Licensing requirements for herbal/natural cosmetics MCQs With Answer

Introduction

This quiz collection on Licensing requirements for herbal/natural cosmetics is designed for M.Pharm students studying Herbal Cosmetics (MPG 204T). It focuses on regulatory frameworks, documentation, safety and quality standards, and practical compliance steps required to manufacture, import, label and market herbal cosmetic products. The questions emphasize Indian regulations within an international context (EU, US) and cover topics such as licensing authorities, product dossiers, GMP, safety assessment, labeling, claims substantiation and stability/microbiological testing. Use these MCQs to test your conceptual understanding, prepare for exams and reinforce the detailed regulatory knowledge needed for real-world product development and registration of herbal cosmetics.

Q1. Which primary legislation governs cosmetics, including herbal/natural cosmetics, in India?

• Drugs and Cosmetics Act, 1940 and Rules, 1945
• Food Safety and Standards Act, 2006
• Pharmacy Act, 1948
• Biologicals Rules

Correct Answer: Drugs and Cosmetics Act, 1940 and Rules, 1945

Q2. Which national authority in India is primarily responsible for framing policies and regulating cosmetics at the central level?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Who normally issues manufacturing licences for cosmetic production (including herbal cosmetics) in India?

• State Drugs Licensing Authority
• Central Drugs Laboratory
• Ministry of AYUSH
• Food Safety Commissioner

Correct Answer: State Drugs Licensing Authority

Q4. A product that claims to ‘treat acne’ or ‘cure dandruff’ would be reclassified from a cosmetic to which regulatory category?

• Drug (therapeutic product)
• Food supplement
• Medical device
• Household chemical

Correct Answer: Drug (therapeutic product)

Q5. Which international regulation mandates a Product Information File (PIF) and a designated Responsible Person for cosmetics sold in its market?

• EU Cosmetics Regulation (EC) No 1223/2009
• US Federal Food, Drug, and Cosmetic Act
• Japanese Pharmaceutical Affairs Law
• African Union Model Law

Correct Answer: EU Cosmetics Regulation (EC) No 1223/2009

Q6. Which standard is widely adopted as the reference for Good Manufacturing Practices (GMP) specific to cosmetics?

• ISO 22716 (Cosmetics — GMP)
• ISO 9001
• ICH Q7
• USP General Chapter

Correct Answer: ISO 22716 (Cosmetics — GMP)

Q7. For cosmetic products in the United States, which statement about pre-market approval is correct?

• The FDA generally does not require pre-market approval for cosmetics except for most color additives
• All cosmetics require FDA approval before sale
• Cosmetics must be registered with the EPA prior to marketing
• Cosmetics must obtain a prescription for sale

Correct Answer: The FDA generally does not require pre-market approval for cosmetics except for most color additives

Q8. Which of the following is an essential component of a cosmetic safety dossier or Product Information File?

• Toxicological profile and safety assessment
• Clinical trials for all cosmetic claims
• Patent filing documents
• Food grade certifications

Correct Answer: Toxicological profile and safety assessment

Q9. What is the commonly required format for listing ingredients on cosmetic labels internationally, especially in the EU and many other markets?

• INCI (International Nomenclature of Cosmetic Ingredients) names
• Common/local trade names only
• Botanical names without INCI
• CAS numbers only

Correct Answer: INCI (International Nomenclature of Cosmetic Ingredients) names

Q10. Which test is specifically used to evaluate a preservative system’s ability to control microbial contamination in finished cosmetics?

• Preservative Efficacy Test (PET or Challenge Test)
• Total Dissolved Solids Test
• Fatty Acid Composition Test
• pH meter calibration test

Correct Answer: Preservative Efficacy Test (PET or Challenge Test)

Q11. Which label element is typically mandatory for cosmetics in most regulatory systems?

• Net contents, batch number, manufacture/expiry date and manufacturer details
• Detailed manufacturing process flowchart
• Full toxicology raw data
• Distributor’s internal audit records

Correct Answer: Net contents, batch number, manufacture/expiry date and manufacturer details

Q12. What is the meaning of ‘PAO’ often used on cosmetic labels?

• Period After Opening — recommended usable period after opening
• Product Authenticity Order
• Preservative Active Optimum
• Primary Application Outline

Correct Answer: Period After Opening — recommended usable period after opening

Q13. Which laboratory test assesses the microbiological quality of a finished cosmetic product?

• Total Aerobic Microbial Count (TAMC) and absence of specified pathogens
• Viscosity profile test
• Heavy metals titration only
• pH stability test alone

Correct Answer: Total Aerobic Microbial Count (TAMC) and absence of specified pathogens

Q14. Which heavy metal is most strictly prohibited or restricted in cosmetics due to toxicity concerns and historical misuse in some traditional products?

• Mercury
• Iron
• Calcium
• Magnesium

Correct Answer: Mercury

Q15. For herbal raw materials, which reference is commonly used in India to provide standard monographs and quality specifications?

• Ayurvedic Pharmacopoeia of India (or relevant Pharmacopoeia/Monograph)
• European Pharmacopoeia only
• USP monograph exclusively for all botanicals
• Food Safety Manual

Correct Answer: Ayurvedic Pharmacopoeia of India (or relevant Pharmacopoeia/Monograph)

Q16. If a licensed cosmetic manufacturer in India changes the manufacturing site address, what regulatory action is typically required?

• Apply for amendment/variation of the manufacturing licence with the State Licensing Authority
• No action required if the product formula is unchanged
• Only notify customers, no licence change
• Re-register as a drug manufacturer with CDSCO

Correct Answer: Apply for amendment/variation of the manufacturing licence with the State Licensing Authority

Q17. Which of the following best describes the documentation required to substantiate product claims for herbal cosmetics?

• Evidence-based data such as safety assessments, clinical or performance studies and relevant literature
• Only traditional use claims without any documentation
• Patent application copies only
• Marketing testimonials alone

Correct Answer: Evidence-based data such as safety assessments, clinical or performance studies and relevant literature

Q18. For cosmetics exported to the EU, who must submit the product notification to the Cosmetic Products Notification Portal (CPNP)?

• The Responsible Person established within the EU
• The consumer buying the product
• The manufacturing plant outside the EU without any EU contact
• The local customs office only

Correct Answer: The Responsible Person established within the EU

Q19. Which professional qualification is typically required to perform a cosmetic safety assessment (as in the EU safety assessor role)?

• A qualified toxicologist or trained cosmetic product safety assessor with relevant scientific background
• A marketing graduate without toxicology training
• An accountant responsible for batch records
• A factory floor supervisor

Correct Answer: A qualified toxicologist or trained cosmetic product safety assessor with relevant scientific background

Q20. Which of the following documents is most commonly requested by importing regulatory authorities to demonstrate that a cosmetic is legally marketed in the country of origin?

• Free Sale Certificate (FSC) or Certificate of Free Sale
• Copy of product advertisements
• Distributor invoice without product details
• Employee payroll records

Correct Answer: Free Sale Certificate (FSC) or Certificate of Free Sale

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