FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _August 17, 2005________

Subject: __NOSB guidance for the review of synthetic and non-synthetic substances_ 

Chair: ____Jim Riddle______________________________________ 

 (sign)

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: ________ 

Guidance Statement: ___X_____ 

Other: ___X_____ 

Statement of the Recommendation (including Recount of Vote):

The NOSB recommends: 

1) Extraction1

 shall be understood to mean: 

Substances removed from naturally occurring plants, animals, or mineral sources can be extracted 

in any manner and with any substance, material, physical process (i.e. centrifugation, heating,

chemical solvents, bases and acids) as long as the extraction process does not chemically change 

the substance that is being extracted. As long as a chemical reaction does not occur, the 

substances that are removed from a naturally occurring plant, animal or mineral source are 

nonsynthetic, provided any synthetic substance used in the extraction process do not remain in the 

final product above insignificant levels and do not have any technical or functional effect. Any 

synthetic substance used in the extraction process that remains in the final extract above 

insignificant levels and any synthetic substance that has a technical or functional effect must be 

on the National List. 

2) Formulation or manufacturing shall be understood to mean: 

Once a substance is extracted, if it then undergoes a chemical reaction as it is processed, 

formulated or manufactured to produce agricultural or handling inputs, it then would be 

considered a synthetic and would have to be petitioned for inclusion on the National List. 

Formulation or manufacturing as defined in this section is not intended to address the processing 

of an agricultural product by a handling operation or food (see definition of processing below). 

This definition applies only to the individual inputs used in crop, handling and livestock 

 

1

 Extraction (NOSB, 1995; Austin, Texas); The concentration, separation and removal of a substance from

a plant, animal microbiological or mineral source. Materials used in plant crop and animal production may

be extracted in any way that does not result in synthetic reaction as defined by 2103(21). The products of

any other methods of extraction shall be considered on a case by case basis and reviewed for compatibility 

under OFPA Sec. 2119 (m) (1-7). 

Page 1 of 11 
operations. Additionally, if an extracted substance is formulated with other substances, those 

substances if synthetic would have to be petitioned for inclusion on the National List. 

The definition of synthetic as defined in the regulation is clarified in this document as it applies to 

adding substances to the National List (205. 601-606). Processing of an agricultural product by a 

handling operation or food may involve synthetic and nonsynthetic substances on the list and 

these substances along with the agricultural component(s) may undergo chemical changes as they

are processed. These chemical changes are allowed under OFPA 2103(21) and the NOP rule 

(205.270). Below is the section of the rule that allows for various methods in the processing of an 

agricultural product by a handling operation or food and it is included in this document to provide 

the distinction between formulation or manufacturing described above as it pertains to substances 

considered for addition to the National List (205. 601-606) and processing as allowed in the 

regulation. 

3) Processing: The following methods are allowed by OFPA 2103(21) and the NOP rule 

(205.270) for organic handling operations. Mechanical or biological methods including but not 

limited to “cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, 

extracting, distilling, slaughtering, cutting, fermenting, eviscerating, preserving, dehydration, 

freezing, chilling, or otherwise manufacturing and includes the packaging, canning, jarring, or 

otherwise enclosing food in a container.” 

4) Chemical reaction (chemical change) shall be understood to mean: 

A chemical reaction has occurred when one or more atoms are removed or added to a molecule. 

Examples of reactions include: 1) Addition or combination reaction: Two substances combine to 

form one: 2Na+Cl2----2NaCl; 2) Decomposition reactions: One compound breaks into two or

more compounds or elements. CaCO3-----CaO + CO2; 3) Displacement reactions: Substances 

exchange parts. Two examples are hydrolysis (a hydroxyl ion from water is added to a substance 

and a hydrogen ion from water is added to a second molecule) and acid-base reactions (proton 

donation or acceptance) and 4) Protein configuration changes as a result of a physical association 

of an added substance. 

