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

Hylobates raccoglie il parere degli esperti in materia di politiche sui micronutrienti per EURRECA, una rete europea di eccellenza

Hylobates Consulting è partner di EURRECA, una rete di eccellenza finanziata dalla Commissione Europea che ha l’obiettivo di elaborare delle linee guida armonizzate per le raccomandazioni nutrizionali su vitamine e minerali. EURRECA sta sviluppando e applicando degli strumenti che aiuteranno l’EFSA, così come qualsiasi altra organizzazione incaricata dell’elaborazione e della revisione delle raccomandazioni nutrizionali su vitamine e minerali (in Italia è la SINU). Il consorzio è composto da scienziati, rappresentanti degli organismi che definiscono le raccomandazioni nutrizionali, le organizzazioni dei consumatori, le piccole e medie imprese e gli stakeholder più importatni di tutta Europa.

Le raccomandazioni nutrizionali ad oggi pubblicate mostrano una notevole diversità fra i paesi europei, nonostante le esigenze fisiologiche delle varie popolazioni siano molto simili. I motivi di questa variazione possono essere riscontare nelle differenze nei concetti e nella terminologia usata per esprimere queste raccomandazioni, negli indicatori dello stato nutrizionale e/o negli indicatori di salute utilizzati da parte di esperti per determinare un adeguato apporto, nei tipi di studi e riferimenti bibliografici utilizzati, ecc. Tuttavia, queste differenze a livello nazionale potrebbe generare confusione fra i decisori politici, operatori sanitari, industria alimentare e consumatori.

Questo è il motivo per cui si rende necessaria l’armonizzazione delle raccomandazioni nutrizionali. EURRECA ha condotto una ricerca su diversi gruppi di popolazioni per identificare i nutrienti per i quali vi è un urgente bisogno di revisione della dose raccomandata. Dieci micronutrienti sono stati identificati, vale a dire vitamina D, il ferro, folati, vitamina B12, zinco, calcio, vitamina C, selenio, iodio e rame.

Tre sono gli obiettivi chiave di EURRECA:

1. Produrre un insieme di standard fornendo una solida base scientifica per stabilire il fabbisogno di micronutrienti e per elaborare le raccomandazioni nutrizionali.

2. Focalizzarsi sulle esigenze di specifici gruppi vulnerabili: neonati, bambini e adolescenti, adulti, donne in gravidanza e in allattamento, anziani, persone con basso reddito e immigrati.

3. Valutare l’impatto dello status socio-economico, l’origine etnica, la variabilità inter-individuale e di vulnerabilità a causa di fattori genetici, fattori ambientali e dei fenomeni epigenetici.

Come membro del consorzio, Hylobates Consulting ha recentemente condotto in Italia una serie di interviste con esperti sulle politiche relative ai folati, allo iodio e alla vitamina D. L’obiettivo delle interviste è stato quello di investigare il processo decisionale relativo alle politiche di questi micronutrienti attraverso la valutazione delle assunzioni fatte nel processo di elaborazione delle politiche, delle evidenze scientifiche e della considerazione dei soggetti interessati e dei consumatori nel processo decisionale (un po’di background qui, purtroppo a pagamento). I risultati delle interviste condotte in Italia, insieme alle interviste degli altri paesi coinvolti, contribuiranno nell’insieme allo sviluppo di uno strumento che aiuti i decisori nello sviluppo di politiche sulla base di raccomandazioni armonizzate per i micronutrienti.

Antonella

Hylobates Science

Questo posto è una traduzione. Il post originale si trova qui.

Hylobates investigates the experts’ opinion on micronutrients policies for EURRECA, an EU Network of Excellence

Hylobates Consulting is a partner of EURRECA, a Network of Excellence funded by the European Commission which has the goal to produce harmonised scientific guidelines for micronutrient (vitamins & minerals) recommendations. EURRECA is developing and applying tools that will help EFSA, as well as any organisation charged with developing and revising nutrient recommendations. The consortium is composed of scientists, representatives of nutrient requirement setting bodies, consumer organisations, small & medium-sized enterprises and wider stakeholders from across Europe.

To date,  published values of nutrient recommendations show a wide variation among European countries despite the physiological requirements of the different populations are very similar. The reasons for this variation may be found in differences in the concepts and sets of terminology used to express these recommendations, the nutritional status indicators and/or health indicators used by scientific experts to determine adequate intake, the types of studies and references used, etc. Nevertheless, these differences at national level might generate confusion for policy-makers, health professionals, food industry and consumers. This is the reason why harmonised recommendations are needed.

EURRECA has carried out a research across several populations groups to identify the nutrients for whom there is an urgent need of review of their recommended intake. Ten micronutrients have been identified, i.e. vitamin D, iron, folate, vitamin B12, zinc, calcium, vitamin C, selenium, iodine and copper.

Three are the key objectives of EURRECA:

1. Deliver an aligned set of standards providing a robust scientific basis for establishing micronutrient requirements and for devising micronutrient recommendations.

2. Focus on the needs of specific vulnerable groups: infants, children and adolescents, adults, pregnant and lactating women, elderly, people with low income and immigrants.

3. Evaluate the impact of socio-economic status, ethnic origin, inter-individual variability and vulnerability due to genetics, environmental factors and epigenetic phenomena.

As member of the consortium, Hylobates Consulting has recently carried out in Italy a set on interviews with experts on folate, iodine and vitamine D on the relevant nutrition policy. The aim of the interviews was to address the policy decision making process related to these micronutrients (background abstract material is available here) by investigating the assumptions in the process of policy formulation, the evidence involved and consideration of stakeholders and consumers in the process of policy making. Results of the interviews from Italy, together with those of the interviews from the other countries participating to the task, will contribute altogether to the development of a tool which will aid policy makers in developing policies based on aligned micronutrient recommendations.

Antonella

Hylobates Science

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

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