1	Regulatory Issues in Preservative Use Janet Winter Blaschke International Cosmetics & Regulatory Specialists, L.L.C.
2	Preservative landmines Differing regulations from country to country Positive lists Negative lists Restricted lists What is better?
3	United States Food and Drug Administration (FDA) No delineated rules/positive lists for Cosmetics Short negative list Adulteration
4	Cosmetic Regulations and Microbiology Adulteration A cosmetic shall be deemed to be adulterated: If it bears or contains any poisonous or deleterious substance which may render it injurious to users….. If it consists in whole or in part of any filthy, putrid, or decomposed substance It has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. And others.. (21 U.S.C., Sec. 361)
5	European Union Positive list Restricted list Negative list New regulations
6	European Union Rulemaking Technical Committee SCCP European Commission
7	Japan MHLW Ministry of Health, Labor and Welfare Japan’s reputation Historical changes in Regulations Positive list/Restricted list for Cosmetics Positive/Restricted/Negative combination list for product types Negative list for Cosmetic ingredients
8	Other countries Adopting all or part of other regulatory systems Have their own system unique to their country or trading bloc “Worldwide formula” trauma
9	Consumer Safety and Microbiology in the E.U. Phase I Initial legislation in 1976 Stability of products from date of manufacture “Best before” date- calendar date Relatively easy to validate
10	PAO labeling parameters Phase II Stability of 30 months or over No “best before” date Good news, bad news Period After Opening date Not an Expiration Date!
11	7^th Amendment “Period After Opening”
12	Period After Opening Symbol
13	7^th Amendment
14	Determination of safe period after opening
15	Dating parameters When to use Best before dating When to use Period After Opening Both?? Inherent formula stability
16	Period After Opening Data Must be a part of your Product Information Package/Dossier Part of your product safety profile Rationale must be developed Rationale must be validated This will be audited by the authorities!
17	Getting a new preservative to be accepted/approved US Ultimately, a company must show finished product safety, no direct regulatory burden on preservative manufacturer, except through producing/marketing company
18	Getting a new preservative to be accepted/approved EU Must be on Approved preservatives list, Annex VI Safety and efficacy testing In vitro and in vivo testing Validated for safe levels of use “Precautionary Principle” No preservative can be used until listed
19	New preservative approval Japan Must be on Approved preservatives, noting any restrictions Safety and efficacy testing In vitro and in vivo testing Validated for safe levels of use Testing on Asian skin No preservative can be used in Cosmetics until listed
20	When is an ingredient a preservative? Prevent or retard microbial growth Protect cosmetic products from “spoilage” In between/multiple use ingredients If it walks like a duck…….. And the government says it’s a duck…
21	……. Then you’d better make sure that Duck doesn’t sink to the bottom of the lake
22	How to “deal” Define your product in regulatory terms Find appropriate information about the ingredient Do your own research! Hearsay doesn’t count Beware of the Worldwide market catch-all
23	Going forward: Stay ahead of dilemmas Stay up to date on pending issues Follow changes in regulations Keep your ear to the ground for consumer awareness Be prepared for changes, external and internal
24	Thank you