EDQM 2nd edition — safety-assessment guidance for cosmetic products intended for children under three (operationalises EU Reg. 1223/2009 Annex I §3)

This is the European Directorate for the Quality of Medicines & HealthCare (EDQM) 2nd edition guidance for manufacturers and safety assessors of cosmetic products intended for infants, defined throughout the document as any child under the age of three. It is published by the Council of Europe and structured in two parts. Part I reproduces Council of Europe Resolution CM/ResAP (2012) 1 on safety criteria for cosmetic products intended for infants, adopted by the Committee of Ministers on 14 March 2012 (1137th meeting of the Ministers’ Deputies). Part II is the technical guidance document approved by the European Committee for Cosmetics and Consumer Health (CD-P-COS) for the 2nd edition, replacing the 2012 1st edition. Its relevance to Heavy Metal Index is structural and toxicological rather than empirical. The document reports no measured contamination values from a market survey; it sets out the criteria a competent safety assessor is expected to apply when evaluating a cosmetic product for the under-three age group, the physiological characteristics and behaviours of infants that drive higher exposure, and ingredient-class recommendations (fluoride, terpenes, sun-protection filters, nanomaterials, endocrine disruptors). The document operates as the Council of Europe / EU operational counterpart to EU Cosmetics Regulation 1223/2009 Annex I Part B §3, which requires “inter alia a specific assessment for cosmetic products intended for use on children under the age of three.” Updates from the 1st edition include a new nanomaterials section, expanded coverage of endocrine disruptors, alignment of margin-of-safety calculations with SCCS Notes of guidance 12th revision (SCCS/1647/22), updated fluoride recommendations consistent with the 2019 European Academy of Paediatric Dentistry guideline, and explicit treatment of impregnated baby wipes. Heavy metals appear as a class throughout the document: as Annex II prohibited substances under EU Reg. 1223/2009 whose trace-level presence in finished cosmetics must be justified as technically unavoidable in GMP (Article 17), as named developmental toxicants where the document calls out inorganic lead (Pb) and organic mercury as substances “demonstrated to affect neural development over the entire period from conception to young adulthood,” as named immunotoxicants where lead is cited as “an example of a substance with a disruptive effect on the immune system of infants,” and as endocrine/growth-axis hazards where “lead and other heavy metals” are identified as substances that may affect growth-hormone-stimulated epiphysial cartilage with resulting growth disorders. The foreword additionally cites OCCL (Official Cosmetics Control Laboratories) European-network market surveillance findings that “banned ingredients (including colorants, preservatives and lead), as well as high concentrations of allergens and impurities (including nitrosamines)” were detected in surveys of so-called ‘kids’ cosmetics, raising the case for continued due-enforcement effort.

Key numbers

Definition and population scope (Resolution Article 1; Introduction)

• Infant — a child under the age of three years. Used throughout the Resolution and the guidance document; the term is not restricted to under-12-months. This is the operative age range for the inter alia specific assessment required by EU Reg. 1223/2009 Annex I Part B §3.

Physiological characteristics — skin surface area to body mass ratio (Main principles, p. 22)

Skin surface area to body mass ratio is higher in children than in adults:

• 2.3× higher in babies at birth
• 1.8× higher at 6 months
• 1.6× higher at 12 months
• 1.5× higher at 5 years

This factor enters the dermal-exposure dose calculation directly: the same applied amount of product spread across the same body-coverage fraction produces higher per-kilogram dermal exposure in infants than in adults. The 2nd edition does not propose an additional uncertainty factor on this basis (see SCCNFP 2002 below) but requires that the ratio be taken into account either in the dermal exposure dose (D_derm) or in the margin-of-safety calculation.

