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To: IAHF List
Subject: JH Gone For Week-Emergency Anti Codex Work: How You Can Back Me Up: Specifics on European Parliament vote: Whats Next!!!
From: "International Advocates for Health Freedom" jham@iahf.com
Date: Sat, 17 Feb 2001 01:39:15 -0500

IAHF List: The two attached files providing details of EU Vitamin Directive vote are worth a minute to check out. See how the HARM-onization juggernaut is steamrolling the EU?

THAT is so called "GLOBALIZATION" and its very dangerous, we must all learn about it and work together to STOP it!
Also visit http://www.tradewatch.org and learn more there.

Hopefully the burgeoning European health freedom movement can keep building in size and strength as the battle there shifts gears and they now have to target their Health Ministers because now it goes to the Council of Ministers who will take about 4 months to deliberate.

AMERICANS: We have a Codex oversight hearing on Feb 28th, and I will be gone for a week doing work relative to trying to insure that our witnesses can get into the hearing. The best way you can back me up is to encourage more people to sign the online petition at http://www.garynull.com/issues/Codex/AboutCodex.htm and circulate the educational materials on that site because we must demonstrate grass roots strength at this time in order to get our witnesses into the hearing. We're up to 3333 sigs, lets see if we can DOUBLE or TRIPLE this number by Feb 28 to send a mssg to the House Oversight Committee.

THANK YOU !! I want to thank those of you who have been downloading and filling in paper petitions from the Null site too! Please keep it up, take some to all the health food stores in your area! The most important thing we can do is keep educating more people about what is going on, and we must make more of an effort to get signatures on these two petitions or we won't stop the juggernaut.

Please write to your Senators and Congressmen about the Codex vitamin issue and the overall topic of harmonization. Tell them to cosponsor the American Sovereignty Restoration Act- see info on scrollbar http://www.iahf.com for details. Tell your Senators and Congressmen about our health freedom petitions, and tell them to pay attention to what is happening in the EU right now.

EVERYONE WORLD WIDE I also encourage vitamin consumers world wide to keep signing the La Leva petition at its new site http://www.laleva.cc/petizione/english/intro_eng.html and please read all the educational materials there and tell more people about them. Americans- you're slowing down! Not good! Denmark is way out in front of everyone signing the La Leva petition, then Sweden, Canada, USA is only 4th! Portugal is catching up on per capita basis, sigs up to 14,916 but USA is asleep at the switch, we should have that many sigs from USA alone, MUCH more work needed to awaken sleeping Americans. Many thanks to Frank Cuny for helping at National Health Federation Show.

Date: Fri, 16 Feb 2001 17:56:55 +0100
To: Tamara Thrsa Mosegaard tamaratheresa@yahoo.dk
From: Josef Hasslberger sepp@lastrega.com
Subject: European Parliament vote

Dear all,

the two attachments are

1) the reasoning of medical and pharmaceutical interests who wanted to keep the directive "on target" so as to not include anything that could be remotely thought of as a medicine, such as any ingredient with a "physiological function".

2) an evaluation of the amendments adopted by the European Parliament on 14/2/2001.

============

here is what I have been able so far to gather of the results of the vote in the European Parliament on the food supplements directive, on 14 February 2001.

The directive inched into a slightly more positive direction, but our major concerns, which are the almost insurmountable hurdle of medicinal/scientific approval for new substances and the uncertainty of what will become of allowed dosages, remain unchanged.

The next round will be played in the Council of Europe, to which national health ministries send their experts. This is expected to last about four months.

Depending on the outcome of discussions in the Council, which will result in a "Common Position" of the member states on the matter, the proposed directive may then go back to the Parliament or, if the Common position is identical to or almost identical to the version voted by the EU Parliament, then the directive could go directly on it's way to approval.

Consumers will now have to target their national health authorities, and possibly national parliaments, while the discussions on the common position are going on.

