Food Contact Materials 1935/2004 — food grade granulate and Declaration of Conformity

Definition

Food contact materials (FCM) are materials and articles intended to come into contact with food, subject to the framework Regulation (EC) 1935/2004 and, in the case of plastics, additionally to the specific Regulation (EU) 10/2011. Food grade polymer granulate — so-called food grade — is an intermediate product that must be accompanied by a Declaration of Conformity (DoC) at every stage of the supply chain.

In terminal practice we deal with this topic constantly, because an ever-larger share of the granulate we transload — mainly PET, polyethylene and polypropylene — is intended for the production of food packaging: bottles, films, containers, closures. The terminal itself does not issue the Declaration of Conformity and is not responsible for the chemical composition of the plastic. It is responsible for something equally important: ensuring that material that entered the yard as food grade leaves it with its status intact — without contamination, with traceability preserved and a clean tank. That is precisely our role within the whole system.

Framework Regulation 1935/2004

Regulation (EC) 1935/2004 is the overarching act for all materials in contact with food — regardless of whether it concerns plastic, paper, metal, glass or ceramics. It establishes three fundamental principles on which the entire system rests:

• The safety principle. Under normal and foreseeable conditions of use, a material must not release components into food in quantities that endanger human health, nor in a way that brings about an unacceptable change in the composition of the food.
• The principle of organoleptic neutrality. A material must not impair the taste, smell or appearance of the food. This sounds obvious, but in practice the migration of minimal amounts of substances can change the taste of a product even though the concentrations are harmless to health.
• The traceability principle. Materials and articles must be traceable at all stages — from production, through processing and distribution, up to placing on the market. This is a requirement that applies directly to us as well: the transloading and transport operator.

The Regulation also introduces the concept of Good Manufacturing Practice (GMP) — described in more detail in a separate Regulation (EC) 2023/2006 — which extends the hygiene and quality requirements to all links in the chain. For the terminal this means that our cleanliness, documentation and control procedures must be consistent with the spirit of GMP, even though we are not the manufacturer of the plastic.

It is essential to understand the scope: 1935/2004 establishes the framework, but it leaves the technical details — lists of permitted substances, migration limits, the format of the declaration — to implementing acts for individual groups of materials. For plastics, that act is Regulation 10/2011.

Regulation 10/2011 for plastics

Regulation (EU) 10/2011 is the specific act covering exclusively plastic materials and articles intended to come into contact with food. It is this act that translates the general principles of 1935/2004 into concrete, measurable requirements. The three most important elements are:

• The Union List. A list of permitted monomers, additives and other starting substances that may be used to produce food contact plastics. A substance not on the list may not — as a rule — come into contact with food.
• Migration limits. Each restricted substance has an assigned specific migration limit (SML), and an overall migration limit (OML) applies to the material as a whole.
• Documentation requirements. The Regulation defines the content of the Declaration of Conformity (Annex IV) and the scope of supporting documentation that the manufacturer must make available to the competent authorities on request.

Food grade polymer granulate is subject to both acts simultaneously: the framework of 1935/2004 and the detail of 10/2011. The plastics manufacturer confirms conformity at raw-material level, and every subsequent participant in the chain — the converter, the distributor and, indirectly, the logistics operator as well — is responsible for ensuring that this conformity is not compromised at their stage.

Overall and specific migration

At the heart of the food contact rules lies the concept of migration — the transfer of components from a material into food. Two types are distinguished, both worth knowing even though they are confirmed by the plastics manufacturer, not the terminal:

Migration depends on the type of plastic, temperature, contact time and the nature of the food (fatty, acidic, aqueous). Migration testing is carried out on food simulants under conditions that reproduce the intended use — a simulant matching the target product is selected, the test temperature and time are set to reproduce the most severe foreseeable contact, and the result is compared with the limit. This is the domain of laboratories and plastics manufacturers — for the transloading operator one thing matters: contamination of the granulate with a foreign substance can disturb the entire, carefully confirmed migration profile.

A single contaminated tank can invalidate a declaration that the manufacturer built through laboratory testing. The mechanism is insidious because it is invisible: the granulate looks the same, yet its composition has been compromised by a trace amount of a substance from the previous cargo or from an uncleaned installation. The migration profile confirmed on clean raw material no longer applies to material that has “picked up” foreign compounds along the way. That is exactly why protecting the cleanliness of the material in transport is not an add-on to the service but a condition for maintaining conformity — and why the logistics operator, though it does not issue the declaration, genuinely shares responsibility for whether that declaration remains true to the end of the chain.

Declaration of Conformity (DoC) along the supply chain

The Declaration of Conformity — DoC — is a document in which the supplier of a material confirms its compliance with the regulations. In line with Annex IV to Regulation 10/2011, the declaration for plastics includes, among other things:

1. The name and address of the entity issuing the declaration and of the manufacturer or importer of the material.
2. The identification of the article or intermediate product — type of plastic, trade name, batch designation.
3. The date of issue of the declaration.
4. Confirmation of compliance with Regulation 1935/2004 and 10/2011 (and, where applicable, other relevant acts).
5. Information on restricted substances — so that the next participant in the chain can ensure the conformity of the final article.
6. Use specifications — for what type of food, and under what temperature and time conditions the material is intended.

