ISO 8124-3:2020 — Safety of toys — Part 3: Migration of certain elements (Third edition, 2020-03)

Overview

This is the third edition of the International Organization for Standardization (ISO) toy safety standard for soluble heavy-element migration, prepared by ISO/TC 181 Safety of toys and published 2020-03 as ISO 8124-3:2020(E). The standard specifies maximum acceptable levels and methods of sampling, extraction, and determination for the migration of eight elements — antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium — from accessible toy materials and parts of toys. Maximum levels are stated in milligrams per kilogram of toy material and are reported as adjusted analytical results after subtraction of a per-element analytical correction. Three material categories receive distinct limit sets: any toy material other than modelling clay and finger paint, modelling clay, and finger paint. The standard’s underlying derivation is a daily bioavailability budget per element combined with an assumed 8 mg/day average ingestion of toy material; the third edition’s main technical changes versus ISO 8124-3:2010 are the introduction of two detailed dewaxing methods for sample preparation and the addition of an informative ICP-OES analytical method in Annex C. The 2020 edition consolidates ISO 8124-3:2010 with its 2014 and 2018 amendments into a single republished document.

Key numbers

Table 1 — Maximum acceptable element migration from toy materials (mg/kg of toy material, adjusted analytical result)

Toy material	Sb	As	Ba	Cd	Cr	Pb	Hg	Se
Any toy material per Clause 1, except modelling clay and finger paint	60	25	1 000	75	60	90	60	500
Modelling clay	60	25	250	50	25	90	25	500
Finger paint	10	10	350	15	25	25	10	50

Material conformity is determined against the adjusted analytical result obtained by subtracting the per-element analytical correction in Table 2 from the laboratory’s analytical result.

Table 2 — Analytical correction (%) applied to the laboratory analytical result before comparison to Table 1

Element	Sb	As	Ba	Cd	Cr	Pb	Hg	Se
Analytical correction (%)	60	60	30	30	30	30	50	60

Worked example provided in §4.2: a measured lead migration of 120 mg/kg, less the 30 % lead (Pb) correction, yields an adjusted result of 84 mg/kg, which is below the 90 mg/kg Pb limit and therefore conforming.

Daily bioavailability budget underlying the limits (Introduction)

The limits are derived from a per-element daily bioavailability budget combined with a working hypothesis of 8 mg/day average toy-material ingestion across material categories:

antimony: 0.2 µg/day
arsenic: 0.1 µg/day
barium: 25.0 µg/day
cadmium: 0.6 µg/day
chromium: 0.3 µg/day
lead: 0.7 µg/day
mercury: 0.5 µg/day
selenium: 5.0 µg/day

The Introduction explicitly notes that the 8 mg/day toy-ingestion figure is the currently accepted working hypothesis and that in certain individual cases this value might be exceeded. Limit values were further adjusted to ensure analytical feasibility taking into account limits achievable under current manufacturing conditions (see Annex D, Background and rationale, which lies outside the iTeh preview’s visible page range — see verification notes).

Scope of application (§1.1–§1.4)

§1.1 — The standard specifies maximum acceptable levels and methods for the eight elements named above, applied to toy materials and parts of toys.

§1.2 — Maximum levels are specified for migration from the following toy materials: coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings (§9.1); polymeric and similar material including laminates, whether textile-reinforced or not but excluding other textiles and non-woven textiles (§9.2); paper and paperboard (§9.3); natural, artificial or synthetic textiles (§9.4); glass/ceramic/metallic materials, excepting lead solder when used for electrical connections (§9.5); other materials whether mass-coloured or not, e.g. wood, fibreboard, hardboard, bone and leather (§9.6); materials intended to leave a trace, e.g. graphite materials in pencils and liquid ink in pens (§9.7); pliable modelling materials, including modelling clays and gels (§9.8); paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and similar materials in solid or liquid form (§9.9).

§1.3 — The requirements apply to: all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys, irrespective of any age grading or recommended age labelling; all toys intended for or suitable for children under 72 months of age; accessible coatings, irrespective of any age grading or recommended age labelling; accessible liquids, pastes and gels (e.g. liquid paints, modelling compounds), irrespective of any age grading or recommended age labelling.

