WA Ecology 2024 — Interim Policy on Lead in Cosmetics (Pub. 24-04-036): enforcement-discretion safe harbor allowing 2 ppm Pb in general cosmetics and 5–10 ppm Pb in color cosmetics and clay masks above the statutory 1 ppm TFCA cap

This is a Washington State Department of Ecology policy statement issued under enforcement-discretion authority interpreting the Toxic-Free Cosmetics Act (TFCA; Chapter 70A.560 RCW; see wa-tfca-hb1047-2023). The TFCA, effective January 1, 2025, prohibits the sale of cosmetic products in Washington that contain (1) intentionally added lead, or (2) lead impurities exceeding 1 part per million (ppm). The TFCA authorizes Ecology to conduct rulemaking to adopt a different lead-impurity limit. In 2024, three petitions asked Ecology to adopt the federal FDA-recommended 10 ppm cosmetic-lead-impurity limit; Ecology declined, and the decision was upheld on appeal to the governor. After consultation with manufacturers, Ecology issued this interim policy on December 19, 2024 (revised with minor clarifications January 15, 2025) establishing a tiered safe-harbor framework: as an exercise of enforcement discretion, Ecology will not enforce strict compliance with the 1 ppm limit for cosmetic products meeting either of two safe-harbor options (Option 1: Pb ≤2 ppm for general cosmetics or Pb ≤5 ppm for color cosmetics or clay masks, with manufacturer notification; Option 2: Pb >5 ppm and <10 ppm for color cosmetics or clay masks, with manufacturer notification and per-batch lead monitoring with retained data). The policy is interim pending Ecology’s open rulemaking on lead impurities in cosmetics initiated in 2025 (WAC 173-339).

Key numbers

Statutory baseline (TFCA, Chapter 70A.560 RCW)

• Statutory cap on lead impurities in cosmetics: 1 ppm (1 mg/kg, 1000 µg/kg, 1000 ppb), effective January 1, 2025 (p. 1, Background). Intentionally added lead is prohibited at any concentration.
• Federal FDA recommended industry maximum: 10 ppm lead impurities in cosmetic products and ingredients (cited at p. 1, Situation). Three 2024 petitions asked Ecology to adopt this 10 ppm cap by rulemaking; Ecology declined, and the decision was upheld on appeal to the governor (p. 1, Background).

Interim safe-harbor thresholds (effective January 1, 2025)

Option 1 — meet the lower tier and notify Ecology (p. 3):

• Lead concentration ≤2 ppm for general cosmetics, AND manufacturer has notified Ecology of its decision to meet these limits for products sold in Washington.
• Lead concentration ≤5 ppm for color cosmetics or clay masks, AND manufacturer has notified Ecology of its decision to meet these limits for products sold in Washington.

Option 2 — color cosmetics and clay masks only, between 5 and 10 ppm Pb (p. 3):

• Lead concentration >5 ppm and <10 ppm for color cosmetics or clay masks, AND manufacturer has notified Ecology of its decision AND is monitoring lead in each batch of the product AND is retaining lead concentration data and information. Submission of supporting data (including analytical methods) is not required unless requested by Ecology.

Implied result. Under the interim policy, the de-facto enforcement ceiling for color cosmetics and clay masks in Washington is 10 ppm Pb (matching the FDA-recommended industry maximum that Ecology declined to adopt by rulemaking). For general cosmetics, the de-facto enforcement ceiling under Option 1 is 2 ppm Pb; Option 2 does not apply to general cosmetics, so general cosmetics above 2 ppm Pb remain subject to enforcement under the 1 ppm statutory cap.

Supporting product-testing data cited (p. 2, Situation)

• The policy cites product-testing data from Germany and the United Kingdom showing 90 percent of cosmetic products can achieve lead concentrations of 2 ppm for general cosmetics (e.g., lotion, cleansers) and 5 ppm for color cosmetics (e.g., blush, eye shadow). Underlying data source citations are not in the body of the policy. This is the technical-feasibility evidence base for the Option 1 thresholds.

