Investigation report to support the Commission on the preparation of a restriction proposal for the use and presence of CMR 1A or 1B substances in childcare articles based on REACH Article 68(2)

Overview

This European Chemicals Agency (ECHA) investigation report, prepared at the request of the European Commission under REACH Article 68(2) and dated 31 October 2023 (Version 2.0 Final), assembles the evidence base for a future EU restriction on carcinogenic, mutagenic, and reproductive-toxicant category 1A or 1B (CMR 1A/1B) substances in childcare articles. The report is not a primary-measurement study; it aggregates measurements and regulatory limits from 48 sources to support seven deliverables specified in the Commission’s November 2022 request: (1) a list of CMR 1A/1B substances that may be present in childcare articles, (2) tonnage/concentration/frequency-of-finding evidence, (3) release/exposure-potential evidence, (4) an inventory of existing Generic and Specific Concentration Limits (GCL/SCL), (5) identification of where GCL/SCL deviations are needed, (6) a summary of available analytical methods, and (7) an overview of stakeholder consultations. Of the 1,559 measurement entries collected across all CMR groups, 39 % (≈ 608 entries) cover metals, with cobalt compounds the single most-reported metal class at 373 entries and lead compounds second at 164 entries (p. 21, confirmed by the p. 17 narrative that “the CMR 1A or 1B substances most frequently detected in childcare articles are metals, being cobalt and lead the most reported followed by phthalates”); phthalates account for 15 % of measurement entries, organophosphorus compounds for 21 %, and all other chemical groups for ≤ 10 % each. The report’s principal HMI-actionable outputs are (a) the per-metal proposed concentration limits, both content and extractable, deviating from the default 10 mg/kg homogeneous-material limit ECHA proposes for the broader CMR-substance class (Table 3, pp. 34); and (b) the reported concentration-range exceedances of existing CLP/REACH limits for lead (Pb) in textiles and synthetic polymers (6 of 106 measurements > 300 mg/kg, non-EU data only) and Co in coatings (3 of 194 measurements > 1,000 mg/kg, non-EU data only). The report explicitly excludes risk-assessment-based threshold derivation in favour of LOQ-anchored content limits, on the rationale that the GCL/SCL framework “may not be sufficiently protective for children” because CMR 1A/1B substances cover genotoxic carcinogens for which “no safe threshold can usually be established” (p. 28).

Key numbers

Aggregate substance and measurement scope (Sections 2.1, 2.2, 3.2)

• CLP ATP-18 entries with harmonised CMR 1A or 1B classification: 1,116 entries; 1,188 individual substances after expansion of defined-set group entries; 108 additional members of open group entries also considered (p. 15).
• Additional substances considered: 27 with CMR 1A or 1B classification agreed by RAC but not yet in CLP Annex VI, and 12 under RAC discussion as of 27 January 2023 (p. 16).
• Substances identified as actually present in childcare articles: 180–181 (the report quotes both numbers; 180 in p. 28 — “For 149 of the 180 substances identified…” — and 181 in p. 30 — “ECHA collected and analysed existing concentration limits and related analytical methods for all 181 substances identified…”); split into 65 measured and 116 suspected (p. 16).
• Measurement entries collected: 1,559 reporting measurements of CMR 1A/1B substances in childcare articles (p. 21).
• Distribution by chemical group (Figure 1, p. 16; shares of the 2,340 “information-collected” entries on measured/suspected CMR-substance presence — per the p. 16 surrounding statement that “the information collected in this report for CMR 1A or 1B substances (2 340 entries)… is categorised in two ways: substances measured and/or substances suspected in childcare articles”): Metals 29 %; Phthalates 23 %; Organophosphorus compounds 15 %; Aldehydes 5 %; Bisphenols 5 %; Aromatic amines 4 %; PAHs 4 %; PFAS 3 %; Organotins 3 %; with the remaining 26 of 35 total chemical groups (per p. 17 statement that “the substances can be divided in 35 different chemical groups”) comprising the residual share. The metal share is the largest single category.
• Distribution by chemical group (measurement-entry shares of the 1,559 measurement entries; p. 21): Metals 39 % (≈ 608 entries; per p. 21 verbatim, “cobalt and lead compounds the most reported (373 and 164 entries, respectively)” — Co compounds 373 entries the single most-reported metal/substance class, Pb compounds 164 entries the second), Organophosphorus compounds 21 % (mainly tris(2-chloroethyl)phosphate, TCEP), Phthalates 15 % (mainly DEHP, DnBP, BBP), all other groups < 10 % each.
• Distribution by childcare-article category (Figure 2, p. 18; measurement-entry shares): Car seats 17 %, Bibs 16 %, Toilet-related 15 %, Bed/mattress 12 %, Diaper/nappy 10 %, Feeding/drinking 8 %, Pram/pushchair/buggy 6 %, Sucking-related 4 %, Playing/walking 4 %, Seating-for-eating 3 %, Other-seating 2 %, with 10 further sub-categories at 1 % or below.
• Substances measured outside EU only (selected, p. 21): acetaldehyde, benzene, tetrabromobisphenol A, vinyl chloride, arsenic compounds, mercury, and cobalt. The report explicitly carries non-EU measurements into the analysis because “the global/internet market” is a relevant source of childcare articles placed on the EU market.

