Published: 24.09.2026. · HACCP

Food additives in Montenegro in 2026: new rules for food manufacturers

Publisher: ConsultHQ

Montenegro has applied a new regulatory framework for food additives since August 2026. Regulation 112/2026 governs requirements and conditions of use, while Rulebook 122/2026 sets out lists of approved additives, food categories, conditions of use and certain labelling rules. Manufacturers should therefore check their recipes, specifications and labels against the current rules.

Food additives were regulated before 2026. The new Regulation replaces the previous framework and brings Montenegrin rules closer to the EU system based on Regulation (EC) No 1333/2008.

For a food manufacturer, the practical question is more specific than whether an E-number is generally approved. The manufacturer must check whether the additive is authorised for the particular food category, at what level and under which conditions.

The new Food Additives Regulation has applied since 8 August 2026

Montenegro adopted a new Food Additives Regulation, published in Official Gazette 112/2026 on 31 July 2026. It entered into force on 8 August 2026.

The Regulation sets requirements and conditions for using food additives and for their labelling. It transposes Regulation (EC) No 1333/2008, as amended, into national law.

The former Montenegrin framework from 2016, including its later amendments, ceased to apply when the new Regulation entered into force. Old internal lists of authorised additives should therefore not be used without checking them against current rules.

The new list of approved additives has applied since 18 August 2026

The second key instrument is the Rulebook on the List of Approved Food Additives, Conditions of Use and Labelling Rules. It was published in Official Gazette 122/2026 on 17 August and entered into force on 18 August 2026.

The Rulebook specifies:

• lists of approved food additives;
• their conditions of use;
• functional classes;
• food categories in which they may be used;
• additional labelling rules for certain food colours.

In practice, manufacturers use these lists to establish where and how a particular additive may be used.

An approved additive is not automatically allowed in every food

Regulation 1333/2008 uses positive lists. An additive must appear on the relevant list and be used only in the foods and under the conditions specified there.

The presence of an E-number on a list is therefore not enough. Check the product, food category, specific additive, permitted purpose, maximum level and any other condition of use. This is especially important when developing a new recipe or adapting one from another market.

An additive needs a justified technological function

The EU framework does not permit an additive merely because its use is convenient. Under Regulation 1333/2008, the proposed use must present no safety concern, meet a reasonable technological need and not mislead consumers.

An additive should not conceal poor raw materials, unhygienic processing or inadequate product quality. Its technological function must be justified.

Quantum satis does not mean an unlimited amount

For some additives, the rules use quantum satis instead of a numerical maximum. The new Montenegrin Regulation defines this as use in accordance with good manufacturing practice, at a level no higher than necessary for the intended technological purpose and without misleading consumers.

The manufacturer still needs a technical justification for the amount used. Quantum satis is not permission to add any quantity.

Check the maximum level against the exact product category

Where a maximum level applies, checking only the substance name is insufficient. The lists are organised by food category and conditions of use. The same additive may be allowed in one category, restricted in another and not authorised in a third.

Correct classification of the product is therefore a regulatory step. A wrong category can lead to a wrong conclusion about permitted use.

Do not apply the carry-over principle automatically

An additive may be present in a compound food because it was permitted in one of its ingredients. This is known as carry-over. The new Regulation sets conditions for the presence of an additive through an ingredient, food enzyme or flavouring.

There are limits and exceptions. Manufacturers should not assume that every additive carried in a compound ingredient is acceptable in the finished product. The specific category and conditions need to be checked.

Foods for infants and young children face stricter rules

The new Regulation restricts additives in foods for infants and young children and in certain foods for special medical or dietary purposes. Use is possible only where the relevant rules expressly provide for it in the specific category.

Manufacturers serving these sensitive groups should verify the regulatory position before releasing a formulation into production.

Food additives and novel food are also different legal categories. Novel Food Regulation 126/2026 excludes additives governed by their own rules. First classify the ingredient, then check the relevant authorization list. Our novel-food guide explains the distinction.

Adding vitamins or minerals to fortify food is not the same as using a food additive. Permitted chemical forms for fortification are checked under Regulation 47/2026, while additives follow their separate list, technological function and food-category rules. See our guide to vitamins and minerals in food.

Additives, flavourings and processing aids are different regulatory categories

Not every substance used during food production is a food additive under Regulation 1333/2008. Certain processing aids, nutrients and food flavourings fall outside its scope or under separate rules.

Montenegro also adopted separate rules for food flavourings in 2026, which the official food legislation register lists separately. Classify each substance correctly before deciding which rules apply.

