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The EU herb laws.

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I have NO idea where gaia-health gets their information from, but they're dead wrong.

So the rumors have been flying, about herbs being totally forbidden in the EU come 2011, about peppermint being totally forbidden in the EU come 2011, about herbs being prescription-only in the EU come 2011, about herb teaching and books being forbidden in the EU come 2011 ... and most if not all of those rumors come from one source: gaia-health.
(Note, if you cry Wolf! too often, you won't be believed when the wolf actually does appear ... so these folks are actually hurting the real hunt for information. On purpose or not, I don't know.)

Nobody in Finland is worried. Nobody in the UK is worried. There are no headlines about herbs being pulled from the shelves up here next year, no headlines about peppermint (where do they even get these things from?), and certainly no headlines about herbs becoming prescription-only products.

Nevertheless, gaia-health continues to spew forth their over-the top news. I imagine that they get a LOT of new readers (and advertising income) with that strategy.

(As to the German who got hits herbs confiscated by customs: 1) the products were called "parasite mix" and suchlike - that's health claims right there. The FDA is slamming down on them already, quite as hard as the EU authorities are. Nothing to see here ...
Also, German laws are interesting in that they have white-lists of allowed herbs. Most if not all other EU countries have black-lists of restricted herbs.)


The truth is that if you wish to make health claims for your herbs, it will be easier to do so from 2011, if said herbs have been in use for 30 years, of which at least 15 years in the EU.

If you don't wish to make health claims for your herbs, there's nothing to see here. Move on move on.

See, I asked my MEP about it (MEP: Member of the European parliament). Here's what she replied:

A few years ago, the EU ratified laws which simplified the acceptance _as meds_ of such herbs that have been in use for at least 30 years, of which for at least 15 years in the EU. It is possible to include herbs in addition to those within the 30/15 rule in this simplified acceptance; that however is less simple.
The Green MEP group has prepared two brief reports about this law. Report #1 gives the parliament's reaction to the first proposal; report #2 gives the parliament's reaction to the second proposal.

Report 1

Key points in the Commission proposal

The purpose of the Commission proposal is to establish a harmonised legislative framework for traditional herbal medicinal products and to provide a special registration procedure allowing the registration and the marketing of certain traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy (for those products on the market for at least 30 years, 15 years of which should have been in the Community).

For reasons of coherence and legibility of the regulatory framework, the specific provisions on traditional herbal medicinal products shall be introduced in the new Community code relating to medicinal products for human use, as contained in Directive 2001/83/EC.

In addition, to ensure a full participation and involvement of experts in the field of herbal medicinal products, a new Committee for Herbal Medicinal Products shall be set up within the European Agency for the Evaluation of Medicinal Products. One of the Committee's major tasks will be to establish monographs that further harmonise and facilitate registration applications concerning herbal medicine.

Key points in the committee report

The committee adopted the following modifications:

  • limited the directive to herbal medicinal products of pharmacological activity, and excluded food, food supplements and cosmetics from it
  • maintained the 30 years reference for simplified registration, but reduced the Community presence therein to 10 years
  • strengthened mutual recognition
  • put the new committee at equal level with the existing committee for human medicinal products

Report 2

Key points in the Commission proposal

A new Committee for Herbal Medicinal Products shall be set up within the European Agency for the Evaluation of Medicinal Products to establish monographs that further harmonise and facilitate registration applications concerning herbal medicine.

Key points in Common position

The Council accepted most of the demands of the EP. It reinstated the clause of 15/30 years, but introduced a committee procedure to decide whether traditional herbal medicines that are on Community market for less than 15 years may also make use of the simplified procedure.

Key points in committee second reading

Only two very minor amendments were adopted, which add little if anything to the common position.


So there you are. Nothing fancy. Nothing to get all worked up about. I'm not surprised at all that nobody is worried about this set of laws.

Now go and spread this message as far as you've spread the hyperbole. Thanks.

Comments

Thank you for this clarification of EU laws on herbal products. There has been a collective panic attack due to misinformation. Here in the US the news about dire restrictions is flooding the web and has found a special place among the conspiracy theory fans. When I try to counter this misinformation with my research that points to this being the best environment in decades for the commercial herbal industry I am considered naive or even a threat. Now I can send them to your Blog, Henriette.
Thanks.

