FAQ - Frequently Asked Questions - Microbiology

FAQ - Frequently Asked Questions

FAQ - Frequently Asked Questions - Microbiology

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Recommendations include e.g. mozzarella, brined cheese, raw meat, meat products, casings, fish and fish products, soft and shellfish, instant and dried products, ready meals, prepared dishes, delicatessen products, cereal products, bread, bakery and pastry goods, pasta, dried fruits, oilseeds, nuts, mixed salads, fruit salads, herbs and spices, ice cream and chocolate.

Microbiological criteria are included in several chapters of the Ph.Eur. Chapter 5.1.4 contains the acceptance criteria for non-sterile dosage forms (Table 1) as well as for raw materials used in their production (Table 2). Chapter 5.1.8 contains the acceptance criteria for herbal medicinal products for oral use.

Furthermore, many monographs of individual substances include specific acceptance criteria for microbiological quality.

Frequent detections occur, for example, in raw milk, fresh meat, spreadable raw sausage, soft cheese, leafy vegetables, and sprouts. Meat from ruminants and game is more frequently contaminated than pork.

Commonly contaminated are, for example, raw milk, raw milk cheese, semi-hard cheese, ready-to-eat sausages, pre-sliced cooked sausages, spreadable raw sausages, sliced packaged fruits or salads (ready-to-eat products), raw seafood, or smoked fish.

The detection of germs in a cosmetic product always requires special attention. Contaminated raw materials, deficiencies in manufacturing, or even contamination of packaging materials can be causes.

Regardless of the detected quantity, identification should always be carried out. Only in this way can a risk assessment be conducted based on the number of microorganisms combined with the type of germ (risk group, hazard potential). This allows the question of the product's marketability to be answered.

Additionally, within the framework of a microbiological risk management system, one obtains information about possible sources of entry with the aim of avoiding similar contaminations in the future.

The purpose of the preservation challenge test is to confirm that the cosmetic product, when used as intended, prevents microbial growth and is thus microbiologically stable. However, it should be noted that preservation challenge tests are merely models and do not guarantee 100% safety.
The execution of a preservation challenge test is required by the EU Cosmetics Regulation as part of the safety assessment (see Annex I, Point 3 of the Regulation).
Exempt from the requirement to conduct a preservation challenge test are products that meet one or more of the following conditions.

  • pH value: <3
  • pH value: >10
  • water-free products
  • alcohol content: >20%
  • filling temperature: >65°C
  • water activity: <0.75
  • solvent-based products
  • oxidizing products
  • aluminum chlorohydrate content: >25%

Other low-risk products may be identified as part of an individual risk assessment.

Certain toxin-producing strains of E.coli can cause diarrhea and more severe illnesses in humans, such as hemolytic uremic syndrome (HUS). Kidney failure and even death can result from this condition.

Listeria monocytogenes can easily overcome anatomical barriers in the body and, for example, penetrate the intestines, the blood-brain barrier, or the placenta without any problems.

For those affected by listeriosis, the disease is associated with a comparatively higher damage than with other foodborne infection pathogens (e.g., fever, muscle pain, gastrointestinal diseases, meningitis, sepsis). The mortality rate is about 10-20% for the general population and up to 75% for risk groups (pregnant women, newborns, young children, immunocompromised adults, those taking immunosuppressants or stomach acid inhibitors).

Since no minimum infectious dose can be determined for Salmonella, the absence of Salmonella is required in ready-to-eat foods. As a food safety criterion according to Annex I Chapter 1 of Regulation (EC) No. 2073/2005, the absence of Salmonella in 25g (or 10g) of food is always required. A quantitative determination is therefore not sufficiently informative for the microbiological assessment of foods.

The Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs establishes sampling frequencies and microbiological limits (process hygiene and food safety criteria). It is directed at food business operators and sets the legal minimum requirements for the microbiological quality of certain foods. These include, for example, ready-to-eat meals, carcasses, meat preparations, milk and dairy products, egg products, and cut fruit and vegetables.