European Commission and Member States on food supplement classification, labeling of wine and health claims

‘On 1 February 2012 the EC Standing Commettee on the food chain and animal health met in order to discuss many topics related to the general food law. Below a feedback of main discussions, with Hylo’s point of view.

Status of the products placed on the market as food supplement/dietetic food for special medical purposes

Member States and EC have recently debated whether the same product can be classified and sold as a food supplement and as food for special medical purposes simultaneously by two entities. EC said yes in theory, no in practice, and pointed out that art. 14 of Dir. 2009/39 cannot apply to food supplements (and quite confusingly mutual recognition would not apply).

In Hylo’s view, the borders between the two pieces of legislation are so blurred, especially with the vast discretion Member States exercise in this area, and the national pieces of legislation that they have put together (including Spain), that this will continue to be uncertain. Some Member States have a strong preference for dietetic foods, some others prefer food supplements; and several Member States have consistently refused to accept the interpretation of other Member States (it is unclear if the EC was supporting this attitude with the remark on mutual recognition).

This is unlikely to change as long as dietetic foods exist, or a single process is established. Confusion will continue to persist.

Spermidine and related health claim

The spermidine and prolongation of the growing phase (anagen) of the hair cycle health claim proposed by the Italian pharma company Giuliani Spa (also known for the GABA novel food application) continues to be mired in controversy. EFSA had opined in December 2011 that since the population studied for the claim (and likely beneficiaries) has a pathological condition. So the claim would be medicinal, and not allowed within Reg. 1924/2006.

The EC has commented, and we @Hylo will follow with interest to see how it goes (not well but it’s still uncertain). Whether EFSA is coherent on this matter, given hypercholestoremia is also a disease, it’s another matter that deserves in-depth analysis.

Sugar beet fibre and related health claim

Member States and the EC seem to have agreed to soften EFSA’s wording on sugar beet fibre and increasing faecal bulk. EFSA proposed “Sugar beet fibre increases faecal bulk”, EC and MS decided to say “sugar beet fibre contributes to an increase in faecal bulk”.

We Hylobates observe that it is not unexpected that the direct, simpler style of health claims in the English-speaking world would be rejected at the EU-level where broadly fuzzier claims are favored by regulators. Moreover, this decision signals the intention of regulators to intervene in the wording of claims much more aggresively than could be anticipated. It is not entirely clear that consumers would perceive the two wordings in different ways.

Status of allergens in wine

After the rejection  of scientific studies on allergens in wine presented in order to avoid the application of allergen labeling requirements, there has been much speculation on what would happen. Member States and the EC could not agree on a solution that would make everyone happy. However, the EC indicated that a decision should come soon – and that it should be pragmatic.

Selling of foods beyond maximum durability

Last but not least, Member States discussed the selling of foods beyond maximum durability at the 1st February meeting. Most said it’s possible but it’s also a complex issue. Our view: each Member State will go its own way.

– Sport Nutrition Team –

Focus on Astaxanthin antioxidant properties

Here’s a second post on health claims and oxidant properties. As commented earlier, EFSA is saying that an antioxidant property per se is not a health benefit, as long as it is not shown that there is a direct effect in the body, on proteins, DNA or lipids. EFSA also argues that only some markers have been validated to show this type of direct beneficial effect on the body’s antioxidant defence network. Astaxanthin is an interesting case-study caught in the middle. EFSA has rejected an application because ‘although astaxanthin has antioxidant properties in vitro, the human studies presented do not provide any evidence in support of an in vivo antioxidant effect in terms of lipid peroxidation following the consumption of astaxanthin’. A recent study, according to the authors, provided support to “benefical effects on the oxidative stress markers in overweight adults”. If we focus on markers, the authors have used: malondialdehyde (MDA), isoprostane (ISP), superoxide dismutase (SOD), and total antioxidant capacity (TAC). Changes in F2-isoprostanes (ISP) in 24-h urine samples in considered the gold standard as direct measurement of lipid peroxidation. TAC has not been evaluated by EFSA. MDA and SOD can be used as supportive evidence in addition to reliable in vivo techniques. The concept itself of “beneficial effects on oxidative stress markers” is rejected by EFSA; if there is no protection of macromolecules in the body, there is no benefit. Companies and scientists seeking to support health claims are warned. Of course science goes its own way.

Sport Nutrition Team

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

Standing Commitee: choice of analytical method in the way of health claim authorisation

The EC’s Standing Committee on the food chain and animal health (Section on General Food Law) met on 5 December 2011; the minutes have just been released. The discussion seems to have been particularly lively, and shows how the health claims legislation is impacting food law and practices across the EU, and potentially leading to harmonization (which Member States naturally object to).

The first issue on the agenda was a health claim related to slowly digestible starch and its role in on reduction of post-prandial glycaemic responses compared to rapidly digestible starch. The claim received a favourable opinion from EFSA under the new science mechanism (art. 13.5 of Reg. 1924/2006).

The applicant used the Englyst method to characterize the food, and EFSA agreed. Nevertheless, the Commission had doubts on whether Member States (MS) were able to use the method for enforcement. Also, EC officers wondered whether ‘slowly digestible starch’ is understood by consumers across the EU.

In fact, most MS said the method could not be mentiond in the final regulation, since itis not internationally recognized, and that the wording of the health claim should be improved.

In summary, getting EFSA to say yes bring you only half-way, and there is a risk that enforcement of the regulation will be even messier than the EFSA process.

– 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

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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