Fact sheet on "Pluralibacter gergoviae (formerly Enterobacter gergoviae)"

General information
Pluralibacter gergoviae belongs to the family Enterobacteriaceae. It is of particular importance for cosmetics because it can cause infections and, at the same time, can survive and grow in water-containing cosmetics if preservation is inadequate. Detection of these bacteria can indicate insufficient hygiene measures during manufacturing, filling, or storage. The hygiene status of water used (process water, water for cleaning purposes, and water for development samples) usually plays an important role. In cosmetic products, according to BfR opinion No. 038/2020 of 07.09.2020, the absence of Pluralibacter gergoviae is required.

Characteristics

• Rod-shaped bacteria
• Gram-negative
• Oxidase-negative
• Catalase-positive

Origin / Occurrence

• Widespread in our environment (e.g., plants, soil, water, intestinal tracts of humans and animals).
• Typical entry routes into cosmetics:
  
  • Production water (e.g., due to biofilms in pipes, tanks, hoses, or stagnant water)
  • Water for cleaning purposes or cleaning solutions
  • Production equipment (hoses, pumps, agitators, filling machines)
  • Raw materials, especially water-containing ingredients or raw materials of plant origin

Significance

• Pluralibacter gergoviae plays an important role in cosmetics with a high water content, as these bacteria can cause infections, particularly in immunocompromised individuals.
• Pluralibacter gergoviae can cause problems in cosmetic products due to the so-called "phoenix effect." This effect describes delayed growth or regrowth of the bacterium in the product, which can lead to unexpected contaminations and recalls.
• In water hygiene, Pluralibacter gergoviae is important as an indicator organism and potential pathogen. Its presence in process, drinking and mineral water, as well as in bathing water, indicates contamination, biofilms, and infection risks.
• In the past, the presence of Pluralibacter gergoviae in cosmetic products has led to numerous recalls. Affected products included, for example, baby shampoo, baby cream, shower gel, and toothpaste.

Growth conditions

• Temperature:
  
  • Optimum: +25 °C to +37 °C
  • Minimum: +5 °C
  • Generally no growth above +50 °C
• pH value: Growth at pH 5.0 to 8.0.
• aw value: Growth at a water activity of at least 0.95.
• Oxygen requirement: Growth with and without oxygen (facultatively anaerobic).

Inactivation by heating

• At +72 °C for at least 2 minutes exposure time (Note: monitor core temperature).

1. Review cleaning and disinfection procedures:
   1. Hygiene plan with details on performing cleaning and disinfection, e.g., dosing, contact time, use of suitable and clean materials and cleaning cloths
2. Training of personnel regarding potential errors and corrective measures
3. Repeat cleaning and disinfection
4. Effectiveness verification through on-site inspections and follow-up testing (e.g., contact plate and swab tests)

1. Check water systems and piping for proper function and condition. Avoid water stagnation in e.g. pipes, systems, hoses, etc.
2. Regularly inspect water systems and piping microbiologically and technically (observe maintenance intervals)
3. In case of contamination of water systems, act immediately and implement measures. If necessary, involve specialized companies
4. Effectiveness verification through regular follow-up testing

1. Inspect incoming goods for e.g. shelf life, packaging, deviations or microbiological anomalies
2. This also applies to materials before their use in production. Do not use raw materials if contamination is suspected
3. Check microbiological specifications. If necessary, arrange laboratory testing of suspicious products or request results from the supplier
4. Effectiveness verification through follow-up testing

1. Ensure compliance with the formulation
2. Possibly perform a preservative efficacy test (challenge test)
3. Adjust preservative system if necessary
4. Verify effectiveness by repeating the preservative efficacy test

1. Review and document production processes
2. Train personnel
3. Effectiveness verification through regular microbiological product testing

1. Review work organization in the facility
   1. Separate work areas, equipment, and utensils
   2. Separation of "clean" and "unclean" areas and activities
2. Training of personnel regarding potential errors and corrective measures
3. Effectiveness verification through on-site inspections and follow-up testing