Product safety - biohazards.

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

Scope

This statement is general and applicable to all Fermentek products and all lots of these. This statement may be supplemented by a product specific, lot specific statement.

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

Definitions

  •  Fermentek Product:  Well-defined, pure chemical substance  manufactured  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 had demonstrated that they fulfil the requirements listed in the European guidance EMEA / 410 / 01 rev. 2 Oct. 2003, as per specific lot of a specific raw material.

Policy

  •  Animal source materials are primarily a concern with regard to Transmissible Spongiform Encephalopathy (TSE) and viral contamination.
  •  No products of Fermentek are directly originated in animals.
  •  No raw materials used by Fermentek are directly or indirectly originated 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 tissues. This applies to all aspects of product manufacturing.

Intended use

Fermentek products which are sold from stock are explicitly intended for use only by trained professionals, not as a drug, not for household purposes.

Non-dedicated equipment

The Equipment, Facilities and Instruments used by Fermentek to manufacture its products are not dedicated. All Equipment, Facilities and Instruments could come in contact with raw materials from safe Sources as defined above.

Allergens, BSE/TSE, biohazard information

The following raw-materials of interest are or were used in Fermentek in manufacturing ( by the method of microbial fermentation) of some of its products,  or could otherwise come  in contact with the generally used equipment:

Potential allergens

The Labelling Directive (Directive 2000/13/EC) and its later amendments is the only piece of EU legislation that specifically refers to allergenic foods. The Labelling Directive requires manufacturers to declare all ingredients present in pre-packaged foods sold in the EU with very few exceptions. This directive has been amended a number of times with regard to allergens. The two most important amendments are:

  • Directive 2003/89/EC introduced Annex IIIa, which is a list of allergenic foods that must always be labelled when present in a product.
  • Directive 2007/68/EC has the most recent amendment of Annex IIIa. It lists all the allergenic foods that must be labelled as well as a few products derived from these foods for which allergen labelling is not required.

The European Food Safety Authority (EFSA) web site also provides information on food allergen labelling in Europe.  The scientific panel responsible for food allergies has for example provided a number of opinions as the scientific basis for the labelling legislation and exemptions from it.

Fermentek  emphasizes that its products are not intended for any use in humans, and they are neither drugs nor food ingredients or 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 :

  • Soy-bean
  • 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 raw materials or reagents sourced in humans whatsoever are used in Fermentek.

GMO, and  Raw materials sourced in GMO

No GMO (Genetically modified organisms) and materials originated in GMO, are used in Fermentek for whatever purpose. Raw-materials such as sugar, soy-meal and the like, which are used as fermentation media ingredients, are not controlled as for being or not being sourced in GMO, as long as they are intended by vendors and approved for human consumption as food, and  are procured as such by Fermentek.

Raw materials of animal source BSE/TSE relevant issues

Only materials from safe-source are used in Fermentek. These include:

  •  Peptonized milk proteins (from safe source)
  •  Proteins from non-animal source peptonized using animal enzymes (from safe source)
  •  Lard oil (not TSE/BSE relevant species)
  •  Beef extract (from safe source)
  •  Peptonized meat (from safe source)

ExceptionsWithin the scope of this document, the term “Animal source” will not include edible fish-meal, and extracts from invertebrates.