QUESTIONNAIRE FOR SCREENING OF SUPPLIER FOR TSE/BSE RISK

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)
 YES  NO
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.
 YES  NO

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
 YES  NO

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?
 YES  NO

5. During manufacturing of supplied material, have any material of animal origin /TSE non complaint been used as a processing aid?
 YES  NO

6. XXXXXX company require to advice immediately in witnessing, if any of the above circumstances change?
 YES  NO

7. You are committing to re-affirm on at least annual basis that the above conditions will not change?
 YES  NO

8. You will provide a statement of compliance to TSE / BSE on with every delivery (COA)?
 YES  NO

Note 1:
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”

Note 2:
Countries / areas affected with BOVINE SPONGIFORM ENCEPHALOPATHY (BSE):
- 9 CFR 94.18

Austria
Japan
Belgium
Liechtenstein
Czech Republic
Luxembourg
Finland
Netherlands
France
Oman
Germany
Poland
Greece
Portugal
Ireland,
Republic of Slovakia/ Slovenia
Israel
Spain
Italy
Switzerland
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

Andorra
Former Yugoslav Republic of Macedonia
Albania
Monaco
Austria
Republic of San Marine
Bosnia –Herzegovina
Norway
Bulgaria
Poland
Croatia
Romania
Federal Republic of Yugoslavia
Slovak republc
Finland
Slovania
Hungary
Swaden

Signed , for and on behalf of :

Company Name :
Name :
Signature :
Designation : Date :

OFFICE STAMP


(To be filled by XXXXX company)

Review & Comments by QA:
Name , Signature & Date