Botanical Claims in the EU: Why the List Is Still Pending

Vitamin and mineral claims in the EU have, for the most part, already been through a full assessment and either cleared or been rejected; a brand owner working with those ingredients knows, category by category, what wording is available. Botanical ingredients are a different story. A large share of botanical health claims submitted years ago are still sitting in an unresolved, on-hold position, neither approved nor rejected, and brand owners building a botanical-led range need to plan around that uncertainty rather than assume it will resolve on their timeline.

This is not a reflection on any specific plant ingredient's quality or your formulation choices, it is simply where the wider assessment process for botanicals currently stands. A brand owner who understands this going in makes very different, and safer, marketing decisions than one who discovers it after artwork is already at the printer.

This distinction matters commercially too. A brand owner comparing a vitamin-led range to a botanical-led one is not comparing two equally settled categories, they are comparing a category with a known answer to one still working through assessment. Building a launch plan that assumes the same certainty in both is where the mismatch starts.

This does not mean botanicals are a weaker commercial category, only a differently paced one. Brand owners who plan around the pace, rather than fight it, tend to build ranges that survive scrutiny rather than ranges that need reworking a year after launch.

A claim sitting in the on-hold category is not the same as a claim that has been approved with conditions, and it is not the same as a claim that has been rejected outright. In practice, this leaves a wide grey area where enforcement approaches differ by market, and where a form of words that reads fine to a marketing team may not hold up to a regulatory review in every destination country.

Some brand owners read pending as probably fine, since nothing has been rejected. That reading carries real risk: an unresolved assessment is not a green light, and a market's authorities can act on a claim they consider unsupported regardless of where it currently sits in the wider EU process.

It is also worth noting that the on-hold position is not unique to one or two ingredients, it covers a wide swathe of the botanical category. A brand owner should not read a specific plant ingredient's pending status as a signal about that ingredient in particular, it reflects where the wider assessment work currently stands across the category as a whole.

Because the botanical claims landscape is unsettled, the steadier commercial position is to lean on what a botanical ingredient genuinely is, its traditional use, its category positioning, its place in a wider formula, rather than on an outcome-based promise that has not cleared assessment. A brand can build a strong botanical story around ingredient sourcing, format and formulation choices without needing to promise a specific result.

This is also why this programme's own product and ingredient copy avoids outcome-based wording for botanical actives: describing what an ingredient is, and how a brand can position it, is a very different exercise from claiming what it does for the person taking it.

A related discipline: keep botanical positioning language separate from any wording that implies a tested or proven outcome, even informally, in places outside the printed label, such as a product page or a social post. The pending status applies to the claim, not to the format it is delivered in.

A simple internal rule helps here: if a piece of marketing copy would need a citation to justify it, treat it as outcome language and route it past your regulatory advisor before it goes anywhere near a shopper, on-pack or off.

A practical approach many brand owners take is to build the emotional and positioning work of a botanical range, name, story, packaging, target shopper, around the ingredient's category and heritage, and leave outcome language to a regulatory advisor's sign-off closer to launch, once your specific ingredient combination and destination markets are confirmed.

Treat your botanical actives list as a moving part of the brief for as long as possible. If your advisor flags a wording risk on one ingredient, that should be a formulation-stage conversation with your manufacturer, not a reprint after the range is already on shelf.

Sourcing and traceability information is a genuinely strong, low-risk substitute for outcome language in the meantime. Brand owners can say a great deal about where a botanical ingredient comes from, how it is standardised, and why it was chosen for a formula, without saying what it does once someone takes it.

A manufacturer can tell you what botanical actives sit in the current catalogue, how they behave across formats, gummies, sachets, oral strips and beyond, and how a formula built around them holds up in production. What a manufacturer cannot tell you is whether a specific claim about that botanical will survive scrutiny in a specific market; that judgement sits with your regulatory advisor, working from the current, market-specific state of the assessment.

Compliance ownership for botanical claims sits with the brand owner in exactly the same way it does for any other ingredient category, the pending status simply raises the stakes of getting that ownership right before print, not after.

This is also where format flexibility helps rather than hinders: the same botanical active can often sit in more than one format, gummies, sachets, capsules, without changing its regulatory position. If one format's positioning feels riskier than another for a given market, that is worth raising with your manufacturer before committing to a single format across the whole range.

This same conversation is worth having before you commit to a specific supplier lot or ingredient specification for a botanical active, since a change at that level can, in some cases, shift which claims category a formula sits in.

It is reasonable to keep an eye on whether the wider botanical assessment process moves forward, but it is not a sound launch strategy to hold marketing copy that only works if a pending claim clears in your favour. Build your range so it reads correctly under today's cautious position, and treat any future movement in the assessment as a bonus update to your marketing, not a plan you are relying on.

Brand owners who wait for full clarity before launching a botanical range are often waiting for something with no fixed date. A steadier approach is to launch on wording that is defensible now, and revisit copy if and when the landscape actually changes.

Keep this in proportion, too. Plenty of botanical ranges exist successfully inside today's cautious position; they are simply built on category and sourcing positioning rather than a promised outcome. That is a real commercial path, not a compromise waiting to be lifted once the assessment eventually resolves.

Bring your botanical actives, your target markets and your draft wording to your regulatory advisor as one package, before your label is finalised, not one ingredient at a time as an afterthought. A single review across the whole range catches inconsistencies a piecemeal check would miss, such as one SKU implying a claim that a sibling SKU in the same range avoids.

Keep a simple internal record of what was reviewed, when, and what your advisor said, ingredient by ingredient. If your assessment position changes later, that record is what lets you update quickly instead of re-checking the whole range from scratch.

If you are working across several EU markets at once, ask your advisor to flag whether any destination market applies its own, stricter local reading of the on-hold position. Enforcement approaches are not identical everywhere, and a wording choice that is comfortable in one country can still be worth reconsidering in another.

Revisit this review on a fixed schedule, not only when you happen to think of it. A range that launched clean two years ago can drift if new SKUs, flavours or markets were added without the same check being repeated.

A botanical range is entirely workable inside the EU's current, cautious position; it just requires treating the pending status as a planning input from day one, not a surprise discovered at proof stage. Bring your botanical shortlist and destination markets to your regulatory advisor early, and to your manufacturing brief once the wording is settled.

If you already know which botanical actives you want to build a range around, start a project brief so the formulation and format conversation can run alongside the compliance conversation, instead of waiting for one to finish before the other starts.

Whatever you decide, keep the decision documented and dated. A brand owner who can show a considered, advisor-reviewed choice is in a very different position from one who cannot explain why a piece of wording was on the label in the first place.