Published: 25.09.2026. · HACCP

Vitamins and minerals in food in 2026: what Montenegrin manufacturers should check

Publisher: ConsultHQ

Regulation 47/2026 updates the chemical forms of vitamins and minerals that may be added to food, affecting recipes, specifications and records.

Montenegro updated its rules on vitamins and minerals added to food in 2026. Regulation 47/2026 replaces the list of permitted chemical forms of vitamin and mineral substances. Manufacturers of fortified and functional foods should review formulations, raw-material specifications and supplier documents against the current rules.

This is not an entirely new fortification system. The underlying regulation has existed since 2021 and was amended in 2025. The 2026 change is specific: Annex 2, listing chemical forms of vitamins and minerals that may be added to food, was replaced.

For a manufacturer, the exact form matters. A recipe stating only “vitamin B3,” “iron” or “folic acid” does not identify the chemical source actually used.

Regulation 47/2026 has applied since 11 April 2026

The amendment to the Regulation on Vitamins, Minerals and Other Substances That May Be Added to Food was published in the Official Gazette of Montenegro 47/2026 on 3 April. It entered into force on 11 April 2026 and remains in force.

It amended the original 2021 regulation, which had also been changed in 2025. Manufacturers should therefore use the current combined framework rather than an old vitamin and mineral list saved in internal files.

The 2026 change directly replaces Annex 2

Article 1 replaces Annex 2 in full. The new annex is titled “Chemical Forms of Vitamins and Minerals That May Be Added to Food.” It lists permitted forms of vitamins A, D, E and K, B-group vitamins, folic acid, biotin and vitamin C, as well as calcium, magnesium, iron, copper, iodine, zinc, manganese, selenium and other mineral substances.

Compliance checks need to reach the exact raw-material specification. The broad name of a vitamin on a marketing label is not enough.

Nicotinamide riboside chloride shows why the chemical form matters

The new Annex 2 includes nicotinamide riboside chloride among the permitted forms of niacin. This reflects developments in the European framework: EU Regulation 2023/1065 amended Annex II of Regulation 1925/2006 to include that source for specified uses in food.

The lesson extends beyond one ingredient. A new or alternative chemical form of a vitamin can have a different regulatory position from another source of the same nutrient.

The rules connect with EU Regulation 1925/2006

Montenegro's regulation reflects the European framework in Regulation (EC) 1925/2006 on the addition of vitamins, minerals and certain other substances to foods, together with later amendments. This remains the EU framework for food fortification.

Its current consolidated text specifies the vitamins and minerals that may be added, the forms in which they may be used and additional rules for certain other substances. Exporters to the EU should review formulations against the current requirements of each destination market.

Not every source of a vitamin or mineral is permitted

The framework uses a positive list of chemical forms. Showing that a raw material contains a vitamin or mineral is not enough; the manufacturer must check that the actual form is permitted for addition to food.

This is particularly important when changing premix suppliers. Two premixes can declare the same vitamin while using different sources or formulations.

A premix supplier change should trigger a regulatory review

Suppliers change for price, availability or technical reasons. For vitamins and minerals, such a change can also alter the regulatory position of a recipe.

Before approving a replacement premix, check its specification and the exact chemical forms it contains. The review can be simple, but it belongs in supplier control and raw-material approval before production begins.

Fortification is not the same as adding any “beneficial substance”

The regulation covers vitamins, minerals and certain other substances with nutritional or physiological effects. Different ingredient groups may still have different legal regimes: additives follow additive rules, novel food follows novel-food rules, and flavourings, enzymes and other categories may be governed separately.

Regulation 1925/2006 does not replace these checks. Product development should begin by classifying the ingredient, then applying the relevant framework.

Novel-food status can overlap with an authorized vitamin source

One ingredient can have more than one regulatory layer. Nicotinamide riboside chloride is an example: the European framework first addressed certain uses through novel-food authorization and later included it among the permitted niacin sources for relevant fortification uses.

Being named on one list does not remove the need to check conditions attached to another applicable authorization. This can also matter for other innovative nutrient sources.

The EU framework also restricts certain other substances

Regulation 1925/2006 is more than a vitamin and mineral list. Its Annex III can prohibit, restrict or place under scrutiny other substances. In recent years, EU amendments have addressed certain concentrated green-tea extracts and monacolins from red yeast rice.

