SCS Certification Standard

for Gluten-Free Products

SCS-107 Gluten-Free Standard

Version 2.1 – December 2023

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Contents
Disclaimer...................................................................................................................................................... 1
Contents ........................................................................................................................................................ 2
1. Introduction .......................................................................................................................................... 4
2. Certification Scope ................................................................................................................................ 6
2.1 Scope ............................................................................................................................................. 6
2.2 Intended Users and Interested Parties ......................................................................................... 6
2.3 Voluntary Standard ....................................................................................................................... 6
3. References ............................................................................................................................................ 7
4. Terms and Definitions ........................................................................................................................... 7
5. Ingredient Classification...................................................................................................................... 11
6. Facility Classification ........................................................................................................................... 11
7. Management and Personnel............................................................................................................... 12
7.1 Business License and DBAs ......................................................................................................... 12
7.2 Commitment from Senior Management .................................................................................... 12
7.3 Roles and Responsibilities ........................................................................................................... 12
7.4 Training ....................................................................................................................................... 13
8. Management System .......................................................................................................................... 13
8.1 Program Documentation Requirements ..................................................................................... 13
8.2 Internal Audits and Continuous Improvement ........................................................................... 14
8.3 Document Control and Recordkeeping....................................................................................... 15
8.4 Corrective and Preventative Action ............................................................................................ 15
9. Identity Preservation .......................................................................................................................... 15
9.1 Critical Control Points ................................................................................................................. 15
9.2 Sanitation and Sequencing ......................................................................................................... 16
9.3 Good Manufacturing Practices ................................................................................................... 16
9.4 Handling Contamination and Mislabeling................................................................................... 16
9.5 Ingredient Sourcing and Vendor Management .......................................................................... 16
9.6 Product Control and Development ............................................................................................. 18
9.7 Transport and Storage ................................................................................................................ 18
9.8 Work in Process and Rework ...................................................................................................... 18
9.9 Waste and Purge Material .......................................................................................................... 19
10. Traceability .......................................................................................................................................... 19
10.1 Production Log Requirements .................................................................................................... 19

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 10.2 Tracing Forward and Back ........................................................................................................... 19
10.3 Mock Recall ................................................................................................................................. 19
11. Testing ................................................................................................................................................. 20
11.1 Raw Materials and Finished Products ......................................................................................... 20
11.2 Equipment ................................................................................................................................... 20
11.3 Visual Inspection ......................................................................................................................... 20
11.4 Test Kits, Labs, and Proficiency ................................................................................................... 20
11.5 Test Result Records ..................................................................................................................... 21
12. Claims and Labelling............................................................................................................................ 21
12.1 Claims .......................................................................................................................................... 21
12.2 Labelling ...................................................................................................................................... 21
12.3 Private Label Claims .................................................................................................................... 22
13. Complaints and Appeals ..................................................................................................................... 22
Appendix A: Minimum Testing Requirements ............................................................................................ 23
A.1. Testing for Ingredients ..................................................................................................................... 23
A.2. Testing for Finished Product and Equipment .................................................................................. 23
A.3. Visual Inspection .............................................................................................................................. 23

List of Tables
Table 1. Version History ............................................................................................................................... 5
Table 2. Ingredient Risk Levels.................................................................................................................... 11
Table 3. Facility Classification ..................................................................................................................... 11

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1. Introduction
1.1 The SCS Certification Standard for Gluten-Free Products (hereinafter SCS Gluten-Free Standard)
describes the requirements for third-party substantiation of gluten-free claims asserted by a
Participant who is seeking to obtain certification against the SCS Gluten-Free Standard for its
products.

1.2 Gluten refers to proteins found in gluten-containing grains such as wheat, rye, and barley,
including their crossbred hybrids. The most common gluten related disorders are celiac disease
(CD) and non-celiac gluten sensitivity (NCGS) or intolerance. Elimination of gluten is the only
treatment available for CD and NCGS.

1.3 The goal of the SCS Gluten-Free Standard is to help consumers make agile, safe, and informed
purchasing decisions when looking for gluten-free products.

