Heavy Metal Index

The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 12th Revision (SCCS/1647/22)

17 min read

Source access

Publication
European Commission, Directorate-General for Health and Food Safety
Year
2023
Authors
Scientific Committee on Consumer Safety (SCCS)
Source type
gov report
License
© European Union 2023; re use authorised under Commission Decision 2011/833/EU with source acknowledgement

SCCS 2023 — Notes of Guidance for the Testing of Cosmetic Ingredients (12th Revision, SCCS/1647/22)

This is the canonical EU regulatory-science methodology document for safety evaluation of cosmetic ingredients under Regulation (EC) No 1223/2009. The 12th revision, adopted 15 May 2023, supersedes SCCS/1628/21 and consolidates the SCCS framework for hazard identification, dose-response assessment, external and internal exposure assessment, MoS calculation, and population-specific risk evaluation including children. For the Heavy Metal Index, it is the regulatory backbone of how dermal, oral, and inhalation exposure to trace heavy-metal contaminants in cosmetic ingredients is parameterised, aggregated, and compared to toxicological reference values in the EU; it also fixes the default child body weights, retention factors, surface areas, and product-category exposure assumptions that any pediatric-cosmetic safety-evaluation cross-walk must inherit.

Key numbers

  • Default daily product exposures (Table 3A, p. 27; based on Hall et al. 2007, 2011 European consumer-use survey). Per product category as q_x (g/d), q_x/bw (mg/kg bw/d), retention factor f_ret (unitless), E_product (g/d) after applying f_ret, and E_product/bw (mg/kg bw/d). Shower gel 18.67 / 279.20 / 0.01 / 0.19 / 2.79. Shampoo 10.46 / 150.49 / 0.01 / 0.11 / 1.51. Hair styling 4.00 / 57.40 / 0.10 / 0.40 / 5.74. Body lotion 7.82 / 123.20 / 1.00 / 7.82 / 123.20. Face cream 1.54 / 24.14 / 1.00 / 1.54 / 24.14. Hand cream 2.16 / 32.70 / 1.00 / 2.16 / 32.70. Liquid foundation 0.51 / 7.90 / 1.00 / 0.51 / 7.90. Lipstick / lip salve 0.057 / 0.90 / 1.00 / 0.057 / 0.90. Deodorant non-spray 1.50 / 22.08 / 1.00 / 1.50 / 22.08. Deodorant spray 0.69 / 10.00 / 1.00 / 0.69 / 10.00. Toothpaste (adult) 2.75 / 43.29 / 0.05 / 0.138 / 2.16. Mouthwash 21.62 / 325.40 / 0.10 / 2.16 / 32.54.
  • Additional product categories not in Hall et al. (Table 3B, p. 28). Hair conditioner 3.92 g/d × f_ret 0.01 = 0.04 g/d (0.67 mg/kg bw/d). Make-up remover 5.00 g/d × f_ret 0.10 = 0.50 g/d (8.33 mg/kg bw/d). Eye shadow 0.02 g/d × f_ret 1.00 = 0.02 g/d (0.33 mg/kg bw/d). Mascara 0.025 g/d × f_ret 1.00 = 0.025 g/d (0.42 mg/kg bw/d). Eyeliner 0.005 g/d × f_ret 1.00 = 0.005 g/d (0.08 mg/kg bw/d). Deodorant aerosol spray (ethanol-based) 1.43 g/d × f_ret 1.00 = 1.43 g/d (20.63 mg/kg bw/d). Semi-permanent hair dyes 35 mL/application, oxidative/permanent hair dyes 100 mL/application (daily exposure “Not calculated” due to low application frequency).
  • Mean exposed skin surface area and frequency per product category (Table 4, p. 29; Bremmer et al. 2006a, b). Shower gel SSA 17,500 cm² (total body, 1.43/day). Hand wash soap 860 cm² (hands, 10/day). Bath oil/salts 16,340 cm² (body minus hands, 1/day). Shampoo 1,440 cm² (hands + ½ head, 1/day). Body lotion 15,670 cm² (body minus head, female; 2.28/day). Face cream 565 cm² (½ head, female; 2.14/day; +320 cm² applied on neck; +80 cm² back of neck). Hand cream 860 cm² (hands, 2/day). Liquid foundation 565 cm² (½ head, female; 1/day). Eye shadow 24 cm² (2/day). Mascara 1.6 cm² (2/day). Eyeliner 3.2 cm² (2/day). Lipstick / lip salve 4.8 cm² (2/day). Deodorant spray / non-spray 200 cm² (both axillae, 2/day). Eau de toilette spray 200 cm² (total body, 1/day). Perfume spray 100 cm² (hands, 1/day). Shaving cream / aftershave 305 cm² (¼ hand male, 1/day). Sunscreen lotion / cream 17,500 cm² (total body, 2/day).
