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 –

Hylobates presents the PlantLIBRA Project in the journal Food & Function

Authors from Hylobates and the University of Milan explain the goals of the EC-funded project PlantLIBRA in the recently published online paper of the journal Food & Function: “The PlantLIBRA Project: how we intend to innovate the science of botanicals” by Luca Bucchini, Alejandro Rodarte and Patrizia Restani

The paper presents the consortium’s plan for improving the science of botanicals and risk and benefit assessment methodologies for plant food supplements (PFS). In this 4 year project, partners are working to expand and generate knowledge on PFS through systematic reviews, intake surveys, new studies on benefits, risks and new analytical findings to ultimately ensure a safer use of PFS by consumers. By doing so, they plan to address data, methodology and consensus gaps in cooperation with different stakeholders and decision makers in the PFS sector.

– Alejandro Rodarte  –

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.

Hylo and PlantLIBRA partners present proposal of risk-benefit approach for plant in food supplements

Hylobates scientist Dr. Antonella Guzzon presented the proposal of risk-benefit approach for plant in food supplements during PlantLIBRA’s first Policy Advisory Board (PAB) meeting in Brussels from the 27th to the 28th of September.  In this event, project partners discussed with policy regulators on the approaches to facilitate science-based decision-making in this area. Dr. Guzzon presented the approach in progress which, based on existing approaches for risk- benefit assessment, proposes to develop a framework for assessing the strength, consistency and biological plausibility of the evidence of the benefits and risks plant food supplements. Within this framework, to each kind of evidence (in vivo evidence, tradition of use, animal and human evidence) related to a specific claimed effect for a certain plant food supplement a category (from convincing evidence to insufficient) would be as attributed.  This should enable the risk assessor to make a statement on the result of the risk-benefit assessment, i.e. whether risks or benefits are dominating, explained Dr. Guzzon. Additionally, the model considers prior beliefs on the existing scientific knowledge on the botanical and how new studies and data can change those prior beliefs. Finally, in order to make the process transparent, all these steps will clearly described, In this sense an open web source accessible to everybody and therefore exposed to open criticism, will be used to develop the model for risk-benefit assessment of plant food supplements.

  The PlantLIBRA Management Team

Time for work exchange at Hylobates Consulting

Hylobates Consulting has just hosted Liesbeth Dewitt, one of the scientists from the University of Surrey, Food, Consumer Behaviour and Health Department , UK working  in the framework of the EU network of excellence EURRECA which has as goal the alignment of the micronutrients recommendations across Europe.  Liesbeth has spent a whole week at Hylobates and I had the chance to work with her on the results of the qualitative interviews with experts in the vitamin D, folate and iodine policies carried out in 10 European countries, including Italy. Liesbeth and I have had very fruitful “scientific conversations”, we did some brainstorming on the highlights of the interviews  in the perspective of the article to be published in a scientific journal that will result from the qualitative research. Liesbeth is now doing the hard job of writing up the whole paper.

 

Antonella Guzzon-Research Team

Hylobates’ director interviewed on the origins of PlantLIBRA and the botanicals meta-database

PlantLIBRA International Innovation Article

In the new issue of International Innovation, Patrizia Restani, PlantLIBRA‘s coordinator, Patrick Coppens, from the European Botanical Forum  and Hylobates’ Luca Bucchini tell about the PlantLIBRA project. As project manager, Luca recounts the origins of the project proposal and one of its key concepts, the botanicals and Plant Food Supplement database. The issue can be accessd on line. The article can also be downloaded, p84-86_PlantLIBRA

– The PlantLIBRA Management Team –

Thinking ahead for the PlantLIBRA project.

After a intensive work week at the PlantLIBRA project meeting in Brasov in the middle of May, the Project Management Team has recharged energies, is taking actions in the project organization, and is planning the next steps of work.

This last meeting has given all of us the chance to reflect and to learn from all the events and outcomes of this international event, and given us helpful insights to even start planning the project’s next meeting in one year. This second project meeting  has provided us with the valuable opportunity to meet our partners, many for the first time in person since the beginning of the project. We exchanged views on plant food supplements, and shared ideas and enthusiasm about the work we are carrying on. The lessons of this first year has made us aware of achievements and problems areas to prepare us for the next work period.

A special acknowledgment for the kind and well appreciated organization and hospitality goes to PlantLIBRA partners of  the University of Transilvania, Dr Mihaela Badea and Monica Florescu, who have provided their constant support and efforts during the whole Project meeting.

