EU Directives - from Alliance for Natural Health website

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EU Directives - from Alliance for Natural Health website

Sat, 29 Oct 2005 19:27:16 +0100

 

 

 

 

http://www.alliance-natural-health.org/index.cfm?action=content.eu.Default

 

 

 

Traditional Herbal Medicinal Products Directive (Directive 2004/24/EC)

 

 

This is actually a sub-Directive, rather than a stand alone Directive,

being part of the Human Medicinal Products Directive (see ANH

Information Sheet, Ref IS 3/05). It is intended only for those herbal

products that are considered as " medicinal " and which have a history

of traditional use. It comes in to force in EU Member States on 30

October 2005, although provides a transition period up to 2011 before

it is fully implemented.

 

Products regulated by this Directive benefit from a fast-track `drugs

licensing regime' where the need to supply costly safety studies can

be avoided if it can be demonstrated that the product in question has

been used safely over a continuous period of 30 years, of which 15 are

in at least one EU Member State.

 

How will it affect practitioners, consumers and manufacturers?

 

1. The Directive is only relevant for herbal products targeting minor

ailments. The Directive applies to herbal medicines for minor ailments

only which " are intended and designed for use without the supervision

of a medical practitioner for diagnostic purposes or for prescription

or monitoring of treatment. "

 

2. Exclusion of some products from non-EU traditional cultures. The

so-called `30-year-rule' will restrict the availability of all

products from non-EU cultures which have yet to be used in the

European Union, or have been introduced within only the last 15 years.

Such products could only be permitted if they were able to

successfully pass through a full drugs licensing regime, likely to be

prohibitively expensive for most non-pharmaceutical manufacturers or

suppliers.

 

3. Food supplements might be categorised as herbal medicinal products.

There is a significant risk that herbal products in some Member States

which should rightly be considered as food supplements, will be

considered by competent authorities as " herbal medicinal products " .If

they then do not qualify for the fast-track under this Directive, they

will again require a full drugs license if they are to be sold.

 

4. Particular combinations of herbal products may be disallowed. The

traditional use must be for an individual herb or specific combination

of herbs, thus preventing use of new or innovative combinations that

might be supported by emerging science.

 

5. Herbal products containing significant levels of nutrients will be

prohibited. Combinations with vitamins and minerals will only be

allowed if the action of the nutrients is considered " ancillary " to

that of the herbal ingredients.

 

6. Products will be subject to pharmaceutical stability tests. It will

be necessary for manufacturers to demonstrate 6-months stability of

mixtures, which will be difficult or impossible for many complex

tinctures which have been used safely and with demonstrated benefit in

specific medicinal cultures (e.g. Ayurveda).

 

7. Increased cost to consumer. Significant compliance costs will

apply, which will need to be passed on to consumers. This may make

their cost uneconomic for some.

 

8. Committee control. Authorisations will be controlled by the

Committee for Herbal Medicinal Products which is weighted strongly

towards drug pharmacologists, as opposed to practising medical herbalists.

 

Link to herbal medicines documents on ANH website.

 

Click here to access one-page ANH Information Sheet on the Traditional

Herbal Medicinal Products Directive (last update: September 2005).

 

Link to UK Medicines & Healthcare products Regulatory Agency website:

traditional medicines registration scheme; guidance and information.

 

_______________

 

The Human Medicinal Products (Pharmaceuticals) Directive (Directive

2004/27/EC)

 

This is the key Directive (2004/27/EC), sometimes referred to as the

`Pharmaceuticals Directive', controlling the use and sale of

pharmaceutical products across the EU. It was first enacted in 1965

and has been amended on several occasions, most recently in 2004. This

most recent amendment is in the process of being transposed into

regulations in the 25 EU Member States. There are two fundamental

problems with this Directive as it relates to natural products, and

these have already caused some governments in the European Union to

consider high dose vitamin C, glucosamine, the amino acid 5HTP and

ethylated Omega-3 fish oils as drugs.

 

 

Problem 1: the definition

 

Firstly, it contains an extremely broad definition of a drug or

" medicinal product " (Article 1), so that absolutely any product, even

a food or food supplement, which has a physiological effect on the

body, can be classified as a drug by regulators. The second (function)

limb of the definition states that any substance or combinations of

substances " which may be used in or administered to human beings

either with a view to restoring, correcting or modifying physiological

functions by exerting a pharmacological, immunological or metabolic

action, or to making a medical diagnosis " should be classified as a

medicinal product.

 

This definition is so broad it technically includes all therapeutic

substances, as well as all foods, water, coffee and more or less

everything that is consumed by or applied to humans. In an attempt to

reduce legal uncertainty, the Directive purportedly provides exclusion

for " food, food supplements, medical devices, biocides or cosmetics " ,

but since this exclusion is contained in a Recital rather than an

Article, it has little legal weight, especially as this Recital

applies to the amending Directive rather than the base Directive of 1965.

 

Problem 2: the scope

 

The Directive has the ability to `trump' other Directives via its

Article 2(2), which states, " In cases of doubt, where, taking into

account all its characteristics, a product may fall within the

definition of a 'medicinal product' and within the definition of a

product covered by other Community legislation the provisions of this

Directive shall apply. " Therefore, there is a real risk that

leading-edge, practitioner-type food supplements may be classified as

medicines, to be controlled by this Directive rather than the Food

Supplements Directive. The full drugs regime provided by this

Directive is so costly that it would be prohibitive for most food

supplement manufacturers.

 

Apart from regulating conventional pharmaceutical products, the

Directive also regulates homoeopathic products and traditional herbal

medicinal products (see below), allowing specific dispensations over a

normal drugs regime for each category.

