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

Advertisements

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.

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 –

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

%d bloggers like this: