cosmetics compliance summit: focusing on the legal aspects of the cosmetic products regulation...

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

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• From competent national authorities

• From European commission

• From competitors

• From retail consumers

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How to avoid litigation?

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• 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

annabelle.gauberti@crefovi.com

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