16 October 2013
Cosmetic compliance summit 2013: Focusing on the legal aspects of the cosmetic products regulation
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Genesis of the cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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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
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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
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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
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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
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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
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Legal strategies to comply with cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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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
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Compliance & regulatory measures
Cosmetic
products regulatio
n complian
t
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
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Compliance with cosmetic product regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
STEP 1: RP designatio
n
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 informatio
n Safety
assessment
Container &
packaging
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Best litigation avoidance strategies
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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Litigation risks
Fashion finance law: tools & tips to get funding while retaining control over your fashion business
• From competent national authorities
• From European commission
• From competitors
• From retail consumers
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How to avoid litigation?
Fashion finance law: tools & tips to get funding while retaining control over your fashion business
• Claims substantiation
• Risk mitigation
• Internal regulatory & compliance policies
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Conclusion
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
Annabelle Gauberti
Founding partner
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation