Transcript P&G Brand Template

icphso
Asia-Pacific Consumer Product Safety
Symposium
Introducing products to the Market:
P&G’s Approach
November 1, 2011
Hirokazu Seto
Regulatory & Technical Relations
Procter & Gamble Japan
Outline
About us
Safety for consumers and environment
Regulatory compliance
Summary
About us
Safety for consumers and environment
Regulatory compliance
Summary
About us
“Touch and improve more consumers’ lives in more parts of the world more completely.”
Headquarters:
The Procter & Gamble Company
Year founded:
1837
Location:
Cincinnati, Ohio, U.S.A
Business Operation:
About 80 countries
Number of employees:
Approximately 127,000 world wide
Products : Touching lives
24 Billion-Dollar Brands
 Beauty (33%)
 Health and Well-being (18%)
 Household Care (49%)
P&G 2011 annual report
Company Policy
Ensuring that:
 The company’s products and
packages are safe for
consumers and environment
when used as intended.
 The company will meet or
exceed all applicable legislative
and regulatory requirements
related to product safety and
labeling.
Worldwide Business Conduct Manual, 2011: Page 15
About us
Safety for consumers and environment
Regulatory compliance
Summary
Safety Capability
 About 700 People world wide
 18 Countries
 About 120 PhDs, MDs, DVMs
 Research Program driven by our safety assessment needs
 About 2,600 publications from P&G Safety Scientists
Safety Assessment in the Product Development Process
Idea
Exploration
Potential hazard ID
Exposure assessment
Consumer Research
Market Research
Technology/material identification
Formula/product definition
Safety
assessment
Refine Assessment
Production
Clearance
Post Market
Surveillance
Market entry
Lab evaluation
In-Market
monitoring
Safety for consumers
The Human Safety Organization employs scientists to cover a broad range of safety topics:
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Skin, eye, inhalation, and reproductive toxicology
Skin and respiratory allergies
Genotoxicity
Carcinogenicity
Risk assessment
Computational modeling and simulation
Approach to risk assessment
Science based safety assessment
HAZARD IDENTIFICATION
What level of a product or ingredient can
cause harm, and what type of harm?
EXPOSURE
ASSESSMENT
DOSE-RESPONSE
The acceptable level of the product
or ingredient that does NOT cause
the identified harm?
Potential exposure to a product or ingredient
RISK
CHARACTERIZATION
The comparison of the exposure to the new product or ingredient at its established
safe level and the confirmation that it is sufficiently below the safe level.
The National Academy of Sciences,
Safety for environment
The Environmental Safety Organization employs scientists for the diverse fields:
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Environmental Toxicology
Microbiology
Biodegradation
Ecology
Environmental engineering
Analytical chemistry
Microbial ecology
Environmental modeling
Life cycle assessment
Life Cycle Assessment
Covers a variety of evaluation factors
Energy consumption
Use of resources
Water consumption
Solid waste
Global warming
Emission into air
Ozone depletion
Human toxicity
Summer smog
Acidification
Emission into water
Eutrophication
Aquatic ecotoxicity
A product does not pose a hazard to the environment during production, use, or disposal.
About us
Safety for consumers and environment
Regulatory compliance
Summary
Regulatory Compliance
“The company meets or exceeds all applicable legislative and regulatory requirements related
to product safety and labeling”
• Few regulations are harmonized in the global.
• New regulations are passed every year.
• Self regulation established by industry associations.
Organization structure
to ensure the regulatory compliance
Global expert/coordinator
Product Development/Marketing
Global expert/
coordinator
Local Expert
Local Expert
Local Expert
 Providing necessary data or information to the local experts.
 Integrating the regulatory requirements from each country where the
company may market products.
 Communication with the local experts based on the technical
knowledge around products as well as regulatory masteries.
Local expert
 Providing early input to R&D and Marketing.
 Monitoring the new regulatory requirements.
 Deep knowledge of the regulations of a country where the expert has
responsibility.
Consideration for Regulatory Compliance 1
To comply with the regulations everywhere we operate.
Considerations are…
Sites:
• Facility/Resources
• System for Quality Assurance/Good Manufacturing Practice/hygiene
standards
• Licenses for manufacturing/marketing/distributing products
Ingredients:
• Function of ingredients in drugs, cosmetics, or others
• Positive/Negative Lists
• Specifications
Consideration for Regulatory Compliance 2
Considerations are…
Formula/Finished Product:
• Product registration/documentation
• Product specification
• Efficacy/performance
• Stability/microbiology
• Safety
• Package
Labeling:
• Regulatory and safety required labeling
• Ingredient list and others
• Visuals/read-ability
Consideration for Regulatory Compliance 3
Considerations are…
Claims/Advertisement:
• Guidelines for claims/advertisement
• Promotion/sampling
Others:
• Consumer testing
• Clinical study
• New regulation
Requirements are unique to each country/region
Regulatory classification
Drugs
Cosmetics
Drugs
Cosmetics
Drugs
Quasi Drugs
Cosmetics
Examples of products in different category
US
EU
Japan
Sunscreen
OTC
Cosmetics
Cosmetics
Hair colorants/Permanent wave
Cosmetics
Cosmetics
Quasi Drugs
Whitening
Cosmetics
Cosmetics
Quasi Drugs
Antiperspirants
OTC
Cosmetics
Quasi Drugs
Anti dandruff shampoo
Cosmetics
Cosmetics
Quasi Drugs
Regulatory Affairs & Technical Relations
Further efforts on…
Regulatory Compliance
• Fundamental role; monitoring any updates in local regulatory requirements
• Delivering the best quality products/services for consumers
Trade association
• Complying self regulation
• Working for common agenda in the industry
Global harmonization
• Minimizing trade barrier due to regulations
• Keeping highest level of consumer protection
example… ICCR; International Cooperation on Cosmetic Regulation
Summary
Ensuring that:
 The company’s products and packages are safe for consumers and environment when
used as intended.
 The company will meet or exceed all applicable legislative and regulatory requirements
related to product safety and labeling.
More opportunities:
 Global Harmonization
 Trade association
Acknowledgements
Dr. Soga Kwon
Central Product Safety, Procter & Gamble
Dr. Heike Scheffler
Central Product Safety, Procter & Gamble
Dr. Charles Peng
Regulatory & Technical Relations, Procter & Gamble Japan
Thank you for your attention
Supplemental Information
An example…
A skin whitening product
Cosmetics regulations
Medicated cosmetics/Quasi drug
A Case in Japan:
 Ingredient specification comply with standards
 Finished product specification/physical chemical properties
 Active ingredient with efficacy/proper dosage
 Safety assurance
 Stability
 Efficacy