EFSA backs broad brush botanical safety assessment

In a follow-up report to a 2009 document on Qualified Presumption of Safety (QPS), EFSA backed the approach, “that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing”.​

It was developed initially for assessing microorganism safety.

“Reiterative applications of the assessment scheme to related botanicals or different botanical preparations obtained from the same plant variety can allow a QPS status to be derived for specific groupings,”​ EFSA wrote.

But it noted there would be exceptions to the system, especially, “botanicals that may be presented in a wide variety of forms or whose morphology and chemical composition may be markedly affected by geographical and environmental factors, makes the possibility to establish QPS status at high taxonomic levels quite limited.”​

While these would need to be dealt with on a case-by-case basis, EFSA said the system was transparent and thorough.

“In addressing the mandate provided, the Committee also considered, within the overall context of the EFSA safety assessment strategy, the value of making the necessary pre-assessments and developing a list of botanicals and botanical preparations which could be presumed safe.”​

“This opinion shows that the pre-assessment of a very large number of botanicals and their preparations would be demanding of resources and time. Where use is likely to be restricted to sensory purposes, the QPS approach offers only limited advantages over the existing methodologies and may not be cost-effective in the short term.” ​

Step in the right direction, but where to now?​

Rome-based herbal expert, Luca Bucchini, managing director of Hylobates Consulting said the paper represented, “​a step forward towards science-based assessment of botanicals.”​

“The QPS is in essence a reasonable attempt to estimate safety with limited data, focusing on composition rather than new toxicological testing.”​

Bucchini said the opinion was a step forward from an inconclusive opinion​ the agency had delivered last year about yohimbe plant extracts.

“Contrary to the ambiguos yohimbe opinion, in this case EFSA's balanced pragmatism is to be praised, and should be welcomed by any forward-looking industry,”​ he said.

“With the scientific knowledge that we have today, assessments based on tradition alone are difficult to defend. The main question is whether the approach is going to be effective for the hundreds of botanicals which a recent consumer survey by the EU-backed PlantLIBRA project has found to be actually in use across the EU.”​

“It's difficult to say where the European Commission will go now; however, this process is a step in the right direction at a time when the inclusion of yohimbe among temporarily permitted botanicals could erode the credibility of EU as a regulator of plants in food supplements."​

Open enough?​

Patrick Coppens, director of scientific and regulatory affairs at Brussels-based industry group, Food Supplements Europe (FSE), said the QPS process should have been more open.

“It is a pity that EFSA has not opened this to a public consultation as they usually do with this kind of documents, but EFSA has indicated this is not a guidance document but a document for internal use.”​

“I am not surprised with the outcome given the wide variability that exist in botanicals, which is not comparable with microorganisms for which the QPS methodology has been established originally, but we still need to gather our comments, especially on the decision tree that is part of the document.”​

He said the group would do that in the coming weeks.

EFSA's QPS report is here​.