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Questions and Answers
Who is responsible for regulating cosmetic products in the Philippines?
Who is responsible for regulating cosmetic products in the Philippines?
- Center for Cosmetics Regulation and Research (CCRR)
- Food and Drug Administration (FDA) (correct)
- Association of Southeast Asian Nation (ASEAN)
- ASEAN Harmonized Cosmetic Regulatory Scheme
What is the main competent department for the regulation of cosmetic products in ASEAN countries?
What is the main competent department for the regulation of cosmetic products in ASEAN countries?
- Center for Cosmetics Regulation and Research (CCRR) (correct)
- Philippines FDA
- Bureau of Food and Drugs
- ASEAN Harmonized Cosmetic Regulatory Scheme
Which document provides guidelines on the safety assessment of cosmetic products in ASEAN?
Which document provides guidelines on the safety assessment of cosmetic products in ASEAN?
- ASEAN Guidelines for Safety Assessment of Cosmetic Product (correct)
- Guidelines on Unified Licensing Requirement & Procedures of FDA
- ASEAN Common Technical Documents
- ASEAN Sunscreen Labeling Guidelines
What is the role of the ASEAN Cosmetic Directive?
What is the role of the ASEAN Cosmetic Directive?
Which division belongs to the Center for Cosmetics Regulation and Research (CCRR) in the Philippines FDA?
Which division belongs to the Center for Cosmetics Regulation and Research (CCRR) in the Philippines FDA?
What type of claims are considered unacceptable for cosmetic products?
What type of claims are considered unacceptable for cosmetic products?
Which entity has developed the ASEAN Guidelines for Product Information File (PIF)?
Which entity has developed the ASEAN Guidelines for Product Information File (PIF)?
What should establishments covered under a certain AO in the Philippines secure prior to operation as per the guidelines?
What should establishments covered under a certain AO in the Philippines secure prior to operation as per the guidelines?
'Reduces the shine of oily skin' is an example of a claim that can be made less functional and more cosmetic using what?
'Reduces the shine of oily skin' is an example of a claim that can be made less functional and more cosmetic using what?
Which region has implemented the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents?
Which region has implemented the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents?
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Study Notes
Cosmetic Regulation History
- In 1938, cosmetics were not yet regulated as drugs.
- In 1966, the FDA regulated cosmetics to be consumer-safe through the Federation of Food, Drugs, and Cosmetics Act.
Cosmetic Science
- Cosmetic science is a multidisciplinary field that includes basic knowledge and a wide range of information from various scientific fields.
- It involves developing, formulating, and producing cosmetics and personal care products.
Cosmetic or Drug?
- The composition of a product includes ingredients and content.
- The proposed use of a product is determined by "cosmetic claimed benefits".
Cosmetic Product Categories
- In Japan, the Pharmaceutical Affairs Law defines three categories: Cosmetic, Quasi-Drug, and Drug.
- Quasi-Drug/Cosmeceuticals are products with minimal to moderate pharmacologic activity, restricted to specific indications.
Cosmetic Directive
- In 1976, the cosmetic directive was adopted to ensure the free circulation of cosmetic products and improve their safety.
- In 1991, the cosmetic directive was amended to prohibit the marketing of cosmetic products containing ingredients tested on animals.
Cruelty-Free Products
- "Not tested on animals" claims can be found on labels or advertisements.
- The FD&C Act does not specifically require the use of animals in testing cosmetics for safety.
Categories of Cosmetics
- Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting structure or function.
- Examples of cosmetic functions: keeps, prevents, gives, repairs, but must not cure or be effective against symptoms, and must be mild.
Cosmetic Industry Evolution
- Cosmetics have existed since the origin of civilization for beautifying, perfuming, cleansing, or rituals.
- In the 20th century, great progress was made in diversifying products and functions, and in safety and consumer protection.
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