The Electronic Voluntary The Electronic Voluntary Cosmetic Registration Cosmetic Registration

Program (VCRP)Program (VCRP)

Donald C. HaveryDonald C. HaveryLeader, Cosmetics Technology TeamLeader, Cosmetics Technology Team

Food and Drug AdministrationFood and Drug AdministrationIndie Beauty Network, March 19, 2009Indie Beauty Network, March 19, 2009

VCRP PurposeVCRP Purpose

Create a way to report postCreate a way to report post--market market cosmetic information to FDAcosmetic information to FDA

Assist FDA to assure cosmetic safetyAssist FDA to assure cosmetic safety Establish partnership between FDA and Establish partnership between FDA and

the cosmetic industrythe cosmetic industry Foster the safety evaluation of cosmetic Foster the safety evaluation of cosmetic

ingredients (Cosmetic Ingredient Review)ingredients (Cosmetic Ingredient Review)

VCRP ProgramVCRP Program

VCRP initiated in 1972 (Petition)VCRP initiated in 1972 (Petition)Series of paper forms to report:Series of paper forms to report: 2511: Establishment Registration2511: Establishment Registration 2512: Cosmetic Product Ingredient Statement2512: Cosmetic Product Ingredient Statement 2513: Cosmetic Ingredient Composition2513: Cosmetic Ingredient Composition 2514: Discontinue Cosmetic Product2514: Discontinue Cosmetic Product 2704, 2705: Adverse Reactions2704, 2705: Adverse Reactions

VCRP BenefitsVCRP Benefits

Active participation in the CIR safety Active participation in the CIR safety review program review program

Enhanced ingredient safety substantiation Enhanced ingredient safety substantiation in light of attacks on the cosmetic industry in light of attacks on the cosmetic industry

Easily manage your formulations and Easily manage your formulations and establishments, particularly with the new establishments, particularly with the new online programonline program

VCRP Online ProgramVCRP Online Program

VCRP OnlineVCRP Online

Electronic VCRP live December 1, 2005Electronic VCRP live December 1, 2005

http://www.cfsan.fda.gov/~ocac/ocacvcrp.html

Go to www.fda.gov, select Cosmetics, and select VCRP

Active VCRP Formulation Filings

0

2000

4000

6000

8000

1985 1990 1995 2000 2005 2010

Year

Num

ber o

f Fili

ngs

Series1

Online VCRP Participation Online VCRP Participation

Current Number of Accounts: 1146Current Number of Accounts: 1146

Our Worst Nightmare:Our Worst Nightmare:

““I entered my ingredient and it is I entered my ingredient and it is unresolvedunresolved””

Check the online dictionaryCheck the online dictionary Enter only a part of the ingredient nameEnter only a part of the ingredient name

Check the International Cosmetic Check the International Cosmetic Ingredient DictionaryIngredient Dictionary If still unresolved, submit itIf still unresolved, submit it

Unresolved Botanical IngredientsUnresolved Botanical Ingredients

The INCI Dictionary is not consistentThe INCI Dictionary is not consistent Butyrospermum Parkii (Shea Butter) Zea Mays (Corn) Cob Meal Rosa Centifolia Flower Extract

Search INCI Dictionary using part of Latin Search INCI Dictionary using part of Latin namename

Search online dictionary using common Search online dictionary using common name or part of the Latin namename or part of the Latin name

Color NomenclatureColor Nomenclature

CI numbers are not recognized by VCRPCI numbers are not recognized by VCRP U.S. color names plus CI numbers are not U.S. color names plus CI numbers are not

recognizedrecognized egeg. FD&C Red 40 (CI 16035). FD&C Red 40 (CI 16035)

Curry Red (uncertified Red 40) is not recognizedCurry Red (uncertified Red 40) is not recognized Note abbreviated color names in dictionaryNote abbreviated color names in dictionary

FDC Yellow #5FDC Yellow #5--Aluminum LakeAluminum Lake Yellow #5Yellow #5--Lake (Label Abbreviation)Lake (Label Abbreviation)

Procedures Requiring Written Procedures Requiring Written DocumentationDocumentation

Transferring product ownership Transferring product ownership Ingredient confidentialityIngredient confidentiality

New VCRP FeaturesNew VCRP Features

Advanced search capabilityAdvanced search capability Search your formulations in the databaseSearch your formulations in the database Download search to spreadsheetDownload search to spreadsheet

New VCRP FeaturesNew VCRP Features

Advanced search capabilityAdvanced search capability Search your formulations in the databaseSearch your formulations in the database Download search to spreadsheetDownload search to spreadsheet

Message boxMessage box

New VCRP FeaturesNew VCRP Features

Advanced search capabilityAdvanced search capability Search your formulations in the databaseSearch your formulations in the database Download search to spreadsheetDownload search to spreadsheet

Message boxMessage box Help linkHelp link

Thank you!!Thank you!!

Questions?Questions?