Handling of animal by-products
All products from the animal kingdom not intended for human consumption and not yet processed as manufactured products, are defined as animal by-products* (often abbreviated as "abp")
Within research activities this pertains to, for example, proteins (over 10 kDA), certain antibodies**, cell cultures, and serum that have an animal origin. Also other tissues as well as whole or parts of dead animals (e.g. organs from laboratory animals) are included.
All animal products are not, however, covered by this regulation***.
Example of what is NOT covered by the regulation for animal by-products:
- Eggs, embryos and sperm intended for breeding (separate permit needed)
- CE-certified products are considered as non-contagious and are exempted from the rules (the company has responsibility for protection against contagion)
- Use of dead wild animals, or parts of wild animals, that are not suspected to be infected with diseases which can be transmitted to humans or animals
Use of animal by-products for research purposes
In order to use animal by-products and products manufactured thereof for research and diagnostic purposes, one must be granted a permit for this from the Swedish Board of Agriculture. One purpose is to ensure traceability.
If your facility gets an inspection from the Stockholm County Board (Länsstyrelsen) you must show that you store, dispose of and destruct the animal by-products in a safe way. Most professional labs already fulfill these requirements.
Import of animal by-products for research and educational purposes
Many street addresses, animal facilities and departments at KI campus Huddinge and campus Solna are already registered as physical entities which may handle and store animal by-products for research purposes (not diagnostics). Contact your local department for more information.
You must hold a permit for receiving animal by-products in research BEFORE the shipment is sent to you.
Apply for the permit here. Payment is by invoice.
You must hold a permit for handling animal by-products in research BEFORE the shipment is sent to you. This permit applies to the physical buildings/addresses where you will work with your animal by-product material.
Apply for the permit here. Payment is by invoice.
Receiving animal by-products from countries outside the EU, Norway, Iceland and Switzerland requires an import permit (imports from the EU as well as Norway, Iceland and Switzerland does not require a permit).
Apply for the permit here. Swedish "Bank ID" app is needed for login. Payment is by card.
Keeping records of received shipments
A continuous record of shipments must be kept and presented during an inspection. You must therefore always note:
- sender and country of origin
- type of animal by-product
- your department
For all types of import there must be a trade document in original, issued by the sender, together with the transport. The trade document is to be saved by you, the recipient, for at least two years. Note that this requirement applies both to national and international transports.
Export of animal by-products for research or educational purposes
A trade document in original, issued by you, has to be included with the shipment. This applies to animal by-products for both national and international transports. Other rules may be applicable for recipients in lands outside the EU, which must be determined before exporting. Note that the recipient can refuse to accept the product if the trade document is lacking.
Only the standardized trade documents downloaded from the Swedish Board of Agriculture's website can be used.
During transport a label must be attached to the container or vehicle stating:
- Which risk category of material the shipment belongs to (Category 1, 2 or 3)
- An easily legible text on the container or vehicle with the text: “For research and diagnostic purposes”
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*Regulated by Regulation EG No 1069/2009 as well as the Swedish Board of Agriculture's Regulation SJVFS 2011:21.
**Affinity-cleaned antibodies are not considered as animal by-products and are not regarded as animal by-products.
***Read more on what is not covered by the regulations (Article 2 EG No 1069/2009).