Friday, January 21, 2011

Onion Onion Seasoning



New Statement sull'Erboristeria

The May 1 2011 will come into force Directive 2004/24/EC concerning the so-called traditional herbal medicinal products transposed in Italy by Legislative Decree 219/2006.

The rule, which among other things provides for a simplified registration for herbal medicinal products having a traditional use at least thirty years in the EC, will therefore enter into force definitively after 7 years since its publication in the Official Journal European Union took place April 30, 2004, as stated in article 2, paragraph 2 of the Directive.
A date that has caused great fear in the herbal world. The media, in fact, primarily the Internet, some months ago had warned that "the entry into force of the new standard will have a devastating impact on the herbal sector and prevent the herbalists selling herbs and teas, that is precisely the traditionally treated in health food stores.
But this really will happen next May? We asked
an official of the Ministry of Health and experts in the sector that, explaining the terms of the question, almost unanimously reassure herbalists.

A concern unjustified
Strate can calm the herbalists. To support and Marco Valussi, herbal medicine, member of the European Herbal and Traditional Medicine Practitioners Association, the European association that brings together the traditional phytotherapy. "The EU Directive 24/2004, which in Italy will come into force on 1 May next," says Valussi, "refers to those products based on plant extracts or plant derivatives that wish to be registered as medicines. One area that has nothing to do with the classic cut the herbalist who sells tea and
mixture in his shop. The herbal products do not fall entirely in this legislation. " It should be remembered, in fact, explains Valussi, that the Italian and European legislation provides for the authorization process different for different types of products made with the same plant. "If you package a product made with chamomile, for example," says Valussi, "saying that the preparation has anti-inflammatory properties, thus using
a drug claim, this product should be classified as a drug and a process to follow the recording, time consuming and expensive. Unlike the case of simple chamomile, a food that can and will in future be sold without any problem. "
The European Herbal and Traditional Medicine Practitioners Association has followed every stage of the Directive 24/2004 , tells Valussi, sharing some aspects, such as
of this measure will ensure greater safety for citizens, but criticizing others. "The real limit of this rule," says Valussi, "covers the plant outside of Europe for which no special procedure is permissible, a simplified approval process. A choice that can not be accepted in principle, as between these plants there are in fact some of which you have little knowledge, but others for which we have data and literature to provide evidence of sufficient quality and safety. " Apart from this, is positive on the proceedings of Valussi European directive comes into force next May. "I see no other problems," he says, "even the remote possibility that over time, for reasons of economic convenience, some of the products currently sold in Erbore-
Steria will change status and become drugs, of course, only if it will
characteristics, should not be a big risk to the herbal sector, if anything, to manufacturers of plant extracts, but it will be a benefit to local people and herbalists who can still boast of legislation that protect consumers and to distinguish clearly and unambiguously the status of drug or food products based on herbs. "

The impact of the rule on business
According to Germano Scarpa, president of FEDERSALUS, the European Directive 24/2004
not have any impact in the field. "It should first be noted that this directive," says Scarpa, applies only to traditional herbal medicines and dietary supplements that, by law, are and remain food. Precisely for this reason are not conceivable direct or immediate effects of the application of EU rules on the herbalists who sell food and not drugs. "
Scarpa The same considerations extend to the corporate world. "Yours strictly by law the two types of products," says Scarpa, "each company will continue or diversify their business in a clear and reliable regulatory framework. Each operator will therefore be in a position to choose the time for "rules of the game" and work accordingly. " Yes, but what are the strengths of the Directive n.24/2004 and in this case, the limits that can and should be remedied in the future? "A point of considerable strength and interest of Directive 2004/24," said the chairman of FEDERSALUS, "is certainly a reference the tradition of use as a criterion to justify the effectiveness under certain conditions, for herbal medicines. Just think of the traditional criterion that can be borrowed in our industry (which we recall that the same policy is already applied in food law, for example in the novel food) to prove the merits, in a context
scientific evidence, Health food claims (health claims).
It would be logical to assume a major contradiction to the tradition of use as
parameter to test the effectiveness of traditional medicines, as laid down by Directive 2004/24, and yet feel it a policy to support unnecessary and unscientific indication of a substance to healthy food. " Opinion a bit 'different is instead Markets Valentino, president of Assoerbe. "At the moment it is difficult to predict how this Directive will relapse," he says, "trumpeted as the priority it attaches to the drug industry, is a hypothesis that if applied would threaten the survival of the herbal sector. The same vision is to be applied to manufacturing companies: the Directive, in my opinion, when viewed under the aspect of herbal products is totally negative. "

