Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs
Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs. (a) Mercury-containing cosmetic preparations have been represented for many years as skin-bleaching agents or as preparations to remove or prevent freckles and/or brown spots (so-called age spots). Preparations intended for such use are regarded as drugs as well as cosmetics. In addition to such use as skin-bleaching agents, mercury compounds have also been widely used as preservatives in cosmetics such as hand and body creams and lotions; hair shampoos, hair sets and rinses, hair straighteners, hair coloring, and other preparations; bath oils, bubble bath, and other bath preparations; makeup; antiperspirants and deodorants; and eye-area cosmetics. (b) The toxicity of mercury compounds is extensively documented in scientific literature. It is well known that mercury compounds are readily absorbed through the unbroken skin as well as through the lungs by inhalation and by intestinal absorption after ingestion. Mercury is absorbed from topical application and is accumulated in the body, giving rise to numerous adverse effects. Mercury is a potent allergen and sensitizer, and skin irritation is common after topical application. Cosmetic preparations containing mercury compounds are often applied with regularity and frequency for prolonged periods. Such chronic use of mercury-containing skin-bleaching preparations has resulted in the accumulation of mercury in the body and the occurrence of severe reactions. Recently it has also been determined that microorganisms in the environment can convert various forms of mercury into highly toxic methyl mercury which has been found in the food supply and is now considered to be a serious environmental problem. (c) The effectiveness of mercury-containing preparations as skin-bleaching agents is questionable. The Food and Drug Administration has not been provided with well controlled studies to document the effectiveness of these preparations. Although mercurial preservatives are recognized as highly effective, less toxic and satisfactory substitutes are available except in the case of certain eye-area cosmetics. (d) Because of the known hazards of mercury, its questionable efficacy as a skin-bleaching agent, and the availability of effective and less toxic nonmercurial preservatives, there is no justification for the use of mercury in skin-bleaching preparations or its use as a preservative in cosmetics, with the exception of eye-area cosmetics for which no other effective and safe nonmercurial preservative is available. The continued use of mercurial preservatives in such eye-area cosmetics is warranted because mercury compounds are exceptionally effective in preventing Pseudomonas contamination of cosmetics and Pseudomonas infection of the eye can cause serious injury, including blindness. Therefore: (1) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-9 (issued May 13, 1939) and concludes that any product containing mercury as a skin-bleaching agent and offered for sale as skin-bleaching, beauty, or facial preparation is misbranded within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j), and may be a new drug without approval in violation of section 505 of the Federal Food, Drug, and Cosmetic Act. Any such preparation shipped within the jurisdiction of the Act after January 5, 1973 will be the subject of regulatory action. (2) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as adulterated within the meaning of section 601(a) of the Act any cosmetic containing mercury unless the cosmetic meets the conditions of paragraph (d)(2) (i) or (ii) of this section. (i) It is a cosmetic containing no more than a trace amount of mercury and such trace amount is unavoidable under conditions of good manufacturing practice and is less than 1 part per million (0.0001 percent), calculated as the metal; or (ii) It is a cosmetic intended for use only in the area of the eye, it contains no more than 65 parts per million (0.0065 percent) of mercury, calculated as the metal, as a preservative, and there is no effective and safe nonmercurial substitute preservative available for use in such cosmetic.
Regulatory decision and full conditions
- Status
- Prohibited
- Legal role
- Binding rule
- Regulatory summary
- Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs. (a) Mercury-containing cosmetic preparations have been represented for many years as skin-bleaching agents or as preparations to remove or prevent freckles and/or brown spots (so-called age spots). Preparations intended for such use are regarded as drugs as well as cosmetics. In addition to such use as skin-bleaching agents, mercury compounds have also been widely used as preservatives in cosmetics such as hand and body creams and lotions; hair shampoos, hair sets and rinses, hair straighteners, hair coloring, and other preparations; bath oils, bubble bath, and other bath preparations; makeup; antiperspirants and deodorants; and eye-area cosmetics. (b) The toxicity of mercury compounds is extensively documented in scientific literature. It is well known that mercury compounds are readily absorbed through the unbroken skin as well as through the lungs by inhalation and by intestinal absorption after ingestion. Mercury is absorbed from topical application and is accumulated in the body, giving rise to numerous adverse effects. Mercury is a potent allergen and sensitizer, and skin irritation is common after topical application. Cosmetic preparations containing mercury compounds are often applied with regularity and frequency for prolonged periods. Such chronic use of mercury-containing skin-bleaching preparations has resulted in the accumulation of mercury in the body and the occurrence of severe reactions. Recently it has also been determined that microorganisms in the environment can convert various forms of mercury into highly toxic methyl mercury which has been found in the food supply and is now considered to be a serious environmental problem. (c) The effectiveness of mercury-containing preparations as skin-bleaching agents is questionable. The Food and Drug Administration has not been provided with well controlled studies to document the effectiveness of these preparations. Although mercurial preservatives are recognized as highly effective, less toxic and satisfactory substitutes are available except in the case of certain eye-area cosmetics. (d) Because of the known hazards of mercury, its questionable efficacy as a skin-bleaching agent, and the availability of effective and less toxic nonmercurial preservatives, there is no justification for the use of mercury in skin-bleaching preparations or its use as a preservative in cosmetics, with the exception of eye-area cosmetics for which no other effective and safe nonmercurial preservative is available. The continued use of mercurial preservatives in such eye-area cosmetics is warranted because mercury compounds are exceptionally effective in preventing Pseudomonas contamination of cosmetics and Pseudomonas infection of the eye can cause serious injury, including blindness. Therefore: (1) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-9 (issued May 13, 1939) and concludes that any product containing mercury as a skin-bleaching agent and offered for sale as skin-bleaching, beauty, or facial preparation is misbranded within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j), and may be a new drug without approval in violation of section 505 of the Federal Food, Drug, and Cosmetic Act. Any such preparation shipped within the jurisdiction of the Act after January 5, 1973 will be the subject of regulatory action. (2) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as adulterated within the meaning of section 601(a) of the Act any cosmetic containing mercury unless the cosmetic meets the conditions of paragraph (d)(2) (i) or (ii) of this section. (i) It is a cosmetic containing no more than a trace amount of mercury and such trace amount is unavoidable under conditions of good manufacturing practice and is less than 1 part per million (0.0001 percent), calculated as the metal; or (ii) It is a cosmetic intended for use only in the area of the eye, it contains no more than 65 parts per million (0.0065 percent) of mercury, calculated as the metal, as a preservative, and there is no effective and safe nonmercurial substitute preservative available for use in such cosmetic.
