This quiz collection focuses on the European regulatory framework covering EFSA, novel foods and nutrition labeling under key EU regulations — tailored for M.Pharm students studying Regulatory Aspects of Food & Nutraceuticals (MRA204T). It explains how scientific risk assessment, pre-market authorization and labeling requirements intersect to ensure consumer safety and clear information. Questions emphasise Regulation (EU) 2015/2283 (novel foods), Regulation (EU) No 1169/2011 (food information and nutrition labeling) and the role of EFSA in evaluating safety and health claims. Expect scenario-based items on application dossiers, timelines, mandatory nutrition declaration components, allergen emphasis, and the interplay between EFSA opinions and Commission authorisations.
Q1. What is EFSA’s primary role within the European food regulatory system?
- Scientific risk assessment and providing independent scientific opinions on food and feed safety
- Issuing binding EU-wide marketing authorisations for food products
- Enforcing national food law in EU Member States
- Setting consumer prices for nutraceutical products
Correct Answer: Scientific risk assessment and providing independent scientific opinions on food and feed safety
Q2. Which EU regulation currently governs the approval and market entry of novel foods?
- Regulation (EU) 2015/2283 on novel foods
- Regulation (EC) No 1924/2006 on nutrition and health claims
- Regulation (EU) No 1169/2011 on food information to consumers
- Regulation (EC) No 178/2002 founding the European Food Safety Authority
Correct Answer: Regulation (EU) 2015/2283 on novel foods
Q3. According to Regulation (EU) 2015/2283, which criterion primarily defines a ‘novel food’?
- Foods not used for human consumption to a significant degree within the EU before 15 May 1997
- Any food produced outside the EU regardless of history of use
- Only genetically modified foods developed after 2000
- Foods with nutrient profiles different from traditional EU diets
Correct Answer: Foods not used for human consumption to a significant degree within the EU before 15 May 1997
Q4. Who grants the final Union authorisation for a novel food to be placed on the EU market?
- The European Commission, by implementing act after EFSA opinion and Member State consultation
- EFSA alone, by issuing a binding authorisation
- Individual Member States through their national competent authorities
- The European Parliament by majority vote
Correct Answer: The European Commission, by implementing act after EFSA opinion and Member State consultation
Q5. Which nutrients are mandatory elements of the nutrition declaration under Regulation (EU) No 1169/2011?
- Energy (kJ/kcal), fat, saturates, carbohydrates, sugars, protein and salt
- Energy, fibre, vitamin C, sodium, iron, calcium and potassium
- Only energy value is mandatory; all others are voluntary
- Fat, sugars, trans fats, cholesterol and water content
Correct Answer: Energy (kJ/kcal), fat, saturates, carbohydrates, sugars, protein and salt
Q6. Where are the nutrient reference values (NRVs) for the nutrition declaration listed in EU law?
- Annex XIII of Regulation (EU) No 1169/2011
- Annex I of Regulation (EU) 2015/2283
- The EU Treaty, Article 168
- Annex II of Regulation (EC) No 1924/2006
Correct Answer: Annex XIII of Regulation (EU) No 1169/2011
Q7. Under which regulatory instrument are nutrition and health claims assessed and authorised at EU level?
- Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
- Regulation (EU) 2015/2283 on novel foods
- Regulation (EU) No 1169/2011 on food information to consumers
- Regulation (EC) No 178/2002 establishing general principles of food law
Correct Answer: Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
Q8. What is the statutory timeframe for EFSA to deliver a scientific opinion on a validated novel food application?
- 9 months from validation of the application
- 3 months from application submission
- 18 months including Member State consultations
- No fixed timeframe; it is determined case-by-case
Correct Answer: 9 months from validation of the application
Q9. Which of the following best represents essential elements that must be included in a novel food application dossier?
- Compositional data, production process, proposed uses and use levels, exposure assessment, toxicology and allergenicity data
- Only an ingredient list and a commercial label mock-up
- Market research, consumer acceptance surveys and price lists
- Copies of promotional materials and health claims already used in third countries
Correct Answer: Compositional data, production process, proposed uses and use levels, exposure assessment, toxicology and allergenicity data
Q10. When is the mandatory nutrition declaration required on prepacked foods under FIC (Regulation 1169/2011)?
