TAGS: Perfumes & Fragrances Toiletries Decorative Cosmetic
The European Commission has requested SCCS for a scientific opinion on the safety of aluminum in cosmetic products - Submission IV.
Commission Department requesting the Opinion: Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs.
Background
Aluminum (Al) and Al compounds are used in a variety of cosmetic products, predominantly in deodorants, antiperspirants, lipsticks, and toothpaste. Several Al compounds are regulated in different entries of the Cosmetics Regulation (EC) No 1223/2009.
In 2013, a risk assessment issued by the Norwegian Scientific Committee for Food Safety reported that cosmetic products, and in particular antiperspirants, constitute a significantly larger contribution to the total systemic Al exposure compared to diet at least for the Norwegian population that was used in the study. As a result, SCCS was mandated to evaluate the possible risk to human health arising from the presence of Al in cosmetics. The assessment was based on products and aluminum compounds that contributed to the highest consumer exposure, namely antiperspirants/deodorants, toothpaste, and lipsticks.
In its Opinion SCCS/1525/14, the SCCS concluded that, due to the lack of adequate data on dermal penetration, the requested risk assessment could not be performed. In 2016, the industry submitted a new safety dossier to address dermal penetration and the fate of Aluminum (after skin application) based on a human exposure study. At its plenary meeting on 3-4 March 2020, the SCCS adopted its final Opinion SCCS/1613/194 and in March 2021, and addendum to this Opinion was published.
In the addendum, the SCCS concluded that the use of aluminum compounds is safe at the equivalent aluminum concentrations up to (a) 6,25 % in non-spray deodorants or non-spray antiperspirants, (b) 10,60 % in spray deodorants or spray antiperspirants, (c) 2,65 % in toothpaste, and (d) 14 % in lipstick.
Following the discussion at the Cosmetics Working Group held on 25 June 2020 and in light of the comments received on the use of Aluminum compounds in a variety of products other than deodorants, antiperspirants, lipsticks, and toothpaste, the Commission considered it opportune to request from industry to submit additional information on the ‘other product categories’ and on the aggregate exposure not only from cosmetics.
In March 2021, the industry submitted a dossier focusing on the aggregate exposure to aluminum concerning the European population when considering the use of cosmetics and personal care products, medicines (e.g., antacids), and dietary intake, and the SCCS was requested to perform a safety assessment in view of the new information provided.
In its Opinion SCCS/1644/226, the SCCS concluded that Aluminum compounds are safe when used in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6 of the SCCS Opinion; and in sprayable products, at the maximum levels indicated in Table 4 of the SCCS Opinion, provided that the percentage of particles/droplets with a diameter of less than 10μm does not exceed 20 % of the total aerosolized particles/droplets. In addition, the SCCS noted that based on a realistic aggregate exposure scenario used in that submission, the contribution to Aluminum exposure from food may be at a similar order of magnitude to that from cosmetics.
This information taken together with the conservative nature of the exposure estimates for cosmetics that were used for calculating the MOS, SCCS concluded that the aggregate exposure to aluminum from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.
The current request concerns the update of use concentrations based on submission IV by the Aluminum consortium, which comprises an amendment to the probabilistic exposure assessment report. The Commission, therefore, requests the SCCS to evaluate the information submitted and review its conclusions in SCCS/1613/19, SCCS/1626/20, and SCCS/1644/22, accordingly.
Terms of Reference
1. In light of the new data provided, does the SCCS consider Aluminum compounds safe when used in cosmetic products? In the event that the estimated exposure to Aluminum from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category and product type.
2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminum compounds in cosmetic products taking into account the newly submitted information?
Deadline: 6 months
Supporting documents:
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Aluminum - CE consortium updated use concentrations - 28-04-23
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Creme Global - Evaluating Aggregate Exposure to Aluminum from Food, Cosmetics and
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Personal Care Products and Antacids (Addendum), dated 22nd September 2022
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Comments by the Cosmetics Europe Aluminum consortium under the public consultation for the
preliminary opinion on the safety of Aluminum (SCCS/1644/22). Final 25/07/22
The SCCS approved this mandate during a plenary meeting on 6-7 June 2023
Source: European Commission