  • Deterministic aggregate exposure for preservatives, Table 5, p. 31. Sum across the standard cosmetic-use panel = 17.4 g/d total product applied, 269 mg/kg bw/d when concentrations are summed at the maximally allowed level. Per-category contributions in g/d: rinse-off skin/hair cleansers (shower gel 0.19, hand wash 0.20, shampoo 0.11, hair conditioner 0.04); leave-on skin/hair (body lotion 7.82, face cream 1.54, hand cream 2.16, deodorant non-spray 1.50, hair styling 0.40); make-up (liquid foundation 0.51, make-up remover 0.50, lipstick 0.06, eye make-up 0.02, mascara 0.025, eyeliner 0.005); oral care (toothpaste 0.14, mouthwash 2.16). Oral-care entries in Table 5 represent dermal exposure via mucosa, not oral ingestion; oral exposure is computed separately.
  • Sunscreen MoS-calculation default: 18.0 g/d applied (p. 30, Section 3-3.4.2.1), distinct from the Table 4 sunscreen entries; this value drives the cosmetic-MoS arithmetic for UV-filter ingredients.
  • Children definitions (Section 3-6.10.1.1, p. 112). Infants 6 months - 1 year. Toddlers 1 - 3 years. Children 3 - 10 years. Adolescents 10 - 14 years and 14 - 18 years. “Children” in NoG usage covers all these strata; the SCCS analysis treats only intact-skin full-term babies (premature neonates are out of scope).
  • Child default body weights, EFSA 2012a (p. 115, cited in Section 3-6.10.2.2). Infants 8.8 kg; toddlers 11.9 kg; children 23.1 kg; adolescents 10-14 yrs 43.4 kg; adolescents 14-18 yrs 61.3 kg. These values feed every child-specific MoS calculation that supersedes the 60 kg adult default.
  • Surface-area-to-body-weight ratio child:adult (Renwick 1998, p. 112). Ratio of SSA/BW children:adults shifts from 2.3 at birth → 1.8 at 6 months → 1.6 at 12 months → 1.5 at 5 years → 1.3 at 10 years. Inter-individual variation across this range is covered by the WHO/SCCS default uncertainty factor of 100 for intact skin (Section 3-5.1.3, Figure 10); no additional UF for children when intact skin is present (SCCNFP/0557/02 position re-affirmed). An additional UF may be relevant in the nappy area when skin is damaged and substance-specific inter-individual variability exceeds the default of 10.
  • Cosmetic product classes by child age (Appendix 7 Table A.7.2, p. 145). Children 6 months - 1 year and 1 - 3 years: shower gel, hand soap, shampoo, body lotion, face cream, hand cream, plus toothpaste at retention factor 40%. Children 3 - 6 years: prior list plus hair conditioner. Children 6 - 10 years: prior list plus mouthwash; toothpaste retention factor 5%, mouthwash retention factor 10%. Adolescents 10 - 14 and 14 - 18 years: same as adults.
  • Toothpaste pediatric-exposure parameters (Section 3-6.10.2.2, p. 114). Children ≤6 years: 0.25 g pea-size amount, twice daily (SCCNFP/0653/03). Retention factor 40% for ages 7 months - 8 years (SCCS/1643/22). Retention factor 5% above 8 years. Oral bioavailability of the ingested fraction is treated as 100% for babies, children, and adults alike.
  • Mouthwash pediatric-exposure parameters (Section 3-6.10.2.2, p. 115). Minimum age 6 years (children under 6 should not use mouthwash). Usage 21.62 g/d, retention factor 10% (SCCS/1628/21).
  • Aerosol/spray particle-size deposition thresholds (Section 3-3.4.1.3, p. 22). MMAD ≤100 µm = inhalable fraction. MMAD ≤10 µm = thoracic fraction. MMAD ≤5 µm = respirable fraction (deep trachea, lungs, alveoli; systemically available). MMAD <1-5 µm = lung-reaching fraction in rodents. Particle/droplet size distribution and post-application drying behaviour both contribute to inhaled dose. Three airborne fractions per CEN 1993 EN 481 workplace standard: inhalable, thoracic, respirable.
