INCI Nomenclature and the INCI
Application Process
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PresentationOverview
➢ U.S. Regulatory Framework for Labeling
➢ INCI Nomenclature – Background
➢ The International Cosmetic Ingredient Nomenclature
Committee
➢ INCI Goals and Naming Principles
➢ INCI Application Process
➢ INCI NomenclaturePublication
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Cosmetic Labeling – U.S. Regulatory Framework
• Two laws govern the labeling of cosmetics:
• Federal Food, Drug, and Cosmetic Act (FDC Act),
21 U.S.C. section 301
• Fair Packaging and Labeling Act (FPLA), 15 U.S.C.
section 1451
• Regulations issued by FDA pursuant to these
laws are contained in the Code of Federal
Regulations (CFR) Title 21, Parts 700 to 740.
• Personal Care Product Council’s Labeling Manual
provides a comprehensive overview of U.S. labeling
requirements.
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CosmeticLabeling – U.S. RegulatoryFramework
• FPL A requires ingredient declaration by common or usual name
in descending order of predominance (21 CFR 701.3(a)).
• 21 CFR 701.3(c) sets out sources for ingredientnomenclature.
• Names established by the Commissioner.
• CTFA Cosmetic Ingredient Dictionary and Handbook
• 21 CFR section 701.3(c)(2)(i)) for International Nomenclature
Cosmetic Ingredient (INCI)names.
• Alternate compendia are listed in the order of preference at 21
CFR 701.3(c)(2).
• In the absence of a listing, use the name generally recognized
by consumers.
• In the absence of that name, use the chemical ortechnical
name.
• For a cosmetic/OTC drug, follow 21 CFR sections 201.66(c)(2), (c)(8),
and (d). OTC ingredients must be labeled according to the
applicable OTCmonograph.
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Cosmetic Labeling – U.S. Regulatory Framework
Colors:
• All color additives used in cosmetics marketed in the U.S. (with the
exception of coal-tar hair dyes) must be approved byFDA.
• In addition to approval, synthetic organic color additives mustbe
batch certified by FDA.
• All color additives must meet the requirements for identity and
specifications stated in the CFR.
• Color additives may be used only for the intended usesand
concentrations stated in the regulations.
• FDA currently does not object to dual declaration as long as
the official FDA name comes first, e.g. Green 3 (Cl42053).
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INCI Nomenclature – Background
• Initiated by consumer movement during1960s
• Industry survey
• Committee formed to reviewsurvey
• Proposal to FDA for uniform system fornames
• FDA recognizes Dictionary byregulation
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INCI Nomenclature – Background
• 1993 CTFA Adopted Names changed to INCI
(International Nomenclature CosmeticIngredient)
• INCI names formally recognized by regulation in
many countries for ingredient labeling
• Benefits of internationalharmonization:
• Uniformity
• Transparency
• Global Trade
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INCI Nomenclature – Background
International status brings about change:
• International Nomenclature Committee
expanded to include representatives fromthe
EU, Canada, and Japan
• The Committee worked closely with COLIPA
(European cosmetic perfumery association) during
the 1990s to codify botanical and
colorant nomenclature
• Colorant names specific to the EU and Japan
are
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published in the Dictionary
INCI Nomenclature – Background
International status brings about change:
• Trivial Names published for ingredientsspecific
to the EU and Japan
• Ingredients are translated into Japanese and
Chinese during the 1990s; Korean translations
were recently added(2015).
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INCI Nomenclature – Background
International status brings about change:
• INCI data base updated to cross-reference
Canadian Hot List, Japan Index, EU Annexes,
REACh, CLP Index, INN Names, UNIICodes
• Specific monograph written for [Nano]in
accordance with the EU regulation, EC
Regulation No. 1223/2009.
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International Cosmetic Ingredient Nomenclature
Committee (INC)
The International Cosmetic Ingredient Nomenclature Committee
(INC), sponsored by the Personal Care Products Council, is
charged with the responsibility of designating INCI names. The
INC is comprised of dedicated scientists from industry,academia,
regulatory authorities and sister associations who volunteer
their time to serve the global cosmetic industry community.