Testing requirements (Option 2, p. 3–4)

• Manufacturers may measure or estimate lead concentrations by (a) testing raw ingredients, (b) testing final products, or (c) tracking lead concentrations in raw ingredients as reported by certificates of analysis. If using certificates of analysis, the measured lead concentration must be reported.
• Any testing must be completed by a third-party laboratory.
• The policy does not specify or require specific analytical methods.
• Lead levels must be verified by measuring total lead (e.g., using digestion), rather than leachate or bioavailable levels (p. 4). The detection limit must be lower than the restriction level (p. 4); the policy does not enumerate specific LOD targets. Wiki-side inference: in practice this requires LOD <1 ppm to verify general-cosmetic Option 1 compliance, LOD <5 ppm to verify color-cosmetic / clay-mask Option 1 compliance, and LOD <10 ppm to verify Option 2 compliance — these LOD values are not in the policy text.

Small-business carve-out (p. 4)

• Manufacturers employing fewer than 50 people may demonstrate a good-faith effort to monitor lead through theoretical calculations from raw-ingredient estimations, composite testing, or by excluding ingredients from estimations if information is not available, so long as a good-faith effort to obtain data has been demonstrated.

Notification requirement (all options, p. 4)

• Manufacturers using the safe-harbor provisions must notify Ecology of their decision via Ecology’s online submission form (https://forms.office.com/g/8aNzPabq83) and provide contact information.

Policy effective dates (p. 5)

• Takes effect January 1, 2025.
• Remains in effect until either a rule is adopted (WAC 173-339 rulemaking, opened 2025), the policy is repealed, or December 31, 2026, whichever occurs first. Ecology may extend the policy if it determines the policy is still needed after December 31, 2026.

Definitions of key regulatory terms (p. 4)

• Color cosmetic: a cosmetic that contains pigments or colorants intended to beautify, promote attractiveness, or alter the appearance by adding color to skin, hair, eyelashes, or nails.
• Cosmetic (per RCW 69.04.011): articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such article; the term does not include soap.
• General cosmetic: all cosmetics excluding color cosmetics and clay masks.
• Manufacturer (per RCW 70A.350.010): any person, firm, association, partnership, corporation, governmental entity, organization, or joint venture that produces a product or is an importer or domestic distributor of a product sold or offered for sale in or into the state.
• Small business (per RCW 70A.500.020): a business employing fewer than fifty people.

Methods (brief)

This document is a regulatory policy statement rather than a laboratory study; it produces no original analytical data. The policy specifies the following testing-method requirements for manufacturers seeking the Option 2 safe harbor (color cosmetics and clay masks at 5–10 ppm Pb): testing by a third-party laboratory; measurement of total lead via digestion (not leachate or bioavailable lead); detection limit lower than the applicable restriction level. The policy does not prescribe a specific analytical method (e.g., ICP-MS vs ICP-OES vs AAS), leaving method choice to the manufacturer and laboratory. Industry-standard cosmetic-lead methods supporting these requirements include nitric acid + hydrogen peroxide microwave digestion followed by ICP-MS quantification (consistent with waecology2023-chemicals-cosmetics-phase1 Phase 1 methods, which used EPA Method 3052 digestion modified to omit hydrofluoric acid followed by EPA Method 6020B ICP-MS).

The policy’s technical-feasibility evidence base (90 percent of cosmetic products in Germany and UK testing data can achieve ≤2 ppm Pb for general cosmetics and ≤5 ppm Pb for color cosmetics) is cited without specific citations; cross-references to opss2023-feasibility-action-limits-cosmetics-uk (UK OPSS 2023) and to the Germany BVL 2017 technically-avoidable-impurity guidance values discussed in waecology2023-chemicals-cosmetics-phase1 suggest these are the likely underlying datasets (the BVL 2017 guidance specifies Pb ≤5.0 ppm in makeup powder / rouge / eye shadow / eye liner and Pb ≤2.0 ppm for other cosmetics, set such that 90 percent of tested cosmetics are expected to pass).

