This is draft FDA guidance dated December 2016. Every page is marked Draft-Not for Implementation. The text says the draft, when finalized, will represent FDA current thinking and does not establish legally enforceable responsibilities. FDA recommends a maximum of 10 ppm lead as an impurity in cosmetic lip products and in externally applied cosmetics marketed in the United States, and concludes that this level would not pose a health risk. The guidance does not apply to topically applied products classified as drugs or to hair dyes that contain lead acetate as an ingredient. No recommended maximum is stated for any metal other than lead. FDA states that it has not set limits for lead as an impurity in cosmetics. FDA quotes a 10 ppm lead impurity limit set by the International Cooperation on Cosmetics Regulation, Canada, and the European Union. The EU instrument is not named in this guidance.
Key numbers
| Analyte | Matrix | Value | Unit | Statistic | N | Where |
|---|---|---|---|---|---|---|
| Lead | cosmetic lip products marketed in the United States (lipsticks, lip glosses, and | 10 | ppm | recommended maximum | Section I, Introduction; Section III.A p.3 | |
| Lead | externally applied cosmetics marketed in the United States | 10 | ppm | recommended maximum | Section I, Introduction; Section III.A p.3 | |
| Lead | cosmetics | 10 | ppm | maximum lead level as an impurity | Section II, Background; Reference 1 p.4 | |
| Lead | cosmetics | 10 | ppm | maximum lead level as an impurity | Section II, Background; Reference 2 p.4 | |
| Lead | cosmetics | 10 | ppm | maximum lead level as an impurity | Section II, Background p.4 |
Methods (brief)
Status is draft, not final, confirmed from the title page (Draft Guidance; Draft-Not for Implementation; December 2016) and from the statement that the guidance, when finalized, will represent current thinking. Date on the title page is December 2016. A separate sentence says that as of December 20, 2016, FDA had verified website addresses for references. Comment instructions say to submit comments within 60 days of publication in the Federal Register of the notice of availability; that Federal Register date is not printed in this file. Lip and externally applied cosmetics are separate scopes under one 10 ppm recommendation. Survey concentration ranges in the guidance are FDA occurrence results and are not copied into the numbers array.
Detection and reporting: Total dissolution method detection limit stated as 0.026 ppm for the lip-product studies and 0.0084 ppm for the externally applied cosmetic studies.
Basis: lead as an impurity in the finished cosmetic, ppm
Evidence fitness
This source can support: FDA draft recommended maximum of 10 ppm lead as an impurity in cosmetic lip products and externally applied cosmetics, December 2016; Confirmation that the document is draft and not for implementation; FDA-adopted dermal absorption fraction and FDA exposure estimates at 10 ppm lead; The 10 ppm lead impurity limit FDA attributes to ICCR, Canada, and the European Union.
It cannot support: A final or legally enforceable FDA lead limit for cosmetics; A recommended maximum for any metal other than lead; Named EU legal instrument for the quoted 10 ppm lead limit; Primary-study or survey occurrence tables.
Limitations
The 10 ppm figure is a recommended maximum in draft guidance, not a codified limit. The guidance states no limit for arsenic, cadmium, chromium, cobalt, mercury, nickel, or any metal other than lead. References name a survey of those elements but do not give their limits or results in this document. Color additives are said to have lead specifications, and those specification numbers are not quoted. Market survey concentrations, including the stated lip range, the lip average, the external maximum, and the body-lotion range 0.04 to 0.10 µg/g, are occurrence results and are omitted from the numbers array except where 0.10 µg/g is the input to an FDA exposure estimate.
Related evidence
Update history
No substantive edit history is available in this build. The full commit record is available in git.