Belgium tightens food and pharma control with new inter-agency protocol

Belgium's Federal Agency for Medicines and Health Products (FAMHP) and the Federal Agency for the Safety of the Food Chain (FASFC) have signed a renewed cooperation agreement that defines and coordinates their supervisory responsibilities across the food, feed and pharmaceutical interface.

The protocol entered into force upon signature on 22 January this year. It covers controls in the distribution chain across five product categories: food supplements, fortified foods (those with nutrients added), foods for specific groups, medicated feed, and medicinal products used in veterinary medicine. Manufacturing is expressly excluded from its scope.

For businesses operating at the intersection of food and pharmaceutical regulation in Belgium, including food supplement distributors, pharmacies, veterinary product suppliers and agri-food operators, the protocol introduces a clearer and in some respects more demanding supervisory framework.

Clarified surveillance powers 

The protocol draws a careful line between the two agencies' respective territories in the pharmaceutical sector. The FAMHP retains responsibility for controlling medicinal products in pharmacies and at wholesale distribution level, while the FASFC holds primary competence for food products -including food supplements, fortified foods and foods for specific groups. This is at manufacturer level and throughout the distribution chain.

Critically, the protocol addresses the practical overlap that arises when both agencies are competent for the same operator; in particular, pharmacies and pharmaceutical wholesalers. To avoid duplicating controls, the FAMHP will also carry out certain food-law controls, including sampling and labelling inspections, on behalf of and in the name of the FASFC.

A pharmacy or food supplement distributor could therefore find itself inspected by FAMHP officials acting under FASFC authority and applying FASFC checklists and inspection criteria, on top of the FAMHP's own regulatory remit.

In the veterinary sphere, the division of tasks is equally clear. The FAMHP is responsible for overseeing veterinary medicinal products from production through to dispensing by pharmacies and veterinarians from their depots, including wholesale distributors. That responsibility also covers the quality, conformity and traceability of veterinarian-prescribed medicines, with farms explicitly carved out.

The FASFC covers feed and medicated feed at manufacturers and in the distribution chain, and controls veterinary medicine stocks on farms. Where irregularities emerge at farm level or in products of animal origin, it also reviews veterinarians' prescriptions and veterinary depot records for food-producing animals.

Delegated controls in pharmacies

What stands out in the protocol is the detailed mechanism by which food-law controls are delegated to the FAMHP to be carried out at pharmacies and pharmaceutical wholesalers.

Each year, no later than 1 October, the FASFC must transmit to the FAMHP its sampling programme for the following year. The programme covers food supplements, fortified foods and foods for specific groups available at that level of the distribution chain. The programme must be proportionate and remain within the FAMHP's available resources. The FASFC provides the necessary procedures, checklists and technical data sheets to enable those to carry out those controls.

In practice, FAMHP inspectors, whose primary focus is medicinal products, will be checking food-law compliance of supplements and specialised nutrition products on the FASFC's behalf, applying the FASFC's own analytical parameters and labelling criteria. Sampling results are reported quarterly to the FASFC using a standardised template.

Where food supplements are involved, results must also be expressed per recommended daily dose so that vitamin and mineral levels can be assessed against applicable recommended daily allowances. The template lists parameters such as vitamin A, calcium and arsenic, across product matrices including food supplements, complete infant formula, follow-on formula, processed cereal-based foods and baby food.

On the quality of these delegated controls, the FASFC commits to providing appropriate training to the FAMHP staff involved, whether through of e-learning modules, shared checklists or joint field visits in which FAMHP inspectors accompany FASFC inspectors at retail outlets or at manufacturers of the relevant food and feed products.

The FAMHP's inspection activities under the protocol are funded from a dedicated budget line financed in part by the relevant levies under the FAMHP's founding act of 20 July 2006. 

Non-compliance and serious risk responsibilities

The protocol sets out a graduated response framework for non-conformities discovered during delegated controls. For ordinary non-compliant results, the FAMHP must notify the relevant FASFC local control unit within seven working days of receiving the laboratory report, providing sufficient information for the FASFC to organise follow-up with the responsible operator. The FASFC then takes over: it follows up directly with the operator, proposing a second analysis where appropriate and takes risk-based enforcement measures.

The deadline tightens sharply to 24 hours where the FAMHP suspects a serious public health risk, such as the presence of pathogens in infant formula.