1.4 This Standard allows a Participant to demonstrate that:

1.4.1 Certified products either 1) inherently do not contain gluten, or 2) do not contain an
ingredient that is:

1.4.1.1 a gluten-containing grain;

1.4.1.2 derived from a gluten-containing grain that has not been processed to remove gluten;
or

1.4.1.3 derived from a gluten-containing grain that has been processed to remove gluten, if
the use of that ingredient results in the presence of 10 parts per million (ppm) or more
gluten in the finished product;

1.4.2 Any unavoidable presence of gluten in the certified product is below 10 ppm;

1.4.3 Critical Control Points for gluten contamination have been adequately assessed, and where
such a potential risk has been identified, the manufacturer has implemented measures to
prevent the introduction of gluten into the finished product during the manufacturing
process; and

1.4.4 A Sampling and Testing Program is in place to verify that adequate measures are taken to
prevent gluten contamination.

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 Table 1. Version History

Version: Release date: Remark/changes:

V1.0 March 1, 2021 Original Version
V2.0 October 3, 2022 Addition of Sections: Introduction,
References, Terms and Definitions
Modification of Sections: Management
Personnel, Management System, Identity
Preservation, Traceability, Inspections,
Testing, Labeling
V2.1 December 22, 2023 Modification of Section: Claims and
Labeling
Modification of Table 4
Removal of Section: Inspections
Removal of a requirement in section:
Internal Audit and Continuous
Improvement
Revised formatting, numbering, verbiage

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2. Certification Scope
2.1 Scope
2.1.1 The SCS Certification Standard for Gluten-Free Products applies to the receiving, storage,
manufacturing, packing, and shipping of:
 Processed foods,
 Raw materials or ingredients,
 Primary products (e.g., crops, fruit, vegetables, etc.),
 Over the counter medicines, dietary supplements,
 Homeopathic remedies,
 Goods for human use that are topically applied, and/or
 Pet foods for domestic animals.

2.1.2 Certification applies only to products that have been manufactured at the audited facility.
The Standard shall not apply to products or activities that are outside the direct control of
the Participant.

2.1.3 The following types of products are not eligible for certification:
 Some medicines and drugs,
 Live animals,
 Controlled substances under applicable law, and/or
 Fermented or hydrolyzed materials, enzymes, or materials produced with an enzyme
that have not been distilled to remove residual protein and for which the substrate or
growth media used to produce them is derived from a gluten-containing grain.

2.2 Intended Users and Interested Parties

2.2.1 Intended users of this Standard are product manufacturers or brand owners (including
individuals, businesses, organizations, or agencies) seeking third-party certification of
selected products to the requirements of this Standard.

2.3 Voluntary Standard

2.3.1 This Standard is voluntary and nonbinding. It is not intended to replace the legal or
regulatory requirements of any country in which gluten-free products are manufactured,
handled, or sold.

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3. References
1. 21 CFR Part 101.91, Gluten-free labeling of food
2. 80 FR 71990 - 2015, Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
3. 85 FR 49240 - 2020, Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
4. ISO 9001:2015, Quality management systems – Requirements
5. ISO 22000:2018, Food safety management systems — Requirements for any organization in the
food chain
6. Mahan, Kathleen, et al. Krause and Mahan’s Food & the Nutrition Care Process. 2012. P 618-
624.

4. Terms and Definitions

Celiac disease (CD). An autoimmune disease triggered by the consumption of gluten, causing digestive
symptoms and damage to the small intestine, impacting the ability to absorb micronutrients and
macronutrients.

Certification Body. An SCS Standards-approved third-party organization authorized to conduct

independent audits to assess conformance with this Standard.

Condition. A minor issue related to a lack of conformity with the Standard that does not represent a risk
to the integrity of the product.

Corrective and Preventive Action Plan. Methodology used by the facility to address non-conformities that
includes root cause analysis, implementation of corrective and preventive measures, and evaluation of
the effectiveness of the corrective and preventive measures taken.

Correction. Action to eliminate a condition or non-conformity.

Critical Control Point. A step in the food production process in which there is a risk of gluten
contamination and preventive measures can be put in place to reduce this risk.

Dedicated facility. A facility that does not handle any gluten-containing ingredients or any high-risk
ingredients that are not in the scope of certification.

Distilled product or ingredient. A product or ingredient that is the result of a process that separates more
volatile components of a liquid mixture from less volatile components by the application of heat. The
remaining components, whose boiling points were too high to undergo vaporization, are left behind.

Enzymes. A specialized protein that acts as a catalyst to speed up a specific reaction. (Source: Enzyme
Technical Association; https://www.enzymetechnicalassociation.org/enzymes/)

Facility. The location where certified products are manufactured and/or packaged with no further
processing prior to sale.

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Fermented product or ingredient. A product or ingredient that has undergone a fermentation process
that typically involves the conversion of complex organic compounds, especially sugars and other
carbohydrates, to simpler compounds. During fermentation, proteins are broken apart into smaller
groups of amino acids known as peptides. Fermentation is not considered as a process to remove gluten.

Finding. An instance of non-conformity or potential non-conformity with a requirement of the Standard.

Findings are graded as non-conformities, conditions, or observations by the certification body.

Gluten. Proteins that naturally occur in a gluten-containing grain and that may cause adverse health
effects in persons with celiac disease.

Gluten-containing grain. Any one of the following grains or their crossbred hybrids (e.g., triticale, which
is a cross between wheat and rye): wheat, including any species belonging to the genus Triticum; Rye,
including any species belonging to the genus Secale; or Barley, including any species belonging to the
genus Hordeum.

Gluten-containing ingredient. A gluten-containing grain, or a material derived from a gluten-containing

grain, that is used as an ingredient.

Gluten-Free product. A product that inherently does not contain gluten; or does not contain an ingredient
that is: (1) a gluten-containing grain (e.g., spelt wheat); (2) derived from a gluten-containing grain and that
has not been processed to remove gluten (e.g., wheat flour); or (3) derived from a gluten-containing grain
and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in
the presence of 10 ppm or more gluten in the product. A gluten-free product may contain an unavoidable
presence of gluten below 10 ppm.

Gluten-Free program. The Participant’s set of policies and systems that ensure conformity with the SCS
Gluten-Free Standard.

Hydrolyzed product or ingredient. A product or ingredient in which chemical components—such as

proteins—are broken into smaller organic compounds by reaction with water. These reactions are often
accelerated by enzymes. Hydrolysis is not considered as a process to remove gluten.

High-risk ingredient. An ingredient that has a high risk of gluten contamination in its supply chain due to
overlap with gluten-containing grains or gluten-containing ingredients.

Ingredient. All materials used in the production of a product, including processing aids.

Inherently gluten-free ingredient. An unprocessed raw ingredient that is not a gluten-containing grain
and has no risk of gluten contamination in its supply chain.

Internal audit. Gluten-Free Program assessment of the facility conducted by the facility.

Lot (or batch). A defined quantity of a specific product that is produced, processed, or packaged under
essentially the same basic conditions.

Low-risk ingredient. An ingredient that has minimal risk of gluten contamination in its supply chain or is
inherently gluten-free.

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Medium-risk ingredient. An ingredient that has some risk of gluten contamination in its supply chain due
to potential overlap with gluten-containing grains or ingredients.

Non-celiac gluten sensitivity or intolerance (NCGS). A condition where the intake of gluten causes
digestive symptoms in the absence of CD or wheat allergy.

Non-conformity. A failure to comply with a certain section of the Standard that could impact the integrity
of the certified product.

Non-dedicated facility. A facility that handles gluten-containing ingredients and/or high-risk ingredients
that are not in the scope of certification. There are two types of non-dedicated facilities: non-dedicated
facilities with dedicated equipment and non-dedicated facility with shared equipment.

Non-dedicated facility with dedicated equipment. A facility that handles gluten-containing

ingredients and/or high-risk ingredients that are not in the scope of certification and in which the
equipment used to produce certified products is not used to manufacture products that contain
gluten or high-risk ingredients that are not in the scope of certification.

Non-dedicated facility with shared equipment. A facility that handles gluten-containing

ingredients and/or high-risk ingredients that are not in the scope of certification and in which the
same equipment is used to produce certified products and products that contain gluten or high-
risk ingredients that are not in the scope of certification.

Participant. A manufacturer or brand owner whose products are certified or are undergoing the
certification process.

Primary Contact. An individual responsible for the conformity with SCS Gluten-Free Standard
requirements and for handling all necessary Gluten-Free related communications.

Processing Aid. Substance that is added to a food: (1) during the processing of such food but is removed
in some manner from the food before it is packaged in its finished form; (2) during processing, which is
converted into constituents normally present in the food, and does not significantly increase the amount
of the constituents naturally found in the food; or (3) 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.

Restaurant chain. Group of restaurants with multiple locations that share a brand, and that follow the
same Standard Operating Procedures, including those used to prevent gluten contamination.

Sampling and Testing Program. Valid sampling and testing methodology selected by the Participant to
verify that adequate measures are taken to prevent gluten contamination.

Sequencing. The act of staging production to produce multiple batches of certified products in a way to
reduce potential gluten contamination from uncertified products.

Termination. Removal from the certification program and cancellation of the certificate due to
uncorrected non-conformities with the criteria in the Standard. A Participant that has been terminated
due to uncorrected non-conformities is not eligible to become recertified until one year after the
termination date.

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Validation. Confirmation through objective evidence that a requirement for a specific intended use or
application is met. Example: a procedure is effective.

Withdrawal. Removal from the certification program and cancellation of the certificate due to
unaddressed administrative or contractual issue(s) (e.g., non-payment of fees). Withdrawals may be
initiated by the certification body; however, Participants may reapply for certification at any time after
correcting the administrative or contractual issue(s). Voluntary withdrawals can be requested by the
Participant so long as there are no unresolved issues or active notices of proposed termination.

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5. Ingredient Classification
5.1 Each ingredient shall be classified in accordance with the risk of gluten contamination in its supply
chain due to overlap with gluten-containing grains or gluten-containing ingredients.

5.2 The SCS Gluten-Free Standard recognizes three ingredient risk levels (Table 2). The risk levels are
assigned by the certification body and used to determine testing requirements for ingredients.

Table 2. Ingredient Risk Levels

Risk Level Definition

Low An ingredient that has minimal risk of gluten contamination in its supply chain or is
inherently gluten-free.
Medium An ingredient that has some risk of gluten contamination in its supply chain due to
potential overlap with gluten-containing grains or gluten-containing ingredients.
High An ingredient that has a high risk of gluten contamination in its supply chain due to
overlap with gluten-containing grains or gluten-containing ingredients.

6. Facility Classification
6.1 Each facility shall be classified according to whether the facility or its equipment handles gluten-
containing ingredients or high-risk ingredients that are not included in the scope of certification.

6.2 The SCS Gluten-Free Standard recognizes three types of facilities (Table 3). The facility
classification is used to determine finished product and equipment testing requirements.

Table 3. Facility Classification

Facility Type Definition

Dedicated facility A facility that does not handle gluten-containing ingredients or high-risk
ingredients that are not in the scope of certification.
Non-dedicated A facility that handles gluten-containing ingredients and/or high-risk
facility with ingredients that are not in the scope of certification and in which the
dedicated equipment equipment used to produce certified products is not used to manufacture
products that contain gluten or high-risk ingredients that are not in the
scope of certification.
Non-dedicated A facility that handles gluten-containing ingredients and/or high-risk
facility with shared ingredients that are not in the scope of certification and in which the same
equipment equipment is used to produce certified products and products that contain
gluten or high-risk ingredients that are not in the scope of certification.

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7. Management and Personnel
7.1 Business License and DBAs
7.1.1 The facility where certified products are manufactured shall be a legal entity and hold a
business license.

7.1.2 If the Participant operates under a DBA (“Doing Business As”), the DBA shall be registered.

7.2 Commitment from Senior Management

7.2.1 The facility shall have documentation demonstrating that Senior Management is committed
to developing, implementing, maintaining, and reviewing, as necessary, a Gluten-Free
Program that ensures conformity with the SCS Gluten-Free Standard requirements.

7.3 Roles and Responsibilities

7.3.1 The facility shall maintain an organizational chart demonstrating the structure of the
company.

7.3.2 The roles and responsibilities of management and staff involved in the production of
certified products shall be clearly documented.

