Profile of Pathogenic Yersinia (e.g., Yersinia enterocolitica) 

General Information and Origin

Yersinia enterocolitica is one of the most common causes of foodborne gastrointestinal infections in Germany and the EU.
These bacteria are often found in pigs, particularly in the tonsils, lymph nodes, and intestines of pigs, but also in pets and our environment (soil, surface water).

Significance

The presence of Yersinia enterocolitica (or pathogenic Yersinia) in ready-to-eat foods is critical as they can potentially cause illnesses. In addition to typical symptoms of food infections such as diarrhea, abdominal pain, vomiting, and fever, chronic joint inflammations can also result from a yersiniosis in rare cases.
This disease is most commonly associated in Germany with the consumption of raw pork products (e.g., minced pork).
It should also be considered that some pathogenic Yersinia strains can still multiply at refrigeration temperatures of +4 °C.

Main Causes of Contaminations

• Poor slaughter hygiene
• Cross-contamination between raw and processed foods due to hygiene errors (e.g., personnel, work tools)
• Hygienic quality of raw materials
• Insufficient heating of food

Growth Conditions

• Temperature: Growth at -1.3 – 43 °C
• pH: Growth at 4.2 - 9.6
• aw-value: Growth up to min. 0.97
• Salt tolerance: max. 5%
• Oxygen requirement: Growth under aerobic and anaerobic conditions

At what temperatures do these microorganisms die?

Generally, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or by an equally effective process. In foods, it's important to note that this temperature-time combination must be reached in the core of the product to safely kill the bacteria.

Further Information and Literature

• www.rki.de: under "Infectious Diseases A-Z"
• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Pathogenic Microorganisms: Zoonoses, W. Heeschen (Behr's Verlag), 2nd edition 2012
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Manual of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Leaflet "Safely Catered – Especially Vulnerable Groups in Community Facilities," Federal Institute for Risk Assessment, Berlin 2017

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Profile of Thermotolerant Campylobacter (especially Campylobacter jejuni)

General and Origin

Thermotolerant Campylobacter or Campylobacter jejuni are the most common causes of bacterial foodborne infections in Europe.

These bacteria are particularly widespread in poultry or poultry meat. But Campylobacter spp. also occurs regularly in other animal species such as cattle, sheep, and pigs.

Significance

Thermotolerant Campylobacter or Campylobacter jejuni is a frequent cause of foodborne infections. The main causes are the consumption of insufficiently heated poultry meat, the consumption of raw milk, and cross-contamination between raw and ready-to-eat foods.

The symptoms of campylobacteriosis include severe abdominal pain, watery-bloody diarrhea, vomiting, headaches, and fever.
Compared to other foodborne illnesses, such as salmonellosis, the course of campylobacteriosis is more prolonged and severe. In rare cases, complications can occur, especially diseases of the nervous system (Guillain-Barré syndrome).

Since the minimal infectious dose of Campylobacter jejuni is relatively low, even small numbers of germs can cause campylobacteriosis. It is not necessary for these germs to multiply in the food. Generally, they do not reproduce in the food, but they survive well at refrigerator temperatures and under protective atmospheres.

Main causes of contamination or illness

• insufficient heating of raw meat
• consumption of raw milk
• poor slaughter hygiene and contamination of animal raw materials (especially poultry meat)
• hygiene errors during production
• cross-contamination

Growth conditions

• Temperature: growth at 25 – 47 °C
• pH value: growth at 4.9 – 9.0
• aw value: growth down to min. 0.98
• Salt tolerance: 0.16 – 1.55%, but strongly influenced by temperature and pH value
• Oxygen requirement: microaerophilic, growth only under a reduced oxygen atmosphere

At what temperatures do these microorganisms die?

In general, it can be assumed that these bacteria are killed by heating to +72 °C for at least two minutes or by an equally effective process. In foods, it is important to ensure that this temperature-time combination is reached at the core of the product to safely kill the bacteria.

Further information

• www.rki.de: under "Infectious Diseases A-Z"
• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Pathogenic Microorganisms: Campylobacter Volume II, G. /F. Reich Behr's Verlag), 1st edition 2013
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Foods, H. Keweloh, 2nd edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Information Leaflet "Safely Catered - Particularly Vulnerable Groups in Community Facilities", Federal Institute for Risk Assessment, Berlin 2017

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Profile of "sulfite-reducing Clostridia" and "Clostridium perfringens"

General Information

Clostridia are capable of forming heat-resistant forms, known as spores. These are very heat stable and can survive heating steps. Furthermore, these bacteria can multiply under the exclusion of oxygen (strict anaerobes) and some strains can produce very dangerous toxins.

