What is needed for Human Supplements Product filing
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Mandatory

Recommended

Good to have

Pack Copy Folder

This is required here if you are getting translation support from us.

Pack copy – if applicable as not used by all companies. This would contain all the information provided on the artwork.

Online Promotional copy – this is key if you are promoting a product online and is recommended to be sense checked to ensure statements and mandatory markings in online promotional materials are present.

General Promotional Copy – Normally we would not need to review this, but if you have particularly sensitive product claims or a risky marketing strategy; we are always happy to sense check your publications.

Product Artwork Folder

Low resolution point-of-sale artwork (PDF/JPG/PNG format – all faces on the printed packaging containing information)

Promotional artwork (off-pack)

 

Product Certifications Folder

  • This is any official certification, approval certificates from 3rd party endorsements. An example could be vegan society logo.
  • A company statement declaring that the product meets food safety standards or relevant documentation i.e. HACCP system in place and or GFSI certified manufacturing.

Product Registrations Folder

Product Specification Folder

  • Finished product specification details such as recipe, allergens, weights, nutrition, micro limits, packaging, shelf life.
  • Product specific supporting documentation/ statements from manufacturers i.e. GMO statements, allergen risk assessments.

 

 

Quality assessment documentation and tolerances that help support the quality of the product.

Documentation that reinforces the quality procedures that are in place such as an example Assessment Quality Level (AQL) report to demonstrate the quality checks done prior to shipping. This information is voluntary in this instance, but helps to reinforce the quality of your product if you are challenged on your product being fit for purpose.

Product Testing Folder

  • Any testing specified in the regulations and directives relating to your product i.e. gluten free claims, sulphite testing.
  • Analytical testing i.e., nutrition, microbiological testing.

Any performance testing (if applicable) that reinforces the quality of the product. This helps to assure market authorities that this product has been well designed and normally avoids further investigation and testing if a product is challenged.

Remember to complete the Product Schedule by adding each product’s unique reference and name. This should align with the product file name in the Product Schedule. You can find guidance for this step in your Product Schedule.

Once your product has been fully approved and signed off, you may proceed with shipping to your intended markets. Do not ship the product before receiving written approval; doing so renders your product non-compliant and illegal.

Glossary of Terms and Definitions.

 

3rd party certificates or endorsements

e.g. FSC certificate of sustainable wood/paper supplied, quality endorsements. Please only upload certification or confirmation of endorsements or registrations into this folder. Test certification and test reports need to be filed in the dedicated ‘Product Testing’ sub-folder.

Bill of Materials (BoM)

The Bill of Materials offers a detailed breakdown of the materials and quantities required to construct the product, including everything up to point-of-sale packaging. It ensures that all supporting documentation accurately represents the complete product. In addition to aiding compliance and quality assurance, the BoM serves future purposes, such as tracking packaging waste for billing. Overall, it demonstrates effective product management and control throughout the development process.

Compliance testing

Screening for ingredients/substances prohibited in the EU/UK market as a minimum.

Extended Producer Responsibility (EPR) registration requirements

Packaging Waste

Health and Safety testing

Stability, Compatibility and Microbiological testing where appropriate.

Off-Pack Copy

Supporting information that is not supplied with the product at point-of-sale, for example online support pages.

Performance testing

If you have had any performance testing done. This is recommended to save on file as it helps to confirm the quality of your product.

Product Specification:

This maps out the construction requirements, tolerances and demonstrates the quality and consistency of your product development.

Risk assessments:

Addressing foreseeable use and mis-use of the product and confirming what testing and product development is in place to engineer out any identified risks.

 

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