7.3.3 The facility shall ensure that management and staff involved in the production of certified
products have access to procedures or other documents that detail activities related to the
production of certified products.

7.3.4 The facility shall designate a Primary Contact for its Gluten-Free Program.

7.3.5 The responsibilities of the Primary Contact shall be documented and include the following:

7.3.5.1 Ensuring its Gluten-Free Program guarantees conformity with the SCS Gluten-Free
Standard;

7.3.5.2 Handling all necessary Gluten-Free Program related communications;

7.3.5.3 Ensuring product conformity with testing threshold; and

7.3.5.4 Ensuring corrective and preventive measures related to gluten-free production are
implemented.

7.3.6 The facility shall ensure continuous conformity to its Gluten-Free Program in the event of
changes in personnel or management.

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7.4 Training
7.4.1 All production management, production staff and any other relevant personnel shall
initially be trained on the SCS Gluten-Free Standard requirements as they assume their
role, and annually thereafter.

7.4.2 Records and materials of such training shall be maintained.

7.4.3 Training shall cover:

7.4.3.1 Gluten-related medical disorders (e.g., celiac disease, non-celiac gluten

intolerance/sensitivity);

7.4.3.2 List of gluten-containing grains and examples of ingredients derived from gluten-
containing grains;

7.4.3.3 Critical Control Points for gluten-free production;

7.4.3.4 Standard Operating Procedures (SOPs) and Sanitation Standard Operating

Procedures (SSOPs) relevant to production under its Gluten-Free Program;

7.4.3.5 Procedures for reporting suspected contamination;

7.4.3.6 Using test kits and conducting tests if testing is done in-house; and

7.4.3.7 For non-dedicated facilities:

a) Identification of gluten-containing ingredients and high-risk ingredients outside

the scope of certification,
b) Prevention of commingling, and
c) Product sequencing, for non-dedicated facilities with shared equipment.

8. Management System
8.1 Program Documentation Requirements
8.1.1 The Participant shall maintain a list of the following:

8.1.1.1 Products and their associated brand names. For any brands that the Participant
does not own, the Participant shall provide evidence of authorization to package
and supply product for the brand owner. The Participant shall provide evidence of
ownership of all owned brand names.

8.1.1.2 Facilities. Each facility shall have a map and floor plan.

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 8.1.1.3 Selling markets. The Participant shall maintain a list of all countries in which
products covered under the Gluten-Free Certification are sold. If selling to markets
where conformity criteria diverge from the conformity criteria of the SCS Gluten-
Free Standard, the Participant shall maintain a copy of the corresponding legislation
and the facility’s Gluten-Free Program shall ensure conformity with the most
restrictive criteria that applies to each product covered under its Gluten-Free
Program as applicable.

8.1.2 The facility shall maintain a list of the following:

8.1.2.1 All ingredients handled in the facility and their suppliers, clearly differentiating
those that are used to produce certified products; and

8.1.2.2 Gluten-free product labels.

8.1.3 Any changes to brands, facilities, ingredients, suppliers, selling markets, and/or labels
involved in the production of certified products shall be disclosed by the Participant and
approved by the certification body before taking effect.

8.2 Internal Audits and Continuous Improvement

8.2.1 The facility shall have a procedure for internal audits to evaluate conformity with the
requirements of the SCS Gluten-Free Standard.

8.2.2 Internal audits shall be conducted at least annually.

8.2.3 The facility’s Senior Management shall demonstrate commitment to continuous

improvement of its Gluten-Free Program through review meetings scheduled annually to
assess the performance of its Gluten-Free Program against the SCS Gluten-Free Standard.

8.2.4 At a minimum, the Management Review shall include:

8.2.4.1 Records showing previous meetings’ decisions (if applicable);

8.2.4.2 Result of gluten-free internal and third-party audits;

8.2.4.3 Customer complaints related to gluten-free production;

8.2.4.4 Corrective and preventive actions taken related to gluten-free production; and

8.2.4.5 Review of effectiveness of changes in its Gluten-Free Program made after last
review meeting.

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8.3 Document Control and Recordkeeping
8.3.1 The facility shall have a procedure for document control.

