€6m EU project tackles herbal supplement issues

02-Aug-2011 - Last updated on 03-Aug-2011 at 13:09 GMT

The project aims to increase knowledge for botanical decision makers

‘European Union project number 245199’ may provide some of the answers to the complex problem of regulating botanicals across the bloc with about 100 scientists, regulators and stakeholders working on the four-year, €6m project.

The projects’ basic aim, as its project manager Luca Bucchini told this publication today is to “increase knowledge to improve regulatory decisions about plant food supplements in the European Union” and other countries where botanical extracts and supplements derive from.

“With the changes that have come into play with the nutrition and health claims regulation (NHCR), from which botanicals are for now excluded and the Traditional Herbal Medicinal Products Directive (THMPD), there is a huge need for discussion and research and that is exactly what this project is all about,” he said.

Pillars of ‘245199’, or PlantLIBRA (Levels of Intake, Benefit and Risk Assessment), which kicked into life in June, 2010, include:

A survey of EU plant food supplement consumption
A systematic review of botanicals/plant food supplement scientific data
Developing new risk assessment methods
Developing a database where decision makers can access plant food supplement data

The project is convening a two-day meeting in Brussels in September that will have input from the US Food and Drug Administration (FDA) and the Chinese State Food and Drug Administration (SFDA) that will discuss some of these issues.

Bucchini noted that despite the harmonising intention of the EU regulations in the herbal sector, there were still many instances of individual actions such as member states establishing their own positive lists of accepted substances as had happened in Italy.

“There are many questions that remain for policy makers and scientists and industry stakeholder,” he said.

The project website stated:

Although the evidence on PFS is often incomplete and complex to evaluate, PFS are doubtless associated with biological effects, with both benefits and risks;
An as yet undetermined number of plant species can currently be used in the EU, mainly based on history of use. Compared with such a vast group of plants, very little, up-to-date scientific information on risks and benefits is available. Hence, decision-making, that needs to be made on a daily basis by authorities and food chain operators, may not be fully science-based;
To respond to the increasing demand for quality data to support decision making, adequate methodologies including vast, sustainable, immediately accessible databanks need to be made available to the authorities making decisions.

More information about the project can be found here.