Margin-of-safety calculation framework (Recommendations, pp. 39-41)

• Default uncertainty factor: MoS ≥ 100, comprising 10× inter-species + 10× intra-species (SCCS Notes of guidance 12th revision; SCCS/1647/22, May 2023).
• Reference equation: MoS = PoD_sys / SED, where PoD is the point of departure (typically NOAEL or BMD from oral studies, mg/kg body weight per day) and SED is the systemic exposure dose.
• Route-to-route extrapolation when oral PoD must be applied to dermal exposure: MoS = (NO(A)EL_oral × F_oral) / (D_derm × F_derm); when oral bioavailability data are absent, the SCCS default is F_oral = 50 %; for poorly absorbed substances F_oral = 10 % may be appropriate.
• For products applied on the buttocks: precautionary 100 % dermal absorption assumed, because the buttocks are a particularly sensitive area due to moisture, occlusion, friction, urine/faecal enzymatic exposure and elevated local pH.
• For all other products: when dermal absorption data are unavailable or only estimated from modelling, 100 % dermal absorption should be assumed.
• For rinse-off products: cutaneous retention factor (R) is applied per category from the SCCS guidelines (e.g., 1 % for shampoos and shower gels). For oily continuous-phase formulations (bath creams), no retention factor is standardised in SCCS guidelines; for rinse-off infant products generally, a 10 % retention factor is to be considered in the absence of specific testing.

Microbiological specifications for finished cosmetic products intended for infants (Recommendations, p. 42)

• Total viable count for aerobic mesophilic micro-organisms must not exceed 10² CFU/g or 10² CFU/mL of product.
• Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans must not be detectable in 1 g or 1 mL of product.
• Microbiological testing per ISO 21148 (General Instructions for Microbiological Examinations) using test samples of at least 1 g or 1 mL.
• Challenge testing is required on the finished product against micro-organisms from official collection strains; the lowest effective preservative concentration is determined by challenge-test result.

Heavy-metal named hazards (Main principles; toxicokinetics/toxicodynamics)

The document does not measure heavy-metal concentrations in any product or class of products. It cites heavy metals by name as developmental and systemic hazards relevant to infant safety assessment, with cross-reference to a single reviewing source (Wolterink et al., RIVM report 320012001, 2007):

• Inorganic lead (Pb) and organic mercury named alongside ethanol and vitamin A as “neurotoxic substances … demonstrated to affect neural development over the entire period from conception to young adulthood” (p. 22, nervous-system subsection of Organs and systems in development).
• Lead (Pb) named as “an example of a substance with a disruptive effect on the immune system of infants” (p. 23, immune-system subsection).
• “Lead and other heavy metals” identified as substances that “may affect” the growth of epiphysial cartilage stimulated by growth hormone produced in the hypophysis, “resulting in growth disorders” (p. 24, endocrine-system subsection).
• OCCL (European Network of Official Cosmetics Control Laboratories) market-surveillance surveys cited in the Foreword (p. 6) found “banned ingredients (including colorants, preservatives and lead), as well as high concentrations of allergens and impurities (including nitrosamines)” in ‘kids’ cosmetics. No quantitative occurrence figure is provided in the EDQM document itself; the document treats these findings as evidence that continued OCCL surveillance and enforcement are warranted.

Heavy-metal trace-impurity framework (Impurities, p. 43)

The 2nd edition restates the EU Reg. 1223/2009 Article 17 framework without setting numeric trace limits:

• “The presence in cosmetics of trace levels of prohibited substances, such as heavy metals, must be justified in an exhaustive way, and the level of technical unavoidability must be established. Some trace substances have a regulatory concentration limit.”
• Impurities from raw materials, packaging materials, the manufacturing process, and chemical changes/interactions in the finished product must be characterised.
• Safety assessors must seek toxicological information on each impurity and account for it in the finished-product safety assessment.
• Impregnated baby wipes are flagged separately: cosmetic carrier materials (impregnated wipes, cotton) can release impurities that may affect product safety; the impurity profile of the carrier material must be characterised and restricted.