There are some clear & much benefits to greater regulation of the herbal industry, agreed. Not least the GMP* certification requirements that will ensure full traceability & safety of ingredients within formulations & strict 'pharmaceutical' levels of quality control, Herbs of Grace already does this. Many herbal supply companies don't. It is after all, vital the herb user can be reassured that what is labeled on the bottle of herbs is in-fact in the bottle & that their safety & quality of product remains a manufactures paramount consideration.

That written, from my companies standpoint it is looking very likely we will lose 50-60 formulations & many simples(single herbs) we have sold since 1976. In part we are simply unable to afford the product licensing costs, many of our best selling formulas such as a version of the Dr John Christopher BTA formula have more than three ingredients in them. There is no way that formula can be licensed. The cost is a minimum of £30.000 per ingredient & a year to trial. So BT-A alone will cost £210-£260.000 minimum to attempt to pass the registration process. If it fails, our company still has to pay for the effort. There are indications that trials may involve animal testing too. See 'herbs in Peril' from the modern herbalist on U-tube. You will see a leading manufacturer & very talented Medical herbalist Tony Carter in the UK telling us how it really is.

The only products that I have seen successfully registered since 2005 are single herbs such as valerian, no more than a handful at that. No blends whatsoever. Ayurvedic medicine is very much about blends & along with TCM is going to be hit hard. Pukka herbs the leading Ayurvedic supply company here in the UK is forecasting a loss of 500k per year which will also result in excess of 200 Indian workers having their livelihood threatened. The legislation when one goes into it as we have, has some diabolical flaws to its very core.

Then we have 2500 correctly qualified herbalists in the UK fighting for statutory regulation of their profession to be agreed alongside this ill conceived directive. If this SR does not happen at the same time as the directive, they will lose the right to supply a wide range of herbal medicine. Check if you will Michael McIntyre & his EHPTA website for the accurate informed details of their plight.

We have the oldest institute of Herbal Medicine in the UK & it appears they as experts are being stonewalled & little credence given to what they are saying. The issues facing European herbalism are simply not as transparent as they may first appear.

Upshot. Conspiracy theories aside. There is a clear indication & not for the first time where herbal medicine & the qualified practitioners are being put through ever tightening hoops. As things are going many companies, professional herbalists & their clients are going to have their choices severely restricted in May of 2011. FACT.

My sincere hope is that this impending legislation of herbal medicine is not going to push European Herbalism so far underground it will be impossible to legislate. If it does I fear safety is going to be problematical and the reputation of herbs, my chief concern will be brought into disrepute. I also fear that too many people already view this complex legislation indifferently & may have opinions based on cursory examination.

To my mind, the foundations of consumer choice for their healthcare is being eroded just that little bit further.

Sincerely

James

Passionate about herbs.

*Good Manufacturing Practice

I have this email from a herb supplier in response to my questions about the coming legislation:

As far as I am aware and I have been informed of this by the DTI and directly by reading the Directive many times over in it's entirety (available FOC from the EU Parliamentary website) is that you will be able to buy any herb in any format ie dried/powdered/essential oil/tincture/extract, off the shelf from a retail or mail order establishment unless the company concerned is making medicinal claims on the herbs being sold or selling it in a format that can be construed to be for medicinal use such as a tablet etc but to buy the loose herb to be used for non medicinal purposes(as far as the business is concerned) will be completely legal.

One small point that many don't seem to realise is that if a large company did decide to put a herb through it's paces to scientifically prove it's efficacy and it is certified through the right bodies as such this means that herb can be sold by anybody giving full medicinal usage not just the company that had it tested.

Dont see the problem? Customers buy the powdered herbs and put them in caps- problem solved.

I'm just guessing here, but I believe the alarm on the web and in specific countries is due to Codex Alimentarius and the implementation of it. Alarming stuff. Thankfully it's not had the effect that it some day may, as yet, but it still could. It's important that those of us who believe in using "alternative" modalities for healing (especially herbs) stay aware.

Thanks Henriette, for clarifying this issue. Too much scare-mongering going on, but I can absolutely see why people who love herbs would become concerned. My only concern had been that my favourite dried herbs (which I buy online) would be affected - this seems to not be the case. I had been buying some single-herb tinctures commercially, but if these are affected, I'm less worried. They are prohibitive in terms of price. Looks like I'll have to start making my own, which is something to be thrilled about!

There's also a great discussion on this very topic on Susun Weed's forum: http://www.healingwiseforum.com/vie...

Brian

Thing is, I don't think anybody really knows what the new laws will mean in practice. I expect the implementations will be widely different across the EU. We'll see ...



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