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 –

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 –

Season’s greatings from Hylo


Wishing a joyful Christmas and a sparkling New Year!

 




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

Hylobates presents the PlantLIBRA Project in the journal Food & Function

Authors from Hylobates and the University of Milan explain the goals of the EC-funded project PlantLIBRA in the recently published online paper of the journal Food & Function: “The PlantLIBRA Project: how we intend to innovate the science of botanicals” by Luca Bucchini, Alejandro Rodarte and Patrizia Restani

The paper presents the consortium’s plan for improving the science of botanicals and risk and benefit assessment methodologies for plant food supplements (PFS). In this 4 year project, partners are working to expand and generate knowledge on PFS through systematic reviews, intake surveys, new studies on benefits, risks and new analytical findings to ultimately ensure a safer use of PFS by consumers. By doing so, they plan to address data, methodology and consensus gaps in cooperation with different stakeholders and decision makers in the PFS sector.

– Alejandro Rodarte  –

Demographic characteristics play a role in consumers trust in the food supply chain

Nowadays consumers are more and more interested in food safety and quality. These two factors influence the overall trust consumers have in the food supply chain, in the sense that to trust a food, consumers want it to be not only safe but also of good quality and this applies to all the steps of the food chain, from production to consumption.

A recent study we have looked at has investigated if demographic differences might exist with regard to the level of consumers trust in the food supply chain, considering a range of safety and quality variables. A telephone survey was conducted on a random sample of the Australian population aged 18+ years, with more than 1000 thousands interviews done. From the results some demographic differences emerged in relation to how much attention consumers pay to safety and quality: females, older persons and lower income groups were most concerned.

The results of this study  are relevant to our research investigating – within FoodRisC as well – of how consumers perceive communication of food risks, on gaps or barriers to communication and on common tools for a more effective communication on food. In fact, by knowing the demographic characteristics behind the importance placed on a certain food issue, an appropriate targeted communication campaign might be developed to increase consumer trust. This might be one potential tool to increase effectiveness of communication on food issues.”

Antonella Guzzon – Research Team

Food additives: EC adopts a new Regulation

The European Commission has  adopted a new Regulation, implementing Regulation EC 1333/2008. The new Regulation includes list of food additives intended for foodstuffs and food ingredients. The lists will replace lists under  Directives 95/2/CE, 94/36/CE and 94/35/CE in 2013.

The Regulation also foresees that anti-caking agent silicon dioxide can be used for salt substitutes at higher levels and that the coating agent basic metacrilate can be used for food supplements. These specific rules will come into force 20 days after the publication of the present regulation, on December 2 2012; the general list apply on 1 June 2013. Products legally marketed before 1 June 2013 can continue to be sold.

It is interesting to note that the list is divided into categories for different foodstuffs. The category for food supplements is number 17 (solid form such as capsules and tablets, liquid form, syrup or chewable). It is noteworthy that category 13 is food with particular nutritional purposes; foods for sportsmen are not included, further confirmation of the upcoming abolition of this category (if not abolished, theoretically from June 1  2013, no additives would be allowed in foods for sportsmen, as well as in other dietetic foods for which specific rules have not been set).

Armando Antonelli- Sport Nutrition Team

Stevia rebaudiana’s steviol glycosides: approved on 12 November by EC

After a long wait we can finally announce that Stevia rebaudiana and its steviol glycosides are approved in European Countries.

This regulation permitting the sale and the use of this natural sweetener was published in the Official Journal of the EU on 12 November The legislation will enter into force on December 2, allowing formulations and sale of products with steviol glycosides.

The upper level permitted in food supplements will be 670 mg/Kg (solid form), 200 mg/l (liquid form) and 1800 mg/Kg (syrup-type or chewable form). The first rollout of this kind of products in shops will be from the first quarter of 2012, but some may be faster.

We think that the approval of Stevia is a very important for food in general, but concerning  food supplements and food for sportsmen, it is a real milestone. Just think the use of sweeteners in these products, and the increased sweetening power than sugar and consequent reduction of calories up to 50-100%.

We also think that countries where naturalness is particularly appreciated will be particularly receptive, as a natural alternative to aspartame, sucralose and acesulfame K becomes available.

Jacopo Angelucci – Sport 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

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

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