5) “Substance” includes compounds and elements. Any synthetic substance for use in crops and 

livestock, and any nonorganic substance for use in processing with a distinct identity (separate 

Chemical Abstract Society number, INS number, or FDA or other agency standard of identity) 

must be separately listed in the National List for use in organic production or handling. 

6) “Substances created by naturally-occurring biological processes” shall be understood to 

mean: 

Chemical changes that occur in living cells or due to the action of products of living organisms, 

such as enzymes are not considered synthetic. For example, lactic acid is a non-synthetic 

substance that is the result of lactose (milk sugar) being fermented by the bacterium

Lactobacillus. 

7) Nonsynthetic (natural). A substance that is derived from mineral, plant, or animal matter and 

does not undergo a synthetic process as defined in section 6502(21) of the Act (7 U.S.C. 

6502(21)). For the purposes of this part, nonsynthetic is used as a synonym for natural as the 

term is used in the Act. [NOP.]

Board vote – August 16, 2005 

12 yes, 1 no, 1 absent 

Page 2 of 11 
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Rationale provided in text of recommendation below.

Response by the NOP:

Updated 2/25/05 

Page 3 of 11 
Final Draft 

Clarification of the definition of Synthetic as it is applied to Substances Petitioned 

for Addition or Prohibition to the National List(s) 

Voted on by the Materials and Handling Committee 6/23/05 

Adopted by the NOSB August 16, 2005 

Introduction: This document is a draft for guidance purposes with the goal of clarifying 

the definition of synthetic as it pertains to determination for substances petitioned for 

addition or prohibition to the National List(s). 

Background: 

The NOSB uses the definition of synthetic as: 

A substance that is formulated or manufactured by a chemical process or by a 

process that chemically changes a substance extracted from a naturally occurring 

plant, animal or mineral sources, except that such term shall not apply to 

substances created by naturally occurring biological processes. (OFPA 2103 (21); 

7 CFR 205.2). 

Any substance other than those naturally occurring in a plant, animal or mineral is 

considered synthetic if it is formulated or manufactured by a chemical process. 

Recommendation: 

1) Extraction2

 shall be understood to mean: 

Substances removed from naturally occurring plants, animals, or mineral sources can be 

extracted in any manner and with any substance, material, physical process (i.e. 

centrifugation, heating, chemical solvents, bases and acids) as long as the extraction 

process does not chemically change the substance that is being extracted. As long as a 

chemical reaction does not occur, the substances that are removed from a naturally 

occurring plant, animal or mineral source are nonsynthetic, provided any synthetic 

substance used in the extraction process do not remain in the final product above 

insignificant levels and do not have any technical or functional effect. Any synthetic 

substance used in the extraction process that remains in the final extract above 

insignificant levels and any synthetic substance that has a technical or functional effect 

must be on the National List. 

2) Formulation or manufacturing shall be understood to mean: 

Once a substance is extracted, if it then undergoes a chemical reaction as it is processed,

formulated or manufactured to produce agricultural or handling inputs, it then would be 

 

2

 Extraction (NOSB, 1995; Austin, Texas); The concentration, separation and removal of a substance from

a plant, animal microbiological or mineral source. Materials used in plant crop and animal production may

be extracted in any way that does not result in synthetic reaction as defined by 2103(21). The products of

any other methods of extraction shall be considered on a case by case basis and reviewed for compatibility 

under OFPA Sec. 2119 (m) (1-7). 

Page 4 of 11 
considered a synthetic and would have to be petitioned for inclusion on the National List. 

Formulation or manufacturing as defined in this section is not intended to address the 

processing of an agricultural product by a handling operation or food (see definition of

processing below). This definition applies only to the individual inputs used in crop, 

handling and livestock operations. Additionally, if an extracted substance is formulated 

with other substances, those substances if synthetic would have to be petitioned for 

inclusion on the National List. 

The definition of synthetic as defined in the regulation is clarified in this document as it 

applies to adding substances to the National List (205. 601-606). Processing of an 

agricultural product by a handling operation or food may involve synthetic and 

nonsynthetic substances on the list and these substances along with the agricultural 

component(s) may undergo chemical changes as they are processed. These chemical 

changes are allowed under OFPA 2103(21) and the NOP rule (205.270). Below is the 

section of the rule that allows for various methods in the processing of an agricultural 

product by a handling operation or food and it is included in this document to provide the 

distinction between formulation or manufacturing described above as it pertains to 

substances considered for addition to the National List (205. 601-606) and processing as 

allowed in the regulation. 

3) Processing: The following methods are allowed by OFPA 2103(21) and the NOP rule 

(205.270) for organic handling operations. Mechanical or biological methods including 

but not limited to “cooking, baking, curing, heating, drying, mixing, grinding, churning, 

separating, extracting, distilling, slaughtering, cutting, fermenting, eviscerating, 

preserving, dehydration, freezing, chilling, or otherwise manufacturing and includes the 

packaging, canning, jarring, or otherwise enclosing food in a container.” 

4) Chemical reaction (chemical change) shall be understood to mean: 

A chemical reaction has occurred when one or more atoms are removed or added to a 

molecule. Examples of reactions include: 1) Addition or combination reaction: Two 

substances combine to form one: 2Na+Cl2----2NaCl; 2) Decomposition reactions: One 

compound breaks into two or more compounds or elements. CaCO3-----CaO + CO2; 3) 

Displacement reactions: Substances exchange parts. Two examples are hydrolysis (a 

hydroxyl ion from water is added to a substance and a hydrogen ion from water is added 

to a second molecule) and acid-base reactions (proton donation or acceptance) and 4)

Protein configuration changes as a result of a physical association of an added substance. 

5) “Substance” includes compounds and elements. Any synthetic substance for use in 

crops and livestock, and any nonorganic substance for use in processing with a distinct 

identity (separate Chemical Abstract Society number, INS number, or FDA or other 

agency standard of identity) must be separately listed in the National List for use in 

organic production or handling. 

6) “Substances created by naturally-occurring biological processes” shall be 

understood to mean: 

Page 5 of 11 
Chemical changes that occur in living cells or due to the action of products of living 

organisms, such as enzymes are not considered synthetic. For example, lactic acid is a nonsynthetic substance that is the result of lactose (milk sugar) being fermented by the 

bacterium Lactobacillus. 

7) Nonsynthetic (natural). A substance that is derived from mineral, plant, or animal 

matter and does not undergo a synthetic process as defined in section 6502(21) of the Act

(7 U.S.C. 6502(21)). For the purposes of this part, nonsynthetic is used as a synonym for

natural as the term is used in the Act. [NOP.] 

Conclusion

The proposed NOSB clarification of definitions regarding chemical reaction is useful for 

determining what substances are synthetic, and should be the basis for determination of 

synthetic status. Further attention to the definition of “extraction” and “substance” will 

also facilitate the determination. When reviewing substances, the NOSB must review the 

steps of production and determine if a chemical change occurred in manufacture of the 

substance. This may include whether the substance was extracted from a natural source in 

an acceptable manner. 

Committees (Materials and Handling) vote: 

 9 accept 

 0 reject 

 0 abstain

NOSB vote: 

12 yes, 1 no, 1 absent 

Page 6 of 11 
Addendum 1: Background information for clarification of the definition of 

synthetic 

Basic Chemistry 

 

The science of chemistry deals with the structure of matter--material things--and 

the changes that matter undergoes. Matter can exist in any size, shape, or color. It is 

solid, liquid, or gas; living or nonliving. Chemistry seeks to identify the simplest parts of 

matter; how they are separated and purified; how they are put together; how they are 

rearranged to produce new forms of matter; and what energy is absorbed or released 

when such rearrangements are made (Matta and Wilbraham, 1986). A distinction should 

be made between chemical and physical changes. The OFPA and NOS definition of 

synthetic specifically mentions chemical change but not physical change. A physical 

property is a quality or condition of a substance that can be observed or measured without 

changing the substance’s composition. It can be specified without reference to any other 

substance. Other physical properties of matter include color, solubility, mass, odor, 

hardness, density, electrical conductivity, magnetism, melting point and boiling point. 