Ingredient exclusion criteria for infant cosmetics (Resolution Article 3; Recommendations, pp. 32-33)

The Resolution and guidance require that cosmetic products intended for infants contain no more than a strict minimum number of ingredients, and the following classes of substances (including impurities) should not be present:

• Substances with carcinogenic, mutagenic or reproductive-toxicity properties (CMRs)
• Substances with endocrine-disrupting activity
• Substances on the Annex XIV candidate list under REACH (Reg. (EC) No 1907/2006) Substances of Very High Concern
• Substances classified as potent allergens
• Persistent, bioaccumulative and toxic (PBT) or very persistent / very bioaccumulative (vPvB) substances per REACH Annex XIII
• Respiratory sensitisers
• CMR category 1A, 1B or 2 substances under Part 3 of Annex VI to the CLP Regulation (Reg. (EC) No 1272/2008) are banned in cosmetics for infants under Article 15 of the EU Cosmetics Regulation. This catches the named inorganic-arsenic, lead, cadmium, Cr(VI), Ni-carcinogen and beryllium compounds listed in CLP Annex VI.
• Substances on the IARC monographs list with potential carcinogenicity should not be present.
• Substances in the registry of CLH intentions for new or revised harmonised CMR classification with proposed CMR potential should be excluded.

Fluoride recommendations for infant toothpastes (Annex, p. 47-48)

Recommended use of fluoride toothpastes in children, per the European Academy of Paediatric Dentistry 2019 Fluoride Guideline (Toumba et al. 2019):

* For children 2–6 years, 1 000+ ppm fluoride concentrations may be considered based on individual caries risk.

• Infants aged 24 to 36 months ingest approximately 60 % of the toothpaste loaded onto a toothbrush (Moraes et al. 2007); the assessor should assume young children may ingest most of the toothpaste applied.
• Total fluoride ingestion from all sources for children 1–3 years should not exceed the accepted adequate intake of 0.7 mg/day, which maximally reduces dental caries without causing fluorosis.
• Annex III of EU Reg. 1223/2009 (as amended by Reg. (EU) No 344/2013) prescribes a mandatory warning on toothpastes containing 1 000 to 1 500 ppm fluoride, unless already labelled contra-indicated for children: “Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”

Terpene concentration limits for infant cosmetics (Annex, p. 49)

The 2008 AFSSAPS recommendation (Council of Europe and French Health Products Safety Agency) is that camphor, eucalyptol and menthol should be avoided in cosmetic products intended for infants; in perfume compositions where their presence is unavoidable, the AFSSAPS-acceptable maximum concentrations are:

• Camphor: 0.015 % (150 ppm)
• Eucalyptol: 0.1 % (1 000 ppm)
• Menthol: 0.45 % (4 500 ppm)

The terpene caps do not apply to oral hygiene products. A special-warning label against use in children should be included on products containing camphor, eucalyptol or menthol that are destined for older consumers.

Sun-protection products for infants (Annex, pp. 49-51)

• Infants under one year of age should be kept out of direct sunlight; older infants should not be exposed to direct sun without adequate protection (clothing, hat, sunglasses, very high protection sunscreens).
• For the safety assessment of sun-protection products for infants, dermal absorption percentages of 1 % or less have been observed for individual sunscreen agents, but exceptions exist (e.g., benzophenone-3, per SCCS Final Opinion SCCS/1625/20, 2021; Calafat et al. NHANES 2003-2004 data).
• The skin surface area to body mass ratio of infants must be considered either at the level of exposure conditions or the level of margin-of-safety (SCCNFP position statement SCCNFP/0557/02, 2002).
• When data on dermal absorption are not available or only estimated from modelling, a default 100 % dermal absorption value is to be used for the MoS calculation.

Buttocks-specific exposure scenario (Exposure characteristics, pp. 26-27)

The infant nappy area is identified as a particularly sensitive cosmetic-application site. Five compounding conditions: (1) moist environment due to urine; (2) elevated local pH from ammonia and faecal enzymes plus alkaline soap; (3) presence of faecal protease and lipase enzymes; (4) almost continuous occlusion and friction with body-weight loading; (5) the resulting skin-problem load (infections, rashes, dermatitis) renders the skin more permeable to ingredients in cosmetic products. The 100 % dermal absorption assumption used in the MoS calculation for products applied on the buttocks (see margin-of-safety section above) derives directly from this exposure scenario.