  • EU-ISO microbiological limits for finished cosmetics (Appendix 9, Table A.9, p. 149; EN ISO 17516:2014). Category 1 (products specifically intended for children under three years, eye-area products, mucous-membrane products): Total Aerobic Mesophilic Microorganisms ≤ 1 × 10² CFU per g or mL (interpretation: out of limit at > 200 CFU). Category 2 (other products): ≤ 1 × 10³ CFU per g or mL (out of limit at > 2,000 CFU). Both categories require absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans in 1 g or 1 mL.
  • Tiered exposure-assessment approach (Section 3-3.4.1, p. 20). First-tier deterministic assessment uses conservative point values (95th percentile or P90 of daily applied amounts from Hall et al. 2007/2011 distributions). Second-tier probabilistic assessment uses the 95th percentile of the European population as the target protection goal; ingredient concentrations should cover the worst case (Annex III maximum allowed; for non-restricted ingredients the maximum realistically foreseeable concentration in a product category); 100% occurrence probability is the default assumption.
  • Inhalation-exposure modelling (Section 3-3.4.1.3 and Appendix 11). Two reference frameworks: ConsExpo Spray (mass-based, calibrated for non-nano substances only; cannot be used for nanoparticles — Consexpo Nano tool covers nanoparticles), and the deterministic 2-Box model (Steiling et al. 2014; Box A = breathing zone, Box B = surrounding room; for conservative estimates air exchange between Box B and the environment is set to zero). For short-timeframe sprayed-cosmetic calculations, no room ventilation should be assumed for the conservative estimate.
  • Margin-of-safety arithmetic for hair dyes (Section 3-6.9.1, p. 110-111). Daily-application PoD is divided by single-application SED rather than averaged over the year, because hair-dye exposure is intermittent (semi-permanent ≈ weekly 20-min application; oxidative/permanent ≈ monthly 30-min application). Daily dose for hair dyes is not averaged over the whole year (ECHA 2012a). In vitro skin-penetration of 14 representative oxidative hair-dye reaction products ranged 3.27 - 717.79 ng/cm² (mean + 1 SD), equivalent to 1.9 - 416 µg absorbed dose per application (0.03 - 6.9 µg/kg bw).
  • Skin-absorption study compartments required (SCCS Basic Criteria + OECD TG 428, Section 3-3.5.1.1, p. 34). Mass balance with 85-115% recovery, measured separately in (1) product excess on skin surface = dislodgeable dose, (2) stratum corneum via adhesive tape strips, (3) living epidermis without stratum corneum, (4) dermis, (5) receptor fluid. LOD/LOQ treatment specified; skin-integrity verification required (Guth et al. 2015; Fasano et al. 2002; Lehman et al. 2017).
  • Aggregate-exposure rule (Section 3-3.4.3, p. 30). Aggregate exposure must be calculated when several product categories contribute to ingredient exposure. Aggregation over routes is conservative: if one route delivers higher uptake than another, the highest possible fraction is attributed to the most-effective route and the rest distributed to other routes. For CMR 1A/1B substances per Article 15d of the Cosmetic Regulation, safety evaluation must take aggregate exposure from all sources (including non-cosmetic) into consideration and must include children-by-age. For endocrine-active substances, child-specific exposure assessment is required for the cosmetic categories children are exposed to (Appendix 7 Table A.7.2).
  • Certificate-of-Analysis content requirements (Appendix 6, p. 142). Required CofA elements include “Heavy metals” as one of the named results categories alongside Appearance, Identity (IR, NMR, MS), Purity, Solubility, and Impurities (% content). The CofA is the chain-of-evidence document for cosmetic-ingredient heavy-metal trace-contaminant verification, even though the NoG does not set numerical heavy-metal limits.

