INCI Nomenclature And The INCI Application Process

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INCI Nomenclature and theINCI Application ProcessJoanne NikitakisDirector, Cosmetic Chemistry

Presentation Overview U.S. Regulatory Framework for Labeling INCI Nomenclature - Background The International Cosmetic Ingredient NomenclatureCommittee INCI Goals and Naming Principles INCI Application Process INCI Nomenclature Publication

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 lawsare contained in the Code of Federal Regulations(CFR) Title 21, Parts 700 to 740. Personal Care Product Council’s Labeling Manualprovides a comprehensive overview of U.S. labelingrequirements.

Cosmetic Labeling - U.S. Regulatory Framework FPLA requires ingredient declaration by common or usual name indescending order of predominance (21 CFR 701.3(a)).21 CFR 701.3(c) sets out sources for ingredient nomenclature. Names established by the Commissioner. CTFA Cosmetic Ingredient Dictionary and Handbook (21 CFRsection 701.3(c)(2)(i)) for International Nomenclature CosmeticIngredient (INCI) names. Alternate compendia are listed in the order of preference at 21CFR 701.3(c)(2). In the absence of a listing, use the name generally recognizedby consumers. In the absence of that name, use the chemical or technicalname.For a cosmetic/OTC drug, follow 21 CFR sections 201.66(c)(2), (c)(8),and (d). OTC ingredients must be labeled according to theapplicable OTC monograph.

Cosmetic Labeling - U.S. Regulatory FrameworkColors: All color additives used in cosmetics marketed in the U.S. (with theexception of coal-tar hair dyes) must be approved by FDA. In addition to approval, synthetic organic color additives must bebatch certified by FDA. All color additives must meet the requirements for identity andspecifications stated in the CFR. Color additives may be used only for the intended uses andconcentrations stated in the regulations. FDA currently does not object to dual declaration as long as theofficial FDA name comes first, e.g. Green 3 (Cl 42053). rAdditiveInventories/ucm115641.htm#table3A

INCI Nomenclature – Background Initiated by consumer movement during 1960s Industry survey Committee formed to review survey Proposal to FDA for uniform system for names CTFA Adopted Names - created and published inDictionary, 1973 FDA recognizes Dictionary by regulation

INCI Nomenclature – Background 1993 CTFA Adopted Names changed to INCI(International Nomenclature Cosmetic Ingredient) INCI names formally recognized by regulation inmany countries for ingredient labeling Benefits of international harmonization: Uniformity Transparency Global Trade

INCI Nomenclature – BackgroundInternational status brings about change: International Nomenclature Committeeexpanded to include representatives from theEU, Canada, and Japan The Committee worked closely with COLIPAduring the 1990s to codify botanical andcolorant nomenclature Colorant names specific to the EU and Japan arepublished in the Dictionary

INCI Nomenclature – BackgroundInternational status brings about change: Trivial Names published for ingredients specificto the EU and Japan Ingredients are translated into Japanese andChinese during the 1990s; Korean translationswere recently added (2015).

INCI Nomenclature – BackgroundInternational status brings about change: INCI data base updated to cross-referenceCanadian Hot List, Japan Index, EU Annexes,REACh, CLP Index, INN Names, UNII Codes Specific monograph written for [Nano] inaccordance with the EU regulation, ECRegulation No. 1223/2009.

International Cosmetic IngredientNomenclature Committee (INC)The International Cosmetic Ingredient Nomenclature Committee(INC), sponsored by the Personal Care Products Council, ischarged with the responsibility of designating INCI names. TheINC is comprised of dedicated scientists from industry, academia,regulatory authorities and sister associations who volunteertheir time to serve the global cosmetic industry community.Scientists on the INC have backgrounds in various disciplines,e.g., biochemistry, polymer chemistry, organic and inorganicchemistry, as well as botany and biotechnology. The INCoversees the continued development of the INCI nomenclaturesystem, and assures the integrity of the information related toINCI names that is published in the International CosmeticIngredient Dictionary and Handbook.

International Cosmetic IngredientNomenclature Committee (INC)International Nomenclature CommitteeJohn Sanzone, Chairman, Estée Lauder CompaniesEric Abrutyn, ConsultantPatricia Aikens, Ph.D., BASFJames Anderson, ConsultantKarolina Brzuska, Cosmetics EuropeGaetano Castaldo, Ph.D., European CommissionFederica DeGaetano, Ph.D., European CommissionKhalid Mahmood, Ph.D., Johnson & Johnson Consumer andPersonal ProductsStanley Milstein, Ph.D., U.S. Food and Drug AdministrationJoanne Nikitakis, Personal Care Products CouncilClaude Salilou, PharmD., Ph.D., Estee Lauder CompaniesKatrika Shaw, Personal Care Products CouncilMike Starch, ConsultantDavid Story, Kao Brands CompanyMichael J. Fevola, Ph.D., Johnson & Johnson Consumer andColleen Sutton, Ph.D., Health CanadaPersonal ProductsJohn Gardlik, Ph.D., The Procter & Gamble CompanyRyuji Sugai, Kanebo Cosmetics, Inc,, JCIA LiaisonMindy Goldstein, Ph.D., Atlantic Coast Media GroupKrishnan Tamaraselvey, LubrizolBart Heldreth, Ph.D., Cosmetic Ingredient ReviewMiao Wang, L’Oreal USA, Inc.Laurie Joseph, Ph.D., Rutgers, The State University of NewJerseyWillem van der Wilden, Ph.D., Life SciencesPeter Kaufmann, ConsultantAkihiro Kinoshita, Ph.D., Shiseido America, Inc.,Robert Y. Lochhead, Ph.D., University of SouthernMississippiShontell Wright, U.S. Food and Drug AdministrationChao Zhu, L’Oréal USA, Inc.

