Melanie Cummings Regulatory Specialist Export Documentation Melanie Cummings Regulatory Specialist

US vs. Foreign Cosmetic Regulations Registration is voluntary via FDA’s VCRP Products must be “safe” - No specified requirements FDA oversight is limited to reactionary action Registration is almost always mandatory Safety testing requirements are usually dictated Government oversight proactive

Product Information File (PIF) Many countries require a PIF Content requirements vary by country but most follow EU Once PIF is prepared for EU, only minor modifications are needed from one country to the next

PIF - Components Summary of who is responsible for product Who is putting product on the market? Who manufactures/fill the product? Who is the in-country responsible party? Who conducted safety assessment? GMP (Good Manufacturing Practices) attestation Manufacturing process Non-animal testing attestation Finished product specs & MSDS

PIF – Components (cont.) Stability/compatibility report Irritation testing report Product composition (by raw material trade names) Ingredient toxicity summary Raw material MSDS & product specs

PIF – Components (cont.) Product labeling Product image Packaging MSDS and specifications Summary of Adverse Reactions Safety assessor qualifications

Claims Substantiation All product claims must be substantiated Okay to use raw material supplier’s data If the use level is comparable to the supplier’s study

Some EU Symbols Period After Opening (PAO) Hand-in-Book Hourglass

Choosing an RP RP / Responsible Person / In-country Representative RP services vary in cost, depending on how much of the work you are willing to do yourself.

EU Cosmetic Directive Positive List Cannot use ingredients not on the list Must use CAS number indicated on the EU list Product Information Package (PIF) Safety Assessment Must be conducted by a qualified person Responsible Person (RP)

Health Canada Cosmetic Compliance Health Canada’s DSL/NDSL Import limitations exist for ingredients not listed Therapeutic Health Products/Natural Health Products vs. OTC Registration requirements and process Hotlist Cosmetic Notification process Canadian distributor required

Brazil Cosmetic Directives Very similar to EU regulations Animal testing is allowed Safety assessment also required Testing requirements not as prescriptive as the EU In-country rep required

China Cosmetic Directives Product registration is required Registration Responsible Party Step 1: Hygiene Permit Step 2: Labeling Record Be prepared - this process can take up to 4 months!

Recommended Product Testing Preservative Efficacy Test Testing to demonstrate absence of irritation HRIPT and/or in vitro methods Ocular irritation testing for eye area products Stability/compatibility Other testing depending on product type

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