After consultations with the European Food Safety Authority (EFSA), the EC concluded that an extract of these three herbal roots was safe for adults when added to food supplements at a maximum daily dose of 175 milligrams (mg).
“Taking into account the intended use and the request for authorisation is only intended for adults, food supplements containing an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) should be appropriately labelled,” the ruling instructed.
EFSA had previously concluded that the risk of allergic reaction to Angelica gigas Nakai was “not dissimilar to that associated with celery as both plants belong to the same botanical family (i.e. Apiaceae)”.
As celery is a food required to be labelled as an allergen under Regulation (EU) No 1169/2011 of the European Parliament and of the Council (6), the EC instructed that labelling must be “in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy”.
Naturalendo Tech application
The EC’s decision brings a successful end to Naturalendo Tech’s application and means the company’s ingredients shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.
On its website, it describes it’s product Estro-G100, as a herbal root extract that claims to relieve 10 out of 12 most common menopausal symptoms including hot flashes, night sweats, trouble sleeping, nervousness, depression, dizziness and joint and muscle pain.
Naturalendo Tech first made its request back in March 2014 for the extract to be placed on the market as a novel food ingredient.
In July of that year, Irish authorities issued its initial assessment report, in which it concluded that an extract of mixture of the three herbal roots met the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.
EFSA adopted ‘Scientific opinion on the safety of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as a novel food’ in September 2016.
The food authority reviewed its opinion in April 2017, where it reconfirmed the maximum daily dose of 175 mg as safe for adults.