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CODEX. CODEX Vitamin & Mineral Guidelines PASSED!. International Guidelines for Trade Vitamins and Minerals. CODEX ALIMENTARIUS. 1. Ancient “to protect consumers from dishonest practices in the sale of food” Codex Website 2005. CODEX ALIMENTARIUS. 3. Codex Alimentarius Austriacus

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CODEX

NHFA 2005


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CODEX Vitamin & Mineral GuidelinesPASSED!

International Guidelines for Trade

Vitamins and Minerals

NHFA 2005


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CODEX ALIMENTARIUS

1. Ancient

“to protect consumers from dishonest practices in the sale of food”

Codex Website 2005

NHFA 2005


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CODEX ALIMENTARIUS

3. Codex Alimentarius Austriacus

Austro-Hungarian 1911

“to determine standards of identity for specific foods.”

Codex Website 2005

NHFA 2005


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CODEX ALIMENTARIUS

5. 1940’s - Consumer Concerns

“…protect consumers from poor quality and hazardous foods.”

NHFA 2005


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FAO

6. 1961 – World Concerns

FAO steps in for

world food safety

NHFA 2005


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FAO

United Nations

Food and Agricultural Organization

NHFA 2005


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FAO

Desire for international agreement

“on minimum food standards…”

NHFA 2005


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1961

FAO Establishment of Codex Alimentarius Commission

  • Protecting the consumer’s health

    - Ensuring quality

    - Reducing trade barriers

NHFA 2005


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CODEX ALIMENTARIUS

Historically -Visible

Underweight contents

Size variations

Misleading labeling

Poor quality

NHFA 2005


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CODEX ALIMENTARIUS

Science based - Invisible Alarm

micro-organisms

pesticide residues

environmental contaminants

food additives

NHFA 2005


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WHO

United Nations

World Health Organization

NHFA 2005


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WHO

“… with the goal of developing sustainable, integrated food safety systems for the reduction of health risk along the entire food chain, from the primary producer to the consumer”.

[1] WHA Resolution 53.15, 2000. [1] Weekly Epidemiological Record, 2004, 79, 173-180, No. 18, April 30. http://www.who.int/wer.

NHFA 2005


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1963

Established

Joint Program

FAO and WHO

Codex Alimentarius Commission

NHFA 2005


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FAO/WHO

Dual Goals

Broad Jurisdiction

. Protecting the health of consumers

. Ensuring fair practices in food trade

NHFA 2005


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CODEX ALIMENTARIUS

172 Countries

Desire to Harmonize

Voluntarily

NHFA 2005


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HARMONIZATION CONCEPT

“The harmonization of food standards is generally viewed as a prerequisite to the protection of consumer health as well as allowing the fullest possible facilitation of international trade.”

Codex website 2005

NHFA 2005


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HARMONIZATION PROMOTED

“…the Uruguay Round Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT) both encourage the international harmonization of food standards.”

Codex Website 2005

NHFA 2005


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CODEX COMMENTSWHY THE PROGRESS OFHARMONIZATION IS IMPEDED

-Different legal and administrative systems

-Varying political power systems

-National attitudes and concepts of sovereign rights

Codex Website 2005

NHFA 2005


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Uruguay Round Agreements

1994 WTO

WORLD TRADE ORGANIZATION

SPS & TBT Agreements

NHFA 2005


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WTO - 1994

Independent Trade Organization

-

Member Countries Join by Contract

-

Enforceable by Dispute Resolution Body

NHFA 2005


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WTO  Codex

WTO Agreements refer to Codexas the international standard to be used by WTO members for trading goods.

NHFA 2005


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WTO

Majority of WTO members

are

Codex Alimentarius members

NHFA 2005


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WTO

Will WTO be a vehicle for the enforcement of Codex?

NHFA 2005


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Regional Trade Agreements

Will other regional trade agreements such as CAFTA andNAFTA point to Codex and affirm the enforcement of Codex standards or guidelines?

NHFA 2005


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EU Food SupplementsDirective

Will Codex adopt a positive list approach and ban everything else like the EU FSD tried to do?

