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


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 –

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

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