What is wrong with the EU Food Supplements Directive
There has been much misunderstanding, and dare I say it, misinformation, regarding the EU Food Supplements Directive and ANH’s legal challenge to it.
As ANH Partners and Members it is vital that you understand what is really going on and I am going to attempt in this letter to put you in the picture.
It is quite involved and may take a little time to read but I urge you to persevere as your continued access to quality and effective food supplements depends on YOU taking appropriate informed action.
What’s wrong with the Food Supplements Directive?
The British Government and many MPs and MEPs when asked about the Food Supplements Directive (“FSD”) will insist that it is a good piece of EU legislation because it harmonises the currently very different laws of all EU Members States in respect of food supplements and ensures high quality standards at the same time. Thereby trade in supplements is increased across the EU and consumers can feel safe.
Seems reasonable you might be thinking.
But what is the price tag?
6 key things principally;
The FSD reverses the burden of proof as regards showing that food supplements are safe. Previously a food supplement could generally be sold as food unless the Regulator could prove scientifically that it is unsafe. (This is the position in the USA for example under DSHEA). Now in the EU it will be for the manufacturer to prove at great cost that it is harmless before he can sell it. It creates a very restricted list (known as the “positive list”) of allowable nutrients which favours synthetic nutrients over those much closer to how they are found in nature. It will, in time set what are anticipated to be very low maximum doses of nutrients In order to get on the positive list of allowable nutrients a technical and very costly Dossier will required which may or may not ultimately be acceptable to the EU Regulators.
If a nutrient (or its source) is not on the restricted list it will be banned across the EU from 1 August 2005 regardless of the fact that it was previously happily allowed to be sold in various EU Member States for perhaps many years.
At present the FSD only applies to vitamin & minerals. However it is a framework Directive and is intended in time to apply to all nutrients and their sources. So the negative pattern we see here applying now to vitamins and minerals will in time be applied to all nutrients.
So what have we got?
Under the guise of a harmonisation Directive ostensibly seeking to improve the supply of food supplements across the EU, we in fact end up with a measure which will ban many nutrients presently on sale in the EU.
And for those that get through, the maximum dose levels are likely to be very impotent.
The Directive thus defeats the whole purpose for which many people take food supplements, namely to supplement their diet in order to promote optimal well being through the addition of key vital nutrients which they cannot get in their normal diets any more (unless they happen to live in an organic tropical paradise).
The fact that the FSD has a negative effect is impossible to hide.
The UK Government when it undertook its Regulatory Impact Assessment (measuring the impact of the implementation of the FSD in the UK) concluded that on balance the FSD had a negative cost / benefit for the UK and conceded that the ban on nutrients which are currently allowed to be sold in the UK (unless they get requalified by submission of a dossier) was “unnecessary”.
You’ll see many statistics flying around but in essence we are looking at the ban of around 75% of the vitamin and mineral sources (“forms”) currently on the EU market. This will translate into a banning of some 300 vitamin and mineral ingredients and possibly around 5000 products currently available.
Now remember, if this is what is happening to vitamins and minerals now what will happen to all other nutrients in the future?
Keep well in mind the 3 FSD bogey men:
The reversal of the burden of proof
The restricted list of allowable nutrients unless proved harmless at huge cost
The very low potencies which will be allowed even if a nutrient gets through and onto the positive list
In summary what the FSD is really doing is to impose quite arbitrarily and unnecessarily, a drugs style licensing regime on food supplements or more particularly on food nutrients which hitherto we have been eating happily for thousands of years!
Well if this is so bad you might be asking how on earth did it get passed into EU law?
Indeed.
ANH has exhaustively researched this question and bottom line no one seems really to be able to justify what has happened.
The usual reason given is as I have explained above. The FSD will promote trade in safe food supplements across the EU.
And yes the price tag for the UK and other more liberal regimes may be high but that was the best we could get in our negotiations in Europe, so says the UK Government in particular.
But we say at ANH that the price is far too high and quite unnecesary and unacceptable.