Evidence Fitness

This is an A-tier US-state-government regulatory policy statement issued under statutory enforcement-discretion authority by the responsible implementing agency (Washington State Department of Ecology, Hazardous Waste and Toxics Reduction Program) under the Toxic-Free Cosmetics Act (Chapter 70A.560 RCW). The document is the authoritative interpretation of the TFCA’s 1 ppm lead-impurity cap for the period January 1, 2025 through December 31, 2026 (or until WAC 173-339 rulemaking concludes). Evidence the policy supports:

• The current operative US-state enforcement framework for lead impurities in cosmetic products marketed in Washington as of January 1, 2025: tiered safe-harbor thresholds at 2 ppm Pb (general cosmetics) and 5 ppm Pb (color cosmetics and clay masks under Option 1) or 5–10 ppm Pb (color cosmetics and clay masks under Option 2, with per-batch monitoring requirement).
• The Washington regulatory distinction between general cosmetics and color cosmetics / clay masks for lead-impurity purposes, with statutory definitions referencing RCW 69.04.011 and RCW 70A.350.010.
• The third-party-laboratory, total-lead (digestion-based, not leachate or bioavailable), and detection-limit-below-restriction-level requirements for Option 2 compliance verification.
• The small-business (fewer than 50 employees) carve-out allowing theoretical calculations and composite testing in lieu of full per-product analytical testing, provided a good-faith effort is demonstrated.
• The administrative notification requirement (manufacturer notifies Ecology of safe-harbor decision via online submission form).
• The interim nature and sunset clause (December 31, 2026) pending WAC 173-339 rulemaking outcome.

The policy does NOT support:

• Any product-testing occurrence data. No laboratory analyses are produced by this document. The policy cites German and UK product-testing data showing 90 percent feasibility at the Option 1 thresholds without identifying the underlying datasets in the body of the document.
• A safety-based threshold determination for cosmetic Pb exposure. The policy is explicitly an enforcement-discretion framework framed around technical achievability, not a toxicological risk assessment. The 2/5/10 ppm thresholds are derived from product-testing feasibility (90 percent compliance under existing manufacturing practice) rather than from health-based exposure modeling.
• Cadmium, arsenic, mercury, or other heavy-metal limits. The interim policy is Pb-specific. Other TFCA-restricted substances (including intentionally added lead and other Chapter 70A.560 RCW restricted chemicals) remain subject to the underlying statutory framework.
• A permanent regulatory limit. The policy explicitly sunsets at the earlier of WAC 173-339 rulemaking conclusion, repeal, or December 31, 2026. The 10 ppm Option 2 ceiling for color cosmetics and clay masks should not be treated as the permanent Washington limit.

Implications

• Certification. This interim policy is the operative US-state enforcement framework for cosmetic lead impurities in Washington during the period January 1, 2025 through December 31, 2026 (or until WAC 173-339 rulemaking concludes). The operative WA-state regulatory ceiling during that period is 2 ppm Pb for general cosmetics (Option 1) and 10 ppm Pb for color cosmetics and clay masks (Option 2). This is more permissive than the 1 ppm TFCA statutory cap and more permissive than the Germany BVL 2017 technically-avoidable values (Pb ≤2.0 ppm general cosmetics; Pb ≤5.0 ppm makeup powder / rouge / eye shadow / eye liner) discussed in waecology2023-chemicals-cosmetics-phase1; it is the same ceiling as the FDA-recommended industry maximum (10 ppm) for color cosmetics and clay masks under Option 2, and tighter than the FDA ceiling for general cosmetics. The interim, time-limited, and feasibility-driven (rather than health-based) character of the policy is critical context for any downstream HMTc threshold-setting workflow that cites it as a regulatory anchor; this page contributes regulatory-context data and does not propose certification thresholds.
• Courses. A clean illustration of how a US state environmental agency uses statutory enforcement-discretion authority to bridge between a strict statutory cap (TFCA 1 ppm) and demonstrated industry feasibility data (German and UK product-testing showing 2 ppm and 5 ppm 90-percent-achievability), without amending the underlying statute. Also a worked example of the interaction between a rulemaking petition (three 2024 petitions to adopt the 10 ppm FDA recommendation), a petition denial upheld on appeal, and a subsequent interim policy that nonetheless functionally allows a 10 ppm color-cosmetics ceiling under Option 2 with the additional per-batch monitoring requirement.
• App. Country-of-origin or state-of-sale “US-WA” triggers different effective Pb ceilings for cosmetic categories depending on the general-cosmetic vs color-cosmetic / clay-mask classification: 2 ppm for general cosmetics, 5 ppm for color cosmetics and clay masks under Option 1, or 10 ppm for color cosmetics and clay masks under Option 2. Direct relevance to a future cosmetics-app contamination-profile workflow; not directly relevant to the food-app workflow.

