EFSA finishes 2758-strong, article 13 health claim job with soy isoflavone rejection

Professor Albert Flynn, the chair of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), praised his panel’s work on a task that has seen it asses 2758 health claim submissions, issuing positive opinions on about 20% (550) of them.

“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,”​ Professor Flynn said.

“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. EFSA’s independent evaluation concluded that a considerable number of claims made on foods are backed by sound science, including claims related to a wide range of health benefits.”​

The opinions now pass to the European Commission and member states for assessment, validation and inscription in the European Union register of accepted and rejected claims, likely in the first half of 2012. Six months after that rejected claims will be prohibited from use across the European Union’s 27 member states.

The final batch of five opinions included a rejection for the ability of soy isoflavones to affect a number of health conditions including menopause, reducing LDL cholesterol and to deliver antioxidant benefits.

Creatine, however, won a positive opinion for “high intensity exercise”.​

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Dialogue is key​

EFSA executive director Catherine Geslain-Lanéelle said the process had highlighted the importance of agency-stakeholder communications.

“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 organisation. As a result, EFSA plans to launch an applications help desk to facilitate dialogue with applicants.​

“By ensuring that 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.”​

Whilst the main part of the article job is complete it is likely certain claims related to probiotics and those that gained “insufficient evidence”​ verdicts will re-enter the system later in the year, and there are 1548 botanical claims that were withdrawn from the process, that will also require assessment at some point although there has been no decision on that as yet.

Soy isoflavone rejection – “no surprises”​

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Claims expert Nigel Baldwin, from Intertek-owned Cantox International, said he was not surprised by the soy opinion that rejected soy isoflavones’ ability to reduce menopausal symptoms, lower LDL blood cholesterol levels and act as an antioxidant.

“That one was always far too complex to be covered by Article 13.1 so no surprises there,”​ he said. “The claims are controversial with some experts anyway so a really thorough dossier was what was needed.”​

The soy opinion can be found here.​

Creatine gains mixed review​

The NDA backed sports nutrient creatine to provide, “​an increase in physical performance during short-term, high intensity, repeated exercise bouts” ​when at least 3g was consumed per day.

But claims for endurance performance and endurance capacity were rejected.

Mark J Tallon, Phd, from NutriSciences in the UK, wondered whether the positive opinion was somewhat of a poisoned chalice because the evidence was stronger for 5g or more, as reflected in the market.

“EFSA’s sign off on 3g as an effective dose for a performance claim could see companies dropping their dose from 3 to 5g across product range,”​ he said.

The creatine opinion can be found here.​

The other three opinions in the final batch were:

• Monacolin K from red yeast rice can maintain normal blood LDL cholesterol concentrations if 10mg consumed daily.
• Carbonate or bicarbonate salts of sodium or potassium do not maintain normal bone.
• Potassium or sodium salts of citric acid do not maintain normal bone.