The international Dimension
You might be reading this from a country outside the EU and thinking well that’s pretty tough for those Europeans but we’re ok here.
True for now, but perhaps not for long.
You may be aware that the EU has the dominant vote in the setting of Codex international standards for food. Thus what they want they can push through even if other countries protest.
This is a complex area of international law but in brief ANH and others are extremely concerned that an EU regime for the treatment of food supplements may be exported world wide under the auspices of Codex and made to have regulatory teeth through the WTO.
More, on this complicated subject in another letter.
But for the time being I repeat my point.
Bad things that happen in Europe may very well in time also negatively affect the rest of the world.
And that means YOU.
The ANH Legal Challenge
As you are well aware pretty early on ANH came to the view that the only way to deal with the FSD was to challenge it in the Courts and ultimately that meant bringing a case in the EU supreme court; the European Court of Justice (“ECJ”).
I will not bore you with the details of our case (for those who are interested, the key documents are available in the “ANH Legal Challenge” documents area of our web site).
But in essence we are saying the following.
Food supplements are food, not drug. Therefore they do not need a drugs style regulatory regime imposed upon them.
You do not need a license to sell food.
Under existing law throughout the EU, food is perfectly well regulated from a legal point of view ensuring quality and safety.
The Food Supplements Directive, if it really was intended to harmonise and promote the supply of safe food supplements across the EU, did not require a ban on nutrients which were not on the positive list.
It could have and indeed should have had merely a minimum list of acceptable nutrients which all Member States were obliged to accept across the EU (sometimes called a "White List"). Whilst leaving individual Member States free to allow a wider selection of nutrients to be used in food supplements within their particular borders if they wanted to.
Indeed we go further and argue that under EU law, the FSD,in imposing a sweeping and draconian ban across the EU without even attempting to provide a scientific justification or rationale, actually infringes EU law.
We conclude that the FSD should be allowed to remain and but should do its job properly.
Thus without the ban.
It would then act as a minimum white list of vitamin and mineral nutrients which all Member States would be obliged to accept across the EU.
That would increase trade.
What are our chances of success?
Cautiously we would say that we are optimistic. EU legal precedent is on our side.
The UK Government chose not to make present oral submissions at the Hearing of the case in the ECJ on 25 January 2005. Paul Lasok QC, our barrister said that in his experience it is most rare for the UK to not attend an oral hearing where it has filed Written Observations as it has done here.
The only Member State to present oral submissions was Greece.
And despite repeated questioning from the Advocate-General (a very senior independent lawyer who advises the ECJ in its deliberations), none of the Community Institutions were able to adequately explain exactly how the procedure for getting a nutrient on to the positive list actually works.
Indeed in some consternation the Advocate-general exclaimed at one point that as far as he could see it the procedure had “the transparency of a black box”.
Aside from being amusing this comment is significant because if the ECJ finds that there was no proper and transparent procedure for getting on the positive list that itself would be a ground for finding the ban as being unlawful under EU law.
As you will have seen from our press releases the Advocate-General will be giving is Opinion on 5th April 2005. This is not the judgment of the Court which will follow probably in June 2005. However as the ECJ tends to follow its Advocate-Generals' Opinions in 80% of cases this Opinion is going to be very significant.
What you can do
First and foremost please understand that we are all in this together.
It’s not a question of you helping the ANH with “its problem.”
No, rather we, together with you are in an alliance to protect the continued supply and availability of natural advanced and safe food supplements in the EU and indeed the world which are able to do their job properly.
What job?
Supplying vital micro-nutrients which are now missing from our western diet.
So when you help the Alliance you need to see that you are helping yourself and your family and those who are dear to you, to be able to maintain optimal health.
More particularly here are some key actions points for you:
Tell your friends and contacts about the problem and forward this and other ANH e-mails to them so that they know what is going on. Recruit your friends and contacts to join the Alliance.
PLEASE TAKE ACTION NOW!
Remember that without you there is no Alliance!
Thanks for all that you do.
Yours in health!
