ALIMENTA
n. 1-2/26
INGREDIENT AUTHORIZATION IS NOT CLAIM AUTHORISATION: THE “AUTHORISATION UNIT” GAP BETWEEN CHINA AND THE EU. WHY CLAIM TRANSLATION BECOMES A TRADE RISK AND A MARKET-ACCESS COST.
di Hui Han
ABSTRACT:
Cross-border foods and nutrition/health products frequently fail compliance not because the ingredient is unlawful, but because the health-related message is treated as if ingredient permissibility automatically carries claim permissibility. China and the European Union both regulate claims through scientific substantiation and anti-misleading objectives, yet they stabilize ‘what can be said’ through different authorization containers. This article explains the divergence through the concept of the authorization unit: the regulatory unit within which a health-related statement becomes legally usable and audit-ready. In China, claimability is largely product- and pathway-centered (directory tools plus the registration/filing conclusion and approved label/leaflet). In the EU, compliance is primarily claim-entry-centered (authorized wording and conditions of use anchored in the EU Register and related lists). The authorization-unit gap is why literal claim translation often becomes a market-access cost across platforms, distributors, and enforcement touchpoints. The article concludes with three executable pathways for converting scientific value into compliant expression, and a replicable sequencing method to reduce trial-and-error.
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PAROLE CHIAVE:
Ingredient authorization – claim authorization – claim translation – EU – China.