Sonia Rebustini, PlantLIBRA Management Team

PlantLIBRA’s 2nd Project Meeting in Brasov, Romania, concluded last week

Thanks to the help of the Transilvania University  of Brasov and with the Coordinator, the University of Milan, Hylobates Consulting managed the practical organization the PlantLIBRA’s 2nd  Project Meeting in Brasov, Romania, which ended last week. This meeting is the culminating point of each year to hear from individual partners and work groups on their achieved results on the topic of plant food supplements.

From 17 to 20 May PlantLIBRA partners from 25 institutes and companies traveled from Bucharest to Brasov through beautiful landscapes of mixed forest and high mountains of the Transylvanian alps to meet and assess project progress.

Some programme highlights were:

•   Presentation of the 1st  year results by each working group (work package)

•   Internal work package meetings

•   Project dissemination events with local authorities and journalists

•   Presentations and dialogue with policy advisors active  in the field of plant food supplements

•   Workshop with  stakeholders representing manufactures and associations of the plant food supplement sector

Among some of the project objectives, results were presented going from the activities for building a meta-database with compositional and toxicological values of botanicals, the multinational surveys on intake and consumption of plant food supplements, to the risk benefit assessment of this product category,

Along with the scientific presentations, we learned as well from national authorities from Romania, Hungary, Italy, Belgium and Germany on the specific requirements for policy and legislation of plant food supplements.

More information on PlantLIBRA on:

http://www.plantlibra.eu/web/

Alejandro Rodarte, PlantLibra managment team

Hylobates’ PlantLIBRA Management Team helps set up forum for dialogue between PlantLIBRA and stakeholders

During its project meeting in Brasov, Romania, PlantLIBRA’s management team based at Hylobates is organizing and inviting participants and interest groups to its workshop:

“Stakeholders in the plant supplement sector-  A needed cooperation “

Considering the varied perceptions and regulations concerning plants supplements within Europe and internationally, the close cooperation between stakeholders, policy makers, consumers, and scientists is essential. The latter to promote sound technological innovation, as well as harmonization of procedures and communication of scientific findings.

Through this workshop PlantLIBRA’s participants will meet and hear from stakeholders of the European plant supplement industry, government and other special groups, and discuss actual issues and needs of the sector. By doing so we seek their valuable feedback on how to redirect our efforts and therefore project’s results for a better interface between industry, science and policy.

Join us on 18th May.

Update on May 13: program available at this link PlantLIBRA Stakeholder Workshop Programme

– Alejandro David Rodarte,  PlantLIBRA Management Team –

Hylobates investigates the experts’ opinion on micronutrients policies for EURRECA, an EU Network of Excellence

Hylobates Consulting is a partner of EURRECA, a Network of Excellence funded by the European Commission which has the goal to produce harmonised scientific guidelines for micronutrient (vitamins & minerals) recommendations. EURRECA is developing and applying tools that will help EFSA, as well as any organisation charged with developing and revising nutrient recommendations. The consortium is composed of scientists, representatives of nutrient requirement setting bodies, consumer organisations, small & medium-sized enterprises and wider stakeholders from across Europe.

To date,  published values of nutrient recommendations show a wide variation among European countries despite the physiological requirements of the different populations are very similar. The reasons for this variation may be found in differences in the concepts and sets of terminology used to express these recommendations, the nutritional status indicators and/or health indicators used by scientific experts to determine adequate intake, the types of studies and references used, etc. Nevertheless, these differences at national level might generate confusion for policy-makers, health professionals, food industry and consumers. This is the reason why harmonised recommendations are needed.

EURRECA has carried out a research across several populations groups to identify the nutrients for whom there is an urgent need of review of their recommended intake. Ten micronutrients have been identified, i.e. vitamin D, iron, folate, vitamin B12, zinc, calcium, vitamin C, selenium, iodine and copper.

Three are the key objectives of EURRECA:

1. Deliver an aligned set of standards providing a robust scientific basis for establishing micronutrient requirements and for devising micronutrient recommendations.

2. Focus on the needs of specific vulnerable groups: infants, children and adolescents, adults, pregnant and lactating women, elderly, people with low income and immigrants.

3. Evaluate the impact of socio-economic status, ethnic origin, inter-individual variability and vulnerability due to genetics, environmental factors and epigenetic phenomena.

As member of the consortium, Hylobates Consulting has recently carried out in Italy a set on interviews with experts on folate, iodine and vitamine D on the relevant nutrition policy. The aim of the interviews was to address the policy decision making process related to these micronutrients (background abstract material is available here) by investigating the assumptions in the process of policy formulation, the evidence involved and consideration of stakeholders and consumers in the process of policy making. Results of the interviews from Italy, together with those of the interviews from the other countries participating to the task, will contribute altogether to the development of a tool which will aid policy makers in developing policies based on aligned micronutrient recommendations.

Antonella

Hylobates Science

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