EFSA health claim opinions

Red yeast rice and creatine win positive health claim opinions (but…)

By Shane Starling

- Last updated on GMT

Related tags Red yeast rice Nutrition European food safety authority

Or not?
Or not?
European health claim experts say the devil may be in the detail of two positive European Food Safety Authority (EFSA) health claim opinions for red yeast rice and creatine that featured in the final batch of article 13, general function claims issued by the Parma-based agency last week.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded a red yeast rice extract could help maintain normal LDL blood cholesterol-lowering benefits while creatine was deemed useful for “high intensity exercise”​ when at least 3g was consumed per day.

Red rice drug links

Joerg Gruenwald, PhD, owner of the German consultancy analyze&realize contacted NutraIngredients to raise drug-food borderline questions about the red yeast rice opinion that was based on its constituent, monacolin K.

We are pleased to see that red yeast rice obtained a positive opinion,”​ said Gruenwald.

“The approved 13.1 claim on normal blood cholesterol LDL-cholesterol concentrations is an important step for red yeast rice products to find their position in the human nutrition arena within the EU. Now it has to be evaluated if a daily dosage of 10mg monacolin K is still regarded as a physiological and not a pharmacological effect. Otherwise we will have a similar discussion as for omega-3 or melatonin.”

“The example red yeast rice shows once again that a positive claim opinion is not a guarantee for the legal status as a food product.”

Monacolin K is not approved for use as a food ingredient in the European Union while the US Food and Drug Administration considers it a food supplement, although its statin-like potential sees some calling for it to be re-classified as a drug.

Indeed, the NDA acknowledged the EU situation in the opinion by stating: "In relation to restrictions of use, the Panel refers to the Summary of Product Characteristics of lovastatin-containing medicinal products available on the EU market."

A similar situation arose with betaine, which won a positive opinion from the NDA for homocysteine metabolism benefits, but which in 2005 was refused Novel Foods status for want of appropriate safety data and is therefore not approved for use in foods in the EU27.

The NDA red yeast rice opinion can be found here.

Creatine dosage issues

UK-based consultant Mark J Tallon, PhD, from Nutrisciences, similarly welcomed the creatine positive opinion but said the recommended dosage of 3g per day to provide, “an increase in physical performance during short-term, high intensity, repeated exercise bouts” ​highlighted NDA assessment problems.

“The opinion from EFSA on creatine although positive, and good news for the industry, is yet another example of the lack of continuity in the way the NDA panel assess claims and the underlying science,”​ Tallon said.

“The peer reviewed data on 3g as a mechanism for enhancing performance is very weak. In contrast the data on 20g per day (4 x 5g – loading phase) followed by a 5g per day maintenance dose makes up the broader body of evidence and higher quality research. Despite 3g a day demonstrating an increase in muscle creatine concentrations - very few studies demonstrate that without a loading phase preceding it a performance effect is rarely evident.”

He added: “The implications are not merely scientific but will result in significant sales drop for raw ingredient manufacturers as companies have traditionally followed a 5g per day plus loading protocol approach. What is most interesting is the hidden information within the opinions i.e. the way EFSA defines its terms or reference. What is performance? What are its determinants (mass, strength etc)?

 “For sports nutrition companies it will be vital to grasp such concepts across all ingredients reviewed as part of the health claims process if they want to make legal and effective marketing claims on pack and in print.”

The creatine opinion can be found here.

Soy isoflavone rejection

Soy industry group, the European Natural Soyfoods Manufacturers Association (ENSA), distanced itself from a rejection of soy isoflavone benefits including LDL cholesterol reduction, antioxidant activity and menopausal symptom relief.

Most of these claims have not been submitted by ENSA; we are therefore not in a position to comment on these dossiers,”​ ENSA said.

“The only claim assessed in this opinion which was submitted by ENSA is on the effect of soy isoflavones and menopause for which EFSA concluded that ‘the evidence provided is insufficient to establish a cause and effect relationship’. ENSA will closely assess the conclusions of EFSA in this respect and will consider submitting additional information throughout the relevant procedure that has been put in place for such cases.”

The soy opinion can be found here.

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