GMP for manufacturers of food-contact packaging
We help food-packaging manufacturers organise GMP and food-contact compliance and separately assess packaging-waste and EPR duties.
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We help food-packaging manufacturers organise GMP and food-contact compliance and separately assess packaging-waste and EPR duties.
Request an initial assessment
Since 2026, manufacturers of packaging and other food-contact materials in Montenegro have worked under an updated national framework aligned with EU rules. ConsultHQ helps companies establish GMP, quality assurance and quality control, traceability and the documentation needed to demonstrate that their products and production processes comply.
For a packaging manufacturer, quality is no longer just about dimensions, printing or how the finished article looks. The material must be suitable for its intended use and made through a controlled process. The company also needs enough information to demonstrate origin, specifications, production controls and the status of the finished product. The 2026 rules make these requirements more explicit in Montenegro.
The Regulation on Materials and Articles Intended to Come into Contact with Food was published in Montenegro’s Official Gazette 91/2026 and has applied since July 7, 2026. It transposes Regulation (EC) 1935/2004 and relevant amendments. It covers material requirements, labelling, placing products on the market and good manufacturing practice.
The Rulebook on Good Manufacturing Practice for Materials and Articles Intended to Come into Contact with Food, published in Official Gazette 102/2026, has applied since July 24, 2026. It transposes Commission Regulation (EC) 2023/2006 and covers relevant stages of manufacture, processing and distribution, excluding the production of starting substances.
A food-packaging manufacturer may face two distinct compliance areas. Food-contact material safety and production control are governed by Regulation 91/2026 and the Good Manufacturing Practice Rulebook 102/2026. Packaging producer status, registration, quantity data and extended responsibility for packaging waste must be assessed separately under the Waste Management Law (Official Gazette 34/2024 and 128/2026).
The 128/2026 amendments provide for a packaging producers register kept by the Environmental Protection Agency and set 31 December 2027 as the deadline for establishing the packaging EPR programme. The applicable duties depend on whether the business manufactures, imports or places packaging or packaged goods on the market; implementing rules provide further detail on the register and scheme. We therefore identify the company’s actual role, product flows and available data, without treating GMP documents as a substitute for EPR compliance.
Read more about the new waste-management rules.
The framework goes beyond conventional plastic packaging. Depending on the product and intended use, it can apply to businesses that make or process:
The detailed technical requirements vary by material. The general regulation may therefore be only one of the rules a company must consider.
Regulation 1935/2004 establishes the underlying principle: in normal or foreseeable use, a material must not transfer its constituents into food in amounts that could endanger health, cause an unacceptable change in food composition or worsen its organoleptic properties.
Compliance is therefore linked to intended use as well as the material itself. Packaging for dry food is not automatically suitable for fatty, acidic or hot food.
Rulebook 102/2026 requires GMP through relevant stages of manufacture, processing and distribution of food-contact materials. EU Regulation 2023/2006 requires an effective and documented quality assurance system to be established, applied and maintained.
The system should take account of staff competence, premises, equipment and the size of the business. Controls should be proportionate rather than create needless administration. ConsultHQ can connect these requirements to the quality system a company already uses.
Quality assurance is more than final inspection. Under the EU GMP framework, it consists of organised and documented arrangements that ensure materials are consistently produced and controlled to meet the rules and be fit for their intended use.
For a manufacturer, this may include approved raw-material specifications, supplier criteria, controlled production parameters, finished-product specifications, assigned responsibilities, change control, management of non-conformities and records. The exact structure depends on the production process. One QMS package does not suit every company.
The GMP framework also requires an appropriate quality control system. It checks that starting, intermediate and finished materials conform to specifications defined by quality assurance.
Final visual inspection alone may be insufficient. Dimensions and physical properties may matter for one product; supplier data, migration testing or material-specific requirements may matter for another. The control plan should follow the product and its intended use.
We begin with the actual processes and records. A new rulebook does not automatically mean that a company needs an entirely new system. Depending on the product and the organisation, work can include:
We tailor the scope to the material and the company’s existing level of control.
Many packaging manufacturers already use specifications, production orders, supplier checks, manufacturing records and final inspection. These elements should not be discarded automatically.
We compare the existing system with the 2026 GMP and food-contact requirements and identify the actual gaps. This is more useful than creating a new binder of procedures without first looking at how production works.
