A survey and health assessment of cosmetic products for children

Overview

This Danish Environmental Protection Agency report (Survey of Chemical Substances in Consumer Products, No. 88, 2007), prepared by FORCE Technology Department of Sustainability and Management with constituent analyses by Eurofins, mapped 208 cosmetic products marketed for children (ages 3-14) on the Danish market in April-June 2006 and conducted targeted analyses on subsets: 17 products for the 26 mandatory-declaration fragrances (Eurofins, GC-MS), 11 products for the preservative Kathon (Eurofins, HPLC-UV), 14 packaging materials for chlorine as a PVC screen, 10 packaging materials for phthalates (GC-MS), and 10 packaging materials for heavy metals (FORCE Technology, XRF). The heavy-metals scope of this report is entirely PACKAGING, not the cosmetic product itself; the report explicitly notes that since total values in packaging are well below EN 71-3 toy-migration limits, no product-migration analyses were performed. All ten packaging materials returned total values for Cr, Ni, As, Se, Cd, Sn, Sb, Ba, Hg, Pb that are “substantially below” (4× to 450× below) the EN 71-3 migration ceilings; the one notable outlier is one bobble-bath valve part at 360 ppm total Sn, attributed in-text to use of organotin heat stabilisers in PVC.

Key numbers

Per-sample heavy-metals concentrations in packaging materials by X-ray fluorescence (XRF) on a Spectro X-LAB 2000, surface analysis to ~100 µm depth, detection limit 1 mg/kg, ±10% relative uncertainty (Table 5.13, p. 62; unit ppm = mg/kg; < indicates below the per-element detection limit which varied between samples and is reported sample-by-sample as in the source):

ID no.	Product type	Part analysed	Cl (NB:%)	Cr ppm	Ni ppm	As ppm	Se ppm	Cd ppm	Sn ppm	Sb ppm	Ba ppm	Hg ppm	Pb ppm
21	Bobble bath	Face	24	<7	5	<0.4	0.8	0.3	2	<0.8	<5.3	0.9	2
27	Body shampoo/bath gel	Arm (glove)	10	<9	15	1.4	0.9	0.8	4	<1.0	52	2	4
32	Body shampoo/bath gel	Peaked cap	19	<6	3	<0.4	0.9	0.4	<1.1	<1.1	<8.1	0.4	3
40	Hairstyling product	Cover (top)	0.01	<3	14	<0.2	<0.2	<0.5	<1	<1.0	<7.7	<0.5	1
74	Shampoo	Cover (top)	<0.003	<15	1	<0.1	0.5	0.7	2	12	<6.7	<2	1
166	Body lotion/cream	Cover (top)	0.01	<3	9	<0.2	0.8	0.5	1	<1.1	<7.8	0.8	2
184	Body lotion/cream	Tube near “body lotion” sign	1	<2	32	<0.3	0.5	2	<2.5	<2.2	<19	<0.5	2
193	Body lotion/cream	Stomach	0.05	<3	12	<0.2	0.8	0.6	1	<0.9	<6.8	<0.5	2
206	Shampoo	Tube near stripes	0.2	<3	24	<0.2	0.6	<1	<1.1	<1.2	<9.0	<0.5	1
207	Bobble bath	Near valve (soft plastic, PVC)	30	15	7	<0.4	1	3	360	<2.6	45	2	3

Per-element maximum total values observed across the 10 packaging samples (Table 5.14, p. 63; cosmetic-product packaging maxima compared to EN 71-3 limit values for migration of substances from toy materials in mg/kg):

Element	EN 71-3 max migration (mg/kg)	Maximum total value measured in packaging (mg/kg)	Ratio (limit / max measured)
Cr	60	15	4× below
As	25	1.4	~18× below
Se	500	1.1	~450× below
Cd	75	3.4 (note 1)	~22× below
Sb	60	12	5× below
Ba	1000	52	~19× below
Hg	60	2	30× below
Pb	90	4	~22× below

Note 1: Table 5.14 reports the Cd maximum as 3.4 mg/kg; Table 5.13 per-sample values show 3 ppm at ID 207 as the highest enumerated Cd value (other samples are 2, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3 or <1/<0.5). The 3.4 figure in Table 5.14 is preserved as the source reports it; the small discrepancy with Table 5.13’s 3 ppm rounding is a paper-internal precision difference rather than a transcription error.

