Major independent scientific study launched on food supplement regulation

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Major independent scientific study launched on food

supplement regulation

Mon, 27 Jun 2005 04:12:48 +0100

ANH PRESS RELEASE: Major independent scientific study launched on food

supplement regulation

 

 

 

 

 

The Netherlands-based HAN Foundation, an independent group of leading

risk assessment scientists, today commences a 9-month study to shed

light on the EU's 'black box' regulation of food supplements.

 

PRESS RELEASE

 

For immediate release

 

 

27 June 2005

 

MAJOR INDEPENDENT SCIENTIFIC STUDY LAUNCHED TO SHED LIGHT ON EU'S

`BLACK BOX' REGULATION OF FOOD SUPPLEMENTS

 

On 5 April 2005, the European Court of Justice's Advocate General,

Leendert Geelhoed, provided his Opinion on a legal challenge filed by

the Alliance for Natural Health which concluded that the EU Food

Supplements Directive was invalid under EU law. The Advocate General

stated that the procedure for admitting ingredients to a `positive

list' had the " transparency of a black box " . The Court's ruling, which

will take into account the Opinion of the Advocate General, will be

issued from the Court in Luxembourg on the 12th of July,

 

Unless the legal challenge is successful next month, the Food

Supplements Directive could potentially ban, as of 1 August 2005, up

to 75 percent of vitamin and mineral forms currently on the European

market including many of those found naturally in foods. Due to the

devastating impact this would have on consumers as well as

practitioners and industry, the Alliance for Natural Health, the lead

party in the legal challenge of the Directive, has today commissioned,

under the sponsorship of the International Nutritional Company (INC

BV, Netherlands), an independent group of professional risk analysis

scientists to evaluate the overall regulation of food supplements in

the EU. The study will focus in particular on developing a new and

appropriate scientific risk assessment methodology for vitamins,

minerals and other micro-nutrients.

 

The €75,000 study, entitled Food Supplements and European Regulation:

Black box or level playing field rationality?, will be led by Dr Jaap

Hanekamp and Professor Aalt Bast, of the Heidelberg Appeal Nederland

(HAN) Foundation, which has previously provided definitive risk

assessment studies to assist governments on key human health issues

such as nitrates in food and drinking water and antibiotic growth

promoters in livestock.

 

Dr. Hanekamp, CEO of the HAN Foundation, said today:

 

" In view of the procedural problems that the Directive poses for

industry, it is essential to develop a straightforward, rational,

transparent, and scientifically coherent benchmark methodology to

regulate food supplements cost-effectively within a European, or even

a global, level-playing field in which assessment and management are

explicitly linked. "

 

INC spokesman Bert Schwitters comments:

 

" Nutrients deserve our fullest credit because they are essential to

life. Their safety must not be evaluated by applying the methods

traditionally used in dealing with chemical and pharmaceutical

compounds. Nutrients are our safest and most economic means to

maintain and restore health. In terms of public health " too little "

poses a far greater risk than " too much. " Evaluating nutrients' safety

must be done in a scientific and balanced way that pays respect to the

fundamental fact that we cannot do without them. "

 

Dr Robert Verkerk, executive director of the Alliance for Natural

Health, added:

 

" It is essential that the issue of food supplements regulation is

looked at by a leading independent group of risk analysis scientists

with a blank sheet of paper, before any amendment to the Directive is

finalised and before the international guidelines on vitamin and

mineral food supplements are finalised through the UN's Codex

Alimentarius Commission in July. The HAN Foundation scientists are

perfectly set to provide a fully independent, bias-free view on this

complex area and it would benefit governments and the UN, as well as

consumers, practitioners and industry, to await the findings of the

study, due in around 9 months time, before any further regulations or

guidelines are finalised. "

 

The Alliance for Natural Health has submitted a detailed report to the

Food & Agriculture Organization and the World Health Organization of

the UN, which are developing a so-called " nutrient-appropriate risk

assessment " system for food supplements likely to be adopted by the

Codex Alimentarius Commission, which is in turn about to finalise

international guidelines on vitamin and mineral food supplements in

its meeting in Rome between 4th and 9th July.

 

Dr Verkerk also noted:

 

" The implications of getting risk assessment wrong are horrendous. You

could actually deprive very large numbers of people from taking

nutrients that improve their health. The cost of this could be very

great. And in our opinion, and that of medical doctors practicing

clinical nutrition and other scientists around the world who have

endorsed our proposal, the existing risk assessment systems being used

by Regulators are deeply flawed. We badly need a new model that takes

into account both risks and benefits of food supplements. This

approach is central to the remit of the HAN Foundation scientists. "

 

The Alliance for Natural Health believes that the results of the study

will greatly facilitate legislation being developed for food

supplements in Europe as well as globally, and will reduce the

likelihood of future legal challenges.

 

The HAN Foundation study, commissioned and overseen by the Alliance

for Natural Health, has been sponsored by International Nutrition

Company (INC), the Netherlands-based worldwide supplier of natural

products originally developed by Professor Jack Masquelier in France.

 

For enquiries and further information contact:

 

Dr Robert Verkerk, Executive Director

Alliance for Natural Health

Tel: +44 (0)1252 371 275

Fax: +44 (0)845 280 4910

E-mail: info

www.alliance-natural-health.org

 

Dr. Jaap Hanekamp, CEO

Heidelberg Appeal Nederland

Tel: + 31 79 346 0304

Fax: + 31 79 346 0643

E-mail: jaapchan

www.stichting-han.nl

 

Notes for editors:

 

ALLIANCE FOR NATURAL HEALTH

 

1. The Alliance for Natural Health (ANH) is a Europe-wide

non-profit alliance of consumers, doctors, complementary health

practitioners, and innovative industry manufacturers and suppliers who

have an interest in food supplements and natural health. More

information, including details of the ANH's support base, will be

found at www.alliance-natural-health.org.

2. Good science and good law underpin all of the ANH's work, and

the scientific reports produced by the ANH are endorsed by many of the

world's leading doctors and scientists working in the field of nutrition.

 

HAN FOUNDATION

 

3. The HAN Foundation (stichting Heidelberg Appeal Nederland) was

established in the Netherlands in 1993 and named after the Heidelberg

Appeal, a declaration signed in 1992 by over 3500 scientists. HAN is

an independent non-profit making alliance of scientists and science

supporters whose aim is to ensure that scientific debates are properly

aired, and that decisions which are taken and action that is proposed

are founded on sound scientific principles. Members are accepted from

all walks of life and all branches of science. HAN has at present over

800 donors, including almost 200 professors.

 

EU FOOD SUPPLEMENTS DIRECTIVE

 

4. If the proposed ban on vitamins and minerals is implemented on 1

August 2005 across Europe, there is much at stake:

 

· Over 5000 products will disappear from the shelves of UK

health stores as a result of the ban removing access to over 300

vitamin and mineral ingredients (out of a total of about 420). These

include, amongst others, the main natural forms of Vitamin E, several

forms of vitamin C, the key natural form of folic acid, MSM and a

range of minerals such as vanadium, silicon and boron, all being

products which millions of consumers choose to take as part of their

regular health regime and have done so without any ill effects for

many years.

 

· An individual's freedom of choice to take safe natural

health products will be removed; 40-45% of the UK, Irish and Swedish

populations take vitamins and minerals.

 

· Products are to be banned with absolutely no scientific

justification. Many of the world's leading scientific and medical

experts in nutrition support the absence of any proper basis for the

proposed bans.

 

· Although the proposed bans related only to vitamins and

minerals, unless overturned, the `Positive list' system will most

likely be transferred to other nutrients used in food supplements,

such as plant extracts, amino acids and enzymes. The precedent set by

an ANH victory will drastically reduce the chance of future bans on

these other nutrient forms.

