Search

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 1st Februray 2023 (60 Pages)Mise en ligne : 2 February 2023https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enhttps://health.ec.europa.eu/system/files/2023-02/sccs_o_266.pdfDetailsPublication date 2 February 2023Author Scientific Committee on Consumer Safety (SCCS)Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 1 February 2023Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when used-in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and- in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, SCCS/1644/22

BackgroundHand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social stigma, and impairment in employment. Many different interventions of unknown effectiveness are used to treat hand eczema.ObjectivesTo assess the effects of topical and systemic interventions for hand eczema in adults and children.Search methodsWe searched the following up to April 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, GREAT, and four trials registries. We checked the reference lists of included studies for further references to relevant trials.Selection criteriaWe included randomised controlled trials (RCTs) that compared interventions for hand eczema, regardless of hand eczema type and other affected sites, versus no treatment, placebo, vehicle, or active treatments.Data collection and analysisWe used standard methodological procedures expected by Cochrane. Primary outcomes were participant? and investigator?rated good/excellent control of symptoms, and adverse events.Main resultsWe included 60 RCTs, conducted in secondary care (5469 participants with mild to severe chronic hand eczema). Most participants were over 18 years old. The duration of treatment was short, generally up to four months. Only 24 studies included a follow?up period. Clinical heterogeneity in treatments and outcome measures was evident. Few studies performed head?to?head comparisons of different interventions. Risk of bias varied considerably, with only five studies at low risk in all domains. Twenty?two studies were industry?funded.Eighteen trials studied topical corticosteroids or calcineurin inhibitors; 10 studies, phototherapy; three studies, systemic immunosuppressives; and five studies, oral retinoids. Most studies compared an active intervention against no treatment, variants of the same medication, or placebo (or vehicle). Below, we present results from the main comparisons.Corticosteroid creams/ointments: when assessed 15 days after the start of treatment, clobetasol propionate 0.05% foam probably improves participant?rated control of symptoms compared to vehicle (risk ratio (RR) 2.32, 95% confidence interval (CI) 1.38 to 3.91; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 8; 1 study, 125 participants); the effect of clobetasol compared to vehicle for investigator?rated improvement is less clear (RR 1.43, 95% CI 0.86 to 2.40). More participants had at least one adverse event with clobetasol (11/62 versus 5/63; RR 2.24, 95% CI 0.82 to 6.06), including application site burning/pruritus. This evidence was rated as moderate certainty.When assessed 36 weeks after the start of treatment, mometasone furoate cream used thrice weekly may slightly improve investigator?rated symptom control compared to twice weekly (RR 1.23, 95% CI 0.94 to 1.61; 1 study, 72 participants) after remission is reached. Participant?rated symptoms were not measured. Some mild atrophy was reported in both groups (RR 1.76, 95% CI 0.45 to 6.83; 5/35 versus 3/37). This evidence was rated as low certainty.Irradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA) may lead to improvement in investigator?rated symptom control when compared to local narrow?band UVB after 12 weeks of treatment (RR 0.50, 95% CI 0.22 to 1.16; 1 study, 60 participants). However, the 95% CI indicates that PUVA might make little or no difference. Participant?rated symptoms were not measured. Adverse events (mainly erythema) were reported by 9/30 participants in the narrow?band UVB group versus none in the PUVA group. This evidence was rated as moderate certainty.Topical calcineurin inhibitors: tacrolimus 0.1% over two weeks probably improves investigator?rated symptom control measured after three weeks compared to vehicle (14/14 tacrolimus versus 0/14 vehicle; 1 study). Participant?rated symptoms were not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well?tolerated application site burning/itching.A within?participant study in 16 participants compared 0.1% tacrolimus to 0.1% mometasone furoate but did not measure investigator? or participant?rated symptoms. Both treatments were well tolerated when assessed at two weeks during four weeks of treatment.Evidence from these studies was rated as moderate certainty.Oral interventions: oral cyclosporin 3 mg/kg/d probably slightly improves investigator?rated (RR 1.88, 95% CI 0.88 to 3.99; 1 study, 34 participants) or participant?rated (RR 1.25, 95% CI 0.69 to 2.27) control of symptoms compared to topical betamethasone dipropionate 0.05% after six weeks of treatment. The risk of adverse events such as dizziness was similar between groups (up to 36 weeks; RR 1.22, 95% CI 0.80 to 1.86, n = 55; 15/27 betamethasone versus 19/28 cyclosporin). The evidence was rated as moderate certainty.Alitretinoin 10 mg improves investigator?rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210). Similar results were found for participant?rated symptom control: alitretinoin 10 mg RR 1.73 (95% CI 1.25 to 2.40) and 30 mg RR 2.75 (95% CI 2.18 to 3.48). Evidence was rated as high certainty. The number of adverse events (including headache) probably did not differ between alitretinoin 10 mg and placebo (RR 1.01, 95% CI 0.66 to 1.55; 1 study, n = 158; moderate?certainty evidence), but the risk of headache increased with alitretinoin 30 mg (RR 3.43, 95% CI 2.45 to 4.81; 2 studies, n = 1210; high?certainty evidence). Outcomes were assessed between 48 and 72 weeks.Authors' conclusionsMost findings were from single studies with low precision, so they should be interpreted with caution. Topical corticosteroids and UV phototherapy were two of the major standard treatments, but evidence is insufficient to support one specific treatment over another. The effect of topical calcineurin inhibitors is not certain. Alitretinoin is more effective than placebo in controlling symptoms, but advantages over other treatments need evaluating.Well?designed and well?reported, long?term (more than three months), head?to?head studies comparing different treatments are needed. Consensus is required regarding the definition of hand eczema and its subtypes, and a standard severity scale should be established.The main limitation was heterogeneity between studies. Small sample size impacted our ability to detect differences between treatments.