icphso Asia-Pacific Consumer Product Safety Symposium Introducing products to the Market: P

1
icphso Asia-Pacific Consumer Product Safety
SymposiumIntroducing products to the Market
PGs ApproachNovember 1, 2011

• Hirokazu Seto
• Regulatory Technical Relations
• Procter Gamble Japan

2
Outline
About us Safety for consumers and
environment Regulatory compliance Summary
3
About us Safety for consumers and
environment Regulatory compliance Summary
4
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
5
Products Touching lives24 Billion-Dollar
Brands

• Beauty (33)
• Health and Well-being (18)
• Household Care (49)

PG 2011 annual report
6
Company Policy

• Ensuring that
• The companys 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
7
About us Safety for consumers and
environment Regulatory compliance Summary
8
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 PG Safety
  Scientists

9
Safety Assessment in the Product Development
Process
Idea
Lab evaluation
Consumer Research Market Research
Post Market Surveillance
Market entry
Exploration
Technology/material identification Formula/product
definition
Production
Potential hazard ID Exposure assessment
Safety assessment
Refine Assessment
Clearance
In-Market monitoring
10
Safety for consumers

• The Human Safety Organization employs scientists
  to cover a broad range of safety topics
• Skin, eye, inhalation, and reproductive
  toxicology
• Skin and respiratory allergies
• Genotoxicity
• Carcinogenicity
• Risk assessment
• Computational modeling and simulation

11
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?
DOSE-RESPONSE
EXPOSURE ASSESSMENT
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, 1983
12
Safety for environment

• The Environmental Safety Organization employs
  scientists for the diverse fields
• Environmental Toxicology
• Microbiology
• Biodegradation
• Ecology
• Environmental engineering
• Analytical chemistry
• Microbial ecology
• Environmental modeling
• Life cycle assessment

13
Life Cycle Assessment
Covers a variety of evaluation factors Covers a variety of evaluation factors Covers a variety of evaluation factors
Use of resources Energy consumption
Use of resources Water consumption
Use of resources Solid waste
Emission into air Global warming
Emission into air Ozone depletion
Emission into air Human toxicity
Emission into air Summer smog
Emission into water Acidification
Emission into water Eutrophication
Emission into water Aquatic ecotoxicity
A product does not pose a hazard to the
environment during production, use, or disposal.
14
About us Safety for consumers and
environment Regulatory compliance Summary
15
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.

16
Organization structure to ensure the regulatory
compliance

• Global expert/coordinator
• 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
Local Expert
Local Expert

• Local expert
• Providing early input to RD and Marketing.
• Monitoring the new regulatory requirements.
• Deep knowledge of the regulations of a country
  where the expert has responsibility.

17
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

18
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

19
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
20
Regulatory classification
Drugs
Cosmetics
Drugs
Cosmetics
Drugs
Cosmetics
Quasi Drugs
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
21
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

22
Summary

• Ensuring that
• The companys 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

23
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
24
Thank you for your attention
25
Supplemental Information
26
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