Oxidative damage (included UV-induced): health claims guideline.

EFSA has published a guidance to explain what are the scientific requirements for health claims referring to: antioxidant, oxidative damage and cardiovascular health.

First of all EFSA states (in accordance with Reg. 1924/2006) that the 2 main requirements to substantiate a claim are that the claimed effects have to be considered as a beneficial physiological effects and that it must be supported by adequate studies in humans.

In the first part of the document the status of ‘antioxidant’ is discussed: the concept of “antioxidant” as a benefit is rejected, but this aspect will be discussed more specifically in another post.

Regarding protection from oxidative damage, which can be claimed and is intended as proven protection of body cells and molecules (i.e. DNA, proteins and lipids) from oxidative damage, EFSA established some general requirements to substantiate these claim with reference to all the cellular structures:

–          An appropriate method of assessment should be able to determine accurately and specifically the oxidative modification of the target molecule in vivo (at least an appropriate market of oxidative modification needed).

–          A marker (method) cannot be accepted for substantiation when (technical) limitations are considered to be severe.  

 Then, as reported above, the food/constituent has to show a real beneficial effect on target molecules and it has to be demonstrated by  setting up adequate scientific studies, involving humans. Below the methods accepted to validate the beneficial physiological effect, specific for every different cellular body:

–          Proteins: the only validated method to detect oxidative damage is HPLC-MS. Proteins by products analysis (ELISA or other colorimetric methods) shows some limitation, then they cannot be considered valid alone, but just in combination with other direct methods.

–          Lipids: F2-isoprostanes in 24-h urine samples is the recommended method. LDL oxidised particles (using specific antibodies) and phosphatidylcholine hydroperoxides (using HPLC) are validated methods as well. Not allowed markers: reactive substances (TBARS), malondialdehyde (MDA), lipid peroxides, HDL-associated paraoxonases, conjugated dienes, breath hydrocarbons, auto-antibodies against LDL particles, and ex vivo LDL resistance to oxidation).

–          DNA: recommended method is the modified comet assay which allow the detection of oxidised DNA bases (e.g. use of endonuclease III to detect oxidised pyrimidines). Conventional comet assay and other methods are not suitable.

Other methods still widely used to measure antioxidant properties are to be considered worthless in the perspective of health claims. This applies to the evaluation of past studies, and future studies of benefits of food.

Armando – Sport Nutrition team

Health claims & unlikely friends: vitamin maximum levels, and borderline with medicines

As noted in an earlier post, health claims are producing, or trying to produce, effects in food law. Member States are fighting any resulting harmonization, with mixed results.

For example, in theory, maximum levels of vitamins have nothing to do with health claims, and are notoriously one of the least harmonizable bits of food supplement law.

EFSA gave a favourable opinion on the effects of vitamin D and the reduction of the risk of falling, which is a risk factor in the development of bone fractures. EFSA also set conditions of use of 20μg of daily intake of vitamin D. This of course was not well taken by those EU Member States who have a deep dislike for high vitamin levels. The European Commission (EC) decided to go back and ask EFSA if those levels are safe. Assuming EFSA will say that they are, it will be interesting to watch how the vote on the health claim authorization goes, and how the regulation on this claim will be enforceable in some MS.

The other interesting bit would seem deeply confusing to most people. If there is a EU law stating that you can say that food A provides a certain benefit B to humans, then most people would assume that  food A can be legally sold across the Union.

However, this is totally wrong, as several Member States remarked at the December 5 meeting. Member States have the right to say that food A is a medicine in their country, so it cannot be sold there as a food, and you cannot claim that benefit B. While this seems very complex, the European Court of Justice has said that it is ok, so the EC will have to play along and add a recital clarifying this.

In any case, it is clear that winning EFSA’s approval is not the end of the story.

– Sports Nutrition Team –

PS: the implementing rules for art. 8 of Reg. 1925/2006 (ie, possibility to restrict use of other subtances, such as aminoacids, botanicals, etc)  moved forward. We expect some trouble from this. Germany’s request to list substances that cannot be used in food has for the moment been sidelined.

Art. 13 health claim list regulation will provide reassurances (and worries)

The first outcome of the discussion in Brussels on the 5th of December was that the Regulation with the “big list” under art. 13.1 (the claims which should have been based on generally accepted evidence) will clarify that only health claims on the list are allowed, all others being forbidden, with two exceptions.

The exceptions include “claims requiring further consideration by the risk managers before a decision on them can be taken; claims requiring a further assessment by EFSA; and claims on “botanical” substances; that have not received an assessment by EFSA following a request by the Commission”. Such claims will be listed on the EC website (botanicals, probiotics, caffeine, some odd claims on arginine, one claim on fructose and one claim on glycaemic carbohydrates, etc). Hopefully the text will be clear enough to avoid unwarranted enforcement (and the situation with caffeine is rapidly resolved).

The Committee also accepted that the claims of beta-glucans cannot be extended beyond EFSA opinion (to all beta-glucans); clarified the conditions for use on water-related health claims and on glucomannan; extended health claims valid for some weight loss products to all products complying with Directive 96/8/EC; and said no to a claim on fat and to one on sodium (as they are not beneficial).

On a related matter, providing a spark of hope, the Committee approved a new Regulation refusing market authorisation to some claims. This smaller Regulation will grant  more generous terms extending “the period granted to operators and national controlling authorities to adapt to the new requirements of the draft Regulation to all claims used in commercial communications and not only to those used on the label of products”. There is widespread concern that enacting terms have been too stringent for stakeholders so far, especially when the health claim had legally been on the market for some time. Hopefully, this reasoning will be applied more broadly in the future.

– Sports Nutrition Team –

The effects of low and high glycaemic carbohydrates on endurance performance

The concept of glycaemic index (GI) was originally introduced to classify carbohydrate-rich foods, usually having an energy content of >80 % from carbohydrates, according to the differences in effects on post-meal glycaemia. The GI, which is a nutritional property of a carbohydrate-rich food, is defined as the incremental area under the blood glucose response curve following a 50 g glycaemic carbohydrate portion of a test food expressed as a percent of the response to the same amount of carbohydrates from a standard reference product taken by the same subject (FAO/WHO, 1998).

Carbohydrate-rich foods can be classified according to their GI values (glucose as the standard): high GI >70 (white bread, most white rices, corn flakes, extruded breakfast cereals, glucose); normal GI 55-70 (whole wheat products, basmati rice, sweet potato, sucrose); low GI 40-55 (most fruits and vegetables, legumes/pulses, whole grains, nuts, fructose) and very low <40.

On the other hand, is not easy to outline glycaemic index of foods rich in carbohydrates because many other factors in the diet (e.g. amount and type of dietary fibre, amount of dietary fat, energy density, physical properties, mode of preparation) are involved.

EFSA (European Food Safety Authority) expressed its negative opinion on the substantiation of health claims related to carbohydrates that induce low/reduced glycaemic responses and carbohydrates with a low glycaemic index. The claims effect was related to carbohydrates with a low glycaemic index (GI) and Impact on blood glucose / Glycaemic control / Glycaemic response or to maintain healthy cholesterol levels. The main cause of rejection of these claims was that the food constituents, carbohydrates that induce a low/reduced glycaemic response and carbohydrates with a low glycaemic index (e.g. <55), which are the subject of the health claims are not sufficiently characterised. On the other hand, there are also positive opinions concerning natural and artificial sugar replacers such as xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt and sucralose for which EFSA approved the claims related to consumption of these substances and reduction of post-prandial glycaemic responses, furthermore the same opinions have been given for slowly digestible starch in starch-containing foods, beta-glucans from oats and barley and others.

Concerning this topic a recent human trial study has highlighted effects relevant to sportsmen. The study involved 10 well trained cyclists to investigate the effects of high and low glycaemic index (GI) 24 h recovery meals on the physiological responses and subsequent athletic performance, following a glycogen depleting protocol.

On day 1, subjects performed a glycogen depleting protocol after which they then consumed either high or low GI recovery diets over the next 24 h, which provided 8 g.kg BWˉ¹ of carbohydrate. On day 2, the subjects returned to the laboratory, 2-3 h postprandial, to perform a 40 km time trial (TT) on the Velotron cyclePro© ergometer. The results showed no significant differences between the two groups of subjects with respect to both physiological parameters (carbohydrate, fat oxidation and blood glucose concentration) and related to endurance performance.

The study suggests that type of carbohydrate intake (low GI or high GI carbohydrate) does not affect performance. This calls into question some long-standing formulation principles, and requires further research. The available evidence strongly supports carbohydrate intake in the context of sports; the final word on the use of low GI carbohydrates over high GI carbohydrates had not been said, and high GI carbohydrates still have a place.

Jacopo Angelucci – Sport nutrition Team

PlantLIBRA, Prof. Silano wishes success to the PlantLIBRA Brasov meeting

Prof. Silano, chairman of EFSA’s Scientific Committee and of PlantLIBRA’s Scientifi Advisory Board, has asked us to share a message with PlantLIBRA partners (he will not be able to attend the meeting):

I would be very grateful if you could express to all our colleagues participating in the PlantLIBRA meeting in Brasov, my sincere regrets for not being able to participate. I hoped to help develop the project in a concrete way and help avoid some pitfalls to the project. In any case, my wish is that everything goes well, considering that this project is unique in its nature and also represents a significant success for those who have put forward the proposal. Furthermore, the results of this project will not fail to provide long-waited responses with substantial benefits for consumers of food supplements with botanicals.

