When evaluating health claims submitted for inclusion in the permitted list of Article 13 health claims, in certain cases, EFSA concluded that due to the incomplete nature of the data submitted, it could not provide a conclusive assessment in relation to their scientific substantiation. The Commission has looked at this, and has agreed with EU countries that, as risk managers, they would not be able to take a final decision on whether or not to include these claims in the list of permitted health claims and a further assessment should therefore be considered. The two categories of claims for which EFSA’s assessment is considered as not conclusive are:

- Health claims on micro-organisms which EFSA considered as insufficiently characterised to proceed with the assessment of the evidence since they were not properly characterised by genotypic identification of the strain using appropriate methodology.
- Health claims for which EFSA concluded that “the evidence provided is insufficient to establish a cause and effect relationship”.

If you are interested by this process, the Nutraveris’experts are at your side to help you follow this strategy or another one (in order)to continue to communicate on your products in your best interests.

As we already mentioned it in this blog, while policosanols have been approved as a cholesterol-lowering drug in over 25 countries throughout the Caribbean and South America, most of the studies reporting therapeutic efficacy of policosanols were carried out by one research group situated in Cuba. Conversely, research groups outside of Cuba have failed to validate the cholesterol-lowering efficacy of policosanols.
Even if more than 50 studies (mostly Cuban) show the efficacy of policosanols to lower cholesterol the absence of independent and external studies confirming the efficacy of policosanols to lower cholesterol, raises questions regarding their true efficacy.
The EFSA’s position in the assessment of an health claim is unequivocal:
“The Panel notes that although the majority of the studies conducted in Cuban subjects reported significant reductions in total and LDL-cholesterol concentrations […] following consumption of policosanols […], no effect on total or LDL-cholesterol concentrations was found in human intervention studies conducted in other parts of the world”

In fact, the English authorities of advertisement received 31 complaints who challenged whether the ad was:
- misleading because it did not make clear that Nutella also contained a high proportion of sugar and fat;
- likely to encourage poor nutritional habits or an unhealthy lifestyle, especially in children.

The English authorities considered the overall impression of the ad, including the “wake up to Nutella” message and considered the ad was unlikely to be interpreted as suggesting Nutella should be consumed in excessive quantities or that it should be eaten daily. They concluded the ad was unlikely to mislead viewers into believing Nutella contained only the ingredients mentioned or that it made a significant nutritional contribution to a balanced breakfast. They concluded that it was unlikely to encourage poor nutritional habits or an unhealthy lifestyle in children

While some claims and health relationship on beauty have already been accepted by EFSA, in the 5th batch of generic claims, other could be out of the scope of the Reg. 1924/2006.

Indeed, for generic claims like « maintenance of normal hair » (vit B8/ positive opinion or vit B5/ negative opinion), « maintenance of normal skin » (iodine/ positive opinion or carthame oil / negative opinion), « normal sebum production » (Ajuga reptans/ negative opinion), in generic claims « improving dry skin conditions » (dry skin by Innéov/ negative opinion) in specific claim, health relationship has been accepted.

Conversely, « Maintenance of normal structure and elasticity of the skin” and “Maintenance of normal structure and appearance of hair and nails”, according to EFSA the claimed effects do not refer to a function of the body as required by Regulation (EC) No 1924/2006.

If these opinions, as well are others as the diuretic effect, also rejected, are not transcribed in regulation by the European Commission, these applications or health relationship could be out of the scope of application. Communication on these products could then be possible again.