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.

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.

Revision date: 2023-04-03

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