The sector's instinctive response to a restriction is to generate science — the route whose return is least well documented. Not because the studies are flawed, but because the administrative procedure in which they are submitted is not designed for negative results to close the file.
The first part concluded that the position of a botanical extract under Annex III of Regulation (EC) No 1925/2006 depends on the procedural channel it is in, and that Article 8 only recognises the operator's right to have its evidence examined during the Union scrutiny phase, and for a very short period. Once the legal position has been diagnosed and the composition of the extract documented, the question that consumes most resources remains: what exactly to do with that diagnosis.
The thesis of this second part is uncomfortable and should be stated bluntly: the sector's instinctive response to a restriction is to generate science, and that is precisely the route whose return is least well documented. This is not because the studies are flawed, but because the administrative procedure in which they are submitted is not designed for negative results to close the file.
Three precedents worth reading before approving any budget
In the file on the species assessed alongside aloe, two interested parties submitted dossiers with eleven additional genotoxicity studies, all negative. The Authority discarded them on the ground that they had been carried out on preparations with a low content of the derivative under examination, applying its statement on the genotoxicity of chemical mixtures, according to which the presence of a single genotoxic component makes the mixture a concern, whatever the overall tests on the mixture show. Yohimbe went the opposite way with the same outcome: nobody submitted any documentation within the deadline, and the substance went straight to prohibition without any new negative data emerging. In practice, submitting scientific evidence and not submitting it led to exactly the same place.
A third precedent, not a laxative botanical, completes the picture, and it is the most conclusive because the sector did everything the procedure allowed. Regulation (EU) 2022/860 placed monacolins from red yeast rice under Union scrutiny on 1 June 2022. The interested parties submitted their files within the deadline. The formal assessment began in June 2024, and a public consultation was opened in which no adverse comments were received. Despite that scrupulous compliance, on 29 January 2025 the Panel on Nutrition, Novel Foods and Food Allergens adopted its opinion (EFSA Journal 2025;23(2):9276), concluding that the data submitted did not allow the safety of monacolins below 3 mg per day to be established, nor any intake level of no concern to be identified. As a direct consequence, the draft regulation of July 2026 shows the entry already in Part A of Annex III. Note one crucial detail: these substances had been subject to a quantitative condition from the outset, and the existence of that maximum limit did nothing to preserve the file or to save the ingredient from a total ban.
None of this means the operator should resign itself; it means investing where the return is efficient or demonstrable. And the three areas where it is — the composition of the product, the channel through which it is sold, and the legal basis on which the measure is adopted — are not scientific, but technical and legal.
First route: changing the classification of the product
If the scientific route yields nothing, the first serious alternative is to change the classification of the product. Regulation (EC) No 1925/2006 prohibits the use of these substances in food, not their use in other sectors. The pharmaceutical channel is open: aloe preparations containing hydroxyanthracene derivatives for laxative use already have an official Union monograph, adopted by the EMA Committee on Herbal Medicinal Products under Article 16h(3) of Directive 2001/83/EC, and the same is true of other traditional laxative plants.
A traditional herbal medicinal product is not a mere change of label. It requires pharmaceutical quality, an official registration and pharmacovigilance obligations. But it allows the lawful sale of what Annex III prohibits in food. The food prohibition therefore does not destroy demand; it shifts it towards the pharmaceutical sector, where economic value moves to the manufacturing process and the ability to certify it.
Second route: the institutional channel
The second option is institutional and has a key date in July 2026. The draft measure moving the preparations of Rheum, Cassia and Rhamnus to Part A is currently under scrutiny by the European Parliament and the Council. It can be opposed on the ground that the Commission is exceeding the implementing powers conferred on it (Article 5a(3)(b) of Decision 1999/468/EC): the General Court has already held that Article 8 does not allow “preparations” to be regulated, and the new draft uses that same term again.
Companies cannot act directly at this stage, but they can do so through their trade associations or their national authorities. It is a short route with an unpredictable outcome, since the institutions rarely oppose such measures, but it has one decisive advantage: it acts before the measure is adopted, not afterwards.
The new reality of submitting defence files
A widespread misconception about submitting documents during the scrutiny period needs to be dispelled. Since Implementing Regulation (EU) 2023/612, EFSA no longer assesses files one by one as they arrive. It waits for the twenty-four-month period to end and carries out a single assessment for all the companies defending the same substance, in order to avoid contradictory or incomplete answers.
For a company, this means that submitting a file early neither speeds anything up nor yields any prior feedback, and that its file will be judged together with those of its competitors: if the rest of the sector's evidence is weak, it will weigh on the operator's own. Coordination with the rest of the sector is therefore no longer optional but a condition for success.
The order of priorities
With all this in mind, the order of steps for any company in the sector is as follows. First, secure the technical analysis: define the extract precisely and demonstrate that what is marketed matches exactly what is documented. That determines whether the product falls within the Annex III prohibitions, and it is the best shield against an immediate inspection.
Second, choose the sales channel — food or medicine. On that decision depend the level of regulatory demand and the type of customer, and it will commit investments that cannot be undone.
Only once those two points are settled should the company join collective institutional action. The overarching common objective should be to align Regulation (EC) No 1925/2006 with Articles 290 and 291 TFEU. That alignment requires a legislative act reopening the Regulation, and it is the opportunity to correct the wording of Article 8, which is the root of the whole problem.
What not to do
What should never come first is commissioning more scientific studies blindly. Experience with the last three sector files shows it clearly. Science is indispensable, but in this procedure studies only count if they are submitted on a fully characterised product, within the legal deadline and in coordination with the rest of the sector. If those conditions are not met, the study will be discarded, however good its results.
Javier Gómez Sanz is the founder and director of Food Tech Legal. Comments on this analysis may be sent to editorial@foodtechlegal.com. Enquiries about a specific product or case are handled through the quote form. The original Spanish version of this analysis is available here.