Origin

These bacteria and their spores are primarily found in soil, water, and also in the intestinal tract of humans and animals. Due to their widespread distribution, both plant and animal foods can be contaminated with these bacteria.

Importance

Many representatives of the group of sulfite-reducing Clostridia play a role as spoilage agents in foods. Also, pathogens like Clostridium perfringens and Clostridium botulinum are found in this group of bacteria.

Clostridium perfringens is significant as a cause of group illnesses in the restaurant and communal catering industries. Surviving spores germinate in the food after the cooking process and subsequently multiply if insufficiently cooled. Their toxins are triggers of food poisoning.

To prevent excessive bacterial counts, it is important to ensure that the critical temperature range between 10 °C – 65 °C is passed through as quickly as possible (max. 3 hours). Frequently affected foods include, for example, larger pieces of meat, soups or sauces in larger containers, vacuum-packed fish products and other vacuum-packed foods, cooked sausages, and improperly sterilized canned goods. Similar applies for Clostridium botulinum, which can form very dangerous toxins (neurotoxins) that cause correspondingly severe to fatal diseases.

Important Causes of Elevated Clostridia Counts

• insufficient heating or sterilization of food, or temperatures that are too low when keeping warm (warming temperatures of, for example, at least +60 °C)
• inadequate curing or smoking, e.g., of ham or fish products
• insufficient cooling or too long storage duration
• use of contaminated raw materials
• too long of a cooling phase. The critical temperature range between 10 °C and 65 °C must be passed through as quickly as possible (usually max. 3 hours)

Growth Conditions

• Temperature: Growth at 12 – 50 °C
• pH Value: Growth at 5.0 – 8.0
• aw Value: Growth up to min. 0.94
• Oxygen Requirement: strictly anaerobic

At What Temperatures Do These Microorganisms Die?

In general, it can be assumed that these bacteria are killed by heating to +72 °C for at least two minutes or by an equally effective process. In foods, it is important to ensure that this temperature-time combination is achieved at the core of the product to safely kill the bacteria.

The C. perfringens enterotoxin is relatively heat-sensitive, with its biological activity destroyed at 60 °C within 5 minutes.

Further Information and Literature

• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Foods, H. Keweloh, 2nd Edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st Edition 2007
• Pathogenic Microorganisms: Clostridium perfringens, U. Messelhäußer (Behrs Verlag), 1st Edition 2013
• Leaflet "Safely catered - Particularly vulnerable groups in community facilities", Federal Institute for Risk Assessment, Berlin 2017

Profile on “STEC / VTEC / EHEC”

General Information and Origin

Some strains of Escherichia coli, such as STEC (Shiga toxin-producing Escherichia coli), VTEC (Verotoxin-producing Escherichia coli), or EHEC (Enterohaemorrhagic Escherichia coli), can cause severe foodborne illnesses. In addition to the classic gastrointestinal symptoms of food infections and intoxications (vomiting, diarrhea, fever, …), diseases caused by EHEC strains can lead to HUS syndrome (hemolytic-uremic syndrome) resulting in kidney failure and death.

These dangerous bacteria often occur in the intestines of ruminants (especially cattle, but also, for example, sheep and goats). They can be transmitted to humans through food, as well as through direct contact, for example, in petting zoos.

Significance

The presence of these pathogenic Escherichia coli strains in ready-to-eat foods is undesirable and considered a potential health hazard. Since these infections can sometimes have severe, life-threatening consequences, including death, these pathogens are feared in food. Appropriate measures must be taken when viable STEC/VTEC is detected in ready-to-eat foods. Often, the cause of contamination with these microorganisms is fecal contamination, but due to their longer survival rate in the environment (e.g., in soil), different contamination causes must be considered situationally (see the paragraph below). In addition to raw animal products, these bacteria are also regularly detectable in raw plant foods. Affected foods include raw milk, raw beef, and raw milk cheese, as well as ready-to-eat sprouts and various mixed and leafy salads, and freshly squeezed fruit juices.

