Batch sample requirements in food production
By Doralise Halepis and John Thisgaard (FoodLegal Consultants)
© Lawmedia Pty Ltd, August, 2017
Retaining production samples is important from a food safety regulatory and quality assurance perspective in food supply and production. Moreover, confusion often surrounds standard procedures and the quantity of samples needed. This article addresses the importance of sample retention and the relevant obligations and considerations
The importance of retention samples
Retention samples are vital in establishing and validating shelf-life, microbial assessment and conducting sensory testing. Customer complaints and rejection of stock are common occurrences in the food industry, and occasionally, more serious events such as a product recall can have major detrimental consequences. When such issues arise, the retained samples are a particularly important reference point. In some instances, the analysis and testing of the retention samples can be the determining factor in whether or not a product recall is to be made.
Standard 3.2.2 of the Australia New Zealand Food Standards Code (ANZFSC) requires food businesses to have a food recall plan in place in the event of a food-safety non-compliance. As part of the food recall plan, businesses have the option to test differing batches of retention samples to determine if the hazard has been detected in all, or some samples. If the particular problem can be identified, traced and isolated to be limited to certain batches, significant financial loss and product unavailability might be circumvented.
An additional legal requirement for food businesses is the documentation of appropriate food safety records in accordance with the relevant Food Act of the State or Territory or other relevant industry regulatory regime. Adhering to these requirements allows a food supplier to account for total number of contaminated products that have been distributed, including their location. Food safety records are discussed in further detail in a previous FoodLegal Bulletin article. “Determining the appropriate length of time for food companies to retain food safety records” (March 2016).
Requirements for retaining batch samples
Australia’s regulators have not developed a set of consistent requirements directly regarding retention samples. However, a number of retention sample processes can be located in guidance documents by regulators other laws and distributor requirements prescribed by major retail groups for their suppliers of by contractual obligation.
The New South Wales Food Authority (NSWFA) makes reference to retention samples in its shelf-life document, stating “quality assurance test results on retention samples stored for the product’s shelf life at realistic temperatures should verify the shelf life claims”.
UK useful protocols
Major differences exist amongst food types accounting for difficulty in establishing standardised protocol because of variation in food composition between categories. In the UK, the Food Standards Agency (FSA) Practical sampling guidance for food standards and feeding stuffs was developed under the UK Food Safety Act 1990, and provides the following guidelines:
i) the sample should represent the food as sold to the consumer and
each part of a divided sample should be truly representative of the
ii) where divided, all parts of the sample must individually be
representative of the food and of each other
iii) the sampling process must not alter the sample in any way that might
affect the analysis
iv) storage and transportation of the sample must not alter it in any
significant way – whether through contamination, loss, deterioration or
Whilst this document does not specify the amounts and numbers of samples that are required for retention, it identifies that the amount of sample required for analysis will differ between different food categories. It also states that “The quantity will vary according to the product and the type of analysis to be carried out. The Public Analyst should be consulted in case of doubt”. Food businesses are therefore encouraged to contact authorities regarding retention sample guidance where necessary.
Supermarket contractual supplier obligations
Many food businesses supply to major supermarkets in Australia and are subject to their internal requirements; for instance, Woolworths requests compliance with its quality assurance standards from all manufacturers of Woolworths branded food and fresh produce items. The Woolworths Quality Assurance (WQA) Standard addresses the requirements of retention samples in clause 15.4 where it states:
Retention samples shall be retained for the entirety of the shelf life of the product (plus an additional time period proportioned to the shelf life of the product) under the recommended storage conditions. For example 10 day product should be kept for 12 days; 12 month product should be kept for 13 months.
For all Woolworths branded products, a minimum of 3 samples per batch, production day or date code shall be retained, whichever is the smaller quantity of production. This generally equates to one for the Vendor, one for Woolworths and one for any regulatory investigations.
These standards outlined by Woolworths are reflective of requirements should any food safety concerns arise. They do not account for shelf-life testing, sensory testing or any other additional requirements.
How other laws apply to retention samples
Ultimately it is up to the food business to determine their retention sample needs; bearing in mind samples are often subject to multiple regulatory schemes.
Use of samples in establishing use-by and best-before dates
Standard 1.2.5 of the FSC states that “food for sale must be date marked on labels” and is a requirement of all food businesses by law. The CSIRO recognises that it is the responsibility of the food manufacturer/packer to establish the use-by and best-before dates. The establishment of these dates relies heavily upon the storage of retention samples. Monitoring samples for microbial growth as well as mapping deterioration of sensory attributes over an extended period of time allows the food manufacturers to date products appropriately within safety and quality parameters. The NSFWA references the importance of challenge tests in establishing accurate best before and use-by dates in shelf life studies. Whilst it is ideal for challenge tests to be conducted, they require a substantial amount of samples to be stored. It is often more feasible for smaller food manufacturers to conduct accelerated shelf-life studies, as it requires less retention samples to be stored. Shelf life protocol methods are addressed in greater detail in a December, 2010 FoodLegal Bulletin article.
Treatment of samples by food safety regulators
Samples taken by food safety officers are subject to treatment under law. Section 71 of the NSW Food Act dictates certain procedures to be followed by both the food business and food safety officer when samples are requested by authorities. For instance, Section 71(2a) states:
An authorised officer who obtains a sample of food for the purposes of analysis must (unless subsection (3) applies) divide the sample into 3 separate parts and mark and seal or fasten each part in such manner as its nature will permit.
One part is to be left with the proprietor of the food business, one part is to be submitted for analysis, and one part is to be retained for future comparison. If dividing a sample into three parts is impracticable, the authorised officer may take as many samples as they consider necessary to enable an accurate analysis to be carried out.
A more detailed system is in place in the UK and is outlined in the FSA’s Food Standards Sampling document. This document lists the protocols in all circumstances of requests for formal samples to ensure they are representative of the manufactured product.
Other considerations in retaining batch samples
Types of testing
Microbial tests, shelf-life validation tests and sensory tests are some tests that must be carried out by food businesses to develop safe, quality products. The cost of retaining samples in the appropriate environment and the resources required to perform these tests will largely determine retention numbers of samples.
Length of retention
It is recommended to retain samples throughout their life cycles to monitor changes in product quality over time. Observation of sensory attributes is an important development step, as deterioration in taste, visual appearance etc., are important in developing best-before dates and consumer acceptance of products throughout the shelf life of the product.
Number of samples
Retention sample numbers will largely be dependent on the food business capability to store products in a suitable environment, combined with the appropriate amount of tests required to be carried out.
Number of batches
When daily production consists of multiple batches, it is of use to retain samples from each batch rather than daily samples. The ability to isolate problematic batches will ensure minimal profit loss if a certain batch is not fit to be sold/in the event of a recall.
This is general information rather than legal advice and is current as of 10 Aug 2017. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.