Imagine that everything is almost ready. The first boxes are waiting in the warehouse, the online shop looks great, and the campaign is due to launch on Monday. Then a seemingly simple question arises: “Can we legally sell this product yet?”
Simply manufacturing the supplement is not the end of the story. You need to check the ingredients and the label, identify the responsible party, ensure the documentation is in order, fulfil health and safety obligations, and notify the Chief Sanitary Inspectorate (GIS). It’s not worth leaving this until the last week. A single disputed claim or ingredient could halt the printing of packaging and delay the launch.
So how do you launch a food supplement in Poland without getting bogged down in red tape? Let’s take this step-by-step approach, which helps to minimise amendments, delays and unnecessary costs.
1. First, work out exactly what your product is
A food supplement is a foodstuff, not a medicinal product. It is intended to supplement the diet and provide a concentrated source of vitamins, minerals or other substances with nutritional or physiological effects. This classification determines the next steps.
The problem arises when the composition, dosage, name or marketing suggest treatment, disease prevention or a pharmacological effect. A product labelled ‘capsules for depression’ will not become a legal food supplement simply by including the appropriate wording on the back of the packaging.
So, even before you start designing the label, you need to answer a few questions:
- Does the product meet the definition of a food supplement,
- Does its form allow for the consumption of measured, small portions,
- Does its composition and the way it is presented not make it more akin to a medicinal product,
- Isn’t this, in fact, a fortified food or another category of food?
An incorrect classification at the outset can render all the work carried out in subsequent stages invalid.
2. Check each ingredient before ordering your raw materials
A trendy ingredient does not necessarily mean one that can be used freely in a supplement. What matters is its legal status, chemical form, origin, purity, dosage, target audience and history of consumption within the European Union.
In the case of vitamins and minerals, only authorised substances and their forms must be used. For plant extracts, new raw materials or ingredients developed outside Europe, it is also necessary to check, amongst other things, the status of novel foods. The EU list may specify whether a particular ingredient is permitted in food supplements, for which groups, and in what quantities.
In practice, the verification of the formulation should include:
- the legality of each raw material and its specific form,
- the safety of the planned daily intake,
- restrictions relating to age, pregnancy, medication or other groups,
- required warnings,
- the possibility of using the planned statements,
- the conformity of the supplier’s specifications with the actual raw material.
This is the stage at which technology must align with food law. It is better to remove a problematic ingredient from the recipe file than to do so after ten thousand labels have been printed.
3. Determine who is responsible for the product
In contract manufacturing, it is easy to assume that the manufacturer is responsible for the paperwork. However, responsibility depends on the division of roles, the contracts and the information on the label.
It must be clearly established that:
- under whose name or brand the product is placed on the market,
- which entity will be named on the label as the responsible party,
- who submits a notification to the GIS,
- who approves the formulation and the label text,
- who keeps the batch records and test results,
- who handles complaints, product recalls or contact with the supervisory authority.
The manufacturer may prepare the formulation, documentation and application, but the brand should be aware of what has been submitted on its behalf and what responsibilities remain with it. ‘We thought another company was doing it’ is not a quality procedure.
4. Check whether the establishment is required to be registered with or approved by the Sanitary and Epidemiological Station
A company operating in the food sector may be required to have its premises entered in the State Sanitary Inspection register, or to have them approved and entered in the register. Storage, distribution, online sales and the organisation of operations are also important factors.
The application must be submitted to the relevant local state district health inspector. In accordance with information for business owners This must be done at least 14 days before the planned start of business operations. However, the correct procedure depends on what the company actually does and what infrastructure it uses.
If production and fulfilment are carried out by partners, one should not automatically assume that the brand has no obligations. The model must be assessed, taking into account the registered office, the warehouse, the shop and the flow of goods.
5. Put your documentation in order before the first inspection takes place
Compliance with the law does not end with a form. A company must demonstrate what the product is made of, who supplied the raw materials, how safety was verified, and where the batches were sent.
Well-organised documentation should include, amongst other things:
- approved formula and product specification,
- specifications and quality documents for raw materials,
- test results specific to the product and risk assessment,
- a sample of the approved label,
- identification of the batch and the best-before date,
- production documents and batch release,
- information enabling the traceability of consignments and consignees,
- complaints, product recalls and crisis communication procedures.
If a company stores, packages or distributes food, there are additional hygiene requirements, as well as HACCP-based procedures. It’s not about a ring binder that nobody will ever open. The documentation is meant to provide a quick answer: ‘Which packages are affected by the problem and where are they?’.
6. Create a label that both promotes sales and complies with the law
In a limited space, you need to combine the brand’s voice, its unique selling points and essential information — clearly, consistently and without misleading the consumer.
In accordance with detailed GIS requirements The supplement’s label should include, amongst other things:
- the term ‘food supplement’,
- the names of the categories of ingredients that characterise the product, or a description of their properties,
- recommended daily intake,
- a warning not to exceed it,
- a statement that the supplement must not be used as a substitute for a varied diet,
- a warning to keep out of reach of small children,
- the amounts of active ingredients in the recommended daily dose,
- the percentage of the reference intakes for vitamins and minerals, where applicable.
The labelling must also include the list of ingredients, allergens, net quantity, best-before date, storage conditions and details of the responsible operator. Products sold in Poland must be labelled in Polish.
It is best to check the label before finalising the design. This ensures that the mandatory text is not crammed in at the end in an illegible font.