 

ANH is involved in preparatory work aimed at challenging the legality

of this Directive. ANH and the Netherlands-based HAN Foundation are

also working to develop a new regulatory framework for food

supplements and functional foods which is proportionate as well as

being legally and rational scientifically.

 

Link to human medicinal products documents on ANH website.

 

Click here to access one-page ANH Information Sheet on the Human

Medicinal Products Directive (last update: September 2005).

 

____________

 

The EU Nutrition and Health Claims Regulation (COM(2003) 424 final -

2003/0165 (COD))

 

The EU Nutrition and Health Claims Regulation (COM(2003) 424 final -

2003/0165 (COD)) will have full control over any and all claims made

about a food product. No claims of any sort will be allowed unless

they are specifically accepted and approved by the European Food

Safety Authority (EFSA). The Alliance for Natural Health (ANH)

considers that there is a real risk that health claims that can be

scientifically proven may nevertheless be rejected since the EFSA may

consider that such claims are not based on " generally accepted

scientific data " .

 

Once finalised, the Regulation will be immediately effective in all EU

Member States and, unlike EU Directives, will not need to be

transposed into the regulatory system of national governments.

 

The Regulation may infringe Article 10 of the Convention on Human

Rights, which guarantees freedom of speech. It seems that bans in

cases where potential claims are accurate, which may result because

commercial interests are unable to meet the data requirement

provisions for substantiation of health claims, may effectively impede

freedom of speech.

 

How will it affect practitioners, consumers and manufacturers?

 

The most serious potential problems for practitioners, consumers and

innovative natural product manufacturers and suppliers, that make up

the bulk of the ANH support base, are as follows:

 

• Health claims may be rejected even if they are able to be

scientifically proven since EFSA may consider that such claims are not

based on " generally accepted scientific data " . This is particularly

problematic for innovative and emerging science;

 

• The scientific substantiation procedure for health claims, as set

out in the proposed regulation, would disproportionately favour large

businesses over small businesses;

 

• There can be no rationale in attempting to ban certain categories of

health claim that can be scientifically proven (e.g. slimming,

behavioural, physiological claims) as per proposed Article 11;

• The proposed Regulation could seriously interfere with the ability

of complementary health practitioners to properly inform and assist

their clients or patients, and;

 

• There are potentially very serious conflicts with existing Community

law, most notably the directive on human medicinal products

(2004/27/EC). This could prevent any significant claim being made for

a food product or nutritional supplement, unless it underwent

medicinal licensing, an extremely costly and time consuming process

that is not economically feasible for most food or supplement

manufacturers.

 

Link to health claims documents on ANH website.

 

Click here to access one-page ANH Information Sheet on the Nutrition

and Health Claims Regulation (last update: September 2005).

 

Codex Alimentarius Guidelines on Vitamin and Mineral Food Supplements

 

The Codex Alimentarius Commission was created in 1963 by the Food and

Agricultural Organization (FAO) and World Health Organization (WHO) to

develop food standards, guidelines and related texts such as codes of

practice under the Joint FAO/WHO Food Standards Programme. The main

stated purposes of this Programme are protecting health of the

consumers and ensuring fair trade practices in the food trade, and

promoting coordination of all food standards work undertaken by

international governmental and non-governmental organizations.

 

The Codex Alimentarius Guidelines on Vitamin and Mineral Food

Supplements apply only in jurisdictions where vitamin and mineral food

supplements are regulated as foods (rather than as medicines). They

have been under development for over approximately 10 years, under the

auspices of the Germany-based Codex Committee on Nutrition on Foods

for Special Dietary Uses (CCNFSDU) which finalised the text in the

final step (8) of the Codex procedure in Bonn, Germany, 1-5 November 2004.

 

The Guidelines, amid considerable opposition from consumer groups and

natural health campaigners, were finally accepted at the 28th Session

of the Codex Alimentarius Commission in Rome on 4 July 2005.

 

One of the most significant aspects of the Guidelines is the setting

of maximum daily potencies for vitamin and mineral food supplements

after considering upper safe levels (based on `scientific risk

assessment', see ANH Information Sheet, Ref 02/05) and dietary intakes

from other food sources.

 

These Guidelines are likely to set, amongst other things, an

internationally recognized borderline between dosages of vitamins and

minerals used as foods and those used as medicines.

 

So-called " scientific risk assessment " approaches have been widely

agreed by various government agencies principally in the US and

Europe, and are also supported by major trade associations in the

natural products area (e.g. the Council for Responsible Nutrition

[CRN] and the National Nutritional Foods Association [NNFA] in the

USA, and the European Federation of Health Product Manufacturers

[EHPM] in Europe).

 

The " scientific risk assessment " approach proposed for Codex

guidelines on vitamins and minerals parallels that set out in Article

5 of the Food Supplements Directive, which has formed the template for

international Codex guidelines.

 

Unless existing, flawed methods of risk assessment for nutrients,

which are derived from those used on toxins such as pharmaceuticals

and pesticides, are substituted for scientifically rational

risk/benefit analysis, unnecessarily low dosage ceilings will be

applied which could restrict very large numbers of people from

accessing dosages beneficial to health.

 

Link to Codex documents on ANH website.

 

Click here to access one-page ANH Information Sheet on the Codex

Guidelines on Vitamin and Mineral Food Supplements (last update:

September 2005).

 

A wide range of health freedom interests in the USA, including the

ANH, have united in mid-2005 to form an umbrella organisation, the

Coalition for Health Freedom, to help protect US citizens from

restrictions on dosages or types of dietary supplement or functional

food which may result from international Codex guidelines.

 

For more information, please email info

www.alliance-natural-health.org

 

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