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 –

Food Colorings maximum levels are going to change

Commission Regulation (EU) 232/2012 (link) establishes new maximum levels for some food colorings, amending the Annex II to Regulation (EC) No 1333/2008. These changes will involve the following dyes: Quinoline Yellow (E 104), Sunset Yellow FCF/ Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124). The  Regulation will apply from 1 June 2013, but food containing these 3 colorings that have been lawfully placed on the market before 1 June 2013 but that do not comply with the provisions of this Regulation, may continue to be marketed until stocks are exhausted.

The reductions in maximum levels mirror the reduced Acceptable Daily Intake (ADI) levels set by EFSA.. and are quite significant.

Several food products are affected. Regarding food supplements the new maximum levels are listed below:

FS supplied in a solid form

E104 from 300 mg/kg to 35 mg/kg
E110 from 300 mg/kg to 10 mg/kg
E124 from 300 mg/kg to 35 mg/kg

FS supplied in a liquid form

E104 from 100 mg/kg to 10 mg/kg
E110 from 100 mg/kg to 10 mg/kg
E124 from 100 mg/kg to 10 mg/kg

FS supplied in a syrup-type or chewable form

Maximum level for all of them is 10 mg/kg (previously not established).

Food businesses should be aware of the changes, and ensure their suppliers are also reformulating in line with the new specifications. It should be noted that in the United States the maximum levels for E110 are not affected (it can be used according to GMPs); E104 and E124 are not permitted in the United States.
– Sport Nutrition Team –


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

International Women’s Day

Oggi celebriamo la Festa delle Donne. A Hylobates, crediamo che le donne che lavorano sono essenziali per il nostro progresso. Antonella, Francesca, Lucilla e Sonia sono membri fondamentali del nostro team – nel lavoro scientifico, nel project management, nelle scienze cosmetiche, e nell’amministrazione. Senza di loro, Hylobates sarebbe un’azienda molto peggiore, ammesso che potesse esistere.

Sappiamo anche che le donne, comprese le madri tra loro, sono risorse straordinarie per le aziende, e creare le condizioni in cui possano lavorare bene – orari flessibili, telelavoro – non è un gesto per aiutare le donne, ma serve al successo della nostra azienda. Dobbiamo continuare a pensare a modi migliori e più efficaci perché possano lavorare con noi.

Tanti auguri a tutte!

http://www.who.int/mediacentre/events/annual/international_womens_day/en/index.html

 

Today we celebrate Women’s Day. At Hylo, we believe that working women are essential to our progress. Antonella, Francesca, Lucilla and Sonia are key members of our team – in science, project management, cosmetic sciences and administration. Hylobates would be a much worse company, if it existed at all, without them.

We are also aware that women, including mothers, are extraordinary resources for businesses, and that creating the conditions for them to work well – flexible schedules, tele-working – is not helping them, it’s helping our company. We need to keep thinking of new and better ways.

Best wishes to you all!

http://www.who.int/mediacentre/events/annual/international_womens_day/en/index.html

– Hylo’s Team –

Twitter-based food risk communication still evolving

Here at Hylo we are following with attention the development of social media-based food risk communication. For example we participate to the EC project FoodRisc. We have also made a preliminary analysis of factors that may affect food recall communication on Twitter. For example we have looked at factors potentially influencing official retweets of the UK FSA’s risk-related messages. We have also produced a simple diagram of two different communication styles, those of the UK FSA and of the USDA: USDA uses hashtags, while the UK FSA seems better at increasing the targeting of message to affected groups.

Luca Bucchini – 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 –

Focus on Astaxanthin antioxidant properties

Here’s a second post on health claims and oxidant properties. As commented earlier, EFSA is saying that an antioxidant property per se is not a health benefit, as long as it is not shown that there is a direct effect in the body, on proteins, DNA or lipids. EFSA also argues that only some markers have been validated to show this type of direct beneficial effect on the body’s antioxidant defence network. Astaxanthin is an interesting case-study caught in the middle. EFSA has rejected an application because ‘although astaxanthin has antioxidant properties in vitro, the human studies presented do not provide any evidence in support of an in vivo antioxidant effect in terms of lipid peroxidation following the consumption of astaxanthin’. A recent study, according to the authors, provided support to “benefical effects on the oxidative stress markers in overweight adults”. If we focus on markers, the authors have used: malondialdehyde (MDA), isoprostane (ISP), superoxide dismutase (SOD), and total antioxidant capacity (TAC). Changes in F2-isoprostanes (ISP) in 24-h urine samples in considered the gold standard as direct measurement of lipid peroxidation. TAC has not been evaluated by EFSA. MDA and SOD can be used as supportive evidence in addition to reliable in vivo techniques. The concept itself of “beneficial effects on oxidative stress markers” is rejected by EFSA; if there is no protection of macromolecules in the body, there is no benefit. Companies and scientists seeking to support health claims are warned. Of course science goes its own way.

Sport Nutrition Team

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.

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