The company, which makes and markets products based on the tropically-sourced Morinda citrifolia or noni plant including beverages, beauty, and weight loss lines, has already received approval for its noni juice and its noni leaves under the bloc’s Novel Foods regulation.
The novel foods approval decision of 21 April published in the Journal of the European Union states that: “…On the basis of the scientific assessment, it is established that the fruit puree and concentrate from Morinda citrifolia (Noni) complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.”
Europe's Novel Foods regulation was introduced in 1997 and requires any food or ingredient not commonly consumed in the EU prior to May 1997 to undergo safety assessment before it can be sold across the EU's 27-member bloc.
It is a notoriously long-winded and unpopular process that has been much criticised by industry for stalling innovation, but the European Commission has mooted that it will be simplified or streamlined or both.
Tahitian Noni said that this latest approval took four years to complete following on from the original application it filed with the EU authorities in 2006.
“This has been a long process but in the meantime the company has strengthened its position in the market with its flagship noni beverage products,” said a spokeswoman for the manufacturer who said that the first approval for the company’s noni juice opened up a completely new market for both Tahitian Noni and its competitors.
She said that with the third Novel Food approval the company has now covered all its food categories relevant for noni products to maintain a sustainable and competitive business.
The noni puree and concentrate ingredients, as a result of this approval, can now be formulated for use in confectionery, powdered nutritional drink mixes, carbonated beverages, ice cream and sorbet, biscuits, buns, cakes and pastries, as well as whole grain breakfast cereal, jams and jellies, sweet spreads, fillings and icings, and savoury sauces, pickles, gravies, and condiments.
The spokeswoman told this publication that noni can be used in such a wide range of foodstuffs due to adaptogenic properties.
She added that several human clinical studies have shown beneficial effects of the fruit on the immune and cardiovascular systems, as well as demonstrating its cholesterol-lowering potential: “Whilst the fruit is known to have a strong antioxidant activity, as well as the leaves, the seeds are high in linoleic acid."
According to the company’s novel foods application, the quantity of noni fruit puree or noni juice concentrate to be included in products will be equivalent to 30 mL of Morinda citrifolia fruit juice per serving.
In March last year, in a scientific opinion, the European Food Safety Authority (EFSA)’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found the Morinda citrifolia noni fruit puree and concentrate under those specified conditions had no safety issues.
According to the EFSA opinion, noni fruit puree will be manufactured in the same way as the juice version, while the noni fruit concentrate will also be made directly from noni fruit puree and the process is “not expected to result in qualitative or quantitative compositional changes which might be of toxicological or nutritional relevance.”
Some adverse effects have been reported over the consumption of noni juice but the Panel stated that the available data “are not sufficient to establish a causal relationship between the consumption of noni juice and hepatoxicity.”
However, the NDA’s opinion also stated that the increasing number of case reports might indicate that some individuals have a particular sensitivity for hepatotoxic effects to noni fruit products.
Meanwhile, Tahitian Noni, which markets its products through its own online and offline channels, said that it is set to begin a market-by-market product launch of its Bioactive noni beverage range in Europe at the end of May.