• This changed in 2025 and a great deal of detox marketing copy has not caught up.
• Since 2010 the Commission has suspended its evaluation of health claims relating to botanical substances, leaving a backlog of over two thousand applications and an “on-hold” list whose claims were tolerated under the transitional provisions of Article 28(5) of Regulation (EC) 1924/2006. Many operators read that suspension as a permissive grey zone.
• In the decision in Case C-386/23 (Novel Nutriology), issued on 30 April 2025, the Court of Justice held that claims relating to the health benefits of botanicals cannot be made unless authorized, despite the suspension of the evaluation procedure. The ban of Article 10(1) still applies, along with the Article 10(3) obligation to provide, in the case of general references to benefit, an authorized claim as well. The transition path remains valid only for the cases in which an application was made to the relevant national competent authorities before 19 January 2008 and the claim is on the on-hold list.
• Consequence in terms of a detox brand. Milk thistle, dandelion, artichoke, turmeric and schisandra cannot make a health claim in the EU, unless there is a specific on-hold application and all the criteria of the transition path are fulfilled. It must be derived from the nutrients in the formula. It is not detrimental to the product but just means that the benefit is attributed to another ingredient in the label, and it is a straightforward design constraint once it is known at concept stage rather than discovered at label review.
• Marker quantification – HPLC-DAD & UHPLC-MS/MS methodologies with validation for specificity, linearity, accuracy, precision, LOD/LOQ, range & robustness in accordance with ICH Q2(R2).
• Microbiology – Total aerobic microbial count and total yeast and mould count in accordance with USP <2021>/<2022>, with absence testing for Salmonella, E. coli, S. aureus & P. aeruginosa.
• Physical Characterization – Particle size distribution (D10/D50/D90), water activity, Karl Fischer moisture content, bulk & tapped density, disintegration and dissolution in accordance with USP <2040>
• Stability – ICH Q1A(R2) protocols with accelerated conditions of 40°C/75% RH and long-term conditions of 25°C/60% RH or, for Zone IVb markets like India and most of ASEAN, 30°C/75% RH; photostability testing in accordance with ICH Q1B; packaging compatibility & moisture permeability testing; overage based on degradation data rather than tradition

If a market claims a specific nutrient, then the nutrient assay becomes a claim-critical specification: the amount of nutrient stated on the label has to last until the end of shelf life as per the requirements of the authorized claim, and the stability protocol would be developed specifically for that nutrient, not the hero botanical.