Declaration Claims and Allergen Requirements for Raw Materials and Finished Products

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1.0 Purpose 
 
 The purpose of this procedure is to provide details regarding any declaration claims and
 
 allergen requirements necessary for raw materials and finished products to support any label
 claims. Example declaration would be organic, kosher, Halal, not Bioengineered, etc. Example
 
 allergen requirement would be, gluten free, soy free, dairy free, etc. 
 
 2.0 Scope 
 
 This procedure is applicable in establishing the definition and internal coding for any
 
 declaration claims for raw materials. This procedure will also be the reference point for any
 raw material that is required to be evaluated for a declaration claims, meaning if the release of
 
 any raw material requires the material to be classified with any declaration then this procedure
 
 will be used as a trigger mechanism on the specification for this evaluation. Management of
 allergen requirements on finished products is also included in the scope of this procedure.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of the Account Managers, QC Laboratory, R&D, QA, and
 
 Purchasing to establish any appropriate raw material declaration and/ or Finished
 
 product allergen requirements. 
 
 3.1.1 The account managers must request any declaration claims or allergen
 
 requirements from the client at the beginning stages of establishing any new
 finished product. 
 
 3.1.2 R&D will formulate to and apply these declarations and/or allergen
 requirements to any raw materials associated with them. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Declaration Claims and Allergen Requirements for D-307 2 | Page 2 of5 
 Raw Materials and Finished Products 
 
 4.0 Definitions 
 
 4.1 Organic — Ingredients grown without the use of pesticides, synthetic fertilizers, sewage
 
 sludge, genetically modified organisms, or ionizing radiation 
 
 4.2 Kosher — Ingredients that fulfill the requirements of Jewish dietary law
 
 4.3 Halal — Ingredients that fulfill the requirements of Islamic dietary law
 
 4.4 Allergen Free — Ingredients declared to not contain any of the specific allergens, i.e.
 
 gluten, nut, dairy, shellfish, soy 
 
 4.5 GMO (Bioengineered) — Genetically modified organism; any organism whose genetic
 material has been altered using genetic engineering techniques. The special declaration
 
 in this case is typically “Non-GMO” or “Non-Bioengineered”. 
 
 4.6 Vegan — Ingredients not of animal origin, including milk, eggs, honey, and gelatin
 
 4.7 Vegetarian — Ingredients not of animal origin, with the exception of milk, eggs,
 beeswax, honey and propolis, their contituents and products derived from them
 
 4.8 NSF - National Sanitation Foundation 
 
 4.9 QA — Quality Assurance 
 
 4.10 QC — Quality Control 
 
 4.11 R&D — Research and Development 
 
 4.12 PPM — Parts per Million 
 
 5.0 References 
 
 dl D-105, SOP, Out of Specification / Out of Trend Investigation 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Declaration Claims and Allergen Requirements for D-307 2 Page 3 of5 
 Raw Materials and Finished Products 
 
 6.0 Procedure 
 
 6.1 Establishment of Declarations 
 
 6.1.1 At the time of project initiation, the responsible account manager will determine
 if any declaration claims are necessary for the finished product. R&D will
 
 transfer these declaration claims to raw materials associated with the
 
 formulation of the product. This information will be communicated with
 purchasing to facilitate obtaining the appropriate documents from the raw
 
 material suppliers to support needed declarations. 
 
 6.2 Storage of Declarations 
 
 6.2.1 Once the needed declarations are obtained, purchasing will forward all
 documents to Document Control and/or QA. Document Control and/or QA will
 
 store documents in an electronic controlled central location.
 
 6.3 Declaration Codes 
 
 6.3.1 When a raw material is required to be of a declaration claim, the raw material
 should be identified with the necessary declaration. When a new raw material is
 created in Batchmaster, the corresponding declaration box will be checked as
 part of its Item master details page set-up. Allergens will also be identified as of
 part of the raw material’s item master details page set up. The declarations are
 coded as defined below: 
 
 Declaration _ ee 0 Abbreviation 
 Vegan VGN 
 
 Vegetarian VGT 
 Organic ORG 
 Not Bioengineered nBE 
 Kosher KOSH 
 Halal HAL 
 Gluten-Free GF 
 Soy-Free SF 
 Allergen-Free AF 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Declaration Claims and Allergen Requirements for D-307 2 | Page 4 of5 
 Raw Materials and Finished Products 
 
 6.4 Testing ~- Raw Materials 
 
 6.4.1 If a specific declaration is needed for any raw material, the raw material
 
 specification will be set-up to indicate this as a necessary test to complete for
 raw material release. This SOP number will be referenced on the specification
 
 along with the specific declaration. This “test” will then be completed by the
 QC Lab by locating the document(s) in the electronic location, confirming the
 
 necessary documents are present, and indicating this on the raw material test
 
 ticket. If the required documentation is not available then that test for the RM is
 not complete until the documentation is collected, or it is confirmed that the
 
 material does not support the declaration claim. If the declaration is not
 supported, then the test will fail and the material will be dispositioned as
 
 applicable. 
 
 6.5 Testing — Finished Products 
 
 6.5.1 For allergen-free finished product certifications, testing procedures will be
 
 executed using the following guidelines: 
 
 6.5.1.1 The name of the testing kit or outside lab used will be identified on
 
 testing documentation. 
 
 6.5.1.2 Allergens will be evaluated individually on, at minimum, beginning,
 
 middle, and end of the final packaged product. Final Packaged product
 is defined as the final process step completed internally before batch
 
 can be released. 
 
 6.5.1.3 For NSF Certified Gluten-Free products, the product lot is considered
 
 compliant if gluten is observed at <15 ppm. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Declaration Claims and Allergen Requirements for 
 D-307 
 Page 5 of 5 
 Raw Materials and Finished Products 
 6.5.1.4 If the results of the allergen testing do not meet acceptance criteria,
 proceed with an Out of Specification investigation per SOP D-105 Out
 
 of Specification / Out of Trend Investigation. 
 
 6.5.1.5 If a product is found to be out of compliance, the quality unit will
 
 notify NSF of the failure. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/27/19 | New procedure. N/A J. Sassman | - | - |
| 1 | 06/09/22 | Scheduled review: Updated logo and format. CC- | 22-0269 | K. Burris |
| 2 | 10/19/23 | Added Finished Products into scope. Added allergen CC- requirements. | 23-0521 | J. Sassman |