For functional-food manufacturers, a formulation can therefore raise regulatory questions even when its sensitive ingredient is neither a vitamin nor a mineral. The product's overall regulatory status needs review.

Food categories can have different fortification rules

EU Regulation 1925/2006 also restricts fortification by food category. Under that framework, vitamins and minerals are generally not added to unprocessed foods such as fresh fruit, vegetables, meat, poultry and fish. Alcoholic beverages have separate restrictions and exceptions.

Checking only the ingredient is insufficient. The finished product's category and applicable legal regime also matter.

Nutrient quantity and chemical form are separate questions

Annex 2 answers which chemical form may be used. It does not, by itself, answer how much of a vitamin or mineral a food may contain or how its content should be declared to consumers.

The wider framework separately addresses conditions of addition, maximum quantities where set, labelling and related composition requirements. A laboratory result confirming a quantity cannot replace a legal check of the source, and the reverse is equally true.

The raw-material specification is central evidence

For fortified food, a supplier specification should identify more than a premix's commercial name. For each relevant vitamin or mineral, the manufacturer should be able to establish:

• the nutrient and its precise chemical form;
• the specification and concentration;
• relevant auxiliary ingredients;
• batch or lot identification;
• the manufacturer or supplier;
• documents needed for the intended use.

This connects the approved recipe with the material actually used in production.

The recipe, specification and label must agree

Problems arise when product development, purchasing and labelling work from different information. A recipe may specify one source while purchasing changes supplier and the label still reflects the former formulation.

In fortified food, that discrepancy can have regulatory consequences. Change control should connect all three records and trigger a recipe and label review when a raw material changes.

Nutrition and health claims are another regulatory layer

Adding a vitamin or mineral does not automatically authorize any nutrition or health claim about a product. Such claims have their own legal framework.

Manufacturers should separate two questions: is the fortification permitted, and what may be said to consumers about it? This matters especially for products marketed as functional or fortified foods.

HACCP does not confirm that the formulation complies with the law

HACCP identifies and controls relevant production hazards. It does not, by itself, establish that a selected chemical form of a vitamin is legally permitted for the intended food. That is a formulation compliance question.

A useful management system connects HACCP with raw-material approval, specifications, recipes, supplier files, change control and product labels. This reduces the risk of a technically safe product that remains legally non-compliant.

Who is most affected by the amendment?

Regulation 47/2026 will not materially change every food company's operations. It is particularly relevant to manufacturers of:

• fortified and functional foods;
• drinks with added vitamins or minerals;
• certain dairy and cereal products;
• foods made with vitamin and mineral premixes;
• other products deliberately fortified during manufacture.

A business producing conventional food without adding these substances is unlikely to need a large compliance project because of this amendment.

What should manufacturers check now?

Manufacturers of fortified food should first review recipes already on the market. The review should cover:

• which vitamins and minerals are deliberately added;
• the chemical forms actually used and their status under the current Annex 2;
• whether supplier specifications identify those forms;
• any additional novel-food status or other restrictions;
• whether the approved recipe matches actual production;
• whether the label matches the real composition;
• whether a supplier change triggers regulatory review.

There is no reason to reformulate a compliant product automatically. The manufacturer should be able to show that its current sources were checked against the applicable list.

Export products also need a review of current EU rules

Montenegro's 2026 amendment incorporates several changes to Regulation 1925/2006, including changes relevant to new sources of vitamins and minerals. The European framework continues to evolve.

Manufacturers exporting to the EU should consult the current consolidated Regulation 1925/2006 when developing or changing products, particularly those using innovative nutrient sources. Domestic and destination-market obligations should be assessed in parallel.

ConsultHQ can connect the review with an existing quality system

A fortified-food manufacturer does not need a new administrative system solely because of Regulation 47/2026. The required check should become part of raw-material approval and recipe development.

Through a targeted regulatory gap review, ConsultHQ can assess premix approval, supplier documents and their connection to the HACCP system. The goal is to establish before production which nutrient form is used, whether it is permitted and whether documents and labels match the actual recipe.

Related pages: HACCP for food manufacturers, novel food, food additives and gap analysis.

Official sources: Official Gazette: Regulation 47/2026; EUR-Lex: Regulation 1925/2006.

← All articles