Published: 25.09.2026. · HACCP

Novel food in Montenegro in 2026: when a product or ingredient needs a regulatory review

Publisher: ConsultHQ

Regulation 126/2026 governs the status, authorization and labelling of novel food in Montenegro under rules aligned with the EU framework.

Montenegro has applied its new Novel Food Regulation 126/2026 since 26 August 2026. It governs how the status of a product is determined, the list of authorized novel foods, conditions of use and specific labelling requirements. A manufacturer should not add an unfamiliar ingredient to a recipe simply because a supplier sells it in another market.

The regulation does not affect every food product. Most traditional ingredients and standard recipes do not become “novel food” because of it. The question arises when a company introduces an ingredient, source, technology or form of food whose regulatory status is unclear.

Regulation 126/2026 has applied since 26 August 2026

The Novel Food Regulation was published in the Official Gazette of Montenegro 126/2026 on 26 August 2026 and entered into force on the same day. It replaced the earlier 2018 novel-food regulation and its subsequent amendments.

The new regulation incorporates provisions of Regulation (EU) 2015/2283 on novel food, as amended. It moves the domestic framework closer to the European model in which a novel food's status and safety are examined before it is placed on the market.

What counts as novel food?

The regulatory concept is broader than a newly marketed product. Under the EU framework, it concerns food that was not used for human consumption to a significant degree in the European Union before 15 May 1997 and falls into one of the specified categories.

Montenegro's regulation lists categories that include food:

• with a new or intentionally modified molecular structure;
• produced from microorganisms, fungi or algae;
• of mineral origin;
• produced or isolated from certain plants or their parts;
• produced or isolated from animals;
• derived from cell or tissue cultures;
• made by a process that significantly changes composition or structure;
• containing certain nanomaterials;
• involving certain vitamins, minerals or other substances produced by new processes or in nanoforms.

A “new product” in marketing language and a “novel food” in law are therefore different things.

A new flavour of an existing product is not automatically novel food

A company may develop a new biscuit, drink or dairy product without entering the novel-food regime. Known ingredients and conventional processes with an established history of use may leave that regime irrelevant.

Conversely, a simple-looking product may need a regulatory review if it contains an unusual botanical extract, a new microorganism or an ingredient obtained through a non-traditional process. The ingredient and process determine the question, rather than how innovative the product looks.

The food business operator must make the initial check

Article 5 requires a food business operator to check whether food it intends to place on the Montenegrin market falls within the regulation. A manufacturer should not wait for an official inspection before asking about an ingredient's status.

The sensible point for this review is before the formulation, label and large-scale commercial purchase of the ingredient are finalized.

Consult the competent Ministry if the status is unclear

The regulation addresses uncertainty about whether a product is novel food. In that case, the operator consults the government body responsible for food safety and provides the information needed to determine its status. The Ministry may also consult the European Food Safety Authority.

This is a reason to organize technical information about a new ingredient before the formal regulatory question arises.

Only authorized novel food may be placed on the market

Novel food may be placed on the market only if it has been authorized and entered on the list of authorized novel foods, subject to the listed conditions of use and labelling requirements.

A supplier's catalogue or a technical file suggesting safety does not by itself establish market authorization. If the product falls within the novel-food regime, the operator needs to check both its listing and the precise terms of its authorization.

The new authorized-food list has applied since 29 August

The Rulebook on the list of authorized novel foods was published in Official Gazette 127/2026 on 28 August and entered into force on 29 August 2026. Its list follows the EU approach established by Implementing Regulation (EU) 2017/2470.

For an individual entry, the name is only the start. The list may specify:

• food categories in which the ingredient may be used;
• maximum levels where applicable;
• special labelling requirements;
• other conditions of use;
• product specifications.

Finding an ingredient on the list is therefore not enough without checking the conditions attached to that entry.

Authorization rests on safety and consumer protection

The Montenegrin regulation sets three basic conditions for entry on the list. Available scientific evidence must not indicate a safety risk; the intended use must not mislead consumers; and, where the novel food is intended to replace another food, normal consumption must not be nutritionally disadvantageous.

The review concerns more than a technical ingredient list. It also considers how the product will be used and presented.

Special labelling may be a condition of authorization

Some novel foods carry extra labelling requirements. An entry may call for information on composition, nutritional value, intended use or implications for specific consumer groups.

A manufacturer should therefore not finalize the label before reviewing the ingredient's regulatory status. The ingredient may be authorized, but its use could require particular wording or a warning. Product development and regulatory review need to meet at this stage.