The most important rule: the DoC must pass through the entire supply chain. The raw-material manufacturer issues the declaration for the granulate, the converter supplements it with their own confirmation for the finished packaging, and every intermediate participant — including the distributor and the logistics operator — is obliged not to break this chain of information. Granulate as an intermediate product does not yet come into contact with food, but its declaration must carry forward all the data that will allow the packaging producer to confirm the conformity of the final article. A broken document trail means broken conformity — no matter how physically clean the material is.

In practice, the granulate declaration usually contains warnings and restrictions that the converter cannot ignore: the permitted types of food, maximum temperatures, contact time, and sometimes information on substances requiring additional control at the finished-article stage. This is conditional data — the granulate is compliant provided it is used within the described scope. It is not the logistics operator’s role to interpret these conditions, but to ensure that the document reaches the recipient together with the correct batch of material and is not assigned to a different one. That is why linking the batch number to the documentation — seemingly an administrative task — is in fact an element of regulatory compliance, and not merely a matter of warehouse order.

Implications for transloading and transport

This is where our real responsibility begins. The terminal does not issue the DoC, but it is one of the links where food grade status is most easily lost. The four pillars on which we base the protection of food contact granulate:

• A clean, dedicated tank. A silo tanker carrying food grade granulate must not have previously carried non-food cargo without documented, confirmed cleaning. The industry standard is the ECD (European Cleaning Document) within the EFTCO system — a document confirming the type and scope of tanker cleaning. Without a clean tank, even the best granulate loses its status.
• No mixing with non-food cargo. We handle food contact material separately — no sharing of batches, no “residual” granulate from a previous load. This follows directly from the principle that cross-contamination is the greatest enemy of conformity.
• Batch traceability. We handle each batch from receipt to release while preserving the batch number and linking it to the delivery documentation. Should a problem arise at a later stage, the recipient must be able to reconstruct the history of the material — this is a direct traceability requirement under 1935/2004.
• Gentle transloading. Transloading without pneumatics — gravity discharge from a big-bag (FIBC) through a sieve into a silo tanker — does not introduce moisture from compressed air, does not generate angel hair and limits contact with installations in which residues of other materials could accumulate. For food contact granulate this is not a luxury but the proper method.

We implement these principles in our big-bag to silo tanker transloading service and in bulk material storage, where we keep food grade granulate in a covered hall, separated from cargo with lower hygiene requirements. We agree the specific scope of documentation and cleaning individually with the recipient according to their specification — ask for a quote.

The terminal’s role in maintaining food-grade integrity

It is easy to think that, since the Declaration of Conformity is issued by the plastics manufacturer and migration testing is carried out by a laboratory, logistics is merely “transport” here. That is a mistake that costs. The entire, carefully built conformity system — the Union List, migration limits, simulant testing, the declaration through all the links — can be invalidated by a single dirty tank or a single mixed-up batch in the yard. The weakest link in the chain determines the safety level of the whole.

That is why a terminal handling food contact materials must take its share of responsibility as seriously as the raw-material manufacturer does. In practice this means process discipline: the same cleanliness procedures for every batch, documenting tank cleaning, not combining food cargo with non-food cargo, maintaining traceability and — when the recipient requires it — providing the full set of documents confirming that nothing at our stage compromised conformity.

Our discipline also has an environmental and quality dimension consistent with the rest of the industry. Cleanliness of operations, reduction of dust and pellet spillage fit into the industry programme Operation Clean Sweep, and gentle transloading protects grain parameters just as it protects food contact status. For plastics manufacturers, choosing a logistics partner for food grade materials is an element of quality and regulatory risk management, and not just a matter of transport price.

Terminal infrastructure in Chorula

Maintaining food grade status requires not only procedures but also the infrastructure that delivers them. From the perspective of food contact material, three elements matter most. The first is a covered transloading hall — food grade granulate cannot stand in the open, exposed to rain, dust and wind; a roof here is a condition, not a convenience. The second is a cleaning sieve built into the gravity-discharge line, which captures mechanical contaminants before the material reaches the tank. The third is documenting silo tanker cleanliness at every change of material — without this the documentation trail breaks and food contact status loses its backing.

This combination of procedures and infrastructure makes it possible to deliver food contact granulate in bulk to converters in Poland, Germany, Czechia and Austria while preserving full food grade integrity. The full bulk material transloading offer is run by the PHS Magnum portal.

Related topics

Food contact materials are best understood in the context of the packaging they come from — the big-bag (FIBC) with a PE liner — and the method that protects their cleanliness: transloading without pneumatics and the prevention of cross-contamination. On the plastics side, the key ones are PET, PE and PP, most commonly encountered in food applications. We deliver cleanliness and documentation in the transloading service and in storage.

Sources

• Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food.
• Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (including Annex IV — Declaration of Conformity).
• Regulation (EC) No 2023/2006 on good manufacturing practice (GMP).
• EFTCO / ECD system — the industry standard for documenting tanker cleanliness.
• Operational practice of the SMIALA terminal, Chorula — Aleksy Pasternak.