CODEX NHFA 2005Slide 2
CODEX Vitamin & Mineral Guidelines PASSED! Worldwide Guidelines for Trade Vitamins and Minerals NHFA 2005Slide 3
CODEX ALIMENTARIUS 1. Old "to shield purchasers from deceptive practices in the offer of nourishment" Codex Website 2005 NHFA 2005Slide 4
CODEX ALIMENTARIUS 3. Codex Alimentarius Austriacus Austro-Hungarian 1911 "to decide benchmarks of personality for particular nourishments." Codex Website 2005 NHFA 2005Slide 5
CODEX ALIMENTARIUS 5. 1940\'s - Consumer Concerns "… shield buyers from low quality and unsafe nourishments." NHFA 2005Slide 6
FAO 6. 1961 – World Concerns FAO ventures in for world nourishment security NHFA 2005Slide 7
FAO United Nations Food and Agricultural Organization NHFA 2005Slide 8
FAO Desire for worldwide assention " on least sustenance principles … " NHFA 2005Slide 9
1961 FAO Establishment of Codex Alimentarius Commission Protecting the customer\'s wellbeing - Ensuring quality - Reducing exchange obstructions NHFA 2005Slide 10
CODEX ALIMENTARIUS Historically - Visible Underweight substance Size varieties Misleading marking Poor quality NHFA 2005Slide 11
CODEX ALIMENTARIUS Science based - Invisible Alarm small scale life forms pesticide deposits ecological contaminants nourishment added substances NHFA 2005Slide 12
WHO United Nations World Health Organization NHFA 2005Slide 13
WHO "… with the objective of creating reasonable, coordinated nourishment wellbeing frameworks for the lessening of wellbeing danger along the whole natural way of life, from the essential maker to the shopper ".  WHA Resolution 53.15, 2000.  Weekly Epidemiological Record, 2004, 79, 173-180, No. 18, April 30. http://www.who.int/wer. NHFA 2005Slide 14
1963 Established Joint Program FAO and WHO Codex Alimentarius Commission NHFA 2005Slide 15
FAO/WHO Dual Goals Broad Jurisdiction . Securing the soundness of buyers . Guaranteeing reasonable practices in sustenance exchange NHFA 2005Slide 16
CODEX ALIMENTARIUS 172 Countries Desire to Harmonize Voluntarily NHFA 2005Slide 17
HARMONIZATION CONCEPT "The harmonization of nourishment benchmarks is by and large seen as an essential to the security of shopper wellbeing and additionally permitting the fullest conceivable assistance of worldwide exchange." Codex site 2005 NHFA 2005Slide 18
HARMONIZATION PROMOTED "… the Uruguay Round Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT) both energize the universal harmonization of nourishment guidelines." Codex Website 2005 NHFA 2005Slide 19
CODEX COMMENTS WHY THE PROGRESS OF HARMONIZATION IS IMPEDED - Different lawful and managerial frameworks - Varying political force frameworks - National mentalities and ideas of sovereign rights Codex Website 2005 NHFA 2005Slide 20
Uruguay Round Agreements 1994 WTO WORLD TRADE ORGANIZATION SPS & TBT Agreements NHFA 2005Slide 21
WTO - 1994 Independent Trade Organization - Member Countries Join by Contract - Enforceable by Dispute Resolution Body NHFA 2005Slide 22
WTO Codex WTO Agreements allude to Codex as the global standard to be utilized by WTO individuals for exchanging merchandise. NHFA 2005Slide 23
WTO Majority of WTO individuals are Codex Alimentarius individuals NHFA 2005Slide 24
WTO Will WTO be a vehicle for the authorization of Codex? NHFA 2005Slide 25
Regional Trade Agreements Will other local exchange assentions, for example, CAFTA and NAFTA point to Codex and avow the implementation of Codex models or rules? NHFA 2005Slide 26
EU Food Supplements Directive Will Codex receive a positive rundown approach and boycott everything else like the EU FSD attempted to do ? NHFA 2005Slide 27
HEALTH FREEDOM PRINCIPLES Freedom of access for wellbeing seekers Freedom to practice every single recuperating technique Regulate by the minimum prohibitive means NHFA 2005Slide 28
SAMPLES OF Health Freedom Responses - Ask WTO for a formal assessment re requirement - Work to reinforce national US laws - Challenge UN/FAO/WHO locale NHFA 2005Slide 29
Codex Guidelines Passed Final Codex Guidelines Approved by Commission Italy July 4, 2005 NHFA 2005Slide 30
Freedom Infringements Core Problem Disregard for Over-expansiveness NHFA 2005Slide 31
Freedom Alert Conceptual Merger FAO + WHO NHFA 2005Slide 32
FAO COMMODITIES LAW FAO Food Safety NHFA 2005Slide 33
WHO PEOPLE LAW WHO People Health NHFA 2005Slide 34
MERGER Regulation Food + People ( how they utilize sustenance ) NHFA 2005Slide 35
DIFFERENT BURDENS OF PROOF Regulating Nutritious Food Regulating Toxic Substances Regulating People NHFA 2005Slide 36
Burdens of Proof Government must appear there is inevitable danger of critical open mischief before directing versus Individuals must demonstrate that it is protected or has advantage before acting NHFA 2005Slide 37
Nutrients and Food Government must demonstrate that there is an unavoidable danger of huge damage before forbidding Example: DSHEA NHFA 2005Slide 38