Important Causes for Elevated Bacterial Counts

• Fecal or cross-contamination during the slaughtering process
• Contamination of raw animal products, e.g., raw milk and plant-based foods
• Use of contaminated raw materials, e.g., in the production of raw milk soft cheese or mixed, ready-to-eat salads
• Hygiene errors: insufficient separation between raw and processed foods
• Lack of personal hygiene in carriers

Growth Conditions

• Temperature: Growth at 8 - 48 °C
• pH value: Growth to min. 4.0
• aw value: Growth to min. 0.95
• Oxygen requirement: facultatively anaerobic

At what temperatures do these microorganisms die?

In general, it can be assumed that these bacteria are killed at a heating temperature of +72 °C for at least two minutes or in an equally effective process. In food, it must be ensured that this temperature-time combination is reached in the core of the product to safely kill the bacteria.

Further Information and Literature

• www.rki.de: under “Infectious Diseases A-Z”
• www.lgl.bayern.de: under „Food“ and then “Hygiene”
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Food, H. Keweloh, 2nd Edition 2008
• Leaflet “Safely Catered – Particularly Sensitive Groups in Community Facilities”, Federal Institute for Risk Assessment, Berlin 2017

Profile of "Salmonella"

General Information and Origin

As a cause of gastrointestinal diseases, Salmonella plays a significant role worldwide. Common carriers of Salmonella are primarily poultry and pigs, but also reptiles.

These bacteria are usually transmitted through raw animal products, especially poultry, eggs, and pork. However, spices like paprika and pepper as well as herbs can also be contaminated with Salmonella. In most other foods, Salmonella is rarely found.

Humans excrete Salmonella during illness, but possibly also long afterward through stool. These so-called "Salmonella shedders" must not be involved in the production and distribution of perishable foods, as inadequate personal hygiene can lead to transmission to food.

Significance

Despite a significant decline in reported cases for over 20 years, Salmonella remains one of the most common causes of foodborne illnesses. In foods, Salmonella is undesirable. Ready-to-eat foods contaminated with Salmonella are considered health-threatening as these pathogens are capable of causing severe gastrointestinal infections, which can have serious consequences, especially for young children, pregnant women, the elderly, or ill individuals.

Key Causes of Contamination

• Use of contaminated raw materials (e.g., eggs, meat, spices, ...)
• insufficient heating of food
• cross-contamination between raw and processed foods due to inadequate separation between clean and unclean areas or work steps (transmission through contaminated work items, tools, hands, ...)
• poor personal hygiene of Salmonella shedders

Growth Conditions

• Temperature: Growth at 7 - 50 °C
• pH value: Growth at 4.0 – 9.0
• aw value: Growth at min. 0.94
• Oxygen requirement: facultative anaerobic

At what temperatures do these microorganisms die?

Generally, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or by an equally effective process. In food, it must be noted that this temperature-time combination must be reached at the core of the product to safely kill the bacteria.

Further Information and Literature

• www.rki.de: under "Infectious Diseases A-Z"
• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Pathogenic Microorganisms: Zoonoses, W. Heeschen, 2nd edition 2012
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Information sheet "Safely provided – Particularly sensitive groups in communal facilities", Federal Institute for Risk Assessment, Berlin 2017

Profile on “Staphylococcus aureus”

General Information and Origin

These bacteria are found in many healthy people on the mucous membranes of the nose and throat (e.g. also in nasal secretions, cough aerosols, and saliva), on the skin (especially the scalp and hair), and in stool.

However, these germs are also important food poisoning agents and, in addition to gastrointestinal diseases, cause skin and wound infections, abscesses, and urinary tract infections. Often, humans are the source of food contamination, but raw animal foods (e.g. raw milk) can also be contaminated with this pathogen.

Significance

Staphylococcus aureus can produce toxins in food, which cause severe intoxications (poisonings) in humans. Elevated bacterial counts of Staphylococcus aureus in food are therefore regarded as very critical and indicate poor sanitary conditions during production (especially personal hygiene).

An important characteristic of certain Staphylococcus aureus toxins is that they can be heat-stable and survive heating steps. Therefore, in addition to hygiene, attention must also be paid to adequate cooling temperatures to prevent the growth of the bacteria and their toxin production.

Important Causes of Elevated Bacterial Counts

• Hygiene errors during production (e.g. poor personal hygiene, contaminated work items, surfaces, and equipment, ...)
• Cross-contaminations between raw and processed foods
• Insufficient cooling
• Processing contaminated raw materials
• Inadequate heating of foods

Growth Conditions

• Temperature: Growth at 6.5 - 48 °C, Toxin formation at 10 - 45 °C
• pH value: Growth at 4.0 - 9.3, Toxin formation at min. 4.8
• aw value: Growth up to 0.86
• Salt tolerance: max. 20%
• Oxygen requirement: facultatively anaerobic; toxin production is significantly higher under aerobic growth than under anaerobic growth

At what temperatures do these microorganisms die?

In general, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or by an equally effective process. It should be noted that this temperature-time combination must be achieved in the core of the product to reliably kill the bacteria.

The toxins are very heat-stable and can only be inactivated at 100 °C after half to a full hour so that they no longer cause illness.

Further Information and Literature

• www.bfr.bund.de: under “Food Safety”
• www.lgl.bayern.de: under “Food” and then “Hygiene”
• Pathogenic microorganisms: Staphylococcus aureus, S. Johler/R. Stephan Behr’s Verlag, 1st edition 2010
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Information leaflet “Safely Fed – Particularly Sensitive Groups in Community Facilities”, Federal Institute for Risk Assessment, Berlin 2017

Growth Conditions

• Temperature: Growth at 6.5 - 48 °C, Toxin formation at 10 - 45 °C
• pH value: Growth at 4.0 - 9.3, Toxin formation at min. 4.8
• aw value: Growth up to 0.86
• Salt tolerance: max. 20%
• Oxygen requirement: facultatively anaerobic; toxin production is significantly higher under aerobic growth than under anaerobic growth

At what temperatures do these microorganisms die?

In general, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or by an equally effective process. It should be noted that this temperature-time combination must be achieved in the core of the product to reliably kill the bacteria.

The toxins are very heat-stable and can only be inactivated at 100 °C after half to a full hour so that they no longer cause illness.

Further Information and Literature

• www.bfr.bund.de: under “Food Safety”
• www.lgl.bayern.de: under “Food” and then “Hygiene”
• Pathogenic microorganisms: Staphylococcus aureus, S. Johler/R. Stephan Behr’s Verlag, 1st edition 2010
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Information leaflet “Safely Fed – Particularly Sensitive Groups in Community Facilities”, Federal Institute for Risk Assessment, Berlin 2017

Profile on "Mold"

General Information and Origin

Molds are widespread in our environment (soil, plants, air, water, humans...) and are therefore found in many foods.

In plant-based foods such as cereal products, nuts, herbs, spices, vegetables, and fruits, molds also regularly occur in excessive amounts. Dried animal-based foods such as raw cured products can also be affected by spoilage caused by molds.

Significance

Depending on the food group, a certain number of molds is tolerated in most foods. However, if these values are exceeded, it indicates potential spoilage of the food. Unlike most bacteria, many molds have the special ability to grow even at low moisture contents and/or low pH values.

Certain molds can also pose a health risk to consumers, as they can produce highly toxic mycotoxins (e.g., aflatoxins, ochratoxins, fusarium toxins, patulin, ...). Moldy raw and intermediate products should no longer be processed since the toxins are partially very resistant (e.g., heat-resistant) and can withstand processing.

Important Causes for an Excessive Number

• Processing of contaminated raw materials
• Improper storage (excessive humidity or temperatures, too long storage duration…)
• High number of molds in the ambient air (storage, production site)
• Inadequate production hygiene

Growth Conditions

• Temperature: Growth at 0 – 60 °C
• pH Value: Growth at 3.0 – 7.0
• aw Value: Growth up to min. 0.62 – 0.85
• Oxygen Requirement: Aerobic; under anaerobic conditions, some molds can ferment, but growth is generally inhibited after a short time

At What Temperatures Do These Microorganisms Die?

Generally, it can be assumed that most molds are killed when heated to +72 °C for at least two minutes or during an equally effective process. In foods, it is important to ensure that this temperature-time combination is reached at the product's core to safely kill the bacteria.

However, it should be noted that there are also highly heat-resistant strains among molds that can survive the aforementioned temperature-time combination.

Further Information and Literature

• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Information Sheet "Safely Catered – Particularly Vulnerable Groups in Community Facilities", Federal Institute for Risk Assessment, Berlin 2017
• Microorganisms in Food, H. Keweloh, 2nd Edition 2008

Profile on "Pseudomonads"

General Information and Origin

Pseudomonads are widespread in our environment (soil, water, and on plants and animals). Therefore, they are also found in many food products such as fresh meat, fish, raw milk, as well as fruits and vegetables.

