DGAV Notification-Only Regime Leaves Portugal Out of the Five-Country EU Pre-Approval Bloc on Food Supplements — 2024 Documentary Analysis Slides to 23% as Half of Europe Publishes Public Databases

Portugal sits firmly outside the small bloc of European Union member states that now require pre-market approval of food supplements, with Cyprus, Latvia, Lithuania, Luxembourg and Romania the only five jurisdictions imposing prior authorisation, Público reported on Saturday. Domestically, the Direção-Geral de Alimentação e Veterinária (Directorate-General for Food and Veterinary Affairs, DGAV) runs the notification-only model — and its documentary-analysis rate on those notifications dropped from above 40% in 2021-2023 to 23% in 2024.

The structural picture matters for consumer protection. The EU Directive 2002/46/EC on food supplements harmonises which vitamin and mineral substances can be sold but leaves enforcement architecture to member states. Most countries — Portugal included — chose the lighter notificação model: producers email DGAV with the formulation and label and may put the product on the shelf within the statutory grace period. Five countries chose the heavier autorização prévia (prior authorisation) route, which subjects every formulation to an administrative dossier review before market entry.

The middle ground — public databases of notified supplements — is where Portugal also lags. Roughly half of the EU operates a publicly searchable registry that lets consumers verify whether a specific supplement has cleared the notification step. Portugal's notifications sit inside DGAV's internal workflow without a consumer-facing front-end, leaving end-users without a reliable way to check whether what they have bought has reached the regulator at all.

The 23% documentary-analysis rate is the operational red flag. With DGAV reviewing fewer than one in four notifications on paper — let alone with sampling and lab analysis — the model leans heavily on post-market surveillance through ASAE (Autoridade de Segurança Alimentar e Económica, the Food and Economic Safety Authority) inspections at retail level. Post-market surveillance catches some non-compliance but cannot stop a non-conforming product from reaching the shelf in the first place.

The published evidence supports tighter scrutiny. A 2024 randomised analysis of 192 Irish supplements published in Food Science & Nutrition found roughly 90% making health claims and around half breaching EU advertising rules under Regulation 1924/2006. Portuguese audit data inside DGAV's internal reports points to similar non-conformity bands, including label-claim breaches and undeclared additives — categories that a documentary-analysis review with sampling would surface before market entry.

The policy choice for Portugal sits at the intersection of three pressures. Consumer-protection bodies, including DECO PROteste, have pushed for a public database and a higher analysis rate. Industry — represented by APARD (Associação Portuguesa de Alimentação e Saúde) and the food-supplement vertical inside APED — argues that a switch to prior authorisation would price small producers out and slow time-to-market. The Ministério da Saúde (Health Ministry), which co-supervises DGAV with the Ministério da Agricultura, has so far backed the notification model on competitiveness grounds.

The European Commission has signalled that a Directive 2002/46/EC review is on its 2026-2027 work programme, with novel-foods and herbal-supplement clarifications expected to feed into a possible legislative proposal. If Brussels moves toward a harmonised database obligation, Portugal will need either to build a public front-end on the DGAV notification tape or to ride the European Food Safety Authority's emerging registry.

The 23% figure is the metric to watch into 2026.