Methods (brief)

EU regulatory-science guidance compiled by the Scientific Committee on Consumer Safety; no primary measurement. The 12th revision was adopted by written procedure on 15 May 2023 and consolidates the SCCS framework for testing and safety evaluation of cosmetic ingredients under Regulation (EC) No 1223/2009. Default daily-amount and retention-factor parameter values in Tables 3A, 3B, 4, and 5 derive from large-scale European consumer-use surveys (Hall et al. 2007, 2011; McNamara et al. 2007; Steiling et al. 2014) for the most-frequent categories, and earlier Cosmetics Europe / Colipa industry data (16.01.97 BB-97/007; SCCNFP/0321/00) for the others. Hall et al.-derived q_x values use the P90 of the relevant probabilistic daily-amount distribution; retention factors derive from SCCNFP/0321/00. Skin surface areas come from Bremmer et al. (2006a, b). Child body weights are from EFSA 2012a. The Cosmetics Europe / Crème Global child-exposure update (0-3 year age group) is referenced as in-progress at time of publication (results awaited). The microbiological limits in Appendix 9 are taken verbatim from the 9th NoG revision (SCCS/1564/15), reflecting EN ISO 17516:2014. Aerosol/spray particle-size and lung-deposition treatment follows Snipes (1989), Valentine & Kennedy (2008), Brown et al. (2013), Braakhuis et al. (2014), CEN 1993 EN 481, and Bremmer et al. (2006a, b). For inhalation modelling, ConsExpo (www.consexpo.nl) and the 2-Box model (Steiling et al. 2014; Rothe et al. 2011) are recommended. Limitations stated by the SCCS itself: parameter values are provided only for the most common product categories (others require case-by-case assessment); ConsExpo Spray is not validated for nanoparticles (Consexpo Nano tool required); commercially-licensed exposure models such as Crème are not publicly accessible, which complicates regulatory transparency. The Cosmetics Regulation animal-testing and marketing bans (Reg (EC) No 1223/2009) apply: no in vivo testing of finished products after 11 March 2004, no in vivo testing for local toxicity after 11 March 2009, no in vivo testing for repeated-dose toxicity (including sensitisation), toxicokinetics, or developmental toxicity from 11 March 2013 for the purpose of cosmetics, which is why the NoG framework emphasises in vitro NAM (New Approach Methodology), in silico, NGRA (Next-Generation Risk Assessment), BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC), AOP (Adverse Outcome Pathway), and DAs (Defined Approaches) such as DAL (Defined Approach for eye irritation, Liquid) and DASS (Defined Approach for Skin Sensitisation). The NoG explicitly excludes airbrush technology and addresses preservatives, UV-filters, hair dyes, CMRs, endocrine-active substances, nanomaterials, hair dye reaction products, multi-constituent natural ingredients, and substances with very low dermal absorption as named special considerations.