NHFA 2005


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HEALTH FREEDOM PRINCIPLES

Freedom of access for health-seekers

Freedom to practice all healing methods

Regulate by the least restrictive means

NHFA 2005


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SAMPLES OFHealth Freedom Responses

-Ask WTO for a formal opinion re enforcement

-Work to strengthen national US laws

-Challenge UN/FAO/WHO jurisdiction

NHFA 2005


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Codex GuidelinesPassed

Final Codex Guidelines

Approved by Commission

Italy July 4, 2005

NHFA 2005


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Freedom Infringements

Core Problem

Disregard for Over-breadth

NHFA 2005


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Freedom Alert

Conceptual Merger

FAO + WHO

NHFA 2005


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FAO COMMODITIES LAW

FAO Food Safety

NHFA 2005


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WHO PEOPLE LAW

WHO People Health

NHFA 2005


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MERGER

Regulation

Food+People ( how they use food )

NHFA 2005


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DIFFERENT BURDENS OF PROOF

Regulating Nutritious Food

Regulating Toxic Substances

Regulating People

NHFA 2005


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Burdens of Proof

Government must show there is imminent risk of significant public harm before regulating

vs.

People must show that it is safe or has benefit before acting

NHFA 2005


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Nutrients and Food

Government must show that there is an imminent risk of significant harm before prohibiting

Example: DSHEA

NHFA 2005


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Toxins/Drugs

Manufacturers must show that it is safe to distribute or has benefit that outweighs the risk before distributing

Example: Ampicillin

NHFA 2005


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People

Government must show that a person will cause an imminent risk of public harm

Example: Contagious Disease

Except…..!!!!!!!!

NHFA 2005


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BEFORE REGULATING PEOPLE

Government MUST consider:

Fundamental rights

Freedom of self-determination

National sovereignty

Human rights

Cultural diversity

Right to fairness and due process

Least restrictive means of regulation

NHFA 2005


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PEOPLE HEALTH FREEDOMS

Educate Freedom of Speech

Pray Freedom of Religion

Sell Commerce Law

Recommend Freedom of Speech

Use Self-determination

Refuse Self-determination

NHFA 2005


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LEAST RESTRICTIVE MEANS

Examples:

Voluntary vs. Mandatory

Treatment vs. Isolation

Exemptions with conditions

NHFA 2005


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Mixing

“food law”

and

“people law”

Freedom Alert!

Watching for merger power

NHFA 2005


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“ These Guidelines apply in those jurisdictions where products defined in 2.1 are regulated as foods.”

Draft Guidelines for Vitamin and Mineral Food Supplements

People:

Some countries consider vitamins and minerals to be food, others don’t.

CODEX GUIDELINESSee merger power

NHFA 2005


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products defined in 2.1 are regulated as foods.”Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet.”

(underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements

People DOGMA:

There is a proper “balanced” way to get nutrients which is considered “normal”

CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

NHFA 2005


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products defined in 2.1 are regulated as foods.”Because foods contain many substances that promote health, people should therefore be encouraged to select a balanced diet from food before considering any vitamin and mineral supplement.” (underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements

People DOGMA

Does this mean Vitamins and Minerals are not really food?

CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

NHFA 2005


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“Vitamin and mineral food supplements products defined in 2.1 are regulated as foods.”should contain vitamins/ provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO.” (underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements

People Violation

Burden of proof shifting with “should”

No preliminary and mandatory showing of imminent risk of significant harm.

CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

NHFA 2005


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“Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufactures shall be set, taking the following criteria into account: (underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements

People Violation

Burden of proof shifted from government to manufacturers

No preliminary and mandatory showing of imminent risk of harm.

CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

NHFA 2005


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“(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity f different consumer groups:” (underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements

People Violation

Conventional science above

people’s choice,

Government has not first proven risk of significant harm.

CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

NHFA 2005


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FREEDOM ALERT! established by scientific risk assessment based on

Maximum Amounts of Vitamins and MineralsShall Be Set !

Upper safe levels…

established by scientific risk assessment!

