Why operational reality is the decisive weak point in most companies — and what really helps
Anyone who attends specialist events on product compliance, follows webinars or reads trade media quickly gains a particular impression: it is all about laws, regulations, recitals and transition periods. Lawyers explain what EU legislation requires of companies, what obligations arise from the new EU product safety regulation (GPSR), what REACH and RoHS mean in concrete terms, how the Packaging Regulation (PPWR) is to be read. This is correct, necessary and indispensable — because no compliance programme can be built without legal clarity.
And yet this is only part of the truth. Anyone who works in practice with companies that source consumer goods from Asia and market them in Europe experiences a different reality: the real problem is rarely a lack of legal knowledge alone. The real problem is operational implementation — the ability to anchor legal requirements in day-to-day business reliably, verifiably and permanently.
Product compliance is therefore more than a legal problem. Above all, it is a management problem. And it is precisely there, in operational implementation, that most compliance risks arise — whether in mid-sized companies or large corporations.
Legal expertise forms the necessary foundation of every compliance programme: anyone who does not know the requirements cannot meet them. Specialised lawyers do valuable work here — they analyse grey areas, clarify questions of interpretation and support companies in administrative and court proceedings.
But on this foundation something must be built that constitutes a discipline of its own, of equal standing: operational compliance management. It does not answer the question of what the law requires — but the question of how a company implements what is required reliably, verifiably and permanently in day-to-day business. It is about processes, responsibilities, systems, data and people. And it is precisely here that most compliance risks arise in practice.
Anyone familiar with companies that market consumer goods in Europe knows these challenges. They affect mid-sized importers just as much as large retail businesses. More employees and larger structures do not automatically bring relief — because as a company grows, the breadth of its range, the number of suppliers and regulatory complexity usually grow too. The challenge scales with it.
A company with 2,000 articles from ten different product categories faces a complex mosaic of requirements: toys, electrical articles, cosmetics and textiles are each subject to different directives, test standards and documentation obligations. The question “Which requirements apply to which product?” is not a trivial legal question — it is an ongoing operational task that demands constant updating.
By far the largest share of non-food consumer goods sold in Europe is produced in China, Southeast Asia or other third countries. This means: the manufacturers are not subject to any EU regulation and orient themselves primarily towards the requirements of their home market — and, where exports play a role, often towards the USA as the most important target market. Many suppliers have the European regulatory landscape — with its specific complexity, far-reaching environmental and sustainability requirements and numerous product-category-specific directives — not on their radar at all, or only insufficiently. The European importer bears full legal responsibility — and at the same time fights against the inertia of distant supply chains that operate by different rules.
In many companies product compliance is not a department of its own with a clear home, but hangs somewhere between purchasing, quality management and the legal department. In mid-sized companies one person often handles it on the side. In larger companies there are more people involved — but also more silos, a broader range and more internal coordination needs. In both cases the topic often only receives priority when the market surveillance authority comes knocking. That is, to put it mildly, not an ideal starting scenario.
Declarations of conformity, test reports, technical documentation, REACH declarations — the European responsible person must keep all of this on file and be able to present it if in doubt. The reality: many suppliers provide no documents, incomplete documents, or documents that do not stand up to closer scrutiny. Obtaining, checking and archiving these documents is a permanent operational task — and an area that is systematically underestimated in many companies.
Requirements change: new standards come into force, transition periods expire, limit values are tightened, new product categories are regulated. Excel-based compliance tracking quickly reaches its limits here — and even proprietary in-house developments at larger companies are often neither dynamic nor integrated enough. What is actually needed is a software solution that updates requirements automatically, brings product and packaging requirements together in one system, and scales across different markets and categories. Such solutions exist — but are by no means in use everywhere.
A product compliance manager must know regulatory requirements, understand technical interrelationships, negotiate with Asian suppliers, coordinate internal departments and master communication with authorities. The profile is demanding and rare — and fiercely contested on the labour market. Many companies do not fill the corresponding positions at all, or fill them with people who bring motivation but not the necessary technical depth.
