Tuesday, February 7, 2012
Category : CLAIMS, CONVICTIONS | Author : experts | Comment : No Comments
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After two rejections pursuant to article 13(1) and 14, EFSA has recently provided a negative opinion on a health claim related to the reduction in LDL-cholesterol and the consumption of isolated soy protein. As it is often the case, this rejection is explained by an insufficient scientific substantiation. However, the applicant has provided a dossier supported by 23 randomized and controlled intervention trials. Moreover, these studies were associated to a meta-analysis prepared specifically for this application, and to several supportive studies (intervention studies, meta-analyses, reviews, mechanistic studies).

Nevertheless, the experts have considered that 4 of the 23 trials could not be considered as pertinent due to inadequate experimental methodologies (mainly low quality of statistical analysis). Among the 19 remaining studies, only four studies have shown a reduction in LDL-cholesterol, whereas all the other trials did not conclude to a significant effect of isolated soy protein. Surprisingly, the meta-analyses provided by the applicant have not been considered as pertinent by the NDA panel, and have been rejected for the substantiation of the intended claim due to low methodologies.

Thus, the soy proteins manufacturers cannot still communicate in Europe about the cholesterol-lowering effect of their product, despite that several countries (US, Japan, Brazil for instance) have accepted similar claims.

Tuesday, January 17, 2012
Category : CLAIMS, CONVICTIONS | Author : experts | Comment : No Comments
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This negative opinion for glucosamine and joint in article 13.5 follows previous rejections. EFSA has already issued an opinion on glucosamine and reduced rate of cartilage degeneration and reduced risk of development of osteoarthritis pursuant to Article 14 with an unfavourable outcome. The Panel has also already issued an opinion on glucosamine alone or in combination with chondroitin sulphate and maintenance of joints pursuant to Article 13(1) with a similar unfavourable outcome.

Nevertheless, EFSA acknowledges :

• The characterization : The food constituent that is the subject of the health claim is glucosamine, is sufficiently characterised.

• The health relationship : The claimed effect is “contributes to the protection of joint cartilage exposed to excessive motion or loading and helps to improve the range of motion in joints”. Maintenance of joints is a beneficial physiological effect.

• The target population : The target population proposed by the applicant is healthy individuals exposed to excessive load on the joints.

But EFSA continues to reject the scientific substantiation. The Panel considers that the evidence provided does not establish that patients with acute knee injury are representative of the target population (healthy individuals exposed to excessive load on the joints) with regard to the status of joint tissues, or that results obtained in studies on subjects with acute knee injury can be extrapolated to the proposed target population.

For joint (as well as for other applications), we anticipated and expressed long time ago in an interview for Nutraingredients that it is essential to prove the efficacy of an ingredient in healthy subjects. The selection of study subjects is essential for the use of the results in a health claim file. Moreover, we implemented our advices and get positives results on joint in healthy subjects.

All claims are accessible online on Nutraveris’on line.

For any question about joint, clinical study or health claim application, contact our experts.

Thursday, December 15, 2011
Category : NEWS, CONVICTIONS | Author : experts | Comment : No Comments
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EFSA recently published three opinions under Article 13.5 of Regulation (EC) 1924/2006 relating to gastrointestinal health. Sugar beet fiber wins a positive opinion on the increase faecal bulk, mainly substantiated by two clinical studies showing significant results. Indeed, the three criteria required by the Panel, the characterization of the ingredient, the health relationship and the scientific justification, are achieved permitting a positive outcome. However, EFSA also rejected a request on the sugar beet fiber and its effect on intestinal transit due to insufficient scientific justification. The quality of studies and methodology are in fact challenged.

An application on the scientific substantiation of a health claim related to a mixture of β-galactooligosaccharides and reducing gastro-intestinal discomfort was also evaluated negatively by EFSA. It seems that although a link between the ingredient and the increase in bifidobacteria in gut is admitted, as the link between health and maintenance of gastrointestinal function, it lacks the connecter between increasing bifidobacteria and the proper gastrointestinal function.

According to EFSA’s opinions on gastrointestinal health, it seems that getting a claim relating to the maintenance function is achievable, but to this day, none of them deals with the concept of intestinal comfort or improvement in function.

For any requirement regarding the “gastrointestinal health application”, do not hesitate to contact our experts.

Tuesday, August 30, 2011
Category : NEWS, CLAIMS, CONVICTIONS | Author : experts | Comment : No Comments
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In the 2nd batch, Melatonin could be used to claim on the alleviation of subjective feelings of jet lag with a 0.5 to 5 mg uptake. In the 3rd batch, Hydroxypropyl methylcellulose (HPMC) could be used to claim both on the reduction of post-prandial glycaemic responses and the maintenance of normal blood cholesterol concentrations with at least 5 g per day. In the 5th batch, Melatonin again, could be used to claim on the reduction of sleep onset latency with a 1 mg of melatonin uptake. However melatonin stays for a long time non authorized in food supplement and HPMC is only an additive authorized in vegetable capsules.
Since the last and 6th batch, monacolin K from red yeast rice can be used to claim on the maintenance of normal blood LDL- cholesterol concentrations. While 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily in order to obtain the claimed effect, this dosage is not possible in food supplement and 10 mg of monacolin correspond to a drug.

Then, while many allowed ingredients, interesting for industrials and the health nutrition market received negative opinion deeply damaging huge market in terms of employment and sales, one can be surprised by these anecdotal cases of accepted claims for unauthorized ingredients, therefore accepted but unusable claims !

Thursday, August 25, 2011
Category : CLAIMS, CONVICTIONS, CLINICAL EVIDENCE | Author : experts | Comment : No Comments
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A systematic review and meta-analysis carried out to determine the effectiveness of vitamin D supplementation for improving bone mineral density in children and adolescents concluded that it is unlikely that vitamin D supplements are beneficial in children and adolescents with normal vitamin D levels. Nevertheless, according to EFSA a cause and effect relationship has been established between the intake of vitamin D and normal growth and development of bone in children and adolescents.

Reference: Winzenberg T, Powell S, Shaw KA, Jones G. Effects of vitamin D supplementation on bone density in healthy children: systematic review and meta-analysis. BMJ. 2011 Jan 25;342:c7254