The report does NOT enumerate per-element EN 71-3 maxima for Ni or Sn in Table 5.14, but Table 5.13 maxima are: Ni 32 ppm (ID 184 body lotion/cream tube) and Sn 360 ppm (ID 207 bobble bath near valve). Both are total-content values, not migration values; the in-text discussion (p. 62) explains the 360 ppm Sn outlier as a likely use of “sulphurous organic tin compounds” as PVC heat stabilisers per Plastics Additive Handbook (Hanser Publications, 2001).

Companion non-heavy-metals findings on the same product survey (reported here for context; not for routing to metal pages):

Phthalate content in 10 packaging materials (Table 5.15, p. 64; quantitative GC-MS): DEHP, DINP, and a tentatively identified DEHIP (possibly DnOP — lacking reference standard) were the phthalates found; maximum total phthalate content was 31% in soft-plastic figure-designed bath packaging. Five packaging materials contained 26-31% DEHP or DINP (IDs 5 DEHP 27%, 33 DEHP 26%, 34 DEHP 27%, 128 DINP 31%, 196 DINP 28%); ID 207 contained 26% DEHIP/DnOP; ID 21 contained 0.4% DEHP plus 15% DEHIP/DnOP; ID 27 was softened with citric acid tributylesteraetat (acetyltributylcitrat) at < 0.05% phthalate; ID 32 contained 11% DEHIP/DnOP; ID 82 had no detectable plasticiser content. DEHP, DINP, and DnOP were banned from April 2007 in toys for children up to 14 years and in child-care articles above 0.1% (DINP and DnOP only in mouthable items).
Chlorine screening in 14 packaging materials (Table 5.12, p. 61; Beilstein’s test plus XRF): 11 of 14 returned positive for chlorine (one of which, ID 82, was mixed +/- across two parts), confirming PVC composition. The three packaging materials returning negative for chlorine across all sampled parts (IDs 40, 193, 206) were of different plastic types — confirmed by trace XRF Cl values of 0.01%, 0.05%, and 0.2% respectively, well below the percent-level Cl content expected of PVC.
26 mandatory-declaration fragrances in 17 cosmetic-product samples (Table 5.7, pp. 52-57; GC-MS; ranges per fragrance reported, max single fragrance 3400 mg/kg butylphenylmethylpropional (Lilial) in an eau de toilette): six of 17 analysed products had declaration that did not match analysis results (illegal under the Cosmetics Statutory Order if produced after 10 March 2005).
Kathon preservative (chlormethyl-isothiazolone + methyl-isothiazolone, 3:1) in 11 cosmetic-product samples (Table 5.10, p. 59; HPLC-UV; range 3.0-12 mg/kg): all 11 below the 15 mg/kg maximum allowed concentration; three of the 11 had detectable Kathon without it being declared on the product (Cosmetics Statutory Order deviation).

The 208 mapped products span (Project results, pp. 8-9): body shampoo/bath gel; bath confetti/caviar/fizzle salt; shampoo; bobble bath; toothpaste; body lotion/cream; soap (solid); eau de toilette - perfume; bath oil; “others” (e.g., body spray); hair dye (rinsing colour); balsam; hairstyling products; deodorant; massage oil; soap (liquid). The volume of yearly sales is not reported; 461 different constituents were found across the 208 products (average 16 per product); 74% of products contained perfume; 63% contained preservatives; 57% contained colouring agents; none contained triclosan; 27% had packaging designed as a special figure; another 24% had figure-decorated packaging without the figure being the package shape; 19 of the 56 figure-shaped products were indicatively classified by the Danish Safety Technology Authority as toys under the Toys Directive.