Physical properties help chemists identify substances (Matta and Wilbraham, 1986). 

When contractors are hired to technical review of substances for the NOSB and 

USDA/NOP, they typically list the physical properties of the substances in their review 

because this is the common way in which substances are described. 

Physical changes may result when the temperature of a substance changes. 

Raising the temperature of a solid may turn it into a liquid (i.e., ice turns into water). A 

conversion without causing a change in the composition of the substance is called a 

physical change (Matta and Wilbraham, 1986). When ice undergoes the physical change 

of melting, this change does not change the nature of water. The physical properties are 

the same for water that has been frozen and melted as for water that has been converted 

into steam and then condensed (Matta and Wilbraham, 1986). Historically, the organic 

industry and the NOSB have acknowledged that physical changes do not render a 

substance synthetic. 

However, there are some substances that have been identified where high 

temperatures during manufacturing do engender a chemical change in the substance. An 

example is mined minerals. Historically, the industry and NOSB has recognized that 

burning or excessive heating of mined mineral is considered to render them synthetic. 

Formerly, NOSB defined mined minerals as any naturally-occurring non-living substance 

derived from the earth or water. A mined mineral cannot have undergone molecular 

change through heating, acidification, basification or fortification with synthetic materials 

(NOSB Final Recommendation Addendum Number 25, Definitions and Interpretations, 

Austin, Texas, 1995). Therefore, heat can alter the physical properties of a substance and 

for other substances act as a catalyst in chemical reactions or change. 

In a chemical reaction, the starting substance or substances, referred to as 

reactants, are changed into new substances or products. Chemists use an arrow as a 

shorthand form of the phrase “are changed into”; reactants Æ products (Matta and 

Wilbraham, 1986). An example to distinguish between physical and chemical changes is 

illustrated when sulfur (a solid) is added to iron filings (a solid). They may be separated 

unchanged from a mixture of the two substances mixed together. This separation is an 

Page 7 of 11 
example of a physical change. If the mixture of these two substances is heated, a 

chemical change takes place and the sulfur and iron are changed into a nonmagnetic 

substance, iron sulfide: Iron + SulfurÆ Iron Sulfide (Matta and Wilbraham, 1986). A 

substances’ composition and behavior in chemical reactions--its chemical reactivity--

comprise its chemical properties. 

What is a substance? 

In chemistry, a pure substance is a homogenous material that has a definite 

chemical composition throughout. There are two kinds of pure substances. One kind can 

be decomposed into two or more different substances by simple chemical change; these 

are called compounds. There are many millions of compounds. 

An example of a compound is pure table salt, which can be decomposed into sodium and 

chlorine by an appropriate process. Many of the substances on the National Lists of 

Synthetic substances allowed for use in organic crop and livestock production (Sections 

205.601 and 205.603) are compounds. Examples include: isopropanol, chlorine 

dioxide, ammonium carbonate, lime sulfur and copper sulfate. 

 The second kind of pure substances are called elements, which cannot be 

decomposed by chemical change. There are 90 natural elements, examples are gold, 

copper, oxygen, sulfur and hydrogen. Elements cannot be separated into simpler 

substances by chemical reactions. An example of an element on the National List is 

sulfur (elemental) for crop production (205.601(e)(3))( Boikess and Edelson, 1978). 

Mixtures consist of a physical blend or two or more substances in which the 

combined substances retain their identity. Most materials found in nature are mixtures. 

