Determining shelf life: how do you substantiate the date on your food product?

Who determines the shelf life of a food?

The shelf life of a food is determined by the food business operator that places the product on the market. Regulation (EU) No 1169/2011 makes the date of minimum durability or the 'use by' date a mandatory particular (Art. 9(1)(f)). Article 24 and Annex X of the same regulation describe how that date must be indicated.

You must be able to substantiate which date you choose and how long the shelf life is. During an inspection or audit, it is therefore not only the label that is checked, but also the data on which the date is based.

'Use by' or 'best before'?

The first choice is the type of date. A 'use by' date is intended for foods that are highly perishable from a microbiological point of view and may pose a danger after a short period. For all other products, a date of minimum durability ('best before') is sufficient, which mainly concerns quality.

In 2020, EFSA published scientific guidance with a decision tree that helps food businesses choose the right type of date on the basis of risk (EFSA Journal 2020;18(12):6306). You can read more about the difference between the two dates in our article 'Use by' or 'best before'?

What does Regulation (EC) No 2073/2005 require?

Regulation (EC) No 2073/2005 on microbiological criteria requires producers to conduct studies, as appropriate, to investigate whether their product complies with the criteria throughout its shelf life (Art. 3(2)). This applies in particular to ready-to-eat foods able to support the growth of Listeria monocytogenes.

Annex II of that regulation lists what such a study includes:

• specifications for the physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of preservatives and the type of packaging, taking into account the storage and processing conditions, the possibilities for contamination and the foreseen shelf life;
• consultation of available scientific literature and research data regarding the growth and survival characteristics of the micro-organisms of concern.

Where necessary, the producer supplements this with additional studies: predictive mathematical modelling (predictive microbiology), challenge tests in which the product is deliberately inoculated with the micro-organism of concern, and durability studies in which naturally occurring contamination is monitored during storage.

Listeria: stricter rules since 1 July 2026

Since 1 July 2026, Regulation (EU) 2024/2895 has applied, amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes. For ready-to-eat foods able to support the growth of Listeria, the criterion "not detected in 25 g" now applies throughout the entire shelf life, unless the producer can demonstrate to the satisfaction of the competent authority that the level of 100 cfu/g will not be exceeded during the shelf life. A well-substantiated shelf-life study therefore becomes even more important. Read more in our article Listeria: from 1 July 2026, zero becomes the norm.

For carrying out challenge tests and durability studies with Listeria, the technical guidance document of the EU Reference Laboratory for Listeria monocytogenes (EURL Lm Technical Guidance Document, version 4, approved on 1 July 2021) is the reference document. That version is aligned with standard EN ISO 20976-1:2019 on challenge tests.

Setting up a shelf-life study: the key steps

1. Describe the product and process. Record the recipe, physico-chemical characteristics, packaging (for example a protective atmosphere) and the process steps that determine the microbiological status.
2. Determine the relevant hazards and quality parameters. Which pathogens and spoilage organisms are realistic? Which sensory or chemical changes, such as oxidation, drying out or loss of colour, limit the quality?
3. Choose realistic storage conditions. Take into account reasonably foreseeable conditions in the chain, including at the consumer, because not every fridge is at the ideal temperature. Read more in our article on the cold chain.
4. Choose the right method. Combine literature and historical data with, where necessary, predictive models, challenge tests or durability studies.
5. Plan sampling points and a safety margin. Analyse at several points in time, up to beyond the intended shelf life, and take into account the variation between production batches.
6. Document and link to your HACCP plan. Record the conclusion and the justification, so that you can present them during an inspection or audit.
7. Revalidate after changes. A new recipe, a different supplier, a different packaging material or an adjusted process can affect shelf life.

Common mistakes in practice

• Copying the shelf life of a similar product or a competitor without your own substantiation.
• Testing only at the ideal storage temperature, while the actual chain is warmer.
• Examining only one production batch.
• Looking only at microbiology and forgetting sensory quality (or vice versa).
• Not repeating the study after a change in recipe, process or packaging.
• Keeping the original date when unpacking and reprocessing products. In its circular on shelf-life dates (version of 20/01/2023), the FASFC clarifies that a new shelf-life study is needed when processing extends the shelf life.

How AMNorman helps you

Our experts help you to substantiate the shelf life of your products scientifically: from choosing the type of date and drawing up a study protocol to interpreting the lab results and linking them to your risk analysis and HACCP plan. When developing new products, we include shelf life from the start through our support in product development, and with our lab support we help you plan and follow up analyses. Finally, through our label control we check whether the date indication on your label is correct.

Please note: always check the provisions mentioned against the consolidated version on EUR-Lex and the current guidelines of the FASFC.