- For most prepacked foods, unless a specific exemption applies (e.g., small packages, certain unprocessed foods)
- Only when a nutrition or health claim is made
- Never — nutrition declaration is voluntary throughout the EU
- Only for foods intended for infants and young children
Correct Answer: For most prepacked foods, unless a specific exemption applies (e.g., small packages, certain unprocessed foods)
Q11. How must allergenic ingredients be emphasised in the ingredients list according to Regulation 1169/2011?
- They must be emphasised using a typeset that clearly distinguishes them from the rest of the ingredients (for example bold type)
- By listing them in a separate paragraph at the end of the label only
- They may be omitted if the presence is only at trace levels
- By printing them in a smaller font to save space
Correct Answer: They must be emphasised using a typeset that clearly distinguishes them from the rest of the ingredients (for example bold type)
Q12. Which EFSA scientific panel is primarily responsible for opinions on novel foods and nutrition-related issues?
- The Panel on Nutrition, Novel Foods and Food Allergens (NDA)
- The Plant Health Panel (PLH)
- The Animal Health and Welfare Panel (AHAW)
- The Plant Protection Panel (PPP)
Correct Answer: The Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Q13. Which article of Regulation (EU) 2015/2283 establishes a specific procedure for traditional foods from third countries?
- Article 14 (traditional foods from third countries notification procedure)
- Article 3 (general definitions)
- Article 27 (enforcement measures)
- Article 50 (transitional provisions for additives)
Correct Answer: Article 14 (traditional foods from third countries notification procedure)
Q14. For nutrition declaration, in which units must energy be declared?
- Both kilojoules (kJ) and kilocalories (kcal)
- Only kilocalories (kcal)
- Only kilojoules (kJ)
- Calories per serving using variable serving sizes
Correct Answer: Both kilojoules (kJ) and kilocalories (kcal)
Q15. Which data source is routinely used for dietary exposure assessment in a novel food dossier?
- EFSA’s Comprehensive European Food Consumption Database combined with proposed use levels
- Only national market sales data without consumption patterns
- Company-supplied consumer survey data only
- Animal feeding studies as a proxy for human consumption
Correct Answer: EFSA’s Comprehensive European Food Consumption Database combined with proposed use levels
Q16. Under Regulation 1169/2011, the nutrition declaration must be expressed per which reference quantities?
- Per 100 g or per 100 ml; it can also be expressed per portion in addition to the per 100 g/100 ml basis
- Only per serving size defined by the manufacturer
- Per 1,000 kcal to standardise across foods
- Per kilogram only for all solid foods
Correct Answer: Per 100 g or per 100 ml; it can also be expressed per portion in addition to the per 100 g/100 ml basis
Q17. Which of the following require EFSA scientific assessment before an EU-wide authorisation or inclusion in a Union list?
- Novel foods and health claims (nutrition/health claims require EFSA scientific substantiation)
- Standard labelling font sizes and meterological data
- Retail price setting and consumer insurance policies
- National dietary guidelines of Member States
Correct Answer: Novel foods and health claims (nutrition/health claims require EFSA scientific substantiation)
Q18. Which of the following is NOT typically required in toxicological assessment for a novel food dossier?
- Long-term toxicity and genotoxicity studies as appropriate
- Allergenicity assessment and information on toxic constituents
- Pharmacovigilance reports from marketed medicinal products unrelated to the food substance
- ADME (absorption, distribution, metabolism, excretion) information when relevant
Correct Answer: Pharmacovigilance reports from marketed medicinal products unrelated to the food substance
Q19. Who is primarily responsible for enforcement of EU food labelling and novel food rules at point of sale?
- The competent authorities of the Member States (national enforcement authorities)
- EFSA’s enforcement division with EU-wide inspectors
- The European Commission’s consumer protection police
- Individual manufacturers without oversight
Correct Answer: The competent authorities of the Member States (national enforcement authorities)
Q20. Under the Food Information to Consumers (FIC) rules, what minimum typographic requirement applies to mandatory particulars on labels?
- The x-height of the font used for mandatory particulars must be at least 1.2 mm, except for very small packages where 0.9 mm applies
- All mandatory particulars must be printed in uppercase only
- No typographic requirements are specified — manufacturers choose freely
- Mandatory particulars must be printed in italics to aid readability
Correct Answer: The x-height of the font used for mandatory particulars must be at least 1.2 mm, except for very small packages where 0.9 mm applies