Mixtures can be either homogeneous (same composition throughout) or heterogeneous 

(has non-uniform composition). A solution is a type of a mixture where there is a 

homogeneous combination of different substances. The difference between a 

heterogeneous mixture and a solution is that any sample of a solution has the same

composition, while the composition of a mixture is not the same throughout. Solutions 

may be gaseous, liquid or solid. Examples of mixtures on the National List are aquatic 

plants and fish emulsions. The various compounds and elements that make up these 

products are within the plant, animal or mineral. When a particular component of the 

plant is desired for use in an agricultural input it typically has to be extracted and in many 

cases undergo additional chemical reactions to make it into a substance that is functional 

when combined with other substances. 

A distinction should be drawn between a mixture and a compound. The elements 

making up a compound cannot be recovered without a chemical change. The 

substances making up a mixture or solution can. Some mixtures can be separated into 

their various components by simple physical methods. An example is a gray-colored 

mixture produced by stirring together powdered yellow sulfur and black iron filings. The 

individual particles of sulfur and iron can be readily distinguished from one another 

under a microscope. The mixture is easy to separate because the iron filings can be 

removed from the mixture with a magnet leaving sulfur behind. Both the sulfur and the 

iron are unchanged in composition (example from Matta and Wilbraham, 1986). 

Page 8 of 11 
The substances making up a mixture or a solution need not be elements. For 

example, one can prepare a solution by dissolving salt, a compound, in water another 

compound. In addition, the substances making up a mixture or a solution can be 

combined in varying proportions. The elements in a compound have fixed proportions. 

(paragraph found in Boikess and Edelson, 1978). Main groups of compounds can be 

classified based on similar chemical properties. The following are descriptions of each 

group (Boikess and Edelson , 1978). 

Salts: a compound of a metal and nonmetal, or of a metal with a negative polyatomic 

group. Compounds that have an ammonium group (NH4

+

) instead of a metal are also 

classified as salts. Some salts are NaCl, KCl, KMnO4 and NH4Cl. A salt is an ionic solid 

a room temperature. Most have two ionic components (a) a cation, which can be a 

polyatomic group such as ammonium or a monoatomic metal such as Na+

, K+, Ca2+ or 

Mn3+ and (b) an anion, which can be a negative polyatomic group or a monoatomic ion 

such as Cl-

 or NH3

-

. A solid salt consists of ions in close association. When the salt 

dissolves in water, the ions are separated. Substances that exist as ions in solution are 

called electrolytes. When NaCl dissolves in water, the correct formula is Na+

 + Cl-. This 

formula treats the component ions of the salts as independent entities, which is 

approximately how they behave in water solution. Salts are called strong electrolytes 

because they usually separate completely into ions in water. (Boyd text) 

Acids: a compound that is a source of H+

 ions. An acid is usually a compound of 

hydrogen and a nonmetal or a negative polyatomic group. Unlike salts, acids usually are 

not aggregates of ions. An acid may be a gas (hydrochloric), liquid (sulfuric) or a solid 

(oxalic). Like salts, acids tend to form ions when the dissolve in water. When a 

substance separates into ions it is said to dissociate. Some acids dissociate completely 

and are called strong acids. Most acids dissociate only partially when dissolved in water. 

These are called weak acids, they are weak electrolytes. 

Bases: a compound that is a source of OH-

 ions in water solution. A compound of a

cation and the OH-

 anion is a base. Bases resemble salts in many ways. They are ionic 

solids that dissociate into ions when dissolved in water. Bases that contain a cation and 

OH-

 are generally dissociate completely in water and are classified as strong bases. Some

strong bases are NaOH (sodium hydroxide) and KOH (potassium hydroxide). 

Compounds that do not contain hydroxide ions are defined as bases if they produce OHions by reaction with water. An example is ammonia (NH3) which reacts with water to 

produce hydroxide ions. 

Nonelectrolytes: Compounds containing only nonmetals usually exist as discrete 

molecules, rather than collections of ions. These compounds do not dissociate into ions 

when they dissolve in water. Many organic compounds are nonelectrolytes and they will 

not dissolve appreciably in water i.e. oil. Some will dissolve in water, although they will 

not dissociate into ions i.e. sugar, and ethyl alcohol. 

