The following is the text of the report submitted to accompany the presentation of the Irish Health Trade Association and the Irish Association of Health Stores to the Joint Joint Oireachtas Committee on Health of the Irish Dail.

Presentation by:

the Irish Health Trade Association

and

the Irish Association of Health Stores

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EU Food Supplements Directive (2002/46/EC)

Presentation to the Joint Oireachtas Committee on Health

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Compiled by Brod Kearon BSc (President, I.A.H.S)

Presented by:

Mr. Martin Forde BA, ND, DO (I.H.T.A.)

Ms. Erica Murray, BSocSc (I.A.H.S.)

Dr. Robert Verkerk BSc, MSc, DIC (Scientific Advisor)

June 2003

The EU Food Supplements Directive (2002/46/EC).

Transposition into National law due July 2003.

Introduction

This Directive is due to be transposed into Irish law by 31^st July 2003. The final text of the Directive was published in the Official Journal of the European Union on the 12^th July 2002.

This is a combined presentation by the Irish Health Trade Association (IHTA) and the Irish Association of Health Stores (IAHS) to illustrate the impact that this directive will have on the industry as well as on the consumer's right to protect and maintain their own health.

The IHTA was established in 1988 and represents the majority of distributors, manufacturers and wholesalers of natural health products. The IAHS founded in 1986 represents over 80% of health stores in Ireland, the traditional route of sale of food supplements in this country for the last forty years.

The purpose of this presentation is to highlight the concerns of the industry with this Directive. We will show that the directive will result in most existing products disappearing from the marketplace, thus endangering livelihoods and will remove the right of consumers to choose an important and effective means with which to maintain and protect their own health.

Food Supplements Directive – Summary of the Main Provisions

1. Provides a definition of food supplements:

“‘Food supplements' means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”. [1]

2. Food supplements to be considered as FOODS.

3. The Directive only applies to vitamins and minerals as a first stage.

4. Only vitamins and minerals appearing on a Positive List will be permitted to be used in a Food Supplement.
Annex 1 lists the vitamins and minerals permitted and
Annex 2 lists the forms of these of these nutrients.

5. The levels of vitamins and minerals permitted in a food supplement will be determined on the basis of three main criteria:-

· The Upper Safe Level - determined by the EU Scientific Committee for Food (SCF)

· The Recommended Daily Allowance (RDA), now known as the Population Reference Intake (PRI)

· Normal dietary intake

6. Labelling requirements ensuring that products are labelled appropriately.

Usage of Food Supplements

A survey carried out by Behaviour & Attitudes in August 2001 found that over 45% of Irish people now consume food supplements.

Usage of supplements increases slightly with age: 50% of the 50+ age group are users, as opposed to 40% in the 15-34 age group.

Perhaps most significantly, the survey found that usage has risen from 29% in 1990 to 45% in 2001, and is remarkably evenly distributed across all socio-economic groups.

By recognising the increase in (a) awareness of the role played by nutrition in determining health status and (b) the consumer's desire to self care, the growth in demand for food supplements over recent years can be readily understood.

Let us stress at the outset that given this high level of usage, it is entirely reasonable and appropriate to ensure that food supplement products are properly regulated, so as to ensure the protection of public health and the removal of unnecessary trade barriers within the EU.

The Market

Currently, approximately 140 Small and Medium-size Enterprises (SMEs) operate at both wholesale/manufacture and retail levels in Ireland in the natural health sector. The industry is worth approximately €45 million annually and employs in excess of 1,000 people directly.

The natural health sector extends into other areas also, such as pharmacy. However, it is not possible to estimate the number of jobs created in this sector as a result of the growing demand for food supplements in recent years.

The Issues

The Food Supplements Directive represents a highly restrictive form of regulation.

At first glance, the Directive may seem perfectly reasonable and indeed laudable, but closer scrutiny reveals that it will, in fact, remove a large portion of the present range of food supplements which have been safely consumed in Ireland for over 40 years.

Good Regulatory Practice ensures that existing products are safe and of good quality. Over-regulation that results in the loss of the majority of products from the market-place is surely self-defeating. Basically this Directive is using a sledge-hammer to crack a nut.

The problems can be listed under four main headings:

1. The Positive List

2. Safety dossiers

3. Determination of Maximum Amounts of Vitamins and Minerals

4. Compliance costs

Issue no. 1: The Positive List ~ omits 300 nutrients

The Directive establishes a Positive List of vitamins and minerals permitted to be used in a food supplement. This list is divided into two annexes. Annex 1 lists the permitted vitamins and minerals, and Annex 2 lists the permitted chemical forms or sources of those vitamins and minerals. The Annexes are based on a pre-existing list of substances approved for the manufacture of foods for particular nutritional purposes, such as baby foods etc. and is known as the PARNUTS list.

This list was not designed for the Food Supplements Directive.

The list relates to substances and additives used in the manufacture of food products, not food supplements, and was drawn up by the EU Scientific Committee for Food (SCF) some time ago, before the Food Supplements Directive was even thought of.

The presence of highly toxic chemicals like sodium hydroxide (caustic soda) and calcium oxide (quicklime) on the list of permitted substances demonstrates beyond all doubt that this list is totally unsuitable for food supplements and could, in theory, at least lead to the production of highly toxic products.

In addition to this, there are approximately 300 nutrients forms which are not included in the Annexes and which, therefore, will no longer be permitted. Many of these are commonly used in food supplements and have been so for a very long time.

Basic mineral nutrients such as silicon, boron and sulphur are missing from the list, while fluoride, the need for which in human nutrition has not been established, is included.

Commonly used substances such as selenium yeast, and GTF chromium are also omitted. Ironically the SCF admits that selenium yeast is a safer form of selenium than the inorganic selenate form that it does allow! Also, the positive list excludes many of the newer and more easily absorbed nutrient forms such as amino acid chelates, the orotates and all yeast based nutrient forms.

Issue no. 2: Safety Dossiers

Article 4 of the Directive allows Member States to allow a derogation until 2010 in respect of these missing substances but only under certain conditions. The conditions are that a full safety dossier is submitted by 12th July 2005, and provided that the European Food Safety Authority (EFSA) has not given an unfavourable report on any of the missing nutrients.

However, these dossiers will be extremely costly and time-consuming to produce, and as many food supplement companies are Small and Medium-sized Enterprises (SMEs), they simply will not have the resources to do so.

There have been talks between the EU Commission and the industry and one suggested solution is that industry gets together to present the dossiers that are required. But only seven dossiers have been completed so far and the work seems to have come to a halt, possibly due to competing commercial interests.

A proposal has emerged that the Commission and the Scientific Committees accept a simplified and less expensive form of dossier for products where there is a history of safe use, and we believe that Ireland should support this initiative.

Issue no. 3 Determination of Maximum Amounts of Vitamins and Minerals

Our concerns in this area are:
(a) the inclusion of the PRI/RDA as a criterion, and
(b) the methods used to set Upper Safe Levels.

(a) Use of PRI/RDA as a criterion is not appropriate - The RDA is not related to Safety

To recap, Article 5 lays down the procedure for determining the permitted maximum amount of a nutrient in food supplement manufacture.

These levels will be determined by the European Commission on the basis of three criteria:-

1. Population Reference Intakes (PRI), formerly the Recommended Daily Allowance (RDA).

2. Upper Safe Levels as determined by the EU Scientific Committee on Food (SCF) and/or the European Food Safety Authority (EFSA) ^[2]

3. Average dietary intake levels

In its original form, the Directive did not require the PRI/RDA to be taken into account for all nutrients. The problem is that many of Member States adhere to an official doctrine that all nutrients over the RDA are dangerous. There is no scientific support for this view.

The PRI/RDA is the bare minimum required to avoid deficiency, and has nothing to do with safety, and therefore should not be taken into account when assessing the maximum safety level of a nutrient.

That a whole industry could be legislated out of existence on the basis of an unscientific falsehood is deplorable.

(b) There are problems with the determination of scientific Upper Safe Levels (USLs)

Nutrients treated as toxic chemicals

The Scientific Committee on Food (SCF) appear to be conducting a toxicological assessment of nutrients as if they were toxic chemicals instead of nutrients which are essential to the body. This is incorrect and inappropriate and can lead to absurd results as in the case of Niacin where the SCF has produced an opinion which is below the current PRI/RDA.

Remember that what we are talking about here are basic essential nutrients, which have been used safely for decades - not synthetic food additives or drugs.

Use of discredited studies and flawed science

Another concern we have is the use of discredited and flawed studies by the SCF, such as Dalton and Dalton (1987) [3] in the case of vitamin B6.

This sixteen-year old study was based on a telephone survey using leading questions, had no control group, and its results have never been replicated despite a number of attempts to do so. It also goes against all other studies on B6, - in fact there is no corroborating data whatsoever. This issue caused a furore in Britain in 1998 where a Parliamentary Select Committee rejected attempts by the British government to restrict vitamin B6 to 10mg on the basis of Dalton and Dalton. The US National Academy of Sciences has also discounted this discredited material.

