The document summarizes a summit focused on the legal aspects of the EU Cosmetic Products Regulation. It describes the genesis and goals of the regulation, which aims to protect consumer health while reducing animal testing and informing consumers. The regulation implemented a single set of rules for cosmetic products across the EU and changed some requirements for responsible persons, distributors, and compliance with good manufacturing practices. The summit discussed strategies for companies to comply with the regulation through their contracts, compliance measures, product documentation, labeling, and best practices to avoid litigation risks.

1. 16 October 2013
Cosmetic compliance
summit 2013:
Focusing on the legal
aspects of the cosmetic
products regulation

2. 2
Genesis of the cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

3. 3
It’s not personal, it’s strictly business
• European commission has adopted “legal package” on
“products security & market surveillance” for non-food
products
• Counterfeiting is endemic, bringing in Europe non-
compliant & dangerous products
• Need to protect health & safety of consumers!
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

4. 4
Why was the cosmetic products regulation adopted?
• Recasts directive 76/768/EEC on cosmetics
• Regulation aims at:
• protecting human health
• reducing & regulating animal testing
• Informing consumers
• In-market control
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

5. 5
How was the cosmetic products regulation implemented?
• Regulation directly applicable in all member states
• Implementation schedule
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
Regulation
1223/2009
signed on
30
November
2009
Regulation
1223/2009
enters into
force on11
July 2013
Executing
directive
2012/21/UE
must be
complied with
by 1
September
2013
Regulation 658/2013 of
10 July 2013 entered
into force on 1
September 2013

6. 6
The thick of it: what changes brought by cosmetic products
regulation?
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

7. 7
So, what’s the story?
• Nothing new under the sun!
• Still no pre-market approval
• Terminology streamlining and clarifications, compared to
dispositions of cosmetics directive 76/768
• Minor changes:
• Obligations of responsible person (art. 5)
• Obligations of distributors (art. 6)
• Identification within supply chain (art. 7)
• Compliance with GMP (art. 8)
• Notification requirements (art. 13)
• In-market control (art. 22)
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

8. 8
Legal strategies to comply with cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

9. 9
Legal strategies for contracts
Contracts with manufacturers
Agency agreements
Distribution agreements
Licencing agreements
Terms & conditions for retail
customers
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

10. 10
Compliance & regulatory measures
Cosmetic
products
regulation
compliant
Appoint
compliance
officer
Update
employee’s
guidelines &
handbook
Devise now a
plan in case a
cosmetic product
is not compliant
Conduct
legal review
of contracts
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
Be proactive
Remember that your
industry-reputation is
at stake
Anticipate
issues

11. 11
Compliance with cosmetic product regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
STEP 1: RP
designation
STEP 2:
product
classification
STEP 3: PIF
STEP 4:
product
description
safety report
GMP
STEP 5:
data on
animal
testing
STEP 6:
labelling
STEP 7: EU
notification
STEP 8: EU
market
Safety
information
Safety
assessment
Container &
packaging

12. 12
Best litigation avoidance strategies
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

13. 13
Litigation risks
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• From competent national authorities
• From European commission
• From competitors
• From retail consumers

14. 14
How to avoid litigation?
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• Claims substantiation
• Risk mitigation
• Internal regulatory & compliance policies

15. 15
Conclusion
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation

16. 16
Cosmetic compliance summit 2013: focusing on the legal
aspects of the cosmetic products regulation
Annabelle Gauberti
Founding partner
annabelle.gauberti@crefovi.com
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation