From production to distribution, how contracts regulate obligations, warranties and responsibilities for non-compliant packaging materials

by Marco Arezio

In the complex world of packaging, where materials, processes, functions, and requirements intertwine, packaging compliance cannot be assessed solely in technical terms. Behind every heat-sealed tray, every barrier film, every screw cap lies a chain of contractual responsibilities that closely links material producers, converters, packagers, and distributors.

When packaging doesn't meet regulatory requirements—for example, due to migrant content exceeding legal limits, errors in environmental labeling, or the use of prohibited materials—it's not just the product that's "non-compliant": it's the entire supply chain contractual system that's called into question.

Far from being an ancillary element, packaging thus becomes a central element of contractual and regulatory risk, and the way in which the parties regulate the management of such risks in supply and processing contracts is fundamental to preventing disputes and protecting the upstream and downstream operator.

The packaging supply chain as a multilevel contractual system

The production of packaging - especially in the food, cosmetic and pharmaceutical sectors - normally involves a number of parties:

- the manufacturer of the material (plastic films, paper, aluminum, glass, etc.)

- the converter (printer, laminator, bag, jar, bottle former, etc.)

- the packager (food or cosmetic industry that fills the packaging)

- the distributor (who brings the product to the market)

This articulation is not only logistical or productive, but also contractual. Each step involves the stipulation of supply, transformation, or processing contracts, often formalized in general contract terms, recurring orders, framework agreements, or more detailed supply chain contracts.

The problem arises when non-compliant packaging causes harm to consumers (e.g., food contamination), customers (e.g., product recall), or the company's image (e.g., press campaign or intervention by the authorities). Who is responsible? Who pays? Who bears the burden of proof?

Legal responsibilities for non-compliant packaging: a multi-layered mosaic

At a regulatory level, the responsibilities arising from non-compliant packaging are divided into various legal forms, which are intertwined:

- Contractual liability (Article 1218 et seq. of the Civil Code): the supplier is liable to the customer for failure to fulfill supply obligations in accordance with the law and the contract.

- Non-contractual liability (art. 2043 of the Civil Code): in the event of damage to third parties, even those external to the contract, due to negligent or intentional conduct.

- Liability for damage caused by defective products (Directive 85/374/EEC and Legislative Decree 206/2005): if the packaging causes damage to health or property, the manufacturer may be held liable.

- Administrative and criminal liability: for violations of the legislation on materials in contact with food (Reg. 1935/2004, Reg. 10/2011), environmental legislation (labelling, recovery, recyclability), or workplace safety.

The legal qualification of the defect or non-conformity therefore determines which party in the supply chain is liable, on what basis, with what burden of proof and with what insurance coverage.

The contract as a tool for risk distribution

In such a fragmented and regulated sector, contracts are the primary tool for managing risk. Yet, in practice, many supply chain contracts are vague, unbalanced, or too general to effectively address non-compliance situations.

However, there are key clauses that, if well drafted, can make the difference between litigation and preventative risk management:

- Regulatory compliance clause: obliges the supplier to guarantee that the material supplied complies with all applicable European and national regulations, including those on migration, MOCA, traceability, etc.

- Indemnity clause: establishes that the supplier undertakes to indemnify the customer from any direct or indirect damage resulting from non-conformity of the material.

- Crisis cooperation clause: obliges the parties to cooperate in the event of a product recall or health alert.

- Declaration of Conformity (DoC) clause: requires that the material always be accompanied by updated technical documentation compliant with Reg. 10/2011.

- Inspection, testing and audit clauses: give the customer the right to carry out checks at the supplier's premises, or to request samples and analyses.

These clauses must be consistent with European food law guidelines and with Good Manufacturing Practice (GMP) criteria according to Regulation (EC) 2023/2006.

The problem of burden of proof and migration testing

One of the most critical issues, from a legal standpoint, concerns the burden of proof. In the case of non-compliant packaging (for example, with migration of substances beyond the limits), who must prove the cause of the problem? The film manufacturer? The company that printed it? The packager who performed the thermoforming?

Without a solid documentation chain, including migration tests, technical data sheets, declarations of conformity, and audit reports, it becomes difficult to determine who is responsible. The contract can (and should) include document traceability requirements and collaboration obligations for managing requests from authorities (NAS, ASL, Ministry of Health, EFSA).

Environmental labeling and new obligations: who's responsible for "end-of-life"?

An area of growing responsibility concerns the environmental labeling of packaging. Starting in 2023, pursuant to Legislative Decree 116/2020 (implementing EU Directive 2018/851), all packaging must display:

- material coding according to UNI standard

- information on waste collection (separate waste)

- information for correct disposal

Failure to provide this information or incorrect information may result in administrative sanctions and product recalls.

In this context, supply contracts should contain clauses on responsibility for environmental information, requiring the supplier to guarantee the accuracy of the wording and coding, based on the actual composition of the materials used.

This is particularly important in the case of multi-layered packaging, which is difficult to recycle, or composed of components produced by different parties (e.g. film, cap, label, liner, etc.).

Joint liability in supply chain contracts: a hidden risk

A clause often overlooked in supply chain contracts is joint liability. In the absence of a clear division of responsibility, multiple parties may be held jointly liable for non-compliant packaging, even if their contribution to the defect was minimal.

This can happen, for example, if:

- the supplier has not communicated a change in the composition of the material

- the packager modified the thermal sealing process, altering the barrier performance

- the distributor mismanaged storage, compromising the properties of the packaging

Only clear contractual planning, with risk allocation clauses, can protect every player along the supply chain.

Conclusion: the contract as a compliance safeguard and protection strategy

In packaging, the apparent simplicity of a box or film hides a complex and often overlooked legal framework. Packaging, now more than ever, is a regulated device, bringing with it regulatory obligations, legal risks, disclosure requirements, and reputational impacts.

Supply chain contracts are the true bulwark against non-compliance. Relying on good technical practices isn't enough: it's essential to transform regulatory responsibilities into clear, operational, and shared contractual clauses that can withstand pressure—whether it's an inspection, a recall, or a legal proceeding.

For every player in the supply chain—from film producers to retailers—packaging compliance isn't just a technical requirement: it's a strategic lever for legal protection, commercial reliability, and business sustainability.

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