Sunday, January 30, 2011

Difference Between Icy And Rock

EEC Directive on herbal medicine. Entrance to the lobbies of the drug here



It is said that from next April 1, 2011, that is between four months, they will disappear from selling supplements, natural medicines, traditional, closed the schools of naturopathy and homeopathy, and will be burned all the books on natural subjects. News
that certainly fall into a clear strategy.
Spreading news is not feasible (at least in the) part of a media strategy to divert masses.
who does will never believe that books will disappear, or even to be closed down schools several decades of naturopathy?
As this in the short term this is impossible, the result is that everything becomes meaningless.

try to do some 'clarity.

Directive 2000/13/EC
studied before the directive of March 20, 2000 when the bureaucrats of the European Parliament and the Council of Europe approved the Directive 2000/13/EC "on the approximation of laws Member States relating to the labeling and presentation of food, and advertising "
In this Directive, entry into force May 26, 2000, s labeling the talks at EU level.

Article 2

1. The labeling and methods used must not:

b) (...) any foodstuff the property of preventing, treating or curing a human disease or refer to such properties .

in this Directive can not be "attributed to food property of preventing, treating or curing a human disease or refer to such property." what the bureaucrats are for "food" can be found in Directive 2002/46/EC.


Directive 2002/46/EC Directive 2002/46/EC, which culminate this time in Luxembourg, " on the laws of the Member States relating to food supplements " is very interesting !

In Italy has been implemented with Legislative Decree no. 169, 21 May 2004 and published in the Official Gazette no. 164, July 15, 2004.


Article 1 1. This directive applies to supplements food marketed as foodstuffs and presented as such.

Article 1 of Directive 2002/46, " food supplements, are marketed as" food , "and as such, the Directive 2000/13 seen before, you are NOT can give them any property " preventing, treating or curing a human disease .
Article 2, paragraph b) instead, you specify that the vitamins and minerals are considered " nutrients "Or" nutrients, "and in paragraph a)" food supplements "may consist of a" concentrated source of 'nutrients' . One can conclude that for both vitamins and minerals are considered "food !

Article 2

the purposes of this Directive shall apply:

a) "food supplements" means products foodstuffs to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological (...);

b) "nutrients" or "nutrient" means the following substances :

i) vitamins,

ii) minerals.

is the first step epochal change " mineral ", " vitamins "and" plants, "first in" supplements "and then" food "(food supplements), also specifying the recommended dose for daily intake (the RDA ridiculous). Dose not to exceed, of course!
not all, because in support of that directive, the Ministry of Health has provided a list of permitted plants (Table B: " herbs used in dietary supplements") and a list of substances not allowed (400, Table A : "herbs whose deliberate use is not allowed ").
All the plants mentioned in the latter list were removed from the market, creating confusion among sellers and consumers, and serious economic problems for producers!
Just to understand the situation, there are many cases where the same tree appears in both lists, only differentiated from the use (seed, flower or bark for example). Even more confusion and enormous economic damage to those small and medium-sized companies who may have invested money on the products, rather than a specific plant.

If we consider that the Directive 90/496/EEC of September 24, 1990, as "food " are those " intended to restaurants, hospitals, canteens and similar establishments " c IOE only food!
typed immediately after Article 1, paragraph 2) that the Directive (90/496/EEC) does not apply to mineral water and " diet integrators / food supplements "
It 's the first time since 1990, which are vitamins and minerals regarded as "food " with the consequences we've seen over and we'll see shortly.
Now we come to the Directive that sparked the riots over the web.

Directive 2004/24/EC
This having been published in the Official Journal The 136 on 30/04/2004, does not enter into force, as is said in the web, April 1, 2011, but the following month, ie May 1, 2011.

Malpensante This eliminates the head of an "April fool" of catastrophic dimensions. The Directive 2004/24
change " for traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use .
has famously become known Directive amending an earlier directive, the 2001 / 83, 6 November 2001, which defines " Medicinal Products for Human Use", to be exact going to change the "traditional herbal medicines .

