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European Directive on Food Supplements

by Mike Abrahams Ph.D.(more info)

listed in brexit and eu directives, originally published in issue 74 - March 2002

On 27 September 2001 the Council of Ministers reached political agreement on the European Directive on Food Supplements. At the time of writing, the measure is now going for a second reading in the European Parliament.

European legislation overrides domestic UK legislation. Now that the Food Supplements Directive is becoming law, it will have to be enforced by the UK. Even if UK legislation continues to permit the sale of our current range of vitamin and mineral supplements, they will still be illegal if the Food Supplements Directive says so.

Supplement Directive

The Directive is split into different sections, called Articles. Each Article deals with a different aspect of the Directive. Article 2 deals with the scope of the Directive, whilst Article 5 deals with the setting of maximum permitted levels of supplements.

There are also two Annexes attached to the Directive that specify what ingredients will be allowed on to the marketplace, both by generic name (i.e. selenium) and the specific ingredient of that mineral (e.g. selenium yeast).

In addition, there is a European Committee called the Scientific Committee on Foods (SCF). This Committee is the body that advises the upper safe levels of all products and ingredients that are placed on the market. The final decisions are then made by the EU Commission and the Standing Committee for Foodstuffs.

Why Does the Food Supplements Directive Raise Concerns?

Article 2
Article 2 has been extended to cover all supplements that possess nutritional or physiological activity. On the face of it this is a welcome development – but only if the rest of the Directive is appropriate. We are nervous about Article 2 because of the implications of Article 5, as below.

Article 5
Article 5 should specify a method of determining the maximum permitted levels of supplement ingredients. Unfortunately, it doesn't. Article 5 can be interpreted in an almost infinite number of ways – most of which would result in the prohibition or reformulation (to a lower potency) of the majority of products that are currently available on the UK market.

We believe that it is irresponsible to accept a directive that is deliberately ambiguous in its wording.

Had the Directive not been agreed by January, then the Presidency of the EU would have moved on to Spain. We understand that Spain might have promoted a very restrictive wording of Article 5, probably limiting all nutrients to 3 x RDA (recommended daily allowance).

There was concern that this might have been approved by other Member States and that 3 x RDA is a lot worse than the current proposals. We understand this concern, and accept that it is real. However, we cannot believe that the UK population, or the UK Government, would have accepted such a draconian restriction on supplements, and a real possibility of overturning the whole legislation would have presented itself. Instead we now have this nebulous directive that declares open season on all high potency supplements, without actually saying so.

The Two Annexes to the Directive

Annex 1
Annex 1 specifies the vitamins and minerals that will be permitted on to the marketplace. The interpretation is very strict and only vitamins and minerals that are considered to be essential are currently allowed, with minerals such as boron and sulphur omitted. Also missing are tin and vanadium, along with other trace elements.

If a vitamin or mineral is missing from Annex 1 once this directive becomes law, then sales of that vitamin or mineral will become illegal – whatever the UK Government position happens to be.

Appendix 1: Vitamins and minerals that may be used in the manufacture of food supplements (according to the Food Supplements Directive, Annex 1)
Vitamins Minerals
Vitamin A (µg †RE) Calcium (mg)
Vitamin D (µg) Magnesium (mg)
Vitamin E (mg (a †TE) Iron (mg)
Vitamin K (µg) Copper (µg)
Vitamin B1 (mg) Iodine (µg)
Vitamin B2 (mg) Zinc (mg)
Niacin (mg †NE) Manganese (mg)
Pantothenic acid (mg) Sodium (mg)
Vitamin B6 (mg) Potassium (mg)
Folic acid (µg) Selenium (µg)
Vitamin B12 (µg) Chromium (µg)
Biotin (µg) Molybdenum (µg)
Vitamin C (mg) Fluoride (mg)
  Chloride (mg)
  Phosphorus (mg)
† RE – retinol equivalents
TE – tocopherol equivalents
NE – niacin equivalents

Annex 2
Annex 2 specifies the form of vitamin or mineral that will be permitted. As an example, selenium is a permitted mineral, but there are many different selenium salts on the market; for instance ascorbate, citrate, ethanolamine phosphate, fumarate, glycinate, lysinate, malate, picolinate, succinate, yeast, selenocysteine, selenomethionine and selenous acid.

We list these forms of selenium because all of them will become illegal under this directive.

As another example, these are the forms of magnesium that will become illegal: amino acid chelate, arginate, ascorbate, aspartate, butyrate, caprylate, chloride-fumarate, citrate, citrate-malate, cysteinate, ethanolamine phosphate, fumarate, gallate, glutamate, glycinate, ketoglutarate, lactate, lysinate, malate, methionate, niacinate, orotate, pantothenate, phosphate, phosphoserine, pyruvate, salicylate, succinate, tartrate, taurate and yeast.

The National Association of Health Stores (NAHS) has compiled a list of nearly 300 ingredients that are currently used in food supplements that will become illegal if this directive is enforced. Whilst industry is preparing dossiers for submission to the SCF for approval, only 35 such ingredients are covered. The submissions may not be successful, but even if they are, we still face losing over 250 legitimate ingredients – for no good reason other than the bureaucrats who devised this law decided to use the PARNUTS1 legislation for their sources of permitted nutrients – they consulted the food manufacturers rather than qualified nutritionists.

Appendix 2: Vitamin and mineral substances (VMS) which may be used in the manufacture of food supplements
(According to the Food Supplements Directive, Annex II)
Vitamins Minerals

Vitamin A

  • Retinol
  • Retinyl acetate
  • Retinyl palmitate
  • Beta-carotene
Calcium carbonate
Calcium chloride
Calcium salts of citric acid
Calcium gluconate
Calcium glycerophosphate
Calcium lactate
Calcium salts of orthophosphoric acid
Calcium hydroxide
Calcium oxide
Magnesium acetate
Magnesium carbonate
Magnesium chloride
Magnesium salts of citric acid
Magnesium gluconate
Magnesium glycerophosphate
Magnesium salts of orthophosphoric acid
Magnesium lactate
Magnesium hydroxide
Magnesium oxide
Magnesium sulphate
Ferrous carbonate
Ferrous citrate
Ferric ammonium citrate
Ferrous gluconate
Ferrous fumarate
Ferric sodium diphosphate
Ferrous lactate
Ferrous sulphate
Ferric diphosphate (Ferric pyrophosphate)
Ferric saccharate
Elemental iron (carbonyl+ electrolytic+hydrogen reduced)
Cupric carbonate
Cupric citrate
Cupric gluconate
Cupric sulphate
Copper lysine complex
Sodium iodide
Sodium iodate
Potassium iodide
Potassium iodate
Zinc acetate
Zinc chloride
Zinc citrate
Zinc gluconate
Zinc lactate
Zinc oxide
Zinc carbonate
Zinc sulphate
Manganese carbonate
Manganese chloride
Manganese citrate
Manganese gluconate
Manganese glycerophosphate
Manganese sulphate
Sodium bicarbonate
Sodium carbonate
Sodium chloride
Sodium citrate
Sodium gluconate
Sodium lactate
Sodium hydroxide
Sodium salts of orthophosphoric acid
Potassium bicarbonate
Potassium carbonate
Potassium chloride
Potassium citrate
Potassium gluconate
Potassium glycerophosphate
Potassium lactate
Potassium hydroxide
Potassium salts of orthophosphoric acid
Sodium selenate
Sodium hydrogen selenite
Sodium selenite
Chromium (III) chloride
Chromium (III) sulphate
Ammonium molybdate (molybdenum (VI))
Potassium molybdate (molybdenum (VI))
Potassium fluoride
Sodium fluoride