INCI Goals and Key Points INCI provides a uniform, standardized system for the globalidentification of cosmetic ingredients Harmonization is essential to the free movement of goods ona global basis. INCI is not an endorsement of safety or acceptability for usein a cosmetic. It is the responsibility of the finished product manufacturerto substantiate safety and to comply with current regulatoryrequirements for the intended market.

INCI Naming Principles Names are assigned through an application process Names are created by the INC on a consensus basis Success of INCI system is based on sound-science Conventions published in the Introduction to theDictionary outline INCI naming principles Conventions are continually reviewed and updatedto reflect current technology Names are essentially based on the composition ofthe final product

INCI Naming Principles Depending on final product, raw material source hastraditionally been used as part of name Consideration is given to existing terminology fromrelated industries Every effort is made to be consistent with existing INCInames Changes to INCI names are avoided whenever possible There is a petition process for name changes

INCI Naming PrinciplesBotanicals: INCI names for plants are based on the Linnaean binomialsystem which uses a scientific genus and species name toidentify an organism. Plant parts are included in the INCI name Some common names are included in the INCI name (i.e.,where the plant was originally identified by its commonname)Rosmarinus Officinalis (Rosemary) Flower ExtractRosmarinus Officinalis (Rosemary) Flower/Leaf/Stem ExtractPinus Pinaster Bark Extract

INCI Naming PrinciplesBotanicals: To facilitate ease for creating product labels, specialpunctuation, formatting, and rules called for in the taxonomiccodes are omitted in INCI names, e.g., italics are not utilized,species is not in lower casing, varieties and subspecies arenot included, and “x” for hybrids is not utilized. Due to the dynamic nature of plant classification, thescientific nomenclature for plants is continually beingupdated based on new research results. INCI names are notreadily updated to minimize economic impact of namechanges. Monograph definitions include the full scientific name wherepossible.

INCI Naming PrinciplesExample monographs:

INCI Naming PrinciplesExample monographs:

INCI Naming PrinciplesExample monographs:

INCI Naming PrinciplesExample monographs:

INCI Application ProcessVisit the Council’s Quick Links box located in the on our home page:

INCI Application nalized byUser, Paid &SubmittedApplicationInitiated by Userinci.personalcarecouncil.orgCouncil For onalInformationSubmitted &ReviewedApplicantContactedFor MoreInformationExistingINCI NameINCI NameAssigned &PublishedINCMeetingnoINCI NameCreatedyesINCI NameProvisionallyAssignedNewMonographDevelopedINC Review ofNewMonographs

INCI Application ProcessINCI Application/Name Assignment Timetable: INC meets generally during the months ofFebruary, April, June, September and November Files are compiled in chronological order anddistributed to the INC 4-6 weeks prior to thescheduled meeting date Name assignments are released approximatelyone month post-meeting In general, application process takes 3-6 months

INCI Application ProcessApplication Reminders: If ingredient utilizes a material with an existing INCI name asa starting material, include this on the application If ingredient is similar to a material previously named, includethis on the application Genus/species must be included for all organisms; botanicalsalso require plant part If a question is posted after the application is reviewed,respond promptly and place answer in the applicationComments Box

INCI Application ProcessApplication Reminders: Identify all starting materials completely Provide a detailed manufacturing method, even for materialswhich have an existing INCI Name Include a reaction scheme with chemical notation wheneverpossible Provide purity information if isolating a specific componentfrom a natural source; describe how material ischaracterized; include technique for separation

INCI Application ProcessINCI Name Change Procedure: There is no form or fee for a name change. Petitions for an INCI name change should include:Current INCI NameTrade NameApplication number, if applicableRequested revisionTechnical rationale to support the petitionSupporting composition information and/or manufacturing detailsAnalytical data where appropriate Petitions for a name change can be sent via email to:Joanne Nikitakis,

INCI Nomenclature Publication INCI names and related information are published in theInternational Cosmetic Ingredient Dictionary and Handbook ,available on the Council’s website in the eweb/DynamicPage.aspx?Site pcpc&WebKey 4513b14e-2f75-4857-85b4-b3697be5d5d9 Electronic Dictionary subscriptions available through wINCI,and the Council’s InfoBase. Data is updated nightly. New 16th edition available first quarter 2016. Ingredient Buyers’ Guide available on Council’s homepage isfree of charge and provides an easy quick check for p/BGSearchPage.jsp

Thank You!Questions?Joanne -0338

Dec 01, 2015 · 21 CFR 701.3(c) sets out sources for ingredient nomenclature. 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).File Size: 1MB

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