Sorbitol death is wake-up call for Internet retailers

In Barletta, a town with 91,000 inhabitants in South-East Italy, a woman has died, and two have been hospitalized after ingesting a vial which seems to have contained sorbitol. According to Carlo Locatelli, of the Poisons Center in Pavia, Italy, which is one of Italy’s leading Poisons Centers, the patients developed methemoglobinemia, a condition in which oxygen cannot be captured by red blood cells. Fortunately, the two surviving patients were saved by prompt administration of methylene blue, a colour dye, which also reverses methemoglobinemia .

Sorbitol is a polyol which naturally occurs in fruit, and is widely used in candies and other low-calorie products. From the outset, the symptomatology suggested that nitrates could be responsible for the tragic deaths. According to Italy’s Ministry of Health, there is no information suggesting product contamination. Nevertheless, the Italian police squad assigned to food safety matters, the NAS, have seized over 1,000 tons of food-grade sorbitol at Cargill’s plants in Northern Italy but have apparently ordered no product testing. The implicated sorbitol was manufactured at Cargill’s plant in Rovigo, in Northern Italy. The most recent media reports indicate that the product was 70% sodium nitrite, and it is unclear how it could have been mistaken for sorbitol. News that implicated an industry-grade sorbitol lot (sorbitol is also used for manufacturing plastics, etc) are not confirmed.

It is early to say what the root cause of the problem was, or what failed in the system that should protect patients, and to separate the root cause from the inevitable legal blame-game that follows tragedies.

The doctors administering the sorbitol-based test seem to have purchased the product from eBay, which has expressed sorrow and halted globally the sales of sorbitol. It is unclear if a recall should follow, or if it will. There’s no basis at this time to suggest that food companies should recall sorbitol-containing products; however, they can trace their sorbitol to exclude the affected lot is involved. Moreover, they should follow closely the events.

Cargill has issued a press release in Italian (well done, and the loss of website formatting means their crisis team had to act quickly), explaining that the lot was manufactured at their site in February 2010, and since packaged elsewhere. The product conformed to tests when it left the production site.

As we wait for further news, it is still unclear how the product was sold over ebay.

For the moment, this tragedy seems to show that Internet retailers, when selling foods or food ingredients, are food business operators, and should ensure the safety of their products – much like grocery retailers do – and issuing recalls when necessary.  eBay seems to be behaving like a responsible food business. Others, like Amazon, should start doing the same even if they think they’re not food businesses.

– Luca Bucchini, Managing Director –

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ASA Adjudication on Leaf Italia SRL

Leaf Italia, maker of Sperlari, Dietorelle, Dietor, Pringles, as well as other brands, was not found in breach of UK advertising regulations (which are similar to those found across the EU) by the ASA. The use of an online game with fruit had been questioned as it suggested that eating Leaf’s candies was equivalent to eating fruit.

Leaf said the purpose of the game was to encourage children to eat fruit, but ASA found that this was unclear. Yet, because individuals exposed to the ads are old enough to differentiate flavored candies from fruit, and would understand the “landmarks” were the flavors of the candies, not actual fruit, and would not imply that the candies had nutritional benefits, ASA decided that the ad ” was unlikely to give a misleading impression of the nutritional and health benefits of the product”.

In our view, it should be noted that ASA has not hesitated to investigate the ads of a business which has its office elsewhere in the EU. On the other hand, ASA seems not to have taken a hard line over online games which are increasingly common, and link a brand of food which is not necessarily in line with recommended nutrient profiles with healthy nutrition. At the same time, as a note of caution, it should be noted that the explanations of Leaf were largely rejected.

Therefore attention is recommended, as other authorities across the EU may take a different stand.

– Luca Bucchini, Hylo’s managing director

Communicating food recalls to consumers is becoming more common in Italy. Leaf Italia, owner of the Sperlari brand, has gone public with a foreign body-caused recall of pralines.

