Frutarom becomes a bigger botanicals player with THMPD range

22-Apr-2014 - Last updated on 24-Apr-2014 at 08:04 GMT

Frutarom on the EU herbal situation: “The only real channel now is the THMPD..."

Related tags European union Directive

Swiss-Israeli supplier Frutarom has beefed up its botanical extracts in response to changing European Union laws for herbal products and medicines.

The fortification of its ‘EFLApharm‘ range is a response to the on-hold situation with about 1500 botanical applications under the EU nutrition and health claims regulation (NHCR) and the rise in importance of the EU Traditional Herbal Medicinal Products Directive (THMPD).

“The only real channel now is the THMPD,” Israeli-based Hadar Sutovsky, global manager of Pharma & OTC segment at Frutarom Health told us this morning.

“We have simplified the process for companies registering products with the THMPD. There has been a grey are in the pharma-food area – this is a response to that and we have funnelled our efforts to fot the regulatory environment.”

The EFLApharm range includes about 20 botanical extracts made to pharma GMP (Good Manufacturing Practices) standards and including Echinacea purpurea L. (purple coneflower), Hedera helix L. (common ivy), and Thymus vulgaris L. (thyme).

It also includes herbal flavours for use in pharma products.

Sutovsky said peace-of-mind around quality was something reputable suppliers needed to go out of their way to ensure so that, “the consumer can feel safe when they reach for the shelf.”

Frutarom was willing to collaborate with other players to drive quality forward and confront issues such as adulteration in botanicals, she said.

The on-hold situation with NHCR botanicals was not ideal, but supported the overall thrust of EU laws that promoted greater transparency and safety.

“We need to make it easy to see who is good and who isn’t. The laws are helping that.”

Frutarom sells its extracts to multiple herbal product manufacturers across the EU.

2 comments

Market access for herbal medicinal products

Posted by Hadar Sutovsky, 29 April 2014 - 12:35 GMT

Today under European medicines legislation, medicinal products containing herbal substances/preparations must fall within one of the following three categories to reach the market:

A. a product can be classified under traditional medicinal use provisions (‘traditional use’) accepted on the basis of sufficient safety data and plausible efficacy
B. a product can be classified under well-established medicinal use provisions (‘well-established use’).
C. a product can be authorised after evaluation of a marketing authorisation application consisting of only safety and efficacy data from the company’s own development (‘stand alone’) or a combination of own studies and bibliographic data (‘mixed application’). As a result the product is granted a marketing authorisation by a Member State or by the Agency via the centralised procedure if all requirements are met.

Irrespective of the regulatory pathway to access the market, the quality of the herbal medicinal product must always be demonstrated.

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Nearly 1/3 of THMP stems from spices or culinary herbs

Posted by Dr Vaclav Bazata, 28 April 2014 - 14:45 GMT

Traditional food use (25 years within EU) is evident from the classification of 165 THMP items, where 27% (45) of it has food or food additive history and in the in light of this there is no background there for usable decision criterion for borderline products.