EC clarifies Echinacea extract supplement use as novel food ingredient

The corrections come after the publication of Implementing Regulation (EU) 2017/2470, in which the Commission identified additional errors in the Annex of this directive.

“Corrections are needed in order to provide clarity and legal certainty to food business operators and to Member States' competent authorities, thus providing for the proper implementation and use of the Union list of novel foods,”​ says the document​​.​

“A correction of the designation and of the specific labelling requirement and a correction of the specifications of the Annex to Implementing Regulation (EU) 2017/2470 of the novel food Echinacea purpurea extract from cell cultures are therefore necessary.”​

Italy’s authorities ​

The source of the errors originate in Italy back in November 2018, where the country’s authorities made a request to the Commission for the correction to the Union list.

They specifically relate to the designation and labelling requirements of the novel food Echinacea purpurea​ extract from cell cultures.

Authorities had specified the name for the cell cultures as ‘HTN®Vb’ when the correct name was ‘EchiPure-PC’ in the designation of the novel food as listed in the Union list.

In realising the error, specific labelling requirement of foods containing the extract, as well as in the specifications of the novel food, also required amending.

Conditions under which the novel food may be used in food supplements now follows the definitions set out in Directive 2002/46/EC.

Maximum levels are now set to follow normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea.​

Additional labelling requirements of products that include the novel food must now state, “Dried extract of Echinacea purpurea from cell cultures EchiPure-PC.”​

Heavy metal units ​

The document also details yeast beta-glucan specifications in Implementing Decision (EU) 2017/2078, where heavy metal measurement units are in milligrams per gram (mg/g) instead of milligrams per kilogram (mg/kg).

The entries for Lead, Arsenic, Mercury and Cadmium in the Table Specifications of Yeast (Saccharomyces cerevisiae​) beta-glucans now states, ‘Lead - less than (<) 0.2 mg/kg,’ ‘Arsenic - < 0.2 mg/kg,’ ‘Mercury - < 0.1 mg/kg,’ ‘Cadmium - < 0.1 mg/kg.’

“This error was transferred in the Union list established by Implementing Regulation (EU) 2017/2470,”​ said the EC.

“Therefore, the specifications of the yeast beta-glucans relating to heavy metals should be corrected accordingly.”​