Members
e-Letter Issue 4 (August 2007)
In This Issue
A Breach in their Armor: An EU Precedent Set for Food-based Supplements
Background:
In 2002, the first in a series of EU Food Supplements Directives (FSD) was approved for each of the member States in the European Community. This Directive effectively banned 2/3rds of existing available vitamin forms. It was challenged initially the UK High Court and that legal challenge was referred directly to the European High Court.
In July of 2005, the European Court of Justice UPHELD the EU Food Supplements Directive leaving little hope for vitamin forms that were effectively EXCLUDED from the positive list.
(Click here to see the Positive List).
In an effort to appear fair however, the EU Food Supplements Directives allowed a complex and extremely costly submission process whereby a company could submit individual vitamin forms in an effort to get them reviewed and hopefully placed back onto the Positive List. To date, few have been successfully approved.
Since the European Court of Justice (ECJ) ruling in July 2005, the Alliance for Natural Health quickly acted on the concept that natural sources of vitamins and minerals should be legally held outside the scope of the Food Supplements Directive. Almost exactly two years to the day since the ruling, this has now been confirmed by the European Commission, in what promises to be a critical precedent for natural health.
Update:
The Alliance received a letter this week, jointly signed by two heads of unit at the European Commission indicating that natural sources of vitamins and minerals, which could have been subject to a ban EU-wide, may escape the EU Food Supplements Directive, and will be regulated as foods.
In a strategic legal move in March 2007, the Alliance entered multiple submissions to the EU Food Supplements Directive’s Positive List. The nutrients used for these submissions were chosen carefully to test the ECJ ruling on natural sources and included “wheat germ oil” as a source of full spectrum vitamin E (mixed *tocopherols), palm oil as a source of vitamin E *tocotrienols and palm fruits as a source of provitamin A mixed *carotenoids.
Definitions:
Tocopherols: An antioxidant used to decrease oxidative rancidity of fat or oil.
Tocotrienols are part of the Vitamin E family. Tocotrienols have similar structure to tocopherols (Alpha-Tocopherol as the most common Vitamin E in the market), but contain three double bonds in the carbon side chain of the molecule.
Carotenoids are natural fat-soluble pigments found in certain plants. Carotenoids provide the bright red, orange, or yellow coloration of many vegetables, serve as antioxidants, and can be a source for vitamin A activity.)
The letter received from Mr Demetris Vryonides, Head of Unit “Legal Affairs” and Mr Basil Mathioudakis, Head of Unit “Food, law, nutrition and labelling”, states:
"We consider that wheat germ oil can be used in food supplements without having to be authorised and included on Annex II of the Directive. For similar reasons the dossiers on mixed carotenoids, food derived *folates, [and two proprietary palm blends containing carotenoids and tocotrienols respectively] will not be processed further.”
Definitions:
Folate: Folic acid, one of the B vitamins that is a key factor in the synthesis (the making) of nucleic acid (DNA and RNA)
Dr Robert Verkerk, Alliance for Natural Health’s executive and scientific director, said “We are delighted to finally have this clarification from the European Commission on a point of law the ANH has been aware of since the ECJ ruling. The wider implications of this for the industry are far reaching and it effectively opens the door to functional foods and supplements containing nutrients derived from natural sources.”
Dr Damien Downing, ANH’s medical director, indicated, “This is a great relief for patients, practitioners and consumers and a vindication of the position that the ANH has maintained throughout. It is now time to focus on the array of other regulatory challenges facing the natural health sector.”
Editor’s note: Legal and PR efforts will continue in order to take full advantage of this precedent.
So, is the battle over?
Well... not really!
It is not all that difficult a concession for the EU Commission to say that products containing food substances from "natural sources" do not have to be authorised or included in the Positive List. They are foods after all.
These pose no problem to the Commission anyway. Nor does it pose a problem for pharmaceutical companies in their efforts to gain additional control of the vitamin market.
The point is - vitamins and minerals are natural substances no matter whether they have been synthesized using a garden type plant or vegetable or if they are synthesized in the laboratory.
Effective vitamin formulas tend to significantly exceed the usual “RDA” (Recommended Dietary Allowances) prescribed by most government or pharmaceutical-influenced agencies and associations.
In order to create effective food supplement products containing vitamin dosages sufficiently high and generate the desired effect or even attempt to prevent or cure illnesses such as heart disease or cancer [the largest causes of death and subsequently the largest “business” on this planet], a vitamin manufacturer must put certain quantities (dosage levels) of vitamins and minerals into such a product. This is not necessarily possible from "natural sources" exclusively.
Since the last century, chemistry as a science has advanced to a point - and many a Nobel prize has been awarded along the way - that it is now possible to isolate the required substances effectively and even synthesize them so that they have become available in the required concentrations.
Let’s not forget; the EU Food Supplements Directives are several in number. Each Directive has a number of extensions, which slowly and systematically add a bit more government and Pharmaceutical control over and taking away a bit more freedom and access from consumers, practitioners and manufacturers of vitamins.
The first of these Directives, the EU Food Supplements Directive has as its primary objective to assist trade in food supplements between EU Member States by harmonising laws for food supplements across the European Union.
This first of the Directives has four main problems:
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Only those food supplement ingredients that are included on the Positive List are allowed. All “excluded nutrients” are at a very real risk of being allowed for sale only if they are licensed as medicines [a process too costly for many natural food supplement manufacturers] and here is where the Drug companies walk in as the “new broom” that sweeps clean the old guard.....
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A system was provided within the EU Food Supplements Directive to allow vitamin and mineral forms used prior to 10 June 2002, but excluded from the Positive List, to be allowed if complex and expensive technical dossiers were prepared and accepted by the European Food Safety Authority. However, few have been approved to date.
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Maximum dosage levels for nutrients will be set in due course and these levels are likely to be unnecessarily low and of little value to a human body.
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Positive lists are likely to be applied to nutrients other than vitamins in due course, such as essential fatty acids, amino acids, plant extracts, enzymes, etc.
So, the Commission doesn’t really care if we buy wheat germ oil in a bottle from a super market or in capsules from a vitamin manufacturer or natural health practitioner.
They DO CARE if we want EFFECTIVE supplements in the dosage levels we need to make a difference in sustainable health and well being.
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