Page 9 of 11 
Oxides: is a binary compound of any element with oxygen, when the oxygen has an 

oxidation number of -2. Almost every element forms at least on oxide. The properties of 

oxides vary widely- depending on the element they may resemble a salt, acid, base or non 

electrolyte. 

What constitutes a chemical change? 

The chemical properties of a substance are those that describe the way in which it 

can undergo change, either alone or in interactions with other substances, to form

different materials. Such changes are called chemical reactions. The chemical properties 

that are characteristic of any substance can be described- iron combines readily with 

oxygen to form the compound called rust. (Boikess and Edelson, 1978). The following 

are common types of chemical reactions that describe what is happening when different 

substances and compounds interact (Boikess and Edelson ,1978). 

1. Addition or combination reaction: Two substances combine to form one: 

2Na+Cl2----2NaCl 

2. Decomposition reactions: One compound breaks into two or more compounds or 

elements. CaCO3-------CaO + CO2

3. Displacement reactions: Substances exchange parts. There are many types of 

these reactions but one of the most important is called metathesis which is the 

exchange of ions by two ionic compounds, with the anion of one compound 

joining the cation of the other compound and vice versa. AB+CD-ÆAD + CB 

1. Hydrolysis is a displacement reaction of a substance or ion with water. 

Water is a source of both H+

 and OH- ions. The OH- anion combines 

with the positive portion of the compound that is hydrolyzed. This 

positive portion may be a cation or an atom with a positive oxidation 

number. The H+

 cation combines with the negative portion of the 

compound, which may be an anion or an atom with a negative oxidation 

number. 

2. Acid-base reaction: an acid is a substance that can donate a proton, and 

a base is a substance that can accept a proton. 

Since many materials used in organic agriculture are derived from plants and 

animals it is important to mention chemical reactions that occur in by products of these 

organisms. In living organisms, enzymes play the role in catalyzing a specific reaction or 

type of reactions. Proteins are substances extracted from living organisms that maybe 

utilized in materials that are petitioned for use in organic production. Proteins are 

sensitive to relatively small changes in pH, temperature, or solvent composition may 

cause them to denature. Denaturation causes physical change, the most observable result 

is loss of biological activity. Except for cleavage of disulfide bonds, denaturation stems 

from changes in secondary, tertiary, or quaternary structures through disruption of 

noncovalent interactions, such as hydrogen bonds, salt linkages and hydrophobic 

reactions. Common denaturing agents include the following: 

1. Heat--most become denatured when heated above 50-60 degrees C. 

Page 10 of 11 
2. Large changes in pH--adding concentrated acid or alkali to a protein in a aqueous 

solution causes changes in the charged character of ionizable side chains and 

interferes with salt linkages. 

3. Detergents--treating a protein with sodium dodecylsulfate (SDS), a detergent, 

causes the native conformation to unfold and exposes the nonpolar protein side 

chains to the aqueous environment. These side chains are then stabilized by 

hydrophobic interaction with hydrocarbon chains of the detergent. 

4. Organic Solvents- such as alcohols, acetone or ether. 

5. Mechanical treatment. Most globular proteins denatured in aqueous solution if 

they are stirred or shaken vigorously. 

6. Urea and guanidine hydrochloride- These substances can cause disruption of 

protein hydrogen bonding and hydrophobic interactions. 

Denaturation can be partial or complete. It can also be reversible or irreversible. 

Irreversible denaturation causes a fundamental change in the protein, in particular

destroying any physiological (biological) activity. In the case of reversible denaturation, 

the change may only be temporary (Brown, 1988). 

References: 

Boikess, R.S. and Edelson, E. Chemical Principles. Harper and Row, New York, 1978. 

Brown, W.H. Introduction to Organic Chemistry. Brooks/Cole Publishing Company, 

California, 1988. 

Matta, Michael, and Wilbraham, A.C. General, Organic and Biological Chemistry. 

Benjamin/Cummings Publishing Company, California, 1986. 

Page 11 of 11