Vitamin D

  • Cholecalciferol
  • Ergocalciferol

Vitamin E

  • D-alpha-tocopherol
  • DL-alpha-tocopherol
  • D-alpha-tocopheryl acetate
  • DL-alpha-tocopheryl acetate
  • D-alpha-tocopheryl acid succinate

Vitamin K

  • Phylloquinone (phytomenadione)

Vitamin B1

  • Thiamin hydrochloride
  • Thiamin mononitrate

Vitamin B2

  • Riboflavin
  • Riboflavin 5'-phosphate, sodium

Niacin

  • Nicotinic acid
  • Nicotinamide

Pantothenic acid

  • D-pantothenate, calcium
  • D-pantothenate, sodium
  • Dexpanthenol

Vitamin B6

  • Pyridoxine hydrochloride
  • Pyridoxine 5'-phosphate

Folic Acid

  • Pteroylmonoglutamic acid

Vitamin B12

  • Cyanocobalamin
  • Hydroxocobalamin

Biotin

  • D-biotin

Vitamin C

  • L-ascorbic acid
  • Sodium-L-ascorbate
  • Calcium-L-ascorbate
  • Potassium-L-ascorbate
  • L-ascorbyl 6-palmitate

Annex 3:
Click here for a full list of the ingredients not included in this list.

The Scientific Committee for Food (SCF)

As if all the above wasn't bad enough, the SCF will play two crucial roles that relate directly to this directive.

1. The SCF will determine the upper levels for each nutrient. These figures will be used by the Commission to set maximum permitted levels for supplements. The maximum permitted level is almost bound to be lower than the upper level for reasons we cannot go into in this document;

2. The SCF will consider whether to permit specific nutrients, and also forms of nutrients, on to the market.

The SCF is supposed to establish upper levels through risk analysis using sound science. However, it has already released a provisional determination that vitamin B6 should be restricted to 25mg. Worryingly, they have used a piece of dubious research2 as justification for this remarkably low amount. This report, the only one ever published that reports toxicity of B6 at such low doses, has long been acknowledged as seriously flawed.

The UK has established the Ad Hoc Advisory Expert Group to determine its own upper levels. Whilst these may be used to influence the SCF in Europe, the final say is from the SCF. So if our Ad Hoc Group recommends 200mg for vitamin B6, and the SCF remains at 25mg, the Food Supplements Directive will mandate 25mg at best, and probably a much lower figure in practice; the 25mg allowance of B6 will be reduced further still by the Commission when it sets the maximum permitted levels for supplementation.

The SCF has also specifically banned four nutrients from being on the EU market. These nutrients are selenium yeast, selenomethionine, chromium yeast and chromium picolinate. If the SCF can ban these ingredients, which have been safely on the UK market for years, if not decades, there is serious doubt that another 300 ingredients will be approved within the next 18 months.

Summary of the Problems Arising

If this directive is accepted in its current form, we face a number of extremely serious concerns:

1. Article 2 could encompass the majority of our product range, and a restrictive directive would completely decimate our industry;

2. Article 5 mandates nothing. We do not want to spend the rest of our lives hoping that the EU will be benevolent to higher dose supplements. We know that most of Europe doesn't want them and we believe that Article 5 will be interpreted in a draconian fashion;

3. Annex 1 omits several important and legitimate nutrients;

4. Annex 2 omits hundreds of safe and legitimate nutrient forms;

5. The SCF has already determined very low levels for B6, and may do the same for other safe and legitimate nutrients;

6. The SCF has already banned four safe and legitimate nutrient forms, and may well deny permission for another 300 that are currently on the UK market;

7. The above combination will completely stifle product development and innovation;

8. The above combination will prevent competition, as smaller companies will be unable to compete with the conglomerates in a restricted marketplace;

9. The above combination will result in the removal of safe and legitimate products that the UK practitioners and consumers have been using safely for decades;

10. The above combination will result in the unnecessary closure of many smaller manufacturers, nutrition-based practices and health food stores throughout the UK.

