Submitting a food product to obtain a health claim is a very complex process. Institut Kurz is specialized in preparation of dossiers for Health Claim applications according to EU-Ordinance 1924. If you want your food product to have a health claim, Institut Kurz does it for you. Contact us: info@institut-kurz.com www.institut-kurz.com

1. INSTITUT KURZ
HEALTH CLAIMS
www.institut-kurz.com
Contact: info@institut-kurz.com

2. HEALTH CLAIMS
European consumers are exposed to a wide variety of statements
about the relationship between diet and health.
Unclear or misleading information about food products can confuse
consumers and lead to distrust of claims about healthy eating.

3. HEALTH CLAIMS
To avoid these situations, the European Union (EU) developed the
“Regulation (EC) no 1924/2006 of the European Parliament and
of the Council of 20 December 2006 on nutrition and health
claims made on foods”
Companies that make claims about food products must prove that
they are true and that their advertising is not misleading.

4. WHAT ARE HEALTH CLAIMS?
The European Commission authorizes different health claims
provided they are:
✓based on scientific evidence
✓easily understood by consumers
Health claim is any statement about a relationship between a food
category, a food or one of its constituents and health.

5. The European Food Safety Authority (EFSA) is responsible for:
• evaluating the scientific evidence supporting health claims
• ensure that claims made on food labelling and advertising
regarding health are meaningful and accurate and can thereby
help consumers in making healthy diet choices.
WHAT ARE HEALTH CLAIMS?

6. TYPES OF HEALTH CLAIMS
→ Article 13 health claims (Function Health Claims) refer to:
• The role of a nutrient or other substance in growth, development
and the functions of the body.
• Behavioral or psychological functions.
• Slimming, weight control, an increased sensation of satiety or the
reduction in available energy from the diet.

7. TYPES OF HEALTH CLAIMS
→ Article 14 health claims (Risk Reduction Claims) refer to:
• Reduction of disease risk.
• Children’s development and health.

8. HEALTH CLAIMS APPROVAL PROCESS
In assessing each relationship between food and health that forms
the basis of a health claim, EFSA considers the extent to which:
• the food/constituent is defined and characterized
• the claimed effect is defined and is a beneficial nutritional or
physiological effect for human health
• a cause and effect relationship is established between the
consumption of the food/constituent and the claimed effect

9. HEALTH CLAIMS APPROVAL PROCESS
If a cause and effect relationship is established, EFSA needs to
analyze whether:
• the amount of food/consumption pattern needed to achieve the
claimed effect can be ingested through a balanced diet
• the proposed text reflects the scientific evidence and meets the
criteria for using the claims specified in the Regulation
• the proposed conditions/restrictions of use are appropriate.

10. HEALTH CLAIMS APPROVAL PROCESS
Depending on the article under which the claim is regulated, there
are some differences in the submission of the case:
• Article 13.1 – if the claim is supported by generally accepted
scientific evidence and is considered to be well understood by
most consumers, it is not necessary to compile a dossier to obtain
authorization.
• Article 13.5 – whether the claim based on emerging evidence
should be authorized by submitting an evidence file.
• Article 14 – the claim is authorized only by submitting a dossier of
evidence.

11. HEALTH CLAIMS APPROVAL PROCESS
Health Claims
Article 13.1 Article 13.5 Article 14
Member States list of
A13 claims
Dossier
submission
EFSA
Opinion
European Commission
Approval or Rejection

12. HEALTH CLAIMS APPROVAL PROCESS
Submitting a food product to obtain a health claim is a very complex
process.
Institut Kurz is specialized in preparation of dossiers for Health
Claim applications according to EU-Ordinance 1924.
→ If you want your food product to have a health claim, Institut
Kurz does it for you.

13. EXAMPLES OF AUTHORIZED HEALTH
CLAIMS
Article Claim Conditions Health relationship
13.1
Choline contributes
to the maintenance
of normal liver
function
The claim may be used only for food
which contains at least 82,5mg of
choline per 100g or 100ml or per
single portion of food.
Maintenance of
normal liver function
13.1
Copper contributes
to the protection of
cells from oxidative
stress
The claim may be used only for food
which is at least a source of copper
as referred to in the claim SOURCE
OF [NAME OF VITAMIN/S] AND/OR
[NAME OF MINERAL/S] as listed in
the Annex to Regulation (EC) No
1924/2006.
Protection of DNA,
proteins and lipids
from oxidative
damage

14. EXEMPLOS DE ALEGAÇÕES DE SAÚDE
AUTORIZADAS
Article Claim Conditions
13.5
Lactitol contributes to
normal bowel function by
increasing stool
frequency
The claim may be used only for food supplements
which contain 10g of lactitol in a single daily quantified
portion. To bear the claim, information shall be given to
the consumer that the beneficial effect is obtained by
consuming 10g of lactitol in one daily dose. The claim
shall not be used for foods targeting children.
13.5
Sugar beet fiber
contributes to an
increase in fecal bulk
The claim may be used only for food which is high in
that fiber as referred to in the claim HIGH FIBRE as
listed in the Annex to Regulation (EC) No 1924/2006

15. EXEMPLOS DE ALEGAÇÕES DE SAÚDE
AUTORIZADAS
Article Claim Conditions
14
Essential fatty acids are
needed for normal
growth and development
of children.
Information to the consumer that the beneficial effect
is obtained with a daily intake of 2g of α-linolenic acid
(ALA) and a daily intake of 10g of linoleic acid (LA).
14
Oat beta-glucan has
been shown to
lower/reduce blood
cholesterol.
Information shall be given to the consumer that the
beneficial effect is obtained with a daily intake of 3g of
oat beta-glucan. The claim can be used for foods
which provide at least 1g of oat beta glucan per
quantified portion.

16. • Buttriss, J. L., & Benelam, B. (2010). Nutrition and health claims: the role of food composition data. European
Journal of Clinical Nutrition, 64(S3), S8–S13.
• Leathwood, P. D., Richardson, D. P., Sträter, P., Todd, P. M., & van Trijp, H. C. M. (2007). Consumer
understanding of nutrition and health claims: sources of evidence. British Journal of Nutrition, 98(03), 474.
• Susanne Bryngelsson and Nils-Georg Asp. Health claims according to Article 13 of the EC Regulation:
suggested priorities with reference to the Swedish Code on health claims and emphasis on relevance. Scand J
Food Nutr. 2007 Sep; 51(3): 127–136.
• EC (European Commission) (2007). Corrigendum to Regulation (EC) No. 1924/2006 of the European
Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official
Journal of the European Union L12/3–L12/18. Available at: http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri¼OJ:L:2007: 012:0003:0018:EN:PDF.
• European Food Safety Authority (EFSA) (2009). Briefing document for Member States and European
Commission on the evaluation of Article 13.1 health claims. EFSA J 7, 1386–1396.
• EFSA. EU Register on nutrition and health claims. Available at:
<https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=search>.
• EFSA. Health Claims. Available at:
<https://ec.europa.eu/food/safety/labelling_nutrition/claims/health_claims_en>.
• EFSA. "General function" health claims under Article 13. Available at:
<http://www.efsa.europa.eu/en/topics/topic/general-function-health-claims-under-article-13>.
REFERENCES