Published: 24.09.2026. · HACCP

Food-contact materials in 2026: new rules for packaging, equipment and manufacturers in Montenegro

Publisher: ConsultHQ

Since July 2026, Montenegro has applied a new regulatory framework for packaging, containers, equipment and other materials that come into direct or indirect contact with food. The Food-Contact Materials Regulation (91/2026) addresses safety, labelling and marketing, while the Good Manufacturing Practice (GMP) Rulebook (102/2026) sets more detailed production requirements aligned with the EU framework.

This matters beyond packaging factories. Food manufacturers need to know that their packaging is suitable for its intended use, while importers, distributors and material manufacturers have their own responsibilities. A company can have a sound HACCP system for its food and still have a gap in controlling the materials that touch it.

The new Regulation 91/2026 has applied since July 7

Montenegro’s government adopted the Regulation on Materials and Articles Intended to Come into Contact with Food on May 28, 2026. It was published in Official Gazette 91/2026 on June 29 and entered into force on July 7, 2026.

It addresses food-contact materials and articles, their labelling, the conditions for placing them on the market and requirements relating to good manufacturing practice. It transposes Regulation (EC) 1935/2004 and relevant amendments into Montenegro’s legal framework.

What counts as a food-contact material

The rules extend beyond conventional plastic packaging. They cover materials and articles intended to contact food, already in contact with it, or reasonably expected to contact food or transfer constituents under normal or foreseeable conditions of use.

Examples include packaging, containers, some kitchen and production equipment, utensils, films, paper, cardboard, plastics, coatings and certain metal, glass or ceramic articles. The exact technical requirements depend on the material. A specific material rule may apply in addition to the general regulation.

Materials must not compromise food safety or composition

Under the EU principle in Regulation 1935/2004, materials should be manufactured so that normal or foreseeable use does not transfer constituents into food in amounts that could endanger health. They should not cause an unacceptable change in food composition or deterioration of its organoleptic properties.

Packaging is therefore more than a purchasing decision. Temperature, food type, contact time and actual use all matter when judging whether a material is suitable.

The new GMP rulebook has applied since July 24, 2026

The Rulebook on Good Manufacturing Practice for Materials and Articles Intended to Come into Contact with Food was published in Official Gazette 102/2026 on July 16 and entered into force on July 24, 2026.

It transposes Commission Regulation (EC) 2023/2006 as amended. Its GMP rules cover stages of material and article production, processing and distribution, excluding the production of starting substances.

This GMP is not pharmaceutical GMP

Here, Good Manufacturing Practice concerns the manufacture and control of food-contact materials. It is neither a pharmaceutical GMP system nor an ISO 9001 certification scheme.

Regulation 2023/2006 treats GMP as part of quality assurance that helps ensure materials are consistently made and controlled to comply with the rules and remain suitable for their intended use.

Manufacturers need a documented quality assurance system

A central GMP requirement is an effective, documented quality assurance system proportionate to the size and type of the business. It must be supported by suitable people, knowledge, premises and equipment.

For packaging and other food-contact material manufacturers, an article that merely looks correct is not enough. The company needs an organised way to control specifications, production processes and the finished result.

Quality control is also required

The EU GMP framework also requires an appropriate quality control system. It supports checks of starting materials, intermediate products and finished materials against the specifications established in quality assurance.

Depending on the material and process, this can include supplier specifications, production parameters, test results and finished-product status. The controls should be proportionate to the operation: a small manufacturer does not need the same system as a large international packaging group.

Documentation may be paper-based or electronic

The GMP system calls for suitable documentation of specifications, formulations and production procedures relevant to compliance and the safety of the finished material. Records of relevant manufacturing operations and quality control results are also needed.

These records may be kept on paper or electronically. They should be controlled and available to the competent authority on request. Existing ERP, QMS and production systems can often be used.

Labelling of food-contact materials matters

Regulation 1935/2004 sets labelling rules for materials and articles that are not yet in contact with food when placed on the market. Depending on the product, the information may include a food-contact statement or symbol, any special intended use, instructions for safe use, details of the responsible business and an identifier supporting traceability.

In business-to-business supply, some information may accompany the article through documents, labels, packaging or the article itself. Manufacturers and distributors should check how this information follows the product through the supply chain.

Traceability applies to packaging as well as food

Regulation 1935/2004 requires traceability of materials and articles at all stages to support control, recall, consumer information and allocation of responsibility. Subject to the applicable rules, a business should be able to identify its source and the next business to which it supplied the material.

Food manufacturers therefore need more than ingredient lot records. They should also maintain an appropriate trail for relevant packaging and other food-contact materials.