Wiki pages this source may touch

• washington-tfca-toothpaste-pb-1000ppb — operative US-WA statutory framework under which this interim policy was issued. The TFCA’s 1 ppm cosmetic-lead-impurity cap remains the underlying statutory limit; this interim policy is an enforcement-discretion overlay that does not modify the statute.
• lipstick — color cosmetic for TFCA / interim-policy purposes (contains pigments intended to alter the appearance by adding color to the lips). Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring) under the interim policy.
• makeup-foundation-powders-blush — color cosmetic. Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• eye-makeup — color cosmetic (eye shadow, eye liner, mascara). Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• face-paint — color cosmetic. Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• childrens-makeup — color cosmetic for purposes of the interim policy. Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• childrens-nail-polish — color cosmetic. Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• manicuring-preparations-leave-on — color cosmetic when pigmented (nail polish, nail lacquer); general cosmetic when clear (base coat, top coat, nail treatment). Subject to the applicable option ceiling.
• makeup-body-paints-bases-fixatives — color cosmetic. Subject to Option 1 (≤5 ppm Pb) or Option 2 (5–10 ppm Pb with per-batch monitoring).
• childrens-lip-balm-plain — general cosmetic when unpigmented. Subject to Option 1 (≤2 ppm Pb).
• childrens-lip-balm-mineral-bearing — general cosmetic when unpigmented. Subject to Option 1 (≤2 ppm Pb).
• body-hand-leave-on-skin-care — general cosmetic (lotion, cream). Subject to Option 1 (≤2 ppm Pb).
• face-neck-leave-on-skin-care — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• baby-lotion-cream — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• baby-shampoo-body-wash — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• baby-oil — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• body-wash-shower-gel — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• shampoo-adult — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• conditioner-adult-rinse-out — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• intimate-washes-cleansers — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• leave-on-hair-preparations — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• deodorants — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• shaving-cream-gel-foam — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• facial-cleansers — general cosmetic. Subject to Option 1 (≤2 ppm Pb).
• hand-soap — applies only where the product meets the RCW 69.04.011 cosmetic definition; pure soap is excluded from the definition. Where the product is a cosmetic, subject to Option 1 (≤2 ppm Pb).
• toothpaste — cosmetic under TFCA scope (the TFCA cosmetic definition incorporates RCW 69.04.011, which includes oral-care products applied to the body for cleansing). Subject to Option 1 (≤2 ppm Pb) as a general cosmetic under the interim policy framework, in addition to the 1 ppm statutory baseline anchored at washington-tfca-toothpaste-pb-1000ppb.
• lead — US-state cosmetic-Pb regulatory ceiling for Washington under TFCA + interim policy: 1 ppm statutory cap with enforcement-discretion safe harbor at 2 ppm (general cosmetics) or 5–10 ppm (color cosmetics and clay masks). Permissive relative to the EU Cosmetics Regulation (EC) 1223/2009 framing (heavy metals only at concentrations unavoidable under good manufacturing practice) and the Germany BVL 2017 technically-avoidable-impurity values (Pb ≤2.0 / ≤5.0 ppm depending on cosmetic type). Same as FDA-recommended industry maximum (10 ppm) for color cosmetics and clay masks under Option 2.

