EFSA News Item, 21 August 2008

CLAIMS - EFSA adopts first opinions on health claims made on foods relating to disease risk reduction and children's health

EFSA's Panel on dietetic products, nutrition and allergies (NDA) has adopted its first series of opinions on claims referring to the reduction of disease risk, and children's development and health [see Footnote 1 below]. Scientists of the NDA Panel examined the scientific evidence for 8 claims, 5 of which related to children's health and 3 to disease risk reduction. The scientific opinions describe the outcome and conclusions of the Panel's evaluation of the scientific substantiation of the proposed health claims submitted by the applicants. This scientific advice is provided to the European Commission and Member States who will proceed with the next steps for the possible authorisation of these health claims.

Prof Albert Flynn, chair of the EFSA NDA Panel, said: “EFSA's independent evaluation of the health claims that companies want to make for their foods is important because consumers want to be able to trust the claims. All of the data provided to us in the dossiers submitted by the applicants to justify their claims have been evaluated according to uniform criteria. The Panel's opinions reflect the quality of the evidence submitted and provide the scientific advice needed for the risk managers”.

The first series of adopted opinions reflects the variability of the submissions received. In some cases adequate evidence to support the application was available, while for others it was not. Claims on the reduction of risk of disease and children's development and health require the evaluation of scientific data submitted by the applicant. EFSA published a guidance document for applicants on the submission of health claims in 2007 [see Footnote 2 below]. The guidance aims to help companies submitting health claims and addresses the kind of information companies need to include in their application, in particular concerning the scientific data and evidence required to support claims.

EFSA's role is to verify whether the health claim is substantiated by scientific evidence, delivering its opinion within 5 months of validating the applications received. Today's opinions have been adopted and published within the deadline specified in the Regulation and are now available on EFSA's website. EFSA's advice is provided to the European Commission and Member States who will proceed with the next steps for the possible authorisation of these health claims.

At present, a further 220 such claims have been received by EFSA and will be evaluated once they have undergone a completeness check. The summaries of the claim dossiers are published on EFSA's website once the application has been validated and is ready for the evaluation by the NDA Panel.

Note to editors:

The opinions published today assessed the health relationship that an applicant claimed existed between a food/food ingredient and either disease risk reduction or children's health. The 8 opinions addressed the following claimed health relationships. Links to the full opinions and conclusions are available on the EFSA website.

• Question No EFSA-Q-2008-085: Health relationship claimed "“Plant sterols” are lowering/reducing blood cholesterol and are therefore reducing the risk of coronary heart disease."
• Question No EFSA-Q-2008-082: Health relationship claimed "Probiotics and fermented vegetables and fruits support general health and show a specific immune modulating activity, which improves the immune system of children during growth."
• Question No EFSA-Q-2008-079: Health relationship claimed "‘a-linolenic acid' and linoleic acid are essential for the proper growth and development of children."
• Question No EFSA-Q-2008-078: Health relationship claimed "Femarelle® induces bone formation and increases bone mineral density, reducing the risk for osteoporosis and other bone disorders among post-menopausal women."
• Question No EFSA-Q-2008-110: Health relationship claimed "Three portions of dairy foods per day are claimed to promote a healthy body weight in children and adolescents, a portion being specified as 200 ml milk, 28 g cheese or 125 ml yogurt."
• Question No EFSA-Q-2008-112: Health relationship claimed "Many foods, including dairy products (milk and cheese), have been shown to be non-cariogenic and do not harm teeth. Some foods also have anti-cariogenic properties, protecting teeth from decay (referred to as “cariostatic factors”). Dairy foods (milk & cheese) demonstrate these qualities and promote dental health in children."
• Question No EFSA-Q-2008-214: Health relationship claimed "NeOpuntia® helps to improve blood lipid parameters associated with cardiovascular risks, especially the HDL-cholesterol. Therefore, there is a clear advantage of using NeOpuntia® in dietary supplements and functional foods for the prevention of cardiovascular risks."
• Question No EFSA-Q-2008-285: Health relationship claimed "Elancyl Global Silhouette® changes body shape by reducing body fat in particular abdominal fat."

Footnotes

[1] Seven out of the eight proposed claims are listed under Article 14 of EC Regulation 1924/2006 and sometimes referred to as “Art. 14 claims”. EFSA will also provide scientific advice to assist the European Commission in drawing up a “positive list” of ‘function' health claims already in use in the EU. This type of health claim, dealt with under Article 13 of the Regulation, includes those referring for instance to growth, development and the functions of the body and to psychological and behavioral functions. EFSA also evaluates health claims based on newly developed scientific evidence and/or which include a request for the protection of proprietary data, these claims are defined under Article 13/5 of the Regulation. One of these claims was adopted in this first series of opinions. For more information view the web page on claim applications.

[2] The Final scientific and technical guidance for applicants for preparation and presentation of the application for authorisation of a health claim is available at EFSA's website at the following address: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178623592471.htm