Case 4

Question 1

Functional foods

Answer 1

• branded foods, which claim to improve health and well-being
• processed food: low sodium food products for blood pressure reduction
• food fortified: with health promoting additives (minerals with vitamins, juices, cereals with folic acid)

Question 2

Novel foods

Answer 2

Food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the 1st Regulation on novel food came into force
- innovative, using new technologies or eaten outside of the EU

Question 3

Regulation (EC) No 258/97

Answer 3

• Parliament and Council
• possess a new or intentionally modified molecular structure
• comes from plants unknown in Europe (exotic fruits)
• consists of microorganisms, fungi, or algae that are new to the human diet
• produced using novel technologies

Question 4

Novel Food Regulation

Answer 4

foods and food ingredients falling within the scope of this regulation must not:

• present a danger for the consumer
• mislead the consumer
• differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer
• if a novel food is only a supplement or additive of the whole food, it does not have to comply with the regulation. However, if primary ingredient, see EU legislation of novel foods
• Genetic modified food could be seen as a novel food, because of the fact that it was not in our diet before. (however still specific)

Question 5

4 classes of novel food

Answer 5

1. pure chemicals or simple mixtures
2. complex novel foods
3. genetically modified foods
4. novel processes

Question 6

EFSA

Answer 6

• EFSA has a strictly science-based advisory function, issuing non-binding advice to risk managers (the European Commission, the European Parliament and EU Member States).
• Main areas of activity:
  • Dietary reference values, including upper tolerable intake levels of vitamins and minerals.
  • The safety of novel foods and nutrient sources (e.g. sources of vitamins and minerals).
  • The safety of other substances intentionally added to food (e.g. plants and herbal extracts).
  • Scientific advice on foods for special groups, in particular infants.
  • The scientific substantiation of health claims.
  • The potential of certain food ingredients to cause allergic or intolerance reactions.
  • Other generic questions related to human nutrition, such as the safety of caffeine.
• Evaluation serves as a basis for the European Commission and Member States to decide whether to authorize the claims
• EU Commission and MS decide the authorization, permission of use and establishment of conditions of use of a health claim
• EFSA only evaluates whereas it does not authorize a claim

Question 7

Claim

Answer 7

Any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics

Question 8

Nutrition claim (energy)

Answer 8

Any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to
- Energy it:
°provides
°provides at a reduced or increased rate
°does not provide

Question 9

Nutrition claim (nutrients)

Answer 9

The nutrients or other substances it:
°contains
°contains in reduced or increased proportions
°does not contain

Question 10

Health claim

Answer 10

Any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health

Question 11

Reduction of disease risk claim

Answer 11

Any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease

Question 12

Article 13 health claims

Answer 12

Health

• The role of a nutrient or other substance in growth, development and the functions of the body
• Behavioural or psychological functions
• Slimming, weight control, an increased sensation of satiety or the reduction in available energy from the diet.

Question 13

Article 14 (1)(a) health claims (disease risk reduction)

Answer 13

• Reduction of disease risk claims must carry a statement that the disease referred to has multiple risk factors and that altering one of these may or may not have a beneficial effect.
• If the health claim (either under article 13 or 14) is based on new data provided by the food business operator, it will be authorised on the basis of proprietary data

Question 14

Article 14 (1)(b) (children’s development)

Answer 14

For example: “Vitamin D is needed for the normal growth and development of bone in children”

Question 15

2006 EU regulation

Answer 15

Decision makers adopted a regulation on the use of nutrition and health claims for foods which lay down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs based on nutrient profiles

Question 16

Claims not permitted

Answer 16

• unethical (e.g. claiming something that it is vegan, although it is not)
• medicinal claims, about preventing, treating or curing a disease
• claims on alcoholic beverages (more than 1.2% alcohol), other than low/reduced alcohol or energy
• claims that suggest health could be affected by not consuming the food
• claims that make reference to a rate or amount of weight loss
• claims that make reference to recommendations of individual doctors and health professionals

Question 17

Requirements for approval of claims

Answer 17

• Define population that will benefit from your claim
• it should be examined in healthy volunteers in several studies
• truthful claims
• not misleading claims
• nutritional labelling must be presented

Question 18

3 main stages EFSA

Answer 18

1. Request
   Receives request from Commission, Parliament or MS
2. Assessment
   Sets up working group of experts to carry out risk assessment
3. Adoption
   Assessment is adopted by majority of panel members -> output of assessment is published for everyone to read it

Question 19

Commission Regulation No 353/2008

Answer 19

establishing implementing rules for applications for authorisation of health claims

Question 20

Commission Regulation No 1169/2009

Answer 20

• amending Regulation (EC) No 353/2008

- establishing implementing rules for applications for authorisation of health claims

Question 21

EC/1925/2006

Answer 21

Regulation on the addition of vitamins and minerals to foods

Question 22

Codex alimentarius

Answer 22

• created in 1963 by FAO and WHO to develop food standards, guidelines and related texts (such as codes of practice) under the Joint FAO/WHO Food Standards Programme
• Main purpose of program:
• > Protect the health of consumers
• > Ensure fair trade practices in the food trade
• > Promote coordination of all food standards work undertaken by international governmental and nongovernmental organisations

Question 23

Passclaim

Answer 23

Aim: Produce consensus on the criteria for the scientific substantiation of health claims on foods in the EU
- used by

Question 24

Example of established nutrients as functional foods

Answer 24

Folic acid -> against neural tube defects
Dietary fibre -> relieves constipation
Calcium-> against osteoporosis