Indeed, the implementation of theTHMPD, in its present form, will wipe out most of the traditional herb sector. Why?
WhileTHMPD was created specifically to accomodate traditional systems, it is financially prohibitive for the very companies active in this sector.
Mainly because of exorbitant registration fees, but also because it tends to enforce unnecessary and expensive quality-safety analytics based on mono-components. This in stead of appropriate and more cost-effective control on the total plant, with much better safety guarantees.
Time honored, safe and proven combinations are not accepted when containing more than four ingredients. This means about 90 % of the classical formulas is excluded.
THMPD does not provide any consistent methodological and scientific framework to accommodate complex and tailored formulas and ignores all the tenets of traditional herbalism
Implementation of THMPD in present form will increase the safety risks and multiply inadequate and inappropriate use of traditional plants.
The few substances rightfully forbidden as Food Supplement, will remain restricted as Traditional Medicine as well. There is no added value in the status of TM. You will not be able to use more herbs after THMPD is operational.
The legal and practical execution of the directive is generally experienced by its target sector as an attempt to keep traditional plants out of the Food Supplement statute, rather than to create a workable framework for Traditional Medicinal products. The THMPD negates the essence of a Food Supplement and a Traditional Medicine alike.
Without significant amendments on every level all companies carrying a full catalog of a traditional system will be out of business by 2011.
But there is more ! If the THMPD is not exactly the EU’s finest hour, then what to say about the Novel Food regulation? Originally designed to regulate gmo’s NF regulation is now coarsely and rashly targeting traditionally used herbs. Novel Food regulation is by far the most intransparant, incoherent and undemocratic piece of legislation the EU ever produced, but today already it is swallowing up important chunks of the traditional pharmacopeias. (e.g. Scutellaria baicalensis and Phyllanthus emblica) Imagine Ayurveda or TCM without these herbs!
The imminent implementation of both THMPD and NF regulation will only aggravate the already confused legal situation our sector finds itself in, and will make it more difficult for manufactorers and distributors to make sure they are operating legally.
EBF was created by a group of people who are professionally active in the field of traditional phytotherapy. They have been monitoring the technical and scientific interpretation of THMPD and NF by the regulatory and have come to the conclusion that our sector is heading for disaster.
EBF wants to highlight the specific situation of traditional disciplines in the European forum and intends to propose safe and viable alternatives on every level in order to obtain a suitable statute for our sector.