EU regulation in the area of product compliance is not a static construct. GPSR has replaced the previous product safety directive, PPWR confronts companies with entirely new challenges, ESPR and the digital product passport are waiting in the wings. Anyone who has built a functioning compliance structure today must be ready to adapt it tomorrow. That requires not only legal knowledge — it requires organisational flexibility.
No compliance topic currently occupies companies that market products in the EU as much as the EU Packaging Regulation PPWR (Regulation (EU) 2025/40) — regardless of their size. The reasons for this are symptomatic of everything that can go wrong operationally:
PPWR is thus a case study in operational complexity: the standard is known, the requirements have been analysed — but operational implementation in processes, systems and supply chains has yet to happen in most companies.
At this point honesty is required: 100 percent product compliance for a broad product range, with suppliers from third countries, in a constantly changing regulatory environment — for most companies this is neither fully achievable nor fully affordable. Large companies have more resources, but also considerably more complexity: more products, more markets, more suppliers, more regulatory construction sites at the same time.
But this by no means means that one should sit on one’s hands. It means that compliance management imperatively needs a risk management perspective. The relevant questions are then:
A structured, documented risk management system not only gives companies internal orientation — in the event of an official inspection it also demonstrates that the company takes the topic seriously and approaches it systematically. Evidence of an orderly compliance process is often more valuable than the attempt to reduce all risks to zero at the same time.
Functioning product compliance — whether at a mid-sized importer or a large retail group — rests on four interrelated elements. None of them is sufficient on its own:
Who is responsible for which product group? When is which document requested from which supplier? How are new products released from a compliance perspective? These questions need clear, written answers — not legal opinions.
The quality of a compliance system stands and falls with the quality of the underlying documentation. A distinction must be made here: test reports, supplier declarations and other evidence are obtained from suppliers and testing institutes — they form the basis for the documents that the manufacturer or importer creates themselves: declarations of conformity and technical documentation. Both levels must be systematically maintained, kept up to date and accessible. This is not a one-off project task but a permanent operational task — and one of the areas where gaps most frequently arise in practice.
Software that brings product requirements and packaging requirements together in one system, automatically takes account of changes in requirements and makes document status transparent is available today. trinasco works with a leading product compliance management solution that integrates both dimensions — product and packaging — and scales for companies with broad product ranges.
Compliance resources flow to where the risk is greatest. Priorities are made transparent, documented and reviewed regularly. This is not an admission of weakness — it is professional management.
Product compliance is more than a legal problem — and therefore needs more than legal answers. What is often missing in practice is the bridge between legal knowledge and operational implementation: someone who knows the regulatory requirements and at the same time knows how to anchor them in the company permanently and verifiably.
What trinasco delivers is holistic operational support for compliance management:
And for companies that cannot or do not want to build up the topic internally, trinasco offers more than consulting: as an outsourced product compliance department, trinasco takes over the operational activities entirely — from ongoing requirements monitoring through supplier communication to document maintenance and communication with authorities. This gives companies compliance expertise without their own staff capacity.
This is exactly the bridge trinasco builds — with an approach that brings together regulatory knowledge, process know-how, software competence and operational experience. Because compliance problems arise in practice. That is where they must be solved.
Product compliance is more than a legal problem — above all it is a management problem. The question “What does the law say?” is important and must be answered. But the decisive questions for operational practice are: Do we have the right processes? The complete documents? The right software? The right priorities?
Companies that can answer these questions are not per se immune to objections. But they are able to respond to requirements, manage risks and, in an emergency, demonstrate that they act seriously and systematically.
That is the actual goal of product compliance management: not theoretical completeness, but operational capacity to act — reliable, verifiable and scalable.
Would you like to know how well your company is positioned for these challenges? trinasco offers a free initial consultation.
What do you need to do now? Book our free initial consultation now.
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What do you need to do now? Book our free initial consultation now.
Save €249!!
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