According to the EBF, the European Food Standards Agency (EFSA) has issued health claims guidance that suggests the principles of the Passclaim project, which developed consensus criteria for the scientific substantiation of EU health claims, may be applied to article 14 health claims approval. This could require sizeable and expensive human studies to substantiate the health claims, which would be difficult for small and medium sized enterprises (SMEs) to carry out because of a lack of resources. Because EFSA has said it cannot apply different methods of assessment to article 13 and article 14 health claims, this would mean they would both be subject to strict testing. "We think they should be treated differently as there is quite a variation in the meaning of the two claims," Patrick Coppens, secretary general for the EBF told NutraIngredients.com. He added: "It should be possible to describe the effect in a way that 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." Article 13 health claims are those based on generally accepted scientific evidence, while article 14 health claims relate to the reduction of disease risk and children's development and health. Posing problems for SMEs Coppens explained that the botanical industry is mainly made up of SMEs "that have been making claims in accordance with national law for decades", and so the need for costly scientific studies could have a significant effect on the sector. "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," he added. He also said some sectors would suffer more than others, with the botanicals industry facing particular difficulties as the evidence required for Passclaim is not feasible. Claims such as camomile having a calming effect is well known by consumers, but has not been subject to substantial human studies, Coppens said. It is not yet certain whether EFSA will apply the strict procedures as no documents have been published, which the EBF says is another fault of the assessment body, as the idea should be open to public consultation.