8.3.2 Documents shall display title, version number, and approval date.

8.3.3 All records shall be retained for at least three years.

8.4 Corrective and Preventative Action

8.4.1 The facility shall have a procedure in place for handling corrective and preventive actions.

8.4.2 Corrective actions shall be taken when:

8.4.2.1 Gluten contamination or suspected gluten contamination occurs;

8.4.2.2 Mislabeling of ingredients or products occurs;

8.4.2.3 Non-conformities related to gluten-free production are discovered during gluten-

free internal and third-party audits;

8.4.2.4 Staff, customer, or external complaints are received related to gluten

contamination or presence;

8.4.2.5 Suppliers who provide ingredients are found to be non-conformant;

8.4.2.6 Mock recalls do not account for all products within reasonable yield; and

8.4.2.7 A positive test result is confirmed.

8.4.3 Non-conformities shall be addressed through a Corrective and Preventive Action Plan that
includes root cause analysis, implementation of corrective and preventive measures, and
evaluation of the effectiveness of the corrective and preventive actions taken.

8.4.4 Corrective and Preventive Action Plans shall be documented.

9. Identity Preservation
9.1 Critical Control Points
9.1.1 Critical Control Points in which there is a higher likelihood of gluten contamination shall be
identified and recorded.

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9.2 Sanitation and Sequencing
9.2.1 Inspection as well as cleaning and/or sanitation shall occur for all necessary equipment
involved in the receiving, storage, batching, production, and/or packaging of ingredients,
work in process, and finished products within the facility.

9.2.1.1 Equipment inspection, cleanout, and sanitation shall be documented.

9.2.1.2 For non-dedicated facilities with shared equipment:

1. Sequencing shall occur to reduce possible instances of gluten contamination,

and

2. Sequencing shall be documented.

9.3 Good Manufacturing Practices

9.3.1 Good Manufacturing Practices (GMPs) shall be established for all relevant staff, temporary
employees, visitors, maintenance, and contractors.

9.3.2 GMPs shall contain procedures that prevent gluten contamination from both inside and
outside of the production area.

9.4 Handling Contamination and Mislabeling

9.4.1 The facility shall have procedures for handling contaminated ingredients, work in process
materials, and finished products.

9.4.2 The facility shall have procedures for reporting suspected contamination and mislabeling of
ingredients and products.

9.4.3 The facility shall ensure the correct labels are used on certified products.

9.5 Ingredient Sourcing and Vendor Management

9.5.1 The facility shall have a procedure to ensure that ingredients are only purchased from
approved suppliers.

9.5.2 Ingredients shall be sourced by the name or specific item code, when possible, to ensure
traceability.

9.5.3 The facility shall ensure that ingredients are compliant for use in the production of certified
products according to the following minimum documentation that shall be required for
each ingredient according to risk level or whether it’s a hydrolyzed, fermented, or distilled
ingredient.

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 9.5.3.1 For Low and/or Medium-risk ingredients:
1. An SCS Gluten-Free certificate or any other Gluten-Free certificate recognized
by the certification body ensuring the ingredient contains less than 10 ppm of
gluten.
OR
2. An ingredient manufacturer’s specification sheet or any other document that
includes disclosure of components.
OR
3. An attestation verifying the ingredient is gluten-free using the certification
body’s “Gluten-Free Declaration” form.

9.5.3.2 For High-risk ingredients:

1. An SCS Gluten-Free certificate or other Gluten-Free certificates recognized as
equivalent to this standard 1 ensuring the ingredient contains less than 10 ppm
of gluten.
OR
2. An ingredient manufacturer’s specification sheet or any other document that
includes disclosure of components, AND an ingredient manufacturer’s
statement showing that the ingredient meets the SCS Gluten-Free Standard’s
definition of gluten-free and ensuring the ingredient contains less than 10 ppm
of gluten.
OR
3. An attestation verifying the ingredient is gluten-free using the certification
body’s “Gluten-Free Declaration” form.

9.5.3.3 For fermented, hydrolyzed, enzyme, distilled ingredients, or components of

ingredients:
1. An SCS Gluten-Free certificate or any other Gluten-Free certificate recognized
by the certification body ensuring the ingredient contains less than 10 ppm of
gluten.
OR
2. An ingredient manufacturer’s documentation showing that the substrate or
growth media used to produce the ingredient, or the ingredient component is
not derived from a gluten-containing grain.