David C. Hinde LLB Solicitor Legal Director Alliance for Natural Health http://www.alliance-natural-health.org
As ANH Partners and Members it is vital that you understand what is really going on and I am going to attempt in this letter to put you in the picture.
It is quite involved and may take a little time to read but I urge you to persevere as your continued access to quality and effective food supplements depends on YOU taking appropriate informed action.
What’s wrong with the Food Supplements Directive?
The British Government and many MPs and MEPs when asked about the Food Supplements Directive (“FSD”) will insist that it is a good piece of EU legislation because it harmonises the currently very different laws of all EU Members States in respect of food supplements and ensures high quality standards at the same time. Thereby trade in supplements is increased across the EU and consumers can feel safe.
Seems reasonable you might be thinking.
But what is the price tag?
6 key things principally;
The FSD reverses the burden of proof as regards showing that food supplements are safe. Previously a food supplement could generally be sold as food unless the Regulator could prove scientifically that it is unsafe. (This is the position in the USA for example under DSHEA). Now in the EU it will be for the manufacturer to prove at great cost that it is harmless before he can sell it. It creates a very restricted list (known as the “positive list”) of allowable nutrients which favours synthetic nutrients over those much closer to how they are found in nature. It will, in time set what are anticipated to be very low maximum doses of nutrients In order to get on the positive list of allowable nutrients a technical and very costly Dossier will required which may or may not ultimately be acceptable to the EU Regulators.
If a nutrient (or its source) is not on the restricted list it will be banned across the EU from 1 August 2005 regardless of the fact that it was previously happily allowed to be sold in various EU Member States for perhaps many years.
At present the FSD only applies to vitamin & minerals. However it is a framework Directive and is intended in time to apply to all nutrients and their sources. So the negative pattern we see here applying now to vitamins and minerals will in time be applied to all nutrients.
So what have we got?
Under the guise of a harmonisation Directive ostensibly seeking to improve the supply of food supplements across the EU, we in fact end up with a measure which will ban many nutrients presently on sale in the EU.
And for those that get through, the maximum dose levels are likely to be very impotent.
The Directive thus defeats the whole purpose for which many people take food supplements, namely to supplement their diet in order to promote optimal well being through the addition of key vital nutrients which they cannot get in their normal diets any more (unless they happen to live in an organic tropical paradise).
The fact that the FSD has a negative effect is impossible to hide.
The UK Government when it undertook its Regulatory Impact Assessment (measuring the impact of the implementation of the FSD in the UK) concluded that on balance the FSD had a negative cost / benefit for the UK and conceded that the ban on nutrients which are currently allowed to be sold in the UK (unless they get requalified by submission of a dossier) was “unnecessary”.
You’ll see many statistics flying around but in essence we are looking at the ban of around 75% of the vitamin and mineral sources (“forms”) currently on the EU market. This will translate into a banning of some 300 vitamin and mineral ingredients and possibly around 5000 products currently available.
Now remember, if this is what is happening to vitamins and minerals now what will happen to all other nutrients in the future?
Keep well in mind the 3 FSD bogey men:
The reversal of the burden of proof
The restricted list of allowable nutrients unless proved harmless at huge cost
The very low potencies which will be allowed even if a nutrient gets through and onto the positive list
In summary what the FSD is really doing is to impose quite arbitrarily and unnecessarily, a drugs style licensing regime on food supplements or more particularly on food nutrients which hitherto we have been eating happily for thousands of years!
Well if this is so bad you might be asking how on earth did it get passed into EU law?
Indeed.
ANH has exhaustively researched this question and bottom line no one seems really to be able to justify what has happened.
The usual reason given is as I have explained above. The FSD will promote trade in safe food supplements across the EU.
And yes the price tag for the UK and other more liberal regimes may be high but that was the best we could get in our negotiations in Europe, so says the UK Government in particular.
But we say at ANH that the price is far too high and quite unnecesary and unacceptable.
The international Dimension
You might be reading this from a country outside the EU and thinking well that’s pretty tough for those Europeans but we’re ok here.
