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News & Views
It's Crunch-Time For Alternative Medicine
Date: 01/12/11
Keywords: European Food Safety Authority, Traditional Herbal Medicinal Products Directive, Alternative medicine, anti-vitamin campaign, Beta Glucans, Co-enzyme Q10, CoQ10, Diet, Glucosamine, Nutrition
On 5th December, a European Commission committee will put forward a proposal for an EU-wide Regulation that will establish a list of authorised 'general function' health claims.
If these regulations get the green-light, all general function health claims for commercial food and food supplement products that are not authorised, will be banned across all 27 EU Member States, within the next 6 months!
Suffice to say, this is very bad news indeed for natural and alternative medicine. Of the 44,000 health claims that were submitted, only 224 (these are limited to just 70 foods or food ingredients) were approved and appear on the draft list. This excludes many botanical substances and probiotics. However, after a massive industry backlash, when around 1500 claims for botanicals and probiotics were largely rejected, public pressure forced the EFSA to re-evaluate these claims.
Many of our regular readers will know that plans to implement
stringent European (EU) Regulations on natural remedies, came
into effect in April this year. The European Food Safety
Authority's (EFSA) 'one-size-fits-all' approach to all
vitamins, nutritional supplements and herbal remedies, is
being enforced under the guise of 'consumer protection'.
Along with this, the EU Food Supplements Directive (EUFSD)
will legally implement the harmonised, maximum permitted
levels (MPLs) for food supplements and fortified foods
throughout Europe.
That's not all... the Traditional Herbal Medicinal Products Directive (THMPD), will make it almost impossible for a traditional herbal medicine (such as an Ayurvedic remedy or Chinese traditional remedy) to be licensed in Europe unless it has been used for 30 years in the European Union (EU) – or 15 years in the EU and 15 years elsewhere.
Crunch time
Much as some herbal products have managed to survive this cull, with some even being licensed as Registered Herbal Medicines, many important alternative medicines and nutrients (and there are plenty) did not.
On 5th December, a European Commission committee will put forward a proposal for an EU-wide Regulation that will establish a list of authorised 'general function' health claims.
If these regulations get the green-light, all general function health claims for commercial food and food supplement products that are not authorised, will be banned across all 27 EU Member States, within the next 6 months!
Suffice to say, this is very bad news indeed for natural and alternative medicine. Of the 44,000 health claims that were submitted, only 224 (these are limited to just 70 foods or food ingredients) were approved and appear on the draft list. This excludes many botanical substances and probiotics. However, after a massive industry backlash, when around 1500 claims for botanicals and probiotics were largely rejected, public pressure forced the EFSA to re-evaluate these claims.
As a result, a number of plant-based ingredients are still undergoing approval. Yet, despite this, only a smidgen of botanicals has so far appeared on the draft list, including the 'natural statin', red yeast rice, with a claim for maintenance of normal blood cholesterol, beta glucans from oats and barley, polyphenols in olive oil for protection of blood lipids from oxidative stress, and walnuts for improvement of elasticity of blood vessels.
How the health benefits of vita supplements like CoQ10 could soon be silenced
A great cause for concern is the absence of important minerals like boron, silicon or sulphur, either from the claims list or the list of permitted minerals in food supplements. The nine essential amino acids (that cannot be made by the body), including lysine, methionine, tryptophan and tyrosine, have also been excluded.
There are numerous other natural ingredients, widely used by millions because of their proven benefits, which do not appear on the draft list. These include:
* Alpha lipoic acid: This powerful antioxidant is invaluable for pre-diabetics and diabetics, in addition to those with neuropathy (including nerve pain).
* Various forms of carnitine: Recognised for cardiovascular support, especially among very active people.
* Co-enzyme Q10: One of the most important supplements used in supporting cardiovascular health. It's one of the body's essential building blocks, depleted by cholesterol-lowering statins and therefore particularly beneficial when taken as a supplement.
* Glucosamine and chondroitin: The two most commonly used ingredients for those looking for joint support.
* Glutamine: used particularly by sportspeople for helping to increase muscle mass.
* Ribonucleotides: Added to infant formulae and taken by immune compromised adults to help support the immune system and support healthy gut function.
Black and white approach takes away a fundamental human right
There are plenty of reasons why so many health claims have been rejected. The single most important one being that the EFSA is working on a Pharma-based evaluation process. The biggest problem with this form of evaluation is that the EFSA requires only human studies on healthy populations to substantiate any claims made. Of this, only clinical (intervention) studies are accepted in their own right, with observational and epidemiological studies only being allowed as supporting data. Animal studies or biochemical evidence are also of little value in the EFSA evaluation process.
This level of scientific scrutiny is simply impossible in the field of nutritional science. The sheer complexity of human physiological and metabolic interactions with our food, genetic variations between individuals, variability in the chemical composition of foods, along with the relatively low investment in research, mean nutritional science is far from being black and white.
In short, the EFSA has laid down rules nutritional science cannot play by...
Unfortunately, this EFSA process of approval has already gone too far for us to make a difference on a national parliamentary level. The best way forward is to get the majority of MEPs in the European Parliament to block this law. This is a mammoth task, but one that can be achieved if every concerned European citizen pulls his or her weight.
First, you need to forward this email to everyone you know who lives in the EU. Get them to become actively involved, because it will impact everyone!
Secondly, we strongly encourage everyone over the age of 18 who lives within the EU to write to their MEP (follow this link to find your MEP). Ask him or her to support blocking the passage of the Article 13.1 health claims list into European law.