§1.4 — Packaging materials are excluded unless they are intended to be kept (e.g. boxes and containers) or unless they form part of the toy or have intended play value. Parts of toys obviously unlikely to be sucked, licked or swallowed (e.g. the coating on the crossbeam of a swing set, the tyres of a toy bicycle) bear no requirement under this document.

Extraction principle (§5)

Soluble elements are extracted from toy materials under conditions that simulate the material remaining in contact with stomach acid for a period of time after swallowing. Concentrations of the soluble elements are then determined quantitatively by inductively coupled plasma optical emission spectrometry (ICP-OES) or other specified analytical methods with specified method detection limits (MDL).

Reagents (§6)

The principal extraction reagent is hydrochloric acid: c(HCl) = (0.07 ± 0.005) mol/L (§6.1), with HCl solutions at approximately 0.14, 1, 2, and 6 mol/L specified for pH adjustment and other procedural uses (§6.2–§6.5). General-purpose reagent n-heptane (C₇H₁₆, 99 %) is specified in §6.6. Water of at least grade 3 purity, in accordance with ISO 3696, is required (§6.7).

Apparatus highlights (§7)

A plain-weave wire-cloth stainless steel metal sieve of nominal aperture 0.5 mm with tolerances per Annex A Table A.1 (§7.1); means of measuring pH to proper accuracy without cross-contamination, with the mixture pH range required between 1.0 and 1.5 as specified in §9 (§7.2); a 0.45 µm pore size membrane filter (§7.3); a centrifuge capable of (5 000 ± 500) g (§7.4); means of agitating the mixture at (37 ± 2) °C (§7.5); a Soxhlet extractor per ISO 8124-6:2018 Figure C.1 (§7.7); a solvent extractor per ISO 8124-6:2018 Figure C.2 (§7.8); high retention filter paper (§7.9).

Selection of test portions (§8)

A laboratory sample shall consist of a toy either in the form in which it is marketed or in the form in which it is intended to be marketed. Test portions shall be taken from the accessible parts (see ISO 8124-1). Identical materials in the toy may be combined and treated as a single test portion, but additional toy samples shall not be used. Test portions may be composed of more than one material or colour only if physical separation (e.g. dot printing, patterned textiles) or mass limitation precludes the formation of discrete specimens. Test portions of less than 10 mg of material shall not be tested.

Coatings extraction (§9.1) — only sub-clause of §9 visible in the iTeh preview

§9.1.1 Test portion preparation: remove the coating from the laboratory sample by scraping at room temperature and comminute it at a temperature not exceeding ambient. Collect enough coating to obtain a test portion of preferably not less than 100 mg passing a 0.5 mm sieve (§7.1). If between 10 mg and 100 mg of uncontaminated uniform coating is available, extract in accordance with §9.1.2 and calculate the quantity of the soluble elements as if a 100 mg test portion had been used; report the test-portion mass per Clause 11(e). Coatings that cannot be comminuted by nature (e.g. elastic/plastic paint) are removed from the laboratory sample without comminuting.

§9.1.2 Extraction procedure: mix the prepared test portion with 50 × its mass of c(HCl) = 0.07 mol/L aqueous HCl at (37 ± 2) °C in a container of appropriate size (§7.6). [For 10–100 mg test portions, mix with 5.0 mL of the same HCl solution at (37 ± 2) °C.] Shake for 1 min; check acidity; if pH > 1.5, add approximately 2 mol/L HCl dropwise while shaking until pH is between 1.0 and 1.5. Protect from light; agitate continuously at (37 ± 2) °C for 1 h; then allow to stand for 1 h at (37 ± 2) °C. Without delay, separate solids by membrane filtration (0.45 µm) and, if necessary, by centrifuging at up to 5 000 g (no longer than 10 min, reported per Clause 11(e)). For storage beyond one working day prior to elemental analysis, stabilize the solution with HCl to approximately c(HCl) = 1 mol/L (§6.3) and report per Clause 11(e).

