05.02.11
The European Commission should undertake a discussion regarding the specificity and limitations of nutritional research and reappraise the claims evaluation process before rejecting claims based on European Food Safety Authority (EFSA) opinions, three industry associations have said. Commenting jointly on the fourth batch of claims opinions published by EFSA, European associations EHPM (European Health Product Manufacturers), ERNA (European Responsible Nutrition Alliance) and EBF (European Botanical Forum) said that continued reliance on criteria that are unfeasible and inappropriate for the majority of claims is contributing to the high number of negative EFSA opinions.
The groups stated that on initial evaluation of the latest batch of opinions, trends have remained consistent in EFSA’s assessment criteria as compared to the third batch published last year, despite weaknesses in the approach. EHPM, ERNA and EBF again highlighted these weaknesses in a letter to Basil Mathioudakis, head of the European Commission’s food law unit. These weaknesses include the discrepancy between the way in which the information has been compiled and presented and the way in which EFSA is carrying out its assessments; EFSA’s almost exclusive reliance on randomized, controlled trials demonstrating measurable and meaningful improvements of health (also called the pharmaceutical approach); and the way in which the claims legislation is being interpreted, which the groups believe is unduly restrictive, making it impossible to acknowledge and assess several health effects.
They further addressed EFSA’s focus on isolated food components, which they said often do not exist in isolation, rather than on foods; the expectation that evidence should show improvement rather than maintenance of physiological functions; the fact that the approach is biased toward effects on reductions of disease risk factors, leaving many more general health effects unaddressed; and the lack of consideration of existing consensus and views or opinions of leading experts in the various research fields.
The groups urged the European Commission to allow claims to be resubmitted for evaluation based on an alternative and more appropriate approach that considers the totality of the evidence to provide a balanced view on the strength, consistency and plausibility of health benefits of food components.
“The EFSA approach has a number of weaknesses preventing the recognition of the health importance of many food components, and we remain concerned about the high number of unfavorable opinions relating to claims on other substances,” said Patrick Coppens, ERNA secretary general. “It has now been widely recognized that the implementation of the claims legislation is a learning process and that consequences only become fully clear as the process progresses. While we appreciate the serious and professional way that the Commission has considered many of these issues, we are observing a mounting concern by the scientific community, which may ultimately affect the credibility of the European system. Many claims, for example, are receiving negative EFSA opinions because the format used to submit them is not consistent with the format adopted by EFSA to assess them. This is the result of no guidance being available for industry on the submission of claims, and as a consequence EFSA has rejected many claims without assessing the evidence.”
The Latest EFSA Opinions
EFSA’s NDA Panel dealing with dietetic products, nutrition and allergies published its fourth series of “general function” Article 13 health claims proposed for use on food products in April. The 442 claims assessed relate to health relationships in such areas as: protection against oxidative damage to body cells, contribution to either cognitive or bowel function and maintenance of normal blood cholesterol levels. According to EFSA, these opinions will help inform future decisions of the European Commission and EU Member States, which are responsible for the authorization of the claims. EFSA has also said it will finalize the evaluation of the remaining 600 “general function” health claims, which need to be assessed by June 2011.
“Experts on the panel have completed the evaluation of about 80% of ‘general function’ health claims, excluding the so-called ‘botanical’ claims, and are committed to finalizing the remaining claims by the agreed deadline,” said Dr. Juliane Kleiner, head of EFSA’s NDA Unit.
Claims evaluated with a favorable outcome include: the relation between walnuts and improved function of blood vessels; the antioxidant effects of polyphenols found in olive oil on LDL cholesterol; and the relation between caffeine and alertness and caffeine and increased physical endurance. The experts also concluded that several claims based on the replacement of certain nutrients were supported by sufficient scientific evidence, including: the replacement of digestible starch by resistant starch to lower the increase of blood glucose levels after meals; the replacement of saturated fatty acids with mono- and polyunsaturated fatty acids to maintain normal blood cholesterol levels; as well as the role of a range of sugar replacers (e.g., xylitol or sorbitol) in maintaining tooth mineralization or lowering the increase of blood glucose levels after meals.
Many of the unfavorable opinions in this series were linked to the poor quality of the information provided to EFSA. Information gaps included, for instance: the inability to identify the specific substance on which the claim is based; the lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions; or the lack of precision regarding the health claim being made. In addition, some claims were outside the scope of the current legal framework.
