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 –

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

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

What does “light” mean? How far can the lack of nutrient profiles be pushed?

According to European Union Regulation 1924/2006, also known as the Nutrition and Health Claims Regulation (NHCR), the claim fat-free can be made when:

“A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of fat per 100 g or 100 ml. However, claims expressed as ‘X % fat-free’ shall be prohibited.”

For example, a line of dairy products with 0,1 g of fat per 100 g can make such a claim,  can express it also as 0,1% fat, and may have features bordering on ligthness (without mentioning it, otherwise it would have to meet the requirements of reduced which are:
A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar product, except for micronutrients, where a 10 % difference in the reference values as set in Directive 90/496/EEC shall be acceptable, and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable

).

That said, no fat or low fat claims do not imply that the product has low energy. With nutrient profiles practically dead (art. 4), this would seem ok, even when with the same “no fat” product line you have some flavors with low calories and some other flavors that practically have the same energy of the regular, full fat line. The consumer may think that the “no fat claim”, especially comparing superficially the two existing product lines, would imply a signficant reduction of energy as well , but this would be irrelevant from a regulatory standpoint.

Is it really so, or could it fall under the scope of misleading advertising? Authorities in at least some EU countries have proved ready to question a strict interpretation of Reg. 1924/2006, and fine companies under a broader interpretation, as int eh case of % cholesterol claims. Cholesterol content claims would be allowed under the Regulation’s annex, but appear to conflict with the principles of the Regulation.

Predictions are difficult to make, and we suggest caution with approaches as the one described (i.e., use the lack of profiles to push for products that are light only in appearance), especially for sports nutrition, which is often a soft target for regulators.

Sports Nutrition Team

No more botulin in olives, please

Preserved olives (“Organic Olives Stuffed with Almonds”) made in Italy have apparently caused a tragic death in Finland, because of botulism. They are being recalled across Europe (in the UK, in Ireland).

At the time of writing, I firmly hope that there is no further exposure to the product, no further illness, and that a totally preventable death does at least help stave off pain from other lives and families.

The tragic event relates to some lines of reflection relevant to our current research and consulting work.

First, one will note that the recall (which concerns currently all batches of the product) is now clearly mentioned on the firm`s website. Starting on October 28, the news had some traction in Italy too. Informing the public of own recalls through their own websites is considered best practice, though only a minority of companies appear to do so on either side of the Atlantic; apparently, on that day the company sent a Press Release to Italy’s leading news agency, ANSA.

Italian authorities, who are certainly taking action in the field, have also been silent about the issue, including whether the same product is distributed locally (it turns out it is), till today, October 31 (the Ministry of Health seems to confirm that the olives were on sale in Italy too, and that the plant has been shut down). Normally Italian authorities go public when botulism is suspected, unlike when other foodborne disease is (Listeriosis, Salmonellosis, etc), or when there is no illness. Italian authorities generally believe that they are capable of controlling risks, and that information to consumers would not reduce the risk to consumers but would result in undue alarmism, with unwarranted losses to the relevant food sector. This is in line with the attitude in Germany and other EU countries, and contrasts sharply with the US/UK approach, though in principle the UK has the same regulatory system (a lay-man reading of the EU General Food Safety Law would support UK`s practice). However, botulism is an exception, and in this case there was lots of media pressure, and a tragic death to confirm the need to go public.

Generally, however, even beyond botulism, we expect more food recalls to be publicized in Italy and other previously shy EU countries, because of several reasons.

Consumers are becoming used to nonfood recalls (for example, those of IKEA are common place), even if they see very few food-related ones. Moreover, when a food recall has in fact been made public and there were no illnesses, the media impact has been nihil or benign. Therefore, the brand damage of issuing a press release in case of a recall can now be estimated with some confidence. The cost of not going public early, on the other hand, is also becoming clearer: consumers are coming to expect public recalls as part of a company`s social responsibility. In this case, the delay has further tarnished, or probably killed, the brand reputation – when the issue was clearly too large to remain silent.

There also seems to be more willingness of international companies to apply best practice across the EU, even against national norms. Carrefour went recently public with a recall.

Also, some online media blogs and magazines are increasing their attention to this topic, and put pressure on firms (and authorities).

Leaving communication aside, organic, or home-made style, preserved olives have caused recurring botulism problems in Italy and elsewhere. This is striking. We have understood botulism for almost two centuries, and there is is strong food technology to keep the toxins out of our food. Preserving food requires knowledge, process and controls: food safety is not a malicious invention of multinational funded, greedy, positivist tradition haters. Most organic or home-made style food businesses may accept the anti-science rhetoric, but refrain from practicing it. Nevertheless, a few, smaller ones may not realize the need for skilled staff; more do not realize that validation of processes is not auditors`latest oddity. How much this applies to the present case it is early to say, though we know for sure that botulin should not have been there, and that the technology to prevent it is available.

In this respect, the organic food industry should be bold, and use its means, without excuses, to rid us of the hazards, least this tarnishes the organic brand (through certification they have strong tools). There is certainly a place for auditors, and official control staff to just say no when preserving can`t be done properly.

In summary, we advise to review recall plans under the communication header and make sure not to make, or stop making, preserved foods (my steadfast advice to all agriturismi is not to do it) or, if you do, that you can make it properly (for every recipe).

And let`s hope nobody hears, or dies, of botulism and olives again.

Luca Bucchini, Managing Director

Update:  on Nov 1st, the FDA made the recall (which is of a voluntary nature) public.

%d bloggers like this: