1. Melanie Cummings Regulatory Specialist
Export Documentation
Melanie Cummings
Regulatory Specialist

2. 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

3. 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

4. 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

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

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

7. 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

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

9. 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.

10. 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)

11. 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

12. 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

13. 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!

14. 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

15. Thank you!