Quick Start Guide: Formulating Multiple Ingredient Products - Transition to Organic Partnership Program

Need a quick reference guide for how-to get started with tracking ingredients, sourcing materials and making sure your following USDA NOP regulations for certification? Oregon Tilth’s condensed Quick Start Guide series is designed to answer your big questions quickly, give examples and point to helpful tools to get started

Quick Start Guide:

Formulating Multiple
Ingredient Products

Oregon Tilth’s Quick Start Guide series is designed to provide
clients with all of the basics necessary to jump right in and get
started on certification-related actions immediately.
Oregon Tilth | (503) 378-0690 | www.tilth.org

FORMULATING MULTIPLE

INGREDIENT PRODUCTS
Getting started on formulating multiple ingredient organic products involves knowledge
of some fundamental definitions, calculators and compliance requirements. The Quick
Start Guide for Multiple Ingredient Products is intended to ask (and answer) the most
important questions as well as provide you with mini case studies, templates and tools to
use when starting the process on your own.

Important

questions & guidelines:

HOw do I
calculate the
“organic-ness”
of my
multi-ingredient
product?

What is the
National List
and why does it
matter for my
product?

What processes
are allowed and
prohibited?

How do I track
and document
ingredients?

Let’s get started!
_ __

Oregon Tilth | (503) 378-0690 | www.tilth.org

How do I calculate the “ORGANIC-NESS”

of my multi-ingredient product?
The formula you should use to calculate the percentage of organic ingredients in your
product is simple. Use the following calculation:

Total net weight or volume of
combined organic ingredients*
____________________________________________________
Total weight of all combined ingredients*
*excluding salt and water

defined:

ingredient
Any substance used in the
preparation of an agricultural product
that is still present in the final
commercial product as consumed.

defined:

processing aid
(a) A substance that is added to a food during the
processing of such food but is removed in some manner
from the food before it is packaged in its finished form;
(b) a substance that is added to a food during
processing, is converted into constituents normally
present in the food, and does not significantly increase
the amount of the constituents naturally found in the
food; and
(c) a substance that is added to a food for its technical or
functional effect in the processing but is present in the
finished food at insignificant levels and does not have
any technical or functional effect in that food.

Oregon Tilth | (503) 378-0690 | www.tilth.org

How do I calculate the “ORGANIC-NESS”

of my multi-ingredient product?
MINI CASE STUDIES
The following mini case studies show you how to this formula applies to a few examples of
multiple ingredient product types:

Made with Organic flour and eggs

Organic Pale Ale
BEER

Organic Whole
Wheat Bread

Bulk/Retail:

Retail

Composition category:

95% – ORGANIC

Actual Percentage:

Vanilla Sugar Cookies

Made with Organic *
Actual Percentage:

97%
(ROUNDING DOWN)

75%
(rounding down)

98%
(ROUNDING DOWN)

Ingredients

OG Wheat Flour

OG Malted Barley

13.00

OG Sugar

OG Hops (Cascade)

00.80

OG Eggs

17.5

Carbon Dioxide

00.30

Butter

Baking Soda

0.1

Vanilla Extract

Water (excluded)
———————————————Total

85.90
———-100

Weight of organic ingredients
Weight of formula w/o H20
Percent of organic ingredients

13.80
14.10
97.80

Salt (excluded)
0.4
———————————————-Total ———-100
Weight of organic ingredients
Weight of formula w/o H20 and salt
Percent of organic ingredients

75.5
99.6
75.8

Processing Aids
Brewing Yeast
Carageenan
CaCl2 – water treatment
Filter Sheets (cellulose pads w/
diatomaceous earth

NA
NA
NA
NA

Ingredients

OG Whole Wheat Flour

OG Barley Flour

Baking Soda

Water (excluded)
Salt (excluded)
———————————————Total

8
1
———-100

Weight of organic ingredients
Weight of formula w/o H20 and salt
Percent of organic ingredients

90
91
98.9

Processing Aids
Organic oil – pan release

TOOL TIPS: FORMULA CALCULATOR SPREADSHEET
We’re not expert mathematicians and don’t expect you should be either. The Oregon Tilth
Product Formulation Sheet is a quick calculator to plug in all of your data from time of product
formulation to determine the percentage of your organic ingredients.
Download the Product Formulation Calculator in our Resource Library.
For more information about the Made with Organic category, read our Organic Product Labeling & Composition Guide.

What is the National List

and why does it matter?
Simply put, the National List catalogs all non-organic materials allowed for use as ingredients,
seasonings or processing aids in your organic products. These include common ones such
as baking soda, yeast and citric acid. The following are some of the most common questions
we receive regarding the National List materials and ingredients:
Why does it matter?
The National List provides the only allowable
non-organic ingredients and processing
aids materials for use in your product.

Is cost a viable indicator of commercial
(un)availability?
Cost does not constitute commercial
unavailability.

What if I’m having trouble finding
commercial sources of agricultural
ingredients?
We understand that it isn’t always easy
to find certain agricultural ingredients as
certified organic for your product. But several
resources exist to guide you to producers
with organic agricultural products, including
those on the 205.606 National List. Please
consult the Tool Tips below.

If an item is found on the National List and
is allowed, can I use it any way I want?
No. There are often restrictions in the form
of “annotations” for individual materials.
Restrictions often apply to sourcing,
identification, form, use and composition
of the material. You must supply the
certifier with documentation demonstrating
compliance with all restrictions.

What if I still can’t find an ingredient
certified as organic?
Call us! We’re here to be of service to you and
see if we can’t help you find what you need.
You will need to demonstrate that a 205.606
product is not commercially available and
the best place to start is a conversation with
the Oregon Tilth certification team.

What types of things are

on the National List?
§ 205.605

Lists allowed non-agricultural substances
605(a) lists non-synthetic substances, some w/ annotations
605(b) lists synthetic substances, some w/ annotations

§ 205.606
Lists allowed non-organic, agricultural
ingredients (if not commercially available
as organic That can be used in products
labeled as organic)

What is the National List

and why does it matter?
MINI CASE STUDIES
The following materials are shown to demonstrate specified restrictions per annotations on
the National List:

Citric Acid
produced by
microbial
fermentation of
carbohydrate
substances

Enzymes
must be derived
from edible,
nontoxic plants,
nonpathogenic fungi,
OR nonpathogenic
bacteria

Cellulose
for use in
regenerative casings,
as an anti-caking agent
(non-chlorine bleached)
and filtering aid

TOOL TIPS: FINDING ORGANIC AGRICULTURAL PRODUCTS

A listing of searchable databases and websites to source difficult-to-find (and common)
agricultural products that are listed in 205.606.
Oregon Tilth Find Organics Tool
A searchable database of all agricultural (and processed) products certified organic by
Oregon Tilth, updated daily.
606organic
A searchable list of organic sources of ingredients currently allowed on the National List
when commercial sources are not available.
OTA Organic Pages
A comprehensive list of organic sources of a variety of materials and ingredients.
NOP Certified Operations List
National Organic Program list of certified operators producing agricultural products
as well as processed products.

What PROCESSES ARE

ALLOWED AND PROHIBITED?
The majority of mechanical and biological processing used for multiple ingredient
products is allowed under the National Organic Program. For quick reference, we’ll
break down what is allowed and what is prohibited:

ALLOWED
•

From ingredients to product: Cooking,
baking, curing, heating, drying, mixing,
grinding, churning, separating, distilling,
extracting, slaughtering, cutting, fermenting,
eviscerating, preserving, dehydrating,
freezing, chilling or otherwise manufacturing

•

From product to retail ready: Packaging,
canning, jarring and otherwise enclosing
food in a container

•

Advanced methods: High pressure
processing, infrared dehydrating/
cooking, freeze drying, various purification
technologies

As new technology comes on the market, the
process or device may not have been evaluated by
a certifier to determine compliance. Oregon Tilth
recommend notifying the certify prior to purchase
and implementation in order to evaluate the new
technology to determine compliance.

PROHIBITED
•

Genetic modification or engineering:
Genetically modify organisms or influence
their growth and development by means that
are not possible under natural conditions or
processes

•

Ionizing radiation: Consult Food and Drug
Administration regulation, 21 CFR 179.26

•

Sewage sludge

The “Big 3” prohibited processes apply to organic
and allowed non-organic ingredients from the
National List. The general guideline for prohibited
processes is that all certified § 205.105 products
must be produced and handled without the use
of (a) non-agricultural substances, except for those
in § 205.605 (National List), and (b) non-organic
agricultural substances except for those in § 205.606
(National List).

