Definition and classification of cosmetics as per Indian and EU regulations MCQs With Answer

Introduction: This concise guide covers the definition and classification of cosmetics under Indian regulations (Drugs & Cosmetics Act and Cosmetic Rules 2020) and the EU framework (Regulation (EC) No 1223/2009). It explains key concepts such as cosmetics definition, scope, product classification, forbidden and restricted substances (Annex II/III), permitted colorants and preservatives (Annexes IV/V), Responsible Person, Product Information File (PIF), CPNP notification, INCI names, safety assessment, nanomaterials, labeling and claims. Geared for B.Pharm students, it links regulatory requirements to safety, quality and market access considerations so you can apply regulatory thinking in formulation, testing and documentation. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the definition of a ‘cosmetic product’ under EU Regulation (EC) No 1223/2009?

• Any substance or mixture intended to be placed in contact with the external parts of the human body, teeth and mucous membranes of the oral cavity with the primary purpose of cleaning, perfuming, changing appearance, protecting or keeping them in good condition
• Any substance used to treat or prevent disease in humans
• Any pharmaceutical preparation intended for systemic absorption
• Any household cleaning product used on skin

Correct Answer: Any substance or mixture intended to be placed in contact with the external parts of the human body, teeth and mucous membranes of the oral cavity with the primary purpose of cleaning, perfuming, changing appearance, protecting or keeping them in good condition

Q2. How does the Drugs & Cosmetics Act (India) broadly define ‘cosmetics’?

• Articles intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body for cleansing, beautifying, promoting attractiveness or altering the appearance
• Any product claiming to cure skin diseases
• Only products sold in pharmacies
• Substances for internal medicinal use

Correct Answer: Articles intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body for cleansing, beautifying, promoting attractiveness or altering the appearance

Q3. Which entity must be established in the EU and is legally responsible for compliance of a cosmetic product placed on the EU market?

• Responsible Person
• Central Drugs Standard Control Organisation (CDSCO)
• Food Safety Authority
• Manufacturer outside EU without representative

Correct Answer: Responsible Person

Q4. What is the requirement for pre-market approval of cosmetics in India?

• Generally no pre-market approval is required; manufacturer is responsible for safety, with specific approvals for some colorants or restricted ingredients
• All cosmetics require central pre-market authorization from CDSCO
• Each product must be registered with the EU CPNP before sale in India
• Only imported cosmetics require approval; domestic need not comply

Correct Answer: Generally no pre-market approval is required; manufacturer is responsible for safety, with specific approvals for some colorants or restricted ingredients

Q5. What is CPNP in the context of EU cosmetics regulation?

• Cosmetic Product Notification Portal, an electronic notification system required before placing products on EU market
• Central Product Numbering Program for India
• Clinical Protocol Number for safety trials
• Certification for natural cosmetics only

Correct Answer: Cosmetic Product Notification Portal, an electronic notification system required before placing products on EU market

Q6. Which document is mandatory to hold for each cosmetic product placed on the EU market and must be kept available for authorities?

• Product Information File (PIF)
• Marketing Authorization Certificate
• Patent document
• Clinical trial record

Correct Answer: Product Information File (PIF)

Q7. Which professional is specifically required by EU regulation to assess product safety before market placement?

• Qualified safety assessor with appropriate scientific training
• Only a marketing manager
• Any person over 18 years
• Only the factory production manager

Correct Answer: Qualified safety assessor with appropriate scientific training

Q8. Which of the following claims would most likely classify a product as a medicinal product rather than a cosmetic?

• Treats and heals eczema
• Improves skin hydration
• Adds shine to hair
• Removes makeup

Correct Answer: Treats and heals eczema

Q9. In EU Regulation (EC) No 1223/2009, which Annex lists permitted colourants for cosmetic use?

• Annex IV
• Annex II
• Annex V
• Annex I

Correct Answer: Annex IV

Q10. Which Annex of the EU cosmetics regulation contains the list of permitted preservatives?

• Annex V
• Annex II
• Annex III
• Annex IV

Correct Answer: Annex V

Q11. What special labeling requirement applies to nanomaterials in the EU ingredient list?

• Ingredients present as nanomaterials must be indicated with the word ‘nano’ in brackets after the INCI name
• Nanomaterials must be omitted from the ingredient list for confidentiality
• Nanomaterials require a different color on the label only
• There is no special requirement for nanomaterials

Correct Answer: Ingredients present as nanomaterials must be indicated with the word ‘nano’ in brackets after the INCI name

Q12. Which language requirement applies to cosmetic labeling in EU member states?

• Label information must be in the official language(s) of the member state where the product is marketed
• Labels must be in English only across the EU
• Latin is the only accepted language for labels
• Labels may be in any language without restriction

Correct Answer: Label information must be in the official language(s) of the member state where the product is marketed

Q13. Under EU rules, when is a Period After Opening (PAO) symbol required on a cosmetic product?