Highlight the following arguments in your letter or email:
If the European Parliament fails to block this half-baked list of authorised claims, it will not only impact our own future, but it will almost certainly affect our children and grandchildren... they will grow up in an environment where they will have no access to scientific information about the health benefits of food.
Imagine what impact this will have on the decisions they'll make about their health?
Sources:
ANH FEATURE: From 44,000 to 224 — the Great EU Health Claims Cull, published online, anh-europe.org/news
Back to topThat's not all... the Traditional Herbal Medicinal Products Directive (THMPD), will make it almost impossible for a traditional herbal medicine (such as an Ayurvedic remedy or Chinese traditional remedy) to be licensed in Europe unless it has been used for 30 years in the European Union (EU) – or 15 years in the EU and 15 years elsewhere.
Crunch time
Much as some herbal products have managed to survive this cull, with some even being licensed as Registered Herbal Medicines, many important alternative medicines and nutrients (and there are plenty) did not.
On 5th December, a European Commission committee will put forward a proposal for an EU-wide Regulation that will establish a list of authorised 'general function' health claims.
If these regulations get the green-light, all general function health claims for commercial food and food supplement products that are not authorised, will be banned across all 27 EU Member States, within the next 6 months!
Suffice to say, this is very bad news indeed for natural and alternative medicine. Of the 44,000 health claims that were submitted, only 224 (these are limited to just 70 foods or food ingredients) were approved and appear on the draft list. This excludes many botanical substances and probiotics. However, after a massive industry backlash, when around 1500 claims for botanicals and probiotics were largely rejected, public pressure forced the EFSA to re-evaluate these claims.
As a result, a number of plant-based ingredients are still undergoing approval. Yet, despite this, only a smidgen of botanicals has so far appeared on the draft list, including the 'natural statin', red yeast rice, with a claim for maintenance of normal blood cholesterol, beta glucans from oats and barley, polyphenols in olive oil for protection of blood lipids from oxidative stress, and walnuts for improvement of elasticity of blood vessels.
How the health benefits of vita supplements like CoQ10 could soon be silenced
A great cause for concern is the absence of important minerals like boron, silicon or sulphur, either from the claims list or the list of permitted minerals in food supplements. The nine essential amino acids (that cannot be made by the body), including lysine, methionine, tryptophan and tyrosine, have also been excluded.
There are numerous other natural ingredients, widely used by millions because of their proven benefits, which do not appear on the draft list. These include:
* Alpha lipoic acid: This powerful antioxidant is invaluable for pre-diabetics and diabetics, in addition to those with neuropathy (including nerve pain).
* Various forms of carnitine: Recognised for cardiovascular support, especially among very active people.
* Co-enzyme Q10: One of the most important supplements used in supporting cardiovascular health. It's one of the body's essential building blocks, depleted by cholesterol-lowering statins and therefore particularly beneficial when taken as a supplement.
* Glucosamine and chondroitin: The two most commonly used ingredients for those looking for joint support.
* Glutamine: used particularly by sportspeople for helping to increase muscle mass.
* Ribonucleotides: Added to infant formulae and taken by immune compromised adults to help support the immune system and support healthy gut function.
Black and white approach takes away a fundamental human right
There are plenty of reasons why so many health claims have been rejected. The single most important one being that the EFSA is working on a Pharma-based evaluation process. The biggest problem with this form of evaluation is that the EFSA requires only human studies on healthy populations to substantiate any claims made. Of this, only clinical (intervention) studies are accepted in their own right, with observational and epidemiological studies only being allowed as supporting data. Animal studies or biochemical evidence are also of little value in the EFSA evaluation process.
This level of scientific scrutiny is simply impossible in the field of nutritional science. The sheer complexity of human physiological and metabolic interactions with our food, genetic variations between individuals, variability in the chemical composition of foods, along with the relatively low investment in research, mean nutritional science is far from being black and white.
In short, the EFSA has laid down rules nutritional science cannot play by...
Unfortunately, this EFSA process of approval has already gone too far for us to make a difference on a national parliamentary level. The best way forward is to get the majority of MEPs in the European Parliament to block this law. This is a mammoth task, but one that can be achieved if every concerned European citizen pulls his or her weight.
First, you need to forward this email to everyone you know who lives in the EU. Get them to become actively involved, because it will impact everyone!
Secondly, we strongly encourage everyone over the age of 18 who lives within the EU to write to their MEP (follow this link to find your MEP). Ask him or her to support blocking the passage of the Article 13.1 health claims list into European law.
Highlight the following arguments in your letter or email:
-
* The draft list of authorised general function health
claims is very limited, comprising just 224 health
claims relating to just 70 foods or ingredients.
* These claims were taken from a list of 2,758 evaluated by the European Food Safety Authority (EFSA) and so represent just 8% of claims evaluated.
* Evaluation of other claims, such as those on botanicals and probiotics, has yet to be completed and it would be disproportionate to apply a ban on rejected claims and not on others that might be rejected in the future.
* There has been no adequate impact assessment on how authorising so few claims, while banning so many that were used in the past, will affect consumer decision- making and ultimately public health.
* There is also a significant risk that mandating such a narrow list of claims will distort the commercial food supply, encouraging food producers to focus more on foods and ingredients for which authorised claims have been allowed. This will narrow the range of foods available and could have serious long-term health consequences on the population.
If the European Parliament fails to block this half-baked list of authorised claims, it will not only impact our own future, but it will almost certainly affect our children and grandchildren... they will grow up in an environment where they will have no access to scientific information about the health benefits of food.
Imagine what impact this will have on the decisions they'll make about their health?
Sources:
ANH FEATURE: From 44,000 to 224 — the Great EU Health Claims Cull, published online, anh-europe.org/news
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