Update to EU Directive for Herbal Medicines
Were you aware that after April 2011 many herbal products and food supplements containing herbs became illegal due to changes in EU law (Traditional Herbal Medicinal Products Directive THMPD)? I wouldn’t blame you if you didn’t…
Unless you’re an herbal enthusiast, you may have missed the debate.
However, nearly a year on debate over this legislation is still raging as campaigners fight to protect traditional medicinal cultures.
What is the purpose of THMPD?
Now if you have missed this debate, don’t worry. Here is a quick overview to what has been going on for the last 12 months.
As of the 30th April 2011, only herbal medicines and supplements which have been registered under the THMPD scheme will be available across the EU.
Now as you can guess this legislation has had a major impact on herbals products from non-European traditions such as Ayurveda and China. Many are now no longer available as it is nearly impossible for them to meet these guidelines or keep up with the expense.
According the THMPD, herbal products have got the meet the following criteria:
- Must have at least 15 out of 30 years of usage within the EU – as you can imagine, this has put non-European herbal traditions from Ayurveda, China, South East Asia, Tibet, the Amazon and South at a disadvantage despite them having the longest and most developed botanical based healthcare in the world.
- Particular combinations of herbs may be disallowed – according to the THMPD, traditional use is seen as one herb or a specific combination of herbs, and as a result have prevented the use of new combinations despite their scientific backing.
- All products are subject to pharmaceutical criteria and Good Manufacturing Practices – this means, manufacturers must meet the same purity and stability criteria as conventional pharmaceuticals.
Now due to the complexity of some herbal mixtures, this will make it difficult for many non-European herbal products to meet the GMP.
- Traditional medicines are only eligible for registration if their purpose is for minor ailments, not major conditions such as heart disease.
- Herbal products containing high levels of vitamins and minerals will be prohibited and allowed ONLY if its nutrients are considered ‘ancillary’.
- Herbal products that contain non-herbal ingredients other than vitamins, minerals are disallowed
And this is forgetting the fact that: the THMPD is controlled by the HMPC who are weighed towards pharmaceutical products rather than herbal medicine, and the huge costs manufacturers will face trying to meet this regime.
Fortunately the Alliance for Natural Health and the European Benefyt Foundation are challenging this legislation, and plan to take them to the UK High Court before progressing to the European Court of Justice.
Hopefully if they are successful, you won’t have to lose out on all the health benefits these herbs and herbal medicine have got to offer. However until then, why not have a go at making your tinctures/capsules of these herbs?
You may not be able to buy these traditional remedies, but this doesn’t mean you cannot have a go a creating them yourself…!
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