Product safety - biohazards

Fermentek Ltd. statement regarding Origin of Products, and BSE/TSE and Allergen relevant issues.


This statement is general and applicable to all Fermentek products and lots. The statement may be supplemented by a product-specific or lot-specific statement.

Only a special manufacturing agreement with a specific customer may overrule this statement.


  • Fermentek Product:  Well-defined, pure chemical substance manufactured by Fermentek Ltd.
  • Non-Fermentek Product:  Well-defined, pure chemical substance purchased, checked, and certified for quality by Fermentek Ltd.
  • Primary raw material: Material from which the target product is directly extracted. This includes Plant materials, Fungal or Microbial biomass.
  • Secondary raw material: Material used to prepare primary raw material by biological and/or chemical modifications, such as chemical or biochemical hydrolysis. This includes fermentation medium ingredients.
  • Safe Sources: Vendors of raw material in question who comply with European standards regarding biohazard, and are able to present relevant documentation on demand.
  • Animal source materials are primarily of concern regarding Transmissible Spongiform Encephalopathy (TSE) and viral contamination.
  • No Fermentek products directly originate from animals.
  • To the best of our knowledge, no non-Fermentek materials or raw materials used by Fermentek directly or indirectly originate in humans.
  • Any products manufactured by Fermentek Ltd. will be classified as animal component-free if no use was made in the manufacturing process of any primary raw materials derived directly from bovine or other animal tissue. This applies to all aspects of product manufacturing.

Intended Use

All products sold by Fermentek are not under any circumstances intended for any use in humans or animals, and particularly are neither drugs nor components of drugs, food or feedstuff, food additives, or any other household purposes. They are sold to be used by trained professionals for research only, or for use as raw materials in manufacturing of chemicals in properly equipped laboratories.

Non-dedicated Equipment

The equipment, facilities, and instruments used by Fermentek to manufacture its products are non-dedicated. All may come into contact with raw materials from any of the safe sources as defined above.


Allergens, BSE/TSE, biohazard information

The following raw materials are or have been used in Fermentek microbial fermentation manufacturing, or could contact generally used equipment:

Potential Allergens

Fermentek emphasizes that its products are not intended for any use in humans, and they are neither drugs, food ingredients nor additives. However, because of the growing public interest, Fermentek agrees to disclose the following information. The raw materials used to propagate the microorganisms may include ingredients such as:

  • Soybeans
  • Maize
  • Lactose
  • Milk
  • Wheat
  • Rice whole or white
  • Yeast
  • Potatoes

These materials are of human-food-grade, approved for human consumption, and have been purchased as such.

Raw materials of human source:

  • No Fermentek product directly originate in animals
  • To the best of our knowledge, no non-Fermentek materials, raw materials or reagents used by Fermentek, directly or indirectly originate in humans.

GMO, and Raw materials sourced in GMO:

  • No GMO (Genetically Modified Organisms) or materials originating in GMO, are used in Fermentek products. Raw materials such as sugar, soymeal and the like, which are used as fermentation media ingredients, are not controlled for sourcing from GMO, as long as they are intended by vendors, approved for human food consumption, and are procured as such by Fermentek.

Raw materials of animal source BSE/TSE relevant issues:

Only materials from qualified safe sources are used by Fermentek . These include:

  • Peptonized milk proteins
  • Proteins from non-animal source peptonized, using animal enzymes
  • Lard oil (not TSE/BSE relevant species)
  • Beef extract
  • Peptonized meat
  • Exceptions: Within the scope of this statement, the term “Animal source” will not include edible fishmeal, and extracts from invertebrates.