1
Other programs are considered equivalent if the requirements are the same as SCS-107 (i.e., must require testing
to the threshold of <10ppm).

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 OR
3. An ingredient manufacturer’s specification sheet or any other document that
includes disclosure of components, AND ingredient manufacturer’s statement
showing that the ingredient meets the SCS Gluten-Free Standard’s definition
of gluten-free and ensuring the ingredient contains less than 10 ppm of gluten.
OR
4. An attestation verifying the ingredient is gluten-free using the certification
body’s “Gluten-Free Declaration” form.
Note: Distilled ingredients and distilled components for which the substrate
used to produce them is derived from gluten-containing grain shall verify the
absence of protein using testing methods that can reliably detect the presence
or absence of protein or protein fragments.

9.6 Product Control and Development

9.6.1 The facility shall ensure that only approved ingredients are sent to production under its
Gluten-Free Program.

9.7 Transport and Storage

9.7.1 The facility shall have a procedure for inspecting incoming and outgoing transport
vehicles, products, and ingredients for potential contamination.

9.7.1.1 Records of the inspections shall be maintained.

9.7.2 For non-dedicated facilities:

9.7.2.1 Ingredients used in certified products shall be segregated from gluten-containing

and/or high-risk ingredients;

9.7.2.2 Ingredients shall be labeled as gluten-free and/or gluten-containing in storage; and

9.7.2.3 Certified gluten-free finished products shall be segregated via physical space or
barriers to prevent gluten contamination.

9.8 Work in Process and Rework

9.8.1 If used, work in process and rework material shall be segregated and labeled
appropriately.

9.8.2 Relevant information for work in process and rework material, including lot number,
quantity, date, and ingredients used, shall be tracked, and recorded.

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9.9 Waste and Purge Material
9.9.1 The facility shall have a procedure ensuring waste material is disposed of in a way to
prohibit inadvertent use.

9.9.2 For non-dedicated facilities with shared equipment that requires purging:

9.9.2.1 Purge material used in lieu of a cleanout shall be segregated and labeled if not
disposed of immediately or used in non-gluten free production;

9.9.2.2 Purging procedure shall be validated; and

9.9.2.3 The quantity and identification of purge material shall be recorded.

10. Traceability
10.1 Production Log Requirements
10.1.1 Production records shall include the date of production, the product name and lot
number, and the quantity and lot number of the raw materials used.

10.1.2 Production and packaging records shall be reviewed and approved before the product
can be shipped.

10.2 Tracing Forward and Back

10.2.1 Traceability procedures shall be in place to track raw materials through all relevant
points of production:

10.2.1.1 From receipt to shipment of finished products and

10.2.1.2 From finished product shipments back to lots of raw materials used to produce
them.

10.2.2 If different lots of raw materials are combined, numbers of all relevant lots shall be
recorded and linked.

10.2.3 Test results shall be linkable to lots and shipments of ingredients and finished products
to which they correspond.

10.3 Mock Recall

10.3.1 The facility shall have a procedure for conducting mock recalls.

10.3.2 A mock recall shall be conducted at least once annually and documented.

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11. Testing
11.1 Raw Materials and Finished Products
11.1.1 A Sampling and Testing Program shall be in place for relevant raw materials and finished
products.

11.1.2 Gluten testing shall be conducted as per the risk schedule in Appendix A. Certification
bodies may require increased testing at their discretion.

11.1.3 If a product or ingredient tests positive for gluten, it shall either be rejected or re-tested
three additional times.

11.1.3.1 If all three additional tests are negative, the product or ingredient can be
considered conformant and used in certified products.

11.1.3.2 If any of the three additional tests are positive, the facility shall follow their
procedure for handling contaminated ingredients and/or products and take
corrective action accordingly.

11.1.4 Any positive (10 ppm of gluten or more) test results for finished products, regardless of
additional test results, shall be reported to the certification body within 24 hours of
receiving the positive result.

