Novel food status and maximum doses in Poland: what to check before launch

Why novel food status and maximum doses in Poland decide your launch

Novel food status and maximum doses in Poland are the two checks that most often force a foreign brand to change its formula. The EU harmonises many rules for food supplements: the permitted vitamins and minerals and their chemical forms (Directive 2002/46/EC), labelling (Regulation (EU) No 1169/2011) and claims (Regulation (EC) No 1924/2006). It also harmonises novel food. It does not harmonise maximum doses of vitamins and minerals, and it only partly covers other substances and plants.

The result is predictable. A product legal in its home market can:

• contain an ingredient that is a novel food in the EU and has never been authorised,
• contain an authorised novel food outside the specification or conditions of use set for it,
• use doses that Polish authorities consider too high for a food supplement,
• include a plant or substance that Polish practice treats with caution or considers medicinal.

Any of these can surface after the GIS notification, when GIS reviews the product. Our approach is to surface them before the label is printed.

Novel food under Regulation (EU) 2015/2283

A novel food is food that was not used for human consumption to a significant degree within the EU before 15 May 1997 and falls into one of the categories in Regulation (EU) 2015/2283. For supplements this typically catches new extracts, new sources of known nutrients, new production processes, isolated compounds and ingredients with a history of use only outside the EU.

Authorised novel foods are listed in the Union list (Implementing Regulation (EU) 2017/2470, regularly amended). Each entry carries a specification and conditions of use, which often include permitted food categories, maximum levels and labelling requirements. Being on the list is not enough: your ingredient must match the specification and your use must fit the conditions.

How to check status

• The Union list - the legally binding reference for authorised novel foods.
• The Novel Food Catalogue - a Commission tool that gives an orientation on the status of many plants and substances. It is not legally binding, but it shows how member states have viewed an ingredient.
• Evidence of use before 1997 - if an ingredient is not in either, you may need to show significant consumption in the EU before May 1997.
• Consultation on status - where it is unclear, an operator can request a consultation on novel food status from the competent authority of the member state where the product is first intended to be placed, following the procedure set out in EU implementing rules.

An unauthorised novel food cannot legally be placed on the market in any member state. There is no national workaround.

Maximum doses: not harmonised, so Poland has its own approach

Directive 2002/46/EC foresees EU maximum levels for vitamins and minerals in supplements, but they have never been adopted. Each member state therefore applies its own approach. In Poland, the reference point in practice is the work of the expert team for food supplements at GIS, which issues recommendations on maximum levels of vitamins and minerals and opinions on many other substances and plants.

These recommendations are what GIS uses when it reviews notifications. A dose above them is a common reason for explanatory proceedings. We do not quote specific numbers here, because they are updated and should always be checked against the current version before you decide on a formula.

A few patterns we see repeatedly:

• US-style high-dose formats of vitamins and minerals are often above Polish practice.
• Stacked products - a multivitamin plus added single nutrients - can exceed recommended levels in total even if each source looks moderate.
• Doses expressed in a different way - per capsule rather than per daily portion, or as the compound rather than the elemental mineral - hide the real number.

Botanicals and other substances

Plants and “other substances” (amino acids, enzymes, probiotics, carotenoids, plant compounds and so on) sit on a patchwork of rules. At EU level, Regulation (EC) No 1925/2006 allows certain substances to be prohibited, restricted or placed under scrutiny through its Annex III. Some well-known supplement ingredients are covered there, with restrictions or conditions.

In Poland, the expert team at GIS has also given opinions on plants and substances, including recommended doses and, for some ingredients, doubts about use in supplements at all. Plants with an established medicinal use, or substances with pharmacological activity, are the ones that most often draw attention.

For each botanical, document at least:

• the Latin name and the plant part used,
• the extract type, ratio and any standardisation,
• the daily amount of extract and of the marker compound,
• the status in the Novel Food Catalogue and any Annex III or national restrictions.

The last point also affects your health claims, since many botanical claims are on hold. See our guide to health claims.

What to do if your dose is higher than Polish practice

You have three realistic options. Which one fits depends on how central the dose is to your product's positioning.

In our experience, most foreign brands choose a Polish or EU-wide formula with doses aligned to local practice, because the alternative is uncertainty on the market's most important shelf.

How we check a formula in practice

Regulations tell you where to look. The work is in the detail of your specification, and most problems hide in three places.

• Ingredient naming. A trade name on a supplier's data sheet says nothing about status. We translate every ingredient into its chemical or botanical identity, source and production method before checking anything.
• Units and bases. Magnesium citrate is not magnesium. An extract at 500 mg is not 500 mg of the marker compound. Doses are compared per daily portion, in the unit used by the recommendation.
• Market comparison. Wellmade Intelligence monitors more than 200,000 products, and the GIS register gives composition data for notifications from 2020 onwards. Seeing how comparable Polish products are dosed tells us whether a formula sits in the normal range for its category or stands out.

The output is a simple traffic-light list for every ingredient. Green goes straight to label design. Amber goes to our food law firm with a specific question. Red goes back to you with options, which is covered in the table above. For brands from the UK and the US, amber and red items are common, as both markets allow ingredients and doses that the EU does not. We cover those cases in our guide to importing supplements from the UK and US.

Pre-launch checklist

1. Build a full specification - every ingredient, form, source and amount per daily portion.
2. Run the checks above and mark each ingredient green, amber or red.
3. Resolve amber items with a food law firm before touching the label.
4. Decide on red items: reformulate, reposition or drop.
5. Only then finalise the label and file the notification.

Our market entry report runs these checks on your formula and shows how competing products in Poland are dosed.