Derogation – A Last Hope?

Derogation is an eleventh-hour concept that may provide some hope. If the Directive is adopted in its current form, the UK can push for exclusion to sections of the Directive. There would be a level playing field for Member States, but each country would be permitted to have higher supplement levels, if it so desired.

On first consideration this appears attractive. However, if the UK is successful in achieving derogation from Article 5, there are two immediate problems:

1. The UK would still have to comply with the upper levels set by the SCF (remember 25mg for B6);

2. The UK would still have to comply with the Annexes (remember the 300 missing nutrients).

Derogation is not an answer unless the UK is also allowed to derogate from upper levels advised by the SCF (we would use the Ad Hoc Group recommendations) and from the restrictive Annexes.

It is inconceivable that this will be permitted.

Also – of less concern, but still potentially a problem – derogation is at the discretion of the Member State. At the moment the UK Government is firmly on the side of upper levels as established by sound science. However, we must remember that due to previous scientific recommendations, current official UK Government advice is that taking vitamin B6 in excess of 10mg per day is harmful.

There is also no guarantee that there will be no further general policy changes at some time in the future.

Conclusion

At the time of writing we have two urgent tasks:

1. We must endeavour to get as many of the missing nutrients on to the approved list as possible, and we now have less than 18 months to complete the task. One obstacle to our success in this is that it will cost an estimated £80,000-£130,000 per dossier. The fact that this, in total, represents more than the profits of the entire UK industry should put into perspective our chances of success;

2. We must endeavour to ensure that the maximum permitted levels of those nutrients that remain are safety levels based on sound science, and not bureaucratic, administratively convenient RDAs.

Meanwhile we may have a seven-year derogation on products not on the list, in other words we can continue to use 'unapproved' products that are currently in use, for the next seven years, after which they will become illegal if they are not on the approved list by early 2003. It's up to all of us to rescue what we can from this debacle.

References

1. No, this is not a new type of food! The acronym relates to a draft Commission directive – Substances that may be added for a specific nutritional purpose in foods – for PARticular NUTritional uses.

Basically, there is a list of vitamin and mineral substances (VMS) that is in existence, and currently relates to sectors such as baby milk and cereal-based foods. It controls the ingredients in such substances. The fears of extending the influence of this list, such as using it as a basis for VMS, sports products, diet foods and diabetic food, have now been realized.

2. Dalton K and Dalton MJT. Characteristics of pyridoxine overdose neuropathy syndrome. Acta Neurologica Scandinavia. 76: 8-11. 1987.

How the EU Directive was Drafted

European legislation is based on Napoleonic Law. This maintains that everything is forbidden unless it is specifically permitted. Thus when setting up the legislation for the control of vitamins and minerals, a positive list had to be set up which defined those permitted nutrients.

The bureaucrats assigned to this task utilised an existing piece of legislation called PARNUTS – Substances that may be added for a specific nutritional purpose in foods – (for PARticular NUTritional uses) dealing with ingredients used in baby milk and cereal-based foods. Most of these were cheap materials used to fortify foods in order to restore them up to a minimum nutritional value, most of the natural nutrients having previously been removed in the refining process. So with no reference to anyone expert in the field of nutrition other than these manufacturers, the positive list was created. This is why we now find that about 350 nutrients are missing from the list, of which 60 are basic elements such as sulphur and boron and the rest are nutritional formulae of these and other substances. Despite a seven year period of derogation, all will be ultimately deemed illegal unless they are added within the next 18 months, through acceptance of submissions of technical dossiers each supporting an individual element or formulation. So far manufacturers have put together only 30 in total.