Reported concentration-range exceedances of CLP GCL/SCL (Section 3.2, p. 21–22)

Reported concentrations exceeding the CLP Generic or Specific Concentration Limit (1,000 mg/kg for carcinogenic/mutagenic substances or 3,000 mg/kg for substances toxic to reproduction) — verbatim from p. 21–22:

The report also notes (p. 22) that “very high concentrations of eight different lead compounds were reported for a baby dish sterilizer in the SCIP database. However, it is not reported in which part of the sterilizer the lead substances are included and if the substances were inaccessible or in contact with the dishes to be later used by children.” No numerical Pb concentration is reported for this SCIP entry in the investigation report.

Proposed content and extractable concentration limits for metals (Table 3, pp. 34–35; Section 5.2 per-metal narrative, pp. 40–42)

Table 3 (pp. 34–35) is captioned “Substances or groups of substances with a considered concentration limit in homogeneous material different from 10 mg/kg (content) and/or with considered extractable-related concentration limits.” Table 3 therefore lists only the metals with a substance-specific deviation from the 10 mg/kg default and/or an extractable limit (As, cadmium (Cd), hexavalent chromium (Cr-VI), Co, Pb, mercury (Hg), organotins DOT/DBT). Lithium, vanadium, and ammonium bromide (Br⁻) take the default 10 mg/kg content limit without an extractable and are therefore not in Table 3; their rows below are sourced from the Section 5.2 per-metal narrative on pp. 42 (Li, V) and p. 38 (Br, in the brominated-flame-retardants sub-section).

Concentration limits in the content column apply to the total elemental concentration of the metal atom or ion in homogeneous material of the childcare article, not to the specific CMR-classified compound. Quoting the report (p. 28, last paragraph): “For metals such as arsenic (As), cadmium (Cd), cobalt (Co), lead (Pb), mercury (Hg), chromium (VI) (CrVI), for dioctyl tin (DOT) or dibutyl tin (DBT) compounds, for boron (B) and bromine (Br⁻), the concentration limits (content, extractable content or migration) reflect the concentration of the species (atom or ion) analysed, and not the concentration of the substances that may be present in childcare articles. Therefore, for the concentration limits the species concerned is indicated, e.g. 10 mg As/kg in case of arsenic.”

ECHA’s general criteria flow-chart for content-limit selection (Figure 4, p. 33): if a REACH restriction limit exists and is lower than 10 mg/kg, use the REACH limit; if higher, use the REACH limit unless technical reasons justify deviation to a lower industry-RSL-derived limit; if no REACH restriction exists, default to 10 mg/kg unless an industry RSL or other concentration limit below 10 mg/kg with a suitable LOQ is available, in which case use the lower limit.

