This is FEI point of view:
PRESS RELEASE
What an alarmism!
We wonder if people who gave the alarm read up on and deeply understood the contents of the Directive 2004/24/EC (Directive 2004/24/EC of the European Parliament and Council of 31 March 2004 amending, as regards traditional herbal medical products, the Directive 2201/83/EC on the Community code relating to medicinal products for human use).
On April 2011 the above mentioned Directive 2004/24/EC of the 31 March 2004, referring particularly to the paragraph 2 of article 2, expires. It reads:
“For the traditional herbal medicinal products as referred to in Article 1, which are already on the market on the entry into force of this Directive, the competent authorities shall apply the provisions of this Directive within seven years after its entry into force.”
Therefore the seven years accrue from the 31 March 2004 and finish on the 1 April 2011. This date, however, is not correct since the Directive was actually published on the Official Journal just on the 30 April 2004 and, consequently, seven years must be counted from that day on. Therefore, the official date should be the 1 May 2011.
By a distorted reading, it can be assumed what has been recently published on several internet websites; it’s clear that, since member states must enforce the Directive within 2011, the European Medicines Agency (EMA, London-based), through the European Commission, has to draw up a list of plants and herbal products suitable to be classified among “traditional herbal medicinal products” and adapt traditional herbal medicinal products already on the market to the provisions of this Directive.
However, this does not necessarily mean that some plants can not be used in other fields, in different ways and with different features.
After all, the directive regulates the drug, that is the plant or the extract used for the drug and thus with therapeutical claims. If the same plant is used for different purposes which are not medical since it’s subject to other specific regulations, such as food regulations, it is not in the scope of Directive 2004/24/EC.
This means that if plants normally used such as for example mallow, balm or others are already present on the market as food supplements because regulated and allowed in Italy by the Legislative Decree n° 169/2004 and in other countries in compliance with the directive 2002/46/EC, they can continue being regularly sold because not included in the Herbal Medicinal Drug Directive.
As for the European Food Safety Authority (EFSA, based in Parma), it has been working for a long time on a European harmonization on the introduction into the market of supplements based on fibres and vegetal extracts.
Actually, it’s important to remember that Community Directive 2004/24/EC (implemented by Legislative Decree n° 219 of April 2006) institutes the Traditional “Herbal Medicinal Drug” while the Community Directive 2002/46/EC (implemented by Legislative Decree n° 169 of 21 May 2004) institutes the supplement based on fibres and vegetal extracts, giving it a precise scope in supporting and optimizing physiological functions. Actually EFSA itself has already created a working team to define the “claims” (physiological indications) concerning food supplements based on fibres and herbal extracts.
As for “physiological” effects, Italian Ministry of Health, in the text of a Draft Ministerial Decree, recently submitted to European Union member states, aiming at pointing out some aspects concerning the enforcement of the rule on food supplements based on fibres and herbal extracts, underlines how the effects are expressed in compliance with the homeostasis model, as defined by Council of Europe document of 7 February 2008, in order to optimize normal body functions.
Even the “Law” expressed its idea.
Actually European Court of Justice has punished Germany for preventing the marketing of Garlic-based food supplements, justifying this fact with the already given marketing authorization of a drug containing garlic extract.
Actually nothing forbids the coexistence on the market of two preparations based on garlic, one (traditional herbal medicinal product) recommended to prevent the formation of atheromatous plaques, the other (food supplement) suggested for physiological well-being of cardiovascular system.
It might be that for some plants criteria will be established indicating the features of the herbal extract used, such as daily dose, both in case of a component of the traditional herbal medicine and in case of a food supplement, but this harmonization will require a lot of time. In the meanwhile, it will be possible to prepare products containing herbs with therapeutic purposes that is medicinal plants, and products containing plants with healthy and physiological purposes, that is foods.
After all, there is an essentially herbal food tradition where herbal products claims have always been of healthy and never therapeutic nature.
In Italy, we do restate, the “remedy based on herbal extracts” has been supported and spread by herbalists category and by those herbalist firms which have developed effective products based on officinal plants, preserving the integrity of the phytocomplex of medicinal plants, which has always been a real discriminating factor between herbal remedy and herbal medicine.
While in Europe, during the last 3 years, about 160 traditional herbal medicinal products have been licensed (more than 60 in Great Britain, more than 40 in Germany, the remaining in different states of the European Union, and only one in Italy), in our country the Ministry of Health has always been careful about supplements, until recently including in the list plants allowed for the production of food supplements: dozens and dozens of “new” medicinal plants among which numerous species used to produce glycerol-alcoholic extracts, commonly known as “gemmoderivates”, which many people considered already “lost”. This risk has been avoided also thanks to the intervention of FEI (Federation of Italian Herbalists) and the constant dialogue with the Ministry of Health.
FEI stands firm on its commitment to get to acknowledgment of the possibility for herbalists to sell traditional herbal medicinal products, an expected measure since they are qualified professionals in Health sector. This does not mean we do not have to monitor and eventually mobilize so that the European Commission legislates in order to safeguard herbalist sector and the professionalism which has characterized especially Italy and has allowed some traditions to be passed down and protected.
Therefore it’s important to inquire and act accordingly with full knowledge of the facts and competence, with correct and suitable information.
IT’S THE ONLY WAY TO BE LISTENED TO.
Rome 7th October 2010
FEI Chairmanship
00153 Roma - Piazza G.G. Belli, 2
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fax 0039 065812750
e-mail: feiroma@tin.it – fei@confcommercio.it
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