 

· Further regulatory proposals by the EU and Codex

Alimentarius are due to be considered by later this and next year.

These include restrictions on maximum dosages of vitamins and minerals

and restrictions on health claims of foods and food supplements.

Again, the ANH is working to help positively shape such legislation

using its mantra of `good science and good law'.

 

CODEX GUIDELINES ON VITAMIN AND MINERAL FOOD SUPPLEMENTS

 

5. The Codex Alimentarius Commission develops international

guidelines for a very wide range of food products. These guidelines

are used by governments with the intention of harmonising rules on

food products to assist international trade as well as ensuring

consumer safety.

 

6. The Codex Guidelines on Vitamin and Mineral Food Supplements

have been in development for approximately 10 years. It is one of a

large number of Guidelines pertaining to food products that has been

developed under the auspices of the Codex Alimentarius Commission

(established in 1963), which is a subsidiary body of the World Health

Organization (WHO) and the Food & Agricultural Organization (FAO) of

the United Nations. Codex Guidelines are frequently implemented into

laws of Codex member countries (172 in total), and they are used as

reference points in any trade disputes brought to the World Trade

Organization.

 

7. The text for the Guidelines was agreed by consensus in the Codex

Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU)

in Bonn in November 2004, and the Guidelines are due to be ratified at

the next CCNFSDU meeting in Rome on 4-9 July 2005.

 

8. The key area of the Guidelines which has yet to be agreed is the

nature of the `nutrient appropriate' scientific risk assessment, which

will be used to establish Upper Safe Levels for the vitamins and

minerals. The process of determining this science has effectively,

although unofficially, been handed to the FAO/WHO, who, in turn, have

allowed an open consultation phase for input from external parties.

The Alliance for Natural Health (ANH) was one of 16 organisations to

submit comments for this consultation in December 2004, and the ANH

submission revealed, with extensive reference to peer-reviewed

science, very substantial flaws in the various existing models that

have been used by US and European authorities. These models are

assumed to form the basis of the risk assessment science to be

employed in establishing upper levels. The ANH's submission has

subsequently been endorsed by over 100 leading clinical nutritionists

in the US and Europe.

 

27-Jun-05

*

 

 

* ANH Legal Executive Summary 10 April 2005 (PDF, 146.30 kbs)

* German language ANH flyer New flyer updated June 2005 for

distribution among German speaking contacts!

(PDF, 2,718.24 kbs)

* Italian Language ANH Flyer New flyer updated January 2005 for

distribution among Italian speaking contacts!

(PDF, 1,303.61 kbs)

* Spanish ANH Flyer New flyer updated January 2005 for

distribution among Spanish speaking contacts!

(PDF, 133.05 kbs)

* US ANH Flyer New flyer prepared for US (updated 24 June 2005) -

please download and tell others about our campaign.

(PDF, 2,119.81 kbs)

* Wake up America! Dr Robert Verkerk's article written for the

January 2005 American College for Advancement of Medicine (ACAM)

newsletter

(DOC, 52.50 kbs)

* UK Parliament Briefing Document July 2003

(PDF, 500.61 kbs)

* Update from ACAM 2004 Background paper on key threats to

nutritional supplements by Dr Robert Verkerk given at the ACAM

conference in San Diego, November 2004

(DOC, 204.00 kbs)

* UK Department of Health discussion document: Choosing Health?

Choosing a Better Diet Consultation document produced by the UK

Department of Health, to which the ANH responded.

(PDF, 147.13 kbs)

* ANH response to Choosing Health? Choosing a Better Diet ANH

response to the UK Department of Health's consultation document.

(PDF, 187.08 kbs)

* Legal Executive Summary, April 2004 Useful summary of the ANH

legal action against the Food Supplements Directive from the ANH Legal David Hinde

(PDF, 148.31 kbs)

* ANH risk assessment submission Read ANH's ground-breaking

submission to FAO/WHO risk assessment project

(PDF, 341.15 kbs)

 

....more documents >>

 

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