For comparison, ECHA’s default for substances without a substance-specific consideration is 10 mg/kg in homogeneous materials = 0.001 % w/w, justified on the grounds that “state-of-art analytical methods/techniques for the quantification of almost any type of substance guarantees LOQs below or at least of 10 mg/kg” (p. 31). The default 10 mg/kg is considered for 78 of 168 substances (46 %) for which a concentration limit is identified (p. 31).

Inventory of existing limits and analytical-method coverage (Section 5.1, p. 27; Section 6, p. 46)

• Substances with an existing concentration limit identified (content, extractable, or migration): 149 of 180 substances ≈ 83 % (p. 28).
• Substances with legally binding concentration limits from REACH restrictions, the Toys Safety Directive, or other EU legislation: 91 ≈ 50 % (p. 28).
• Substances for which the 10 mg/kg default is considered to apply: 78 of 168 with an identified limit ≈ 46 % (p. 31).
• Analytical-method availability conclusion (p. 46): standard analytical methods exist for the majority of identified substances; methods are largely from CEN, DIN, ISO, US EPA, and US CPSC; portable ED-XRF allows on-site screening for As, Cd, Co, chromium (Cr), Pb, V (p. 48); portable FT-IR allows screening for total phthalate content in synthetic polymers (mainly PVC).

Childcare-article categorisation under scope (Table 1, pp. 10–11)

The report defines childcare articles per a merged REACH Annex XVII entry 51–52 + CEN/TC 252 definition: “any product intended to facilitate seating, sleep, relaxation, hygiene such as bathing, changing and general body care, feeding, sucking, sleeping, transportation and protection of children” (p. 8). Six main categories with 17 sub-categories:

ECHA’s age-of-children scope aligns with the Toys Safety Directive (2009/48/EC) at under 14 years of age, rather than the more restrictive under-36-months or under-3-years conventions used by ecolabels and the EU Ecolabel for textiles (p. 9).

Other ECHA-considered concentration limits relevant to the broader CMR-substance scope (Table 3, p. 34–35)

(Recorded here for completeness; non-metal substances are outside the HMI metal panel but appear in the same childcare-articles regulatory context.)

Methods (brief)

Source aggregation and substance inventory (Sections 2.1–2.2). Starting set is the 1,116 CLP ATP-18 entries with harmonised CMR 1A or 1B classification, expanded by member-substance enumeration for defined-set group entries (e.g., the group entry covering three phthalates, index 607-426-00-1) and by inclusion of 108 identified members of open group entries (e.g., 2-ethylhexanoic acid and its salts, index 607-230-00-6). Substances with RAC-agreed CMR 1A/1B classification but not yet in CLP Annex VI (27 substances) and substances under RAC discussion (12 substances, CLH proposal submitted) as of 27 January 2023 are also considered. Identification of substances actually present in childcare articles draws on 48 sources: literature search, REACH restrictions, REACH registration dossiers, the SCIP (Substances of Concern In articles, as such or in complex objects) database, Substance in Articles (SiA) notifications, RAPEX rapid-alert recalls, the 2019 COM study on childcare articles, industry Restricted Substances Lists (AFIRM, AAFA, ALDI, Amazon, Bed Bath & Beyond, Bluesign, Versace, Cradle to Cradle), ecolabels (OEKO-TEX Standard 100, EU Ecolabel for textiles and shoes for children, GOTS, Blue Angel textiles, Bluesign, Nordic Swan), Member State authority reports (BfR, BAUA, ANSES, RIVM, KEMI, Danish EPA), and stakeholder consultations. The full substance inventory and per-substance evidence summary live in the report’s Appendix_A_Summary Excel workbook (columns Q tonnage, N concentration ranges, R exposure potential, V existing concentration limits, W extractable content limits, X considered limits).