NHFA 2005


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Rational for Risk Assessment established by scientific risk assessment based on

EXPORTS

Countries cannot block imports coming in that are equal to or less than Codex limits. They also cannot set maximum limits for importation of lower than Codex amounts such as the lower RDA values.

FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?

NHFA 2005


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Rational for Risk Assessment established by scientific risk assessment based on

IMPORTS

RDA can no longer be used to set maximum limit a country will allow to be imported.

A product cannot be blocked from importation if it contains equal to or less than the Codex limits.

FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?

NHFA 2005


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FREEDOM ALERT! established by scientific risk assessment based on

No rational for upper limits on food!

  • Low RDA

  • Mandatory Risk Assessment

  • No Upper Limits

    Burden of Proof shifting

    AT THE PRICE OF FREEDOM

NHFA 2005


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FREEDOM DEMAND! established by scientific risk assessment based on

Freedom Demand: On behalf of the people, no upper limits shall be placed on amounts of food content in products being traded where a food has not been shown by a government by clear and convincing evidence to cause imminent and significant harm to the public.

Burden of Proof remains with the government

FREEDOM OF ACCESS!

NHFA 2005


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Alliance for Natural Health established by scientific risk assessment based on Dr. Robert Verkerk BSc MSc DIC PhD

“11.2 There is no evidence that they [food supplements] pose more risk than foods, in fact, existing evidence suggests they pose significantly less risk to humans than foods….As such, from a risk management viewpoint, it is rational to treat food supplements in a more similar manner to conventional foods, rather than as synthetic food additives, environmental chemicals, or medicinal products.”

FAO/WHO nutrient risk assessment project. ANH submission. December 2004

NHFA 2005


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Alliance for Natural Health established by scientific risk assessment based on Dr. Robert Verkerk BSc MSc DIC PhD

“3.1.3 Science-based risk assessment cannot be justified for a large number of nutrient forms where; a) nutrients are known to be safe even when consumed in high dosages, and; b) there is no evidence that the nutrient form has caused any significant adverse effects in a population despite the fact that they are consumed by hundreds of millions of people around the world on a daily basis….”

FAO/WHO nutrient risk assessment project. ANH submission. December 2004

NHFA 2005


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Burden of Proof established by scientific risk assessment based on

Food – burden ongovernment

People – burden ongovernment

Toxins/Drugs – burden onmanufacturers

NHFA 2005


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CODEX BURDEN established by scientific risk assessment based on

Should Be:

Food – burden ongovernment

People – burden ongovernment

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Purity – No Adulteration

Quality – No spoilage or diminished value

NHFA 2005


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Consumers Want established by scientific risk assessment based on

NO TOXINS

Toxic chemicals and chemical residues

Toxic food additives

Toxic Pesticides and Fertilizers

Toxic Pathogens

Toxic ingredients and preservatives

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Content Verification

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Safe Packaging

Safe Shipping Environment

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Truthful Labeling

Significant Facts that Impact Choice

Non-misleading labeling

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Warnings

When probable cause shows need.

NHFA 2005


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Consumers Want established by scientific risk assessment based on

Maximized Options

NHFA 2005


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Consumers Don’t Want established by scientific risk assessment based on

Consumers do not want their access to foods that they desire or foods that they need limited or blocked.

NHFA 2005


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ITALY 2005 established by scientific risk assessment based on

Which countries stood up during the floor debates at Codex and spoke to health freedom?

NHFA 2005


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China at Codex established by scientific risk assessment based on ITALY 2005

China stated that every government in making decisions about vitamins and minerals should take into account the dietary limitations of their own countries, that governments can select vitamins and minerals according to the customs and habits of their country. China also pointed out that there should be definitions of the sources of vitamins.

NHFA 2005


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ITALY 2005 established by scientific risk assessment based on

Which NGO stood up during the floor debates at Codex and spoke to health freedom?

