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Private label

What a private label regulatory file should contain before you ship

Artwork is the easy part. The file behind it (claims substantiation, allergen assessment, nutrition panels per market) is what gets a product detained.

Published
19 November 2025
Reading time
3 min
Topic
Private label

01 / Briefing

A private label programme fails at the artwork stage far less often than it fails at the file stage. The label looks right, the product is right, and then a regulator asks for the substantiation behind a claim on the front of the pack.

The seven components of a complete file

  1. Product specification: the formulation, the process, the critical quality attributes and the acceptance criteria. This is the document the factory works to and the one the inspector tests against.
  2. Claims substantiation: for every claim on the pack, the evidence supporting it. “High in fibre” needs a nutritional analysis. “Natural” has a legal definition in most markets. “Detoxifying” has a regulatory definition in some and a problem in others.
  3. Allergen assessment: the ingredients that are allergens in the destination market, the cross-contact risk from the line, and the controls in place. This requires knowledge of what else runs on the line, not just your product.
  4. Nutrition panel: calculated per 100 g and per serving, in the format the destination market requires, using your own portion sizes.
  5. Market compliance statement: the named regulatory framework, the applicable standard or regulation number, and the responsible person or local representative where required.
  6. Batch coding and traceability record: the coding scheme, how a batch is traced back to production, and how a recall would be executed.
  7. Approved reference sample: a sealed sample retained by you, by us and by the factory, used as the arbiter when a question arises.

Sequencing matters

The order is not administrative. Artwork is produced after the specification and before the pilot run, because the pilot run proves the claims. The nutrition panel comes from a laboratory analysis of the pilot batch, not from a spreadsheet.

Get this sequence wrong and you will produce a label that does not match the product.

Who owns what

You own the trademark, the formulation and the artwork. We do not retain any of it, and it is covered by mutual non-disclosure from the point of disclosure. We produce the artwork, manage the print relationship, run the pilot, and assemble the file.

What we will not do

We will not put a claim on a pack that we cannot substantiate, and we will not ship a product to a market whose file we cannot complete. If that means declining a label, we will tell you why and propose an alternative claim that will survive an audit.

If you are building a private label programme and want the file template for your market, send us the target market and the product category and we will send the template back.

Private label Labelling Regulatory

Applying this to an order

If the point in this briefing affects a shipment you are planning, send the product, quantity and destination port. We will tell you how it applies to that order.