Concentration-range and frequency aggregation (Section 3.2). ECHA collected 1,559 entries reporting measurements of CMR 1A/1B substances in childcare articles. 39 % cover metals (per p. 21 verbatim, Co compounds the most reported at 373 entries; Pb compounds second at 164 entries); 21 % organophosphorus (mainly tris(2-chloroethyl)phosphate, TCEP); 15 % phthalates (mainly DEHP, DnBP, BBP); other chemical groups < 10 % each. ECHA notes that the dataset cannot support frequency-of-finding conclusions because negative measurements are rarely reported, only “positive” results; this is identified Uncertainty 2 in Table 5 (p. 64). The dataset cannot discriminate EU-produced vs non-EU-produced articles in most cases; specific substances were measured only outside the EU (acetaldehyde, benzene, tetrabromobisphenol A, vinyl chloride, arsenic compounds, mercury, cobalt), and the report carries non-EU data into the analysis because globally/internet-sourced products reach the EU market.

Exposure-potential estimation (Section 3.3). For the 107 substances under REACH registration with physico-chemical data, oral/dermal/inhalation exposure potential was estimated using log Kow, aqueous solubility, and vapour pressure thresholds per the 2019 COM study’s Table 5.1. Concentration detected only at trace level (≤ 0.01 % = 100 mg/kg) was treated as potential low exposure. ECHA did not perform substance-specific risk assessments; REACH Article 68(2) does not require them. Of the 107 substances assessed, exposure potential was estimated as low for 39, medium for 8, and high for 59 substances.

Concentration-limit derivation (Section 5.2, Figure 4 flow-chart, Table 3). The default content concentration limit is 10 mg/kg in homogeneous material (0.001 % w/w), justified because state-of-art analytical methods (CEN, ISO, US EPA, OEKO-TEX, EN ISO standards) guarantee LOQs at or below 10 mg/kg for almost any substance type. Deviations from 10 mg/kg are considered when (i) a REACH-restriction concentration limit is already in place, (ii) technical reasons make 10 mg/kg infeasible, (iii) the LOQ for a standard analytical method is higher than 10 mg/kg, or (iv) industry RSLs and ecolabels consistently apply a stricter limit. For metals, both content limits and extractable-content limits are considered; the extractable limit for As, Cd, Co, Pb, Hg in textiles is anchored to the EU Ecolabel for textiles and shoes for children, OEKO-TEX, and GOTS ecolabels. For chromium VI, no method exists to measure total CrVI content via acid digestion without loss of the +VI oxidation state; the existing REACH entry 47/72 extractable limits are retained.

Testing-strategy guidance (Section 6.2). Five-step testing strategy for enforcement: (1) identify whether the article meets the childcare-article definition; (2) identify the materials accessible to children (skin, mouth, or inhalation contact); (3) determine which substances need testing for those materials, using Table 4 testing-priority matrix; (4) perform screening tests (e.g., portable ED-XRF for As, Cd, Co, Cr, Pb, V in any material; portable FT-IR for total phthalate content in synthetic polymers, mainly PVC); (5) perform targeted analytical tests for confirmation. CEN/TC 252 standards (EN 14372 child cutlery and feeding utensils; EN 14350 child drinking equipment; EN 1400 + A2 soothers; EN 12586 + A1 soother holders; EN 14988 + A1 children’s highchairs) provide chemical-safety requirements and test methods for several childcare-article categories (p. 14).

Speciation discipline (HMI Part 14). The report’s per-metal concentration limits are anchored to total elemental content/extractable measurements (the atom or ion analysed, not the specific CMR-classified compound), per the explicit statement at p. 28. The HMI source metadata accordingly uses:

• tAs for the diarsenic-trioxide substance entry because the analytical methods measure total elemental As content without speciation between inorganic and total arsenic;
• tHg for mercury because the report does not separate methylmercury from total mercury;
• Cr-VI for chromium VI compounds because the report explicitly speciates Cr-VI in its substance entry, regulatory framework (REACH entries 47, 72), and concentration-limit derivation;
• Sn for the organotin entries (dioctyl tin DOT and dibutyl tin DBT compounds) because the metals abbreviation vocabulary uses elemental tin (Sn); routing to [[metals/organotins]] carries the speciated context;
• Pb, Cd, Co, Li, V follow standard elemental tags.

