|NATIONAL ORGANIC PROGRAM QUESTIONAIRE - NATIONAL ORGANIC PROGRAM USE
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) respectively prohibit so-called "excluded" methods (GMOs) and ionizing radiation from being used to produce or during the handling
of any ingredients or products under the NOP.
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).
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): ||
TOBACCO EXTRACT /
Supplier Name and Address: Advanced Biotech / 85 fifth Avenue Paterson, NJ 07524
Type of flavor (Select one or more as necessary):
Natural Flavor Product
- Flavor Constituents
- Do all of the flavor constituents in the natural flavor product named above meet
the FDA definition of natural flavor (See above)?
- 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-ptroleum based solvents. Is/are the natural flavor
consituent(s) made using NOP-suitable extraction solvents?*
- Please list any solvent(s) used in the production of this Natural Flavor Product: restricted to the following natural solvents; WATER, ETHANOL, 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.
- Non-flavor constituents and other ingredients
Natural flavors authorized for use in NOP "organic" or "made with organic" products must not contain any sythetic carrier systems
or any artificial preservatives, including but not limited to,
propylene glycol, polyglycol esthers of fatty acids, mono- and di-glycerides, benzoic acid, polysorbate 80.
- Please list any carrier system(s) used in this Natural Flavor Product or attach an Ingredient statement:
- Please list any preservative(s) used in this Natural Flavor Product or attach an Ingredient Statement: None
- 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.
- This natural flavor product, including any solvents, carriers, preservatives or other processing aids used or contained therein, was produced and handled without the use of excluded (GMO) methods?
- 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.
- Ionizing radiation as described in 21 CFR 179.26 was not 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), 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 DESIMONE||Title: CEO-OWNER