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 –

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ePlantLIBRA- A plant food supplement database filling in the information gaps for better regulation and safety

A new database of information on food ingredients will help clarify the fuzzy boundary between food supplements and herbal medicines across Europe” is the headline of a recent post of the Europe Research Media Center. In this article, Institute of Food Research (UK) scientist Paul FINGLAS explains the value of the database being developed and how it will pool together the existing knowledge on the beneficial and adverse effects of bioactive compounds in supplements. The database is one of the EU fundedPlantLIBRA project’s main outcomes and it will define a consistent set of references for bioactive ingredients for all member states, where presently the categorisation between plant food supplements and traditional herbal medicinal products varies between countries. This is particularly important for imported plant food supplements that need harmonized regulation to improve quality and consumer safety.

In this sense, PlantLIBRA is taking an appropriately broad strategy in analysing all relevant aspects of the research needs for the science and regulation of botanicals, such as intake and consumption patterns, supplement composition and analysis, and the evaluation of benefits and risks. Hylobates is one of the project partners currently working on the risk-benefit assessment of plant food supplements for an improved science-based decision making approach.

PlantLIBRA Management 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 –

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  –

Synephrine, octopamine: limits, doping and natural sourcing

According to Nutraingredients USA, Health Canada is going to revise its 2011 p-synephrine guideline increasing the daily amount “‘likely to cause any adverse health consequences’ from 30 mg per day to 50 mg per day. The 30 mg maximum allowable dose applied to the sum of p-synephrine and octopamine. Sources of the substance included Citrus species such as C. aurantium, as well as certain species of some other genera (e.g. Evodia rutaecarpa), and synthetic sources. A number of warnings and other conditions of use were identified by the 2011 guidelines.

A sample of similar EU guidelines indicates that Italy has a limit for synephrine, irregardless of chirality but requiring natural origin and sourcing from C. aurantium subps. amara, of 30 mg per day, and a mandatory warning measure has not been approved at EU level). UK’s MHRA states that synephrine is to be considered medicinal , and thus not allowed in supplements, though naturally present synephrine appears to be allowed in food supplements in the UK and elsewhere.

Synephrine is of particular interest (and concern) to segments of the sports nutrition and food supplement industry as it can be sourced naturally, though it also appears in the WADA list of doping substances. As a consequence, athletes cannot ingest products with synephrine and it has to be determined at country level whether  C. aurantium subps. amara with synephrine content are permitted under national law and practices. Warnings may be considered, again at national level, to inform athletes.

A similar situation occurs with octopamine, though allowed levels have not been set in most countries and it appears to be naturally present in very low levels.

More generally, in the EU context, the natural source of the extracts is of particular relevance, with synthetic versions normally clashing with the Novel Foods Regulation; this applies to extracts not only synephrine and octopamine, that are regulated under doping (if it exists) or medicinal legislation, but to dozens of other molecules. It is increasingly reported that substances presented as natural are in fact of synthetic origin, either because the substance is truly absent in the plant (an apparent case of scientific and technical fraud), because it is available in nature but in minute quantities, or because of costs. Companies should be aware of the difference betwen natural and synthetic, ensure that they have the skill to evaluate and test their supply, and recognize that analytical methods to discriminate between natural and synthetic are increasingly reliable and available to enforcement bodies.

– Sports Nutrition Team –

Plant food supplements market show increased sales in the US

An improved risk- benefit assessment of plant food supplements, as investigated in the project  PlantLIBRA (this part of the work is led by Hylobates and Dr. Antonella Guzzon as work package leader), is motivated not only by the needs of better science and regulation in this sector, but also by the clear sales increases worldwide. In 2010, for example, the plant food supplement, or with US terminology herbal dietary supplement (DS),  market in the USA increased by an estimated 3.3 percent in all channels of retail trade, as reported in the HerbalGram Herb Market Report of the American Botanical Council.

The robust growth in the herb market seen in recent years reflects the increasing consumer interest in good nutrition and natural lifestyles. The report discusses this growth and the complexity of doing total sales analysis of this segment. For instance, the degree of increase depends widely on the source of the sales information and the data collection parameters (inclusion of combination herbal dietary supplements with primary ingredients, for example). Sales growth data analysis from the Mainstream Food, Drug, and Mass Market (FDM) channel (drugstores, grocery stores, mass market retailers, et al., but not including Wal-Mart) is lower as when buyers’ clubs and convenience stores, including Wal-Mart, Sam’s Club, Costco, et al. are also considered in the FDM channel.

The report includes the 20-top- selling herbal dietary supplements in the Food, Drug, and Mass Market (FDM) channel in the United States in 2010. According to the authors, the list shows the trend of consumer interest in many relatively well known herbs due to a growing body of scientific and clinical research conducted on them. These include, as noted in order of ranking: cranberry, saw palmetto, garlic, ginkgo, echinacea, milk thistle, black cohosh, Asian ginseng, green tea, etc.

This ranking (see table below) also shows several plants that are investigated within PlantLIBRA´s different research groups, and reflect as well some trends in the European plant food supplement market.

– Alejandro Rodarte  –


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