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SCCS Scientific Advice on children's exposure to Methyl Salicylate (methyl 2-hydroxybenzoate) — revision of SCCS/1654/23 (SCCS/1676/25)

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Overview

This is the EU regulatory-science re-assessment of children’s aggregate exposure to Methyl Salicylate (CAS 119-36-8; methyl 2-hydroxybenzoate) in cosmetic products intended for children of age 0–3 years, adopted by written procedure on 30 April 2025. It supersedes SCCS/1654/23 by adopting the updated toothpaste-amount data introduced in the SCCS Addendum on Hexyl Salicylate (SCCS/1668/24). The substance itself is not a heavy metal; the document is in scope for the Heavy Metal Index as the EU-canonical exposure-assessment framework for children’s-personal-care safety evaluation. Its product-use amounts, retention factors, dermal-absorption defaults, child body weights, and toothpaste ingestion values are the inputs that any heavy-metal MoS calculation for the children’s-personal-care HMTc category must inherit, alongside SCCS/1647/22 (the 12th Notes of Guidance, see The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 12th Revision (SCCS/1647/22)).

Key numbers

  • Currently allowed Methyl Salicylate concentrations under Annex III entry 324, Cosmetic Regulation (EC) No 1223/2009 (Table 1, p. 9). Leave-on skin products (excluding face make-up, spray/aerosol body lotion, spray/aerosol deodorant, hydroalcoholic-based fragrances and leave-on hair products) 0.06%. Face make-up (excluding lip products, eye make-up and make-up remover) 0.05%. Eye make-up and make-up remover 0.002%. Leave-on hair products (spray/aerosol) 0.009%. Deodorant spray/aerosol 0.003%. Body lotion spray/aerosol 0.04%. Rinse-off skin products (excluding hand wash) and rinse-off hair products 0.06%. Hand wash 0.6%. Hydroalcoholic-based fragrances 0.6%. Lip products 0.03%. Toothpaste 2.52%. Mouthwash for children 6–10 years 0.1%. Mouthwash above 10 years and adults 0.6%. Mouth spray 0.65%. Annex III footnote: “Not to be used in preparations for children under 6 years of age, with the exception of toothpaste.”
  • Cosmetic-product categories considered for children 0–3 years (Table 2, p. 10). Up-to-1-year category: shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, fragrance products, plus toothpaste at retention factor 40%. 1-to-3-year category: same as up-to-1-year list plus hair conditioner. Hair conditioner is excluded for infants 0–1 year because Ficheux & Roudot 2017 does not record any infants below 1 year using conditioner.
  • Default child body weights (EFSA 2012, P50 medians; Section 3.2.4 p. 15). Infants 0–6 months 4.8 kg. Infants 6–12 months 8.7 kg. Toddlers 1–3 years 11.6 kg. These supersede the 8.8 / 11.9 kg values used in earlier SCCS opinions when full-pediatric stratification is required (SCCS now treats 0–6 months as a distinct age stratum below the 6–12 month infant class).
  • Dermal absorption default for Methyl Salicylate (Section 3.2.2 p. 11). 50% for skin penetration in the absence of reliable substance-specific data. Maximal absorption time-window dermal route 1–4 h, mostly as salicylic acid and secondary metabolites; first-pass hydrolysis in blood and liver removes parent compound within a few hours.
  • Oral and inhalation bioavailability (Section 3.2.3 p. 11). Oral absorption 100% (rapid and extensive gut absorption; complete hydrolysis to salicylic acid and methanol). Inhalation absorption 100% on the limited data available; inhalation considered negligible vs dermal in children and not modelled in this advice.
  • Toothpaste pediatric-use parameters for children 0–3 years (Section 3.2.4 oral exposure p. 14–15; Table 4 p. 15). Amount used per day 1.92 g/day (P95 from Gomez-Berrada et al. 2018 of N=96 French children 2–6 years, weighing toothpaste tubes before/after use; supported by Garcia-Hidalgo et al. 2017 picture-questionnaire data and by Adé et al. 2024 Swiss preschool data showing higher amounts than the SCCS Notes-of-Guidance 0.25 g/application default). Retention factor 0.4 (40%). Oral bioavailability 100%. Daily systemic-exposure mass to MeS in toothpaste at 2.52% MeS content = 1.92 g × 0.4 × 2.52% × 100% × 1000 = 768 mg/day across all three 0–3 yr age strata (mass identical because the amount and retention factor do not vary by age stratum). Body-weight-normalised relative daily exposure therefore differs only by body weight: infants 0–0.5 yr 160.00 mg/kg bw/d → SED 4.03 mg/kg bw/d; infants 0.5–1 yr 88.28 mg/kg bw/d → SED 2.22 mg/kg bw/d; toddlers 1–3 yr 66.21 mg/kg bw/d → SED 1.67 mg/kg bw/d. Footnote: “the use of toothpaste starts after the growth of the first teeth” — i.e., the 0–0.5 yr toothpaste entry applies from first eruption only, not from birth.
  • Dermal SED for cosmetic products at 0.02% MeS, by age (Table 3 p. 13–14). Computed as (daily-product-amount mg/kg bw/d) × (MeS%) × (dermal-absorption 50%). SHOWER GEL (Ficheux & Roudot “gel douche”): infants 0–0.5 yr 7.40 mg/kg bw/d → SED 0.74 µg/kg bw/d; 0.5–1 yr 7.40 → 0.74; toddlers 1–3 yr 9.37 → 0.94. HAND SOAP (same F&R “gel douche” surrogate): same as shower gel (0.74, 0.74, 0.94 µg/kg bw/d across the three age strata). SHAMPOO (F&R “shampoing”): 4.79 / 4.79 / 4.52 mg/kg bw/d → SED 0.48 / 0.48 / 0.45 µg/kg bw/d. HAIR CONDITIONER: NA for the two infant strata (no F&R data <1 yr); toddlers 1–3 yr 4.52 mg/kg bw/d → 0.45 µg/kg bw/d. BODY LOTION (F&R “Crème Hydratante corps”): 839 / 839 / 981 mg/kg bw/d → SED 83.90 / 83.90 / 98.10 µg/kg bw/d (the dominant dermal contributor). FACE CREAM (SSA-derived): 53.2 / 44.5 / 42.5 mg/kg bw/d → SED 5.32 / 4.45 / 4.25 µg/kg bw/d. HAND CREAM (SSA-derived): 74.6 / 62.4 / 59.6 mg/kg bw/d → SED 7.46 / 6.24 / 5.96 µg/kg bw/d. LIP PRODUCTS (SSA-derived, dermal absorption assumed 100% rather than 50%): 1.97 / 1.65 / 1.57 mg/kg bw/d → SED 0.39 / 0.33 / 0.31 µg/kg bw/d. FRAGRANCE PRODUCTS (F&R “Eau de Toilette”): 96.9 / 96.9 / 84.4 mg/kg bw/d → SED 9.69 / 9.69 / 8.44 µg/kg bw/d. AGGREGATE DERMAL SED at 0.02%: infants 0–0.5 yr 108.72 µg/kg bw/d; 0.5–1 yr 106.57; toddlers 1–3 yr 119.84.
  • Toxicological Point of Departure (Section 3.3 p. 16–17). Oral NOAEL 50 mg/kg bw/d (Webb & Hansen 1963 repeated-dose; LOAEL 150 mg/kg bw/d). Dermal LOAEL 585 mg/kg bw/d (Webb & Hansen 1963). Inhalation NOAEL 700 mg/m³ ≈ 120 ppm (Gage 1970). Developmental NOAEL 75 mg/kg bw/d (Collins et al. 1971, 3-generation oral rat study) — used for the MoS calculations in this advice. Subcutaneous-rat developmental NOAEL <60 mg/kg bw/d (FDA 2006b, GD6 to LD21). CMR Category 2 classification for developmental effects agreed by RAC September 2019, consistent with the 2016 CMR-2 decision on salicylic acid (the principal MeS metabolite via dermal and oral routes). Skin sensitiser CLP class 1B; non-irritating to skin up to 12%; may cause severe eye damage. No genotoxic hazard; no carcinogenic effect in available data. Endocrine-disruption: not on EU ED-list; only oestrogenic pathway tested by applicant — no specific concern.
  • MoS for dermally-applied products at MeS=0.02% (Table 6 p. 19). Computed as (75,000 µg/kg bw/d NOAEL) ÷ SED. Shower gel: infants 0–0.5 yr 101,351; 0.5–1 yr 101,351; toddlers 1–3 yr 80,043. Hand soap: 101,351 / 101,351 / 80,043. Shampoo: 156,576 / 156,576 / 165,929. Hair conditioner: NA / NA / 165,929. Body lotion: 894 / 894 / 765. Face cream: 14,106 / 16,852 / 17,655. Hand cream: 10,058 / 12,016 / 12,588. Lipstick: 190,355 / 227,447 / 238,919. Fragrance products: 7,740 / 7,740 / 8,886. Aggregate dermal MoS at 0.02%: 690 / 704 / 626 — all above 100, i.e., safe for aggregate dermal exposure at the 0.02% maximum.
  • MoS for toothpaste-only oral exposure (Table 7 and Table 8 p. 20). At MeS=2.52% (current Annex III limit): infants up-to-0.5 yr MoS=18.6; infants 0.5–1 yr MoS=33.7; toddlers 1–3 yr MoS=45.0 — all below 100, i.e., unsafe. At MeS=0.4%: 117.2 / 212.4 / 283.2 — all at or above 100, i.e., safe for toothpaste-only exposure.
  • Aggregate dermal-plus-toothpaste MoS at MeS=0.02% in dermal products and MeS=0.4% in toothpaste (Table 9 p. 20). Dermal MeS in products 109 / 107 / 120 µg/kg bw/d; toothpaste MeS 640 / 350 / 260 µg/kg bw/d; aggregated 749 / 457 / 380 µg/kg bw/d; aggregate MoS 100 / 164 / 197 — at-or-above 100 across all three age strata, defining the SCCS’s safe-use envelope.
  • SCCS conclusion (Abstract p. 4; Conclusion §1 p. 22). “The concentration of Methyl Salicylate should not exceed 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0–3 years.”
  • Comment-period addition (acknowledgement p. 3). The Final version followed a 4-week public comment period (20 January – 17 February 2025) on the preliminary opinion. Main changes from the preliminary document: Table 2, Section 3.2.4 exposure assessment, Section 3.4 conclusion-1 narrative, and reference list. Numerical conclusions unchanged.

