cosmetics compliance summit: focusing on the legal aspects of the cosmetic products regulation...
DESCRIPTION
Detailed presentation on the legal bits of the EU cosmetics products regulation. Learn everything you need to know about cosmetics law and compliance. This webinar was presented at the Cosmetics compliance summit in London, in 2013.TRANSCRIPT
16 October 2013
Cosmetic compliance summit 2013: Focusing on the legal aspects of the cosmetic products regulation
2
Genesis of the cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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
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
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
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
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
Legal strategies to comply with cosmetic products regulation
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
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
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
11
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
12
Best litigation avoidance strategies
Cosmetic compliance summit 2013: focusing on the legal aspects of the cosmetic products regulation
13
Litigation risks
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• From competent national authorities
• From European commission
• From competitors
• From retail consumers
14
How to avoid litigation?
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• Claims substantiation
• Risk mitigation
• Internal regulatory & compliance policies
15
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