The new Information sheet 85 on microbiological criteria for foodstuffs

As from 20 September 2021, the new NVWA (‘Netherlands Food and Consumer Product Safety Authority’) Information sheet 85 entered into force. In this Information sheet, NVWA provides an explanation of a number of texts from Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (hereinafter: 'the Regulation'). This blog discusses the most important changes.

What is the (legal) status of Information sheet 85?

Information sheet 85 has no legal status, but serves as a guideline. The text of the Regulation is always guiding. It (only) contains an explanation of how the NVWA interprets certain texts from the Regulation. In discussions with the NVWA, it is important to always refer to the consolidated version of the Regulation and the appendices (including the footnotes in which a further explanation is often provided!) and, if it specifically concerns the control of Listeria monocytogenes (Lm), to take the two Technical Guidance Documents[1] as a starting point.

In addition, a new version of the Technical Guidance Document on challenge tests and durability studies for assessing shelf-life of ready-to-eat foods related to Listeria monocytogenes was published on the 1st of July 2021.[2] This new Technical Guidance Document entails many changes: for example, the temperature with which to calculate in the shelf-life studies in the consumer phase was reduced from 12 to 10 degrees (in the Netherlands this is 9 degrees: the difference is now only 1 degree).

However, the new Information sheet 85 still refers to the old Technical Guidance Document. The new version is not fully included. It is also important to look carefully at the definitions of, for example, the terms “placing on the market”[3], “ready-to-eat”[4], “batch”[5], etc. in the Regulation (and the basic regulation: the General Food Law Regulation, Regulation (EC) No 178/2002). In practice, we notice that the NVWA often has a different (broader or narrower) interpretation than that which, strictly speaking, follows from the text of European regulations.

Listeria limit and discussions in practice

With regard to chapter 6 of Information sheet 85, we note the following. The Regulation sets a standard for the presence of Lm in ready-to-eat food. In ready-to-eat food, such as carpaccio or cold smoked salmon, in which Lm can grow, two criteria have been formulated in Annex I, food category 1.2 of the Regulation. A product may be placed on the market if one of the two criteria is met:

• The first criterion is that the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that its product will not exceed the limit 100 cfu/g throughout the shelf-life. The Technical Guidance Document explains how these studies can be carried out.
• The second criterion, if the company cannot demonstrate to the satisfaction of the authorities through shelf life studies (the first criterion) that Lm does not exceed the limit within the shelf-life, requires that the company monitors the absence of Lm by batch sampling. Lm should not be found in any of the 25g samples (in five samples according to the diagram n=5, c=0) before the products have left the direct control of the food producer. This criterion is called positive release. In that case, Lm may not be present in five samples of 25 grams each that are taken immediately after the production of the batch in question. This is an alternative requirement and only applies if the producer has not met the first criterion.

Chapter 6 of Information sheet 85 also includes a decision tree where this subject is explained in a simplified manner by the NVWA. The NVWA also explains what its supervision consists of in this context. In that explanation it is striking that the following is stated with regard to the positive release test: “The basic principle is that every batch must be tested. At the same time, the company should immediately start carrying out the necessary studies to substantiate the control of L. monocytogenes. If L. monocytogenes is found, the batch in question must be withdrawn from the market and reported to the NVWA. This situation is temporary until there is an accepted study.” (underlining added). However, this criterion (positive release) applies if a product is not yet on the market.

In practice we see that regular discussions take place about the interpretation and implementation of the above criteria. The NVWA sometimes sends a warning (waarschuwing) to companies that, in its opinion, do not meet the first criterion. That warning states, for example, that due to the lack of sufficient studies, not the first criterion, but the second criterion should be applied. In addition, additional studies in accordance with Annex II of the Regulation must be performed to demonstrate that the product will still comply with the limit of 100 cfu/gr during the shelf-life. However, there is not always a basis for the latter. The latter also applies to the obligation to perform challenge tests. It is therefore advisable to respond to a warning from the NVWA and to see whether the NVWA is right.

Main changes for practice

The most striking changes of the new Information sheet 85 are:

• Page 14: samples for sampling schedule process hygiene criteria are included
• Pages 14-15: text and reference for sampling frequency for process hygiene criteria at small and medium sized red meat slaughterhouses
• Page 24: additional explanation about the use of growth predictive models (including an example of determining critical parameters)
• Page 26 ff.: additional explanation of the interpretation of the results of a challenge test
• Page 27 ff.: adjustment of temperature profile for carrying out an additional study (this must therefore be done according to the new Technical Guidance Document!)
• Page 29-30: additional explanation of the relationship between the start of infection/intermediate limit and maximum growth potential

According to the NVWA, the new version of Information sheet 85 mainly clarifies existing interpretations. More substantive changes will follow, but a consultation round will first be held. In particular, the new Technical Guidance Document will be taken into account. Compared to the 2017 version, this new version (just like the 2019 version) already contains improvements, for example with regard to the explanation of the management of the Listeria risk.

If you have any questions about the Regulation, related regulations or Information sheet 85 or if you would like advice about your position in dealings with the NVWA, we will be happy to assist you.