ES
EN
Brands that come to us with a vitamin project almost always assume it is the easy end of the catalogue. One active instead of eight, no flavour problem to solve, no texture to argue about. Compared with a pre-workout, they are right: the manufacturing is simpler.
Then the label turns out to be the hard part, and that reversal is what catches people out. In a sports formula you have wide latitude over the dose and a narrow set of things you can say. In a vitamin, what you are allowed to say is a closed list, and what it lets you say is what fixes the dose. Get that order wrong and you redo the formula after the artwork is finished, which is the expensive way round.
This is what actually changes when the product is a vitamin, in the order it comes up.
The regulatory frame is the same as any food supplement; the room for manoeuvre is not. Two closed lists govern a vitamin product: which vitamin and mineral sources may be used at all, and which claims may be printed and under what conditions. The second is the one that surprises brands, because a claim's conditions of use are what determine the dose — so the claims decision has to come before the formulation decision, not after. Everything else that differs (blend uniformity at microgram doses, stability of the declared amount across shelf life, and who files the market notification) follows from those two.
1. Two closed lists, and brands usually only know about one
Most brands arrive knowing that health claims are regulated. Fewer know that the ingredient itself is.
Which vitamins and minerals may be used in a food supplement, and in which chemical forms, is a closed list set out in the EU food supplement legislation — Directive 2002/46/EC, transposed in Spain by Royal Decree 1487/2009. You do not simply specify “vitamin D” or “B12” and leave the rest to the plant: you specify a permitted source of it, and that choice has consequences downstream for stability, for the format, and for whether the product can be positioned as suitable for a particular diet.
The second closed list is the one for claims:
- Nutrition claims — the “source of” and “high in” family — have their conditions set out in the Annex to Regulation (EC) 1924/2006, and they work off the nutrient reference values in Regulation (EU) 1169/2011.
- Health claims — anything that connects the nutrient to a function of the body — are prohibited unless authorised and listed, under the system Regulation (EU) 432/2012 established.
We are deliberately not reproducing the thresholds or the authorised wordings in this article. They are amended, and the operative source is the register entry itself on the day you sign off the artwork — not a blog post, ours included. Check the current entry and its conditions of use in the EU Register of nutrition and health claims and in the table of authorised claims published by AESAN, and always use the consolidated text of 432/2012, never the 2012 original, which has been amended since.
2. The claim decides the dose, not the other way round
This is the practical consequence, and it is worth stating on its own because it inverts the order most briefs are written in.
A brief usually arrives as: here is the dose we want, now tell us what we can say about it. For a vitamin, the useful order is the opposite: decide what the label has to be able to say, look up the conditions attached to that claim, and let those conditions set the floor for the dose. A formula built the other way round frequently lands just under the condition of a claim the brand had already designed its packaging around — and at that point you are either reprinting artwork or reformulating, and both cost more than the conversation would have.
It is the single question we ask first on a vitamin brief, and the one brands most often have not thought about: which claims does this label need to carry?
3. Vitamin D and B12 are the two most requested, and the two with the least slack
Between them they account for most of the vitamin enquiries that reach us, in own-brand and in private label alike. They are also the two where the point above bites hardest, because both are surrounded by entries in the register that carry their own conditions, and because both attract brands from adjacent markets — sports, wellness, plant-based, and the men’s and women’s health lines that are usually built around them.
Two things worth deciding early on either of them:
- The source, before the formula is fixed. If the product has to suit a particular diet or positioning, the permitted source you use is part of that decision and not a detail to settle at production. Changing it later changes the stability profile and can change the format.
- The market, or markets. A formula designed for one EU country is not automatically the right formula for another: the claim framework is EU-wide, but notification, language and some national requirements are not. Say up front where you intend to sell.
4. Formats: the active is a rounding error, and that changes the manufacturing
Vitamins are dosed in milligrams and micrograms. In a protein powder the active is the product; in a vitamin, the active is a fraction of a percent of what goes in the bottle. Everything else is carrier, and the engineering problem moves from taste and solubility to blend uniformity — every unit has to carry the declared amount, not an average of it.
That is what actually decides the format conversation:
- Powder in bottles, doypacks or single-serve sticks, when the vitamin sits inside a wider formula or a drink.
