With 350 million of consumers of high average income per capita, the European Union market is the most important food market in the world. But its 27 independent member states with various sets of legal requirements, make legal compliance a highly complex puzzle. The formation of the Union has facilitated inter-European commerce, yet food businesses have to sort out and comply with a wide variety of market entry requirements.
EU food law and regulatory compliance
With more than 4,000 pieces of intertwined food laws, EU regulatory affairs is often an intricate puzzle for food companies. Food laws apply at various levels: to the raw materials, additives and ingredients, intermediates and finished foods; to product composition, formulation, process and packaging; to label, claims, supporting documents, data and communication; to traceability, intellectual property and so forth. There are horizontal and vertical laws; horizontal laws apply to all foods, vertical ones apply to specific products.
Thus, besides legal aspects, a main compliance hurdle are questions related to the food product itself. Yes, effective and efficient food compliance goes beyond the legal aspects of rules and regulations: it involves technical food knowledge and proven experience, directly dealing with food authorities, a good professional network in various countries as well as knowing shortcuts to reduce costs.
Although efforts have been made to reach a working level of harmonization in EU food law, this is far from being the case. And even in the most harmonized cases, national differences in law enforcement are a sad reality. Yet knowing which requirements apply to each product and how to comply in the various countries is essential for food companies.
Further, sometimes scientific evidence must be submitted, dossiers must be prepared, pre-market authorization must be obtained. Market and competitor data comes sometimes useful. Generally food regulatory compliance is an intricate combination of food regulatory affairs with science & technology, industrial experience and know-how. And in the European Union, knowledge of differences in the member states with regards to laws, languages, approach and functioning is essential.