[translated from Italian]

The PlantLIBRA Management Team

Altroconsumo, Federsalus e gli integratori alimentari

No agli integratori alimentari

Nei giorni scorsi si è registrata un’editoriale polemica di Altroconsumo sugli integratori alimentari, partita da un’inchiesta (dei cui meriti non intendo discutere), cui è seguita la replica di Federsalus, con un articolo comparso su ilfattoalimentare.it che riassume il tutto.

Per chi lavora nel settore, in tutte le componenti della filiera, questi attacchi – quando sono generici ed apodittici – dispiacciono, anche per la confusione che creano nel consumatore, senza in realtà modificarne i comportamenti. Nel mondo degli integratori alimentari – come tanti settori paralleli, da quello del farmaco da banco a quello dell’alimento funzionale – c’è una grande varietà di qualità, efficacia, comunicazione. Indispensabile in questo senso è – e soprattutto sarebbe – un’azione critica, puntuale, basata su dati scientifici ed analitici, da parte del movimento consumerista, a cominciare dall’organizzazione più qualificata, che è Altroconsumo. Ritengo che la qualità di molti prodotti non sia sufficiente e che i controlli vadano incrementati.

Non posso condividere invece l’atteggiamento pregiudiziale che non è solo del movimento consumerista, ma anche di alcuni noti studiosi e personalità. Non è un pregiudizio, nella sua generalità,  basato sui dati scientifici: ci sono buone evidenze che alcuni integratori alimentari funzionano, e fanno bene, anche se, per tanti altri, la comunicazione si è svincolata dal dato scientifico (basta fare un giro in farmacia o leggere il giornale per verificarlo). Come fa notare Federsalus, non si possono poi mettere in luce solo i pareri negativi di EFSA: l’Autorità comunitaria ha ritenuto scientificamente fondati numerosi claim che riguardano gli integratori alimentari, soprattutto su vitamine e minerali (in maniera che non mi trova d’accordo, peraltro). Inoltre, se è vero che la dieta varia ed equilibrata è un obiettivo corretto, è anche vero che non è la realtà di tutti, e, in nome di un ideale corretto, non mi sembra giusto non favorire uno status nutrizionale adeguato, anche se raggiunto mediante l’integrazione. Infine, si ignorano le oggettive carenze di micronutrienti che riguardano anche la popolazione italiana (e di cui si parla pochissimo): dal ferro in numerose donne, all’acido folico, alla vitamina D e alle vitamine del gruppo B negli anziani. Forse serve la fortificazione (che non c’è), spesso modificare la dieta è poco realistico o praticabile e numerose persone potrebbero trarre un significativo beneficio da un’integrazione adeguata, e conforme alle più recenti indicazioni scientifiche.

Se insomma le organizzazioni dei consumatori si occupano di distinguere tra integratore ed integratore, senza proclami generici, fanno un buon servizio al settore industriale, prima di tutto, e, poi, ai consumatori che sono quelli che stanno a cuore a tutti.

Luca Bucchini, Managing Director

Low glycaemic “properties” claims: EFSA brings new hope

Low glycemic “properties” are an industry’s favorite when it comes to sports nutrition, particularly for bars. Though such claims are rather carelessly used in some EU countries, with little official scrutiny, there was concern that claims such as those would not be allowed under Reg. 1924/2006 or would fall outside its scope and hence in a limbo of regulatory uncertainty.

Although the recent batch of EFSA opinions on health claims resulted in several sadly negative opinions, sugar replacers such as xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose came out as clear winners. EFSA’s NDA panel declared that “a cause and effect relationship has been established between the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose instead of sugar and reduction in post-prandial blood glucose responses (without disproportionally increasing post-prandial insulinaemic responses) as compared to sugar-containing foods/drinks“.

The Panel was apparently convinced that the Regulation’s restrictions on comparative claims as well as art. 3 (“...the use of nutrition and health claims shall not….give rise to doubt about the safety and/or the nutritional adequacy of other foods“, with sugar possibly the loser in this case) did not present a problem, although this may come back at the enforcement level in Member States.

In practice, while the immediate implications of this EFSA opinion vary in different Member States, there is a clear possibility of making “low glycemic” claims on food supplements (e.g., protein with sucralose) and bars with polyols (news which will make many happy).

However, the conditions set by the Panel deserve a careful analysis before using the claims.

– Sports Nutrition Team –

NB: Stevia, which, at the moment, is not allowed anyway, is not in the list.

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