If the SCF's opinion to limit vitamin B6 to 25mg or less is upheld, we estimate that this will have the effect of removing about 75% of all vitamin B preparations from health store shelves, despite the fact that no adverse events have ever been observed at levels less than 200mg in long term use.

Many of these concerns also apply to the opinions of the UK Expert group on Vitamins and Minerals (EVM) which has just released its report. The report recommends an upper limit of 10mg for vitamin B6. Of the twelve members of this Expert Group, five are from the medical profession and seven have declared interests in the pharmaceutical industry. [4] Also, only one member and one observer holds any qualifications in nutritional science. Astonishingly, with regard to B6, one member of this Expert Group is on record as stating the following:-

“It is most disquieting that the Department of Health should have taken this paper (the Dalton study) as giving evidence on the question of what is the safe dose of vitamin B6 The paper is so flawed as to be essentially useless… the 10mg limit is ridiculous.”

~ Professor Andre McLean BCh PhD FRCPath. Professor of Toxicology University College, London [5].

Issue no. 4: Compliance costs

The compliance costs to industry is a major concern.

Re-labelling costs to industry have been calculated to be in the region of GB£300-500 per product by the UK Food Standards Agency (FSA). [6]

The FSA also estimate reformulation to be in the region of GB £3,000 per product.

However, the main costs to industry involve the submission of a full safety dossier to the SCF, which is estimated at between GB £80,000 and GB £250,000 per ingredient (not per product).

Our members rely, in the main, on products manufactured by the smaller innovative companies, as opposed to the multinational pharmaceutical companies. These smaller companies will undoubtedly suffer under the FSDdue to compliance costs and other restrictions (viz. annexes).

The UK Food Standards Agency reports that “small specialist retailers (such as health stores) stand to lose significant amounts of business if a wide range of specialist products is no longer available”. [7]

Implications of the Directive

Implications for Industry

The industry estimates that the omissions of nutrients from the Positive list, will necessitate the re-formulation of approximately 85% of vitamin/mineral supplements including nearly all of the multivitamin preparations on our shelves. Moreover, the SCF opinion on just one nutrient (vitamin B6) will result in the loss of 75% of all B complex and B6 supplements from health store shelves.

Thus it can readily be seen that the Food Supplements Directive will have quite a severe impact on the range of food supplements.currently being sold in health stores. As food supplements form over 50% of most of IAHS members' stock at any one time, the livelihood of many members is at stake. Although designed to remove barriers to trade, as well as to protect public health, the Directive will in fact achieve the opposite. As virtually none of the food supplements being imported from outside the EU, from countries such as the USA, Canada or Australia will comply with the Directive, these products will be barred from entering the EU. Within the EU, many of the smaller manufacturers will not have the resources to be able to comply with these requirements, and will close down, leading to loss of jobs. Remaining food supplement manufacturers will be forced to drastically reduce or re-formulate their product range, thus adding immeasurably to costs once again.

In Ireland this will be more acutely felt because nearly all of the 120 companies involved in the industry are Small to Medium-sized Enterprises (SMEs).

Implications for the consumer

The stated purpose of the Directive is to harmonise the market, and also to protect public health. Both are laudable objectives, but the net effect of this directive will almost certainly be the removal of many food supplement products from the marketplace, not because they are unsafe, but because of overly restrictive regulations. This, in turn, will lead to loss of jobs in the manufacturing, distribution and retail areas. Consumers will still want these products, so they will turn to mail order, the black market and the Internet as a source for them, where quality and safety controls are non-existent.

Therefore the directive will actually have the effect of increasing the hazard to the consumer.

Conclusions

Whereas:-

• Large sections of the population fail to reach recommended daily intakes of nutrients

• This can lead to ill health and increase the risk of chronic disease.

• 45% of Irish people regularly use food supplements

• The benefits of food supplements are widely acknowledged.

• Food supplements can reduce healthcare costs

• The safety record of food supplements is exemplary

But:-

• The Food Supplements Directive will remove most existing products from the shelves

• This is disproportionate to the risks presented by food supplements

• Compliance costs will drive many SMEs out of business causing closures and job losses.

• Health stores will be forced to close

• Consumers will be deprived of a valuable means of safeguarding their health.

• Over-regulation will encourage black market conditions where no quality or safety standards exist at all

What can be done ?

