EFSA health and behavioural claims

Question 1

Where do EFSA claims cover?

Answer 1

Europe

Question 2

What are the 3 types of claims?

Answer 2

1. Health claims (relate a substance (food, food component or dietary ingredient to a disease or health-related condition)
2. Nutrient content claims (describe level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite)
3. Structure/function claims (cover the role of a specific substance in maintaining normal healthy structures or functions of the body)

Question 3

What are the 2 essential components of a health claim?

Answer 3

(1) a substance (whether a food, food component, or dietary ingredient)
(2) a disease or health-related condition

Question 4

What are the 2 types of claims on food?

Answer 4

1. type A = enhanced function

2. type B = reduction of disease risk

Question 5

What are article 14 claims?

Answer 5

Health claims relating to:

• Reduction of disease risk claims
• Children’s development and health

Question 6

What re the requirements for a positive opinion by EFSA?

Answer 6

Food characterisation (Well-recognised and available nutrient, Measurable in foods by established methods)

• Conditions of Use (e.g. daily dose required/achievable? – is it achievable in usual intake)
• Target population
• sufficient evidence
• availability of evidence

Question 7

How can an ingested dietary component establish cause and effect?

Answer 7

• bring about physiological change in central process e.g. neuronal signalling
• more generically = improved health e.g. reduced blood pressure

Question 8

When can animal studies be used?

Answer 8

To support the mechanism of action - cannot be used to support claim directly

Question 9

What is the 3 stage EFSA process?

Answer 9

1. Sufficient characterisation of food
2. Whether claimed effect Is beneficial to health
3. Is there scientific substantiation (Show that a cause and effect relationship exist)

Question 10

Which cog domains does iron affect?

Answer 10

Beneficial effects on attention and concentration

Question 11

Does iron affect IQ?

Answer 11

Only if person is iron deficient

Question 12

In the PREDIMED study why were effect sizes inflated?

Answer 12

because the trial was stopped early after interim analyses showed benefit.

Question 13

What are some problems with fMRI studies on cognition?

Answer 13

• No widely accepted best practices for design and analysis
• Studies rarely describe how or whether the task design was optimized for efficiency
• Studies don’t report why ppts were excluded from analysis
• studies lack statistical power
• flexibility may pose risk of inflated false positives