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 abp) (1).
Within research activities this pertains to, for example, proteins (over 10 kDA), certain antibodies2, 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 regulation3. Examples of what is not covered:
- 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 that can be transmitted to humans or animals.
- Eggs, embryos and sperm intended for breeding.
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 Agriculture4. One purpose is to ensure traceability.
Karolinska Institutet is registered as a facility for handling of animal by-products for research purposes (not diagnostics) and has a permit for use of these.
The permit is available by e-mailing Comparative Medicine at firstname.lastname@example.org.
Import of animal by-products for research and educational purposes
No import permit is required for import from the EU as well as Norway, Iceland and Switzerland. The transporter must, however, be approved for transporting animal by-products.
For import from countries outside the EU, Norway, Iceland and Switzerland, an import permit is required. Karolinska Institutet has an import permit for samples from mice, rats, pigs, rabbits, hamster, guinea pigs and zebrafish from USA, Canada, Taiwan, Japan, Singapore, China, Russia, Israel, Australia and South Africa.
A time-limited copy of the permit for single imports can be sent to you upon request; e-mail Comparative Medicine at email@example.com. Institutions/groups at KI may also have their own import permits for frequent imports.
The permit requires that Karolinska Institutet/Comparative Medicine keep a continuous register of these imports, which upon request are to be shown to the Swedish Board of Agriculture. You must therefore indicate:
- sender and origin country
- 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.
Please send a copy of the received trade document to Comparative Medicine, firstname.lastname@example.org, after receipt of the shipment.
Export or send animal by-products for research or educational purposes
A trade document in original, issued by you, has to be included with the shipment. The recipient of the products must save the trade document for two years. 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. A copy of the completed trade document shall then be sent to email@example.com.
During transport a label must be attached to the container or vehicle stating:
- Which 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”
1Regulated by Regulation EG No 1069/2009 as well as the Swedish Board of Agriculture's Regulation SJVFS 2011:21.
2Affinity-cleaned antibodies are not considered as animal by-products and are not regarded as animal by-products.
3Read more on what is not covered by the regulations (Article 2 EG No 1069/2009).
4Research with animal byproducts that have been produced within an animal facility are not covered by this if the usage is contained within the animal facility.