What are these medicines?
The Directive is clear in this purpose and defines " medicine "," traditional herbal medicinal product "and" medicinal plant. "
The generic term " medicine", the definition is as follows:

(Step 2) paragraph a) any substance or combination of substances presented for treating or preventing human, or paragraph b) any substance or combination of substances that can be used in or administered to human beings with restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological metabolic, or to making a medical diagnosis.

For " traditional herbal medicinal product":

29) herbal medicinal product that meets the requirements of Article 16 bis, paragraph 1.

For " herbal medicinal product":

30) Any medicinal product exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more herbal substances in combination with one or more herbal preparations.

Article 16 bis, paragraph 1 is said to have established a simplified registration procedure for herbal medicinal products that meet ALL the following requirements:

a) they have indications exclusively appropriate to traditional medicines plant which, by virtue of their composition and their purpose, are intended for use without medical supervision for diagnostic purposes, a prescription or monitoring of treatment;

b) they are administered only in a specified strength and dosage;

c) it is a preparation for oral use, external and / or inhalation;

d) has passed the period of traditional use of Article 16 c, par. 1, letter c);

s) data on the traditional use of medicine is sufficient, in particular the product proves not to be harmful under conditions of use and the pharmacological effects or efficacy are plausible on the basis of long use and experience date.

Apart from the first three paragraphs, the letter d) provides a traditional period of time established in Article 16 quater, paragraph 1 letter c). Quarter
Article 16, paragraph 1 letter c).

" bibliographical or expert evidence expert evidence that the product, or a corresponding product has been in medicinal use for at least thirty years before the date of application, including at least 15 years in the Community. At the request of the Member State in which it was submitted the registration application for traditional use of herbal medicinal products the Committee expressed an opinion on the demonstration of the use of long-standing product, or the corresponding product. The Member State shall submit relevant documentation supporting the request "

A product that works, if you can not establish his continued employment for at least 30 years before the date of application is likely to be banned and removed from the market.
But the points that most interest us, running the 2004 Directive, are 3 and 5.

Step 3:

"Despite a long tradition of use, many drugs do not meet the requirements for well-established medicinal use or with recognized efficacy and an acceptable level of security and therefore can not be the subject of a marketing authorization. (...) "

Step 5:

" (...) However, even a long tradition does not exclude any concerns about the safety product, the competent authorities should be empowered to request all information necessary for the safety assessment. The quality of the medicinal product is independent of its traditional use. Therefore should not be granted exemptions from the requirement to conduct the necessary physico-chemical, biological and microbiological tests. The products should meet the quality standards contained in the relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State "

Here chaos is desired.

On the one hand they say that a long tradition of medicinal plant you do not have the preclinical and the other say, however, because " even a long tradition does not exclude any concerns about the safety of the product, the competent authorities should be empowered to take all the necessary data for evaluation security "Here's the trick
implemented by bureaucrats in Strasbourg, Brussels and Luxembourg.

The supervisory authorities is completely swallowed up by the chemical and pharmaceutical corporations, should take - having the power and authority - the data required for safety assessment of a traditional plant product.
know how to assess the safety of a product for human use? He explains the same Directive 2004/24/EC:

"Applications for marketing authorization of a medicinal product should be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological, microbiological, pharmacological and toxicological tests and clinical trials carried out on the product and proving its quality, safety and efficacy "

Therefore, if a company wants to sell an herbal product (plant or plant parts), however, describing the features of "therapeutic" and / or "healing" this will be regarded as a "synthetic drugs", even if it is Used by thousands of years.
For a small or midsize company that is virtually impossible!
To produce natural therapeutic remedies, we must provide the authorities: physico-chemical, biological, microbiological, pharmacological, toxicological and clinical studies.

The question arises: Who can afford that? And unfortunately the answer is always the same: the usual suspects ... Only the drug companies can register a herbal product economically and then hold it in a drawer, or earning billions in the face of small companies that work well and honestly.

Posted by admin at 9:11 AM

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