- Capsules and tablets, when the product is the vitamin itself and the dose is small — which is most of the time.
The formats we produce and the packaging that goes with them are on the contract manufacturing page. What we will tell you in the first conversation is whether the format you have in mind is a sensible vehicle for that particular active, because sometimes it is not.
5. The number on the label has to survive the shelf life
Vitamin content is not static: it declines over the life of the product, at a rate that depends on the source used, the format, the packaging and how the product is stored. So the amount you print is not the amount you blend — it is the amount the product has to still be carrying at the end of its declared shelf life.
Getting that right is a manufacturing decision, and it is made with stability data rather than with a rule of thumb. It is also a fair question to put to any manufacturer you are evaluating: ask what stability data supports the declared amount, and for how long. A manufacturer who has run the study will show you; one who has not will talk about overages in general terms. Our manufacturer capacity checklist covers what else is worth verifying before you sign.
6. Notification, and who actually files it
A food supplement cannot be placed on the market in Spain until it has been notified, and this is the step most first-time brands discover last.
The filing is regional, not national. When the operator responsible for placing the product on the market has its registered office in Spain, and the product is manufactured in Spain or comes from another EU country, the notification goes to the competent authority of the autonomous community — which then informs AESAN. It reaches AESAN directly in the other cases. It is subject to an administrative fee, and it has to be in before the first sale.
It is filed in the brand owner’s name, because the brand owner is the one placing the product on the market — the manufacturer prepares the dossier and supports the filing, but does not replace you in it. The full procedure is in our guide to food supplement registration and notification, and the entry point for the procedure itself is the electronic office for the consumer administration.
7. What to put in the brief
If you are about to request a quote for a vitamin product, these are the lines that make the reply useful rather than generic. They map onto the seven blocks in our guide to writing a manufacturing RFQ:
- The claims the label has to carry, in the words you intend to print. This is the one that saves the most time, and it is the one almost every brief omits.
- The market or markets you will sell into, and who will be the responsible operator.
- The format you have in mind, and whether that is fixed or open to advice.
- Any positioning constraint — a diet, a certification, a channel — that limits which permitted sources you can use.
- Whether you want private label or contract manufacturing: a catalogue formula that already carries validated claims, or your own formula, exclusive to you.
You do not need a finished formula to ask. You do need to know which claims the product has to be able to make, because that is the variable everything else is built around.
Working on a vitamin or mineral line? Tell us what the label has to say and where you intend to sell it, and we will tell you what is feasible before anything is formulated — request a quote or read how our contract manufacturing service works.
Frequently asked questions
What is vitamin contract manufacturing?
It is the service in which a manufacturer produces a vitamin or mineral supplement to your specification, under your brand, in its own facility. Two models exist: contract manufacturing (OEM), where the formula is yours and stays exclusive to you, and private label, where you launch on a formula the manufacturer already developed. For vitamins the choice matters more than for sports formulas, because the label conditions attached to a claim are what fix the dose — so if you take a catalogue formula you are also taking the claims it was designed to carry.
Can I decide the dose of vitamin D or B12 myself?
Not freely, and this is the single most common misunderstanding. Which vitamin and mineral sources may be used at all is a closed list in EU food supplement law, and any nutrition or health claim you intend to print carries its own conditions of use in the authorised register. In practice the claim you want determines the dose, not the other way round. That is why we ask which claims you intend to make before we formulate, and not after the artwork is designed.
Does the manufacturer file the notification, or do I?
The notification is filed in the name of the operator who places the product on the market, which is normally the brand owner rather than the manufacturer. We prepare the technical dossier and support the filing. In Spain the filing is regional rather than national: when the responsible operator has its registered office in Spain and the product is made in Spain or comes from another EU country, it goes to the competent authority of the autonomous community.
Which formats work for vitamins?
Powder in bottles, doypacks and single-serve sticks, capsules and tablets. The deciding factor is usually not preference but the amount of active: vitamins are dosed in milligrams or micrograms, so the active is a tiny fraction of the unit and blend uniformity carries more weight than it does in a protein powder, where the active is most of the mass. Tell us the format you have in mind and the market you sell into, and we will say whether it is the right vehicle for that formula.