The Council is not losing any time. Already on Thursday 15 February, a meeting of the Council was to be held, for the permanent representatives of each country (not the national ministerial experts) to discuss the outcome of the vote of the day before.

Kind regards

Josef

================================================

Josef Hasslberger's home page: http://www.hasslberger.com
see also La Leva di Archimede
Consumers favoring freedom of choice: http://www.laleva.cc

================================================

Decisions of the European Parliament on the food supplements directive

The plenary session of the European Parliament (EP) discussed and voted on the food supplements directive as proposed by the European Commission and on amendments as proposed by the Parliament's Environment Committee, on 13 and 14 February 2001.

Reports available so far indicate that industry (ehpm) successfully countered a last minute heavy lobbying by pharmaceutical and medical interests, who asked the Parliament not to extend the concept of food supplements to products containing substances with a physiological function, arguing that this would confuse consumers and would make some products that are today sold as medicines "switch category" to become food supplements. (The text of the medical/pharmaceutical arguments is available as a separate file).

With regard to substances missing from the "positive" lists in the annex, the Parliament apparently voted to create a list of possible additions to be put into a sub-annex and ask the Commission and the Scientific Committee on Food to expedite the examination of these substances.

Amendments to article 5 of the proposed directive (on how to set upper safe limits for supplements) were all rejected.

The next stage in the process of approval of the directive will be meetings of the Council of Ministers (the member state authorities) who, among themselves, must now reach a Common Position.

Apparently if the member states representatives reach a Common Position that is more or less identical to the decisions reached by Parliament, there will be no second reading in the EP. If instead the Member states position is different, the directive will have to return another time to the Parliament for discussion.

Some of the amendments accepted by the EP are:

1) The definition of a food supplement in article 2 was amended to include "other substances with a nutritional or physiological function" as permitted ingredients in food supplements.

(The original proposal by the Commission stated that only those vitamins and minerals listed in the annex could be used in food supplements)

2) Such "other ingredients" would however in any case have to be included in the annex to the directive, "as soon as the necessary scientific data is available".

3) A new part B of annex II is created, and the Commission is asked to ensure that nutrients and ingredients contained in food supplements marketed in the EUprior to the date of adoption of the directive and listed in this new part of the annex "undergo scientific evaluation as soon as the necessary documents are submitted" and are then moved (or not) to the actual annex, after examination by the SCF.

4) Combination products have been expressly acknowledged as existing, and "supplements containing substances other than those covered by the directive should be subject to national laws. Products containing both vitamins or minerals and other ingredients should be subject to the directive only in respect of their vitamin and mineral content." However: "Specific rules concerning other nutrients or other substances in food supplements should be laid down as soon as adequate scientific data is available".

Comment:

Although industry is apparently very satisfied with the result, we are still at the mercy of the Scientific Committee on Food for the scientific evaluation of substances (even asking them to evaluate not only vitamins and minerals but other ingredients as well) and the setting of upper levels of dosage is still in the hands of the SCF and the Commission in a procedure of little transparency. The two major concerns pointed out in our letter to Members of the EP have not been removed by the amendments adopted by the Parliament in their Valentine's day decision.

================================================

The doctors and pharmacists of the European Union, represented by the Standing Committee of European Doctors (CP) and the Pharmaceutical Group of the European Union (PGEU) agree upon the following policy in order to protect public health.

CP and PGEU are concerned for the consequences the adoption of certain amendments proposed to the Plenary on the Muller Report (AS-0025/2001) might have on Public Health. Please find attached a short statement which clarifies the issue and explains the reasoning of our concerns.

In order to protect Public Health we believe it is essential to vote against Amendment 33, and consequent 34, 35 and Amendment 44 and consequent 46, 47

Yours sincerely


Lisette Tiddens Engwirda                  Gretha Assved
Secretary General                         Secretary General
PGEU                                      CP

an evaluation of the amendments adopted by the European Parliament on 14/2/2001

The doctors and pharmacists of the European Union, represented by the Standing Committee of European Doctors (CP) and the Pharmaceutical Group of the European Union (PGEU) agree upon the following policy in order to protect public health.

