Published: 24.09.2026. · HACCP

Microbiological criteria, contaminants and food traceability in 2026: what manufacturers in Montenegro should check

Publisher: ConsultHQ

Montenegro significantly updated its technical food safety rules in 2026. The new measures cover microbiological criteria, maximum contaminant levels, batch or lot marking and additional traceability for food of animal origin. Manufacturers should review these requirements together with their HACCP controls, laboratory plans and production records.

This is a group of separate regulations, not one new law. Together, they affect how a business demonstrates product safety and responds when a particular batch presents a problem. Manufacturers and processors are most directly affected, while some requirements also apply to distributors, warehouses and other food businesses.

Four important rules entered into force in 2026

The Rulebook on Food Batch or Lot Marking, published in Montenegro’s Official Gazette 58/2026, entered into force on May 7, 2026. The Rulebook on Detailed Traceability Requirements for Food of Animal Origin entered into force on the same day.

The Regulation on Microbiological Criteria for Food, published in Official Gazette 84/2026, entered into force on June 24, 2026. The Regulation on Maximum Levels of Contaminants in Food, published in Official Gazette 98/2026, has applied since July 17, 2026.

Together these instruments add a technical layer to the Law on Food Safety (59/2026). The rules that matter to a business depend on its products and activities.

Microbiological criteria are not the same as HACCP

HACCP manages hazards through the production process. A microbiological criterion determines the acceptability of a food, batch or process according to the presence, absence or amount of specified microorganisms, their toxins or metabolites.

Montenegro’s Regulation 84/2026 addresses food safety and process hygiene criteria, sampling, testing and certain studies. It transposes Commission Regulation (EC) 2073/2005 as amended. A manufacturer should use laboratory results to check whether its product and process deliver the expected result, rather than operate the testing plan separately from HACCP.

Food safety criteria and process hygiene criteria serve different purposes

The EU framework distinguishes criteria used to determine whether a product is acceptable from criteria indicating whether the production process is operating hygienically. An unfavourable result therefore does not always call for the same response.

Where a food safety criterion is involved, the business must assess the status of the product. A process hygiene result may instead signal that hygiene, the process or another control needs improvement. Laboratory reports should always be interpreted in the context of the product and the process.

The August amendment did not change microbiological limits

An amendment published in Official Gazette 126/2026 entered into force on August 27, 2026. It deleted Article 11 of Regulation 84/2026, which contained monetary penalties. The Food Safety Administration does not describe a change to the technical microbiological criteria in that amendment.

It would therefore be inaccurate to say that a new microbiological standard began on August 27. The principal technical framework entered into force on June 24 through Regulation 84/2026.

The EU changed a Listeria monocytogenes criterion from July 1, 2026

Manufacturers of ready-to-eat foods intended for the EU market should also check Commission Regulation (EU) 2024/2895, which applies in the EU from July 1, 2026. It changes the criterion for certain ready-to-eat foods that can support the growth of Listeria monocytogenes.

Where the manufacturer cannot demonstrate that the level will remain at or below 100 cfu/g throughout shelf life, the criterion of “not detected in 25 g” applies while the product is on the market during its shelf life. Montenegrin exporters should check the current requirements of the destination market as well as domestic rules.

New contaminant rules apply from July 17, 2026

Regulation 98/2026 sets maximum levels for specified contaminants in food. It transposes Commission Regulation (EU) 2023/915 as amended.

Depending on the food category, the regulated substances include cadmium, perchlorate, deoxynivalenol, T-2 and HT-2 toxins, nickel, inorganic arsenic and others. This does not mean every manufacturer must test for every contaminant. Relevance depends on the raw materials, product and applicable limit.

A contaminant is not the same as a microbiological hazard

These hazards may appear in one laboratory plan, but they have different legal and technical bases. Microbiological hazards concern bacteria and other microorganisms. Contaminants can include chemical substances associated with raw materials, production or the environment.

The manufacturer should establish what matters for its particular product before deciding on a testing and control plan.

EU contaminant rules continued to change in 2026

Regulation (EU) 2023/915 is not static. EUR-Lex lists a consolidated version dated August 19, 2026. Food exporters should check the domestic rules alongside the current rules in their destination market, especially for categories whose maximum levels change frequently.

