The Washington State Department of Ecology (Ecology) has recently announced substantive revisions to the Interim Policy on Lead in Cosmetics issued under the Toxic-Free Cosmetics Act (TFCA).
The updated version was issued on August 31, 2026, removing the previous expiration date of December 31, 2026 and extending the interim policy indefinitely — it will remain in effect until Ecology adopts a rule or rescinds the policy. At the same time, Ecology has specified the consequences for manufacturers using Option 2 that fail to submit the required data upon request.
Background
Effective January 1, 2025, the TFCA restricts the manufacture, sale, and distribution in Washington State of cosmetic products containing intentionally added lead and lead compounds, and sets a statutory limit of 1 ppm on lead impurities.
However, as some products have difficulty consistently achieving the 1 ppm limit, Ecology issued the interim policy in December 2024, providing two alternative compliance paths that allow manufacturers — provided specific conditions are met — to temporarily defer strict enforcement of the 1 ppm requirement, while simultaneously initiating a rulemaking to assess the feasibility of a different lead impurity limit. The present policy revision was made in the course of this ongoing rulemaking.
Key Points of the Two Compliance Paths under the Interim Policy
| Path | Applicability | Key Requirements |
| Option 1 | Lead concentration of 2 ppm or below for general cosmetics, or 5 ppm or below for color cosmetics or clay masks | The manufacturer must notify Ecology of its decision to meet these limits for its products sold in Washington |
| Option 2 | Lead concentration of a color cosmetic or clay mask above 5 ppm and below 10 ppm | The manufacturer must notify Ecology of its decision; monitor lead in each batch of the product; and retain lead concentration data and information for submission to Ecology upon request |
| Testing and Data Requirements | Option 2 manufacturers | All testing must be completed by a third-party laboratory; lead levels must be verified by measuring total lead, rather than leachate or bioavailable levels; the detection limit must be lower than the applicable restriction level; lead concentrations may be measured or estimated by testing raw ingredients or final products, or by tracking lead concentrations in raw ingredients as reported in the Certificate of Analysis (CoA); if using a Certificate of Analysis, the measured lead concentration must be reported |
In addition, small businesses using Option 2 may rely on theoretical calculations based on estimations from raw ingredients or composite testing, or may exclude certain ingredients from their estimations where information is not available, provided they demonstrate a good faith effort to obtain the data.
Consequences of Failing to Submit the Required Data
The core addition of this revision is the data call-in procedure. In fall 2026, Ecology will randomly select 10 manufacturers from those using Option 2 and issue data call-in requests:
- Manufacturers not selected are not required to submit data at this time, but must continue to fulfill their obligations for per-batch lead monitoring and data retention.
- Selected manufacturers must submit complete and accurate data for all of their Option 2 products by the deadline set by Ecology; failure to do so will result in loss of eligibility for the interim policy, and manufacturers will be considered ineligible to re-enter the policy. Upon loss of eligibility, all of the manufacturer’s cosmetic products must comply with the statutory lead limit of 1 ppm.
Rulemaking Proceeds in Parallel
This extension runs in parallel with the lead in cosmetics rulemaking that Ecology initiated in December 2024. Ecology states that it is collecting and analyzing existing data on lead levels in cosmetic products to determine a feasible regulatory approach, and may adopt a lead impurity limit different from the current statutory 1 ppm.
The current estimated timeline is:
- Summer 2027 — informal comment on the preliminary draft rule;
- Spring 2028 — rule proposal (formal comment period);
- Fall 2028 — rule adoption.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
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