Mouthing-behaviour exposure scenario (Exposure characteristics, pp. 28-29)

Five additional infant-specific exposure scenarios are itemised: (1) accidental ingestion of product when sucking the container or consuming its contents; (2) ingestion of small amounts of rinse-off products (e.g., swallowing rinsing water after shampoo or bath gel use, swallowing some toothpaste); (3) ingestion of small parts of the container (screw caps, dosage pump heads); (4) aspiration of liquids, particularly dangerous for products containing hydrocarbons; (5) eye exposure to shampoos, bath foams, sprays directly or indirectly. The OECD ENV/JM/MONO(2019)29 guidance on assessing children’s exposure to chemicals from products is cited as the methodological reference (Ref. 27).

Routing rationale

This is a regulatory-guidance document (Council of Europe Resolution + EDQM technical guidance), not a market survey. It is registered under source_type: gov-guidance and evidence_tier: A. The products: list targets the infant cosmetic product classes the document specifically addresses through its safety-assessment guidance and Annex ingredient recommendations: shampoos and bath products (baby-shampoo-body-wash), leave-on creams and lotions (baby-lotion-cream), oils (baby-oil), talc and cornstarch powders (baby-talcum-powder, baby-powder-cornstarch), impregnated wipes (baby-wipes), sunscreens including the Annex sun-protection section (baby-sunscreen-mineral, baby-sunscreen-chemical), nappy-area products that the buttocks exposure scenario governs (diaper-cream-non-zno, diaper-cream-zno), toothpastes that the fluoride Annex governs (toothpaste — the document discusses infant-specific use rather than adult), and the children-personal-care umbrella that covers other infant cosmetics including fragrance compositions, perfumes and bubble baths discussed in the Resolution and Foreword. The matrix slug cosmetic-personal-care carries the horizontal scope.

This document is not the canonical home for any single ingredient contamination_profile cell; it provides no measured occurrence data. Its role in the wiki is as the European safety-assessment baseline that infant-cosmetic product pages should reference for their regulatory-context section, alongside eu-2009-1223-cosmetic-products-regulation (the binding horizontal regulation it operationalises), the SCCS Notes of guidance 12th revision (SCCS/1647/22, May 2023; cited throughout but not yet a wiki source page), and any agency-specific national guidance for member states applying CM/ResAP (2012) 1.

Metals: the document explicitly names lead (Pb) and mercury — specifically organic mercury in the neurodevelopmental-toxicant statement. iAs/tAs and MeHg/tHg are not separately distinguished in the EDQM body text. The frontmatter is registered as tHg (the document’s “organic mercury” maps to MeHg in the strictest reading but is reported here without speciation methodology so tHg is the conservative listing per HMI speciation conventions; methylmercury is the relevant species developmentally but the document does not measure or distinguish it). Other heavy metals are referenced as a class (“lead and other heavy metals”); they are not added to the metals: array because the document neither names them nor proposes specific guidance for them.

Jurisdiction: the document is binding (qua Resolution) on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia, which includes the EU 27 plus Norway, Switzerland, Turkey, the UK, and other Council of Europe states (the 2012 footnote enumerates 37 states). The jurisdictions: array uses EU as the conservative slug because (a) most operational implementation is in EU member states via Reg. 1223/2009 and (b) HMI does not currently carry a CoE jurisdiction slug. The broader Council of Europe scope is captured in this Routing rationale.

Pages updated

• eu-2009-1223-cosmetic-products-regulation — the EU 1223/2009 page’s existing forward-reference to this document (previously demoted to plain prose pending REG-007 ingest) can now be re-linked as a proper wikilink in a future revision of that page. Not modified in this ingest per skill v2 Phase 1 scope.
• Regulation hub page for CM/ResAP (2012) 1 / EDQM 2nd edition does not yet exist. Per CLAUDE.md Part 10, regulation pages are created at first encounter; this source-page ingest surfaces the proposal but does not author the regulation page itself (Karen’s Step 0 / regulation-hub workflow).