DEFINED:

processing (mechanical/biological methods)
Cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extracting,
slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling, or
otherwise manufacturing and includes the packaging, canning, jarring, or otherwise enclosing food in a
container.

What PROCESSES ARE

ALLOWED AND PROHIBITED?
MINI CASE STUDIES

Excluded
Process 1:

Excluded
Process 2:

Excluded
Process 3:

Genetic

IONIZING

SEWAGE

modification + engineering

Radiation

SLUDGE

Use of cobalt-60, cesium-137,
and other sources of radiation
for controlling microbial
contaminants, pathogens, and
pests in food.

A solid, or liquid residue
generated during the treatment
of domestic sewage in a
treatments work.

Includes cell fusion,
microencapsulation and
macroencapsulation, and
recombinant DNA technology
(including gene deletion, gene
doubling, introducing a foreign
gene, and changing the positions
of genes when achieved by
recombinant DNA technology).
Does not include the use of
traditional breeding, conjugation,
fermentation, hybridization, in
vitro fertilization, or tissue culture.

Does not include
FDA-approved applications of
X-rays for inspecting food.

Does not include ash generated
during the firing of sewage sludge
in a sewage sludge incinerator
or grit and screenings generated
during preliminary treatment of
domestic sewage
in a treatment works.

TOOL TIPS: VERIFICATION FOR NON-ORGANIC INGREDIENTS

Use the OTCO Non-organic Ingredient Declaration (NOID) form to receive proper
verification for allowed non-organic ingredients in your product.
Download the Non-organic Ingredient Declaration on our website.

How Do I Track and

document ingredients?
Ingredient documentation requires the use of declarations and affidavits to verify sourcing
and allow for ease of traceability. The most common ways to accomplish transparent
documentation is through use of:
Non-organic Ingredient Declarations
To be used to address compliance with the “Big 3” prohibited processes and certain
annotations for items on the National List
Manufacturer Statements
Allowable if information provided is clear and adequate
Certifier Forms
Certifiers often supply ingredient documentation form sheets for use with your suppliers

Ingredient
Documentation 101
We need to know:
• What’s in it?
• Who made it?
• How was it made?
Why we need to know it:
• To show compliance to the regulation
Common mistakes:
• Lack of ingredient declarations on specification sheets
• Atypical ingredients being included in a non-organic ingredient that may
not be allowed within the standard

How Do I Track and

document ingredients?
MINI CASE STUDIES
The following mini case studies show you how to take the right steps for ingredient
documentation:

Sample ingredient

Vitamins

606 item
(not commercially Available as organic)

Provide a Specification Sheet lising all ingredientss found
in the vitamin
Complete a Declaration of Nutrient Vitamins and
Minerals (DNV). Need to verify that the Vitamins and
Minerals fall within the annotation requirements

Only applies to products certified in the
“organic” category
Complete a commercial availability search form (CAF) to
Show that an organic form is not commerically available

for the FDA Nutritional Quality Guidelines for Food.

From at least three sources

Verify that you’ve met the requirements for the

Must complete a Non-Organic Ingredient Declaration

Big 3 Prohibitive practices

(NOID) to confirm Big 3

TOOL TIPS: INGREDIENT AND INVENTORY MANAGEMENT

In addition to providing all of the above information, keeping excellent track of your
ingredients for production lot codes and batches is equally important and parallels
your documentation process.
Learn more about inventory management with the Oregon Tilth Sample Audit
Documentation Tool.

Product Submission

Checklist

When you need to add a product to your organic certificate, please be sure to include
the following information:

Label
• Draft of label
• Does it need a Private Label Agreement?

ORganic ingredients
• Master Ingredient List (updated)
• Certificates for new suppliers

Formulation
• OTCO Formulation Sheet

non-organic ingredients*
(*for new ingredients)

• Non-organic Ingredient Declaration (NOID)
• Natural Flavor Questionnaire (NFQ)
• Commercial Availability Form (CAF)
• Declaration for Nutrient Vitamins and Minerals

Oregon Tilth | (503) 378-0690 | www.tilth.org

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