 This breaks with Italy’s reluctance to go public with recalls, even if – interestingly – the company has prohibited the copying or distributing or discussing the press release issued on their website (for that reason we do not link to it; this discussion is based on what is reported on another source, see below).

“Companies in Italy have in their procedures to go public in these cases”, says Hylo’s Luca Bucchini, “Nevertheless, companies and national authorities have hesitated on the ground that ‘nobody ever goes public with a recall’. This is clearly changing. For example, last year, Carrefour went public. In this case, one should also note that foreign bodies in Italy have always been a low priority for regulators, in contrast with the UK or the US. As in other EU countries, regulators focus on microbial or chemical risk. This is therefore a significant departure from tradition, and we expect to see more of this since regional authorities are eager on this, and several companies were just waiting for someone to break the ice”.

At Hylo we believe that ordinary recalls, even if publicized, when no serious illnesses are involved, are not detrimental to a brand – Ikea is perhaps the best example – and are in line with EU law.

This news piece is not based on the Sperlari website. It is based on the information below:

http://www.ilfattoalimentare.it/sicurezza-alimentare-allerta-dalla-valle-daosta.html

Hylo Team

European Commission and Member States on food supplement classification, labeling of wine and health claims

‘On 1 February 2012 the EC Standing Commettee on the food chain and animal health met in order to discuss many topics related to the general food law. Below a feedback of main discussions, with Hylo’s point of view.

Status of the products placed on the market as food supplement/dietetic food for special medical purposes

Member States and EC have recently debated whether the same product can be classified and sold as a food supplement and as food for special medical purposes simultaneously by two entities. EC said yes in theory, no in practice, and pointed out that art. 14 of Dir. 2009/39 cannot apply to food supplements (and quite confusingly mutual recognition would not apply).

In Hylo’s view, the borders between the two pieces of legislation are so blurred, especially with the vast discretion Member States exercise in this area, and the national pieces of legislation that they have put together (including Spain), that this will continue to be uncertain. Some Member States have a strong preference for dietetic foods, some others prefer food supplements; and several Member States have consistently refused to accept the interpretation of other Member States (it is unclear if the EC was supporting this attitude with the remark on mutual recognition).

This is unlikely to change as long as dietetic foods exist, or a single process is established. Confusion will continue to persist.

Spermidine and related health claim

The spermidine and prolongation of the growing phase (anagen) of the hair cycle health claim proposed by the Italian pharma company Giuliani Spa (also known for the GABA novel food application) continues to be mired in controversy. EFSA had opined in December 2011 that since the population studied for the claim (and likely beneficiaries) has a pathological condition. So the claim would be medicinal, and not allowed within Reg. 1924/2006.

The EC has commented, and we @Hylo will follow with interest to see how it goes (not well but it’s still uncertain). Whether EFSA is coherent on this matter, given hypercholestoremia is also a disease, it’s another matter that deserves in-depth analysis.

Sugar beet fibre and related health claim

Member States and the EC seem to have agreed to soften EFSA’s wording on sugar beet fibre and increasing faecal bulk. EFSA proposed “Sugar beet fibre increases faecal bulk”, EC and MS decided to say “sugar beet fibre contributes to an increase in faecal bulk”.

We Hylobates observe that it is not unexpected that the direct, simpler style of health claims in the English-speaking world would be rejected at the EU-level where broadly fuzzier claims are favored by regulators. Moreover, this decision signals the intention of regulators to intervene in the wording of claims much more aggresively than could be anticipated. It is not entirely clear that consumers would perceive the two wordings in different ways.

Status of allergens in wine

After the rejection  of scientific studies on allergens in wine presented in order to avoid the application of allergen labeling requirements, there has been much speculation on what would happen. Member States and the EC could not agree on a solution that would make everyone happy. However, the EC indicated that a decision should come soon – and that it should be pragmatic.

Selling of foods beyond maximum durability

Last but not least, Member States discussed the selling of foods beyond maximum durability at the 1st February meeting. Most said it’s possible but it’s also a complex issue. Our view: each Member State will go its own way.

– 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.

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 –

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

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