11.2 Equipment
11.2.1 Equipment shall be tested as per the schedule outlined in Appendix A.

11.2.2 Equipment testing can be completed via protein swab testing.

11.3 Visual Inspection

11.3.1 Supplier lots for seeds and beans sold as finished products shall be visually inspected for
gluten contamination as per the schedule outlined in Appendix A.

11.4 Test Kits, Labs, and Proficiency

11.4.1 If testing occurs in-house a rapid test kit that is Association of Official Analytical
Chemists (AOAC) certified and that tests to 10 ppm or less shall be used.

11.4.1.1 The certification body shall observe an employee conducting a gluten test
during the annual audit to confirm proficiency in testing procedures.

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 11.4.2 If testing is conducted by an outside laboratory, the laboratory shall be ISO 17025
accredited for gluten testing or use an AOAC certified test kit.

11.5 Test Result Records

11.5.1 All test results shall be recorded.

11.5.2 If testing occurs in-house, test results shall contain the following information:

11.5.2.1 Name and lot of ingredient/product or name and location of equipment

tested;

11.5.2.2 Ingredient risk level;

11.5.2.3 Date of test;

11.5.2.4 Test kit name, lot number, and expiration date;

11.5.2.5 Person responsible for taking the test; and

11.5.2.6 Result of the test.

11.5.3 If testing is conducted by an outside laboratory, test results shall contain the following
information:

11.5.3.1 Name and lot of ingredient/product;

11.5.3.2 Date of test;

11.5.3.3 Test kit name or testing method; and

11.5.3.4 Result of the test.

12. Claims and Labelling

12.1 Claims
12.1.1 Claims and logo usage shall be reviewed and verified by the certification body.

12.2 Labelling
12.2.1 All uses of the Certification Label or references to the certification on the product and in
product advertising shall be conducted in conformance with U.S. Federal Trade
Commission guidelines or other national guidelines if outside of the U.S.

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 12.2.2 Packaging and/or marketing materials for certified Gluten-Free products may
contain the phrase “Gluten-Free”. Misleading terms such as “Contains Zero Gluten”
are prohibited.

12.2.3 The Participant shall comply with the requirements of the Labeling and Language
requirements of the certification body at all times.

12.2.4 A certified and non-certified product cannot have the same trade name or trademarked
designation.

12.3 Private Label Claims

12.3.1 Private Label Customers are permitted to use the Certification Label as a pass-through
certified claim only.

12.3.2 Private Label Users shall obtain permission for private label use from the approved
certification body and may be subject to administrative fees for using the Certification
Label.

12.3.3 The approved certification body shall manage and monitor private label usage.

12.3.4 Private Label Customers are not permitted to make any changes to the final product
before it is sold or embellish the recycled content or other environmental claims
associated with the product.

13. Complaints and Appeals

13.1 A Participant has the right to appeal a certification decision within 30 days of receiving the
final report. Appeals shall be submitted to the certification body for evaluation and
resolution.

13.2 Complaints shall be handled directly by the approved certification body. If a satisfactory
resolution is not found, a complaint may be elevated to SCS Standards.

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Appendix A: Minimum Testing Requirements
A.1. Testing for Ingredients
The minimum gluten testing requirements for ingredients used to manufacture certified products are
described in Table A.1.

Table A.1. Minimum Ingredient Testing Requirements

Ingredient Risk Level Testing Requirement

Low-risk ingredients No testing is required for low-risk ingredients

Medium-risk ingredients One test per manufacturer’s lot per shipment

High-risk ingredients Three tests per manufacturer's lot per shipment or one for each
container, whichever is lower

A.2. Testing for Finished Product and Equipment

The minimum gluten testing requirements for finished product and equipment are described in Table
A.2.

Table A.2. Minimum Finished Product and Equipment Testing Requirements

Facility Type Finished Product Equipment

Dedicated facility One lot per month None

Non-dedicated facility with Two lots per month None

dedicated equipment

Non-dedicated facility with Three lots after production Test three locations after
shared equipment containing gluten or two production containing gluten or
lots per month whichever is high-risk ingredients, prior to
higher Gluten-Free certified production

A.3. Visual Inspection

A 2.5 kg sample of each lot of seeds and beans sold as finished products shall be inspected to confirm it
does not contain any gluten-containing grain.

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