Introduction: This blog presents a focused set of multiple-choice questions on import and export regulations for herbal cosmetics, tailored for M.Pharm students studying Herbal Cosmetics (MPG 204T). The quiz highlights essential regulatory frameworks, documentation, classification issues, international conventions, labeling and claims, quality and safety standards, and export-import procedures relevant to herbal formulations and ingredients. Questions are designed to test both conceptual understanding and practical regulatory knowledge required for global trade compliance. These MCQs will help students reinforce key concepts needed for regulatory affairs roles, quality assurance, export documentation, and preparation for professional examinations.
Q1. Which primary Indian legislation governs the manufacture, sale and import of cosmetics including herbal cosmetics?
- Food Safety and Standards Act, 2006
- Drug and Cosmetic Act, 1940
- Biological Diversity Act, 2002
- Ayurveda, Siddha and Unani Practitioners Act
Correct Answer: Drug and Cosmetic Act, 1940
Q2. Which authority in India is principally responsible for regulating imports of cosmetics and issuing related export/import certificates?
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of AYUSH
- Pharmaceuticals Export Promotion Council (Pharmexcil)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q3. What export document certifies that plant material meets phytosanitary requirements for entry into an importing country?
- Certificate of Analysis (CoA)
- Certificate of Free Sale (CFS)
- Phytosanitary Certificate
- Certificate of Origin
Correct Answer: Phytosanitary Certificate
Q4. Which document demonstrates that a cosmetic product is freely sold in the exporting country and is commonly required by foreign regulatory bodies?
- Export Licence
- Good Manufacturing Practice (GMP) Certificate
- Certificate of Free Sale (CFS)
- Phytosanitary Certificate
Correct Answer: Certificate of Free Sale (CFS)
Q5. Which international guideline specifically provides Good Agricultural and Collection Practices for medicinal plants used in herbal cosmetics?
- ISO 22716
- WHO GACP (Good Agricultural and Collection Practices)
- ICH Q7
- OECD GLP
Correct Answer: WHO GACP (Good Agricultural and Collection Practices)
Q6. Which EU legislative instrument governs cosmetic product safety, labeling and market placement for herbal cosmetics in the European Union?
- Regulation (EC) No 1223/2009
- Directive 2001/83/EC
- Regulation (EU) 2017/745
- REACH Regulation
Correct Answer: Regulation (EC) No 1223/2009
Q7. In the United States, what is the FDA’s pre-market approval requirement for most cosmetic products and ingredients?
- All cosmetics require full FDA pre-market approval
- No pre-market approval is required for most cosmetics except certain color additives
- FDA requires registration and pre-market safety review for all cosmetics
- Only herbal cosmetics require FDA approval
Correct Answer: No pre-market approval is required for most cosmetics except certain color additives
Q8. What is the standard international Harmonized System (HS) code length used for global tariff classification?
- 4-digit
- 6-digit
- 8-digit
- 10-digit
Correct Answer: 6-digit
Q9. When should a cosmetic product display a Period-After-Opening (PAO) symbol instead of a “best before” date according to common regulatory practice?
- When shelf-life is less than 6 months
- When shelf-life is more than 30 months
- Always for herbal cosmetics
- Only if product contains preservatives
Correct Answer: When shelf-life is more than 30 months
Q10. Which document provides hazard identification, handling and transport information for raw botanical extracts used in cosmetic manufacturing?
- Certificate of Analysis (CoA)
- Material Safety Data Sheet / Safety Data Sheet (MSDS/SDS)
- Certificate of Free Sale (CFS)
- Product Information File (PIF)
Correct Answer: Material Safety Data Sheet / Safety Data Sheet (MSDS/SDS)
Q11. Which export document is essential for customs valuation and is universally required for shipment of herbal cosmetic consignments?
- Packing List
- Commercial Invoice
- Bill of Lading
- Certificate of Origin
Correct Answer: Commercial Invoice
Q12. Which Indian regulatory body typically issues the Certificate of Pharmaceutical Product (CPP) or similar export certificates used to support exports of herbal medicinal-cosmetic products?
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of Commerce
- State Drug Control Authorities
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q13. How does regulatory classification change if a herbal cosmetic makes therapeutic claims such as “reduces inflammation” or “treats eczema”?
- It remains a cosmetic irrespective of claims
- It may be classified and regulated as a drug/therapeutic product
- It becomes a food supplement
- It falls under consumer product safety without any additional requirements
Correct Answer: It may be classified and regulated as a drug/therapeutic product
Q14. Which entity compiles and maintains the EU lists of prohibited and restricted substances for cosmetics (e.g., Annex II and Annex III)?
- European Medicines Agency (EMA)
- European Commission under Regulation (EC) No 1223/2009
- World Health Organization (WHO)
- International Organization for Standardization (ISO)
Correct Answer: European Commission under Regulation (EC) No 1223/2009
Q15. Which international standard specifically provides guidelines for Good Manufacturing Practices (GMP) for cosmetics?
- ISO 9001
- ISO 22716
- ICH Q10
- GMP for Pharmaceuticals (WHO)
Correct Answer: ISO 22716
Q16. Which authority generally issues a Certificate of Free Sale (CFS) for cosmetics intended for export from India?
- State Pollution Control Board
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of AYUSH
- Indian Council of Medical Research (ICMR)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q17. On what basis do customs authorities determine applicable import tariffs for a herbal cosmetic consignment?
- Manufacturer’s recommended retail price
- Declared HS code and customs classification
- Number of units only
- Country of distributor
Correct Answer: Declared HS code and customs classification
Q18. Which international convention must exporters check if their herbal product contains plant species that are endangered or protected?
- Stockholm Convention
- Rotterdam Convention
- Convention on International Trade in Endangered Species (CITES)
- Basel Convention
Correct Answer: Convention on International Trade in Endangered Species (CITES)
Q19. For cosmetic products placed on the EU market, who must be designated and responsible for regulatory compliance and safety files?
- Importer located outside EU
- Responsible Person established in the EU
- Manufacturer only, regardless of location
- National Competent Authority of the exporting country
Correct Answer: Responsible Person established in the EU
Q20. Which document provides analytical confirmation of batch quality (identity, purity, assay) typically requested by importers of herbal cosmetic products?
- Product Information File (PIF)
- Material Safety Data Sheet (MSDS)
- Certificate of Analysis (CoA)
- Certificate of Free Sale (CFS)
Correct Answer: Certificate of Analysis (CoA)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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