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Index
Cover
Title Page
Copyright
A Note from the Publisher
About the Editor
AUTHORS
Contents
PART 2 – REGULATORY
PART_2.1 – REGULATORY REQUIREMENTS, INTELLECTUAL PROPERTY AND ACHIEVING GLOBAL MARKET SUCCESS FOR COSMETIC PRODUCTS
PART_2.2 – AN OVERVIEW OF THE CHANGING REGULATORY LANDSCAPE IN THE U.S. AND THE E.U. AND HOW TO DEAL WITH THEM...
2.2.1 The challenge of "changing standards"
2.2.2 Regulatory Requirements for Cosmetics in the United States
a. Introduction: roles and responsibilities
b. Rules and references
c. Definition of Cosmetic, field of application, drugs and cosmetics, cosmeceuticals
d. Classification of Cosmetic/Drug
e. How to manage Cosmetic/Drug
f. Cosmetics and Soaps
g. Labeling and package of cosmetics
h. Warnings
i. Missing INCI name; what to do
j. How to get the assignment of a new INCI name
2.2.3 Guide to Cosmetic Development and Safety Evaluations
a. Compliance of limited/regulated ingredients
b. Safety assessment of cosmetics according to FD&C Act
c. Regulated/limited substances
d. Prohibited ingredients and impurities according to the FDA
e. Color additives
f. Safety profile of substances: source of information
g. Safety profile of finished product
h. Microbiological requirement
i. Activity of manufacturers/importers/exporters
j. FDA plant inspection checklist
k. Activity of public health authorities: notification/permissions, audits
l. Future developments of U.S. legislation
2.2.4 Regulatory Requirements for Cosmetics in the European Union
a. Introduction, roles, and responsibilities
b. "Intercontinental" products
c. Classification of cosmetic/drug, borderline products
d. Roles and Responsibilities
e. Definition of "safety"
f. Labeling
g. Troubles on EU INCI names, and what before and after the "Glossary"
h. Guidelines on labeling
i. Manufacture of cosmetics for the European market
2.2.5 PIF and safety assessment of European cosmetics
a. Profile of the safety assessor
b. The structure of documents
c. Annex I: CPSR
d. Annexes that have to be considered: II to VI
2.2.6 Safety profile of substances: source of information
2.2.7 The safety assessment from raw material to finished product
a. Animal Testing
b. CMR
2.2.8 The Notification in the CPNP
2.2.9 Market Surveillance, activity of EU Authorities (Articles 22-23), RAPEX
a. Other laws that affect the EU 1223/2009: REACH (EU regulation on chemicals)
2.2.10 Practical features: how to move towards compliance with EU regulations
Conclusions
References
PART_2.3.1 – ACHIEVING GLOBAL MARKET ACCESS- FOCUS ON RUSSIA
2.3.1.1 Introduction
2.3.1.2 What is the customs union and what is its aim?
2.3.1.3 What were the old requirements and procedures of product conformity assessment and how have they progressed to date?
1. Prior to July 1, 2012
2. Since July 1, 2012
2.3.1.4 Overview of the new customs union technical regulation “about safety of perfumery and cosmetic products"
1. Definition of perfumes and cosmetics according to CU Technical Regulation
2. Conformity assessment documents
a. State registration
b. TR declaration of conformity to customs union
3. Requirements for perfumes and cosmetics
4. Labeling requirements
5. Mark of conformity
2.3.1.5 How different are the new rules from european requirements?
2.3.1.6 Do the new rules simplify access to the combined russian and cu market? How do new rules affect exports of cosmetics to russia?
2.3.1.7 Business climate in russia and reforms—russia joined WTO
References
PART_2.3.2 – KINGDOM OF SAUDI ARABIA (KSA): COSMETICS AND PERFUMERY PRODUCTS: MARKET ACCESS AND REGULATIONS
2.3.2.1 Regulatory Framework
a. Cosmetic ruling authority
b. Cosmetic regulations and sanctioned standards
1. Sanctioned Safety Standard
2. Guidance for Products Classification
3. Product-specific standards
2.3.2.2 Definition and Scope of Application
a. Definition
b. Classification
2.3.2.3 Labeling
a. General rules
b. Specific rules
2.3.2.4 Market Access
a. Certification process
b. Conformity assessment
c. Key issues
References
PART_2.3.3 – ACHIEVING GLOBAL MARKET ACCESS- FOCUS ON CHINA
2.3.3.1 Category of cosmetics in China: special use and nonspecial use cosmetic
2.3.3.2 Oral products requirements
2.3.3.3 Document and testing requirements during product registration
2.3.3.4 Animal testing requirements in China
2.3.3.5 Safety assessment for ingredients and finish products
2.3.3.6 Comparison of EU and China regulation requirements
2.3.3.7 Existing and new cosmetic ingredients in China
PART_2.3.4 – NANOMATERIALS IN COSMETICS: REGULATORY AND SAFETY CONSIDERATIONS
2.3.4.1 Regulation of Cosmetics Containing Nanomaterials
a. Definition of Nanomaterial
b. Regulation in Europe
c. Regulation in the United States
d. Regulation in Canada
2.3.4.2 Safety Assessment Considerations for Nanomaterials
a. Study Design Aspects
b. Nanomaterial Characterization
c. Dose Metrics
d. Assay Interference
Conclusion
References
PART_2.4 – INTELLECTUAL PROPERTY (IP) ISSUES: PATENTS AND TRADE SECRETS
2.4.1 Introduction
2.4.2 Typical IP Timing in Cosmetics and Personal Care
2.4.3 Procuring IP Rights
a. Patents
b. Utility Patent (most common patent)
c. U.S. Provisional Application
d. Design Patent or Industrial Design (for nonfunctional look of product)
e. Plant Patent (for live plant species)
f. Utility Model (sometimes called patent-lite, mainly in China, Japan, and Korea)
2.4.4 General Criteria of Patentability
2.4.5 Patent Application Timeline
2.4.6 Patent Organizations Across the World
a. National Patent Systems
2.4.7 Patent Cooperation Treaty (PCT) – The main route for obtaining patents international
a. European Patent Convention
b. Regional Patent Organizations
2.4.8 Trade Secret
2.4.9 Trademarks & Service Marks
a. Trademark
b. Service Mark
c. Trade Dress
d. Copyright
2.4.10 Enforcing IP Rights & Reducing IP Risk
a. Freedom to Operate
b. IP Information from Packaging
c. IP Issues While Partnering with Third Parties
d. IP Litigation & Patent Infringement
2.4.11 Recent and Hot IP Issues
a. Asian Natural Herbal Ingredients
2.4.12 Mining IP Information—for Search, Analytics, Competitive Intelligence
a. Patent Searching
b. Patent Classes
c. Patent Search Sites
d. Trademark Searching
e. Searching for Industrial Designs
Abbreviations
References
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