Importance

In foods with high water content such as fresh meat, fish, cream, chopped vegetables... Pseudomonads play an especially important role as potential spoilage organisms. Elevated counts of pseudomonads can have various causes (see below), but often errors in hygiene and/or storage are of crucial importance.

In dry and/or vacuum-packed foods, their significance as spoilage organisms is much less relevant because they require a lot of water and usually also oxygen to grow.

In water hygiene, Pseudomonas aeruginosa plays an important role as an indicator organism. The presence of Pseudomonas aeruginosa in drinking and mineral water, as well as in bathing water, is undesirable, as it indicates further contamination and biofilms on one hand, and on the other hand is a feared pathogen for, e.g., wound and urinary tract infections in medical facilities and hospitals.

Important Causes for Elevated Numbers

• Hygiene errors during production (e.g. contaminated work items, surfaces, and equipment, insufficient personal hygiene...)
• Processing of contaminated raw materials
• Cross-contamination between raw and processed foods
• Errors in storage (elevated temperatures, too long storage duration...)
• Insufficient heating of food

Growth Conditions

• Temperature: Growth at 0 - 41 °C
• pH-value: Growth at min. 5.0
• Water activity (aw-value): Growth down to min. 0.95
• Oxygen requirement: obligate aerobic

At what temperatures do these microorganisms die?

Generally, it can be assumed that these bacteria are killed when heated to +72 °C for at least two minutes or through any equally effective process. It should be noted in foods that this temperature-time combination must be reached at the core of the product to safely kill the bacteria.

Further Information and Literature

• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Food Microbiology, J. Krämer and A. Prange, 7th edition 2017
• Microorganisms in Food, H. Keweloh, 2nd edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st edition 2007
• Information Leaflet "Safely Catered – Especially Vulnerable Groups in Community Institutions," Federal Institute for Risk Assessment, Berlin 2017

Profile of "Presumptive Bacillus cereus"

General Information

Presumptive Bacillus cereus are capable of forming heat-resistant forms, known as spores. These are very heat-stable and can withstand heating processes. Furthermore, these bacteria are sometimes able to produce heat-stable toxins that are very resistant and can cause poisoning with vomiting and/or diarrhea.

Origin

These bacteria or their spores are widespread in our environment. They are found in soil, dust, water, animals, and humans. Therefore, practically all raw plant and animal foods can be contaminated with this germ.

Significance

Spores often germinate in food after the cooking process and multiply there if cooling is inadequate. To prevent excessive germ counts, it is therefore important that the critical temperature range between 10°C - 65°C is passed through as quickly as possible.

Particular caution is advised when cooling large portions! Foods that play an especially important role in this disease are cooked rice, pasta, sauces, spices, dairy products, salads/vegetables, herbs, and desserts.

A special significance is attributed to these bacteria as the cause of group diseases in communal catering. Therefore, these bacteria play a significant role as food poisoners in communal catering and gastronomy.

Important Causes of Excessive Germ Counts

• too low temperatures when keeping warm (generally, warming temperatures of > +60°C are required)
• cooling phase too long. The critical temperature range between 10°C and 65°C must be passed through as quickly as possible (generally max. 3 h)
• insufficient cooling and/or overstocking of foods (exceeding the shelf life)
• microbially contaminated raw materials e.g., herbs, spices,…

Growth Conditions

• Temperature: Growth at 4 - 50°C, toxin production at 37 - 42°C
• pH-value: Growth at 4.3 – 10.5, toxin production up to max. 10.0
• aw-value: Growth up to min. 0.92 – 0.95
• Salt tolerance: 0.5 – 9 %
• Oxygen requirement: facultative anaerobic, preferably aerobic

At What Temperatures Do These Microorganisms Die?

In general, it can be assumed that the vegetative bacteria are killed by heating to +72°C for at least two minutes or by an equally effective process. In foods, it is important to ensure that this temperature-time combination is reached in the core of the product to safely kill the bacteria.

However, foods often also contain spores of these bacteria. These are usually very heat-resistant and even survive cooking processes.

Further Information and Literature

• www.bfr.bund.de: under "Food Safety"
• www.lgl.bayern.de: under "Food" and then "Hygiene"
• Pathogenic Microorganisms: Bacillus cereus, B. Becker (Behr’s Verlag), 1st Edition 2005
• Food Microbiology, J. Krämer and A. Prange, 7th Edition 2017
• Microorganisms in Foods, H. Keweloh, 2nd Edition 2008
• Handbook of Food Hygiene, K. Fehlhaber/J. Kleer/F. Kley (Behrs Verlag), 1st Edition 2007
• Information Sheet "Safely Catered - Particularly Vulnerable Groups in Community Facilities", Federal Institute for Risk Assessment, Berlin 2017

Fact Sheet on "Bacillus spp."

