How to get a BSE/TSE (Prion Diseases) Declaration

O

orangeisenergy

#1
My company received a supplier questionnaire from a European company that buys our products. In this questionnaire it asks if we have a BSE/TSE Declaration available. We do not have a declaration, and don't know what the process is to get one... can anyone help?

Thanks!
 
Elsmar Forum Sponsor
O

orangeisenergy

#3
Re: How to get a BSE/TSE Declaration

bovine spongiform encephalopathy (BSE) - aka mad cow disease
Transmissible spongiform encephalopathies (TSEs), also known as prion diseases, are a group of progressive conditions that affect the brain and nervous system of many animals, including humans.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
My company received a supplier questionnaire from a European company that buys our products. In this questionnaire it asks if we have a BSE/TSE Declaration available. We do not have a declaration, and don't know what the process is to get one... can anyone help?

Thanks!
Basically, if you have no ingredients / components from animal origin it's pretty simple. Just draw a general declaration and have a relevant senior director sign and date, and that's it.
 
O

orangeisenergy

#5
We do use ingredients of animal origin but they are ingredients in agar, and do not contact people in any way. We are trying to get our suppliers to give us declarations, but they say that they are not needed in the US, only if the product is exported. Also, they said that they are not needed on any products that are not from bovine, but our customer wants it for all animal products, not just bovine.

What I am looking for now, I guess, is a guidance or resource that says what defines the product being ok - country of origin, testing results, species, some sort of risk assessment, etc. :confused:
 
O

orangeisenergy

#7
Thank you for that guidance material, that will be helpful.

It still doesn't (that I can easily find) tell me what constitutes product being acceptable & that we can write a declaration that it is BSE/TSE free - to our knowledge. I believe the country of origin of the product is main determining factor (i.e. the origin of the sheep's blood we use is the USA, therefore it is accepted), but I want to see this written before I take our supplier's word for it...
 

Ajit Basrur

Staff member
Admin
#8
Thank you for that guidance material, that will be helpful.

It still doesn't (that I can easily find) tell me what constitutes product being acceptable & that we can write a declaration that it is BSE/TSE free - to our knowledge. I believe the country of origin of the product is main determining factor (i.e. the origin of the sheep's blood we use is the USA, therefore it is accepted), but I want to see this written before I take our supplier's word for it...
I think this EMEA document will answer your questions - Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)
.

This document does talk about the geographical sourcing and GBR (Geographical BSE Risk)
 

Attachments

apuigvert

Involved In Discussions
#9
Do you know if MEDDEV 2.5-8 is still valid? I cant find it on the official EU webpage, but I couldn't find a replacement document either. Seems strange that there is no guidance about animal origin raw material.

Thanks!
 
Thread starter Similar threads Forum Replies Date
J Does anyone have experience in submitting TSE Dossiers to EDQM? EU Medical Device Regulations 1
Top Bottom