A declaration of compliance may be important supplier evidence

For materials covered by specific EU measures, Regulation 1935/2004 provides for a written declaration of compliance and supporting documentation. That evidence should be available to competent authorities on request.

This does not mean the identical document is required for every possible material. The requirement must be checked against the material and its specific rules. Instead of asking every supplier for a generic “packaging certificate”, a food business should know which evidence applies to the product it uses.

Plastic has an additional regulatory layer

Certain materials have specific rules alongside the general food-contact framework. Montenegro adopted a new Rulebook on Special Conditions for Plastic Materials and Articles Intended to Come into Contact with Food in October 2025; it remains in force.

A business using plastic packaging should therefore check both the 2026 framework and the plastic-specific requirements for its intended use. Migration assessment and supplier documentation can be particularly important.

A new ceramics rulebook entered into force in 2026

The Rulebook on Ceramic Articles Intended to Come into Contact with Food was published in Official Gazette 87/2026 and entered into force on July 2, 2026. It sets material-specific conditions, limits for lead and cadmium migration and methods for verifying compliance, transposing Directive 84/500/EEC as amended.

It is particularly relevant to manufacturers, importers and distributors of ceramic tableware intended for food contact.

Printing inks on packaging are more than a design issue

The EU GMP rules address inks printed on the side of a material that is not meant to contact food. Processes should prevent substances from passing through the material or transferring during stacking or winding onto the food-contact side at unacceptable levels.

Under these rules, the printed surface should not directly contact food. This is especially relevant to flexible packaging, labels and other printed materials.

What food manufacturers should do

Food manufacturers may not make packaging, but they use it as part of the finished product. Purchasing and product approval should check that suppliers provide relevant documentation and that the material is suitable for its actual use.

Review the position when a supplier, material composition, filling temperature, heat treatment, shelf life, storage condition or intended use changes. A packaging change can require more than a new graphic design.

What this means for restaurants and hotels

Hospitality businesses are not the primary focus of the packaging GMP rules, but they use many food-contact articles: containers, utensils, delivery packaging, cups and equipment. These should suit the intended use.

Pay particular attention when an article is used differently from the supplier’s stated purpose. Packaging meant for cold food should not automatically be treated as suitable for high temperatures. Purchasing decisions should consider specifications as well as price and appearance.

What this means for packaging manufacturers and distributors

For these businesses, the impact is more direct. The Montenegrin framework connects product compliance with Regulation 1935/2004 and the GMP rules in Regulation 2023/2006.

Manufacturers should review quality assurance and quality control, raw-material and finished-product specifications, process controls, GMP records, traceability, labelling, applicable declarations of compliance and any material-specific rules. Distributors should know which information and documents they must retain and pass along the chain.

HACCP and food-contact documentation are different

A food manufacturer’s HACCP analysis may identify packaging as a relevant input or potential source of hazards. A HACCP plan does not, however, establish that the material itself complies with food-contact legislation.

The reverse is also true: a supplier’s declaration of compliance does not show that the food manufacturer uses the material correctly in its own process. Purchasing and packaging approval should connect these two sets of controls.

ISO 9001 can help but does not replace legal requirements

A packaging manufacturer’s ISO 9001 system can support supplier management, specifications, records, non-conformities and corrective action. An ISO 9001 certificate does not prove that every product meets the applicable food-contact requirements.

The legal and technical requirements need their own checks. A useful quality system brings ISO processes and product-specific regulatory controls together.

What businesses should review after July 2026

Start with the materials the business manufactures, imports, distributes or uses. Identify the general and material-specific rules that apply.

Manufacturers and distributors should review GMP, traceability, labelling and accompanying documentation. Food companies should review supplier approval and evidence that their packaging is suitable for its real use. The aim is to request the right evidence for each material, not the same “certificate” from every supplier.

ConsultHQ can connect food-contact requirements to the existing quality system

Businesses do not need another separate binder of regulations. They need to connect food-contact requirements with purchasing, specifications, suppliers, HACCP and the quality system they already use.

Through a gap analysis, ConsultHQ can review the materials a company uses or markets, the evidence already available and gaps against the 2026 framework. For packaging manufacturers, this can also include a review of the GMP quality system under Rulebook 102/2026. The aim is demonstrable compliance without duplicating processes that already work.

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

Official sources: Montenegro Food Safety Administration: current food rules, including Regulation 91/2026 and GMP Rulebook 102/2026; Official Gazette 91/2026; Official Gazette 102/2026; ceramics rulebook; plastics rulebook; EU 1935/2004; EU 2023/2006.

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