Scientists on the INC have backgrounds in various disciplines,
e.g., biochemistry, polymer chemistry, organic and inorganic
chemistry, as well as botany and biotechnology.. The INC
oversees the continued development of theINCI nomenclature
system, and assures the integrity of the information related to
INCI names that is published in the International Cosmetic
Ingredient Dictionary andHandbook.
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INCI Goals and KeyPoints
• INCI provides a uniform, standardized system for the global
identification of cosmeticingredients
• Harmonization is essential to the free movement ofgoods on
a global basis.
• INCI is not an endorsement of safety or acceptability for use
in acosmetic.
• It is the responsibility of the finished product manufacturer
to substantiate safety and to comply with current regulatory
requirements for the intendedmarket.
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INCI Naming Principles
• Names are assigned through an application process
• Names are created by the INC on a consensusbasis
• Success of INCI system is based on sound-science
• Conventions published in the Introduction tothe
Dictionary outline INCI naming principles
• Conventions are continually reviewed andupdated
to reflect current technology
• Names are essentially based on the compositionof
the final product
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INCI Naming Principles
• Depending on final product, raw material sourcehas
traditionally been used as part of name
• Consideration is given to existing terminologyfrom
related industries
• Every effort is made to be consistent withexisting INCI
names
• Changes to INCI names are avoided whenever possible
• There is a petition process for namechanges
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INCI Naming Principles
Botanicals:
• INCI names for plants are based on the Linnaean binomial
system which uses a scientific genus and species name to
identify anorganism.
• Plant parts are included in the INCIname
• Some common names are included in the INCI name(i.e.,
where the plant was originally identified by its common
name)
Rosmarinus Officinalis (Rosemary) Flower Extract
Rosmarinus Officinalis (Rosemary) Flower/Leaf/Stem Extract
Pinus Pinaster Bark Extract
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INCI Naming Principles
Botanicals:
• To facilitate ease for creating product labels, special
punctuation, formatting, and rules called for in the taxonomic
codes are omitted in INCI names, e.g., italics are not utilized,
species is not in lower casing, varieties and subspecies are
not included, and “x” for hybrids is not utilized.
• Due to the dynamic nature of plant classification, the
scientific nomenclature for plants is continually being
updated based on new research results. INCI names are not
readily updated to minimize economic impact of name
changes.
• Monograph definitions include the fullscientific name where
possible.
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INCI Naming Principles
Examplemonographs:
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INCI Naming Principles
Examplemonographs:
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INCI Naming Principles
Example monographs:
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INCI Naming Principles
Example monographs:
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INCI ApplicationProcess
Additional
Information
Submitted
Application Applicant
Application
Finalized by Council Staff Applicati no Contacted
Initiated byUser User, Paid & Review on For More
inci.personalcarecouncil.org Submitted Complete Information
yes
INC
Pre-review
INCI Name
New Existing
Ingredient INCIName Assigned &
Published
Additional
Information INC
Submitted& Meeting
Reviewed
Applicant
INCI Name New INC Review of
Contacted no INCIName yes Provisionally Monograph New
For More Created
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Information
INCI Application Process
INCI Application/Name Assignment Timetable:
• INC meets generally during the monthsof
February, April, June, September andNovember
• Files are compiled in chronological order and
distributed to the INC 4-6 weeks prior to the
scheduled meeting date
• Name assignments are released approximately
one month post-meeting
• In general, application process takes 3-6months
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INCI Application Process
Application Reminders:
• If ingredient utilizes a material with an existing INCI nameas
a starting material, include this on theapplication
• If ingredient is similar to a material previously named,include
this on the application
• Genus/species must be included for all organisms;botanicals
also require plant part
• If a question is posted after the applicationis reviewed,
respond promptly and place answer in the application
Comments Box
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INCI Application Process
Application Reminders:
• Identify all starting materialscompletely
• Provide a detailed manufacturing method, even for materials
which have an existing INCIName
• Include a reaction scheme with chemical notationwhenever
possible
• Provide purity information if isolating a specificcomponent
from a natural source; describe how material is
characterized; include technique for separation
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INCI Application Process
INCI Name Change Procedure:
• There is no form or fee fora name change.
• Petitions for an INCI name change shouldinclude:
• Current INCI Name TradeName
• Application number, if applicable Requested revision
• Technical rationale to support thepetition
• Supporting composition information and/or manufacturingdetails Analytical data where appropriate
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THANK YOU
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