- Copper and Colloidal Copper (CAS 7440-50-8)
- Gold, Colloidal Gold (CAS 7440-57-5), Gold Thioethylamino Hyaluronic Acid (CAS 1360157-34-1) and Acetyl Heptapeptide-9 Colloidal Gold (CAS not provided)
- Platinum, Colloidal Platinum (CAS 7440-06-4), and Acetyl Tetrapeptide-17 Colloidal Platinum (CAS not provided)
More recently, in March 2023 (SCCS/1648/22), it was concluded that the use of Hydroxyapatite (nano) (CAS 12167-74-7 / 1306-06-5) is safe if its concentration in toothpaste and mouthwash is restricted and its specific characteristics are taken into account. Additionally, it is prohibited in applications that may lead to inhalation exposure.
In summary, what are the restrictions, prohibitions, and transition periods?
So far, we have discussed the evolution of nanomaterials, especially regarding their definition. We have also covered which nanomaterials are affected by Regulation 2024/858 according to various SCCS opinions.
These regulatory changes are mandatory and subject to transition periods.
The following summary table contains all the information:
| Regulated substance (INCI) | CAS | Regulatory Change | Observations | Cannot be introduced to the market | Cannot be marketed |
| Styrene/Acrylates copolymer (nano)
Sodium Styrene/Acrylates copolymer (nano) |
9010-92-8 | Added to Annex II | Prohibited its use | 01/02/2025 | 01/11/2025 |
| Copper (nano)
Colloidal Copper (nano) |
7440-50-8 | Added to Annex II | Prohibited its use | 01/02/2025 | 01/11/2025 |
| Colloidal silver (nano) | 7440-22-4 | Added to Annex II | Prohibited its use | 01/02/2025 | 01/11/2025 |
| Gold (nano)
Colloidal Gold (nano) |
7440-57-5 |
Added to Annex II |
Prohibited its use |
01/02/2025 |
01/11/2025 |
| Gold Thioethylamino Hyaluronic Acid (nano)
|
1360157-34-1 | ||||
| Acetyl heptapeptide-9 Colloidal gold (nano) | – | ||||
| Platinum (nano)
Colloidal Platinum (nano) |
7440-06-4 | Added to Annex II | Prohibited its use | 01/02/2025 | 01/11/2025 |
| Acetyl tetrapeptide-17 Colloidal Platinum (nano) | – | ||||
|
Hidroxiapatita |
1306-06-5 |
Added to Annex II
·Toothpaste: 10% Max. ·Mouthwash: 0,465 % Max. |
Do not use in applications that may result in exposure of the consumer’s lungs by inhalation.
Only nanomaterials with the following characteristics are permitted: · [composed of] rod-shaped particles, of which at least 95.8% (by number of particles) have an aspect ratio lower than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9. · The particles are neither coated nor surface modified.
|
01/02/2025 |
01/11/2025
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