• When the minimum durability is greater than 30 months
• For products with durability less than 6 months only
• PAO is never required under EU law
• Only for oral care products

Correct Answer: When the minimum durability is greater than 30 months

Q14. What is the primary criterion to distinguish a cosmetic from a medicinal product?

• The primary intended mode of action—cosmetics act mainly cosmetically while medicines have a pharmacological/therapeutic action
• Price of the product
• Color of the packaging
• Whether sold online or in a shop

Correct Answer: The primary intended mode of action—cosmetics act mainly cosmetically while medicines have a pharmacological/therapeutic action

Q15. Who can act as the Responsible Person for an EU cosmetic when the manufacturer is based outside the EU?

• The manufacturer, importer or an authorised representative established in the EU
• Only the original non-EU manufacturer
• Any retailer selling the product
• Only the consumer

Correct Answer: The manufacturer, importer or an authorised representative established in the EU

Q16. Which authority is primarily responsible for enforcement of cosmetics regulations in India?

• Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers under the Drugs & Cosmetics Act
• European Commission
• US FDA
• World Health Organization

Correct Answer: Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers under the Drugs & Cosmetics Act

Q17. Which ingredient nomenclature system is commonly used for listing cosmetic ingredients in both EU and India?

• INCI (International Nomenclature of Cosmetic Ingredients)
• USAN
• CAS Registry Numbers only
• Food Additive Index

Correct Answer: INCI (International Nomenclature of Cosmetic Ingredients)

Q18. Which educational background is typically acceptable for a cosmetic safety assessor in the EU?

• Scientific degree such as pharmacy, toxicology, medicine or equivalent experience in relevant sciences
• Only a business administration degree
• No scientific background required
• Only a legal degree

Correct Answer: Scientific degree such as pharmacy, toxicology, medicine or equivalent experience in relevant sciences

Q19. Which EU body gives scientific opinions on consumer safety of cosmetic substances?

• Scientific Committee on Consumer Safety (SCCS)
• European Central Bank
• World Trade Organization
• International Cosmetic Regulatory Board

Correct Answer: Scientific Committee on Consumer Safety (SCCS)

Q20. What is the EU position on animal testing for cosmetics?

• Animal testing for finished cosmetic products and their ingredients is prohibited under Regulation (EC) No 1223/2009
• Animal testing is mandatory for all new cosmetics
• Animal testing is allowed without restriction
• Only insects may be tested for cosmetics

Correct Answer: Animal testing for finished cosmetic products and their ingredients is prohibited under Regulation (EC) No 1223/2009

Q21. Which Annex of EU Regulation lists substances that are banned for use in cosmetics?

• Annex II
• Annex IV
• Annex V
• Annex I

Correct Answer: Annex II

Q22. For how long must the Product Information File (PIF) be kept available by the Responsible Person after the last batch of a cosmetic product has been placed on the EU market?

• 10 years
• 1 year
• 5 years
• 25 years

Correct Answer: 10 years

Q23. When must a cosmetic product be notified via CPNP in the EU?

• Before the product is placed on the EU market
• Only if it contains nanomaterials
• Within 5 years after first sale
• Notification is optional

Correct Answer: Before the product is placed on the EU market

Q24. Which authority issues manufacturing licenses for cosmetics within Indian states?

• State Licensing Authority under the State Drug Control administration
• European Responsible Person
• US FDA district office
• International Cosmetic Board

Correct Answer: State Licensing Authority under the State Drug Control administration

Q25. If a shampoo label claims ‘treats dandruff by eliminating the causative fungus’, how is it likely to be classified?

• Likely a medicinal product because it claims therapeutic action against disease
• Clearly a cosmetic because it is a shampoo
• A food product
• A household chemical

Correct Answer: Likely a medicinal product because it claims therapeutic action against disease

Q26. What is ‘CosIng’ in the context of EU cosmetics?

• Commission database of cosmetic substances and ingredients (CosIng)
• Clinical investigation number for cosmetics
• Indian ingredient registry
• Certification for organic cosmetics only

Correct Answer: Commission database of cosmetic substances and ingredients (CosIng)

Q27. Which claim would be unacceptable on a cosmetic label because it implies medicinal properties?

• Cures psoriasis
• Moisturizes dry skin
• Adds volume to hair
• Provides long-lasting fragrance

Correct Answer: Cures psoriasis

Q28. Which of the following is a required component of the EU Product Information File (PIF)?

• Safety assessment
• Trademark ownership documents only
• Retail price history only
• Export license to third countries

Correct Answer: Safety assessment

Q29. Which organization manages and updates the CosIng database?

• The European Commission
• The Indian Ministry of Health
• The US FDA
• The World Health Organization

Correct Answer: The European Commission

Q30. Under EU rules, what must be provided when a cosmetic ingredient is used in nanoparticle form?

• Specific safety data and notification in CPNP with nanomaterial indication, plus ‘nano’ in ingredient list
• Only a sentence stating it is modern technology
• No additional information beyond standard labeling
• Removal of ingredient from label for secrecy

Correct Answer: Specific safety data and notification in CPNP with nanomaterial indication, plus ‘nano’ in ingredient list

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