Recent Developments in Regulatory Matters on Herbal Medicinal Products in Europe
Bibliographic record
Abstract
Within the group of industrially prepared herbal or botanical products there is a large variation worldwide with regard to the properties and the legal status of these products. Some herbal products are close to or are medicines, while others are close to or even identical to foods such as dietary supplements, functional foods, novel foods, etc. and still others are considered as cosmetics or medical devices. Therefore it is not surprising that recently appropriate regulatory actions have been undertaken to regulate and harmonize the legal status of these various groups of plant preparations throughout Western countries. The European Union (EU) has recently considered herbal products in several legislative texts. Medicinal use has been harmonized for herbal medicinal products (HMP) with regard to well-established (WE) and traditional (T) uses through Directives 2004/27/EC and 2004/24/EC amending Directive 2001/83/EC. Use of herbal preparations in unit dose form under food law is covered in the Food Supplements Directive (FSD) 2002/46/EC. Regulations on nutrition and health claims and the addition of vitamins and minerals and certain other substances to foods have been adopted on December 12, 2006. (Council Regulations (EC) n°1924/2006 and 1925/2006). Nevertheless, the distinction between traditional herbal medicinal products and food supplements containing herbal products without nutritional value but having physiological effects remains vague and controversial. In this presentation the implementation of the current European regulations at the level of the EU Member State authorities and manufacturers in terms of quality, safety and efficacy of these herbal products will be discussed. A comparison will be made with other concepts existing worldwide, taking into account not only the above mentioned properties, but also aspects such as access to the market, cost price, and prospects for innovation of herbal products.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".