21 de November de 2025

Intelligent Product Compliance. The new standard to compete in regulated markets.

Xabier Uriagereka

Product safety management has always been a critical aspect in companies working with regulated substances, mixtures or articles. For years, organizations have relied on traditional models that allowed them to control essential documentation, generate safety data sheets or assess specific risks. That approach – based on Product Safety –served its purpose in a more stable and predictable regulatory environment. But that world no longer exists.

Today, companies operate in global markets, with changing regulations and increasingly stringent requirements. The speed at which legislation evolves exceeds the capacity of any manual process. The result is a challenge that can no longer be solved with partial tools or late validations. A paradigm shift is needed: from classic Product Safety to an intelligent, integrated and proactive Product Compliance.

A regulatory scenario that demands a different speed

Regulations affecting chemicals, mixtures and articles have multiplied and diversified. Each region, country or even state can impose its own conditions for marketing, storing or transporting a product. Substance categorization, market restrictions, mandatory registration, labeling, transport control and waste management are just some of the dimensions that must be taken into account.

This picture is not only complex; it is dynamic. Restricted substances lists change, new prohibitions emerge, classification criteria are modified and documentation requirements are updated. Operating on the basis of Excel sheets, manual processes or spot checks is, today, an invitation to error.

A single oversight can result in penalties, refunds, customs detentions, production stoppages or even temporary sales bans. And when these problems arise, it is too late to correct them without impact.

This is where the traditional approach falls short.

The limits of traditional Product Safety

The classic Product Safety model was created to meet specific needs: documenting substances and mixtures, controlling their classification, generating safety data sheets and meeting transport obligations. These capabilities are still necessary, but they are no longer sufficient.

Its greatest weakness is structural: it acts as an external layer to the process. It evaluates compliance when decisions have already been made – a product designed, a quotation sent, a batch prepared – and not before. The result is a chain of decisions that is born with uncertainty and is only validated at the end. When non-compliance occurs, the impact falls on sales, engineering, production, logistics and, ultimately, the customer.

Companies cannot afford to operate like this in a globalized environment.

Intelligent Product Compliance. An integrated and proactive model

The natural evolution of Product Safety is intelligent Product Compliance. This new approach introduces two fundamental changes: integration and anticipation.

Integration means that regulatory compliance ceases to be an isolated process and becomes part of every phase of the business. From the moment sales receives a requirement, the system must be able to identify whether the product is viable, what substances it contains, what regulations apply in each destination and whether the plant where it will be manufactured meets the necessary standards. Engineering designs evaluating compliance in real time. Production consumes raw materials under control. Logistics generates packaging and labeling automatically. Warehouse manages compatibilities and storage limits without risk.

Anticipation means that compliance is not checked at the end, but before any operational decision is made. It no longer matters only whether the product complies, but whether it will be able to comply in each market, under what conditions and with what documentation.

This change completely transforms the model: regulatory compliance ceases to be a brake and becomes a business accelerator.

The invisible pillar. Regulatory content

To speak of intelligent Product Compliance is to speak of regulatory content, although, paradoxically, it is the least visible part of the system. Its role is critical because it makes it possible to automate processes that would otherwise be unmanageable.

Regulatory content providers collect, update and structure global information: substance lists, country requirements, transport obligations, labeling regulations, composition limits, documentation formats and classification criteria. This content is integrated directly into the system and acts as an “intelligence” that enables the ERP to evaluate products, identify risks and generate automatic warnings.

A Product Compliance solution without reliable regulatory content is simply a shell. With it, on the other hand, it becomes a tool capable of anticipating and preventing errors before they occur.

Choosing the right model and ensuring a cross-cutting process

Companies must decide how to manage Product Compliance according to the level of confidentiality of their information. When the formulation is not sensitive and the composition is not part of the strategic value, outsourcing documentation generation or regulatory assessment is efficient and practical. But when the recipe is at the core of the business, exposing it to third parties is unacceptable. In such cases, compliance must be managed within the ERP, with regulatory content that allows automation without revealing critical information. This choice determines whether the organization protects its competitive advantage or puts it at risk.

Regulatory compliance is also a cross-cutting process that involves all areas. Sales needs to validate the viability of the product before committing it; engineering must design under regulatory criteria; production and MRP plan according to authorized substances; warehouse controls quantities and compatibilities; and logistics ensures that documentation, packaging and labeling comply with destination regulations. Without real integration, errors multiply throughout the process.

As a result, more and more companies are incorporating Product Compliance directly into their ERP. This approach makes it possible to analyze compositions, validate substances, automatically generate documentation, manage waste and comply with transport regulations from a single system. The aim is to anticipate risks before they arise and to ensure that every business and operational decision is based on up-to-date information.

The leap to smart Product Compliance is not an incremental improvement, but a structural evolution. It defines a company’s ability to operate safely, avoid penalties, gain speed and compete in regulated markets. Turning compliance into a competitive advantage makes the difference between leading or falling behind.

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Xabier Uriagereka

Head of Innovation and Transformation at i3s

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