True for now, but perhaps not for long.
You may be aware that the EU has the dominant vote in the setting of Codex international standards for food. Thus what they want they can push through even if other countries protest.
This is a complex area of international law but in brief ANH and others are extremely concerned that an EU regime for the treatment of food supplements may be exported world wide under the auspices of Codex and made to have regulatory teeth through the WTO.
More, on this complicated subject in another letter.
But for the time being I repeat my point.
Bad things that happen in Europe may very well in time also negatively affect the rest of the world.
And that means YOU.
The ANH Legal Challenge
As you are well aware pretty early on ANH came to the view that the only way to deal with the FSD was to challenge it in the Courts and ultimately that meant bringing a case in the EU supreme court; the European Court of Justice (“ECJ”).
I will not bore you with the details of our case (for those who are interested, the key documents are available in the “ANH Legal Challenge” documents area of our web site).
But in essence we are saying the following.
Food supplements are food, not drug. Therefore they do not need a drugs style regulatory regime imposed upon them.
You do not need a license to sell food.
Under existing law throughout the EU, food is perfectly well regulated from a legal point of view ensuring quality and safety.
The Food Supplements Directive, if it really was intended to harmonise and promote the supply of safe food supplements across the EU, did not require a ban on nutrients which were not on the positive list.
It could have and indeed should have had merely a minimum list of acceptable nutrients which all Member States were obliged to accept across the EU (sometimes called a "White List"). Whilst leaving individual Member States free to allow a wider selection of nutrients to be used in food supplements within their particular borders if they wanted to.
Indeed we go further and argue that under EU law, the FSD,in imposing a sweeping and draconian ban across the EU without even attempting to provide a scientific justification or rationale, actually infringes EU law.
We conclude that the FSD should be allowed to remain and but should do its job properly.
Thus without the ban.
It would then act as a minimum white list of vitamin and mineral nutrients which all Member States would be obliged to accept across the EU.
That would increase trade.
What are our chances of success?
Cautiously we would say that we are optimistic. EU legal precedent is on our side.
The UK Government chose not to make present oral submissions at the Hearing of the case in the ECJ on 25 January 2005. Paul Lasok QC, our barrister said that in his experience it is most rare for the UK to not attend an oral hearing where it has filed Written Observations as it has done here.
The only Member State to present oral submissions was Greece.
And despite repeated questioning from the Advocate-General (a very senior independent lawyer who advises the ECJ in its deliberations), none of the Community Institutions were able to adequately explain exactly how the procedure for getting a nutrient on to the positive list actually works.
Indeed in some consternation the Advocate-general exclaimed at one point that as far as he could see it the procedure had “the transparency of a black box”.
Aside from being amusing this comment is significant because if the ECJ finds that there was no proper and transparent procedure for getting on the positive list that itself would be a ground for finding the ban as being unlawful under EU law.
As you will have seen from our press releases the Advocate-General will be giving is Opinion on 5th April 2005. This is not the judgment of the Court which will follow probably in June 2005. However as the ECJ tends to follow its Advocate-Generals' Opinions in 80% of cases this Opinion is going to be very significant.
What you can do
First and foremost please understand that we are all in this together.
It’s not a question of you helping the ANH with “its problem.”
No, rather we, together with you are in an alliance to protect the continued supply and availability of natural advanced and safe food supplements in the EU and indeed the world which are able to do their job properly.
What job?
Supplying vital micro-nutrients which are now missing from our western diet.
So when you help the Alliance you need to see that you are helping yourself and your family and those who are dear to you, to be able to maintain optimal health.
More particularly here are some key actions points for you:
Tell your friends and contacts about the problem and forward this and other ANH e-mails to them so that they know what is going on. Recruit your friends and contacts to join the Alliance.
PLEASE TAKE ACTION NOW!
Remember that without you there is no Alliance!
Thanks for all that you do.
Yours in health!
David C. Hinde LLB Solicitor Legal Director Alliance for Natural Health http://www.alliance-natural-health.org
Starmail - 9. Feb, 22:21
