09.01.11
This summer the European Food Safety Authority (EFSA) issued its final evaluations regarding Article 13.1 “general function” health claims, excluding those related to botanical substances, culminating more than three years of work by experts.
Since 2008, the panel has assessed 2758 food-related general function health claims to determine whether they were supported by sound scientific evidence, thereby assisting the European Commission and Member States in the establishment of a list of claims authorized for food. These approved claims will enable European consumers to make informed choices about their diet.
“This very challenging task was completed thanks to the dedication and commitment of the experts on the NDA Panel in collaboration with EFSA staff, who have had to cope with an unprecedented and unforeseen workload, coupled with very tight deadlines and often poor information, said Professor Albert Flynn, chair of EFSA’s NDA Panel. “Despite these challenges our experts have assessed the claims consistently and fairly to the highest possible scientific standards. All this was achieved within the deadline agreed with the Commission.”
The outcomes of evaluations were favorable when there was sufficient evidence to support the claims. This was the case in about one in five claims, which related mainly to: vitamins and minerals; specific dietary fibers related to blood glucose control, blood cholesterol or weight management; live yogurt cultures and lactose digestion; antioxidant effects of polyphenols in olive oil; walnuts and improved function of blood vessels; meal replacement and weight control; fatty acids and function of the heart; the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralization or lowering the increase of blood glucose levels after meals; and carbohydrate-electrolyte drinks/creatine and sports performance.
Experts issued unfavorable opinions in cases where the information provided did not allow a relationship between the food and the claimed effect to be established. Reasons included: lack of information to identify the substance on which the claim is based (e.g., claims on “probiotics,” or on “dietary fiber” without specifying the particular fiber); lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g., food with “antioxidant properties” and renal claims related to “water elimination”); lack of precision regarding the health claim being made (e.g., claims referring to terms such as “energy” and “vitality,” or claims on women’s health or mental energy); lack of human studies with reliable measures of the claimed health benefit; claims referring to food categories which were considered to be too broad, such as “fruits and vegetables” and “dairy products” to be linked to specific effects.
“EFSA’s work on general function health claims has highlighted the importance of constructive dialogue between risk assessors, scientists, decision-makers and stakeholders and has contributed to our thinking on the future shape of our organization, said Catherine Geslain-Lanéelle, EFSA’s executive director. “As a result, EFSA plans to launch an applications help desk to facilitate dialogue with applicants. By ensuring there is a shared understanding of the scientific evidence required, the work we have undertaken will, we trust, support the work of industry by helping to establish future directions for research and innovation.”
The NDA Panel will continue to assess health claims, such as those submitted by individual applicants concerning claims based on children’s development or health. Following a meeting with stakeholders last year, EFSA has finalized a guidance document for health claims related to gut and immune function and has launched online consultations on guidance for health claims related to: bone, joint and oral health; oxidative damage and cardiovascular health; and satiety, weight management and blood glucose concentrations.
Since 2008, the panel has assessed 2758 food-related general function health claims to determine whether they were supported by sound scientific evidence, thereby assisting the European Commission and Member States in the establishment of a list of claims authorized for food. These approved claims will enable European consumers to make informed choices about their diet.
“This very challenging task was completed thanks to the dedication and commitment of the experts on the NDA Panel in collaboration with EFSA staff, who have had to cope with an unprecedented and unforeseen workload, coupled with very tight deadlines and often poor information, said Professor Albert Flynn, chair of EFSA’s NDA Panel. “Despite these challenges our experts have assessed the claims consistently and fairly to the highest possible scientific standards. All this was achieved within the deadline agreed with the Commission.”
The outcomes of evaluations were favorable when there was sufficient evidence to support the claims. This was the case in about one in five claims, which related mainly to: vitamins and minerals; specific dietary fibers related to blood glucose control, blood cholesterol or weight management; live yogurt cultures and lactose digestion; antioxidant effects of polyphenols in olive oil; walnuts and improved function of blood vessels; meal replacement and weight control; fatty acids and function of the heart; the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralization or lowering the increase of blood glucose levels after meals; and carbohydrate-electrolyte drinks/creatine and sports performance.
Experts issued unfavorable opinions in cases where the information provided did not allow a relationship between the food and the claimed effect to be established. Reasons included: lack of information to identify the substance on which the claim is based (e.g., claims on “probiotics,” or on “dietary fiber” without specifying the particular fiber); lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g., food with “antioxidant properties” and renal claims related to “water elimination”); lack of precision regarding the health claim being made (e.g., claims referring to terms such as “energy” and “vitality,” or claims on women’s health or mental energy); lack of human studies with reliable measures of the claimed health benefit; claims referring to food categories which were considered to be too broad, such as “fruits and vegetables” and “dairy products” to be linked to specific effects.
“EFSA’s work on general function health claims has highlighted the importance of constructive dialogue between risk assessors, scientists, decision-makers and stakeholders and has contributed to our thinking on the future shape of our organization, said Catherine Geslain-Lanéelle, EFSA’s executive director. “As a result, EFSA plans to launch an applications help desk to facilitate dialogue with applicants. By ensuring there is a shared understanding of the scientific evidence required, the work we have undertaken will, we trust, support the work of industry by helping to establish future directions for research and innovation.”
The NDA Panel will continue to assess health claims, such as those submitted by individual applicants concerning claims based on children’s development or health. Following a meeting with stakeholders last year, EFSA has finalized a guidance document for health claims related to gut and immune function and has launched online consultations on guidance for health claims related to: bone, joint and oral health; oxidative damage and cardiovascular health; and satiety, weight management and blood glucose concentrations.