Start With the Framework

In the EU, a food not consumed to a significant degree before 15 May 1997 is a novel food and requires authorisation before it can be placed on the market. Authorised novel foods appear on a Union list, each entry setting out the food and its conditions of use.

For most concentrated botanical extracts the position is unresolved — the plant may be traditional, the concentrated preparation may not be, and a buyer has to work it out for their specification. Noni is different.

What Happened With Noni

Noni juice was authorised as a novel food in the EU, and noni preparations appear in the Union list of authorised novel foods with conditions of use attached.

This puts noni ahead of most of the botanical extract category, where nobody has been through the process at all.

That is a genuine commercial advantage for an EU-facing product — provided the material you buy is within the scope of what was authorised.

The Qualification That Matters

Novel food authorisations attach to defined preparations, produced in defined ways, for defined uses. They do not authorise a plant in the abstract.

The practical consequence for noni:

QuestionNot the same as
Is this preparation authorised?Is noni authorised?
Is this use within the conditions?Is noni a food?
Does my specification match the entry?Is my supplier reputable?

A spray-dried juice powder, a dried whole-fruit powder and a concentrated iridoid-standardised extract are technically different materials produced by different routes. It cannot be assumed that all three sit in the same place, or that any given intended use falls within the conditions attached.

What This Means Practically

Three things a buyer should do, in order:

  1. Establish exactly what preparation you are buying. "Noni extract" is not a sufficient description for this purpose. Juice powder? Fruit powder? Ratio extract? Marker-standardised?
  2. Have your regulatory reviewer read the current Union list entry against that description and your intended use and intake;
  3. Get the supplier's documentation to match — preparation type, process description, specification, all consistent with what the reviewer is assessing.

Step one is where suppliers can genuinely help or genuinely hinder, which is why we declare preparation type on every certificate rather than describing everything with one word.

Why We Will Not Just Tell You It Is Fine

It would be commercially easier to answer "yes, noni is authorised in the EU" and leave it there. It is also the answer most likely to cause a buyer real damage.

A supplier is not in a position to determine whether your product falls within an authorisation. We do not know your intended use, your intake levels, your finished-product category or your full formulation. A confident reassurance from us has no regulatory standing and would be relied upon by exactly the buyers least equipped to check it.

What we can do — accurately and usefully — is state precisely what the material is, supply the process and specification detail your reviewer needs, and tell you where the question actually sits.

Two Other Points Your Reviewer Will Raise

The hepatic question

Reports of liver effects associated with noni juice consumption have been examined by European food safety authorities on more than one occasion during the ingredient's regulatory history. The current authorisation framework and its conditions are the operative position. We mention it not to alarm but because a reviewer will encounter it, and it is better encountered in advance.

Potassium

Noni is potassium-rich. For products likely to reach consumers with renal impairment, or used at high daily intakes, this is a number the safety assessment will want. We report it on request.

Outside the EU

Other markets have their own frameworks and noni's position differs. India, several Asian markets and others treat the ingredient more straightforwardly. Market selection is a legitimate part of the strategy, and the EU is generally where the most homework is required.

What We Supply Your Reviewer

Tell us your market and intended use and we will supply the documentation set your review needs.