EFSA and its scientific experts are pursuing dialogue with stakeholders to further explain their work and to provide applicants with additional guidance on preparing applications. Following consultations carried out in 2010, EFSA will launch three additional on-line consultations on guidance for health claims related to: 1) bone, joint and oral health; 2) oxidative damage and cardiovascular health; and 3) satiety, weight management and blood glucose concentrations.
The groups stated that on initial evaluation of the latest batch of opinions, trends have remained consistent in EFSA’s assessment criteria as compared to the third batch published last year, despite weaknesses in the approach. EHPM, ERNA and EBF again highlighted these weaknesses in a letter to Basil Mathioudakis, head of the European Commission’s food law unit. These weaknesses include the discrepancy between the way in which the information has been compiled and presented and the way in which EFSA is carrying out its assessments; EFSA’s almost exclusive reliance on randomized, controlled trials demonstrating measurable and meaningful improvements of health (also called the pharmaceutical approach); and the way in which the claims legislation is being interpreted, which the groups believe is unduly restrictive, making it impossible to acknowledge and assess several health effects.
They further addressed EFSA’s focus on isolated food components, which they said often do not exist in isolation, rather than on foods; the expectation that evidence should show improvement rather than maintenance of physiological functions; the fact that the approach is biased toward effects on reductions of disease risk factors, leaving many more general health effects unaddressed; and the lack of consideration of existing consensus and views or opinions of leading experts in the various research fields.
The groups urged the European Commission to allow claims to be resubmitted for evaluation based on an alternative and more appropriate approach that considers the totality of the evidence to provide a balanced view on the strength, consistency and plausibility of health benefits of food components.
“The EFSA approach has a number of weaknesses preventing the recognition of the health importance of many food components, and we remain concerned about the high number of unfavorable opinions relating to claims on other substances,” said Patrick Coppens, ERNA secretary general. “It has now been widely recognized that the implementation of the claims legislation is a learning process and that consequences only become fully clear as the process progresses. While we appreciate the serious and professional way that the Commission has considered many of these issues, we are observing a mounting concern by the scientific community, which may ultimately affect the credibility of the European system. Many claims, for example, are receiving negative EFSA opinions because the format used to submit them is not consistent with the format adopted by EFSA to assess them. This is the result of no guidance being available for industry on the submission of claims, and as a consequence EFSA has rejected many claims without assessing the evidence.”
The Latest EFSA Opinions
EFSA’s NDA Panel dealing with dietetic products, nutrition and allergies published its fourth series of “general function” Article 13 health claims proposed for use on food products in April. The 442 claims assessed relate to health relationships in such areas as: protection against oxidative damage to body cells, contribution to either cognitive or bowel function and maintenance of normal blood cholesterol levels. According to EFSA, these opinions will help inform future decisions of the European Commission and EU Member States, which are responsible for the authorization of the claims. EFSA has also said it will finalize the evaluation of the remaining 600 “general function” health claims, which need to be assessed by June 2011.
“Experts on the panel have completed the evaluation of about 80% of ‘general function’ health claims, excluding the so-called ‘botanical’ claims, and are committed to finalizing the remaining claims by the agreed deadline,” said Dr. Juliane Kleiner, head of EFSA’s NDA Unit.
Claims evaluated with a favorable outcome include: the relation between walnuts and improved function of blood vessels; the antioxidant effects of polyphenols found in olive oil on LDL cholesterol; and the relation between caffeine and alertness and caffeine and increased physical endurance. The experts also concluded that several claims based on the replacement of certain nutrients were supported by sufficient scientific evidence, including: the replacement of digestible starch by resistant starch to lower the increase of blood glucose levels after meals; the replacement of saturated fatty acids with mono- and polyunsaturated fatty acids to maintain normal blood cholesterol levels; as well as the role of a range of sugar replacers (e.g., xylitol or sorbitol) in maintaining tooth mineralization or lowering the increase of blood glucose levels after meals.
Many of the unfavorable opinions in this series were linked to the poor quality of the information provided to EFSA. Information gaps included, for instance: the inability to identify the specific substance on which the claim is based; the lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions; or the lack of precision regarding the health claim being made. In addition, some claims were outside the scope of the current legal framework.
EFSA and its scientific experts are pursuing dialogue with stakeholders to further explain their work and to provide applicants with additional guidance on preparing applications. Following consultations carried out in 2010, EFSA will launch three additional on-line consultations on guidance for health claims related to: 1) bone, joint and oral health; 2) oxidative damage and cardiovascular health; and 3) satiety, weight management and blood glucose concentrations.
