Technical Bulletin

German Safety Rating

The German Federal Institute for Medical Supplies and Medicinal
Products’ Federal Bulletin No. 40, February 26, 1994, (updated
September 25, 1995), “Guidelines on Safety Measures in
Connection with Medicinal Products Containing Body Materials
Obtained from Cattle, Sheep, or Goats for Minimizing the Risk
of Transmission of BSE and Scrapie,” outlines a specific
quantitative method for evaluating the risk of transmissible
Spongiform Encephalopathy (TSE) in biological products. This
guideline is commonly referred to as the “German Safety
Rating.” The method determines the level of risk for each of
the 6 factors associated with biological products manufactured
with or containing animal-derived components.
The “Safety Rating” determines the negative of the log base10
risk reduction for each of the 6 risk factors. The sum of the
logs of the 6 factors predicts the log reduction in risk of the
product in comparison to a product that carries the highest
potential risk. If the sum of the logs is 20 or higher, the product
is considered safe. If it is less than 20 then it cannot be sold
in the German market. The Safety Rating has become a useful
tool in assessing the relative risk or safety of these products.
The table below lists the 6 German Safety Rating risk factors
and their classification acronym. Also listed in the table is the
rating for SAFC Biosciences’ bovine serum sourced from both
the USA and Australia. It should be noted that only 3 of the 6
factors can be applied directly to a raw material of a biological
product. Also, the serum rating only applies to serum used in
the manufacturing of these biological products. If other animal-
derived components used in the process have a lower Safety
Rating, then that rating applies to the final product. For
example, SAFC Biosciences’ fetal bovine serum rates 8 points
for the MAT classification. However, if another component
of the product has a rating of 7 points for the MAT classification
then the 7 points apply toward the total safety rating.

SAFCB Bovine Serum SAFCB Bovine

Classification Definition
USA Serum Australian
HRK Country of Origin 7 8
MAT Starting Material 8 8
ABR Inactivation/Removal BSE Pathogens 0 0
Quantities of Animal materials required to provide
APT N/A N/A
one Daily Dose
ANZ Number of Daily Doses N/A N/A
APL Route of Administration N/A N/A

N/A = Not Applicable

For more information about this subject or other SAFC Biosciences’ products and services, please contact our Technical Services
department.

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SAFC Biosciences SAFC Biosciences SAFC Biosciences
13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive
Lenexa, Kansas 66215
USA
Phone +1 913-469-5580
Andover, Hampshire SP10 3LF
UNITED KINGDOM
Phone +44 (0)1264-333311
Brooklyn, Victoria 3025
AUSTRALIA
Phone +61 (0)3-9362-4500
www.safcbiosciences.com
Toll free-USA 1 800-255-6032 Fax +44 (0)1264-332412 Toll free-AUS 1 800-200-404
Fax +1 913-469-5584 Fax +61 (0)3-9315-1656
 Warranty, Limitation of Remedies
SAFC Biosciences warrants to the purchaser for a period of one year from date of delivery that this product conforms to
its specifications. Other terms and conditions of this warranty are contained in SAFC Biosciences’ written warranty, a
copy of which is available upon request. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED
WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXCLUDED. In no case will SAFC
Biosciences be liable for any special, incidental, or consequential damages arising out of this product or the use of this
product by the customer or any third party based upon breach of warranty, breach of contract, negligence, strict tort,
or any other legal theory. SAFC Biosciences expressly disclaims any warranty against claims by any third party by way of
infringement or the like. THIS PRODUCT IS INTENDED FOR PURPOSES DESCRIBED ONLY AND IS NOT INTENDED FOR
ANY HUMAN OR THERAPEUTIC USE.
Additional Terms and Conditions are contained in the product Catalog, a copy of which is available upon request.

© 2005 SAFC Biosciences

Issued December 2005 XT033

0103

United States Europe Asia Pacific

SAFC Biosciences SAFC Biosciences SAFC Biosciences
13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive
Lenexa, Kansas 66215 Andover, Hampshire SP10 3LF Brooklyn, Victoria 3025
USA UNITED KINGDOM AUSTRALIA

www.safcbiosciences.com Phone
Toll free-USA
Fax
+1 913-469-5580
1 800-255-6032
+1 913-469-5584
Phone
Fax
+44 (0)1264-333311
+44 (0)1264-332412
Phone
Toll free-AUS
Fax
+61 (0)3-9362-4500
1 800-200-404
+61 (0)3-9315-1656