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Policy Statement: Interim Policy on Lead in Cosmetics — enforcement discretion under the Washington Toxic-Free Cosmetics Act (Chapter 70A.560 RCW)

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Overview

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 Washington State Toxic-Free Cosmetics Act (HB 1047) — statutory cap on heavy metals in cosmetic products). 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: lead (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 Chemicals in Cosmetics Used by Washington Residents — Report to the Legislature Pursuant to ESSB 5693 (2022) Section 302 (56) 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 A Feasibility Study Investigating Action Limits for Certain Heavy Metal Impurities in Cosmetic Products (UK OPSS 2023) and to the Germany BVL 2017 technically-avoidable-impurity guidance values discussed in Chemicals in Cosmetics Used by Washington Residents — Report to the Legislature Pursuant to ESSB 5693 (2022) Section 302 (56) 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, more permissive than the EU Cosmetics Regulation (EC) 1223/2009 (heavy metals only at concentrations unavoidable under good manufacturing practice), 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 Chemicals in Cosmetics Used by Washington Residents — Report to the Legislature Pursuant to ESSB 5693 (2022) Section 302 (56); 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.

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