Market access & commercial
A product claim is admissible exactly as far as the substance is definable and the effect measurable; panels are instruments built out of people.
The cluster is about what stands between a product and its label claim. A trained sensory panel is an instrument assembled from people, with its own calibration and drift. A health claim is substantiable only if the substance can be defined, the effect measured, and the link between them demonstrated — that is how EFSA is built. Substance identity under REACH decides whether a fermentation-derived product inherits another molecule’s registration data. Feed-additive authorisation stands on two study designs. Focus groups and A/B tests measure what people say about buying, not what they buy — and the honest page keeps the two apart.
Start with health claim substantiation: the triad of definable substance, measurable effect and demonstrated link sets the rules for the whole cluster.
Articles 7
| Consumer concept and A/B testing Asking people what they would buy measures something other than what they buy, and the gap is widest exactly where bio-based products make their claims. |
| Feed additive authorisation Whether a feed additive is permitted turns on two study designs — a tolerance trial in the animal that eats it, and an efficacy trial that has to detect a small zootechnical effect. |
| Health claim substantiation A claim is substantiable only if the substance can be defined, the effect is a measurable physiological benefit, and a human study links the two. |
| Pre-approval access to investigational medicines Giving an unapproved drug to a patient outside a trial is an evidentiary decision as much as a clinical one: it produces data that cannot be interpreted, from doses that could have been randomised. |
| Substance identity under REACH A fermentation-derived chemical can inherit the registration data of its petrochemical twin only if it is the same substance, and sameness is decided on the impurity profile. |
| Sensory evaluation panels A trained panel is an instrument built out of people — and like any instrument it has to be calibrated, and it drifts. |
| Biomass certification and chain of custody Segregation, mass balance and book-and-claim are three different promises, and only one of them is about the material in front of you. |