Stakeholder process (Chapter 7). 233 stakeholders informed (203 EEA + 30 non-EEA across UK, Canada, US, Switzerland) via two calls for evidence (15 February – 31 March 2023 and 10 May – 7 June 2023), ten individual meetings (Environment Protection Agency of Austria, a worldwide childcare-article manufacturer, BEUC, Danish Consumer Council THINK, Finnish Customs Laboratory TULLI, Swedish Chemicals Agency KEMI, Norwegian Environment Agency, CEN, TÜV SÜD Product Service GMBH, SGS), the ECHA Forum for Exchange of Information on Enforcement, the RIME+ platform (informal Risk Management and Evaluation), CARACAL (Competent Authorities for REACH and CLP), and the draft-report consultation (28 August – 29 September 2023). 41 of the 233 stakeholders provided relevant substantive input. Stakeholder distribution by type (Figure 6, p. 58): Authority/Agency 30 %, Producer 21 %, Testing laboratories 18 %, Industry Association 16 %, Environmental organisation 6 %, Consumer Association 5 %, ECO label 1 %, Consultant 1 %, Children-protection Association 1 %, Chemicals-safety Association 1 %. EEA stakeholder counts by country (Figure 7, p. 59): Germany 38 (largest), Belgium 26, Italy 17, France 16, Sweden 10, Denmark 9, Austria 7, Ireland 7, Portugal 6, Poland 6, Netherlands 5, Finland 4, with smaller counts for the remaining 19 EEA countries.

Uncertainty analysis (Chapter 8, Table 5, p. 64). Seven key uncertainties identified per EFSA’s 2018 uncertainty-communication guidance: (1) completeness of the CMR-substance list as potentially-present in childcare articles; (2) representativeness of findings and share of childcare articles potentially containing CMR 1A/1B; (3) exposure potential and consequent risk; (4) suitability of some proposed concentration limits in specific materials; (5) applicability of the 10 mg/kg default to substances for which no concentration-limit or method data were collected; (6) applicability of identified analytical methods to some substances/materials; (7) availability of analytical methods for substances assigned the 10 mg/kg default without method-data collection. None of the uncertainties is judged to alter the report’s main conclusion that CMR 1A/1B substances should be banned in childcare articles.

Implications

• Direction of finding — broad-context regulatory evidence for childcare-articles category. This is an aggregating regulatory investigation report, not a primary-measurement study. Its HMI role is broad regulatory context for childcare-articles product categories where heavy-metals data was the largest single-class signal across the assembled 1,559 measurement entries (39 % of entries; Co compounds the single most-reported metal class at 373 entries and Pb compounds second at 164 entries, per p. 21). For HMTc product categorisation, the report supplies regulatory baseline and surveillance context across at least 16 HMI-mapped childcare-article product slugs (car seats, bibs, high chairs and booster seats, cribs and bassinets, strollers, swings and bouncers, walkers, play yards and gates, diapers and components, baby wipes, infant bottles, infant bottle nipples, sippy cups and toddler drinkware, pacifiers and sucking/teething aids, toy pacifiers, blankets and sleep sacks). Where HMTc product taxonomy has direct measurement coverage (feeding-related items in particular: bibs, infant bottles, infant bottle nipples, sippy cups, pacifiers), this report contributes regulatory-baseline context but does not substitute for direct measurement data, which the report itself notes is sparse (Uncertainty 2, p. 64).