A supplier specification does not establish permission for your use

A supplier may correctly identify an E-number and provide its specification. That alone does not show that the additive is permitted in every recipe.

Ingredient approval should link the additive's identity and technological function with its specification, the intended food category, permitted amount and any special restrictions. This is more reliable than relying only on a commercial technical sheet.

A recipe change should trigger a regulatory review

A recipe is both a production document and a regulatory one. Changing an additive, its concentration, the supplier of a preparation or a compound ingredient may affect compliance.

This matters especially when a commercial preparation contains several additives or auxiliary substances. Change control should assess the impact before the problem reaches the final label or an official inspection.

The label must reflect the actual recipe

Changing an additive can change the information given to customers. The new Regulation addresses labelling of additives sold as such; labelling of additives in finished food also interacts with consumer food information rules.

For business-to-business additives, the new Regulation requires information such as the additive name or E-number, its food use, lot identification, relevant conditions of use and other prescribed details. This helps food manufacturers dose the additive correctly and label the finished product.

Certain colours require additional labelling information

Rulebook 122/2026 identifies food colours for which additional information must appear on the food label. It is not enough to confirm that a colour is allowed in the recipe; its presence may also trigger a specific labelling requirement.

This is particularly relevant when developing new products or redesigning labels.

Additives sold to businesses have specific labelling rules

The new Regulation addresses additives that are not intended for direct sale to final consumers. Depending on the case, their packaging or accompanying documents must include relevant information such as the name or E-number, intended use, storage conditions, lot identification, operator details and instructions for proper use.

This matters to additive manufacturers, importers, distributors of food ingredients and the food producers who buy them. Complete business-to-business documentation reduces the risk of incorrect use in production.

Additive manufacturers and distributors may have to provide information to the authority

Under the new Montenegrin Regulation, an operator producing or placing food additives on the market must, at the competent authority's request, provide new scientific or technical information that could affect their safety assessment. The authority may also request information about actual use.

Regulatory responsibility does not end when the product is placed on the market. Relevant documentation and data must remain available.

EU additive lists continued to change in 2026

Regulation 1333/2008 changes over time. EUR-Lex currently shows a consolidated version dated 18 August 2026. Montenegrin Rulebook 122/2026 also entered into force on that date, and the national authority says it transposes Regulation 1333/2008 with its amendments.

Exporters should nevertheless check the current EU text directly, because EU lists and use conditions may change again after a domestic rule is adopted.

HACCP does not replace an additive compliance review

An additive may belong in a HACCP hazard analysis, particularly where incorrect use could create a chemical hazard or compliance issue. A HACCP plan does not, by itself, establish whether a particular E-number is permitted in a specific food category.

Both checks should work together: HACCP controls the process, while a recipe review establishes that the additive is authorised for the intended purpose and amount.

What food manufacturers should check after August 2026

Not every recipe needs to change. Start by reviewing existing products against the new framework. Products with several additives, compound ingredients, colours, sweeteners or long-standing formulations merit particular attention.

Check:

• the correct food category;
• every additive in the recipe;
• each additive's technological function;
• permitted conditions of use;
• maximum levels or quantum satis;
• carry-over from compound ingredients;
• supplier documentation;
• consistency between the production recipe and label;
• special requirements for certain colours;
• destination-market rules where the product is exported.

This review can uncover a compliance problem before the product reaches the market.

The new Regulation does not automatically require a new HACCP manual

The new additive rules do not require every manufacturer to rewrite its entire HACCP system. The first task is to review recipes and associated documents.

If the existing HACCP analysis is sound, it may need a change only where an additive affects an identified hazard, raw-material control or a process. Much of the work may instead concern specifications, ingredient approval, change control and labels. A focused regulatory gap analysis is more useful than automatically rebuilding the system.

ConsultHQ can connect recipes with quality management and HACCP

Manufacturers do not need separate administrative systems for each new regulation. Recipes, raw-material specifications, HACCP, supplier approval, labels and change control should work together.

ConsultHQ can review existing processes against Regulation 112/2026 and Rulebook 122/2026 through a regulatory gap analysis and identify where corrections are needed. The goal is to show why a particular additive is used, under which conditions and how the finished product was checked against current requirements.

Related services: HACCP for food production, gap analysis and HACCP documentation.

Official sources: Montenegrin authority: Regulation 112/2026; Montenegrin authority: Rulebook 122/2026; Official Gazette: Rulebook 122/2026; EU 1333/2008.

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