Following the most recent update, the Compendium of Botanicals now contains 2,701 plant species and 1,538 naturally occurring substances. An extensive search of the available scientific literature has been used to inform the database, which classifies whether certain plant species contain compounds which could be harmful to human health.
However, while the database is designed to help with safety assessments of botanical ingredients, EFSA states that it does not conclude whether a plant species is safe or unsafe to be used in dietary supplements.
Botanicals are listed regardless of their possible novel food status and, importantly, the list is not exhaustive. Indeed, the Compendium only includes botanicals appearing on a negative list or those subject to restricted use in at least one European Member State, meaning not all plants which contain substances of concern will be catalogued.
In addition, the Compendium also does not always account for the plant part (i.e. the root, leaf, seed or bark), the preparation method, or variability in compositions due to environmental factors, for instance. This means that while some botanical preparations may contain concentrated levels of harmful substances, others will not. It also does not address possible synergies or antagonisms with other ingredients.
The database therefore does not reflect a plant species’ safety or imply a risk to the consumer, raising questions about the usefulness of this tool for food business operators.
Informative or incomplete?
According to Katia Merten-Lentz, partner at Food Science & Law Partners, the Compendium “undoubtedly” helps food business operators (FBOs) to assess the safety of their ingredients made from botanicals.
“In this time of legal uncertainty surrounding botanicals – which might last some indefinite time – any kind of objective information related to safety is highly recommended,” she told NutraIngredients. “Based on this list, [FBOs] can have a first orientation regarding their innovation.”
However, Dr. Thomas Brendler, founder and CEO of botanical consultancy firm Plantaphile, said while the Compendium is a useful source of information for those who are not looking for an EFSA opinion, the information within the database can easily be ‘misconstrued’.
“My concern would be that some overzealous national competent authority could misconstrue the listing of a plant as it being ‘of concern’,” he told NutraIngredients. “Also, while it informs reasonably comprehensively, in terms of decision-making with regard to utility value and safety of a given botanical, it is less helpful than the national negative lists that it draws from. As it stands, one could derive fennel being of concern.”
Food regulatory expert Luca Bucchini agreed, adding that the data can easily be misinterpreted, leading formulators to avoid utilizing potentially useful or novel plant compounds.
“The compendium has its uses,” he told NI. “Many experts in the industry check it for information to guide internal risk assessments. The data, including the new QSAR prediction, are helpful for experts, but the data need advanced competence for interpretation and can be easily misunderstood, or need confirmation.”
“For example, one manufacturer could look up a plant, find that it contains a substance for which there is some concern, and request testing or avoid the plant when formulating. An in-depth assessment of the data may reveal that the substance has been recorded in an equivocal study, or in plant parts that are not relevant,” he added.
‘Better guidance’ needed
The key issue, according to Bucchini, is that there is no tool to assess the safety of botanical ingredients beyond this database. EFSA’s database simply highlights data from scientific literature, but as pointed out in the many disclaimers that come with the Compendium, it cannot guarantee any certainties about the safety of individual plant species.
“EFSA has not developed a method for assessing the safety of botanicals – unlike EMA for herbal medicines – which enjoys, in principle, the trust of stakeholders,” Bucchini said. “EFSA tried to develop such a method when the late Vittorio Silano was chair of the scientific committee, but momentum passed.”
Bucchini says clearer guidance is therefore necessary to give food business operators greater clarity over the safety of botanical ingredients, with the database serving more as a starting point than a provider of any definitive answers.
“Overall, it’s good that EFSA has kept the Compendium alive and updated, but better guidance is needed,” he said. “The scientific issues for botanicals in food supplements are only addressed by this re-making of the Compendium in a very limited manner.”