General Information and Origin

• Gram-positive, mostly motile rod-shaped bacteria
• Aerobic or facultatively anaerobic growth
• Widespread in the environment, preferably in soil/dust
• Very resistant to environmental influences
• Characteristic is the formation of endospores

Significance in Cosmetics and Pharmaceuticals

Bacillus spp. are capable of forming resistant forms, known as spores. These are very heat stable and can withstand heating steps. Furthermore, these bacteria can partially produce heat-stable toxins that are very resistant and can cause poisoning with vomiting and/or diarrhea. This can lead to critical situations, especially in the food sector.

In the cosmetic or pharmaceutical sector, Bacillus spp. are generally considered uncritical because the number of vegetative cells in a contaminated product usually remains stable and multiplication throughout the products' lifecycle is rather unlikely.

The spores of Bacillus spp. often survive the production process due to their mentioned heat stability. Since they are neither considered "specified microorganisms," which should not be detectable in 1g of product, nor classic spoilage organisms in cosmetic products, germ counts below the threshold value are generally considered uncritical. The cause of contamination is often found in contaminated raw materials or insufficient equipment hygiene. As Bacillus spp. are spore-formers, equipment cleaning and disinfection are particularly crucial. If cleaning and disinfection, especially regarding the mentioned spores, are inadequate, they can remain in the system and multiply. When favorable growth conditions occur, the transition from spores to the vegetative reproductive form is possible.

Major Causes of Contaminations

• Use of contaminated raw materials (often unevenly distributed in powders)
• Environment (air, packaging, etc.)
• Insufficient cleaning and disinfection, e.g.
  • of manufacturing equipment (plants and devices)

Important Measures

• Selection of reliable raw material suppliers and microbiological examination of raw materials
• Proper cleaning and disinfection of manufacturing equipment (plants and devices)
• Cleansers and disinfectants must also be capable of removing spores
• Good operational hygiene

Interesting link: https://www.bav-institut.de/de/newsletter/Special Issue Pharmaceuticals No. 2: Assessment of Critical Microorganisms in Non-Sterile Pharmaceutical Products Part 2

Profile of Pseudomonas aeruginosa

General Information and Origin

• belong to the family of Pseudomonads
• gram-negative, motile rods
• obligate aerobe
• widespread soil and water germ
• pathogenic for humans and animals

Significance in the Cosmetic and Pharmaceutical Field

Due to its pathogenic properties (e.g. causing purulent infections), the guideline for Cosmetic Products – Microbiology – Microbiological Limits (DIN EN ISO 17516) requires that Pseudomonas aeruginosa must not be detectable in 1g of product.

An important characteristic of Pseudomonas aeruginosa is its extreme indifference to external living conditions. Pseudomonas aeruginosa can survive for long periods in both moist and dry environments. In cosmetic and pharmaceutical manufacturing plants, pseudomonads can be found anywhere where sufficient water is present (washrooms, pipelines and equipment with residual moisture, water system, etc.). They can adapt to the environment and thus resist preservation and disinfection.

A particularly critical aspect of this microorganism, besides its resilience and ability to survive under unfavorable environmental conditions, is that it is often found in biofilms. Detachment of individual parts of the biofilm, which then irregularly enter the product, makes it particularly difficult to safely and reliably detect the microorganism during the finished product release inspection.

Even with small quantities of this bacterium in the product, it is important to monitor further development, as in many cases there can be a delayed increase in germ numbers.

Important Causes of Contamination:

• insufficient cleaning and disinfection, e.g.
  • of the water treatment system
  • of the water pipe system
  • of the manufacturing equipment (plants and devices)
• poor plant design, e.g.
  • residual water in plants and pipes
  • dead spots
  • incomplete cleaning and disinfection

⇒ The consequence of poor plant design and/or errors in cleaning and disinfection is usually biofilm formation in the water system or in plant parts, especially in pipelines, seals, valves, etc.

