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 –

Leucine plays a key-role in protein synthesis during moderate steady state exercises

Leucine is one of the essential amino acids (EAA) and belongs to the group of BCAAs (branched chained amino acids), the only ones (together with Isoleucine and Valine) that are not degraded in the liver. BCAAs are found mainly in the skeletal muscle and offer an important contribution to the muscle building. Studies suggest that leucine offers the greatest contribution to the energy production at muscular level, slowing the degradation of the tissue by stimulating muscle protein synthesis. In fact, through the insulin-pathway signaling, leucine seems able to trigger muscle anabolic process.

Nevertheless, EFSA‘s Panel on Dietetic Products, Nutrition and Allergies (NDA) published a scientific opinion regarding BCAAs, providing a negative opinion related to the proposed claims, such as ‘Growth or maintenance of muscle mass’, ‘Faster recovery from muscle fatigue after exercise’ and ‘Reduction in perceived exertion during exercise’, noting that there was no proof of benefit over that of all aminoacids as protein building blocks. Some countries, however, are still allowing claims to be made on leucine and BCAAs.

A recent study was performed in the US to evaluate how supplementation with essential amino acids containing two different amounts of leucine can influence post-exercise muscle protein synthesis. Eight adults drank two amino acid based beverage containing respectively 1.87 g and 3.5 g of leucine during their physical exercises. Muscle protein synthesis was determined by using two stable carbon and hydrogen isotopes as marker. Results showed that muscle protein synthesis was 33 % greater (P < 0.05, then statistically significant) after drinking the leucine-enriched beverage, than after consumption of non-enriched one. This trial suggests that ‘increasing the concentration of leucine in an EAA supplement consumed during steady state exercise elicits a greater MPS response during recovery’. It should be noted however that EFSA has indicated that the markers used are not adequate, as positive effects on muscle mass should be proved via actual measurements of mass, not through markers of degradation or synthesis.

The study supports higher ratios of leucine in BCAA supplements, or increasing the leucine content of supplements and other foods for sportsmen.

Given EFSA’s negative opinion, claims on the effect of BCAAs on muscle protein synthesis (which EFSA said is not a benfit per se) rest on shaky ground. It’s just possible, and only for now, to claim BCAAs effects allowed at national level (e.g. for Italy: ‘trophism and muscle recovery’); this must be checked country by country.

Armando Antonelli – Sport Nutrition Team

EFSA: caffeine for sports ok, but not for weight loss

The 8 of April 2011 EFSA’s NDA Panel has published the outcome of the evaluations of a fourth series of ‘general function’ health claims proposed for use on food products.

Only few opinions are positive for sports nutrition. Among these 442 health claims, the most relevant are related to caffeine; in particular  health claims such as ‘Increased alertness’ , ‘ increased attention’, ‘increase in endurance performance’, ‘increase in endurance capacity’, ‘reduction in the rated perceived exertion/effort during exercise’ are now accepted for caffeine. Other positive outcomes are related to resistant maltodextrins ( ‘Changes in bowel function’), Choline (‘ Contribution to normal lipid metabolism ‘) and olive poliphenols  ( ‘Hydroxytyrosol protects LDL particles from oxidative damage’).

Instead most EFSA opinions are negative. It should be noted that all the health claims on ‘reduction of body weight’ related to caffeine and green tea have been rejected. Other negative outcomes are related to several aminoacids such as  L-Arginine, Lysine, Tryptophan and aminoacidic derivatives such as Taurine and Carnosine, particularly interesting are the rejected health claims concerning  ‘management of body mass’  and “improvement of endothelium-dependent vasodilation’ (Arginine),  ‘Contribution to normal protein synthesis’ (Lysine), ‘Maintenance of normal muscle function’ (Taurin). Also Quercetin, Lutein, Alpha Linoleic Acid (ALA), FOS and PUFAs DHA/EPA (Omega 3) received general negative opinions from the Panel.

“The positive opinion on caffeine is important specifically for the benefits which EFSA has recognized within the domain of the Nutrition and Health Claims Regulation, and the standard that it sets.” commented Luca Bucchini, managing director of Hylobates “Though EFSA’s opinions are important when thinking to new products, they should not be the only driving force. EFSA’s processs is welcome when compared to the less than transparent situation in several EU countries; at the same time, it should be noted that EFSA’s approach has been less than consistent between micronutrients and other substances. It is time for the sports nutrition industry to think carefully about the future.”

– Armand and Jacopo, Sport Nutrition Team –

EFSA: la caffeina per lo sport funziona, altre sostanze no

In data odierna il gruppo di esperti dell’EFSA ha pubblicato i risultati della valutazione di 442 claim sulla salute proposti per l’uso nei prodotti alimentari.

Solo poche opinioni possono essere considerate positive nel campo della nutrizione sportiva,  in particolare sono stati accettati claim relativi al consumo di caffeina e aumento dello stato di allerta/attenzione, diminuzione della percezione dello sforzo durante l’esercizio fisico ed aumento della capacità in esercizi fisici di resistenza. Gli esperti dell’EFSA hanno dato inoltre parere positivo per il claim relativo alle maltodestrine resistenti affermando che c’è una relazione di causa effetto tra il consumo di questi carboidrati e il miglioramento della funzionalità intestinale. Altri esiti positivi sono riscontrabili per claim relativi alla Colina (‘contribuisce al normale metabolismo lipidico’) e ai polifenoli dell’ulivo (‘Idrossitirosolo protegge le LDL dal danno ossidativo’).

Gran parte dei claim valutati sono stati respinti, tra cui i principali relativi al consumo di caffeina e tè verde che riguardano ‘mantenimento e controllo del peso corporeo’ non potranno più essere utilizzati per prodotti ed integratori alimentari, a meno che il processo a livello comunitario abbia un esito diverso e solo quando i pareri diventeranno legge, con lo specifico regolamento di attuazione. Nessun parere positivo per quel che riguarda i claim  sugli aminoacidi come arginina, lisina, triptofano e derivati aminoacidici quali taurina, carnosina: infatti i principali claim sulla massa muscolare, attività di tipo tonico e vasodilatazione sono stati bocciati.Numerosi altri claim sono stati valutati e bocciati, in particolare molti relativi a Quercetina, Luteina, Acido Alfa Linoleico (ALA), FOS e i PUPA DHA/EPA (Omega 3) generalmente per carenza di dati sufficienti.

“Non bisogna dimenticare che EFSA ha ampiamente riconosciuto i benefici di vitamina e minerali che sono i tipici principi degli integratori alimentari, anche per lo sport (come per vitamina C e sistema immunitario dello sportivo)” ha commentato Luca Bucchini, direttore gestionale di Hylobates “Per le altre sostanze ha usato uno standard di prova molto diverso e a volte discutibile, anche se riteniamo un processo trasparente e scientificamente qualificato come quello di EFSA sia importante e necessario. Il riconoscimento per la caffeina è importante ed univoco; sarà importante bilanciare l’effetto positivo dei pareri EFSA con la necessità di portare sul mercato prodotti equilibrati, indirizzando attentamente la ricerca. Su un piano più squisitamente tecnico è importante, che con l’opinione sulla caffeina, EFSA ha confermato la possibilità di claim sulla salute nel quadro del Regolamento 1924/2006 riferiti ad attività sportive”.

Le indicazioni fornite dal Ministero della Salute sul proprio sito, fino all’entrata in vigore di un regolamento applicativo (atteso per metà 2012), restano permesse.

– Armando e Jacopo, Sport Nutrition Team –

Aggiornato alle ore 18:03 dell’8/4 con riferimento al Ministero Salute

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