Subject:

PROPOSAL FOR A DIRECTIVE ON FOOD SUPPLEMENTS
VOTE IN PLENARY ON THE 14TH OF FEBRUARY

THE ISSUE:
The Directive on Food supplements is before the European Parliament for its first reading. In the current review of the food legislation the Commission tabled on May 2000 a proposal for a directive on the approximation of the laws of the Member States relating to food supplements.
The Environment Committee of the EP has approved an amendment concerning the definition of substances covered by this Directive. The amendment reads as follows:
Art. 2(b) which defines what is nutrients
(i) "Vitamins as listed in point 1 of annex 1" (the list will be drawn up by the Scientific Committee on Food)
(ii) "Minerals as listed in point 1 of annex 1" (the list will be drawn up by the Scientific Committee on Food)
(new text:)
(ii) Other ingredients with a nutritional function which in accordance with Article 4(4) are included in Annex I.

The amendment was a result of a compromise. The original text of the amendment was reading:

(ii) Other ingredients with a nutritional or physiological function which in accordance with Article 4(4) are included in Annex 1.

The Environment Committee has decided for a compromise on the grounds of public health protection because otherwise the amendment would have significantly broadened the scope of the Directive and would have undermined the original goal of the Directive. This compromise is again under discussion and amendments to broaden the scope of the Directive by adding "ingredients with physiological effect" will again be up for vote in the Plenary.

CP and PGEU are very concerned about this. Our two organisations support the compromise adopted by the Environment Committee that does not endanger the objectives of this directive and recommend to the Plenary not to further amend this point. The consequences of this addition would have severe negative impact on Public Health. The effect would be the exact opposite to the original intent of the Directive.

JUSTIFICATION OF OUR POSITION

The Directive was meant to clarify the area of food supplements by increasing transparency and consumers confidence. The Directive sets certain requirements to be fulfilled by those products (doses, labelling, notification etc.) and to clarify the status of certain borderline products by setting a clear distinction between medicine and food supplements. (Footnote: So far it is possible to have products which are considered medicines in certain Member States and food in others.)

To achieve this the Commission decided to draft a Directive applicable to FOOD SUPPLEMENTS defined as substances with a nutritional effect. The set of provisions established by the Directive was meant to respond to these categories of products with certain criteria. Adding the word "physiological" would include products which would require different provisions in order to keep the same guarantees for Consumers and for Public Health Protection, in fact it would include medicinal products.

Directive 65/65/EEC defines medicine as "any substance or combination of substances which might be administered . . . with a view to making a medical diagnosis or to restoring correcting or modifying physiological functions".

This definition, widely recognized, would be conflicting with the proposed addition.

Doctors and Pharmacists are concerned about the possible addition and the consequences it might have.

Last but not least, the addition of the word "physiological" would also create a high degree of uncertainty among European citizens because products considered medicines in certain Member States could "switch" into this category. This would have impact also on Public Health Protection and would confuse European citizens.

CONCLUSION:

In order to keep the original aim of the Directive, to respond to the concerns of Public Health Protection the Scope of the Directive should stay as was defined by the Commission, or eventually, as was approved by the ENVIRONMENT Committee of the EP. The inclusion of "ingredients with a physiological function" would pose European Citizens at risk and should therefore be rejected.

------------

Footnotes:

1) CP members are 17 National medical associations (Named) of the EU member states and the EFTA countries as well as 14 observers and associate members NMA's from other European countries, many of them applicant countries to EU. The CP represents 1,4 million doctors within the EU/EEC.
http://www.cpme.be

2) The Pharmaceutical Group of the European Union or PGEU exists was founded in 1959 and has the national organisations of pharmacists within the 15 member states as member, plus 11 countries as observer member, all in all PGEU represents in around 600.000 people working in community pharmacies.
http://www.pgeu.org