A company with ISO 9001 may have a useful foundation in document control, supplier management, non-conformities, corrective action and internal audits. An ISO 9001 certificate alone does not demonstrate that a food-contact product meets Regulation 91/2026 and Rulebook 102/2026.
The regulatory requirements need to be linked to the actual process and product. An integrated quality and GMP system is generally more practical than two parallel systems.
Food-contact materials have their own traceability requirements. Regulation 1935/2004 calls for tracking through relevant stages to support control, product recall, identification of responsible businesses and information when needed.
For a manufacturer, a finished article should be traceable to relevant supplier and production information. There is little value in building a separate spreadsheet if an existing ERP already provides the necessary trail. We review that system first.
GMP requires records of relevant specifications, formulations and production operations, together with evidence that the GMP and quality control systems are carried out. Documents may be electronic.
The company should be able to show which materials it used, how it manufactured the article and which criteria it applied when approving the result. During an official or customer review, this is more useful than a procedure nobody follows in production.
There is no universal “packaging certificate” that settles every product. Regulation 1935/2004 provides for declarations of compliance and supporting technical evidence where specific measures apply to a material group.
We therefore identify the material before defining the required documentation. Plastics, ceramics and other groups may have additional rules. This avoids sending a generic document that does not establish compliance with the requirement relevant to the actual product.
Plastic has a material-specific regulatory layer alongside the general food-contact framework. Manufacturers and users need to check the rules that apply to the type of plastic and its intended use.
Composition, migration, conditions of use and evidence through the supply chain may all be relevant. The GMP system should connect those requirements to product specifications and supplier controls instead of keeping them in a separate regulatory file.
With printed packaging, the food-contact risk is not confined to the surface that directly touches food. EU GMP rules specifically address inks printed on the non-food-contact side, so that substances do not transfer at unacceptable levels through the material or during stacking and winding.
This matters to packaging printers, flexible-film manufacturers, label producers and converters. Printing procedures can therefore be relevant to food-contact compliance.
A change to a raw material may directly affect the finished packaging article. Changing granulate, ink, adhesive, coating or another input should not be treated solely as a commercial purchasing decision.
The GMP system should set out how relevant changes are assessed. A document review may be enough in one case; another may need additional technical evidence or testing. The level of control should reflect the risk.
An article that has not passed the defined checks should not be mixed with approved stock. The quality system needs a clear status for non-conforming material, supported by segregation, an electronic hold or another suitable control. The same applies to raw materials awaiting incoming inspection.
Production staff should never have to guess whether an item may be used or dispatched.
Food-industry customers may notice a problem that escaped the packaging manufacturer’s final inspection. Complaints should provide data for investigation. If a problem repeats, the cause may lie in raw materials, the process, equipment, storage or transport.
A corrective action should address the cause, not merely replace the affected delivery. Companies with ISO 9001 can integrate this work into their existing CAPA process.
Food manufacturers are responsible for the materials they use. They may ask packaging suppliers for specifications, declarations of compliance, intended-use information or other relevant evidence.
The 2026 framework makes this documentation chain more important. A packaging manufacturer with an organised GMP system can answer these requests more readily, which also supports commercial relationships.
The outcome should be a system the company can use to manage production and demonstrate compliance, rather than just a bundle of new procedures. Depending on scope, deliverables may include:
Where ISO 9001 is already in place, much of this can be integrated into the existing QMS.
Packaging GMP is not a collection of universal SOP templates. Film production differs from printing cardboard packaging, and the risks differ too.
Documents should reflect the products, raw materials and real manufacturing process. Otherwise the company may have attractive procedures that provide weak evidence of compliance.
A company with ISO 9001, a developed laboratory or strong production controls may already meet many GMP requirements. There is no reason to rebuild everything automatically.
ConsultHQ compares the current system with Regulation 91/2026, Rulebook 102/2026 and the relevant EU and material-specific rules. The result is a practical plan showing what can stay, what needs to be added and which controls deserve priority. The goal is one working quality and GMP system that the manufacturer can use every day and demonstrate to customers or the competent authority.
Official sources: Montenegro Food Safety Administration: current rules, including Regulation 91/2026 and Rulebook 102/2026; Official Gazette 91/2026; Official Gazette 102/2026; EU 1935/2004; EU 2023/2006.
An initial assessment helps us define scope and next steps based on your actual business.
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