Fact sheet on Burkholderia sp.

General information
Bacteria belonging to the Burkholderia cepacia complex play an important role in cosmetics. They can especially grow in water-containing products if preservation is insufficient. Detection of these bacteria can indicate inadequate hygiene during manufacturing, filling or storage. The hygiene status of the water used (process water, water for cleaning purposes, and water for development samples) typically plays an important role. For cosmetic preparations, according to the DGK position statement of 01.08.2020, the absence of Burkholderia cepacia and Burkholderia cenocepacia is required.

Characteristics

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

Source / Occurrence

• Widespread in our environment (preferentially found in water)
• 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, mixers, filling machines)
  • Raw materials, especially water-containing ingredients or raw materials of plant origin

Significance

• Burkholderia species are found in water. They are undemanding, resilient and can potentially survive and even multiply in Aqua purificata; mouthwash and disinfectant solutions that contain quaternary ammonium compounds or chlorhexidine.
• Burkholderia spp. play an important role particularly in water-rich cosmetics, as these bacteria can act as pathogens, for example in wound infections.
• In water hygiene, Burkholderia serves an important function as an indicator organism. Its presence in process water, drinking and mineral water, as well as in bathing water, indicates contamination and biofilms.
• Burkholderia can cause problems in cosmetic products due to the so-called "phoenix effect". This effect describes delayed or recurring growth of the bacterium in the product, which can lead to unexpected contaminations and recalls.
• There have been repeated recalls of cosmetics in the past due to contamination with members of the Burkholderia cepacia complex. Affected products included, for example, baby shampoo, baby cream, shower gel and toothpaste.

Conditions for growth

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

Inactivation by heat

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

1. Check the performance of cleaning and disinfection:
   1. Hygiene plan with details on cleaning and disinfection procedures, e.g., dosing, contact time, use of suitable and clean materials and cleaning cloths
2. Train employees regarding potential errors and corrective measures
3. Repeat cleaning and disinfection
4. Verification of effectiveness by
5. On-site inspections and follow-up tests (e.g., contact plate and swab examinations)

1. Check water systems and piping for correct function and condition. Avoid stagnation of water in e.g., pipes, systems, hoses...
2. Regularly check water systems and piping microbiologically and technically (observe maintenance intervals)
3. In case of contamination of water systems, react immediately and initiate measures. Involve specialist companies as needed
4. Verification of effectiveness by regular follow-up tests

1. Check incoming goods for e.g., shelf life, packaging, deviations or microbiological abnormalities
2. This also applies to the material before use in production. Do not use raw materials in case of suspicion
3. Check microbiological specifications. Possibly arrange laboratory testing of suspicious products or request results from the supplier
4. Verification of effectiveness by follow-up tests

1. Ensure compliance with the formulation
2. Possibly perform a preservative efficacy test (challenge test)
3. Possibly adjust the preservation system
4. Verification of effectiveness by a repeat preservative efficacy test

1. Check and document production processes
2. Train personnel
3. Verification of effectiveness by regular microbiological product testing

1. Check work organization in the facility
   1. Separate work areas, equipment and items
   2. Separation of "clean" and "unclean" areas and activities
2. Train employees regarding potential errors and corrective measures
3. Verification of effectiveness by on-site inspections and follow-up tests