Methods (brief)

EU regulatory-science opinion compiled by the Scientific Committee on Consumer Safety under Article 15(1) of Regulation (EC) No 1223/2009; no primary measurement. The SCCS Working Group composition (acknowledgements p. 2): Members Bernauer, Bodin, Chaudhry (Chair), Coenraads (Vice-Chair, WG Chair), Ezendam, Gaffet, Galli, Panteri, Rogiers (Vice-Chair), Rousselle (Rapporteur), Stepnik, Vanhaecke, Wijnhoven; external experts Benfenati, Cabaton, Corsini, Delmaar (final-document only), Koutsodimou, Louro, Uter, von Goetz. Adopted by written procedure 30 April 2025 (preliminary opinion 17 January 2025). Chemical and physical specifications and toxicological evaluation are inherited verbatim from SCCS/1633/21 (parent MeS opinion); this advice updates only the exposure assessment and safety evaluation for the 0–3 year age group, prompted by the SCCS Addendum on Hexyl Salicylate (SCCS/1668/24) which adopted higher toothpaste-amount values for children below 3 years than had been used in SCCS/1654/23. Dermal exposure was calculated by age category using the Systemic Exposure Dose (SED) framework: SED = (product daily amount, mg/kg bw/d) × (substance concentration, %) × (dermal absorption fraction, %). For product categories with children-specific use data (shower gel, hand soap, shampoo, hair conditioner, body lotion, fragrance products) the SCCS used Ficheux & Roudot (2017) French data (n=395 parents) in preference to Garcia-Hidalgo et al. (2017) Swiss data, on the grounds of (a) larger sample size, (b) age-stratification matching the 0–3 year target, and (c) gravimetric (weighed) rather than questionnaire-based amount measurement. For face cream, hand cream and lip products no children-specific data were available so the Skin Surface Area (SSA) approach was used, scaling adult use-amounts by child SSA/BW ratios per the methodology of the Hexyl Salicylate Opinion (SCCS/1668/24). Oral exposure to toothpaste used P95 amount 1.92 g/d (Gomez-Berrada et al. 2018, weighing toothpaste tubes before/after use in N=96 French children 2–6 years), retention factor 0.4, oral bioavailability 100%. Body-weight defaults: EFSA 2012 P50 medians of 4.8 kg (0–0.5 yr), 8.7 kg (0.5–1 yr), 11.6 kg (1–3 yr). Inhalation was deemed negligible vs dermal and not modelled. Aggregate exposure summed dermal-product-route and toothpaste-oral-route SEDs by age stratum. The PoD for MoS was the developmental NOAEL of 75 mg/kg bw/d from Collins et al. (1971) 3-generation oral rat study; no adjustment for oral bioavailability was applied because the rat exposure was oral. MoS = NOAEL ÷ SED, with a target safe MoS ≥ 100 (default Inter- and Intra-species 10×10 uncertainty factor). Limitations explicitly noted by the SCCS: Ficheux & Roudot (2017) covers French children only, so Garcia-Hidalgo et al. (2017) Swiss data are retained as supporting evidence to extrapolate to Europe; face cream and hand cream are used by only 8% and a small percentage of 0–3-year-olds respectively (Garcia-Hidalgo Figure 8), so retaining them at full daily-use frequency in the aggregate is conservative; SSA-approach values for face cream / hand cream / lip products use adult population amounts because European 0–3-year-old data are not available. The toxicological evaluation in Section 3.3 is taken from SCCS/1633/21 in summary form and is not re-derived.

