Claims substantiation criteria too strict for SMEs says EBF

Scientists may be applying too strict criteria for the substantiation of article 13 health claims that will disadvantage small businesses, the European Botanical Forum (EBF) has said.

The EBF expressed concerns that while the EU claims regulation states article 13 health claims (which are based on generally accepted scientific evidence) should undergo a different type of assessment and authorisation to claims relating to reduction of disease risk and children’s development and health (article 14 claims), scientists at the European Food Safety Authority (EFSA) may not be intending to apply different assessment procedures.

Patrick Coppens, Secretary General of the EBF, said that according to EFSA’s guidance document it may be intending to apply an approach guided by the principles of the PASSCLAIM project which might require substantial and expensive studies in humans, and would therefore be problematic for small and medium enterprises (SMEs) who may not have the resources to conduct these studies.

Mr Coppens said: “There is no explicit reference requiring compliance with PASSCLAIM criteria in the legislation. The only requirement that is retained is that the totality of the evidence available should be taken into account and weighted. It was intended to simplify the approval of claims based on generally accepted scientific evidence, mainly used by SMEs who do not have the necessary resources to submit full applications under the authorisation procedures.”

He added: “Our sector is composed mainly of SMEs that have been making claims in accordance with national law for decades, on the basis 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.”

Mr Coppens said that the regulation leaves 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 is a legitimate factor to be considered.

He said: “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 early this month to further discuss the requirements for the assessment of article 13 health claims.


The European Botanical Forum aims to consolidate the efforts undertaken by national associations and individual companies to work to protect national systems currently in place, contribute to the creation of appropriate national systems where not currently in place, and build a pan-European system for the trade of herbs under food law.

For more information contact Patrick Coppens, European Botanical Forum, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0)2 209 11 50.

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