Tomasz Krawczyk - EU Food Law Expert.
15+ years of experience in EU and Polish food regulations.

The authorisation process requires scientific substantiation assessed by EFSA. Currently, the EU Register (Reg 432/2012) contains approximately 240 authorised health claims for vitamins, minerals and other substances. Additionally, around 2,078 botanical claims remain "on hold" under the SANCO/11074/2013 list pending final assessment. Food business operators must use the exact wording from the Register and meet specific conditions of use (minimum doses, target populations).

The process is governed by the Polish Act on Food Safety and Nutrition (Art. 29). GIS reviews the notification and may raise objections if the product contains non-compliant ingredients, makes unauthorised health claims, or poses safety concerns. The notification does not constitute an "approval" - it is an informational obligation. Products from other EU Member States benefit from mutual recognition but must still be notified. Processing time varies but typically takes several weeks.

The Novel Food Catalogue maintained by the European Commission provides guidance on which ingredients are considered novel. Common examples include CBD extracts, certain exotic plant extracts, and new food production processes. The authorisation procedure involves submitting a safety dossier to EFSA, which conducts a risk assessment. The process typically takes 12-18 months. Unauthorised novel foods may not be marketed in the EU, and enforcement varies by Member State.

The requirement applies to all food products including food supplements, regardless of the country of origin. Multi-language labels are permitted as long as Polish is included. Additionally, for food supplements, the label must comply with the specific requirements of Directive 2002/46/EC as implemented in Polish law, including mandatory warnings and the statement "food supplement" in Polish ("suplement diety").

Common enforcement actions include orders to correct labelling (particularly health claims used without authorisation), product recalls in case of safety concerns, and financial penalties. For unauthorised health claims, authorities typically issue a decision requiring immediate cessation and may impose fines. Additionally, competitors may file complaints, and consumer organisations can take action under unfair commercial practices law. Early legal support significantly reduces the risk of escalation.

Our proprietary tools (C.L.A.I.M.S. for health claims, NutriMetr for nutrition tables) accelerate compliance work that traditionally takes days into hours. We offer a practitioner's perspective - having worked both inside food companies (Regulatory Affairs) and as external counsel - which means advice that is practical, business-oriented and immediately actionable. Free initial consultation with no obligation.

Food additives are identified by E-numbers and must be declared on the label with their function category followed by their specific name or E-number. The Regulation distinguishes between sweeteners, colours, and other additives, each with specific maximum levels. EFSA regularly re-evaluates authorised additives for safety. Non-compliance can lead to product withdrawal and administrative penalties.

The regulation covers production rules, certification procedures, labelling, import requirements and controls. The EU organic logo is mandatory for pre-packaged organic food produced in the EU. The code number of the control body and the place of farming must appear near the logo. Food supplements can be labelled as organic if they meet all requirements. Non-certified operators face significant penalties for misusing organic claims.

The labelling obligation applies regardless of whether GMO DNA or protein is detectable in the final product. Products from animals fed with GM feed (meat, milk, eggs) do not require GMO labelling. The 0.9% threshold applies per ingredient, not to the whole product. "GMO-free" labelling is not harmonised at EU level and varies by Member State. Operators must maintain traceability documentation throughout the supply chain.

The scope extends to all commercial communications including social media, influencer marketing, and packaging design. Each Member State may have additional national rules - for example, Poland prohibits advertising food supplements as medicines and requires specific disclaimers. Cross-border advertising must comply with the rules of the target market. Enforcement varies significantly between Member States, with some relying on self-regulatory bodies and others on public authorities.

In practice, mutual recognition is often contested by national authorities. Member States may restrict market access on grounds of public health protection, but must follow a specific procedure including a prior notification to the operator. The CJEU has consistently held that restrictions must be proportionate and scientifically justified. For food supplements, this is particularly relevant as maximum levels of vitamins and minerals are not harmonised, and national lists of permitted ingredients vary considerably across the EU.

The situation is complex because the CJEU ruled in Case C-663/18 (Kanavape) that CBD derived from the whole hemp plant is not a narcotic. However, this does not affect its novel food status. EFSA has paused assessment of CBD applications due to concerns about potential effects on the liver, GI tract and the endocrine system, requesting additional data from applicants. Enforcement varies significantly by Member State - some tolerate CBD products while others actively remove them from the market. The UK has established a separate post-Brexit pathway for CBD novel food authorisation.

For food supplements, vitamins and minerals must fall within -20% to +50% of the declared value at end of shelf life (with stricter requirements for vitamin A and D at -20% to +30%). For macronutrients in standard foods, tolerances are typically +/-20% for values above certain thresholds. The guidance is not legally binding but is followed by enforcement authorities across the EU. Understanding tolerances is critical when formulating products and designing labels to avoid non-compliance during official controls.

Foreign operators must notify food supplements through the GIS electronic system before placing them on the Polish market. GIS can request cooperation from other Member States' authorities through the Administrative Assistance and Cooperation (AAC) system. In practice, enforcement against foreign e-commerce operators has increased significantly since 2022. Polish law requires a responsible person within the EU for each food product on the market. Cross-border enforcement is also facilitated by Regulation (EU) 2017/625 on official controls.

The process begins with an application submitted to a Member State's competent authority, which forwards it to the European Commission and EFSA. EFSA has 5 months (extendable) to deliver a scientific opinion. The Commission then proposes authorisation or rejection through the comitology procedure. The high rejection rate (over 80% historically) reflects EFSA's strict evidence requirements - randomised controlled trials in healthy humans are generally required, and biomarker-based evidence alone is often insufficient. Applications under Article 13.5 (new evidence) and Article 14 (disease risk reduction) follow specific sub-procedures.

The European Commission has repeatedly postponed harmonisation. EFSA has established Tolerable Upper Intake Levels (ULs) for most nutrients, but translating these into maximum levels for supplements requires political decisions on safety factors, contribution from other dietary sources, and population reference intakes. Some Member States (France, Italy, Belgium) have established detailed national maximum levels, while others (Poland, UK pre-Brexit) rely on case-by-case assessment. This fragmentation creates significant compliance challenges for companies operating across multiple EU markets and is a frequent source of mutual recognition disputes.

The "on hold" status creates legal uncertainty because the European Commission has not decided whether to assess or withdraw these claims. Member States have adopted different approaches - some (like France and Italy) have established national guidance on which botanical claims are acceptable, while others apply minimal scrutiny. The practical implication is that botanical health claims exist in a regulatory grey zone. They are not "authorised" in the same sense as Article 13.1 claims in Regulation 432/2012, but they can be used if the company can demonstrate they are truthful and based on generally accepted scientific evidence. This situation has persisted for over a decade with no clear timeline for resolution.