Implications

  • Certification: Provides the EU-canonical product-use envelope (1.92 g/day toothpaste at retention 0.4; body-lotion daily use 839–981 mg/kg bw/d as the dominant dermal contributor; shower-gel + hand-soap + shampoo + hair-conditioner + face-cream + hand-cream + lip-product + fragrance-product co-exposures for children 0–3 years) that any children’s-personal-care HMTc threshold-setting workflow must use as its denominator when converting between as-placed-on-market ppm/ppb and body-weight-normalised systemic dose. The Collins et al. (1971) developmental NOAEL of 75 mg/kg bw/d and the MoS≥100 target are the EU benchmark; for heavy-metal trace contaminants in children’s-personal-care, the analogous PoD is the metal-specific TWI/PTMI/BMDL from EFSA or JECFA (see EFSA — Lead in Food (2010), No-Threshold Position, EFSA — Tolerable Weekly Intake for Cadmium, 2.5 µg/kg b.w./week, EFSA — Arsenic in Food (2009), No-PTWI Position, EFSA — Inorganic Mercury Tolerable Weekly Intake (4 µg/kg b.w./week), EFSA — Aluminium Tolerable Weekly Intake (1 mg/kg b.w./week), EFSA — Nickel Tolerable Daily Intake (13 µg/kg b.w./day)), with the same aggregate-dermal-plus-oral arithmetic. The Annex III entry 324 limits (0.02% other products, 0.4% toothpaste for children 0–3) are organic-substance limits and do not bind heavy-metal trace contamination directly; they fix the exposure-arithmetic precedent only.
  • Courses: Worked example of the SCCS aggregate-exposure framework as applied to a CMR Category 2 substance in children’s cosmetics, with explicit ingredient-by-product-category SED breakdown and the body-lotion-dominates-dermal-exposure finding for infants 0–3. Useful as paired reading with the 12th Notes of Guidance (The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 12th Revision (SCCS/1647/22)) which provides the abstract methodology; this opinion shows what the methodology yields in practice on a specific substance. The retention-factor / dermal-absorption / bodyweight defaults illustrated here are the same ones used for cosmetic-trace-contaminant heavy-metal MoS arithmetic.
  • App: The age-stratified product-use amounts (mg/kg bw/d) for shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lip products, fragrance products, and toothpaste are direct inputs for any pediatric cosmetic-exposure module that needs to layer trace-contaminant exposure on top of dietary intake. The P95 toothpaste-amount of 1.92 g/day and retention factor 0.4 are the EU-canonical defaults for an oral-care exposure-from-product-ingestion calculation. Numerical methyl-salicylate-specific values (SED, MoS, Annex III concentration limits) are not consumed by the app, which only uses heavy-metal contamination data.

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