Formulation Formulation development development

for global filingsfor global filings

THE IMPACT OF WORLD THE IMPACT OF WORLD REGULATIONS TO DEVELOP AND REGULATIONS TO DEVELOP AND LAUNCH HARMONIZE COSMETIC LAUNCH HARMONIZE COSMETIC

PRODUCTSPRODUCTS

““ How can we develop a cosmetic product How can we develop a cosmetic product that can have its inventory ready to be that can have its inventory ready to be exchanged around the globe.exchanged around the globe.””

Same package with all information inSame package with all information in Same formulaSame formula ““In other words: How to make one fit allIn other words: How to make one fit all”” Understand what is required in each Understand what is required in each

country to sell cosmeticscountry to sell cosmetics

Global Cosmetic Global Cosmetic Regulation ScenarioRegulation Scenario

We have a lack of global We have a lack of global harmonization on Cosmetics:harmonization on Cosmetics:

USAUSA EuropeEurope AsiaAsia Latin AmericaLatin America Robust R&D system is requiredRobust R&D system is required

Latin AmericaLatin America

MercosurMercosur CANADACANADA Central AmericaCentral America MexicoMexico ChileChile PanamaPanama All othersAll others

MercosurMercosur

Pre Marketing approval processPre Marketing approval process Lists of ingredients harmonizedLists of ingredients harmonized In place process to update the listIn place process to update the list Unique requirements still present in each Unique requirements still present in each

countrycountry Administrative procedures to get product Administrative procedures to get product

registration are not harmonizedregistration are not harmonized Requirements change country by countryRequirements change country by country Labeling requirements not harmonizedLabeling requirements not harmonized Claims /Safety support data requirements not Claims /Safety support data requirements not

harmonizedharmonized

CANADACANADA

PreMarketing Approval processPreMarketing Approval process Recognition Process in placeRecognition Process in place Adopts List of Ingredients from Europe and Adopts List of Ingredients from Europe and

USAUSA Administrative procedures to get product Administrative procedures to get product

registration are almost quite harmonized:registration are almost quite harmonized: Requirements quite clearRequirements quite clear Labeling requirements almost quite Labeling requirements almost quite

harmonizedharmonized Claims /Safety support data requirements Claims /Safety support data requirements

almost quite harmonizedalmost quite harmonized

Central America Central America Costa Rica, Salvador, Guatemala, Honduras, Costa Rica, Salvador, Guatemala, Honduras,

Nicaragua.Nicaragua. New Harmonized cosmetic regulation since New Harmonized cosmetic regulation since

early 2009early 2009 PreMarketing approval processPreMarketing approval process Adopts List of Ingredients from Europe and Adopts List of Ingredients from Europe and

USAUSA Administrative procedures to get product Administrative procedures to get product

registration are not harmonized:registration are not harmonized: Requirements change country by countryRequirements change country by country Labeling not harmonizedLabeling not harmonized Claims /Safety support data requirements not Claims /Safety support data requirements not

harmonizedharmonized

Mexico Mexico

Pos-Marketing Surveillance process Pos-Marketing Surveillance process for cosmeticsfor cosmetics

Pre-Marketing approval process for Pre-Marketing approval process for HygienicHygienic

Has list of allowed, restricted and not Has list of allowed, restricted and not allowed ingredients updated on allowed ingredients updated on March 21, 2007March 21, 2007

Specific labeling requirements ( INCI Specific labeling requirements ( INCI translated to Spanish)translated to Spanish)

Chile and PanamaChile and Panama

PreMarketing approval processPreMarketing approval process Adopts List of Ingredients from Adopts List of Ingredients from

Europe and USAEurope and USA Specific labeling requirements Specific labeling requirements

R&D ProcessR&D Process

Product DevelopmentProduct Development R&D systems should be able to provide to R&D systems should be able to provide to

the Formulator the ingredientthe Formulator the ingredient’’s regulation s regulation around the global/region so that only around the global/region so that only approved ones can be usedapproved ones can be used

Product Safety:Product Safety: Make sure that ingredients that are not Make sure that ingredients that are not

regulated are safe.regulated are safe. Make sure that final formulation is safeMake sure that final formulation is safe Make sure claims are substantiatedMake sure claims are substantiated

Regulatory AffairsRegulatory Affairs

Make sure to update database systemMake sure to update database system Ingredients updateIngredients update Safety test requirementsSafety test requirements Specific country/region product Specific country/region product

registration requirements:registration requirements: Words/expression restriction / Words/expression restriction /

forbiddenforbidden Claims requirementsClaims requirements Unique requirementsUnique requirements

Harmonized ProductHarmonized Product

Define Manufacturing strategyDefine Manufacturing strategy This will drive the last regulatory This will drive the last regulatory

requirements to have harmonized requirements to have harmonized product:product:

Same packageSame package Same formulaSame formula Same label copySame label copy Approved in the countries according Approved in the countries according

strategystrategy

The impact of world regulation to The impact of world regulation to develop and launch harmonized develop and launch harmonized

cosmetic productscosmetic products

Time to launch harmonized product Time to launch harmonized product is too long impacting:is too long impacting:

Marketing strategyMarketing strategy Supply Chain strategySupply Chain strategy Adding Premium costsAdding Premium costs Service issuesService issues

REFERENCESREFERENCES

http://www.personalcarecouncil.orghttp://www.personalcarecouncil.org http://ec.europe.eu/enterprise/http://ec.europe.eu/enterprise/

cosmetics/cosmetics/ http://www.cirsafety.http://www.cirsafety.

THANK YOUTHANK YOU