Comments from the Industry

Solgar Ltd
     The original motivation for this European Food Supplements Directive was to remove barriers to European trade in Food Supplements.
     A perplexing diversity of national regulations for vitamins and mineral supplements made their free movement impossible across Europe and that of course is anathema to the spirit of the economic community. The European Legislators saw an ideal opportunity to harmonize food supplement legislation so that each country would be selling identical products. We should have known at the beginning what harmonization would bring. Authorities never look to harmonize up to the highest standard, but down to a lowest common denominator.
     The enabling legislation stipulated a bizarrely brief and inadequate list of permitted nutrients and sources. Our industry has identified no fewer than 290 ingredients currently used in UK vitamin and mineral products that are omitted from the impoverished 'positive list' that Brussels want the British to conform to.
     We have just 18 months to compile dossiers to persuade the European Scientific Committee for Food to include these ingredients on the positive list. But the data requirements they have specified for the preparation of these dossiers is spectacularly onerous and it is going to cost many thousands of pounds and many hundreds of hours to put together each dossier. Even with extensive collaboration there is no way that the UK supplements industry is going to be able to prepare more than 100 dossiers before the deadline in 18 months time. The British public will therefore be denied the freedom of access and choice to select from around 200 proven nutrients which will be effectively banned from June 2004. The Independent Health Food Trade has achieved some wonderful victories against some of the more foolish legislative initiatives in the past. Now, we must come together and enlist public support in letting our national and European parliamentarians know that enough is enough and that some fundamental concessions must be negotiated so that British consumers can continue to enjoy the health freedoms that are their right.

Gerald Eva
Managing Director,
Solgar Vitamins

Biocare Ltd
     Consumers in the UK benefit from a food supplement industry that ranks amongst the most sophisticated in the world. This is completely at odds with the European norm. Many of the supplements that form a part of the diet for millions in the UK have never been permitted to be freely sold in most European Union (EU) states. Additionally, the dietary habits within many states (e.g. the Mediterranean diet) are so different to our own that the need for supplementation is not seen to have the same relevance. Add to this the huge cultural gulf between the way in which laws are formulated in Europe to that in the UK. In a nutshell, Europeans are used to a system where "you cannot do anything unless the law states that you can" (Code Napoleon) whereas our Common Law heritage has produced the opposite – a system where "you can do anything unless the law states that you can't." Applying this to the forthcoming Food Supplements Directive, many ingredients, combinations and dosages that have been safely and beneficially used within the UK for decades will simply become illegal.
     For supplement manufacturing companies such as BioCare, the Directive will create a nightmare. We shall be forced to stop producing some supplements demanded by our customers without being able to provide an alternative. Other products will need reformulating at lower dosages so that consumers will have to pay more to obtain the nutrient levels they require. To attempt to get unclassified nutrients on to the permitted list might cost up to £100,000 per ingredient in bureaucratic fees (without any certainty of success) – again causing an increase in the cost of products. Products that are common and regarded to be safe in the UK, Canada, USA, Australia and New Zealand could start to disappear from the shelves in as little as eighteen months time, and yet it is likely to be at least a year before the maximum allowable dosages for nutrients will be published – allowing a minimum amount of time for changes to be responsibly implemented.

Robert Joy
Marketing Director

Viridian Nutrition
     The Directive is inevitably worded in an attempt to appease all. It is a horse designed by an enormous European committee and instead of even managing a camel, they have created a kangaroo! The draft legislation has bounced from country to country and the final wording, particularly Article 5, is vague and open to interpretation, more-than-likely leading to restrictive dosage levels and certainly leading to many, many products becoming unavailable.
     Viridian would like to openly do business in Europe, but we are not willing to reduce potencies or de-list perfectly safe supplements in order to do that.
     The argument in this country is divided straight down the middle – either you are a company with Pan-European ambitions and will accept, or are happy to welcome, harmonization whatever the permitted levels of nutrients; or you are a company content to supply health food stores in the UK and some in Europe who are willing to 'run the gauntlet' with higher dose supplements. The Directive has tried to find middle ground and has failed.
     The trade associations are doing as much as they can – and it is possible to question the motives of some campaigners throughout this last ten years. If you favour conspiracy theories you will hypothesise that certain companies, individuals and/or organisations have long been campaigning simply for free sale across Europe whatever the cost in terms of potencies and range, but whatever the truth, ultimately, it will be the consumer that has the final say. When it is made public that Vitamin B6 will be restricted to say, 10mg and so on, then there will be a mighty wave of protest and the legislators will have to listen – the Governments must fear the creation of a 'black market' by their actions.
     There is a lesson for us all in terms of personal responsibility in campaigning on these big issues and not leaving it to those whose interests may lie elsewhere. There are considerable battles ahead for the natural products industry and we need to be as united as possible, but we can be confident that common sense will prevail and we will win the war. The consumer wants our products, our ethos and our advice; no Directive will be able to legislate that passion and enthusiasm away.

