A Collection of SCCS Final Opinions and Scientific Advice in 2021

Nanomaterials

1. Opinion on HAA299 (nano)

Based on the current available scientific evidence, SCCS considers HAA299, either as non-nano or nano form, safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%. But the HAA299 (nano) should be covered within the provided characteristics, i.e., minimum purity equal to or above 97%, median particle size in terms of particle number equal to or above 50 nm. Moreover, the SCCS does not recommend the use of HAA299 (nano) in applications that could lead to exposure of the consumer's lungs via inhalation.

The SCCS also holds the opinion that the combined maximum concentration of non-nano and nano forms of HAA299 should not exceed 10% in a cosmetic product.

2. Opinion on Hydroxyapatite (HAP-nano)

The available information indicates that HAP-nano in needle-shaped form is of concern in relation to potential toxicity. Therefore, SCCS is of the opinion that needle-shaped HAP-nano should not be used in cosmetic products. At the same time, SCCS requests further relevant information to conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles.

Fragrances

Opinion on Methyl Salicylate (Methyl 2-Hydroxybenzoate)

The SCCS considers Methyl Salicylate safe when used in cosmetic products up to the maximum concentration as detailed in the following table: 

The SCCS also notices that wintergreen oil 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. 

Hair Dyes

1. Opinion on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5)

In light of the data provided, the SCCS considers that Acid Yellow 3 is safe when used in non-oxidative hair dyes at on-head concentrations of up to 0.5%. 

2. Opinion on Resorcinol

Keeping in view the evidence on endocrine disrupting properties of resorcinol, the SCCS is of the opinion that resorcinol is safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25% and up to 0.5% in hair lotions and shampoos. 

Preservatives

Opinion on Propylparaben (PP)

On the basis of safety assessment of propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS concludes that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14%.

UV Filters

1. Opinion and Advice on Homosalate

According to the SCCS, the use of homosalate as a UV filter is safe for the consumer up to a maximum concentration of 0.5% in the final product. The SCCS also indicates that homosalate is safe as a UV-filter at concentrations up to 7.34% in face products, such as face cream and pump spray. 

2. Opinion on Octocrylene

On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene, the SCCS holds the opinion that Octocrylene is safe when used individually as a UV-filter at concentrations up to 10% in cosmetic products or for a combined use of sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%.

The SCCS also points out that use of Octocrylene in sunscreen propellant spray is considered safe when its concentration does not exceed 9% when used together with face cream, hand cream, and lipstick containing 10% Octocrylene.

3. Opinion on Benzophenone-3

On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of benzophenone-3 (BP-3), the SCCS is of the opinion that:

1. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray, is not safe for the consumer;

2. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in face cream, hand cream, and lipsticks is safe for the consumer;

3. The use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation is safe for the consumer.

The SCCS also concludes that, the use of BP-3 as a UV filter in the following sunscreen products is safe for the consumer up to a maximum concentration of:

1. 2.2% in body creams, in propellant sprays and in pump sprays, provided that there is no additional use of BP-3 at 0.5% in the same formulation for protecting the cosmetic formulation;

2. Where BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays.

Others

1. Opinion on Butylated Hydroxytoluene (BHT)

On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS considers BHT safe when used up to a maximum concentration of 0.001% in mouthwash, 0.1% in toothpaste and 0.8% in other leave-on and rinse-off products. 

BHT is also considered safe for a combined use of mouthwash at a concentration of 0.001%, toothpaste at a concentration of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.

2. Opinion on Aluminium

In the light of the new data provided, the SCCS considers aluminium compounds safe when used up to a maximum concentration of 6.25% in non-spray deodorants or non-spray antiperspirants, 10.60% in spray deodorants or spray antiperspirants, 2.65% in toothpaste and 14% in lipstick. 

Further Reading

• News | EU Cosmetic Regulatory Updates in 2021H1

• News | EU Regulates the Use Requirements of Deoxyarbutin and Dihydroxyacetone

• News | EU Prohibits the Use of CMR Substances in Cosmetics, Zinc Pyrithione (ZPT) Included