Toxins/Drugs Manufacturers must demonstrate that it is sheltered to circulate or has advantage that exceeds the danger before appropriating Example: Ampicillin NHFA 2005Slide 39
People Government must demonstrate that a man will bring about an inescapable danger of open mischief Example: Contagious Disease Except… ..!!!!!!!! NHFA 2005Slide 40
BEFORE REGULATING PEOPLE Government MUST consider: Fundamental rights Freedom of self-determination National power Human rights Cultural differing qualities Right to reasonableness and due procedure Least prohibitive method for control NHFA 2005Slide 41
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 2005Slide 42
LEAST RESTRICTIVE MEANS Examples: Voluntary versus Required Treatment versus Confinement Exemptions with conditions NHFA 2005Slide 43
Mixing "sustenance law" and "individuals law" Freedom Alert! Looking for merger power NHFA 2005Slide 44
" These Guidelines apply in those purviews where items characterized in 2.1 are controlled as nourishments." Draft Guidelines for Vitamin and Mineral Food Supplements People: Some nations consider vitamins and minerals to be sustenance, others don\'t. CODEX GUIDELINES See merger power NHFA 2005Slide 45
" Most individuals who have entry to an adjusted eating regimen can as a rule acquire every one of the supplements they require from their ordinary eating routine." (underline included) Draft Guidelines for Vitamin and Mineral Food Supplements People DOGMA: There is a legitimate "adjusted" approach to get supplements which is viewed as "typical" CODEX GUIDELINES FREEDOM INFRINGING LANGUAGE NHFA 2005Slide 46
" Because nourishments contain numerous substances that advance wellbeing, individuals ought to hence be urged to choose an adjusted eating routine from sustenance before considering any vitamin and mineral supplement." (underline included) Draft Guidelines for Vitamin and Mineral Food Supplements People DOGMA Does this mean Vitamins and Minerals are not so much nourishment? CODEX GUIDELINES FREEDOM INFRINGING LANGUAGE NHFA 2005Slide 47
"Vitamin and mineral nourishment supplements ought to contain vitamins/provitamins and minerals whose healthful worth for individuals has been demonstrated by investigative information and whose status as vitamins and minerals is perceived by FAO and WHO." (underline included) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Burden of confirmation moving with "ought to" No preparatory and obligatory appearing of up and coming danger of critical damage. CODEX GUIDELINES FREEDOM INFRINGING LANGUAGE NHFA 2005Slide 48
"Greatest measures of vitamins and minerals in vitamin and mineral sustenance supplements per every day segment of utilization as suggested by the produces might be set , considering the accompanying criteria: (underline included) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Burden of evidence moved from government to makers No preparatory and compulsory appearing of up and coming danger of mischief. CODEX GUIDELINES FREEDOM INFRINGING LANGUAGE NHFA 2005Slide 49
"(an) upper safe levels of vitamins and minerals set up by exploratory danger evaluation in view of for the most part acknowledged experimental information , contemplating, as fitting, the changing degrees of affectability f distinctive customer bunches:" (underline included) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Conventional science over individuals\' decision, Government has not first demonstrated danger of noteworthy damage. CODEX GUIDELINES FREEDOM INFRINGING LANGUAGE NHFA 2005Slide 50
FREEDOM ALERT! Most extreme Amounts of Vitamins and Minerals Shall Be Set ! Upper safe levels… built up by logical danger appraisal! NHFA 2005Slide 51
Rational for Risk Assessment EXPORTS Countries can\'t piece imports coming in that are equivalent to or not as much as Codex points of confinement. They likewise can\'t set most extreme breaking points for importation of lower than Codex sums, for example, the lower RDA values. Flexibility ALERT! Shouldn\'t something be said about NO UPPER LIMITS ? NHFA 2005Slide 52
Rational for Risk Assessment IMPORTS RDA can never again be utilized to set most extreme breaking point a nation will permit to be foreign made. An item can\'t be hindered from importation on the off chance that it contains equivalent to or not exactly as far as possible. Opportunity ALERT! Shouldn\'t something be said about NO UPPER LIMITS ? NHFA 2005Slide 53
FREEDOM ALERT! No sound for maximum points of confinement on nourishment! Low RDA Mandatory Risk Assessment No Upper Limits Burden of Proof moving AT THE PRICE OF FREEDOM NHFA 2005Slide 54
FREEDOM DEMAND! Opportunity Demand: for the benefit of the general population, no furthest points of confinement might be set on measures of nourishment substance in items being exchanged where a sustenance has not been appeared by a legislature by clear and persuading e
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