Document changes vs ISO 8124-3:2010 (Foreword)

The third edition cancels and replaces the second edition (ISO 8124-3:2010) and incorporates Amendments ISO 8124-3:2010/Amd.1:2014 and ISO 8124-3:2010/Amd.2:2018. Foreword-stated main changes:

two detailed dewaxing methods have been introduced to replace the original one
an ICP-OES method for determination of the elements is given in Annex C as informative content

Normative references (§2)

ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8124-1:2018, Safety of toys — Part 1: Safety aspects related to mechanical and physical properties
ISO 8124-6:2018, Safety of toys — Part 6: Certain phthalate esters in toys and children’s products

Methods (brief)

ISO 8124-3:2020 specifies a stomach-acid simulation extraction followed by quantitative elemental analysis. The extraction acid is c(HCl) = 0.07 mol/L (the approximate molarity of resting human gastric acid), the temperature is (37 ± 2) °C (body temperature), the extraction is 1 h of continuous agitation followed by 1 h of standing, and the liquid-to-solid ratio is 50 × the test-portion mass. The pH of the extract is brought into the 1.0–1.5 range using approximately 2 mol/L HCl if the initial value exceeds 1.5. Solids are removed by 0.45 µm membrane filtration and centrifugation up to 5 000 g (≤10 min). The recovered solution is analysed for the eight target elements by ICP-OES per Annex C (informative) or by other methods with comparable method detection limits per §10.2 (not visible in the iTeh preview’s page range). Method-specific dewaxing procedures cover materials containing grease, oil, wax, or similar (§9.7.4, §9.8.3, §9.9.4, also outside the visible preview). Quantitation requires a method blank, calibration blank, calibration check solution, and per §3.3 a method detection limit equal to three times the standard deviation of the result obtained in the method blank by the analysing laboratory; per §3.11, the instrument detection limit equals three times the standard deviation of the calibration-blank result. The analytical result is then reduced by the per-element analytical correction in Table 2 before comparison to the maximum acceptable level in Table 1.

What this preview does not contain. The PDF ingested is the iTeh STANDARD PREVIEW for ISO 8124-3:2020 (12 pages total, the first ~13 pages of the full ~30+ page standard). The visible content covers the Foreword, Introduction, Clauses 1 (Scope), 2 (Normative references), 3 (Terms and definitions), 4 (Maximum acceptable levels, including Table 1 and Table 2), 5 (Principle), 6 (Reagents), 7 (Apparatus), 8 (Selection of test portions), and 9.1.1–9.1.2 (Coatings of paint, varnish, lacquer, printing ink, polymer and similar coatings extraction procedure). The preview does not visibly contain §§9.2–9.9 (extraction procedures for polymeric materials, paper and paperboard, textiles, glass/ceramic/metallic materials, other materials, materials intended to leave a trace, pliable modelling materials, paints), §10 (Elemental analysis, including §10.1 Methods of analysis, §10.2 Method detection limit MDL values, §10.3 Calculation of results), §11 (Test report requirements), Annex A (normative Sieve requirements), Annex B (informative Selection of procedure), Annex C (informative Methods for analysis of elements, including the ICP-OES method that is the third edition’s headline addition), Annex D (informative Background and rationale, including the per-element MDL and per-material-category derivation that ties the daily bioavailability budget to the Table 1 limits), or the Bibliography. The numerical limits (Tables 1 and 2) and the per-element daily bioavailability budget (Introduction) are the highest-value extractable content from the preview; the per-material extraction details and per-method MDLs are not visible and a future ingest from the full ISO 8124-3:2020 document is warranted if the wiki ever needs to reference Annex C MDLs or §9.2–§9.9 per-material procedures.