Cheryl Thallon,
Co-Director

Higher Nature
     The EU directive is going to mean some very serious changes to what food supplements and herbal products will be available in the future. As an individual I feel very concerned that the basic right of each of us to take care of our health as we choose is going to be infringed. Vitamin and mineral doses will be lower and some herbs will virtually disappear.
     However as a manufacturer I do not believe that this will affect our business or that of the health shops we supply. We have already adapted 20 formulas to conform to the regulations now being enforced, and as a resourceful, go-ahead company we are confident we will continue to be able to offer leading edge products. Of course the small manufacturers and health shops will not go out of business.
     If we want to defend our right to choose our own path to health, we have to form a single voice and take our demands to the other member countries (who really do not understand our health supplement industry) and not fight amongst ourselves.

Celia Wright,
Director

Health Food Manufacturers Association (HFMA)
     The Food Supplements Directive has been in development for at least 12 years. During that time the industry has carried out a sustained programme of education, information, lobbying and discussion aimed at increasing understanding of the purpose and benefits of food supplements – and the food supplement market has seen rapid growth.
     Whatever the future of the current text of the Directive, (which at time of writing seems to hang in the balance), European regulation to cover the safety and free trade elements of this fast-growing market is inevitable – and it is hard to argue that it is not also desirable.
     Its real problem lies in the detail which underpins the framework of the Directive and the consequences for the UK market. The challenge for the future will be to make the best of the inevitable changes that implementation of the Directive will bring: by working with the practical detail to deliver the essential elements – sensible upper safe levels and extended positive lists.
     No one wants to see unnecessary limitation on the consumer's freedom of choice – neither the retailer that sells the products nor the manufacturer that makes them.

Penny Viner

Comments:

  1. Dr. Vik Gurtu said..

    These Directives to limit many supplements is really bad as many supplements are beneficial and contain much less than their prescribable medication igredients which is not the optimal way to treat disorders initially.
    I mean it is better to prescribe melatonin and sleep hygiene protocols than benzodiazepenes which have higher risk of hip fractures in the elderly and memory dysfunctionality but the new Directives to essentially limit these types of OTC choices for the public cost the taxpayer and the health insurance ( Public & private) more in the long run from the morbidity associated.
    Lets us have bettter quality control and allow important supplements to be produced to high verifiable standards for all consumers worldwide.


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About Mike Abrahams Ph.D.

Mike Abrahams PhD is a partner in Wild Oats Wholefoods, a large natural foods grocery in Bristol, which he started together with his wife in 1980. Wild Oats began as a small natural foods shop of just 500 sq ft with a small café attached. It is now over 1,100 sq ft and has over 460 customers a day. Mike studied oriental medicine at the Kushi Institute in London in the early 1980s and has extensively studied nutritional medicine. He is an experienced speaker and teacher in these fields. He also ran a large pioneering vegetarian restaurant for five years in Bristol in the early 1980s.

In 2000, Mike was elected as Chairman of the National Association of Health Stores, and is a member of the Institute of Health Food Retailers. Mike is 58 years old and lives in Bristol. He can be contacted via mike@wildoats.force9.co.uk

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