Cosmetic Product Formulation Lecture PDF

COSMETIC PRODUCT FORMULATION Lecture MARC NATHAN L. RODRIGO BS Pharmacy 3E PRELIM Notes  Page 2 LESSON 1 priorities, blending ut...

COSMETIC PRODUCT FORMULATION Lecture MARC NATHAN L. RODRIGO BS Pharmacy 3E PRELIM Notes  Page 2 LESSON 1 priorities, blending utility with Overview and Introduction on Cosmetics artistry. LEARNING OBJECTIVES COSMETICS IN ANCIENT CIVILIZATIONS 1.​ Define Cosmetics and Cosmetic Science and Discuss their historical EGYPT development and significance. ​ Kohl 2.​ Explain the ASEAN guidelines for cosmetics, with an emphasis on Good ○​ Protection against eye Manufacturing Practices (GMP). ailments, such as reflecting 3.​ Describe the steps involved in the sunlight. cosmetic product notification and ○​ AKA Powdered Galena apply these steps in preparing a sample ○​ Lead sulfide (PbS) notification. CHINA ​ Nail Colors THE ORIGINS OF COSMETICS ○​ Symbolizes Social Status ​ No Color means ANCIENT BEGINNINGS Low Class ​ Colored Nails with ​ The true origin of cosmetics may Gold and Silver date back over 30,000 years, as symbolizes Royalty ​ Rice Powder suggested by cave paintings ○​ Used by Chinese women to depicting body adornments used whiten their complexion or during mating and hunting rituals skin. ​ Safflower and Ochre HISTORICAL SIGNIFICANCE ○​ Applied in order to give the reddish complexion in the ​ Religious Rituals: Early civilizations face used cosmetics in spiritual practices. GREECE ​ Lead Carbonate ​ Beauty Enhancement: cosmetics ○​ PbCO3 have been a tool to enhance ○​ Utilized by Greeks to appearance for centuries whiten their complexion ​ Health and Practicality: Products ○​ Long-lasting than Rice were often used for practical Powder purposes, such as sun protection, JAPAN or to reflect social status and ​ Oshiroi beauty conventions. ○​ A substance made from the mixture of Lead (Pb) and REFLECTION OF CULTURE Mercury (Hg) ○​ Used to whiten the ​ The use of cosmetics can reveal a complexion of the skin. civilization’s concerns and Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 3 COSMETICS IN THE MIDDLE AGES the name Avon. The Avon line cosmetics were introduced the Perfume next year. ​ Used in 1200 ​ Revlon also borrowed the concept of “Planned Obsolescence” from Hair Dyes General Motor Corporation to ​ Popular in 1300, during the reign of introduce seasonal color changes. Queen Elizabeth I. Until World War II, women tended ​ Venetian ceruse to use an entire lipstick or bottle of ○​ AKA The Mask of Youth nail polish before purchasing a new ○​ A substance made from the one. mixture of Lead (Pb) and Vinegar. DEFINITION OF COSMETICS COSMETICS IN THE MIDDLE AGES AND RENAISSANCE Cosmetics ​ France and Italy ​ Derived from the Greek word ​ Perfume became more popular in Kosmetikos meaning: France ○​ Kosmetikos ​ Decrease of the usage of Lead ​ Having the power to ○​ They found out that Heavy arrange, skilled in Metals are VERY TOXIC to decorating one’s health. ○​ Kosmein ○​ Alternative: Zinc oxide ​ To adorn THE MODERN COSMETIC INDUSTRY ○​ Kosmos Key Milestones ​ Order ​ Harmony ​ In 1909, Schueller named his company Societe Francaise de ○​ Cosmetique Teintures Inoffensives pour Cheveux ​ French term of (Safe Hair Dye Company of France), Cosmetics which today has become L’Oreal. ​ Does NOT cure/treat, prevent, ​ Chemist T.L. Williams creates diagnose, mitigate Maybelline Mascara for his sister, ​ Articles intended to be rubbed, Mabel, the product’s inspiration. poured, sprinkled, or sprayed on, ​ Max Factor, a Polish-American cosmetician and former cosmetics introduced into, or otherwise applied expert for the Russian Royal family, to the human body or any part invents the word “make-up” and thereof for cleansing, beautifying, introduces the Society Makeup to promoting attractiveness, or altering the General Public, enabling the appearance WITHOUT affecting women to emulate the looks of structure or function. their favorite movie stars ​ In 1928, California Perfume Company (CPC) sold its first products–toothbrush, powdered cleanser, and a vanity kit– under Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 4 Substance or Preparation ASEAN GUIDELINES FOR COSMETIC GMP ​ QUASI Drug - something between ​ Good Manufacturing Practices (GMP) drug and cosmetics are comprehensive guidelines that ​ AKA F-Pop or Functional Pop Beauty help cosmetic businesses ensure: ○​ Consistency in manufacturing External Parts of the Human Body processes. ​ Hair ○​ Safety of products for ​ Scalp consumers ​ Teeth ○​ High Quality that meets ​ Oral Cavity intended use. ​ Skin ​ GMP is a key component of quality assurance that integrates: Purpose ○​ Operational Rules: Ensuring ​ Perfuming production procedures ​ Cleaning adhere to quality standards. ​ Protecting ○​ Organizational guidelines: ​ Promoting attractiveness Establishing control ​ Correcting body odor throughout the production ​ Keeping in good condition process. ​ Focused on all aspects of production CLASSIFICATION OF COSMETICS and quality control. ​ Purpose of the GMP Guidelines: ○​ Developed to assist the cosmetic industry in complying with the provisions of the ASEAN Cosmetic Directive (ACD). ○​ Focused exclusively on cosmetic products, ensuring a clear distinction from Drug GMP and Pharmaceutical GMP. ​ Key Considerations for Manufacturers Cosmetic Science ○​ Developing internal quality ​ It is a multidisciplinary field involved management systems. with developing, formulating and ○​ Establishing standard producing cosmetics and personal operating procedures (SOPs) care products. tailored to the business. ​ Manufacturers must prioritize: ○​ Product safety for consumers. Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 5 ○​ Consistent quality standards ○​ Contract Manufacturing and appropriate for the product’s Analysis intended use. ○​ Documentation ○​ Equipment BENEFITS OF COSMETIC GMP ○​ Internal Quality Audit ​ Ensures Product Safety and Quality ○​ Personnel ○​ Provides confidence that ○​ Premises cosmetics are safe for ○​ Product Complaint consumers. ○​ Production ○​ Ensures premium-quality ○​ Quality Control products meet customer ○​ Quality Management expectations. ○​ Recall ​ Builds Brand Trust and Loyalty ○​ Sanitation and Hygiene ○​ Enhances brand reputation ○​ Storage and credibility ○​ Drives customer satisfaction QUALITY CHARACTERISTICS AND and long-term loyalty QUALITY ASSURANCE OF COSMETICS ​ Boosts Sales and Marketability ​ Guaranteeing Quality for Consumer ○​ High-quality products attract Confidence more customers and improve ○​ Ensures full customer sales. confidence and satisfaction ○​ Competitive edge in a during purchase and use. crowded market by meeting ○​ Products must meet international standards. standards for long-term usage ​ Supports Internal Operations and reliability. ○​ Encourages regular internal ​ Contribution to Daily Life inspections and quality ○​ Enhances health maintenance checks. and hygiene for skin, hair, and ○​ Streamlines manufacturing teeth. processes and reduces risks ○​ Provides cosmetic therapies of errors. and psychological aromatic benefits. 13 ASEAN MODULES FOR GOOD ​ Consumer Safety and Trust MANUFACTURING PRACTICES (GMP) FOR ○​ Cosmetics are perceived as COSMETIC MANUFACTURERS AND safe, rarely linked to serious TRADERS (CMT) health hazards. ​ This program provides a detailed ○​ Predictive safety evaluations discussion on FDA’s implementation ensure new products are safe on the 13 ASEAN GMP Training for consumers. Modules for Cosmetics ​ Focus on Toxicological Safety Manufacturers and Traders ○​ Addresses potential hazards early in product development. Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 6 ○​ Verifies safety-in-use before AGREEMENT ON THE ASEAN products are launched to the HARMONIZED COSMETIC REGULATORY market. SCHEME QUALITY CHARACTERISTICS OF Objectives COSMETICS ​ Enhancing Cooperation ○​ Ensure the safety, quality, and claimed benefits of all cosmetic products marketed in ASEAN. ​ Facilitating Trade ○​ Eliminate restrictions on the trade of cosmetic products QUALITY ASSURANCE OF COSMETICS among Member States. ○​ Promote Mutual Recognition of Product Registration Approvals. ○​ Adopt the ASEAN Cosmetic Directive for standardized regulation. ​ SCHEDULE A: Mutual Recognition Agreement (MRA) ○​ Product registrations processed and issued by one ASEAN country are recognized by other ASEAN countries that have signed the MRA. ○​ Facilitates seamless trade and minimizers regulatory barriers within the ASEAN region. ​ SCHEDULE B: ASEAN Cosmetic Directive ○​ Operates under a Product Notification scheme rather than a registration process. ○​ Companies are required to notify the regulatory agency in the respective country before launching cosmetic products in the market. Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 7 ○​ Simplifies market access and encourages faster entry of cosmetic products while ensuring compliance with safety and quality standards. ASEAN COSMETIC CLAIM GUIDELINE ​ Role of Claims in Defining Cosmetics ○​ Claims are a key factor in determining whether a product qualifies as a cosmetic. ○​ Evaluation of claims is integral to distinguishing cosmetics from other product categories. ​ 5-Step Decision-Making Process ○​ A simple and structured approach to identify UNACCEPTABLE CLAIMS acceptable products and claims that meet the definition of cosmetics. COMPOSITION AND CHARACTERISTICS OF COSMETICS a.​ Composition of Cosmetics b.​ Target Site of Application c.​ Intended Main Function d.​ Product Presentation e.​ Physiological Effects ASEAN Handbook of Cosmetic Ingredients ​ The ASEAN Handbook of Cosmetic Ingredients documents ingredients that are currently regulated differently from the ASEAN Common Ingredient Listings. ○​ The ASEAN Cosmetic Committee (ACC) created the Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 8 ASEAN Cosmetic Scientific FDA Memorandum Circular Body (ACSB) with the primary No. 2013-011. task of: ○​ This update aimed to ​ Reviewing each streamline the process and ingredient in the improve the efficiency of Handbook. submission requirements. ​ Determining whether ​ 2015 - E-Portal Integration the status of an ○​ In August 2015, further ingredient should be enhancements were made to rejected or adopted incorporate the Cosmetic across ASEAN Product Notification Scheme countries into the FDA E-Portal. ○​ Objectives: COSMETIC PRODUCT NOTIFICATION ​ Improve the efficiency of applications Background ​ Enhance transparency ​ The notification scheme for cosmetic of information products in the Philippines was established with the adoption and APPLICATION PROCEDURE implementation of the ASEAN 1.​ Submission Harmonized Cosmetic Regulatory 2.​ Payment Scheme in 2005. This was enacted 3.​ Download Result through the following: 4.​ Revalidation ○​ DOH Administrative Order No. 2005-0015: Guidelines INFORMATION TO BE DECLARED for the regulation of cosmetic ​ Brand Name/ Product Name/ products Product Variants ○​ DOH Administrative Order ​ Product types No. 2005-0025: Further ​ Particulars of the Product details for the ​ Intended Use implementation of the ASEAN ​ Product Presentations Cosmetic Directive (ACD). ​ Local Company Responsible ​ 2007 - Manual Application Process ​ Establishment Information ○​ The Notification Scheme was ​ Local Company Representative initially implemented as a ​ Product Ingredient List manual application process through FDA Bureau Circular REVALIDATION OF COSMETIC No. 2007-013-A. NOTIFICATIONS ​ 2013 - Shift to Electronic Process ​ Application Process ○​ In March 2013, the process ○​ The revalidation follows the transitioned from manual to same procedure as the electronic submissions via the Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo  Page 9 original e-notification ​ Consequences of Non-Compliance application. ○​ Any non-compliance or ○​ Applicants must select the inconsistency with these previously acknowledged parameters renders the notification case in the FDA cosmetic product unnotified. E-Portal to proceed with the ​ Product Verification by FDA: Revalidation Application Task. ○​ FDA collects actual products ​ No Modifications Allowed sold in the market to verify ○​ Revalidation can only be that the information availed if there are no submitted during premarket modifications to the notification matches the label information provided in the on the product sold. original application. ○​ If the product formulation on ○​ Any changes to the the label is entirely different information will require the from the approved submission of a new notification, the product is notification application. considered unnotified due to ​ Cancellation Option formulation inconsistency. ○​ If the applicant wishes to cancel the notification instead of revalidating it, they may opt for the Cancel Application option available within the Revalidation Application Task POST-MARKETING SURVEILLANCE (PMS) IN COSMETICS ​ Validity of the License to Operate (LTO) and Certificate of Product Notification (CPN). ​ Consistency between the ingredient list in the CPN and the Actual Product Label ​ Absence of banned ingredients in the product formulation ​ Use of restricted ingredients within the allowable maximum limit. ​ Claims aligned with the product’s intended use and within the scope of cosmetics. ​ Compliance with labeling requirements. Cosmetic Product Formulation (Lecture) Transcribed by: Marc Nathan L. Rodrigo