• Metals coverage and proposed regulatory anchoring. The proposed extractable limits for As (0.2 mg/kg), Cd (0.1 mg/kg), Co (1.0 mg/kg), Pb (0.2 mg/kg), and Hg (0.02 mg/kg) — applicable to babies and children under 3 years of age and anchored to EU Ecolabel for textiles and shoes for children, OEKO-TEX, and GOTS limits — are the strictest harmonised regulatory limits ECHA could derive without exceeding the LOQ of available standard methods. The proposed content limits (10 mg/kg for As, Cd, Co, Pb; 0.5 mg Hg/kg) deviate from existing CLP GCL (1,000 mg/kg) and from the existing REACH entry 23 plastic-material Cd limit (100 mg/kg) and REACH entry 63 consumer-articles Pb limit (500 mg/kg) on the rationale that the GCLs/SCLs are not substance-specific risk-based limits and “may not be sufficiently protective for children” because CMR 1A/1B substances cover genotoxic carcinogens for which no safe threshold can usually be established (p. 28). For HMTc certification work, the report provides defensible baseline anchoring for Pb, Cd, As, Hg, and Co limits in the childcare-articles domain (LOQ-based 10 mg/kg content + 0.1–0.2 mg/kg extractable), with the caveat that the report’s scope is the EU regulatory framework rather than the food-and-personal-care HMTc scope.

• Chromium-VI speciation discipline. ECHA explicitly notes (p. 41) that “no methods are available to analyse the total content of the chromium VI ion (CrVI) in articles through acid digestion of the material without losing the +VI oxidation state,” and therefore retains the existing REACH extractable limits (1 mg CrVI/kg textiles per entry 72; 3 mg CrVI/kg leather per entry 47) without proposing a content limit. This is the regulatory analogue of HMI’s speciation-discipline rule (Part 14): the Cr-VI species cannot be derived from total Cr by acid digestion, and any HMI source that claims Cr-VI quantification without species-preserving methodology (alkaline extraction, EN ISO 17075 or similar) should be flagged.

• Phthalate, organophosphorus, and TBBPA non-EU exceedances are the leading concentration-range exceedance signals. Of the 1,559 entries, the highest-frequency exceedances of CLP GCLs/SCLs are for DEHP (85 of 202 measurements > 3,000 mg/kg), TCEP (9 of 310 > 3,000 mg/kg), and TBBPA (4 of 5 > 1,000 mg/kg, non-EU only). Pb exceedances in textiles/synthetic polymers (6 of 106 > 300 mg/kg, non-EU only) and Co in coatings (3 of 194 > 1,000 mg/kg, non-EU only) are the leading metal exceedance signals. The report notes that the high-DEHP exceedances are “mainly reported in articles placed on the market before 2020 and/or in old articles (e.g., second hand),” consistent with REACH entry 51’s 2007–2020 progressive restriction of DEHP, DBP, BBP, and DIBP in toys and childcare articles.

• App and Courses. Courses: the report’s five-step testing strategy (identify article → identify accessible materials → identify substances by material × substance matrix → screen with portable ED-XRF/FT-IR → confirm with targeted methods) and the explicit role of portable ED-XRF for As, Cd, Co, Cr, Pb, V in any material is a directly transferable Cochrane-quality enforcement playbook for the childcare-articles domain (p. 47–48). App: the proposed per-metal content and extractable limits anchored to OEKO-TEX/GOTS/EU Ecolabel limits provide the regulatory floor against which the app’s downstream HMTc-aligned thresholds for feeding-related childcare products (bibs, infant bottles and nipples, sippy cups, pacifiers/teethers) should be benchmarked when those rows reach the Step 0 Lock workflow. Microbiome: not addressed by this source.

Related evidence

• Lead
• Cadmium
• Chromium, Hexavalent
• Cobalt
• Arsenic, Total
• Mercury, Total
• Tin
• Lithium
• Vanadium
• Car seats (if retained in HMTc scope)
• Bibs
• High chairs and booster seats
• Cribs and bassinets
• Strollers
• Swings and bouncers
• Walkers
• Play yards and gates/enclosures
• Diapers and diaper components
• Baby wipes
• Bottles (plastic, glass, stainless steel)
• Bottle nipples and spouts
• Sippy cups and toddler drinkware components
• Pacifiers and sucking/teething aids
• Toy pacifiers (toy-designated)
• Blankets and sleep sacks

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