Using products from animals in research and for diagnostics
A permit is required to carry out research on samples that are wholly or in part animal by-products, or to carry out diagnostics such as examining blood samples or conducting post-mortem examinations on animals. In many cases, a permit is also required to use animal by‑products or derived products in research or diagnostic activities.
Using animal products in the context of research or diagnostics
There are many different types of animal products that are used as an aid in research or diagnostics. Such products include blood, serum, plasma, and antibodies. These are normally commercial products. They are used in some cases as they are but are often also part of media for e.g. cell cultures or antibodies or are part of an analysis kit. A commercially available product on the market in the EU must always come from an approved establishment, and this means that no specific permit is required to use that product. However, special requirements apply to imports from other countries, whether or not the products are commercial.
If you are using so-called intermediate products
Intermediate products are products which, at the time of import, can be regarded as derived products, even if they have only been cleaned and not processed. The products are to be used in the manufacture of e.g. pharmaceuticals, medical devices, laboratory reagents, or cosmetic products. They may be used in the production of the end product in itself, or as part of e.g. verification of a manufacturing process or quality control. In order to be called an intermediate product, the product in question must be considered a derived product and must be usable directly or as a component in a product. However, there must always remain a need to process the product further, e.g. that it needs to be mixed, surface treated, assembled or packaged, in order to be suitable for marketing or use.
Intermediate products must pass a veterinary border control when they are brought into the EU. This, however, requires no accompanying veterinary certificate. Instead, the recipient must fill in and present a declaration at the border control post.
To use intermediate products, your activities must be registered with the Swedish Board of Agriculture. You register your activities with a form.
Products in an animal media
Purified antibodies or cell cultures which are in an animal media always require an import permit. You can apply for a permit in our e-service. The application must have been submitted to the Swedish Board of Agriculture at the latest 30 days before the product arrives in Sweden.
You need a permit to use the product
If you want to receive animal by-products, e.g. in the form of blood from an abattoir or from living animals, you must have a permit from the Swedish Board of Agriculture. You can apply for a permit on a form.
If you are importing, among other things, blood products, the products must have a veterinary certificate and they must pass a veterinary border control when they arrive in Sweden.
Carrying out research or diagnostics on animal materials
If you are going to carry out research or diagnostics on animal materials, e.g. on blood samples, or on whole or parts of dead animals, you must register these activities with the Swedish Board of Agriculture. In most cases, you will also need a permit from the Swedish Board of Agriculture.
You may use the following products for research or diagnostics without a registration or a permit:
- whole or parts of wild animals which you do not suspect may pose a risk of infection
- materials which were generated at the farm or research institution where you are carrying out the research or diagnostics
- derived products of category 3
- products which are fully embedded on slides
- processed DNA samples.
Register your activities and apply for a permit
You register your activities with a form.
In addition, you will need a permit for the activities in themselves. The application is subject to a SEK 500 fee. You apply for this permit using a form.
Unless you state that this is a purely temporary activity, we typically give permits valid for three years.
We will send you a confirmation of your registration together with your permit. Remember to cancel the registration if you cease with these activities.
Materials from other countries
If the products come from countries outside the EU, Norway or Switzerland, you must have a permit to bring them into Sweden. This also applies to several of those products which do not otherwise require registration or permits to use. The permit must, either in the original or a copy thereof, accompany the consignment from the sender to the receiving establishment. However, the products do not need to pass a veterinary border control in Sweden if they come directly from the country of dispatch.
You can apply for a permit in our e-service. The application must be received by the Swedish Board of Agriculture no later than 30 days before the material comes to Sweden.
If you do not already have a permit for the use of the material, you can apply for it when you apply for the import permit using the e-service. These activities are registered using a form.
Products sent to Sweden from a country outside the EU via another EU Member State
If you receive samples from a country outside the EU, Norway or Switzerland, and these are transported via another EU Member State, or Norway or Switzerland, before arriving in Sweden, the samples must be presented to a border control post in that country together with the import permit in the original or a copy thereof. The Swedish Board of Agriculture only issues import permits in Swedish. There may be delays if the border control post requires an import permit in the language of the country in question. In this case, you may hire a certified interpreter to translate the import permit. In individual cases, the Swedish Board of Agriculture may be able to confirm that an import permit has been issued for the consignment.
Product samples
If you are importing product samples, they are normally to be accompanied by a veterinary certificate or pass a veterinary border control.
Rules for research or diagnostic activities on animal by-products
When you research or carry out diagnostics on animal by-products, you must
- maintain good hygiene by ensuring that premises and equipment can be cleaned and disinfected
- ensure the premises are free of pests
- avoid risks of contamination
- keep records
- handle any remnants in a correct fashion.
You must observe good laboratory practice and take appropriate measures to ensure that the handling does not risk the transmission of diseases to people or animals.
You may store the samples for the purpose of reference for the period for which the permit is valid.
Any other use is prohibited
The use of the materials for purposes other than research and diagnostics, or any related teaching or instruction, is prohibited.
Produce documentation
The material which you receive must be accompanied by at least one document or referral specifying the following:
- description of the material and the species of animal from which it is derived.
- the category of the material.
- the amount of material.
- the place of origin and the place of dispatch of the material.
- the name and address of the sender.
- the name and address of the recipient and/or user.
The sender may use a commercial document instead.
Take care of the remnants
No matter which country the material comes from, it can always be incinerated in a waste incineration plant registered by the Swedish Board of Agriculture for incineration of that category of material.
You must draw up a commercial document, and this document must accompany the material. The original and one copy thereof must accompany the material. You must retain a copy of this document for two years.
Materials coming from the EU, Norway or Switzerland can be treated under conditions at least equivalent to the validated method for steam sterilisation, and then disposed of as waste or waste water in accordance with environmental legislation if:
- the products in question are of category 2 or 3 or some types of products of category 1
- the products are included in cell cultures, laboratory batches or laboratory samples.
Detailed information about the validated method for steam sterilisation can be found in the document Detailed rules for research and diagnostics on animal by-products. That document also sets out the rules for how you must handle the remnants if the material originated in another country.
All types of materials may be processed in an approved processing establishment which applies pressure sterilization. However, there is no such establishment in Sweden.
The remnants of derived products of category 3 can be handled as waste in accordance with environmental legislation. Please contact your municipality for more information about this.
If you wish to send the remnants onward, the recipient must have the permits required to receive and handle the material. If you wish to send the remnants to another country, there may be rules in the destination country which must be followed.
Transport
If you are transporting the material yourself, you need to apply for a permit to do so. You can do this in conjunction with applying for an import permit or a permit to receive the products.
In any other case, the transporter must be registered with the Swedish Board of Agriculture as a transporter.
Some test samples and diagnostic materials may be considered dangerous goods or hazardous waste.
Control
The purpose of the control in the area of animal by-products and derived products is to ensure that products are handled in accordance with current regulations in order to prevent and minimise risks to public and animal health, and in particular to protect the safety of the food and feed chain.
It is the operator that are responsible that handling of animal by-products and derived products are safe. The competent authority’s role is to assess whether the operators succeed with that. After the control, we will send you a report where you can see the results of the control and what may be required from you.
The fee for the official control depends on how often your business will be inspected. The control frequency is depending on type of activity and risk class. Before each year, you will receive a letter where you can see your fee.
If you have questions regarding fees or control, please contact us.