Details
| Original language | English |
|---|---|
| Pages (from-to) | 412-429 |
| Number of pages | 18 |
| Journal | European Food and Feed Law Review |
| Volume | 14 |
| Issue number | 5 |
| Publication status | Published - 2019 |
Abstract
According to Regulation (EC) 1924/2006, health claims made on foods need an authorisation and the effect must be ‘established by generally accepted scientific data’. The scientific assessment on applications for health claims is the responsibility of the European Food Safety Authority (EFSA). Thus, the Authority plays the crucial role in the scientific acceptance or rejection of health claims. In accordance with Regulation (EC) 353/2008, in order to substantiate a health claim, data from human studies are required to prove the relationship between the consumption of the food/food constituent and the claimed effect. In this context, EFSA considers double-blind randomised controlled trials in humans to be the gold standard. So far, the Authority has not published an exclusive guidance for reporting of human intervention studies in order to present transparent and consistent criteria for these studies. Thus, clear and concrete guidelines for adequately performing such studies aremissing, which represents a general problem for applicants. Therefore, based on an evaluation of all scientific opinions on claims according to Article 13, this paper addresses key factors that EFSA requests to report on the design, conduct and statistical analysis of human intervention studies with foods or food constituents for scientific substantiation of health claims. It also shows that EFSA’s work often is neither transparent nor consistent.
Keywords
- EFSA, Food labelling, Health claims, Human intervention studies, RCTs
ASJC Scopus subject areas
- Agricultural and Biological Sciences(all)
- Food Science
- Social Sciences(all)
- Law
Sustainable Development Goals
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In: European Food and Feed Law Review, Vol. 14, No. 5, 2019, p. 412-429.
Research output: Contribution to journal › Article › Research
}
TY - JOUR
T1 - Designing human intervention studies for scientific substantiation of health claims - how EFSA thinks
AU - Jakobs, S.
AU - Hahn, A.
PY - 2019
Y1 - 2019
N2 - According to Regulation (EC) 1924/2006, health claims made on foods need an authorisation and the effect must be ‘established by generally accepted scientific data’. The scientific assessment on applications for health claims is the responsibility of the European Food Safety Authority (EFSA). Thus, the Authority plays the crucial role in the scientific acceptance or rejection of health claims. In accordance with Regulation (EC) 353/2008, in order to substantiate a health claim, data from human studies are required to prove the relationship between the consumption of the food/food constituent and the claimed effect. In this context, EFSA considers double-blind randomised controlled trials in humans to be the gold standard. So far, the Authority has not published an exclusive guidance for reporting of human intervention studies in order to present transparent and consistent criteria for these studies. Thus, clear and concrete guidelines for adequately performing such studies aremissing, which represents a general problem for applicants. Therefore, based on an evaluation of all scientific opinions on claims according to Article 13, this paper addresses key factors that EFSA requests to report on the design, conduct and statistical analysis of human intervention studies with foods or food constituents for scientific substantiation of health claims. It also shows that EFSA’s work often is neither transparent nor consistent.
AB - According to Regulation (EC) 1924/2006, health claims made on foods need an authorisation and the effect must be ‘established by generally accepted scientific data’. The scientific assessment on applications for health claims is the responsibility of the European Food Safety Authority (EFSA). Thus, the Authority plays the crucial role in the scientific acceptance or rejection of health claims. In accordance with Regulation (EC) 353/2008, in order to substantiate a health claim, data from human studies are required to prove the relationship between the consumption of the food/food constituent and the claimed effect. In this context, EFSA considers double-blind randomised controlled trials in humans to be the gold standard. So far, the Authority has not published an exclusive guidance for reporting of human intervention studies in order to present transparent and consistent criteria for these studies. Thus, clear and concrete guidelines for adequately performing such studies aremissing, which represents a general problem for applicants. Therefore, based on an evaluation of all scientific opinions on claims according to Article 13, this paper addresses key factors that EFSA requests to report on the design, conduct and statistical analysis of human intervention studies with foods or food constituents for scientific substantiation of health claims. It also shows that EFSA’s work often is neither transparent nor consistent.
KW - EFSA
KW - Food labelling
KW - Health claims
KW - Human intervention studies
KW - RCTs
UR - http://www.scopus.com/inward/record.url?scp=85074704351&partnerID=8YFLogxK
M3 - Article
VL - 14
SP - 412
EP - 429
JO - European Food and Feed Law Review
JF - European Food and Feed Law Review
IS - 5
ER -