Implications

  • Certification: Provides the SCCS aggregate-exposure framework that any EU-jurisdiction HMT&C threshold-setting work for children’s-personal-care must inherit when expressing limits in terms of body-weight-normalised SED rather than as-placed-on-market ppm. The Table 5 aggregate E_product/bw value of 269 mg/kg bw/d across the 12-product full-adult panel anchors the upper-bound preservative-exposure scenario; the Appendix 7 Table A.7.2 product-class proposal by child age anchors the corresponding pediatric panel. The CofA requirement (Appendix 6) for “Heavy metals” as a named test category is the EU regulatory anchor for cosmetic-ingredient trace-contaminant verification, even though the NoG does not itself specify numerical Pb/Cd/As/Hg/Ni/Cr/Sb limits. Child body weights (8.8, 11.9, 23.1, 43.4, 61.3 kg) and the SSA/BW age curve (2.3 → 1.3 child:adult ratio across birth → 10 years) are the EU-canonical numerators for pediatric MoS arithmetic.
  • Courses: Foundational regulatory-affairs and brand-QA teaching reference for the EU framework that governs cosmetic-ingredient safety evaluation under Regulation (EC) No 1223/2009 — covering exposure assessment (deterministic vs probabilistic), MoS derivation, the NoG-locked retention factors, the child-specific UF treatment, the nappy-area special considerations, and the in vitro / NAM / NGRA / TTC / iTTC / BER / AOP / DAs methodology vocabulary that any EU cosmetic-ingredient dossier must use. Useful as paired reading with the SCCS opinions on specific substances (parabens SCCS/1446/11; phenoxyethanol SCCS/1575/16; aluminium SCCS/1613/19; salicylic acid SCCS/1601/18; etc.) and with the SCCS/1643/22 toothpaste retention-factor opinion.
  • App: Not directly relevant to ingredient contamination_profile data. The age-stratified default body weights (8.8, 11.9, 23.1, 43.4, 61.3 kg) and the product-by-child-age class assignments in Appendix 7 Table A.7.2 are infrastructure for any pediatric exposure calculator that has to layer cosmetic-dermal exposure on top of dietary intake. The Table 3A / 3B / 4 / 5 daily-amount, retention-factor, skin-surface-area, and frequency values are the EU-canonical defaults a pediatric cosmetic-exposure module would consume.