7. Check each password separately, away from the packaging
The law doesn’t stop at the label. The same rules apply to product pages, adverts, newsletters, influencers and social media.
A supplement must not be claimed to prevent or treat any diseases. Phrases such as ‘for depression’, ‘antiviral’ or ‘treats inflammation’ can turn an appealing slogan into a serious problem. Permitted nutrition and health claims It may only be used once the relevant conditions have been met.
It is worth drawing up an approved set of messages for the team and partners. If the label refers to supporting the body’s normal functions, an influencer must not promise therapeutic results after a week.
8. Submit a notification to the GIS via e-Sanepid
A food supplement placed on the market in Poland for the first time must be notified to the Chief Sanitary Inspector. The form is submitted electronically at the e-Sanepid system.
The notification must include the name of the product and the manufacturer, the form of the product, its detailed composition and the labelling template in Polish. The details must correspond to the product. If there is a change to the composition, name or label, the impact on the previous notification must be checked.
A GIS notification does not constitute a marketing authorisation, a quality certificate or an approval of efficacy. The trader is responsible for compliance and safety. GIS may examine the notification, initiate proceedings and request further documentation.
Therefore, an entry in the public register will not rectify an unauthorised element or an incorrect advertisement. The submission should serve as a final confirmation of work already carried out, rather than an attempt to replace it with a form.
9. Prepare for online sales and packaging requirements
When selling food online, the mandatory food information — subject to the specified exceptions — should be available before the purchase is made. The front of the packaging alone is usually not sufficient. The description must correspond to the label and must not include any claims that are not included on the label.
You should also check Environmental responsibilities at BDO. An entity placing packaged products on the market may be subject to registration, record-keeping and reporting requirements. Who is considered the ‘placer on the market’ depends on the specific production and sales model; it is therefore advisable to clarify this issue before the first batch is produced.
The checklist should also include consumer procedures, the shop’s terms and conditions, the handling of returns and complaints, and the consistency of data displayed on marketplaces. Product and sales formalities come together in one place — when a customer places their first order.
10. Don’t leave compatibility until launch day
The safest process does not work like this: first we manufacture the product, and then we check whether everything complies. Verification should accompany the product from the initial formulation right through to the first advert.
In practice, the sequence of steps is as follows:
- product classification and verification of ingredients,
- identifying the responsible party and the division of responsibilities,
- verification of the requirements relating to the premises and operations,
- preparation of documentation and a research plan,
- design and verification of the label,
- approval of marketing communications,
- notification to the GIS via e-Sanepid,
- preparation for the launch, traceability and post-launch procedures.
Whilst this procedure does not eliminate all issues, it significantly reduces the risk that the finished product will have to be unpacked, relabelled or recalled just before launch.
The most common mistakes made when launching a supplement onto the market
It is usually not the complex regulations that cause the most problems, but rather rushing and assumptions that nobody has verified. Common mistakes include:
- treating a GIS notification as authorisation to sell,
- selecting a component based on a trend without checking its status,
- printing of packaging prior to label verification,
- copying statements from a competitor’s product,
- discrepancies between the label, the shop and the influencer’s advert,
- the lack of a clear division of responsibility with the manufacturer,
- inadequate traceability of batches,
- failure to register the business or to fulfil the BDO’s obligations.
Bureaucracy should not stand in the way of a good idea. Its purpose is to ensure that a product can be safely developed, marketed and scaled without constantly having to put out fires.
How does Pharma Dot support the launch of a dietary supplement?
At Pharma Dot, we view regulatory matters as part of product development, rather than a separate stage carried out just before launch. The formulation influences the label, the label influences communication, the packaging influences logistics, and the sales model influences the company’s obligations. All these decisions should be consistent with one another.
We support brands from refining their concept and selecting the right format, through product development, manufacturing and packaging, right through to preparation for sale and fulfilment. We also help to coordinate the documentation and activities required to launch the product successfully onto the market.
Do you have a concept ready but aren’t sure which formalities apply to your particular model? It’s worth checking these before you order your packaging. One good decision made at the outset can save you weeks of revisions before the launch.
FAQ – placing a food supplement on the market in Poland
Does a food supplement need to be registered with the GIS?
The supplement must be notified to the Chief Sanitary Inspectorate (GIS) upon its first placing on the market in Poland. However, this is not a registration or an authorisation procedure of the same nature as that for a medicinal product. Responsibility for compliance and safety remains with the business operator.
Do you have to wait for the supplement to be approved by the GIS?
The notification system does not function in the same way as the process for granting marketing authorisation for a medicinal product. You should therefore not expect to receive a certificate confirming the product’s efficacy. However, the Chief Sanitary Inspectorate (GIS) may examine the notification and conduct an investigation; for this reason, the product should be fully verified before it goes on sale.
Who submits a notification for a contract-manufactured supplement?
This depends on the agreed model and the division of responsibilities. The application may technically be prepared by the manufacturer or a consultant, but the entity placing the product on the market and responsible for the food information must be clearly identified.
Does the label on a supplement have to be in Polish?
Yes. Food placed on the market in Poland must be labelled in Polish. Other languages may also be used, provided that the mandatory information in Polish remains legible and consistent.
Is it permissible to advertise a supplement as a product ‘for a medical condition’?
No. The labelling, presentation and advertising of food must not attribute to it the ability to prevent or treat diseases. Only lawful nutrition and health claims may be used, provided that the conditions for their use are met.