Methods (brief)

Heavy metals in packaging — analytical method (Section 5.3.1.1, p. 60): X-ray fluorescence (XRF) on a Spectro X-LAB 2000 instrument. All elements at atomic number ≥ 11 (Na) detected. Surface analysis to approximately 100 µm depth depending on material. Detection limit reported as < 10 ppm in general per the instrument specification, and operationally 1 mg/kg for the heavy-metals quantitative analysis (Table 5.11, p. 60). Relative uncertainty: ±10%. Total-content values only — these are NOT migration values from EN 71-3 leach testing. Sample selection (Section 5.1.3, p. 48): 10 of 208 products selected for heavy-metals analysis with emphasis on strongly coloured packaging (highest a-priori probability of pigment-based heavy-metal content) and common product types (body shampoo/bath gel, shampoo, bobble bath) plus body lotion/cream and hairstyling product chosen for strongly coloured packaging materials. Figure-designed packaging was weighted in selection because such items might be used as toys and put in the mouth by small children/siblings, motivating heavy-metals screening against toy-directive limits.

Phthalates in packaging — extraction with dichloromethane and analysis by GC-MS on a Varian Saturn 2000 ion-trap system; detection limit migration 0.005 mg/l, quantitative 0.001 W/W%; ±10% relative uncertainty (Section 5.3.1.3 / Table 5.11, p. 60).

Polymer identification — Beilstein’s test (qualitative chlorine flame test as PVC screen) carried out on all packaging polymer samples (Section 5.3.1.2, p. 60).

Fragrances — partial sample extracted in water plus tert-butylmethyl ether with suspension/heating/cooling for ~16 hours; GC-MS, repeat determinations; detection limit 1 mg/kg; 10-15% RSD (Section 5.2.1.1, p. 50).

Kathon — ~2.5 g sample extracted and diluted in demineralised water, 0.45 µm filtered, HPLC-UV (212 and 280 nm; 35% methanol / 65% water isochratic; 0.500 mL/min; 15 min run); detection limit 2 mg/kg; 10-15% RSD (Section 5.2.1.2, p. 50).

Speciation: total content only for all metals (XRF is a total-elemental technique; no inorganic-vs-organic Pb, As, Hg, Cr speciation). Per Part 14, this paper’s metals enter the wiki as tAs (not iAs), tHg (not MeHg), Cr (not Cr-VI), Sn (not organotins) even though the report’s discussion proposes that the high Sn value at ID 207 is from organic-tin heat-stabilisers. The Sn measurement itself does not separate inorganic from organic tin; the organic-tin attribution is a discussion-section hypothesis based on prior literature on PVC additives, not a speciation measurement.

Risk-assessment scope of the report: the report’s quantitative risk assessments (Chapter 7) cover Kathon and benzyl alcohol acute toxicity only, not heavy metals. The heavy-metals discussion (Section 8.2, p. 94) explicitly does NOT compute risk because total content is well below toy-migration limits and migration testing was not conducted.

Implications

Certification (HMTc): The packaging-only scope is important to preserve in any downstream use. This source contributes packaging-material total-content data on children’s cosmetic-product containers for ten metals; it does NOT contribute occurrence data on heavy metals in the cosmetic formulations themselves. For HMTc threshold work on children’s personal care (Cat 2) — where the certified analyte is concentration in the product as placed on market — these values are NOT direct occurrence inputs to threshold percentile pools. They are relevant as context for a separate question: whether colourful, figure-designed plastic packaging contributes meaningful heavy-metals exposure to the child via dermal contact or hand-to-mouth transfer (the report itself concludes “no” relative to EN 71-3 toy migration ceilings, based on total content well below migration limits and without performing migration testing). The 360 ppm Sn outlier in PVC bath-packaging is the single value that an HMTc reviewer might revisit if Cat 2 threshold work extends to packaging composition.
Courses: Useful as a teaching case for (a) the distinction between total content and migration limits, (b) the EU Toys Directive vs. Cosmetics Directive intersection when a cosmetic product’s packaging is figure-shaped enough to qualify as a toy, and (c) the policy logic of using XRF as a cheap upstream screen with EN 71-3 migration testing reserved only for samples above a total-content trigger threshold.
App: Not relevant to ingredient contamination_profile (the paper does not measure metals in cosmetic ingredients or in cosmetic formulations).
Microbiome: Not addressed.

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