Certain novel foods may have maximum use levels

List entries may impose maximum levels or other limits to protect particular population groups or address risks from excessive consumption. This resembles one aspect of additive control, but novel food and food additives are separate legal regimes.

A novel-food ingredient should not be checked against the additives list as a substitute for its own authorization conditions.

Post-market monitoring may be an additional condition

An entry on the novel-food list may require monitoring after the product has been placed on the market. This does not apply to every entry, but it shows that regulatory duties may continue after approval and the start of sales.

The operator should read all conditions associated with the particular listing.

Traditional food from third countries has a separate concept

The EU novel-food framework also recognizes traditional food from a third country: certain foods from primary production with a documented history of safe use in at least one non-EU country. Under the EU framework, that history includes at least 25 years of continuous consumption in the customary diet of a significant number of people.

Montenegro's new regulation also defines traditional food from a third country. This may matter to importers of exotic plants, seeds or other unfamiliar ingredients. A claim that a food is “traditional somewhere” is not enough without the required evidence and regulatory basis.

A new source of a vitamin or mineral may also have novel-food status for its proposed use. Alongside the permitted chemical form under Regulation 47/2026, the operator may need to check novel-food authorization and its conditions. See our guide to vitamins and minerals in food.

The regulation excludes some categories governed elsewhere

The novel-food regulation expressly excludes several products subject to their own regulatory systems:

• genetically modified food;
• food enzymes;
• food additives;
• food flavourings;
• extraction solvents used in food production.

Correct classification is the first step. An unusual ingredient should not automatically be directed into the novel-food procedure.

A supplement ingredient may face a separate novel-food question

The EU definition includes food used exclusively in food supplements before the reference date if it is now intended for use in another food category. This is relevant to functional products.

Years of use of an extract in capsules do not automatically establish that it can be used in a drink, yoghurt or other ordinary food. The intended use can change the regulatory assessment.

A supplier should provide more than a commercial data sheet

For an unfamiliar ingredient, a manufacturer needs enough information to establish its regulatory position. This can include:

• precise identity, origin and method of production;
• composition and intended use;
• history of consumption;
• any existing regulatory authorization;
• specification and conditions of use;
• labelling requirements.

If the supplier cannot answer basic questions about the ingredient's status, that is a regulatory risk before it becomes a production problem.

Change control should include the new ingredient's regulatory status

A company can have a sound HACCP system and still make a mistake by introducing an ingredient without regulatory review. Approval of new raw materials should therefore be part of product-development change control.

Before commercialization, check whether the ingredient is novel food, whether it is authorized, the food categories and quantities permitted, any warnings, and whether the HACCP analysis or label must change. This is far less costly than correcting a finished product after packaging has been printed or distribution has started.

HACCP does not establish novel-food authorization

HACCP identifies hazards and controls the manufacturing process. The novel-food regulation determines whether a new food may legally be placed on the market. These controls are related, but they answer different questions.

An ingredient may be microbiologically and chemically controlled under HACCP while lacking the required novel-food status for the proposed use. Manufacturers need both levels of review where the regulation applies.

Who should examine Regulation 126/2026 closely?

The topic has higher priority for businesses that:

• develop innovative or functional foods;
• use new plant or animal sources, extracts or bioactive ingredients;
• introduce algae, fungi or microorganisms;
• adopt new food-production technologies;
• import unusual ingredients from third countries;
• develop nanoform ingredients;
• move an ingredient from supplements into ordinary food.

A conventional bakery using standard ingredients is unlikely to face major new compliance work because of this regulation alone.

What should manufacturers check now?

A company developing a new product should add a simple regulatory review before finalizing its recipe. It should establish:

• whether the ingredient or product may meet the novel-food definition;
• whether evidence of significant use before 15 May 1997 is relevant;
• whether the ingredient appears on the authorized list;
• its permitted uses, maximum levels and special labelling;
• any limits for specific consumer groups;
• whether the Ministry should be consulted about status;
• whether supplier documents support the conclusion.

The review belongs before large purchases of raw materials and printing of packaging.

ConsultHQ connects novel-food review with product development and HACCP

A manufacturer does not need a parallel compliance system for each new ingredient. Regulatory review should become part of raw-material approval and product development.

Through a regulatory gap review, ConsultHQ can examine how a company develops formulations, assesses supplier documents and approves new ingredients against Regulation 126/2026 and List 127/2026. Where a formal status decision or authorization is required, the company must follow the competent regulatory procedure. The aim is to resolve the question before it becomes an expensive commercial problem.

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

Official sources: Official Gazette: Regulation 126/2026; Official Gazette: List 127/2026.

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