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 –

Italy’s Ministry of Health increases maximum levels for vitamin C and group B vitamins in supplements

The Italian Ministry of Health updated  its guidelines on the maximum amounts of vitamins allowed in food supplements. The new guidelines went online yesterday, 21/12/2011 at noon,

The main changes compared to the previous values concern vitamin C and some B vitamins.

In particular, the maximum level for vitamin C has been raised to 500 mg (625 % RDA), compared to the previous level of 240 mg (300 % RDA).

Regarding B vitamins the greatest change involves vitamin B12, which goes from a maximum level of 3.75 mcg (150% RDA) to 18 mcg (720% RDA).

Other important changes are related to B1, B2 and B6 vitamins: maximum levels have been doubled to 4.2 mg (382 % RDA), 4.8 (343 % RDA) and 6 mg (428 % RDA), respectively. Niacin’s previous maximum level of 27 mg (169 % RDA) has been increased to 36 mg (225 % RDA).

This update signals Italy’s willingness to abandon a xRDA approach and adopt a risk-based approach to setting maximum levels, in line with Directive 2002/46 and Court of Justice case-law. Only few EU member states, such as Belgium, still adopt a xRDA approach.

The guidelines are effective immediately, and likely to be used as guidelines for enforcement.

Sports 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

Is mutual recognition working for food supplements?

When a company decides to import a foodstuff, including supplements, in a Member State (MS) of the European Union from another MS, it becomes important to evaluate the national legislation of that specific Member State, in terms of nutrients and substances permitted and their levels of use, but considering also the principle of Mutual Recognition, often ignored by companies and authorities alike.

According to Regulation (EC) 764/2008, Mutual Regonition is the principle of free movement of products within the market of the European Union. It applies to products not subject to harmonized legislation: “according to that principle, a Member State may not prohibit the sale on its territory of products which are lawfully marketed in another Member State, even where those products were manufactured in accordance with technical rules different from those to which domestic products are subject.”. The only exception to this principle are restrictions based on Article 30 of the EU Treaty.

However, our experience in the food supplement sector shows that this principle is often neglected by national authorities. It is often the case that an authority of a Member State practically bans a notified product based on national legislation or administrative practices. Even if the principal of mutual recognition under Regulation 764/2008 is claimed, the authorities flatly ignore the reference.

For such cases, Regulation 764/2008 also establishes Product Contact Points included in a list published on the EC website. One company may contact these points to get information to proceed with mutual recognition. However, they are often of little help. In one case, for instance, they got back to us saying that since there is no harmonization in substances permitted in food supplements in the EU, so they concluded that there is no wrong application of the EU law. This contrasts with the very reason Regulation 764/2008 was set up for.

We are looking forward to the European Commission’s steps to ensure the application of the regulation, as well as court rulings.

Matteo

Sports Nutrition Team

2011 PlantLIBRA project meeting to be held in May on Dracula’s homeland

Hylobates Consulting is happy to announce that in less than two month the 2nd PlantLIBRA project meeting will take place. Our  Project Management Team is working hard on these days to tie up loose ends for the organization of the event, and make it as relevant and scientifically exciting as we can.

This year, the congress which annually brings together all the partners contributing to PlantLIBRA’s development and success will be held in Brasov, placed in the well-known Romanian region of Transylvania.

The 2nd project meeting hosted by the our Romanian partner, the Transilvania University of Brasov, will take place between 17-20 May.

This international congress will also help the Coordinator, Prof. Restani of the University of Milan, to assess the progress of PlantLIBRA, ten months after the project start-up in June, against the objectives agreed with the EC.

The tight schedule of the 4 day-event include plenary sessions to discuss the first year results, WP meetings, to interact with policy-marks, stakeholders, other scientists and a dedicated session to discuss the latest news from the world of botanicals and policy- making.

Hylobates Consulting would like to thank Dr Mihaela Badea from the Universitatea TRANSILVANIA din Brasov for her help in the organisation of the meeting, and wishes this PlantLIBRA annual congress to be a key event to achieve the project goals – thanks to the participation of all partners and guests.

Sonia

PlantLIBRA Management Team

“No” and “free of”: is it a new trend in sports nutrition?

Consumers in Italy and elsewhere in the European Union seem to have a particular appreciation for a series of “no” statements: “no GMO” (“GMO free”), “no artificial colors”, “no preservatives”, “no artificial sweeteners” and so on. On common foods, these series of “no statements” seemed to be effective and to link the products’ image with a valued concept of naturalness.

Especially in Italy where consumers, especially women with children, seem particularly wary of additives or anything “not natural”, even packaged foods such as breakfast cereals, which do not belong to Italy’s tradition and are relatively homogeneous across the European Union, often boast several “no statements”.

In the case of sports nutrition products, such claims (which are not regulated by Regulation 1924/2006) were not very frequent. “Aspartame free” or “lactose free” claims are rather common, but other claims (“preservative free”) were rare. Sports nutrition products appear to be targeted to consumers who favor technology over naturalness, and the products themselves appear the result of the mixing of several substances which are either chemically synthesized or produced in sophisticated ways, certainly not available straight from a tree branch. Even whey is not communicated with beautiful cows grazing immaculate Alpine lawns.

At least in Italy, a new trend may have begun. A major sports drink company has started a “No artificial” campaign, which can be seen across Italy, emphasizing the absence of artificial colors and sweeteners. This may be linked with their brand which targets children 8-12, whose mothers may be doing the purchasing and are particularly keen on natural products.

Whatever the reasons a new trend may have started.

The Sports Nutrition Team

Article available in Italian

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