Background

The Swedish Board of Agriculture (SJV) requires a licence for the use, import and transport of animal by-products for research and diagnostic purposes. One background to the rules is the need to ensure traceability. Stockholm University has obtained a general licence from SJV for the import and use of animal products and by-products for research purposes. The University must keep a continuous import register that can be presented on request. A complete list of products imported must be sent to SJV every six months.

Definition: All products from the animal kingdom that are not intended for human consumption are defined as animal by-products and are regulated in Regulation (EC) No 1069/2009 of the European Parliament and of the Council. This includes proteins (excl. antibodies, cell cultures or other proteins that are affinity-purified and are placed in a salt water solution) and animal-origin serum.

CE-certified products are counted as finished products and are exempt from the provisions, as are entire bodies or parts of Swedish wild animals (incl. wild-caught fish that is not bearing any communicable disease).

Third-country import: All import from a third country, i.e. outside the EU, Norway, Iceland and Switzerland, must be accompanied by an import permit and a commercial document (issued by the sender). A copy of the commercial document must be sent to Mats Hansson at the Safety Section (08-16 22 51,mats.hansson@su.se). The original must be retained by the recipient for at least two years.

Import within the EU/transport: No import/entry permit is required to bring in research material within the EU, but the carrier must be approved for this and a commercial document must accompany the material. When transported, samples for research and diagnostic purposes must be marked "For research and diagnostic purposes". Export consignments may need to be marked in another language depending on the receiving country.

Commercial document

The sender must ensure that samples for research and diagnostic purposes are accompanied by a commercial document in accordance with Commission Regulation (EU) No 142/2011, which shall specify the following:

  • a description of the material and the animal species of origin
  • the category of the material
  • the quantity of the material
  • the place of origin and the place of dispatch of the material
  • the name and the address of the sender, and
  • the name and the address of the recipient and/or user

The commercial document is available on the website of the Swedish Board of Agriculture.

Classification/separation

Animal products/by-products are divided into three different categories on the basis of a risk assessment, where category 1 is considered to be the greatest risk and category 3 the least risk to human and animal health. Some examples are given below:

Category 1: Entire bodies or body parts of animals suspected of being infected by a TSE (Transmissible Spongiform Encephalopathy). Animals that have ingested prohibited or hazardous substances. Laboratory animals used in experiments, wild animals suspected of being infected with diseases communicable to humans or animals. Specified risk material (defined according to Article 3.1 (g) and Annex 5 of EC 999/2001).

Category 2: Droppings and digestive tract content of production animals. Animals that do not belong to category 1 and have not been slaughtered for human consumption (e.g. died in an accident). Laboratory animals that have not been used for experiments, with the exception of domestic game not deemed to be infectious.

Category 3: Parts of slaughtered animals that are fit for human consumption but are for commercial reasons not intended for human consumption. Parts of slaughtered animals rejected as unfit for human consumption, but which do not show any signs of communicable diseases. Animal by-products obtained in the production of products intended for human consumption.

Handling/storage

Users handling and storing samples for research and diagnostic purposes shall take all the necessary measures to avoid the spread of diseases that can be communicated to humans or animals, primarily by observing good microbiological practice (according to AFS 2005:1).

Non CE-marked animal products/by-products for research and diagnostic purposes and those originating from the use of such products shall, if they are not saved for reference purposes or returned to the third country of origin, be disposed of in the following way:

  • Animal products from the EU, Norway, Iceland and Switzerland can, after autoclaving, be treated as household waste and be poured out in a sink. Alternatively they can be disposed of by combustion.
  • Animal products/by-products from a third county can, after autoclaving, be treated as household waste and be poured out in a sink if the volumes are not in excess of 2000 ml and they originate from a country from which the EU permits the import of fresh meat (list in EU 206/2010, Part I, Annex II). Alternatively they can be disposed of by combustion.
  • Other products including animal carcasses are disposed of by combustion. Category 1 products that contain or are suspected of containing infectious organisms shall, if possible, be treated so that the pathogenic organisms are inactivated before the products are handed over to the approved waste contractor.

Animal products/by-products for combustion must be packed in yellow plastic containers (SU Shop article no 6342-030 or 6342-050) intended for this purpose and immediately be deposited with the waste contractor. The waste may be held in intermediate storage in a refrigerator (max + 8 C) for 1–5 days; for storage for more than 5 days freezer-storage is required. Storage may take place at the department concerned.

The Animals Section has its own handling procedure for waste, e.g. cage material, dead animals and organs. For more information see the special document obtained via the Animals Section.

Marking/labelling

Stockholm University waste label filled in with:

  • Special storage: refrigerator or freezer?: (x)
  • Type of waste, specification: “Animal products/by-products” and specification
  • Submitting department, department number and reference
  • Submitter’s name, phone no and date

Animal products that have been inactivated and classed as household waste must NOT be marked.

Hand-over/transport

Waste can be deposited on Wednesdays or Fridays at 10.30-11.00 in room M212 at KÖL (Chemical Education Laboratories), Svante Arrhenius väg 16F. If refrigerator/freezer storage is required, waste may only be deposited on the same day that the carrier has for collection. Contact the University´s waste contractor for hazardous waste to decide a date. The waste contractor then transports the waste for destruction.

Final disposal

Combustion arranged by the waste contractor.

Specific legislation

EC 1069/2009     Regulation of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 177/2002 (Animal by-products Regulation)

EU 142/2011     Commission regulation implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

SFS 2006:805      Act on Feed and Animal By-products

SFS 2006:814      Ordinance on Feed and Animal By-products

SJVFS 2006:84   Involvement with Animal By-products and the Import of Other Products, apart from Products for Human Consumption that can Spread Communicable Diseases to Animals

SJVFS 2007:21   Public Control of Feed and Animal By-products

Futher information is available at:

http://www.jordbruksverket.se/amnesomraden/djur/produkterfrandjur/