Name of the Supplier : ___________________________________
Address : ___________________________________
Telephone No. : ____________________________________
Contact Person : ____________________________________
Material Supplied : ____________________________________
1. Does the material to be supplied have any animal derived ingredients? YES NO
2. If yes, which animal species it is derived from?
3. Is the animal a ruminant?
(Refer to Note 1 below for a definition and list of ruminant animals)
a) If the animal is ruminant , answer to the following:
From which tissue of the animal, the ingredient is derived?
(Examples: Lungs , Intestines , Brain, Liver ,Spine , Skin , Bones , Blood , Serum , etc)
b) Is the animal from which the material is derived born/brought up / slaughtered in a BSE /TSE risk country as listed by logriatory antharhes USFDA/MHRA/ Canadian
c) Is the material manufactured in a BSE / TSE risk country?
(Refer Note 2 below for list of BSE / TSE risk countries as published by USFDA.
d) Do you have documentation or access to documentation tracing the animals used in the production of the material to its source country, farm, and individual animal identification tag?
e) Do you have a certificate of animal origin issued by your country’s responsible Government Agency?
If Yes attach a copy
4. Is the material to be supplied manufactured in a facility where BSE/TSE risk materials are also processed?
If yes, how would you ensure there is no risk of cross –contamination?
5. During manufacturing of supplied material, have any material of animal origin /TSE non complaint been used as a processing aid?
6. XXXXXX company require to advice immediately in witnessing, if any of the above circumstances change?
7. You are committing to re-affirm on at least annual basis that the above conditions will not change?
8. You will provide a statement of compliance to TSE / BSE on with every delivery (COA)?
Section 589.2000(a) (7) of the Federal Register defines “ruminant” as including “any member of the order of animals which has a stomach with four chambers (rumen, reticulum, omasum and abomasums) through which feed passes in digestion. The order includes, but is not limited to cattle , buffalo , sheep , goats, deer , elk and antelopes”
Countries / areas affected with BOVINE SPONGIFORM ENCEPHALOPATHY (BSE):
- 9 CFR 94.18
Republic of Slovakia/ Slovenia
United Kingdom (UK) [includes Great Britain (England , Scotland , Wales and isle of man ],Ireland, Northern Ireland and the Falkland islands]
#3. Countries that are considered to have a substantial risk associated with BSE due to:
Lack of implementation of an adequate surveillance program, or
Potential of disease exposure/ introduction , or
Uncertainty of status because insufficient information is available to conduct a full risk assessment
Former Yugoslav Republic of Macedonia
Republic of San Marine
Federal Republic of Yugoslavia
Signed , for and on behalf of :
Company Name :
Designation : Date :
(To be filled by XXXXX company)
Review & Comments by QA:
Name , Signature & Date