ECJ backs botanicals
This article was originally published in OTC Bulletin & The Rose Sheet
Executive Summary
The European Court of Justice (ECJ) has dismissed a case accusing the European Commission (EC) of a “failure to act” over the massively delayed list of health claims for botanicals.
The European Court of Justice (ECJ) has dismissed a case accusing the European Commission (EC) of a “failure to act” over the massively delayed list of health claims for botanicals.
It marks the second time the case – brought by the German firms Bionorica and Diapharm – has been rejected by the ECJ, with the court ruling in 2015 that the EC had acted on the delays and that neither Bionorica nor Diapharm had been harmed by the delays and thus had “no interest to act”.
However, the firms appealed the ruling and in April 2017, the case was returned to the ECJ by European Union (EU) advocate general Micka Bobek (OTC bulletin, 12 May 2017, page 12).
Having looked again at the case and finding that the EC had failed to act on the botanicals issue, the ECJ ruled that the case was inadmissible, believing that Bionorica had “no interest to act” as the company produced herbal supplements rather than food.
Responding to the ruling, Bionorica said it was a “defeat for customers and patients” as it did not end the 10 year delay on assessing health claims for botanicals.
The European Food Safety Authority (EFSA) evaluated and rejected around 500 Article 13(1) health claims for botanicals, which led to the Commission putting the work on hold back in 2010. While the EC announced a further “reflection” on the issue in the summer of 2012 (OTC bulletin, 10 August 2012, page 1), there has been no further action.
The problem was that botanical ingredients were being treated differently under the food claims regulation than they were under legislation covering traditional herbal medicines (OTC bulletin, 15 October 2010, page 1).
In response to the concerns, the EC announced in 2010 that the community list of permitted general health claims for foods would be established in two steps.
The list for all substances other than botanicals would be adopted in a single step, it explained, with claims for botanicals considered once the first step had been completed.
This has meant that while a list of 222 permitted health claims was agreed in 2012, evaluating 2,078 Article 13(1) general-function claims for botanicals has remained on hold.