1. Ensure that the primacy of nutrition in protecting public health - supported by supplementation when necessary - be written into national health policy.

2. Ensure that a Regulatory Impact Assessment be carried out before this Directive is transposed into domestic law, consistent with Good Regulatory Practice.

3. Ensure that the S.I. allows the derogation for substances which are the subject of dossiers.

4. Recommend that the Irish government request the EU authorities to accept simplified Safety Dossiers in respect of nutrients which are currently on the market and have a long history of safe use.

5. Recommend that nutritional products currently available with a history of safe use remain available under food law in Ireland.

6. Ensure that Ireland fully supports safety limits rather than the RDA in upcoming EU negotiations

Background Information

The Health Service in crisis

The public health service is generally accepted to be in crisis. Patients are left for long periods on hospital trolleys, and waiting lists are growing all the time. Elective surgery procedures are being cancelled, and hospitals are being forced to close wards. Doctors' surgeries are being inundated by people with a litany of health problems, mostly minor and preventable. Annual expenditure on the health service rose from €3.1bn in 1996 to €8.2bn in 2002. You would think that the health authorities would be encouraging people to look after their own health by whatever means possible. The evidence for the protective effects of food supplements on health is now overwhelming – there are literally thousands of supporting references in the scientific literature.

Health Promotion

Health stores are primarily engaged in the promotion and maintenance of good health, using natural means as far as possible, by encouraging good dietary practices, using fresh unprocessed foods, preferably organic. Health promotion also involves regular exercise, adequate rest and sleep, good lifestyle principles such as stress management techniques, emotional and spiritual welfare, and the judicious allocation of sufficient personal and family time. Good nutrition is fundamental to good health, and the relationship of diet and lifestyle factors to the maintenance of health is now well established, and recognised by all health authorities. Food supplements may be utilised as an additional health promotion measure, not only to ensure adequate nutrition levels, but to enhance normal physiological function by ensuring optimal nutrition levels. It is this latter concept of optimal nutrition which has become a relatively new and exciting research subject particularly in recent years.

Any health authority wishing to review the "strategic changes necessary to promote best health and well-being" would be failing in its duty if it did not at least monitor and evaluate developments in this area with an open mind.

The World Health Organisation (WHO) has developed some interesting principles regarding Health Promotion [8].

· Health as a basic human right and essential for social and economic development.

· Health promotion is a process of enabling people to increase control over, and to improve, their health.

· Health promotion goes beyond health care. It puts health on the agenda of policy makers in all sectors and at all levels, directing them to be aware of the health consequences of their decisions and to accept their responsibilities for health.

· The role of the health sector must move increasingly in a health promotion direction, beyond its responsibility for providing clinical and curative services.

· Health promotion must be a fundamental component of public policies and programmes in all countries in the pursuit of equity and better health for all.

What is health?

Good health is not merely the absence of disease. It is a dynamic and vibrant state and encompasses the spiritual, mental, and physical states of being. This is what is meant by “holistic health”, central to which is the concept of the human body being a perfectly balanced self-regulating organism continuously growing and rebuilding itself, and which constantly needs to be nourished and developed. Illness or disease occurs when this fine balance is disturbed for some reason, possibly by invading pathogens, or by poor nutritional practices which cause nutritional deficit, and eventually leading to chronic illness. The body has the innate ability to heal itself using its own resources, and can most effectively do this when its nutritive status is at an optimum level. Optimum nutritive levels are established and maintained primarily by means of a wholesome well-balanced and diverse diet consisting of foods which are as close as possible to their natural state.

Optimal Nutrition

Central to the concept of optimal nutrition is that long-term nutrient deficit can lead not only to deficiency states, but also to mild symptoms of ill-health, such as fatigue, frequent infections, dry skin, mouth ulcers etc, as well as increasing the risk of chronic disease [9]. These risks may be greater in certain vulnerable sub-groups such as the elderly, the very young, or the ill and infirm. Optimal nutritional levels are those which not only protect against deficiencies but also protect against damage sustained by environmental toxins, and reduces the risk of chronic illness.[10] The application of the concept of optimal nutrition may require higher intakes of certain nutrients compared with levels considered necessary for essential needs.

Nutrient Deficit and Benefits of Role of Food Supplements

However, it is often not possible to maintain optimal levels through diet alone, due to factors such as a hectic lifestyle, environmental pollution, declining nutrient levels in foods,stress, poor diet, consumption of junk food, and special demands made on the body by pregnancy, physical training, smoking, disease etc.

· It is