In the form of biofilms, Pseudomonas aeruginosa is largely protected against:

• high temperatures
• pH-value fluctuations
• chemical disinfectants
• UV radiation

Important Preventive Measures

• Proper design and cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as removing an existing biofilm is usually very difficult.
• Correct cleaning and disinfection of manufacturing equipment (plants and devices)
• Good operational and personnel hygiene

For more interesting information about this microorganism, please refer to the following publications:

www.wissenschaft.de

www.ecv.de

Profile of "Pluralibacter gergoviae" (formerly Enterobacter gergoviae)

General Information and Origin

• belong to the family of Enterobacteriaceae
• gram-negative rods
• facultative anaerobes
• widely distributed in the environment, e.g., in the intestines of humans and animals, on plants, and in water
• facultatively pathogenic germs, partially with antibiotic resistances

Importance in the Cosmetics and Pharmaceutical Sector

The number of recall notifications in recent years due to Pluralibacter gergoviae in cosmetics is increasing. Affected products are often baby shampoo, baby cream, shower gel, toothpaste, etc.

In a recent statement from the BfR in 2020, it is required that all cosmetic products must be fundamentally free of P. gergoviae. This must be demonstrated through appropriate investigations.

For example, although shower gel is quickly rinsed off, contact with mucous membranes or open wounds cannot be excluded. There is thus a risk that the microorganisms could enter the bloodstream.

Pluralibacter gergoviae is known for the so-called "Phoenix effect," in which a contamination believed to be gone reappears after some time, usually in very high numbers. Pluralibacter gergoviae can adapt to preservatives, meaning it can acquire but also lose certain properties. The entry into the product usually occurs through water used as a raw material. However, poor system hygiene also plays a major role. The germ frequently occurs in biofilms.

Important Causes of Contaminations

• insufficient cleaning and disinfection, e.g.,
  • of the water treatment plant
  • of the water piping system
  • of the manufacturing equipment (systems and devices)
• poor system design, e.g.,
  • residual water in systems and pipes
  • dead spots
  • incomplete cleaning and disinfection

⇒ The consequence of inadequate system design and/or errors in cleaning and disinfection is usually biofilm formation in the water system or system parts, especially pipes, seals, valves....

In biofilms, Pluralibacter gergoviae is largely protected from:

• high temperatures
• pH value fluctuations
• chemical disinfectants
• UV radiation

Important Measures

• proper design as well as cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as the removal of an existing biofilm is usually very difficult
• correct cleaning and disinfection of the manufacturing equipment (systems and devices)
• good operational and personal hygiene

The BfR statement titled "Skin creams, make-up, and shampoos should be free of Pluralibacter gergoviae" can be found here:

www.bfr.bund.de

Escherichia coli

General Information and Origin

• belongs to the family of Enterobacteriaceae

• gram-negative, acid-forming, flagellated rods

• part of the natural intestinal flora of humans and animals

• there, producer of vitamins and part of the immune defense

• some species pathogenic toxin producers

Significance in the Cosmetic and Pharmaceutical Industry

Escherichia coli (E. coli) is one of the most well-researched microorganisms and holds significant importance in the food industry, in addition to cosmetics. It is considered a model organism for the entire family of Enterobacteriaceae. Although detection in cosmetic settings is extremely rare, its absence in 1g of product is required by DIN EN ISO 17516 (microbiological limits for cosmetic products). It serves here as an indicator for hygiene-related contamination. In preservation stress tests for cosmetics, E. coli is included as one of a total of five test organisms and as a representative of enterobacteria.

In the pharmaceutical industry, it is a lead germ for all products for oral use, whose exclusion is required in non-plant products. However, even in plant-based products, which usually have quite high microbiological limits, E. coli is relatively strictly regulated.

Important Causes of Contamination

The microorganism is multifaceted, and so are the causes for product contamination. As a natural inhabitant of plants, a possible entry path is the use of non-sterile raw materials. At the same time, as a typical intestinal resident, it can also be an indicator of poor hygiene. In this case, production water or humans are often cited as the cause.

Important Preventive Measures

The occurrence of these bacteria can be significantly reduced by appropriate hygiene measures. Due to the fact that pathogenic E. coli strains exist, which can cause severe poisoning symptoms, reduction and killing are usually indispensable (for oral intake). For cutaneous intake, E. coli plays only a very minor role.

The germ is relatively sensitive to higher temperatures. The so-called D65 value for E. coli is 0.1 minutes (reduction of the germ count by at least 90% in 0.1 minutes). Therefore, thermal treatment of a contaminated product is a suitable measure for germ reduction. Furthermore, a number of well-known disinfectants and preservatives are effective against the growth of E. coli.

The most important measure, however, remains preventing contamination through appropriate operational and personal hygiene.

