Adam Smith

Science and Communications Officer, ANH-Intl

KEY POINTS

  1. The European Union (EU) herbal product sector is in turmoil from the twin threats of the EU herbal Directive and health claims Regulation

  2. A new project, PlantLIBRA, aims to foster "science-based decision-making by regulators and food chain operators"

  3. The multi-pronged project will develop new methodologies, data and databases for use by regulators

  4. PlantLIBRA is an ambitious project, and ANH-Intl wishes it well

 

As even a casual reader of the ANH-Intl website cannot fail to observe, natural healthcare in the European Union (EU) is currently in turmoil. A range of EU legislation is rewriting the rulebook for all forms of natural healthcare, affecting everything from the products available in shops to the health claims permitted by product manufacturers and even practitioners. 

The herbal sector is feeling the pressure more than most. A new project, entitled PlantLIBRA – short for PLANT food supplements: Levels of Intake, Benefit and Risk Assessment – is attempting to shine the light of clarity on the herbal sector's problems. With the Traditional Herbal Medicinal Products Directive (THMPD) affecting herbal medicines sold over-the-counter, at the same time, the Nutrition and Health Claims Regulation (NHCR) is preparing to slap a gagging order on health claims for those botanical food supplements that remain. Although assessments of proposed health claims for botanicals has been delayed, we can expect an extremely narrow range of permitted claims if decisions made by the European Food Safety Authority (EFSA) so far are anything to go by.

An attempt to bring clarity

Central to much of the controversy over the THMPD is the issue of whether an herbal product is a botanical food supplement – in which case it is subject to the relatively light touch of food regulation – or an herbal medicine, which brings it under the THMPD's umbrella. More and more products that have previously been sold as food supplements are now being classified by regulators as herbal medicines, and are becoming illegal if their manufacturers cannot obtain a traditional use registration (TUR). PlantLIBRA "aims to foster the safe use of food supplements containing plants or botanical preparations, by increasing science-based decision-making by regulators and food chain operators". On paper, this sounds like a wonderful idea, since we continually see regulators taking many such decisions that have little or nothing to do with science! Furthermore, "PlantLIBRA is structured to develop, validate and disseminate data and methodologies for risk and benefit assessment and implement sustainable international cooperation. International cooperation is necessary to ensure the quality of the plants imported in the EU."

At present, many manufacturers, retailers, practitioners and consumers in the herbal sector are extremely confused about just where they stand in relation to the new regulation. We believe that the THMPD as it stands contains numerous and significant problems, and that the NHCR represents a massive threat to freedom of speech in natural healthcare. Both of these areas must be addressed if a fair and open market in herbal products is to be maintained in the EU. 

PlantLIBRA: composition and aims

The PlantLIBRA project began in June 2010 and represents a consortium from four continents, made up of 25 universities and public research institutions, small- and medium-sized enterprises (SMEs), industry and non-profit organisations.  The great majority of the consortium is drawn from EU Member States, plus interests from Argentina, Brazil, China and South Africa. Heading up the project are Dr Patrizia Restani of the University of Milan and Dr Luca Bucchini of Hylobates Consulting.

Dr Bucchini recently told Nutraingredients that PlantLIBRA aims to, "Increase knowledge to improve regulatory decisions about plant food supplements in the European Union...with the changes that have come into play with the [NHCR], from which botanicals are now excluded and the [THMPD], there is a huge need for discussion and research and that is exactly what this project is all about".

PlantLIBRA's objectives are organised into 'work packages', and include:

  • Surveying the current intake of plant botanical supplements in the EU

  • Risk and benefit assessment of botanical food supplements

  • Research into adverse effects of plants and botanical food supplements

  • Creation of a 'meta-database' of information on composition, biologically active compounds, safety information, residues and contaminants, which will be available to regulatory authorities

  • Development of new methods to investigate botanical food supplements and ingredients, and collection of new data to support the database, part of which will include setting up a network of laboratories

  • Determination of consumer and stakeholder perceptions of botanical food supplements

Time will tell

We cannot fault the aims of PlantLIBRA: if the regulators are going to make truly scientific judgments as to the benefits of plant food supplements – and indeed, whether products are medicines or food supplements in the first place – then the more objective data that they have to work from, the better. The project's organisers have set themselves a huge task, however, and we hope that reaching a consensus or compromise will not be hampered by the wide range of collaborating partners. We can only wish PlantLIBRA well, and cross our fingers for a positive result!

 

ANH Homepage

ANH THMPD legal challenge page

ANH Health Choice campaign page