BSE / TSE Certification

Prion-Induced Diseases: Strong Public Concern

Transmissible Spongiform Encephalopathies (TSE)
Bovine Spongiform Encephalopathy (BSE)

TSE includes BSE, the bovine form occurring in cows (mad-cow-disease), the scrapie disease in sheep, as well as the human form: the variant-Creutzfeldt-Jakob-Disease (vCJD).

In order to minimize the alimentary and iatrogenic contamination-risk, material with a potential risk of BSE/TSE-infectivity must be eliminated from the human and animal food-chain. Thus, the nature of a substance - synthetic, mineral, vegetable or animal – has to be fully taken into account. Where animal derived material is concerned, careful attention is paid to its origin (animal species, region or country) and inactivating treatment (temperature, pH-value).

Food Industry

Certificates can be ordered for a broad range of products, both for production purposes as well as for laboratory use. They inform about the origin and, where applicable, the animal species, the type of tissue, the country of origin as well as the inactivating treatment.

Raw Materials

Merck has taken all known measures outlined by the note for guidance EMEA/410/01 Rev. 02, classifying tissues by their potential risk of TSE infection. Thus, it is ensured that raw materials for the production of food and pharmaceuticals supplied by Merck are manufactured from ingredients with a low risk of BSE / TSE. These raw materials can be identified by the declaration of the respective pharmacopoeias, the brand Emprove®, the E-Number or the FCC.

Dry Culture Media

The complete range of Merck's dry culture media has been manufactured from low-infectivity category peptones, enzymes, amino acids, bile salts, sugars and other additives. All relevant bovine ingredients used originate from the BSE "low risk" countries, e.g. Australia, New Zealand and South America.

Laboratory Applications

In order to minimize the risk of exposure to BSE/TSE in laboratories, Merck has developed granulated culture media. They minimize the formation of dust and reduce the spread of powder, thus reducing the risk of inhalation or lab contamination.

Pharmaceutial Industry

Certificates can be ordered for a broad range of products, both for production purposes as well as for laboratory use. They inform about the origin and, where applicable, the animal species, the type of tissue, the country of origin as well as the inactivating treatment.

Raw Materials

Merck takes all known measures outlined by the note for guidance EMEA/410/01 Rev. 02, classifying tissues by their potential risk of TSE infection. Thus, it is ensured that raw materials for the production of food and pharmaceuticals supplied by Merck are manufactured from ingredients with a low risk of BSE / TSE. These raw materials can be identified by the declaration of the respective pharmacopoeias, the brand Emprove®, the E-Number or the FCC.

Laboratory Applications

In order to minimize the risk of exposure to BSE/TSE in laboratories, Merck has developed granulated culture media. They minimize the formation of dust and reduce the spread of powder, thus reducing the risk of inhalation or lab contamination.