On-hold botanical health claims: formulating when the claim isn't settled

The EU's botanical health claim situation is a regulatory limbo that has lasted over a decade. A large set of claims related to plant substances was suspended into an "on-hold" list, and those claims may still be used under the responsibility of the business operator while a final decision is pending. For a manufacturer, that creates a peculiar formulation problem: you can make a claim that is neither approved nor rejected, and that could change at any time. Formulating responsibly inside that ambiguity is a tracking discipline. Here is how it works.

"On hold" is not "approved"

The crucial distinction is that an on-hold claim is permitted to be used, but is not authorized in the way a settled vitamin or mineral claim is. It rests on the operator's responsibility to ensure the product complies with the underlying claims regulation, and it carries the standing risk that a future decision tightens or removes it. A label built on on-hold claims is a label with a contingent liability attached — fine today, potentially non-compliant after a ruling.

The claim's status belongs on the ingredient

Managing this starts with treating claim status as data attached to the ingredient and the claim, not as marketing copy typed onto a label. Each botanical claim a product uses has a status — authorized, on-hold, rejected — and a manufacturer needs to know, per product, which claims are resting on the on-hold list. A formulation system that links claims to ingredients with their regulatory status makes the contingent claims visible across the catalog instead of buried in label artwork.

When a decision lands, you need the affected list fast

The value of tracking status shows the day a botanical's claims are finally decided. If a claim is rejected or restricted, every product using it needs its label — and sometimes its positioning — revisited. A system that can list "every product using this on-hold claim" turns the response into a defined task. Without it, the manufacturer is searching label files to reconstruct which products leaned on a claim that just disappeared.

Formulating with a fallback in mind

Because on-hold claims can vanish, the prudent approach is to know what the product is without the contingent claim. Does it still have an authorized claim to stand on — a vitamin or mineral contribution, for instance — if the botanical claim falls? Modelling all of a product's claims together, with their statuses, lets the manufacturer see which products are fragile (resting only on on-hold claims) and which are robust (backed by authorized ones too).

Substantiation is still your responsibility

Using a claim under operator responsibility means you carry the burden of compliance if challenged. Keeping the substantiation — the file, the evidence, the rationale — linked to the claim at the formula level means that if a question comes, the answer is attached to the product, not lost in someone's drive.

Because the status of on-hold botanical claims is unsettled and evolving, confirm the current EU position for your specific claims and products rather than relying on a general summary.

Where Lemoniq fits

Lemoniq links claims to ingredients with their regulatory status — authorized, on-hold, rejected — and their substantiation, so the contingent claims across a catalog are visible at a glance. When a decision lands, listing every affected product is one query, and each product's claim robustness is already modelled.

The takeaway

On-hold botanical claims let you say things that aren't settled — a useful freedom with a built-in liability. The manufacturers who use them safely are the ones who track claim status as data, know which products depend on them, and can respond to a final decision with a list instead of a search.

Lemoniq tracks claim status and substantiation per ingredient, so an unsettled claim never blindsides your label. We solve this exact problem. See how it works