NHFA 2005


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NHF at Codex established by scientific risk assessment based on ITALY 2005

NHF - National Health Federationrequested the guidelines not be adopted but rather be sent back to committee for 3 important reasons. First, according to Codex rules a "purpose" statement must be part of all guidelines adopted and the Vitamin and Mineral guidelines did not contain a purpose. Secondly, the guidelines did not define vitamin and mineral and therefore it is unclear as to what is being regulated. And lastly, that the Chinese comments were substantive and according to Codex rules on page 27 of the procedural manual, a substantive amendment request should be addressed at the committee level

NHFA 2005


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After Italy established by scientific risk assessment based on

WHO - World Health Organization presented Lim 6 –“Implementation of the WHO Global Strategy on Diet, Physical Activity and Health: Action that Could be Taken by Codex” (CAC/28 LIM/6):

NHFA 2005


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Leaders Representing YOU! established by scientific risk assessment based on

We need to be at the table long term if we plan to make a difference and protect health freedom.

NHFA 2005


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Congressmen/women established by scientific risk assessment based on Hoodwinked!

They say don’t worry about Codex because it is just international!

BUT

Then they say they are going to vote for H.R. 3156 because Dietary Supplements are dangerous!

NHFA 2005


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You Can Make a Difference! established by scientific risk assessment based on

Send A Clinton Miller One Page Fax to your Congressman!

NHFA 2005


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HR 3156 established by scientific risk assessment based on

The Dietary Supplement Act (DSHEA)

Is Under Attack!

NHFA 2005


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HR 3156 - Section 1. established by scientific risk assessment based on

It has a misleading clever title.

Dietary Supplement Access and Awareness Act.

NHFA 2005


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HR 3156 – Section 2. established by scientific risk assessment based on

It calls for new laws

- product listing

- reporting

- post market surveillance

- and changing safety responsibilities

NHFA 2005


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H.R. 3156 – Section 2. established by scientific risk assessment based on

It treats herbs and amino acids as

RISKY DRUGSinstead ofNUTRIENT FOODS

that are generally regarded as safe!

NHFA 2005


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HR 3156 – Section 2. established by scientific risk assessment based on

It could ban a product when there is “even a relatively small risk…”

NHFA 2005


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HR 3156 – Section 2. established by scientific risk assessment based on

Instead of the U.S. government needing to prove harm

----

Manufacturers would have to prove it is not harmful

NHFA 2005


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HR 3156 – Section 3. $$$ established by scientific risk assessment based on

Calls for 10 million dollars

5 million targeting health care professionals

5 million targeting consumers

NHFA 2005


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HR 3156 Section 3. $$ established by scientific risk assessment based on

5 million targeting health care professionals

“on the importance of reporting adverse health experiences to the FDA”

NHFA 2005


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HR 3156 –Section 3. $$ established by scientific risk assessment based on

5 million targeting consumers

- educating consumers on the importance of informing their health professionals of the dietary supplements and drugs they are taking.

NHFA 2005


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HR 3156 established by scientific risk assessment based on

Sign and Send Your One Page Fax!

NHFA 2005


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Fundamental Right established by scientific risk assessment based on

“Health freedom is a fundamental natural right of survival and personal sovereignty. Such a profound gift must be forever protected and maintained by all peoples in relationship with each other and together, honoring our interdependence, while holding sacred our individual cultures, spirits, and intentions.”

Diane M. Miller JD

NHFA 2005


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NATIONAL HEALTH FREEDOM established by scientific risk assessment based on COALITIONA 501(c) 3 Educational Nonprofit Organization

NATIONAL HEALTH FREEDOM ACTION

A 501 (c ) 4 Lobbying Organization

PMB 218, 2136 Ford Parkway, St. Paul, MN 55116-1863

www.nationalhealthfreedom.org, E-mail: [email protected]

651-690-0732

NHFA 2005


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National Health Freedom Coalition established by scientific risk assessment based on

We promote access to all health care information, services, treatments and products that the people deem beneficial for their own health and survival; we promote an understanding of the laws and factors impacting the right to access; and we promote the health of the people of this nation.

PMB 218, 2136 Ford Parkway, St. Paul, MN 55116-1863

Phone: 651-690-0732 Fax: 651-699-8306 www.nationalhealthfreedom.org ,

NHFA 2005


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NHFA 2005 established by scientific risk assessment based on


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