Sources

• European Directorate for the Quality of Medicines & HealthCare (EDQM). 2023. Safe cosmetics for young children: a guide for manufacturers and safety assessors. 2nd edition. Council of Europe, Strasbourg, France. ISBN 978-92-871-9360-5 (English). 56 pages. https://freepub.edqm.eu/publications/PUBSD-94/detail
• Council of Europe Committee of Ministers. 2012. Resolution CM/ResAP (2012) 1 on safety criteria for cosmetic products intended for infants. Adopted 14 March 2012, 1137th meeting of the Ministers’ Deputies. https://search.coe.int/cm/Pages/result_details.aspx?ObjectID=09000016805cb622
• 1st edition (English only): EDQM. 2012. Safe cosmetics for young children.
• Reference [1] in the document: Scientific Committee on Consumer Safety (SCCS). Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 12th revision, 15 May 2023, SCCS/1647/22. https://health.ec.europa.eu/publications/sccs-notes-guidance-testing-cosmetic-ingredients-and-their-safety-evaluation-12th-revision_en

Verification notes

Fresh ingest from raw/Manual Fetch Kimi /June 1 Infant cosmetics metals papers/02_Regulatory_Reports/REG-007_EDQM_2023_Safe_Cosmetics_Young_Children_2nd_Ed.pdf. Document is the 2nd edition of an EDQM/Council of Europe guidance document; not a primary research paper and not a binding hard regulation. Classified as gov-guidance rather than gov-regulation because the operative legal instrument is CM/ResAP (2012) 1 (a Recommendation to member states), not a directly-applicable Regulation. The EU-level binding instrument it operationalises is eu-2009-1223-cosmetic-products-regulation Annex I Part B §3.

No numerical contamination values are reported in this document; the Key numbers section therefore captures the operational thresholds the document does set (population definitions, skin/body-mass ratios, MoS defaults, microbiological caps, fluoride and terpene caps) plus the heavy-metal substance-by-substance hazard statements (lead, organic mercury) and the trace-impurity framework. This is consistent with the EU Reg. 1223/2009 source page (eu-2009-1223-cosmetic-products-regulation), which is similarly registered as a regulatory-framework page rather than a market-survey page.

Page authored 2026-06-02 per the v2.0 ingest skill (Phase 1 single-PDF, Phase 2 auto-audit completed same date).

Audit subagent (2026-06-02, fresh-context general-purpose Agent) returned verdict PROMOTE. Checks 2-5 (slug vocabulary, speciation, brand firewall, wiki/HMTc firewall) returned ✅ clean. Check 1 (numerical fidelity) returned ✅ across all measured values and three ⚠️ on reference-identifier verifiability that the subagent could not confirm because it had only partially extracted the EDQM References list (pp. 52-56). Independent verification against the References list confirms all three subagent ⚠️ concerns are false positives:

• Ref [42] (cited in wiki Annex/fluoride section as “Moraes et al. 2007”): verified against EDQM References p. 55 as Moraes SM, Pessan JP, Ramires I, Buzalaf MAR. Fluoride intake from regular and low fluoride dentifrices by 2-3-year-old children: influence of the dentifrice flavour. Braz Oral Res 2007;21(3):234-40. Surname “Moraes” and year 2007 are correct.
• Ref [60] (cited in wiki sun-protection section as “SCCNFP position statement SCCNFP/0557/02, 2002”): verified against EDQM References p. 56 as Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP). Position statement on the calculation of the margin of safety of ingredients incorporated in cosmetics which may be applied to the skin of children. SCCNFP/0557/02, final; 2002. Document identifier and year are correct.
• Refs [63] and [64] (cited in wiki sun-protection section as “SCCS Final Opinion SCCS/1625/20, 2021; Calafat et al. NHANES 2003-2004”): verified against EDQM References p. 56 as Calafat AM, Wong LY, Ye X, et al. Concentrations of the sunscreen agent benzophenone-3 in residents of the United States: National Health and Nutrition Examination Survey 2003-2004. Environ Health Perspect 2008;116(7):893-7; and Scientific Committee on Consumer Safety. SCCS Final Opinion on Benzophenone-3. SCCS/1625/20; 2021. NHANES 2003-2004 cycle, SCCS/1625/20 opinion number, and 2021 year are correct.

No content changes were applied as a result of the audit. The PROMOTE verdict stands.

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.