Implications

Regulatory baseline for international toy-metals migration. ISO 8124-3:2020 is the current international voluntary consensus standard for migration of antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium from toy materials and parts of toys for children under 72 months. Many national toy safety regimes either incorporate ISO 8124-3 by reference (AS/NZS ISO 8124, IS 9873 Part 3 in India) or align technical limits with the ISO 8124-3 / EN 71-3 lineage that shares its 1985 derivation. The standard sits in the lineage that produced ASTM F 963 §4.3 in the U.S. (which until F 963-07 used the legacy EN 71-3 limits unchanged) and EN 71-3 in the EU (which the 2009/48/EC Toy Safety Directive subsequently tightened, particularly for cadmium (Cd), mercury (Hg), Se, and a new Cr-VI-specific limit not present in ISO 8124-3:2020). Heavy Metal Index pages for toy-materials contamination should treat ISO 8124-3:2020 as the international floor against which national variations (ASTM F 963, EN 71-3 / 2009/48/EC, GB 6675.4 in China, ST 2016 in Japan) are compared.
Speciation gap. The standard regulates total elemental migration: total chromium (Cr) (no Cr-III vs hexavalent chromium (Cr-VI) distinction), total Hg (no methylmercury (MeHg) vs iHg distinction), total arsenic (As) (no inorganic arsenic (iAs) vs total arsenic (tAs) distinction). This is a known limitation; the EU 2009/48/EC Toy Safety Directive introduced Cr-III and Cr-VI as separately regulated species, and the toxicological assessments underlying both standards (CPSC 2012 Versar review, RIVM 2006, ATSDR profiles) explicitly derive species-specific ADIs. ISO 8124-3:2020 reflects the ISO/TC 181 decision to keep the regulated quantity at the total-elemental level for analytical-feasibility and inter-laboratory comparability reasons; the underlying toxicological derivation (Annex D, not visible in the preview) is presumably based on the same species-specific PODs as the EU and U.S. analogues.
Migration vs total-content. ISO 8124-3 regulates migration (the fraction released into a stomach-acid simulant under controlled conditions), not bulk substrate concentration. A toy material may contain heavy metals in concentrations far above the Table 1 migration limits and still pass if the metals are not bioaccessible under the §9 extraction procedure; conversely, a damaged or aged surface (e.g. scratched paint) can release substantially more than an intact surface. The Kawamura et al. 2009 finding (summarized in Status Report: Review of Metals in the Toy Safety Standard, ASTM F 963) that 1 000 mg/kg Cd or Pb painted on glass plates released 310–910 mg/kg under the ISO 8124-3 scratched-paint extraction (3.5- to 12-fold above the migration limits for both metals) is the canonical illustration of why ISO 8124-3 cannot be back-translated to a total-content limit. HMT&C toy-related thresholds should distinguish migration- vs total-content limits explicitly rather than treating ISO 8124-3 numbers as content limits.
Analytical correction is part of the conformity rule. The Table 2 analytical correction (30–60 % per element) is not a precautionary buffer that conservative labs may choose to apply; it is the standard’s required adjustment between the raw analytical result and the value compared against Table 1. Sb, As, and Se receive the largest correction (60 %), reflecting the standard’s recognition of inter-laboratory variability for these three elements under ICP-OES at the relevant concentration range. Pages on toy-product testing should explain the adjusted-vs-raw distinction explicitly because it can cause apparent disagreement between certificate-of-analysis values reported by different labs that use different conformity-decision rules.
Modelling clay and finger paint are separately and more tightly regulated. Modelling clay tightens the Ba limit from 1 000 to 250 mg/kg, the Cd limit from 75 to 50 mg/kg, the Cr limit from 60 to 25 mg/kg, and the Hg limit from 60 to 25 mg/kg. Finger paint tightens further: Sb 10, As 10, Ba 350, Cd 15, Cr 25, Pb 25, Hg 10, Se 50 mg/kg. The rationale (per the Introduction’s reference to Annex D) is that ingestion of these material types is substantially more likely and quantitatively larger than for the general toy-materials category, so the underlying 8 mg/day toy-ingestion assumption is effectively re-scaled by a category-specific factor. Children’s art-and-craft material pages should reflect that ISO 8124-3 treats modelling clay and finger paint as a higher-exposure category, not as a lower-exposure one despite their generally lower bulk-metal content.
App. Not directly relevant to ingredient contamination_profile data because no food matrix is involved. Relevant to a future toy-screening surface: the standard’s three-tier classification (general toy material vs modelling clay vs finger paint), the 8 mg/day toy-ingestion assumption, and the 0.07 mol/L HCl / 37 °C / 1 h stomach-acid extraction principle are the underlying logic a consumer-facing toy explainer needs to convey when contrasting “migration limit” vs “total content.”
Courses. Useful primary international-standards document for the toy-metals regulatory-trajectory teaching module, particularly as the international consensus baseline against which the ASTM F 963 (U.S.) and EN 71-3 / 2009/48/EC (EU) trajectories are compared. The 2020 third edition’s headline addition of an informative ICP-OES method in Annex C (not visible in the preview) is the analytical-method anchor for many national toy-safety lab workflows.

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