- Conditions and restrictions
- A prohibition entry may contain no separate condition text because the regulatory outcome is the prohibition itself. Open the cited source and apply the market-wide requirements below.
Substance identity
- Official source name
- Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs
- CAS
- Not supplied in this source row
- EC
- Not supplied in this source row
- Identity mapping
- standalone:official_cfr_section
Cross-market snapshot for this identity
Exact linked records currently present in this site. An absent market means no imported exact match, not permission to use the substance.
United States
Current record1 linked record
Open supporting recordOfficial source and provenance
- Registered source
- US FDA cosmetic ingredient framework
- Source reference
- 21 CFR 700.13
- Source record ID
700.13- Source version
- 2026-08-27
- Source language
- English
- Translation status
- Original is English
- Source updated
- 2026-08-27
- Snapshot checked
- 2026-08-30 04:30 UTC
- Validation method
- eCFR XML subpart/section parse; 99 records
- SHA-256
25a55a997379f510077dfb234fe3f366e8a1429cec3d0b20fe4b60e2baf3c36d
Registered dataset notes
- Dataset coverage
- Federal ingredient framework, prohibited/restricted examples and color-additive rules
- Authority note
- The US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
How this record fits the market dataset
Status distribution
Condition text is present on 90 of 99 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.
United States market context
Complete enumerated federal ingredient rules
Coverage version: eCFR Title 21 issue date 27 August 2026
All cosmetic prohibitions/restrictions in Part 700 Subpart B and cosmetic-use colour additive listings in Parts 73, 74 and 82.
Verification checklist
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
Official market sources
- US FDA cosmetic ingredient frameworkThe US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
Verification workflow and record completeness
Before using this result in a compliance decision
- Confirm that “Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs” and every CAS/EC identifier refer to the material in your supplier specification.
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
- Document the source version and recheck the regulator before manufacture, notification or market placement.
Fields available in this record
- Official substance nameAvailable
- CASNot supplied
- ECNot supplied
- Separate condition textNot present in source row
- Effective dateNot supplied
- Snapshot hash and methodAvailable
Questions this page answers
Stable citation
Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs. 21 CFR 700.13. United States. Source version 2026-08-27. CosIng Checker regulatory record: https://cosingchecker.com/regulations/us/records/716/
Cite the regulator as the legal authority. This page is a structured evidence index and verification aid, not a substitute for the official text or professional legal assessment.
Interpretation and limits for United States
This official record identifies the substance as prohibited for cosmetic use in the stated market scope.
Do not rely on a formulation containing this identity until the cited source, effective date and exact substance match have been verified.
How to interpret the legal role
The cited row forms part of a binding rule or legally incorporated list for this market.
Evidence on this page
- Recorded outcome: Prohibited
- Legal role: Binding rule
- Source version: 2026-08-27
What it does not prove
FDA has no general approved-cosmetic-ingredient catalogue; absence from these sections is not approval or proof of safety.
Further authoritative substance research
These sources can add identity, safety, exposure or hazard context. A link is not evidence that the database contains this exact substance, and none of these sources overrides the market decision above.
Cosmetic Ingredient Review safety assessments
Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents
Independent expert review considered by FDA; not a government approval or binding market rule
Research this identity at the sourceFDA Global Substance Registration System
UNII identifiers, preferred names, substance types, codes and public substance relationships
Identity registry only; UNII availability does not imply FDA review or approval
Research this identity at the sourceILO/WHO International Chemical Safety Cards
Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals
International occupational chemical-safety reference; not cosmetic-use approval
Research this identity at the sourceJapan NITE-CHRIP
Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information
Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules
Research this identity at the sourceNIOSH Pocket Guide to Chemical Hazards
REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals
US occupational-health guidance and limits; not a cosmetic ingredient decision
Research this identity at the sourceOECD eChemPortal
Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records
Discovery gateway; each linked authority remains responsible for its data
Research this identity at the sourceUS EPA CompTox CTX APIs
API key required for importDTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data
Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality
Research this identity at the source