Where a market withdrawal is required, the FAMHP may take immediate provisional measures at the pharmacy or wholesaler concerned, within the limits of its legal powers, and must alert the FASFC if there is any uncertainty about whether it has the legal authority to act. The FASFC then ensures follow-up with the responsible operator of the product concerned and takes any further measures on the basis of a risk assessment. Where a serious risk involves other EU member states, the FASFC is responsible for issuing a RASFF notification – the rapid alert system for food and feed.

For consumer-facing recalls, the FASFC supplies all relevant information, including press releases and lists of affected pharmacies which the FAMHP uses to produce in-pharmacy recall notices based on a FASFC-supplied template. The FAMHP subsequently verifies, through routine and targeted inspections, that notices are properly displayed and that recall instructions have been implemented.

Borderline products 

The protocol addresses one of the most persistent challenges in the food-pharma space: products sold as food supplements that may, in reality, qualify as medicinal products. The question matters well beyond enforcement: it determines the entire legal framework applicable to the product, from authorisation requirements to labelling, pharmacovigilance and liability.

The default rule in the protocol is that infringements are pursued under food law unless it can be clearly demonstrated that the product manifestly meets the definition of a medicinal product. The competent authority is then determined by whether the product placed on the market qualifies as a food or as a medicine. Where doubt arises (for instance, when the applicable law is uncertain or product status is genuinely unclear), the FASFC's and FAMHP's investigation units consult each other and, where needed, organise joint inspections, triggered when the information at hand appears to engage both legislative frameworks. During a joint inspection, the two teams agree on site which authority takes the lead.

That said, this protocol-level enforcement default sits alongside and cannot override the EU rule under article 2(2) of the recently overhauled Directive 2001/83/EC, which provides that in cases of doubt as to whether a product is a medicinal product or falls within the scope of other EU legislation, the medicinal product provisions shall apply. The protocol's arrangement is a practical inter-agency enforcement tool but it does not alter the underlying legal classification framework.

Companies whose products could plausibly be characterised as either food supplements or medicinal products, including botanical preparations and high-dose nutrient products, are therefore operating in an area where the applicable regime can remain genuinely contested, regardless of which enforcement path the agencies choose to take in a given case.

The agencies also maintain a shared, regularly updated list of infringements categorised as falling under medicines law. This records how previous borderline cases have been resolved, is reviewed at periodical coordination cell meetings and, over time, shapes the developing enforcement practice of both agencies.

Governance and oversight

The protocol also builds in several governance safeguards. The FASFC retains the right to audit the FAMHP's compliance with the agreement, and the FAMHP is required to cooperate in relevant external audits and to draw up action plans in response to any recommendations. Complaints relating to delegated controls are handled by the FAMHP under its own procedures and communicated to the FASFC via the coordination cell. Any disputes arising under the protocol are first referred to the heads of both agencies for amicable resolution and, failing that, escalated to the competent supervising ministers. A copy of the agreement is transmitted to the Ministers of Public Health and Agriculture.

Osborne Clarke comment

Belgium's new FAMHP-FASFC protocol is, at first glance, a document about inter-agency process. Look a little closer, and it carries some pointed implications for any business operating in the food supplements, specialised nutrition, veterinary medicines or agri-food distribution space in Belgium.

For businesses distributing food supplements, fortified foods or foods for specific groups through pharmacies or pharmaceutical wholesalers in Belgium, the practical change is immediate: FAMHP inspectors may carry out sampling and labelling checks that were previously the FASFC's domain, following FASFC procedures and checklists. A single pharmacy visit could therefore encompass both the FAMHP's own medicinal product inspection and a FASFC-delegated food-law review of the supplements on the shelf. Operators should be familiar with the FASFC's annual sampling priorities and the analytical parameters it typically applies and ensure that product labelling and composition are squarely aligned with food-law requirements.

For those operating in the veterinary and agri-food space, the articulation between FAMHP and FASFC competencies across the distribution chain offers useful clarity that may inform both compliance programmes and the structuring of distribution arrangements. The 24-hour notification obligation for serious risks identified during delegated controls is worth flagging for regulatory and compliance teams: in particular, it sets a very tight operational deadline for inter-agency communication, with consequences that can run directly upstream to manufacturers, importers and distributors.

Borderline products remain the trickiest part of the picture. While the protocol establishes a practical "food law first" enforcement default, that arrangement does not displace the EU law principle that the pharmaceutical legislation prevails in cases of doubt. Product classification remains a fact-specific legal question, and companies with products that could be characterised as either food supplements or medicinal products may find it useful to keep in view the developing case practice recorded in the agencies' shared list. Proactive engagement with the relevant agencies at an early stage, where product status is uncertain, tends to reduce the risk of regulatory disruption significantly more than a reactive approach once enforcement has begun.