Aluminum in Cosmetics: Regulatory Updates and Restrictions
Aluminum and its compounds are mainly used in cosmetic products as antiperspirant agents and as bases for carrying pigments in lipsticks and toothpastes. In particular, aluminum chlorohydrate is the most widely used aluminum compound in cosmetics, especially in antiperspirants. Although aluminum chlorohydrate itself is not currently subject to specific restrictions under Cosmetics Regulation 1223/2009, other aluminum salts such as aluminum zirconium complexes are regulated under entry 50 of Annex III for antiperspirants, with specific conditions of use.
In 2013, the risk assessment issued by the Norwegian Scientific Committee for Food Safety showed that cosmetic products, and particularly aluminum-containing antiperspirants, contribute significantly more to total systemic exposure than diet. As a consequence, the European Commission asked the Scientific Committee on Consumer Safety (SCCS) to assess the possible risk to human health arising from the presence of aluminum in cosmetics, taking into account exposure from other sources such as food and food supplements. In October 2016, Cosmetics Europe submitted a new safety dossier to the Commission services, including a clinical study on the absolute bioavailability of aluminum following dermal exposure to a representative antiperspirant formulation.
Aluminum toxicity
There is an extensive literature on the health effects and toxicity of aluminum. Several authoritative reviews and assessments were published before 2014 (WHO IPCS 1997; Krewski et al., 2007; ATSDR, 2008; EFSA, 2008; FAO/WHO JECFA 2007; Environment Canada & Health Canada 2010; AFSSAPS 2011; FAO/WHO JECFA 2012; VKM 2013; Willhite et al., 2014). For the 2017 SCHEER opinion on aluminum in toys, a literature search covering the period from 01/01/2008 to 31/01/2017 was carried out. The JECFA assessment was based on new data including a developmental toxicity study specifically evaluating neuro-behavioural endpoints (Poirier et al., 2011). The LOAEL values identified in those studies were consistent with the body of data already reviewed by other committees; however, the oral developmental toxicity study in rats provided a robust NOAEL suitable for risk assessment (30 mg/kg bw/day). By applying the standard uncertainty factor of 100 to this NOAEL and considering the bioavailability of aluminum citrate, JECFA considered it appropriate to revise the PTWI to 2 mg/kg bw/week.
Conclusions
The SCCS considers that systemic exposure to aluminum resulting from daily application of cosmetic products does not significantly add to systemic exposure from other sources. Aluminum exposure can also derive from sources other than cosmetics, and diet remains one of the main sources for the general population.
In light of the new data provided, the SCCS considers the use of aluminum compounds safe up to the following equivalent aluminum concentrations:
6.25% in non-spray deodorants or non-spray antiperspirants
10.60% in spray deodorants or spray antiperspirants
2.65% in toothpaste
0.77% in lipstick