NATURAL FLAVOR PRODUCT QUESTIONAIRE - NATIONAL ORGANIC PROGRAM USE

The USDA National Organic Program (NOP) allows the use of certain natural(non-synthetic) substances, including flavors, in products labaled as "Organic" or "Made with Organic ... (specified ingredietns or food groups)" providing they comply with provisions established in the USDA NOP (7CFR Part 205).


The NOP defines Non-synthetic (natural) in 7 CFR 205.2: a substance that is derived from mineral, plant or animal matter and does not undergo a sythetic process as defined in section 6502 (21) of the Act (7 U.S.C. 6502(21)).  Under the terms of the Act, "synthetic" means a substance that is formulated or manufactured by a chemical process or by a process that checmically changes a substance extracted from naturally occuring plant, animal or mineral sources, except that such term shall not apply to substances created by naturally occuring biological processes.


Non-synthetic Flavors authorized under the NOP, Section 205.605 (a)(9) must be from non-synthetic sources only and must not be producted using synthetic solvents, carrier systems or any artificial preservative.  In addition, Sections 205.105 (e) (f)(g) respectively prohibit so-called "excluded" methods (GMOs), ionizing radiation or sewage sludge, defined in 205.2, from being applied to any ingredients or products un der the NOP.


FDA Definition of Natural Flavors FDA 21 CFR Part 101.22(a)(3): "... natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydroxylsate, distillate, or any product of roasting, heating or enzymolosys, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.  Natural flavors include [but not exclusively] the natural essences or extractives obtained from plants listed in%% 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in 172.510 of this chapter."


In order to approve the use of a natural flavor used in an "organic" or "made with" product, QAI requests the information below in order to determine compliance under the terms of the NOP.  QAI may request additional information as needed.


Identification of Natural Flavor Product (Name/Code): METHYL THIOACETATE 1% IN TRIETHYL CITRATE NATURAL / 1505
 

Supplier Name and Address: Advanced Biotech / 85 fifth Avenue Paterson, NJ 07524


Type of flavor (Select one or more as necessary):


Natural Flavor Product
  1. Flavor Constituents

    1. Do all of the flavor constituents in the natural flavor product named above meet the FDA definition of natural flavor (See above)?
    2. Natural flavors authorized for use in NOP "organic" or "made with organic" products, in addition, must not be produced using synthetic extraction solvents.  Extraction may only use natural, non-petroleum based solvents.  Is/are the natural flavor consituent(s) made using NOP-suitable extraction solvents?*
      1. Please list any solvent(s) used in the production of this Natural Flavor Product:
        restricted to the following natural solvents; water, natural ethanol, carbon dioxide, essential oil, glycerol or vegetable oils

        * Allowed natural extraction solvents include water, natural ethanol, super-critical carbon dioxide, authentic essential oil, and natural vegetable oils. No hydrocarbon solvents, or chlorinated, or halogenated solvents may be used. Propane, hexane, and freon are examples of solvents that are prohibited.

  2. Non-flavor constituents and other ingredients

    1. Natural flavors authorized for use in NOP "organic" or "made with organic" products must not contain any sythetic carrier systems or any artificial preservatives. this extends to synthetic processing aids, emulsifiers or antioxidants; i.e. prohibited substances include but are not limited to, e.g., propylene glycol, polyglycol esthers of fatty acids, mono- and di-glycerides, benzoic acid, polysorbate 80.
      1. Please list any carrier system(s) used in this Natural Flavor Product or attach an Ingredient Statement:
      2. Triethyl Citrate
      3. Please list any preservative(s) used in this Natural Flavor Product or attach an Ingredient Statement:
      4. NONE
    2. Are these NON-flavor constituents certified "organic" and/or are they authorized sythetic or non-synthetic materials under the NOP National List (205.605)?

  3. Genetically Modified Organism (GMO) products may not be used at any stage in the process of making natural flavor products for NOP goods. Excluded methods (=GMO use) include a variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include, but are not limited to, recombinant DNA technology (including gene deletion, gene doubling, introduction of a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology); therefore, GMO-plant extracts may not be used nor may natural flavors be the product of GMO-yeast fermentation.
    1. This natural flavor product, including any solvents, carriers, preservatives or other processing aids used or contained therein, was produced and handled using excluded (GMO) methods?

  4. Ionizing Radiation is prohibited for all uses involving food preservation, pest control and pathogen control in NOP products. Other radiation uses, including food inspection, are permitted providing such use meets applicable FDA regulations, which establish limitations applicable to all (organic and non-organic) food products.
    1. Ionizing radiation as descrbed in 21 CFR 179.26 was used in the processing of this natural flavor product?
    Please sign this questionaire below
    Pursuant to 7CFR 205.605(a)(9) and 205.105(e)(f)(g), I, on behalf of the supplier, hereby attest that the information provided in this form is accurate and truthful to the best of my knowledge.



Company Name: Advanced Biotech
Printed Name: ROBERT DESIMONETitle: CEO_OWNER
Signature: Date:  9/9/2010

Copyright © 2010 Advanced Biotech. Inc.   85 Fifth Avenue, Building #5, Paterson, NJ 07524   Tel: 973-357-0577   Fax: 973-357-0644