Suppliers of botanical products could be hit hard if scientists apply too strict criteria under the EU's Nutrition and Health Claims Regulation, according to the European Botanical Forum.
The EBF said that while the regulation said 'article 13' health claims — those which are based on generally accepted scientific evidence — should undergo a different type of assessment and authorisation to those relating to reduction of disease risk and children's development and health (known as 'article 14' claims), scientists at the European Food Safety Authority may not be intending to apply different assessment procedures.
Patrick Coppens, secretary General of the EBF, which is based in Brussels, Belgium, said that according to EFSA's guidance document it may be intending to apply an approach guided by the principles of the European Commission's Passclaim project, which sets out criteria for substantiating claims.
This could mean "substantial and expensive studies in humans" were required, said Coppens, and would therefore be problematic for small and medium-sized companies that might not have the resources to conduct such studies, hitting the botanicals sector particularly hard.
"Our sector is composed mainly of small and medium enterprises that have been making claims in accordance with national law for decades, on the basis of all evidence available. The strict application of Passclaim criteria would clearly prevent this and would in practice remove substantiated and long-standing claims and thus products from the market."
Coppens said that the regulation left room for elements other than scientific substantiation to be taken into account, such as evidence of traditional use and observational evidence, which in the case of many botanical ingredients was a legitimate factor to be considered.
"For botanicals, the level of evidence required by Passclaim is simply not available. This is recognised in medicinal law and we believe that EFSA should also consider this when assessing claims in relation to foodstuffs.
"It should be possible to describe the effect in a way the reflects the evidence available, and it is essential that the Commission's terms of references to EFSA expressly reflects the provisions of the regulation applicable to article 13 claims, in particular the need for a different type of assessment to those of article 14."
The European Commission's expert working group on claims will meet this month to further discuss the requirements for the assessment of article 13 health claims.