World’s biggest study of food allergies gets underway

7_Allergy_FoodsHylobates is one of the SME participants of the world’s biggest ever study of allergies known as the Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) which officially got underway on 19 March. The €9million project spearheaded by the University of Manchester builds on an earlier €14.3 million research study and will involve the worlds leading experts in the UK, Europe, Australia and US. The parting point is the lack of evidence to either prevent food allergy developing or protect adequately those who are already allergic. The 38 partners iFAAM consortium will produce a standardised management process for food manufacturing companies and will also develop tools designed to enforce these regulations and produce evidence-based knowledge to inform new health advice on nutrition for pregnant women, babies and allergy sufferers.

Up to 20 million European citizens suffer from food allergy which may be triggered by a list of foods including milk, egg, peanuts, soya, wheat, tree nuts, mustard, lupin, fish, crustacean and molluscan shell fish and celery which have to be labelled irrespective of the level at which they are included in a recipe. However, management of food allergens that accidently find their way into foods which might otherwise be free of allergen, for example through the use of common processing equipment, remains problematic and often gives rise to precautionary “may contain” labels.

Professor Clare Mills, from the Allergy and Respiratory Centre of The University of Manchester’s Institute of Inflammation and Repair and based in the Manchester Institute of Biotechnology, will head the study. Professor Mills said: “This is a massive research project which will have far reaching consequences for consumers and food producers. The evidence base and tools that result from this will support more transparent precautionary “may contain” labelling of allergens in foods which will make life easier for allergy sufferers as they try to avoid problem foods.”

Sue Hattersley, Head of the UK Food Standard’s Agency’s Allergy Branch said: “We anticipate that the information learned through iFAAM will help determine a more consistent approach to providing consumers with information, so they can make safe choices about the food they eat. Furthermore it will provide a greater insight into the development of food allergies. From an industry and regulatory perspective, it is expected that the results of the project will provide more guidance on the management of food allergens.”

New risk models will be built on pre-existing clinical data sets to support management of these allergens in a factory environment to minimise the use of such labels. Luca Bucchini, manager director of iFAAM partner Hylobates Consulting which will contribute to contamination modelling and in disseminating risk analysis methods to food industry and SMEs, said: “Managing food allergens is still a challenge for many food businesses, particularly smaller SMEs.  Better tools can benefit consumers with food allergies, including children.”

Other researchers will look at tools to measure allergens in food to allow validation and monitoring of allergen management plans. Other strands of the three year project will seek to predict who is likely to suffer a severe reaction, identify whether early introduction of allergenic foods and other nutritional factors may be protective against development of allergies later on in life.


Hylo’s Research Team

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BRAMA Kick-off meeting

BRAMA  (contract no.12/2337)

Rome, 20-21 July 2012

The new 4 year project BRAMA- Botanicals Risk Assessment training in the Mediterranean Area, meet last Friday 21st of July in the center of Rome to have their kick-off meeting. The project composed of four organizations from Mediterranean countries will promote the mobility and exchanges of knowledge in the field of plant food supplements (PFS) through the training and professionalism of young people.

The project is a Cross-Border Cooperation (CBC) within the European Neighbourhood and Partnership Instrument (ENPI) Mediterranean Sea Basin Joint Operational Programme.Project manager Dr Luca Bucchini  of Hylobates Consulting Sr in Rome, Italy, welcomed partners and ENPI CBC MED officers, and emphasized the core goal of BRAMA which is to build up the competences and professional skills of young researchers, technicians and inspectors in the field of botanicals.

Partners had the chance to present their institution, their experience in the botanical field, and their role in the project. Partners had the chance to present their institution, their experience in the botanical field, and their role in the project. Hylobates Consulting Srl in Rome, Italy, will be conducting the project management and developing the courses and training in quality control and safety assessment of botanicals for both technicians of SME’s and inspectors of regulating authorities. Dr Hanem M. Awad of the National Research Centre (NRC) of Egypt, will be training two selected PhD students on state-of-the-art and novel methods in risk assessment practice of compounds with toxicological activity that can be present in botanicals. Within its modern technical and analytical laboratory facilities, Jordan partner       Alà Al-Subeihi of Aqaba International Laboratories – BEN HAYYAN will train students in applied research for developing physiologically based kinetic (PBK) models for bioactivation and detoxification of selected substances found in PFS. Added to this Mediterranean mix, Prof Anastassios Troganis, University of Ioannina in Greece, brings analytical chemistry research in the project for the comprehensive phytochemical analysis of botanicals, the chemical structure elucidation of compounds of interest, and the development of methods using NMR spectroscopy.

Besides  of training PhD students, BRAMA will train young technicians in quality assurance and safety assessment of botanicals for industry, particularly seeing to the needs of Small and Medium Enterprises. The young  professional counterpart are the inspectors and competent authority staff that will also be trained within modules specifically designed and structured

In addition, ENPI CBC MED officers explained the ENPI programme structure and objectives,  and guided the BRAMA partners with their questions of the financial aspects and rules for the effective implementation of the project.

In the last day of the meeting, project associate Dr Jacques Vervoort of Wagenigen University (NL), remarked that “we need to improve the capacities of young people. That is what BRAMA is about” as he explained the needs for the specialized PhD training courses to be prepared by the partners.

“The project BRAMA is implemented under the ENPI CBC Mediterranean Sea Basin Programme (www.enpicbcmed.eu), and is financed, for an amount of 1,53 million Euro, by the European Union through the European Neighbourhood and Partnership Instrument.

“The 2007-2013 ENPI CBC Mediterranean Sea Basin Programme is a multilateral Cross-Border Cooperation initiative funded by the European Neighbourhood and Partnership Instrument (ENPI). The Programme objective is to promote the sustainable and harmonious cooperation process at the Mediterranean Basin level by dealing with the common challenges and enhancing its endogenous potential. It finances cooperation projects as a contribution to the economic, social, environmental and cultural development of the Mediterranean region. The following 14 countries participate in the Programme: Cyprus, Egypt, France, Greece, Israel, Italy, Jordan, Lebanon, Malta, Palestinian Authority, Portugal, Spain, Syria, Tunisia. The Joint Managing Authority (JMA) is the Autonomous Region of Sardinia (Italy). Official Programme languages are Arabic, English and French.”

– BRAMA Project Management Team –

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 –


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.

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 –

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