Verification notes

• Cite-key choice. Issuer-and-year convention matches waecology2023-chemicals-cosmetics-phase1 and waecology2024-chemicals-cosmetics-phase2: waecology2024-interim-policy-lead-cosmetics. The year 2024 reflects the document’s date of issue (December 19, 2024) and its Publication 24-04-036 numbering. The raw filename uses “2025” (REG-013_WA_Ecology_2025_Interim_Policy_Lead_Cosmetics_TFCA.pdf) because the policy takes effect January 1, 2025 and the document was revised with minor clarifications on January 15, 2025; the raw_handle deviates from the filename’s “2025” to maintain consistency with the cite-key’s publication-year convention. Raw filename is preserved as-is per raw-tree immutability.
• Document type. This is a regulatory policy statement (source_type: government-policy), not a study report (government-report) or statute (regulation). It is a regulatory interpretive document issued by an agency under enforcement-discretion authority, distinct from the underlying TFCA statute (wa-tfca-hb1047-2023) and distinct from Ecology’s product-testing reports (waecology2023-chemicals-cosmetics-phase1, waecology2024-chemicals-cosmetics-phase2).
• License. Washington State Department of Ecology publication, public domain by US state-government work-product status. No copyright assertion on the publication summary page or the document itself.
• Speciation. The policy specifies “total lead” measurement via digestion (not leachate or bioavailable lead) for Option 2 verification (p. 4). The metals: [Pb] field captures total elemental lead. No lead-species (organic vs inorganic) distinction is made by the policy; cosmetic lead impurities are characterized as bulk-elemental Pb arising from raw-ingredient mineral and clay sources (p. 1, Background).
• Routing — broad cosmetic scope. The interim policy applies to all cosmetic products as defined in RCW 70A.560.010 (which incorporates the RCW 69.04.011 / FDA cosmetic definition). The products: array enumerates the cosmetic-category product slugs currently in the taxonomy that are within scope of the policy, separated mentally into (a) color cosmetics and clay masks subject to the 5 ppm Option 1 / 5–10 ppm Option 2 thresholds (lipstick, makeup-foundation-powders-blush, eye-makeup, face-paint, childrens-makeup, childrens-nail-polish, manicuring-preparations-leave-on, makeup-body-paints-bases-fixatives) and (b) general cosmetics subject to the 2 ppm Option 1 threshold (childrens-lip-balm-plain, childrens-lip-balm-mineral-bearing, body-hand-leave-on-skin-care, face-neck-leave-on-skin-care, baby-lotion-cream, baby-shampoo-body-wash, baby-oil, body-wash-shower-gel, shampoo-adult, conditioner-adult-rinse-out, intimate-washes-cleansers, leave-on-hair-preparations, deodorants, shaving-cream-gel-foam, facial-cleansers, hand-soap, toothpaste). Children’s lip balms are routed as general cosmetics on the assumption they are unpigmented; pigmented children’s lip products would be color cosmetics under the policy’s definition. The taxonomy does not contain dedicated slugs for clay masks (potentially routable to exfoliants-scrubs or face-neck-leave-on-skin-care, but the cleanest mapping would be a future clay-masks slug or addition to an existing facial-care row); the routing here omits clay-masks to avoid mis-routing.
• Routing — soap exclusion. RCW 69.04.011’s cosmetic definition explicitly excludes soap, and the TFCA cosmetic definition inherits this exclusion. hand-soap is routed only where the product meets the cosmetic definition (e.g., cleansing-and-moisturizing combination products); pure-soap products are out of scope.
• Routing — toothpaste. Toothpaste is within TFCA scope as a cosmetic (the RCW 69.04.011 definition includes products applied to the body for cleansing, which encompasses oral-care). Under the interim policy, toothpaste is a general cosmetic (no pigments; not a clay mask) and is subject to the Option 1 ≤2 ppm Pb safe harbor in addition to the underlying 1 ppm TFCA statutory cap anchored at washington-tfca-toothpaste-pb-1000ppb. The existing TFCA source page (wa-tfca-hb1047-2023) routes toothpaste at the 1 ppm statutory level; this interim-policy source extends that routing to capture the enforcement-discretion overlay.
• Routing — no new regulation slug created. A dedicated regulations page for this interim policy (e.g., washington-ecology-2024-interim-policy-lead-cosmetics) would be appropriate and would parallel the existing washington-tfca-toothpaste-pb-1000ppb regulation page. Per CLAUDE.md Part 10 (“Regulations: create a new regulation page on first encounter … but only … with the correct rule ID/citation, do not guess”) and per the ingest-next-manual-fetch-pdf skill stop conditions (“New regulation slug needed … surface in stop-report … do not guess”), this source page does NOT silently create the new regulation page mid-ingest. Surfaced for Karen’s Step 0 review: the appropriate regulation slug name and any cross-reference to the in-progress WAC 173-339 rulemaking should be Karen-decided. The existing washington-tfca-toothpaste-pb-1000ppb is referenced in ## Wiki pages this source may touch as the closest existing anchor.
• Brand firewall (Part 12, strict reading 2026-05-17). This policy document names no individual brands or products. The policy describes “many cosmetics manufacturers” consulted by Ecology in aggregate (p. 2, Situation) without identifying any of them. No Part 12 risk on this page.
• Wiki/HMTc firewall (Part 2). The policy’s framing (“To protect human health and the environment, Washington’s goal is to reduce lead in cosmetic products to the lowest level possible,” p. 2) and its characterization of the Option 1 thresholds as supporting “the technical feasibility of lower concentrations” (p. 2) are reported on this wiki page as the policy’s own framings, not adopted as wiki-level safety claims. The Implications section flags that the 2/5/10 ppm thresholds are feasibility-driven (90-percent-achievability under existing manufacturing practice per German and UK product-testing data) rather than health-based, and that the policy is explicitly interim and time-limited. This characterization is essential for any future HMTc threshold-setting workflow that cites this policy: the interim policy’s 10 ppm ceiling for color cosmetics under Option 2 should not be mistaken for a permanent or health-based threshold determination. The HMTc-relevance discussion in Implications is bounded to “contributes regulatory-context data for cosmetic-category rows” and does not propose threshold values.
• Relationship to TFCA source page. wa-tfca-hb1047-2023 documents the underlying statute. This source documents Ecology’s enforcement-discretion policy interpreting that statute for the period January 1, 2025 through December 31, 2026 (or until WAC 173-339 rulemaking concludes). The two source pages are companion documents (cross-listed via near_duplicates:); they are not duplicate ingestions of the same document. A future ingest of an Ecology-issued WAC 173-339 final rule, when published, will supersede this interim policy and warrant its own source page.
• Jurisdictions. US-WA only. The policy is a Washington-state-specific enforcement framework. Federal FDA recommendations (10 ppm cosmetic-lead-impurity maximum) and the German and UK product-testing data are cited as context but the policy itself binds only manufacturers selling cosmetics in or into Washington State.
• DOI / publisher. No DOI; Washington State government publication identified as Publication 24-04-036 and indexed at apps.ecology.wa.gov/publications/SummaryPages/2404036.html. The access_url points to the report’s summary page (canonical and stable across PDF revisions).
• Raw path / handle. Filed under raw/Manual Fetch Kimi /June 1 Infant cosmetics metals papers/02_Regulatory_Reports/REG-013_WA_Ecology_2025_Interim_Policy_Lead_Cosmetics_TFCA.pdf. The “Infant cosmetics” folder name does not match this policy’s scope — the interim policy applies to all cosmetics regardless of age tier, with no children-specific provisions. Folder placement is preserved as-is per raw-tree immutability; routing reflects the actual content (broad cosmetic-category scope, both adult and child-marketed cosmetics).

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.