The new lot-marking rulebook has applied since May 7

The Rulebook on Food Batch or Lot Marking replaced the 2016 rulebook and aligns with Directive 2011/91/EU. A lot is a quantity of food produced, processed or packed under practically the same conditions.

The lot identifier is more than a label. It connects a product to a defined production batch and becomes particularly valuable when a withdrawal or recall is needed.

Food generally cannot be marketed without an appropriate lot mark

The rulebook sets out how to identify and mark batches or lots. The Administration states that food must carry the appropriate mark before marketing, subject to specified exceptions.

Depending on the situation, the producer, processor, packer or first seller established in Montenegro determines and marks the lot. The letter “L” normally precedes the identifier unless the identifier is clearly distinguishable from other label information.

The same lot should also be traceable inside the business. A label that cannot be linked to production records provides little operational protection.

Traceability extends beyond a lot number

A lot number alone is not a complete traceability system. Businesses should be able to identify relevant incoming materials and the onward movement of the product. The Law on Food Safety provides the general framework, while the May 2026 rulebook adds requirements for food of animal origin.

Reliable traceability supports a targeted response to a problem with a particular batch. Without it, a business may have to treat a much larger volume as potentially affected.

Food of animal origin has additional traceability requirements

The Rulebook on Detailed Traceability Requirements for Food of Animal Origin has applied since May 7, 2026. It transposes Commission Implementing Regulation (EU) 931/2011, which supplements the general EU traceability framework in Regulation (EC) 178/2002.

It covers a range of unprocessed products, including fresh meat, raw milk and fishery products, as well as processed foods made from such raw materials. Businesses in this chain should verify the specific data they must retain and provide. Recording only the supplier’s name may be insufficient.

Manufacturers should connect the lot, production and distribution

The practical test is whether a company can reconstruct one product batch. Which raw materials were used? Which production records and relevant laboratory results belong to it? Where was it delivered?

Those answers connect HACCP, laboratory controls and traceability. If the information exists in disconnected systems and cannot be retrieved quickly, the business has data but a weak response capability.

Laboratory testing does not replace process control

More testing does not automatically make food safer. A microbiological result describes the tested sample and provides information about the product or process. HACCP should control the conditions that affect that result every day.

The laboratory plan should support the system, not replace it. An unfavourable trend may justify a process review before a formal limit is exceeded.

What manufacturers should check now

The first step is to assess which requirements apply to the actual food and process, rather than order more tests automatically. A manufacturer should check:

• which version of the microbiological criteria it uses and which criteria apply to its food categories;
• whether its laboratory plan supports the HACCP hazard analysis;
• which contaminants are relevant to its raw materials and products;
• whether lot marking meets the 2026 rulebook and records link each lot to production;
• whether traceability allows a prompt response and whether animal-origin food has additional requirements;
• whether exported products also meet the current rules in the destination EU market.

A product-specific review is more useful than a universal testing plan.

Update an existing HACCP system only where the change matters

The new regulations do not mean every HACCP system must be rewritten. A sound existing hazard analysis may remain useful. Review its links to microbiological criteria, relevant chemical hazards, lot control, traceability, recall and verification.

If an applicable criterion has changed, update the affected part of the system. That is the purpose of a focused regulatory gap analysis.

The greatest risk is collecting laboratory results that nobody uses

A company may pay for tests and still have a weak quality system if results are merely filed away. They should inform trend monitoring, process decisions and changes in risk.

The same applies to traceability. A database that cannot quickly retrieve the records for a particular batch has limited value during an incident.

ConsultHQ can connect the new rules to an existing HACCP system

Food manufacturers do not need another parallel compliance system. They need to connect the applicable requirements to HACCP, the laboratory plan and existing production records.

Through a gap analysis, ConsultHQ can review the relevant microbiological criteria, contaminants, lot controls and traceability for the company’s products and markets. The result should identify what already works and where a focused change is needed, without adding unnecessary tests, forms or procedures.

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

Official sources: Regulation 84/2026; amendment 126/2026; Regulation 98/2026; lot marking 58/2026; traceability 58/2026; EU Listeria amendment.

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