The potential toxicity of aluminum in cosmetics has been a concern for several years. Often accused of promoting breast cancer or Alzheimer’s disease, he was the subject of an assessment by the Afssaps regarding his job security. The Agency has just published its conclusions in an expert report published on 17 November 2011. Conclusion: the risk exists and consumer health safety is not ensured.
The issue has been studied by French health authorities since 2000. In 2003, a first report was published highlighting the lack of relevant data on dermal absorption of aluminum from cosmetic products. It was then impossible to conclude on the risks associated with the use of products containing them.
The assessment published today takes into account two new data: a dermal absorption study provided by the cosmetics industry, and a synthesis of toxicological data, partly based on the recent opinion of the European Food Safety Agency.
After repeated-dose administration of aluminum, this new report states, neurotoxic effects as well as effects on the testicles, embryo and nervous system development are observed in animals.
Effects in humans (neurotoxicity, bone damage, anemia) are known in chronically exposed renal insufficiencies as well as in premature infants fed by parenteral route.
On the other hand, animal studies do not show any carcinogenic potential. Nor can epidemiological data establish a conclusive link between dermal exposure to aluminum and the development of cancer.
Even if the fate of aluminium after dermal exposure is very poorly known, the Afssaps reminds us that it is widely distributed throughout the body, can reach the brain and cross the placental barrier.
Its elimination, mainly by the renal route, may take several years when administered chronically.
Exposure via cosmetics
More than twenty-five aluminium compounds are among the substances that may be present in cosmetic products. Aluminium chlorohydrate (INCI: Aluminum Chlorohydrate) is one of the most widely used, particularly as an antiperspirant.
The dermal absorption study provided by the cosmetics industry was conducted in vitro on human skin. It estimated the quantities of aluminum absorbed via daily exposure to an antiperspirant containing 20% aluminum chlorohydrate (or 2.5% aluminum).
Two scenarios were studied:
• Exposure of normal skin leads to a dermal absorption rate of 0.5%
• Exposure of injured skin results in an absorption rate of 18%
The Afssaps indicates that in the case of normal skin, the safety margin is 20 (it should be greater than or equal to 100 to ensure job security). In the case of damaged skin, it is less than 1.
Concentrations to be revised downwards
The Agency concludes that the risk assessment shows that exposure to antiperspirants with concentrations of 20 % aluminium hydrochloride (2,5 % aluminium) does not ensure consumer health safety under normal conditions of use.
In order to protect the population from the bone and neurotoxic risks associated with long-term regular application, this report states, it should be necessary:
• On the one hand, to limit the concentration of aluminium in cosmetic products to 1.2%
• On the other hand, to prevent any use on damaged skin, as no safety margin can be achieved in this case
However, this risk assessment does not take into account the total exposure to the various cosmetic products that may contain aluminum. This is also the case:
• In the abrasive active ingredients of dental products or facial and body care products
• In the viscosity agents of care products and make-up products
• In face mask absorbents (aluminium silicate can be used up to 80% for this purpose)
However, animal studies have shown additional effects related to exposure to aluminum. The Afssaps therefore indicates that the conclusions adopted today are likely to evolve subsequently according to an evaluation taking into account the different product categories and their uses.
In the meantime, the Agency recommends:
• For industry: limit the concentration of aluminium in antiperspirants or deodorants to 0.6%
• For consumers: do not use cosmetic products containing aluminium on damaged skin, especially after shaving or in the event of skin damage such as microcuts.
The Afssaps recommends that this information should appear on the packaging.
Another point raised by this report is skin tolerance.
Cases of skin irritation related to cosmetic products containing chlorinated aluminium compounds have been reported in humans. The Afssaps stresses that additional data would be required to confirm the risks of irritation associated with these products, as the data available today do not allow to conclude on the local tolerance of antiperspirants containing aluminium salts.
On the other hand, awareness cases are rare.
On the basis of these conclusions and at this stage of knowledge, the Afssaps considers that it is appropriate to refer the matter to the European Commission in order to define the conditions for the safe use of antiperspirants and other cosmetic products containing aluminium.
This could eventually lead to an evolution in the regulation of cosmetic ingredients and products containing them.
For futher information
• See the full text (in French) of the Rapport d’expertise concernant l’Évaluation du risque lié à l’utilisation de l’aluminium dans les produits cosmétiques (Risk assessment related to the use of aluminum in cosmetic products)