You -use solution to the problem
"Who sounded the alarm over the Internet," says Giorgini Giorgio CNA Erbe, "is not well documented and has been shown to have a superficial knowledge of the situation and regulations, standards of which we are aware, however, for many years and whom we have always been a garrison and thorough. " Directive 2004/24/EC, transposed
in Italy with Legislative Decree 219-2006, recalls Giorgini, fixed in May 2011, ie seven years after its publication in the Official Journal of the European Union on 30 April 2004, a deadline that is refer to art. 2 paragraph 2 of said Directive 2004/24/EC of 31 March
2004, which reads as follows: "traditional herbal medicinal products referred to in Article 1 and by the time of entry into force of this Directive, competent authorities shall apply the provisions of this Directive within the first seven years after its entry into
force. " In practice, Member States, says Giorgini, having to give effect to the Directive by 2011 by the European Medicines Agency EMA (European Medicines Agency ), through European Commission should establish a list of plants and plant substances likely to be included in the "traditional herbal medicines and traditional herbal medicinal products conform already on the market with the parameters set by the Directive. "This does not necessarily mean that certain plants can not be used in other areas with different modes and features," says Giorgini, "moreover, it regulates the drug or the plant or extract used as such, and then with complaints about treatment . If the same plant is used for purposes other than those drugs, because falling in specific regulations,
as precisely those products, is a problem not related to the Directive 2004/24/EC.
The EU Directive 2004/24/EC (enforced by the Legislative Decree No. 219 April 24, 2006), in fact, stressed the representative of CNA Herbs, established the traditional herbal medicinal products "Traditional Herbal Products", while the EU Directive 2002/46/EC (enforced by the Legislative
May 21, 2004 No. 169), the food supplement made from plant extracts, giving the latter a very precise function in assisting the physiological functions in the body. "So much so that the Court Justice of the European Union ", tells Giorgini," has issued rulings favorable to us punishing Germany, which had prevented, considering drugs, the marketing of food supplements based on garlic and
Seine. Nothing, in fact, prohibits most trade can coexist in the same plant-based preparations, with different intended uses (medicine - traditional herbal medicine - food supplement - normal food). Examples of this are manifold: one for all who can give a good idea is coffee and / or its active ingredient, caffeine, which are commercially available drugs - supplements - Normal food - liquor - ice cream etc .... " "Our plants can grow up happy," echoes of Confartigianato Mauro Dogwood, "is the intended use discriminating factor between the real food,
supplements and drugs." "The intended use - said Dogwood - depends on how the product is presented: it is presented for treating human disease and medication, if presented as an adjunct of the physiological functions of the organism, is a dietary supplement. The road sector as we have done so: surely many more will we have to do. "

reassure the Ministry of Health
to do so and Bruno Scarpa, director of the Office of the Directorate General IV Security
Food and Nutrition of the Ministry of Health. "The Directive 24/2004," Scarpa insists, "is the traditional herbal medicines and food supplements. There are two distinct areas, regulated differently. " Therefore, suggests Scarpa, 1 May 2011
for food supplements and herbal derivatives nothing will change the current situation.
Where is therefore emerged concern of herbalists? "I think from a misinterpretation of the standard on traditional herbal medicines," says Scarpa recalling that in Italy you are still working to harmonize the rules governing respectively the pharmaceuticals and food, in a world community where there are several borderline situations.
"Emblematic is the case of melatonin," observes Scarpa, "in Italy have long allowed contributions up to 5 mg of the substance in food supplements to adapt to changes in time zone (which is also validated by EFSA as the slogan), while in Europe has been granted a permit as a drug product with a daily dose of 3 mg. However it should be considered as new and positive development, says Scarpa, the European Commission announced its intention to review the evaluation approach on claims for botanicals in food supplements, including assessment of considering the traditional use as evidence in Like what has been admitted in
of traditional herbal medicines.
This underlines Scarpa, to introduce the elements of balance in a position clearly disproportionate time to require proof of force only as ad hoc support of the claims of supplements and therapeutic activity of these medicines.
"For these reasons," says Scarpa, "we have withdrawn the ministerial decree on food supplements to the European Commission notified a few months, for later in the light of the new situation is emerging." It will take time, therefore, to understand whether and how to change the industry. Of course there is only one fact: May 1, 2011, with the entry into force of Directive 24/2004 for herbalists will be business as usual.

careful, but do not worry

The opinion on the European Directive 24/2004 Mauro Serafini, Professor of Pharmacognosy, Faculty of Pharmacy, University of Rome 'La Sapienza', since January 2008 member of EFSA Scientific Cooperation Working Group on Botanicals, the group of experts who worked on the preparation of the compendium on the plants containing active toxic.

Professor Serafini, 1 May 2011 will enter into force the Directive 24/2004: what will change for herbalists?

Nothing, because the rule in question regards traditional herbal medicinal products, an area unrelated to the skills dell'erborista.
However, it is also true that today many dietary supplements are used as herbal medicines, but this is a speech that falls outside anyway ... dall'erborista

What is the value of this directive?

to begin to bring order to the area and to define what is a traditional herbal medicinal product. In fact, today there is still much confusion about this.
As you know, the same plant can be used as a drug, or dietary supplement. It is necessary to determine precisely when you are in front to a drug and when a food supplement.

Consequently, the world of nutritional supplements may undergo some change?

is too early to tell. The European Commission is reviewing the whole system on food supplements, so that the ministerial vision sent to the EC was then withdrawn in anticipation of new directions. To date, however, herbalists have no reason to worry, but only to pay attention to developments there may be .
Do not worry, the coming into force now
forthcoming European Directive 24/2004
on traditional herbal medicinal
will have no impact on the sector
herbal At least so say
experts we have asked
clarification on the rule
in recent months had caused great
concern among herbalists

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