Literature

www.bav-institut.de

www.bfr.bund.de

Profile of "Acetic Acid Bacteria"

General Information and Origin

• also called Acetobacteriaceae
• gram-negative rods
• oxidize ethanol to acetic acid
• tolerate low pH values
• found in foods containing sugar
• in plant raw materials (e.g., fruits)

Importance in the Cosmetics and Pharmaceutical Sector

Acetic acid bacteria lead to microbial spoilage of the product through their breakdown of ethanol to acetic acid. This usually results in less health impairment and more sensory changes. The product becomes more acidic due to the formed acetic acid, and the smell changes towards acetic acid. In the food sector, acetic acid bacteria are typical spoilage organisms that are very frequently found.

Important Causes of Contamination

Causes are often the use of raw materials contaminated with acetic acid bacteria. Another possibility is introduction from the environment, as they can be easily transported through the air from contaminated areas. However, acetic acid bacteria can also indicate weaknesses in operational hygiene. For example, they can grow in product residues in pipelines and can be flushed out at various times, contaminating further or later products.

Important Measures

One of the most important measures to prevent contamination of cosmetics with acetic acid bacteria is the appropriate selection and examination of the raw materials used. Since acetic acid bacteria grow particularly well in acidic conditions, reducing pH levels is not a suitable method of control. In contrast, thermal treatment is possible, as the microorganisms are relatively sensitive to temperature. Literature reports a decimal reduction time of 0.09 – 0.14 minutes at 60°C and 1.20 - 1.30 minutes at 54°C [1].

Examination for Acetic Acid Bacteria

To determine acetic acid bacteria, determining the total microbial count using CASO medium is often not sufficient, as they do not grow well on this universal medium. They are often found in routine testing on the medium used for yeast and mold determination, as it has a lower pH value and the incubation time is longer (acetic acid bacteria only form very small colonies that grow very slowly). If acetic acid bacteria are suspected, a targeted examination for this type of microorganism is suggested. For this, orange-fruit juice agar is used as a nutrient medium based on a method derived from the food sector.

Bibliography

[1] G. Rachon, C.J. Rice, K. Pawlowsky, C.P. Raleigh: Challenging the assumptions around the pasteurization requirements of beer spoilage bacteria, J. Inst. Brew. 2018

Profile on "Burkholderia spp."

General Information and Origin

• belong to the family Burkholderiaceae
• gram-negative motile rods
• obligately aerobic
• widely distributed in the environment, preferably in water
• facultatively pathogenic for humans, animals, and plants

Importance in the Cosmetic and Pharmaceutical Sector

Burkholderia species are found in water. They are undemanding, resilient, and survive in purified water and disinfectant solutions containing quaternary ammonium compounds, hexachlorophene, or chlorhexidine. In water-rich cosmetics and pharmaceuticals, Burkholderia can potentially multiply significantly.

A large portion of all recalls of the aforementioned products is due to Burkholderia cepacia. Affected products included baby wipes, nasal sprays, and mouth rinses. In most cases, contaminated water was identified as the main cause.

A critical aspect of this microorganism, in addition to its resilience and ability to survive unfavorable environmental conditions, is that it frequently occurs in biofilms. Detachment of individual parts of the biofilm, which then irregularly disperse into the product, makes it particularly difficult to detect the microorganism during finished product release testing.

Even if Burkholderia is detected only in small amounts, it is important to examine this contamination more closely and monitor further development, as in many cases there may be a delayed increase in germ numbers.

Major Causes of Contamination

• insufficient cleaning and disinfection, e.g.
  • of the water treatment plant
  • of the water piping system
  • of the manufacturing equipment (facilities and devices)
• poor equipment design, e.g.
  • residual water in facilities and pipes
  • dead-ends
  • incomplete cleaning and disinfection

⇒ The consequence of poor equipment design and/or errors in cleaning and disinfection is usually the formation of biofilms in the water system or in parts of the equipment, especially pipelines, seals, valves….

In biofilms, Burkholderia spp. is largely protected from:

• high temperatures
• pH fluctuations
• chemical disinfectants
• UV radiation

Important Measures

• proper design as well as cleaning and disinfection of the water system. In particular, biofilm formation must be avoided, as removing an existing biofilm is usually very difficult
• correct cleaning and disinfection of the manufacturing equipment (facilities and devices)
• good operational and personal hygiene

Interesting link: www.deutsche-apotheker-zeitung.de