Italy has legally adopted a harmonised list of about 1000 approved botanicals for use in food supplements, following a joint research effort with Belgium and France (BELFRIT).
Experts say the move could provoke further harmonisation of botanical products across the European Union’s 28 member states – even those which tend to classify them as medicines like the UK, Germany and the Nordic nations.
It was also likely to strengthen the implementation of ‘mutual recognition’, the European Union principle that a product authorised in one member state shall be permitted for sale in all.
The three countries have been working for years to finalise a list of safe herbals and Belgium quantified a version of the list in its law books in 2012. France is in the process of adding 500 from the list to its own legislature.
On its website , the Italian Ministry of Health said there would be a transition period for those herbals that did not make the list to sell through, and that the 1000-strong list was not definitive.
The Italian Ministry of Health said the list was based on, “current scientific evidence”.
“This list may still be updated with the inclusion of plants, including but not today admitted in at least one of the three countries.”
Christian Artaria, marketing director and head of functional food development at Italian herbal giant, Indena, backed the Italian initiative, even if it meant an eventual reduction in the approved list from the current 1200 to the 1000 on the BELFRIT list if companies cannot provide requested data for those ommitted..
“I believe this is a positive move,” Artaria told us.
“In the near future at least three very important supplement countries like Italy, France and Belgium will have a common list of authorised plants that will greatly facilitate the business in each country and between countries.”
“This is one of the pillars of the European Union, so we welcome this move in our sector.”
He said he hoped Italy’s move would lead to broader adoption across the EU.
Addition, recognition, resistance
Rome-based botanicals expert, member of the EU project, PlantLIBRA, and founder of Hylobates Consulting, Luca Bucchini, PhD, agreed the move was a positive one that would resonate across the EU.
“For companies, the Italian list likely to be seen as reference for speedy mutual recognition assessment,” he said.
“Some plants are added to the new Italian list, others may not be permitted as a consequence of harmonisation where experts did not identify sufficient data to back tradition of use.”
Examples there included maqui, goldenseal (permitted in Belgium) and muira puama.
He noted stakeholders are able to provide missing data and praised the transparency and inclusiveness of the Italian system.
“Companies are consulted before adoption of the new list so they can provide data on plants which may not be permitted in future.”
Of the mutual recognition principle that was not always followed in all member states, Bucchini noted, “Though member states try not to apply this fundamental EU law principle, they know they have to deal with it and that is why they would favour harmonisation. The challenge is which plants can stay on a shared list.”
He said the UK, Germany and Nordic countries remained the most resistant to a unified list as their traditional position was, “to classify many plants included in BELFRIT as medicinal only.”
Despite this, some German advisors to the European Commission have expressed support for the BELFRIT project and the impending Italian occupancy of the EU presidency could also play a role in change.
What kind of science?
But Bucchini warned of the same scientific predicament that had left more than 1500 botanical submissions on hold under the EU nutrition and health claims regulation.
“My view is a more science-based approach is needed for an agreement among all EU member states. The European Food Safety Authority (EFSA) may play positive role.”
He said a PlantLIBRA congress in Vienna, Austria, next month would discuss BELFRIT and other scientific and policy issues.
In Europe, botanicals are typically classified as either food supplements, medicines or under the EU Traditional Herbal Medicinal Products Directive (THMPD) depending on the country.