Wiki pages this source may touch

Verification notes

  • Source is a 12th-revision EU regulatory-science methodology document (SCCS/1647/22), not an original measurement study. It contains no occurrence data on heavy metals in cosmetics and sets no numerical heavy-metal limits. Its relevance to the Heavy Metal Index is regulatory infrastructure: it (i) is the EU framework under which trace heavy-metal contaminants in cosmetic ingredients are dossier-assessed and MoS-evaluated, (ii) names “Heavy metals” as a required Certificate-of-Analysis test category (Appendix 6), and (iii) fixes the default child body weights, retention factors, skin surface areas, daily-amount distributions, and product-category-by-age assignments that any pediatric cosmetic-exposure module or child-stratified HMT&C threshold-setting workflow must use as inputs.
  • The frontmatter metals: field lists Pb, Cd, As, tHg, Ni, Cr, Sb because these are the heavy-metal trace contaminants for which the EU Cosmetics Regulation Annex II (banned substances list, EC No 1223/2009) and Annex III (restricted-use list) are the binding upstream rule, and because Appendix 6’s “Heavy metals” test category covers exactly these analytes in routine ingredient-dossier CofAs. The NoG does not itself enumerate Pb/Cd/As/Hg/Ni/Cr/Sb limits; the metal list reflects the analytes for which routing this guidance to the metal pages is relevant, not metals the SCCS measured.
  • The frontmatter metals: field uses As (umbrella) and tHg (total mercury) because the document does not separate inorganic from total arsenic and does not separate methylmercury from total mercury; the Appendix 6 CofA category and the Annex II ban specify “arsenic compounds” and “mercury and its compounds” generically. Cr is the umbrella (not Cr-VI) for the same reason. Sb is the umbrella (not Sb-III/Sb-V); antimony compounds are in Annex II of EC 1223/2009.
  • products: is restricted to the children-personal-care umbrella plus the specific pediatric product slugs the document explicitly covers in Section 3-6.10 and Appendix 7 Table A.7.2 (toothpaste, baby shampoo / body wash, baby lotion / cream, baby sunscreen, baby wipes, diaper / nappy creams). Adult cosmetic categories from Tables 3A, 3B, 4, 5 (body lotion, face cream, hand cream, lipstick, mascara, eyeliner, foundation, etc.) are extensively discussed but the document is being ingested into the Children Personal Care Papers / babycare_01_Exposure_Pathways folder; broader routing to adult-cosmetic product slugs is intentionally not added here because adult-cosmetic product pages are out of scope for this ingest. Mouthwash is discussed extensively for children but no products/mouthwash slug exists in the current taxonomy; surfacing as a potential pediatric oral-care slug for Karen’s review only — not creating.
  • matrices: uses cosmetic-personal-care (the established bare-string matrix vocabulary for cosmetic-occurrence and cosmetic-methodology sources) plus exposure-modeling (parallel to the bashir2025 SCCS-formula treatment) because this document IS the SCCS exposure-modelling methodology document. No new matrix terms introduced.
  • jurisdictions: is [EU] because Regulation (EC) No 1223/2009 and the SCCS framework apply to the EU single market. The default body weights cited (EFSA 2012a) are EU-anchored; the consumer-use survey (Hall et al. 2007, 2011) sampled Spain, Great Britain, France, Germany, and Denmark as proxies for southern, UK/Ireland, French, mid-European, and northern-European populations respectively. The framework is not formally binding outside the EU but is referenced internationally; the wiki labels it EU.
  • The Regulation (EC) No 1223/2009 (the EU Cosmetics Regulation itself) does not yet have a dedicated regulations/ page in the wiki. This source page does not propose creating one; surfacing as a routing-gap for Karen — when a regulations/eu-1223-2009 page is created, this source will be a contributing reference.
  • The hair-dye reaction-products in-vitro skin-penetration range (3.27 - 717.79 ng/cm²) is reported in the document as derived from SCCS Opinion SCCS/1311/10 on reaction products of oxidative hair-dye ingredients, not as an SCCS-original measurement; the NoG is summarising the earlier opinion. Captured here as a teaching reference for the magnitude of dermal uptake possible from oxidative hair-dye exposure, not as a primary occurrence value.
  • The sunscreen MoS-calculation default of 18.0 g/d (Section 3-3.4.2.1, p. 30) differs from the Table 4 sunscreen-lotion/cream SSA-based entry of 17,500 cm² × 2 applications/day; the 18.0 g/d figure is the dosing-amount default used by the SCCS in MoS arithmetic for UV-filter ingredients and supersedes the Table 4 entry for that arithmetic. Both values are reported here so the distinction is preserved.
  • Toothpaste pediatric retention factor of 40% is for ages 7 months - 8 years per SCCS/1643/22, and drops to 5% above 8 years. Below 7 months the SCCS does not specify a retention factor for toothpaste because routine toothpaste use begins with first erupted teeth (≈6 months); the 40% factor applies from the first relevant pediatric age.
  • The document explicitly identifies premature neonates as out of scope (“only intact skin of full-term babies is considered,” Section 3-6.10.2.1, p. 114) and notes that premature-baby skin-barrier impairment, pH differences, and the use of nappy-area baby cosmetics with potentially-damaged skin would require additional substance-specific UFs beyond the default 10. The wiki treatment of cosmetic safety for premature neonates is therefore explicitly out of the scope of this regulatory framework as currently stated, and would need to reference dedicated premature-skin literature (Visscher et al. 2015, 2020a, 2020b; Fluhr & Darlenski 2018; Proksch 2018; Rodriguez 2020; Gustin et al. 2020 are cited as the relevant body of evidence).
  • The Cosmetics Europe / Crème Global child-exposure update (0-3 year age group) is referenced as “results not yet been published” at the time of NoG adoption (May 2023). When that dataset is published it will supersede the current adult-derived pediatric exposure estimates for the 0-3 year age stratum.

Page history

The five most recent substantive edits to this page. The full version history lives in git; when DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.

CommitDateDescription
ce3e07c2026-05-28activation | Vercel DATACITE env slots set, curators.md filled with founder entry + six scoped reviewer invitations, peer-review onboarding playbook drafted
51400b92026-05-28audit-queue: gasparik2017-wild-boar-slovakia-metals audited-revised